What's he done now?

Holy fucking crap. I am so sorry.

Having read Patrick's additional comment, I understand Teresa's anger perfectly. Nader alone isn't to blame for this sort of thing. A friend of mine is married to a wonderful woman who has MS, and is in constant pain. The only thing that works to control the pain is Oxycontin, but that is now almost completely unavailable to people who need it because the DEA believes its more important to ban a drug that is abused than consider the lives of those who need it.

WHAT!?!?!?!?! I'm running out of Cylert in two days! I take it for ADHD...and I can't take anything else, because they all cause heart palpitations, and I have tachycardia. God damn Ralph fucking Nader to a thousand nameless alkaline hells!

I'm going to lose my job. There's just no way I can keep it with no medication.

Or I can take one of the other things anyway, and be at risk of a heart attack. If I die of a heart attack in the next few years, you can blame Ralph Nader. Ditto if I freeze to death in the street.

How come my fucking pharmacy didn't tell me this med was being discontinued?

This is unbelievable. Ralph Nader is one of the most misguided men in America.

This link gives you Public Fucking Citizen's comments:

http://www.yourlawyer.com/topics/overview/cylert/

Here's a quote:

Reports given to the FDA show that at least 193 patients have suffered serious consequences from the drug, said Dr. Peter Lurie, deputy director of the group, Public Citizen. "This is an outmoded drug," he said, "and there is no reason for it to be still on the market. Generic companies sell copycat versions of the drug under the name Pemoline.

Public Citizen asked the U.S. Food and Drug Administration to ban Cylert and its generic competitors immediately. Generic companies can still sell their versions even after Abbott pulls the medicine, unless the FDA determines the drug was withdrawn for safety reasons. Britain and Canada removed the drug from the market, but the F.D.A. instead twice chose to stiffen warnings on the drug's label, the petition said. In 1996, the agency sent a letter to Abbott saying that the drug's marketing could continue "if and only if a good faith effort is made on your part to collect the data necessary" to measure the drug's risks.

Thank you Dr. Lurie! Let me know if I can do you a favor someday!

Here's a quote from Narcolepsy Network (one of the links Patrick gave):

In a statement today [27APR05], Sharon Smith, President of Narcolepsy Network, said, "Even with treatment, narcolepsy limits patients in every aspect of their lives. A ban on Pemoline will have a tremendously negative impact on those narcolepsy patients who cannot tolerate other agents. Tolerance levels for risk associated with a medication are tied to the existence of alternatives and the consequences foregoing treatment. Without a medication to relieve excessive daytime sleepiness, these patients will no longer be able to function well enough to continue their present daily activities. No life event is as devastating and far-reaching as the loss of one's ability to function. A ban on Pemoline will force individuals to resort to disability. They and their family members will suffer the economic consequences of a significantly reduced income and loss of medical and retirement benefits. Others will no longer be able to achieve sufficient wakefulness to accomplish the ordinary tasks essential to independent living and will become burdens to their families, the Social Security, Medicare and Medicaid Systems and to society in general. The ADHD population has many alternative medications from which to choose."

...

"We should all write letters," she says, "to let them know that there are usages for Pemoline other than ADHD, and to insist they not leave individuals with narcolepsy and idiopathic hypersomnia in the intolerable situation of having no treatment at all. Everyone needs to write. If we don't, we have only ourselves to blame."

As I pointed out, not EVERYONE in the ADHD community has good alternatives.

Needless to say, we were entirely blindsided by all this news, as (obviously) was Xopher.

Hard though it may seem to believe, Teresa doesn't find her narcolepsy the most interesting thing in the world, and she doesn't type the names of her medications into the search box in Google News first thing every morning. Perhaps we should have been on the Narcolepsy Network's mailing lists, but we weren't.

Trying to figure out what to do now.

Have you tried Modafinil? That seems to be the most promising narcolespy treatment in years.

Suggestion:

Find a friendly lawyer who works on contingency.

Sue Public Citizen. Sue Abbott Labs. Sue the FDA.

I'm so sorry to hear this, Teresa, Xopher -- I've got ADHD myself, but the other meds work well enough for me (when I remember to take them) that I'd never tried Cylert. Good luck to you and your doctors in finding the next best weevil!

Oh, wow. I'm sorry.

Until now I used to think that my conservative Republican dad's vitriolic anti-Nader rants were the product of residual bitterness stemming from a run-in he had with Nader and Public Citizen 25 or so years ago (my dad ran our town's water and sewer system, and IIRC Nader and his boys came to town claiming that there was excessive mercury in our water supply; when he didn't find any evidence to support his much-publicized claims, as the story goes he literally slipped out of town in the dead of night and never spoke of it again, even to retract his claims).

Now I'm pretty sure my dad wasn't embellishing after all.

I'm going to bed now. I hope I dream about pounding little tiny nails into Ralph Nadir's stupid head, until there's a little Chia Pet forest all over it, and then winding string in and around all the nails, this way and that, and then, all at once...yank.

Jon, Teresa has been taking Modafinil (Provigil) for years. It's great but it's not, for her, effective all by itself.

I'm presuming we all understand that, scientifically, "narcolepsy" is still a big fuzzy reification--a cloud of symptoms that occur more or less together in a bunch of people. It's not something well-defined like "measles" or "the flu." Different people respond differently to different treatment regimens, for reasons far from entirely understood.

Thanks, Jim, but: Public Citizen just expressed its opinion, and we still have freedom of speech in this country, at least for a few more weeks, until the President decides he can just revoke that by Executive Order. Besides, a successful lawsuit against them, justified as it is, will spawn thousands of lawsuits agains legitimate public safety organizations.

Can't sue a manufacturer for discontinuing a risky (or even just unprofitable) product. Besides, they didn't have a choice: FDA came down on them, the idiots.

Suing the FDA...well, if I believed in American justice it might be worth a try, but: George Bush is in the White House, rather than in prison where the traitor belongs. Therefore American justice is a sham and a failure. So no go.

It's a lousy thing, and I hope Nader and Public Citizen hear from a lot of people about it. I also hope the makers of the drug hear from people; I don't know if letter-writing will help in a campaign to bring it back, but it might.

The medical is political.

*sigh*

I'm really sorry, Teresa. As you know, it doesn't hit me personally since my transition off Cylert a little while ago, but if I were still taking it, I'd be livid right beside you. I still pretty much am, though on behalf of you and others.

Will have my thinking cap on; if I come up with something, I will tell you.

Public Citizen didn't just express an opinion: They launched an active campaign to get the drug banned, and were successful at doing so.

They should be held accountable.

I will avenge you. I'm training my army of black goats to eat human testicles. At his next public appearence I'll unleash my goats. He will suffer greatly!

This really sucks. Can the drug be imported from another country, semi-legally?

It appears to be available in Belgium through Celltech.

I already take Modafinil, a.k.a. Provigil. It doesn't do what Cylert does. Neither does Ritalin, nor Dexedrine, nor Adderal. Those are all good drugs. I can function on any of them -- when taken in combination with Cylert.

Xopher and I and god knows how many other people with narcolepsy, ADHD, and other tricksy neurochemical impairments are looking at THE END OF OUR FUNCTIONAL WORKING LIVES.

Peter Lurie did his residency in Family Practice and Preventive Medicine. The fact that he's got the Narcolepsy Network screaming in protest over this action should tell you how wrong he is when he dismisses Cylert as "an outmoded drug." That man has no idea what he's talking about. He can't have asked the narcoleptic community; they'd have told him right off that for many of us, there's no other drug that substitutes for Cylert. This is gross professional irresponsibility. Lurie ought to have his license yanked.

I've been stunned, frozen in panic and horror, since just before Christmas. I went in for a routine refill of my prescription, and instead got this news. I've spent Christmas and New Year's watching my supply dwindle, feeling like I should be setting my affairs in order.

More info, Kevin?

My sympathies.

First thing to do is contact your doctor, who may be aware of alternative sources. I think...if there is anywhere in the world where the stuff is still available (and I think there is), an emergency trip is probably in order.

I assume Kevin is referring to this page, which is a listing of Celltech's products. It doesn't say anything except that they manufacture pemoline and sell it in Belgium. Celltech was purchased recently by UCB Group, whose site does not mention pemoline that I can find, but they don't have a comprehensive product list

Drugstore.com claims to still have pemoline in stock, which might make a good stopgap measure except that as it is a Schedule IV item they have special restrictions on it, among which is that you can't transfer a prescription for it from a New York pharmacy to them.

Gods, I'm sorry.

I'm also confused--the news of the drug's cancellation is from April and March. Shouldn't someone at Teresa and Xopher's pharmacies have warned them and other people with pemoline prescriptions that this was coming? Or are these prescriptions that only get filled once a year, so that this could conceivably be the first time since the ban that Teresa had seen her pharmacist? Even then, there ought to be a mailing or something. Or something from her doctor. Teresa shouldn't have to Google her prescriptions every month to find out about news like this. Heck, the news report said that physicians should be talking to their patients about transitioning them onto other treatments; if the doctors had that news in April, that conversation should have happened six months ago.

Not, it seems, like it would do any good. What is there to transition to, when it's already been determined that there is nothing else? But is some warning from doctors and pharmacists too much for a person to ask for?

Please, is there anything we can do at this late date? Letters to write, phone calls to make?

Teresa, Xopher -- this totally sucks. Sorry. I hope the info from Kevin gets you what you need. We've got a bunch of Canadians hanging out here: is Cylert or its equivalent available up north?

Meanwhile: someone find us all an address to write to or better yet, an e-mail address or six to which we may all send furious but cogent complaints on behalf of our friends.

"Shouldn't someone at Teresa and Xopher's pharmacies have warned them and other people with pemoline prescriptions that this was coming?"

Gosh, one would think.

"Or are these prescriptions that only get filled once a year, so that this could conceivably be the first time since the ban that Teresa had seen her pharmacist?"

No, nothing of the sort.

"Even then, there ought to be a mailing or something. Or something from her doctor. Teresa shouldn't have to Google her prescriptions every month to find out about news like this."

Why, yes.

Lizzy: I'm going to work on finding that address.

Meanwhile, Britain and Canada are no help; they both banned pemoline in 1995.

What happened in March and April was Abbott stopped making Cylert (overall not surprising -- they've been getting out of the CNS stimulant business); other manufacturers continued to make generic pemoline.

The FDA order banning the drug is from October; it went into effect in November, with the word getting out to the people who needed the drug in December as they discovered they couldn't refill their prescriptions.

I suspect Celltech is simply reselling (in Belgium) Sandoz's generic pemoline, and will stop when stocks run out. Yes, of course I'll look into it, but I'm not optimistic.

From the Narcolepsy Network press release:

Smith urges those with disorders of excessive sleepiness, especially those who take brand or generic Pemoline, to call the Network toll-free at 1-888-292-6522 to obtain the names and addresses where they can send letters about their experience with Pemoline in order to preserve this medication option.

The contact info on the press release is:

Eveline Honig, 914-741-5680; evelinevvh@optonline.net

Emailed to Sen. Kennedy and Kerry:
============================

A friend of mine, Teresa Nielsen Hayden, is a narcoleptic. She is functional ONLY because she takes drugs. Cylert has been essential for her, to stay awake, alert, functional, and a productive citizen earning a living and paying taxes.

Ralph Nader's successful campaign to get the FDA to ban Cylert banned is making her a hapless, angry victim and someone who sees dyfunctionality staring her in the face. She's furious. Her husband is furious. Is there ANY way that the FDA's decision can be reversed, to keep her and other who are dependent on that drug to be able to function in society as competent adults with jobs and lives?

http://nielsenhayden.com/makinglight/archives/007140.html#007140 discusses her situation, and another person has commented in the thread that with Cylert he too will not longer be socially functional and will not be able to hold a job anymore.

James: Teresa and Xopher should probably contact Eveline and add their "experiences" to her list. But I think it will not help if their outraged friends call the same number. Can we call the FDA? How about the medical board that certifies whatever specialists deal with narcolepsy -- neurologists? (I don't know and am happy to be enlightened.) They must occasionally reverse this sort of decision because of pressure from Somewhere or Someone. Hell, call your congressman's office, send e-mail, write a letter, all three. And sure, talk to a lawyer who specializes in dealing with the FDA, why not?

Fucking self-righteous busybodies.

I'm not on it, but I have a friend for whom it's the only successful treatment for his ADHD.

I knew him before he started taking it, and without it, it doesn't much matter whether his liver is functioning or not: he hasn't got a life.

I am purely disgusted with this pack of morons.

From the FDA CDER link referenced in the Nat'l MS Society's press release that Patrick linked:

Report serious adverse events to FDA's MedWatch at 1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
Druginfo@cder.fda.gov

If there were some phone calls to that 301 number and some e-mails to the CDER address it might provoke something.

(CDER: Center for Drug Evaluation and Research)

Patrick: Britain and Canada banned Pemoline in 1995, so what are they using instead, and are any of these drugs chemically equivalent to Pemoline? Or, which is more likely, are there any drugs approved in Europe for narcolepsy that have not yet been approved for use in this country? Your doctor might know this. I have no idea how, given the new security regulations, one obtains such drugs, but it used to be doable.The European countries were using ibuprofen products for years before they were available here; it's not uncommon.

You want to know how many cases of liver failure caused by pemoline there have been since 1999 (when the Seriously Scary Warnings about liver failure went on the box?

One.

There's been one case in six years. In a population of about 10,000 people who take the drug.

That's why Public Citizen and the FDA should be forced to explain themselves in open court.

Abbott should be forced to explain why the drug wasn't labeled for narcolepsy.

No recent studies on narcolepsy and pemoline in Medline. Last one appears to be here:

Sleep Med Rev. 2004 Oct;8(5):339-54.

Pharmacotherapy for excessive daytime sleepiness.

Banerjee D, Vitiello MV, Grunstein RR.

Sleep and Ventilation Unit, Department of Respiratory Medicine, Birmingham Heartlands Hospital, Bordesley Green East, Birmingham B9 5SS, UK.

Excessive daytime sleepiness (EDS) has recognized detrimental consequences such as road traffic accidents, impaired psychological functioning and reduced work performance. EDS can result from multiple causes such as sleep deprivation, sleep fragmentation, neurological, psychiatric and circadian rhythm disorders. Treating the underlying cause of EDS remains the mainstay of therapy but in those who continue to be excessively sleepy, further treatment may be warranted. Traditionally, the amphetamine derivatives, methylphenidate and pemoline (collectively sympathomimetic) psychostimulants were the commonest form of therapy for EDS, particularly in conditions such as narcolepsy. More recently, the advent of modafinil has broadened the range of therapeutic options. Modafinil has a safer side-effect profile and as a result, interest in this drug for the management of EDS in other disorders, as well as narcolepsy, has increased considerably. There is a growing school of thought that modafinil may have a role to play in other indications such as obstructive sleep apnea/hypopnea syndrome already treated by nasal continuous positive airway pressure but persisting EDS, shift work sleep disorders, neurological causes of sleepiness, and healthy adults performing sustained operations, particularly those in the military. However, until adequately powered randomised-controlled trials confirm long-term efficacy and safety, the recommendation of wakefulness promoters in healthy adults cannot be justified.

Publication Types:

* Review

PMID: 15336235 [PubMed - indexed for MEDLINE]

Subsequent trials to relabel drugs for conditions other than the ones they were initially approved for are pretty uncommon - they cost a lot of money and don't really buy you anything other than more marketing freedom. And if it's only 10k people taking the drug, and the liver problems came up well into the patent lifetime, it's pretty understandable why Abbott didn't go through the trouble.

Still sucks mightily, and I hope you can find some discount mexican pharmacy or whatnot.

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Sent to Senators Murray and Cantwell, and Representative McDermott (who is a doctor with a psychiatric residency)

In November the FDA, under pressure from Ralph Nader and Public Citizen, banned Cylert and its generic pemoline. Dr. Peter Lurie, deputy director of Public Citizen, said, "This is an outmoded drug and there is no reason for it to be still on the market. " Peter Lurie's residency was in Family & Preventive Medicine - to my knowledge, he is not an expert in psychiatry or neurology which are the specialties which use the drug.

The FDA's release says:
________________

FDA is aware of 13 reports of liver failure resulting in liver transplant or death, usually within four weeks of onset of signs and symptoms of liver failure.  Although the absolute number of reported cases of liver failure with pemoline is not large, the reporting rate for liver failure with pemoline is 10 to 25 times greater than the background rate of liver failure in the general population.

Despite diminished use of Cylert and generic pemoline products since the addition of the boxed warning in 1999 (about 1/5 the number of prescriptions now compared to before the boxed warning) and restrictive labeling (e.g., boxed warning, second line therapy, Medication Guide), a risk of liver failure remains (FDA is aware of 1 new case of pemoline-associated liver failure since the introduction of the boxed warning in 1999).   Given the availability of multiple other drug treatments for ADHD, including 1 that is not scheduled and several products that can be given once a day, FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits.
________________

That's one case of liver failure in 6 years; more people die from various allergies such as milk and peanuts yet we ban neither of these.

There are some ADHD cases who have no other recourse; A close friend of mine has tried every other available drug to treat his ADHD - none of the others works at all. Another friend has tachycardia which is exacerbated by all of the other ADHD effective drugs. If he has to take them, he could die of a heart attack.

And then there are the narcolepsy patitents - some 10,000 of them (one who I know) for who there is no other effective treatment. My friend knows this because she's tried everything else - and none of it worked.

None of these people are taking this drug for fun and games. They are taking it because without it they are crippled and can not lead normal lives. My friends with ADHD can not hold jobs, nor can my friend with narcolepsy. Instead of being productive members of society, they will be disabled and a drain on their families and society.

Most drugs and many things are dangerous when taken improperly; that Cylert/pemoline requires some care in its administration should not be enough to have it banned. Neither should occasional adverse effects; life is full of risks and adults should be free to chose which ones they are willing to take.

I hope that you will have your staff look into this matter and work with the FDA to rescind this poorly considered decision. Thank you very much.

Margaret Organ-Kean Durocher

As I live in Thailand- land of over the counter everything- I will rush right off to my pharmacist and see if I can find any to airdrop to the land-of-the-free.

A stopgap measure to be sure, but better than nothing.

The National Institute of Neurological Disorders and Stroke (NINDS) says in its condensed Narcolepsy fact sheet that it's studying the disorder. If that's the case, its scientists might be interested in knowing that FDA just outlawed one of the treatments.

NIH Neurological Institute
P.O. Box 5801
Bethesda, MD 20824

Voice: (800) 352-9424 or (301) 496-5751
TTY (for people using adaptive equipment): (301) 468-5981

Contacting your politicians isn't enough. Contact media outlets, too. Call your local NPR station and talk to a producer of a local affairs show. Talk to the New York Times.

Clinical trials.gov lists seven studies of narcolepsy treatment, five of which are actively recruiting. Two are looking at Xyrem, two modafinil, one armodafinil.

I have just about had it with the FDA, "consumer safety" crusaders, and the way that fear of litigation has come to override common sense in the US. Bipolar disorder has been being treated with lithium since someone first sorted out that you could effectively treat it with lithium. Sure, other drugs have come about that don't require toxicity monitoring, but for some folks, lithium is all that works. I can't imagine the FDA one day deciding it's become "outmoded" because other BPD drugs don't present a risk of liver problems.

My sympathies, Teresa. I have nothing useful to offer, except to suggest you talk to your doctor and see if s/he can finagle a prescription directly to an internet source like drugstore.com that might be liquidating what they have left of the drug. Maybe you could get a scrip for a few months to fall back on while trying to sort out a more permanent solution and/or storm the FDA and demand justice.

I had something similar but comparatively inconsequential happen when Seldane was taken off the marked and "replaced" by another allergy drug. I've been resigned to sniffling or sleeping (mmmm, benadryl) ever since.

Best wishes.

Harry Connolly has a good idea. Eric Nagourney is one of the NYT's health writers. He might be interested in this. So might Robert Pear, who writes about the intersection of medicine and government.

Mark Atwood: I'm sure every event in human history fits into one of just a few easily-remembered categories within a simple taxonomy which allows one to quickly and painlessly render judgement on each such event and its human participants, bypassing thought altogether.

TNH - you are a better woman than I. Under similar circumstances, I'd be hoping that Nader and his minions would die - after a long, slow, debilitating illness. Preferably MS, so that they could squeak about needing pemoline.

Sigh. New Year's resolution - cultivate a less vindictive personality.

PS - they squeak because they're rats.

Cylert is my little brother's ADHD medication. (Actually both of my little brothers take it, but one is noticeably more ADHD than the other. Ritalin caused that brother to have hand tremors.) I wonder if they've heard of this....

BTW, I'm very sorry to hear about this, Teresa. I know your battle with narcolepsy has been pretty rough already without this complication. I hope there's some alternative that opens up hella soon.

Dexamphetamine sulphate is currently available in Australia via the pharmaceutical benefits scheme for narcolepsy (PBS listing). I don't know where we get it, but it perhaps suggests an alternative supply exists... Of course, this may mean you have to move to Australia.

Dexamphetamine sulphate, aka Dexedrine, is one of TNH's regular meds. So far as I'm aware she can still get it.

And yes, calling your friends at the New York Times (didn't they mention you in a story about the Flatiron Building?) and NPR (aren't they always calling Patrick for quotes?) sounds like a heck of a good plan.

Thank you, all. I'm still so angry I feel like I have a sunburn.

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Alex Merz, are you returning M*rk *tw**d's fire because you know him from Usenet, or because you don't?

Cylert and liver failure: After twenty-plus years on Cylert, my liver is just fine. I don't see why I shouldn't have the option of self-monitoring for symptoms of liver failure plus regular tests. I'd sure like to know whether they've identified any common risk factors in the handful of people who did have liver failure.

By the way: Cylert is old and cheap, a backlist title among drugs. Modafinil is new, heavily promoted, and very expensive. And Modafinil is indeed a swell drug; but it doesn't do what Cylert does.

Fragano, I know all about the FDA's pigheaded attitude toward potentially recreational drugs. Amphetamines are a major component in narcolepsy's pharmacopia. The bleeping FDA gives us and our neurologists a tremendous amount of grief -- this, when a month's worth of the highest dose of Dexedrine I've ever been on is still less than the amount a former speedfreak friend of mine used to take every day.

I've been a fully diagnosed narcoleptic since the early 1980s. I'm a respectable middle-aged editor. All you have to do is take one look at me to know that I haven't been taking speed recreationally. They nevertheless make it damned near impossible for me to get any. Meanwhile, amphetamines are a major industry in rural America.

I notice that right-wing gasbags can get Oxycontin in quantity, and get nothing more than a wrist slap when they're caught at it.

My former pharmacist, a saintly fellow, got a lot of business from narcoleptics and sickle-cell cases because he'd stock our drugs, no matter how much paperwork they entailed. The narcoleptics didn't have the worst of it. NYC has a lot of black teenagers who have sickle-cell anemia. It's a very painful condition. But when they walk into a pharmacy with a legitimate prescription for heavy-duty painkillers, they're often denied service. My old pharmacist regarded only the correctness and legitimacy of the prescription, and gradually came to fill prescriptions for a substantial chunk of the city's sickle-cell cases.

well, shit.

I loathe the man to the extent that I'd prefer not to pile on for the sake of fairness, but damn, he does keep doing damage, doesn't he.

I'm so sorry, Teresa. This sucks.

Because I don't, Theresa. (I try to confine my troll-baiting to the bountiful fields of talk.origins andThe Panda's Thumb). Apologies for baiting a "known" on your board.

I'll be contacting my Rep. & Senators about Pemoline tomorrow. If we're to start ixnaying drugs for liver toxicity, we should start with acetominophen, and I don't really think that even acetominophen should go away.

If you want to talk about liver damage, let's talk about alcohol. (And while I was with Uncle Sam I picked up some liver damage myself (in the line of duty, not due to my own misconduct) that occasionally has an amusing symptom that I can't really talk about on a family board.)

As you probably know, Jim, alcohol in combination with Tylenol is the quickest way of all, short of Amanita phalloides. And yes, you're absolutely right about the relative risks that we're talking about here.

Oh, God, the idiocy of some people / organizations.

Let us know if there's anything we can do to assist at the European end. In particular, if that Belgian source isn't just reselling of stocks that are going to go away, maybe we can assist in getting some in for you -- as fetch & carry folks if nothing else.

So why did Public Citizen get Cylert banned, rather than Tylenol?

Because if they tried to get Tylenol banned people would say, "What, are you nuts? I use that stuff!" while Cylert is used by a vanishingly small percentage of the population.

But if they weren't pushing to get anything banned at all, people would say, "Why are you guys still in business? Why are you still asking for donations?"

================

Dr. Peter Lurie's phone number is: (202) 588-7781

Maybe someone can call him and ask exactly what the hell he was thinking, if he was thinking?

I just saw Ms. Oran-Kean's LJ post on this, and am going to summarize what I replied there. That 10 to 25 times increase in risk of liver damage is in the same range as in increase risk of lung cancer for heavy smokers. The risks from 2nd hand smoke run in the range of 10% to 50%, less than a doubling in risk.

Now that the FDA has issued a ban, even if they were to rescind it I suspect that manufactures will be too worried about lawsuits to go back into production. See http://www.injuryboard.com/view.cfm/Topic=9996

I suspect that the best hope for the next few years will be suppliers in developing countries; perhaps they package it with labeling as a magnesium supplement so as to make it easier for travelers to bring back.

Pemoline-Mg was an early 'smart drug'. and fairly easy to manufacture. I'd not be surprised to see it on the underground within a couple of years.

Oh Theresa, this sucks so much. I googled but it's not sold in italy either. I wouldn't *talk* about hurting Nader in your place - I'd go and manhandle hime myself. It's only the airfare that's stopping me right now.

For what it's worth, here's what I fired off to Senators Murray and Cantwell, and Congressman Reichert:

In November of 2005 the FDA announced the total withdrawal of the drug Cylert, and its generic Pemoline, from market due to concerns about liver toxicity. The move was apparently prompted by pressure from Ralph Nader and Public Citizen, and the spokesman for Public Citizen, Dr. Peter Lurie, asserts that the drug is outmoded and no longer has any reason to be on the market. The problem is that Dr. Lurie is mistaken – there are very compelling reasons to keep Pemoline on the market and available to those who need it -- and the FDA move means that hundreds or thousands of people for whom Pemoline is the only medication that allows them to lead normal lives, hold down jobs, or even be conscious most of the day, are facing the dire prospect of having their working lives abruptly cut short, without hope of reprieve.

Pemoline is a central nervous system stimulant, and approved as such for the treatment of ADHD. There are other stimulants available for ADHD sufferers, but for some, Pemoline is the only one that helps them. For ADHD patients who also happen to have heart ailments such as tachycardia, stimulants that also cause heart palpitations are proscribed due to risk of heart attack. For such patients, such as my friend Christopher, Pemoline can be the only option for treating ADHD. Without any treatment, Christopher cannot focus enough to hold down a job or lead a normal life. For him, Pemoline is what makes normality possible. Without it he has to make a choice between heart attack or permanent joblessness. As you can imagine, his prospect is bleak. Multiply that prospect by the number of people who simultaneously suffer from ADHD and heart disease.

And, contrary to the claims of Public Citizen, Pemoline isn’t only used in the treatment of ADHD. It is also one of a battery of drugs sometimes prescribed to try to combat narcolepsy. Narcolepsy is a rather poorly understood and complex galaxy of symptoms that affect the central nervous system, and affects different sufferers differently. But it can certainly take the form of leaving the victim unable to stay awake more than a few hours a day, and those few hours may be experienced as if in a drugged or drowsy stupor, without the ability to think clearly, carry on lucid conversation, read, or write meaningfully, follow the plot of a TV show, or do much of anything else that gives life content, joy, or savor. Imagine sleeping your life away, interrupted only by brief moments of hazy, ineffectual, and dimwitted drowsiness. Now imagine having found a way out of that darkness and back to being able to hold a meaningful job, enjoy your family, write sparkling prose, engage in and appreciate witty conversation, do gardening and cooking and reading and teaching again. Now imagine that someone has told you that you have to give all that up again and go back to the darkness.

That is the prospect my friend Teresa now faces. She’s had narcolepsy for 24 years. In the early years she spent a lot of time being shuttled between various neurologists who couldn’t quite pinpoint the nature of her problem. They tried her on varying cocktails of stimulants, searching for one that would restore her ability to function. Sometimes things helped for a while, sometimes she slept much of her life away, and when she was awake felt as if her brain had been taken away. Teresa is a woman of considerable brain, so having it taken away is a terrible punishment. Eventually her doctors found a combination of medications that, with monitoring and occasional breaks, allows Teresa to have a life again. That combination is absolutely dependent on Pemoline. Other drugs also help her, but only in synergy with Pemoline. I really can’t imagine the panic and despair she’s in right now. I hope I never have to face such despair myself; no one should have to.

And the thing is, again, Teresa is not alone. Over 200,000 Americans suffer from some variant of narcolepsy or idiopathic hypersomnia. Some of them will be able to find alternatives to Pemoline, but some of them won’t. And for the ones who won’t, the FDA has sentenced them to a grim twilight existence, bereft of work, of meaning, of understanding, and of joy.

There is no question that liver toxicity is a matter of concern where prescription medicines are concerned. But the risk should surely be kept in perspective. Since warnings of the danger of liver toxicity were made more emphatic in the packaging of Pemoline in 1999, the drug has been implicated in one death. One death, in six years, in a user population of 10,000 patients. By comparison, Isoniazid, commonly used in the treatment of latent tuberculosis, was implicated in 7 deaths in the three year period from 1989-1992. Acetaminophen, the active ingredient in Tylenol, is also capable of causing liver toxicity in large doses. In one study of 179 patients who had overdosage of acetaminophen, two patients died. From a drug that is available over the counter without prescription, you see a greater death rate than from Pemoline.

It is the nature of our modern pharmacopeias that effective medicines often come with increased risks and side-effects. It certainly behooves us all to be well informed of these risks and side effects, and to know our alternatives in order to be able to weigh them, and it is part of the FDA’s brief to make sure that we are so informed. But there will still be times when no entirely good choice is available, and at those times it seems to me that it is up to the well-informed patient, in collaboration with her doctor, to decide what risks and side-effects are worth the candle. Liver function can be medically monitored on an ongoing basis so long as there is awareness of the need. But for Teresa and Christopher, and untold others like them, there is no substitute for Pemoline, and the more normal lives it gives them.

Please join me in petitioning the FDA to reconsider its decision. Whole lives depend on it.

Yours in hope,

Oh, god. Spam.

Teresa, I'm so sorry, and there's not a damn thing I can do except say that. No use me writing a US public official. Probably the converse, me being a furriner and all.

Teresa writes: Lurie ought to have his license yanked.

This suggests another avenue: Write to whichever medical board granted and renews his license to practice medicine, and complain about his gross incompetence.

Oh, and you want some real irony? Lurie also signs press releases for the Treatment Advocacy Center (another of Public Citizen's groups). And what is their brief?

The Treatment Advocacy Center is a nonprofit organization dedicated to eliminating legal and clinical barriers to timely and humane treatment for millions of Americans with severe brain disorders who are not receiving appropriate medical care.

Good job, Lurie, eliminating those legal barriers to treatment for folks with severe brain disorders. Way to see that they get appropriate medical care.

What's he going to do for an encore?

I'm sorry, but it's not available for common prescribers here in Sweden, either. Had it been, I could have arranged something, at least two years from now.

Mentioning sickle-cell anaemia was a hit. This story was almost unbearably sad to me, a childfree unsiblinged person: Promise of a new life ends in tragedy. I can barely conceive how it would have affected parents & those with close family & friends.
(There is now argument about details of just what happened, but it still is not what you'd expect.)

I live with a man whose sleep disorders are only partially diagnosed and almost completely untreated. (On optimistic days, I add "so far," since we are trying.) It's so good to know that these people use their Special Psychic Powers to determine what he doesn't "really" need before the doctor has to go through silly unnecessary steps like thinking about it or testing how it works for him.

You have my sympathies. This is intolerable.

Theresa, I'm sorry to hear this. I live in the UK, can't do much to help -- when we try to put pressure on your politicians, we usually get the opposite results.

BTW, that's the big problem with "grassroot" organisations, unelected and answerable to no one: publicity is their lifeblood.
The FDA not bothering to even argue scientific issues with them, well, that's a political problem and should be solved accordingly: blame the executive branch of government and put pressure on your representatives.

Health Canada has a "Special Access" program for drugs which are otherwise not approved; if the drug is manufactured anywhere in the world, it can perhaps be gotten in Canada. "Practioners treating patients with serious or life-threatening conditions request Special Access in cases where conventional therapies have failed, are unavailable or are unsuitable." link.

I find this extremely weird. If there is basically only one medication that helps tens of thousands and that's going to get banned what happens economically. Wouldn't the theory be that this medication get produced in a black market situation, or in some country where it is not banned and imported to the banned area because of the absolute need for it. But from what I'm reading here this does not seem to be the situation.

As a paranoid the only other explanation would be, to me, the drug is no longer especially profitable to the drug companies, but they have another slight variation of the drug that could be profitable ready to go, if they could just get rid of the no longer profitable drug.

That said, it seems like an especially bad situation. This is the kind of thing that prompts my inner anarchist to start thinking of the good old times when I was also a practicing anarchist with bastard tendencies.

Mrk twd, you may be above the LD50 for Schadenfreude. But don't worry; even Nader can't get the FDA to ban drugs our own bodies generate. "The bastards are running around full of adrenaline and endorphins, and we can't touch 'em!"

Bryan --

It may make sense purely as a way to stop making a non-profitable generic; get the FDA to make you, so it's not your fault and not your PR hit.

More likely, there was no one in the chain with any knowledge of the important therapeutic uses, or no one with that knowledge willing to buck the lobbying effort. (Or the lobbying effort combined with the obvious willingness on the part of the manufacturers to stop.)

It saddens me that no one has thought of this yet.

I am a reporter. This is a fantastic news story.

It's got everything: conflict, strong feelings, and a large number of affected individuals.

At the NYT, Gardiner Harris appears to have the public health beat and he's written about Nader's quest to ban Cylert, but not (yet) about the other side.

Teresa, you should call the papers. This is what we are here for.

I come from another one of those families where my father still bitterly curses Nader's name for atrocities committed before I was old enough to be aware. In my father's case, the outrage was Nader's first notorious one (the one that gave him his reputation): his success in getting the Corvair automobile banned, by claiming that (because it was a light small sporty fuel-efficient car in a world of gas-guzzling heavy-iron behemoths) it was "unsafe at any speed".

Now obviously, there was no one hurt by that shenanigan in quite the intensely frightening and personal way that Teresa and Xopher are threatened here. (Indeed, I was reluctant to post because folks would think I was trying to equate the two situations, which I in no way am.)

However, getting the Corvair banned had the effect of destroying the American auto industry's first serious effort to make and sell a small (and thus relatively fuel-efficient) car. The result was to leave that market WIDE open to foreign auto producers, while encouraging US makers to go ever further astray with big heavy smoking iron behemoths. Arguably, the carnage in the US auto industry in the 1980s was considerably worse than it would have been if Nader hadn't poisoned the well for U.S. producers of small light cars.

The point of which is that this is what Nader does and always has done. He's a despicable man, not because of his recent contributions to disarray in Democratic party politics, but because he's utterly, willfully, blind to the human costs and adverse effects of the reforms he advocates. He simply doesn't appear to give a shit. Which makes him both terrifying and dangerous.

Dear Teresa,

My sympathy. I know how hard this is on you, and I hope you find a solution soon.

I would think the short-term solution might be to see if you can drum up some stock in Third World countries. Any of your Arizonan friends heading to Mexico anytime soon?

Dear Ralph,

Beware the wrath of a jonesing Teresa.

Teresa, hugs and sympathy from down here in Georgia. I have a relative with narcolepsy, and though she is not on Cylert, I have a very good idea of what you are facing without the necessary meds.

Oh, how this sucks, for everyone who'll be affected by it.

Add this little twist in:

Except in very rare, extreme cases, the Social Security program in the US is unlikely to provide disability benefits for someone in the position Teresa and Xopher find themselves--because their condition "can be controlled by prescribed treatment"--never mind the complications or side-effects of the available medications, never mind whether or not the medications you can find to take return you to your best level of functioning, or simply produce an individual who is, at best, capable of packing widgets in a box or running a dishwashing machine in a restaurant kitchen.

Happy happy joy joy indeed. /snark.

Theresa:I'm horrified by what you must be going through and will write letters where needed. I am amused (in a sad way) by the sudden concern for the liver that appears to be reducing one's access to many drugs these days. I have liver damage and needless to say am careful what medication I take. However, when I recently (I'm diabetic) had such a severe case of thrush that I wanted to shoot myself and none of the regular meds were wroking I took the stuff that's black boxed for the liver. I'm doing my LFH tests monthly for awhile to monitor any changes, but I needed to wipe out the thrush. It's called informed consent. I am spitting mad that so many citizens have to do without medication that literally saves their lives, because of such over zeolousness. I am also cynical and believe that in the case of some more attractive drugs and illnesses (say, erectile dysfunction) it's easier to overlook the possible dangers.

And someone may have pointed this out up stream, but why is acetemetaphin on the market? If I forget and use that stuff for pain or fever I'll trash my liver in no time!

Be well.

Gods.

I live in fear that I'll wake up one morning to find that one of my essential asthma medications will be off the market.

How terrifying for you, Teresa and Christopher. I'm so sorry.

I've asked at work for advice - I'm a statistician working at a (British) pharmaceutical consultancy, but don't (yet) have too much knowledge about the wider field. Will get back to you tomorrow.

There are companies that import discontinued medicines and medicines not available in specific countries either due to not being available yet or due to having been banned. Below is the link to the one recommended by my boss (a former professional pharmacist).
http://www.idis.co.uk/

I can't imagine what I'd do if they banned prednisone or any of the other myriad of drugs that my sweetie, Ericka, needs to survive, much less function at some sort of reasonable level. Drugs have side-effects, some of them worse than the ailment they are treating, but for so many people there just aren't other choices. Do I take my drugs and suffer these side-effects (or risk that potentiality) or do I lay down quietly and die?

My sincere sympathies and if there are resources that I can draw on to help, let me know. (I am thinking, specifically, that if an individual can import X amount of this drug from other sources that I and many other individuals would be willing to multiply that X and convey the supply to you. Also, I have contacts in India if that turns out to be a source for acquiring the medication. Fandom: drug trafficing for all the right reasons.)

Theresa, you and Xopher have my complete sympathy. I hope you can work with your doctors to find some solution.

While Googling to find out when (and why) Canada and Europe had banned pemoline, I found this:
ABBOTT PARK, IL — June 24, 2005 — Abbott Laboratories is taking Cylert® (pemoline) off the market “based on declining sales,” according to a letter the company sent to doctors last month. One can only wonder whether the real reason for the decision is bad publicity about Cylert®’s link to liver problems. Prescribing information, enclosed with the letter, reveals that Cylert® can cause “life threatening hepatic [liver] failure” and “should not ordinarily be considered as first line drug therapy.”
Here

This means your doctor had over 6 months to find other drug(s). I'd be mad as hell at your doctor (and pharmacist) for not letting you know. And while I hate Ralph Nader, the reason it was banned in Europe and Canada has nothing to do with him.

So charge up your righteous anger anger and ask your doctor: "WTF??????"

There's been one case in six years. In a population of about 10,000 people who take the drug.

Fscking over-reacting statistically-uneducated idiots! One in 10000 is damn low risk. And you educate the doctors and patients about the risks and what to look out for. And you work on alternatives for when you have to have them. You DO NOT leave people hanging out to dry because you're afraid that someone *might* be hurt.

Teresa, Xopher, I'm sorry you got run over by these idiots.

I don't think my situation is quite as severe as Teresa's. I certainly will not function at my current level, and I probably will start getting fired all the time again, but I will be able to get jobs even if I can't keep one.

I'm still panicked. I was completely beside myself last night. I think I'd rather take the heart risk and be able to focus than die a homeless bum, so maybe I'll just go on one of the other ADHD meds.

I didn't think it was possible for me to hate Ralph Nadir any more than I already did. I was wrong by an order of magnitude. And the nails-string-yank thing? It usually fades quickly, but it just seems more and more attractive the more I think about this.

And Ulrika...thank you so much. That's really eloquent. Thank you.

What "should not ordinarily be considered as first line drug therapy" means is "only try this if nothing else works."

Which is, approximately, the exact situation we're looking at.

Recall too that while Abbott stopped manufacturing the drug, the generics were tootling along happily until the FDA was panicked into unjustified action by Public Citizen.

I've written Feinstein and Boxer. Don't know if it will do any good, but it's another feather on the scale for Truth , justice, and the American Way.

DAMN!! on behalf of Teresa, Xopher, and all the other people affected.

How dare they - they reject emergency contraception for political reasons, now this.

Isn't this why we have a prescription system? So that drugs that are dangerous and need to be monitored can be overseen by a responsible physician?

Well, no, not any more. Between the "war on drugs" and the fact that a lot of medical insurance pays only to see a doctor for about five minutes, the assumption is, you aren't really supervised. And the drug companies are so afraid of lawsuits... nevermind, it has all been said.

Teresa: I should be unsurprised by corporate and government behaviour, but it still amazes me that people who *need* specific treatments/pharmaceuticals can just be ignored by the powers that be.

Xopher: Not nails, rivets.

Terrific. Nader strikes again.

Teresa and Patrick, I'll second other folks recommendation to bring this to the attention of the press, I'd suggest one of your local TV stations 'action' reporter.

One death in 10,000 cases...methinks it's not the drug's toxicity in question here. I'd be willing to bet it's not profitable enough for the manufacturer to continue producing. (Which is NOT a valid excuse IMO.)

In the meantime, I'll go write my Senators and Rep...

So long as pharmaceutical manufacturers are transparent about the side-effects of a particular drug, it should be left to the individual to judge whether the risks outweigh the benefits. Control freaks like Nader claim to have our best interests at heart, but in effect treat us like gurgling infants who can't be trusted to decide what to do with our own bodies. Callous bastard.

Fragano Ledgister: Hmm, the idea is to yank all the nails out at once, and not - or not necessarily - to tear the top of his skull off.

But your alternative certainly has merit as well. If I ever have the man completely in my power, and my conscience is completely eradicated between now and then, I'll carefully consider my choices.

Ulrika, I hearby publicly beg your pardon -- I cut and pasted your post to email it to my Senator and Rep. It was so much better than anything I could have written...

Very sorry to hear of this; I hope there's a way out.

I will risk a sort of devil's advocacy here, in two parts:

1.) Public Citizen cut its teeth on General Motors at the height of the latter's power, arrogance, and indifference to safety; it's easy for organisations to treat all problems as hex nuts when they first achieved success as developers of the Allen wrench. This is an explanation, not an excuse.

2.) Abbott have a history of ignoring the FDA. A few years (seven?) back, the FDA told Abbott that one of their factories was not in compliance with the former's standards for diagnostic test manufacture. Abbott management's answer was, in essence, "Waddaya gonna do about it?" It dragged on for years, and eventually the FDA's answer worked out to, "Fine you $100,000,000 and get ready to shut down the plant, that's what." Abbott's executives were guilty either of colossal arrogance or of gross ignorance of the terms under which they do business.

The net effect is that Public Citizen has a predisposition to setting SAMS on flies, and Abbott (these days) is inclined to do whatever the FDA ask of them, without protest. Generic manufacturers probably take their cues from the giant actors---if Abbott, with all its pull and resources, is too worried about regulatory or civil action to keep on producing a particular drug, what's GenCo going to do?

(Meanwhile, it turns out that the mine that just collapsed had over 200 safety violations to its name last year.)

Two resources: I can't read all the pages linked from this page for Teva, a big Israeli/European/American generics firm---in particular, it would be useful to know what the Hungarian and Lituanian branch produce, given their countries' formal commitments to economic liberalism.

Secondly, the American Public Media show "Weekend America" actively solicits independently-produced pieces. I can't make radio-quality recordings, but someone here might be able to---and I'll ask around.

Good luck, let none of us end up saying, "First they came for the opium smokers...."

I'm very sorry. I wrote my senators and representative, and also the senior neurology folks I could find at Harvard, Yale, Duke and UNC Medical Schools. I'll probably write more people later. Good luck.

Well, fuck.

Not that I'd been tempted to vote for him for quite some time, but this certainly is the last straw. I'm so sorry, Teresa. I know how hard it's been for you to find medications that made your life even a little bit normal.

More bad news--if you or anyone you know is covered by Medicare, you should know that the caps on physical therapy, speech therapy and occupational therapy have been reinstated as of 1/1/06.

Details here, but the short version is: $1740 per patient per year for physical therapy and speech therapy COMBINED--so if you have a stroke, you can either work on relearning to walk or talk, but not both, and the amount is probably inadequate for either; occupational therapy (for example, relearning how to feed yourself) has a separate cap.

Disclosure: I'm a student in a degree program for physical therapist assistants. The link is to a page on the website of APTA, the American Physical Therapy Association, which is a PT advocacy group. Google at will for other points of view.

Further disclosure: I have an elderly relative who just had an above-knee amputation.

Teresa,

I am truly in awe of a level of anger that would make you inarticulate with rage. But how horrid for you! And Xopher too, and all the others who have been depending on this drug for so many years. I'd be furious too. If I said what I really want to say here, you'd probably disemvowel it. I am angry on your behalf, and will write to my Congresscritters as soon as I get a chance (later today, I hope) about it, probably cribbing off the letters others have posted here.

Gently burning email sent to congresscritters - check.

Feelers sent out to former congressman & employer (who is a drug-controlled epileptic) to see what pressure he can offer - check.

Now I can sit here and wonder if the Nader bunch were Crazy Eddie from the beginning, or if it just snuck up on them over the years. Patrick and Teresa, you remain in my prayers.

Teresa, I can't imagine the fear and frustation you and Patrick must be going through. I've contacted my congressional representatives, and I hope some avenue of redress works to get this lunkheaded decision reversed.

I just spent 15 minutes on the phone with the NIH Neurological Institute at 877-562-3434; Office of Communications and Public Liaison. Very nice guy named Paul. He didn't know about this but when I gave him the facts he tracked it down pretty easily and was fascinated and totally sympathetic. He is going to try to locate a phone number for complaints or someone who can be called and he promised to get back to me; I told him to leave the message on my voicemail. I also told him to put whatever numbers he finds next to his desk because a bunch of other people WOULD be calling him about this. He said that would be fine, he'll pass on whatever he knows.

He recommended writing representatives and senators and calling local newspapers -- Teresa, since your local newspaper is the New York Times, if you can get someone there interested that person will be speaking with a VERY LOUD voice. Six degrees of separation time -- who do we know at the Times? Can anybody get to Gina Kolata?

Baby, meet bath water.
SPLASH!
I am so fukking tired of Nader sanctimony, and that of the groups he supports and has helped found.
We have Bush because of him. Plus all the other things that have been banned due to his efforts. Are we as a species so dense that we can no longer be relied on to get the facts and make our own decisions?

Too bad my sister-in-law is out of the journalism business, or I'd sic her on the story; her older son has seizure problems, so she knows about drug issues.

As I've E-mailed you, if we share a congressman (mine is Major Owens) I'll tell him as well as Senators Schumer and Clinton all about it. Are you receptive to people directing their reps to this webpage to sound out popular indignation on the matter?

Teresa, Xopher, Patrick, everyone, I wish I had something more useful to offer than my heartfelt sympathies and concern. I'm sending all my Stateside friends over here, and asking them to write their representatives. Pemoline remained available to Canadians for whom other treatments didn't work through the aforementione Special Access Program; I don't know what those people will do if it's not being made. My guess is that Health Canada will have to find out whether it's being made someplace other than Canada or the U.S., but I don't really know how the SAP works here.

I know we're all quite literate and articulate here, but if anyone writing to their representative wants their letter copy edited or proofread, feel free to contact me.

I've posted a link to this on Baen's Bar, and I noticed that Diane Duane linked this on her blog. I've got an account at Daily Kos and will post there if I have time today.

Let me also suggest that you post this at RASF.

Alex

My father is a professor of pharmacology, and on the editorial board of the US Pharmacopeia (although not on the neurology drug committee, alas), so I asked his advice.

His first recommendation was to talk to the AARP. If you're over 50, you're eligible for membership. They're very good at fighting this sort of campaign, and the FDA _listens_ to them.

His other suggestion was to see if a similar drug is manufactured overseas. It wouldn't be listed in the U.S. Physician's Desk Reference, but you could check (or ask your pharmacist to check) the Pharmacopeias for Japan, England, Holland, and Germany. He also said a faster way to do this would be to call the previous manufacturer and ask if they know of any overseas equivalents; they all know what the competition is doing.

Meanwhile, I'm going to see if I can get you a useful contact within AARP.

My rdnt sympths. Prhps TNH wld lk t rcnsdr hr pstn n trt rfrm, s t s prcsly th crrpt plntffs' br tht hs wrkd hnd n hnd wth Pblc Ctzn t tk ths drg ff th mrkt n n ffrt t mprv thr chncs n lwsts gnst bbtt nd thr phrmctcl cmpns. Jst bcs Bsh spprts smthng dsn't ncssrly mk t bd.

There seems to be a generic version (identified as Pemoline) which *LOOKS* like it's manufactured in Israel, by a company called Rekah.

The company's info is here: http://www.rekah.co.il/products_list.htm

and the description of their version (tablets; marketed under the name of NITAN) is here: http://www.rekah.co.il/products_list_n.htm

Most of the pertinent info on the pages is not in Hebrew, but if there's something you need translated, drop me a line or call me. dena at shunra dot net (Xopher, same for you).
http://www.drug.co.il/bygeneric.asp?gen_id=1049&drugID=3876

Wow, I'm really sorry for the predicament you find youself in, Teresa and Xopher. No one should have to go through this.

As not useful as it is, my standard reaction always seems to be to wish that people have to deal first hand with the immediate ramifications of their deliberate actions. This is clearly a case of the system not working (if, in fact, this system ever worked.)

I hope that you find another source and/or that you and your doctor find another drug stack that keeps you at at least an adequate level of function. (The process sounds decidedly not fun though. Is there anything you can do besides trial and error?)

Teresa, Xopher, I've written to the LA Times also. Maybe it will help - they seem to be not interested in a lot of things these days.

"Anon" --

Sure it does. Anything Bush supports will be implemented in such a way that any public utility which may have accidentally existed in the original idea will be crushed out of existence by the corrupt and incompetent implementation.

In this particular case, TNH happens to have noted, in a lengthy, factual, and carefully thought out post, that "tort reform" as it exists as a political cause, was all about removing legal responsibility for their acts from large corporations.

This is still true. That the FDA has done something bone-headed doesn't make this less true. That the drug company in question is afraid of being sued because it has a history of poor manufacturing standards and flouting the relevant laws, or that the legal pressure the company is under because of that history may have contributed to this particular stupid decision by the FDA doesn't make it less true.

Individuals are not able to handle enough complexity to deal with all the complexity in any society that involves living in groups of more than about fifty people, and rarely then. (Hunter-gatherers have to know terrifying amounts of stuff to stay fed, but individual hunter-gatherers don't know everything anyone in the tribe knows.)

May I recommend to you a sufficient acquaintance with the facts of the matter that you are able to satisfy yourself of both the necessity of managing complexity and the frequent rapacity and misconduct of pharmaceutical manufacturers?

If that appears overly difficult, you might wish to consider exercising your capacity for empathy and nuance sufficiently that posts of the form this is in some vague moral way your fault made to persons faced with horrific privation due to the folly of others cease to come to you in the forms of good ideas.

Dear Anonymous Drive-by:

Thanks so much for wasting no time in blurring the distinction between "this was an incredibly stupid thing for the FDA to do" to "the entire legal system should be thrown out." It's most welcome in these trying times.

Same goes doubly for you, twd.

Found a list of other names for Pemoline, still searching for the makers:

A 13397; Azoksodon; Azoxodone; Centramin; CS 293; Dantromin; Deltamine; Endolin; Fenoxazol; FWH-352; H 3104; Hyton; Juston-wirkstoff; Kethamed; LA 956; Nitan; Notair; Okodon; Pemolina; Phenoxazole; Phenylisohydantoin;
Phenylpseudohydantoin; PIO; Pioxol; PN/135; Pondex; PT 360; Ronyl; Sigmadyn; Sistra; Stimul; Tradon; Tradone; Yh 1

http://www.inchem.org/documents/pims/pharm/pim940.htm

Damn. My sympathies Teresa, Xopher, all. I count myself luckier everyday that the only things I need to get through life are aspirin and antihistamines (both only occasionally).

Some of my more conventionally liberal friends ask why my politics is, in some ways, skewed toward the libertarian. My short answer: Ralph Nader.

When Nader's book "Unsafe at Any Speed" came out I was a college student majoring in physics. Since I was too poor to afford a car, I sublimated my desires by reading Car and Driver magazine. Back in the 1960s Car and Driver was a magazine noted for being critical of Detroit. It wasn't always critical, but it said things the rah rah car mags wouldn't say. It was also a real enthusiast for quality European cars. When I was finally working, Car and Driver was one of the reasons I bought a BMW 2002 as my first new car.

Nader, since he was a lawyer and not an automotive engineer or even, apparently, an auto enthusiast, cited a fair number of people with solid credentials in his book condemning Detroit. Car and Driver -- and those critics Nader used -- roundly condemned the man and his positions. That's right -- knowledgable Detroit critics slammed Nader. That got my attention.

In the years following I encountered a variety of leftists. Most of the ones I met were thoughtful, reasonable people. I could agree -- or disagree -- with them. They seemed to have democratic world views. Some, though, were like Nader. They exhibited highly authoritarian personalities and were quick to condemn people who didn't follow their particular line. Yes, there are people like that on the right as well. Tom DeLay comes to mind.

I don't like these kinds of highly authoritarian individuals. They do our species and world great harm. About the only time they do anyone any good is when they are led by more democratic people who can tell when something is worth doing or not worth doing.

I'm going to bring this to the attention of Senator Mikulski's and Congressman Hoyer's respective staffs.

Again, my sympathies to all affected.

Th FD ddn't wk p n mrnng nd dcd "Lt's d smthng ncrdbly stpd." Thy wr lbbd t d s by spcl-ntrst grp wh wll fnnclly bnft frm th dcsn bcs f flws n th cvl jstc systm.

TNH's nfrtnt sttn s nt hr flt n th slghtst. Bt hr rflxv ttck n trt rfrm (whch s nt "thrwng t th lgl systm") cms strght frm th plybk f th sm spcl-ntrst grp tht nt nly pts th fnncl ntrsts f ts bnfctrs hd f cnsmr chc, bt hs th gll t clm tht t's dng s n bhlf f cnsmrs.

mrly sggst tht sh rcnsdr sm f th pstns sh hs tkn nw tht th dngrs d f "ny ncrs f rsk s pttng prfts bfr ppl nd mst b pnshd" hs cm t pss n wy tht hrts hr spcfclly, rthr thn bstrctly. nd tht whn TNH's rdrs s prss rls frm Pblc Ctzn r n TL r sm thr tntcl f ths mlt-blln-dllr--yr ltgtn lbby, rthr thn rflxvly chrng t bcs t ttcks crprtn, prhps n shld cnsdr whthr t s ls rlly hrtng ppl lk Trs wh wnt t hv th cnsmr chc tht th Ndrts sk t tk wy, nd r ncrsngly bng sccssfl n dng s.

I'd love to know Anon's IP address... Not the whole thing, just the block it's in. A quick WHOIS query, and perhaps a lot might be explained.

WTF? How does Public Citizen profit from this?

Paul at NIH called back, still sympathetic but unable to help. He said the only thing to do is rattle cages at the FDA, and recommended that we find a celebrity (!!!!) with narcolepsy. Decision-making on complex medical questions through notoriety -- what a fckd way for a society to operate. But sure, WHATEVER we need to do.

Nice work, Dena.

Anon, shut up. Your post stinks of "Neener, neener, neener." Not helpful, not compassionate, not welcome. You may come back and post about this another time, when this particular problem has been (we hope and pray) dealt with positively and we are all feeling generous and benign. Or maybe not. Were I Teresa, I would invite you to get lost, not because I disagree with your position on tort reform, but because you have shown yourself to be extremely mean-spirited.

I don't really have anything to add here except a generic statement of both support and bogglement. The Law of Unintended Consquences radically sucks. I'm sorry.

when TNH's readers see a press release from a Public Citizen or an ATLA or some other tentacle of this multi-billion-dollar-a-year litigation lobby, rather than reflexively cheering it because it attacks a corporation

Gee, nice of you to assume we cheer when we see these. Some of the time they may be right, but they can make, as we are seeing, major mistakes. One of which is not bothering to find out who is affected and how before they go off on a crusade. Tort reform may be an improvement - but if it protects companies from suits over malfunctioning products, it's not good. (See the new bankruptcy law for another example of laws made by the beneficiaries.)

If the foxes are designing the security system for the henhouse, what do you think is going to happen when a fox shows up?

Appearances over risk assessment reigns.

This falls in the same general category as prosecuting cancer patients for use of medical marijuana instead of vigorously pursuing criminal growers, prosecuting digital artists [or grandparetns] for depicting nude children instead of child prostitution organizations, and prosecuting grandmothers whose grandkids' friends downloaded a few songs instead of pursuing Filipino mass CD/DVD piracy duplication operations.

As someone who's undergone sinus surgery, it's inane that I -- and tens of millions of other cold sufferers -- have to produce ID and sign a log in order to receive a monthly ration of pseudephedrin products because the US government can't go after illegal crystal meth manufacturers.

I empathize with you, Theresa, even if my common plight is a nuisance rather than life threatening.

JJB

I once got caught by a drug vanishing from the market. It was replaced by a different version, which could have had different effects, and the first I knew was when I went for my regular prescription.

Making the transition to the new version was worrying. As I recall, some people did have problems with different reactions.

But there's a huge difference between that, possibly no more than a mistake, and the sort of deliberate action that's hit you. Pharmaceuticals are a balance of benefits and risks: that's why they have Doctors and Pharmacists and Prescriptions. Any negligence in not telling you is distinct from the vile and detestable attack made by Public Citizen.

(Any chance of getting them classed as terrorists?}

No, there's nothing I can think of to help. Looking at your past accounts of the obstacles put in your path by the US Government, is it going to be a choice between narcolepsy in New York and living on some other continent?

It's too early to know whether there is any possible better place, and too many places that would be no fun with fully functioning consciousness.

And, oh fuck, the State Department has started to threaten Iran.

Protected Static: Power begets power. If Public Citizen, under an administration that isn't exactly friendly to it, can push a government agency (and build an alliance with a major corporation into the bargain), then it's going to get a lot more respect inside the Beltway. And that translates into more power and influence.

Without even reading everybody else's comments, I sent this to Public Citizen:

"A ban on Pemoline" (used for narcolepsy) "will force individuals to resort to disability. They and their family members will suffer the economic consequences of a significantly reduced income and loss of medical and retirement benefits. Others will no longer be able to achieve sufficient wakefulness to accomplish the ordinary tasks essential to independent living and will become burdens to their families, the Social Security, Medicare and Medicaid Systems and to society in general. The ADHD population has many alternative medications from which to choose."

If we took every medication off the market that might affect my liver adversely, almost every medication now in use would be banned.

Push for better education in our schools. We have these problems because our people are not taught to think for themselves: "read the chapter and answer the questions at the end." Why must I and my friends be penalized because people want someone else to take responsibility?

Put narcoleptics on Medicare. Put more pressure on Medicare spending. Watch Medicare spending go even higher. Watch the deficit go even higher. Watch the donimos fall *tink* *tink* *tink*

Read Jack Williamson's "With Folded Hands" and get a clue!

----
A bit incoherent but maybe one sentence will get thru to the right people. *tink* *tink* *tink*

Teresa, Xopher, and others for whom this is not an academic issue - my prayers and sympathy. I wish I could do more of a practical nature, but as I'm a resident alien not entitled to vote, I'm not sure how much attention my elected representatives will pay to me (especially as it will be at least three weeks before I can send a snail mail letter with a US rather than a UK stamp).

Earlier this week I was making a list of books to write reviews of when I get home. Making Book went high on the list, with the intention of specifically mentioning the section that gives an insight into the horror of untreated narcolepsy. I think I'll put that review to the top of the list, and spread it a little wider than I was originally intending to. I think my local free paper takes reader-written book reviews. Maybe it'll help spread a little more awareness.

> f t prtcts cmpns frm sts vr mlfnctnng prdcts, t's nt gd

Ths ncrrctly ssms tht ll sts vr mlfnctnng prdcts r gd. Ths s nt s. ll drgs hv sd ffcts; sm sd ffcts r sffcntly rr tht thy r nt dscvrd ntl ftr mllns f ss, t whch tm thy cld ffct thsnds f ppl. f mnfctrr s thrtnd wth bnkrptcy vr ths (s Mrck s wth Vxx), t wll dtr thm frm prdcng nw drgs n th frst plc.

Prtctd Sttc, lrg prt f Pblc Ctzn's rl ths dys s s frnt grp fr th ltgtn lbby; sd Pblc Ctzn's >bnfctrs bnftd frm ths, nd th wthdrwl wll b sd n cntlss mrtlss sts gnst bbtt, s wll s jstfctn gnst ftr rfrm f phrmctcl rgltn.

s fr m, my P ddrss s 69.143.115.175. spprt sm frms f ltgtn rfrm, bt nt thrs. 'm lbrtrn. Hvng t shw my drvrs' lcns t by Sdfd nnys th hll t f m. ws ffndd by TNH's rlr ttck whch rptd nmbr f rbn lgnds bt ltgtn rfrm, ncldng th mystrs d tht th McDnld's cff st ws smhw jstfd, nd nyn wh thght thrws ws stg r nf. hp tht nswrs yr qstn, bt ths dscssn sn't bt m.

Graydon, I doubt that anon's grasp of nuance is such that he/she recognizes what you did in that post, but I enjoyed it immensely.

Beautifully done.

Michael Turyn wrote:

"I can't make radio-quality recordings, but someone here might be able to---and I'll ask around."

Actually, you might be surprised. I've been fooling around with a freeware sound recording program called Audacity lately, and the results are pretty decent. My recollection is it took me about 10min to install and another 10min to figure out enough to start playing with it.

My hardware is a mid-range Dell, the on-board sound card and a $50 headset I got at Best Buy. The resulting MP3 files probably wouldn't impress an audio engineer, but they sound OK to me.

Yay open source!

Following up on some of Jen B.'s research:

German Article on Tradon (R) (Pemolin): My German's not up to understanding more than that it seems to be a general article about the drug, at a cursory read from my work computer, but I bet someone here can give a good synopsis.

From ADD Online: I think this indicates that Lilly makes (or made? I really need to study more German) Tradon.

French page on pemodin, giving other brand names and the countries in which they are sold under those names. Alas, no names of companies that make each brand name.

There are numerous pages in Russian, that seem to discuss Sigmadyn.

Hope this helps.

> Yr pst stnks f "Nnr, nnr, nnr." Nt hlpfl, nt cmpssnt, nt wlcm.

sncrly plgz. Tht ws nt my ntnt, nd, s sd, vw Trs s vctm. wsh Trs th bst, nd hp sh cn fnd th mdcl rlf tht mdrn tchnlgy prmts nd r flsh rgltry systm crrntly ds nt, nd shr hr wht-ht htrd fr th prnng f Rlph Ndr's crw.

spprt ltgtn rfrm prcsly bcs th ffrts f Ndrts hv gn wll pst prtctng cnsmrs nt hrtng rl ppl lk Trs, nd th ppl hrt by th lck f ffctv ltgtn rfrm nd th pwr f th ltgtn lbby dn't gt thr strs md nt scr-wnnng mvs. Jst rmmbr tht t's nt lwys bt prfts, nd tht vry n f ths Pblc Ctzn prss rlss hs smbdy's stry lk Trs's bhnd t.

Gd dy.

Where along the line did "libertarian" come to mean "staunch defender of corporate rights?"

Hopefully Helpful Info and How to Get to It.

http://www.medicinescomplete.com/mc/

set up a 14 day free trial

search for "la 956" (the synonym for Pemoline I’ve found the most results for on this site)

click on the 2nd icon (blue with a reddish “m”)

Click on the drug name and then the manufacturer name for contact info for that manufacturer.

Also: even more snynoms for Pemoline
http://pubchem.com/chemical/Pemoline.html

What is ATLA in this context? I doubt it's what I'm familiar with - the American Theological Library Association.

Teresa and Xopher:

If contacted, would you be willing to be interviewed for a podcast on public health issues? There are podcasts on every conceivable subject, including this one. I've got some moderate influence in the podcasting community, and I'm putting the word out now to try to find someone who can help bring attention to this injustice.

I'll also be having dinner with Senator John Edwards and his wife on Friday night with about a dozen other podcasters. I'm not sure how that's going to go, but I promise you I will do my best to mention this story to him. This sounds like the sort of thing he'd want to know about.

Where along the line did "libertarian" come to mean "staunch defender of corporate rights?"

I'm damned if I know. The kind of libertarianism I came up in is generally hostile to corporations as entities. Libertarianism, after all, is strongly about individual rights and, by extension, individual responsibility. The way I learned it, a corporation is a legal fiction designed to mask real individuals' responsibility for their actions inside the fictitious corporate person, and as such is inimical to libertarian principles. But then, anyone who claims to be simultaneously libertarian and in favor of limiting individual rights to use the courts to seek redress for transgressions against them just hasn't thought through what "libertarian" means.

Fragano: Oh, trust me - I know how Public Citizen will politically benefit from this (an ex- used to write campaign letter copy for them; I've never been overly fond of them myself), but Anon's comment was that they "...will financially benefit from the decision because of flaws in the civil justice system." Perhaps, in the sense that they can use this in their fund-raising, but I see that as stretching it quite a bit.

Anon, you stated that P.C. will directly benefit from it, not their 'benefactors'. I also withdraw my comment about your IP address - it was immature. But at the risk of pushing this thread further off course, part of what turned me off contemporary American L/libertarianism is the degree to which y'all are willing to assume that such large institutions as corporations and churches have more benevolent intentions than the government bureaucracies you rail against... The individual is grist for all their mills, and I fail to see how 'tort reform' will change that other than giving many of these mills larger stones (double meanings fully intended).

Start checking the Web -or- do you have any trips to Canada scheduled in the near future? Someone you know going there, maybe?

Scorpio, I'm not sure how Teresa's taking a trip to Canada would help. It's not as if pemolin can be easily obtained here (we banned it in 2000, and the drugs available under the Special Access Program aren't exactly easy to get at. As I understand it, your doctor has to apply on your behalf.)

Or am I missing something?

Stef, around the time when that became a profitable field for Republicans who toke to lend the libertarian label to.

TL = ssctn f Trl Lwyrs f mrc

Prtctd Sttc, vw Pblc Ctzn s ctng n bhlf f th trl br fr th crrnt sbst f ntnts nd prpss, s y r crrct tht ws nclr n my rfrncs.

'll vd dscssn f flvrs f lbrtrnsm nd th ncrrct ssmptns tht r bng drwn frm my s f th wrd ('v nvr tkd nr gn t chrch); shldn't hv rsd t n th frst plc prcsly bcs thngs r gng frthr ff tpc, nd ths sn't bt m.

Hyperilex appears to still be available in Germany, fwiw.

Anon, it's about you and in topic-drift because you're the one who brought in tort reform, and Teresa's views thereon. (BTW, I did not say that there were no justified suits against manufacturers. Or unjustified ones, either. Both exist.)

I'm delurking to answer Magenta Griffiths' question: ATLA, in this context, probably stands for the Association of Trial Lawyers of America (their website is http://www.atlanet.org/). Among other things, the organization is involved in trial advocacy, allowing lawyers to practice and refine skills that will allow them to advocate successfully in courtrooms-- and on both sides of the tort reform issue. While I am sure there are some ambulance chaser types within the association, I would hesitate to tar all of the member-attorneys with that particular brush.

Teresa (and Xopher): I am so sorry that this is happening, and I wish you the best of luck in finding a solution that will allow you to continue to work productively in jobs you enjoy.

Quoth Anon: I was offended by TNH's earlier attack which repeated a number of urban legends about litigation reform, including the mysterious idea that the McDonald's coffee suit was somehow justified[....]

Wikipedia seems to have a reasonably balanced article about that case. I dunno what exactly the standards are for justifying a lawsuit, and this other article about the case may fall under suspicion from those who distrust trial lawyers, but "[a] vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body [in the] inner thighs, perineum, buttocks, and genital and groin areas"? Ow. That's all I can say. Much ow.

Patrick (and Teresa):

Patrick, this is a comment that reflects back to my phone call earlier --- GET STEVE ELEY to include YOU *and* Teresa in that dinner with Senator Edwards.

Steve Eley? Willing to do so?

Teresa, Xopher,

I wish I could offer more than sincere sympathy.

I'm facing the possibility of losing my permanent desk at work, and with it the desk lamp that I use to fend off clinical depression in winter (thank you, SAD, my constant companion...) But if I lose my desk tomorrow, I have three months of no-life-but-light-exposure in my leisure hours while I try to keep my job and the respect of my colleagues. And then I have six months of normal-to-manic to arrange matters better for next year.

It scares me, but it's a smaller thing than you are both looking at. From my tiny taste of that fear, I can extrapolate a little of how you feel.

And Teresa, knowing that, I am impressed by the glee with which you saw in the New Year.

I've just seen this.

*HeadDesk*

Call Oprah. Get Nader and Teresa on the soundstage together with a live audience...

Anon: I apologize to you -- to the extent that I read into your post an attitude which you claim not to have. And it is not my place to invite you to get lost.

Steve: absolutely, talk to Senator Edwards about this. Maybe he has a family member/friend/fellow Senator with narcolepsy. It can't hurt.

full thickness burns (or third-degree burns)

I once had second-degree on one percent of mine (about the size of a hand), in a much-less-sensitive area. The ow doesn't compare, but it is really not fun. (A Sunday evening. Boiling water, safer than coffee because no oils in it. Went to doctor next morning. Why I keep antibiotic ointment around.)

A couple of years ago, a friend and I were discussion the steps that should be taken to survive and eventually florish if civilization collapses. I told him I'm dependent on civilization for antibiotics for recurring kidney infections (and now I need the exotic ones, as I've become antibiotic resistant). He said, what about cranberry juice? To which I replied, that requires a certain amount of civilization for processing and transport. He said, what would you do if civilization collapses? I replied,

Die.

If this keeps up, I won't have to wait for civilization to collapse.

Subsequent trials to relabel drugs for conditions other than the ones they were initially approved for are pretty uncommon - they cost a lot of money and don't really buy you anything other than more marketing freedom.

Google up "Attenace." Hint -- it's mentioned upthread.

Ths sn't th frst tm Pblc Ctzn hs dn ths: whn thy gt Ltrnx plld frm th mrkt n 2000, t tk BS sffrrs twnty mnths bfr thy cld prsd th FD t chng ts mnd, nd plntffs' lwyrs (nd thr prxs t Pblc Ctzn) fght t vry stp f th wy bcs t hrt thr chncs f jckpt jdgmnt fr th hndfl f ppl wh'd bn hrt by th drg. Chck wth bsgrp.rg; thy hv xprnc wth prcsly ths prblm, bt t's lng-trm, rthr thn shrt-trm sltn.

PJ, plgz; sncrly blvd tht t ws pprprt t ddrss th qstn tht thrs wr dscssng f why Pblc Ctzn nd th FD wld d ths srt f thng. Ths ws snstv sbjct t dlrk n, 'm nt rglr frqntr f ths prtclr cmmnt-brds, nd shld hv bn mr crfl t wrt n sch wy s tht thr ws n qstn f my ntnt, spclly snc s mny ppl rsrt t drv-by cmmnts npprprtly nd t ws ntrl Bysn ssmptn tht ws dng th sm. 'm tld tht ths s n spclly cls-knt cmmnty, nd, t th xtnt my jnng th dscssn ws nsnstv nd ntrsv, plgz. gn wsh Trs th bst nd hp sh fnds sltn t ths nfr prblm.

including the mysterious idea that the McDonald's coffee suit was somehow justified, and anyone who thought otherwise was a stooge or a naif.

Says all that needs be said, and removes any doubt, Good Day indeed.

Teresa, doing what little I can, letters to Senators, and a couple of reps. Hope, prayer and condolence.

TK

My sympathies to Teresa, Xopher, and other affected by this drug ban.

I have to wonder about the economics of the ban. Others have pointed out the legal implications re: lawsuits and Abbott's vulnerability to accusations of uncooperative behavior, and that certainly looks like a good reason for them to not fight a ban, but I haven't seen people crunch numbers on a dollar-per-person basis.

10,000 patients looks like a lot, but it isn't, in international pharmaceutical terms. This is especially so when some portion of those patients do *not* require the drug specifically banned, but have recourse to other treatments that will work adequately well for them. I've seen anecdotes in this thread for half a dozen patients; only Teresa and Xopher specifically give reasons why Cylert and only Cylert will work for them. At least one other patient has said that she gets adequate relief from a different drug combination.

Below a certain number of patients, it becomes unprofitable for a company to manufacture a drug (see 'orphan diseases' on Google for a list.) One article I skimmed mentioned 6000 such diseases, affecting 25 million Americans. Simple math gives a number of roughly 4200 sufferers per disease... except I recognize progeria on the list (about 10 sufferers per year) and Alzheimer's (at about 1,000,000).

I suspect that the ban did not get serious opposition from Abbott because a: it was in a vulnerable position regarding litigation; b: Nader's group was in a position to take advantage of that vulnerability, and c: the drug was not and had not been profitable for some time. Another company making a generic version is going to be in the same profitability position, if not the same litigation position; even if the FDA reverses its decision, the drug may not become available again simply for that reason.

If the FDA reverses, AND a generic is available, I would expect a price increase. The ban is going to chase some current users away, never to return, and is going to discourage new users from coming on board. Ergo, the customer base is going to be even smaller than it was, with everything that implies for the economics of production.

Best of luck; I think you're going to need all the luck you can get.

This is the email I just sent to the local affairs show at my NPR affiliate:

----------------------------------------

Linked from here:

http://nielsenhayden.com/makinglight/archives/007140.html#007140

This is an article on a blog that speaks to the costs of public activism.

Making Light was once listed on one of your shows as one of the best blogs out there. One of the hosts, a NY editor and writer named Teresa Nielsen Hayden, is also a narcoleptic. A drug she has been taking for 20 years (generic name: pemoline) has just been taken off the market because Ralph Nader's group, Public Citizen, pressured to FDA to ban it. They claimed it caused liver failure.

Apparently, there's only been one case of liver failure related to pemoline in the last six years when the big scary warning went onto the box. That's out of 10,000 people taking the drug.

Ms. Nielsen Hayden (yeah, that's her last name) has tried many drugs to deal with her condition over the years, and this is the only one that's worked for her. Without it, she will in all likelyhood be unable to work. Pemoline is also used to treat people with severe ADHD.

So, when does public advocacy begin to harm to the people it's supposed to help? When does a public advocacy group surrender to its momentum--hunting out issues to work on just because it has an apparatus in place to make protests rather than because there is a real danger to address? Why shouldn't patients taking a drug be free to take it no matter what the risks? Ms. Nielsen Hayden's doctor has been checking her for liver damage and she has suffered no harm--why does Public Citizen need to take that decision away from her?

Is this consumer activism, or is it making decisions for consumers that they should be making for themselves?

Love your show,

Harry Connolly

----------------------------------------

I'm now going to resend the email to national shows I listen to.

Anne KG Murphy ---

EXACTLY!

Teresa'd have him sliced and diced before he would even know he'd been rogered.

And an event like that would generate LOTS of heat. TV would love it.

The press and TV will also love it when (not if) Nader starts to refuse to face Teresa (or anyone for that matter) on this question, which is probably from the start. On Oprah: "Gee, why won't Mr. Nadar face little ole' me, hmmm? Me, just a simple tootsie?" Press eats it up.

Nader would send his surrogates, such as Dr. What's-his-face.

This is just one of among hundreds of possible tactics, *ALL* of which must be pursued. ALL OF THEM. This is a political campaign and must be recognized as such, and fought as such. It ain't going to be any small thing.

("Of course you realise, this means war!")

I do not see what exactly tort reform and the legal system have to do with this case, which I am given to understand results directly from an FDA decision, not a court. I am currently under the impression that it is a red herring dragged in here by someone with an anonymous axe to grind.

I don't actually have any educated opinion on tort reform. The only thing I really know about it is that is is pushed by people whom I don't trust.

Wikipedia:
"According to the 2000 edition of DSM-IV-TR, ADHD affects three to seven percent of all children in the U.S. According to 2002 data from the CDC's annual National Health Interview Survey, released in 2004, nearly 4 million children younger than 18 in the United States had been diagnosed with attention deficit hyperactivity disorder (ADHD)."

"It is estimated that there are as many as 3 million people worldwide affected by narcolepsy. In the United States it is estimated that narcolepsy afflicts as many as 200,000 Americans, but fewer than 50,000 are diagnosed. It is as widespread as Parkinson's disease or multiple sclerosis and more prevalent than cystic fibrosis, but it is less well known."

That's a lot of people. Maybe most of them don't need Cylert - but it's still enough to justify considering making it somewhere. (For companies who keep claiming it's uneconomical to make these drugs, the pharmas seem to be making nice profits on something. Possibly it's that they keep moving people to newer forms that they can keep the prices high on. [There's a story in today's LA Times about the Long Beach, CA, hospital that checks out drugs to keep costs down, and limits what the salespeople can do to push stuff. Educational.])

Harry, thank you. Stolen (with slight mods) and submitted to AARP, of which I am a member.

And angry letters sent to congresscritters, pointing out the financial side of this: A taxpayer is turning into a tax-user, putting more pressure on Medicare and other government subsidies.

And a very nasty one sent to Public Citizen. I figured they wouldn't pay attention to it anyway, so I allowed myself a slight bit of rudeness ("smooth move, ex-lax"). And said they should read Jack Williamson's "With Folded Hands." I don't know how many will, but one more is one more.

I've written my congresswoman and both Senators!

("Of course you realise, this means war!")

Teresa already did the earth-shattering k'boom part, so we're ready to go!

I've sent additional messages through the NPR story suggestion page, and also to To The Point, Talk of the Nation--Science Friday and the Diane Rehms Show.

I can't think of any more appropriate NPR programs. The NPR story suggestion page covers an awful lot of them.

Good luck with this. This sucks.

Patrick, this is a comment that reflects back to my phone call earlier --- GET STEVE ELEY to include YOU *and* Teresa in that dinner with Senator Edwards. Steve Eley? Willing to do so?

Unfortunately, it's not in my power. I'm not organizing this event, and I haven't actually met nor spoken with the senator myself yet. It was organized by a friend of mine who's helping Edwards produce his own podcast. It really is a small event -- I was specifically told there was no room to invite anyone else, even my wife. (Not that she's going to North Carolina with me anyway; I'm driving up mainly for a PodcasterCon, in which she's monumentally uninterested.)

So, I'm sorry. The best I can do is tell him about it, either on Friday night or later on if I can establish a relationship with him. Since this is a guy who's almost certainly going to run for President again in 2008, it can't hurt to give him one more government injustice to talk about.

Teresa & Xopher, my sympathies. Keeping my fingers crossed and all that.
Um, I read the thread in one sitting and without noting who/what I should email/call. If it's not too much trouble, can Patrick put another update on what we can do to help?
(Anyone know which senators/congresspeeps have the most influence on the FDA?)

PJ Evans:

You're not thinking like a corporation. 14,000,000 ADHD sufferers... and only 10,000 of them use Cylert? That's only ... uh, about .007 percent of the possible customer base. Considering the amount of time the drug has been on the market already, expansion of that percentage is unlikely (especially in light of the liver issues. We are talking mostly children, here.)

Narcolepsy is better; at 200,000 potential patients, one quarter of which have been diagnosed, you have about 20% using the drug. There's a potential to sell to 40,000 patients, there.

Except you don't; the 10,000 number is total users for all therapies, and some unknown number of those users don't require Cylert per se to get the relief they need. So, say half of the 10,000 are dedicated users who need Cylert as opposed to other therapies, with half going to ADHD and the other half to narcolepsy. At 5,000 users, you're getting really close to that orphan disease average of 4200. Taken separately, the numbers fall well short.

It's probably economical for a small company serving a niche to make the drug, but it needs a decent market environment (no ban) to interest one despite the distribution/advertising costs.

Harold Ickes is a famous narcoleptic. It's mentioned in this article in the last sentence of the sixth? paragraph.

Teresa, Xopher, this is horrible. I'm so sorry. I've drafted this letter to one of my senators: John Warner. (I can't stand Allen--Warner is the big cheese, anyway.) Legislators like to be seen acting in a bipartisan way, so I'm appealing to his ego a bit.

I need an editor: I overlook my own mistakes. Please offer suggestions/corrections. And yeah, I voted for Warner. He's our best defense against the far religious right in this state. Besides, last time he was up for re-election no democrat ran against him and he got 96% of the vote. Sure I'd prefer a democrat, but... this is Virginia.

Dear Senator Warner:

I’ve been a Virginian since 1989, and although I’m a lifelong democrat I’ve voted for you since moving to this state. You have an outstanding record of reaching across the partisan divide when circumstances demand it.

A drug called Cylert (the generic name is pemoline) has been banned by the FDA under pressure from Ralph Nader’s organization, Public Citizen. The drug has been linked to liver damage in a relatively small number of cases; there is a higher death rate associated liver damage caused by overdoses of acetaminophen (Tylenol). Although Abbott, the manufacturer of Cylert, stopped sales in May, their action is only now coming to the attention of many who are dependent on the drug, as their pharmacies run out of it and are unable to refill prescriptions.

Although the drug was approved for treatment of ADHD, it is the only drug that alleviates the symptoms of narcolepsy/idiopathic hypersomnia for many who cannot tolerate other stimulants. The drug has been prescribed for this “off label” condition since it was approved in 1975. Adult ADHD sufferers with heart conditions rely on this drug as well. For some, there is no other recourse.

The deputy director of Public Citizen, Dr. Peter Lurie, described Cylert as “an outmoded drug," but Dr. Lurie's residency was in Family and Preventive Medicine; he is not an expert in psychiatry or neurology. Nader’s organization no doubt needs the occasional success to continue raising funds, but they have taken this action without adequately investigating the uses of Cylert/pemoline.

I learned of this from an acquaintance in New York who suffers from narcolepsy, but who has been able to pursue a successful and fulfilling career as an editor at a publishing company, thanks to Cylert. She and many like her are outraged and panicked by the FDA’s buckling under pressure from Public Citizen regarding this drug.

As a result of what I and others have learned today, people in a number of states are writing letters to senators and representatives. Could you work together with others in the senate to reinstate Cylert/pemoline for those whose quality of life depends on it? You’ve reached across the aisle before with great effect. If hearings could be held to enable some of those dependent on this drug to testify, perhaps the decision of the FDA would be reconsidered.

Sincerely,

Protected Static said "I'd like to know Anon's IP address..."

I wouldn't usually hand that out; but for Anon, I'll make an exception. I'll explain my reasons if someone asks. All of Anon's posts have come from 69.143.115.175.

jennie,

rough translation of the German articles follows. Unfortunately my English is bad today.

***

http://www.akdae.de/20/20/Archiv/2000/20000211.html

This is published by the Medical Association, Department of Drugs, and aimed at medical doctors. It informs them on new regulations and recommendations because of possible liver damage through Pemolin (sold under the trademark "Tradon").

It was written Feb 11, 2000, so it's not exactly brand-new.

The article says, paraphrased:

Doctors can prescribe Pemolin against AHDH in children. It's not the first choice of drugs. It's not a controlled drug ("controlled" as in Opiates), but is has to be prescribed. It works slower than Methylphenidat, but as some patients do not react well to M., it's a useful alternative.

A side effect of P. it liver troubles in 2-3% of the patients. That's why it got withdrawn in the UK in 1997 and the FDA shoved it down the list of drugs-of-choice the same year. In Germany, the risk profile of P. was re-evaluated.

The manufacturer will inform the doctors on details, a short list of relevant points:
- P. may be decribed only by child- and youth psychatrists, and only after Methylphenidat and Amphetamine failed.
- Progress must be evaluated after three weeks, if no progress, stop the drug.
- Do not prescribe to people with liver damage. Do not combine with other stimulants or tri- or tetracyclical antidepressiva. Do not use to treat muscle illnesses.
- Check for liver troubles every two weeks.
- Stop if liver troubles appear.
- Tell the parents about the risk.

They ask that the doctors' association be informed if a doctor discovers a case of side effects

***

http://www.adhs.ch/add/pemolin.htm

This is new (May 8, 2005). The artical has been written by two medical doctors, but it adresses patients suffering from AHDH.

They warn at the beginning that people getting Pemolin, Tradon(R), Hyperilex(R) or Cylert(R) for AHDH should *not* stop taking their meds because of the info in the article: They are only telling you the news.

The article then quotes a memo from the drug manufacturer Lilly, dated Feb 3, 2000, which says the same as the akdae.de article in less jargon.

Then they speak of rumours that Tradon(R) bzw. Hyperilex(R) won't be available anymore, because of potential liver damage. They note that the described side effect is rare, and that the drugs in question have worked very well for a lot of patients. However, they fear that PR considerations by the manufacturer might get the drugs off the market.

If you have been taking the probably-soon-disappearing drugs, you might try international pharmacies. The article then lists other drugs one might want to try, some of them experimental. They end with, "talk with your doctor".

Further paragraphs give background info on Pemolin, lists names it is sold under (Tradon(R), Hyperilex (R), Cylert(R)), inform on dosage, risk (refers to the FDA warning strongly agains the drug), lists considerations for the prescribing doctor, and quote a study on the effectiveness on P. in adults with ADHD. Also, usefulness for children with ADHD, a warning that you should't stop taking your meds, and a summary.

The summary says: We got lots of questions on Hyperilex (R). This is not a new drug. It has been proven useful for adults, although newer drugs do better on tests. Harmful side effects are rare, but severe. Try everything else first. Due to the drugs bad international repute, use very carefully or not at all on children.

***

I can do a better translation given some time. If anybody would like one, my e-mail adress is valid.

Theresa, Xopher: I wish you success in finding a way around this stupidity.

Here's another place to send an essay: Newsweek's My Turn column.

Those numbers are US only - there must be a lot more people than that in the world. I didn't go looking for how many are using this drug; I wondered how many have these conditions. Worldwide, there might be enough to make it worth covering as an orphan drug, or to make it worthwhile importing from someplace where it is made. (Google gets more than 2 million hits on narcolepsy alone. Didn't Google ADHD, that would be horrendously large.)

I've written to MoveOn, citing the Nader angle. Maybe it will light another fire. (I don't think they're too fond of him.)

Boy, folks in Arlington spend a lot of worktime reading blogs...

On second thought, I'll explain right now why I'm willing to finger Anon: my weblog is not a billboard for political astroturf. If Anon's employers want to see their message here, they can buy ad space.

I linked here through Bruce Baugh's blog. Teresa, I am truly sorry for the travails you may be about to face. I have done what little I can: I passed this URL on to a friend of mine who is a reporter for Bloomberg in NYC. I don't know if it will do any good.

Sending good thoughts your way.

If any of you haven't written to your Representativ and your Rep. is listed here as a member of the Health subcommittee of the House Energy and Commerce committee, please do so. I'll be writing to a nearby NJ congressman, as my rep. isn't on the list.

In the Senate, the relevant committee is the Committee on Health, Education, Labor and Pensions. (An odd collection of interests which I think was chosen for the acronym) Note that Senator Clinton (NY) sits on this committee. (Sadly, neither of my senators is on this committee)

Anyone know someone who knows someone who can whisper this issue into Bill Frist's ear? He's kind of had a minor political cloud hanging over him since the whole Schiavo fiasco, but he was at some point a doctor and might have some direct understanding of the careful weighing of side effects. (Both of Tennessee's senators sit on this committee)

Unfortunately, the only people I know in Tennessee are: 1) mostly apolitical, 2) Democrats when they aren't apolitical, and 3) only recently Tennessee residents.

Teresa, I've e-mailed Oprah. My address and phone: they should be able to find you though. They have a show upcoming on prescription drug use. You might want to fill in that form; they want things like address and phone; I didn't use that page (secure site). (I don't think this was what they had in mind, but it's strictly according to topic.)

Cln: th FD dsn't prt n vcm. Thy md th dcsn bcs thy wr lbbd by n nstttn hpng t hlp trl lwyrs n ltgtn. Th mnfctrr thr fnd t t xpnsv t rspnd r ddn't wnt t rsk bng ccsd f pttng "prfts bfr ppl," whch s wht Glx s stll bng ccsd f bcs t fght gnst Pblc-Ctzn/trl-lwyr-mtvtd bn f drg crtcl fr mny BS sffrrs. Tht's wht th ltgtn systm hs t d wth ths cs.

Rn: Bcs f th blck-bx wrnng n th drg, nd th fct tht sls dclnd 75% ftr th wrnng ws mpsd, strngly sspct tht th mjrty f th ppl tkng Cylrt wr dng s bcs t ws th bst ptn fr thm; ths tht hd bttr ptns lrdy swtchd. Th nmbrs fr cnms f scl r rlvnt fr >dvlpng drg; ths s drg tht lrdy xsts, s th rsrch-nd-dvlpmnt csts hv lrdy bn spnt, nd th mrgnl prdctn csts r cls t zr. Th nly rsn t wldn't b prftbl t cntn sllng th drg s bcs f th ltgtn rsk. (Wll, n thr rsn: f bbtt hs ptntd drg tht's sbsttt fr Cylrt, thy'd wnt th gnrc cmpttn ff th mrkt. dn't knw whthr tht's th cs.)

Stv, wsh yr mssn wll, bt Jhn dwrds hs nvr crssd th ltgtn lbby n hs crr. n 2004, whn t cm tm fr Krry/dwrds t dcd whthr t ws mr mprtnt t bt Grg Bsh r prpnd th mst rdcl gnd f th trl lwyrs t th cst f 2-3% f th vt, thy tk th lttr crs. (t's sd trnd fr th Dmcrtc Prty: Snt Mnrty Ldr Hrry Rd, n prpsng Sprm Crt nmns, sggstd fr frvntly nt-chc Rpblcn sntrs, fr th sl rsn tht ths wr th fr mst prmnnt ppnnts f ltgtn rfrm; th Dms r s n thrll t th bllns f dllrs md by plntffs' lwyrs tht thy'll vn sll t R rthr thn spprt th mldst f rfrms tht bnft mrcns s whl. frmr cllg f mn wh srvd n th Clntn dmnstrtn ws pplld t th rsstnc sm lmntry cmmn-sns rfrms gt nd hs bn nfrly ttckd fr hs spprt f clss ctn rfrm.) smhw dbt dwrds s gng t strt crtczng Pblc Ctzn nw, bt lk frwrd t hrng hw yr cnvrstn gs.

Jl: typ fst nd wrk mst nghts. Bt thnks fr th glt n rmndng m nd t gt bck t my rtcl.

Trs: Thnks fr cnfrmng tht ws tllng th trth whn gv t my P ddrss. t's nw SP tht rplcd my prvs n tht stppd srvc t my prtmnt-bldng Dcmbr 31. 'm srry y dn't blv smn hnstly spprts ltgtn rfrm bcs f wht th stts q ds t ppl lk y, nd tht y'r mkng ths bt m rthr thn my ds. stll wsh y th bst, nd sncrly hp y cn fnd sltn. D tlk t th BS ppl, bcs thy sccdd whn thy wr n th sm bt y wr n n 2000.

A few thoughts:

Another venue to publicize this issue might be the Phoenix-area newspapers, since there's a local connection thru your family. (Might be best if the initial contact came thru a family member here.)

The Arizona Republic's health reporter is Mary Beth Fuller, 602-444-8167. The East Valley Tribune has no specific health reporter listed, but suggestions for news stories can be sent to newstips@aztrib.com.

Another thought: I know you left the Mormon Church a long time ago, but you and Patrick have both mentioned being Christians. Do you have a particular sect or church, that word could be spread thru the church network? (For that matter, could your family use the Mormon network on your behalf?)

A lot of the advice being given here essentially boils down to 1) pressure your Congressmen to reverse the FDA decision, and 2) spread the word so that even more people will pressure their Congressmen.

The thought occurs, especially seeing how rapidly people are responding to and spreading your post, that dealing with this issue may displace your editing as your primary occupation. In short, you may end up having to become a public spokeperson for narcoleptics, whether you want to or not.

I will send letters to my Congressfolk by tonight.

I'm trying to sort through that special access page for getting the drug in Canada and figure out how that works.

If it involves coming up here, please add Ottawa to the list of places where there's a spare room near good transit, which you may use anytime.

(Xopher, you too, though in that case the actually not very difficult step of locating someone both of us have met in person who will tell me it's safe to give you my street address and you it's safe to show up at it is probably involved. I estimate this will take four seconds.)

Anon: you're making this about me rather than my ideas.

That's because it is about her. In it's simplest and most direct form. Her blog, her health, her life.

Regarding hazard information for drugs and patient decision-making:

I once was prescribed a drug (for a non-life-threatening condition I didn't have, as it was the first visit to that doctor and he didn't have a full history). I read the information pamphlet, which said that use of the drug had a 16 percent chance of resulting secondary infection from something else. I chose not to use it - 1 in 6 is a fairly high risk, IMHO.

For people with narcolepsy, what about Xyrem?

Lin Daniel ---

Ah, c'mon; that's the only time in years I've been able to make a Looney Tunes reference! [grin]

Harold Ickes a nacrolept: That's political capitol that can be used; a-yup.

The guy who ran the Johnson Space Center for years and years, George Abbey, is a narcolept. FWIW.

Tim - and "earth-shattering k'boom" is overused

--I've just sent email that should get to my cousin who is a big name at the Arizona branch of the Mayo clinic, asking does she know anybody else who's cage we can rattle.

Congressional letter writing will commence this evening. All Dems so effectiveness may not be high, although Patty Murray is on the Health, Education, Labor & Pensions committee and Jim McDermott is always going on about health issues.

I wish there was more I could do and some comfort I could offer.

And you're totally right F*ck Ralph F*cking Nader.

De-lurking to report I fired off emails to my Senators / Congressman urging them to get a clue. I live in Chicago, IL area, so hopefully if a few different congresscritters get pinged in this, some action will result.

My sympathies.

I sent an impassioned plea to my local news agencies, including the local NPR station with links and everything. I'll be looking into sending a copy of the email to my local representatives. Kudos to Diane Duane for the link off her blog.

A little bird has suggested that Waxman might be a useful man to contact.

inge,

Thanks for the translations/summaries. That's more or less what I thought the articles might say, but my notion was extremely hazy.

Wow, on my own behalf I'd like to thank those of you who've written letters to congressbeings of various types. I'll do that a little later (as in later tonight). My Congressman just moved up to the Senate after Senator Corzine got to be governor, so I don't know who the interim congress(wo)man is or will be.

Steve Eley, I'd certainly be willing to be interviewed. Teresa would make a much better subject, I think, but if you want me, you got me.

I just found out that my pharmacy still has some Cylert, so I'll be OK for another month (they won't give me more than 30 days' supply, because it's a Controlled Substance). I've emailed Patrick and Teresa with the contact info for this pharmacy.

Andrew Hackard: Thank you for reminding me, a high school classmate of mine works for WNBC NewsChannel 4. Let me try to contact him.

Jennie-- Thanks so much for editing my letter. All your suggestions were definitely improvements. I'll send it off tomorrow, when I'm back at work and my professional signature will automatically appear at the bottom of the letter.

blahblahblah ~ -> nslookup 69.143.115.175

Non-authoritative answer:
175.115.143.69.in-addr.arpa name = pcp09268001pcs.arlngt01.va.comcast.net.

DC, hello!

Well, I started just skimming posts after a while, so pardon me if I repeat anything here.

First of all, how f*cked up is that?

Second, I'm not sure how much help the "local papers" will be... even considering the fact that Teresa's local paper is the New York Times. My humble opinion is that you ought to go for national T.V. "60 Minutes" or "Frontline". You know, think big. There are some interesting angles to this story that just might intrigue them.

I have a friend who was an Associate Producer on some "Frontline" documentaries. I believe she's living in Ireland at the moment, but I imagine she's still in touch with a people or two who might be interested in looking at this. If you want me to track her down over there, lemme know.

Third, if you haven't already done it, I'd also suggest tracking down a lawyer who's got some knowledge of, and/or experience with this sort of thing. Public pressure is good. Excellent, in fact. But a lawyer who knows how to apply the right screws can be a big help, too.

Sorry if I didn't add anything new to the discussion.

I don't mean to be disrespectful or snotty or stuff like that, but what can a lawyer do? Specifically? I can't see myself going to a lawyer and saying "the FDA just discontinued my favorite drug; I want you to sue..." What can I ask a lawyer to do for me?

I'm so sorry to read about this!

For what it's worth, I have just written to Jon Carroll of the San Francisco Chronicle. I hope that he can help- it seems like the kind of thing he could write very well.

If anyone else has more pull with him, perhaps they could use it?

Harold Ickes Harold Ickes Harold Ickes.

Tim, can you reach him? I'm going to try my own route too.

Teresa and Xopher, I'm so sorry. A similar thing happened to a friend with diabetes who took Rezulin. It's been removed from the market because of potential liver damage, and now his blood sugar zings up and down. His liver's fine, though.

My congressworms are all Republican--remember John Cornyn, box turtles, and activist judges?--but I'll try to talk to them again.

Wishing you peace, with or without more Cylert. I still cling to Patrick's Christmas from a few years ago: Fear not. I realize this is a pretty tall order when faced with some of your top nightmares.

I don't mean to be disrespectful or snotty or stuff like that, but what can a lawyer do? Specifically? I can't see myself going to a lawyer and saying "the FDA just discontinued my favorite drug; I want you to sue..." What can I ask a lawyer to do for me?

What can a lawyer do for Patrick and Teresa in this situation? He can tell them something neither you nor I can tell them. To wit, what a lawyer can do for them in this situation.

What can a lawyer do for Patrick and Teresa in this situation? He can tell them something neither you nor I can tell them. To wit, what a lawyer can do for them in this situation.

I'm looking for a generic list of things to ask, so I know what kind of lawyer to get. They specialize, you know. And I'm actually asking for myself as well as for Teresea and Xopher, as I expect this will happen to me and I like being prepared.

Keywords for searches in FindLaw searches, federal statutes, federal regulations, proposed statutory and regulatory changes, would help, as I truly despise not knowing if my paid expert is an expert or only an ex-pert.

This happened with my favourite (old, cheap, reliably effective) migraine medicine here in France. Now I wonder... if you email me all the possible names for your medicine, I could look for it here in case it's still sold, and send some to you? And unless there's a huge discrepancy in prices, perhaps you could send me Migril in exchange? (ex-Glaxo-Wellcome, now CP Pharmaceuticals, I think; Ergotamine tartrate 2mg + cyclizine hydrochloride 50mg + caffeine hydrate 100mg)

Teresa, Xopher, Patrick, this is horrible. Since I'm on the wrong side of the pond I don't think there's much I can do, but I've emailed an American friend who's knowledgeable and vocal on issues relating to quality of life for the chronically ill (narcolepsy isn't her field, but maybe she knows someone) and I will pass on the word to anyone else I can think of. We must win this one. Chin up.

I'm looking for a generic list of things to ask, so I know what kind of lawyer to get.

If you have a lawyer that you trust now, you should describe for her the situation and ask her if she can refer you to someone who might be able to help you. If she can't, ask her if she can ask around for someone who can refer you to somebody.

I work in a law office. You'd be astonished how "networked" lawyers are... people they went to school with, people they've met through professional associations, people they've gone up against in court. And so forth. Lawyers are in the best position to know whether another lawyer is competent.

If you don't have a lawyer right now, query your own personal network until you find somebody competent.

I am more and more of the opinion that your www.Flesh&Blood.net is a hell of a lot more reliable for this sort of thing than the World Wide Web could ever be.

I've sent a letter to my congressman, John Dingell, who is an ex officio member of the subcommittee on health.

FDA aside this is going to be tough. My husband works in biotech and we hear over and over that the big pharmas are less and less interested in anything but making blockbuster drugs. Best hope is that the FDA will reconsider their ban and the generic will be available. Eventually the drug marketplace will change with small companies doing the research and the giants doing marketing, manufactering and distribution. This is not a good scenario for people needing small market drugs and I'm sorry to see Teresa and Xopher get caught by it. :-(

Two more people to write a letter and/or e-mail to:
1) Bob Dole, because he's incredibly well-respected and he was the go to guy on the Americans with Disabilities Act. I know he's no longer in Congress but his wife is, isn't she? and as I said, he has Respect.
2) John McCain. Whatever you may think of his politics -- he HATES bullies.

TNH - sorry to hear about the loss of pemoline.

Short term: go to the online pharmacies and stockpile as much as they will let you. It's faster than calling local pharmacies, and they balk less at large orders, though with scheduled drugs, they might scrutinize your order a bit more. Get your doc involved by calling those scripts in.

Long term: what everyone else is already doing.

Sorry if this has been mentioned before--but when people brought up Harold Ickes as someone who has narcolepsy, that made me think of Jimmy Kimmel. Not exactly politically powerful, but.

Oh, hell and damnation and my deepest sympathies.

I have inattentive ADHD which can cause me to suffer from EDS and I wouldn't wish it on anyone. I'm glad that pemoline was pulled back from front-line usage for ADHD, but it's despicable to stop production completely. Yes, there's a risk... but there are risks with all drugs that alleviate suffering.

I've got an email ready to send to Boxer and Feinstein, but before I send it I wanted to ask if this would be considered "Drugs" or "Health"?

I would consider it "health."

Teresa, I can't imagine how infuriating and awful this must be.

I wouldn't expect this avenue to go anywhere really, but the Ombudsmans of the FDA's Center for Drug Evaluation and Research, Warren Rumble, can be reached at 301-594-5480. It could be helpful to have a complaint on file with them that you can cite when talking to media.

http://www.fda.gov/cder/ombud/default.htm

Nancy Wallace: They don't have the same set of categories. Feinstein does have Health/Medicare. I had to use 'drugs' on Boxer's site; she didn't have anything else suitable, but there is a 'subject' box to fill in, IIRC. My congresscritter doesn't have e-mail available, as far as I can tell (poor site design, contact requires going through a questionnaire on whatever he thinks is currently important.)

Delurking just to say how terribly sorry I am that such a worrying cloud would be cast over your festive season. Not that it'd have been any better at any other time of year, but... The very best wishes to Teresa, Xopher, and anybody else affected by this. There's sadly nothing much I can do from this side of the pond, but I wanted to say that the incredible amount of activity from everybody here is really inspiring.

*relurks*

It strikes me that as we are writing our congresscritters etc., we should all of us also be firing off letters to Public Citizen to let them know that they're not going to get away with this.

It also occurs to me to ask whether anyone here has posting access to /.? That's an easy way to get the word out to a much wider audience.

I'll just add my voice to the chorus. This completely sucks, I'm sorry it's happening, and where can I go to rip off Nader's nads? I've emailed all my relevant senators and congress people.

Theresa, I'm adding my voice to the chorus, this just sucks, and I'm hoping something can be worked out.

I did send an email to Sen. Judd Gregg, (I'm in NH)he's on the Senate Committee on Health, Education, Labor and Pensions. And while he isn't my senator, I'm terribly fond of Ted Kennedy, so I sent a copy to him as well.

This is unfortunatly not the type of thing to be posted to /., as it's the wrong field for them. I saw someone say something about Daily Kos...the other major politcal/legal blogs are where I'd put this. I don't have posting access, but I may have access to people who do.

On the lawyer thing...Teresa, Patrick, I know you guys have a phenomonal network of your own, but if you want me to pull potential names from mine, let me know. Lawyers are one field where I know far too many for my own good.

Another route to think of are your professional associations with lobbyists. You are a reasonably well known editor with a not-small house. If part of your dues go to paying for someone in Washington, why not use them? This effects your work. If I knew anyone on pemoline in real estate (and now that I'm thinking about it, I may. So I will follow this up locally) I'd tell them to go to our NAR lobbyists. And it's another route to try for everyone effected.

One strong point in favor of Kos: the desire to do unpleasant things to Nader is extraordinarily powerful there.

Today's robber barons head up Big Pharma?

A couple years ago, the DP supply in the USA had dropped down to where there was ONE manufacturer/supplier with it on-hand and in continuing manufacture, a non-profit drugmaker most people are unaware of that is making drugs and putting the income above expenses in theprogram, back into R&D and making orphan drugs that the for-profit companies decided to not bother with (not not bother also suppressing... the Wall Street Journal a year or so ago had a front page column about a situation where a company developed a drug for allergy sufferers, that enabled people deathly allergic to peanuts, to be able to eat a half a peanut without untoward effects. The drug had gone through the approval cycle, and got pulled before being commercialized--the Big Pharma company which had bankrolled the small new company which developed and tested the drug, decided it was competition for a drug the Big Pharma company was in the development process of--not ready for trials, even was the Big Pharma's project--, and forced the company it had invested in, to discontinue its plans for sales, production, and distribution).

The drugmaker that was making the DP? [used to be DPT, but dropped the T apparently... I thnk it was the tetanus part of the shot that got dropped]? It's the Commonwealth of Massachusetts.

Steve Ely - Write this up. You may not get a chance to say much to Mr. Edwards, but you will almost certainly be able to hand him something and ask him to look at it when he has time.

I'll write my people, just to add a snowflake to the avalanche.

This is a terrible situation. I can't imagine what it would be like to be denied essential medication.

It is ridiculous that the FDA will not allow doctors and patients to make an informed risk-benefit analysis and decide whether to take the drug (or not). I suspect that part of the problem is that some doctors prescribe whatever is well-advertised or pushed by the local drug rep without determining if it is the best course for the patient, putting some of their patients unnecessarily at risk for complications (although it sounds like the 1999 warning label did its job). Drug companies that want an excuse to discontinue a less profitable medication are probably quick to comply with the FDA without putting up a fight. Ultimately, the people who lose are those that really do need the drug, in spite of the possible side effects.

Upthread Daniel Martin pointed to a couple of the Congressional committees to target with letters. Those do seem to be the most appropriate. I thought I would expand a little with a longer list. According to the FDA, these are the Congressional committees with "FDA-Related Responsibilities":
Senate
(click on the links to the full lists of committee members)
- Committee on Appropriations, Subcommittee on Agriculture, Rural Development, and Related Agencies

- Committee on Health, Education, Labor and Pensions

House of Representatives
(click the links to see the lists of committee members)
- Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies

- Committee on Energy and Commerce

-- Committee on Energy and Commerce, Subcommittee on Health

-- Committee on Energy and Commerce, Subcommittee on Oversight and Investigations

- Committee on Government Reform

-- Committee on Government Reform, Subcommittee on National Security, Veterans' Affairs, and International Relations

I imagine that a letter to my own local Representative or a Senator representing my state would carry more weight than a message to a Congressperson who does not directly represent me, so that is where my letters are going. The FDA has clearly shown that it is vulnerable to political pressure; I hope we can make a difference in this case.

Teresa and Xopher, you have my deepest sympathies and my prayers. This is mind-crunchingly fucked-up and hits terrifyingly close to home, as my bipolar disorder is also managed by a particular combination of drugs and I can very easily imagine finding out in this fashion that one of them's been banned and going back to suffering full-blown suicidal depression or wacked out mania while I search for a new functional cocktail that may not exist. (I have, in fact, been imagining this in a state of genuine horror for the last hour since I read this post.)

Anyway, I've written to Sens. Allen and Warner and Rep. Davis, for what it's worth.

Peace to you, and justice.

- Mike

the NYC FDA office is at:
158-15 Liberty Ave.
Jamaica, NY 11433-1034
(718) 340-7000

How about staging a "sleep in" to protest?

Lin: this was an FDA decision. A DC lawyer specializing in pharmaceutical issues can draft a petition the appropriate FDA channels and start the wheels moving to try to reverse the decision.

Now, gosh, who might possibly specialize in pharmaceutical legal issues? Could it be the person who came to discuss pharmaceutical legal issues who you just chased away for failure to toe the party line?

For some reason (possibly related to Martian Death Flu or medications thereof), now I'm trying to envision a post that combines tort reform, slumming, and prime numbers. Surely it would be the conceptual equivalent of simultaneously juggling a kitten, a torch, and a chainsaw, each one of them awake and angry in its own peculiar way.

Boxer and Feinstein have mine now...

(My wife has MS, but doesn't need this group of meds quite yet.)

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Sorry, what I meant to say was: are you genuinely willing to help out here, Anon, or do you only help needy cases who manage to remain solicitous even after you have gone out of your way to offend them? At the moment I suspect the community here would take any help they can get, without demanding an immediate political change of heart.

Because what you appear to be doing in your last message is the equivalent of burning banknotes in front of the homeless. Please tell me that's not the case.

I bet she/he/it isn't even a real lawyer.

More letters sent to Murray and Cantwell.

God, I'm so sorry.

The situation in Canada is a bit more complicated. While permoline is not generally available there is a Special Access Programme for those situations in which the treating physician deems use of pemoline necessary.

For details see:

pharmacy.dal.ca/youcanfindit/discontinued.html

I don't know:

1. if the end of production in the US will curtail this program,
2. if the information I have is still current; or
3. if there is a similar program in the US

but it may need something that deserves more research.

- Bill Seney

Meredith suggested contacting Public Citizen. Here's the link to the contact page for their Health Research Group.

Failing that, the e-mail address for that part of PC is hrg1@citizen.org

I don't know how much I'm willing to give Public Citizen credit/blame for this. Yes, I realize they want very much to claim credit— and the more I read about this, the more it boggles my mind that anybody could honestly claim that this effort was intended to serve the public interest. Still, I know some things about Abbott Labs— since my father retired from their laboratory equipment division a few years ago. I will freely confess: I'll need to be dragged kicking and screaming into admitting that Abbott Labs might ever put the public interest before even the whimsical fascinations of its preferred shareholders.

Go ahead and kick Public Citizen and Ralph Nader. It sure looks like they're not on the side of the good guys here. Still, I have a question: is Abbott Labs really all that broken up about the FDA having banned generic pemoline? Is it possible that Public Citizen is doing their dirty work for them? Just asking...

I'm so sorry to hear this. I'm a scientist in Sweden currently working on a solution to a similar problem (including MS fatigue), and I know how devastating this kind of problems can be.

1 in 10 000? That's so low a risk I doubt it's even been statistically confirmed. You'd need a massive number of people just to discriminate the extra liver failure from chance.

What worries me is what happens when they look at the drugs for controlling schizophrenia. They have severe side effects, like total collapse of the bone marrow, but before we had them every other hospital bed in the civilized world was occupied by a schizophrenic.

Still, I guess Tom Cruise is happy...

I have to add my words of sympathy. I'm a male with fibromyalgia and thus have somewhat tenuous access to serious pain relief, but I can't imagine what it would be for me to lose a medication so vital to functioning.

I'll write my (Oregon) congressmen on this - thanks to those above who've shared their letters. And best of luck, Teresa, Xopher - may fate swing back around.

Oh God. :(

I'm terribly sorry. My best wishes to you (and to Xopher! too) as you look for a solution.

Rebecca

"A DC lawyer specializing in pharmaceutical issues can draft a petition the appropriate FDA channels and start the wheels moving to try to reverse the decision. "

a lawyer for tort reform eh?

Teresa - Sorry and shocked to read about this. Unfortunately, I no longer have a local Congressperson to whom to express my outrage.

Dexamphetamine sulphate is currently available in Australia via the pharmaceutical benefits scheme for narcolepsy (PBS listing). I don't know where we get it, but it perhaps suggests an alternative supply exists... Of course, this may mean you have to move to Australia.

OTOH, I will be coming from Australia to Boskone. If Damien is correct, perhaps there is something I can do from this end. If so, please feel free to let me know. Hang in there.

Best of luck finding a solution, Teresa -- but thanks to the networking powers of blogging and the Internet, your chances are better than bad.

Don't lose hope; as you can see, people are coming together to help. I'm sure it's going to work out somehow.

I did a Google search on pemoline in Scandinavia... it seems to be unavailable or restricted here, and is mentioned in the local news only as a "banned substance found in athlete". :(

Here is a link to the registered suppliers of Pemoline

http://www.buyersguidechem.de/AliefAus.php?pname=Pemoline&pnu=550505757755&cass=

There are 2 US, 3 German, and 3 Chinese companies. There are corporate web pages and email links.

To review possibilities: US, England, Canada, and Sweden are out. Someone in France offered to inquire there. Other EU countries should be checked (especially Germany).

While there are potentially risks of not getting what you think you're purchasing, India, China (Hong Kong especially), and Brazil seem good candidates, since they are perennially fighting with the West over production of generics. I'll talk to my father and see if he can find out anything about acquiring drugs in India.

Apologies; I never should've been anonymous; I never really was, and it made it look like I was hiding something when I wasn't.

"A DC lawyer specializing in pharmaceutical issues can draft a petition the appropriate FDA channels and start the wheels moving to try to reverse the decision. "

a lawyer for tort reform eh?

Yes, Bryan. A lawyer for tort reform. Because, like it or not, that's what Teresa needs right now. Because we're the ones who have been arguing for years that the FDA, at the behest of organizations like Public Citizen, make far too many mistakes like this--I repeated that argument in a paper I wrote just last month on the Vioxx litigation.

If narcolepsy sufferers are going to get the FDA to reverse this decision, John Edwards and his ilk are going to be the one who are fighting to keep the drug banned. How do I know this? Because this is not the first time this happened. As I said in a post that was disemvowelled, IBS sufferers had the same problem with a Glaxo drug and Public Citizen, were facing the end of their productive working lives, and had to fight extensive trial lawyer lobbying before the FDA would make a decision based on science, rather than based on the plaintiffs' bar's economic interest in soaking pharmaceutical companies.

PC already knows that their lobbying hurts people like Teresa. They just don't care. Teresa and regular people aren't their constituency except to the extent their interests coincide with that of the trial bar. So lobbying them is like making a personal appeal to Stalin during a purge. It greatly misconstrues who's on and against your side. This isn't an aberration; this is what Public Citizen does.

So, yes, I came here, and suggested that this was an opportunity for Teresa to reevaluate her views towards tort reform, pointed her to a (non-ideological) organization that has experience dealing with this problem, the IBS Group, and apologized to the extent people misconstrued me as attacking Teresa. This isn't neener neener neener. It's a sincere request for Teresa to help herself by joining a cause that has been trying to help people like her for decades, even as she unfairly characterizes it as a giveaway to corporations.

This isn't about solicitousness. Teresa has the right to disemvowel my posts. But I have dozens of projects on my to-do list, and can't possibly do all of them, so I have to pick and choose. A NH fan pointed me to this site, which I hadn't read in a long time, and I thought this might be a promising real-life example of how trial lawyers hurt people. (More data is needed; this situation might reflect other economic circumstances rather than litigation-related ones.)

I would like to make this one of my causes, because the abstract idea of "Type II errors" hasn't been persuasive without a human face of someone suffering because of those false negatives.

If there's someone out there whose problem I can highlight that I can write a prominent op-ed about who won't turn around and make incorrect accusations about that cause to the world, I can do it. Teresa doesn't want to be one of my causes. That's her right. I respect that. It's her right to decide that only voices on one side of the discussion should be heard on her site and others should be disemvowelled; I respect that less, but it's her right. It's everyone's right to decide that they only care about pemoline, and are willing to let the FDA and Public Citizen go on and do this to someone else for some other drug next year. But that means I need to turn my efforts to causes that are more likely to produce larger positive results.

I've gone on too long as it is, since there's a great chance this post will be disemvowelled, too. But I really do wish the best for Teresa; I'm sorry that her cause is also a cause she's mistakenly long opposed, and hope she can find a solution she's comfortable with, and am sorry that she doesn't want me to be part of that attempt at a solution.

Again, I apologize to the extent that people think I'm being inappropriate or insensitive. That has not been my intention, and I'm truly sorry to the extent I've failed to execute my intention to be helpful; if I were more persuasive, I could do more to help.

If there's someone else out there who is suffering from narcolepsy or ADHD who really needs pemoline, and is willing to be a public face on this issue, I'm still interested.

wow, that's pretty noble. and he wasn't ever really anonymous either you know. I'm sort of misting up over here.

If there's someone else out there who is suffering from narcolepsy or ADHD who really needs pemoline, and is willing to be a public face on this issue, I'm still interested.

There's no question that sometimes the course of events marries strange bedfellows, and a lot of times people with normally opposing interests can unite on a particular issue. One of the most obvious recent examples would left-wing and right-wing groups uniting to resist elements of the Patriot Act.

But really, a lawyer's first obligation is to his or her client's best interests. I take it you believe that the interests of your cause and Teresa's and Xopher's interests exactly coincide, but suppose at some point they diverge?

How would you go about assuring someone who might consider engaging your services that your best efforts will be directed toward their personal best interests and not the best interests of your cause?

I repeat: I assume you believe there would be never be any divergence there, but you can't really guarantee that. So where would your loyalties lie?

I am sorry for your despair over the loss of effective treatment for your narcolepsy.

The meaning of my nom de plume is that I am a homeopath, and became one because of the serious, intractible illness of my children. Homeopathy helped them. A good homeopath can help you. I can help you find one. Email if you wish, take out the *DELETE* and you've got my address (I don't want a spambot to harvest my address - happened before, not pretty!).

I am so sorry you will have to suffer at the hands of Collective hysteria generated by the likes of organizations such as Public Citizen.

Think of the horrible misery hundreds of millions have suffered when such Collective hysterias banned the use of DDT to fight the dreaded disease Malaria. It is awful to think we have the ability to help save human lives but help is denied by collective thinkers who rightously believe junk science uber-alles for the purposes of serving the greater good.

Here's the way I believe it went down:

Abbott dropped Cylert, claiming poor sales.

Public Citizen petitioned the FDA to have the generic product, pemoline, banned.

The FDA complied.

Meanwhile:

http://www.pemoline.com/

Not too useful, but there is a discussion board.

Narcoleptics:

Sorry for your dismay.

Ralph Nader had nothing to do with this. He hasn't had any official involvement with Public Citizen for 25 years. Blaming him is like blaming George Washington for invading Iraq.

And unless I am mistaken, the Food and Drug Administration regulates prescription medication, not Public Citizen.

Your ire is misplaced.

Tell you what, Ted, let's see your op-ed. After it's been published perhaps we can talk more.

syn --

DDT stopped working at killing mosquitoes. (Very short generation times = very fast evolution, even against neurotoxins.)

It didn't stop working at killing everything else in the food chain; that would have taken rather longer. It's been close to fifty years now, and the raptor populations in NorAm are only just clearly starting to recover.

There are plenty of human nasty health effects, as well. Not what could be described as a net win.

None of this is the least bit controversial in the peer-reviewed scientific literature.

I'm not proposing to create an attorney-client relationship; I don't have malpractice insurance, so I wouldn't be representing anyone. I have other attorneys in mind for that--whether they'd do this pro bono, I don't know. I'm proposing to try to make this part of a larger cause so that what Public Citizen did to Teresa they don't do to other people.

James D. Macdonald: I've already mentally drafted an op-ed that would have more influence than a thousand letters to congresspeople, but I can't write that op-ed if the star of the op-ed doesn't agree with me and holds a press conference to denounce what I wrote. I also can't write the op-ed without a face to talk about this issue in more than the abstract--I've been talking about this issue in the abstract for quite a while and I can tell you in advance that the response will be a grieving widow of one of the 1-in-10,000 who suffered liver failure, and we'll lose the public debate without the equivalent person on the other side.

There's no quid pro quo; if Teresa doesn't want me involved or the taint of helping consumers through regulatory reform on her conscience, I can give her the names of a couple of attorneys who specialize in FDA petitions, and she can approach them herself--though I'd imagine that they'd see the potential for using this in support of the tort reform cause, too. I think it would be easier to get those attorneys and other helpful people on board if they see this as part of a larger campaign (I can think of a more than a few op-ed pages who wouldn't care about this issue if it's characterized as merely one that affects a few narcolepsy sufferers as opposed to one that epitomizes a larger problem with the system), but others can disagree and decide a different strategy.

For example, everyone can network and find a gray-market supplier for Teresa in Asia, and leave the thousands of pemoline users who aren't well-networked in the dark. Or one can adopt the tactics of the IBS Group and just make this about one or two medical conditions, without regard for the next time the FDA and Public Citizen does this to someone who needs a particular drug, and hope that the FDA is as conducive in post-Vioxx-hysteria 2005 to patient needs for "risky" drugs as it was in 2002. Or one can recognize that this is a larger problem, that reformers are right about this, and that plaintiffs' lawyers in pursuit of their own self-interest are making things worse for Americans. (JZT: The FDA wouldn't have acted if Public Citizen wasn't beating the drums falsely accusing the FDA of caring more about manufacturers than people. So the ire at Public Citizen is appropriately placed.)

Your comments are very shrill.

Would you prefer that we go back to the good old days of thalidomide? I wonder how the people who developed liver problems as a result of the medication would feel about your rant?

Ted:

As you know, the FDA is a federal agency. Public Citizen is a consortium of consumers. Public Citizen has as much right to petition the government as you do. And its a completely transparent process.

If you want(ed) this drug on the market, you were free to weigh in. You still are. And the FDA doesnt act without considering costs and benefits. Even if you dont formally petition the agency they of course consider the adverse effects of restricting this product's sale.

The FDA is not a small cadre of unsophisticates. These are scientists and physicians who evaluate medical necessity and public health. You are way off base if you believe the FDA would be bamboozled by the tiny health research group at PC.

If your position is based in scientific fact, you've got to explain why the FDA acted this way.

Hi

I am so sorry to read about what has happened.

I live in the magical land of Oz, a friend of mine (who is chronically ill and disabled) and I (clinically depressed for 15 years now) once speculated on the formation of a charity agency to assist the disabled in crisis. I would think that getting you medication would fit the mandate. I think the idea is needed.

Are these meds no longer on the market at all, or only in the US?

Teresa, I'm sorry to hear about your medical condition and about having the one working remedy taken away. One thing I don't understand is how there is no mechanism to let users of a medication know in advance about what's going to happen. (I'm one of those people who do NOT believe in the old saying that no news is good news.)

Dear "none:"

You wrote:

Your comments are very shrill.

Get a copy of Making Light by Teresa Nielsen Hayden. Read the chapter about narcolepsy and treatments for it. Then come back here, if you still have the stomach to do so, and tell us more about how shrill the comments here are.

The entire discussion here is a kind of sequel to that chapter.

(TNH: is that chapter on-line?)

Dear none:

What Bill Higgins said.

Incidently, thalidomide is a perfectly good medication--when it's used for leprosy, instead of morning sickness.

I don't know if it will help, but a friend of mine works for NPR's All Things Considered, and I have forwarded this page to her. I also have friends in Israel, so if it turns out that Teva is a possible source, I can see if I can do anything about it that way, too.

Teresa - best wishes for you in your quest.

John

I do not like Ralph for reasons I will not go into here. However, he and his group ought not take the rap! It is after all the FDA that decides Yes or No...if they cave in to Ralph, they might also cave for others, for good or for bad causes. Why not direct hatred against a govt agency rather than a private citizen?

I don't get why everyone's pissed at Nader. From a google search, looks more like the company discontinued it based on sales. The FDA didn't ban it, they just announced that it was risky to take and by the way the company that sells it is no longer going to sell it because they arent making enough money.

Now, of course, some people really rely on this drug, and the company doesn't really care about that if they aren't making a profit....

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Danny:

Again, Abbott discontinued Cylert, citing poor sales.

The generic manufacture continued.

Public Citizen petitioned the FDA to have generic pemoline banned.

The FDA did so.

For your future Google reference:

Here is the FDA's order banning pemoline.

Here's one of Public Citizen's letters to the FDA concerning pemoline. Observe their sticky fingerprints.

It does give us an address to write to at the FDA:

Andrew Von Eschenbach, M.D., Acting Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

I'm appalled and heartsick about this whole thing, though there's some comfort in seeing the blog's network gathering together to offer so many potential ways of dealing with it. I hope something can be done, ASAP! Alerting some major public forum or media platform does seem like the way to go (as long as it's viewed more as a major scandal than a minor "human interest" story).

In the countries where the drug has been banned for some time, is it always available by special prescription? If not, have the neurologists found any way to help their patients? From my own experience with a (far less serious) neurological problem, I get the feeling the field still has a long way to go before such things can be thoroughly understood, but damn all the villains mentioned above for making things even worse!

Dear Gods. Theresa, you and Xopher (and others affected) have my deepest sympathy on this.

My pain reliever of choice is Orudis KT (ketoprofen). Because it has the potential to cause stomach bleeding, it has been discontinued. The suggested replacement is its direct competitor, Aleve (naproxin sodium). I'm allergic to Aleve. The suggested alternative when I called Whitehall-Robbins? Just take lots of ibuprofen. I have high blood pressure and have been told by my doctor that the amounts of ibuprofen I have to take to get the same relief as two Orudis KT could esily trigger a heart attack or stroke. The only difference is that since Orudis KT is over-the-counter, I have had all my friends searching for it and grabbing any they can find as a stockpile for me.

Oh, and when I asked the lady at Whitehall-Robbins why it was being discontinued, she said it was less the FDA pressure to do so than the fact that it wasn't selling well, since everyone is buying Aleve instead.

My sympathies. I don't know what to say, really.

none brought up Thalidomide.
The problem with Thalidomide was that the testing for it was flawed, and didn't include testing to see if it had teratogenic effects on fetuses--FDA approval in the US was delayed for this reason, because the nit-picking little bureaucrat at the FDA wasn't comfortable with what she was seeing, with good reason, as it turned out. However, Thalidomide is still prescribed--and has very valuable uses, if you happen to suffer from prostate cancer, or multiple myeloma. Since the men with prostate cancer aren't vulnerable to the teratogenic fetal effects, and people with malignant myeloma have far greater problems to face than delivering a healthy child, the side effects aren't a major issue there. The key is that the side effects are known, and the risks can be weighed.
The issue with Celebrex and Vioxx is that the potential side-effects were downplayed, for drugs that were intended, originally, to take the place of other analgesic NSAIDs for people vulnerable to stomach problems from drugs like aspirin, naproxen, indomethacin, and ibuprofen. For those people, the risks might well have been tolerable; the current consensus is that for the general population, these risks are not tolerable, because for the general population, there are drugs available with fewer severe risks--namely the older (less-profitable) analgesic NSAIDs. Once again, it's a matter of risks and choices--and if the companies producing and selling these drugs hadn't gotten greedy, a couple of useful drugs would have been available to people who might well have found the benefits outweighed the risks.

Would you prefer that we go back to the good old days of thalidomide? I wonder how the people who developed liver problems as a result of the medication would feel about your rant?

In today's society, there is enough information out there where people can make their own choices about such matters. And not EVERYONE who took thalidomide died from it - it actually helped some, otherwise it would never have been used in the first place.

In a free country, our hosts could make their OWN decisions on which meds to take, and the FDA would have no say in the matter. Alas, this is not a free country anymore.

Regarding tort reform - how can anyone hold a straight face and say that leaving the legal system as it is now is a better choice? Are you serious?

Drug companies pull drugs off the market because of lawsuits, and the lawyers are aided and abetted by the FDA. You have a consortium of the legal system and the federal government trying to bring you down because of their greed and hunger for power. And the hell with the people who still need these drugs - they're secondary.

Tort reform would curb questionable lawsuits, and allow those companies to still sell to those who require the drug.

You can't blame those eeeeevilll drug companies, as much as many of the misguided would like. It's simple economics - if it costs too much to sell a drug, it will be pulled from the market.

TV (Harry)

Michael Weholt,
It seems to me that you're asking "Because you are a probationary citizen in poor standing aka a conservative, I'd like an affidavit that you won't commit a crime that could result in disbarment."

Of course, IANAL, and I am a right-wing, neo-con, bush-bot death-beast, but still...

And I'm not affilliated or paid by anyone, drat the luck.

Now my personal annoyance story is that of Tavist D which got taken off the market for I believe liver damage which made me unhappy (I did find a good substitute), but this Tavist D was the first thing that really worked on my massive sinus condition--at that time,I wanted to dedicated one of my upcoming novels to the mfg. of Tavist D because I was so happy with them. It 'broke the chains' which is a really gross image, but accurate, and allowed me to have a mostly normal life. Chronic illness is no way to live if you can help it.

And liver damage, similiar to Teresa and Xopher's suffering...interesting. I wonder how many of the recent drug take-offs have been due to worries about liver damage.

Bill Higgins,

Do you mean Making Book?

Anders Starmark,

1 in 10 000? That's so low a risk I doubt it's even been statistically confirmed. You'd need a massive number of people just to discriminate the extra liver failure from chance

Would you be comfortable with people citing this statement in their letters and articles?

Ted: I can all-but-guarantee that Teresa won't hold a press conference denouncing tort reform.

Email me for my phone number; let's talk.

For folks in need of these medications, you might consider inquiring w/ overseas pharma distributors. I've personally purchased from http://www.inhousepharmacy.com/, and though they don't list Cylert, or its generics, it's likely they'll know where/how to acquire it.

As to Nader and PC, they've long been bought and paid for by the plaintiff's bar. Their income is derived by champerty - i.e. they get money for abetting and promoting litigation. That's why their actions are so closely synchronized w/ the introduction and prosecution of class action suits.

If you really want to make your blood boil, look into PC's role in setting the air bag standards - they were convinced that the industry's attempts to design a safer adjustable air bag were somehow nefarious and pushed for a single standard appropriate to a 200lb man. This is why children's heads were being crushed by the burst pressure.

It seems to me that you're asking "Because you are a probationary citizen in poor standing aka a conservative, I'd like an affidavit that you won't commit a crime that could result in disbarment."

It seems to me that you're pulling self-inflicted martyrdom, not to mention smoke, out of your ass.

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Otherdeb, I'm glad to know other people are allergic to Alleve. That had to have been the most unpleasant day I've had in a long while (I sneezed at least once every 15 minutes while it ran out of my system, and it took nearly 12 hours. I hurt for two days...).

I don't know what to say but Yikes and all my best wishes toward finding a replacement/substitute.

Harry --

The drug companies spend more on marketting than research. So, you know, the research can't be all that expensive in terms of their bottom line.

Nor can it fail to be obvious to anyone with intellectual achievements exceeding those of half a dead bat that profit maximization -- the legally mandated and enforced behaviour of those self-same companies -- will inevitably produce precisely this situation where a drug, vital to those who take it, happens to have a small volume of sales and is consequently discontinued.

But, hey -- if you can produce In today's society, there is enough information out there where people can make their own choices about such matters. And not EVERYONE who took thalidomide died from it - it actually helped some, otherwise it would never have been used in the first place with a straight face, why should anyone begin to take you seriously on these matters?

Medical risk evaluation is really, really hard; the interconnectedness of all things is bad enough if you can find out what all the things are, which one can't in the majority of medical cases, because, hey, there's a heap of stuff that just isn't known yet.

Thalidomide's problem wasn't killing people; it functioned as a teratogen when prescribed to pregnant women.

So why should anyone take you seriously, when you're harping on the -- entirely beside the point -- need to reduce the legal responsibility of corporations? That same mandated profit maximization encourages a great many cut corners; testing done over an insufficient span of time, with insufficient care.

It would be more effective to remove the mandated profit maximization, that cause of carelessness and haste, rather than the legal consequences of sloppiness and error. (Leaving aside the aggressive and deceptive marketing.)

Leaving, you know, choice -- shareholders could buy into companies with reputations for care and reliable, modest profits, rather than being compelled to pick the company they figure will hit the jackpot before the corpses pile up.

Why is it that you're supporting the removal of -- constitutionally mandated -- responsibility, rather than actual choice?

And no, profit maximization isn't a requirement of doing business; profit is, but that's not the same thing, and the entire industrial revolution happened before the requirement for maximum short term profit was imposed on public corporations.

"These are scientists and physicians who evaluate medical necessity and public health. You are way off base if you believe the FDA would be bamboozled by the tiny health research group at PC."

Writing as a civil servant, many government decisions have nothing to do with thoughtful analysis and everything to do with legal and political heat. If the FDA doesn't want to spend a portion of it's budget to fight a legal battle, then it will pass a ban even if it is scientifically unfounded.

I recommend we work both sides of the aisle. I realize this is the Bush Administration, but this is fundamentally a civil service issue. It is unlikely that the official who made this decision is a Republican political appointee and very likely that they have been serving under Democrat and Republican alike. This is an issue that can be successfully worked from both sides of the political divide and will be much stronger for it. Republicans and Democrats both hate Nader/PC. If we only work the left, someone might try to make this a Dem/Repub issue. Then everyone loses.

Thalidomide.

I wondered how long it would be before that one was brought up. I wondered, because this isn't the first time a friend or acquaintance of mine has been affected by an attempt to ban a drug outright, rather than tightly regulate it so that it is still available to those for whom the benefits outweigh the risks. Thalidomide is slowly making a come-back, because there are a number of conditions for which it is the best or only treatment. Some are potentially lethal; others are like narcolepsy, in that that they are not normally fatal, but symptom control can provide an enormous improvement in someone's quality of life.

And at the time that one of my friends was diagnosed with one of those conditions, the Thalidomide Society was campaigning to prevent even the tightly controlled special licence prescribing of thalidomide. Quite simply, they had suffered, so nobody else could be allowed to benefit from the drug. I can understand what leads to that attitude, and if I was in that position I'd probably feel the same. But *my* personal experience was watching my officemate suffering on a daily basis, with an orphan disease that one day might progress to the point where he'll need thalidomide to be able to lead a normal life.

I think thalidomide prescribing should be tightly controlled. Quite apart from the horrifying teratogenic effects (which *were* picked up in testing, as noted), when taken long-term it has some very nasty side-effects, and it is not a drug to be prescribed without very careful consideration of whether the benefits outweigh the costs for a specific patient. But there is a very large part of the spectrum between outright banning of drugs, and allowing drug companies to market anything they like without taking responsibility for the side-effects.

There are a good many drugs which are inappropriate for the general population because the the risks outweight the benefits, but which are the best or only treatment for certain groups who have a different set of risks and benefits to balance. I don't see why the latter should be made to suffer to protect the former when it is feasible to have prescription regimes slightly more sophisticated than a choice of either anyone or no-one.

FWIW:
I'm a relative newcomer here; I've never met any of the principals; if I come off sounding a bit detached, I appologize -- that's not my intent.

James:

Your chronology is missing a step:

2) Abbott discontinued Cylert, citing poor sales.
3) The generic manufacture continued.
4) Public Citizen petitioned the FDA to have generic pemoline banned.
5) The FDA did so.

The missing step 1 is:
England, Canada, Germany, et al, banned pemoline or put it on a special list. If pemoline were widely available elsewhere (which might be the case with a relatively safe drug that the FDA banned in ignorance, like RU482), you could make a case that PC was the main cause of the problem.

What I'm seeing is a lot of APPROPRIATE grief and anger, and PC certainly didn't act in everyone's best interest, but it's not as if they acted out of the blue, either. (I surely wish they'd gone after Viagra instead...) It's comforting to put a face on that which is causing so much pain, but in this case, I'm not sure you have the right face.

The Narcolepsy Network has been working with the government to try to help get Cylert to those people with Narcolepsy who find it to be the only drug that is effective for them. You may want to contact them yourself, and see if they may be able to help you They already have letter writing campaigns started and have made some progress with the government.

http://www.narcolepsynetwork.org/

I'm a psychiatrist, and (oh, BTW, Graydon, DDT is as effective as it ever was, just hounded out of business like pemoline) and the fact is that pemoline was NEVER approved to treat narcolepsy.

While "off-label" treatments are legal, trial lawyers, Ralph Nader, and the FDA are free to ignore them, dissemble about them, lie about them, or remonstrate against them. Pemoline's use as a treatment for narcolepsy was thus not a factor in the FDA's decision--in the eyes of the FDA, it WASN'T a treatment for narcolepsy.

Pemoline does have a side-effect profile unacceptable in a target treatment population of children (kids with ADD). I can remember when it was a first-line treatment, but it became a second-line treatment, then got the dreaded Black-Box warning about liver failure. Anybody could have seen this coming about 3-4 years ago.

It's not George Bush's fault, or even the FDA's, really. It's lawyers. That's who Public Citizen is, and they just did it to help you. Whether you want or need the help or not. Again, I repeat, pemoline has never been an officially recognized treatment for narcolepsy. It has been a dangerous, and pretty well superfluous, treatment for children with ADD. That's what got it banned. That and the fact that there is no adult supervision of lawyers.

Quoth Julia:

I think thalidomide prescribing should be tightly controlled. Quite apart from the horrifying teratogenic effects (which *were* picked up in testing, as noted), when taken long-term it has some very nasty side-effects, and it is not a drug to be prescribed without very careful consideration of whether the benefits outweigh the costs for a specific patient. But there is a very large part of the spectrum between outright banning of drugs, and allowing drug companies to market anything they like without taking responsibility for the side-effects.

I thought that the point of prescription medications was to ensure that someone would be aware of and monitoring for the interactions and side effects that the patient might not know about.

My oldest friend suffers from bi-polar disorder. She was on lithium for over a decade. It's pretty much destroyed her digestive system, so she's off it now, and on another cocktail. She sees her physician and her psychiatrist monthly, when they're tinkering (she sees her psychiatrist monthly anyway), and everyone involved (she, her shrink, her doc, her partner, and her friends and family) keeps an eye on her behaviour and her health to track the side effects.

Nobody would have considered givig her Lithium if anything else would have worked as well. She knew the risks and she accepted them, and she and her doctors took responsibility for minimizing them to the extent that they could.

That's how health care is supposed to work.

Would you prefer that we go back to the good old days of thalidomide? I wonder how the people who developed liver problems as a result of the medication would feel about your rant?

Because a blanket refusal to allow anyone else to take the drug, under any circumstances, regardless of their own liver condition (or lack thereof), will magically give those people their liver function back! And their choice of a unicorn or a pony delivered to their front door! It's magic!

Isn't it nice to live in a world where all medications affect all people in the exact same way at all times? Say, could you possibly tell the rest of us who don't time-share in that particular la-la land how the fuck to get there? Thanks.

Yesterday, I e-mailed the SAP to ask about whether pemoline would continue to be made available to Canadians who currently take it. Here's the reply I received:

Dear Jennie:

CYLERT(pemoline) is currently available via the SAP for repeat patients only. Abbott Laboratories has informed us that supply will only be made available until spring/summer 2006. SAP access to CYLERT(pemoline) after this point can only be considered if another manufacturer is identified by your practitioner.

Regards,

The Special Access Programme/Programme D'Accés Spécialé

P:(613) 941-2108
F:(613) 941-3194

So Canadians who need the stuff will have to find their own sources (or their doctors will), but if they can find a source, Health Canada will get them the drugs.

In all honesty, if you depend on the drug to lead a normal life then you should make an annual trip to Canada or Mexico to stock up. That is what I would do.

jhlipton:

Cylert was on a special list here, too. It's a scheduled drug with a black-box warning.

I can't speak to England, but in Canada it continued to be available through the Special Access Programme. The information that I'm seeing is that pemoline continues to be manufactured in Germany, but I don't know what may have happened there in the recent past.

Like everything else, this is a question of risks, benefits, and informed consent.

Given the choice I'm certain that Teresa would rather not have narcolepsy at all and never take a Cylert again in her life.

Thanks to the many, many people here who have suggested useful approaches to this problem. Obviously we'll be following up on many of these in the days to come.

No thanks to people who want to use this as a springboard to argue for "tort reform," or post snippy comments about the supposed wholesale evil of lawyers. In my view, while there are plenty of problems with our legal system, the "tort reform" movement is largely a con job by the strong against the weak. I've written about this before and I may do so again. At the moment, in this thread, I'm not interested, and neither is Teresa. Further infestation of this thread with "tort reform" discussion will be met with draconian measures.

I shouldn't have to note that Teresa and I have always been critical of aggressive federal drug regulation, whether by the FDA or the DEA, and we have on many occasions argued that doctors and patients should be allowed wide latitude to choose effective treatments from as broad a set of options as possible. And while our overall politics are more to the left than not, neither of us has ever hesitated to criticize politicians of any stripe who advocate constraining that latitude. This doesn't need to be explained to people who know us, but it may come as news to people parachuting in.

Meanwhile, again, my apologies for not having been here more frequently over the last couple of days. We owe a bunch of you some very specific thanks.

Teresa, have you contacted any news stations about this. I'm thinking about John Stossel specifically at 20/20. He would help --- I think.

Eli M Rachlin, DDS

Bill Higgins - Beam Jockey: I think you meant Making Book.

Ted: OK, here we go. Thanks for contributing more usefully to the conversation. Your posts as Anon really did sound like you were saying "Ha! That's what you get for opposing tort reform!" Your Ted posts don't sound that way at all, at least to me.

Dirty Harry: AFAIK no one who took Thalidomide died from it. Their fetuses were born with missing limbs. And the objections raised to tort reform have to do with the specific and sweeping changes the Bush Administration was advocating, which to me and many sounded like more of the same: protecting the right of corporations to swindle, hoodwink, and cause grave bodily injury to individuals and classes of individuals.

I think we do need some reforms in our legal system (in fact, don't get me started). Among them would be some reform in how torts are handled. My own ideas include: punitive damages should not go to the plaintiff, but to a general victim relief fund (or be split; we do want lawyers to continue to take on poor plaintiffs); and impose civil penalties for deliberately, knowingly and with malice aforethought bringing a frivolous lawsuit with intent to harrass the defendant.

So you're creating a false dichotomy: either keep the legal system as it is, or change it to make it far worse. I think there's an obvious third answer.

Whoops. Patrick, your post came in while I was writing mine. Sorry for the tort reform discussion engagement. You can delete that part if you want to (to keep the thread on-topic).

CG, I don't know about Mexico, but that certainly wouldn't work in Canada. And if you read the thread more carefully, you'll note that it's not just that it's banned; it's that no one is going to make it on this continent.

I'm so sorry about this mess. I'm taking Actos (which is also being watched for liver damage) and I'd be really angry if it were taken off the market.

As a former chemist with some knowledge of the pharmaceutical industry and the FDA, the problem that you're having here is that there is no upside for the FDA in approving (or continuing to allow, in this case) treatments that might cause damage to someone. If someone is injured or dies, it's because the FDA (and the drug manufacturer) screwed up. It's almost never a case where someone was allowed to take a risk because the alternative was worse.

Going back to the case of thalidomide (which was mentioned earlier in this thread), the problem at the time was that no one did teratogenetic testing on drugs. They do now, because thalidomide was the big splash that made it obvious that there was a problem. Based on the tests that were conducted, thalidomide was a wonderfully safe drug. The FDA employee who held up thalidomide's U.S. approval did so more as a case of a lucky instinct than having any actual reason to do so. (Her stated reason was that there was a problem with "peripheral neuralgia" in people taking high dosages of the drug. Then the news from Germany broke and it was obvious that the drug couldn't be approved.) I think JWC was the one who observed in a long-ago issue of Analog that Marilyn Monroe couldn't have died from an overdose of thalidomide, because as a sleep aid, it was just that safe.

My parents both died of metastatic colon cancer, so I've an acute personal interest in the treatments that the FDA makes available for terminal cancer. They make it really difficult for patients who are going to die without treatment to get into experimental studies. I understand that there are ethical questions about using humans as guinea pigs in such a situation, but shouldn't the patient be allowed to make an informed decision about whether or not to take the chance? (The Wall Street Journal, by the way, has been all over this topic. They'd probably be interested in your case.)

I wish you all the good luck in the world. I hope that you don't need to use it all up on this problem.

Ralph Nadar. Where to begin about this paranoid,
very frightened very small male homo sapien. Truthfully he cannot be called a man, and not insult the rest of that gender.
The do gooders continue to wreck havoc on our society, in the vain hope they can create perfection
from from materials not perfect themselves.
For the damage they cause, I say sue them.

Thalidomide is also a treatment for multiple myeloma.

As Ted Sturgeon once said, "There are very few absolute statements of fact." [Or a reasonable facsimile thereof.]

JJB

Jake McGuire said: Subsequent trials to relabel drugs for conditions other than the ones they were initially approved for are pretty uncommon

Yes, uncommon, but not unheard of. Thalidomide is a perfect example. It got much more negative publicity than Pemoline, and was pulled from the market in 1961. More recently, it has been found to be an effective treatment for a variety of skin diseases, as well as HIV, and was approved by the FDA in 1998. If thalidomide can be approved, then I think there's hope that pemoline could be re-approved.

I know it's small consolation to somebody who's on the verge of running out of their medication. I hope that somebody sees sense and gets it reapproved very soon.

How many of you who are sympathetic to the sufferer actually recognize that the FDA by it's nature is an organization founded to eliminate an individual's right to their own body? How many of you simultaneously applaud the anti-tobacco political steamroller without recognizing that the same principle motivates their elimination campaign? Forgive me for not getting too choked up about your predicament. It's been a long time coming, but the health Nazis are knocking at your door now and there is no one left to speak for you.

"Would you prefer that we go back to the good old days of thalidomide?"...this is a bizarre comment. No one here is proposing that drug regulation be eliminated; merely that it be accomplished with a better balance of risks and benefits.

Regarding the FDA: No one questions that the people in the FDA are mostly decent, competent, hardworking scientists. But their incentives are probably a bit skewed. The career impact of an error on the "approve" side is probably much greater than the impact of an error on the "disapprove" side.

Interestingly, St. Giles is the name of the hospice where lepers are cared for in the Cadfael novels by Ellis Peters. This is interesting because Thalidomide is a treatment for leprosy.

There is nothing else interesting about that post.

St Giles: Tobacco is a really bad example. I don't know of anyone who didn't choose to use it. It's known to be addictive, with few if any redeeming qualities. Using a prescription drug because it's needed to be functional at anything resembling normality is a completely different animal. Using a drug which may cause damage, when you know it can, and are keeping an eye out for that damage, is most definitely a differnt animal. Now, since you seem to think they're identical, do you want the apple, the orange, or the banana?

For those curious about Miss Teresa's Making Book, more information is here.

If you want to order it direct from Amazon, it's here.

This is a collection of essays; many touch directly or indirectly on narcolepsy and life with a chronic disease.

Graydon: Drug companies "spend more on marketing than on research"?

Not quite, it seems.

(And more definitively, the Pharmaceutical Research and Manufacturers Association is happy to tell you that its members spend over $33 Billion a year on R+D, while the entire industry (perhaps just in the US, they're not clear) spends only $21B on product promotion. I think we can all agree that 33 is a bigger number than 21, yes? Indeed, it's half again bigger.)

Though, even if they did, what's the problem with that? Do you think that maybe they might need ... income, in order to fund further research? And that income is generated partially through the efforts of what the sales guys call "marketing"? And that since most R+D money brings exactly zero return, maybe marketing expenditures that makes more money in terms of sales are necessary to keep the company afloat in-between Drugs So Useful They Sell Themselves.

(Derek Lowe over at In The Pipeline is a pharmaceutical researcher (ie, the guy who actually goes trying to find and make the new drugs), and has more about the latter.)

It's very easy to stamp your feet and complain that Nasty Mean Big Drug Companies aren't pumping out new useful drugs left and right... but, well, it ain't easy. And unless you want the state to fund them (nevermind the inefficiencies that would have to cause), they rather have to fund themselves, partially by the use of wicked, nasty, not-spending-on-what-you-want Marketing - even if they do, in fact, spend half again as much on R+D.

Sigivald: Considering the number of drug commercials on television and radio, and the ads in magazines and newspapers, all of them for the Latest and Greatest prescription drugs, they probably are spending more on advertising than on R&D. [Given that R&D and maintenance seem to be considered by MBAs as Bad Expenses, while advertising is A Really Good Thing (along with stock dividends and executive stock options), I'm not surprised.]

Anon/Ted is a legal specialist in this field. This is how he looks at the world. There isn't a problem with that, except in what's called "chunk size." Teresa and Patrick, and most of us, are looking at very small, personal chunks of the issue. Anon/Ted is looking at the issue in a much larger chunk size, not realizing that this is far too painful and personal for us to pull ourselves out to a larger chunk size.

Anon/Ted, you sound like a reasonable person to me. However unless you can chunk down to our very tight and personal level, you might want to wait until we all stop bleeding before coming back in.

One wonders who "St. Giles" is addressing. The hosts of this weblog have never been anti-tobacco crusaders. I think the tobacco industry is largely run by mendacious pricks, but I think smoking is a much more complicated issue than a lot of anti-smoking zealots make it out to be. I've said so, too.

(With all due respect to P J Evans, I think a lot of people wind up smoking as a form of self-medication for subtle neurological or metabolic problems we're only beginning to understand. I smoked for 15 years, and quit 13 years ago, and I would never say nicotine has no good qualities. It's a fantastic drug in many ways, and cigarettes are a tremendously nuanced delivery system which allow the user impressive control over the exact level of their ongoing dose. Cigarettes will also kill you; there's definitely that. But people don't just get hooked on them because they're stupid. Some people get hooked on them because they smoke a couple of cigarettes and suddenly for the first time ever their head is clear and life doesn't feel like broken glass. Note, however, that while I mildly disagree with P J Evans, P J Evans isn't being a rude jerk.)

I'd like to see "St. Giles" try that bit of liberal-baiting on Avedon Carol.

My wife is bedridden with serious spinal problems and is in constant pain. There are medicines that work for her but not at the limited quantities her doctor is allowed to prescribe.

Since Nadar is the poster child for all of this nonsense I would to send for a nice long ride in a vintage Corvair with Teddy Kennedy at the wheel.

The pharmaceutical industry and its advertising and research, isn't the problem, isn't the solution, and isn't the topic here.

There is possibly a helpful parallel to the Cylert withdrawal in the case of Lotronex for irritable bowel syndrome (IBS). Like narcolepsy, those with severe cases of IBS cannot live normal lives because of the need to be in close proximity to a bathroom and the uncertainty of when attacks will occur. Some are literally unable to leave their homes. In early 2000 Lotronex was approved by the FDA as the first treatment for IBS in women. The response was tremendous and within months over 150,000 people were using it. People reported the ability to live "normally" for the first time in their lives, to go out, to enter into relationships. But there were problems. Despite warnings to physicians by the manufacturer about complications if misused or mis-prescribed, by fall of 2000 the FDA had received notice of 70 cases of severe intestinal side effects which included 10 emergency surgeries and 3 deaths. Public Citizen (surprise!) lobbied the FDA to ban its use. After several meetings with the FDA, the manufacturer (Glaxo Wellcome, now GlaxoSmithKline or GSK) voluntarily withdrew it in November of 2000. There was no generic substitute.

The outcry was intense and immediate. The FDA and GSK were inundated with letters from patients and their doctors about the impact withdrawal was having on users' lives. As a result, the FDA re-entered discussions with GSK and over time they agreed on a strictly controlled process by which Lotronex would be made available to those who most need it and who would be willing to assume the risks and to closely monitor for the onset of side effects. Physician and pharmacist involvement was also part of the monitoring requirement. Lotronex was returned to the market in 2002 and to my knowledge is still available under the strict marketing program for severe IBS sufferers .

It appears the FDA will listen to the patient community if they are made aware in a considerate yet significant way of the impact of their decisions, so there is possibly hope for Cylert. If it hasn't been tried already, perhaps an organized letter-writing/e-mail campaign by sufferers and their doctors would be useful for Cylert although there appears to be a difference in the size of the patient community. But it can't hurt, and the Web can be a powerful organizing tool. I think involvement by sufferers' physicians is essential in dealing with he FDA. Perhaps there is a national IBS group like there is for narcolepsy that could lend advice on what they did with regard to Lotronex.

In any case, good luck to you on this dilemma.

(I'm sure I've missed some aspects of the Lotronex story. For more info on it, Google: "irritable bowel syndrome" Lotronex FDA .)

One editorial comment: Drugs are tested prior to approval. The testing process is never as thorough as we would like, probably flawed in some instances, and possibly fraudulent in a very few cases. But even after the best-designed and ethical testing regimen, the drug is then released for use by thousands, perhaps hundreds of thousands, of individuals -- each with a unique biology and unknown ability to follow label directions. Is it realistic to expect drugs, especially those that attack tough syndromes and diseases, to work yet also have no problems over an entire patient population? I don't know if the folks at Public Citizen actually expect that but it sometimes seems like it, or else they just have a reflexive animus toward corporations in general and drug companies in particular.

Re: smoking & cigarettes.

The difference, I think, is that smoking a cigarette (or a joint) is the only example I can think of in which users are damaging not only their own health but also the health of those around them.
(I realize I'm using a condition in which I ignore the deaths of people struck by automobiles piloted by drunk drivers, etc.)

When someone around me sniffs cocaine, it does not damage the cartilage in my nose, nor elevate my heart rate.
When someone around me smokes cigarettes, however, my lungs are put at risk.
(and of course, yes, I realize, their are a billion other pollutants in the air. But really, is there a need to contribute further to an already toxic situation?)

Patrick: Some people don't get hooked on tobacco - my sister isn't, although I know she's used it. (I understand that researchers think it's genetic.) My problem with users is that there are so many of them who seem to stop thinking while smoking (this is probably not a tobacco problem so much as a problem with trying to do two things at once). Personally, I have a problem with cigarette (but not usually cigar or pipe) smoke: it tends to set off my asthma, even at a distance which would appear safe.

I sure hope that Teresa and Xopher can get a reliable supply of Cylert. I'd certainly miss them.

Forgive me for not getting too choked up about your predicament.

To St. Giles and others of his or her ilk: GO AWAY. What the fuck is wrong with you? The people posting on this thread are trying to help someone whom many of them consider a friend. You are treating this as an opportunity to push a political agenda. This is not the time or place to do it, and your doing so makes you appear to be self-righteous, insensitive -- many, many words deleted here -- assholes. You do no good to the causes you espouse. Rather, you infuriate. Don't answer back, don't argue, just find another thread to haunt for a while. What part of the word "inappropriate" do you not understand?

Sigivald:

It's very easy to stamp your feet and complain that Nasty Mean Big Drug Companies aren't pumping out new useful drugs left and right... but, well, it ain't easy.

I rather thought we were concerned that a drug company had been pressured to cease pumping out an old, useful drug.

In fact, Graydon said ...profit maximization...will inevitably produce precisely this situation where a drug, vital to those who take it, happens to have a small volume of sales and is consequently discontinued. [Emphasis mine]

I went to kindergarten at a school with a big lot next door. In the spring, the lot would fill with puddles, and the puddles would fill with little green frogs. Little boys would pick up those little green frogs, and, among other things, they would chase little girls around the school yard. They didn't chase me. I remember another girl asking me why the boys didn't chase me. I said, "because I don't run."**

Little boys grow up, little green frogs change into other things, but they're still little boys and little green frogs.

In the case of trolls, they may be of either gender, but they're still carrying little green frogs to see if we'll run.

Lizzy L, deep breath, ground, center. It's a little green frog. If you don't react to it, they'll take it somewhere else.

** I also discovered that if I offered to hold the frog, the boy in question would run away from me, not wanting his frog contaminated with cooties.

Lin: No ax-murderer in the shower scream?

I remember a kid daring me to hold a garter snake. The garter snake went home with me and got turned loose later in an appropriate habitat. No problems with that kid afterward.

Well said, Lin.

I suffer from multiple sleep disorders, and if my treatment was taken away, especially with no warning, I'd be pretty damned angry, too. It took long enough for sleep disorders to be recognized and diagnosed (over ten years for me) as a health problem for many of us, but to be denied treatment when one that's so successful is available? That's one huge load of the stinkiest elephant crap imaginable! I'm sorry you and others are going through this.

PJ: Would you please stop making cryptic references in public that I then have to explain!!

My mother is seriously afraid of frogs/toads. We refer to her reaction as "the ax murder in the shower scream." One year, we planted tomatoes, which gathered a large number of toads, which generated a large number of screams. The neighbor finally called the police, thinking we were "doing something" to my mother. We never planted tomatoes again.

Public Citizen want to be, and act as much as possible, like dictators.

It wasn't enough to just get information out there so adults could make informed decisions. No, they had to make our decisions for us.

All of us have to realize, though, this is what happens when the government gets to decide what chemicals we voluntarily put into our bodies.

Nix the FDA and the DEA.

The parallel with the IBS drug Lotronex isn't quite right, because that drug was intended from the start to be used to treat that condition. Cylert was being used off label to treat narcolepsy. As such, the FDA likely couldn't consider this use when deciding whether to ban it. Getting them to reconsider the ban is likely to require making the argument that it should be relabeled as a narcolepsy treatment.

It appears that it would be possible to classify Cylert as an orphan drug (less than 200k patients in US), with money available to fast-track testing as a treatment for narcolepsy. But that still needs a drug company who cares enough to make the effort to apply for orphan status, with no guarantee of success.

Sadly, it seems that Teresa has been living on borrowed time...

John

The FDA and DEA both serve useful functions. However, they react (as do we all in some form) to the last, loudest or most threatening. I don't know how much threatening we can be, but it sure sounds like we're all being very loud and certainly the most current.

I'd thought about mentioning thalidomide, but didn't want to be the first one. :}

My mother and I were just discussing thalidomide over the holidays. For a brief time in the past year she was on it for a severe auto-immune skin condition (we joked that she had "the leprosy" even though that wasn't the actual diagnosis), and if it had worked for her she would still be on it.

The measures she and her doctor had to take in order for her to receive the drug were extraordinary, and all meant to ensure that no one who takes it is capable of or even thinking about getting pregnant. As a post-menopausal 72-year-old woman she didn't have to deal with the monthly pregnancy tests, but she did have to sign statement forms and a log in order to get her script filled.

Thalidomide is still out there, and it is still helping people -- and it is extremely tightly controlled to ensure that it doesn't cause any more birth defects.

My question is, why couldn't similar measures be mandated for Pemoline, rather than removing it from the market completely?? Thalidomide has been proven to be much more harmful when not properly administered and controlled, and the public relations firestorm that it generated was much, much more intense and widespread than the news of 1 in 10,000 patients dying of liver failure.

Not exactly a level playing field here.

Lin, I am quite centered, thank you. All the words in that post were correctly spelled. And, no, it is not a little green frog. It is many words deleted behavior which should not be allowed to pass unchallenged. I don't like bullies either.

Like Bill Roper, way upthread, I don't understand why people who are terminally ill can't guinea-pig in studies of drugs for whatever-it-is that's killing them. Isn't that part of what 'informed consent' is about? What does 'Public Citizen' not get here? Do they really think we all are in need of protection from our own actions? Yes, there have been drugs that got through with inadequate testing - I've heard that aspirin would not be approved today, because of its side effects, and I know personally about DES - but pulling something without finding out if there are adequate substitutes, when it's possible to find and talk to the users, is not a Bright Idea.

Lin: I was wondering if you have a good ax-murderer in the shower scream. Maybe I need to find some tomato worms next summer?

May every horrible thing that has the opportunity to befall Ralph Nader succeed in doing so. I still don't see why there are people in the world who listen to him, let alone support him. His intentions are unsafe at any speed, even the incredibly slow one at which his mind apparently operates.

Very, very sorry to hear about this. I hope an effective alternative (or a repeal of the decision to ban) comes about soon. Good luck until then.

Thalidomide is still out there, and it is still helping people -- and it is extremely tightly controlled to ensure that it doesn't cause any more birth defects.

Accutane is another example of a drug that can cause horrific teratogenic damage if taken during pregnancy, but which is still prescribed under carefully monitored conditions. When I was on it, my health plan required that I get blood drawn monthly for a pregnancy test and to check my liver function. No test = no prescription refill. (Please note that I'm bringing up Accutane only in the context of causing teratogenic damage - not in the context of any of the other problems it's accused of causing.)

Jim, my other half, is a notary public, working primarily in real estate loans. When he and I bought our house twenty years ago, we filled out/signed probably thirty or forty pages of forms. Now? He routinely gets over a hundred forms for loan customers to fill out/sign for a loan. All of it "You know you can/must/don't have to..." for something or other.

Having the patient read an information sheet, then fill out/sign a form and have the doctor sign it as well, it might cut down on "I was never told." A copy could be kept in the patient's file, a copy could go with a prescription to the pharmacist so his butt's covered, the patient could have a copy. It would partially solve the problem of the doctor who can't explain clearly, the patient who doesn't listen, the doctor who isn't given adequate time with the patient, etc. etc. One problem is how to make sure the latest information is on the information sheet. There are others, but they can be solved. The question is, who will?

No no no, we do not want to get rid of the FDA. No, we don't hates pharmaceutical companies. (My personal thanks to the good folks at Schering-Plough for the nasal spray Afrin.) We just want the FDA to allow Cylert to be reissued as a treatment for narcolepsy, with a strong warning concerning possible liver damage. It shouldn't be too much to ask, since it was apparently banned as a treatment for ADHD without consideration of off-label uses.

As a cataleptic with narcoleptic tendencies and being freshly diagnosed and beginning treatment this past July, this sort of thing has me worried. Modafinil does well to curb my cataleptic attacks, but has a saw-tooth effect on my energy, wakefulness and ability to concentrate, which all move at their own cycles now. My neurologist will be looking into alternatives to it this year...

I feel deepest sympathy and give you my appreciation of this problem. Quite truthfully I am getting fed up with 100 ill side-effects in 10,000 when the benefits are so great to those it is effective for becoming the standard for asessing a drug as negative and harmful. While another medication may have caused my problems, I fully understood most of what it could do and will not be seeking to start a crusade against it. And because it interacted with something I did not know I had, that is no reason for me to get on a warpath about it. And this falls far, far, far lower than that.

Haven't these wonderful Nanny busybodies ever heard of people signing a waiver? I would gladly do so for a drug that was effective for me and yet harmfully impacted so few. If Modafinil ever fell into that category, I would do so... rather than face my body giving out on me multiple times a day. Tell me my chances, and what the known problems are and I will make an informed decision on my own. If necessary I will 'Roll dem dice and take my chances' based on what I think is best for me.

I am an *adult*. I am not the ward of a Nanny state.

James D. Macdonald: I've already mentally drafted an op-ed that would have more influence than a thousand letters to congresspeople

Offhand, Ted, I'd say that this claim raises your ambulance chasing from crude to grandiose, but good on you if you're willing to help without forcing the people you help into being your posterchildren in an unrelated project of your own.

Which you don't seem to be.

I think you misinterpreted the gist of St Giles comments. Please question the argument about harming others. Harm? Someone who is drinks only one glass of wine who takes your child home and kills them on the way...someone who has a fight and the subsequent lack of concetration makes them slip while cutting vegetables and slices 75% of the way through the finger of the person who is helping them... or a very big one: children of divorced parents have far more missed school days, rates of illness, lack of completion of school, more time in jail etc. Actions have consequences some intended some not. So don't put the smokers in another category from the rest of humanity. That is why Pastor Nielmoller's words are so strong...
First they came for the Jews
and I did not speak out
because I was not a Jew.
Then they came for the Communists
and I did not speak out
because I was not a Communist.
Then they came for the trade unionists
and I did not speak out
because I was not a trade unionist.
Then they came for me
and there was no one left
to speak out for me.

It is very hard to see the "Jews" until "they" are "you".
Best wishes for finding the drug. You seem to have a wonderful group of posters. Quite an accomplishment. Bravo.

Teresa,

For what its worth, my sympathies. This is really bad.

Everyone,

I followed the link here from Instapundit, and yes, I am to the right of this blog. That said, at risk of inviting a flaming, has anyone considered broadening the appeal? Put bluntly, this seems an issue that would be much more likely to gain traction with people and media on my side of the ideological divide. I mean lets face it who's more likely to run with a story attacking Ralph Nader's regulatory zealousness: Fox News or the NY Times. Just a thought.

Carol: if you were referencing my post about cigarettes in talking about harm, of course you were right, and I specifically mentioned I was ignoring those circumstances (i.e., a drunk nanny's negligence of her ward). I was speaking of the fact that someone else's smoking a cigarette in my proximity harms me as much or more than it harms them, in a way that is not analogous to the consumption of other drugs. That is to say, another person's consumption of alcohol in my presence does not harm my liver (even though I'm at great risk if I drive with them).

All:
I e-mailed Teresa specifically but now realize I should let everyone know: if you or anyone you know are affected by this ban, or, indeed, have any questions or problems related to such disorders, please e-mail me. I'm the assistant editor of The Journal of Psychosocial Nursing and Mental Health Services. We're already trying to figure out both a workaround to the problem this ban may cause in the industry and also how how best the mental health care community and drug companies can react to this and, most importantly, provide care for the clients and patients who need it.

Carol, you said things politely. St. Giles was rude, crude and socially unattractive. We don't usually jump up and down on someone for what they said, but mostly for how they said it.

I mentioned upthread Jack Williamson's "With Folded Hands." It is a frightening take-it-to-the-extreme look at what happens when we end up with someone who takes care of us, takes complete care of us. I who re-read books many times have only read this once, many years ago. It haunts me to this day.

The problem is that there aren't enough people willing to jump in a beer truck and run down the Ralph Naders of the world.

The problem is that there aren't enough people willing to jump in a beer truck and run down the Ralph Naders of the world.

The problem is that I can't do it and not get caught. There are people out there who object to that sort of thing, and I'd just as soon not come to their attention.

Otherwise, hand me the keys!

Shorter Ted:

If Teresa -- an articulate and influential woman with narcolespy -- will agree with all my opinions, I will agree to take on her case.

Geez, somehow this doesn't seem like the world's greatest bargain.

Sympathies from here, too, and good luck.

damn, from what I can read in antidoping.dk pemoline is forbidden in denmark as a stimulating drug.

Public Citizen is a nonprofit, nonpartisan public interest group founded in 1971 to represent consumer interests in Congress, the executive branch and the courts. The Health Research Group, headed by consumer advocate Dr. Sidney Wolfe, works for research-based, system-wide changes in health care policy. A primary focus is working to ban or relabel unsafe or ineffective drugs and to encourage greater transparency and accountability in the drug approval process. We also work towards improving the system for monitoring and responding to postmarketing safety concerns in the U.S., improving the information available to consumers regarding drugs and dietary supplements, and helping doctors and patients make safe and economically wise decisions about drug treatment.

Representing consumer interests? Transparency and accountability? Way to go, guys! You should have taken another few days to find out who you were harming.

Meredith, my cousin also has an auto-immune disorder of the flesh -- pyoderma gangrenosum -- for which thalidomide is prescribed.

She had a hysterectomy more than a decade before and still had to jump through all kinds of hoops to obtain it.

[And, yes, we jokingly refer to it as the curse of Job.]

JJB

I'd like to see "St. Giles" try that bit of liberal-baiting on Avedon Carol.

Can I buy a ticket to that party?

On a more serious note, a friend of mine commented to my LJ that she'd popped in here, and that she's also seen this post by Derek Lowe, on the issues we're discussing here, specifically referring to Teresa.

She told me about it because, as she put it, "Being in the biotech/pharma industry, I read this guy on a regular basis (I like his R&D views of the drug development process) and he's got quite a following, so hopefully it will help. FYI".

I'm so sorry, Teresa (and Xopher). This whole thing just sucks the farm right down to the last little piglet. Letters likewise sent here. Let us know what else we can do to help.

My question is, why couldn't similar measures be mandated for Pemoline, rather than removing it from the market completely?

I have not studied the issue, but one of the comments upthread has this:

FDA is aware of 13 reports of liver failure resulting in liver transplant or death, usually within four weeks of onset of signs and symptoms of liver failure.

If that's "within four weeks of ANY sign of liver function decline, there was total liver failure", then I can see why the FDA might want to sharply restrict (not ban) the drug.

If, instead, it's "the patient went from reduced liver function to irreversible damage and then quickly to death", that's a different matter entirely and no different from coumadin or accutane or any of a thousand other sometimes-harmful drugs.

I'm sorry, Teresa. I have little influence; what I have is yours.

May I suggest to the people writing their congresscritters: I think paper and stamp bear a greater weight than email, because they're slightly harder to send, and slightly harder to ignore.

Of course, you could send both.

"I followed the link here from Instapundit, and yes, I am to the right of this blog. That said, at risk of inviting a flaming, has anyone considered broadening the appeal?"

Bill, I assure you, if we wind up doing actual political activism on this issue, we'll want to talk to and work with anyone with whom we can make common cause. If my next-door-neighbor's car were on fire, I wouldn't be demanding to know his views on the PATRIOT Act before helping put it out.

Bill, thank you for suggesting that people who want to make an issue of this should look rightward (i.e. Fox News) for allies. While such an alliance carries with it its own dangers, yours was an honest suggestion and perhaps there are people here who will choose to pick up on it.

No flame.

More searching on the other names for pemoline reveals that Bentanamin appears on a number of Japanese sites. None of the links I've clicked through Google looks like a drug company's website, alas.

Am enlisting help from someone who reads Japanese.

Back on the left side of the political divide, try Eric Alterman. He loathes Nader, and has an (out-of date :-( ) blogroll link to Electrolite.

Lisa, Julia,

The issue of Type II errors is a problem that has interested me well before Teresa learned of how the problem affected her personally, and will continue to interest me long after Teresa finds her own personal workaround.

I've invited Teresa to help me publicize this problem, which at the same time would help publicize her particular instantiation of the problem, which in turn would help provide pressure for the FDA to do the right thing with respect to Cylert notwithstanding pressure from Sen. Grassley and Public Citizen and the plaintiffs' bar.

She's declined the invitation, because she views my solution to the problem as a "con job by the strong against the weak," which is her right. (I'm not sure why Kline & Specter are "the weak," but.) I think she and Patrick are going to be sorely disillusioned by the people she thinks are the defenders of the weak at an FDA hearing in 2007 or 2008 when the plaintiffs' bar lines up many witnesses to keep the drug off the market. Cylert users are up against a very organized, powerful, and successful lobby. I wish them all the luck in the world, and feel sad that I've failed to persuade Patrick and Teresa that they're in that fight and that we're on the same side. I'm going to try to find a way to write about this without Teresa's help.

As for "grandeur," I wasn't trying to brag; I was merely pointing out the sad reality that at the federal level, it's a rare occasion that someone other than low-level staffers and interns see letters from constituents. This isn't about me, but about achieving results beyond getting a form letter back.

I've e-mailed James D. MacDonald with information about other potential sources of help, including the name of the best FDA attorney in town. I don't know what more Julia and Lisa think I should have done, but if they have suggestions that I haven't thought of, they should feel free to e-mail me.

Re: Paper letter vs. email

My Senators' sites request that email be used rather than postal due to the new mail security measures...

Teresa, Patrick,

This is horrible news.

I saw in one of the messages that a similar drug is sold in Belgium -- and that's where I live. Is there anything I can do? Please let me know (best by e-mail); I'd be happy to help if I only can.

Mel

BTW, I'm forwarding this to a NY Times journalist I know. Hope I can get thier attention.

Not that I don't have sympathy for this situation, but this, too, is Bush's fault?! Liberalism is great until your ox is the one that's gored.

A primary focus is working to ban or relabel unsafe or ineffective drugs and to encourage greater transparency and accountability in the drug approval process.

Well ... let's see if they're willing to try relabeling pemoline for narcolepsy. As a consumer advocate group that should be right in their balliwick.

Ted, how disingenuous can you get. Your first post in this thread didn’t say “I might be able to help you.” It didn’t even say “I might be able to help you if you’ll let me use your plight to further my political agenda.” Your first post in this thread, posted anonymously, was a jab-- a purely political statement about tort reform. No sympathy, no suggestions, no help. Now you’re suggesting Teresa is being political by refusing your offer to help. It’s like yelling “Get a job!” at a homeless person, then after witnesses berate you for it, offering assistance only if the homeless person will claim environmental regulations cost him his job.

James: They'd have to admit error in their campaign to ban it. I don't see these people doing that, at least not until their noses get rubbed in it. I hope I'm wrong. (Of course, if they'd actually done their homework when they decided it was Too Dangerous To Use, they might have found out about the other uses. Off-label use isn't a deep dark secret, is it?)

Liberalism is great until your ox is the one that's gored.

I fail to see how this problem was caused by "liberalism," or why liberalism isn't among the solutions.

On the subject of Fox News: If Bill O’Reilly wanted to interview Teresa about Cylert and narcolepsy, I have no doubt that she'd agree.

Has anyone got a way to get in touch with Geraldo?

I can guarantee you this drug will resurface on the black market.

I can guarantee you this drug will resurface on the black market.

If you have contact information for a supplier, let me know.

The problem is black market prices. Insurance is unlikely to cover black market drugs, quality control is ... iffy ... and getting your doctor to go along with it will be very difficult, assuming your doctor enjoys keeping his or her license.

Jim said: "On the subject of Fox News: If Bill O’Reilly wanted to interview Teresa about Cylert and narcolepsy, I have no doubt that she'd agree."

You know, I would love to see that occur, whether the interview were about Cylert and Narcolepsy or not. I realize other topics would alter the tone from that of a Cylert interview, but boy how, I'd pay to see Teresa just *flummox* O'Reilly into flabbergasted, stupefied, can't-say-anymore-because-she-gets-him-on-everything silence.

I've sent letters to both of the Michigan senators. Holy god I hope that the FDA revokes the ban.

James D. Macdonald asks

Anyone know how to get in touch with Geraldo?

Yay! An easy question: He has a story submission page.

OK, it's not a personal connection, but it might work.

Well, I actually do know someone who works for Geraldo, and would be happy to send along a pitch from someone more articulate than I, though I can't guarantee anything will come of it.

If anyone here really wants to associate with Fox News....

Dana

Dana: Human interest. Scandal. Sounds right up their alley (as long as you don't get mugged)!

I've got some bizarre form of IBS that manifested as morning sickness - I'm male and yes, that morning sickness - just about every day for around six years. Fall before last things became so bad I would miss half a day of school at least twice a week, and was pretty much out of it the rest of the time from losing sleep and weak bowels plus stomach misery.

A teacher who'd long ago had similar problems suggested Imipramine, and it took about a week after getting that for me to wake up feeling fine.

Considering imipramine is primarily used as an antidepressant (in at least triple the dosage I'm on), and at that one that is rather dated, this makes me quite worried.

I'm afraid all I can do for you is wish you good luck. And damn the FDA for overstepping reason again.

For what it's worth, I sent the following to James Taranto at the Wall Street Journal:

Mr. Taranto,

I’m sure you’ve run across this story (I found it through Glenn Reynolds.), but it might be of some interest: http://nielsenhayden.com/makinglight/archives/007140.htm. While only a blog entry, it’s essentially the case of someone who has narcolepsy and the FDA decision to withdrawal the drug pemoline (branded Cylert) from the market, at the behest of Ralph Nader’s Public Citizen. Apparently the drug is a very important treatment for the author’s narcolepsy and there’s little available to replace it.

Regards,
Bill Dalasio

Maybe he'll publish something.

My Japanese is slow, but I'm looking around. Betanamin is the a Japanese name for Pemoline, made by a company called Sanwa Kagaku. It's still being made, though there are warnings about potential liver damage based on the FDA's bannings. Apparently it's approved there as a treatment for narcolepsy and also depression.

I'm not sure if that's in any way useful information, and I'd sure have no way to get my hands on some, but best wishes to you both, Teresa and Xopher.

An article is now posted to my blog as "Ralph Nader Is Screwing People Over *Again* and cross-opsted to a diary on DailyKos

Alex -- it only gives increased exposure if you put up an additional diary entry or insert this into an open thread, so don't let my diary preclude yours.

ANd I'll be sending an e-mail off to my Senators and congressional Reps tonight on this.

If the FDA ruling withdrawing the drug from marketing can be rescinded, it may prompt the generic makers to restart the production lines.

It would be one thing is the economics decided the firms to stop manufacturing, but this kind of mandate without proper backgrounding (or even identifying who all the stakeholders are) sounds just like the NCLB fiasco.

Let's look at the situation, shall we, Ted?

You came in here anonymously to do a bit of sneering at someone who disagreed with the position that your corporate clients have paid you to take, notwithstanding the fact that it was both cruel and grossly inappropriate to do so under the circumstances. You were then outed as what you are - a corporate shill using someone's personal tragedy to score points on behalf of your employers.

You then "identified" yourself as who you were already identified as being, flang a bit of grandiose rhetoric around about your connections and the awesome power of your Op Ed pieces, and suggested (but did not guarantee) to Teresa and Patrick that your mighty influence would amply repay them if they agree to shill for your clients for free.

Presumably you would still be billing for your time.

IOW, by the evidence you're a rather disingenuous troll who is now trying to lessen the embarrassment you've caused for your employer by being clumsy at it, and you're hoping you can somehow make the situation pay off for you.

Again, if this is not the case, good on you.

You just keep pointing out that it is.

I'm also pretty amused that you appear to think you're the only person involved in this conversation who has contacts in government, but I suppose you can't be expected to understand that there are people in the world who just flat don't give a shit how important perfect strangers think they are.

Honestly, Ted, I don't think you're helping yourself here.

Emily, thanks. That's the bit of information I couldn't find.

I don't know if this can help Teresa or Xopher, but it might be of help to anyone who can access the SAP in Canada.

At the very least, more information can't be a bad thing.

A Kos diary now has the story.

Ted's URL certainly has interesting associates, doesn't it? They certainly aren't likely to be on the side of the average consumer, given their past stands.

P J Evans: Lin: I was wondering if you have a good ax-murderer in the shower scream. Maybe I need to find some tomato worms next summer?

I thought it was tomato toads that elicited the scream. Anyway, if you want a scream, you could do worth than choose the Wilhelm, courtesy of Film Sound Clichés.

Best wishes for a successful outcome to Teresa, Xopher, and all. And I hope I find the right meds for me before they are taken away.

I fail to see how this problem was caused by "liberalism," or why liberalism isn't among the solutions.

Because, even after you ignore all of the tort reform bullshit being thrown around, the reason that Theresa got well and truly shafted is that if you want to sell a drug in the US, it has to be shown to be safe and effective, and it has to be shown to be effective through a clinical trial rather than by finding people who will say "it works for me." Isn't that a liberal idea?

Keep in mind that as far as the FDA is concerned, pemoline does nothing against narcolepsy, and if you want the marketing ban lifted, the best bet is to find people for whom pemoline is the only thing that works for their ADHD.

The more I think about this, the less I can imagine what it must be like. I'm really sorry to hear it, and hope that even if the FDA doesn't change their mind that Public Citizen sees some negative fallout from this.

Jim O'Sullivan -- nowhere in this thread of postings does it say this is Bush's fault. A quick check upthread reveals that YOU'RE the first person to mention Bush.

If you don't have anything constructive to contribute, get lost.

Please note the subjects of this thread are Ralph Nader + Cylert + FDA...

I would be beside myself with rage.

I too require a daily drug in order to cope. If someone comes along and takes it away from me, "to protect me" in some other way, I would not be able to function, and yes, I would be just furious at having the choice removed.

***
I have heard that a lot of AIDS patients are similarly fed up by their inability to get experimental drugs, because some bureaucrat "knows better" than they do.

I think the FDA's role should be ensuring complete & honest labelling... and nothing further.

Jake, I agree with you, FWIW, but I don't think this is the time or place for such an argument.

Of course this is my first visit, so what do I know.

While not an entirely disinterested party, and sharing few if any of Teresa and Patrick's political views, I'd like to note that this same sort of thing is liable to happen to the MS community with regards to Tysabri. It's been making its way back towards the market, but I'm already seeing the tort-law crowd warming up for a class-action run, and I can't imagine that Public Citizen is far behind.

(Again, for the record, I'm not a disinterested party. I know several folks suffering from MS, and I'm also a stockholder in one of Tysabri's manufacturers. I don't think either of those conditions materially impact the facts of the matter.)

I was under the impression that good science, open information, and personal choice and responsibility were liberal values.

As Eric Raymond points out:

"The Cylert ban isn’t an accidental failure of the system, it’s an essential one. It wasn’t perpetrated by villains, but by well-intentioned people working the levers of a system designed to elevate “public safety” above individual choice. "

An article is now posted to my blog as "Ralph Nader Is Screwing People Over *Again* and cross-opsted to a diary on DailyKos

-------------

Alex -- it only gives increased exposure if you put up an additional diary entry or insert this into an open thread, so don't let my diary preclude yours.

--------------------
Daniel Martin:
Anyone know someone who knows someone who can whisper this issue into Bill Frist's ear? He's kind of had a minor political cloud hanging over him since the whole Schiavo fiasco, but he was at some point a doctor and might have some direct understanding of the careful weighing of side effects.

Worth a try, but public percdeption of Frist's ability as a medic have taken a little hit since his remarks about Schiavo's condition without even meeting the patient.
------------------------

And I'll be sending an e-mail off to my Senators and congressional Reps tonight on this.

If the FDA ruling withdrawing the drug from marketing can be rescinded, it may prompt the generic makers to restart the production lines.

It would be one thing is the economics decided the firms to stop manufacturing, but this kind of mandate without proper backgrounding (or even identifying who all the stakeholders are) sounds just like the NCLB fiasco.

Oh, I think that liberalism is a good thing. And I also think that requiring drugs to be safe and effective is a good thing, and requiring them to be demonstrated as such rather than just taking the manufacturer's word on it is too.

How to resolve this desire with someone who may literally have her life ruined is... difficult. And said resolution should probably wait until after Theresa lines up an alternative supply of meds.

It's not cheap (but I don't know how expensive)... BUT there is an option for those that can afford it, or have a doctor willing to fight tooth and nail with an insurance company. The drug has been discontinued, not banned. This means that it's still legal to produce, therfore a compound pharmacist can still make it for you. Compound pharmacies, unlike your typical CVS clone or mom&pop pharmacies, actually MAKE drugs there. They often specialize in doing the very thing I am proposing. A friend of mine with CFS has one make her phentermine (one of the components of the banned diet drug fen-phen)... ohentermine is the only drug that keeps her BP high enough to stay conscious.

You might also be able to get generic versions of the drug, and since the ban has just gone in recently you might be able to work it out with your doctor and some pharmacy somewhere that still has some left so as to stock up enough to hold you over till you can find an alternative (like the aformentioned compound pharamcy idea).

I don't know precicely where my friend goes, or where you live, but she's located in Edison NJ and I know she doesn't have to go far... it might even be located there.

Oh, I think that liberalism is a good thing. And I also think that requiring drugs to be safe and effective is a good thing, and requiring them to be demonstrated as such rather than just taking the manufacturer's word on it is too. After all, fen-phen for weight loss was an off-label use...

How to resolve this desire with someone who may literally have her life ruined is... difficult. And attempts at said resolution should probably wait until after Theresa lines up an alternative supply of meds.

No one here is arguing that drugs shouldn't be safe and effective.

The fact is, Cylert is both safe and effective. I don't think there's any debate on that. It's also necessary.

Which gets us back around to how best to make it available to the people who need it.

Sandy, since the anthrax letters, all paper mail to congresspeople are checked at a remote location and then usually just stored. Email is really the best bet.

I take 16 meds a day -- three of them are teratogenic. Two have black-box liver failure warnings. I just make sure to get my labs done regularly. When testing is available, there's no excuse for a broad ban.

Alex - I'm pretty sure that compounding pharmacies have to have the basic drug to compound. They just have the ability to make it up into non-standard dosages, or in pills or liquid or some other form, if a patient needs it in a dose or form other than the standard manufactured ones. But you do bring up an interesting point: the state of New Jersey is home to a huge number of pharmaceutical manufacturers... which makes them easy for people in the NYC area to contact.

I want intelligent adults to be able to make decisions for themselves to the greatest extent possible. And I want the government to be able to protect people from predation and fraud. I'm aware there's a potential conflict there, and I'm aware that there's an intellectually-respectable libertarian critique of the idea that there should be an FDA. In essence I'm like a lot of Americans: we want individual freedom and we want our government to be competent-yet-reasonable. Whether these are achievable goals or hopelessly contradictory is open to question, and reasonable people can and do disagree. As it happens, right this moment is probably not the optimal time to address me with glad cries of "yar boo liberalism sux see what progressive reforms get you neener neener." Actually, the optimal time for that kind of thing is probably, come to think of it, never.

I'm so sorry to hear that, Teresa. Good luck.

(...Re-lurking)

Here's a quick link to the online compounding pharmacy I've been using for a year (thyroid and bio-identical HRT meds). They've always been very responsive both by phone and by email. It's set up so they just ship the meds out every month, I don't have to ping them at all.

I'm sure there are many others out there, I just happen to have this handy (and I have no business relationship with them beyond being a satisfied customer).

Bellevue Pharmacy Solutions
800-728-0288 or 314-727-8787
info@BPharmacySolutions.com
www.bpharmacysolutions.com

What a nightmare -- my sympathies.

Here's hoping to contribute something new to your efforts to deal with the problem.

I consulted my Dad, who worked for many years for pharmaceutical firms like Roche and Warner Lambert, figuring that he would know more about the ins and outs of dealing with FDA bans, generics, etc. Here are his comments, verbatim:

"The only suggestion I have is that she should try to contact the manufacturer either directly or through her physician. In this kind of situation there is typically a considerable amount of the product in the manufacturer's
possession that is awaiting destruction. The manufacturer may be able to make the product available under the terms of what is known as a "Compassionate IND (Investigative New Drug)" or something similar."

Since Abbot stopped producing the brand version earlier, and Sandoz was producing (or just planning to?), I'm unsure which company you want to approach first. Maybe see which one tends to send more reps your doctor's way trying to sell the latest and greatest brands, since they have an incentive to try to make your doctor happy.

"Another option may be to try to obtain the product from another country in which the product is still on the market (e.g., Canada or Mexico). Of course, she must be wary of counterfeits and ensure that the product is identical in every way to what she is currently taking.

That's about all I can think of at the moment."

Of course, you've already established that pemoline got banned earlier in certain other countries; but it's still worth looking into, especially in those countries known for making generic versions of stuff still under patent in the US.

"One other thought is that if there are "thousands of people" in the same situation they can petition the FDA for an exception. They could also see if good old Sidney Wolfe at the Healthcare Public Interest Group would support their case with the FDA."

I know that petitioning the FDA has come up before on this post, but didn't see any mention of HPIRG or Sidney Wolfe by name as possible allies.

Again, offered for whatever it's worth, and I wish you the best of luck. Will shortly research my Congress critters' current stance on such things and determine if it's worth sending a missive directly.

Yes, post-anthrax attacks, you gotta fax your reps if you want their attention these days. Paper still works better than e-mail, but it apparently takes forever for snail-mail to get through security.

There are a number pages such as this one that provide information on how to contact your representatives. Or you can just phone up your local Leage of Women Voters and get details from them. But fax definitely seems to be the way to go.

As it happens, right this moment is probably not the optimal time to address me with glad cries of "yar boo liberalism sux see what progressive reforms get you neener neener." Actually, the optimal time for that kind of thing is probably, come to think of it, never.

Oh, well, see, the mistake you are making, Patrick, is that you are imagining your optimal time is somehow important here. No, no, for some people the time to trash liberalism and progressive causes and government is always optimal. You as a particular person don't enter into the equation. Doing harm to individuals is something only liberals and progressives and government can do, see. Yeah, that's your mistake right there.

HTH.

Thanks, Mike!

Scott Harris, I had wondered about getting hold of existing stocks. We'll definitely look into that.

Damn- banned in Thailand, too.

Will check Malaysia tomorrow.

It brings me joy to see the various solution finders working on short, mid and long term strategies to change this particular injustice.

The necessity sucks, 'tho.

Don't look for help from Sidney Wolfe. He's Peter Lurie's boss over at Public Citizen.

Wolfe signed the letter requesting not just that pemoline be banned, but that all existing stocks at wholesalers be recalled and destroyed.

James:
I'm going to reply on the latest Open Thread. I'd prefer to keep this thread for helpful posts; and move general discussion elsewhere.

How to petition the FDA:

http://www.fda.gov/ora/fed_state/Small_business/sb_guide/petit.html

Letter sent to congress critter. Good luck.

Never doubt that I'm reading every word here. If I tried to respond to everything that makes me want to respond, I wouldn't stop writing this side of exhaustion. Thank you all.

Well, thank you all except for Ted, formerly Anon.

Why am I singling out Anon./Ted? Because he's a paid astroturf professional. For those of you who aren't familiar with the term, astroturf organizations and campaigns are run by professionals, and are paid for by corporations, trade associations, heavily funded think tanks and political pressure groups, and suchlike fatcats; but they pretend to be grassroots just-plain-folks individuals and political groups. Get it? Fake grassroots = astroturf.

I've written about the phenomenon before, starting with Disinformation, which was an analysis of a professionally written "letter to the editor" that was making the rounds in e-mail. Said piece -- which did not start out as a letter to the editor in a local newspaper, as the post's exceptionally clever and tenacious comment thread went on to demonstrate -- told a lot of fibs in an attempt to counter the perception that Bush is the worst chief executive in American history.

My most focused analysis of astroturf, and probably the piece that got up Anon./Ted's nose, was Common Fraud, which started with an analysis of an odd flowchart, opened out into a discussion of astroturf in general, and finished up talking about "tort reform", which is an all-fraud all-astroturf all-the-time non-issue.

The weblog On Rational Grounds used the last line of "Common Fraud" as the title of their own piece, Deceiving Us Has Become an Industrial Process, which delved deeper into the subject of astroturf.

Amusingly, the only post in Making Light that was actually titled Tort Reform was written by Patrick.

Notice that Anon. posted six substantial comments, and watched them all get disemvowelled, before he gave himself a common first name and linked himself to the American Enterprise Institute's Liability Project. People tend to assume that an unidentified poster is writing as an individual. If Anon./Ted hadn't been called on it, he would never have mentioned that it's his job to write and propagate professional-grade codswallop about tort reform.

That's why Anon./Ted is here. I sincerely doubt he gives a damn about me, Xopher, or any of the other Pemoline-deprived persons mentioned in this thread. He's a paid flack who's trying to use my weblog as an occasion to take swipes at the whole idea of government regulation and consumer protection groups -- both of which are excellent things, even if on this particular occasion these particular government regulators and consumer protection mavens are being real fuggheads -- and to try to promulgate a completely spurious link between the Pemoline problem and some nonexistent "crisis of litigation."

Which is pretty damned cold of him, say I.

Incidentally: As APO notes, Anon.Ted's employers, AEI, are part of the same right-wing noise machine as the Heritage Foundation, the Cato Institute, the Club for Growth, the National Center for Policy Analysis, et cetera ad boric acid. AEI is an ever-flowing fount of targeted disinformation, viz. Brad deLong has waxed eloquent about them on a number of occasions.

(Is it paranoid or self-aggrandizing of me to think Making Light is worth the attention of a professional liar like Anon.Ted? Alas, no. As the far right wing figured out long ago, lobbyists are expensive, and legislators are very expensive; but writers cost next to nothing. Relatively speaking.)

A trivial point by comparison, but "Ted" is also evidently unclear on that whole "Patrick and Teresa are two different people" thing. Yeah, I know, that's a surprise.

I'm still confused.

This is apparently the chronology...

1) England, Canada, Germany, et al, banned pemoline or put it on a special list. Japan and a few others still appear to permit its sale. Hmmm, interesting set of intellectual property regimes on each side there.
2) Abbott discontinued Cylert, citing poor sales.
3) The generic manufacture continued.
4) Public Citizen petitioned the FDA to have generic pemoline banned.
5) The FDA did so.

Reading up on the petition, I'm still not seeing how Public Citizen was serving the public interest by putting all that work into bulldozing FDA into banning the generic pemoline.

Here's what I want to know. Is there a patented drug that patients are being shoved into taking as a replacement for the non-patented Cylert and pemoline?

As far as I can see, no-one in this thread has mentioned the names of the other drugs which aren't suitable for Teresa and Xopher, so I apologise if this is only retreading well-known ground.

Australia has a Pharmaceutical Benefits Scheme providing subsidized prescription of drugs that treat medical conditions. According to the latest published list of approved medications (http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/health-pbs-general-schedule-schedpdf.htm), the following drugs are approved for Narcolepsy treatment (I've tried to find alternative/generic names for the drug as well if possible):

Clomipramine hydrochloride / Clomicalm / Anafranil
Dexamphetamine sulfate
Modafinil / Modavigil / Provigil

Again, you've probably looked into all these multiple times, but I felt I should at least pass this on. In particular, Modafinil is suggested for those with an intolerance for Dexamphetamine sulfate, so I wondered if that might be a possibility.

Teresa already takes modafinil (trade name Provigil), as discussed upthread; along with pemoline, it's a fine therapeutic regimen for her.

Other common anti-narcolepsy drugs are Dexedrine and Ritalin, both of which she's been on for extended periods and neither of which work anything like as well as Cylert/pemoline. These days a compound called Adderol is evidently often prescribed in preference to Dexedrine; my impression is that it's just an amphetamine compound with the sharper edges buffered off, so while I'm sure it would be better than nothing, I don't see any reason to believe it would be the magic bullet that pemoline is. There are a bunch of other drugs--including something called Xyrem--which are often prescribed to those narcoleptics who are eager to suppress the symptoms of cataplexy, which is the falling-down-when-surprised component of the disorder whose full name is Polysymptomatic Narcolepsy/Cataplexy Syndrome. Teresa's position has always been that she isn't all that worried about the falling-over part and doesn't see any need to take special drugs to prevent it.

I have to admit that my first thought when I learned about this was, "Are they about to roll out a new drug?"

Leaving aside the fact that it fits the pattern, there's also the fact that Nader lately seems to have some very nasty friends.

don't see any reason to believe it would be the magic bullet that pemoline is

CNS drugs are weird. Look at pemoline - not only is it not a magic bullet for all narcoleptics, but the RAF examined it (and found it suitable!) for use as a stimulant for flight crews. So just because Xyrem is commonly prescribed for cataplexy doesn't mean it won't work for whatever is going on with Theresa, just because Adderall is a mixture of amphetamines likewise. Of course, it doesn't mean that it WILL...

It also shows the kind of trouble you'll likely have trying to find alternative sources for these things, since Xyrem is just the trade name for GHB. Which was banned a few years back due to fears of use as a party and/or date-rape drug, although I think that was the Drug Warriors instead of the Naderites.

Best of luck. Perhaps the FDA can be brought around.

I'm so sorry to hear about this, TNH and Xopher. I think I'm up to two perscription drugs pulled out from under me now, which was upsetting even with crappy-but-workable alternatives. I can't imagine going through that with no other alternative. I've got my fingers crossed for you finding a source overseas for the short term, and for the FDA and one of the drug companies taking another look at it under the orphan drug program and getting narcolepsy approved as an on-label use for the long term. As well as fingers typing on the email-writing front, of course.

(A side note to CJ, waaaaay upthread: I also had Seldane pulled out from under me, and Allegra (the replacement) had very similar effects for me. Mood-altering Stepford purple KoolAid effects, but similar ones nontheless. Claritin works passably for me -- and is even OTC! -- and I've heard really good things about Zyrtec, although it's expensive and I for one don't have a chance in hell of convincing my insurance to let me go on it. And a lot of people swear by the new perscription nasal sprays. So -- there's lots of new stuff out there in the post-Seldane world that's worth trying.)

Of all the stupid thigs to be going on. My sympathies, Teresa. While my neurological problems are not as severe as yours are, I do indeed sympathise.

I noticed that Anafranil is mentioned up thread as an approved Narcolepsy drug in AU. That is very interesting stuff - as I was on it for control of severe myoclonus/migraines several years ago. You have to ramp up the dosage in 25 mg increments. My first reaction to this medication was - ahem - interesting. I begged to be taken off this medication after a day - and when I hit the recommended adult dosage of 125 mg - I went from being in either in a drug induced stupor or to raging, crying and being incredibly emotionally unstable in a very short period of time. Luckily my Neurologist took one look at me and yanked me off of it, (it had been prescribed by my PCP.), and we started making the rounds with Verapamil, Klonopin, Neurontin, and Topamax.
Some of these drugs - Verapamil and Topamax were not intended to be used for Migraine relief - but were found to have positive effects in some people for prevention of Migraines. Topamax is an anti spasmodic and has since been FDA approved for use in a migraine prevention regimen. Verapamil is beta blocker that has shown to be effective in reducing the frequency and severity of Migraines. None of the above worked to supress my migraines/myoclonus, except for the klonopin for the myoclonus. I also take adderall for my mild ADD.

Right now I'm taking none of these meds, as I'm almost 6 months pregnant. I desperately miss the clarity that adderall gives me - the focusability, time management and the sweeping away of truly trivial things that eludes me right now. (Not to mention the fact that I drive my SO crazy with this behavior.)

I wish that the idiots in Nader's group could see what it's really like to live with a neurological problem, to have a drug work sucessfully on it, and then be faced with losing that drug and the capability to live a "Normal" life that it gives.

Maybe Oprah Winfrey can help - she takes show suggestions by email on her web site. If a whole bunch of us emailed - it might get somewhere.

j h, the patented drug you're looking for is Modafinil/Provigil.

My take on Xyrem is that every anti-cataplectic drug that's ever been tried on me has zapped my concentration, focus, short-term memory, fine-gauge reading comprehension, processing speed, hand-eye coordination, sense of duration, inventiveness, general high spirits, and my ability to read maps and calculate restaurant tips. Also, none of them have entirely cleared up my cataplexy, unless "rendering me so poleaxed that I can't understand the jokes" counts.

Compared to all that, falling flat on the floor when something funny takes me by surprise is not a big problem.

Tidbits I haven't seen mentioned yet (with apologies if I just missed 'em somewhere in the verbiage):

- another term to look for is "Pemadd" or "Pemadd CT". You might get lucky calling every pharmacy in the phone book to see if any of them happen to have some under that name, Cylert, or just plain Pemoline.

- Walgreens online offers Pemoline in two dosages here

- CVS online likewise offers three different dosages here

- another manufacturer is Tyco subsidiary MALLINCKRODT, which has a website here. A call to their customer service line reveals that they've stopped making it, but I didn't ask about undestroyed stockpiles.

- Getting a drug authorized for a new and formerly off-label use is not short-term practical - it requires much (not all) of the same testing done for the original use. A far better bet is to try to get it un-banned for ADHD. Find allies in that community, if you can.

- Sorry, but your doctor fckd up bigtime by not letting you know about this back in the spring when it was still an open or at least a recent issue. See if guilt at letting you get blindsided like this will make him or her collaborate by generating prescriptions if you attempt to stockpile. You might also see if drug reps stop by the office - they can be leaned on pretty easily for free samples, though maybe not for a drug with these restrictions.

- Pemoline is one of those things athletes use to jack themselves up; they screen for it in at least some sports. That suggests a market that a Balco-like company might still want to discreetly serve.

- I seem to have hit the jackpot on congresscritters - one of my Senators is the second Democrat on the relevant committee and my Representative is the ranking Dem on the House committee. My other Senator is Joe Lieberman. I'm pondering whether email or simply trotting my smiling face and stubborn nature over to sit on the doorsteps of the latter two would be more useful.

Besides, it's funny. As long as you fall on something soft. Even if it's me.

I keep forgetting not to tell you jokes when we're walking down the street...

Kate: That's interesting, I take Verapamil to slow my heart. The BP-lowering is a side effect for me (since my BP wasn't high to begin with). This morning I had the White Fog effect when I stood up quickly during my workout...

Interestingly, we think it was double-dosing the Verapamil (I have ADHD, remember?) that triggered my worst migraine ever, the one that had me leaving the office on a stretcher. Carbon monoxide poisoning may have been a factor as well.

Now I have a pill organizer, I don't go anywhere near Port Atrocity Bus Terminal in my commute, and it hasn't happened again. My migraines since then have been relatively tame beasts.

"Funny" was Teresa falling down at jokes (onto something soft, e.g. me). Not Susan sitting on doorsteps.

Whoops -- Xyrem is GHB? I'm fine with that. I guineapigged for the original GHB study at Sunnybrook in Toronto.

I've always wondered why they didn't just make GHB a prescription drug, instead of leaving it over the counter and then yowling about date rape.

Jake, when I was first given Cylert, they were prescribing it for hyperactive kids, senile elders, and some narcoleptics. It calmed down the kids, perked up some (if not all) narcoleptics, and increased the likelihood that elderly patients would dress themselves, fix regular meals, and interact with other people. The fun part, my neurologist told me, was that they weren't sure why it did any of those things.

Come to think of it, my initial diagnosis of narcolepsy was based on Cylert: they gave it to me and the lights came back on.

Well, well, I'll be damned... Blogs really are the new USENET.

Anon/Ted is Ted Frank of the AEI. He got his JD from UChicago. Which leads me to suspect he's the same Ted Frank (thf2@midway.uchicago.edu) who became net.famous as one of USENET's most active trolls. How nice to see that he's now being paid to waste other people's time!

And what a pity that we didn't have disemvowelling back in the 90s.

The fun part, my neurologist told me, was that they weren't sure why it did any of those things.

Welcome behind the scenes of CNS pharmaceuticals. To a first approximation, no one really knows why any of them work. Taking one to market is generally a matter of giving it to a bunch of people, seeing what it does, and looking for a disorder that it mostly fixes and nothing else seems to, then counting on doctors handing it out off-label for everything under the sun. Because hey, it might work, and you won't know until you try.

It's a hell of a system, but it's not clear what's better and it is clear that there are a lot of things that are worse.

Regarding the prescription drug vs. banning, a) the clinical data wasn't fully in yet, b) the regulatory continuum is not very smooth (what do you do with a CNS depressant that is neither an approved drug, illegal, or alcohol?) and c) there's a lot of political hay to be made as a drug warrior (or "protecting the public" in general).

Making political hay of an unfortunate event:
I seem to recall there being a Russian play called The Suicide in which a man declares himself ready to commit an eponym against the laws of Man and God...he is promptly waylaid by a series of devoted individuals, all eager to have him commit suicide for their particular cause. I don't remember how it ends, but I do know they've taken all the fun out of it by then..."You might as well live."

I don't know if this will work since your drug is schedule IV. Check these people - http://www.discount-pharmaceuticals-and-prescription-drugs.com/. They are based on the island of Vanuatu and I have been able to get drugs not available in the US from there in the past, they were shipped conventionally without a problem. But I was not dealing with a stimulant or narcotic, I do not know if they can or would supply that.

As for the sub-thread on Thalidomide, some things should be noted. It was teratogenic because it caused women to metabolize B6 more quickly. Women who took pre-natal vitamins did not have the problem. Also, it was and still is the only hypnotic that did not cause death in overdose. There were cases of children taking an entire bottle, and sleeping for 20-30 hours with no further problems. I wanted to use it for pediatric burn patients - so they would not have to suffer the pain of having dressings changed - but was never allowed to. Also GHB is available by perscription, but with a very restrictive program. (sorry for the topic drift)

Xyrem is indeed GHB, according to the FDA:

The Food and Drug Administration approved Xyrem (sodium oxybate or gamma hydroxybutyrate, also known as GHB) for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted.

And Xyrem even has a website, put together by something called Orphan Medical. Of itself, Orphan Medical says:

Orphan Medical, Inc. is dedicated to patients with inadequately treated or uncommon diseases. Orphan Medical acquires, develops, and markets products of high medical value that address inadequately treated or uncommon diseases within selected market segments. We put patients first and believe that each patient deserves the best treatment available for their condition.

Susan, if you show up at the door of Lieberman's office with a donation check in hand, I'm sure he'll be more than happy to listen to what you have to say.

(Fellow CT resident here... very disgusted with Lieberman in case you can't tell.)

A.J.: Yes, I'm the same thf2@midway.uchicago.edu who was "net.famous" for opposing sex discrimination by fraternities and arguing against racism and anti-Semitism in alt.conspiracy. I'm not being paid to post here, but if you know someone who does pay for that sort of thing, please let me know, and maybe I can make a hobby pay for itself.

Patrick, I apologize for thinking that you were speaking on behalf of Teresa when you said you were speaking on behalf of Teresa. I meant no offense, and do understand you are two different people.

Teresa: My job has nothing to do with this comment board. If I wanted to be working at 2:30 a.m., I could be at a law firm making a lot more money. I supported civil justice reform long before I took a giant paycut to get a job specializing in civil justice reform, and supported civil justice reform precisely because it helps people in situations like yours who don't have any special-interest groups helping them. (The astroturf allegation is especially ironic, since the Public Citizen subgroup that petitioned the FDA is the prototypical astroturf group acting on behalf of a special interest in the name of "consumers.")

A friend is a big fan, recognized the connection between your issue and a paper I had written on the general subject, and pointed it out to me. I made the mistake of thinking that I had something to offer someone my friend admired, and then the second mistake of addressing the issue clumsily through a comment-board (and, worse, through an anonymous username that would inevitably be misconstrued, which I should have realized if I had put ten seconds of thought into it) before I had thought through how it would be received in the environment of a comment-board.

And I truly regret this, because I've failed to persuade people that one needs to change the incentives in the status quo that lead the trial bar to unfairly attack drugs that help people, because I hate the fact that I'm going to see this same thing happen to other people with other diseases who rely on other drugs--including drugs that haven't even been developed yet.

You can doubt my sincerity, but you can look it up that I've been speaking out about this problem for a long time (including before I took my current job). I'm very sorry that it manifested itself with a drug that is important to Teresa. I hope that you succeed in the uphill battle against Public Citizen and the trial bar.

If it resolves cognitive dissonance to believe that the pemoline ban is an aberration, rather than just another in a long line of beneficial drugs that the plaintiffs' bar has driven from the market, that's your choice. If it makes you feel better to bash me for opposing what the trial bar's actions do to regular people, then go to it. But I'm the one who's on your side on this issue, and who's been on your side since before you knew the issue affected you personally. I'm truly sorry that that offends you.

Again, I'm truly sorry this has happened to you and wish you a happy resolution to this problem.

A. J.: Well, well, I'll be damned... Blogs really are the new USENET.

*Sigh* Trolls aside, the amount of traffic on this thread since I last read it yesterday, and the high signal-to-noise ratio it comprises, is heartening. All the sheer information here and the rallying of the troops... it's almost enough to restore faith in humanity. Or at least in that cross-section represented here.

I wish I had goodusefulbrilliant information to share. I can at least put my own letters to the various Powers That Be, recommended here and elsewhere, in today's mail. (There will probably be some borrowing from Harry Connolly's wonderful letter involved. I cannot fathom how to say things better.)

Occurred to me: Would Working Assets Long Distance take on this issue, and send alerts to their customers in their phone bills? Can't hurt to try. I'll include them in my letter/email-writing.

And whoever first mentioned the possibility of this story getting on Fox News... Oh my. Thank you for the giggle and the wild-eyed optimistic hope. If there were anything Right and Left could come together on, this does seem to be the right sort of issue.

... take swipes at the whole idea of government regulation and consumer protection groups -- both of which are excellent things, even if on this particular occasion these particular government regulators and consumer protection mavens are being real fuggheads --

I wish you well and hope that you are able to find your medication or get it released to to the marketplace again. However, your sentiment above is the reason you are in this predicament to begin with. You have allowed the government to substitute its judgment for your own. Now you have the arduous task of persuading the government to rescind its judgment (this one time) because you are the better judge of what should enter your body.

On an practical note: there is a black market for almost everything. If I were in your position, I would consider myself absolved of the general responsibility to obey the laws of the land. Right to privacy and all that. Just a thought.

India has a fairly active pharmaceutical industry, albeit one that tends to copy generics. I found this
interesting.

I seem to recall there being a Russian play called The Suicide in which a man declares himself ready to commit an eponym against the laws of Man and God...he is promptly waylaid by a series of devoted individuals, all eager to have him commit suicide for their particular cause.

By Nikolai Erdman! It's brilliant! (And difficult to do right.) Lost for a number of years because the main character is unemployed and depressed and, as we all know, there was no such thing as unemployment and depression in the Soviet Union. Rediscovered about 30 years ago.

I wrote a paper on it in grad school so I'm, you know, An Expert. :)

For those who are interested, more here.

Ralph Nader has the same freedom of speech and the same right to push his agenda as you do, but other than that, he has no power. Don't blame him, blame the FDA.

Nader's advocacy group didn't make the decision. It's not their *fault*. If a bad decision is made -- and I'm neither doctor, chemist, or public health expert, so I have no idea -- than it was made by the FDA. Your beef is with them.

The FDA has very specific requirements from drug companies, drug tests, and the reactions by people on those drugs. If Cylert doesn't pass those tests, it needs to come off the market until either (a) it passes, or (b) the FDA changes its rules. In either case, Nader's right to encourage the FDA.

Find another bogeyman, would ya?

I've been reading this, trying to work out what I might have to offer. The answer I've come to is (sadly) nothing other than wishes of luck for Teresa and Xopher. :/ So I'll just make those and continue reading.

Ralph Nader has the same freedom of speech and the same right to push his agenda as you do, but other than that, he has no power. Don't blame him, blame the FDA.

And there was me thinking politics exists in the US.

Meredith writes
Susan, if you show up at the door of Lieberman's office with a donation check in hand, I'm sure he'll be more than happy to listen to what you have to say.

(Fellow CT resident here... very disgusted with Lieberman in case you can't tell.)

The virtue of Lieberman in this case is that he's easy for me to get to physically since he lives nearby and is a relative homebody as Senators go. I've met both him and DeLauro, though not in any context where they'd remember me in particular.

Did you see this week's NH Advocate? Gah. It'll be interesting if Weicker has a go at him.

Nader's advocacy group didn't make the decision. It's not their *fault*. If a bad decision is made -- and I'm neither doctor, chemist, or public health expert, so I have no idea -- than it was made by the FDA. Your beef is with them.

It is likely that without the active pushing of "Public Citizen" the FDA would not have made this decision. This makes them culpable.

Just because "Public Citizen" doesn;t have any offcial power does not mean they do not have the responsibility to make sure their actions do not do harm.

Nader's advocacy group didn't make the decision. It's not their *fault*. If a bad decision is made -- and I'm neither doctor, chemist, or public health expert, so I have no idea -- than it was made by the FDA. Your beef is with them.

It is likely that without the active pushing of "Public Citizen" the FDA would not have made this decision. This makes them culpable.

Just because "Public Citizen" doesn't have any official power does not mean they do not have the responsibility to make sure their actions do not do harm.

I hear ya man, Nader took away my right to die by being impaled on a steering wheel.

Did you see this week's NH Advocate?

Pre-caffeine reaction: "But they can advocate for themselves perfectly well, even with Teresa at half-strength!"

The whole concept of what the FDA does is bogus. There's no such thing as a "safe" drug. It all depends on the circumstances and the individual. Give patients and doctors information. But don't restrict their options.

There's always a judgement call. And it should be made by individual patients and doctors on a case by case basis.

We need medical liberty.

Kevin P apparently fails reading comprehension, or else just doesn't care.

Teresa, Patrick, I've been reading the thread looking for something we can do. I'll write letters this weekend, and I shall be pondering fundraising ideas in the event that a source is found that insurance won't cover.

If you suffer from a condition that is life threatening, and the medication to improve your condition/save your life is not available here, you can import from any country (try India) legally. Period. Don't freak out

The trouble is, narcolepsy isn't life-threatening. Just being unable to read, unable to stay awake all the way through a half-hour TV show, unable to go to the supermarket without falling asleep in the aisle ... won't kill you. Make it impossible to hold a job, to carry out even a semblence of a normal life, yes. But kill you, no. You can go on for forty or fifty years that way, no problem.

You know what you felt like after pulling three all-nighters in a row back in college? Try feeling like that all the time, for the rest of your natural life.

As another poster mentioned above compounding pharmacies will be able to compound pemoline for your wife. Pemoline, as a bulk chemical, is still available to pharmacies. With a valid prescription from your physician, these pharmacies will compound the powder into the appropriate dosage form (capsules) and strength.

Visit the International Academy of Compounding Pharmacists to find a compounding pharmacy near you.

IACP site

It's interesting, at least to me, to see how many people see the FDA as existing purely to stop them from doing what they want to do.

The FDA exists because it was decided, in the early 20th century, that it was time to restrain the eager capitalist instincts of individuals who felt the best way to make more money faster was to either adulterate food and drug products, or not bother to take the extra steps to make sure they were safe for consumption, or by claiming they were selling one thing, and actually selling something else (you know, committing fraud). It was also felt that medicines should actually do what they claimed to do, and that, as a further advantage, people should have some guarantee that those medications were safe. It's been pretty clearly demonstrated that businesses often don't stop to consider safety when they're anxious to market a product; current drug-testing practices got a big boost in 1937 when a good many people died as a result of taking a sulfanilamide elixir (that is, liquid preparation) made with (not contaminated with accidently, made with purposely) diethylene glycol, AKA antifreeze, which, like its cousin ethylene glycol, AKA antifreeze, is really posionous.
Most of us aren't equipped to test the food we eat and the drugs we need to see if they're safe and the drugs are effective, and the history of the world has not convinced me that I can unreservedly count on manufacturers and marketers to be absoutely honest when a buck is at stake. Some will be, and some will not. I'd like someone to keep them honest, someone who can make their corporate lives hell if that's what it takes. While there are times (and this is one of them) when I'd like to slap the FDA's collective heads sideways, until businessmen become angels, we're going to need either the FDA, or something like the FDA.

Yes, I'm getting sideways from the main point of this thread, and I apologize. But the prospect of canny businessmen using exciting compounds like diethylene glycol as an artificial sweetener, or selling me a solution of diluted alcohol with licorice flavoring as a cure for my headache (never mind guaranteeing that it's ethanol rather than methanol, either), or dyed powdered sugar compressed into pills as a treatment for infectious diseases is not an impossible, or even improbable one, if there's no one there to stop them. And no, the history of popular American pharmacology does not lend me confidence in the whatsis hand of the marketplace. Compounds of flavored alcohol, water, and opiates are not the first, best choice of medications for most disorders, no matter how popular they were in my great-grandparents' day, or how popular they'd be now, if such were marketed.

I'm working on letters to my senators, the egregious Frist and the oleaginous Alexander--who have Senate health committee seats. Since my feelings for both of these men are, well, nonpositive, they'll need rewriting, I suspect.

As nearly as I can tell, most of the people in this thread (including Ted) agree that the FDA serves a useful purpose. The problem is that the FDA is strongly incented to guarantee that no one will die or be injured as the result of a side effect from an approved medication, even if the medication is quite useful and the side effects are rare. The more useful a medication is (effective and unique in its action), the more likely the FDA is to tolerate side effects.

The problem is that we all have different body chemistries and they may respond differently to different drugs. I recall a statement made by the CEO of one of the major drug companies a couple of years ago which was (loosely quoted) "We are deliriously happy to find a drug that works for twenty percent of the population."

Well, he may be happy, but that may not make the FDA happy. Iressa (if I recall correctly), which is a treatment for a very specific type of cancer, turns out to only work for people who carry a specific genetic marker, common in Asia. The manufacturer and the FDA are fighting over keeping the drug on the market, despite the fact that there is now a genetic test available that will let you know whether or not Iressa is likely to be effective on your cancer.

To be honest, I wouldn't like to be one of the people working at the FDA, because they can't win. But I think that they're too close to a zero-tolerance-for-risk strategy for our -- and in this case, Teresa's -- own good.

Fidelio: My understanding is that the FDA was established to make sure that the actively harmful foods, drugs, and cosmetics were eliminated (some of the stuff that was out there would curl your hair just reading about it). The proof-of-safety bit came later, and is generally a good thing. What's happening here, as far as I can tell, is that 'Public Citizen' decided that any risk is too high on this drug, didn't do the research to find out whether it had any genuine uses or users, and got the regulation pushed through with very little attention from the public, or, apparently, the medical community. (This seems to be a fine example of political power at work.)

Teresa, Xopher, you've probably already enlisted your doctors to write letters or make phone calls. I see from Google that there are several narcolepsy groups with websites. Can we get them involved too?

On the side issue of individual chemistry and drugs: I've tried using niacin to lower my 'walking dead' cholesterol level. Both regular and slow-release niacin have the same effect: my brain function drops noticeably (I notice it) after two or three days. It isn't a listed side effect ....

I have had some experience with Public Citizen, and I can guarantee that Ralph Nader had nothing to do with the anti-Pemoline campaign.

Let me repeat this: Ralph Nader had nothing to do with the problem you all are discussing.

Ralph has very little contact with the staff at Public Citizen. He does have contact with the principals, particularly Joan Claybrook and some of the directors.

He probably has not heard of Pemoline.

Criticize Public Citizen all you want, but bringing Ralph into this is a huge stretch.

Finally, rather than jumping to the conclusion that Lurie and PC are evil, why doesn't somebody try to engage in a dialogue with Joan Claybrook? Might be more productive than posting blog rants.

Let me repeat this: Ralph Nader had nothing to do with the problem you all are discussing.

Ralph has very little contact with the staff at Public Citizen.

If you train an attack dog, and then turn that dog loose, and that dog subsequently goes out and starts mauling people . . . are you not responsible for its actions?

OK, a couple of things.

First, I'm sorry for your medical condition, Teresa. You found a solution, and the FDA has taken it away from you. Nothing that I'm about to say is meant to minimize how much that sucks. But I need to make a few points.

First, Ralph hasn't been associated with Public Citizen since the late '80's. I know. I used to work there. He is the founder, but he left in a huff and has not been back. He's not even on the board anymore. That's not to say that many who work there aren't friends with him, or that he didn't weigh in on Public Citizen's work. It's to say that he had no control, no more influence than the many Washington activists we worked with. And, just as it was a mistake for people to blame Public Citizen when Ralph did an amazingly stupid thing and ran for President in 2000 (over the objections of a group of over 60 staffers who asked him to withdraw), it's a mistake to blame him for the work of Public Citizen. I hate the man, but being fair to him matters.

Second, I find it interesting that nobody else seems to think it germane that the rest of the world already banned this drug. Again, I'm not suggesting that this doesn't suck for Teresa. I am suggesting that drug regulatory agencies across the globe studied the efficacy and safety of this drug and decided that it wasn't worth the risk. Public Citizen didn't do that. The governments of Britain, Canada, etc. (ad infinitum) did. So I'm inclined to think that this was not pernicious decision making.

Look, in general, we ask the FDA to do what it did here. Look at risks and benefits and ban or control drugs where the former outweighs the latter. Thalidomide is the most well known example, of course, but there are literally thousands of others. The difference is that they never banned thalidomide, and brought it back with proper monitoring. Where was that proposal?

Look, if you deal with regulatory politics, (and I'm not suggesting this is your responsibility personally, but I am suggesting that the narcolepsy network fell down on the job on this one) you know that there's a comment period before a decision on reclassification. And the FDA puts HUGE weight on the comments of those affected by the change. This is exactly why. Because Public Citizen sees a few things: there is a 1000-2500% increase in risk of liver failure with the drug; most other nations long since banned the drug for an out of line risk/reward balance; the literature suggests that other drugs with fewer risks work better.

They don't know that you've tried those other drugs and they don't work. The literature suggests that there are other options that are safer. Only you, and your fellow narcoleptics, can bring this to the attention of the FDA. But your doctor NEEDS to be paying attention to this. And the Narcoleptic Network needs