HIV/AIDS Skepticism

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

Posts Tagged ‘lipodystrophy’

Having it both ways

Posted by Henry Bauer on 2011/09/25

HIV/AIDS theory and practice force its adherents to commit absurd fundamental contradictions.

On the one hand, they say, the disease is acquired primarily through culpably risky behavior: promiscuous unprotected sex or injecting harmful drugs with second-hand needles. On the other hand, they urge us earnestly and perpetually not to stigmatize people who have acquired the virus through (in most cases) their own fault.

On the one hand, they say, breast feeding by “HIV-positive” mothers transmits HIV to their infants. On the other hand, they urge African mothers to breast-feed their infants to the exclusion of formula because the exclusively breast-fed infants become “HIV-positive” less frequently.

Dr. Frank Spinelli offers another example. He is “is the former Clinical Director of HIV Services at New York City’s Cabrini Medical Center. Today, he serves the community in a more comprehensive capacity as a board certified internist, with a large HIV+ and gay men’s health private practice in Manhattan. Dr. Spinelli is also an Associate Clinical Professor of New York Medical College. Dr. Spinelli is the monthly healthcare columnist for The Advocate, the oldest continuing gay publication in the United States and the host of Ask the Doctor on” — evidently an eminently authoritative expert on HIV matters. He offers cosmetic Sculptra® treatment to hide the ravages of lipodystrophy inflicted by HAART:
“It’s not like other cosmetic procedures; it’s about restoring someone’s normal appearance. They shouldn’t be punished for having HIV by looking as though they have an illness” [emphasis added].

“HIV” is not an illness.
Why then administer lipodystrophy-inducing drugs in the first place?

Posted in experts, HIV absurdities | Tagged: , , | 8 Comments »

HIV/AIDS grift

Posted by Henry Bauer on 2010/11/14

1.    Money made dishonestly, as in a swindle.
2.    A swindle or confidence game.
— American Heritage Dictionary, 3rd ed.]

“Grift” popped into my head because of this recent news item with an apt choice of name for a new drug:
“FDA approves Egrifta to treat Lipodystrophy in HIV patients”
Despite occasional waffling and evasiveness, even mainstreamers do know that “HIV-associated lipodystrophy” is actually ARV-caused lipodystrophy, perhaps specifically protease-inhibitor-caused lipodystrophy. So here’s an iatrogenic [caused by treatment] ailment that is then to be treated with yet another medication — which, of course, will then have its own “side” effects.
It’s not unique to HIV/AIDS medical practice, unfortunately, that treatment may turn out instead to be iatrogenic illness, which is then sought to be treated by drugs with yet further “side” effects. Ask around, perhaps especially among us senior citizens, how many of us are taking statins and diuretics and blood thinners as well as other medications to counteract the muscle weakness, mental confusion, etc., etc., that are “side” effects of those statins, diuretics, blood thinners that we are supposed to take for as long as we survive.
In this instance, Egrifta not only sometimes lessens the lipodystrophy, as desired, it also produces “joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia) [and] Worsening blood sugar control”.
Note too that these “side” effects showed up already in a 26-week trial. ARVs are to be taken forever, so these effects are likely to get increasingly unpleasant, and additional ones might also show up. Plenty of opportunity to be prescribed medications to control muscle pain, joint pain, blood sugar level, etc.

Not that all HIV/AIDS activists, doctors, researchers and others are consciously propagating a vast confidence racket; they are doing it unconsciously, and they are themselves victims of this racket. As I’ve tried to make plain always, the HIV/AIDS mess is not the result of any conscious conspiracy, it is a reflection of the state of science and medicine in contemporary society.
Researchers and doctors are victims in that they suffer cognitive dissonance. They are unable to conceive that a mainstream consensus could be plain wrong, in this instance HIV/AIDS theory, and therefore they either ignore evidence to that effect or find ways to explain it away, to their own satisfaction at least.
An increasingly common device is to ascribe to “HIV” what are actually the effects of ARVs, as with lipodystrophy. This is increasingly accomplished by ascribing to “HIV” a chronic stimulation or activation of the immune system which produces chronic inflammation that can be blamed for any and every ailment or organ failure.
Osteoporosis, and its precursor, the loss of bone mineral density (BMD), is another “side” effect of antiretroviral drugs that mainstreamers attempt to ascribe to “HIV” itself. Thus the recent news item, “Bone loss more common in HIV”:
“In a group of people with HIV, researchers found eight in 10 had either osteoporosis, the brittle-bone disease that raises the risk of fractures, or osteopenia, abnormally low bone mass that could progress to osteoporosis.  It’s unclear exactly why people with HIV are more likely to experience bone loss, study author Dr. Anna Bonjoch of the Lluita contra la SIDA Foundation in Barcelona, Spain. . . . HIV patients also appear at higher risk of heart disease, cancer, kidney problems, diabetes, and cognitive decline. ‘All these big chronic diseases that increase with age do occur earlier in HIV’”.
The study referred to is “High prevalence of and progression to low bone mineral density in HIV-infected patients: a longitudinal cohort study” by Bonjoch et al., AIDS, 24 [2010] 2827-33. Note that the news report accurately reflected that the article emphasizes “HIV infection” and not antiretroviral treatment. The article’s abstract is truthful in reporting the association, though:
“Factors associated with bone loss and progression were age . . . , low body mass index . . . , time on protease inhibitor . . . , time on tenofovir . . . , and current use of protease inhibitors . . . . Our findings support the importance of applying adequate strategies to prevent bone demineralization and of close monitoring of BMD in HIV-infected patients, specifically in at-risk patients who are taking antiretrovirals that affect bone mineralization” [emphasis added].
Yet note how the authors blend the drug “side” effects with other matters. That age and low body mass index may be associated with bone loss should have been irrelevant, since those associations are also found in HIV-negative individuals; the point is that protease inhibitors and tenofovir are independently associated with bone loss.
A meta-analysis, published 4 years before this study, had demonstrated quite clearly the association between bone loss and antiretroviral treatment (Brown & Qaqish, Antiretroviral therapy and the prevalence of osteopenia and osteoporosis: a meta-analytic review, AIDS, 20 [2006] 2165-74):
“ART-exposed and  PI- exposed  individuals  had  a  higher  prevalence  of  reduced  BMD [bone mass density] and  osteoporosis compared with their respective controls”.
But here too the authors try to find some way to blame “HIV”, for example, “other factors, such as the effects on chronic immune activation [5], appear to be important in the pathogenesis of reduced BMD in HIV, and other studies have failed to show an association with ART in general or PI, specifically”.
The point of a meta-analysis is to determine what the cumulation of studies shows to be the case, namely here that antiretroviral drugs cause bone loss. That a few studies did not report this is irrelevant, since those studies were included in the meta-analysis. Figure 1 shows details of 7 studies, 5 of which individually reported osteoporosis associated with ART, with an overall odds ratio of 2.38 (95% confidence interval 1.20, 4.75); the incidence of bone loss, as one would expect, was greater than of actual osteoporosis, with an odds ratio of 2.5. Protease inhibitors were specifically associated with osteoporosis at an overall odds ratio of 1.57; since this is markedly lower than the overall 2.38 for ART, evidently it is not only the protease inhibitors of HAART that cause bone loss.
And still the authors try somehow to exculpate antiretroviral treatment by emphasizing possibly confounding factors, such as that some longitudinal studies did not find increasing bone loss among HAART-treated individuals. But it is the initiation of HAART that needs to be examined, because bone loss is not rapid, and “the two published studies of treatment-naive HIV-infected patients show decreases in BMD with ART initiation”.
But let’s not accept the evidence too willingly:
“It is  not  clear,  however,  whether  the  decline  in  BMD observed with the initiation of ART can entirely account for  the  increased  prevalence  of  osteoporosis in  ART- treated  patients” [emphasis added].
Since bone loss tends to occur naturally as we age, and also in certain other conditions, for example after menopause in women, of course ART will not account “entirely” for all bone loss; it shouldn’t be expected to.
From the mainstream HIV/AIDS view, though, what is really needed, naturally, is more research:
“Further  longitudinal  studies  of  HIV  patients beginning therapy will be needed to clarify the effect of ART initiation and also provide information on the effect of individual antiretroviral agents on bone density”.
But how much does it matter if HAART does not “entirely” account for osteoporosis? Might it not be wise to abstain from HAART in the case of individuals whose only “symptoms” are being “HIV-positive” and having a CD4 count lower than that currently in vogue criterion (<200? <350? <500?) for beginning treatment?

Posted in antiretroviral drugs, clinical trials, experts, HIV skepticism | Tagged: , , | 1 Comment »

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:

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.

Posted in antiretroviral drugs, clinical trials, HIV/AIDS numbers, Legal aspects, uncritical media | Tagged: , , , , , | 12 Comments »