Recall of Roche Antiretroviral Viracept Disrupted Treatment for Thousands of HIV-Positive People in Developing Countries, New York Times Reports
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.
William Burns, CEO of Roche's pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. Investigators still are trying to determine what occurred in the Swiss plant where the drug is manufactured. It is believed that the contamination might have occurred in March and has affected supplies of the drug for three months. Roche later announced that it plans to establish patient registries to monitor the health of HIV-positive people who were taking the drug (Kaiser Daily HIV/AIDS Report, 6/25).
Although the recall "went largely unnoticed" in developing countries when it was announced, it has "caused growing concern among global health officials and in AIDS programs in many poor nations," according to the Times. They say that Roche did an insufficient job of providing information to patients and officials about potential risks of Viracept and helping them to find affordable, alternative drugs, the Times reports. Roche said that it has been working with health officials worldwide and that risks associated with the affected Viracept batches are low. The company said it immediately notified health providers in affected countries to discontinue use of Viracept. Roche also said it would cover the "reasonable costs" of the recall but did not define "reasonable costs," the Times reports.
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).