The FDA Guerillas of Wonky DrugWonks - Part II

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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.”

The blog concludes with the comment: “As Jimmy Durante said, ‘I’m surrounded by assassins.’”

Mr Pitts seemed particularly riled up over Ms Mundy’s report that Senator Grassley believes the FDA Office of New Drugs has been compromised by its relations with industry lobbyists, and among them “former top FDA officials.”

“And what does that mean?” He demands to know on DrugWonks. “Any evidence to back up such blowhard accusations?” He asks in his blog.

FDA officials "are too cozy with the companies they regulate," Senator Grassley told the Journal, and new leadership must "fix the culture."

“What does “too cozy” mean?” Mr Pitts asks in his blog. “Really, what does it mean?” He demands to know.

Industry insider protection by DrugWonks

Mr Goldberg identified three cozy FDA officials that lawmakers wanted gone in a blog on February 20, 2008, when responding to what he described as “Anna Mathews puff piece” on Bart Stupak, the Michigan Democratic Congressman, in the Wall Street Journal.

Under the headline “WSJ Overlooks Stupak Stupor,” Mr Goldberg wrote: “Good thing she didn't include this stirring Stupak statement -- from an LA Times article -- about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA's cafeteria guy should resign...”

"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."

On April 23, 2008, in the midst of the Heparin scandal, Mr Goldberg ran the headline: “Heparin Hypocrisy - Hyped Up Safety Fears on ADHD Drugs - Does Medicaid Kill Poor People,” and wrote: “Yet another show trial held by another congressional committee on the FDA...There have been four or five over the last two months on heparin alone.”

“Andy von Eschenbach,” he said, “who is gaining momentum, along with the FDA, in shifting the agency towards a science and systems based approach to regulation -- using real time technology to promote full time compliance -- has to sit and take the following from the likes of Bart Stupak (D-Michigan):”

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

“That's rich,” Mr Goldberg said, “coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting.”

“Andy must have to shower after sitting through such a show trial,” he added.

“Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD,” Mr Goldberg continued, referring to the world-renowned cardiologist from the Cleveland Clinic.

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