Consensus Statement in Opposition to Licensure of Remune As Monotherapy for HIV Infection in Thailand
"Without a large burden for past research and development ... and based on a minimum gross profit of $75 per dose of Remune sold ... gross profit potential could rise to $35 million [a year] or higher."
-- James S. Namnath
Chief Executive Officer, Trinity Medical Group
(Source: SEC form 10KSB, 3/18/2002)
We wish to express our strong concern about pending plans for the so-called Remune HIV vaccine to be sold as a drug to combat HIV infection in Thailand. Remune is an inactivated HIV preparation that was developed by the Immune Response Corporation originally of Carlsbad, CA. The company's original plan for Remune was that it should be a vaccine to prevent HIV infection, a role for which it is ill-suited, and for which it has yet to demonstrate any form of efficacy. In recent years, Remune has been evaluated extensively in the U.S. and Europe as a therapeutic vaccine, initially by itself; more recently as an adjunct therapy in people receiving combinations of approved antiretroviral drugs. There is no scientific evidence to support the use of Remune as monotherapy; it does not work, and it is unlikely ever to be licensed by the U.S. FDA for this purpose in the U.S. Studies in both the U.S. and Europe are in progress to determine whether Remune might have some role as an adjunct therapy, but the available data are ambiguous at best, and controversial at worst.
Remune has been licensed by the Immune Response Corporation to the Trinity Medical Group, a Thailand-based company, for development within Thailand. Clinical trials of Remune are ongoing in Thailand, in part conducted by a leading official in the Trinity Medical group who is also an influential figure in the Thai medical/business community. A recent decision was made by Trinity Medical Group to have Remune evaluated by the Thai FDA as a drug, not as a vaccine, a decision that is ill-founded in science but which has been perceived as providing the company with an easier route to licensure. The practices that have led to the now-pending licensure of Remune in Thailand would not be permitted in the U.S., due to procedural breaches. The problems appear to include, but may not be limited to, inattention to conflict-of-interest regulations that should apply to the conduct of clinical trials by a product's sponsor.
It now appears that Remune will be licensed as a drug for use in Thailand as front-line monotherapy (i.e., the drug will be sold to HIV-infected Thai people to be used as the only therapy they are taking against HIV), despite the lack of any evidence of clinical benefit. We deplore and condemn this situation. A product developed by an American biotechnology company should not be sold to HIV-infected people in the developing world unless it has been proven to be safe and effective in the population for which the product is to be marketed, in studies which meet U.S. ethical and regulatory standards. Studies of HIV vaccine products may need to be conducted in different populations depending on the viral strains on which they were based, and taking into account the hypothesis being studied in the particular vaccine trial). That situation does not apply to Remune in this case. Indeed, all the available scientific evidence strongly suggests that Remune has no effect on the course of HIV disease when used as monotherapy. It is morally unacceptable for an American company and its Thai subsidiary to profit in any way from the sales of an ineffective drug. The sums of money spent by Thai citizens on this product will be wasted; instead, the treatment priorities in Thailand should be the provision of highly active antiretroviral therapy (HAART) and of treatment and prophylaxis for opportunistic infections and tuberculosis.
There is an urgent need for the countries of the Western world to bring effective HIV therapies to the nations of the developing world. These efforts will be compromised if American companies behave other than ethically in attempting to sell their products. The sale of an ineffective drug in Thailand could have serious, long-term and widespread adverse implications for the reputations of Western science and industry. We therefore demand that the Immune Response Corporation and its local affiliate cancel all their attempts to make money from sales of Remune in Thailand, unless and until they develop clear evidence from properly-performed, well-controlled clinical trials that Remune preserves health or prolongs life among HIV-infected individuals when it is used, as is now proposed, as the sole modality.
Global Strategies for HIV Prevention
Critical Path AIDS Project
AIDS Action Baltimore
National Association of People with AIDS
Gay Men's Health Crisis
University of Minnesota
Treatment Action Group
Soweto, South Africa