AT F.D.A., STRONG DRUG TIES AND LESS MONITORING

Gardiner Harris, The New York Times, 12/06/2004

When federal drug officials suspected in 1992 that a popular allergy pill might cause heart problems, they turned to their own scientists. Their trial confirmed the danger, and the drug was pulled from the market. Eight years later, similar worries surrounded the arthritis pill Vioxx. But by then, the Food and Drug Administration had shifted gears, slashing its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that arose under an unusual agreement that has left the agency increasingly reliant on and bound by drug company money. Discovering Vioxx's dangers would take four more years. That delay has led to a firestorm of criticism. Members of Congress, an internal F.D.A. whistleblower and prominent medical journals have said the agency is incapable of uncovering the perils of drugs that have been approved and are in wide distribution. Some have accused it of being cozy with drug makers. Dozens of former and current F.D.A. officials, outside scientists and advocates for patients say the agency's efforts to monitor the ill effects of drugs that are on the market are a shadow of what they should be because the White House and Congress forced a marriage between the agency and industry years ago for the rich dowry that industry offered. Under the 1992 agreement, the industry promised to give the agency millions - in the 2003 fiscal year, $200 million - but only if the agency spent a specified level of money on new drug approvals.