The Sleep of Death

Diane Duane pointed me to this note which highlights a serious problem that's about to hit thousands of people who rely on a certain medication.

Seems that the medication was implicated in 13 liver failures since 1976 (yes, it's been on the market that long), so the company that made the medication carefully made sure that all doctors and patients were aware of the potential problem. But that wasn't enough for Nader, even though the instances had dropped to only one case in the last 6 years. No, Nader and Public Citizen got the medicine banned by the FDA, even though it's the only therapy that works for a great number of people who suffer from Narcolepsy.

Says Teresa: "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."

Contact your congresscritters today, a good example note is here:

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.