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 U.S.
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.
THE PROGRESSIVE, June 1986, “Death By Prescription,” by Matthew Rothschild, pp 18-22.