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companies can still sell their versions even after Abbott pulls the medicine, unless the FDA determines the drug was withdrawn for safety reasons.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.