Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Wall Street Journal - November 10, 2004
Jeanne Whalen at jeanne.whalen@wsj.com and Leila Abboud at leila.abboud@wsj.com
Ranbaxy Laboratories Ltd. voluntarily withdrew its seven HIV medicines after finding "discrepancies" in laboratory documentation about the drugs' equivalence to the original medicines, the Geneva-based WHO said in a statement. The drugs, however, have not been pulled off the market. Ranbaxy is conducting new studies of the drug combinations, and plans to resubmit them for WHO approval, the agency said. Ranbaxy officials were unavailable for comment yesterday.
Andre van Zyl, a project manager at WHO, said the Ranbaxy withdrawal doesn't necessarily mean the drugs are unsafe or ineffective. But WHO is recommending that patients suspend use of the treatments if WHO-approved alternatives are available. If none are available, patients should stick with the Ranbaxy treatments, "as the risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven," the agency said in its statement. At least half of the 54 HIV drugs remaining on the WHO list are generics, Mr. van Zyl says.
The drugs and drug cocktails made by Ranbaxy and their equivalent brand name are: indinavir, which Merck & Co. markets as Crixivan; lamivudine, which GlaxoSmithKline sells as Epivir; lamivudine/stavudine in 30 and 40 milligram tablets, which is a combination of Glaxo's Epivir and Zerit, which is made by Bristol-Myers Squibb; nevirapine, sold by Boerhinger Ingelheim Pharmaceuticals Inc. as Viramune; stavudine, sold as Zerit; zidovudine, which GlaxoSmithKline sells as AZT and Retrovir.
The WHO is aiming to get three million people in the developing world to take HIV drugs, known as antiretrovirals, by 2005. Over 40 million people world-wide are infected with the AIDS virus. It was unclear how many patients could be affected by Ranbaxy's drug withdrawal, WHO says.
As part of the WHO effort, the agency has compiled a list of "prequalified" medicines it deems to be of good quality. Big purchasers of HIV drugs for the developing world, including the United Nations and nongovernmental organizations such as Doctors Without Borders, consult the WHO list before buying treatments. The list also includes drugs to fight tuberculosis and malaria.
Ranbaxy's withdrawal follows the WHO's removal in August of three other generic antiretrovirals made by Ranbaxy and two made by Cipla Ltd. WHO delisted the medicines after inspecting the laboratories where studies had been carried out to prove the treatments were equivalent to patented medicines.
The WHO found discrepancies between lab data examined during the inspections and lab data that the companies had previously submitted to the WHO to prove equivalency. The agency also found that the labs didn't meet certain international standards of clinical practice.
At the time, Ranbaxy said it was conducting new studies on the three treatments to show they were equivalent to branded drugs. It added that the drugs met "all required quality standards." Ranbaxy discovered data discrepancies of its seven other drugs when it decided to inspect all of its labs after the withdrawal of the three other drugs.
Generic HIV drugs made by Ranbaxy and other manufacturers aren't sold in the U.S. because they violate the patents of big drug makers. The Bush administration's position has been that these generics haven't been adequately proven safe and effective and so far Washington has refused to buy such generics for its five-year, $15 billion global AIDS fund.
This leaves the fund paying far more for AIDS drugs and therefore treating fewer sick people than it would if it followed the WHO practice of buying generics. The U.S. has said it will buy such generics only if drugs' makers submit to a new Food and Drug Administration application process to show equivalence to branded originals.
The WHO and other public-health groups say the availability of low-cost generic drugs is vital to treating HIV infection in poorer nations. Mr. van Zyl said the withdrawal of the Ranbaxy products could raise the cost of providing drugs to patients in Africa and Asia, but probably not substantially, as there are plenty of generic alternatives to the Ranbaxy products.
Ranbaxy's annual report says the company's HIV drug business had "robust growth" in 2003 but doesn't specify what portion of Ranbaxy's total sales of $972 million such drugs represented.
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