William Punshon
Strongly recommend that you read “Lynched in absentia” from this week’s edition of BioCentury.Here’s sampler – and it should leave a bitter taste in your mouth.
Based on her performance at last week’s hearing on the safety of Avandia rosiglitazone, Rep. Rosa DeLauro (D-Conn.) would have been quite comfortable in Brezhnev’s Russia, a time and place where political science trumped objective science and public inquisitions were pre-scripted to produce politically correct results.
The focus was allegations that GlaxoSmithKline plc had suppressed evidence about the dangers of its diabetes drug Avandia, and that top FDA officials were too biased by “cozy” relationships with industry or blinded by intellectual myopia to take obvious actions that would have saved thousands of lives. When BioCentury asked DeLauro after the hearing why she hadn’t solicited testimony from GlaxoSmithKline, FDA, or a diabetes expert, she replied that “they probably wouldn’t have wanted to come.” DeLauro, whose subcommittee sets FDA’s budget, noted that the company and agency are engaged in discussions over Avandia, and said she “didn’t want to put them on the spot. When did members of Congress become so solicitous of the feelings of corporate executives they accuse of intentionally killing their customers, or of government officials? Senior management from Goldman Sachs who sweated under the cameras for seven hours at a Senate hearing last week would have appreciated such courtesy.
In fact, GSK spokesperson Bernadette King told BioCentury the company learned of the hearing only a day in advance and “would have welcomed an invitation” to testify. DeLauro also told BioCentury there was no need for other witnesses because she’d invited two “independent experts” — Sidney Wolfe, director of the Health Research Group at Public Citizen, and Harlan Krumholz, professor of medicine and epidemiology and public health at Yale University School of Medicine.
Wolfe may be independent, but he certainly isn’t objective. In over two decades on the job, he’s prided himself on vigorously attacking the pharmaceutical industry and FDA. Krumholtz, a prominent and highly credentialed academic cardiologist, served as an expert witness in litigation against Merck and Co. Inc. over its Vioxx rofecoxib. But he’s not a diabetes expert, nor does he represent the thinking of most cardiologists: he has published comments on Avandia dissenting from a joint American Heart Association and American College of Cardiology Foundation science advisory that concluded the evidence for potential harm from Avandia is “inconclusive.”DeLauro wasn’t shy about criticizing the agency in its absence, saying that whenever difficult drug safety issues come up it “always appear[s] to act on behalf of the industry.” FDA’s “notion is let us leave this [sic] go on for another several years while people die,” she said. DeLauro and Wolfe repeatedly pointed out that FDA’s John Jenkins had signed the original approval documents for Avandia in 1999 and is now in charge of its oversight, and asserted this somehow demonstrates systemic bias at FDA.
They didn’t note that in 1999 Jenkins was director of the Office of Drug Evaluation II, a position that gave him ultimate sign-off authority on approvals of new molecular entities. Nor did they note that Avandia decisions have been bumped up to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).
Wolfe did attack Woodcock, who like Jenkins was not present. The consumer activist said he’s “had many conversations talking with Dr. Woodcock about [drug safety] and she’s just uncomfortable being a regulator,” a charge that would be news to the companies that complain bitterly about FDA’s regulatory actions.
Wolfe, who has called for Woodcock’s dismissal, added that “being uncomfortable being a regulator is incompatible with being the head of the center.”
Wolfe supported this assertion by noting that Saudi Arabia — not usually on the list of the most advanced drug regulators — has banned Avandia. “FDA has more employees [working on] drugs than the rest of the world combined,” but less sophisticated regulatory agencies “are more attuned to public health than the FDA,” he charged.Wolfe conveniently failed to note that the European Medicines Agency has looked at the evidence and decided Avandia can remain on the market.
Star Chamber proceedings featuring half-baked reform ideas and populist attacks on regulators are wrong-headed and ethically challenged. In a better political world, FDA would ignore them.
“Conscience and cowardice are really the same thing. Conscience is the trade-name of the firm.”
Oscar Wilde
The complete BioCentury commentary can be found here.
