Saturday, May 29, 2010

Gay men of integrity and spineless homosexuals

You might find this a very odd comparison, but it's kind of apt I think.

On the one hand there are Malawians Steven Monjeza, 26, and Tiwonge Chimbalanga, 33. They, were arrested in December 2009 after they threw themselves an engagement party at the Blantyre lodge where Mr. Chimbalanga worked as a cook and a housekeeper. They were eventually found guilty of some 'unnatural' (a contradiction in terms) or other by a Malawian court and sentenced to 14 years jail by a Christian judge keen on 'deterring' others from engaging in homosexual conduct in that country. Well, Malawi, being just another more or less failed African state depending on Western hand-outs, was told literally by the world (from the Canadian foreign minister to the newly elected UK Prime Minister to very many other people) to get a grip. The current UK's international development minister (ie the guy in charge of the Malawian international aid) is an openly gay man. The UN general secretary told Malawi's president that this verdict violated international human rights. Duly, and no doubt to the great disappointment of US evangelicals that usually have a hand in these sorts of homophobic actions, the Malawian president pardoned the gay men and they'd be free by now. There are a lot of aspects to this that are worth commenting on. However, I mean to compare the integrity with which these gay men have conducted themselves with the deeply embarrassing conduct of other gay men. Think of David Laws, the former UK Treasury Chief. He was caught with his hands in the till, well, sort of. Laws resigned after it became public knowledge today that as an MP he had himself reimbursed from the public purse for 'renting' a room in his same-sex partners properties. 'The Daily Telegraph disclosed that he claimed as much as £950 a month in parliamentary expenses for eight years to rent rooms in two London properties.The houses were owned by his partner, James Lundie, a political lobbyist. In 2006, MPs were banned from “leasing accommodation from a partner”. ' Laws says that he kept his sexual orientation a secret from both his family and the public, and hence did not disclose that his partner was his partner. Laws was probably not motivated by greed, being an independently wealthy former investment banker.

So, here's this rich guy then who doesn't have to worry about losing his job, who doesn't have to worry about jail sentences, who lives in a society where the civil rights of gay people are very well protected, and yet he engages in embarrassing shenanigans to hide what doesn't need to be hidden. He serves in a conservative-liberal government with other openly gay ministers, yet he remains in the closet. Worse, he's a member of the Liberal Democrats, so by any stretch of imagination he had no reason to worry about negative political repercussions if his sexual orientation ever became public knowledge. Compare Laws' lack of personal integrity with how the two Malawian gay men have conducted themselves under much much more difficult circumstances.

Strange times.

I have to be honest, I have no sympathy for gay people who choose to hide their sexual orientation (by means of living a life designed to deceive everyone around them, from their families to their business partners, friends etc etc) when there is no good reason to do so. All other things being equal, anyone who, like Laws, is independently wealthy, has little reason to reside in a closet. If you live in places where your life might be threatened or other serious repercussions are to be feared, you might have a reason to keep your sexual orientation a secret, but otherwise, you do not deserve any sympathy when you are found out (Laws being a case in point). This deceitful behavior is offensive to other gay people who are open about who they are.

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.

So, here's my advice to Montreal, THINK prior to instituting such schemes. I for one won't touch your green bike scheme ever again. Let the buyer beware!

Sunday, May 16, 2010

Apologies for the brief hiatus

Folks,

I have been away for a week on Barbados. Sand, palmtrees, lukewarm water and rum ain't exactly my cup of tea, so I's worried about being bored out of my mind. Thankfully I got plenty of lifts around the porous island, but still, a week was more than enough. My suspicion about life on such places was kind of confirmed. All pretty to look at, but the reality is nonetheless dead boring. I've had a great time though and took my fair share of photos. Good enough for a week-long trip, but imagine you had to live there. Invariably there's an overwhelming number of God people, so there were training sessions preparing people for the Rapture on offer. How cool is that? In case you didn't know, it's coming on October 21, 2011. Oi wei. I uploaded my photos on a low-to medium-level size only, so they're not print quality. Feel free to browse. - We flew on JetBlue, and it's been a great experience. Highly recommended, just don't expect any service from their ground staff in Barbados. They're badly trained and pretty much useless. Other than that, beats air Canada at any time, both in terms of in-flight experience and in terms of price (by a long long stretch).

Well, coming back home I face more US brabrabra. Obama's Supreme Court nominee is rumored to be a lesbian woman. Bill O'Reilly, funny man at Fox News, decided that we've a right to know as she might have to vote on gay marriage. I kinda wonder why the same logic shouldn't apply to heterosexual, bisexual and other-sexual members of the court?

Wednesday, May 05, 2010

A study that should not have been done

Here is a piece Sean Philpott and I have published today in the Hastings Center Forum.

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 2007 almost two million people died of TB and over nine million people were newly infected. TB-related morbidity and death is profound among people living with HIV/AIDS; nearly 7 percent of new cases and over a quarter of all TB-related deaths occur among people living with HIV/AIDS. Doctors treating TB in this population face a difficult challenge. Serious side effects can occur with concurrent HIV and TB treatment, leading some clinicians to suggest that antiretroviral therapy for HIV be delayed for several weeks after treatment for TB is started. But serious side effects are also a risk of delaying ART therapy. Guidelines state that ART therapy should be started as soon as possible, but there is disagreement over when that should be.
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 Sch√ľklenk 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?