Don't Get Stuck With HIV

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

How is Ebola transmitted in the ongoing West African outbreak?


Getting an answer to the question in the title is crucial for people in countries with ongoing epidemics – to protect themselves they need to know the ways they are most likely to get Ebola. The answer is important for people in other African countries as well – to help them assess the probability the epidemic will reach their country, and to prepare for this possibility.

People outside Africa also need the answer. Politicians and bureaucrats who vote and manage aid funds can make better decisions with a clear account of whether and how what they are paying for is saving lives. Finally, although there is only an outside chance the virus has changed or will change to transmit more efficiently, that small possibility represents big risks to people around the world. We want to know what’s happening.

There are two steps for health aid managers to answer the question in the title. They must:
• Get the answer through surveillance.
• Report what they find to the general public.

As of September 2014, public health experts have not reported the relative contribution of various exposures in transmitting Ebola in the current outbreak. Their failure to do so may be due to missing the first step (ie, they don’t know) or the second (ie, they know but don’t say).

Contact tracing to find the source of infections

The public health response to West Africa’s Ebola epidemic includes a lot of effort to trace contacts of people with Ebola to identify new cases as soon as possible – as soon as they get symptoms. For example, at end-August, “WHO and its partners are on the ground establishing Ebola treatment centres and strengthening capacity for…contact tracing…” (WHO, Ebola virus disease update, 28 August, at: http://www.who.int/csr/don/archive/year/2014/en/).

However, I have found no reports of contact tracing to find where and how people with Ebola got their infections. How to do this is straightforward: Ask people with new Ebola infections if they had touched someone who was sick or if they had attended a funeral in the previous 21 days; touching someone sick or dead with Ebola is a recognized risk. Ask if they got injections, infusions, or any other skin-piercing procedure in the previous 21 days; such procedures are also recognized risks. Then trace contacts and visit and investigate reported health care settings.

If more than a few people with new infections report no contacts with other cases and no skin-piercing procedures, that is cause for concern and, more critically, further investigation. Such unexplained cases could be showing the virus is transmitting in unexpected ways.

John Potterat has been a practitioner and advocate of contract tracing and partner notification as a public health tool to understand and control the spread of infectious diseases. In a recent article on partner notification for HIV in Africa, written before the explosion of West Africa’s Ebola outbreak, Potterat presciently recommends the skills required to diagnose what has allowed that outbreak to grow: “Nurturing public health investigatory (and people and community rela¬tions) skills that one can acquire by conducting PN [partner notification] would be of great service anywhere that new communicable infections or public health emergencies are likely to emerge” (http://www.la-press.com/perspective-on-providing-partner-notification-services-for-hiv-in-sub–article-a4370-abstract).

Telling people what is happening

This second step to answer the question in the title is not automatic. Based on reports from previous Ebola outbreaks, patient-to-patient transmission in health care settings – eg, through injections with contaminated syringes and needles – contributes to expanding outbreaks. Considering the persistent expansion of the ongoing Ebola outbreak in West Africa, it is probable that patient-to-patient transmission plays an important part. If anyone has such information, they have not disclosed it.

In Africa, it has been common practice for ministries of health – encouraged by health aid managers – not to disclose evidence that patients have gotten blood-borne infections such as HIV from unsterile health care procedures. Not warning the public is excused by the assertion that warning might cause more harm than it would prevent: the infections prevented would be outweighed by disease and death due to patients avoiding health care.

Such body count calculations ignore doctors’ ethical obligations. The World Medical Association’s Declaration of Lisbon on the Rights of the Patient avers: “1d. Quality assurance should always be a part of health care… 9. Every person has the right to health education that will assist him/her in making informed choices about…the available health services…” (see: http://www.wma.net/en/30publications/10policies/l4/).

Furthermore, the assertion is based on a misleading mention of only two options – no health care vs. unsafe care. But there is a third option – safe care. Getting to the third option is not, primarily, a matter of money. It costs little or nothing to avoid unnecessary invasive procedures, shift to oral medication, boil instruments, or use plastic disposables. What is lacking is public awareness – lacking due to misinformation by ministries of health and health aid managers.

If ministry officials and/or health aid managers have evidence that people have gotten Ebola infections from health care procedures and settings during the current outbreak, will they tell the public?

Will concern to stop West Africa’s outbreak over-ride public health managers’ unwillingness to warn the public about risks in health care settings? Will the world public’s interest to know if the virus is changing over-ride health aid managers’ unwillingness to acknowledge the contribution of unsafe health care to the current outbreak?

Intersection between HIV and Ebola in Africa


A long history of unsafe health care

During the 20th century and continuing, millions of Africans have gotten blood-borne infections, including tetanus, hepatitis B, hepatitis C, HIV, and Ebola, from unsafe healthcare. With some exceptions, the health aid community’s response has been to deny that health care accounts for more than minorities of blood-borne infections. Instead of fixing unsafe procedures, the health aid community’s repeated response has been to promote solutions involving more invasive procedures.

For example, women and infants in Africa were observed to get tetanus infections from unsterile and contaminated instruments during childbirth. The health aid community responded with tetanus vaccinations – arranging for young women to get as many as five more injections, and for babies to be injected at birth. Vaccinations protect mothers and babies from tetanus, but because additional injections are not reliably sterile, an unknown number get other blood-borne infections.

Across much of Africa in the late 20th century, 70%-95% of adults had been infected with hepatitis B at some time in their lives, while 7%-15% had continuing (chronic) infections. Most chronic infections came from exposures during infancy or early childhood. Studies in Africa reported as many as 50% of children infected before their 5th birthday. The health aid community denied an important role for unsterile health care. Instead of making sure children received safe care, the health aid community introduced another injected vaccine to protect them from hepatitis B. Vaccinations currently protect many Africans from hepatitis B but increase their risk for other blood-borne infections.

Enter HIV. Recent mainstream research traces the origin of the world’s HIV epidemic to colonial health care programs spreading a rare HIV infection (from an otherwise self-limiting outbreak, likely beginning from a chimp butchered for bush meat) to thousands of Africans through unsterile injections for sleeping sickness, yaws, and suspected sexual infections. A lot of evidence suggests blood-borne transmission continues to drive Africa’s peculiar HIV epidemics. Unlike epidemics in almost all countries outside Africa, women in Africa are infected more often than men. Outside Africa, HIV is rare except in adults who inject illegal drugs and men who have sex with men; whereas in much of Eastern and Southern Africa, as many as 20%-50% of adults, most with conservative sex lives and often an HIV-negative spouse, can expect to get HIV during their lifetime.

Missing an opportunity to find and fix unsafe health care

In 1988, Russia investigated an unexplained HIV infection in a child with an HIV-negative mother – thereby uncovering and stopping a chain of transmission through unsterile procedures in 13 hospitals that spread HIV from one to 265 children in 15 months. Several years later, tests in four African cities (Kampala, Kigali, Lusaka, and Dar es Salaam) on 5,593 inpatient children and their mothers found 61 children (1.1%) to be HIV-positive with HIV-negative mothers. Instead of initiating investigations, WHO staff blithely and incredibly concluded “the risk of…patient-to-patient transmission of HIV among children in health care settings is low” (p. 85, 1992-1993 Progress Report, Global Programme on AIDS).

The health aid community has spent billions on HIV prevention messages for Africans focusing almost exclusively on sexual risks. Such messages, with their roots in European and American racial prejudices, smear all Africans – including millions of HIV-positive married women with HIV-negative husbands – with suspicions of uncontrolled sexual behavior.

Although the health aid community has done its best to ignore HIV from unsafe health care in Africa, the US Congress has not only been aware of the problem, but has also made available billions of dollars to fix it. In 2003, the US Congress pressed USAID and CDC to spend $300 million allocated for HIV prevention to improve injection safety and blood safety, primarily in Africa. In 2008, when Congress approved $48 billion for HIV aid, primarily for Africa (see: http://www.pepfar.gov/documents/organization/108294.pdf), it asked the President to develop a 5-year strategy, including (page 8): “(C) promoting universal precautions in formal and informal health care settings; (D) educating the public to recognize and to avoid risks to contract HIV through blood exposures during formal and informal health care and cosmetic services; (E) investigating suspected nosocomial infections to identify and stop further nosocomial transmission…”

At the same time, Congress (page 39) asked the US Global AIDS Coordinator to submit an annual report assessing impact on “capacity to identify, investigate, and stop nosocomial transmission of infectious diseases, including HIV and tuberculosis…” Regrettably, during 2008-13, USAID and CDC spent nothing on outbreak investigations in Africa or to warn the public about blood-borne risks. Instead, USAID and CDC promoted more invasive procedures – male circumcision in unreliably sterile conditions – to reduce HIV infections.

Ebola shines a spot-light to unsafe health care

In 2014, West Africa’s Ebola outbreak exposed unsafe health care systems. Health aid managers were quick to acknowledge that health staff are at risk – this was impossible to deny as more than 100 doctors and nurses died. On the other hand, health aid managers have been silent about patients getting Ebola from unsafe health care.

Health aid managers have for decades been able to get away with a head-in-the-sand response to HIV from unsafe health care. This has been possible because HIV infections from health care are relatively easy to ignore – most victims don’t recognize their infections, which are silent for years. Even when unsafe health care fuels atrocious HIV epidemics, health aid managers have been able to divert attention, adding insult to injury, by blaming infections on victims’ supposed sexual misbehaviors.

With Ebola as with HIV, health aid managers are faced with the choice between warning the public to be wary of skin-piercing health care procedures or staying silent about the risk and thereby allowing preventable infections. With HIV, health aid managers’ have chosen to deny problems, even at the cost of millions of unnecessary infections. With Ebola, however, health aid managers may not have that option. People who see family members, friends, and neighbors get Ebola within days after health care procedures may demand action to find and stop unsafe health care procedures.

If West Africa’s current Ebola outbreak gets people to see and stop reuse of unsterile instruments in health care, the beneficial consequences of the current outbreak – fewer HIV and other blood-borne infections – could far outweigh its current terrible human costs.

To stop Ebola: Tell people about bloodborne risks and treat them with respect


With recent US and WHO statements and commitments, the health aid community is escalating the war on Ebola in West Africa. That’s good news. But I’m still worried. Escalation does not necessarily lead to success, especially if health aid managers escalate failed strategies. Two errors in the response to date have been:
• Not warning the public about risks to get Ebola during invasive health care. This error may well be the principle cause of the continuing increase in numbers of infections.
• Not respecting patients’ rights to choose where to be treated. This error breeds public distrust, undermining cooperation. A strategy to stop Ebola that does not rely on and respect the public is like trying to clean up a puddle with a hammer. The health aid community should switch to towels – to a softer approach.

Based on experience from past outbreaks, as soon as health aid managers fix these errors, we can expect a sharp fall in numbers of new infections, with the outbreak ending in a matter of weeks to months. To fix these errors, public health programs should:

1. Warn people that injections, infusions, and other skin-piercing procedures can spread Ebola, and to avoid such procedures as much as possible

An important observation from earlier outbreaks is that Ebola transmission in health care settings amplifies what is otherwise a self-limiting outbreak. Transmission during home-based care, even with some dangerous funerals, has not been enough to sustain an outbreak. Aside from what happens in the community, preventing any additional (“excess”) transmissions in health care settings has been enough to stop previous Ebola outbreaks.

Most transmissions in health care settings fall into two categories – transmissions from patients to health care workers, and patient-to-patient transmissions. In the current West African outbreak, health aid managers have addressed doctors’ and nurses’ risks to get Ebola from patients by providing protective gear such as gloves and aprons. However, health aid managers have been silent about patient-to-patient transmission, especially through reuse of unsterilized skin-piercing equipment for injections, infusions, and other procedures. This “oversight” may be the error that allows continuing “excess” transmissions in health care settings to amplify what would otherwise be a receding outbreak.

The urbanization of the current outbreak makes it especially important to warn the public to avoid invasive procedures with unreliably sterile instruments. In rural areas, where most Ebola outbreaks have been observed to date, options for invasive procedures are limited. But in towns and cities, where many who are infected with Ebola currently live, people can get injections, infusions, and other skin-piercing procedures from scores of enterprising healers in formal and informal sectors, including pharmacists, private clinics, quacks, etc.

How to stop “excess” patient-to-patient transmissions during invasive procedures? In theory, public health managers could assure that health care is safe by educating and supervising doctors and nurses. However, health care in the affected countries in West Africa was not safe for patients even before the current Ebola outbreak. With the outbreak further stressing the system and reducing available staff, health care is even less safe than in “normal” conditions. To stop transmission of Ebola during invasive procedures, there is no option except warning the public. That is also the only ethical option.

2. Demonstrate respect for the public by letting people choose where to be treated and by acknowledging risks in health care settings, including Ebola isolation wards

The World Medical Association’s Declaration of Lisbon on the Rights of the Patient (available at: http://www.wma.net/en/30publications/10policies/l4/) presents guidelines for doctors to respect patients. According to article 3: “The patient has the right to self-determination, to make free decisions regarding himself/herself… A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy…” such as, for example, entering an Ebola isolation ward vs. taking treatment at home.

Ebola response teams in West Africa have violated patients’ rights by coercing them to enter isolation wards. When health agencies allow Ebola suspects and even cases to choose treatment at home, it frees money and staff to give better treatment to remaining inpatients and to improve community outreach. Based on previous outbreaks, home treatment results on average in less than one new infection for each current case – which is all that is required to stop the epidemic.

Giving suspected cases and their families the option to treat at home will defuse tension between health care personnel and the general public. Healing this rift is essential to allow public health authorities to gain accurate information about the epidemic. People who are not afraid are more likely to talk.

Lessons from three previous Ebola outbreaks


Newspapers, web, and TV have been delivering a crescendo of reports and comments on West Africa’s Ebola epidemic. A lot of what is available for public consumption scares people who are not at risk. At the same time, people at risk are not getting adequate advice from official sources to make informed decisions about how to protect themselves and their loved ones.

In this situation, it’s useful to take a look back at three well-studied and well-reported Ebola outbreaks: the first two recognized outbreaks in 1976 in Sudan and Zaire (currently Democratic Republic of the Congo) and a later outbreak in Kikwit, Zaire, in 1995. Official committees of experts studied each of these outbreaks and reported what they found in the Bulletin of the World Health Organization in 1978 and in the Journal of Infectious Diseases in 1999.

Nzara and Maridi, Sudan, 1976

The first recognized Ebola outbreak began in Southern Sudan in late June 1976 and ended in November 1976. A WHO/International Team coordinated a detailed and thorough investigation of the outbreak, reporting 284 cases and 151 deaths. Information and quotes in this and following paragraphs are from: Bulletin of the World Health Organization, 1978, pp 247-270, available at: http://whqlibdoc.who.int/bulletin/1978/Vol56-No2/ (accessed 2 August 2014).

The outbreak in Southern Sudan was traced to infections among workers at a cotton factory in Nzara town beginning in late June. The source of the virus is suspected to be bats or other animals living in the factory. During the outbreak, 9 factory workers got ill with Ebola (p 253); most subsequent infections came from household contact. “The outbreak in Nzara died out spontaneously” (p 254) after 31 deaths. Before the Nzara outbreak ended, cases from Nzara spread Ebola to two other communities, Tembura and Maridi. In Tembura, a woman from Nzara introduced Ebola that killed three close contacts; that was the end of it in Tembura. In Maridi, Ebola spread from two people from Nzara treated at Maridi’s hospital, which “served both as the focus and the amplifier of the infection” (p 252). Transmissions in Maridi lead to 116 deaths. Several patients from Maridi went for treatment in Juba, resulting in one additional infection and death among Juba’s hospital staff.

“The difference between the Nzara and the Maridi outbreaks is best exemplified by examining the focus where patients most probably became infected. Few patients (26%) were even hospitalized in Nzara, and they seldom stayed more than a few days, but in Maridi almost three-quarters of the patients were hospitalized, and often for more than two weeks. As a result, Maridi hospital was a common source of infection (46% of cases), whereas the Nzara hospital was not (3% of cases)…” (p 253).

A WHO/International Study Team arrived in Maridi towards the end of the epidemic and stayed to the end. The Study Team recruited surveillance teams to scout for cases in communities around Maridi. “A large number of cases of active infection were soon discovered; each was reported to the Sudanese officials and an ambulance accompanied by a Public Health Officer was sent to the house. Patients were persuaded to enter the isolation wards at the hospital” (p 250). Significantly, Public Health Officers did not force suspected cases to go to the hospital: “Some refused, and in these cases relatives were warned of the grave risks, and advised to restrict close contact with the patient, and to limit it to only one close relative or friend. Protective clothing was offered but usually refused.”

Yambuku, Zaire, 1976

The first recognized case reported symptoms on 1 September. The last death occurred just over two months later on 5 November 1976. An International Commission managed a detailed and thorough investigation of the outbreak, reporting 318 cases and 280 deaths. The information in this and following paragraphs is from the Bulletin of the World Health Organization, 1978, pp 271-293, available at: http://whqlibdoc.who.int/bulletin/1978/Vol56-No2/ (accessed 2 August 2014).

“The index case in this outbreak had onset of symptoms on 1 September 1976, five days after receiving an injection of chloroquine for presumptive malaria at the outpatient clinic at Yambuku Mission Hospital… [A]lmost all subsequent cases had either received injections at the hospital or had had close contact with another case. Most of these occurred during the first four weeks of the epidemic, after which time the hospital was closed, 11 of the 17 staff members having died of the disease…” (p 271).

“Five syringes and needles were issued to the nursing staff [at the Yambuku Mission Hospital] each morning for use at the outpatient department [with an average of 200-400 outpatients each day], the prenatal clinic, and the inpatient wards [with 120 beds]. These syringes and needles were apparently not sterilized between their use on different patients but rinsed in a pan of warm water. At the end of the day they were sometimes boiled” (p 273).

“The epidemic reached a peak during the fourth week, at which time the YMH [Yambuku Mission Hospital] was closed [on 3 October], then it receded over the next four weeks” (p 279). “[I]t seems likely that closure of YMH [Yambuku Mission Hospital] was the single event of greatest importance in the eventual termination of the outbreak” (p 280). The last recognized transmission occurred in late October.

The International Commission organized surveillance for cases in communities around Yambuku. “Suspect cases were not closely examined, but medicines were given to them and arrangements were made for their isolation in the village… [P]hysicians were sent to follow up suspect cases…” (p 276). Notably, surveillance teams did not force or even urge suspect cases to go to hospital. In any case, the outbreak in and near Yambuku had already died out on its own, with the last probable case dying on 5 November, four days before surveillance began on 9 November (p 277).

The International Commission collected and reported data on transmission from cases to family members. In 146 families with one or more cases acquired from outside the family, 1,103 family members were exposed, of which 62 (5.6%) got sick with Ebola (p 282). In other words, there was less than a 50% chance a case would infect a family member (146 cases, or more if any family had more than one case, infected a total of 62 family members). Thus, once the hospital closed, each case infected on average less than one family member, so the epidemic died out on its own.

Kikwit, Zaire, 1999

An International Scientific Commission investigated an Ebola outbreak in Kikwit, DRC, a large, sprawling town with a population reported at 200,000-400,000 at the time of the outbreak. The investigation identified 315 cases between 6 January and 16 July; out of 310 cases with adequate information, 250 died. Information in this and subsequent paragraphs is from a 1999 special issue of the Journal of Infectious Diseases, available at: http://jid.oxfordjournals.org/content/179/Supplement_1 (accessed 3 August).

During the Kikwit outbreak, 80% of case patients were hospitalized to treat their Ebola illness (page S82). However, hospitalization did not interrupt contacts between family members and case patients (p S88): “As in much of Africa, the families of inpatients are responsible for providing food and many other aspects of patient care, such as cleaning bedpans and washing soiled clothing and linens. Often family members arrange to sleep on the hospital ward [even sharing the patient’s bed; p S90] to assure continued care through the night.”

A study of secondary infections among 173 household members of 27 case patients found 28 secondary infections in 15 households (7 had >1 secondary case). “The exposure that was most strongly predictive of risk for secondary transmission was direct physical contact with the ill family member, either at home in the early phase of illness or during the hospitalization” (p S89). The 28 secondary cases occurred in 95 household members who had touched the case patient during early or late illness; whereas none of 78 household members who had not touched the patient at that time got sick, even though many slept in the same room, shared meals, or touched the patient before illness (p S89).

“There was an additional risk associated with a variety of exposures to patients in the terminal stages of illness, such as sharing a hospital bed or hospital meals and touching the cadaver” (p S90). “[T]he use of barrier precautions by household members and standard universal precautions in hospitals would have prevented the majority of infections and deaths…” (p S91).

During case surveillance in and around Kikwit town (p S78), “persons who met the case definition…were instructed to seek medical evaluation and possible hospitalization at Kikwit General Hospital…” However, this was not forced; if the sick person chose to stay home, family members “were educated on how to reduce their risk of infection…. Nurses previously trained in the sentinel clinics also visited household of probable case-patients to distribute protective materials (eg, a pair of gloves, soap, and wash basin) as needed and to reinforce educational messages about risks of transmission and symptoms suggesting disease in subsequent family members.” During surveillance outside Kikwit (p S78-S79), “Probable case-patients were confined in their households, instructions for care were given, and basic protective equipment was provided to the primary care givers.”

Lessons for West Africa, 2014

Based on reports from previous epidemics, here are several recommendations. The first is for people at risk to protect themselves. The second is for public health managers to deal with cases in a way that is acceptable to the community while at the same time ensuring transmission is too low to sustain the outbreak. Stopping the outbreak involves reducing the average transmission from each current case to less than one more case. Both recommendations contribute to that goal.

1. Recommendation to the public: If you are living in a community with Ebola cases, avoid injections, infusions, dental care, manicures, and all other skin-piercing procedures with instruments that might not have been sterilized after previous use. If you do this, and if you stay away from people with suspected Ebola infections, you have virtually no risk to get Ebola.

If someone stays away from sick people and funerals, the only remaining risk to get Ebola is through unrecognized contact with some unknown case. In previous epidemics, acquisition of Ebola from unrecognized contacts with unknown strangers has been confirmed through only one form of contact – blood-to-blood contact when health care workers reuse syringes and needles without sterilization to give injections to one patient after another. Reused, unsterilized skin-piercing equipment can pass Ebola from someone with the virus to complete strangers. If people in communities with Ebola avoid skin-piercing procedures – in hospitals, pharmacies, dental clinics, barbershops, beauty salons, from traditional healers, etc – the risk to get Ebola from some unknown source is near zero. Moreover, the public health risk – that people with Ebola will infect strangers not involved in patient care – will be too low to sustain the outbreak. (If you do go for an injection, manicure, or other skin-piercing procedure, you can ensure instruments used on you are sterile by following advice at: http://dontgetstuck.org/.)

2. Recommendation to public health managers: Accept and accommodate home-based care of suspected and even confirmed cases, if that is what the family wants.

For the sake of effective management of the epidemic, the challenge is to reduce transmission on average from each case to less than one more case. Based on reports from three well-studied outbreaks in 1976 and 1995, caring for an Ebola case at home results on average in less than one new case – that is enough to wind down the epidemic, which is a lot better than what has been achieved so far in West Africa in recent months.

If a suspected case with common symptoms (fever, diarrhea, sore throat) goes to the Ebola ward, what is the chance he or she does not have Ebola? If so, what is the chance he or she will get Ebola from another patient? Without good data showing near zero risk for patients to get Ebola in an Ebola ward, it is reasonable for people to fear and resist going there. And, because getting all cases into isolation wards is not necessary to stop the epidemic (see previous paragraph), there is no good public health excuse for using government coercion to force people to go. Can we expect parents willingly to send children with sore throats to isolation wards?

The risk to family care-givers is, nevertheless, substantial if the suspected case turns out to have Ebola. If families accept the risk, that’s their choice. However, that risk can be reduced by giving care-givers detailed advice about specific risks, providing protective gear, and advising in-house quarantine measures to protect family members and others.

In any case, forcing suspected cases to go to isolation wards is likely to undermine rather than enhance epidemic control. Consider: When people are afraid government will force them or their loved ones to go to an Ebola ward, they may hide sick family members (suspected cases), avoid public health personnel, and seek secret treatment from cooperative doctors or others who may or may not practice barrier nursing or sterilize instruments after use. Thus, the threat of force may well reduce, not enhance, the ability of public health managers to advise and to supervise treatment of cases to prevent onward transmission.

This recommendation to accommodate home-based care agrees with a recent decision by Sierra Leone’s President Ernest Bai Koroma to quarantine sick patients at home, a decision appreciated by Heinz Feldman at the US National Institute of Allergy and Infectious Diseases: “It could be helpful for the government to have powers to isolate and quarantine people and it’s certainly better than what’s been done so far…” See: West African outbreak tops 700 deaths, Associated Press 31 July 2014, available at: http://www.patriotledger.com/article/ZZ/20140731/NEWS/140739987/12662/NEWS (accessed 31 July 2014).

Risks the current outbreak will spread to other countries

Are people living in the US or UK or Australia at risk? No. Just as in Maridi, Sudan, in 1976, the risk is that a patient with Ebola acquired elsewhere will go to a hospital with poor infection control, and that the hospital will amplify the infection, spreading it into the community. This is not going to happen in Europe, the US, or most other countries because hospitals with adequate infection control will not amplify the outbreak.

However, there is a risk that Ebola from West Africa’s ongoing outbreak might spread to other countries in Africa. Wherever HIV, a slow-acting bloodborne virus, transmits through unsafe healthcare, there is a risk that Ebola, with an incubation period of weeks not years, will similarly spread through unsafe healthcare. Most countries in Africa have generalized HIV epidemics, with more women than men infected, and with only small minorities of infections explained by men having sex with men or people injecting illegal drugs. The public health community likes to blame Africa’s generalized epidemics on sex, but no one has been able to find sexual differences between Africa vs. Europe or the US that could explain Africa’s generalized HIV epidemics. What is different is that Africans get more exposures to reused but unsterilized skin-piercing instruments during health care and cosmetic services.

The existence of generalized HIV epidemics in a country is best explained by a lot of HIV transmission through unsafe health care along with some sexual transmission. The fear that Ebola from West Africa might spread to other countries is a realistic concern for countries with generalized HIV epidemics.

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).