When Schering-Plough recalled 59 million asthma inhalers last year, saying some may actually be missing the active drug, there was no public evidence that anyone had been hurt.
But the advocacy group Public Citizen says it's now uncovered a pattern of deaths--17 of them.
"Before these defective products got on the market, there weren't any deaths, and after they were cleared off the market, there weren't any deaths," says Dr. Sidney Wolfe of Public Citizen.
The deaths are linked to Schering-Plough albuterol inhalers--sold under the names Proventil and Warrick.
According to the Food and Drug Administration (FDA), adverse events reports of victims include: a 16-year-old boy, a 10-year-old boy, and a 21-year-old man who complained shortly before his death that his "inhaler did not seem to treat his asthma attacks as usual."
Despite that, Schering-Plough today said it has no evidence of any injuries or deaths and that every inhaler returned by a patient claiming injury was "tested and found to contain active ingredients."
Public Citizen's Dr. Sidney Wolfe wants a criminal investigation. He says Schering-Plough knowingly put defective products on the market and dragged its feet on a recall even though it knew of one death early on.
"The company is really lying in trying to get out the idea that they never have had any problems with their products," says Wolfe.
As CBS News reported earlier this year, the FDA repeatedly cited the Schering-Plough factory in New Jersey for dozens of serious violations involving Proventil and a dozen other drugs including the popular allergy drug Claritin. A company internal audit of the plant revealed:
- Production was emphasized over quality.
- Sewage and feces "had a pathway" into Proventil.
- There was no system for measuring how much--if any--medicine was going into the inhalers.
The defective inhalers have all been recalled, but Schering-Plough can't get approval to produce its new version of Claritin, called "Clarinex," because the plant still doesn't meet standards. The FDA is letting the plant continue making inhalers and all the other drugs while it tries to fix its problems.
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