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The FDA Guerillas of Wonky DrugWonks - Part II

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He was particularly annoyed over Dr Wolfe saying FDA “has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed.”

“USA Today” was attacked on November 15, 2007, under the headline: "USA Today Adds Its Own Avandia Warning," for quoting FDA career scientist, Dr David Graham, when discussing the cardiac risks of GlaxoSmithKline’s diabetes drug, Avandia, instead of talking to the FDA official from the CMPI team. "Here's USA Today crawling through the mud -- past Janet Woodcock who officially speaks for the FDA -- to talk to David Graham about Avandia," Mr Goldberg wrote.

Road to Extinction

In a July 30, 2008 blog, Mr Pitts seemed really rattled over a story by Alicia Mundy in the Wall Street Journal with some pretty good hints that the tribe of CMPI Guerillas promoting Big Pharma’s agenda, with the help of industry insiders at the FDA, might soon be on the path to extinction, when reporting that:

“Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.”

Leading the drive are Rep John Dingell (D Mich) and Senator Chuck Grassley (R Iowa), she said. “Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry,” Ms Mundy reported.

In a DrugWonks rapid response, Mr Pitts asked, “isn't the FDA already an entirely independent government agency?”

“To lay the groundwork for their FDA overhaul,” Ms Mundy reports, “Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA.”

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“Mr. Grassley began his campaign to overhaul the FDA in 2004 during an uproar about the agency's slow reaction to potential links between popular antidepressants and teen suicides,” she notes. “Now he has four staffers and a parade of FDA whistleblowers helping him investigate a plethora of FDA controversies, such as its approval of the antibiotic Ketek,” she reports

Mr Pitts calls this revelation about the opening of a new website to air criticisms of top FDA officials, “some really shoddy reporting”:

“Some current and former FDA safety reviewers have opened a whistleblower website to air their concerns that FDA leaders are pushing them to approve some drugs”

He points out that this site defines itself as “a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.”

Apparently Mr Pitts took the time to check it out and found Jim Dickinson, who is not a former FDA employee, registered the website, and is a “long-time FDA antagonist,” he says. But then Mr Pitts is a “long-time antagonist” of Senator Grassley and whistleblowers as well. He can be found taunting the Senator on DrugWonks as early as November 18, 2005, in calling him, “the new father-confessor of disgruntled FDA employees.”

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On February 21, 2008, he posted the headline, “Not the real FDA – a Grahamatization,” in highlighting what he described as an, “Interesting omnibus piece from by Warren Ross of Medical Marketing & Media on the various slings and arrows being tossed at the worlds premier medical regulatory agency,” in which Mr Pitts just happens to be quoted.

“Here’s what I had to say,” he writes in the blog, “about the David Grahmatization of the whistleblower culture:”

Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.” Whistleblowers, he acknowledges, at least deserve “grudging respect” for letting it be known who they are, “but what is truly damaging are the silent leakers” who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.”

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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