Will Gay Men Be Forced to Take Drugs for Pseudo AIDS Prevention?

A suspiciously-timed report. Expensive drug. False impression of efficacy. High risk of adverse effects. And it's aimed at all homosexual men.

by Heidi Stevenson

10 December 2010

A study report is timed to give an impression of an expensive drug's efficacy that likely doesn't exist. The risks of known adverse effect are minimized. The target of the tested drug is all homosexual men to sell a drug as prophylaxis against HIV-AIDS. It looks like the entire gay male population is being targeted by Big Pharma.

A Bill and Melinda Gates Foundation funded study claims that an HIV drug can provide 44% extra protection against contracting HIV in men who also received a package of prevention services. The cost of the drug is $13,140 per year.

Either this is intended for use only by the few who could afford it, or the goal is to have it paid by government agencies—which means you and me. Since a trial like this won't be funded unless there's an expectation that funding will be made available—and the Gates Foundation is certainly savvy enough to have a plan for funding—so there must be anticipation that the cost will be covered by government.

If funding is expected, then is the goal simply to provide the drug to those who want it? That is unlikely, especially in light of the severe adverse effects involved.

The Drug(s) and the Trial

The drug trialed, Truvada, is actually a combination of two existing HIV-AIDS drugs, Emtriva (emtricitabine) and Viread (tenofovir). Even singly, these drugs carry extremely severe adverse effects. Combining drugs is notorious for increasing bad effects.

The study, published in the New England Journal of Medicine,⁽¹⁾ is the first report of an ongoing trial. It was started on 10 July 2007, and the study reports through 17 December 2009, with subjects enlisted throughout this time. The authors refer to a total of 3,324 person-years, which is the total of the amount of time each person spent in the study. The average time in the study of the 2,499 subjects was 1.33 years.

Results

It's interesting to note that the authors seem to be evasive in their reporting of results. They state that there's an improved efficacy with Truvada of 44% over those given placebos. While that sounds impressive, in the overall picture, the result is far less impressive. About 4.4% (110) of the total number of subjects (2499) developed HIV, 38 who received Truvada, and 72 who received placebo. About 5.7% (72) of the placebo group were diagnosed with HIV, and 3.0% (38) of the treated group were. That indicates a 2.7% improvement in odds of getting HIV, not the 4.4% presented by the study.

Trial Trend

The full picture, though, is not yet known—and it's also quite clear why results are being reported at this particular point in the trial. The trend lines between the two groups, those who received Truvada and those who received placebo, clearly appear to be converging, as shown in the graph above. At about week 72, the gap between treated and untreated groups was about 1.5% different. The gap widens until about week 100, when it reaches about 4.25%. Then it narrows, until it has returned to 1.5% by week 132, the same difference as week 72.⁽²⁾

A fully honest representation of the data would have charted the results based on the length of time each participant had been in the trial. That might demonstrate how long an effect the drug has. The use of person years is a means of obfuscating the results by treating each year of treatment as if they were equivalent.

It's no surprise that the authors reported on results at this point, though the subjects were enrolled for the entire length of the reporting period, since the trend is clearly towards the difference disappearing, even after only a couple of years. Of course, there is no mention of this in the article.

So, what we have is a carefully crafted study clearly designed to produce results that give the impression of a drug's benefit, and a report produced just before it appears that the results are demonstrating a lack of efficacy.

Adverse Effects

The drugs from which Truvada is made, Emtriva and Viread, cause severe adverse effects, especially to the liver and kidneys. Such negative effects tend to be cumulative; that is, they are the result of an ongoing harmful effect, usually not because of a short-term assault. This study's report comes at an early stage, when the harmful effects of the drugs would not often be seen.

Nonetheless, the authors noted an increase in creatinine levels, which indicate overstressed or damaged kidneys and possible systemic harm in the form of muscle breakdown. As it turns out, the rate of elevated creatinine in the treated group was nearly double that of the placebo group: 28 (2.2%) versus 15 (1.2%) While that may seem minor, this is a number that can be expected to increase significantly with time. In a situation in which long term treatment is the goal, this can be highly significant.

What's the Purpose of Such a Trial?

An expensive drug that's a combination of two highly toxic drugs is being trialed as a potential prophylactic for HIV-AIDS. There's a great deal of fear surrounding this diagnosis. The trial itself, on close examination, demonstrates that the long term efficacy for the stated purpose seems to be, at best, limited, and the long term risks are severe. The timing of reporting the results is suspicious in light of the converging of the probability lines of the treated and placebo groups. So, what's the real purpose?

Homosexual men have been targeted by Big Pharma since the beginning of the AIDS diagnosis. This trial, with its suspicious timing of results reporting and the media hype engendered, appears to be part of a campaign to bring gay men even deeper into the maw of Big Pharma. Not only are they to be treated with highly dangerous drugs of questionable efficacy, they may soon be pressed into accepting prophylaxis with a combination of those same drugs.

Women have been turned into Big Pharma profit centers by redefining menopause as a disease. Children are being diagnosed with ever more nonexistent mental disorders, such as Opposition Defiance, for the purpose of drugging them. Many, perhaps most, healthy men have been turned into profit centers by defining certain blood traits as predisease states.

So, it should come as no surprise that homosexual men are now being targeted for prophylactic treatment with dangerous drugs. This is Big Pharma reaching ever deeper into the people's pockets by fear mongering, pseudo-science, and hiding the immense harm their unneeded products produce.

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