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“Roots in a Test Tube”

Posted by Osagie Obasogie on February 7th, 2008

Henry Louis Gates Jr. with Jackie Joyner-Kersee

On the heels of the acclaimed 2006 PBS series African-American Lives- where Harvard's Henry Louis Gates Jr. uses genetic ancestry testing to trace several prominent Blacks' genealogies - comes the second installment, African-American Lives 2. Here, Gates brings out a new all-star cast of Black entertainers, athletes, and other icons to demonstrate how genetic ancestry testing can subvert the genealogical disconnect created by the slave trade and tell African-Americans which tribes and regions they came from - all with the presumed pinpoint accuracy of DNA technologies, or what Gates calls "roots in a test tube." For an interesting discussion on these technologies' promises and pitfalls, check out Troy Duster's review of the series' first installment. Duster makes an interesting observation that might be helpful to keep in mind:

. . . the series performs a disturbing sleight of hand. Conventional wisdom has it that we can choose our friends, but that our families are a given. But with long-term genealogical work, there is a sense in which this can be inverted. We each have two parents, four grandparents, eight great-grandparents, etc. As Gates points out . . current technology permits us to link via DNA analysis to only two specific lines. On the Y chromosome, one's father's father's DNA, going back as far as we can locate the genetic material, can be determined with a high degree of certainty. . . .On the female side, mitochondrial DNA (mtDNA) can link one's mother's mother's mother going back as far as we can garner the DNA. So, while we have 64 great-great-great-great-grandparents, the technology allows us to locate only two of those 64, if we're going back six generations, as our real legacy and genetic link to the past. But what of the other 62? Those links are equal contributors to our genetic makeup, and we ignore them only because we do not have access to them. What an arbitrary "choice" of a branch on the family tree!

Should rich and poor alike be free to sell their kidneys?

Posted by Marcy Darnovsky on February 6th, 2008

A massive kidney trafficking racket exposed last week in India continues to unravel. Indian publications (1, 2) are tracking its twists and turns, but the brief flurry of U.S. coverage (1, 2) has largely subsided.

The story so far: Dozens of doctors, nurses, and medical professionals appear to have participated in the illegal procurement of some 500 kidneys, mostly from poor workers, that were sold to foreign clients. Some of the kidney “donors” were offered sums of about $1000. Others were kidnapped and knocked out, learning only when they regained consciousness that their organs had been harvested. They were then threatened with their lives if they told anyone about the racket.

The mastermind of the operation is still being sought by Indian police and Interpol. Several similar scandals in recent years have raised the question of whether hospitals and police have been involved.

For most, kidney trafficking exploits the desperation of both buyers and sellers, and its horrors call for stricter enforcement of laws against it. But some libertarians, including market enthusiast Ron Bailey at Reason Online and the Cato Institute's Arthur Matas, counsel instead that the sale of kidneys be legalized.

The only country now on that path is Iran. There, the state sets an initial price and runs kidney referral agencies, but haggling between buyers – who have money – and sellers – who urgently need it – is common. A 2007 documentary called Iranian Kidney Bargain Sale gives a blow-by-blow account, and it’s not pretty.

Nature Biotech reports CGS skepticism about IRBs-for-hire

Posted by Marcy Darnovsky on February 5th, 2008

Jolee Mohr

Here's a belated pointer to an article published last September in Nature Biotech. "Death in gene therapy trial raises questions about private IRBs" opens with concerns raised by Biopolitical Times' own Osagie Obasogie, in an op-ed about Jolee Mohr's summer 2007 death in a gene transfer trial for rheumatoid arthritis sponsored by the biotech company Targeted Genetics:

[T]he institutional review board [IRB] charged with ensuring that the trials were conducted ethically is a for-profit enterprise also on Targeted Genetics' payroll. When a review board is being paid by the company that it is supposed to oversee, incentives often lean the wrong way: toward helping industry profit and away from patient safety. Such practices are common in today's clinical trials, and they put people's lives in danger. With so much money in play and so little enforceable oversight, corners may be cut more often than we'd like to think.
The FDA allowed the trial to resume in late November, saying that the gene transfer product was not responsible for Mohr's death. But a few days later, the NIH committee responsible for overseeing gene transfer tests reached a different conclusion, refusing to rule out the experiment as a factor.

We'll probably never know for sure. But as Osagie pointed out in his op-ed, "[T]his isn't simply about regulatory failure. It's also about how profit motives embedded in the clinical trial process can undermine patient safety."

Those who don't know (recent) history

Posted by Jesse Reynolds on January 31st, 2008

Daniel Sulmasy

While I was away from my desk last week, a member of the ethics committee of New York's stem cell research program accused the new $600 million agency of ignoring the committee's recommendations and "steam-rolling" ethics in the process. Granted, this committee member, Daniel Sulmasy, is an opponent of embryonic stem cell research and likely has an ax to grind. But in his op-ed, he claims that the committee, realizing that there was pressure to get funds out the door as soon as possible, unanimously recommended that grants go only to noncontroversial research for a few months, allowing the committee the time to draw up research standards. But the Empire State Stem Cell Board rejected this, worried that it would "send the wrong message to scientists." Sulmasy concludes:

This precipitous funding decision sends the wrong message - namely, that the discussion of research ethics should never encumber scientists' work. That's a dangerous premise for any society to hold. Was a six-month delay to allow ethical review really too much to ask? It's preposterous to propose that this would've had a "chilling effect" on science.

New York citizens deserve a serious ethical review of how $600 million of taxpayer money will be spent on a potentially valuable but extraordinarily controversial field of research. If the ethics committee had been permitted to do its job seriously, the whole nation might have benefited from a rigorous, public, dispassionate debate of the weighty ethical issues at stake.
Not surprisingly, the governor was able to hold a press conference, touting the first round of $14.5 million in funding.

These developments have an element of déjà vu. At the first full meeting of the nascent California stem cell research program in January 2005, board chair Robert Klein announced his intention to get funds out the door by May. We and other public-interest advocates pointed out the lack not only of research standards, but also of intellectual property policies and any resemblance of a strategic plan. Fortunately, in California's case, a mix of our advice and circumstance prevailed, and policies were in place before the first research grants were awarded in February 2007.

Unfortunately, the leaders of the New York program seem to have not learned lessons from the California experience.

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