Losing a weapon in the war on disease

This one has me steamed. It's somewhat old news, but I only just learned about it.

In October,
the Food and Drug Administration banned pemoline,
a drug used to treat narcolepsy (a sleep disorder) and ADD (attention deficit disorder). The drug, which has been on the market for 30 years, caused liver failure in 21 patients.

That's not a misprint. 30 years. Over ten thousands of patients. And 21 cases of liver failure — less than one a year.

Patients rights groups are outraged over the ban. They feel the risk is small — and with a doctor's supervision, it can be close to zero. Meanwhile the benefits of the drug — a healthy, normal life — are tremendous.

The FDA notes that 21 cases of liver failure, though small, is well above the normal rate. The FDA was created to protect the American public from dangerous drugs. But some people think the FDA is going too far, and trying to protect us from ourselves.

As you might gather, I tend to agree with the patients. If I were sick, I would want my doctor to have as many options as possible. We could then decide together whether the benefits of the drug are worth the risk. When it's my life and my health, I want to make the decision myself, not some bureaucrat in Washington.

Well, that's my opinion. What do you think?

Your Comments, Thoughts, Questions, Ideas

bryan kennedy's picture

I totally see your point about choice Gene, but in this situation our government should protect the vulnerable not the well educated. Not everyone is going to be able to be able to make the educated choice about the safety of this drug.

I do wonder how we would make rules about acceptable risks that fit all situations. The FDA has an article about how it weighs the benefit vs. risk of a drug. I have to admit though that with major drug companies pulling dangerous drugs that originally passed FDA approval, I would rather this agency err on the side of precaution.

I also am not sure that all of the employees are "bureaucrats". I suspect they are mainly medical health and science professionals, I could be totally wrong but didn't want to pay to have to read the employee directory listed for sale.

posted on Wed, 01/04/2006 - 9:40pm
Gene's picture
Gene says:

I acknowledge that many people are terrible judges of risk -- we all know people who are afraid to fly (which statistically is very safe), but think nothing of speeding on the highway without wearing a seatbelt (which is statistically very stupid).

However, I believe this was a prescription drug. You could not get it without consulting with a doctor -- who, by law, is educated, and who, by professional ethics, is required to discuss the risks with the patient. Virtually all treatments carry some risk. I believe the FDA should ban treatments when the cure is worse than the disease. But when the risk of side-effects is small, I would argue that the educated doctor and the affected patient should be allowed to weigh the risks and benefits as they apply to the individual case.

And that, I suppose, is the bottom line: the difference between the abstract and the concrete. When you look at ten thousand patients and find that, on average, they contract liver disease at twice the normal rate (or whatever), then yes, it seems like a serious problem. But when you look at one individual patient, you may find that their liver is stronger than average, or their disease is worse than average. In the individual case, the balance of risk and benefit may be very different than the average. (And, of course, the individual may have a greater or lesser tolerance for risk.)

PS: The FDA would, I believe, qualify as a bureau. And while I am sure they carefully weigh all of the valid medical research, the final decision is made by a bureaucrat. In fact, the back story to this incident is that both pro-drug and anti-drug groups were lobbying the FDA. No matter what they decided, someone would accuse them of being politically motivated.

posted on Thu, 01/05/2006 - 10:28am

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