Uproar in Togo

The BBC reports that a government ban has been enforced on radio and television advertizements for traditional medicines in Togo. Phillipe Evegnon, president of the delightfully named High Audio Visual and Communication Authority, states that the advertizements poses risks to listeners and viewers, because the commercials give false information about the supposedly miraculous curative effect of herbal concoctions. Togolese radio and television stations are outraged, for obvious reasons: they get much of their revenue from traditional medicine commercials. About 80% of sub-Saharan Africans consult traditional healers; that is first-line medicine for the vast majority, who often cannot afford Western-style health care services anyway.

The relationship between traditional medicine in Africa and bioethics is sensitive. On the one hand, respect for culture seems to demand that the importance of traditional medicine in the life of Africans be acknowledged, particularly because it involves a gamma of longstanding, physical and spiritual healing practices. On the other hand, when clients are offered herbal remedies whose efficacy and side effects have not been tested, and when informed consent is considered a challenge to the authority of the healer, bioethicists (no matter where they are located) should raise objections. The more serious the ailment, and the more extravagant the claims made by the healer, the more responsibility the bioethicist (and lawyer, minister of health, and so on) has to advocate for the protection of patients. Aceme Nyika wrote a good article on this in Developing World Bioethics recently, though it makes you wonder whether traditional healers will survive being regulated by ethics committees and medical boards.

The rubber hits the road: the Vatican on condoms

The Vatican has long had two basic objections to the use of condoms. First, condoms are a form of contraception, and runs counter to strong connection between sex and reproduction in the Christian tradition. Married Christian people should not use them. If they do not want children, they should simply abstain from sex. Second, the Church believes that the use of condoms promotes premarital and extramarital sex, both of which are immoral. People who are not married and consider themselves Christian should not use them. Unmarried people who want to have sex should either get married or abstain from sexual activity (Of course, gay men should neither get married or use condoms to commit their abominations). A third, putatively scientific argument sprung up some years ago: that condoms are not useful in the prevention of HIV anyway, because that sneaky little virus can burrow its way through the rubber. The bottom line is: no Christian should use condoms. Of course, there are those that depart from the script. But there is a script, and it gets read.

Many Africans, after centuries of missionary activity, have embraced Christ and, with the help of Church doctrine, have rejected the condom as immoral. Not all, but many faith-based health care organizations and Christian health care workers have assisted in the demonization of the condom in Africa. In the 25 year history of the HIV/AIDS epidemic, it is unknown just how many African lives have been lost on account of this aspect of Christian sexual morality. But considering the amount of time and size of the populations involved, the numbers cannot be unsubstantial. One would think that an institution which is 'pro-life' on many fronts would be ethically concerned about policies that are effectively pro-death. But the Church has held its hardline position on the condom as HIV infections have continued to rise, and the majority of the 25 million people who have died of AIDS were sub-Saharan Africans. In his trip to Africa last year, the Pope was worried about the epidemic, but not about the Church position on the condom.

There are currently murmurings that the Church may budge on its position, if ever so slightly. Pope Benedict XVI has commissioned a report on the scientific and moral aspects of the use of condoms. The 200 page report will be reviewed by top theologians, and may be used to inform a papal document on the subject. Most observers believe that the revised position could allow for the use of condoms among married couples, when one of them is HIV positive. If this is the case, it will be interesting to see how theologicans will justify this use of the condom, while condemning all the other uses.

The World Health Organization seems to welcome this development, even if it is a question of 'too little, too late.' The change of position would be welcome, because many African women are vulnerable to being HIV infected by their husbands, and it hardly helps that the latter can cite the Pope and the Catholic Church to justify their not using a condom. A new Papal document might help change the dynamics of the Christian African bedroom. But the change might be too little, because it would not help with the sexual activity that takes place among persons not married to one another. And, of course, it is too late for all those who have died, or are HIV infected already, under the traditional position. One can't help but wonder: if the Vatican was not located in Rome, but somehow in Durban or Gaborone instead, wouldn't the position have changed ages ago?

The new UNAIDS report on global HIV/AIDS: counting in millions

It is the time of year for UNAIDS -- sometimes known as the Joint United Nations Programme on HIV and AIDS -- to issue its global AIDS epidemic report. The UNAIDS report over the years has been reliably depressing and horrifying, as the mortality statistics and rate of new infections are counted in millions. In some respects, this year's edition is no break from the past. Approximately 2.9 million people will have died of HIV/AIDS in the world this year, and 2.1 millon of them (or 72%) were sub-Saharan Africans. It does not speak well of the millions of dollars poured into HIV prevention programs around the world that approximately 4.3 million people were newly infected with the virus. Uganda seems to have taken a backward step: a prevalence of 5.6% infection among men and 6.9% among women in 2000 has rise to 6.5% in men and 8.8% in women by 2004. The Guardian is quick to judge that the regression is due to the commitment of the Ugandan government -- strongly backed by the Bush administration -- to abstinence promotion at the expense of other ways of preventing HIV. Another alarming note is the rise of HIV infections via injection drug use in Africa, which has not been much recorded before -- what Africa does NOT need is another vector of HIV transmission. Some see glimmers of hope in the report, such as the decline in HIV infection among youth (15-24) in African cities in Ivory Coast, Malawi and Zimbabwe, and rural areas of Botswana.

But overall, it is not a rosy picture: HIV prevention is stagnant or faltering, while the increased access to AIDS treatment and care in sub-Saharan Africa is not keeping up with the march of death. The piecemeal initiatives of HIV/AIDS superstars (Gates, Clinton, Bono) cannot substitute for major economic, social and political changes needed in Africa and between Africa and the rich countries of the north. Until then, it seems we will be faced with the symptoms of global inequality, in the form of grim reports by UNAIDS.

Harvesting organs from the condemned

It is interesting how some news items have no real news content. Take the criticism, by a representative of Human Rights Watch, of the use of the organs of executed criminals in China for transplant purposes. The piece in Salon is an opportunity to review what is known about this practice and the ethical concerns it raises, but it does not offer any new information beyond an official acknowledgment by the Chinese government of what many knew, since Human Rights Watch outed the Chinese government document entitled 'Rules concerning the Utilization of Corpses or Organs from the Corpses of Executed Prisoners' back in 1984. What looks like a news item partly functions as an exercise in consciousness raising, which (especially in this case) is a good thing.

Capital punishment in China should trouble everyone, including those who support the death penalty. To the extent that the numbers are documented, China is by far the world leader in executions, and is by far the most 'liberal' in terms of what counts as a capital offense (68 crimes, including tax evasion). Serious problems in the Chinese legal system -- from the use of torture to obtain confessions to judges with major conflicts of interest -- draw into question whether the condemned received anything resembling a fair trial before being dispatched. It is within this dubious system of legal punishment that the Chinese practice of prisoner organ 'donation' finds itself. Although Chinese authorities insist that the condemned or their family members are required to give informed consent, it seems unlikely that the consent form will include a sentence like this: "Your organ may save the life of a fellow Chinese. However, your organ may also go to a rich foreigner, and the lucrative proceeds of this exchange will disappear into the pockets of unnamed officials." If that sounds far-fetched, read the first chapter of Trust is not enough: bringing human rights to medicine by David and Sheila Rothman. They recount the following story:

Several years ago a heart transplant surgeon told us that he had been invited to China to perform a transplant; accustomed to long waiting periods in America, he asked how he could be certain that a heart would be available when he arrived. His would-be hosts told him they would schedule an execution to fit his travel schedule. He turned down the invitation.

Officials willing to time their executions to meet the travel needs of foreigners are probably willing to do a whole lot else.

The current Chinese system allows for the worst case scenario: a man is innocent of any crime, but condemned to death; his kidney is removed under unsafe conditions; it is transplanted to a Japanese recipient who, after paying a hefty fee, dies of an infection. Could happen, probably already did, and if it manages to reach the light of day, it will be news.

New book on biomedical research in developing countries

It is no longer news that pharmaceutical companies are increasingly conducting clinical trials in many low-income (i.e. impoverished) countries, mostly in order to reap a greater profit margin. And the main ethical issues with the globalization of pharmaceutical research are also pretty well known, at least in the academic and development communities: the local participants, who often have little formal education, may not be in a position to give meaningful informed consent; the poor and sick may have no real option to refuse to join a study, especially when the trial offers a decent standard of medical care; and the trials may be testing drugs for conditions that are mainly of interest to the richer countries, while neglecting to do drug research for serious health conditions if they are not sufficiently marketable in the industrialized world. And so on. Every student who takes a course on international research ethics gets a steady earful of this: inequality, injustice, exploitation.

Familiarity with these issues may not breed contempt, but it can breed a certain level of indifference. This potential indifference is dangerous to the extent that ethically questionable trends and practices in international research continue to go on. That is why the new book by Sonia Shah (The Body Hunters: Testing New Drugs on the World's Poorest Patients) comes at a good time. The book has a Foreword by John Le Carre (of The Constant Gardener fame, among other accomplishments), and Ms. Shah has done some of her own investigations of research cultures in South Africa and India.

This blogger has ordered the book and eagerly awaits its arrival. Since scandal sells, and the theme of 'rich white corporation exploits poor black people' sells even more, will the book be an unbalanced diatribe against the pharmaceutical industry? Or a rich account that carefully explores the inherent ethical tensions when health research takes place in a world of inequality, and offers decent support for its claims and conclusions about the practices of pharmaceutical companies? Playing advocate for the vulnerable is both admirable and risky. In some articles, Ms. Shah's readiness to link international research with the Tuskegee Syphilis experiment seems to betray a taste for sensationalism. Hopefully the book is made of stronger stuff.

The MeNZB vaccine redux

The strange case of the MeNZB vaccine has been reopened by a new Norwegian documentary. Back in 1988, the Norwegian Institute of Public Health started testing a new vaccine against meningococcus b. Meningococcal disease is, well, nasty. It is caused by the bacterium Neisseria meningitidis, and the disease usually affects the membranes around the brain and spinal cord or the bloodstream, causing meningitis or septicemia, and can result in brain damage, blindness, deafness, limb amputations and death. Meningococcus b mainly affects children. For some 13 years, a strain of meningococcus b was responsible for epidemic of meningcoccal disease in Norway. As a response, the largest clinical trial in Norwegian history was designed and implemented, involving 170,000 people and over 2000 doctors and nurses.

The vaccine trial was not a glowing success. As reported in the Lancet in 1991, the vaccine did not provide a high enough degree of effectiveness (57%) and it was never licensed for use in mass vaccination in Norway, where the epidemic had in any case started to subside. In addition, there were scientific and ethical questions raised throughout the trial. The vaccine had a relatively high number of side effects, and it was unclear to some that the risks of these side-effects had been properly communicated to the parents of the children. Compensation was offered to some of the children seriously injured in the study.

This is where the New Zealand part of the story comes in. A few years ago, the World Health Organization requested that a vaccine similar to the Norwegian one be exported to New Zealand, which was suffering its own meningococcus b epidemic. Using the same technology and the same methodology from 1980s, researchers from the Norwegian Institute of Public Health tailored a new vaccine for New Zealand. The multinational pharmaceutical company Chiron was awarded rights to mass produce the vaccine. Part of the controversy is that what is now called the MeNZB vaccine was never subjected to a Phase III trial. According to critics, this means that a vaccine whose safety and efficacy has not been sufficiently proven is being used on hundreds of thousands of New Zealand children. According to defenders, the safety and efficacy had been well-enough proven without the need for Phase III trials, and doing so would have been unethical itself in the face of a public health emergency.

A new Norwegian documentary entitled The Vaccine Experiment -- In the Service of the Good that aired recently on New Zealand television draws doubt on the science and ethics of the Norwegian trial, and by extension, the use of the vaccine in New Zealand. The New Zealand Ministry of Health has responded vigorously, labelling participants in the documentary 'anti-immunization zealots' and issuing a press release in unyielding defence of their vaccination program. One of the alleged zealots (Professor Jan Helge Solbakk) has recently been named head of bioethics at UNESCO.

Not to mention the Finns

Part of the old Cole Porter song, Let's Do it (Let's Fall in Love), goes:

The Dutch in old Amsterdam do it
Not to mention the Finns
Folks in Siam do it - think of Siamese twins

The idea being that everybody, everywhere, is doing it. The same goes, it seems, with research ethics abuses. In April 2004, The Breastfeeding Support Association of Finland lodged a complaint with the Finnish Parliamentary Ombudsman about a study led by researchers within the Finnish National Public Health Institute. The study aimed at finding out whether removal of bovine insulin from infant formula would reduce type 1 diabetes (IDDM) and the mechanisms of the condition. The study involved giving infant formula to newborns, and continuing to provide free formula after discharge of mother and child from the hospital.

Sounds good, until you go into the details. The study proceeded for six months before ethics approval was sought. The participants were not told that the study was funded entirely by a Finnish baby formula manufacturer (Valio), or that the principal investigator of the study was an inventor and benefactor of the patent for the formula being given to participants. The participants were not told that they were basically in a product development study for a private company, and worse still, they were not adequately informed about the benefits of breastfeeding as opposed to formula. The free distribution of formula raises additional concerns about undermining the ability of mothers to breastfeed and making mother and child dependent on the research product. The more the Ombudsman dug, the worse it got. Shades of Nestle's infant formula marketing in Africa, though a fair judgment of the case will have to wait until the researchers respond to the Ombudsman's findings.

An interesting twist to the story is that Pekka Puska, head of the Finnish National Health Institute, signed off on the study, claiming that it "complies with the law regarding medical research and good research practice. ... informed consent fulfills the requirements of the law. ... distribution of infant formula does not deviate from legal norms." Mr. Puska is also one of the leading candidates for the position of Head of the World Health Organization, which is planned to be filled by next week. Which means that he still has time to reflect on the differences between the law and ethics, and to brush up on that other Finnish product, the Declaration of Helsinki.