Weighing in on the New FDA Commissioner

By MERRILL GOOZNER

Patient advocacy groups, most of them drug industry-funded, have asked President-elect Barack Obama to appoint a Food and Drug Administration commissioner who won't cave in to pressure from lawmakers or the news media, according to the Wall Street Journal.

It is news to me that the news media has much say about decisions at FDA. There are reporters who highlight problems, especially safety problems, in the nation's food and drug supply. And there are reporters who highlight every study suggesting the next miracle cure is just around the corner. Large news organizations like the New York Times have both. For every Gardiner Harris, there is a Gina Kolata. The news media are megaphones. They are not, to use someone else's phrase, the decider.

Vioxx and Avandia didn't come to light because of the press or angry legislators on Capitol Hill. What consumers and patients, legislators and the press learned about the lethal side effects of those drugs was due to diligent researchers like Steve Nissen and Eric Topol and courageous whistleblowers inside the FDA like David Graham. Ditto for most of the other safety scandals that have plagued the agency in this decade.

That said, patient advocates who are worried that the agency under a more safety-conscious commissioner will somehow abandon the search for faster cures should know that their views are well represented inside the transition team. Josh Sharfstein, the Baltimore health commissioner, formerly on Rep. Henry Waxman's staff, who took up cause of making pediatric cold medicines safer, may be leading the effort. But his co-conveners include Greg Simon, who heads a group called . . . da da . . . Faster Cures (not industry-funded, according to Simon). The other team leader is attorney Alta Charo from the University of Wisconsin, whose expertise is primarily in bioethics, not drug safety.

I don't think I'm talking out of school by confirming that I was one of a dozen or so consumer advocates who met with the transition team last week. A memo I prepared on behalf of the Center for Science in the Public Interest will be posted on the transition team's website in short order (as per the president-elect's instructions; he wants the process totally transparent). I raised a number of concerns well beyond the narrow topic of drug safety, including several familiar to regular readers of this blog like rejoining the Helsinki Declaration on protecting human subjects in clinical trials, comparative effectiveness and biogeneric legislation.

Our group didn't get special treatment. As we entered for our one-hour session, a group of patient advocates, including representatives from the National Organization on Rare Diseases (NORD) and several cancer advocacy groups, was leaving. As we departed, a phalanx of lawyers and lobbyists for Advamed, the medical device industry trade association, entered.

When President Clinton took office, he left the sitting FDA commissioner -- David Kessler -- in place. He went on to become a fervent advocate of reining in the tobacco industry, even as he allowed the drug division to drift toward closer collaboration with industry. The current commissioner Andrew von Eschenbach, a faithful servant of the Bush administration with close ties to the cancer research establishment, signaled this week he will resign on inauguration day. I suspect the appointment of a new commissioner will come quickly. There's much work to be done in implementing last year's safety amendments.

But the new commissioner will not have the option of being anti-industry. The drug and biotechnology industries recognize they are at a crossroads. Their blockbusters are coming off patent. The era of personalized medicine based on validated biomarkers is at hand. But as we learn more about these drugs (this week's hearing on EGFr inhibitors like Erbitux and Vectibix and how they don't work on colorectal cancer patients who have the K-RAS mutation is a case in point) means new drugs in the pipeline will be useful to ever smaller segments of the patient population.

Getting the science right, so that the right drugs get to the right patients and only the right patients so that they will be affordable to the health care system as a whole, is the challenge that now confronts agency scientists and whoever becomes the next commissioner. That's not faster cures. That's smarter cures, even as the new commissioner insists that they still meet the agency's statutory hurdles for safety and efficacy.

December 21, 2008 in Pharma | Permalink

Aside from whomever the new FDA commissioner will be, the FDA is really one of the better agencies in government. Dedicated, smart, hard working group of people. They want to protect the American people from harm and, at the same time, get the drugs out to the American people that have the potential to really help them.

The FDA has more often been criticized for being too restrictive than for being too permissive. The trade off is between access to an effective drug versus exposure to unforseen toxic effects.

The truth is that drugs can't be said to have passed the test of time, until they have passed the test of time. I do think that a drug for arthritis (e.g. Vioxx) has to be held to a different standard than a drug for erectile dysfunction (e.g Viagra) and both need to be held to different standards than a drug for pancreatic cancer.

But it will always be a trade off between access versus risk. And the FDA will periodically be criticized for coming down to hard on one side versus the other.

Posted by: Greg Pawelski | Dec 21, 2008 1:28:32 PM

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