No Conflict Of Interest For FDA’s Woodcock
9 CommentsBy Ed Silverman // February 5th, 2010 // 8:00 am
The research collaboration between Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency, according to FDA legal counsel Ralph Tyler, The Baltimore Sun writes.
But Woodcock voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals, which raised the allegations last April, the paper reminds us. Both companies are developing a generic version of low molecular weight heparin, which is currently sold by Sanofi-Aventis as Lovenox.
“We’ve determined that there’s no conflict here,” Tyler tells the paper, adding that as an “act of good grace” Woodcock stepped aside from any involvement in both applications last August. He adds an investigation by the Department of Health and Human Services Inspection General has been dropped.
But an Amphastar attorney couldn’t believe it, noting the FDA sent a letter last September saying there was no conflict. “Why did she step aside right before they sent us a letter telling us that she has no conflict?” Jason Shandell tells the paper. “And why didn’t they tell us that she stepped aside?” And he complains that contacting reporters before notifying his company, “flies square in the face of transparency” advocated by the Obama Administration.
Woodcock and several Momenta scientists were among a team of researchers that identified a contaminant in Chinese-imported heparin marketed by Baxter International that killed patients. The version of heparin being developed by Amphastar and Momenta is similar but distinct from the form of the Baxter drug, the paper notes.
Amphastar alleged that Woodcock’s research work with Momenta created the appearance of a conflict. In its complaint, Amphastar cited earlier contacts in 2007 between Woodcock and scientists connected with Momenta discussing issues that would later figure in requirements for both applications, the paper writes.
FDA principal deputy commish Josh Sharfstein tells the paper the agency needed to be able preserve its ability to respond to public health emergencies and also assure safety of new drugs - and that officials involved in both activities aren’t automatically conflicted. “It’s not either or,” he tells the paper. “We need to be able to do both.”
Lisa Van Syckel
This woman couldn’t find her way out of a brown paper bag…
patrons99
Yet another demonstration of the “revolving door” policy at FDA, CDC, and WHO. Conflicted interests? Probably just the tip of the iceberg.
vince
Is this the same person described in this article “Alosetron: a case study in regulatory capture, or a victory for patients’ rights? ” http://www.bmj.com/cgi/content/full/325/7364/592?ijkey=L5Wv.i0oPq.U6
harry
Interesting, she doesn’t seem like a good fit for the more patient friendly (I hope) FDA. why are they keeping her. Hasn’t she worked there long enough?
Mastiff
These comments are uninformed. There is no indication she did anything other than try to help address a public health problem, and tried to use the best scientific resources available. And she recused herself even though it wasn’t necessary — she went above and beyond here and your criticism is completely unwarranted.
Condor
Hello Mastiff —
With all due respect, the timing (alone — even without anything else) of her recusal, raises a fair question about cause and effect. It cannot be plausibly said that she was unaware that the letter was coming.
So, it is easy to infer a quid pro quo here: “recuse yourself, and we’ll indicate we find no conflict.” This sort of governing was an everyday occurence in the two Bush administrations.
And what of the choice to have a discussion with the press, BEFORE discussion with the involved companies (as a regulator charged with oversight)?
That seems strange — even in the most charitable soft candle-light I am able to muster.
So — on balance — I think these are fair questions. Please explain why any of the above is unfair, as a matter of inductive reasoning.
Namaste
james
If the drug chief didn’t have any link with conflicted interest, why she stepped aside the so important position of drug approval of this 4 billion market drug. This time she acted voluntarily withdrew from approval,and next time I expect that she will voluntarily resign from FDA.
Lisa Van Syckel
Ed,.. is this her pic from the 2004 Congressional hearings on antidepressants?
FDA
The situation with alosetron in the press and the subject of congressional hearings only dealt with shananigans post marketing when there was an outside U of Maryland Professor who was working temporarily at the FDA and he was suppressed and there were backdoor negotiations with Glaxo.
However we at FDA knew even prior to approval that this drug would kill people if released and that the labeling and plans to address it were nonexistant. Reviewers who raised concerns prior to the initial approval were removed from disccusions and backchannal discussions with Glaxo occurred then too.