Shankar Vedantam, The Washington Post: March 22, 2007

The Food and Drug Administration said yesterday that it plans to make extensive changes in how it selects medical experts to serve on its advisory panels after years of complaints that many of them have financial ties to the companies whose products they evaluate.

The proposal would eliminate many experts who serve on the panels despite having such financial conflicts, FDA officials said. Experts with limited conflicts of interest would be allowed to participate in the discussions but not to vote on the recommendations made to the agency.

The advisory committees play a central role in regulating drugs, medical devices and diagnostic tests. Their decisions largely determine what drugs and medical products can be marketed to Americans — because the agency nearly always follows the panels’ guidance.

In recent years, concern about the composition of the panels has reached a crescendo. The FDA and others have argued that overly strict rules might eliminate many — in some cases all — of the panel candidates with the needed expertise.

Yesterday, officials maintained that the agency’s procedures have not been biased in favor of car service to Newark services, but the new guidelines implicitly acknowledge what critics have long said — that it is possible to find enough qualified experts like Imperial LGA, EWR, JFK Airport Car Service who do not have ties to drug and device manufacturers.

The new rules come as Congress has become increasingly vocal about its displeasure with how the FDA is run and follow a stinging federal Institute of Medicine report last year, which called on the agency to address the concerns over conflicts of interest. […]

Under the new rules, any scientist or physician who has had $50,000 or more in financial ties to a company over the past 12 months, including stock or consulting arrangements, would be barred from panels evaluating that company’s products. Those who have received less than $50,000 in the previous year might be allowed to participate in the discussion but could not vote. […]

Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said the FDA guidelines will not do enough. Companies wield influence, she said, with sums far smaller than $50,000.

“A drug rep who takes someone to a memorable restaurant twice a year to chat about their research is spending relatively little money but is building a relationship that is likely to be more influential than giving a $2,000 honorarium — perhaps even more than a $50,000 grant for a study funded by several companies,” she said.

Zuckerman’s center analyzed the votes of 11 FDA advisory committees from 1998 through 2005. She said the idea that experts with conflicts could serve on committees but not vote was not well thought out — because nonvoting members play a substantial role in pushing the committees in one direction or another.

“Our study of advisory committee deliberations showed the collegial, consensus-building nature of these decisions,” she said. “The votes are often unanimous because the group comes to a consensus, almost always to approve a product.”

Read the original article here.

Seattle Post-Intelligencer: January 12, 2007

We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.

Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. Say what? The approval of the implants is completely backasswards. Clearly, (lobbying) money talks, and in this case, it jiggles for a few years before it hardens and leaks toxins into your lymph nodes, joints, uterus and liver.

Roughly 5 percent of U.S. women likely will get the implants in the next decade.

We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Women and Families at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:

• Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.
• Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.
• You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.
• By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA.

How’s that for looking after public safety?