HIV/AIDS Skepticism

Pointing to evidence that HIV is not the necessary and sufficient cause of AIDS

ANTIRETROVIRAL DRUGS: HISTORY AND RHETORIC

Posted by Henry Bauer on 2007/12/12

The previous post (BEST TREATMENT…, 10 December) mentioned these aspects of the official Treatment Guidelines:
—They change incessantly.
—The recommendations are based more on opinion than on scientific evidence.
—The available evidence is overwhelmingly about surrogate markers rather than patient health.
—The recommendations are so complex and change so often that physicians must suffer constant dilemmas over how to advise their patients.
Several further posts will examine aspects of these Guidelines in more detail, in particular, “side” effects of the drugs and conflicts of interest among those who draw up the Guidelines. First, however, a quick look back at how and why antiretroviral treatment began.

* * * * * *

Wainberg, in his single-minded lauding of “lifesaving” antiretrovirals (WAINBERG’S HAMMER, 5 December), suggested that “Many people had forgotten” what went on in the early days of AIDS. Wainberg himself seems to have forgotten the genesis and rationale of antiretroviral treatment.

In the early 1980s, small clusters of people were coming down, it seemed suddenly, with otherwise rare opportunistic infections, predominantly fungal ones; and death was following within months. There were two obvious possibilities as to cause: either some shared environmental exposure, activity, or lifestyle; or perhaps a previously unknown infectious agent.

The question was effectively settled by fiat rather than freely attained scientific consensus with the official announcement by the Secretary of Health and Human Services that HIV (then called HTLV-III) was the probable cause. Since that came from the prime source of research funds, those seeking grant support naturally framed their proposals in that vein. The immediate goal became to find an HIV-killer. A desperate rummage among all conceivable chemicals turned up AZT, a twenty-year old candidate for cancer chemotherapy that had never been used because it is too toxic. AZT seemed effective against HIV in the test-tube and, in brief trials, AIDS patients appeared to survive for several months on AZT treatment. Given that the prognosis for a person newly diagnosed with AIDS was death within months, an apparent extension of a few months was regarded as worthwhile. Moreover, activists were clamoring for rapid approval of anything that offered some hope, so AZT was approved without the evidence of “safety and efficacy” that was normally demanded before drugs were allowed into general use.

The situation nowadays is entirely different. Although HIV is still regarded as the agent causing AIDS, the official belief holds that there is an average period of about 10 years between infection with HIV and the first appearance of symptoms of illness. This is very different than expected death within months, and should–but apparently has not–set a very different basis for weighing possible benefits of treatment against the known risks from drug toxicity.

In point of fact, the official treatment guidelines of October 2006, introduced in the previous post (10 December), make abundantly clear the high risk of serious, indeed often fatal “side” effects of antiretroviral treatment. The risks and possible benefits are summarized in this way in the Introduction to those Guidelines (p. 10):

Potential Benefits of Deferred Therapy include:
—avoidance of treatment-related negative effects on quality of life and drug-related toxicities;
—preservation of treatment options;
—delay in development of drug resistance if there is incomplete viral suppression;
—more time for the patient to have a greater understanding of treatment demands;
—decreased total time on medication with reduced chance of treatment fatigue; and
—more time for the development of more potent, less toxic, and better studied combinations of antiretrovirals.
Potential Risks of Deferred Therapy include:
— the possibility that damage to the immune system, which might otherwise be salvaged by earlier therapy, is irreversible;
—the increased possibility of progression to AIDS; and
—the increased risk for HIV transmission to others during a longer untreated period.

A conspiracy theorist might wonder why this useful summary has been shifted in the December 2007 revision of the Guidelines to an inconspicuous place following Table 5 at the bottom of p. 58. Was it perhaps realized that having it up front is too unintentionally revealing of the grave and common risks associated with these drugs?

An analyst of rhetoric might point to a choice of words designed to play down the risks. Since the drugs supposedly do something good, the only reason not to use them is because of their harmful “side” effects; so “Potential benefits of deferred therapy” is a euphemism for “Treatment-associated risks”. Furthermore, those risks are spoken of in a rather masked way–“negative effects” on quality of life, “drug-related toxicities” instead of simply “drug toxicities”. The revealing need for “less toxic” drugs is inserted between the two hoped-for benefits of “more potent” and “better studied”. “Treatment demands” and “treatment fatigue” are euphemisms for the fact that a large proportion of patients find the “side” effects of antiretroviral treatment intolerable.

(Another common euphemism in mainstream discourse about antiretroviral drugs is “HIV lipodystrophy” or “HIV-associated lipodystrophy” for the dysfunctional distribution of body fat occasioned particularly by protease inhibitors. The drugs, not the HIV, are responsible for the lipodystrophy, but the terms in quotes are designed to give the opposite impression.)

In any case, the question nowadays is–or should be–whether the acknowledged, well known toxicity of all antiretroviral drugs calls for their use when people are not yet ill. It is highly pertinent here that the consensus in the United States asserts that “illness” warranting antiretroviral drugs can be diagnosed purely on the basis of laboratory tests, for example, CD4 cell counts below 200 (not to mention the HIV test itself!–see HIV TESTS: DANGER TO LIFE AND LIBERTY, 16 Nov ), whereas the consensus elsewhere, for instance in Canada, does not accept this as a conclusive marker of AIDS-illness.

A further, important datum not mentioned in these Treatment Guidelines is the fact that large numbers of HIV-positive people have lived healthy lives for a couple of decades or more without antiretroviral treatment. That was not known in the early days when an AIDS diagnosis presaged early death, and when HIV was first suggested as the culprit.

We cannot know, of course, how many HIV-positive people are quietly living healthy lives. People are rarely tested for HIV unless they are in high-risk groups or need medical attention for some reason. Official estimates that about one quarter or one third of HIV-positives don’t know their status implies that many of them suffer no ill effects from that condition–after all, about 1 million Americans have supposedly been HIV-positive steadily since the mid-1980s. The “long-term non-progressors” or “elite controllers” acknowledged in mainstream discourse have been estimated to number in the thousands, but this is surely an under-estimate because, again, only people with known risks tend to be tested; so these thousands represent chiefly high-risk non-progressors or controllers; there are likely to be a larger proportion of such people in low-risk groups. In addition and not usually acknowledged in mainstream discourse are those HIV-positive people who have eschewed treatment by their own decision; though many of them have joined in support groups, there is no reliable way to estimate their numbers, but it is certainly in the thousands.
************
Drugs too toxic for cancer chemotherapy were approved for use at a time when a few months of extra life seemed a worthy objective. Infection by HIV is believed to produce no serious symptoms for an average of 10 years. Where is the rationale for feeding highly toxic medications to asymptomatic people? When moreover the mechanism by which HIV is supposed slowly or eventually to destroy the immune system is unknown? When it turns out that people being treated with these drugs are experiencing typical drug toxicities, and cancers, within the 10-year period during which it is officially acknowledged that HIV by itself on average does no harm?

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