FREQUENTLY ASKED QUESTIONS

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6.) How can we know this treatment is safe if the government hasn't approved it?

Government approval is no guarantee of safety. Recent provisions for “fast-track” approval of new medicines have compounded the problem. A few examples of the experience with “fast-track” approved drugs makes this all too clear.

Duract: Within a year of its introduction, Weyth-Ayerst voluntarily withdrew Duract from the market after 13 reports of liver failure among patients who had taken the drug. Ultimately Duract would be suspect in at least 68 deaths, 17 of which involved liver failure.

Posicor: In early trials of Posicor, it was found that the drug would interact with other drugs posing severe risks of serious side effects. Most disturbing, though, was the fact that 143 of the 2,400 patients participating in clinical trials died suddenly.

Despite the disturbing evidence of sudden deaths among their clinical study participants, Hoffman-La Roche officials insisted that Posicor was not to blame, stating that “There is no signal that there is arrhythmic or potentially arrhythmic risk with this drug.”

Raxar: Two years after its introduction, Glaxo-Wellcome, Raxar’s manufacturer would voluntarily pull it off the market following seven fatalities linked to the drug. It has also been cited as suspect in some 18 deaths in the U.S. and abroad.

Dr. Raymond L. Woolsey, who is chairman of Georgetown University’s pharmacology department and has served as a member of an FDA advisory panel, believes drugs with potential problems like Raxar should not be approved. He summarized his rationale succinctly “[Raxar] goes on the market, kills people and has to come off. “

Relenza: By a vote of 13 to 8 an FDA advisory panel rejected Relenza. Why? Because it didn’t work and had potentially fatal side effects. In a rare move, the agency overruled the panel’s decision. The result? As many as 50 deaths have been linked to Relenza to date. Given the fact that the FDA cited Relenza’s manufacturer on three occasions for false and misleading advertising, and the fact that the FDA advisory panel said flatly it didn’t work, why hasn’t the Maryland Attorney General moved to ban its sale in his state?

Propulsid: When the drug Propulsid was undergoing review in 1993, FDA medical officers knew of 48 patients participating in clinical trials who had experienced changes in their heart rates and rhythms. The reviewers did not, however, consider the problems important. As a result, on July 29, 1993 Propulsid was approved for general use. Buy the time Propulsid was ordered off the market on March 23, 2000, some 301 deaths including those of several infants had been linked to the drug.

Redux: Promoted by the Weyth-Ayerst division of the pharmaceutical giant American Home Products for weight loss, Redux soon became wildly popular in combination with another Weyth-Ayerst product Pondimin. Together they were known by the name “Fen-Phen.” After a year, Redux and Pondimin were removed from the market following a flood of reports that they had caused at least 123 fatal heart injuries or respiratory problems among patients taking the drugs.

Lotronex: While the “fast-track” approval process for drugs is supposed to be reserved for those intended to treat “life-threatening” or “serious” conditions, where the pharmaceutical industry is concerned, “serious” is largely in the eye of the beholder. Lotronex was used to treat irritable bowel syndrome. While this condition is unpleasant and inconvenient, it is rarely life threatening. More important, there are a number of existing medications that can be used to treat it. Nonetheless, Lotronex was still given the  “fast-track” approval. On July 17, 2000, less than a month after that decision, the first fatality linked to Lotronex was reported. Glaxo, however, denied the connection. By the time Lotronex was pulled from the market on November 28,2000, 93 patients had been hospitalized with complications related to the drug, 49 of whom suffered the most serious complication, ischemic colitis. Five of the patients died.

Trovan: In December of 1997, the FDA announced its approval of Trovan, the latest addition to the family of powerful fluoroquinolone antibiotics – super-drugs that are often the only effective treatment for life threatening infections.

Six months before Trovan was approved for general use, reviewers at the FDA had noted disturbing findings in animal studies of the drug. Human studies of Trovan had equally disturbing results. In one study, Trovan was given to 140 patients suffering from prostatitis: 10 percent or 14 of the patients experienced liver abnormalities. Five had reactions serious enough to be dropped from the study prematurely.

Despite these facts, the FDA approved Trovan for general use in December of 1997. Almost immediately, adverse event reports began to stream in. Within a year and a half, 140 adverse events, including five deaths had been reported to the FDA. As a result, on June 9, 1999, the FDA issued an “advisory” withdrawing the drug from general sales so that it could only be obtained from hospital pharmacies. The advisory also severely restricted the use of Trovan limiting it to patients who had “life or life threatening” infections which did not respond to other alternatives.

To date 140 people have become ill, five have died and three have needed liver transplants because of the rush to approve Trovan.

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