years of supposedly protecting the public from dangerous food and
drugs, the FDA has embarked on a path to protect corporate profits
at all costs. Even death is no obstacle. The stakes for no industry
oversight jumped in November when a leading FDA scientist, Dr. David
Graham, acknowledged that Merck’s drug for arthritis sufferers,
Vioxx, caused as many as 139,000 heart attacks, strokes, and deaths.
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
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.
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 pro- tection from deadly
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.
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.
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 morning after 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
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
2004, the FDA failed to meet 70 percent of their own bench- marks
for proposed rule-making, 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 drug’s manufacturer, Wyeth, to
write their own regulations, which they have failed to complete.
to OMB Watch, the FDA has withdrawn 48 identified food and drug
safety priorities, almost half of all items on their agenda in May
for changing the FDA is Bush appointee for legal affairs, Daniel
Troy (a former clerk for Robert Bork), litigant for the anti-regulatory
Washington Legal Foundation, and tobacco lawyer, who last represented
drug maker Pfizer, collecting up to $415,000 a year in fees.
his predecessor who held 1 meeting with industry lobbyists, Troy
has held over 129 meetings during his 3 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.
is a California-based writer who follows politics.