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Hepatitis C eradication and profit


Note: This is a guest blog by Helmut Jäger. Dr Jäger’s website and blog provides more information and thoughtful comments on healthcare issues at: http://www.medizinisches-coaching.net/

Good news: hepatitis C can be cured

Since 2016, the World Health Organization recommends treating hepatitis C infection with sofosbuvir (NS5B-Polymerase-inhibitor)The manufacturer (Gilead) demands an extremely high price, and

“.. the public paid twice: for the pharmaceutical research and for the purchase of the product. The enormous profits flow to the Gilead shareholders.”(Roy BMJ 2016, 354: i3718)

The evidence for the effectiveness of direct-acting antivirals (DAA) for chronic hepatitis C comes from short-term trials. Cochrane is unable to determine the effect of long-term treatment with these drugs:

DAAs may reduce the number of people with detectable virus in their blood, but we do not have sufficient evidence from randomised trials that enables us to understand how SVR (sustained virological response: eradication of hepatitis C virus from the blood) affects long-term clinical outcomes. SVR is still an outcome that needs proper validation in randomised clinical trials. (Cochrane 18.09.2017: http://www.cochrane.org/CD012143/LIVER_direct-acting-antivirals-chronic-hepatitis-c.)

Egypt is particularly affected by hepatitis C. Here the government negotiated special discounts with Gilead, so that relatively cheap treatment will be available. It’s the foundation of just another lucrative business based on a man-made disaster.

tourcure

Tour’n Cure: The profitable medical eradication of a problem that would not exist without medicine.

Bad news: Hepatitis C will still be transmitted by skin piercing procedures

About 2-3% of the world’s population is infected with the hepatitis C virus (HCV); 350,000 of these 130-170 million people die per year. HCV causes liver infections, which are chronic in more than 70% of infected persons. That is, they do not completely cure after an infection. After one or maybe two decades, the damaged liver can fail, or develop cancer. The survival rates are low in the late stages of the disease, even under optimal treatment conditions.

Hepatitis C viruses are very sensitive to environmental influences so they are transmitted almost exclusively through blood or blood products or unclean syringes. Unlike hepatitis B or HIV/AIDS, HCV infections through sexual contacts are rare. Hence, the incidence of HCV is an indicator of a dangerous handling of needles, syringes, other medical instruments or products that lead to a direct blood contact. And new cases of HCV are acquired most likely in health care facilities or by intravenous drug use.

Treatment of disease and prevention of new infections 

The World Health Organization (WHO) announced in 2016 that it wants to “combat” hepatitis C and “exterminate” it by 2030. (WHO 2017: http://www.who.int/mediacentre/factsheets/fs164/en/)

unsafe-needles

Hazardous needles somewhere in Africa (image: Jäger, Kinsahsa 1988)

WHO’s optimism is caused by the availability of sofosbuvir. The drug is said to have cured up to 90% of affected patients in clinical trials, and consequently was added to the WHO list of essential medicines. The pharmaceutical company Gilead faces a huge global market with high profit margins (WIPO 2015): The treatment costs in the US are US$84,000 and in the Netherlands €46,000. The production cost of the drug is estimated not to exceed US$140.(‘T Hoen 2016)

Most people affected by hepatitis C are poor. They now learn through the media that their suffering could be cured, and at the same time that this solution seems to be unavailable to them. Consequently, they will demand the necessary funds for humanitarian reasons from their governments. Gilead expects sofosbuvir will not be manufactured and sold without a license (about 100 times cheaper). The Indian authorities already concluded in 2016 a license agreement with Gilead, which will guarantee high profit rates on the subcontinent.(‘T Hoen 2016)

Attractive medical products and markets increase the risk of the production of counterfeit medicines

In India, the requirement to allow the production of the hepatitis C drug in the “national interest” license-free is not only risky for legal reasons. India already is the world’s leading producer of fake medicines. Counterfeit drugs look exactly like real ones, but contain nothing (in the best case) or poison. About 35% of the malaria drugs in the African market are fake or useless, and they are mostly from India or China (see below: fake drugs). In the case of Egypt, medical institutions tried to open up a lucrative international market (“Tour’n cure”). Therefore, it will not be long until the first fake “sofosbuvir preparations” are offered.

The history of the hepatitis C epidemic in Egypt

The disaster of hepatitis C contamination started in Egypt more than sixty years ago. Efforts to regulate the Nile increased the risk of schistosomiasis infections. These parasites cause numerous health problems, mostly in the pelvic organs, and in rare cases, cancer. The worm larvae swim in stagnant water that has been contaminated by human urine or feces, and they enter the blood system of healthy people by piercing the skin.

The frequency of these worm infections increased rapidly after 1964, when the fast-flowing Nile was tamed by the Aswan Dam. In a relatively short time 10% of the Egyptian population was colonized by the parasite. The Ministry of Health then treated large parts of the population with injections containing antimony potassium tartrate. Until 1980 this toxic compound was considered the only effective remedy for this worm-infection. Today it is no longer used, not even in veterinary medicine.

Many years after the start of the campaign an initially unexplained epidemic of hepatitis C  was noticed in Egypt. It turned out that most of the patients with hepatitis C virus received anti-schistosomiasis injections.

Those initially infected with hepatitis C virus had higher risks to be treated in health care facilities, where the virus was then transmitted to other patients. Today (according to different estimates) 3-10% of the Egyptian population is infected with hepatitis C, and 40,000 patients die per year with the disease. Because many patients are infected, today the risk to acquire hepatitis C infection in Egyptian health facilities, even in optimal hygenic conditions, is significantly higher than in countries where hepatitis C is relatively rare.(Strickland 2006, WHO 2014)

Hepatitis C epidemic in industrialized countries

But Egypt is not an isolated case. Hepatitis C affects mostly the residents of developing and emerging countries. But even in Germany more than half a million HCV infections are recorded.

In England, in 2015 the government had to apologize for the infection of nearly 3,000 people who received infected blood products between 1970 and 1990.(Wise 2015)

In the US hepatitis C is called a “hidden epidemic” because 300,000 people were infected each year a few decades ago.(Ward 2013, Warner 2015, CDC 2015, RKI 2015, Pozzetto 2014)

Syringes and blood products are dangerous if handled improperly or if they are used although they are not necessary

blood

Blood Bank in Kinshasa (Congo, 1990, image: Jäger)

Needles (in particular the worldwide introduction of disposable syringes and their inflationary use) contributed to the spread of viruses like HCV, HIV and others.(Jäger 1990-92) The problem of the HCV epidemic is caused by the health care system and its waste products that fall into the wrong hands. The causes of the infections mostly are: bad medicine or intravenous drug addiction. What happened in Egypt is just another example that sometimes (medical) solutions of seemingly controllable health problems can lead to much larger problems: because sometimes “the things bite back.”(Tenner 1997, Dörner 2003)

Therefore WHO’s strategy to eradicate hepatitis C, based only on treatments, cannot succeed as long as the much of the medical sectors in many poor countries remain dangerous-purely-commercial and in large parts uncontrolled. The WHO campaign certainly will enrich Gilead and some health institutions, but a reduction of the hepatitis C incidence will not take place if “bad medicine” and “drug addiction” are not targeted, preferably eradicated, or at least reduced.

Unnecessary medicine is risky and should be avoided

WHO and other international health organizations should strive to avoid unnecessary therapeutic skin piercing procedures, injections, surgery and transfusions, and (if these sometimes life saving procedures are necessary) establish strict quality control. The commerce of medical tourism and beauty-interventions (botox, piercing, tattoo) should be strictly controlled.

unsafe-injection

Hazardous needles anywhere else in Africa (image: Jäger)

And we should invest in training patients: They should be supported to reduce their demand for health-care-products and to increase their knowledge in order to distinguish “good” and “bad” medicine.

 More

Literature

Bad Medicine in economically weak countries (such as “fake drugs”):

Why things bite back

WHO to Warn About Unsafe Healthcare Transmitted Hepatitis, but not HIV?


UNAIDS, WHO, CDC and other institutions continue their insistence that HIV is almost always transmitted through heterosexual sex in African countries (though nowhere else), and that unsafe healthcare, cosmetic and traditional practices play a vanishingly small and declining role in transmission.

It was suggested to me recently by someone who questions the above views that these well funded institutions will eventually have to change their tune. However, he felt that they would not admit that they are wrong, or that they have known since the 1980s about the risks posed by unsafe healthcare and other non-sexual HIV transmission routes.

Perhaps hepatitis C is the opportunity needed? The WHO is now warning people about the dangers of infection through unsafe blood, medical injections and sharing of injecting equipment. They are also recommending the use of injecting equipment that cannot be reused, rather than equipment that should not be reused, but frequently is.

Unfortunately, the WHO is not very explicit about the problem: there are many health professionals who are unaware about the risks of reusing skin piercing equipment, especially injecting equipment. These health professionals do not warn their patients because they are unaware that they should not reuse syringes, needles, even multi-dose vials that may have become contaminated.

People may be surprised that there are health professionals who are unaware of these risks, or that they take these risks even if they are aware of them. But every year there are cases of infectious, even deadly diseases, being transmitted to patients through careless use of skin piercing equipment. Tens of thousands of people are put at risk, and that’s just in wealthy countries.

As for poor countries, especially sub-Saharan African countries, where the highest rates of HIV are to be found, no one knows how many people have been put at risk, how many have been infected with hepatitis, HIV or other blood borne viruses, or how many are still at risk. People are not being made aware of the risks they face, so they can not take steps to avoid them.

The US National Institute of Allergy and Infectious Diseases (NIAID) still carries the rather limp “HIV cannot survive for very long outside of the body”, instead of warning people that they should not allow the blood of another person enter their bloodstream. It is irrelevant how long these viruses survive; people need to know that contaminated blood may be entering their bloodstream so that they can take steps to avoid this.

Unsafe healthcare, cosmetic and traditional practices carry huge risks, especially in countries where blood borne viruses such as hepatitis, HIV and others are common. People can avoid infection with these blood borne viruses by avoiding potentially unsafe healthcare, unsafe cosmetic practices, such as tattooing or body piercing, and traditional practices, such as circumcision or scarification.

Whites Only? Investigations Reveal Hospital Transmitted Hepatitis Infections In US


The satirical site The Onion ran the headline ‘Experts: Ebola Vaccine At Least 50 White People Away‘ at the end of July. I’m not citing this article because I think it is funny, but because it raises a shocking point very succinctly, one that must have passed through the minds of many over the past few months.

If such an outbreak were to become established in a wealthy country, mainly inhabited by white people, would it still be raging 9 months later? And what efforts would be made to establish the source of the infections?

There is probably no wealthy country precedent to compare with the sort of epidemics that are frequently found in poor countries, often without even attracting the notice of the western world (or not for very long). But a recent article published in the Mayo Clinic Proceedings outlines the kind of work that went into investigating the infection of 84 people with hepatitis C (HCV) and another 34 with bacterial infections in US hospitals over a 14 year period. In fact, the paper outlines a whole series of investigations, very impressive work, too.

Six healthcare personnel were identified as a result of these many, lengthy and thorough investigations. That’s an average of almost 20 patients infected for each worker. An estimated 30,000 patients were potentially exposed to blood-borne pathogens by these six people. Twenty three different hospitals were involved, in 10 different states. (Naturally, I don’t really know if the victims were all white people; the authors are far too polite to mention such detail.)

A 2009 article entitled ‘Injection drug use, unsafe medical injections, and HIV in Africa: a systematic review‘, by Savanna Reid, estimates that 20 million medical injections contaminated with blood from a patient with HIV are administered every year in Africa. Other research by Yves Hutin, entitled ‘Use of injections in healthcare settings worldwide, 2000: literature review and regional estimates‘, estimates that out of the 17 billion injections administered every year globally, 7 billion of them are unsafe.

So where are the HIV and hepatitis outbreak investigations carried out in African countries? They are not listed in PubMed, unless they are called something else, to throw investigators off the scent. Such an investigation was carried out in Pakistan in 2008, but as it confirmed the worst fears of those who believe that unsafe healthcare is a serious risk it appears to have attracted very little attention (and turned into what looks like a cover-up).

So what do we know about unsafe healthcare in African countries, in the absence of such investigations? We know that infants with HIV negative mothers were probably infected through unsafe healthcare in Mozambique, and some of the infants may have gone on to infect their mothers (though it hasn’t been seen fit to explain to these mothers how their infants may have been infected, nor even the likely source of their own infection).

We know that people who have received medical injections in Kenya and several other countries are several times more likely to be HIV positive than those who have not. We know that women who have sex only with other women in Namibia and other southern African countries have been infected and that their non-sexual risks have not been investigated. We know that many people found to be infected with HIV in most African countries have said they have not had sex, or that they have not had sex with a HIV positive person, or that they have only engaged in safe sex [earlier version corrected].

In fact, there are numerous instances of HIV outbreaks in African countries, and probably other diseases, which have very likely been caused by unsafe healthcare, reused syringes and other equipment, failure to comply with infection procedures, etc. But none of them have been investigated. Instead, there are vast quantities of data shoved into mathematical ‘models’, showing that HIV is almost always transmitted through heterosexual behavior in African countries (this being just one example).

Completely untrue, but in accordance with the ‘promiscuous African’ myth, which has a long history in the medical (and eugenics) literature. The authors of such papers systematically ignore empirical data and fail to investigate outbreaks, they assume that African people themselves are either seriously mistaken about their sexual history or just tell lies, and they go unchallenged by their fellow academics and even peer reviewers, who have the luxury of remaining anonymous, but seemingly prefer to toe the party line.

No doubt these mathematical models are great examples of academic prowess and rigor, that stand up to the highest levels of scrutiny. But they are no substitute for the kind of investigations that have been carried out into what is thought to be a mere tip of the iceberg in hospital transmitted hepatitis and bacterial infections in the US. However brilliant these models are in the field of epidemiology, they are the work of people who care nothing about their fellow human beings in African countries.

Why do these highly qualified academics care so little about poor black people and, apparently, so much about people more likely to be wealthy and white? Is it academic vanity, money, some kind of animalistic competitive instinct, or a combination of these? The challenge to all these clever academics, who can publish their work in the most prestigious journals and be cited in the cream of the western media, is to go to the same lengths investigating and stopping HIV (and ebola, HCV and other diseases) in African countries as they do in parts of the US before the epidemic spreads any further.

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: https://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).

Outbreak investigations: Facing and fixing problems


If a hospital or clinic infects you or your child with HIV, you’d probably call it a disaster. Health care bureaucrats and managers call it an “adverse event.”  How often do patients get HIV from health care in Africa? The World Health Organization (WHO) has estimated it happens 50,000-100,000 times each year.  Other estimates are higher.

That’s a lot of “adverse events.” In more than 25 years, no international agency, no donor health aid program, and no African government has done the right thing to stop them.

When a department of health finds one or several unexplained HIV infections in patients that can be traced to a suspected hospital or clinic, the recommended “textbook” response is to investigate — to invite others who attended the same facility to come for tests to see how many, if any, others are infected. By finding others infected in the same outbreak, an investigation can pin-point the errors that did the damage. This alerts health care workers to fix things they didn’t know were problems, and warns patients to demand safe care. In this way, investigations save lives.

Consider the response to “adverse events” in other countries. For example, although the US health care system is not the best or safest in the world by a long shot, US state and federal governments have been doing the right thing in response to unexplained infections of hepatitis B and C virus. In health care settings, these viruses transmit just like HIV – from patient-to-patient through blood-to-blood contact when doctors and nurses reuse instruments without sterilization.

In 10 years from 1998 through 2008, the US Centers for Disease Control (CDC) recorded 33 investigations of hepatitis B and/or C transmission through health care in clinics, nursing homes, etc. Each investigation tested from 4 to >12,000 patients. The 33 investigations found a total of 448 hepatitis B and C infections from health care (average of 13 infections per outbreak). During the next 3 years, 2008-11, 32 investigations (including 3 from the previous list plus 29 new ones) invited a total of more than 90,000 patients to come for tests and identified a total of 217 infections (average of 7 per outbreak).

Did these investigations scare people to stay away from health care? Maybe some people got scared. But the real impact goes the other way: The fact that government is alert to investigate unexplained infections assures the public that someone is watching.

Consider the alternative – what happens when there are no investigations? Not investigating unexplained infections is like smelling smoke, ignoring it, and letting the house burn down. Or yelling at your dog to be quiet when she barks at night – and waking up to find your motorcycle missing.

Aside from a few HIV infections traced to blood transfusions, there have been no investigations of any of the thousands of recognized HIV “adverse events” in Africa. During 1991-93, for example, a WHO study in Rwanda, Tanzania, Uganda, and Zambia identified 61 children aged 6-60 months who were HIV-positive with HIV-negative mothers. There is no report of any investigation in any of the four countries to find the source of these unexplained infections. Incredibly, the WHO study team concluded “The risk of nosocomial [hospital-acquired]…HIV infection appears low among these populations.”

Ideally, foreign experts and agencies would be at the forefront to help with investigations. That has not happened.

Lack of interest on the part of international agencies and donors leaves African governments with the task. Which government will take the lead to begin to investigate unexplained HIV infections? Investigations are not expensive in monetary terms – but they may ruffle feathers. Someone has to push — to persuade health care bureaucrats to recognize and investigate HIV “adverse events.”

Have we ignored a very simple procedure that could significantly reduce the risk of sexual transmission of HIV to men from women?


This was written together with Joseph Sonnabend [go to or return to first circumcision page]

In 2010 there was a great deal of outraged comment about the US government’s award of $823,000 to an HIV related project in Africa. Specifically, the taxpayer dollars were to be used to teach uncircumcised African men how to wash their genitals after having sex. The grant states; “If we find that men are able to practice consistent washing practices after sex, we will plan to test whether this might protect men from becoming HIV infected in a later study.”

The reasoning behind the project was based on the assumption that the reported protective effect of male circumcision was due to improved genital hygiene. This is in the project description:

“The protective effect of male circumcision on HIV acquisition may be due to improved genital hygiene. We propose to evaluate the feasibility of a post-coital genital hygiene study among men unwilling to be circumcised in Orange Farm, South Africa. Men in high prevalence settings could potentially benefit from improved genital hygiene if this intervention proved to be efficacious in reducing HIV acquisition risk” Genital hygiene was to be improved by asking men to wash their penis after sex.

Widespread criticism of such a use of public funds might have missed the main problem. As it turns out, not washing immediately after sex may actually have a significant protective effective for men at risk from heterosexual intercourse – including both circumcised and uncircumcised men

This was noted in two randomized studies of male circumcision to prevent HIV infection in the Rakai region of Uganda in 2003-2007. Although the effect of washing on HIV acquisition received some media attention at the time its relevance to HIV prevention remained generally unnoticed. It apparently also remained unnoticed or considered to be of no consequence to the applicants as well as the funders of the $823,000 grant noted above.

Combining results from these two trials, Tobian and colleagues in an article in AIDS in 2009 report information on risks for 105 HIV seroconversions in 6,396 initially HIV-negative men observed during 9,604 person years (PY) of follow-up. Half the men were circumcised for the trial and half remained uncircumcised.

These 105 HIV seroconversions represent 1.09 infections per 100 PY.

Among the questions that trial participants were asked in attempting to define risks for HIV infection was whether or not they washed their genitals after sex.

Among men who did so there were 1.35 infections per 100PY compared to only 0.38 infections per 100PY among men who did not wash their genitals. The adjusted relative risk for washing vs. not washing was 3.04 (95% confidence interval: 1.11-8.33; P = 0.031).

The authors make the following comment in their discussion,

“The finding that HIV incidence was increased with washing genitals after sexual intercourse is counterintuitive, but supports previous finding that washing the penis within 10 min of sexual intercourse increases the risk of HIV acquisition among uncircumcised men. The increased HIV acquisition with penile washing may be due to the removal of acidic vaginal secretions or the addition of water with a neutral pH may assist HIV survival and infectivity”.

The “previous finding” referred to is an earlier report by Makumbi and colleagues in 2007, who interviewed 2552 uncircumcised men enrolled in the control arm of a randomized trial of circumcision for HIV prevention in the Rakai region of Uganda (these men are included in the data reported by Tobian and colleagues in 2009). Some of the information reported by Makumbi and colleagues is shown in the last four slides in this presentation prepared by i-Base, UK.

This is one of the slides showing that there were 2.32 HIV infections per 100PY among men who washed their penis within 3 minutes of intercourse, but only 0.39 infections per 100PY among men who waited for 10 minutes or longer before washing.

If we were to express the efficacy of delayed washing in the same way that the results of PrEP trials were reported, that is as relative risk reductions, this would mean that not washing immediately, but waiting for at least 10 minutes after intercourse before washing can reduce the risk of infection by 83%. Compare this to the 44% efficacy of Truvada in the iPrEx trial, the 39 % efficacy of tenofovir gel in reducing the risk of infection in women in the Caprisa 004 trial, and the 38-66% efficacy reported for circumcision over 24 months.

Genital washing after sex may be quite common in parts of Africa. A study in Nairobi in 2004 found that a majority of men washed their genitals after sex. Here is a link to a table in the report; 60% of men reported always washing their genitals after sex.

We have had evidence that this practice may contribute to the risk of HIV infection in men since 2007. We have to wonder if the many questions this raises have been addressed, or even considered.

Could the practice of immediate post-coital genital washing contribute to the risk of sexual transmission of HIV to men?

Are there regional variations in this practice, and could this be related to HIV prevalence to some extent?

Should there be a debate on the evidence by experts, with recommendations for further research – such as adding questions to on-going or proposed studies, laboratory testing of HIV viability in semen and vaginal fluids at body temperature or conducting a trial to nail down the risk of immediate washing, or in other words, the protective effect of delayed washing?

If immediate washing increases the risk of infection does this not raise the question of the extent to which infection occurs after withdrawal?

Considering how innocuous the intervention is do we have sufficient evidence now to advise African men at risk of HIV through heterosexual contact not to clean their penis for at least 10 minutes after sex? Should a dry cloth without water or soap be used?

The study teams for these trials have more information on post-coital penis cleaning that they have not reported. We know that for uncircumcised men, wiping was safer than washing, and waiting at least 10 minutes to clean significantly reduced risk for HIV (see the last several slides in this reference. But we don’t have similar details for circumcised men. What information has been collected but not reported?

We have evidence that a common practice, at least in certain regions can substantially increase the risk of HIV infection in men through heterosexual intercourse. Considerable attention has been given to newer prevention methods in the past few years, notably pre – exposure prophylaxis and male circumcision, but almost none to the simplest of procedures that may be even more effective in preventing the sexual transmission of HIV.

Many other questions and concerns will no doubt arise as more people look at the evidence, and figure out what to do about it. Lives are at stake. Scientific competence and integrity are also at stake – researchers have overlooked and/or incompletely reported information that could save lives.

Lessons from North American outbreaks – changing needles alone is not enough


[go to first injections page] [Note: Stephen F. Minkin (sfminkin@yahoo.com) submitted the following as a guest blog.]

The CDC [US Centers for Disease Control and Prevention] first reported on four large outbreaks of hepatitis B and hepatitis C at outpatient medical facilities between 2000 and 2002. Two outbreaks occurred in a private physician’s offices in New York, one at an Oklahoma pain remediation center, and one at a hematology/oncology clinic in Nebraska. A total of 247 patients were known to have been infected at these facilities.

In addition, unsafe practices were uncovered at a phlebotomy center in California in 2001, where needles for drawing blood were reused. As a result, 15,000 people had to be tested for HIV, hepatitis B, and hepatitis C.

Two more recent outbreaks discovered in Nevada and New York garnered considerable media attention. In November 2007, reports surfaced that a New York anesthesiologist reused syringes when withdrawing medicine from multi-dose vials. In the process he potentially exposed thousands of patients to blood-borne viruses. On December 14, 2007 the New York Department of Health contacted approximately 8,500 patients exposed by this practice and urged them to be tested for Hepatitis and HIV.

On February 29, 2008 health officials in Las Vegas closed the Endoscopy Center of Southern Nevada after six patients were diagnosed with hepatitis C.  The outbreak was traced to nurse anesthetists reusing syringes to draw up medicine from single use vials for multiple patients.

According to the CDC,

A clean needle and syringe were used to draw medication from a single-use vial of propofol, a short acting intravenous anesthetic agent.  The medicine was injected directly through an intravenous catheter into the patient’s arm.  If a patient required more sedation, the needle was removed from the syringe and replaced with a new needle; the new needle and old syringe was used to draw more medication.

This was a “common practice” at this center for at least 4 years. As a result 40,000 patients were potentially exposed to this risk of hepatitis and HIV infections.

The CDC suggests two possible ways the syringes could have been contaminated.

Backflow from the patient’s intravenous catheter or from needle removal might have contaminated the syringe with HCV (hepatitis C) and subsequently contaminated the vial. Medication remaining in the vial was used to sedate the next patient.

Investigators concluded that each of these outbreaks resulted from “unsafe injection practices primarily the reuse of syringes and needles or contamination of multiple-dose vials leading to patient to patient transmission” (page 901 in this link).

The changing of needles while reusing the syringe is very, very risky and is not a WHO recommended practice (page 35 in this link).

The 2002 Oklahoma outbreak was traced back to a nurse anesthetist supervised by an anesthesiologist at a hospital outpatient clinic. In response the American Association of Nurse Anesthetists (AANA) mailed copies of the AANA Infection Control Guidelines to its members

The organization also hired a research firm to conduct a random telephone survey of Certified Registered Nurse Anesthetists (CRNAs) and anesthesiologists “to learn more about practices and attitudes on needle and syringe reuse.”  A spokesperson termed the finding as “eye opening.”

Among the different categories of health professionals surveyed, 3 percent of anesthesiologists who responded indicated they reuse needles and/or syringes on multiple patients. CRNAs, other physicians, nurses and oral surgeons reported reuse at 1 percent or less.

Extrapolating the survey findings – 3 percent of anesthesiologists plus 1 per cent of CRNAs – equated in 2002 to approximately 1,000 anesthesia professionals who might have been exposing more than a million patients to the risks of contaminated needles and syringes.

They were forced to revisit the problem of the reuse because of the events in New York and Nevada. On March 6, 2008, Dr. Wanda Wilson, the AANA President, commented on the sad state of affairs.

It is astounding that in this day and age there are still nurse anesthetists, anesthesiologists and other health professionals who still risk using needles and syringes on more than one patient, or know of such activities and don’t report them. Published standards and guidelines dictate that single-use and disposal of these products is the best way to ensure patient safety. Patient safety is our primary focus – not cost savings, time savings, or any other factor

If the hepatitis C outbreaks in New York and Nevada demonstrated anything, it was that such incidents occur regardless of a provider’s degree, credentials, or title.  For any group to suggest otherwise is to put its collective head in the sand—it is irresponsible, negligent, and a sure invitation for yet another Nevada or New York situation to occur.

A 1990 study by Canadian researchers experimentally examined the risk of cross infection related to the multiple use of disposable syringes connected to IV tubing during anesthesia.  The authors were motivated because  “the practice of reusing disposable plastic syringes for several patients is still prevalent in North American operating rooms despite warnings about possible hazards.”

In some operating rooms, the usual practice is to reuse disposable syringes while changing needles.  This practice is based on the assumption, that since only needles enter the injection site, it is the only part that can be contaminated.  A high proportion of reused syringes were contaminated even if only the needle had contact with blood.  The probable mechanism of contamination is by aspiration into the syringe of blood remaining in the needle because of the negative pressure generated while removing the needle.

In view of these finding the authors emphasized that “changing needles alone is a useless procedure to prevent contamination.”

CDC PUBLIC HEALTH SYRINGE ADVISORY

Wait and wipe, don’t cut


[go to or return to first circumcision page]

Last week, while looking for something else, I ran across a report that has big implications for HIV/AIDS prevention in Africa: Almost five years ago, a trial of circumcision to protect men in Rakai, Uganda, reported that intact (uncircumcised) men who waited at least 10 minutes after sex before cleaning their penis were at less risk to get HIV than men who had been circumcised: intact men who waited to clean got HIV at the rate of 0.39% per year compared to 0.66% per year for circumcised men. Although the study team reported these results to an international AIDS conference in 2007, and several newspapers wrote about it at the time, the report has dropped out of view. That is a big mistake.

Why is this report important? Here are three reasons.

First, if you are intact, this report says you don’t need to get circumcised to reduce your risk to get HIV. Use a condom, of course, if your partner has or might have HIV. But if that fails, this report says you are as safe with a foreskin as you would be without one. Just don’t clean your penis for at least 10 minutes after sex, and then wipe it with a dry cloth, without water. A later report from the Uganda study team suggests waiting to clean is good for all men, both circumcised and intact: men who didn’t “wash genitals after sexual intercourse” got HIV less than 1/3rd as fast as men who did.

Second, if you are a politician or public health official who is considering whether to go along with the largely US-promoted program to circumcise 20 million African men by 2015, you can take another close look at the evidence and options. The evidence that advocates use to promote circumcision comes from three studies (in South Africa, Kenya, and Uganda during 2002-06) that recruited thousands of intact, HIV-negative men, circumcised some and not others, and then followed and retested them to see who got HIV. All three studies reported that circumcised men got less HIV. But the study team for at least one of those trials – the trial in Uganda – has data showing that intact men who waited to clean after sex got less HIV than circumcised men.

Circumcision is expensive and dangerous and takes doctors and nurses away from other tasks. Why put scarce public resources into campaigns to circumcise millions of men if you can get the same results by advising men to use condoms, and if that fails to wait least 10 minutes after sex before wiping their penis with a dry cloth?

Third, this is another example of people reporting important evidence that contradicts well-funded misinformation about HIV risks. WHO, USAID, and other organizations pay for a lot of messages – some are true and helpful, but some are at best only partial truths. It’s important for people to speak up when they have good information about how to avoid HIV risks, even though what they say disagrees with the official “line” at the time.

Here are some examples of truth meeting official misinformation.

WHO warns UN employees they might get HIV from health care in Africa, but doesn’t warn the African public. But not everyone goes along with such misinformation. For example, Demographic and Health Surveys finds and reports HIV-positive children with HIV-negative mothers (in Mozambique, Swaziland, and Uganda) and virgin men and women with HIV. As more people speak up, Africans hear that a lot of infections come from minor blood exposures, and learn how to protect themselves.

Another example of official misinformation is WHO’s continuing promotion of Depo-provera injections for birth control without warning Africans that good evidence shows – and many experts believe – using Depo-provera increases a woman’s risk for HIV. One expert who has spoken out – eloquently and repeatedly – on this issue is Paula Donovan, a former high-ranking UNICEF official, who has had the heart and courage to challenge official misinformation.

Circumcision is another issue with a lot of well-funded misinformation, but also with many people speaking out to set the record straight (eg, see the article by Daniel Ncayiyana, editor of the South African Medical Journal, in this link). Unfortunately, crucial evidence is still unreported from the three key trials of circumcision to protect men: A lot of men in the trials got HIV despite no reported sex partners – what were their risks? None of the three study teams has reported the HIV status of any of the men’s sex partners, and only two have reported minimal information about blood exposures.

As for waiting and wiping to reduce HIV risk, here’s the record of partial and incomplete information from the 2003-06 trial of circumcision to protect men in Rakai, Uganda:

13 December 2006: The US National Institutes of Health reported that men circumcised in the trial had 48% lower HIV incidence compared to intact men, WITH NO MENTION OF POST-COITAL CLEANING.

24 Feb 2007: The Uganda study team reports selected trial data in Lancet, concluding: “Male circumcision reduced HIV incidence in men… Circumcision can be recommended for HIV prevention in men.” THE ARTICLE MAKES NO MENTION OF WAITING TO CLEAN, WHICH THE TEAM’S UNDISCLOSED DATA SHOWED TO BE MORE EFFECTIVE THAN CIRCUMCISION.

28 March 2007: WHO announces recommendations from an experts’ meeting: “Based on the evidence presented…experts attending the consultation recommended that male circumcision now be recognized as an additional important intervention to reduce the risk of heterosexually acquired HIV infection in men.” SEVERAL MEMBERS FROM THE UGANDA STUDY TEAM TOOK PART IN THE MEETING. THERE IS NO INDICATION THEY TOLD ANYONE ABOUT THEIR UNDISCLOSED EVIDENCE THAT WAITING TO CLEAN WAS MORE EFFECTIVE THAN CIRCUMCISION IN PROTECTING INTACT MEN FROM HIV.

25 July 2007: Frederick Makumbi and several other members of the Uganda study team tell an international AIDS conference: Among intact men reporting post-coital cleaning with all partners, “HIV incidence was significantly higher among those reporting cleansing within 3 minutes (2.32/100 py [person-years]), compared to those reporting a delay of more than 10 minutes (0.39/100py [person-years…).” (The best source i have found for these data is the last several slides in this link.)

So there you have it: In December 2006, the Uganda study team reported that circumcised men got less HIV than intact men. Not until 8 months later, in July 2007, did they disclose evidence that intact men who waited to clean their penises got less HIV than circumcised men. Despite their 2007 report, the Uganda study team has continued to say that circumcision is the way to go, and has said nothing more about waiting to clean as an effective option to reduce HIV risk for intact men.

Africans facing HIV risks from both blood exposures and sex need good information. Well-funded official fountains of stigmatizing misinformation blame Africa’s HIV epidemics on too much sex and too many foreskins. But there are also a lot of people offering good information and evidence. As more people speak up – telling what they know about HIV risks, even if it does not coincide with the party line – the African public will get a better idea about HIV risks and how to protect themselves.

SAVE families, stop HIV!


The International (formerly African) Network of Religious Leaders living with or Affected by HIV/AIDS (INERELA+) promotes SAVE as a response to Africa’s HIV/AIDS epidemic. SAVE stands for: Safe sexual and skin-piercing behavior; Access to treatment; Voluntary counseling and testing; and Empowerment. This note considers some of the ways that SAVE could strengthen HIV prevention in Africa.

AIDS was first recognized in Africa in 1982. In 2010, 28 years later, the World Health Organization (WHO) estimated that 22.9 million Africans were living with HIV, including 1.9 million with new infections in that year. These infections are not distributed evenly. The people most at risk live in cities in 15 countries, primarily in Southern and Eastern Africa. In these cities, from 20% to more than 50% of men and women aged 15 years today can expect to get HIV at some time during their lives.

Help husbands and wives stop intra-familial HIV transmission

Unlike Western countries, where almost all HIV transmission occurs outside families, a lot of HIV transmission in Africa happens within families – mother-to-child and spouse-to-spouse transmission together account for an estimated 45% of new infections.

(a) Mother-to-child transmission: According to WHO estimates, 390,000 babies in Africa got HIV from HIV-positive mothers in 2010, accounting for an estimated 20% of 1.9 million new HIV infections in Africa in that year (390,000/1,900,000 = 20.5%, rounded to 20%).

(b) Spouse-to-spouse transmission: An estimated 30% of all HIV-positive adults in Africa are married to HIV-negative partners, and the resultant spouse-to-spouse transmission accounts for approximately 470,000 HIV infections per year, equivalent to 25% of all new infections each year (470,000/1,900,000 = 25%). (A note at the end of this blog shows the source of these data and explains this estimate.)

Most Western experts continue to identify high risk groups in Africa, as in the US and Europe, according to extramarital sex – prostitutes, clients, truck drivers, and youth are considered to be at high risk because they have more than average levels of extramarital sex. But in Africa, none of these groups defined by extramarital sex has risks as high as babies born to HIV-positive mothers (without treatment, 35% are infected in 2 years) or spouses not aware their partners are HIV-positive partners (8% per year). In other words, the term “high risk groups” in Africa applies first and foremost to persons with intra-familial risks.

With good information and with some medical assistance husbands and wives can work together to stop 700,000 infections per year – reducing mother-to-child transmission by 320,000 (from 390,000 to 70,000) and spouse-to-spouse transmission by 380,000 (from 470,000 to 90,000; see the note at the end of this blog). This would reduce total HIV transmission from all causes by 37% – from 1.9 million to 1.2 million infections per year. There are two major challenges to achieve this outcome.

The first challenge is to reform and extend couple counseling. A lot of men and women don’t think they could have HIV because they and their partner have had very conservative sex lives. Many women who test HIV-positive are afraid to tell their husbands and/or assume they got it from their husbands, so there is no reason to tell them. The best way to overcome these testing problems is to make it clear – both in public messages as well as in counseling – that a lot of HIV in Africa comes from blood exposures. This is important for couples to know – it means an HIV infection is not a reliable sign of sexual behavior. It also means that conservative sexual behavior provides no assurance that anyone is HIV-negative.

It will take some work to get people to realize that their own or their spouse’s HIV infection might well have come from a skin-piercing event, because this realization has to overcome several decades of stigmatizing and misleading half-truths – blaming victims for their infections rather than acknowledging that unsafe health care has been an important part of the problem.

Once husbands and wives can go get tested and talk with each other about their HIV test results without distrust and blame generating family crises, then couples will be better able to plan for what to do to protect babies and uninfected spouses, and to care for those who are infected. Aside from changing messages to de-link HIV from sex, testing should be readily available, with or without counseling. People should be able to buy kits to test themselves (as in South Africa). Opt-out testing is a good way to go. However, compulsory testing is almost always a bad idea.

The second challenge is for governments and donors to prioritize prevention of mother-to-child transmission in allocating scarce resources for HIV prevention. Protecting babies will take a lot of money and medical personnel. This requires: testing pregnant women; testing husbands to get them involved; giving anti-viral drugs to HIV-positive women and their new babies; and helping HIV-positive mothers wean early (after 6 months is a common recommendation, but some may want to do so earlier or later). With these interventions, infected mothers will infect less than 5% of their babies, which would cut the annual number of infections from mother-to-child by an estimated 320,000 (from 26% to 4.5% of babies born to 1,490,000 HIV-positive mothers). Even lower rates of mother-to-child transmission can be achieved with anticipated new drugs or other options.

Whereas preventing mother-to-child transmission requires substantial assistance from outside the family, once husbands and wives know one of them is HIV-positive, they can protect the HIV-negative partner with little or no outside assistance. Condoms are almost 100% effective against sexual transmission (some studies reporting lower efficacy did not consider that condom-users might have gotten HIV from bloodborne risks). If the HIV-positive partner is eligible for antiretroviral treatment and achieves a low viral load, unprotected sex may be safe. If the wife is HIV-positive, circumcising the husband might reduce his risk, but he would not be safe without other protection (eg, condoms). Couples must also take care to avoid blood-to-blood contact through shared razors, toothbrushes, syringes and needles, etc.

Stopping HIV from getting into families

Extra-familial HIV transmission threatens families as well. Some men but many more women get HIV before they are married and bring it into the marriage. But that’s not all – even among old married couples, most couples with HIV are discordant. Husbands and wives continue to import HIV into marriages. According to Western ideas about HIV epidemics that have been imposed on Africa, all these infections come from sex. But those ideas don’t fit facts. Surveys find a lot of HIV in babies with HIV-negative mothers, in young and old virgins, and in men and women married for years with no outside partners and an HIV-positive spouse.

The best way to protect families from outside risks is to warn them about all risks, from blood contacts as well as from sex. African governments could improve these warnings by belatedly asking researchers and investigators to trace a lot of HIV infections to their source to see what risks are infecting babies, young women, etc — including especially people with limited and no sexual risks.

Conclusion: focus on the family

Whereas HIV in the US and Europe has been a tragedy for men who have sex with men and has largely avoided families, in Africa it hits families hard – weakening and killing husbands and wives, interfering with child-bearing, killing babies, taking huge expenses for treatment, and threatening family trust.

African families are strong and can carry much more of the burden to fight the epidemic. To do so, they need honest information – that an unknown but important proportion of infections comes from unsterilized instruments in health care and cosmetic services. Such messages not only allow people to see and avoid risks, but also make is easier for husbands and wives to test and to share HIV test results – the foundation for intra-familial HIV prevention.

Enlisting families to cut intra-familial transmission and supporting them with programs to prevent mother-to-child transmission could cut HIV transmission in Africa by an estimated 700,000 infections per year (37% of total transmission). This can be achieved with available budgets and personnel; but because these resources are limited, governments and donors would have to prioritize. One program that competes for money and personnel asks for $1.5 billion$2.7 billion and several thousand surgical teams to circumcise 20 million men by 2015. Critics argue, inter alia, that condoms are more reliable. But even if one ignores the critics, circumcision looks like an expensive distraction: even advocates estimate the 20 million circumcisions would reduce annual HIV transmission by less than 200,000 (10% of total transmissions) in 2015 – far less than can be achieved with the intra-familial focus proposed in this note.

Statistical note: According to WHO, 19.8 of the total 22.9 million Africans living with HIV in 2010 were adults (page 210 of this link). From national surveys in several dozen African countries over the last decade, the percentage of adults with HIV who are married ranges from roughly 53%-77% for men and 49%-69% for women (see Table below). From the same source, the percentage of adults with HIV who are married to HIV-negative partners ranges from roughly 10%-25% in the worst epidemics in Southern Africa to 25%-35% in mid-range epidemics in East Africa, to 50% in countries with low level epidemics (see Table below).

From these data, an estimated 5.9 million HIV-positive adults (30% of 19.8 million adults) are married to HIV-negative spouses. In studies that followed discordant couples who were not aware of their infections, approximately 8% of HIV-positive partners infected their spouses each year. Thus, 5.9 million HIV-positive adults in discordant couples infect an estimated 470,000 spouses each year (0.08 x 590,000 = 470,000). Assuming that expanded testing and couple counseling reaches all discordant couples, and that they use condoms and take other precautions to cut spouse-to-spouse transmission from 8% to 1.5% per year, this would reduce annual spouse-to-spouse HIV transmission in Africa by 380,000 per year, from 470,000 to 90,000.

Table: HIV in adults, married adults, and married adults with HIV-negative partners (selected countries in Africa)

Country year Sex % adults who are HIV+ % HIV+ who are married Among married HIV+ people, % with a spouse who is HIV- % of HIV+ people with a spouse who is HIV-
A B C = AxB
DR Congo 2007 Men 0.9 53 75 40
Women

1.6

66

85

56

Burkina Faso 2003 Men 1.9 75 70 53
Women

1.8

68

70

48

Ethiopia 2005 Men 0.9 77 73 56
Women

1.9

54

77

42

Ghana 2003 Men 1.5 75 62 47
Women

2.7

67

60

40

Tanzania 2007-08 Men 4.6 70 58 41
Women

6.6

59

53

31

Uganda 2004-05 Men 5.0 72 45 32
Women

7.5

50

35

18

Kenya 2008-09 Men 4.3 67 47 31
Women

8.0

49

53

26

Mozambique 2009 Men 9.2 74 52 39
Women

13.1

60

51

31

Zambia 2007 Men 12.3 56 45 25
Women

16.1

69

37

26

Lesotho 2009 Men 18.0 65 33 21
Women

26.7

53

28

15

Swaziland 2006-07 Men 19.7 54 21 11
Women

31.1

43

23

10

Source: data are from country surveys available at this link; click on the country, and then on DHS (Demographic and Health Survey) or AIS (AIDS information surveys.

Respecting women’s human rights by telling them about all their HIV risks


(A posting for International Women’s Day, 8 March)

For many years, WHO, USAID, UNAIDS, and other international and foreign aid organizations have misinformed women in Africa about risks for HIV. Experts inside and outside these organization have challenged bureaucrats to tell women what they need to know to protect themselves. But to no avail.

WHO, USAID, and other official organizations have blocked three messages that could help HIV-negative women to avoid HIV and help HIV-positive women to retain family trust: (a) Depo-Provera injections for birth control may boost women’s risk for HIV; (b) skin-piercing procedures in health care may infect women with HIV; and (a) an HIV infection is not a reliable sign of sexual behavior.

(a) Risks with Depo-Provera injections

Beginning in the early 1990s, studies that followed and re-tested HIV-negative women to see who got HIV found that women taking Depo-Provera got HIV faster than other women (Depo-Provera, injected every 3 months, mimics the hormone progesterone). As early as 1996, the South African Medical Journal reported high level debates about whether to promote Depo-Provera in Africa.

Evidence of risk to women had no apparent impact on donors’ efforts to inject hormones into African women. From 1996 to 2009, the number of women given hormone injections (primarily Depo-Provera) increased across Africa, especially in countries with the worst HIV epidemics. For example, among partnered women aged 15-49 years, the percentage using injected hormones increased from 5.5% to 17% in Swaziland, from 12% to 19% in Lesotho, from 20% to 28% in South Africa, and from 7.7% to 22% in Namibia. These rates are extraordinary on a world scale – outside Africa, only 3.1% of partnered women used injected hormones for birth control in 2009.

HIV is not the only health threat linked to Depo-Provera. In 2004, the United States (US) Food and Drug Administration forced Pfizer, the company that makes Depo-Provera, to add a “black box” warning to packages of Depo-Provera sold in the US: “Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density… Depo-Provera Contraceptive Injection should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate…”

Despite evidence linking Depo-Provera to HIV (and other health risks), WHO designates Depo-Provera as safe for general use (except for women with specific serious health problems, such as heart disease or breast cancer). WHO’s claim that Depo-Provera is safe came under renewed criticism in July 2011, when a study among discordant couples (one partner infected with HIV, the other not infected) in Africa reported that women using injected hormones were more than two times as likely to get HIV compared to women not using hormones for birth control.

WHO didn’t budge. Seven months later, in early 2012, WHO declared the new evidence – along with all previous evidence – to be inconclusive. WHO reissued its advice that “women…at high risk of HIV can safely continue to use hormonal contraceptives.” WHO’s only nod to the evidence was to say “women using progestogen-only injectable contraception [primarily Depo-Provera] should be strongly advised to also always use condoms…”

Why would WHO not warn women? Paula Donovan, co-director of AIDS-Free World and a long-time former UNICEF and UN official, explains that UN officials “were afraid that African women might abandon hormonal contraceptives altogether” leading to “more pregnancies…more maternal deaths…unsafe abortions” and more infected babies. Citing and quoting several UN documents about women’s rights, Donovan charges that “WHO and UNAIDS have violated [women’s] human rights by withholding the information. They have failed to inform women that using hormonal contraceptives may carry some risk… Women have the right to make fully informed sexual and reproductive health decisions, whether or not the UN likes those decisions.”

In a later publication, Donovan reminds those who wish to promote specific birth control methods that “No global experts or family planning organizations have the right to censor the life-and-death information women need in order to weigh their own risks… Women need information: complete, uncensored, and factually correct.”

(b) Risks to get HIV from skin-piercing health care procedures

Just as international and foreign aid organizations don’t warn women in Africa about evidence that Depo-Provera increases their risk to get HIV, these organizations also don’t warn them about risks to get HIV from reused and unsterilized instruments during skin-piercing health care procedures.

From the time AIDS was first recognized in Africa in 1982, there has been a lot of evidence that women have gotten HIV during health care. National surveys find that many clinics and hospitals do not sterilize instruments. Studies link HIV to injections, operations, blood tests, and other skin-piercing procedures. And studies and surveys report unexpected infections – for example, among women aged 15-49 years in Congo (Brazzaville) in 2009, more women who claimed to be virgins were HIV positive (4.2%) than all women (4.1%).

It’s clear from what WHO and UNAIDS tell UN employees that pretty much everyone throughout the UN system knows that health care available to the African public sometimes transmits HIV. In a 2004 booklet for UN employees, WHO and UNAIDS warn (p. 9): “In several regions, unsafe blood collection and transfusion practices and the use of contaminated syringes account for a notable share of new infections.” But, “[b]ecause we are UN employees, we and our families are able to receive medical services in safe healthcare settings, where only sterile syringes and medical equipment are used, eliminating any risk to you of HIV transmission as a result of health care.”

Outside an approved clinic or hospital, WHO advises UN employees to (p. 23): “Avoid any procedures that pierce the skin, such as acupuncture and dental work, unless they are genuinely necessary. Before submitting to any treatment that may give an entry point to HIV, ask whether the instruments to be used have been properly sterilized.”

These organizations do not extend similar warnings and advice to African women. Just as not warning women about risks with Depo-Provera violates their human rights, similarly not warning women about risks to get HIV from unsterile instruments in health care violates their human rights.

(c) An HIV infection is not a reliable sign of sexual (mis)behavior 

Surveys and studies routinely find HIV-positive women who report no sexual exposure to HIV – some say they are virgins, others have an HIV-negative spouse and report no other sexual partners. The almost universal response to these findings by study teams has been that women lied – no matter what they said, they got HIV from sex.

By routinely disbelieving women, researchers protect and preserve the theory that almost all HIV in African women comes from sex. This theory – which grew out of racial stereotypes of sexual behavior and survives despite evidence – guides HIV prevention messages to misinform Africans that almost all HIV infections in adults come from sex.

What happens next completes a circle of distrust: These messages encourage men who are HIV-negative to think their HIV-positive wives got HIV from sex, no matter what their wives say (and similarly, encourage wives to think HIV-positive husbands were unfaithful). This is not a trivial matter. Most African couples living with HIV are discordant – only one is infected. Among discordant couples, the wife is equally likely to be HIV-positive as the husband.

Telling men and women in discordant couples that HIV surely comes from sex is like the town trouble-maker telling people their husband or wife is running around when there’s no evidence that’s so. An HIV infection is not enough evidence to show a wife was unfaithful. Many African women get HIV from health care. HIV prevention messages that focus only on sex add insult to injury, encouraging husbands, families, and friends to blame them for sexual misbehavior.

Conclusion: Getting good information to women is a do-it-yourself challenge

If international and foreign aid organizations waste – misuse – their money to misinform women about risks, that’s too bad. But let’s not let a bunch of irresponsible bureaucrats get in the way. Women’s lives are at stake. We can get these three messages to women through churches, NGOs, community groups, unions, and just talking to friends. Even bureaucrats who keep their jobs by telling approved official half-truths during working hours can pass these messages privately to friends and other contacts. Abraham Lincoln, the US president who ended slavery, said: “You may deceive all the people part of the time, and part of the people all the time, but not all the people all the time.” So despite the well-funded official half-truths from too many places, let’s take heart, and do what we can to get life-saving messages to women.