- The Washington Times - Tuesday, June 5, 2007

Today, Rep. Henry Waxman will preside over a hearing on whether the Food and Drug Administration acted too slowly in responding to signals about the heart attack risks of taking a popular diabetes drug Avandia. Mr. Waxman already has the answer he wants: Indeed, well before the public knew, well before the New England Journal of Medicine ran the study claiming such a risk existed, the author, Dr. Steven Nissen. director of the Cleveland Clinic’s cardiovascular center, had told Mr. Waxman of his findings. Before the article had surfaced in the press, Rep. Waxman had sent a letter to FDA Commissioner Andrew von Eschenbach informing him of the results and his intent to hold a hearing.

Dr. Nissen thus used his prominence and ties to Mr. Waxman and the media in order to engage in what one pundit has called drug safety vigilantism. So, while the media and Mr. Waxman have put Avandia, the FDA and drug companies on trial (once again) the real question is: Do we want Mr. Waxman and those he has anointed to usurp the authority of the FDA and scuttle proposed improvements to the current approach to regulation?

The Waxman-Nissen approach is clear: Come up with possible safety problems with questionable statistical approaches; share them with friendly members of Congress and editorialists who will use the findings to attack the FDA; hold hearings in order to put companies on the defensive and generate more lawsuits.

As today’s editorial by Robert Goldberg and Peter Pitts suggests, this is prescription for spreading fear and for self-promotion, not better and safer medicines. The FDA — for all its dysfunction — is trying to develop scientific tools that will predict the genetic sources of the rare side effects that cause heart problems and better information systems that allow researchers to obtain and share information about risks and benefits months, rather than years, after a medicine hits the market. And such changes are at the heart of proposed legislative changes to the agency.

Mr. Waxman and Dr. Nissen believe they have a better approach, one that bypasses or at least is superior to proposed reforms. Distilled to its essence, it requires transferring trust from the FDA and to Dr. Nissen, his editorial allies and his congressional patron. In this regard, and since Dr. Nissen has made even the appearance of bias a litmus test for regulatory probity, the professional conduct and biases of Dr. Nissen — as well as others who act as de facto regulators — are relevant. Since the media has failed thus far to examine or provide information about their track record and methods, in the interest of accountability, this paper is obliged to do so.

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