HIV/AIDS Skepticism

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

How antiretroviral drugs are approved

Posted by Henry Bauer on 2009/10/09

* FDA document says Selzentry “well tolerated” (“Pfizer HIV drug seems safe for new use — FDA staff”; Susan Heavey, 6 October 2009)

“Through 48 weeks, fewer participants discontinued maraviroc [generic name of Selzentry] because of toxicity (4.2%” [in a comparison against efavirenz; NIH Treatment Guidelines, 3 November 2008, pp. 36-7].

In the world of HIV/AIDS,
a medication that brings toxic effects
within 48 weeks in more than 4% of patients
is said to be “well tolerated”.

Here’s the fuller context:

“Pfizer Inc’s . . . HIV drug Selzentry appears to be safe for wider use in certain patients with the disease who have not yet begun taking any medications, U.S. Food and Drug Administration staff said in a document released on Tuesday. The drug, also know by its generic name maraviroc, is already FDA-approved in combination with similar drugs for HIV patients who have tried other antiretroviral medications. Pfizer is seeking FDA permission to market Selzentry for HIV patients who have a certain variation of HIV-1 — one of two strains of the human immunodeficiency virus that causes AIDS — who have not yet tried any medications. It would be taken with other antiretroviral drugs. An FDA staff document said the drug appeared to be “well tolerated” in patients in a company-funded study [that in itself is cause for concern, of course]. A review of an FDA database also found no new reported safety concerns [apparently the 4.2% toxicity in less than a year is not a “NEW” safety concern] in HIV patients who have already been taking the drug. . . . The FDA released the document ahead of a public meeting on Thursday when the agency will ask its outside advisers for a recommendation on whether to approve the drug’s wider use. It usually follows their advice. [How can the conclusion “well tolerated” precede the advisory panel’s discussion?] Pfizer said its trial showed the drug is safe [to 95% of patients, provided they don’t take it for more than 48 weeks] and effective.”

NIH Treatment Guidelines, 3 November 2008, regarding Selzentry (generic is maraviroc, MVC)

Table 13 —
Hepatotoxicity (clinical hepatitis or asymptomatic serum transaminase elevation):
All NNRTIs; all PIs; most NRTIs; maraviroc

Appendix Table 6:
“Side” effects include — Abdominal pain, cough, dizziness, musculoskeletal symptoms, pyrexia, rash, upper respiratory tract infections, hepatotoxicity, orthostatic hypotension.

Pp. 36-7: Maraviroc-Based Regimen. The MERIT study compared the CCR5 antagonist maraviroc with efavirenz . . . . Only participants who had CCR5 virus and no evidence of resistance to any drugs used in the study were enrolled (n = 633). At 48 weeks, virologic suppression (defined as HIV RNA <400 copies/mL) was seen in 75.3% of maraviroc recipients and in 78.9% of efavirenz recipients, and HIV RNA <50 copies/mL was observed in 65.2% of maraviroc recipients and in 69.2% of efavirenz recipients. The HIV RNA <50 copies/mL results did not meet the criteria set by the investigators to demonstrate noninferiority for maraviroc in this study. CD4 counts increased by an average of 170 cells/mm3 in the maraviroc arm and by an average of 143 cells/mm3 in the efavirenz arm. Through 48 weeks, more participants discontinued maraviroc because of lack of efficacy (11.9% vs. 4.2%), whereas fewer participants discontinued maraviroc because of toxicity (4.2% vs. 13.6%).

13 Responses to “How antiretroviral drugs are approved”

  1. Guy Harris said

    Dear Sir,

    You indicate that over 4% suffered toxicity. My reading is that over 4% quit because of toxicity. Could there have been more toughing out the toxic effects because they thought the alternative was death?

    • Henry Bauer said

      Guy Harris: Your suggestion is very plausible; and you’re right to point out that they actually dropped out because of toxicity, making it likely that others had similar but not as strong symptoms.

      I think the notion that “HIV” is a death sentence also underlies the attitude of HIV/AIDS researchers and doctors, making it possible for them to justify to themselves that they treat people with substances that are so dangerous to health.

  2. MacDonald said

    “Discontinuation for lack of efficacy” is a great category for someone who would want to keep the numbers on toxicity drop-outs down.

    Whichever way you spin it, to 15% benefits, measured solely by CD4 markers, didn’t outweigh the harmful effects.

    BTW, I am thrilled to see that there are only two strains of HIV that cause AIDS

    HIV patients who have a certain variation of HIV-1 — one of two strains of the human immunodeficiency virus…

    Or do they mean that HIV-2 is a strain of HIV, HIV-1 being the other? That would be even more breathtaking news, since in order to have two strains of something, HIV-1 and HIV-2, you would need a third HIV they could both be strains of. Would that third HIV be a strain unto itself?

    The more technically minded can pursue this fascinating discussion with Parmenides:

    I suppose it is because of the following sort of thing that you think that each virus is one: whenever many things seem to be strains to you, there perhaps seems to you to be, when you have looked at them all, some one and the same idea. Hence you think the virus is one.

    True, he said.

    What, then, if in the same way you look in your soul at all these ? At the virus itself and the other strains? Will not some one virus appear again, by which all these will appear to be strains?

    It seems so.

    So another form of strain will appear besides the strain itself and its participants. And in addition to all these, yet another, by which all these will be strains. And so each of the viruses will no longer be one for you, but infinitely many.

    Brian Foley, distinguished Keeper of the HIV Genome at Los Alamos has told us that the viciously regressing strains of HIV are as different as elephants and mice, but now we learn that they are mere “variations”, one variation distinguishing itself by being “CCR5 tropic”.

    I am fully expecting to read in the next Zoology textbook that a mouse is really just another strain of elephant, and that some mice are elephant-trunk tropic, which just goes to prove that they are one and the same.

    • Henry Bauer said

      MacDonald: If your remarks are directed at knowledge seekers, they certainly hit the mark. But remember that Foley and other AIDStruthers are neither philosophically inclined nor logical, and above all that they are utterly lacking in sense of humor.

  3. MacDonald said

    I know it’s bad form, but since there might be knowledge seekers out there who are a little confused, perhaps I should explain the joke.

    According to HIV lore, for the first time maybe in millions of years, two distinct human immune deficiency retroviruses, originating from distinct sources, pan troglodytes and sooty mangabeys, decided to jump the species barrier at the same time in the same part of the world, West-Central Africa.

    This story is so improbable that not even science journalists can get their head around it. That is why we are told here that HIV-1 and HIV-2 are two strains of the same virus.

    Parmenides’ interlocutor with the short replies in the exchange is Socrates.

  4. Sabine Kalitzkus said


    Though these NIH treatment guidelines will possibly soon be replaced by updated (and presumably even more dangerous) ones, I find this disturbing:

    Strength of Recommendations The D (should usually not be offered) and E (should never be offered) ratings have been removed.

    Quality of Evidence Previously, only randomized trials with clinical endpoints were given a I ranking. In this new rating scheme, a I ranking includes randomized trials with either clinical or validated laboratory outcomes (e.g., viral load). (Italics added.)

    Obviously the NIH guidelines ignore the study by Egger et al., published in Lancet in 2006, HIV treatment response and prognosis in Europe and North America in the first decade of highly active antiretroviral therapy: a collaborative analysis, whose researchers concluded:

    Virological response after starting HAART improved over calendar years, but such improvement has not translated into a decrease in mortality.

    Referring to this study David Rasnick commented on an article published by the South African periodical “Business Day”:

    The article also begins by saying, “For ethical reasons, there has been no placebo-controlled randomized trial of HAART (Highly Active Antiretroviral Therapy). The effectiveness of this treatment over several years is therefore unknown.”

    This is what I, and many other “dissidents,” have been saying for years. In other words, after American taxpayers have spent a total of $170 billion on AIDS (through 2005), there is still no controlled clinical study showing that people taking the antiretroviral drugs live longer, or at least better, lives than a similar group of people not taking the drugs. And, as The Lancet authors acknowledge, their study doesn’t qualify either.

    Rasnick quotes from another paper published in Lancet:

    Patients were included if they had been examined after January 1996, when HAART became available in Switzerland, were not on HAART, and were free of AIDS at baseline.

    Here are the numbers of so-called “AIDS deaths” for Switzerland published by EuroHIV:

    1990: 372
    1991: 446
    1992: 584
    1993: 619
    1994: 686
    1995: 650 (1994 – 1995 < 5.25%)
    1996: 449 (< 30%)
    1997: 241 (< 45%)
    1998: 156 (< 35%)
    1999: 131 (< 16%)
    2000: 125 (< 4.6%)
    2001: 117 (< 6.44%)
    2002: 102 (< 12.8%)
    2003: 95 (< 7%)
    2004: 90 (< 5.3%)
    2005: 70 (< 22.3%)
    2006: 56 (< 20%)


    Obviously, whether people are dying or not has nothing to do with HAART.

    • Henry Bauer said

      Sabine: What are those percentages?

      • Sabine Kalitzkus said

        The decrease of death cases from one year to the following.

      • Oigen said

        Looks like percentage reductions of previous year’s AIDS deaths which appear to be rather erratic.

      • Henry Bauer said

        Sabine, Oigen: I don’t quite see what an erratic rate of decrease means? Isn’t the point being made that there is a decrease?

      • Oigen said

        Ok. So called AIDS deaths bouncing about from one year to the next in these reports doesn’t mean much when the trend, as in this case, is definitely downward. But if “they” are determining “AIDS” deaths (just what is written on their death certificates? ) in a manner similar to how an HIV+ diagnosis is made, then the numbers would at least be suspect in my estimation. But then for my impoverished layman’s mind anything to do with numbers generated in HIV fantasy land are nebulous as well as suspicious.

      • Henry Bauer said


        “anything to do with numbers generated in HIV fantasy land are nebulous as well as suspicious” — I agree wholeheartedly

  5. Sabine Kalitzkus said


    I agree with Oigen. The decrease is erratic:

    5.25%, 30, 45, 35, 16, 4.6, 6.44, 12.8, 7, 5.3, 22.3, 20.

    This is not a steady decrease, but an erratic one. Numbers are jumping up and down for undetectable reasons, thereby causing dizziness and making it impossible to predict what the next number might be.

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