Industry Opponent Wolfe Named to FDA SeatJan 9, 2009 | Parker Waichman LLP
On the heels of news that the U.S. Food and Drug Administration (FDA) is riddled with corruption and all sorts of routine inappropriate and unethical practices, a key drug industry opponent has been appointed to its Drug Safety and Risk Management Committee. The Wall Street Journal (WSJ) is reporting that Sidney Wolfe, MD, head of health at Public Citizen, has been appointed to the four-year term at the FDA.
The Journal says the Committee is a critical entity in advising the agency on which drugs are and are not safe and points out that Wolfe has important connections in government including Joshua Sharfstein, a former aide to Henry Waxman, head of the Obama transition team looking at the FDA. Waxman worked for Wolfe in the past.
Public Citizen is the advocacy firm founded by Ralph Nader and which—under Wolfe—successfully removed 16 drugs from the market; imposed restrictions on a variety of other controversial products; and fought against medications such as Merck & Company’s painkiller Vioxx, which was withdrawn in 2004 and GlaxoSmithKline PLC's diabetes drug Avandia, which saw a huge decrease in sales after being forced to black box label a cardiac risk warning, the WSJ said. The WSJ predicts Big Pharma has a lot to worry about with Wolfe.
Wolfe, with Public Citizen for over 30 years is well-known for his aggression toward the FDA under the Bush administration and went so far, the WSJ said, as to call the FDA’s 2006 100th-anniversary celebration a "propaganda campaign" to hide its "unprecedented assault on the American public."
Wolfe is not without industry critics, says the WSJ, which points out that despite this, Wolfe was invited to sit on the panel in May and then invited full-time this past August, ostensibly because consumer groups were owed a seat on the committee. Wolfe describes the FDA as, according to the WSJ, “a tool of its corporate ‘clients,’” describing the recent developments at the FDA by saying, "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.”
The way-too-close relationship between Big Pharma and the FDA has been making all sorts of news lately regarding, for example, industry-sponsored events in which doctors are paid exorbitant fees to promote emerging drugs, professionals are flown to exotic sites to attend industry-sponsored events, and ghostwriters are hired by industry to put positive spins on articles and papers about new drugs, while slapping expert names in the bylines for hefty sums. Recently NBC’s Gabe Pressman described the glaring conflicts of interests saying, “The incestuous relationship between physicians and medical institutions and the drug manufacturers must be ended.”
Meanwhile, nine scientists with the FDA wrote a second letter outlining the corruption at the agency, this time sending the letter to John Podesta, President-Elect Obama’s transition team head. The first such letter was sent to the House Energy and Commerce Committee which advised FDA Commissioner von Eschenbach and his assistant commissioner of accountability and integrity, Bill McConagha, that it had “received compelling evidence of serious wrongdoing," quoted the WSJ.