In my memoir of serving as an academic dean, I had written “I would find myself thinking, Now I’ve seen everything; nothing can surprise me anymore, only to experience a novel surprise the next day or the next week”. That’s how I’ve been feeling the last few days as the media have being hyping the approval by the Food and Drug Administration of prescribing Truvada to prevent HIV infection — administering Truvada to perfectly healthy people as supposed prevention.
Truvada is emtricitabine (FTC) plus tenofovir (TDF). In “HAART is toxic: Mainstream concedes it, in backhanded ways”, I cited earlier blogs about the toxicity of tenofovir and a few salient bits:
— The federal warning that “Tenofovir . . . alone or in combination . . . may cause serious damage to the liver and . . . lactic acidosis”
— The manufacturer’s warning that “Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with . . . nucleoside analogs, including tenofovir”
— “increasing exposure to tenofovir was associated with a higher incidence of CKD [chronic kidney disease] . . . . and there are numerous studies . . . demonstrating that tenofovir is associated with impaired kidney function”.
— The federal warning that “Tenofovir . . . alone or in combination . . . may cause serious damage to the liver and . . . lactic acidosis”
— The manufacturer’s warning that “Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with . . . nucleoside analogs, including tenofovir”
— “increasing exposure to tenofovir was associated with a higher incidence of CKD [chronic kidney disease] . . . . and there are numerous studies . . . demonstrating that tenofovir is associated with impaired kidney function”.
For the combination of FTC plus TDF, the NIH Treatment Guidelines (updated 14 October 2011) cite as advantages superiority in suppressing viral load and also these disadvantages:
“• Potential for renal impairment, including rare reports of Fanconi syndrome and acute renal insufficiency
• Potential for decrease in bone mineral density”
(as well as failure to suppress viral load when combined with nevirapine [!])
“• Potential for renal impairment, including rare reports of Fanconi syndrome and acute renal insufficiency
• Potential for decrease in bone mineral density”
(as well as failure to suppress viral load when combined with nevirapine [!])
Given these serious and quite common toxicities, what is the supposed benefit of PrEP — pre-exposure prevention or prophylaxis — with Truvada?
A couple of years ago I discussed the failure of TDF in a PrEP trial: “Pre-exposure prophylaxis: A flawed clinical trial that no one should take seriously”. The media descriptions of the evidence on which the FDA and its Advisory Panel approved Truvada for PrEP suggest that this evidence is again anything but trustworthy:
“The committee voted 19-3 in favor of approval for the prevention indication — PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus” (Panel recommends approving Truvada to prevent HIV infection, Sandra Young, CNN, 10 May). Those votes mean that the panel judged it a greater risk when HIV-negative men have sex with men, or when the uninfected partner in a couple where the other is infected, than when “individuals . . . engage in risky sexual behavior that could result in their contracting the virus”? What possible basis could there be for such a comparative judgment?
“Committee members also heard concerns about the drug’s side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density”. Those committee members will not be able in the future to deny that they were voting to cause iatrogenic harm to healthy individuals who had other options for protecting themselves.
As history lauds in retrospect the FDA officer who held off from approving thalidomide, so in future we may look back approvingly on the attempt to block Truvada PrEP by one member of the committee:
“Dr. Lauren Wood of the National Cancer Institute said she voted against all preventive applications because clinical studies did not measure the dangers of drug-related renal problems among black people, who are among the hardest impacted by HIV infection and the most susceptible to kidney problems linked to AIDS drugs”.
A couple of years ago I discussed the failure of TDF in a PrEP trial: “Pre-exposure prophylaxis: A flawed clinical trial that no one should take seriously”. The media descriptions of the evidence on which the FDA and its Advisory Panel approved Truvada for PrEP suggest that this evidence is again anything but trustworthy:
“The committee voted 19-3 in favor of approval for the prevention indication — PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus” (Panel recommends approving Truvada to prevent HIV infection, Sandra Young, CNN, 10 May). Those votes mean that the panel judged it a greater risk when HIV-negative men have sex with men, or when the uninfected partner in a couple where the other is infected, than when “individuals . . . engage in risky sexual behavior that could result in their contracting the virus”? What possible basis could there be for such a comparative judgment?
“Committee members also heard concerns about the drug’s side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density”. Those committee members will not be able in the future to deny that they were voting to cause iatrogenic harm to healthy individuals who had other options for protecting themselves.
As history lauds in retrospect the FDA officer who held off from approving thalidomide, so in future we may look back approvingly on the attempt to block Truvada PrEP by one member of the committee:
“Dr. Lauren Wood of the National Cancer Institute said she voted against all preventive applications because clinical studies did not measure the dangers of drug-related renal problems among black people, who are among the hardest impacted by HIV infection and the most susceptible to kidney problems linked to AIDS drugs”.
Two-faced arguments are ubiquitous in the HIV/AIDS Wonderland. Typical of the mainstream Janus-faced propaganda were such comments as, on the one hand, “What we need currently is additional tools” even though, on the other hand, there already exists a “powerful tool box” which nevertheless hasn’t been any good: “We are not winning the battle” — all these comments are from the same individual.
“”Existing interventions have not reduced the number of new infections annually” (FDA panel backs Gilead’s Truvada to prevent HIV).
“Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling” (Truvada for HIV prevention backed by advisory panel, FDA may decide by June). That’s the study I debunked in “Pre-exposure prophylaxis: A flawed clinical trial that no one should take seriously
“”Existing interventions have not reduced the number of new infections annually” (FDA panel backs Gilead’s Truvada to prevent HIV).
“Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling” (Truvada for HIV prevention backed by advisory panel, FDA may decide by June). That’s the study I debunked in “Pre-exposure prophylaxis: A flawed clinical trial that no one should take seriously
Apparently this panel of experts was not aware of Nancy Padian’s success, more than a decade ago, in totally preventing infections merely by counseling and advising use of condoms: “We observed no seroconversions after entry into the study” (Padian et al., American Journal of Epidemiology 146 [1997] 350-7) among 175 discordant couples with >280 couple-years of follow-up; and they attributed the lack of transmission to the success of counseling. Since counseling brings no serious physiological side-effects, and the preventive success is 100%, there would seem to be no need for Truvada with its serious side-effects.
The case against approving Truvada PrEP is entirely separate from AIDS Rethinking: Mainstream data speak against administering so toxic a drug to healthy people, no matter how high may be estimated their risk of contracting a virus that supposedly causes illness only after an average latent period of a decade or so, and that is controlled without medication among some proportion of the infected, the “elite controllers”. Truvada PrEP incurs the certainty of early iatrogenic illness in exchange for some probability, which is undoubtedly low, given that the transmissibility of HIV with sex is on the order of 1 per 1000 unprotected acts.
On the PBS NewsHour on May 11, Anthony Fauci was featured. Not a single word was spoken about the toxic “side” effects. Not mentioned was the very low transmissibility, nor Padian’s astounding success with counseling and condoms. The only concerns mentioned had to do with cost and the need to adhere strictly to a pill-a-day. Fauci’s statements were fine examples of bureaucratic mumbo-jumbo, for instance:
“[I]t would add to the armamentarium of proven prevention modalities.
Prevention for HIV is really a comprehensive, multifaceted group of prevention modalities that’s kind of a tool kit. This one can be potentially very effective. So if it’s approved and added to the recognized prevention modalities, it would be an important advance in making available for certain people a very effective way to prevent HIV infection.”
“[I]t would add to the armamentarium of proven prevention modalities.
Prevention for HIV is really a comprehensive, multifaceted group of prevention modalities that’s kind of a tool kit. This one can be potentially very effective. So if it’s approved and added to the recognized prevention modalities, it would be an important advance in making available for certain people a very effective way to prevent HIV infection.”
To me, Fauci looked very stiff, as though he was unenthusiastic but trying to make up for it with plenty of “clearly”, “absolutely”, and the like. Could the utter absurdity of this FDA approval perhaps have penetrated his armamentarium of cognitive-dissonance modalities?
As I said at the outset: I thought I was familiar with all the aspects of the HIV/AIDS blunder, only to hear about this scandalous extrapolation of earlier misdeeds: hyping faulty evidence to give official approval to the poisoning of innumerable healthy individuals in a hugely expensive way ($12,000-14,000 annually)
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