Friday, April 08, 2005

Conflicts of interest. Prop 71. NIH


In 2001, President Bush limited federal funding to the 22 stem
cell lines in existence at the time, asserting that the destruction of embryos for stem-cell use meant taking human life.

"Scientists in states that do not fund stem cell research will be at a significant disadvantage," said Wise Young, director of the
neuroscience center at Rutgers University. "And many of them will be moving."

California, Wisconsin, Kansas, New Jersey, Maryland, and Massachusetts have addressed the issue of state funding.

California passed Prop 71 creating 3 billion in funding over 10 years. From Sacramento to San Diego, the state's major cities made their bids March 16, 2005 to become the hometown of the largest-ever state-funded research program, the California Institute for Regenerative Medicine.


Also on March 16, 2005, the Sacramento Democrat Ortiz and Sen. George Runner, R-Lancaster, introduced a constitutional amendment that would impose stricter conflict-of-interest rules on the oversight committee and its working groups. It would require that California receive royalties from state-funded stem-cell treatments and impose open meeting and open record act requirements on the working groups.

from the San Diego Union-Tribune:
But, as is the case with most initiatives, many voters did not read the fine print. Not discussed widely during the campaign was the fact that the institute would be governed by a 29-member board with no oversight from anyone.
The bonds would be authorized from the state treasury, and the institute would distribute the money. Language in the initiative also allows a number of decisions to be made behind closed doors.

That lack of legislative oversight and a few other concerns are
causing a delayed reaction. In February, two groups representing people who opposed Proposition 71 filed petitions with the state Supreme Court raising constitutional questions about the control of taxpayer funds and the power of the nonelected oversight board. (Members of the board are appointed by the governor, other constitutional officers, University of California
chancellors and others.) State Attorney General Bill Lockyer said last week that the institute likely will not be able to begin distributing grant money until the suits are decided.


Washington Post, April 2, 2005:

Agitation [at the NIH] has been fermenting since early February, when agency director Elias A. Zerhouni imposed the rules after a congressional committee found that about 120 NIH scientists had not disclosed outside consulting deals, as required. Less than a month later, the NIH acknowledged that most of the researchers had been unfairly accused because of agency clerical errors.

"A lot of these researchers really want to understand the
commercial side of their work," said Jerry Feigen, former director of the Macklin Center for Entrepreneurship at Montgomery College, who teaches a business class at NIH that features lectures by local venture investors.

"If the NIH wants to land the brightest brains, they have to come to grips with helping do-good researchers understand the commercial side of science," Feigen said. "I don't think there's anything wrong with that." [LBE note: Huh? Are brightest brains, do-good research and no commercial understanding all linked? Is "understanding the commercial side" a euphemism here?]

Agency officials said classes like Feigen's will continue and argue that concerns about the impact on private industry are somewhat exaggerated. Researchers can still work with companies as part of their official NIH duties, particularly under agreements in which each side provides resources to develop products.

And NIH employees will still be entitled to to $150,000 a year in royalties if companies license their discoveries and develop a product. MedImmune Inc., one of Maryland's most successful biotechs, developed Synagis, a billion-dollar product, this way.


"The new [conflict of interest] rules [at the NIH]imposed an insurmountable problem for me," said Battey, who has applied for the job of president of the new California Institute of Regenerative Medicine [of Prop. 71]. "I manage a family trust . . . which supports the education of my father's seven grandchildren, and it contains assets I'm told I 'd have to divest. That would cost a lot of money, and I can't do that to my family."

[Better look before you leap. CA may have some tough conflict rules too.]


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