Senator calls for Probe of FDA Conduct

posted on:
July 21, 2006


WASHINGTON – Since Vioxx was pulled from the market in September, 2004 for increasing the risk of heart attacks and strokes, Merck has been slapped with more than 16,000 lawsuits.

Now, as CBS News correspondent Sharyl Attkisson reports, documents turned over in some of those cases are providing new glimpses into the relationship between the FDA and Merck a relationship that critics say was far too cozy.

Well before Vioxx was pulled from the market, an FDA senior scientist, Dr. David Graham had flagged its heart issues.

But, e-mails and handwritten notes reviewed by CBS News suggest FDA management which was supposed to be regulating Merck was giving the pharmaceutical company and not the public advance notice of those safety findings.

Dr. Graham butted heads with his FDA managers in trying to get the word out about Vioxxs risks.

“The FDA officials didn’t want to allow me to present my work at a scientific conference, but at the same time they wanted to be sure that Merck had a copy of my scientific presentation,” Dr. Graham said. “So it’s good enough for Merck, but it’s not good enough for the American people?”

Sen. Chuck Grassley said the FDA and Merck went so far as to conspire together to undercut Dr. Graham’s findings.

Grassley says handwritten notes from a phone call between an FDA official and a Merck manager indicate that the FDA apparently proposed “an official rebuttal on Graham” and said they were looking for an “opportunity to get the message out on Graham” and “suggests we provide journalists a copy of our critique on Graham.”

“It was a conspiracy on the part of the company employee, the FDA employee, to just smother Dr. Graham or to ruin his reputation,” said Sen. Grassley.

Grassley has asked the inspector general to investigate the FDAs conduct.

The FDA had no comment for this story, and Merck said it has the “right to express our views when we believe information others have presented is not fair and balanced.”

Merck goes on to say that on the topic of Vioxx, Dr. Graham differed with Merck and others at FDA, so they separately gave their scientific views.

Sen. Grassley is sending a fresh letter to the FDA accusing the agency of making the pharmaceutical industry the “FDAs first client” when that client should be the American people.

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