HIV/AIDS Skepticism

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

Posts Tagged ‘STARHS unreliable’

The “science” of AIDS

Posted by Henry Bauer on 2009/07/28

A Google Alert led me to a very uninformative news item (“Risky sex in Tijuana ups HIV rate”, UPI)   about potentially interesting material having to do with HIV in Tijuana; I was prompted to look at the original article. It’s currently in press at the journal AIDS, and to locate it I had to scan through a list of dozens of articles in press. That reminded me of something I’d long forgotten, how very trivial most of the scientific literature is. One indication of that: the overwhelming majority of research articles are never cited, which makes it exceedingly unlikely that they have been of any use — except for padding a vita for career purposes or for making money for commercial journal publishers whose income derives from advertisements and from “page charges” that authors pay — not personally, of course, but out of their grants. I continue to get invitations to suggest titles for new journals that I might like to edit, the latest one from India mentioning a page-charge rate of $250. In the humanities, it’s called “vanity” publishing when an author has to pay to get into print.

The titles of some of the articles in press in AIDS — accepted for publication, in queue to be printed — suggest why so many publications are never cited, much the same reason as why Senator Proxmire never failed for candidates for his “Golden Fleece” awards satirizing the researches that federal funds supported. The numbers of authors illustrate the career-enhancing purpose of these publications:

“Knowledge of HIV status, sexual risk behaviors and contraceptive need among people living with HIV in Kenya and Malawi” (11 authors)
“The effect of educational attainment and other factors on HIV risk in South African women: results from antenatal surveillance, 2000-2005” (5 authors)
“Comparison of previous and present World Health Organization clinical staging criteria in HIV-infected Malawian children” (11 authors)

Scanning those lists of papers also shows that a number of American researchers have made careers for two decades by doing this sort for research at specific sites in Africa, enthusiastically helped by African colleagues who would otherwise not find it easy to get any research support at all.

But this is a digression from what stimulated this post: several of the articles to be published in AIDS are highly damaging to HIV/AIDS theory, for instance:

Beware antiretrovirals
“Stavudine in antiretroviral therapy: is this the end?” — editorial comment by Kees Brinkman, DOI:10.1097/QAD.0b013e32832d3c5e
“After 1-2 years on HAART, symptoms like lipodystrophy, dyslipidemia, cardiovascular disease, diabetes and lactic acidosis frequently materialized in exposed patients. In particular the development of a stigmatizing lipoatrophy of the arms, legs and face moved many patients to postpone the start of their treatment. . . .  stronger recommendations should be installed not to allow any use of stavudine anymore and to replace stavudine in people currently taking this drug by safer alternatives like abacavir and tenofovir. The longer we wait, the more damage will be done” [emphases added].

It’s not only stavudine, of course, it is all the NRTIs (nucleoside reverse transcriptase inhibitors) whose type specimen is AZT. The November 2008 NIH Treatment Guidelines (Table 9, p. 47) has this very belated statement:

Monotherapy with NRTI. Single-NRTI therapy does not demonstrate potent and sustained antiviral activity and should not be used” [emphasis in original]

Very belated, because from the introduction of AZT in 1987 until the mid-90s start of the HAART era, that is precisely what “HIV-positive” people and AIDS patients were being subjected to. But, of course, when we “denialists” venture to remark that AZT “treatment” killed several hundred thousand people during that period, the HIV/AIDS groupies deny it.

Perhaps in time the NIH Treatment Guidelines will be warning correctly against ALL antiretroviral drugs even as misinformed and misguided practitioners continue to prescribe them. Just following the statement quoted above comes this:
“Single-drug treatment regimens with a ritonavir-boosted PI, either lopinavir [1] or atazanavir [2], are under investigation with mixed results, and cannot be recommended outside of a clinical trial at this time” [emphasis in original] which would seem to disqualify protease inhibitors as well as NRTIs.

In case the NIH Treatment Guidelines aren’t enough to dissuade anyone from antiretroviral treatment, consider what RxList has to say (updated 3/26/09) about Zerit (stavudine):

Stavudine Warning

Beware antiretrovirals — because THEY KILL
“Non-AIDS-defining deaths and immunodeficiency in the era of combination antiretroviral therapy” (12 authors on behalf of the CASCADE collaboration; only one of the authors declares a conflict of interest, consulting fees from several drug companies; DOI:10.1097/QAD.0b013e32832e9b78).
“Among 9858 patients . . . , 597 died, 333 (55.7%) from non-AIDS-defining causes” — consistent with the NIH Treatment Guidelines (3 November 2008, p. 21):
“In the era of combination antiretroviral therapy, several large observational studies have indicated that the risk of several non-AIDS-defining conditions, including cardiovascular diseases, liver-related events, renal disease, and certain non-AIDS malignancies [14-19] is greater than the risk for AIDS in persons with CD4 T-cell counts >200 cells/mm3; the risk for these events increases progressively as the CD4 T-cell count decreases from 350 to 200 cells/mm3.”
The present article confirms also that higher CD4 means lower death-risk, but describes it in this rather peculiar fashion:
“Conclusion: In the cART era, the most frequent non-AIDS-defining causes of death are associated with immunodeficiency, only cardiovascular disease was associated with high viral replication. Avoiding profound and mild immunodeficiency, through earlier initiation of cART, may impact on morbidity and mortality of HIV-infected patients.”
In other words, “non-AIDS” renal and liver failure are now being attributed to immunedeficiency, which is supposed to be caused by “HIV” in “HIV-positive” people, so there’s a justification for starting antiretroviral drugs earlier. Non-AIDS cardiovascular disease is “associated” with “high viral replication”, so that “non-AIDS” disease too can be attributed to the presence of HIV through guilt by association, overlooking as usual that correlation does not prove causation. Thus antiretroviral treatment is being suggested to stave off non-HIV/AIDS ailments?!
I also relish the term “cART”, combination ART instead of highly active ART, reflecting perhaps a belated acknowledgment that it isn’t highly active as well as being deadly.

Use antiretroviral drugs EVEN WHEN THE PROBLEM IS NOT HIV
Here’s another independent instance of recommending antiretroviral drugs to treat non-HIV/AIDS conditions:
“The effect of HAART in 254 consecutive patients with AIDS-related Kaposi’s sarcoma” (9 authors; no conflicts of interest declared, but 3 authors are from Department of HIV Medicine, Chelsea and Westminster Hospital, London, UK; DOI:10.1097/QAD.0b013e32832d080d)
The fact that KS has been ascribed for well over a decade not to HIV but to KSHV or HHV-8 does not prevent talk of “AIDS-related Kaposi’s sarcoma”, because “Recognized as an AIDS-defining illness for over two decades [3], Kaposi’s sarcoma has always been the most common HIV-associated malignancy” — reference [3] being from 1987: MMWR Morb Mortal Wkly Rep 1987; 36 (Suppl 1):1S-15S.
It’s a shame the authors didn’t follow the Kalichman Mandate to ignore publications earlier than 2000 and especially those before 1990 (“Proving HIV/AIDS — Kalichman’s blunders, in a nutshell”, 11 March 2009).

Use antiretroviral drugs even though THEY CAUSE OSTEOPOROSIS
“Continuous antiretroviral therapy decreases bone mineral density” (10 authors, for the INSIGHT SMART Body Composition substudy group; 6 authors declare no conflicts of interest, the other 4 declare many with many drug companies; the primary article was written by two authors, one of them multiple conflicts of interest; DOI:10.1097/QAD.0b013e32832c1792).
Light relief is provided — at least for me — by the penchant for cheery up-beat acronyms like SMART (Strategies for Management of Anti-Retroviral Therapy), even though it might really be “SMARTER” to avoid such therapy. INSIGHT I haven’t yet decoded, but it seems quite popular. For example, I found “International Nifedipine GITS Study Intervention as a Goal in Hypertension Treatment” as well as “Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment”.

“With continuous ART, BMD [bone mineral density] declined per year by 0.8% (hip), 0.4% (spine), and 2.4% (spine). BMD declined significantly less with intermittent ART. Estimated . . . differences in mean BMD change . . . were 1.4% [hip . . .], 1.3% (spine DXA . . .), and 3.0% (spine qCT . . .). . . . 10 of 2753 participants in the VS [continuous HAART] group and two of 2720 in the DC [intermittent HAART] group reported serious fractures (hazard ratio 4.9 . . .).”
Continuous HAART is associated with a 5-fold greater risk of serious fractures because HAART weakens bones.

Use antiretroviral drugs: they HURT SOME PEOPLE LESS THAN OTHERS
“Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy” (11 authors on behalf of the Nevirapine Toxicity Multicohort Collaboration; DOI:10.1097/QAD.0b013e32832d3b54) 2 authors declare no conflicts of interest. The listing of the various cohorts and their members covers about 3 full pages of the 10½ page article.

The rationale for such a study is rather clear:
“Nevirapine is frequently used as part of combination antiretroviral therapy (cART) regimens . . . for example, to minimize diarrhea or to reduce cardiovascular risks associated with protease inhibitors, to avoid the neuropsychiatric side effects of efavirenz . . . . However, nevirapine is occasionally associated with severe adverse events, typically hypersensitivity reactions that usually occur within the first 18 weeks of treatment . . . . Six to seven percent of patients discontinue the use of nevirapine because of clinically significant hypersensitivity reactions [2–5]. Severe, life-threatening and even fatal cases of hepatotoxicity [6,7] and/or skin rashes [8–10] have occurred in patients taking nevirapine. HIV-1- seronegative adults using nevirapine for postexposure prophylaxis appear at particularly high risk of lifethreatening hepatotoxicity [11]. Among HIV-positive patients, the risk of hypersensitivity reactions is highest in patients with higher CD4 cell counts”.

The conclusions, however, are rather baffling:
“Our results suggest it may be relatively well tolerated to initiate NVPc in antiretroviral-experienced patients with high CD4 cell counts provided there is no detectable viremia”
Perhaps I don’t understand this properly: NVPc (combination nevirapine-based antiretroviral therapy) is relatively well tolerated in patients who have already survived other antiretroviral treatment, provided they have a high CD4 count and no detectable viral load.
It is NOT tolerated even “relatively” well in treatment-naïve patients or those with low CD4 and appreciable viral load.
?So people who are not immune-suppressed and who do not have an active infection can tolerate this antiretroviral drug relatively well. Those people who are immune-deficient and “infected”, and therefore supposedly need treatment, don’t tolerate it?

Use antiretroviral drugs even though THEY CAUSE LEPROSY
“Increased incidence of leprosy following HAART initiation: a manifestation of the immune reconstitution disease” (Research Letter, 8 authors, no declared conflicts of interest; DOI:10.1097/QAD.0b013e32832bb5b7)
Within 3 months of starting HAART, the adjusted hazard ratio for contracting leprosy is 18.5 (1.6-217) at a p value of 0.02, considerably more “significant” than the typically used criterion of p ≤0.05.

Testing antiretroviral drugs
“Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/ emtricitabine with lopinavir/ritonavir for initial HIV treatment” (DOI:10.1097/QAD.0b013e32832cbcc2).
Of the 12 authors, only one disclosed no conflict of interest; 6 of them are employees of  Glaxo-Smith-Kline [GSK], which sponsored the study. Another 80 members of the HEAT study team are acknowledged without information about conflicts of interest, plus 21 team members who are employees of Glaxo-Smith-Kline).

Although the article’s title mentions “placebo-matched”, no results are reported that compare drugs to placebo; the two drug regimens are simply compared to one another, and the criterion is “non-inferiority”:
“Primary endpoints were the proportion of patients with HIV-1 RNA below 50 copies/ml at week 48 (missing = failure, switch included analysis) and the proportion of patients experiencing adverse events over 96 weeks. . . . Premature study discontinuation due to adverse events occurred in 6% of patients in both groups. Protocol-defined virologic failure occurred in 14% of patients in both groups.”
In other words, in less than two years, 6% of patients suffered “adverse events” from the drugs, which also failed to suppress “viral load” in 14% of patients.

Detect “recent infections”?
“Performance of an immunoassay at detecting recent infection among reported HIV diagnoses in France, 2003-2007” (DOI:10.1097/QAD.0b013e32832d8754; 7 authors, no declared conflicts of interest)

Testing the CDC-developed STARHS (Serological Testing Algorithm for Recent HIV Seroconversion) on nearly 6800 individuals for whom there was independent information about the time of seroconversion did not confirm an earlier smaller study that had seemed to validate STARHS. Instead, there were marked discrepancies near the 180-day cutoff used to define “recent”, and results varied by geographic origin of the patients, a surrogate marker for sub-type of HIV.
My not-unbiased conclusion: the STARHS test doesn’t do what it’s supposed to.

Posted in antiretroviral drugs, clinical trials, HIV skepticism, HIV/AIDS numbers | Tagged: , , , , , , , | 10 Comments »