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Potential stem cell trouble in South Korea

Posted by Jesse Reynolds on March 18th, 2009

A team of researchers in South Korea has applied for approval to conduct cloning-based stem cell research. The concerns this raises should be placed in a wider context.

Three years ago, the scientific world was rocked when stem cell researcher Hwang Woo Suk was revealed as a fraud. Not only did he falsify the data which supported his claim of deriving stem cell lines via cloning (a feat that still hasn't been accomplished), he also obtained over two thousand human eggs unethically (putting several women in the hospital with adverse reactions to their extraction) and embezzled much of his grant support.

In reaction, stem cell research policies in South Korea, where Hwang was based, were tightened. After some deliberation, policy makers decided that cloning-based stem cell research would only be permitted for work on serious, incurable diseases.  They also ruled that the human eggs needed for cloning  would be limited to those deemed unfit for fertilization, or those leftover from fertility treatments. Either way, the eggs are not to be purchased. Finally, they required that the National Bioethics Committee approve any such research.

Hwang has applied to the Committee to proceed with cloning-based stem cell research, but it looks like he has been, or will be, denied. However, researchers led by Chung Hyung-min at the CHA Medical Center have also applied, and it looks like approval is imminent. The Committee previously delayed a decision, citing an inadequate application.

While the need to clear such controversial work with an oversight body is partially reassuring, this detail  in particular is disturbing:

According to Cha officials, bio ethicists had ordered the hospital to tone down the titles of some subjects that could invite ``excessive expectations,'' reduce the amount of 1,000 eggs it planned to obtain and include an outside member in its institutional review board. ...

``We will reduce the number of eggs to about 300,'' the official said.

Eggs are typically not leftover during fertility treatments unless the prospective parents agree to donate some to research beforehand. Although this is generally preferable to advertisements of financial inducements, it too creates potential conflicts of interests. Larger doses of hormones increase both the number of eggs and the likelihood and severity of side effects. Who is counseling the prospective parents? Does the fertility doctor have a professional or personal stake in the stem cell research? If the eggs come from a woman other than the intended mother, was the egg provider paid, which is permitted in South Korea in the fertility context? Who decides which eggs are unable to be fertilized?

Furthermore, the CHA team is arguing - inaccurately - that the change in US federal stem cell policy means that Washington will soon be supporting cloning-based stem cell research.

However, with the new U.S. government deciding to lift the country's restrictions on federal funding for new stem cell research, Korean regulators are feeling increasing pressure to do the same for researchers here.

A CHA team previously applied for funding for cloning-based work from the California stem cell research agency. The application was initially approved, despite reviewers characterizing it as "overly ambitious." But a number of concerns were raised, including previous problems with acquiring eggs at the CHA fertility clinic. The application was voluntarily withdrawn.

Previously on Biopolitical Times:

Shake-up Coming in Biotech?

Posted by Pete Shanks on March 16th, 2009

Plummeting graph

The financial condition of the biotech industry is looking very bad. The Wall Street Journal published an article today [subscription required; summarized on their blog] titled "Cash Dries Up for Biotech Drug Firms." Since November, 10 biotechs have declared bankruptcy and raising money is getting much harder -- and much more expensive for entrepreneurs, who may have to give up as much as 90% of their equity.

Burrill & Co's 23rd annual report on the industry is out, if you have $395-$695 to spare; there is a teaser with some statistics here. Of 356 public companies (down from 365 a year earlier):

  • half have less than a year of cash remaining (180, up from 26)
  • one-third have less than six months of cash on hand (120, up from 12)

Of course, a few people are doing well, including some Genentech investors, but they seem to be a fortunate minority. DNAPrint, a leading maker of forensic and ancestry-testing software, has shut down after Nanobac Pharmaceuticals failed to raise the cash to buy it out, and is facing at least one lawsuit. Altus Pharmaceuticals Inc. and Isolagen are said by the Journal to be close to bankruptcy; Akesis Pharmaceuticals Inc. filed in January. Even the California Institute for Regenerative Medicine (CIRM) is facing a "looming cash crisis" according to David Jensen of the California Stem Cell Report.

Quite what the full implications are is hard to say. Steven Burrill is quoted in the Journal as saying that 100 publicly traded biotechs will disappear this year:

"[w]e are clearly in unprecedented times. This isn't a 'This too will pass,' " he says. "The implicit assumptions that we've built the industry off of for 30 to 40 years have changed."

Previously on Biopolitical Times:

One more stem cell opinion

Posted by Jesse Reynolds on March 13th, 2009

Melody Barnes

Here's one more commentary that I wish to add to my recent compilation of opinions following the change in federal stem cell policy. This comes from Melody Barnes, President Obama's domestic policy adviser and director of the Domestic Policy Council. In an op-ed in yesterday's San Francisco Chronicle, she wrote:

In the Obama administration, the scientific community will be empowered, but not unaccountable. Scientists who wish to conduct stem cell research must do so in a responsible manner and the president Obama will not allow scientists to leave our shared values at the laboratory door....

We must move forward, but we must do so in a responsible, respectful manner. Stem cell research is the subject of diverse, deeply held views. While we will not always agree, the president respects these views. The Obama administration will support stem cell research only when it is scientifically worthy, and carried out responsibly. Our administration will ensure stem cell research is never taken lightly, conducted unnecessarily or abused.

The president will vigorously oppose cloning for human reproduction. It is dangerous, it is wrong, and it will not be tolerated. The National Institutes of Health will continue to be prohibited from funding research during which an embryo is destroyed.

Do Convicts Have A Right to DNA Testing?

Posted by Osagie K. Obasogie on March 12th, 2009

On the heels of the Innocence Projectís 200th exoneration last year through post-conviction DNA testing, the United States Supreme Court has decided to take up a case that will determine whether all prisoners should have a right to such tests. Many of the requests for new DNA tests come from prisoners convicted prior to the widespread use of genetics in criminal cases or before the technology reached its current level of sophistication. Six states currently do not have laws to allow prisoners access to DNA evidence after their conviction.

Although the right to further testing may seem obvious, victims rights groups, most states, and the federal government are in strong opposition. They are concerned with frivolous claims, overburdening the system, and the need for finality. This is unfortunate; all of these parties should be heavily invested in making sure innocent people arenít languishing behind bars.

While the use of DNA in the criminal justice system raises a number of issues (see Chapter 3 of Playing the Gene Card?), thereís an important difference between using genetic technologies to exclude those wrongly accused and using them to fish for suspects. Given that many speculate that the 200+ people freed by the Innocence Project is only the tip of the iceberg regarding false convictions, it will be interesting to see how the Supreme Court balances these competing interests. 

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