John Solomon of Associated Press has published a horrifying report that the United States was sending drugs for AIDS patients to Africa when it knew that the drug was flawed and potentially lethal. This is very similar to the approach the FDA and Merck took with Vioxx (also sold as Ceoxx in some countries). Both the FDA and the drug manufacturer seem to have hidden facts related to Vioxx and the drug was withdrawn only after tens of thousands are either dead or seriously injured. (Related article: Vioxx recall scandal calls for fundamental changes in drug approval process)
Nevirapine, an AIDS drug (pronounced Nee-VERA-peen), is made by Boehringer Ingelheim Corp. and is marketed under the brand name Viramune. There are two generic versions, Nevimune, made by Cipla, and Nevirex, made by Aurobindo Pharma. The drug has also been used in the US since the 1990s to treat adult AIDS patients and is known to have potentially lethal effects like liver damage and severe rashes when taken over time.
According to documents obtained by The Associated Press, the National Institutes of Health in the United States, the government's premier health research agency, chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of nevirapine in Africa as a cheap solution. The data, from a flawed study in Uganda, raise significant safety questions about a relatively easy and inexpensive way to prevent mother-to-child (MTC) transmission of the HIV. The regimen has been widely used in the developing world to prevent HIV infections in newborns.
The AIDS Healthcare Foundation (AHF), the largest AIDS organization in the United States which operates free AIDS treatment clinics in the US, Africa, Central America and India, is calling upon the US government to create a new, independent blue ribbon commission or panel to review all drug research.
"The FDA and NIH are clearly letting the American public -- and the world at large -- down with regard to their so-called roles as regulatory bodies overseeing the safety and efficacy of our drug supply," said Michael Weinstein, AIDS Healthcare Foundation president. "From Vioxx to the flu vaccine, we've recently seen the deadly consequences of not having truly independent voices in the approval, licensing and regulation of our nation's drugs. The system is riddled with conflict of interest and needs to be fixed. The creation of a new independent body to review all drug industry research would be a good first step."
"More than 90 percent of researchers and scientists working at the NIH also receive some form of drug industry money," added AHF's Weinstein. "The fox really is watching the henhouse, and as a result, the credibility of these agencies is shot and the public's trust has been squandered."
"With regard to MTC transmission and nevirapine, we believe the best course is to treat the entire family unit, mother and child," said Dr. Charles Farthing, AHF's Chief of Medicine. "There are ethical issues that arise if one tries to prevent HIV infection in a newborn, yet lets the mother go untreated and die. Who then cares for this HIV-negative child?"
"We also have grave concerns about the possibility that people in resource-poor countries around the world may be participating in studies and research treatments that the drug companies might not undertake here in the US and that should cease," added AHF's Weinstein. "However, more and more people in Africa and the developing world are living now because they are beginning to have access to such life-saving AIDS drugs, and these setbacks with the FDA and NIH should be no excuse to slow the process of rolling out proven treatments. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust and one which the world can look to."
Viramune® (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principle clinical trial that demonstrated prolonged suppression of HIV-RNA and on two smaller supportive studies. Boehringer Ingelheim, the drug's manufacturer, does not intend to seek FDA approval.
On the other hand, the company is applying for approval of another drug in the category, Tipranavir, which is a non-peptidic protease inhibitor (NPPI) for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients who are protease inhibitor experienced. The application for approval is supported by data from Phase II and Phase III studies of tipranavir boosted with low-dose ritonavir (tipranavir/r) in more than 2,500 patients worldwide.
Recommended article: Why Merck did not recall Vioxx?