THURSDAY, Aug. 9, 2001 (HealthDayNews) -- A consumer watchdog group today asked for a criminal probe into the drug giant Schering-Plough Corp. over its handling of an asthma medication the group has linked to 17 deaths.
In a letter to Health and Human Services Secretary Tommy Thompson, Public Citizen accuses Schering of sacrificing patient safety for financial considerations when it chose to delay a wholesale recall of its albuterol inhalers after some of the products were found to be lacking any active drug.
The company issued a recall in September 1999, but limited the action to 190,000 Proventil and generic inhalers. At the time, Schering-Plough and its generics subsidiary, Warrick Pharmaceuticals, said the problem affected "fewer than 150 canisters."
By the following March, though, Schering-Plough had ultimately withdrawn 59 million Proventil and Warrick inhalers from the market over what it called the "remote possibility" that some of the devices did not have adequate albuterol to control an asthma attack.
Public Citizen's letter says the devices were being made under a "seriously flawed" manufacturing process. It says FDA figures show Schering's albuterol was the "primary suspect" in 17 deaths in the period leading up to the first recall notice and March of 2000. Of those, 10 were known to have been using or attempting to use inhalers from recalled lots, while the source of the other seven could not be determined. No deaths have been reported since that time, the group adds.
"Schering-Plough made a financially conservative but public health reckless decision in September 1999 that, despite a long history of systemic problems involving the manufacture of albuterol inhalers, only the lot from which the patient was unable to relieve his/her asthma attack would be recalled," writes Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in the letter to the FDA.
The letter also says an audit Schering commissioned from a private Maryland company, ACC Consulting Group, as well as an FDA review dated January 2001, turned up quality control problems in the company's manufacturing of albuterol.
William O'Donnell, a Schering spokesman, says the Kenilworth, N.J.-based company disputes Wolfe's allegations and believes it handled the recalls in a "proper and appropriate" manner.
"We have no evidence that a patient was ever harmed by the inhaler subject to the recalls. We have no evidence that any of the deaths were caused by one of the recalled products," he says.
O'Donnell says that although Proventil's manufacturing problems have become the grist for "several" lawsuits, "to date every inhaler returned to us by a patient claiming injury and alleging that it lacked active ingredient has been tested [by the company] and found to contain active ingredient." O'Donnell could not say how many inhalers had been returned by patients.
In December 1999, Schering-Plough also was forced to recall batches of another asthma inhaler, Vanceril, after some canisters were found to be missing active ingredient.
Crystal Rice, an FDA spokeswoman, would not comment on the petition or the prospect of a criminal investigation against the company. "FDA will carefully review and consider the issues addressed in the petition, and respond to the petitioning party in a timely fashion," Rice says.
Dr. Jerry Shier, a Washingon, D.C. asthma specialist and a board member of the Asthma and Allergy Foundation, says he knows of no case of a patient being harmed or dying after attempting to use a faulty Proventil canister.
The drug is intended to be a "rescue" treatment for people with acute forms of the condition, not a maintenance therapy, like steroids, to be taken daily.
The National Institutes of Health recommends that patients use albuterol three to four times a week, and that if they find themselves needing it more often they should contact their doctor.
"I'm not protecting Schering, but if we're going to follow the NIH guidelines you shouldn't reach for [Proventil] once or twice and drop dead," Shier says.
What To Do
Read the letter by clicking on Public Citizen.
To learn more about asthma, try the American Academy of Allergy, Asthma and Immunology or the Centers for Disease Control and Prevention.
