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Geron's Steadfast Optimism

Posted by Jesse Reynolds on February 12th, 2008

Geron CEO Thomas Okarma

Yesterday at the annual biotechnology industry convention, the CEO of the company hoping to develop the first products from human embryonic stem cell research said that he expects the first clinical trials to begin around June of this year. We've highlighted Geron's Thomas Okarma 's habit of promising these clinical trials "next year" in every year since 2004. What's surprising about his advancing the date to just a few months from now is that the timing is completely out of his hands. Geron has submitted the application to the US Food and Drug Administration to test human embryonic stem cells in 40 patients with spinal cord injuries. The ball is now in court of the federal government.

Does Okarma really believe that the feds will so quickly turn around the first application for human testing of an entirely new method of medicine, a technique that has a track record of producing cancer in lab animals? I consider myself lucky if my 1040EZ gets processed in a few months. An analyst in the CNN story is quoted as saying, "This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise." That's putting it mildly. 

Investors appear to be skeptical as well. Geron's stock value is up only 2% for the day. That will do little to compensate for the dramatic fall it's taken over the last year, in which it lost nearly half its value.

Previously on Biopolitical Times:

File Under: What You Talkin’ Bout, Willis?

Posted by Osagie Obasogie on February 11th, 2008

Arnold from Diff'rent Strokes

From a recent Yahoo News story on embryos created with DNA from 3 different people:

"We are not trying to alter genes, we're just trying to swap a small proportion of the bad ones for some good ones," said Patrick Chinnery, a professor of neurogenetics at Newcastle University involved in the research.

Cloning, Children, and Consent

Posted by Jesse Reynolds on February 8th, 2008

There was once a time when I placed much faith in the UK's governance of reproductive and genetic technologies. But after a string of actions that are a mix of the rushed and the unjustified, now I am reluctant to offer the benefit of the doubt. It's not just that the National Heath Service is offering 15,000 pounds ($32,000) to surrogate mothers or approving genetic deselection to avoid congenital squinting. Current proposals would be significant steps in the erosion of the key bioethical principle of informed consent.

The latest moves are considerations by the government to alter the long-debated bill to revise oversight of assisted reproduction and research with embryos. Under the its current version, tissue donors must consent for their cells to be used in cloning-based stem cell research, and children must be "competent" in order to give consent. This makes sense, even beyond the typical goals of informed consent: The cloning process raises novel questions, and many potential research subjects will be opposed to the creation of embryonic clones of themselves. Furthermore, if a stem cell line were to be successfully derived through this technique, the subject's genetic material could be propagated and spread throughout the world, raising concerns of genetic privacy.

Some researchers, though, are pressuring for two changes, both of which are under consideration. One would allow cloning research using banked tissues whose donors did not give consent for their cells to be used in that manner. And under the other, the requirement for the "competence" of the child would be removed. It is unclear from news reports if the child's consent would be presumed, or would need to be obtained from the parents.

(Using an unfortunately common tactic, the advocates for this change cite the medical necessity of cloning-based stem cell research in a way that distorts the fact that no stem cell lines have yet been derived in this manner. This language is not only unchallenged by the media, but is parroted.)

Regardless, there is a clear trend on both sides of the Atlantic in bioethics rhetoric, recommendations, and policy. The potential benefits of research are increasingly seen as more important than the need to obtain informed consent.

In the United Kingdom, for example, Prime Minister Gordon Brown recently proposed that consent for postmortem organ donation be presumed. And here in the US, a panel of the esteemed Institute of Medicine recommended that prisoners be "permitted" to participate in clinical trials. The former was shot down amid a barrage of criticism, but the latter proposal seems to have traction, despite the fact that true voluntary consent by prisoners is essentially impossible due to institutionalized power relations.

Of course, these are examples of a common tension within bioethics. But there are strong reasons, many of which are historical, that the first sentence of the Nuremberg Code is, "The voluntary consent of the human subject is absolutely essential."

Previously on Biopolitical Times:

Doubts on ScienceDebate2008 from Nature

Posted by Jesse Reynolds on February 8th, 2008

The journal Nature has raised serious apprehension about the proposal for a presidential candidates' debate on science. An editorial states:

Well meant though it may be, the idea of Tim Russert or some other journalist-interrogator looking Republican hopeful John McCain in the eye and asking "What balance will you seek in federal science funding between major-programme project research and investigator-initiated basic-research grants?" is somewhat fantastical.

It is also slightly disturbing. For all that it claims to be a 'grass-roots' phenomenon, the proposed debate can be seen as an attempt by various élite institutions to grab the microphone and set the agenda from the top down.
And, in an accompanying column, Harvard's David Goldston points out that
The increasing tendency to conflate science questions — Are we experiencing man-made climate change? — with policy questions — What, if anything, should we do about it? — has been a damaging trend. It has helped to turn science into a political football and has muddied policy debates. At a 'science debate', candidates will try to claim that their position is the one supported by 'science', and the very structure of the debate will send voters the faulty message that these are questions that the natural sciences can resolve. Framing questions of economics, ethics and other aspects of policy as 'science issues' does no favour for either science or politics. And it makes one wonder if the sponsors of the debate merely want to find out whether the candidates agree with their personal opinions on these topics.

Previously on Biopolitical Times:

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