Tomorrow, a House Energy and Commerce subcommittee will hold a hearing on the unprecedented spate of drug recalls. "This administration does not like regulation, this administration does not like spending money, and it has a hostility toward government. The poisonous result is that a program like the FDA is going to suffer at every turn of the road," said Rep. John D. Dingell , chairman of the full House committee.
Drug safety is not the only area in which FDA officials get failing grades. The FDA, it seems, flunks each and every arena over which the agency has regulatory authority. None of the divisions overseeing safety in in drugs, vaccines, food, and medical devices--for human as well as animal use-can be said to be functioning for the public good. The consequences of FDA's failure to protect the public health are documented in preventable harm to humans and animals.
The Washington Post reports that FDA officials have known "for years" about contaminated food that sickened hundreds of people and killed at least three. But FDA officials who are entrusted with safeguarding the public health, did nothing to prevent illness and death from contaminated peanut butter and spinach.
"Congressional critics and consumer advocates said both episodes show that the agency is incapable of adequately protecting the safety of the food supply. FDA officials conceded that the agency's system needs to be overhauled to meet today's demands, but contended that the agency could not have done anything to prevent either contamination episode."
The Associated Press has documented details about a case of abusive bullying of an FDA veterinary safety officer. A case that has much in common with the bullying of safety officers Andrew Mosholder, MD whose analysis of pediatric SSRI antidepressant drug data revealed a twofold increased risk of suicidal behavior, and David Graham, MD whose analysis of Vioxx data revealed an
increased risk of cardiac arrest.
Like these courageous public servants, Victoria Hampshire, adverse events coordinator in the veterinary division, was anxious about thousands of reported autoimmune, allergic, liver and other reactions to Wyeth's drug, Proheart 6, to prevent heartworm. For doing her job by insisting that the agency pay attention to drug safety hazards--in this case, almost 500 dogs had died after taking Wyeth's Proheart 6-more deaths than all competitors combined-she ran afoul.
"What happened next - and the price she paid for speaking up - have spurred a U.S. Senate inquiry and shined a spotlight on the complex topography of drug safety, where interests collide like tectonic plates and squeeze decisions from all sides. On this landscape, the government's watchdogs come in disparate breeds too. Some whimper at approaching trouble; others bark gamely. And some, like Hampshire, won't give an inch."
After withdrawing the drug in September 2004, "Wyeth has pulled all the plugs at the level of commissioner." After a meeting between Wyeth CEO and (then) Commissioner Lester Crawford, attended by (then) Chief Counsel, Daniel Troy, Hampshire was removed from her professional job, barred from speaking to FDA's advisory committee hearing about Proheart 6 recall, then FDA officials set the agency's intimidating Internal Affairs division upon her. Although a prosecutor had already ruled out most criminal charges, the Internal Affairs investigator made her sign a statement saying she could be fired and, if she lied, charged with perjury, and reminded her about the jailing of domestic guru Martha Stewart.
This same abusive tactic was used against Dr. Mosholder and Dr. Graham when they insisted that the hazards of SSRIs and Vioxx be made public. AP reports that in June 2005, a Wyeth manager made a sales call at an Alabama veterinary practice, "where he openly blamed Hampshire for the Proheart 6 recall, according to a confidential letter written by a vet there to the FDA. The Wyeth employee boasted that the company had her investigated by private detectives, and she had been "taken care of," according to the letter obtained by The Associated Press. He then predicted the drug's swift return to market."
Congressman Dingell is considering introducing legislation to boost the agency's accountability, regulatory authority and budget.
Contact: Vera Hassner Sharav