COMMENTARY:

Dealing in Death: Bush's FDA

The stakes for no industry oversight jumped in November when a leading FDA scientist, Dr. David Graham, acknowledged that Merck's drug Vioxx caused as many as 139,000 heart attacks, strokes and deaths.

Testifying before the Senate, Graham charged that Vioxx had killed between 28,000 to 55,000 people since the FDA placed it on a fast track for approval in 1999. The FDA approval came despite reports that Vioxx carried a high risk for heart attack and stroke. Internal Merck documents reveal that the company has known about the dangers of Vioxx for several years but suppressed the data and marketed it aggressively.

The FDA jumped to Merck's defense and denounced Graham as "irresponsible" and his opinions as "junk science." Previously, Graham said the agency suppressed his findings of increased risks after he reviewed 1.4 million patient records from Kaiser Permanente health care systems, showing that heart attack rates were five times higher with Vioxx, when compared to another drug.

On November 25, Graham announced that he was facing pressure from FDA officials to move out of drug safety into an administrative role, which would sidetrack him from criticizing FDA enforcement procedures. Graham warned that the FDA has abandoned its watchdog role in favor of a cozy relationship with the pharmaceutical industry and that the public can no longer expect government protection from deadly medications.

The Senate hearings came on the coattails of the influenza vaccine disaster in October, when half the nation's supply of flu vaccine was found to be contaminated. Some 48 million doses of vaccine from Chiron were taken off the market, leaving the nation far short of the 100 million doses needed for at-risk patients. With flu deaths of approximately 55,000 a year, some predict that tens of thousands will die as a result.

After finding bacterial contamination at Chiron's vaccine plant in England, the FDA inspected the plant several times and then relied on telephone conference calls, letters and emails for "reinspection." In October, the British government shut down the plant for drug contamination, to the shock of the FDA.

Public reassurances over the flu vaccine and the FDA's response to the dangers of Vioxx are in stark contrast to the recent warnings about the abortion drug RU-486. The FDA issued detailed warnings after one death, reinforcing public perception of the FDA being used for ideological purposes that have little to do with public health.

The RU-486 warnings come as a surprise from an agency that's increasingly siding with the pharmaceutical industry. OMB Watch, a nonprofit government watchdog group found, "This administration has abandoned work on scores of long-identified public health, safety, and environmental problems. The FDA and EPA alone have withdrawn 60 percent and 52 percent, respectively, of the agenda items carried over from previous administrations."

In 2004, the FDA failed to meet 70 percent of their own benchmarks for proposed rulemaking, final deadlines and reaching decisions on petitions with deadly consequences. For example, in October 2003, the FDA announced they would issue warnings about the risks and fatal side effects of a toxic heart drug, Cordarone. After 1,000 deaths and thousands of severe medical complications, the FDA has yet to act. The FDA asked the drugs manufacturer, Wyeth, to write their own regulations, which they have failed to complete.

According to OMB Watch, the FDA has withdrawn 48 identified food and drug safety priorities, almost half of all items on their agenda in May 2002. It's no wonder.

Responsible for changing the FDA is Bush appointee for legal affairs, Daniel Troy. Former clerk for Robert Bork, litigant for the anti-regulatory Washington Legal Foundation, and tobacco lawyer, Troy last represented drug maker Pfizer, collecting up to $415,000 a year in fees.

Unlike his predecessor who held one meeting with industry lobbyists, Troy has held over 129 meetings in his three years in office. But Troy's boldest move has been helping drug companies defeat lawsuits. In four separate cases since 2002, the government has asked judges to dismiss potentially costly claims against drug makers.

The lack of FDA enforcement is consistent with Bush's policy of allowing corporations to regulate themselves--akin, critics claim, to "allowing the fox to guard the henhouse." If there's a theme to Bush's oversight of public health and welfare, it's that corporate profits trump public safety and public interest.

Unfortunately, FDA regulations are not like the long-term health effects of allowing air pollution, contaminated drinking water or forest clear-cutting. FDA oversight is a life-and-death issue for the American public. A slight majority put Bush in the White House in 2004, but they evidently overlooked the dire consequences of their choice.

How many people have to die before the Bush Administration steps in with government regulators to oversee illegal and unhealthy industry practices?