With all of the bad news that we are hit with daily, it’s good to get some good news for a change. When I learned that Dr. Sidney Wolfe had become a “player” at the Food and Drug Administration — that was great news. Over three decades, Dr. Wolfe, head of the health group at Public Citizen, has helped take 16 drugs off the market and put restrictions on several multibillion-dollar products. The drug safety crusader has been so hostile to the FDA under President George W. Bush that he decried its 100th-anniversary celebration in 2006 as a “propaganda campaign” to hide its “unprecedented assault on the American public.”
Now Dr. Wolfe is riding the wave of a larger shift in the Washington pendulum toward tougher company regulation. The drug industry had to be greatly concerned when it learned Dr. Wolfe was being appointed to a four-year term on the FDA’s Drug Safety and Risk Management Committee. This group plays a key role in telling the agency which drugs are safe. What’s more, Dr. Wolfe is so widely known and so well respected that he has the ear of several health leaders and members of Congress who are expected to influence FDA policy during the Obama Administration. As a matter of interest, Joshua Sharfstein, a former aide to Rep. Henry Waxman, who led the Obama transition team assessing the FDA, worked for Dr. Wolfe several years back.
Dr. Wolfe was invited once to the safety panel in May, when he helped torpedo Cephalon Inc.’s application to expand the use of its popular painkiller Fentora. The FDA named him to the panel full-time in August, at the urging of consumer groups that were owed a seat on the committee. Any person who believes protecting the public from a health and safety perspective is a worthwhile endeavor, has to feel very good about this development with Dr. Wolfe.
A graduate of Case Western Reserve Medical School in Cleveland and former researcher at the National Institutes of Health, Dr. Wolfe helped found Public Citizen’s health group in 1971. The FDA, as Dr. Wolfe sees it, has been a tool of what he describes as the agency’s corporate “clients.” While acknowledging life-saving drugs for heart disease and cancer, Dr. Wolfe says, “the history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.” I am in total agreement with Dr. Wolfe’s views and feel very good about his new role with the FDA.
Source: Wall Street Journal
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