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French African Study Offers Critical Challenge to Generics Obstructionists

Railing Against Randall Tobias

As if there were ever any legitimate doubt, it is now official: the three-in-one generic HAART pill (“Triomune,” manufactured in India by the huge generic outfit Cipla) has proved just as safe and effective as its branded components: nevirapine, d4T, 3TC. Results of the six-month study, ANRS 1274, were published in the July 3 issue of the journal Lancet, just in time for release at the international AIDS conference in Bangkok, July 11-16.

Results of the six-month study reported that viral load drops (the study’s primary endpoint) and CD4 rises among the 60 Cameroonian volunteers were equivalent to those expected with the branded products: median viral load change at 24 weeks was -3.1 log copies/mL with 80% of people showing viral loads below the limit of detection (400 copies/mL). CD4 cell counts rose from a baseline median of 118 to 201. There are, however, two key differences: the generic 3-in-1 costs a mere $20 a month; also, since there are no dueling Big Pharma marketing departments to contend with, all three drugs (of BMS, GSK and Roxane/BI) can be combined in a single pill instead of three separate ones. Perhaps it should come as little surprise, then, that adherence rates for the trial logged it at an incredible, if self-reported, 99%. (Of course, the people enrolled in the study were characterized as having advanced HIV disease, and regimen adherence is often best among those with symptomatic infection.)

But just when it would seem all spurious quality assurance concerns could be laid to rest, advocates for brand name meds criticized the joint French-Cameroon study for its short duration (six months) and lack of a control group. Eric Delaporte, lead author of the paper, doesn’t see it that way. “Thanks to these results,” he said in a July 1 press release, “it is no longer credible to cast scientific doubt on the large-scale use of these fixed dose generic ARVs.” So far as adherence is a factor in the long-term sustainability of viral control, long-term follow-up is likely to show the generic three-in-one combination regimen superior to its separate and branded counterparts. After all, who wouldn’t find it easier to pop two pills a day rather than six?

Rachel Cohen, of Médecins Sans Frontières, one of several co-sponsors of the study, was quick to mock the disingenuous caution on the part of the generics’ detractors. “A controlled study was not necessary,” she told veteran Wall Street Journal AIDS reporter Marilyn Chase. “The [generic fixed-dose combination] regimen was already proved safe and efficacious through the WHO pre-qualification program.”

Not surprisingly, the Bush administration has spearheaded the effort to sideline WHO’s pre-qualification of generics ARVs. Since the release of George W’s Emergency Plan for AIDS Relief, the U.S. global AIDS coordinator and former C.E.O. of Eli Lilly, Randall Tobias, and other Bush administration officials have made public remarks that question the quality of generic antiretroviral drugs and undermine international quality standards set by the World Health Organization.

In March, the Bush administration informed the first organizations to receive money from its Emergency AIDS plan that they could not spend the funds on foreign-made generic drugs until those drugs undergo further evaluation — even though they have been tested and approved (“pre-qualified”) by WHO, which uses the same standards as the FDA.

In the meantime, these groups would be forced to buy the much more costly U.S.-made, name-brand drugs. Which means that many people with HIV/AIDS in the developing world will have to wait longer to initiate antiretroviral therapy — until either the Bush administration approves the use of generic drugs or it allocates more money so they can afford the pricier brand-name ones. UCSF’s Dr. David Bangsberg portrayed the situation to National Public Radio as a “choice between generic therapy and no therapy.” Meantime, MSF’s Essential Medicines Campaign director, Ellen ‘t Hoen, blasted the Bush administration’s hypocrisy in a strongly worded letter in April:

“There is no medical or scientific basis for the Bush administration’s attacks against WHO prequalified medicines, and the United States is isolated in its view that WHO-prequalification standards are not sufficient. We call upon the United States to join the international consensus by allowing its grantees to procure quality generics, including fixed-dose combinations, and by supporting the WHO prequalification project. We cannot stress enough how disruptive it will be if the United States fails to do so.”

“The only possible explanation we can imagine,” she adds, “for the Bush administration’s current position on procurement of quality-assured generic medicines is that it is more interested in protecting the interests of the pharmaceutical industry than it is in expanding antiretroviral treatment to the largest possible number of people. We would like to be proven wrong.”

The fixed-dose generics equivalency study was conducted at two hospitals in Yaoundé, Cameroon, by Drs. Eric Delaporte and Christine Laurent of the University of Montpellier (France) and collaborators at the Agence National de Recherches sur le Sida (ANRS), Doctors without Borders (MSF) in Switzerland, and the University Hospital Center of University Bichat Claude Bernard in Paris. African collaborators included the Pasteur Center of Yaoundé, the Yaoundé Mobile Laboratory of Health and Hygiene, and the National AIDS Program of Cameroon.

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