Schering-Plough’s Faulty Asthma Inhalers Caused Deaths, Group Says

Calling for a criminal investigation of Schering-Plough, the consumer advocacy group Public Citizen said yesterday that "at least 10 asthma patients" may have died after using inhalers made and later recalled by the company because they may not have contained the active ingredient, the New York Times reports (Petersen, New York Times, 8/10). Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, sent a letter to HHS Secretary Tommy Thompson stating that albuterol inhalers were the "primary suspect[s]" in 17 asthma-related deaths that occurred from October 1998 through June 2000, a period that overlapped with two recalls of the inhalers in September 1999 and March 2000 (Richwine, Los Angeles Times, 8/10). The recalls affected 59 million inhalers, sold under the brand-name Proventil and the generic name Warrick (also made by Schering). Schering -- which has had "persistent manufacturing woes" -- issued the recalls primarily because it "didn't have a quality-control system to guarantee" that all the inhalers contained albuterol, the Wall Street Journal reports. In the past three years, the FDA has found a "torrent of flaws" at the company's New Jersey and Puerto Rico manufacturing plants.

Analyzing an FDA database of adverse events, Public Citizen concluded that at least 10 of the 17 patients who died were known to be using albuterol inhalers that were later recalled (Carroll/Harris, Wall Street Journal, 8/10). Information on the other seven deaths was insufficient to determine whether they involved recalled inhalers. The group also said that no similar deaths were reported to the FDA before October 1998 and after June 2000, the period affected by the recall (Los Angeles Times, 8/10). "This pattern of deaths, with none occurring before or after the interval during which the defective albuterol inhalers were shipped for use, is known as a point source epidemic and strongly implicates these products as causes of the deaths," Wolfe wrote. The letter, which follows up on a March letter to Thompson requesting a criminal investigation of Schering, said that the company also waited three months after learning that a patient who died after an inhaler-related incident in January 2000 to begin the second recall. "Based on this new information concerning the deaths, there is even more reason for criminally prosecuting Schering-Plough for introducing these defective products into the marketplace and failing to recall them much earlier," the letter said (Public Citizen letter, 8/9).

Schering yesterday disputed Public Citizen's findings, saying that their analysis was "flawed." Schering also noted that "more than 5,000 Americans" die every year due to asthma, the New York Times reports. "We have no evidence that a patient was ever harmed by an inhaler subject to the recalls," Schering spokesperson William O'Donnell said (New York Times, 8/10). He added, "[E]very inhaler returned to the company by a patient claiming injury and alleging the canister lacked active ingredient has been tested and found to contain active ingredient" (Wall Street Journal, 8/10). Laura Bradbard, an FDA spokesperson, said the agency is "looking very carefully at the situation with Schering-Plough" and will consider the new information (Los Angeles Times, 8/10).