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In the News this Week

Posted by Jesse Reynolds on May 23rd, 2008

The UK Parliament, debating a bill to overhaul its oversight of assisted reproduction and embryo research, rejected proposed bans on both PGD "saviour siblings" and animal-human hybrid embryos for cloning-based stem cell research.

In contrast, South Korea did ban the hybrids.

Here in the US, President Bush signed a bill to prohibit genetic discrimination into law, while a leading member of Congress spoke of future oversight of stem cell research by the National Institutes of Health.

The former head of a failed pet cloning company and most disgraced and fraudulent scientist in recent memory teamed up to launch a new pet cloning company.

UK's Prime Minister Brown vs. scientists

Posted by Jesse Reynolds on May 22nd, 2008

Gordon Brown

The debate surrounding the controversial bill to overhaul the UK's regulation of assisted reproduction and embryo research gets stranger and stranger. Prime Minister Gordon Brown, struggling with dismal approval ratings, further raised the stakes of his support for the bill by authoring an opinion piece in the Guardian. But the shortcomings of Brown's argument are revealed when it is compared with the statements of less political-minded stem cell researchers.

Like so many writings advocating cloning-based stem cell research (i.e., somatic cell nuclear transfer), Brown's op ed drifts to distortion and hyperbole. First, he implies that only the current bill would establish oversight of stem cell research. Second, he concocts a supposed shortage of embryonic stem cells, caused in turn by a shortage of human eggs:

That is why we have - patiently and with full regard for religious concerns - sought to introduce clear laws which permit the use of stem cells within a clear, managed, legal framework, subject to the strictest supervision.

And there is one major and controversial issue we must confront head on if we are to make further progress. Around the world, researchers now face a severe shortage of embryonic stem cells....

By permitting the use of this technique [animal-human cytoplasmic hybrids], we may be able to bring to an end the critical limiting factor in stem cell research: the lack of human eggs from which to create embryos and collect stem cells.

Right now, teams of scientists in London and Newcastle are researching conditions such as Alzheimer's using this technique, but they face uncertainty because there is no clear legal framework to govern their work.

Despite Brown's claims, the UK regulates stem cell research - and has allowed animal-human hybrids - under the original 1990 law. And there is no "shortage of embryonic stem cells": any one of the dozens of currently available lines can readily be cultured into millions of cells and distributed throughout the world.

The truth about the proposed hybrid cloning technique is that some - but not all - scientists believe that stem cell lines with a known genome would be a critical step. One way to get such cells may be through cloning, which does require eggs, although that's not yet succeeded in yielding cells. In contrast, reprogramming via induced pluripotent stem cell has already created cell lines with known genomes.

Brown's specious assertions stand in sharp relief to the statements of some stem cell scientists. For example, sixteen researchers from six countries wrote a letter to theTimes questioning whether the proposals would lead to treatments:

In particular, given the current state of more conventional embryonic stem-cell research, of adult stem-cell research, and of induced pluripotent stem-cell research, there is no demonstrable scientific or medical case for insisting on creating, without any clear scientific precedent, a wide spectrum of human-non-human hybrid entities or "human admixed embryos".

We therefore question the scientific validity of proposals to create such embryonic combinations currently before the UK Parliament. We note with concern that, though not widely reported, the Bill does not just propose licensing so-called cybrids (99.9 per cent human, 0.1 per cent other species). It also proposes that embryos "created by using human gametes and animal gametes" (50 per cent human, 50 per cent other species) or human embryos "altered by the introduction of one or more animal cells" (ie, any percentage of human material) could be created under licence (UK Human Fertilisation and Embryology Bill 2007-08, Section 4A(5) and Schedule 2. 3(3)).

All such proposals are highly speculative in comparison to established sources of human stem cells, and we remain unaware of any cogent evidence suggesting any might yield significant therapeutic dividend.

Nevertheless, the bill is on track to complete passage.

Previously on Biopolitical Times:

Maybe Next Year?

Posted by Jesse Reynolds on May 15th, 2008

Geron CEO Thomas Okarma

The CEO of Geron has repeatedly promised that it will begin the first clinical trials of potential embryonic stem cell therapies any day now. It now looks like Thomas Okarma will assure us once again the trials will begin "next year" - just as he's done since at least 2004. Yesterday, his company announced that the US Food and Drug Administration has delayed the decision regarding approval.

Okama may attribute this to frustrating bureaucratic red tape. While that may be true, it seems that he has consistently either underestimated the complexity of his undertaking, or misled investors. Regardless, those of us who support embryonic stem cell research should urge caution, not haste. A botched clinical trial will set the field back years, if not decades.

Previously on Biopolitical Times:

Goozner on the FDA and the Declaration of Helsinki

Posted by Osagie Obasogie on May 15th, 2008

Over at, Merrill Goozner describes what may be a significant yet silent step backwards in protecting human research subjects: an FDA decision to no longer adhere to aspects of the Declaration of Helsinki that require clinical trial participants in control groups to receive best available care.

Goozner describes the FDA’s new rule as only requiring drug companies to follow good clinical practice, meaning that control group subjects are only entitled to the standard care they would otherwise receive in their locale. Goozner argues that this can have a significant impact on the growing number of clinical trials outsourced to the developing world. He notes:

What will this mean for the concept of "informed consent" in a poor country? Imagine for a moment that you live on $2 a day in, say, Zimbabwe, and have high blood pressure. Since the disease isn't life-threatening, you skip buying the available anti-hypertensives being sold in the village pharmacy because you can't afford them and none are on the national formulary. Hence, there is no local standard of care.

Now say you learn while visiting the village clinic that an international pharmaceutical company is recruiting patients for a clinical trial testing a new anti-hypertensive drug. If you join the trial, you may only get the placebo. But there's a 50-50 chance you will get the new drug, which hasn't been proven yet, but might work.

Are there risks associated with taking this new drug? Well, so far, none that the doctors think are serious enough to cancel the trial. But it says right on the form that something may turn up in the clinical trial in which you are being asked to participate. You sign up. After all, a 50-50 chance of getting a drug that has a good chance of working (the drug industry wouldn't be here testing it if it didn't, right?) is better than no drug at all. And how much risk could there be, anyway?

Is that really non-coerced, informed consent?

[Update: There has still been no coverage of this development in the mainstream media, but Sonia Shah discusses it over at The Shah is the author of The Body Hunters: Testing New Drugs on the World's Poorest Patients.

See also bronxdoc's post at The Social Medicine Portal.]

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