Conflicts of Interest at the FDA

When the Food and Drug Administration (FDA) evaluates a new drug or medical device, it often faces a terrible dilemma. In an era when many new therapies offer at best marginal improvements for most patients, evaluating a new drug can turn into an agonizing balancing of relative risks and benefits.

Take the latest cancer drugs, for instance. Many offer benefits that are measured in months of additional life – not years – and often at terrible physical toll. Drugs for some common conditions like allergies or depression offer relief at a rate that is barely distinguishable from placebo. Other new drugs are no more effective than medicine already on the market, yet come with substantially greater risk. The Cox-2 painkillers like Vioxx are a tragic example of this phenomenon.

It’s the FDA’s job to calculate these tradeoffs. Moreover, it must do so with limited data that is usually derived from clinical trials sponsored by the firm that manufactures the product.

To sort through this evidence, the agency relies on hundreds of outside scientists who sit on its 30 advisory panels. The agency almost always follows their advice. So the make-up of these panels is crucial. Should they be comprised of doctors who work every day with patients suffering from the disease and have collaborated the maker of the drug or one of its competitors? Or should the panels contain scientists and clinicians who know the disease and can interpret clinical trial data, but are not involved in any way with firms that have a financial stake in the outcome of the committee’s deliberations?

In recent months, a slew of high-profile drug-safety disasters have brought this issue to the forefront. Scientists with direct financial ties to drug companies have been allowed to sit on panels evaluating whether antidepressants cause suicides in teenagers; the magnitude of the heart attack risk from big-selling painkillers known as Cox-2 inhibitors; and the long-term safety of silicon gel breast implants.

In at least one case – involving the painkillers sold by Merck and Pfizer – the FDA advisers with financial ties to the drug makers held the swing votes on the committee and voted in favor of continued marketing of the drugs. The FDA staff later overruled its own advisory committee’s recommendations – an almost unheard of event.

In June, the House of Representatives moved to rectify this situation by approving a rider, sponsored by Rep. Maurice Hinchey (D-NY), to the FDA appropriations bill that would prohibit the agency from placing scientists with conflicts of interest on its advisory panels. The notion is simple: outside advisers should be expert, of course; but they also must be scrupulously objective. Allowing advisers with financial ties to firms with a stake in the outcome to remain on a committee would inevitably taint the public’s perception of the process and potentially skew the results.

The Senate will soon consider a similar measure sponsored by Richard Durbin (D-IL). In recent presentations on Capitol Hill, the FDA is fighting against this commonsense approach. Commissioner Lester Crawford raised similar objections during his nomination hearings.

They claim that in many medical fields, there are almost no experts who don’t have ties to companies producing products for that specialty. Moreover, to deny such experts a role in the FDA process would deny the public the best advice since it is inevitable that both industry and the government turn to the same key thought leaders in any particular medical field. As a result, the FDA granted special conflict-of-interest waivers to one of every eight scientists who served on FDA advisory committees over the past several years with some committees dominated by conflicted scientists.

The FDA is wrong on both counts. Their protests that there aren’t highly qualified, non-conflicted scientists to fill these slots is a terrible insult to the thousands of physician-scientists at the nation’s 125 medical schools, not to mention foreign experts, who have chosen not to work with industry on clinical trials. Some turn to government to fund their clinical trial work. Others rely on institutional support or concentrate on researching the basic science of the disease while monitoring the latest medical advances reported in the literature. Many would leap at the opportunity to serve the public as objective arbiters of the latest advances in medicine.

And that, in the end, is what is at stake in this relatively simple reform. In the increasingly blurry world of advancing medical technology, Congress must insist that the FDA’s decisions be informed by a scientific jury whose only loyalty is to the best interest of patients. The alternative is to turn advisory committees – a vital piece of the regulatory system for protecting public health – into another partially-owned subsidiary of the pharmaceutical, biotechnology, and medical-device industries.

Posted by gooznews at September 19, 2005 01:39 PM