Don't Get Stuck With HIV

Look both ways! HIV is caused by sex AND by unsafe healthcare and cosmetic practices

Today’s denialists undermine HIV prevention and stigmatize Africans with HIV


Yesterday’s AIDS denialists claimed HIV did not cause AIDS. With insignificant exceptions, that stupid belief has gone the way of the dodo. Although that belief was all over the internet, it had little influence on policy except in South Africa, where it delayed government support for anti-retroviral drugs to prevent mother-to-child HIV transmission and to treat HIV infection.

Today’s denialists accept that HIV causes AIDS but they deny – despite evidence to the contrary – that a large proportion of Africans infected with HIV got it from blood through skin-piercing procedures in health care and cosmetic services. Today’s HIV-from-blood denialists are influential and dangerous:
• They draft and fund HIV prevention messages that ignore risks in skin-piercing procedures.
• They stigmatize HIV-positive Africans and threaten them and their families by blaming them for sexual misbehavior.
• They promote racist stereotypes of African sexual behavior by claiming that most African adults with HIV (more than 200 in 1,000 in several countries) got it through heterosexual sex (whereas elsewhere in the world less than 1 in 1,000 adults gets HIV that way).
• They mismanage research to avoid unwanted results; researchers who are denialists do not ask about or report skin-piercing procedures as risks for HIV.

In sum: today’s HIV-from-blood denialists contribute to Africa’s continuing high rates of HIV infection. Whereas most of yesterday’s denialists were outside the medical profession and had little money to play with, today’s HIV-from-blood denialists are led by medical professionals in WHO, donor governments, and leading universities. Medical professionals have a conflict of interest when it comes to Africa’s HIV epidemics: Recognizing and admitting infections from blood on skin-piercing instruments would motivate and empower the public to demand safer and better health care. Health care professionals divert critical attention by blaming infections on victims’ sexual behavior.

 

More junk science underestimating HIV from medical injections


AIDS experts still haven’t figured out what is different about Africa that can explain why HIV epidemics there are so much worse than elsewhere. The continuing failure to find what is different exposes persistent (intentional or natural) incompetence on the part of respected researchers.

Specifically, scores of studies that have tested, followed, and retested hundreds of thousands of HIV-negative Africans to find when and how they get HIV have failed to trace the source of observed new infections.[1] Without tracing the source, there is no way to say infections came from sex – but “HIV from sex” is nevertheless the conclusion (and racist slur) from decades of incompetent, incomplete research. When such studies find people with new HIV infections who report no possible sexual exposure to HIV, researchers characteristically reject the evidence: “hmmmm, an African with HIV…must have lied about sexual behavior….”

With that “scientific” method, the US National Institutes of Health and UK’s Medical Research Council could save money by paying researchers sitting in offices in Baltimore, US, or Oxford, UK, to make up data to fit pre-determined conclusions. That would be more efficient than paying them to go to Africa, collect data, and then reject what doesn’t fit desired conclusions.

While funders have avoided funding good science to explain Africa’s HIV epidemics – for 30 years and counting – they have been all too happy to fund junk science that will get the desired results. One popular junk-science strategy to get desired results has been to model Africa’s HIV epidemic with unreliable parameters and weak, selected, or made-up data.

The latest paper by Pepin and colleagues[2] falls into that category of junk science – presenting a model with unreliable parameters and data, and using results from the model to claim that unsafe medical injections accounted for less than 1% of new HIV infections in Africa in 2010 (8,000-16,000 from injections vs. 1.9 million total new infections[3]).

Several obvious problems with the estimate are as follows:

1. Pepin’s assumed rate of HIV transmission through a contaminated syringe or needle – 1 in 150-300 injections – is far too low to allow observed HIV outbreaks through health care in Russia, Romania, Libya, and elsewhere. If those outbreaks occurred – they did! – then Pepin’s proposed rate of HIV transmission through injections is misleadingly low. For example, in Russia in 1988-89 hospital procedures passed from HIV from 1 child to more than 260 children in 15 months. Most transmissions in this outbreak came from children who had been infected less than 6 weeks earlier – enough time for infected children to get dozens but not 150-300 skin-piercing procedures followed by reuse of unsterilized instruments.[4]

2. Pepin’s same model estimates 4,300-8,500 new hepatitis C virus (HCV) infections in Africa from unsafe injections in 2010, less than 1% of estimated new HCV infections (cf: an estimated 18 million Africans were living with HCV in 2005[5], which corresponds to approximately 1 million new infections per year). Because virtually all new HCV infections come from blood, not sex, it’s likely that unsafe injections account for a lot more than 1% of new HCV infections – and by extension, more than 1% of new HIV infections as well. Furthermore, other skin-piercing procedures aside from injections likely account for a lot of new HCV infections – and by extension a lot of new HIV infections as well.

3. Pepin’s estimates distract from facts that need answers. Why do 16%-31% of HIV-positive children in Mozambique, Swaziland, and Uganda, have HIV-negative mothers (among children with tested mothers)?[6] Why do so many mutually monogamous couples find that one or both partners are HIV-positive?

In his conclusion, Pepin commendably recognizes “other modes of iatrogenic transmission” including[2]: “use of multi-dose medication vials, phlebotomies with re-used needles, dental care with improper sterilisation of instruments, unscreened transfusions, ritual scarifications and circumcisions performed by traditional practitioners… Better measurement of such exposures and of their impact on viral dynamics is an essential first step…”

Even so, Pepin does not hit the nail on the head. What is required to measure the “impact [of such procedures] on viral dynamics” is to trace HIV infections to their source. When infections are traced a hospital, dental clinic, tattooist, etc, then continue with outbreak investigations to determine the extent of the damage from unsafe health care or other skin-piercing procedure.

References

1. Gisselquist. Randomized controlled trials for HIV/AIDS prevention in Africa: Untraced infections, unasked questions, and unreported data. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1940999 (accessed 14 June 2014).

2. Pepin et al. Evolution of the global burden of viral infections from unsafe medical injections, 2000-2010. PLOS one 2014; 9: 1-8. Available at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0099677 (accessed 14 June 2014).

3. Annex table 9 in: UNAIDS. Global HIV/AIDS Response: Epidemic update and health sector progress towards Universal Access, progress report 2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241502986_eng.pdf?ua=1 (accessed 15 June 2014).

4. See: http://dontgetstuck.org/russia-cases-and-investigations/

5. Hanafiah et al. Global epidemiology of hepatitis C virus infection. Hepatitis 2013. Available at: http://onlinelibrary.wiley.com/doi/10.1002/hep.26141/pdf (accessed 14 June 2014).

6. See pages for Mozambique, Swaziland, and Uganda at: http://dontgetstuck.org/cases-unexpected-hiv-infections/; see also: http://dontgetstuck.wordpress.com/cases-unexpected-hiv-infections/).

The curious state of medical ethics in the UK


The UK’s Medical Research Council funded a long-running study that watched HIV-positive men and women in Masaka, Uganda, who didn’t know they were infected, pass HIV to unsuspecting spouses. The same study asked adults who didn’t know they were infected to come to a clinic every three months so a doctor (who didn’t know they were infected) could see how they got sick and died of AIDS. The doctor had no drugs to treat HIV infection.

Leading medical journals have been silent about that and other ethical outrages perpetrated on Africans in the name of HIV research and prevention.

So it’s good to see Lancet Infectious Diseases, a leading medical journal published in the UK, pay some attention to ethics. Specifically, an editor’s note in the March 2014 issue suspects an unnamed reviewer to have committed a “breach of ethics”[1] by leaking an article [2] under review to an organization that put it on the web.

But was the leak unethical? Consider what was leaked.

The leaked article is a revised draft of a still-secret document that reviews evidence of the effect of Depo-Provera (hormone) injections for birth control on women’s risk to get HIV. The secret document was prepared by employees of USAID and the US Centers for Disease Control and Prevention. Because the document is still secret, we don’t know whether it could pass scientific scrutiny. The revised and published version, with serious methodological flaws,[3] concludes (p 806): “[A] causal effect [of Depo-Provera use on women’s HIV acquisition]…has not been shown.”

This conclusion is curious. Medical researchers accept that giving monkeys Depo injections increases their susceptibility to HIV-like virus.[4] Most studies that follow women to look for new HIV infections and ask about Depo find that women taking Depo are more likely to get HIV compared to women not taking Depo.[5]

The secret review was presented at a meeting organized by WHO in early 2012, bringing together 75 experts from 18 countries.[6,7] “The meeting was closed to the public. Invitees “were required to sign confidentiality agreements… They had to promise not to divulge anything that was said during the three days…”[8]

According to WHO, “The experts [attending the closed meeting] recommended that women living with HIV, or at high risk of HIV, continue to use hormonal contraceptives to prevent pregnancy.” Because WHO swore attendees not to talk about the meeting, there is no record of attendees’ support or opposition to that statement. Less than a month after the experts meeting, WHO recommended that “women…at high risk of HIV can safely continue to use hormonal contraceptives to prevent pregnancy.”[9]

With this recommendation, WHO urges health professionals to violate women’s human rights. According to the UN, “Failure to provide information, services and conditions to help women protect their reproduction health…constitutes gender-based discrimination and a violation of women’s rights to health and life.”[10] Similarly, the World Medical Association’s Declaration of Lisbon on the Rights of the Patient states: “Every person has the right to health education that will assist him/her in making informed choices about personal health and about the available health services.”[11]

Who currently controls the secret document? Lancet Infectious Diseases did not publish the draft document as submitted, but rather participated in review and revision. Is that an ethical violation – withholding from women the information used to develop birth control recommendations?

How is it that none of the 75 technical experts sworn to secrecy have leaked the document? Do they consider their promise to WHO to keep the paper secret to over-ride their ethical obligations as health care professionals to tell women about health risks?

————————————-

1. McConnell J. Editor’s note. Lancet Infectious Diseases 2014; 14: 182. Available at: http://download.thelancet.com/pdfs/journals/laninf/PIIS147330991370344X.pdf?id=caaVoShgq9KZ0gA3_6Rxu (accessed 10 May 2014).
2. Polis and Curtis. Use of hormonal contraceptives and HIV acquisition in women: a systematic review of the epidemiological evidence. Lancet Infect Dis 2012; 13: 797-808. Available at: http://download.thelancet.com/pdfs/journals/laninf/PIIS1473309913701555.pdf (accessed 10 May 2014).
3. The review of evidence excluded two studies that met the review’s stated criteria for inclusion but disagreed with the review’s conclusion (Malawi 2003-05 as reported in Kumwenda et al, Clin Infect Dis 2008, vol 46, pp 1913–20; and South Africa, as reported in Wand et al, AIDS 2012, vol 26, pp 375-380).
4. Highleyman L. ICAAC 2013: Tenofovir vaginal ring protects monkeys on Depo-Provera against HIV-like virus. 13 September 2013. Available at: http://www.hivandhepatitis.com/hiv-aids/hiv-aids-topics/hiv-prevention/4307-icaac-2013-tenofovir-vaginal-ring-protects-monkeys-from-hiv-like-infection (accessed 13 May 2013).
5. Don’t Get Stuck with HIV. Hormone injections increase women’s risk to get HIV. Available at: http://dontgetstuck.wordpress.com/hormone-injections-increase-womens-risk-to-get-hiv/ (accessed 13 May 2014).
6. WHO. WHO to issue guidance on hormonal contraceptives and HIV. WHO Media Center Statement 3 February 2012. Available at: http://www.who.int/mediacentre/news/statements/2012/contraceptives_20120203/en/ (accessed 10 May 2014).
7. WHO. WHO upholds guidance on hormonal contraceptive use and HIV. Media Center Notes for the Media. 16 February 2012. Available at: http://www.who.int/mediacentre/news/notes/2012/contraceptives_20120216/en/ (accessed 10 May 2014).
8. Donovan P. The UN’s gag order on reproductive health. AIDS-Free World, 13 February 2012. Available at: http://aids-freeworld.org/Our-Issues/Womens-Rights/~/media/Files/Womens%20Rights/UN%20gag%20order%20reproductive%20health.pdf (accessed 10 May 2014).
9. WHO. WHO upholds guidance on hormonal contraceptive use and HIV. Media Center Notes for the Media. 16 February 2012. Available at: http://www.who.int/mediacentre/news/notes/2012/contraceptives_20120216/en/ (accessed 10 May 2014).
10. http://www.unfpa.org/gender/empowerment.htm
11. World Medical Association. 2005. Declaration of Lisbon on the Rights of the Patient. Ferney-Voltaire, France: WMA. Available at: http://www.wma.net/en/30publications/10policies/l4/ (accessed 18 August 2012).

Absurd and stigmatizing estimates about how most adults in Malawi get HIV


The WHO and UNAIDS promote their Modes of Transmission model[1] to estimate numbers of HIV infections that adults get from various risks. The model has a simple mistake in its design – causing anyone who uses it to overlook crucial data on HIV in married couples and leading thereby to grossly inflated estimates of numbers of HIV infections acquired from spouses.[2,3]

Several experts recently used WHO’s and UNAIDS’s Modes of Transmission model to identify important risks in Malawi’s HIV epidemic. Their published results[4] provide another illustration of ridiculous, stigmatizing, and anti-family estimates produced by the model. Here’s the gist of what they conclude: Infections from spouses account for 81% of new HIV infections in Malawi (76,688 out of an estimated total of 94,455 infections; see Table).

Simple logic says this is absurd, even without looking at any evidence or data: The number of people getting HIV from their spouses cannot exceed the number of spouses bringing HIV into their families (from any source, such as unsafe health care or non-spousal sex partner). This is logically necessary year-by-year in an epidemic, such as Malawi’s, that has been more or less stable over time. Furthermore, a large percentage of people who are married and HIV-positive die without ever infecting their spouses. So the number of new infections coming from spouses will be much less than half of all new infections.

But that’s not what the model says. Where’s the problem?

The model starts out OK: Using data for 2007, the model finds 2,095,000 married men and 2,497,000 married women (roughly 20% of women were in polygamous marriages).[4] Next, using data from Malawi’s 2004 national Demographic and Health Survey,[5] the model recognizes that more than 10% of married men and women were HIV-positive. So far so good.

But then the model falls off the rails. It assumes that almost all HIV-positive married adults were a risk to infect their spouses. This ignores the well-documented fact that many people who are married and HIV-positive have partners who are also HIV-positive – no one is going to infect anyone in such couples. According to the same 2004 national survey, only 4% of married men in Malawi were at risk to get HIV from their wives (that is, 4% were HIV-negative with an HIV-positive wife), and only 5.7% of married women were at risk to get HIV from their husbands.

Table 1: Estimated number of HIV infections acquired from spouses

Model, risk category for married adults Number of married men Number of married women Model’s estimated number of infections from spouses
Estimates from the Modes of Transmission model (see reference 4)
People who are mutually monogamous 882,000 1,284,000 34,673
Married people who have casual partners 589,000 222,000
People whose spouses have casual partners 222,000 589,000 25,023
Clients of sex worker and wives of such men 388,000 388,000 16,978
 Men who have sex with men and wives of such men 14,000 14,000 14
Total married adults and total estimated infections from spouses according to the Modes of Transmission model 2,095,000 2,497,000 76,688
Alternate estimate recognizing that most HIV-positive married adults have HIV-positive spouses
Total married adults (from Modes of Transmission model) 2,095,000 2,497,000
Married and at risk to get HIV from a spouse (4% of married men, 5.7% of married women; see table12.10 in reference 5) 84,000 142,000
Estimated new infections (assuming a 6.6% annual rate of HIV transmission from wives to husbands and 9.9% from husbands to wives; see reference 2) 5,500 13,500 19,000

Thus, only 226,000 married adults (4% of husbands and 5.7% of wives) were at risk to get HIV from their spouses (see next to last row in the Table). How many of these 226,000 will get HIV from their spouses in a year? During the 1990s, 5 studies in Africa followed discordant couples (only one spouse HIV-positive) to watch HIV transmission from one to the other – distressingly, these studies did not routinely warn participants that they or their partner was infected. With few couples taking care to avoid transmission, 6.6% of HIV-positive wives infected husbands in a year, and 9.5% of HIV-positive husbands infected wives in a year (these rates are from a recent review [2]). With these rates of transmission, 226,000 HIV-positive married men and women in Malawi infected an estimated 19,000 spouses in 2007 – only 20% of the estimated 94,454 new HIV infections in Malawi in 2007.

The Modes of Transmission model’s gross and logically absurd overestimate of numbers of HIV infections from spouses is not harmless. Consider these damaging consequences:

1. Diverting attention from HIV risk in unsafe health care: If sex in marriage accounts for only 20% of new HIV infections instead of 81% as estimated by the Modes of Transmission model, then most infections need to be explained by other risks. What are those other risks? The Modes of Transmission model estimates that all non-spousal sex – casual, commercial, and male-male sex – accounts for a combined total of only 18% of infections. If all sexual risks account for only 38% of infections – 20% from spouses and 18% from other sex partners – what non-sexual risks account for the remaining 62% of infections? The Modes of Transmission model avoids this question by grossly overestimating numbers of HIV infections from spouses.

2. Stigmatizing HIV-positive adults: The estimate produced by the Modes of Transmission model – that sex accounts for more than 99% of HIV infections among adults – stigmatizes all HIV-positive adults with the charge they got it from sex. Publishing such estimates contributes to what could be considered a form of sexual abuse – spouses, relatives, and others accusing people of sexual behavior for which there is no evidence. The estimate coincides with racist stereotypes of sexual behavior, which protect it from critical review.

3. Undermining families: Stigmatizing all HIV-positive adults with the charge they got if from sex breeds suspicion among married adults when one or both learn they and/or their partner are HIV-positive. Lack of trust between spouses weakens families and harms children.

The motivation for such misinformation may be traced to a conflict of interest common among health care professionals – who do not want people to know that unsafe health care contributes to Africa’s HIV epidemics. Rather than admitting the obvious (and doing something about it), health care professionals have been blaming victims, insinuating that almost all African adults with HIV got it from sex. The Modes of Transmission model is part of that stigmatizing and racist smear.

References

1. UNAIDS. Modes of Transmission spreadsheet. Geneva: UNAIDS, 2012. Available at: http://www.unaids.org/en/dataanalysis/datatools/incidencebymodesoftransmission/ (accessed 24 April 2014).

2. Gisselquist D. UNAIDS’ Modes of Transmission model misinforms HIV prevention efforts in Africa’s generalized epidemics. Social Science Research Network, 24 August 2013. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2315554 (accessed 24 April 2014).

3. Gisselquist D. Misinformation from UNAIDS’ flawed Modes of Transmission model. dontgetstuck, 14 September 2013. Available at: http://dontgetstuck.wordpress.com/2013/09/14/misinformation-from-unaids-flawed-modes-of-transmission-model/ (accessed 24 April 2014).

4. Maleta K, Bowie C. Selecting HIV infection prevention interventions in the mature HIV epidemic in Malawi using the mode of transmission model. BMC Health Services Research 2010; 10: 243. Available at: http://www.biomedcentral.com/content/pdf/1472-6963-10-243.pdf (accessed 22 April 2014). At the end of this article, see the link to Additional file 1: Data sources used to populate the Mode of Transmission model – Malawi 2007.

5. ORC Macro. Malawi Demographic and Health Survey 2004. Calverton: ORC Macro, 2005. Available at: http://dhsprogram.com/pubs/pdf/FR175/FR-175-MW04.pdf (accessed 26 April 2014).

Using Bad Data to Obscure Deadly Errors


In an article published in early December 2012, Jacques Pepin and colleagues reported that less than 1 in 20 Africans received an unsafe injection in 2010.[1] According to them, this was a huge improvement from the situation in 2000, when more than 1 in 3 got an unsafe injection.

The story sounds good, but let’s put it into context.

First, these rosy estimates distract from facts that need answers. Why do 16%-31% of HIV-positive children in Mozambique, Swaziland, and Uganda, have HIV-negative mothers (among children with tested mothers; see: http://dontgetstuck.wordpress.com/cases-unexpected-hiv-infections/). Why do so many mutually monogamous couples find that one or both partners are HIV-positive?

Second, the authors accept a double standard. In countries that fund health aid programs in Africa, governments respond to recognized reuse of unsterile instruments in health care with investigations to see if patients have been harmed. For example, after authorities in New Zealand found that a clinic had reused unsterilized instruments, governments of New Zealand and Australia issued a public notice warning people who had attended the clinic during 2010-12 that they might have been exposed to hepatitis B, C, or HIV and inviting them to come for tests.[2] But if the clinic with recognized unsafe procedures is in Africa, the response is entirely different. In Africa, people who present themselves as concerned and knowledgeable about health care safety, such as Pepin and colleagues, estimate that percentages of procedures are unsafe without asking for investigations. Such bland acceptance of deadly errors endorses a double standard.

Third, what Pepin and others state as facts are weak estimates based on unreliable data. Most of their data for 2010 comes from national surveys that asked people – in the midst of several hours of questions[3] about diet, education, birth control, sexual behavior, and blah, blah, blah – how many injections they had in the last year and whether the syringe and needle for the last injection came from a sealed pack. In a long survey, people are not able to take time to think and remember. Even with time to think, it’s hard to remember numbers of injections over the past year. Consider: A survey in India asked people if they had received an injection in the last 2 weeks and if they had received an injection in the last 3 months. The estimated number of injections per person per year was 5.9 based on 2 week recall, but only 2.9 based on 3 month recall.[4]

A bad manager listens to sycophants who tell him soothing fantasies that encourage him to ignore uncomfortable facts. I expect there will be many bad managers in health aid organizations and in African ministries of health who will be only too ready to cite Pepin and colleagues’ soothing fantasies rather than to do the right thing – to trace and investigate sources of HIV infection. Pepin and colleagues are not alone. For decades, sycophants who can cobble together weak evidence and arguments to say Africans only rarely get HIV from health care have gotten more attention than so many HIV-positive children with HIV-negative mothers.


 

[1] Pepin J, Abou Chakra CN, Pepin E, Nault V (2013) Evolution of the Global Use of Unsafe Medical Injections, 2000–2010. PLoS ONE 8(12): e80948.

doi:10.1371/journal.pone.0080948. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3851995/pdf/pone.0080948.pdf (accessed 22 December 2013).

[2] NZers warned over HIV at Sydney clinic. New Zealand: NZCity, 16 December 2013. Available at: http://tinyurl.com/l34v4ab (accessed 22 December 2013).

[3] ICF International. Demographic and Health Surveys Methodology: Questionnaires: Household, Woman’s, and Man’s. Calverton, Maryland: ICF International, 2011. Available at: http://www.measuredhs.com/pubs/pdf/DHSQ6/DHS6_Questionnaires_5Nov2012_DHSQ6.pdf (accessed 23 December 2013).

[4] See Table II in: Arora N K, et al. Assessment of Injection Practices in India, Executive Summary. New Delhi: InClen Trust, 2005. Available at: http://www.inclentrust.org/uploadedbyfck/file/complete%20Project/Executive%20summaru/15_Main%20Report%20Book%20(29-6-06)%20only.pdf (accessed 22 December 2013).

Do medical researchers in Africa protect babies? Maybe not always


[Note: For more information, see Jim Thornton’s 11 October blog on “Boston/Botswana circ. trial update,” available at: http://ripe-tomato.org/2013/10/11/bostonbotswana-circ-trial-update/]

As part of medical research to find the best technique to circumcise new-born boys in Africa, a doctor in Botswana circumcised 300 babies 2-11 days old during 2009-10. The US government paid for the research, and a doctor from Brigham and Women’s Hospital in Boston managed the research [reference 1, below].

Three of the 300 babies died within 4 months after being circumcised [reference 2]. There is no controversy about two of the deaths: one baby died after “prolonged coughing and diarrhea” more than 10 weeks after being circumcised; a second died of gastroenteritis 25 days after circumcision [3].

However, one baby’s death raises questions. The day after being circumcised, the baby was brought to the local health center with fever and difficulty breathing, and was then transferred to the district hospital. He died that day – only 3 days old and 1 day after being circumcised. The research staff did not learn of his hospital admission or death until the next day [3].

Did the circumcision contribute to his death? Without reporting any information from blood or other tests or any observation of the infant’s circumcision wound, the study team in April 2013 reported the baby “died of neonatal sepsis on his second [3rd?] day of life, with the death reviewed by the study Data Safety and Monitoring Committee, Botswana Health Research and Development Committee, and Brigham and Women’s Hospital Institutional Review Board and not thought to be procedure related” [emphasis added; from pp e133-134 of reference 1].

So, with stout denials but minimal information, the question is still there: Did the circumcision contribute to the baby’s death?

Here’s an expert opinion by Dr Jim Thornton, former editor of the British Journal of Obstetrics and Gynecology (quoted from: http://ripe-tomato.org/2013/10/11/bostonbotswana-circ-trial-update/): “A healthy term baby dies 24 hours after a research operation and no tests nor autopsy are done. However the researchers, their own DSMC [Data Safety Monitoring Committee], and the two IRB’s [Institutional Review Boards] who had approved the research all conclude ‘that it was extremely unlikely that the baby’s death was related to the circumcision procedure’! Am I going mad? ‘Extremely unlikely’! How can any sane doctor possibly conclude that?”

Medical researchers are ethically and legally responsible to protect research participants. Because the study was funded by the US government, US laws apply. The research team did not report adequate information to support their claim the death was unrelated to the circumcision. Without convincing evidence the death was not related, it should have been reported as possibly related, as required by US regulations (see section b in this link: http://www.hhs.gov/ohrp/policy/advevntguid.html#Q2; see also regulation 45 CFR 46.103(b)(5) in this link: http://www.gpo.gov/fdsys/pkg/CFR-2011-title45-vol1/pdf/CFR-2011-title45-vol1-sec46-103.pdf ). Accepting the possibility the circumcision was at least partially responsible for the baby’s death, the researchers should have reported the death as an adverse event and compensated the parents for the death of their child.

Because the death was not adequately explained, because researchers’ denied responsibility with insufficient evidence, and because the Institutional Review Board at Brigham and Women’s Hospital’s did not insist that researchers adequately explain the death and/or acknowledge the possibility the death may have been related to the research, the US government’s Office for Human Research Protections should investigate the death, the management of the research project, and the conduct of the Institutional Review Board.

On 18 July 2013, eight doctors disturbed by the baby’s death wrote to the US Office of Human Research Protections asking for an investigation and complaining that the Institutional Review Board’s “monitoring of adverse events [ie, the 3rd baby’s death] was inadequate.” The doctors stated: “In our opinion the conclusion that ‘it was extremely unlikely that the baby’s death was related to the circumcision procedures’ is irrational. This was a healthy newborn baby. The death occurred 24 hours post procedure. No investigations were done… We believe that the IRB [Institutional Review Board] had ceased to protect the research participants, and was protecting the researchers from criticism” (quoted from their letter, available at: http://ripetomato2uk.files.wordpress.com/2013/10/allegation-to-ohrpe.pdf (accessed 24 October 2013).

Overlooking the unexplained death, the research team concluded: circumcising babies “can be performed safely in Botswana”[quoted from p e136, reference 2]. That conclusion is doubtful. Here’s an unintended conclusion from the research: If you agree to be a participant in medical research funded by the US government in Africa, you might not be protected by US regulations. Here’s another unintended conclusion: You probably shouldn’t believe everything you read about the safety of circumcision in health care settings in Africa.

References

1. Plank RM. Infant male circumcision in Gaborone, Botswana, and surrounding areas: feasibility, safety, and acceptability. Study record, trial NCT00971958. Available at:  http://clinicaltrials.gov/show/NCT00971958 (accessed 26 October 2013).

2. Plank RM, Ndubuka NO, Wirth KE, et al. A randomized trial of Mogen Clamp versus Plastibell for neonatal male circumcision in Botswana. J Acquir Immune Defic Syndr. 2013: 62: e131-e137. Available for free download at: http://journals.lww.com/jaids/Fulltext/2013/04150/A_Randomized_Trial_of_Mogen_Clamp_Versus.14.aspx (accessed 24 October 2013).

3. Plank RM. Author’s Reply: A Randomized Trial of Mogen Clamp Versus Plastibell for Neonatal Male Circumcision in Botswana. J Acquir Immune Defic Syndr. 2013; 64: e13-e14. Available for free download at: http://journals.lww.com/jaids/Fulltext/2013/10010/Author_s_Reply___A_Randomized_Trial_of_Mogen_Clamp.20.aspx (accessed 24 October 2013).

Misinformation from UNAIDS’ flawed Modes of Transmission model


To defeat HIV/AIDS in Africa, UNAIDS recommends: “Know your epidemic.” The best way to do so is to investigate to trace the source of infections – especially in children with HIV-negative mothers, virgins, and married people with HIV-negative spouses and no outside partners.

But that’s not what UNAIDS urges African governments to do. Instead, UNAIDS urges governments to use its Modes of Transmission (MOT) model to estimate numbers of infections from various risks.

But the MOT model contains a glaring error. Because of this error, whoever uses the model ends up estimating far too many infections coming from spouse-to-spouse transmission.

In Uganda, for example, the MOT model estimates that 60,948 married adults got HIV from their spouses during 2008. This is two-thirds of the model’s estimated total new infections from all risks in Uganda in 2008.

The MOT model got this number by supposing that 5.9% of married adults (421,000 adults) were HIV-negative with HIV-positive spouses, and that 14.5% of these spouses at risk got HIV from husbands or wives in 2008 (60,948 = 14.5% x 421,000).

But the number of spouses at risk is far, far less. Uganda’s 2004/5 HIV/AIDS Sero-behavioral Survey reports that 6.2% of husbands and 5.2% of wives were HIV-positive.  But – and this is the important fact the MOT model ignored – most HIV-positive husbands and wives were married to each other. Only 2.8% of wives and 1.8% of husbands were HIV-negative with HIV-positive spouses.

Overall only about 2.3% of married adults (averaging 2.8% of wives and 1.8% of husbands) were HIV-negative with HIV-positive spouses – only 222,000 vs. the 421,000 estimated in the MOT model. If 14.5% of these 222,000 adults got HIV from their spouses in a year, that would account for 32,100 new infections (14.5% x 222,000), far less than the 60,948 estimated in the MOT model.

Why is this important? Because if fewer infections are coming from spouses, how did so many Ugandans get HIV in 2008? In other words, the MOT not only over-estimates HIV from spouses, but also underestimates infections from other risks.

What risks are underestimated? Hold on now! Don’t run away with sexual fantasies about young people and some married adults having too much fun with non-spousal partners. Indulging in racist and stigmatizing sexual fantasies is something too many official AIDS experts like to do. But the evidence does not support such fantasies. The best information on sexual behavior does not come close to explaining Uganda’s epidemic.

Setting aside sexual fantasies, the underestimated risks are more likely to be those that UNAIDS’ staff and other health professionals want to ignore – skin-piercing procedures with unsterile instruments, such as injections, dental care, manicures, etc. This is true not only in Uganda but also in more than 15 other African countries that have used the MOT model to get ridiculous figures on numbers of HIV infections from spouses.

Remember how we began: The best way to “know your epidemic” is to trace infections. Let’s challenge HIV/AIDS researchers — finally — to do their job. Although it’s decades too late, tracing is still needed to find all the important risks and to stop Africa’s generalized HIV/AIDS epidemics.

[Note: This blog summarizes evidence and arguments in: Gisselquist D. UNAIDS' Modes of Transmission model misinforms HIV prevention efforts in Africa’s generalized epidemics, available at:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2315554.]

Mainstream scientists have not explained Africa’s HIV epidemic. Why not?


John Potterat, a senior and well-published international expert on sexually transmitted diseases, has taken part in scientific debates about the relative contribution of sex vs. blood (injections, tattooing, etc) in Africa’s HIV/AIDS epidemics. He’s been frustrated for years. The loudest voices with the most money talking about HIV/AIDS in Africa — UNAIDS, WHO, USAID, Gates, and others — want to blame it all on sex. But they haven’t got the evidence to support what they say and what they want everyone to believe. Why are so many scientists who build their careers on HIV/AIDS in Africa so unscientific, so uncurious, and so careless about what they say and about the evidence?

Earlier this month, John Potterat published a brief but pointed and thoughtful critique of HIV research in Africa. You can download his article free from the SSRN website: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2310200

As a teaser, here’s the Abstract of the article:

The Enigma of HIV Propagation in Africa: Mainstream Thought Has Narrowly Focused on ‘Heterosexual Sex’

John J. Potterat, Independent consultant
August 14, 2013

Abstract:

Introduction: Three decades after the identification of AIDS, epidemiologists still do not fully understand HIV transmission dynamics in sub-Saharan Africa, nor its differential geographic and demographic spread.

Discussion: Despite mounting evidence suggesting a substantial role for nonsexual (puncturing) exposures in HIV transmission, researchers have not systematically investigated its impact on HIV propagation in Africa. Mainstream researchers initially reacted to this idea skeptically, then dismissed it in the short run as apostasy and chose to ignore it in the longer run. This research design flaw has been the Achilles Heel of efforts to explain the rapid propagation of HIV in Africa, a flaw that continues to this day — much to the detriment of scientifically trustworthy interventions.

Conclusion: A science that ignores potentially important modes of transmission, especially when confronted by challenging and respectable evidence, is inadequate and needs remedial attention.

10 years later: Continuing unethical and incompetent behavior by medical professionals coincides with conflict of interest, leading to millions of unexplained HIV infections


Health care professionals in African ministries of health, the World Health Organization (WHO), donor organizations, and foreign universities participating in HIV-related research in Africa know the proper response to unexpected HIV infections (eg, in children with HIV-negative mothers, in spouses with one lifetime HIV-negative sex partner). That response is to find the source of the infection by tracing and testing others who attended suspected hospitals and clinics, and thereby to identify and correct unsafe practices to protect other patients. There have been no such investigations of unexpected HIV infections in any country in sub-Saharan Africa.

Health care professionals are ethically obligated to give patients accurate information about risks. The World Medical Association’s Declaration of Lisbon on the Rights of the Patient[1] states: “A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions…” and “Every person has the right to health education that will assist him/her in making informed choices about personal health and about the available health services.”

Medical researchers trying to find what is different about HIV transmission in Africa that could explain the world’s worst HIV epidemics know that the best way to do so is to trace and test sex and blood contacts when someone shows up with a new or unexplained infection. Unfortunately, medical researchers (who are also health care professionals) have been reticent to find their colleagues’ contribution to Africa’s HIV epidemics. For example, 44 studies[2] that followed more than 120,000 adults in Africa and observed more than 4,000 new HIV infections linked only 186 (4.6%) of those infections to HIV-positive sex partners, all of which were spouses the study had been following all along. No study traced and tested any sex partner (spouse or other) not already included and followed in the study. No study traced blood contacts, and few studies reported any information about blood risks. Despite lack of evidence (avoided and ignored evidence) all studies assumed infections came from sex. (These 44 studies were randomized controlled trials of interventions to prevent HIV in African adults.)

For 30 years, medical professionals have accused HIV-positive Africans of careless or immoral sexual behavior. But if one looks for what is different in Africa vs. the US and Europe, what jumps out is not sexual misbehavior but rather unethical, immoral, and incompetent behavior by health care professionals: not investigating unexpected HIV infections; not warning the public about unsafe health care; and mismanaging research so as not to find risks for HIV.

Ten years ago, on 14 March 2003, WHO held a one-day meeting to discuss the role of unsafe medical injections in Africa’s HIV/AIDS epidemics. WHO staff arranged the meeting after a series of articles[3][4][5] in the International Journal of STD & AIDS during 2002-03 called attention to decades of overlooked evidence that unsafe health care infected Africans with HIV. The 20 invited attendees[6] included three co-authors of these articles (Brody, Gisselquist, and Potterat).

WHO staff managed the meeting as part of a continuing cover-up of hospitals’ and clinics’ contribution to Africa’s HIV epidemics. The meeting was closed to the public. A first press release, prepared by WHO staff in the days before the meeting and released before it ended, misleadingly claimed:[7] “An expert group has reaffirmed that unsafe sexual practices are responsible for the vast majority of HIV infections in sub-Saharan Africa…”

Later that year, WHO’s meeting summary[8] acknowledged that “No consensus emerged from the conference” on whether “sexual transmission was responsible for the large majority of HIV infections.” The summary also noted “universal agreement…that better data on the possible role of unsafe injections, and other health care practices, in HIV transmission are needed to more definitively determine their role in HIV transmission in sub-Saharan Africa.”

Unfortunately, the events of the last 10 years show a continuing unwillingness on the part of too many health care professionals to do what is needed to find and stop HIV transmission through unsafe health care in Africa.


[1] World Medical Association. 2005. Declaration of Lisbon on the Rights of the Patient. Ferney-Voltaire, France: WMA. Available at: http://www.wma.net/en/30publications/10policies/l4/ (accessed 18 August 2012).

[3] Gisselquist D, Rothenberg R, Potterat JJ, Drucker E. HIV infections in sub-Saharan Africa not explained by sexual or vertical transmission. By: Int J STD AIDS 2002; 13: 657-666. Available at: http://www.robertogiraldo.com/reference/Gisselquist_TransmissionIsNotSexual.pdf

[5] Gisselquist D, Potterat JJ, Brody S, Vachon F, Let it be sexual: how health care transmission of AIDS in Africa was ignored. Int J STD AIDS 2003; 14: 148-161. Available at: http://www.cirp.org/library/disease/HIV/gisselquist1/gisselquist1.pdf

[6] WHO. Unsafe injection practices and HIV Infection. Meeting summary (14 March 2003 meeting, undated summary posted by WHO later in 2003). Available at: http://www.who.int/hiv/strategic/mt14303/en/index.html (accessed 6 January 2013).

[7] WHO. Expert group stresses that unsafe sex is primary mode of transmission of HIV in Africa. Media Center statement 14 March 2003. Available at: http://www.who.int/mediacentre/news/statements/2003/statement5/en/index.html (accessed 6 January 2013).

[8] WHO. Unsafe injection practices and HIV Infection. Meeting summary (14 March 2003 meeting, undated summary posted by WHO later in 2003). Available at: http://www.who.int/hiv/strategic/mt14303/en/index.html (accessed 6 January 2013).

WHO’s and UNAIDS’ response: If there’s a problem, we warned Africans


On 15 October, three managers of dontgetstuck along with five other experts sent an Open Letter to the heads of WHO, UNAIDS, and World Bank, challenging them to warn and protect Africans from HIV through health care. There is no indication that Chan, Sidibe or Kim read the letter. The only response we have received is from De Lay of UNAIDS and Nakatani of WHO (see below).

The response, which falls short of what WHO and UNAIDS could do under the circumstances, leads to several questions:

Question 1: If the evidence we presented (16%-31% of HIV-positive children with HIV-negative mothers) had come from Europe, would WHO and UNAIDS let it go by without recommending urgent actions to correct whatever happened to infect children?

Even asking this question brings the realization that governments and populations in Europe would not wait to see what WHO or UNAIDS said about the situation – they would insist on investigations to find how children had been infected and thereby to ensure that their health care is safe. We can see such investigations in Russia under Gorbachev, Romania under Ceausescu, Libya under Kaddafi, Kazakhstan, Kyrgyzstan, and Uzbekistan – all of which countries acted without waiting for WHO advice or assistance.

Question 2: Since WHO and UNAIDS have not recommended a specific response to evidence of large numbers of HIV-positive African children with HIV-negative mothers, who if anyone is going to respond to protect African children?

De Lay and Nakatani say that WHO and UNAIDS have warned African governments about unsafe health care, in effect putting the onus on Africans to respond to the evidence in the Open Letter. Whether the onus belongs there or not, it seems clear that WHO and UNAIDS are not ready to do more to protect African children from unsafe health care. Will African governments step up, or will they take the low road, like WHO and UNAIDS, letting things go on and on?

[See also Simon Collery’s comments on WHO’s and UNAIDS’ reply, with information about health care conditions in Africa.]

WHO’s and UNAIDS’ letter responding to Open Letter

23 October 2012

Dear Dr Gisselquist and colleagues,

Thank you for the open letter sent to Mr Sidibe, Dr Chan and Dr Kim on 15 October, 2012. We recognize that unsafe injections, skin piercing, blood transfusions and surgical procedures can contribute to HIV transmission, and advise countries that an effective HIV response should take into account all available data on modes of transmission in the design and implementation of their response.

As part of our commitment to reducing HIV incidence and new HIV infections, both the World Health Organization (WHO) and UNAIDS have produced guidance with unsafe skin-piercing procedures. UNAIDS Prevention Policy Paper, and the WHO Global Health Sector Strategy on HIV/AIDS, 2011-2015 make explicit reference to the importance of preventing unsafe injections, surgical practices and blood transfusions. WHO and UNAIDS advise countries to scale up proven and cost-effective strategies, policies and programmes that are tailored to their actual HIV epidemic and its social, economic and health system context (Know Your Epidemic/Know Your Response).

Recently, WHO’s Director-General, Dr Margaret Chan called for action on injection safety. Since this call, a cross-departmental working group has been created to develop a policy document and implementation plan on the safety of all therapeutic injections.

Thank you for raising these issues in the letter and for your efforts in the fight against HIV.

Best regards,

Paul De Lay, Deputy Executive Director, Programme, UNAIDS
Dr Hiroki Nakatani, Assistant-Director General, HIV/AIDS, Tuberculosis, Malaria and Neglected Tropical Diseases, WHO