Conflict of interest and drug regulation
The recent review by the US Food and Drug (FDA) administration of the anti-inflammatory drugs Vioxx, Celebrex, and Bextra offers insight into the new Age of Oligopolies. Studies had indicated that those drugs, in varying degrees, might lead to heart problems in a significant number of users. Merck quickly pulled Vioxx, the most fully implicated one, off the market. Pfizer did not follow suit, but sales of Celebrex and Bextra dropped precipitately. All there drugs were crucial to the financial health of these companies, and so the stocks plunged as well.
Merck and Pfizer were accused by some of keeping the bad test results secret and endangering the lives of customers. These drugs had been supported by a relentless marketing campaign that pushed customers to demand that their doctors prescribe these brands, even though there are far less expensive generic drugs that are effective for moist users.
The FDA set up a panel to review the evidence on the drugs and decide whether they should be taken off the market. A fourth similar drug, created by Swiss drug maker Novartis, but not yet on the market was also looked at.
The result was that all four drugs were allowed to stay on the market. The news was greeted with joy at Merck and Pfizer, and the companies' stock soared again, while competitors with different anti-inflammatories saw their stock go down. But the votes on the 32-doctor panel were narrow, with only small majorities voting for the continuation of the drugs. Some people complained that public health policy should not be made on the basis of such narrow majorities.
Now it comes out that at least ten of the members of the panel have serious conflicts of interest, in the form of significant consulting contracts with the Big Pharma companies whose drugs they were looking at. These experts at universities and medial centers had gotten lab financing, were given handsome speaking fees, and were brought in to consult.
According to a Forbes article, ("The FDA's Conflict Of Interest Problem", 2/24/2005)
Normally, before an FDA advisory committee meets, a list of potential conflicts of interest is read aloud. Some experts with material conflicts, such as having received fees for lectures from drug companies or owning stock in them, are allowed to sit on the panel. But this occurs only when the doctor's expertise is considered irreplaceable to the FDA. In at least one case, a panelist owning tens of thousands of dollars in one drug firm's stock was allowed to give advice about a competitor.
But this time, there seems to have been more secrecy, according to the Forbes piece:
As the panel convened last week to consider the arthritis drugs, no disclosures were read. Instead, the panel's secretary read a statement explaining why they weren't necessary.
Moreover, these ten voted 9 to 1 to keep the drugs on the market. Had they recused themselves, the drugs would have been taken off the market and the companies would have suffered major losses. These conflicts of interest were not documented publicly by the FDA, but came out through some good old-fashioned research by reporters.
The argument by the FDA is that almost all true experts in this, and most, medical fields have similar conflicts of interest. That's the way the industry works, and it's how research is financed. Furthermore, experts who deal constantly with arthritis pain are in a better position to evaluate the trade-off between not taking the pills and suffering on one hand, and taking the pills and running other risks. In fact, panel members who did not specialize in arthritis were far more likely to vote to suspend use of the drugs.
Few are suggesting that the drug companies threatened the panel members in any way. But it's pretty clear that if these companies represent a significant source of funding, panelists are less likely to bite the hand that feeds them, whether consciously or not. By contrast, it's almost certain that a smaller company with a drug on the market with similar problems would not expect such treatment. The #1 and #2 companies get a break.
And the problem goes far beyond the arthritis field. As a Washington Post article ("10 of 32 FDA Vioxx Panelists Had Industry Ties", 2/25/2005) notes
Major, pervasive conflicts of interest among senior scientists at the National Institutes of Health were documented by the Los Angeles Times beginning with a major expose on December 7, 2003. The scope and severity of NIH scientists' conflicts of interest is staggering - 94% of the top paid NIH scientists failed to report their financial deals with pharmaceutical companies.
