Comments on: Deafening Silence

By: EGL

EGL — Mon, 22 Sep 2008 14:44:47 +0000

Since approvals are made by national agencies, nationally aggregated incentive determines willingness to fund the (expensive) review process. The U.S. is often the largest market in sales and patients and places high valuations on life and thus has the highest aggregated incentive to fund “correct” decisions. Under a policy that the FDA would accept approval in certain other countries, drug companies would have a strong incentive to find the review agency with the least ability to stage a critical review. It probably won’t be the U.S FDA.

So yes, I might know better than Billy’s parents if I have more time and money to spend investigating.

By: Douglas Knight

Douglas Knight — Fri, 19 Sep 2008 04:30:21 +0000

duplication (at great expense) of previous findings in other countries

A lot of people on this thread seem to believe that, but it’s not true: they use the same studies.

By: Cyan

Cyan — Thu, 18 Sep 2008 20:43:48 +0000

If you grant the FDA is capable of making a good judgment on that matter, why argue in favor of the idea that the judgment it *has made* is bad? Shouldn’t you accept the decision they’ve come to, on the basis of trust based on evidence?

You and I have been arguing past each other. I took as a premise that the FDA requires duplication (at great expense) of previous findings in other countries, but that the findings are typically in agreement. You seem to be talking about the case where the findings are in disagreement, which I assumed to be rare on account of stability of the causal mechanism. Hmm.

By: Douglas Knight

Douglas Knight — Thu, 18 Sep 2008 03:03:31 +0000

Here is a scenario for separate drug regulations that actually operates in the real world, but by no mean a large part of why things are organized as they are. Drug effects can vary racially and Japan’s regulatory apparatus uses its control of the market to force studies of Japanese samples, especially in the case of “me-too” drugs. (By “scenario,” I mean merely what happens; I make no claims about market failure.)

By: Jor

Jor — Wed, 17 Sep 2008 22:42:11 +0000

BTW, other COX II inhibitors are still on the market. Vioxx was not the only one. Merck fudged the safety data on it, in their submission to the FDA. That might be part of the reason they decided to withdraw it themselves.

By: Jor

Jor — Wed, 17 Sep 2008 22:38:57 +0000

There is a pretty simple answer to this — America is clearly the leader in bio-medicine. The NIH is the largest biomedical funding research agency in the world. The FDA most likely has much more qualified people making these decisions than its counter parts. The FDA also recently has come under scrutiny for some conflicts of interest. I’m not sure why I would expect drug regulatory industries in smaller countries to be more instituationally sound. In an ideal world, one supreme drug-regulatory agency would make the decision for everyone — but we live on Earth.

This type of “multiple review” inefficiency is in lots of systems. Peer Review. Job Interviews, etc. It’s just not financially important enough to whine about.

By: Robin Hanson

Robin Hanson — Wed, 17 Sep 2008 21:48:36 +0000

Peter, while drug spending has better support in the literature for giving health benefits than overall spending, yes my relative skepticism about drug benefits makes me see less at stake in drug regulation. But something is at stake, and it is a nice clear example of paternalism to help us understand paternalism more generally.

By: Caledonian

Caledonian — Wed, 17 Sep 2008 21:35:54 +0000

I have friends who work in the Canadian equivalent of the FDA. They actually run their inspections differently from the FDA, on purpose, to cover off things that the FDA might miss.

So they think they’re smarter than the FDA, eh?

Damn straight. Good for them.

By: Zubon

Zubon — Wed, 17 Sep 2008 20:47:37 +0000

Merck made that decision. One can speculate about what the FDA might have done, but in this case the manufacturer acted first.

You are absolutely right and I am wrong. Wikipedia also tells me that an FDA advisory committe voted 17-15 that Vioxx should be brought back because the benefits outweighed the costs. Updated.

I will avoid the tort reform debate on why the costs to Merck outweighed the benefits to Merck.

By: Peter McCluskey

Peter McCluskey — Wed, 17 Sep 2008 18:59:26 +0000

Robin, you made a comment here indicating that you think drugs are less valuable than most of us think. I'm wondering whether that view can be reconciled with your interest here in more access to drugs and the view Eliezer mentioned:

According to this source, the FDA's longer approval process prevents 5,000 casualties per year by screening off medications found to be harmful, and causes at least 20,000-120,000 casualties per year

Are the benefits of new drugs low, but still positive enough to be an exception to your general rule that the marginal benefit of medical spending is zero? Or is the benefit of new drugs unrelated to how much is spent on medicine?