“A total recall of an important AIDS drug widely used in developing countries 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 reported this past weekend.
Roche Pharmaceuticals of Switzerland began the recall of its AIDS drug, Viracept, in early June, because some batches were found to contain a dangerous chemical.
While the recall has largely gone unnoticed in the developed world, Elisabeth Rosenthal of the New York Times reports that it is having a devastating impact on developing countries, many of whom rely on the drug as their sole or only reasonably priced option for HIV/AIDS treatment.
The U.S. version of the drug is made by Pfizer and is not part of the recall. The use of the drug in developed countries, in any case, is “falling out of favor” — since more convenient alternatives with less side affects are available.
The European Medicines Agency, the regulatory body of the European Union, has canceled Roche’s license to sell the drug. Officials there and with the World Health Organization in Geneva assert that “Roche had not provided information they consider essential for safeguarding public health: which countries the tainted medicine was shipped to, the concentration of the contaminant and what the company will do for its patients.”
Dr. Lembit Rago, the WHO coordinator of quality assurance and safety for medicines, sees Roche’s response as a “sort of a disaster,” and said Roche “failed in communication” — a charge Roche has denied.
Roche says that it promptly provided information to health providers and that it will cover the “reasonable costs” of the recall. Rosenthal, however, notes, “It did not define ‘reasonable costs.’”
“It’s fine for Roche to say ‘withdraw and replace,’ but there may not be much else at hand to substitute,” in many places, Rago told the Times. “This is not just about Europe.”
Health advocates from around the world are confirming Rago’s claims:
In some places, newer substitutes are not available to patients, either because they are not licensed or are much more expensive, said people with H.I.V. and international health experts. In Panama, for example, a substitute drug, Kaletra, costs three times as much as Viracept.
“Roche has provided information, but there has been much less support in terms of who is going to pay the additional cost,” said Dr. César Nuñez, the United Nations AIDS program’s coordinator for Latin America, who is based in Panama. [...]
In Venezuela, 3,000 people were on Viracept, paid for by the national health service, and the effect of the recall was “severe,” because many had no other options, said Edgar Carrasco, an advocate on issues relating to AIDS in Caracas.
Alberto Nieve, another advocate, said Roche had promised to make a donation of another medicine. “Most people are still waiting,” he said. “They have not switched yet, especially outside Caracas.” [...]
Tido Von Schoen-Angerer, director of the essential medicines campaign at Doctors Without Borders, said about half of the 400 patients who received therapy supplied by the group in Africa were on Viracept. The alternate from Abbott is not yet available, he said.
According to a recent UN report, HIV/AIDS is having a greater effect on women in developing countries than men. Young women, for example, are three times more likely to be infected as men in sub-Saharan Africa. Yet, the report notes, “women know less than men about how HIV/AIDS is transmitted and how to prevent infection, and what little they do know is often rendered useless by the discrimination and violence they face.”