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
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
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
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
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
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.