Rules of engagement: 1) You do not have to register to leave comments on this blog. 2) I do not respond to anonymous comments. 3) I reserve the right to delete defamatory, racist, sexist or anti-gay comments. 4) I delete advertisements that slip thru the google spam folder as I see fit.
Sunday, July 18, 2010
Ethics of dealing with irresponsible HIV/AIDS denialist parents
Saturday, July 17, 2010
Citizens of the World Against Stoning: International Sakine Mohammadi Ashtiani Day
Citizens of the World against Stoning
We, the undersigned, are extremely concerned about the fate of 43 year old Sakine Mohamadi Ashtiani and fear she may be executed in Iran at any time for ‘having an illicit relationship.’
We call on people everywhere to intensify their protests by marking Saturday 24 July as the International Sakine Mohamadi Ashtiani Day. On the Saturday, we ask you to come out on to the streets and in city centres across the globe at 2pm local time bringing photos of Sakine and messages in her defence and against stoning and execution. Other measures that can be taken include highlighting her case wherever possible, signing petitions (http://stopstonningnow.com
The mother of two has already received 99 lashes and been sentenced to death by stoning. Sajjad, her 22-year-old son, who raised the alarm of her imminent stoning when there was no further legal recourse via an open letter to the people of the world (http://notonemoreexecution
As a result of the public outcry, the embassy of the Islamic Republic of Iran in London has issued a press release stating that the regime did not intend to stone her, that stoning in Iran was rare and that there was no truth to the reports (http://iransolidarity.blog
On 24 July 2010 at 2pm join us and make the world stand still in its rage against medievalism and barbarity and in its support of humanity. Sakine, her children and the many others awaiting death by stoning and execution deserve nothing less.
Mina Ahadi, International Committee Against Stoning and International Committee Against Executions (Germany)
Maryam Namazie, Iran Solidarity, Equal Rights Now – Organisation against Women’s Discrimination in Iran and One Law for All (UK)
Maria Rohaly, Mission Free Iran (USA)
Shahla Abgari, Human Rights Activist (USA)
Nazanin Afshin-Jam, Stop Child Executions (Canada)
Russell Blackford, University of Newcastle (Australia)
Caroline Brancher, Union des Familles Laïques (France)
Helle Merete Brix, Journalist and Writer (Denmark)
Roy Brown, International Humanist and Ethical Union (Switzerland)
Ed Buckner, President, American Atheists (USA)
Peter Calluy, Belgian Humanist Society (Belgium)
Pierre Cassen, Riposte Laïque (France)
Megan Cornish, Seattle Radical Women (USA)
Parvin Darabi, Dr. Homa Darabi Foundation (USA)
Richard Dawkins, Scientist (UK)
Sanal Edamaruku, Rationalist International (India)
Bill Flanagan, Queen's University (Canada)
Tahir Aslam Gora, Writer and Journalist (Canada)
AC Grayling, Writer and Philosopher (UK)
Laura Guidetti, Marea Association (Italy)
Maria Hagberg, Network against Honour-Related Violence (Sweden)
Johann Hari, Journalist (UK)
Farzana Hassan, Author (Canada)
Tasneem Khalil, Independent World Report (Sweden)
Hope Knutsson, Sidmennt, the Icelandic Ethical Humanist Association (Iceland)
Leo Igwe, Nigerian Humanist Movement (Nigeria)
Sonia Jabbar, Journalist (India)
Trefor Jenkins, University of the Witwatersrand (South Africa)
Ghulam Mustafa Lakho, High Court Advocate (Pakistan)
Monica Lanfranco, Marea Feminist Review (Italy)
Anne-marie Lizin, Belgian Senate Honorary Speaker (Belgium)
Marieme Helie Lucas, Secularism Is A Women's Issue (France)
Kinga Lohmann, KARAT Coalition (Poland)
Mohamed Mahmoud, Centre for Critical Studies of Religion (UK)
Irshad Manji, European Foundation for Democracy and New York University (USA)
Caspar Melville, Rationalist Association (UK)
Behnaz Parman, Artist (Germany)
Angela Payne, Anti-Injustice Movement (UK)
Clancy Pegg, Bioethics Journal (UK)
Naomi Phillips, British Humanist Association (UK)
David Pollock, European Humanist Federation (UK)
Venita Popovic, Zenicke Sveske Journal (Bosnia and Herzegovina)
Gita Sahgal, Human Rights Campaigner (UK)
Terry Sanderson, National Secular Society (UK)
Nina Sankari, European Feminist Initiative (Poland)
Udo Schuklenk, Queen's University (Canada)
Aisha Lee Shaheed, Women Living Under Muslim Laws (UK)
Issam Shukri, Defense of Secularism and Civil Rights in Iraq (Canada)
Elizabeth Sidney, Women Worldwide Advancing Freedom and Equality (UK)
Joan Smith, Writer and Activist (UK)
Roy Speckhardt, American Humanist Association (USA)
Annie Sugier, Ligue du Droit International Des Femmes (France)
Richy Thompson, National Federation of Atheist, Humanist and Secular Student Societies (UK)
Christine Tasin, Résistance Républicaine (France)
Peter Tatchell, Human Rights Campaigner UK)
Giti Thadani, Writer and Filmmaker (India)
Shishir Thadani, South Asian Voice (India)
Gianni Verdoliva, Journalist (Italy)
Notes:
1. The new and comprehensive list of persons stoned to death or awaiting death by stoning in Iran compiled by Farshad Hosseini of the ICAE is available in Persian:http://countmein-iran.com/
2. See a 17 July article in the Times calling for the eviction of the Islamic Republic of Iran from the UN Commission on the Status of Women: http://iransolidarity.blog
3. For more information, please contact:
Mina Ahadi, Germany, ICAE and ICAS Coordinator, minaahadi@aol.com, 0049 1775692413
Ahmad Fatemi, ICAE Public Relations, fatemimark@gmail.com, 0046 0735203817
Maryam Namazie, UK, Iran Solidarity Spokesperson, iransolidaritynow@gmail.co
4. To donate to the important work of the International Committee Against Stoning and International Committee Against Executions, please make your cheque payable to ‘Count Me In – Iran’ and send to BM Box 6754, London WC1N 3XX, UK. You can also pay via Paypal (http://countmein-iran.com/
5. You can also find the latest news on the following websites:
International Committee Against Executions (http://notonemoreexecution
International Committee Against Stoning (http://stopstonningnow.com
Facebook Page of Save Sakine Mohamadi Ashtiani: http://www.facebook.com/gr
Tuesday, July 13, 2010
Was the University of Illinois at Urbana-Champaign right to fire Catholic instructor?
The academic in question didn't actually have tenure, he was an adjunct instructor. In his letter he states - among other things - the following:
'To the best of my knowledge, in a sexual relationship between two men, one of them tends to act as the "woman" while the other acts as the "man." In this scenario, homosexual men have been known to engage in certain types of actions for which their bodies are not fitted. I don't want to be too graphic so I won't go into details but a physician has told me that these acts are deleterious to the health of one or possibly both of the men. Yet, if the morality of the act is judged only by mutual consent, then there are clearly homosexual acts which are injurious to their health but which are consented to. Why are they injurious? Because they violate the meaning, structure, and (sometimes) health of the human body.'
What wrong about this statement?
1) It is not the case that in same sex relationships one of the partners necessarily acts as the 'woman' and the other one acts as the 'man'. Even if this was the case, nothing at all followed normatively.
2) Empirically it makes no sense at all to speak of people engaging in sexual acts that their bodies are not fitted (by whom?) to undertake. Everything that we are physically able to undertake with our bodies are able ('fitted'?) to do.
3) It is question begging to claim that a sex act violates the meaning of our bodies? As in 'how', 'why', 'by means of what'? Are we violating our bodies each time we engage in sexual acts for the fun of it as opposed to in order to breed? What's he on about here?
4) What is meant by the 'structure of the human body' being violated by a same sex act?
And so he concludes,
'Catholics don't arrive at their moral conclusions based on their religion. They do so based on a thorough understanding of natural reality.'
This, of course, is patently untrue and unprofessional a statement. By necessity Catholics (qua Catholics) arrive at their moral conclusion about sexuality (amongst others) by means of a normative understanding of natural reality (ie their interpretation of what nature, especially human nature ought to be like, as opposed to what it really is like). For that reason the preacher (aka teacher) sneaks in Natural Moral Law and Reality. Really he's saying that natural law theory thinks that human reality ought to be such and such, when quite obviously it is different. The problem then ain't with the theory but with our behavior. All quite silly stuff to be honest.
Was it sensible to fire him? Well, given that the topic of the class was 'Utilitarianism and sexuality' (I can't see how anyone could teach that topic for a whole term, but hey), he clearly went on an agitprop exercise, even trying to hide is real reasons (Catholic doctrine) by claiming that his views have nothing to do with religion. He said, for instance, 'As a final note, a perceptive reader will have noticed that none of what I have said here or in class depends upon religion.' That's a plain lie. No wonder his University chose to take him down.
A nice analysis of some other nonsense in the good preacher's email to his students can be found at the - as ever - dependable Pharyngula.
Wednesday, July 07, 2010
Britain becomes safe heaven for gay refugees
A "huge gulf" had opened up in attitudes towards gay people, he said. "It is one of the most demanding social issues of our time. Our own government has pledged to do what it can to resolve the problem, but it seems likely to grow and to remain with us for many years." More gay and lesbian people were likely to have to seek protection in this country if it was denied in their home countries, he said.
Another member of the court, Lord Rodger, said normal behaviour of gay people must be protected just as it was for heterosexual people. "What is protected is the applicant's right to live freely and openly as a gay man. To illustrate the point with trivial stereotypical examples from British society: just as male heterosexuals are free to enjoy themselves playing rugby, drinking beer and talking about girls with their mates, so male homosexuals are to be free to enjoy themselves going to Kylie concerts, drinking exotically coloured cocktails and talking about boys with their straight female mates."
Leaving aside for a moment the characterization of gay men as being typically this or being typically that, the point is well taken that if this is how you express your identity you have every right in the universe to do so without risking your life. You can see how important this judgment is when you look at how bad the situation for gay people in many countries is.
Tuesday, July 06, 2010
German Federal Court on PID
Monday, July 05, 2010
Jamaican papers are at it again – homophobia in 'reporting' action

Having just redeemed themselves in the eyes of regular readers with pretty sharp reporting about the Dudus' affair, Jamaica's journalism is back to its usual quality-wise lows.
Two of Jamaica's papers, the Observer and the Gleaner have a long and distinguished history of anti-gay agitprop. The Gleaner frequently does it under the guise of pseudo-openness perpetuated by one of its columnists. He's a quite eloquent chap who likes to gives his musings an air of scientific soundness when really he picks and chooses biased academic content usually from low-ranking academic journals likely gleaned from the Family Research Council's (or some other Christian fundamentalist organisation like it) treasure chest of anti-gay 'research'. You know, the kind of research 'demonstrating' that gays are more likely to rape little kids, murder your grannie and have a hotline to the devil. A long running Jamaican agitprop feature on that front has been this: Antigay violence in Jamaica ain't the real problem (empirical research undertaken by international human rights organisations be damned) but violent gay men beating each other up are the real problem.
Here's an example taken from the Observer. In last Sunday's edition, under the byline of 'DONNA HUSSEY-WHYTE Sunday Observer staff reporter', the campaign continues. Hussey-Whyte notes in her introductory line that 'Many may argue that the gay community is falsely accused of excessive violence against its own members, but the horrible wounds on Keron Brown's body tell a different story.” Her story is about a gay man who she reports has been abused pretty badly by his partner and that partner's mates. Assuming that the case is true – I have no way to verify it, but it's perfectly possible, of course, that a gay man was abused by his partner – nothing follows with regard to how the average gay person treats his or her partner(s).
No doubt Donna Hussey-Whyte doesn't know what inductive reasoning is, and even less why we know that such modes of analysis don't work as a scientific method. So, to her benefit: You can't really use anecdotal cases to make a general point. Say, assume I see someone jumping out of a 10th floor window and ending up on the ground floor without injury. I shouldn't make that the story line of an article suggesting that generally speaking it's sensible to assume that jumping out of 10th floor windows isn't a risky activity. I'm sure you get the drift. So, before Donna Hussey-Whyte's agitprop piece even goes into full swing, anyone who took Scientific Method 101 knows already that not only is her first sentence wrong, but more importantly, that anyone can know with certainty that her story can't prove her point about the gay community being pretty violent against its own members. It's not even clear what she means with gay community to be honest. Is her proposition that the average gay person is more likely, or a membership club called 'gay community' or is something else tickling her incisive reporting mind?
Even if there was a whole bunch of such cases, nothing would follow regarding the question of how the majority of gay people in Jamaica treat each other. Short of a representative survey, this bunch of cases would be just that, a bunch of anecdotes. The question is: Could such research even be undertaken in a society where gay people are hunted out of their houses, beaten up randomly in the streets, and where homosexual conduct and relationships are still illegal. The truth is, if we bothered investigating what amounts to an odd-indeed hypothesis to begin with, we would really have no means to undertake such a study in current-day Jamaica.
Anyhow, back to Donna Hussey-Whyte's agitprop piece: Just think of a counter example of similar disingenuity, think of the number of crimes committed by heterosexual people in Jamaica. Most of those crimes are committed against other heterosexual people. Would this tell us anything at all about a purported link between heterosexuality and violent behaviour? Not at all – that is unless you're Donna Hussey-Whyte. Oddly, she never filed this particular investigative report. Makes you wonder why...
Having said that, from societies more peaceful than the Jamaican we do know that gay people are – if anything – less prone to be violent than their straight counter parts. Is it possible that anti-gay violence and general societal homophobia cause possibly surplus violence among gay people that otherwise would not exist? This truly is an interesting question, if we accept the local media's as yet unsubstantiated premise that gay people in Jamaica are really more prone to abuse each other than they are in other countries. Do we know whether they are more prone to this sorts of behaviour than they are in other countries, or do we know whether they're more prone to violence than are heterosexual people in Jamaica? We know none of this, unless we believe that Donna's inductive 'reasoning' is a good substitute for actual evidence.
As ever, beware of Jamaica's newsmedia when it comes to the issue of homosexuality. Their reporting is by and large in the service of anti-gay prejudice. It's mostly propaganda, no more, no less.
Friday, July 02, 2010
Circumcision time again
The time honored barbarism of killing young (South) African men in that traditional practice of circumcision has again yielded a decent crop of dead men in South Africa. Reportedly about 150 young men died in circumcision ceremonies (or as a result of their participation) between the beginning of 2008 and the end of 2009. So-called traditional healers (elevated to a profession under the able guidance of the late Dr Beetroot, the former South African health minister and arch AIDS denialist Manto Tshabalala-Msimang) are frequently involved in botched circumcisions, causing so substantial numbers of avoidable deaths. The opposition DA party suggests that the actual circumcision should take place in a hospital. Now that's a thought.Of course, there will be those who say that circumcision is always wrong, and - my own preferences to the contrary notwithstanding - there's some truth in that. The thing is though, since we have fairly strong evidence that circumcision dramatically reduces the risk of catching HIV there's probably a public health argument to be had - in Southern Africa - for undertaking circumcisions. Wouldn't it be nice though, if authorities in that country managed to have them conducted in such a way that not so many young men needlessly lose their lives over them?
Monday, June 28, 2010
G8 and G20 cost
What's the point of hosting these G8 and G20 events in big cities? Toronto was transformed into a police state for the duration of the event, the losses in terms of tourism revenue and productivity were/are large, and the list goes on.I can see that there is an argument to be had that democratically elected heads of state should be able to meet even if there's violent protesters threatening to disrupt their meeting. In Canada, what was odd were marketing exercises (like a - get this - fake lake) that might have been of interest to tourists (who saw mostly violent protests on TV) but that were certainly of no interest to the attending heads of state (they got their own lakes). The photo shows an artist rendering of the lake ...
So, my question is this: if these heads of state believe it's worth meeting - the official results along would suggest that perhaps they might be mistaken - why can't they meet in some out-of-nowhere place? You know, all things considered, it might be cheaper building them a hotel in some place in the sticks and have em take their helicopters or planes there. Should be cheaper than shutting down multi-million people cities. What a waste!
Friday, June 25, 2010
Assisted dying OK in Germany under certain circumstances
So, today said court ruled that if someone competent has decided they wish to die, even if the nature of their illness does not suggest that their dying process has begun, whoever removes pro-actively their means of life-support has not broken German law. Further, in the case of unconscious patients the patients' likely intention is considered sufficient to make the removal of life support systems legal. In the case under consideration a reportedly a woman who had been in persistent vegetative state for 5 years had her means of life support terminated by her daughter based on the patient's expressed wishes. Part of the problem was that her wishes were only expressed verbally to her daughter prior to her coma, hence no written advance directive existed. The patient had no chance of an improvement of her clinical situation. I wonder whether different circumstances might have changed the verdict or whether this really suggests that self-determination takes priority over the purported sanctity of life in German law.
This, of course, is terrible news for those God people who believe that we are not entitled to make respect demanding decisions about how we wish to die.
Tuesday, June 22, 2010
Publicationethics.org on Ghostwriting
Ghostauthors, ghost management and the manipulation of medical research
There are three articles in the June issue of Bioethics on different aspects of ghostwriting.
The first article, by Tobenna D Anekwe, “Profits and plagiarism: the case of medical ghostwriting” argues that “medical ghostwriting often involves plagiarism and, in those cases, can be treated as an act of research misconduct” and suggests measures to counter ghostwriting.
The second article, by Sergio Sismondo and Mathieu Doucet, “Publication ethics and the ghost management of medical publication" discusses the wider issue of management of the whole publication process, showing how “pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles."
The final article, by Carl Elliott and Amy Snow Landa, "What’s wrong with ghostwriting?" concludes that ghost authorship and ghost management are part of a much larger problem, “the manipulation of medical research for marketing purposes.”
Sunday, June 20, 2010
Bioethics and Developing World Bioethics show improved impact factors
As you probably know, I am a co-editor of two peer reviewed international journals called Bioethics and Developing World Bioethics. Each year a commercial Canadian outfit called ISI (owned by Thomson Reuters) delivers its verdict on journals' impact (often confused with quality by journalists, academics and university administrators). Sunday, June 13, 2010
Should someone smack her or her parents?
I am not in favor of corporal punishment (really). Still, in the case of the recently rescued teenage woman who was determined to sail around the world, I can't help but think some should smack her for attempting this or her parents for permitting her to attempt this. Her voyage floundered in bad weather and a major rescue operation had to be launched, involving planes, boats and whatnot. I hope someone, someone please bankrupt this family for its selfish conduct. Sue them for the resources wasted in this unnecessary rescue mission. This woman should have entertained herself (and her ego) by staying at home and doing something useful (for crying out loud: help in the local homeless shelter, teach younger folks locally how to sail etc etc). Beats me why this kind of stuff happens again and again and again. What drove this family to permit her ill-prepared daughter to undertake this trip? And why should anyone other than the family pay for rescuing this person out of her self-inflicted problems?Sunday, June 06, 2010
More corruption at UN?
Do not trust a word BP is uttering
April 28 2010, BP - against the opinions of many qualified scientists - insists that a maximum of 5000 barrels of oil per day flows into the sea. The company is duly supported by US Pres (yes we can walk on vacuous pronouncements) Obama's experts. Well, today the company announces that its current fix results into them pumping 10000 barrels of oil per day to a ship above the leak. In case you still watch the live video from the leak, you will have noticed that despite this effort oil is leaking in large quantities into the ocean. 5000 barrels a day, BP, really?
Tuesday, June 01, 2010
Offense ain't a good reason for censorship
This debate about whether it's acceptable (with reference to free speech) to draw cartoons of the Muslim's prophet Muhammad or not is just weird. Let's be clear about what I mean by acceptable: Acceptable in the sense of unacceptable being a sufficient reason to prohibit (or prevent by threat of violence) someone else from drawing a cartoon of the prophet (both depicting him negatively or positively). Islam seems to have a prohibition to depict the prophet. That's all quite all right for adherents of that ideology who voluntarily agree not to draw such cartoons. However, what about the majority of people on the planet who happen to be adherents of other ideologies (or none)? Should they be bound (as in legally, or by threat of force) by such a prohibition?Saturday, May 29, 2010
Gay men of integrity and spineless homosexuals
Industry greed vs patient needs
Another chapter in the never-ending story of patient survival needs vs pharmaceutical industry greed. The Danish company Novo Nordisk, the world's leading supplier of insulin has decided to stop supplying near-bankrupt Greece with insulin, because the Greek government in a desperate attempt at saving money decreed a 25% price cut on all medicines. Patients are being held hostage here by a profit-driven organisation, to the extent that their well-being is at stake. So far for the myth that pharmaceutical companies are in the business of health... - One would hope that eventually the important lesson is learned by the powers that are that we cannot leave drug R&D more or less exclusively in the hands of for-profit operators. That the patients of whole societies can be held hostage by organizations such as Novo Nordisk, without recourse, is surely unacceptable.
Monday, May 24, 2010
Montreal's environmental rip-off
Montreal has this widely hailed scheme where you can rent bikes to travel about town. I think London is considering using the same scheme. The bikes are called Bixi, and they're kind of public bikes. The idea is great. There's plenty (I will get back to that one) locations (bike-racks) all over Montreal where you slot in your credit card and you can use the bikes. The idea is that you use them for short trips, quasi from bike-rack to bike-rack. You pay for the time that you use them. That's all dandy, until you realize that there's no bike-racks in lots of places. So, while working in Montreal last week I duly used the Bixi. Well, after a 15 minute ride I ended up where I had to go (by no means an off-the-beaten track location) and, surprise surprise, there were no bike-racks anywhere close by. In other words, I had no bike-rack to return my Bixi to, and had to keep on paying until my work meeting was over and I was able to return to where I picked it up. The result was a bill of 39.50 $. For that I could have rented a car for a full day or probably used a comfy limousine service forth and back. It's been a complete and utter waste of time and money! I suspect the rip-off scheme is hugely profitable for the city of Montreal. Sunday, May 16, 2010
Apologies for the brief hiatus
Folks,Wednesday, May 05, 2010
A study that should not have been done
The New England Journal of Medicine in February published the results of a deeply flawed clinical trial in South Africa. The SAPIT (Starting Antiretroviral Therapy at Three Points in Tuberculosis Therapy) trial was designed to determine the most effective way to treat patients infected with HIV and tuberculosis. But it raises a number of disturbing questions about the oft-debated and vexing issue of appropriate standards of care in clinical trials undertaken in developing countries like South Africa. It also raises serious concerns about the quality of ethical review undertaken in those countries, and it highlights some surprising deficiencies in existing U.S. regulations regarding when ethical review should be undertaken by American IRBs.
In the SAPIT trial, 642 individuals co-infected with HIV and TB were randomized to receive one of three treatments: early integrated ART (started during the intensive phase of TB therapy), late integrated ART (started during the continuation phase of TB therapy), or sequential ART (started after completion of TB therapy).
Individuals randomized to the two integrated arms received ART within three months of study entry. Antiretroviral treatment of individuals randomized to the sequential treatment arm, however, was delayed on average for almost nine months. For several unlucky study participants, ART was delayed even longer; mean time to initiation of ART in this group was six to 11 months (260±71 days), regardless of CD4 cell count, an indicator of HIV disease progression, at study entry. This matters, as patients with CD4 cell counts lower than 200 cells per cubic millimeter face a significantly increased risk of death.
Forty-four months after the first SAPIT participants were enrolled, the study’s Data Safety Monitoring Board stopped the sequential treatment arm and required that all of its participants be started on ART immediately. In its interim analysis, the DSMB had found that participants in the sequential treatment arm had a much higher rate of death than participants in the integrated treatment arms.
The majority of these deaths occurred among patients with CD4 counts below 200 cells per cubic millimeter at study entry. Twenty-seven of 213 participants, or 12.7 percent, in the sequential therapy arm died during the abbreviated treatment and observation period, of whom 21 had CD4 counts of less than 200 per cubic millimeter at study entry, while only 25 of 429, or 5.8 percent, in the integrated therapy arms died over the course of the study. Integrated HIV and TB treatment thus reduced the likelihood of death among study participants by more than twofold.
The trial conclusively showed that integrated HIV and TB treatment is more effective than sequential treatment. The question is whether obtaining that data justified the 10 or more preventable deaths that occurred among trial participants. Even before the study began, years of observational data had shown that the risk of HIV-related death among patients not receiving ART therapy was highest during the first few weeks of TB treatment, calling into question the need to conduct a randomized, controlled trial in which ART was delayed by as long as 11 months for some study participants.
The side effects of concurrent HIV and TB treatment can often be managed by observant clinicians; given this, the WHO Global TB/HIV Working Group recommended as far back as 2003 that “any decision on treatment should be individualized, based on response to anti-TB therapy, side-effects, and readiness for ART.” More recently, based primarily on data from the SAPIT trial, WHO urged that ART be given within eight weeks of starting TB treatment in co-infected individuals.
Current treatment guidelines recommend that patients infected with both TB and HIV should start ART as soon as possible. Where CD4 testing is routinely available, these guidelines recommend starting ART when CD4 cell counts drop below 350 cells per cubic millimeter, and they require ART once cell counts drop below 200 cellsper cubic millimeter. Where routine CD4 testing is not available, these guidelines suggest that HIV-infected individuals with TB should start ART immediately.
In a recent article in The Lancet, several of the SAPIT investigators argued that “an estimated 10,000 deaths could be prevented every year by the initiation of ART in HIV/tuberculosis co-infected patients with CD4-cell counts below 500 cells per cubic millimeter.” However, the level of care provided to participants in the sequential treatment arm of the SAPIT trial fell considerably below this standard. The level of treatment provided to these volunteers even violated existing domestic standards of care for patients in South Africa, which recommend starting patients with CD4 cell counts of less than 200 per cubic millimeter on ART after just two months of TB treatment.
Although the SAPIT investigators noted that trial participants’ primary care physicians were free to start them on ART as necessary – in keeping with the 2003 recommendations of the WHO Global TB/HIV Working Group – this ignores the reality of public sector HIV care and treatment in South Africa. It is unlikely that most of the study participants even had a primary care doctor, let alone a physician who would initiate ART despite the restrictions imposed by the SAPIT protocol. Who then could have started these patients on life-preserving treatment if not the clinician-investigators on the study? Individualized treatment decisions based on medical need were not made in the sequential arm of the study, despite the ethical obligation of study clinicians to ensure the safety and well being of individual study participants.
Aggravating these problems, the trial design violated the golden rule of ethical study design and conduct: No clinical equipoise existed between the trial arms. Given decades of research showing that untreated patients with CD4 cell counts of less than 200 cells per cubic millimeter are at great risk of HIV-related complications and death, coupled with observational data showing that this risk is even higher during the first few weeks of TB treatment for co-infected individuals, the sequential treatment arm never should have been considered a viable treatment strategy. Patients randomized into the sequential arm were knowingly subjected to substandard clinical care.
The fundamental ethical (and legal) issue is this: the SAPIT study caused foreseeable harms and preventable deaths for a substantial number of impoverished and poorly educated South African trial participants. In doing so, the trial violated the Declaration of Helsinki’s requirements on standards of care of the then-applicable 2000 revision:
The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.For the South African researchers involved with the SAPIT trial, the Declaration of Helsinki is not only a moral exhortation but also a legally binding obligation. South Africa’s Good Clinical Practice Guidelines require that all investigators “follow fully the guidelines set out” in the Declaration of Helsinki, in addition to other national research ethics guidelines.
Organizations such as the Welcome Trust in the U.K. and the National Institutes of Health in the U.S. have directed millions of dollars to train members of African ethical review committees, and yet this trial was reviewed and approved by a committee in South Africa. The failure of this research ethics committee to recognize the clinical, ethical, and legal deficiencies in this study is shameful and, we hope, will be investigated by the relevant South African authorities.
Another issue is worth noting. As published in the New England Journal of Medicine, the study boasts a large number of authors. This is not an uncommon practice for large clinical trials like SAPIT. The authors of the article are located in South Africa and the U.S., and some authors list both South African and U.S. institutional affiliations. It is unfortunate, however, that U.S. research ethics guidelines (at least as interpreted by the American institutions involved) did not require these authors to submit the study protocol for ethical review by committees in the U.S.
If, as these institutions suggest, the study investigators were not acting on behalf of the U.S. institutions or were not engaged in what these universities define as human subjects research, it is worth asking why these institutions are listed on the published research papers. If they want to share in the academic glory associated with a study published in a prestigious journal like the New England Journal of Medicine, then they have the obligation to ensure that the trial meets accepted standards of ethical conduct and the responsibility to protect the rights and safety of all study participants. Further review might have made an appreciable difference to the ethical design and conduct of this study.
Sean Philpott is an assistant professor of bioethics at Union Graduate College and a former science and ethics officer for the Global Campaign for Microbicides. Udo Schüklenk holds the Ontario Research Chair in Bioethics at Queen's University, Canada, and is the joint editor-in-chief of BIOETHICS.
Monday, May 03, 2010
Drill baby drill -2-
As an addendum to my April 29 post.Turns out that the platform actually had a so-called blowout-preventer to prevent the disaster that happened. A German news agency has investigated these so-called blowout-preventers. There are at least 171 known cases where they failed to do their job. It's a bit of a misnomer then to call them blowout-preventers, isn't it? Makes you wonder why drill baby drill President Obama notices only now that there's a problem and he wants to investigate... and where is drill baby drill Sarah Palin? Lost in an oil spill?
Ethical Progress on the Abortion Care Frontiers on the African Continent
The Supreme Court of the United States of America has overridden 50 years of legal precedent and reversed constitutional protections [i] fo...
-
5 Jan 2015 Update on the post below. Dalhousie University announced today that the dental students in question have been suspended from pa...
-
The Canadian Society of Transplantation tells on its website a story that is a mirror image of what is happening all over the w...
-
I bought this watch a year or two ago on an international flight. I always fancied Jacob Jensen's simple and clean designs. It's a r...