Recall of Roche Antiretroviral Viracept Disrupted Treatment for Thousands of HIV-Positive People in Developing Countries, New York Times Reports
July 24, 2007
The recent recall of Roche's antiretroviral drug Viracept worldwide has "disrupted treatment for tens of thousands of the world's poorest patients, with no clear word from the manufacturer on when shipments will resume," the New York Times reports (Rosenthal, New York Times, 7/23). The European Medicines Agency in June recalled Viracept because of contamination. Roche in a statement said that it is recalling all batches of the drug in cooperation with EMA and Swissmedic, Switzerland's drug regulator, in Europe and other undisclosed countries. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester -- a chemical normally used in the drug in small quantities.
Lembit Rago, an official with the World Health Organization, said that tens of thousands of people worldwide take Viracept, many of whom are impoverished and live in developing countries. The recall has "left those patients with the painful choice of discontinuing a lifesaving medicine or using a drug that might contain a dangerous contaminant," according to the Times. WHO and EMA officials have said that Roche did not provide vital information for guarding public health, including where the affected drugs were shipped, the concentration of the contaminant and what the company plans to do for people taking the drug. EMA has canceled Roche's license to manufacture Viracept, which also is known as nelfinavir.
Roche said that the recall affected "Europe and some other world regions" but has not been more specific, the Times reports. Although the company has been in talks with Pfizer about supplying Pfizer's version of Viracept -- which is made in the U.S., Canada and Japan -- to some affected nations, regulatory and licensing issues could take "some time," Roche spokesperson Martina Rupp said. Rupp said that Roche has shipped "at least one packet of Viracept with high levels of the impurity to 35 countries" but would not say which countries. Contaminants were "observed in batches of Viracept that had been released to countries since March 2007," she added.
Rupp said that Roche made the worldwide recall to "avoid confusion," adding that the company estimates about 45,000 people were affected by it. Roche is conducting studies on the issue, and the results will not be available for several months, according to Rupp.
In some countries, newer alternatives to Viracept are not available because they are not licensed or are too expensive, according to some people living with HIV and international health experts. In some countries, such as Panama, patients or treatment programs have made up the difference in cost between Viracept and more expensive alternatives. However, in countries like Venezuela, alternatives to the drug are unavailable.
Asia Russell, coordinator of international advocacy for Health Gap, said, "It seems that Roche has abandoned these patients since in many places there aren't ready alternatives." EMA spokesperson Martin Harvey-Allchurch said, "We have not gotten information, not even an order of magnitude." Harvey-Allchurch added, "I understand sales figures are confidential, but I would have thought by now we would have this information" (New York Times, 7/23).
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.