David R. Henderson  

We Smell a Rat

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Two Questions for Orszag... Socrates Meets Deficit Neutral...
Which group should the U.S. Food and Drug Administration care about more: humans or rats? That's not a trick question. The FDA's recent decision to reject the drug Horizant suggests that, at least in this case, it cares more about rats. And because of the FDA's decision, some people (not rats) with restless legs syndrome (RLS) will suffer more.
This is from my latest, co-authored with Charley Hooper, "We Smell a Rat."

Here's how we end:

Seventeen years of human data in millions of patients showing that gabapentin doesn't cause pancreatic cancer in humans were trumped by a two-year study in 200 rats given extremely high doses. The real danger to our health comes from such myopic views of safety and a hyperconservative, opaque, and capricious FDA keeping useful medicines out of the hands of American doctors and patients. The FDA needs to be reminded that it is reviewing drugs for humans, not for rodents.
The FDA is getting worse and worse.

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COMMENTS (11 to date)
Sam writes:

David,

What do you suggest they do in this case? Go ahead with human trials, even though the drug appears carcinogenic? Who would pay the settlement if the drug is (even mildly) carcinogenic to the trial participants?

I know there are problems with the rat model and lab rats are allegedly so inbred they are more likely to develop cancer than wild-type rates. But over the years there's a lot of useful data built up in this animal model, and they do use a straight control where the rats are not dosed. Would you recommend an additional control? If so, with a related substance, the next best drug, or what?

Or would you rather abolish the FDA and replace it with -- what? Nothing? How does that work? (A link to a vision you mostly agree with would be great.)

Tom writes:

Sam, sounds like we have the data already:

"Seventeen years of human data in millions of patients showing that gabapentin doesn't cause pancreatic cancer in humans "

MGROOP writes:

The article states that the real danger is "a hyperconservative, opaque, and capricious FDA". This exactly what Milton Friedman said when he criticized the FDA in his video series "Free to Choose". The bureaucracy of the FDA creates an environment that rewards overly protective bureaucrats. If you approve a drug and somebody dies, you are in trouble. If you don't approve a drug, then nobody knows who will die from the lack of that drug.

Tom West writes:

hyperconservative

I think this probably accurately represents the electorate. Everything I've seen indicates that the electorate in general (i.e. not just the sick electorate) strongly prefer a super-safe system and find the rate of perceived drug failures (Vioxx, et al) already alarmingly high.

I suspect that overall happiness of the population is greater with a strict FDA than with a lax (for lack of a better word) FDA as most don't need any treatment, and with a strict FDA, they don't have to deal with the background worry of more drug failures.

Of course, the overall happiness of the *sick* population might be better off with a lax FDA, but it's society as a whole that generally determines policy.

jsalvati writes:

I normally find your writing much too ideological, but this was pretty good; it's a point that doesn't get discussed enough.

John Turner writes:

Nicely written and argued article, David. Thanks!

Nick writes:

MGROOP,

Maybe you never heard of the Vioxx scandal?

The FDA ignored warnings from their own people that Vioxx was killing people. The GAO (several years ago) said they need to reform their organizational structure to prevent a repeat, the FDA has refused reforms.

The FDA is not overly careful they are simply corrupt.

Nick writes:

Tom West,

The problem with the FDA trial system is less that they keep potentially unsafe drugs from the market (if you have a serious condition you can get permission to take unapproved drugs) it is that they keep "ineffective" drugs from the market. Most countries do not require test of efficacy to approve drugs for use. This is just common sense, if a drug is not effective, the market will reject it. Relaxing these regulations would go to making drugs cheaper to bring to market, as it would mean less testing.

Of course even with regards to safety there is evidence that drug companies have been able to corrupt regulators at the FDA. There is probably more of this than is ever publicly known.

Tom West writes:

it is that they keep "ineffective" drugs from the market

I've wondered about that. As far as I can tell, drug X has to be more effective than a placebo to pass (rather than being more effective than nothing).

However, no doctor will prescribe you a placebo for a real condition, so in the absence of a drug better than a placebo, you get stuck with nothing, which is a lot worse than drug X...

Nick writes:

Tom West,

I'm not completely clear I understand your point.

I believe the placebo effect is vastly overstated. As evidence a recent article in the NEJM stated that the FDA has found increasing numbers of unregulated homeopathic products are being illegally spiked with pharmaceutical drugs by the manufacturers. Why? It seems clear enough people can tell the difference between an effective drug and placebo. The market works.

Tom West writes:

Pulling numbers out of thin air, assume you have a condition for which no treatment results in a 15% cure rate and a placebo results in a 25% cure rate.

If drug X has a 22% cure rate, then it won't get approved. However, since a doctor won't prescribe a placebo, you get stuck with no treatment, leaving you with a 15% cure rate, rather than the 22% you would have if drug X was allowed.

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