Healthy Skepticism Library item: 944

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Herper M.
Breast Implants, Bextra And Fair Disclosure
Forbes.com 2005 Apr 11

Full text:

From breast implants to pain pills, the perception that top U.S. medical experts have been paid off by drug and medical device companies is tarnishing debates that should be about science and patient safety.

Today, a panel of experts begins meeting to advise the U.S. Food and Drug Administration as to whether silicone breast implants should be more widely used. Investors and patients could be forgiven a sense of déjà vu. A similar FDA panel met for three days in 2003 and recommended allowing wide use of the devices, made by Inamed (nasdaq: IMDC – news – people ) and Mentor (nyse: MNT – news – people ). But allegations of financial conflicts of interest flew, and the panel’s chairman, Thomas Whalen, argued that the data presented had been of low quality.

The FDA decided that the silicone implants, which surgeons feel are more lifelike than the saline ones now in use, should be available only in special cases, going against the panel’s narrow vote.

Last week, the FDA went against another recommendation from one of its panels by pushing Pfizer (nyse: PFE – news – people ) to pull its arthritis pain pill Bextra off the market. The panel had decided that although Bextra raised the risk of heart attacks, it had a place. Again, there were widespread complaints that panel members had financial ties to drugmakers (see: “The FDA’s Conflict Of Interest Problem”). The FDA eventually decided that the risks described to the panel, along with a risk of deadly skin reactions that the FDA advisers didn’t address, meant Bextra didn’t belong on pharmacy shelves (see: “Doctors Back Bextra Ban”).

The FDA can always overrule its panels, which are merely advisory. But patients shouldn’t be left feeling that commercial interests played any role in the decision. Matters are only made worse when it seems that potential conflict of interest problems weren’t made public. At the Bextra panel, which also dealt with Pfizer’s Celebrex and Merck’s (nyse: MRK – news – people ) Vioxx, the FDA decided not to read potential conflicts of interest aloud, as is its custom. (Panel members say they did go through tough background checks.)

Similar snafus have come up elsewhere. When new U.S. cholesterol guidelines were announced that would put many patients on powerful drugs like Pfizer’s Lipitor and Merck’s Zocor, critics pointed out that most of the authors had done work for the drugmakers. The problem is that research medicine generates financial conflicts by its very nature.

It takes some 60 pages to list all the authors who presented studies at the annual meeting of the American College of Cardiology in March, and another 30 pages to list all their financial conflicts. Many academic researchers serve on the speakers’ bureau of one company or another, helping to educate other doctors. Others work as consultants, often a necessary step in bringing drugs to market. Still others work on company-funded clinical trials, the main way that medicines are studied for safety and efficacy.

All of these are lucrative gigs that can make or break a career in medical research. If a researcher wants to run a clinical trial on a Genentech (nyse: DNA – news – people ) cancer drug, it’s unlikely to happen if the company doesn’t want to pay. (The National Institutes of Health funds relatively few trials.) Speaking can help raise an expert’s profile among his peers.

That puts the FDA in a bind, but it’s also bad for the doctors who do a lot of this consulting. In the end, creating an environment where FDA advisers are left hanging in the wind because they had a supposed conflict that wasn’t disclosed doesn’t help anybody. That’s essentially what the current system does.

Some doctors have been known to argue that they’re “equally conflicted” because they consult for every company competing in a given area. But to really make things clear—and to give everyone confidence that drug companies aren’t trying to pay off their critics or rig the regulatory process—maybe it’s time for deeper disclosure.

Instead of just telling us whom they work for, maybe medical experts should consider disclosing exactly how much they’re being paid. That way the rest of us can follow the money trail more easily. If all speaking and consulting fees were disclosed in a public database, they would probably seem a lot less mysterious and a lot less onerous. If the cash were handed out in broad daylight, it would be a lot less likely to look like a bribe.