Gilead’s Greedy Gamble
By AIDS Healthcare Foundation
04/06/2011
Los Angeles, California
Gilead Sciences will soon apply to the Food and Drug Administration (FDA) for approval to market its HIV chemo-therapy Truvada to HIV negative gay men. Truvada is currently only approved for use in HIV+ patients. However, it can be prescribed off-label to HIV negative patients by any doctor who feels that their patient is at high risk of contracting HIV.
The multi-billion dollar profit that Gilead is currently making on Truvada is not enough for them. Bloomberg has estimated that Gilead would add $1 billion in revenue if the FDA approves Truvada for use in HIV negatives. One billion dollars is more than the entire US government budget for HIV prevention.
Gilead is basing its application on a single study that found that it reduced infection by only 44%. What medication is approved based on only a 44% success rate? That means that 56% of the gay men who participated in the study were not protected.
The study itself is not reflective of the real world. The study participants were paid; they went to the doctor monthly and were tested for STDs and HIV monthly; they were individually intensively counseled to take their medication; the US participants were only drawn from San Francisco and Boston; and the overwhelming majority of study participants in the US were white and educated. Nevertheless, when their blood was tested, 51% of them had no Truvada in their system at all – they weren’t taking the medication.
Gilead intends to charge $10,000 a year for the drug as a preventative. It is highly unlikely that government programs will pay for it. There are already 7,000 HIV infected patients on waiting lists nationwide who do not have access to medication. So only the wealthy and insured would have access.
About 26,000 gay men are infected with HIV every year in the United States. More than half of these are the result of men who are positive but don’t know it. If the majority of gay men were not currently practicing safer sex most of the time these numbers would be much higher.
If we tell gay men that there is a magic pill that will protect them, fewer of them will use condoms and more of them will become infected. Gilead is irresponsibly seeking more profits based on a single study with dubious results. We respectfully urge them to hold-off in applying to the FDA to use Truvada for prevention until extensive studies in real-life situations, with diverse populations have been completed.
The first obligation of healthcare providers is to do no harm. Gilead is playing a very dangerous game.
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