Recall Of Roche Antiretroviral Viracept Disrupted Treatment For Thousands Of HIV-Positive People

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Roche Antiretroviral Viracept Recall

The recent recall of Roche's antiretroviral drug Viracept worldwide has"disrupted treatment for tens of thousands of the world's poorestpatients, with no clear word from the manufacturer on when shipmentswill resume," the New York Times reports (Rosenthal, New York Times, 7/23). The European Medicines Agencyin June recalled Viracept because of contamination. Roche in astatement said that it is recalling all batches of the drug incooperation with EMA and Swissmedic,Switzerland's drug regulator, in Europe and other undisclosedcountries. According to Roche, the drug was recalled after testsindicated that certain batches were contaminated withhigher-than-normal levels of methane sulfonic acid ethyl ester -- achemical normally used in the drug in small quantities.

WilliamBurns, CEO of Roche's pharmaceutical division, said the impurity hadbeen caused by the interaction of two chemicals in a vessel where thedrug is produced. Investigators still are trying to determine whatoccurred in the Swiss plant where the drug is manufactured. It isbelieved that the contamination might have occurred in March and hasaffected supplies of the drug for three months. Roche later announcedthat it plans to establish patient registries to monitor the health ofHIV-positive people who were taking the drug (Kaiser Daily HIV/AIDS Report, 6/25).

Althoughthe recall "went largely unnoticed" in developing countries when it wasannounced, it has "caused growing concern among global health officialsand in AIDS programs in many poor nations," according to the Times.They say that Roche did an insufficient job of providing information topatients and officials about potential risks of Viracept and helpingthem to find affordable, alternative drugs, the Timesreports. Roche said that it has been working with health officialsworldwide and that risks associated with the affected Viracept batchesare low. The company said it immediately notified health providers inaffected countries to discontinue use of Viracept. Roche also said itwould 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 ofwhom are impoverished and live in developing countries. The recall has"left those patients with the painful choice of discontinuing alifesaving medicine or using a drug that might contain a dangerouscontaminant," according to the Times. WHO and EMAofficials have said that Roche did not provide vital information forguarding public health, including where the affected drugs wereshipped, the concentration of the contaminant and what the companyplans to do for people taking the drug. EMA has canceled Roche'slicense 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 Timesreports. Although the company has been in talks with Pfizer aboutsupplying Pfizer's version of Viracept -- which is made in the U.S.,Canada and Japan -- to some affected nations, regulatory and licensingissues could take "some time," Roche spokesperson Martina Rupp said.Rupp said that Roche has shipped "at least one packet of Viracept withhigh levels of the impurity to 35 countries" but would not say whichcountries. Contaminants were "observed in batches of Viracept that hadbeen released to countries since March 2007," she added.

Ruppsaid that Roche made the worldwide recall to "avoid confusion," addingthat the company estimates about 45,000 people were affected by it.Roche is conducting studies on the issue, and the results will not beavailable for several months, according to Rupp.

In somecountries, newer alternatives to Viracept are not available becausethey are not licensed or are too expensive, according to some peopleliving with HIV and international health experts. In some countries,such as Panama, patients or treatment programs have made up thedifference in cost between Viracept and more expensive alternatives.However, in countries like Venezuela, alternatives to the drug areunavailable.

Asia Russell, coordinator of international advocacy for Health Gap,said, "It seems that Roche has abandoned these patients since in manyplaces there aren't ready alternatives." EMA spokesperson MartinHarvey-Allchurch said, "We have not gotten information, not even anorder of magnitude." Harvey-Allchurch added, "I understand salesfigures are confidential, but I would have thought by now we would havethis information" (New York Times, 7/23).

Reprinted with permission from kaisernetwork\t\t\t\t\t\t\t

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