Promoting California's Stem Cell Giveaway

Stem cell advocate Don Reed is beating the publicity drum for the Big Event this month, and it is not the Super Bowl.

Reed, who has a keen sense of PR, is pitching Feb. 16 as an "unbreakable date" in San Francisco. On Jan. 31, he wrote on his blog, stemcellbattles.com:

"There will be lots of reporters… If our friends are not there, who will they talk to?

Hint: the opposition will definitely be there…"

The date is when the CIRM Oversight Committee is expected to conclude its decisions on the first wave of more than $100 million in research grants to be dished out this year.

Reed is well-connected in the patient advocate community. He knows that TV cameras cannot resist sympathetic interviews with persons afflicted diseases or other problems that could be treated with future stem cell therapies. And the TV audience is likely to be much more sympathetic to their concerns than those opposed to ESC research on theological grounds.

Perhaps state Sen. Sheila Kuehl, D-Santa Monica, is also considering being on the scene, which could be an excellent venue to promote her legislation concerning the stem cell agency. TV rarely covers the agency, and it is not likely to become excited about a legislative story unless it becomes truly extraordinary.

Legislators Target California Stem Cell Agency

The California stem cell agency may have believed its difficulties with the California legislature had vanished, but no such luck.

A bipartisan attempt is underway to change the composition of CIRM's Oversight Committee and dictate some terms of its intellectual property policies, among other things. The effort must be bipartisan because a colossal majority of 70 percent of both houses is required to pass a bill affecting CIRM. The governor's signature is required as well.

Reporter Malcom Maclachlan of the Capitol Weekly was the first to break the news about the latest effort to assert legislative influence over CIRM. He said Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will author the legislation. Kuehl is the chair of the Senate Health Committee, replacing Deborah Ortiz, who stem cell Chairman Robert Klein once denounced as an "ongoing threat." Ortiz left the legislature because of term limits. Runner is a Republican leader in the Senate, serving as its GOP caucus chair.

Maclachlan wrote that legislation now being drafted would require that two "public interest" representatives be appointed to the 29-member CIRM Oversight Committee. That presumably would mean that two persons now on the board could lose their seats, since the measure does not provide for increasing the size of the committee.

The legislation also "would allow the ICOC to negotiate royalties of 2 percent to 5 percent on any treatments developed via grants to for-profit entities; there would be no cap on the royalties the state could receive."

Maclachan, who has produced a number of stories on the stem cell agency, continued:

"The bill would also force for-profit entities to offer these treatments to the state at the Medicaid prices, rather than the current requirement that they be offered in line with weaker standards under the California Prescription Drug Discount Program. Finally, it would widen the definitions of what state agencies would be eligible for the discounts. Current CIRM regulations limit this to the state discount drug program, while the legislation would open it to any state agency, including prisons and county indigent health-care programs."

Maclachan quoted Dale Carlson, spokesman for CIRM, as saying the agency would have no comment until it had an opportunity to review the bill.

Carlson also said:

"We have benefited greatly from the Legislature's advice and counsel in years past, and we look forward to a continuing cooperative partnership. We are interested in any and all ideas that can bring stem-cell treatments and therapies to fruition."

Winning passage of the legislation would be a remarkable achievement. No other legislation requires 70 percent approval – not even the state budget or tax increases. Negative votes from only 13 senators can kill the bill. But the measure will certainly provide a forum for lawmakers and others to make their voices heard at more length than the three minutes allowed for each public comment at CIRM meetings.

For more on the reasoning behind the legislation see the item below.

Rationale Behind Kuehl's Stem Cell Legislation

The new chair of the California State Senate Health Committee will "push the CIRM to live up to its promises," including insuring that all Californians will have access to any therapies developed as the result of state-funded stem cell research.

So says the January newsletter put out by Sen. Sheila Kuehl, D-Santa Monica. The newsletter carried a piece by Peter Hansel, staff director of the Senate Health Committee, that discussed the California stem cell agency at some length, including needed changes. Hansel, it should be noted, also served as a Health Committee analyst when it was chaired by Sen. Deborah Ortiz, who is now out of office.

Hansel wrote that Kuehl disagrees with arguments that CIRM should should go easy in terms of royalty requirements and affordable access to cures and therapies. He noted that CIRM has adopted some IP rules that respond to legislative concerns. Hansel continued:

"However, regulations governing the pricing of stem cell therapies in California run counter to assurances given to the Legislature. While at first proposing that grantees and licensees sell such therapies to publicly funded programs at the federal Medicaid price, the CIRM has recently reduced that to a requirement to sell at the same prices they offer them to the state’s new California Prescription Drug Discount Program, a significantly less favorable price. Similarly, the regulations for grants and loans to commercial entities propose to cap the amount of revenues coming back to the state associated with most products developed with Prop. 71 funds, as opposed to giving the state an open-ended return commensurate with its investment. By contrast, New Jersey, which also allows commercial entities to receive grants under its stem cell research program, requires such grantees to share a percentage of revenues—one percent—on an open-ended basis from licensing or commercialization of inventions (two other states that fund stem cell research, Illinois and Connecticut, do not allow for-profit entities to receive funding while another two, Maryland and Illinois have yet to develop policies for grants to for-profits). Capping returns from joint research ventures also appears to run counter to the practices of most universities who co-fund research with commercial entities and the venture capital industry.

"In addition, recent changes require grantees to grant exclusive licenses for inventions they develop to entities that agree to have plans at the time of commercialization to provide access to resultant therapies and diagnostics for uninsured patients, consistent with 'industry standards,' The current industry standard, the patient assistance programs that have been developed by the major drug companies, have been shown to be woefully inadequate in encouraging access to free or reduced price drugs for uninsured persons. Thus, it is incumbent on the CIRM to develop a more meaningful standard than this."

calif legislation, IP, affordability, access, skuehl, phansel