Another Leader Against Prop 71

I voted against Proposition 71, the stem cell research initiative, not because of ideology but because of policy concerns. Mitch Kapor sent out an email last night that sums up the reasons why he is voting against Prop 71.

From: Mitchell Kapor [mailto:@osafoundation.org]

Sent: Monday, Oct 25, 2004 18:46 PM

To: Mitchell Kapor

Subject: For stem cell research, against Proposition 71

Dear Colleague,

I thought I'd be supporting Proposition 71 on stem cell research because I'm pro innovation and the Bush administration has blocked progress in this important area. As I've learned more about its details, I've concluded Prop. 71 represent the wrong way to do the right thing. While stem cell research holds major promise, it's not the shoo-in for guaranteed results its backers are implying and there are concerns about conflicts of interest, accountability, and ethical issues that warrant finding other ways to support stem cell research. We would all like to see a cure for diabetes and other debilitating diseases that affect ones we love, but we need to recognize Prop. 71 is not the best route.

Under Prop. 71, the governing body (a new "Institute for Regenerative Medicine") which would control the $3 billion of public funds will be dominated by people who are part of or close to both the institutions and companies that would benefit from the funds. This is a conflict of interest. Comparable oversight boards for other types of research which have been established at the federal level are far more inclusive and often mandate that disinterested experts and members of the public and/or other stakeholders without financial conflicts be included.

The Institute would set its own rules, exempting it from oversight by both the public sector (e.g. officials and from a body of federal and state regulations) and the private sector, including those that address informed consent and protection of research subjects.

By setting itself apart from the normal ground rules under which research is conducted and commercialized, there is a greatly increased risk of downstream lawsuits and other unforeseen problems. The lack of accountability leaves everyone, including researchers, taxpayers, and businesses which want to capitalize on the research more vulnerable. It would be far better to promote stem cell research either through Federal activity (if Senator Kerry wins) or through the California legislature.

The terms under which the state would benefit and the taxpayers repaid in the event of successful commercialization are murky and lack sufficient protection for the public. As we've seen elsewhere, murky intellectual property issues often mean protracted legal fights.

As Dan Gillmor said yesterday in his column in the San Jose Mercury News, "The scope of this project is too massive for comfort given the state's shaky fiscal position. And the benefits to taxpayers -- who are likely to foot a large bill -- are too abstract."

The language guarantees California only an "opportunity" to benefit from patents while also guaranteeing that the researchers are "not unreasonably hindered," suggesting continuing lack of precision in what happens to royalty and patent payments. Although this is being touted as a revenue generator for the state, payments could be siphoned to
private interests, which would in turn surely be challenged in the courts. Similarly, sharing the risk through state funding that might entice the private sector to participate will be undermined by the lack of clarity.

Unique ethical issues surround one specific type of embryo stem cell research - somatic cell nuclear transfer (also known as "embryonic cloning," "therapeutic cloning," or "research cloning"). Because there are significant health risks to women who agree to undergo the egg retrieval necessary to conduct the embryo cloning, a much clearer and
stricter regulatory framework needs to be created before proceeding. The FDA has received over 4000 reports of adverse drug events among women given the drug Lupron to prepare them for the hyperstimulation that enables egg extraction. This includes 325 hospitalizations and 25 deaths. Prop. 71 would create a huge need and therefore huge pressure for women to donate eggs and raises the possibility of exploitation as has happened in similar situations such as blood donors.

So, please give careful thought to this, pass this on to colleagues and friends, and vote No on 71 on November 2.

For more information, see:

http://www.genetics-and-society.org/policies/california/assessment.html
http://www.allianceagainstprop71.org/analysis.htm
http://www.allianceagainstprop71.org/articles.htm
http://www.siliconvalley.com/mld/siliconvalley/10003162.htm

Regards,
Mitch