Friday, December 03, 2010

“Pre-Exposure Prophylaxis”: Big Pharma's Latest AIDS Drug Marketing Strategy


Copyright © 2010 by Mark Gabrish Conlan for Zenger's Newsmagazine * All rights reserved

“Pill Is Found to Cut Risk of HIV,” read a headline in the November 23 Los Angeles Times that reported on a study in the New England Journal of Medicine that claimed giving an anti-HIV medication called Truvada (actually a pill containing two drugs, emtricitabine and tenofovir), reduced the risk of so-called “HIV transmission” between Gay men leading “high-risk” sexual lifestyles. The study, conducted by an international team headed by Dr. Robert M. Grant of the Gladstone Institute of Virology and Immunology at UC San Francisco and Dr. Javier R. Lama of Investigaciones Medicas en Salud in Lima, Peru, enrolled 2,499 Gay men and male-to-female Transgender people and gave half of them a once-a-day dose of Truvada and half of them a harmless placebo.

The results, observed over 14 months, were that 36 people in the Truvada group “seroconverted” – went from testing HIV antibody-negative to antibody-positive – versus 64 in the control group. The Los Angeles Times article noted that the difference between 36 and 64 was 43.8 percent, and that “the reduction in risk … was very sensitive to how regularly the subjects took the medication.” For those who took their daily dose more than 50 percent of the time, the article reported, the seroconversion rate fell by 50.2 percent. For those who took the drug more than 90 percent of the time, the rate fell by 72.8 percent.

Notice that the Times report was framed in a way that completely ignored another fact shown by those numbers: how unlikely it is, even for Gay and Transgender people picked specifically for their “high-risk” sexual practices and therefore their vulnerability to sexually transmitted diseases, to become “HIV positive” in the first place. Of the total number of people in the study, just 100 seroconverted – 4 percent. Assuming that both the Truvada and the control group were of equal size, which is the standard practice, the conversion rate among the people taking the drug was 2.9 percent and among the people on placebo was 5.1 percent.

For decades sexually active Gay men have been fed a steady diet of propaganda about how supposedly easy it is to get HIV – to the point where it's backfired, convincing a lot of people that it doesn't pay to use condoms or otherwise reduce sexual risks because seroconversion isn't a matter of “if,” but “when” – yet here is hard evidence from an establishment source of just how difficult it is to become “HIV positive” from sex. But that isn't stopping the AIDS establishment from declaring yet another “victory.”

The initial Los Angeles Times report was followed up by two additional articles. The first came out November 24, the day after the initial piece, and was by the same author, science reporter Thomas Maugh II. It was called “Anti-HIV Pill's Trial Success Rekindles Hope” and quoted researcher Grant as saying that they had “tried all the easy things” to prevent HIV seroconversion, and now, “We had to embolden ourselves to consider something like a pill a day, even though it is expensive and requires medical monitoring.” When he said the pills were expensive, he wasn't kidding; later in the article Maugh reported that Truvada costs $7,000 to $10,000 per year, and like most anti-HIV medications it's not available in a cheaper generic form. What's more, Maugh reported, it probably won't be covered by health insurance because Truvada is currently approved only for anti-HIV treatment, not prevention – and a lot of people might not want the drug anyway because it will mean “outing” themselves in their medical records as Gay men leading “high-risk” sexual lifestyles.

A third Times story, a November 29 op-ed by International AIDS Vaccine Initiative CEO Seth Berkley, both added to the myth-making and offered some fascinating clues as to why the long talked-about strategy of “pre-exposure prophylaxis” – giving anti-HIV drugs to HIV antibody-negative people in hopes of keeping them from seroconverting – is suddenly being pushed now, 17 years after it was first broached at the 1993 international AIDS conference in Berlin. “Thanks largely to AIDS activists who demanded expedited research and approvals, today there are more drugs licensed to treat HIV than there are for all other viruses combined,” Berkley wrote. “Generous donors and innovative pricing mechanisms have made these antiretroviral drugs available to about 36 percent of those in the developing world who [allegedly] need them to stay alive and healthy.”

But even with those so-called “innovative pricing mechanisms” – basically discounts that reduce the drug companies' profits on them from obscene to merely swollen – it's getting harder for the AIDS establishment to persuade governments, international agencies and private donors to keep coming up with the huge levels of funding needed to buy anti-HIV medications for all the people the establishment says “need” them. According to Berkley, this year the Global Fund to Fight AIDS, Tuberculosis and Malaria committed $12 billion to buy these drugs – “$1 billion less than the minimum amount … needed.” In the face of a global economic downturn and the election victories of austerity-minded Right-wing parties in the U.S. and western Europe's three largest countries – Britain, France and Germany – Berkley and other AIDS establishmentarians worry that donors won't “continue making the enormous investment required to provide access to treatment to all those living with HIV” without “reasonable assurance that one day the bill will be paid in full. This will require having ways to reliably prevent new infections.”

Throughout its quarter-century existence, the AIDS establishment's number one priority has been the development, merchandising and selling of high-priced anti-HIV “treatments.” In the 1980's drug companies were actually unwilling to invest money in creating and marketing AIDS drugs because they didn't think there'd ever be enough people with full-blown AIDS to make them profitable. That changed in 1989, when the Burroughs-Wellcome company (now part of GlaxoSmithKline) got its first anti-AIDS drug, AZT, approved by the U.S. Food and Drug Administration (FDA) not only for people actually sick from AIDS but for otherwise completely healthy people who tested “HIV positive.” The market for AIDS drugs zoomed upward – though the high toxicity of AZT and other early AIDS drugs killed off a lot of their customers – and it zoomed up again after 1996, when doses of AZT and other first-generation drugs were reduced and they were combined with protease inhibitors and other sorts of drugs that were less toxic.

But the markets for anti-HIV medications in the U.S. and other developed countries started flatlining in the late 1990's, as fewer Gay and Bisexual men took the HIV antibody test – the gateway to being declared “sick” and in need of such “treatment” – and as fewer of them died of AIDS. AIDS moved from epidemic to endemic, and in the process many Gay and Bisexual men either lost their fear of it or, in the case of young people just entering sexual activity, never got deathly afraid of AIDS in the first place. The AIDS establishment needed new markets for their drugs, and they found them first among people of color in the developed countries, then among people of color in their home countries. The U.N. AIDS program obediently created mountains out of molehills of statistical data to proclaim that Africa, and later Asia, were inundated with “HIV positive” people who didn't know it and this threatened the very survival of countries in those regions.

Since these nations and their people didn't have the money to pay for anti-HIV drugs themselves, the AIDS establishment started a campaign of shaming the people who did – governments and rich people in developed countries – to cover the cost. “Helping” the Third World by providing their people anti-HIV drugs (for medical conditions that could have been addressed far more effectively through clean water, sanitation, adequate diet and simple antibiotics and other drugs to use against genuine health threats like malaria and TB) became a personal charitable priority of the two richest men in the world, Bill Gates and Warren Buffett, as well as plenty of politicians and officials in non-governmental organizations (NGO's) looking at what sorts of health-care projects to fund in the less-developed world. But, as Berkley admitted in his article, the recession is drying up that gravy train and forcing the drug companies to turn away from the Third World and look again for customers who actually have money.

Hence the turn towards “pre-exposure prophylaxis” that can be sold to Gay men in developed countries as a way of not needing to worry about AIDS – even though that will mean condemning themselves to a lifetime of medical monitoring and will essentially redefine being Gay itself as a “disease” needing “treatment.” It will also mean confronting the adverse (so-called “side”) effects of these drugs, including nausea, serum creatinine increases (which in the normal medical world is often a sign of kidney failure) and “unintentional weight loss.” (A little-noticed paper read at the 2004 international AIDS conference in Barcelona said that the number one cause of death among people diagnosed “HIV positive” today is liver failure from the toxicities of anti-HIV drugs.) Quite a few much-ballyhooed AIDS drug regimens in the past have turned out to have had devastating “side” effects that weren't discovered until well after the drugs were mass-marketed because the AIDS establishment has a way of stopping their trials early before all the adverse effects are known – though, to their credit, Grant and Lama are keeping their study going for another 18 months to assess long-term risks.

My thought is that not very many developed-world Gay men are going to fall for the lure of “pre-exposure prophylaxis.” Had this been announced 15 or even 10 years ago, while the AIDS scare was at its height, Gay men might have rushed to their doctors and asked to be prescribed these regimens. Now that AIDS has long since ceased to be either a consuming emotional issue in the Queer community or a particularly trendy charity – the “in” cause among Queer philanthropists and organizations right now is reaching out to Queer teenagers and keeping them from committing suicide or ending up homeless – it's likely that the thought of spending thousands of dollars on anti-HIV drugs before you've even seroconverted is going to go over like a family-planning convention inside Vatican City. But I've been proven wrong before about the AIDS establishment and its ability to make money and maintain prestige despite the patent absurdity of most of their “science” and their inability to deliver either a “cure” or a workable “vaccine” against an elusive “virus” that doesn't behave anything like an ordinary sexually transmitted microbe.