HIV/AIDS Skepticism

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

Misleading is worse than lying — The case of “HIV-associated” lipodystrophy

Posted by Henry Bauer on 2008/11/10

Years ago, I found instructive — and have remembered ever since — the distinction Paul Halmos makes between misleading and lying:

“There is a difference between misleading statements and false ones; striving for ‘the clear reception of the message’ you are sometimes allowed to lie a little, but you must never mislead….. A part of the art of lecturing is to know when and how to lie. Don’t insist on protecting yourself by being cowardly legalistic, but lead the audience to the truth”
(I Want to Be a Mathematician, 1985, pp. 113 14; for further applications, see To Rise above Principle, p. 168 ff.).

That insight was obviously ignored in a recent blurb from Theratechnologies and its media dissemination:

“MONTREAL, QUEBEC, Nov 06, 2008 (MARKET WIRE via COMTEX)
Theratechnologies presents additional results from its Tesamorelin Phase 3 Studies at the 10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV
. . . new 26-week data from a combined analysis . . . testing tesamorelin in HIV-associated lipodystrophy were presented as a poster (Poster Number 19) at the 10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, in London, England. . . . a daily administration of 2 mg of tesamorelin is beneficial in reducing visceral adipose tissue (VAT) in HIV-infected patients regardless of the type of antiretroviral therapy (ART) regimen used to treat the HIV infection”.

Note “HIV-associated lipodystrophy”, underscored by “regardless of the type of antiretroviral therapy (ART) regimen”: the impression is left, and surely intended, that lipodystrophy is one of the effects of infection by HIV. Neither phrase is a straight-out lie, yet the result is completely misleading:

1. Lipodystrophy is associated with HIV only because antiretroviral drugs are administered to HIV-positive people.

2. That tesamorelin acts against lipodystrophy irrespective of ART regimen is only because all the antiretroviral drugs so far used have been reported at one time or another to induce lipodystrophy.

Those misleading statements are underscored by “Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy” [emphasis added]. No source is given, of course, to identify those who “think” “the virus itself” contributes to lipodystrophy.

“The combined trials represented 816 patients who were treated with the following ART regimens: NRTI/PI 45%, NNRTI/NRTI 33%, NNRTI/NRTI/PI 10%, NRTI monotherapy 5% with the remaining other combinations representing 7%. The average time since initial diagnosis of HIV infection was 13 years with the average duration of ART therapy being 4.5 years. Patients in these studies, on average, had been diagnosed with lipodystrophy syndrome for 3.9 years”.

In other words, patients were free of lipodystrophy for an average of more than 9 years (13 minus 3.9) following diagnosis of HIV infection, and contracted lipodystrophy an average of about 7 months (0.6 years, 4.5 minus 3.9) after beginning ART therapy — rather obvious proof that it’s the antiretroviral drugs and not HIV that causes “HIV-associated” lipodystrophy.

Minor points of misleading by omission include that tesasmorelin doesn’t prevent or cure, and addresses only one of several aspects of lipodystrophy, which is “characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation” [emphasis added]. All that’s claimed for tesasmorelin is that it decreases by about one sixth the amount of fat accumulated around the stomach area; no mention is made of the lipodystrophy-associated loss of fat from other parts of the body, commonly the face: “VAT decreased from baseline by 13% in tesamorelin-treated patients after 26 weeks”.

Wanting to check published scientific sources, I was temporarily frustrated by the statement, “Long term safety results from the first Phase 3 study were published in the Journal of the International AIDS Society, on September 2, 2008”; the actual publication is in AIDS, which is not the Journal of the International AIDS Society, and it appeared on 12 (not 2) September: “Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation” by Julian Falutz et al. (corresponding author, Stephen Grinspoon), AIDS  22 [2008] 1719-28.

That article concludes that “Treatment with tesamorelin was generally well tolerated”. However, the detailed results provide grounds for questioning that conclusion. Only 62% completed the one-year study (256 out of the initial 412 patients), presumably because they didn’t tolerate it, for one reason or another. The specific reasons for that large drop-out rate given in Figure 1 include “lack of compliance” (10), “withdrew consent” (22), “lost to follow-up” (6), “discontinued” (59), “had adverse event” (20) — all reasons that could be subsumed under “ NOT well tolerated”, after all. Moreover, Table 3 reports a much larger rate of adverse (162) and serious adverse (9) events; admittedly, only 71 of these are said to be “related to treatment”, prompting the obvious question, to what were the other 100 adverse events related?

The safety of tesamorelin is further said to be supported by the fact that “the death rate in terms of overall person-year exposure to tesamorelin (2/270 patient years, 7.4/1000 person-year), is well below expected mortality rate of patients treated in the modern era of ART (25.4/1000 person-year)”; which prompts further questions:
That ART-era mortality of 25.4/1000 is about 3 times the overall age-adjusted mortality in the United States (see data in annual “Health, United States” reports ), scarcely in keeping with the popular shibboleth that “life-saving” HAART has made HIV/AIDS  a chronic but manageable disease. On top of that, it is simply not to be believed that the mortality could actually be so much less among people treated with tesamorelin , since the only claimed effect is on lipodystrophy, and moreover —as pointed out above — on only one aspect of that.

As so often with the primary literature of HIV/AIDS, the numbers don’t inspire much confidence, and the claimed conclusions inspire even less confidence. In the present case, that may be why the press release — though not, of course, the scientific article about safety — ends with several paragraphs of disclaimers about the claims made for tesamorelin.

12 Responses to “Misleading is worse than lying — The case of “HIV-associated” lipodystrophy”

  1. This to me is a sad reminder how many drugs an indoctrinated person actually has to endure. It’s such ridiculousness to keep adding yet another daily dose of toxicity to a myriad of things one must consume in order to fit mainstream protocol. Most people aren’t even sick, just afraid and all too trusting even in the face of misleading information.

  2. Henry Bauer said

    Brian:

    Yes indeed. But this is not restricted to the HIV/AIDS mess by any means. Standard practice in the US nowadays is to prescribe as though every pill does its intended work without side effects and without interference with other medications. Over the years, my wife and I have cared for three elderly parents in our home, and we’re both now fully “seniors” ourselves, so I’ve seen this at first hand. An incredible number of medications are being prescribed, often not even to treat any manifest illness but as “prevention” or “lowering of risk” supposedly stemming from blood pressure higher than some imagined “normal” level, ditto with cholesterol, and other stuff as well; there are even some pills stated to halt the progression of Alzheimer’s, entirely unwarranted because the data simply don’t show a definite effect. And then there’s Gardasil, a vaccine suggested to work against one of umpteen strains of HPV that might (or might not) be a contributing cause of cervical cancer. Within the last few days, the media have been agog at the medical advance represented by the proposal that a statin drug — Crestor, cost about $100 per month — be given for its anti-inflammatory action to people with “normal” cholesterol who have levels of a certain protein that might indicate the presence of an inflammatory process somewhere.

    That statins exert an anti-inflammatory action has ben long known, according to a friend who is an eminent biochemist in Australia, and who has been trying for years to have people become aware that anyone taking statins is interfering with certain metabolic processes in the mitochondria and should be taking Coenzyme Q10; something the drug companies know but won’t admit to knowing because of potential law suits.

    It’s madness, but in a mad world it’s the sane ones who are ignored, if not excommunicated.

  3. Marcel said

    Prof. Bauer,

    Perhaps the drug corporations will finally admit to knowing about the statin problems after they achieve their goal of immunity from lawsuits:

    http://globalresearch.ca/index.php?context=va&aid=10869

  4. Henry Bauer said

    Marcel:

    That’s a truly chilling thought.

    The issues raised in that link (http://globalresearch.ca/index.php?context=va&aid=10869) are too deep in matters for law for me to understand what difference there might be between approved medical devices and approved drugs. I wonder whether it’s relevant, that quite a few drugs have had to be withdrawn after receiving initial approval (and the interval between approval and withdrawing has been getting quite short).

  5. Joe said

    Henry:

    The situation with respect to over-prescription is here in the UK too. My father complained of chest pains, and was examined for heart problems. Nothing was found but they put him on anti-angina medication. He told them the pains were still there, but they still kept him on the medicine. A few years later he collapsed, and had most of his intestines removed, and came very close to death (maybe the chest pains were a sign of something amiss in his abdomen). On recovery from that, the chest pains had gone, but they still tell him to take the anti-angina meds! A similar problem occurred with another elderly friend with heart problems — they put him on beta-blockers, yet the problems continued. Finally after years of taking beta-blockers which had manifest debilitating side-effects but no apparent benefit (his heart problems continued) they took him off them and he looks 20 years younger. Throughout all of this I keep saying that if medicines had no obvious benefit to my health, I stop taking them, but clearly diligent people are mostly obedient to their doctors.

    My friend with AIDS is being urged to take statins because his blood cholesterol levels have risen. No mention of exercise or dietary changes from the doctors, despite the fact that they know that my friend is knowledgeable about medicines and physiology, so I’m sure they are not suggesting that to anyone else. Thankfully he understands that taking more medicines for the side-effects of ARVs is likely to just add to his health problems, and he’s trying dietary control and increased exercise to reduce his cholesterol levels.

    I wonder if the increased cholesterol levels are not the body’s attempt at defending itself from the effects of ARVs, or is increased cholesterol just a sign of increased cell death? I’d like him to stop taking ARVs to see how his health fares, since the ARVs clearly fixed what was wrong with him a few years back and I see no need to continue with them unless his health issues returned.

    But naturally, having come so close to death before taking ARVs, he’s reluctant to abandon them. He’s been on ARVs for about 3 years now, and has put on some weight, which I think is attributable to the medication.

  6. Marcel said

    And I wonder whether it’s relevant that FDA officials and scientists involved with drug approvals tend to get “rewarded” after they leave the FDA and are offered plum jobs with the drug makers at many times their FDA salaries.

  7. Henry Bauer said

    Joe:

    I guess the infatuation with pills is quite general, I suppose the drug companies seduce doctors everywhere by the sort of tactics Marcia Angell (for one) has written about (in “The truth about the drug companies: how they deceive us and what to do about it”, Random House, 2004).

    Re cholesterol, I recommend highly “The cholesterol myth” by Ravnskov, see the review at
    http://www.scientificexploration.org/jse/bookreviews/pdf/v15n4.pdf

    Also, the book “Malignant Medical Myths” by Joel Kauffman (who wrote that review) has a chapter on cholesterol as well as other medical myths. The fad for “reducing risk factors” in medicine is an application of the mistaken belief that correlations prove causation. Our bodies need cholesterol, that’s why our metabolisms synthesize it.

  8. Henry Bauer said

    Marcel:

    Conflicts of interest have become enormously damaging. An excellent discussion is by Sheldon Krimsky, “Science in the Private Interest”.

  9. Oigen said

    How about the case of: Cholesterol, the lower is better scam, the chemotherapy and radiation for cancer idiocy, and……….

    The worst misleading practice has to be the quoting of figures for drug efficacy, justification for viral causation of disease, or any medical intervention for that matter, in percentages reckoned in “relative” terms. In my layman estimation, publishing percentages in such a manner for these insufferable interminable studies and whatnot without providing “hard data” ought to be outlawed. “Heart attacks reduced by 50% by gobbling our pills”, scream the headlines, which are meaningless without “hard data”. The public with a paucity of understanding for statistical mumbo-jumbo or even elementary arithmetic will usually take the 50% figure to mean that 50 out of 100 people gobbling the junk would benefit when in reality, given the hard data,the benefits are usually in the order of one or two or even fractional percentage points in “absolute” terms which, in my estimation, are results utterly insignificant and are more probably due to chance. And when, on rare occasions, they do provide data for drug “side-effects”, it is probably done by quoting percentage figures in not-so-spectacular “absolute” terms, further duping the public. Argh!!! For the public, it’s time to get Pwizer to Pfizer and the rest of the prescription-pill mongers. The unbridled uncensored WWW might be our salvation yet for judging from comments from the public in the MSM [mainstream media?]; on such topics as cholesterol, for example, the public may indeed be getting Pwizer.

  10. Henry Bauer said

    Oigen:

    Amen!

    Everyone ought to read at least the Introduction of Malignant Medical Myths , http://www.amazon.com/Malignant-Medical-Myths-Treatment-Yourself/dp/0741429098/ref=pd_bbs_sr_1?ie=UTF8&s=books&qid=1226614389&sr=8-1

    The author, Joel Kauffman, presents very clearly the various ways in which pharma and medical propaganda can and do mislead.

    One of the most common practices in the “research” literature is to cite decreases in mortality from a given condition, allegedly showing the benefit of some drug, by citing only the decrease in mortality that’s ascribable to that condition; but the proper thing to do is to compare ALL-CAUSE MORTALITY with and without the drug treatment; after all, for example, a decrease in deaths from some cancer, say, might be outweighed by deaths induced by the chemotherapy (the treatment was a success but the patient died anyway, from the treatment!).

  11. Matthew said

    I have to take issue with at least one thing you said. I am a Research Manager at a private practice in California (basically I manage the business and some of the clinical aspects of clinical trials). I do not work for any Pharma company, nor do I believe them to be saints but you said:

    “In other words, patients were free of lipodystrophy for an average of more than 9 years (13 minus 3.9) following diagnosis of HIV infection, and contracted lipodystrophy an average of about 7 months (0.6 years, 4.5 minus 3.9) after beginning ART therapy — rather obvious proof that it’s the antiretroviral drugs and not HIV that causes “HIV-associated” lipodystrophy.”

    Your conclusion that it is obvious that they Anti-Retrovirals caused the lipodystrophy and not the virus leaves out one very important factor: the strengthening of the virus prior to treatment. I am not necessarily saying you are wrong or that it is not the ARVs that are causing lipodystrophy, I am only saying that we need to consider more before stating an obvious culprit. The reason the patient has finally started ARVs is due to the progression of the virus within their bodies to the point where the risks of treatment no longer outweigh the benefits. In other words, they have a very high viral load (copies of HIV in their blood) and a low CD4 (T cell) count. Could we not at least surmise that the lipodystrophy could be caused or at least encouraged by the rampant virus and its effects on the body?

    I am not a physician or a scientist, but I do have some first hand experience with patients who are starting ARVs for the first time and I just wanted to posit this thought.

    • Henry Bauer said

      Matthew:

      Your thoughts are quite reasonable a priori, but I think the weight of the evidence points in my direction. The strongest indication of that, I suggest, is that lipodystrophy entered the picture only with antiretrovirals, in particular the protease inhibitors. Let’s not forget that AIDS was diagnosed years earlier than “HIV” was recognized. By current estimates of an average 10-year latent period, the people who died of AIDS in the early 1980s, typically within a year or so of diagnosis, had been “HIV+” for an average of 10 years. None were reported as ever having had lipodystrophy. They had PCP, candidiasis, or KS (and later it was realized that many KS patients are not HIV+ and don’t have low CD4 counts, by the way).
      “HIV-associated” lipodystrophy is a commonly employed misnomer to deflect attention from the fact that there’s no evidence at all that “HIV” causes it. It’s associated with “HIV” only in people who are on HAART.

      There are also thousands of “elite controllers” or “long-term non-progressors” known to AIDS physicians and researchers, “HIV+” people who remain healthy without treatment, and without lipodystrophy. There are also some unknown, but surely large, number of people who are “HIV+” — some of them for a couple of decades or more — but who have abstained from treatment and not developed lipodystrophy; these are people in HEAL and other “dissident” groups around the world; I know a few such individuals personally.

      As to CD4 counts and viral load, look at Rodriguez et al., JAMA 296 (2006) 1498-1506: viral load fails to predict loss of CD4 cells. A further indication that viral load, CD4 counts, and clinical condition are essentially independent of one another — or at least are not tightly correlated, as HIV/AIDS theory would demand — is that the NIH Treatment Guidelines find it necessary to distinguish between “immunologic failure” (CD4 counts don’t go up), “virologic failure” (viral load doesn’t go down), and “clinical failure” (the patient gets worse). Those Treatment Guidelines also list lipodystrophy or “lipid abnormalities”, “dyslipidemia”, “fat maldistribution”, “hyperlipidemia” as side effects of “PI-based regimens” as well as of some NRTIs (stavudine, d4T, ZERIT; lopinavir/ritonavir).

      So there’s actual evidence that antiretrovirals cause dyslipidemia, but no evidence that it occurs in untreated “HIV+” people. So your surmise, unexceptionable a priori, turns out to have no evidence for it and considerable evidence against it.

      I’d also point out, re “progression of the virus within their bodies”, that we still have not been told exactly what the pathogenic action(s) of HIV are supposed to be, other than killing CD4 cells by a mechanism that remains to be discovered. It’s sadly true that we’ve become willing to contemplate as reasonable, or even to accept without proof, statements about “HIV”‘s ill effects on just about anything—when the only original reason for conjecturing that “HIV” might cause “AIDS” was that there seemed to be an association between “HIV+” and “AIDS”. Since then, we’ve seen names like “HIV dementia” or “HIV encephalopathy”, etc., just because the conditions are sometimes seen in “HIV+” people. It’s also been generally forgotten that by the early 1990s, so many “HIV”-negative “AIDS” patients had been reported that a new disease was invented, “idiopathic CD4-T-cell lymphopenia”: low CD4 counts for no known reason, “AIDS” without “HIV”.

      Thank you for posing your query in a matter-of-fact and civil way, and I hope my response is likewise. I also hope you will continue to think about these matters, and read about them, and reach your own conclusions eventually on the basis of the weight of evidence.

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