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Mo’ Money, Mo’ Problems
Posted by Osagie K. Obasogie on April 6th, 2007
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"Everyone has a price," goes the adage. Before last week, the FDA apparently thought this wasn't true for physicians, biomedical researchers, and others serving on advisory committees that give expert opinions on pending drug approvals. Last Wednesday, however, the FDA released draft guidelines to curb growing concerns that pharmaceutical companies may be greasing the wheels by giving advisory committee members exorbitant gifts and cash.
This is certainly an important first step to building confidence and integrity in the drug review process. But, what boggles the mind is why the FDA still thinks anything up to $50,000 is an appropriate amount for an advisory committee member to take and still give "impartial" advice. Put it this way: even under the revised rules, an advisory committee member could still take $49, 999.99 from Pfizer, Eli Lily, and other drug companies and then suggest that the FDA approve their drug applications the next day.
The Economist recently ran a special report on the etiquette of bribery, and a person more cynical than I might think that the guidelines laid out here are not unlike meeting a guy in a back alley with a stuffed brown envelope. And, evidence of committee members' substantial conflicts of interest in addition to their remarkably high 'yes' votes does little to dissuade this perception. Given the mounting evidence that, for example, doctors' behaviors can be skewed by gifts as small as a ballpoint pen or a ham sandwich, in what world is it ok to allow government advisors to take what Tony Soprano would call '50 large' before rendering decisions? How does it promote public health to allow public servants (albeit temporary ones) to take this kind of money from the private industries they are charged to regulate?
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| Restrictive Stem Cell Patents Overturned
Posted by Jesse Reynolds on April 4th, 2007
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The licensing arm of the University of Wisconsin has long been criticized for its patents in embryonic stem cell research. Researchers, companies, and public interest groups have all asserted that, by effectively covering all embryonic stem cell lines, the patents are stifling research and delaying potential treatments. Earlier this week, a federal agency agreed with these charges, and invalidated the patents.
After James Thompson of UW became the first scientist to isolate human embryonic stem cells in 1998, the Wisconsin Alumni Research Foundation obtained three patents that cover essentially all human stem cell research, and even the cells themselves. Last July, the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation, with support from stem cell researcher Jeanne Loring, requested that US Patent and Trademark Office review the patents. On Monday, the PTO sided with the advocacy groups in a preliminary ruling and invalidated the patents. Although WARF will pursue a lengthy appeals process (the patents do bring in millions of dollars, after all), Loring said that the decision will "remove one of the highest barriers to progress."
Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, said, "the PTO decision marks a welcome turning point in the battle against the unnecessary and unproductive privatization of mankind's quest to understand the natural universe." The next logical step would be to reexamine the wisdom of issuing patents on the human genome. Now's the time: A bill introduced this February in the House of Representatives would end future gene patenting.
Congratulations to Loring, FTCR, and the Public Patent Foundation on their victory.
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| Pushing the Chimeric Envelope
Posted by Osagie K. Obasogie on March 30th, 2007
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After President Bush’s 2006 State of the Union, I wrote an op-ed for
the San Francisco Chronicle that tried to contextualize what many
thought to be his out-of-the-blue call for legislation to prohibit
human–animal chimeras. When I wrote the piece, the reported proportion
of human cells being injected into animal fetuses was relatively small
(circa 0.1%), which led some to discount ethical objections to this
research. Yet I did note:
Can
this really comfort us? Is there any question that scientists may push
the envelope as far as they can, from 0.1 percent to 1 percent to 10
percent? Why not 100 percent?
Sadly, it looks like this may have become true sooner than I thought. It was reported this week that Esmail Zanjani
at the University of Nevada has created the first human-sheep chimera,
with 15% human cells. That’s right: the decimal point is to the right of the five.
The
biomedical rationale for this research is to create animals with organs
that could be transplanted into humans. Given the significant number of
people waiting for organ transplants, this is surely a laudable goal.
Yet substantial ethical considerations still remain.
As these
procedures advance and transplanting organs from chimeras to humans
becomes more feasible, the proportion of human cells may come to rival
the number of animal cells. And we currently don’t even have the
language to think about these animals’ social and legal standing, let
alone any public policies to govern this research or these organs’ use.
So
now we face ethical questions about harvesting human body parts from
partial as well as from full humans. How to assess this is a difficult
question that deserves more thought than this blog post. What is clear,
however, is that mutton lovers might want to eat up now. Their favorite
dish may soon be regarded as a form of cannibalism.
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| Eugenics, Democracy, and Freedom
Posted by Osagie K. Obasogie on March 22nd, 2007
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300 is arguably the most racially charged movie since D.W. Griffith's The Birth of a Nation. In true post 9/11 form, Brown becomes the new Black; the Battle of Thermopylae is dramatically recreated to depict Persians as bloodthirsty barbarians temporarily thwarted by a small contingent of chiseled White freedom fighters looking to preserve democracy at all costs. And, like Griffith's early 20th century cinematic screed, this mixture of race, racism, and violence has proven remarkably profitable: 300 grossed over $70 million in its opening weekend and remains atop at the box office.Karl Rove couldn't have done a better job putting together what some are calling a pro-West propaganda flick; its opening a few days before the Iraq War's four year anniversary is beyond ironic. But while race and racism are certainly dominant themes, another troubling aspect has gone largely unnoticed: its unrestrained glorification of eugenics.
Within the first few minutes, moviegoers are introduced to Spartan eugenics whereby every newborn is inspected; those showing defect or disability are abandoned to die. Initially shocking to the audience, they are quickly reassured that this is all for the greater good: nation, freedom, and democracy. 300's crafty narration and erotic imagery easily legitimates these practices. After all, Spartans are brave, noble, and beautiful. And did I mention they have great abs?
This pro-eugenics trope is only magnified by the film's dramatic climax which implausibly suggests that were not the Spartans betrayed by Ephialtes - a disabled Spartan whose parents hid from the authorities - the 300 eugenically engineered soldiers would have outlasted Xerxes' minions. Put differently, the taste left in viewers' mouths is that but for the failure of Spartan eugenics to catch Ephialtes at birth, King Leonidas may very well have led the outmanned and overmatched army to victory. Health and reproductive choice are today's justifications for eugenic decision making. But, at what point will using reproductive technologies to create "better" humans be framed as a national security issue? DARPA is already looking at human enhancement to make better soldiers; starting from scratch may very well be around the corner. Tonight, we dine in hell, indeed.
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