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How the (Not so) Mighty Have Fallen

Posted by Osagie Obasogie on October 2nd, 2008

Just three years ago, NitroMed (makers of BiDil, the first FDA-approved race specific medicine) was heralded as a promising pharmaceutical company with a business model for BiDil that led some analysts to predict sales of between $500 million and $1 billion by 2010.  

Yet, BiDil’s fortunes have swung drastically in the other direction. Amongst sluggish sales and massive layoffs, Nitromed was recently notified by NASDAQ that its stock risks delisting since its price has been below the $1 minimum for over 30 straight days.

What does NitroMed’s slow but steady demise mean for future endeavors into race based medicine? It’s hard to pinpoint exactly why BiDil failed. Some say it was overpriced compared to the availability of its constitutive generic components at a fraction of BiDil’s cost. Others suggest that the fraught history between Blacks and the medical community may have led many African Americans to think twice about taking any medication claimed to be designed just for them.

Regardless of the reason, it seems that even BiDil’s strongest supporters are starting to rethink their approach. One of them, Dr. Keith Ferdinand, told the Newark Star Ledger that “he now wonders whether the smarter strategy would have been to market BiDil as a general heart failure drug and let the data about its particular effectiveness in blacks ‘stand on its own.’”

Not a bad idea.

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California Stem Cell Program to go Under the Microscope

Posted by Jesse Reynolds on October 1st, 2008

The governance of our state's $3 billion stem cell research program will finally face some long-overdue scrutiny. The biggest problem with the California Institute for Regenerative Medicine (CIRM) is that it is fundamentally unaccountable. Although it spends taxpayer dollars, CIRM's leadership doesn't report to any elected official, as it has its own dedicated stream of funding and governing board members can't be removed.

But a state governmental reform commission will examine the CIRM's "governance and transparency." The oddly-named Little Hoover Commission is a bipartisan standing advisory body that "promotes efficiency and effectiveness in state programs." The Commission generally instigates its own investigations, but in this case, it is taking its cue from the Legislature. A bill passed that called on the Commission to review CIRM's governance, but was just vetoed. However, the Commission picked up on the message.

This is a positive development. Proposition 71, which created the CIRM, established a very high bar for legislative reform. A report from the Commission could catalyze action in the Statehouse, and provide some necessary political cover. This is all the more important, as the CIRM increasingly appears to be the personal fiefdom of board chairman Robert Klein.

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Australia Oversees Cloning-based Stem Cell Research

Posted by Jesse Reynolds on September 26th, 2008

Sydney from the air

Last week, an Australia regulatory agency issued its first license for cloning-based stem cell research. I continue to doubt the need for continuing this speculative line of research that has yielded so little and costs so much, particularly with respect to its need for large quantities of women's eggs. That aside, the details of the licensing process are reassuring, particularly relative to the US, where the oversight remains remarkably inadequate.

Researchers at Sydney IVF had to demonstrate to an accountable, external body - the National Health and Medical Research Council (NHMRC) - that their protocol complied with national research and ethical standards. This is in addition to obtaining approval from an institutionally-affiliated review board, which is all that is recommended in the US.

The NHMRC employs inspectors to ensure that research is carried out in a manner complying with the standards. In fact, the scientists must report the source and fate of each egg and embryo used.

The NHMRC posts the licenses on its website.

In this case, the clinic's three licenses - each for a different source of DNA in the cloning process - permit the use of 2400 eggs per method, for a total of 7200 eggs. But any of the protocols must cease if two-thirds of its egg allotment (i.e. 1600 eggs) are used, or if 160 clonal blastocysts are created, and no stem cell line has been yet derived.

And in this case, Sydney IVF is authorized to use only eggs that have failed to properly fertilize. Coupled with Australia's prohibition on paying for eggs, this means that women won't be recruited to specifically provide eggs for research.

Reproductive cloning is prohibited in Australia.

Still, the stem cell work is being done by the staff of the IVF clinic. This leaves the possibility for professional conflict of interest among the staff who perform the egg extraction. If they, or their employer, hope to receive credit for the successful derivation of a stem cell line, they may be tempted to increase the hormone dosage. While this will produce more eggs for their research, it will also increase the likelihood and severity of side effects to the women providing eggs.

Previously on Biopolitical Times:

Eugenics — Again

Posted by Pete Shanks on September 25th, 2008

Carrie Buck
Carrie Buck, who was sterilized after a 1927 ruling of the U.S. Supreme Court

Compulsory sterilization is in the news yet again, in at least three different places:

  1. A Texas judge has "ordered a woman, as a condition of her probation, to stop having children."
  2. In Vancouver, there has been widespread discussion of whether a pregnant 27-year-old mother whose five children have been taken into care should be sterilized.
  3. A Louisiana State Representative "wants to pay poor people to get sterilized and reward rich people for having children." He claims that "the black community will say this is some sort of race-based genocide" but it's not because "the majority of people on welfare in the nation are white. ... The politically safe thing to do is to not touch this, but the train is potentially going off the cliff and everyone just wants to ignore the problem."

The Times-Picayune has lambasted that last proposal in an extraordinarily strong attack, saying that the Representative in question "is known for bone-headed ideas" and that other lawmakers "have even named a tongue-in-cheek award for the session's dumbest piece of legislation after him." (His seat was once held by Klansman David Duke.) The editorial does call the proposal eugenics, and does remind us of the horrific history in this country, and of the Nazi version.

Similarly, the Vancouver Sun's report does mention the history of Canadian eugenics, and the Wall Street Journal's article on the Texas case does place it in the context of history, emphasizing that after "the horrors of eugenics in Nazi Germany, the sterilization movement dwindled." Nevertheless, the paper opened up a blog on the topic for comments, and the conversation (in that case, largely thoughtful and varied) begins again.

Some struggles are never completely over.

Previously on Biopolitical Times:

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