HIV/AIDS Skepticism

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

Posts Tagged ‘Norvir’

HAART kills hearts

Posted by Henry Bauer on 2010/10/22

The latest version of the Treatment Guidelines issued by the National Institutes of Health — 1 December 2009 —  includes among “Preferred Regimens” (p. 39, Table 5a) ritonavir-boosted saquinavir plus tenofovir/emtricitabine or tenofovir/lamivudine (SQV/r + TDF/FTC; FTC interchangeable with 3TC).

The “Adverse Events” of Saquinavir (a.k.a. Invirase) are listed (p. 156, App. B,. Table 3) as
• GI intolerance, nausea, and diarrhea
• Headache
• Elevated transaminase enzymes
• Hyperlipidemia
• Hyperglycemia
• Fat maldistribution
• Possible increased bleeding episodes in  pts with hemophilia

Those of Ritonavir (a.k.a. Norvir) are listed as
• GI intolerance, nausea, vomiting,  diarrhea
• Paresthesias — circumoral and extremities [tingling, “pins & needles”]
• Hyperlipidemia (especially  hypertriglyceridemia)
• Hepatitis
• Asthenia [lack of muscle strength, tiredness, dizziness, malaise]
• Taste perversion
• Hyperglycemia
• Fat maldistribution
• Possible increased bleeding episodes in  pts with hemophilia

Less than a year after these newly revised Guidelines appeared, a warning is issued against the frequent combined use of these two drugs in the “Preferred” category:
“The Food and Drug Administration has amped up warnings on the label of the commonly prescribed HIV antiviral Invirase, adding information about potentially life-threatening cardiac side effects when used in tandem with Norvir, another widely used antiviral.
[Note that cardiac events were not even among those listed in the Treatment Guidelines]
The new labeling requirement follows an FDA warning in February that the drugs taken together could affect electrical activity in the heart, prolonging what are known as QT and PR intervals — indicators of heart rhythm on an EKG.
[Note the warning in February — just a couple of months after the updated Treatment Guidelines that did not mention cardiac events]
Prolongation of the QT interval can lead to an abnormal heart rhythm known as torsades de pointes, which can cause lightheadedness or fainting and, in some cases, life-threatening ventricular fibrillation. A prolonged PR interval can lead to an abnormal cardiac rhythm called a heart block.
Thursday’s announcement also includes a requirement that the drug’s marketer, San Francisco-based Genentech, include an informational pamphlet for consumers that describes Invirase’s potential risks.”
“Invirase was first approved as antiretroviral medication in 1995, to be used in combination with Norvir and other antiretroviral medicines to treat HIV” (AFP; emphasis added).
“The FDA approved Invirase in 1995 to lower HIV levels in the blood. It is often combined with Norvir to improve its effectiveness” (AP; emphasis added).
“The agency emphasized that the benefits of the drugs outweigh their risks, but advised patients to talk to their doctors. As the Los Angeles Times points out, Norvir helps boost the effectiveness of Invirase, so the two meds are often taken together” (FiercePharma; emphasis added).
“Separately, the European Medicines Agency said it reviewed all the available data on potential heart risk and recommended that patients start off treatment with a lower dose of Invirase for a week as a precaution. It added that the benefits of the drugs outweighed the potential heart risks” (Reuters; emphasis added).

That FDA and the European Medicines Agency claim that the benefits of the drugs outweigh their risks is no surprise; that this assertion could be solidly based on evidence would be a great surprise, however. Did they, for instance, take into account that the median age at which AIDS patients die is mid-forties, and that the majority of adverse events are non-AIDS events? (HAART saves lives — but doesn’t prolong them!? )

The standard weasel words, “Talk to your doctor”, are particularly shameful under these circumstances. What’s a doctor supposed to do, when the experts and the authoritative bodies say that the drugs’ benefits outweigh their risks? Are physicians supposed to become researchers into the technical literature?

The central problem — a general problem with all drugs, not just with antiretrovirals — is that once drugs are approved, there is no systematic gathering of data about “side” effects. The Food and Drug Administration has no specific rules under which it acts to arrange the withdrawal from the market of a previously approved drug (e-mail of 17 August 2004 to Henry Bauer from CDER DRUGINFO <>); but, in any case, FDA could not act without information, and there is no systematic collecting of pertinent data. For example, only in mid-June 2009 did FDA advise consumers against using certain Zicam products even though it had received more than 100 reports of loss of smell among Zicam users as far back as 1999. The manufacturers had received 800 such reports without feeling obliged to notify the federal agency.
Moreover, manufacturers themselves can know about problems only if physicians report them, and it is not necessarily easy for a doctor to recognize when a new drug does something undesirable. Are the symptoms new and caused by the drug, or are they caused by the underlying illness and just more aggravated? Since FDA had ruled the drug safe and effective, it would be natural for a doctor to presume that any worsening of a patient’s condition stems more probably from the illness than from the drug. Such a conclusion would be particularly plausible with HIV and antiretroviral drugs, given that HIV is being blamed officially for every possible ailment: general inflammation, damage to any and every organ, cause of any and all cancers, and anything else experienced by antiretroviral-treated “HIV-positive” people.
Even fatal side effects may not bring official warnings for quite a long time. The antihistamines Seldane and Hismanal were on the market for a dozen years before they were withdrawn because torsades de pointes is a possible side effect; the gastrointestinal medication propulsid was marketed for 7 years before it was recognized that it too has that side effect.

Since the manner in which such adverse effects become known is so haphazard, it’s highly probable that only a small proportion of occurring side effects are actually reported, and that harm has been done to a large number of patients before drugs are withdrawn.
Clinical trials intended as a basis for approval of new drugs extend over limited periods; at least 6 months is the requirement, but rarely more than a couple of years. It is no surprise that serious adverse events do not show up in large numbers during such a limited period. But a “side” effect that shows up in only a few percent of cases in the first year is most likely to produce that effect in a much larger number of people when they are taking the drug for extended periods of time; and HAART is supposed to be a lifelong treatment.
And it is lifelong: until the median age of death, that is, which is about 45.
As the Treatment Guidelines acknowledge, more than half of all “AIDS” deaths are iatrogenic nowadays:
“In the era of combination antiretroviral therapy, . . . the risk of several non-AIDS-defining conditions, including cardiovascular diseases, liver-related events, renal disease, and certain non-AIDS malignancies . . . 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” (p. 13, 28 January 2008 version of Treatment Guidelines).
Exactly. HAART damages heart, liver, kidneys, and causes cancer. And it is not only the Invirase/Ritonavir (Saquinavir/Norvir) combination that is responsible.

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