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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Comments Welcome - Really | Main | Mice, Humans, and Cancer »

January 3, 2006

Pemoline Problems

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Posted by Derek

The FDA has recently pulled pemoline (sold in its non-generic days as Cylert) from the market, citing risks of liver toxicity. It's used for narcolepsy, ADHD, fatigue in multiple sclerosis patients, and other indications. In theory, there are several other drugs that are useful for all of these.

In practice, though, we're talking about some poorly understood CNS indications here, and the patient response to drugs of this sort is so heterogeneous that no one understands what's going on. There are people who respond to pemoline that don't respond nearly as well to anything else. And they're an unhappy bunch, because they seem to be willing to take on the liver risks in order to have a drug that works.

One such customer is Teresa Nielsen-Hayden, well-known for the Making Light blog, and this issue has been the hot topic over there, as you'd imagine. You'll notice that the linked blog post takes a rather hostile attitude toward Ralph Nader and his Public Citizen group, because they're taking credit for petitioning the FDA for the drug's removal. The Nielsen-Haydens (no fans of the Bush administration) have been furious at Nader and his people since at least the 2000 election, so this new accomplishment has understandably pushed about all their accessible buttons.

I think they've got a point. I think that if the risks of a given drug are known, that informed patients should have a right to choose that drug's benefits with its risks in mind. Pemoline has had a black-box warning on it for years now, so it's not like its risks have been hidden. Now, it's true that if such a drug remains on the market, some people are going to take it who shouldn't, black box or no black box. But I have to wonder if such people are going to find some other way to get into trouble, no matter how much concerned bureaucracies try to save them.

The situation with Accutane (isotretinoin) and pregnancy is a similar one: there's no way you can miss the fact that it should by a pregnant woman. But every year, some do, despite strenuous efforts to prevent such cases. Mind you, Nader's people have been agitating for years to get that one pulled from the market as well.

Wouldn't a similar registration and/or liver-monitoring regime work for the people who have to have pemoline? Perhaps coupled with some sort of indemnification for its manufacturers? How many more potentially useful medications could we have available under such conditions?

If any of my industry readers have suggestions on where to obtain pemoline, I'd be glad to hear them, although Teresa Nielsen-Hayden and many others would be even happier.

Comments (35) + TrackBacks (0) | Category: Toxicology


COMMENTS

1. Puff on January 3, 2006 10:36 PM writes...

Unfortunately pemoline is schedule IV, so none of the online and out of country pharmacies will touch it with a 10 foot pole, and importing it is the same as importing cocaine.

Permalink to Comment

2. Steve C on January 4, 2006 2:23 AM writes...

Derek

Let me throw in a quick point.

I agree with you. And I have a similar type of personal investment in the general question as Pemoline users do.

However, the concept of "informed patients" is a delusion. This can be seen in the issues around patients and informed consent in biomedical research. Somewhere on TV in the last few years I saw the following:

A practicing physician who had occassion to have patients in studies, said, [paraphrased], "I'd take patients through the whole information process that easily took twenty minutes. I'd explain to them what a double-blind, placebo-controlled experiment was. I explained that they could as likely receive the experimental medication as a useless one. That nobody knew in advance who was going to receive which, that everything was coded. Even I wouldn't know. Only after the experiment was complete would a seperate group of scientists decode who got what, so they could evaluate the experiement.

"I'd ask them if they understood, repeatedly. Finally, they signed the consent forms. When that was done, they would lean a little closer, lower their voice a bit, and say, 'Doc, I trust you. I know you're going to give me the real medicine.'"

It's from the same root as my observations about the public in the ID post.

Permalink to Comment

3. Steve C on January 4, 2006 2:55 AM writes...

Derek

Two more thoughts.

Accutane is not a good example to use in arguing for patient access. It's one thing to take risks with yourself to try to improve a serious disease state, or even make that decision for minors under your care. It a completely different matter to risk creating a deformed, disabled fetus with a potential cradle-to-grave institutional life at the expense of the state just because you're a moron with pimples. Sorry, I couldn't resist.

I thought up a solution to this entire issue of controlled patient access to dangerous meds, but it's very expensive and too draconian for the American public. But it's doable.

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4. John Johnson on January 4, 2006 6:20 AM writes...

Steve, did you really need to explain a double-blind placebo-controlled trial to somebody? Why not a slightly more detailed version of "We know it helps a lot of people, and so I think it will help you. Please let me know as soon as possible, call your office, if you notice A, B, or C." It seems to me that describing how clinical studies actually work only confuses the issue.

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5. Marc on January 4, 2006 8:10 AM writes...

John:

Because that would be lying to the patient.

I know that most patients do not understand everything about medicine. That is why they consult and trust doctors. The feeling that I am getting from the few posts that are up already is that doctors should treat patients like complete idiots because they do not have all the information.


Steve is right when he says that draconian methods exist to solve this problem, but the responsibility of the industry, doctors and pharmacist is to inform these patients, not take decisions for them.

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6. Timothy on January 4, 2006 11:06 AM writes...

This brings to mind a discussion I had with a friend of mine in college a couple of years ago. That there should be "fair warning" laws.

In my opinion everything but antibiotics should be over-the-counter but extremely well labled. If you take something dangerous and screw yourself up, well, you had a label that you didn't read and that's just too damned bad. Make the disclosures complete, limit the ability of folks to file torts based on properly labled drugs, and maybe eliminate the efficacy trials for FDA approval. Keep the safety trials, better to know if a drug is going to kill you, the marketplace will figure out which ones work. Do something stupid (OD, take with a drug you shouldn't mix, etc), you had fair warning.

The original conversation stemmed from my frustration with hippies who tresspass, sit in trees, and then keep the owners from cutting down said trees for fear of murder/manslaughter/assault charges, but I think it applies equally well here.

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7. The Novice Chemist on January 4, 2006 11:17 AM writes...

Having never suffered serious acne other than the typical (slight) teenager stuff, I'm guessing that taking a prescription drug (Accutane) means that it's debilitating.

You know, the structure of pemoline doesn't look all that tough to make. One wonders.... (just kidding)

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8. RKN on January 4, 2006 12:16 PM writes...

Nader? Good grief. Just to piss that idiot off I think it might feel good to mainline pemoline inside a Corvair.

Besides, given that we are experiencing the dawn of the Pharmacogenomic era, isn't one-size-fits-all (or harms some)regulation of drugs by the FDA woefully out of date?

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9. Carolyn Smth on January 4, 2006 1:08 PM writes...

I agree with Chris on the label/warning, let people take it with caveat. I have been trying to get Seldane D for years as it seemed a miracle drug for sinus problems and caused a few people who had heart disease already, to pass on. My MD was convinced that Allegra was nearly the same, but it sure did not help me like Seldane did.

However, I agree with Steve C, who says that informed consent just does not work. He is right. It is an illusion that a person who is barely literate, and has no scientific background can be an "informed consentor" to anything. I am always amazed that nurses are expected to get consents signed pre-op in the hospital.

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10. Dr Toot on January 4, 2006 1:29 PM writes...

I suggest a federal steering committee tasked with developing a cabinet level Dept. of Good Intentions. Halliburton would get the contract for the ensuing road to hell, & a small slush fund could then be set aside to have Iranian separatists smuggle pemoline back into the USA using illegal alien mules. It's really quite simple when you think about it.

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11. Sandra on January 4, 2006 2:33 PM writes...

Why can't the person with the disease decide if they want to take the chance on taking a certain medication. If they know the side affects and the possible destruction of the liver or any other organ and the blood tests are there to check on levels weekly or monthly why can't the patient make the decision themselves? I know that I would want to be informed of all this and I would make my own decision!

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12. Deoxy on January 4, 2006 2:59 PM writes...

The primary problem here stems back to our current legal situation: There is no such thing as a legally binding release form.

Schools get sued all the time (and lose at least some of them) when cheerleaders or athletes get hurt, despite a medical release form. Other areas of law are the same.

So, currently, no matter how much you say you understand (or how much you really DO understand - you could be the fricking INVENTOR of the drug, wouldn't matter) or how much you sign that says you take responsibility for it, when something bad happens to you, all that paper, all those promises and oaths and legally binding contracts GO AWAY, and you can still sue them.

That's a serious problem, and it has serious consequences (like this example). As someone on another site mentioned, even if the FDA changed their mind, the damage is done: no sane company will make any more of this drug, because they WILL get sued by someone who has a bad side effect (or their estate), and that suit WILL cite this ban (even if temporary) as evidence.

So, as a conclusion, here's a good January-after-eating-too-much-in-December joke:

What is the proper weight for a lawyer?

Four pounds, including the urn.

Permalink to Comment

13. Paul Schlick on January 4, 2006 3:12 PM writes...

Derek,

I posted the following at the Neilsen-Hayden site as an example of accommodation betweem the FDA and a drug company in a similar case that allowed seriously affected people to be served (although someone pointed out that the drug below was labeled for the disease in question while Cylert is off-label for narcolepsy). Hopefully, something similar can be done for desperate Cylert users:

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 the 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.

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14. inmypajamas on January 4, 2006 3:22 PM writes...

John, in doing any type of clinical research, you are required to obtain ridiculously detailed informed consents, that include explaining the risks of venipuncture (drawing blood), a procedure most people undergo without a moment's thought and little hesitation. You can't assume that your patient knows anything.

The irony is, that even with these consents on file, you are not protected legally if patients wish to sue because they were "never told that". We had patients sue over Norplant to the point that it was removed from the market, even though our patients were required to watch a film, read a booklet, sign a consent and have documented understanding of specific questions on their charts. None of our efforts made any difference in the ensuing legal feeding frenzy. The patients just claimed that they were "never told".

The situation of providing discontinued drug to patients who "understand" the risks is no different from the situation we have now with "informed" consent. People will sue you into oblivion regardless and that is why drug companies hesitate to do it.

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15. Vaxalon on January 4, 2006 3:37 PM writes...

The reason that people can't be trusted with drugs without stringent controls, is that they'll take them, injure themselves, then sue the drug company, the doctor, his practice, the pharmacist, and the pharmacy, and win multi-million-dollar judgements from juries that are just as ignorant as they are.

Basically, we have a choice. We can set up OUR ENTIRE CULTURE to function on personal responsibility, or we can base it on protecting people from their own stupidity. You can't have it both ways.

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16. Guerrilla Pharmacist on January 4, 2006 5:17 PM writes...

It should be noted that a single motivated person with a rifle could solve the Public Citizen problem. "But murder is illegal!" Well Nader should have thought of that before he helped suspend the rule of law.

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17. Steve C on January 4, 2006 5:23 PM writes...

Dr. Toot discovered my "very expensive and draconian system"! Great minds think alike.

But, seriously, as a brainstorm. How about giving our education-averse patients[public] standardized tests. If you can't master the material, you don't pass on to the next stage.

And just to toss out another discussion point. Virtually everyone agrees we need to computerize/digitize/network our vast balkanized health care delivery system, but the return on investment for doing so isn't enough. So let the feds setup the nucleus, just like they did DarpaNet.

Accutane is a good example. If you want Accutane and you're a fertile female, you get a pregnancy test every week. They draw the blood then you get a chit for a week's worth of med. You'd have small reservoir for emergencies, there'd be ways to do vacations, waivers for being too ill, remedial work and cut-off for repeat screwups, etc. But basically, the medical system knows you're pregnant within a week, and you get no more Accutane. There's a real-time, or say daily-updated, computerized system/database that tracks all this and is programmed to automatically react and notify. The feds finance and run it.

Like I said, it's expensive.

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18. Bostonian on January 4, 2006 6:07 PM writes...

"Steve is right when he says that draconian methods exist to solve this problem, but the responsibility of the industry, doctors and pharmacist is to inform these patients, not take decisions for them."

So instead it is the responsiblity of the government? How is that right?

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19. Anonymous on January 4, 2006 6:08 PM writes...

Steve: "However, the concept of "informed patients" is a delusion. "

Please go try saying this to Theresa Nielsen-Hayden

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20. Steve White on January 4, 2006 6:09 PM writes...

I'm an academic pulmonary physician. We're going to have a similar problem soon. For the treatment of moderate to severe asthma, there is a class of drugs known as 'long-acting beta agonists', such as Serevent and Foradil, that are extremely useful 2nd drugs in treatment. They've allowed literally hundreds of thousands of patients to have better lives by providing better control of their asthma.

And now there is a movement to ban these drugs, because in a couple of studies, in patients with serious heart disease, there is a statistical increase in the number of coronary deaths in patients taking LABAs. The FDA just slapped a black-box warning on the drugs, and an FDA administrator recently testified to the Senate that the drugs should be removed because they are 'killers'. That's the mindset of the FDA now.

The killers will be my asthma patients when they find out they can't get the drugs that have allowed them to live normal lives.

I think it's a problem that comes back to the distrust of authority we've had in our society. Yes, authorities have been at times self-serving and deceitful, and we have lots of Hollywood movies about the hero fighting the sinister government/big business/military people (wonder if Ralph Nader imagines that Robert Redford will play him in a movie?). The result of this distrust, combined with a runaway tort system, is to make our society incapable of judging risks in a rational, sober manner.

Vaxalon notes the relationship between protecting people and personal responsibility. I don't know that the relationship is that absolute, but I sure do wish society leaders would learn risk assessment.

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21. annonymous coward on January 4, 2006 6:43 PM writes...

As an example of close reading consider that there is no hyphen in Nielsen Haydon.

The last name really is Nielsen Hayden, not “Hayden” or “Nielsen-Hayden”. Read about it: http://nielsenhayden.com/name.html.

Leaves me wondering how many people do read instead of guess.

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22. Steve C on January 4, 2006 7:15 PM writes...

I didn't mean NO patients qualify as informed. There are many. I'M an informed patient.

I meant the process currently used is a sham. There are many patients, especially those participating in therapy trials, who haven't a clue, but they want in, so they nod their heads and sign. That was the point of my introductory story.

The NSF runs an annual science literacy survey. Results are on it's website. 20% of adult Americans think the sun revolves around the Earth.

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23. Tresho on January 4, 2006 9:10 PM writes...

--------- #9's point must be re-emphasized again and again: some people are incapable of giving informed consent no matter how much information they are given, although in most other ways the same people are quite capable of making appropriate decisions to guide their lives. To say "Informed consent is a delusion" is to make a gross over-generalization. The abdication of personal responsibility and the injustice and collateral damage produced by the current tort system is the other half of this issue.
-------- "Risk assessment" is difficult for many people -- just look at those residents of New Orleans who survived below sea level in a hurricane target zone for decades, until Katrina flooded them out. The local newspaper had even run a series years before 2005 that was uncanny in its predictions, which were ignored until it was too late. See http://www.nola.com/hurricane/?/washingaway/ It's not just a problem with the court system or with a distrust of authority, it's human nature, both at the individual and organizational level. Education by vigorous exercise of free speech and the free press as opposed to hysterical and/or biased rhetoric is about the only way to improve our situation.
--------- #13's tone is too diplomatic: the bias of "Public Citizen" and its like against corporations and the profit motive is blindingly obvious to those with eyes to see. There's plenty more like Ralph Nader in the pipeline.
----------- I was truly surprised by the resurrection of Lotronex from the dead. Had there been any substitute possible, I think it would still be off the market. There are substitutes for Cylert. With only about 10,000 Cylert users (see http://www.ascribe.org/cgi-bin/behold.pl?ascribeid=20050427.140850&time=14%2055%20PDT&year=2005&public=1), the FDA isn't as likely to be swayed by their feedback.

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24. La Resistance on January 4, 2006 9:18 PM writes...

"But, seriously, as a brainstorm. How about giving our education-averse patients[public] standardized tests. If you can't master the material, you don't pass on to the next stage."

Because you'd be sued for racism the first time the composition of one of your study groups is analyzed.

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25. Steve C on January 4, 2006 9:26 PM writes...

La resistance,

I take your [sarcastic] point, but I'm fuzzy on your reference. By "study groups", do you mean groups of potential subjects studying to pass an "informed consent" test?

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26. Steve C on January 4, 2006 10:12 PM writes...

Let me be more specific by what I meant by "informed consent is delusional/current system is a sham".

The informed consent process exists only to provide whatever legal protection there is. Medicine also believes it has an ethical duty not to experiment on people unless they understand. But that's a sham, it's obvious. It's all there to get the signature.

What happens to a patient, who, when Doc asks "Do you understand?" says no? Repeatedly. Is a physician going to spend an hour and a half on a mini-seminar, or is the head nurse? Of course not. That patient won't get into the cohort. We don't want those professionals doing that; it's very inefficient. The earlier point about the pre-op consent form is the same thing.

It's not surprising that when you take such a pro forma signature in front of a jury of like-knowledged people you have problems. It takes an entire trial to get the jury informed which, in essence, demonstrates to them the signator didn't understand when he/she signed. Think how different such a trial would be if the plaintiff had gotten 90% on a 50-question test before signing, a test composed of modules specifically related to the situation.

I'm not blaming anybody; it's nobody's fault. It just is. Everyone is good intentioned, etc, but still, we're all pretending.

However, this is a solvable problem, if it's acknowledged. So solve it.

[I AM arguing for personal responsibility. But on the part of everyone involved, not soley on the part of the patient.]

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27. Chris on January 4, 2006 10:27 PM writes...

Two more cents on the informed consent issue:

A (frighteningly) large number of people are too stupid or lazy to make informed decisions, even if the information is rammed down their throats. Some of these people are too spineless to accept fault when their ignorance hurts them. You in pharma know this better than anyone.

The standard bureaucratic response is to make rules with these people in mind, and not to make exceptions for the real people out there. I had to live through it in school, and the government acts the same way: ‘adult’ really just means a child who can drive and pay taxes.

If anyone has a solution to that, please don’t keep it to yourself.

I take your [sarcastic] point, but I'm fuzzy on your reference. By "study groups", do you mean groups of potential subjects studying to pass an "informed consent" test?

I suspect resistance’ point is that any attempt to institute an aptitude test for legal adulthood would lead to accusations of racism. If nothing else because it would be biased against people who do not have access to educational resources (eg: the extreme low end of the economic ladder) and this segment is disproportionately non-white, non-Asian.

Question for the lawyers: Is there a good legal reason why release forms are not valid? What differentiates a waiver from a contract (I agree to provide these services in this manner and you agree not to hold me liable for these potential consequences)?

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.

My experience (with the local congregation) has been that ‘reflexive animus’ is putting it mildly. I’m sure there are reasonable people in that camp, but there is a surprisingly vocal section that believes corporation are inherently evil. There is usually some rhetoric about people and profits involved.
Pharma gets it even worse. 1) Because of the expectation that new developments in medicine will be as frequent and easy to use as new cell phone gadgets. 2) Their recognition that pharma charges much more than their production costs, and their inability to understand development costs 3) Trendy antipathy for all things ‘western,’ including medicine. 4) The overlap with people who dislike science for other reasons (animal rights, etc).

Like I said, these are only the things I encounter on my campus. I’m sure that they don’t apply to the entire organization, though reasons 1 and 2 seem to be common in the general population.

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28. Rick on January 5, 2006 10:56 AM writes...

I followed a link from instapundit to Nielsen-Hayden's site, and initially had a great deal of sympathy. When I started reading the comments,I found them quickly degenerating into Bush bashing, trying to tie him personally to this problem. I lost virtually all sympathy, because while the FDA mess is bipartisan in origin, the nanny state mentality they are decrying is much more strongly associated with Democrats. To the extent that they continue to believe all evil originates from a vast Republican conspiracy, they deserve the suffering they incur.

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29. Margaret Organ-Kean on January 5, 2006 2:29 PM writes...

Rick -

I've read all of the comments on this thread at the Nielsen-Hayden site and to check my perceptions, ran a search on it.

Out of a thread with 462 comments, 10 mention Bush. Out of those 10, 5 were anti-Bush (usually just in passing), 4 were neutral, and one was pro-Bush.

So, for you, less than 1% negative comments constitues a quick descent into Bush bashing.

I will not comment on your last sentence save to say that this Republican finds it objectionable in the extreme.

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30. Steve C on January 5, 2006 2:40 PM writes...

Chris

I'm not a lawyer, but I can give you two reasons off the top of my head signed contracts can be invalid.

1. If the contract requires you to commit a crime.

2. If there's material lying about/in the contents of the contract.

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31. Marc on January 5, 2006 6:31 PM writes...

Steve: I am not a lawyer either, but

3) If you can show that you were misinformed, did not understand

4) You signed under duress. (you are sick, if you do not say you understand and agree, you do not get the drug.)

Those are the two that are problematic, and that juries love to hear.

Instead of a complete labelling system, as proposed by Timothy (6) I would suggest a generic “Drugs have side effects, you moron” sign on all pharmacy doors for those who expect a miracle.

Did anybody watch “Red Dwarf” ? in one episode, they had a drug (or some biological agent) with a warning sign on it:
A stick man throwing up while his intestines explode, all on a yellow background. We should put that label on prescription drugs.

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32. B. Durbin on January 5, 2006 10:48 PM writes...

Steve White (#20) makes a very good point about asthma drugs potentially being on the line. This is an issue close to my heart, as my in-laws are very susceptible to asthma— to the point where my husband's niece almost died before the age of twelve due to large-scale immune collapse and bones breaking every time she moved, and my father-in-law suffered for twenty years the long-term results of asthma and the side effects of the drugs that kept him alive (he died last spring.)

Both of them were involved in many clinical trials and with many drugs that had horrible potential side effects. My father-in-law was not expected to see his son, my husband, grow up, let alone graduate from college and get married. Yet those horrible drugs saved his life, and from my conversations with him, he was grateful, despite the pain.

As for the niece, she's not only alive but in pretty good health, only having to go on standard medications for asthma. The extreme drugs kept her alive long enough to let her live a fairly normal life, including cheerleading.

If the FDA started banning those drugs, I can only imagine the furor from my in-laws. And they're rather complacent people, generally.

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33. Anonymous on January 6, 2006 2:05 AM writes...

If you look at a PDR book you will see that all drugs have dangerous side effects. The main complaint is that people say there doctor never told them. Now if your liver goes bad who is going to pay for there medical care?. I can understand why some are angry, I have narcolepsy and multiple sclerosis. Most medications for both carry risks. People will hear what they want to hear. It seams doctors are willing to prescribe it despite the flaws, then it should be left between them and the doc. We have to listen to our Doctors and also take time to reserch medications on our own. We need to take the TIME to get informed, something people dont do. They just want a quick fix.

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34. Anonymous on January 25, 2006 11:07 AM writes...


I don't want to send her on a wild goose chase for pemoline but a derivative, fenozoline, seems to still be available in France. I don't know its half life in the body so it may not be similar enough to pemoline to fill in for it in her treatment regimen. Nor how it's scheduled there.

http://www.biam2.org/www/Sub718.html

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35. Fading Fast on January 31, 2006 7:44 AM writes...

I have taken Cylert continouly since 1978. My greatest fear is that I might return to life as I knew it prior to being placed on medication for narcolesy. Prior to being diagnoised, I was dismissed from nursing school for sleeping in class and fell asleep at the wheel on several occassions. I could not work a full day without taking a nap every couple of hours. I am an RN with 2 Masters Degrees and well aware of the risks associated with Cylert. I am also aware of what that without it I may have no future. Thank you Mr. Nader for taking my will to live!! I also suffer from sleep apnea and cataplexy. While people like Nader can spend their days making decisions for everyone else, they are condemming people like me to a fate worse than death! If there is anyone out there who can give me hoope please let me know.

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