19. FELBENE: PFIZER'S BEST-SELLING DEADLY DRUG
Feldene is the most widely sold nonsteroid anti-inflammatory drug in
the world. It is marketed in 106 countries to more than 20 million people.
It is the most lucrative product sold by the Pfizer Corporation. And,
according to critics, it also kills people. Since Feldene was introduced
in the U.S. in 1982, the U.S. Food and Drug, Administration (FDA) has
received a total of 2,621 non-fatal and 182 fatal adverse reaction reports
associated with the drug's use.
These figures, based on a November 1985 FDA printout, may greatly underestimate
the total number of adverse reactions to Feldene. Dr. Sidney Wolfe,
director of the Public Citizen Health Research Group in Washington,
said "At least 1.75 million elderly American people now receiving
this drug are at risk of developing life-threatening gastrointestinal
reactions." He has petitioned the FDA to ban "as an imminent
hazard to the public health" the use of Feldene in patients aged
60 and over. The National Council of Senior Citizens has urged the FDA
to take the drug completely off the market.
Feldene can cause stomach
and intestinal bleeding, ulcers, intestinal perforation, hematemesis (vomiting
of blood), and melena (blood in stools). It also can cause congestive heart failure
and reactions such as burning, itching, redness, and small swellings on the skin
after brief exposure to light.
Feldene is the latest in a series of drug
scandals in which giant pharmaceutical companies, as a matter of corporate policy,
place profits before human life. But Feldene also represents a case study in how
the FDA fails to perform its regulatory function. First the FDA bent the rules
to allow Pfizer to market its product and then it took no action after the company
repeatedly violated the law.
Pfizer originally submitted a new-drug application
for Feldene to the FDA in March 1978 and again in May 1980. Both times the applications
were rejected because Pfizer had not conducted the necessary tests. In September
1981, Pfizer resubmitted its application but it did not perform any new tests;
it simply reanalyzed old data.
Then, while the FDA was still considering
the application, Pfizer sponsored a reception at the meeting of the American Rheumatism
Association in Boston and showed a film promoting Feldene which the FDA said was
illegal. Nevertheless, on April 6, 1982, the FDA approved Feldene for use in the
And even while the FDA was deliberating on Pfizer's application, Feldene
users already were dying in Europe. The FDA did not learn of Feldene's record
in Europe until after it was approved. About six months after approval, Pfizer
submitted 26 adverse drug reports from Britain; the reports showed the Pfizer
may have held onto them as long as two and a half years. And between July and
November 1983, Pfizer reported almost two dozen patient deaths in Europe. Aware
of the potential impact of adverse publicity, Pfizer attempted to censor articles
considered for publication in medical journals in Europe.
PROGRESSIVE, June 1986, "Death By Prescription," by Matthew Rothschild,