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BACKGROUND The FDA's advisory panels make important drug safety decisions that affect the lives of citizens like you and me. So we need to guard against undue influence from those with a financial interest in the outcomes. |
By PAUL THACKER
Dr. Janet Woodcock, who runs the FDA's new drug division, has responded to a piece I wrote about the misleading claims she's been making to the press and Congress regarding the agency's purported inability to find qualified researchers without ties to industry to sit on drug safety advisory panels.
My piece was an exhaustive, five-part analysis to counter Dr. Woodcock's claims. I also pointed out that Janet might be making statements contrary to available evidence and favorable to drug companies because of her cozy ties to industry. I pointed out that Big Pharma floated her name for FDA Commissioner to The Wall Street Journal shortly after President Obama was elected.
So how did Janet respond?
She told FDA Webview, “As far as the allegations about my putative relationship to industry, I consider those non-substantive.”
Oh, please. Why make a statement that flies in the face of the obvious? Perchance, because Janet remains blinded by her own brilliance as FDA’s seer. A couple years ago, The Wall Street Journal reported on a morale-boosting conference for 500 of the FDA’s top officials, in which a slide show presented Janet as a visionary leader alongside others such as Gandhi, Golda Meier, and Margaret Thatcher.
Behold:
Congressman Joe Barton (R-TX) was far from amused:
It's a cinch that if I spent a nickel of taxpayers' money to rank myself with [Sam] Houston and [Stephen F.] Austin, I'd have some explaining to do after the laughter died down.
For his part, Congressman John Shimkus (R-IL) was annoyed by the presence of Janet’s favorite supporters. He noted that the conference organizer "lists numerous pharmaceutical companies as clients—at a time when those same ties are being questioned within FDA."
No kidding.
By Your Friends Will Ye Be Known
Prior to Janet’s name being floated as Commissioner, Congressman Bart Stupak (D-MI) sent President-elect Obama an angry letter demanding that he choose someone outside the agency. The agency’s top officials, he wrote, “are too close with the industries they regulate, creating a question of who they are working for.”
The Congressman did not name Janet directly, but the concern was obvious, as congressional leaders were batting her name around as interim Commissioner.
Of course, Janet’s friendship with industry is no secret in Washington. Months prior to the 2008 elections, she took over the agency’s powerful drug approval center. The move elicited praise from none other than…Billy Tauzin—the head of industry trade group PhRMA—who praised the new hire in a press release.
Oddly enough, allegations of Janet’s cozy ties to industry commonly appear in the press during drug scandals. Back in 2002, the British Medical Journal ran a scathing article implying that the FDA suffered from “regulatory capture” by industry.
Dr. Paul Stolley, an FDA senior consultant, charged that the FDA’s closeness to GlaxoSmithKline put patients at risk when the agency debated how to regulate one of the company’s drugs. He told BMJ that when a safety official takes a position that is counter to industry, dissenting voices are intimidated and ostracized, and scientific debate is repressed.
In response, Janet told BMJ, “It's our responsibility to be dispassionate and not develop emotionally based positions.”
When the agency struggled with decision on Glaxo’s diabetes drug Avandia, Janet once again found a reason to favor Big Pharma. The British government pulled the drug off the market, but our FDA kept it on the shelves, with restrictions. Why?
According to The Wall Street Journal:
By keeping the drug on the market with restrictions, FDA Commissioner Margaret Hamburg gave a nod to a powerful internal faction led by drug chief Janet Woodcock, who maintained for years that the evidence against Avandia wasn't conclusive.
Pharma expert, John Mack, editor and publisher of Pharma Marketing News, argues that Woodcock’s decision on Avandia helped to position her as the next FDA Commissioner:
IMHO, it looks like Janet Woodcock is keeping on the good side of the drug industry, which is now donating large sums of money to the GOP in the hopes of defeating Obama in the 2012 presidential elections. If that happens, it is unlikely that Margaret Hamburg will remain on as FDA Commissioner and the one person remaining who has the backing of the drug industry is Janet Woodcock.
Back in 2008, Mack surveyed over 250 pharmaceutical insiders to see who they favored to run the FDA. The survey was not scientific, but does give a glimpse into people’s thinking.
Industry’s favorite? Janet Woodcock.
Paul Thacker is a POGO Investigator. Slideshow visionary montage via The Wall Street Journal. Mack survey published with permission.
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