Bloodborne HIV: Don't Get Stuck!

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?

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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: https://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).