June 11, 2007
FDA Reform On Tap This Week
Reform of the Food and Drug Administration moves front and center this week as the House Energy and Commerce Committee takes up legislation approved by the Senate last month. Hearings will be held Tuesday morning in the health subcommittee, with a mark-up hearing slated for Thursday.
I want to spend a few moments this morning talking about one aspect of the bill that pertains to my work at the Center for Science in the Public Interest, where I head the Integrity in Science project. The proposed House bill includes language that would limit FDA advisory committees to just one scientist with a conflict of interest per meeting. Currently, nearly a quarter of all scientists appointed by the FDA to advisory panels have ties to companies with a stake in the outcome of the committees' deliberations, whether the sponsors of the drug or device, or their competitors.
This one-waiver language, taken from a failed effort to sway the Senate, does not go far enough.
There is one overriding reason for eliminating all conflicted scientists from these panels. It will send a clear message that Congress wants a culture change at the agency.
Since passage of the Prescription Drug User Fee Act in 1992 and comparable legislation for drug devices a few years later, the FDA's resources, increasingly dependent on industry fees, have been targeted towards expediting the approval of new drug and device applications. The result has been a mindset at the agency that downgrades concerns about safety.
The advisory committee system, which brings in outside physicians and scientists to review the clinical trial data about new drug and device applications, has been similarly transformed. Most committees, whose advice the FDA usually follows, are filled with physicians whose primary professional interest is in having more options for their patients. Many have close personal and financial relationships with the industry. They don't bring a green eyeshade mentality to the advisory committee proceedings, they bring a green light mentality.
Will filling these committees with scientists who bring a more critical perspective slow down the pace of innovation? Any company that has a true breakthrough product, one that will cure a disease or slow its advance where none existed before, or ameliorate its symptoms, need not fear an objective review. Even if there are safety risks like the heart attacks recently associated with the diabetes drug Avandia, the new drug will gain approval because the clear benefits of taking the drug outweigh the occasional risks.
On the other hand, new drugs for conditions where there are already many options on the market -- like Avandia -- may have a harder time getting through. After all, if there is no additional benefit from this new drug, but it poses a greater risk than other, proven medicines already on the market, the benefit-to-risk ratio is greatly reduced, and a truly independent committee may decide against approving it. After all, the magic of mass marketing, where a new drug can seize an overwhelming share of a large market like the one for diabetes drugs even though there are cheaper, proven alternatives available, means millions of people will wind up taking this new drug. And if there is even a slightly elevated risk, that could translate into tens of thousands of unnecessary incidents like heart attacks or strokes. The FDA was set up to protect the public from such unnecessary risks.
Objections may be raised that in some fields -- rare diseases, for instance, or certain pediatric conditions -- there are very few true experts and nearly everyone who is anyone has ties to industry. But there's nothing in a total ban on conflicts of interest that would prohibit the FDA from hiring these experts to make presentations to an advisory committee and answer any questions those chosen to serve may have.
These conflicted experts, however, wouldn't be allowed to participate in the discussions at the end of the meeting leading up to the final vote, which would give them a chance to sway the proceedings. Nor would they be allowed to vote.
The claim that everyone does it, another frequent objection to banning conflicted scientists from these committees, is a slander on the thousands of academic physicians and scientists who do not take money from industry, preferring instead to stay on the National Institutes of Health grant treadmill or to get their research funding from foundations or their own institutions. By voting for a total ban, the House will send a clear message to the FDA leadership that it's time for a culture change at the agency, and it can find independent scientists if it just spends a little time looking for them.