Monday, April 27, 2009

CIRM's Initial Assessment on NIH hESC Rules; Task Force to Develop More Analysis

A key group of directors of the California stem cell agency this morning moved to create a task force to study and comment on the proposed NIH rules for human embryonic stem cell research.

The Legislative Subcommittee of the CIRM board of directors voted 7-0 to proceed with the work on the NIH rules, which have drawn fire from scientists in California. The action now goes to the full board for expected approval at its meeting Tuesday and Wednesday in Los Angeles.

CIRM plans to consult with institutions, scientists, the public and others in developing an analysis and recommendations on the NIH rules by May 24. Meetings of the task force are expected to be conducted in public. The CIRM board will hold a telephonic, public meeting on the final CIRM document, according to CIRM Chairman Robert Klein.

CIRM will also work with the Interstate Alliance on Stem Cell Research in developing its proposal. The alliance previously scheduled a May 5 meeting in Washington, D.C., which could provide a venue for exploration of the issues, said Geoff Lomax, senior officer for medical and ethical standards.

Following the 7:30 a.m. meeting today, CIRM posted background material and other information on the issues on its website. They include a comparison between the NIH guidelines and CIRM regulations and an intial assessment of the impact of the NIH proposal.

Among other things, CIRM's first-cut at the rules said,
"Our conclusion from this preliminary analysis is that the consent protocol for some lines does not include all items identified by NIH in its eligibility criteria, suggesting some scientifically significant lines may not qualify. All lines evaluated were derived from balstocysts created for reproductive purposes but no longer required for family planning."

"The draft policy sets ' high bar' for consent and disclosure. There are concerns that established cell lines may not meet the proposed standard. Substantial foundational research has been performed utilizing established lines. NIH should consider a 'grandfathering' clause or other mechanism that enables continued use of established lines. NIH should give consideration to whether a particular line was derived in accordance with consensus guidelines or the legal requirements at the time of consent or derivation."

"Further, experience suggests there may be uncertainty to whether specific cell lines conform to every requirement of the draft guidelines. This uncertainty may result in qualifying lines not being utilized. There was broad consensus that a registry of compliant lines would be the most efficient method for identifying lines and ensuring promising research materials are not unnecessarily disqualified."

"For grantee institutions the promulgation of NIH guidelines raises question related to the implementation of grants where a mix of funding is involved. For example, one institution identified the case where research involves a comparative analysis of multiple hESC lines. It is conceivable that such a study could involve lines not recognized or approved by every funding source. Harmonization of rules, to the extent allowed by law, would be desirable from this grantees perspective."
CIRM said,
"As the largest funder of human embryonic stem cell research in the world, CIRM has an interest in ensuring that the NIH rules are consistent with CIRM’s medical and ethical standards, which were modeled upon guidelines adopted by the National Academies of Science, and with the best interests of science and patients."
The NIH announced its proposed new rules only 10 days ago. CIRM completed its preliminary analysis last Friday. However, the actually posting of documents relies on a state department that does not work during the weekend.

The Legislative Subcommittee also voted to support 6-0 with one abstention (Jeff Sheehy) a federal bill dealing with biosimiliars, which are copies of the original biotechnological drugs following the expiration of patent protection.

The panel backed HR 1548, by Rep. Anna Eshoo, D-Palo Alto, which is also supported by the Biotechnology Industry Organization. The industry group opposes a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles. The subcommittee did not take a position on Waxman's bill.

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