An excellent commentary from today's edition of the Wall Street Journal ...
Drug Crazy
By RICHARD A. EPSTEIN
In an industry advisory last week, the U.S. Food and Drug Administration announced tough new conflict-of-interest rules against doctors who sit on its advisory committees, which recommend whether the FDA should allow pharmaceutical companies to market their new products. The agency's rationale is that greater transparency is necessary to remove any taint that might undermine the public's confidence in the approval process.
The new rules categorically bar any individual from sitting on any committee to evaluate a drug up for approval when that individual has a financial interest exceeding $50,000. The $50,000 figure includes stock ownership, related research and consulting arrangements. Unfortunately, this measure sweeps too widely by lumping together experts who do clinical trials with those who have a direct economic stake in the success of a drug. The precise measurement of that stake mysteriously turns on the extent that the drug has a "potential for gain or loss" to the committee members or their families. Persons whose financial stakes are less than $50,000 may be allowed to meet with these committees, but not to vote.
The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxx and Bextra, when at least 10 members of the FDA advisory panel who voted to leave these drugs on the market had some ties to their respective manufacturers, Merck and Pfizer.
It is here that the difficulties begin. The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases. One common, but cavalier, notion is that people should learn to cope with pain to stave off the greater potential harm of a heart attack. The evidence on the ground suggests another story.
"Suffering boomers want to fill Vioxx void" is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.
This evidence should put the FDA's zeal in a new light. Just how do these advisory committees "protect" informed product users by limiting their choices for dealing with crippling chronic conditions?
The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.
The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.
Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions. Nor would a the change go unnoticed by drug manufacturers or venture capitalists.
Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further.
Drug Crazy
By RICHARD A. EPSTEIN
In an industry advisory last week, the U.S. Food and Drug Administration announced tough new conflict-of-interest rules against doctors who sit on its advisory committees, which recommend whether the FDA should allow pharmaceutical companies to market their new products. The agency's rationale is that greater transparency is necessary to remove any taint that might undermine the public's confidence in the approval process.
The new rules categorically bar any individual from sitting on any committee to evaluate a drug up for approval when that individual has a financial interest exceeding $50,000. The $50,000 figure includes stock ownership, related research and consulting arrangements. Unfortunately, this measure sweeps too widely by lumping together experts who do clinical trials with those who have a direct economic stake in the success of a drug. The precise measurement of that stake mysteriously turns on the extent that the drug has a "potential for gain or loss" to the committee members or their families. Persons whose financial stakes are less than $50,000 may be allowed to meet with these committees, but not to vote.
The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxx and Bextra, when at least 10 members of the FDA advisory panel who voted to leave these drugs on the market had some ties to their respective manufacturers, Merck and Pfizer.
It is here that the difficulties begin. The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases. One common, but cavalier, notion is that people should learn to cope with pain to stave off the greater potential harm of a heart attack. The evidence on the ground suggests another story.
"Suffering boomers want to fill Vioxx void" is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.
This evidence should put the FDA's zeal in a new light. Just how do these advisory committees "protect" informed product users by limiting their choices for dealing with crippling chronic conditions?
The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.
The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.
Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions. Nor would a the change go unnoticed by drug manufacturers or venture capitalists.
Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further.
