Saturday, June 1, 2013

PEPFAR To Blow Millions on PrePex


PrePex had been running paid ads on high-end news outlets bidding for the WHO approval that would allow them to cash in on the African HIV/circumcision pie. They had a video on BBC, and ran dedicated articles on the Washington Post and the New York Times, as well as others.

Well, it looks like PrePex entrepreneurs have finally gotten their wish. According to the New York Times, the WHO has finally given their approval for the PrePex device, and PEPFAR leader Eric Goosby has already pledged to buy PrePex devices to circumcise as much as 20 million boys and men in Africa by 2015, under the ostensible pretense of "reducing HIV."


Grinning like a french poodle

In the New York Times, PrePex CEO Tzameret Fuerst said that the estimated price for each PrePex device would be an estimated $15 to $20 range. If PEPFAR pays for 20 million devices, that's a minimum of $300,000,000 a maximum of $400,000,000 American tax dollars that the program would spend on a dubious practice with speculative benefits, a waste of money considering that there are cheaper, less invasive, more effective ways of preventing HIV transmission.

No Demonstrable Scientific Proof Circumcision Prevents HIV
The sound bite that "circumcision reduces HIV 60%" is repeated over and over like a mantra, the WHO has given their blessing, and interested programs and manufacturers are promising to circumcise millions for foreign aid, but there is actually no scientifically demonstrable proof that circumcision does anything to prevent HIV transmission.

Close scrutiny of the so-called "research," however, reveals that there is actually no demonstrable scientific proof that circumcision does anything to prevent, or even "reduce the risk" of HIV at all, let alone by "60%." Circumcision promoters brush past this fact by distracting their listeners with the less-than impressive "60%" figure, and by mentioning how many men are "lining up to get circumcised." They need the money now, now, now.

There have been recent attempts to posit yet another hypothesis that attempts to explain "how circumcision prevents HIV," but they miss the mark, instead arriving at irrelevant conclusions, and not coming anywhere closer to furnishing the causal link for the so-called "effect" the much talked about "studies" were supposed to measure in the first place. Without a causal link, the "studies" are nothing more than statistics embellished with correlation hypothesis, and the efforts to circumcise millions in Africa are myth-based, not evidence-based.

African Men Not Buying into Circumcision for HIV Prevention
Despite the hyped up "mass circumcision" programs in Africa, it's been report after report of programs failing to meet their quota of circumcising boys and men in the past year.

Though they tried and tried, the much hyped Soka Unkobe program failed in Swaziland, where approximately 34,000 out of the expected 200,000 men (about 17%) were circumcised. Rather than abandon the strategy to mutilate the genitals of the men of Swaziland, American organizers are trying to figure out "what went wrong."Apparently, they feel they feel getting men to agree to have part of their penis cut off is simply a matter of "sending the right message." There is something wrong with an HIV prevention program that measures its progress by how many men they've circumcised, and not by how many they've educated about condoms and safe sex.

Three years into the 5 year program, only 80,000 of 1.2 million targeted men (about 6.7%) have been circumcised in Zimbabwe, and here too circumcision promoters are scratching their heads. Why aren't the men biting?

[There is no evidence that circumcising men in Zimbabwe has any effect against HIV.]

Zimbabwe - more circumcised men had HIV in 2005 and still do
Click to enlarge

In Botswana, programs are also failing to convince men to cut off part of their genitals. One program circumcised only 685 out of an intended 10,000. In another program, promoters convinced only 360 out of 2560 men (approx. 14%) to get circumcised. Here too, promoters are dumbfounded and can't find the right people to blame. It couldn't possibly have anything to do with the fact that they're trying to convince men to undergo permanently altering surgery on their genitals, could it?

In Zambia, circumcision uptake has also been low.

In Kenya, Homabay district, only 11,000 men have been circumcised out of the estimated 42,000 since September 2008 when the program was initiated. Here too, circumcision uptake has been low, so coordinators are targeting children who are neither at risk for HIV, nor putting others at risk, not to mention the ethical dilemma of forcibly cutting off part of the genitals of healthy, non-consenting individuals. (So much for "Voluntary Medical Male Circumcision.")

The WHO may have given their coveted blessing to plunder African HIV funds to PrePex, and PEPFAR leader Eric Goosby may have pledged American money to pay for their devices, but it remains to be seen whether the devices will actually ever be used, or if they'll simply remain sitting in storage compartments unused.

While a failure to implementing PREPEX would be ironically heartening insofar as it shows that African men aren't buying into the circumcision propaganda, it remains disturbing that millions of dollars that could be providing more effective aid and advances in public health are being wasted and squandered by PEPFAR.

Real World Data Fails to Correlate with "Findings"
While the "60% reduction" claim is repeated, it fails to manifest itself in the real world.

It is interesting that PEPFAR is so eager to help circumcise millions of men in Africa, while circumcision has done America no favors in terms of HIV reduction.

80% of America's male population is circumcised from birth, yet AIDS rates in some US Cities rival hotspots in Africa. In some parts of the U.S., they're actually higher than those in sub-Saharan Africa. According to a 2010 study published in the New England Journal of Medicine, rates of HIV among adults in Washington, D.C. exceed 1 in 30; rates higher than those reported in Ethiopia, Nigeria or Rwanda.

The Washington D.C. district report on HIV and AIDS reported an increase of 22% from 2006 in 2009. According to Shannon L. Hader, HIV/AIDS Administration, Washington D.C., March 15, 2009, "[Washington D.C.'s] rates are higher than West Africa... they're on par with Uganda and some parts of Kenya." (Hader once led the Federal Centers for Disease Control and Prevention's work in Zimbabwe)

According to a recent report:

"HIV/AIDS is the seventh leading cause of death in the United States among people age 15 to 24, and half of young people infected with HIV are not aware of it. An unbelievable 26 percent of all new HIV infections are among those 13 to 24."

Countries where circumcision falls below 20%, and HIV is less prevalent than the United States (By rank in HIV prevalence):
 
Colombia, Argentina, Uruguay, Cambodia, Peru, Nepal, Switzerland, Vietnam, Ecuador, France, Chile, Spain, Moldova, Mexico, Italy, India, Iceland, Costa Rica, Canada, Belarus, Austria, Paraguay, Netherlands, Ireland, Denmark, Bolivia, Bhutan, United Kingdom, Belgium, Nicaragua, Laos, Bulgaria, China, Cuba, Cyprus, Czech Republic, Finland, Georgia, Germany, Greece, Hong Kong, Hungary, Japan, Lithuania, Mongolia, New Zealand, Norway, Poland, Romania, Serbia, Slovakia, Sri Lanka, Sweden

There is a prevalence of European, South American and Asian countries. Countries where one might expect a higher HIV prevalence rate have a surprisingly low prevalence rate. One would expect a higher prevalence of HIV in these countries, but they fare better than the United States, where 80% of the men are circumcised, instead.

Before handing out millions to gold-mining circumcision device manufacturers, PEPFAR ought to address the question of why something that never prevented HIV in this country is suddenly going to start working miracles in Africa.

PrePex CEO Tzameret Fuerst Gloats
In the following video, Tzameret Fuerst can be seen gloating about securing billions from PEPFAR, one can almost see the dollar signs in her eyes, as if she actually cared about HIV prevention. She repeats the same old circumcision/HIV propaganda, touting circumcision as a "one-time intervention with the efficacy of a vaccine." Sharp viewers may note other thinly veiled interests.

It'd be interesting to see her credentials. She holds degrees in urology, surgery and epidemiology, and can explain to us the mechanism whereby circumcision immunizes a man against HIV I'm sure.





But all is not lost; this new device makes the argument that circumcision would be "more painful, more complicated and more traumatic as an adult" a moot point, if in fact, as Tzemeret tells us, her product is "virtually painless and simple to do."


Related Posts:
CIRCUMCISION: BBC Runs Paid PrePex Ad

CIRCUMCISION: The Washington Post Folds to the PrePex Ad Campaign

NYTimes Plugs PrePex, Consorts With Known Circumfetish Organization

Where Circumcision Doesn't Prevent HIV 

Where Circumcision Doesn't Prevent HIV II


CIRCUMCISION "RESEARCH": Rehashed Findings and Misleading Headlines
 
Politically Correct Research: When Science, Morals and Political Agendas Collide

18 comments:

  1. Israeli/Jewish ingenuity? 'We help our friends'? Collaborating nations/cultures working to spread genital mutilation to vulnerable countries...I feel frightful for both Americans and Jews abroad after watching this. History will not be kind and one word of derision will be 'Obama'. Shame.

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    1. "Ingenuity?"

      More like "opportunism."

      I am ashamed to call myself an American.

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  2. Thanks Joseph. No surprises that comments have been disabled for the youtube video of that woman spouting all her Jewish propaganda and misinformation.

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  3. Calling 60& less-than impressive is the first sign that everything that follows also comes from not understanding basic HIV science and epidemiology. Please save yourselves some embarrassment by first getting to grips with HIV epidemiology - otherwise, no-one who is serious about science will take you seriously

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    1. Well, since you are so serious about science, and have understanding of basic HIV science and epidemiology, then you should have no trouble explaining to us, right here in this comments section, precisely what this 60% figure means, and why it is so impressive.

      You should have no trouble explaining to us why this "60%" fails to manifest itself in the real world. (e.g., 10 out of 18 countries in Africa, America, the rest of the world, etc...)

      Furthermore, you should have no trouble explaining for us, right here, precisely how the foreskin facilitates HIV transmission, and how removing it "reduces" it at all, let alone by "60%."

      You may find the one who may need to save himself embarrassment is YOU.

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    2. That 60% just doesn't seem to happen in the real world though.

      From that USAID report:
      "There appears no clear pattern of association between male circumcision and HIV prevalence—in 8 of 18 countries with data, HIV prevalence is lower among circumcised men, while in the remaining 10 countries it is higher."
      http://www.measuredhs.com/pubs/pdf/CR22/CR22.pdf

      It seems highly unrealistic to expect that there will be no risk compensation. The South African National Communication Survey on HIV/AIDS, 2009 found that 15% of adults across age groups "believe that circumcised men do not need to use condoms".
      http://www.info.gov.za/issues/hiv/survey_2009.htm

      The 60% (more like 55% actually) only applies in trials of female-to-male transmission, but it is unclear if circumcised men are more likely to infect women. The only ever randomized controlled trial into male-to-female transmission showed a 54% higher rate in the group where the men had been circumcised:
      http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60998-3/abstract

      This 1993 study found that "partner circumcision" was "strongly associated with HIV-1 infection [in women] even when simultaneously controlling for other covariates."
      http://ije.oxfordjournals.org/cgi/content/abstract/23/2/371

      ABC (Abstinence, Being faithful, and especially Condoms) is the way forward. Promoting genital surgery seems likely to cost African lives rather than save them.

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    3. I don't understand how that 60% can be taken seriously, when the total number of lost individuals to the 3 RCTs is 3 times larger than the total number of seroconverted individuals, which means that if their information was known the results could be completely different. Not only that, but from the scientific method point of view, what you have there is a correlation but the main variable is unknown, in other words we don't know if all the individuals in the trial were exposed to the risk - in other words, had unprotected sex with an HIV+ female.

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    4. The scientific method also demands that results are reproduced, never mind the fact that it's been nearly 30 years, and "researchers" can't seem for the life of them to produce a demonstrable causal link between circumcision and a reduced likelihood of HIV transmission.

      We still haven't talked about what "60%" actually means (if indeed a causal link can be produced that substantiates it).

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    5. Joseph, I think you could have stated it better. The 60% reduction, which the crazy lady in the video inflated to 70%, does sound impressive until you realize that it is a relative risk and the absolute risk reduction in the randomized clinical trails was only 1.3%. That means that for every 75 circumcisions, 74 did not see any benefit from it. The relative risk reduction is a form of hyperbole for an intervention that has very little impact. Anyone who leads with the 60 or 70% reduction without mentioning the absolute risk reduction is trying to sell some snake oil. Regarding the woman in the video, if she is the woman I met at the AIDS conference in Washington, DC in 2012, she is a complete lunatic, and our tax money is going to make her rich. What some people will do for money, it makes prostitution look respectable.

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  4. The header on this site does not bode well for the kind of filter that needs to be applied to a scientific analysis of the effectiveness of Male Circumcision as a preventative agent against HIV. Joseph will always be an angry intactivist no matter what evidence is presented. It is always thus that our opinions are driven by something we are angry about. Thus, we can exclude Joseph's angry opinions from any scientific discourse. Having got rid of Joseph we can point casual readers to the gold standard of academic research, The Cochrane Collaboration. Please check this yourself. I quote:
    Siegfried N, Muller M, Deeks JJ, Volmink J
    Published Online: May 31, 2013
    Results from three large randomised controlled trials conducted in Africa have shown strong evidence that male circumcision prevents men in the general population from acquiring HIV from heterosexual sex. At a local level, further research will be needed to assess whether implementing the intervention is feasible, appropriate, and cost-effective in different settings.

    We conducted a meta-analysis of the secondary outcomes measuring sexual behaviour for the Kenyan and Ugandan trials and found no significant differences between circumcised and uncircumcised men. For the South African trial the mean number of sexual contacts at the 12-month visit was 5.9 in the circumcision group versus 5 in the control group, which was a statistically significant difference (p < 0.001). This difference remained statistically significant at the 21-month visit (7.5 versus 6.4; p = 0.0015). No other significant differences were observed.

    Incidence of adverse events following the surgical circumcision procedure was low in all three trials.

    Reporting of methodological quality was variable across the three trials, but overall, the potential for significant biases affecting the trial results was judged to be low to moderate given the large sample sizes of the trials, the balance of possible confounding variables across randomised groups at baseline in all three trials, and the employment of acceptable statistical early stopping rules.

    Authors' conclusions:
    There is strong evidence that medical male circumcision reduces the acquisition of HIV by heterosexual men by between 38% and 66% over 24 months. Incidence of adverse events is very low, indicating that male circumcision, when conducted under these conditions, is a safe procedure. Inclusion of male circumcision into current HIV prevention measures guidelines is warranted, with further research required to assess the feasibility, desirability, and cost-effectiveness of implementing the procedure within local contexts.

    Please note that this is in no way an attempt to persuade Joseph to change his mind about intact foreskins. That is impossible and undesirable. I just hope that for his own sake his wisdom teeth which he had clearly also refused to have extracted will not cause him unnecessary pain in his old age.

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    1. "The header on this site does not bode well for the kind of filter that needs to be applied to a scientific analysis of the effectiveness of Male Circumcision as a preventative agent against HIV. Joseph will always be an angry intactivist no matter what evidence is presented. It is always thus that our opinions are driven by something we are angry about. Thus, we can exclude Joseph's angry opinions from any scientific discourse."

      Points are valid, whether or not the person who makes them is angry.

      My opinions are driven by my anger, it's true. But I have never failed to declare my interests. In fact I never try to hide them, but have been up front from the very beginning.

      It is those who attempt to veil their interests in male genital mutilation with an interest in "disease prevention" and "public health" whose potential conflicts of interest need to be scrutinized.

      It is true that I will always be an angry intactivist no matter what "evidence" is presented; it is a mistake to think that the moral acceptability of genital mutilation depends on "evidence"; there is no amount of "evidence" that would ever justify the forced genital mutilation of females.

      This ought to render any talk of research and science moot, but I find a problem with what interested "researchers" are trying to pass off as "scientific evidence." If the "research" is flawed, then it needs to be pointed out for its own sake. The premise that a violation of basic human rights can be justified with "research" is angering enough.

      You can excuse my angry opinions, yes. But I ask valid questions that remain valid despite my anger and my opinions.

      Let it be known; as in female circumcision, or other human rights atrocities, there will never be enough "evidence" to justify male genital mutilation, euphemised as "circumcision." Pseudo-science needs to be called out when interested "researchers" present it. It ought to anger real researchers and scientists that this crap that the UN has used to endorse the mass genital mutilation of Africa passes as "science."

      "Having got rid of Joseph we can point casual readers to the gold standard of academic research, The Cochrane Collaboration."

      ad verecundiam

      You can dismiss me if you want; right after writing your vindictive comment ;-).

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    2. As for your quote, I'm afraid this is yet another one of those "meta-analyses," isn't it, which suffers from the same gargbage-in-garbage-out problem as the rest of them.

      You can keep calling a dog's tail a leg ad nauseam, but it will always be a tail.

      Your quote fails to address questions I ask throughout this blog.

      1. If male circumcision prevents men in the general population from acquiring HIV from heterosexual sex, and the so-called "evidence" is so "strong," why isn't this self-evident in the real world? Why isn't this effect manifested in populations where circumcision is already prevalent? The United States, for example? Are you aware that the United States, where 80% of the male population is already circumcised, has a higher HIV transmission rate than 53 countries in the world where circumcision is rare? (e.g. below 20%?) According to USAID, HIV transmission was found to be more prevalent among the circumcised population in 10 out of 18 countries?

      2. Without a demonstrable causal link, how can "researchers" be sure that circumcision reduces HIV transmission at all, let alone 60%?

      3. Even if it can actually be proven "beyond the shadow of a doubt" that circumcision does "reduce HIV transmission" by that magical "60%," how is this even impressive, when condoms prevent HIV by over 90% in BOTH partners, not just from female to male? Even if circumcision prevented HIV by "60%" in males, how does this benefit females, who will be exposed 100% to viral load in HIV+ semen?

      What kind of idiot would choose to circumcise himself knowing full well he'd still have to wear a condom?

      Not me, that's for sure.

      You'd have to be given misinformation, which I believe is happening in these "mass circumcision trials" in order to fulfill quotas. (Apparently, despite all their efforts, many programs are failing to meet their quotas BTW...)

      These questions need to be explained first before assessing "whether implementing the intervention is feasible, appropriate, and cost-effective in different settings."

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    3. "Please note that this is in no way an attempt to persuade Joseph to change his mind about intact foreskins. That is impossible and undesirable."

      What I think about intact foreskins or circumcised penises is irrelevant.

      It's about the many principles being violated; genital integrity, self-autonomy, informed consent, intellectual honesty.

      Just as female genital mutilation is deemed always wrong, and there would never be enough "evidence" to justify it, the same is also true with male circumcision.

      The premise that a human rights violation can be justified with "scientific evidence" is deplorable enough; that interested "researchers" are writing pseudo-science to justify a deliberate human rights violation is despicable. Josef Mengele comes to mind.

      It should be of concern to adherers of the scientific method that interested "researchers" are trying to get away with insulting peoples' intelligence with crap they're trying to pass off as "the gold standard."

      "I just hope that for his own sake his wisdom teeth which he had clearly also refused to have extracted will not cause him unnecessary pain in his old age."

      Oh? Have we met? Something tells me we have. :-D

      Thank you for wishing me well. If and when the extraction of my wisdom teeth becomes necessary, I will submit to it. But this really applies to any other part of my body in old age, doesn't it...

      Let it be known; I think the current "research" is complete crap. The very fact that it's been almost 30 and "researchers" have yet to produce a demonstrable causal link should be damning enough.

      But even if the "research" could be proven to be 100% accurate, this still does not justify the forced genital mutilation of infants.

      When and if, and only when and if, a causal link between circumcision and a reduced transmission of HIV would finally produced, I would cease my criticism of the "research." But it would still not justify the forced circumcision of males. It still needs to be an informed male's choice.

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    4. And how do you explain that the number of loss individuals to the three RCTs is 3 times that of the number of seroconversions? How can the result be statistically significant with such large unknown?

      Also, as I mentioned above, it is impossible to know if all the participants of the RCTs were exposed to the risk, in other words had unprotected sex with a HIV+ female. Any individual who either didn't have sex with a HIV+ female, or was using a condom when he did so, wouldn't add any information to the RCT.

      Finally, I'm sure we will agree that there is no proven causal link between circumcision and lower risk of contracting HIV - in other words, something that can be observed, that can be described, in other words real evidence. So all there is, is a roll call of individuals with a lot of uncontrolled variables used to draw some wishful conclusions from them.

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  5. The Cochrane Collaberation looked at HIV and circumcision twice. The first time, before the three RCTs, they found insufficienct evidence of a connection. The second time they looked only at the three RCTs and found a connection, so the claims rely solely on the RCTs. But like everyone else, they weren't able to examine the raw data, and the various criticisms of the RCTs still apply.

    "60% reduction" has become a mantra, but it is ONLY of female-to-male transmission, a much less significant direction than male-to-male or male-to-female. The RCTs assume that all the HIV acquisition was 1) sexual and 2) from females. Non-sexual transmisison is a large and under-considered issue in Africa. When one of the trials was carried out in Uganda, where crowds may charge through the streets calling for death for homosexuals, male-to-male contact and hence transmission is sure to be underreported.

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  6. The attitude of Andre Smith reminds me of Richard Wamai and reminds me of Jake Waskett. Basically, arrogance that expects to overwhelm with an appeal to authority but without providing substance.

    Circumcision program promoters should be willing to discuss their conclusions, their data and the methodology, if they really expect to have any chance. If they don't have solid data or methodology, then all they can do is try to be authoritarian and hope that will shame critics into silence.

    If they want to get men to give up part of their genitals, they better have a solid reason and the ability to relay it.

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  7. So PrePex is supposed to be painless, eh? Good. Let it be known that it is now indeed LESS painful to be cut as an adult. A device like this should take away one of the "pros" of infant circumcision (less pain) and be further reason to wait.

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  8. A "Call to Action" post, to alert the State Department to the adverse consequences of funding circumcision programs in Africa (via PEPFAR), has been made over at F-R.net. Deadline 14 June 2013.

    Due to a past lack of oversight by the CDC, the State Department is proposing to require recipients of PEPFAR funds to account for expenditures by program area. This response is in agreement with this requirement, also highlighting the lack of oversight and free-spending culture of the NIH at the time of sponsoring the circumcision trials in Africa (evidenced by the six OIG reports cited), the adverse affects of funding circumcision in Africa (coercion of men and boys to be circumcised, misdirection of scarce medical resources from higher priority health areas), and continuing problems within the CDC raising questions about the ability of the organisation to oversee recipients of federal funds (the more recent OIG report identifying problems in the management of the 'Vaccines for Children' program).

    For further details, please see:

    http://www.foreskin-restoration.net/forum/showthread.php?t=14318

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