Legal battle plays out as loans fund program

The San Diego Union-Tribune

BURLINGAME, CA — The board of California’s Institute for Regenerative Medicine today is expected to award the first round of research grants funded by the state’s groundbreaking $3 billion stem cell initiative.

People around the world will be watching.

California’s initiative, voted into law in November 2004, is the nation’s first state program that seeks to circumvent federal funding restrictions on human embryonic stem cell research. Its mission, and success with voters, prompted other states to follow suit with their own taxpayer-supported funding programs, fueled in part by a desire to stem a brain drain of talent to California.

“This is very exciting. It’s what we’ve been working toward for the past two years,” institute president Zach Hall said yesterday, as the institute’s governing board prepared to review the grant applications.

Lawsuits challenging the initiative kept the institute from making its first grants in May 2005 as originally planned. State lawyers were in state appeals court Wednesday, arguing against the latest legal challenges. It could be 90 days before the appellate court rules.

Meanwhile, $180 million in loans from philanthropists and the state are allowing the grants to get rolling while the legal battle plays out.

The board had planned a two-day meeting to review the 232 applications it received for its “Seed Grants,” which are designated to support innovative research by young investigators or work in new areas by more seasoned scientists.

The 27-member board of scientists, patient advocates and biotechnology executives isn’t making its decision in a vacuum. The grant applications have been reviewed by a working group made up of patient advocates who serve on the board and by scientists from outside California. That working group scored the applications based on the quality of the proposed experiments, the researchers’ background, and access to the proper lab facilities and support.

But the board could only make “provisional” votes on the recommendations last night because only 16 members attended the meeting. Eighteen were required for a quorum. Several board members who had said they would be present for the historic vote could not make it at the last minute, said Dale Carlson, an institute spokesman.

“It’s outrageous that they could not get a quorum for what is their most high-profile event next to their first board meeting,” said John Simpson, of the Foundation for Consumer and Taxpayer Rights, who has been following the board’s actions closely.

Robert Klein, board chairman, defended those absent.

The initiative made the board large so that it would encompass a wide range of experience and expertise, including executives, medical professionals and patient advocates, Klein said. And professional obligations or personal emergencies can prevent people from attending meetings, Klein said.

The potential embarrassment of not making a quorum rises today, with Gov. Arnold Schwarzenegger planning to attend the meeting to speak to the board. Schwarzenegger has supported the initiative, and made a $150 million loan available to the institute so it could continue to operate during its legal struggles.

There is a second issue the board could vote on today: whether to raise the Seed Grant funding from $24 million to $45 million.

Originally the board estimated that it would fund 30 Seed Grants, for a total of about $24 million. When reviewing the grants, the scientific working group determined that 38 projects could be funded for $24.2 million.

Moreover, the working group was so impressed with the caliber of the proposed research, and with the investigators seeking funding, that it proposed funding a second tier of 34 grants for an additional $21 million, said Jeff Sheehy, a patient advocate and board member who serves on the working group.

If the board does not want to allocate $45 million, the working group suggested funding nine of the 34 projects in the second tier for $5 million, Sheehy said. These are not necessarily the highest-scoring proposals in the tier, but they would expand the portfolio of research funded by the CIRM.

For example, after some discussion, the board agreed it wanted to fund a second-tier proposal for work that would try to coax human embryonic stem cells into cells that comprise the hairs in the inner ear. Loss of these hairs contributes to hearing loss.

A brief synopsis of each grant and comments from the working group reviewers has been posted on the institute’s Web site for public review.

All the grants recommended for funding involve work with human embryonic stem cells that would not be funded by the National Institutes of Health, because President Bush ordered that no federal money be spent on stem cell lines created after August 2001.

“That makes sense, and it’s how the initiative can make a unique impact on the science,” said University of California San Diego stem cell researcher Larry Goldstein.

Around the state, scientists have been reviewing the list and the projects favored for funding. And many people have been able to identify some grant applicants, although the list does not contain the name of researchers or their institutes.

It’s a small scientific community, and its members are familiar with who has a particular expertise, said Jeanne Loring, an embryonic stem cell researcher at the Burnham Institute in La Jolla. But that means many scientists are also uncomfortable with their scores being posted on the Internet for the world to see.

It appears that numerous grant applications filed by researchers in the San Diego region are highly recommended for funding, scientists said. Four of those grants, including one of the most highly rated, appear to be from researchers at the University of California San Diego. Three appear to be from the Burnham Institute.

The grant application that ranked highest with the scientific review committee is from UCSD. The scientist is requesting $612,000 over two years to fund experiments that would coax stem cells to become forebrain neurons, which may one day be used to replace neurons damaged by Alzheimer’s and other disease.

The grant receiving the second-highest score asks for $638,000 over two years to perform research using stem cells pulled from human embryos that have been donated to a stem cell bank in La Jolla by a local in-vitro fertilization clinic.

One task this team of researchers — apparently Loring’s lab at the Burnham Institute — would try to perform is to standardize embryonic stem cell cloning. This is the technique that a North Korean scientist claimed to have mastered, but his work was revealed to be fraudulent in late 2005.

The Burnham application specifically seeks to clone embryonic stem cell lines predisposed to a childhood disease, so that the cells could be used to track the disease progression and to test possible therapeutics in a Petri dish.

Another grant application recommended for funding would use human embryonic stem cells to track the earliest stages of human development, with special attention given to what leads to abnormalities in implantation of the embryo that could result in the death of the fetus or mother.

All of the work is basic embryonic stem cell research, which would lay the foundation for the still nascent field, said Mahendra Rao, a former embryonic stem cell researcher at the NIH who is now at Invitrogen in Carlsbad.

The projects recommended for funding encompass an array of disease groups, and the basic work of trying to standardize the reproduction of embryonic stem cell lines and characterizing the different changes caused by a change in their environment, Rao said.
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Terri Somers: (619) 293-2028; [email protected]