Pfizer's Greed A National Shame




The drug
maker Pfizer “reaffirmed its commitment” over the weekend to keep its
prescription painkiller, Celebrex, on the market, despite a disclosure
last week that the drug more than tripled the risk of heart attacks,
strokes and death among those taking high doses in a national trial.
That level of risk is even greater than the one found in patients
taking the similar painkiller, Vioxx, in a similar trial that led Merck
to withdraw Vioxx in September. The results have “raised new questions
about how well federal drug regulators protect the public and worsened
drug makers' already dismal image.” Indeed, reports following the
discovery have shown Celebrex, “fast-tracked” by the agency and never
even proved it protected the stomach from gastrointestinal problems
associated with aspirin and ibuprofen – its primary advantage over
existing pain relievers.



MARKETING
TO MIDDLE AGE: Celebrex and Vioxx were designed for senior citizens,
who have the highest risk of stomach bleeding – “principally people
over 65 years who have suffered from gastrointestinal problems,” – but
marketed aggressively to middle-aged Americans, who could have
benefited just as well from traditional painkillers like aspirin.
Dorothy Hamill, the 1976 Olympic figure skating gold medalist, “was the
middle-aged celebrity face of Vioxx,” while commercials for Celebrex
targeted “baby boomers beginning to suffer from arthritis.” Many
medical experts “now say that Celebrex and Vioxx, selling for $2 or $3
a pill, have been too widely prescribed to patients who could safely
obtain the same pain benefits from over-the-counter drugs costing
pennies apiece.” Under pressure from the FDA, Pfizer now says it will
halt advertising to consumers, but not to doctors.



THE
PASSING LANE: Celebrex, like Vioxx, was “fast-tracked” by the FDA,
because it was suggested the drug would help cut the rate of
gastrointestinal bleeding associated with older painkillers. That meant
the FDA took only six months to approve the drug, even though
scientists concluded it had not “sufficiently demonstrated” it reduced
the rate of the gastrointestinal problems compared with existing
painkillers. Later studies by Pfizer “were never convincing enough for
the agency to remove the warning from Celebrex's labeling.” In other
words, Celebrex “has never been proven to the FDA's satisfaction to
have the stomach-protecting benefits that originally were supposed to
be the point of that category of drugs.”



THE
'SPECTACULAR' FDA: Celebrex and Vioxx are not the only drugs to come
under scrutiny lately. On the same day the Celebrex study broke, “in
less than 12 hours,” AstraZeneca reported that a trial of Iressa, a
lung cancer drug approved in the United States last year, showed that
the drug did not prolong lives. Eli Lilly warned doctors that
Strattera, its drug to treat attention deficit disorder had caused
severe liver injury in at least two patients. And doctors writing in a
prominent medical journal recommended that physicians stop prescribing
Pfizer's Bextra painkiller. So what was the White House's reaction to
the finding that several FDA approved drugs are ineffective or
dangerous? White House Chief of Staff Andrew Card said the agency was
doing a “spectacular job.”



SPECTACULAR
NEGLIGENCE: The Washington Post reports the FDA, “which regulates
almost one-quarter of the U.S. economy, has been without a permanent
chief for almost two-thirds of the time that Bush has been in
office.” The agency also has had a “high number of temporary appointees
administering its centers, offices and divisions, including the key
positions running the offices that evaluate new drugs and monitor the
safety record of approved medications.” The White House's negligence
plays right into the hands of major drug companies, which would rather
“have no one there than someone who favors a proactive stance that
might slow down the industry or raise hard questions about profitable
drugs.” Observers say the agency's lack of leadership has made it “less
able to respond quickly and effectively to emerging problems.”



SPECTACULAR
FUNDRAISERS: Another reason Bush has not appointed an FDA head may be
that some Democrats have signaled they would “strongly oppose any
nominee from the pharmaceutical industry.” But the pharmaceutical
industry, which was the major winner in last year's prescription drug
bill, includes some of the GOP's biggest supporters. And of health
industry contributors, Pfizer is number one. Company executives have
contributed $2.7 million to Republicans since 2000, and the drugmaker's
political action committee (PAC) has pitched in more than $1.4 million.
Since 2000, 79 percent of the company's contributions have gone to
Republicans. Merck has made almost $1.8 million in political donations
since 2000, 74 percent to Republicans.