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Dirty little secrets regarding FDA operating practices

Backstage Tour

I wonder how things are going at work for Dr. David Graham.

Dr. Graham is the associate science director of the FDA’s Office of Drug Safety, and for several years now he’s been an outspoken critic of the drug approval process at the FDA.

In 2004, Dr. Graham testified before a Senate committee, naming five popular drugs that he said should be avoided because of safety concerns. He added that the FDA was largely ignoring those concerns.

Since then, Dr. Graham has also been an outspoken critic of the agency’s involvement in the Vioxx fiasco.

So I wonder what a normal workday is like for someone who publicly berates the policies of the top officials in his agency? You’ve got to imagine there’s plenty of friction there. On the other hand, a surprising new survey reveals that Dr. Graham is not exactly a lone wolf.

Behind the curtain

“I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.”

That’s a remarkably candid statement, coming from a scientist employed by the FDA. But that statement wasn’t made by a single scientist; about 180 FDA scientists agreed that they could honestly make that astonishing claim.

Last month, the Union of Concerned Scientists (UCS) released the results of a survey sent to nearly 6,000 FDA scientists. About 1,000 replied. Here’s a sampling of their responses:

  • 20 percent said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.”
  • 61 percent said, “Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.”
  • 60 percent said they were aware of instances “where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.”
  • 40 percent said they would fear retaliation if they publicly expressed “concerns about public health”

When asked if the FDA “routinely provides complete and accurate information to the public,” less than half agreed.

Hearts of gold

In a press release about the survey, the UCS offered these three steps to address the deplorable situation revealed by the 1,000 participating scientists:

  1. Accountability: FDA leadership must face consequence if they side with commercial or political interests and not with the American people.
  2. Transparency: Scientific research and reviews should be open so any undue manipulation is immediately apparent.
  3. Protection: Safeguards must be put in place for all government scientists who speak out.”

Hard to argue with those measures. But until the day comes when greed and cronyism can be controlled by bureaucrats with hearts of gold, you can be sure the current drug approval process will continue, business as usual.

As the UCS survey implies, the dirty little secrets regarding FDA operating practices rarely see the light of day. As a result, many people still believe the agency is dedicated to protecting Americans from evil vitamins and one or two dangerous drugs. So we need to spread the word that fear and intimidation are typical elements of the regular drug approval process.

Science and safety? They come in a distant second, at best.

Sources:
“FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns” Union of Concerned Scientists, 7/20/06, ucsusa.org
“Summary of the FDA Scientist Survey” Union of Concerned Scientists, 7/20/06, ucsusa.org