California stem cell agency head vows to keep May deadline

February 4, 2005

SAN DIEGO – California remains on target to issue its first grants from its novel $3 billion stem cell research institute by May, according to its chairman, although biotechnology companies and other industry applicants might be frozen out of the initial grant-making process.

Bob Klein, chairman of the committee tasked with overseeing the California Institute for Regenerative Medicine, pledged Thursday to issue grants by May at the end of an eight-hour meeting of the Independent Citizens' Oversight Committee.

The 29-member committee was scheduled to discuss restricting the first rounds of grants to nonprofit labs and universities because of patent and profit issues but delayed extensive conversation on the matter until its next meeting next month.

Earlier this week, an influential institute subcommittee floated the nonprofits-only plan and it appears to have widespread support of the full committee. Committee vice chair Ed Penhoet said at the subcommittee meeting Monday that it would be relatively simple to create a single, boilerplate intellectual property agreement between the institute and nonprofit grant recipients spelling out who owned the rights to any drugs or other commercial products created with taxpayer money.

A much thornier issue, Penhoet said, was hammering out similar agreements with companies applying for grants. Complicating the matter is the fact the University of Wisconsin, where human embryonic stem cells were first discovered, and its corporate partner Geron Corp. of Menlo Park claim broad commercial rights to any stem cell-based products.

Ensuring that California taxpayers recoup their $3 billion bond investment, which is expected to balloon to $6 billion once interest is added, has become a political hot potato for the nascent agency. Putting off making grants to corporate interests is seen as a way to put off the controversial issue until the agency has better intellectual property standards in place.

Still, Klein and the board dealt with other controversial issues Thursday, including how Klein intends to collect the $1 million he loaned the campaign that backed Proposition 71, which created the institute he now heads.

An Oakland public interest group said it was concerned Klein and the campaign organization he led might cross conflict-of-interest guidelines in their efforts to pay back the debt to Klein.

"This raises the prospect of the head of a powerful state agency asking for money to reimburse his own campaign expenses from people who may desire grants from that agency," said Jesse Reynolds of the Center for Genetics and Society.

Klein said he and the campaign organization had no intentions of actively soliciting potential donors and he called the loan a "long-term obligation." Klein also contributed an additional $2 million to a campaign that spent nearly $35 million. Proposition 71 passed with 59 percent of the vote in November.

Klein said he would "not accept a contribution from any entity" that has any connection or potential connection to the institute. Klein, a wealthy Palo Alto builder and financier of low-income housing, wrote much of Proposition 71 and led the campaign because he said his teen son has diabetes and his mother suffers from Alzheimer's disease.

Meanwhile, the committee voted to move the institute's temporary headquarters to Emeryville until it can find a permanent home. Klein said he expects the institute to remain in Emeryville for about six months. The institute lease agreement calls for free rent for seven months. Cities throughout California, including San Francisco, San Jose, Sacramento and San Diego, are competing to win the permanent headquarters with similar offers of free rents and other incentives.

The institute itself is expected to employ no more than 50 workers, but the cities view winning the headquarters as a prestigious victory that could be used to lure biotechnology companies to relocate.

Also on Thursday, the committee hired a headhunting firm to recruit a president for the institute. Lisa Pieper, a representative of the San Francisco-based SpencerStuart recruiting firm, said the institute may pay a total salary package of roughly between $300,000 and $600,000 annually for the job. That's at the lower end of what deans of prestigious medical schools make.

"The position isn't about money," Pieper said. "It's about impact and influence."

By Paul Elias
ASSOCIATED PRESS

5 with Prop. 71 campaign land jobs at new institute

February 4, 2005

Work on the campaign for Proposition 71 has led to more permanent employment for several former staffers.

Five people who worked on the stem cell initiative that voters approved in November are among the first eleven employees of the California Institute of Regenerative Medicine, which will dole out $3 billion in stem cell research grants.

Four of those five staffers will receive salaries ranging from $95,000 to $125,000. The fifth employee's salary has not been determined.

Robert Klein, chairman of the citizens oversight committee that will govern the institute, had the committee's approval to hire a skeleton staff. He told the committee at its monthly meeting yesterday that it is no coincidence some of the people who helped him run the Proposition 71 campaign were among the first hired.

"Approximately five or six individuals over the last two years have developed a great deal of expertise, first through the Proposition 71 campaign, and then through the nonprofit entity that followed," he said.

That expertise is now needed at the institute, said Klein, who wrote the job descriptions, conducted the interviews and filled the positions.

"The (new hires) have built a tremendous network of individuals in patient advocacy groups, medical associations, nonprofit and business organizations around the state," Klein said. He also pointed out that a number of campaign workers were not hired.

A member of an Oakland-based citizens' watchdog group questioned whether the job openings had been posted and whether anyone else knew to apply.

"There still is a disturbing amount of blurring of lines between the Yes on 71 campaign, the California Institute for Regenerative Medicine, the nonprofit coalition supporting stem cell research and Klein Financial Services," said Jesse Reynolds of the Center for Genetics and Society.

The Proposition 71 campaign was based in Klein's Palo Alto offices and had much of the same staff as the nonprofit coalition and now the institute, Reynolds said.

Klein said there was no blurring of the lines. Last month, he announced that he would no longer be involved in the nonprofit coalition supporting stem cell research to address concerns over potential conflicts of interest.

The hires were among numerous issues the committee discussed yesterday at its third monthly meeting, which was held at the Neurosciences Institute in La Jolla.

The committee also discussed an agreement to house the institute's temporary offices in Emeryville, near Oakland. Additionally, it hired Spencer Stuart, an executive search firm that will be paid $150,000 plus expenses to find candidates for the job of institute president.

The institute's new staffers who worked on the Proposition 71 campaign include Amy Daly, 41, a registered nurse from Redwood City who will be paid $110,000 a year to serve as director of patient and medical organization relations and as a liaison to the oversight committee that will govern the institute.

Amy Lewis, 30, of San Francisco, will be paid $125,000 as Klein's chief of staff. Lewis, who received an MBA from the University of California San Francisco, previously worked as a development associate at the Juvenile Diabetes Research Foundation and as a coordinator of event planning for the New Venture Center at UCSF.

Klein, whose 14-year-old-son has diabetes, is a board member of the Juvenile Diabetes Research Foundation.

One new hire who did not work for the campaign, Mary Maxon, 42, of San Francisco, will be paid $155,000 to serve as deputy to Edward Penhoet, vice chairman of the oversight committee.

Maxon has a Ph.D. from the University of California Berkeley's department of molecular and cell biology, and she recently was chairwoman of a National Academies of Science symposium on neglected disease.

All but one of the institute's hires are based in the San Francisco Bay Area, where Klein lives and where his businesses are based. Bay Area locales as well as San Diego are among cities vying to become home to the institute's permanent headquarters.

Two other institute employees are on loan from other state departments – the controller's office and the administrative office of the courts.

As mandated by Proposition 71, the salaries of institute employees are comparable to similar positions in the University of California system, Klein said.

According to a UC Web site, someone in a government affairs position would be paid between $80,000 and $143,000 a year. Chief of staff to the dean of a medical school would get between $96,000 and $217,000.

On Feb. 11, the institute's skeleton staff will move into temporary offices on Horton Street in Emeryville. Klein said the institute will not have to pay rent for the first seven months of a month-to-month lease on the 7,400-square-foot office. The rate for the following five months is still being negotiated but is expected to be below market, he said.

The office space, in a complex within 100 yards of Amtrak and local train lines, is owned by Warehan Development, which has more than a million square feet of office and lab space for lease. Klein said the company is not connected to him, to any committee member or to any entity that might benefit from the stem cell grant money.

By Terri Somers
UNION-TRIBUNE STAFF WRITER

UNMC to do embryonic stem cell research

February 4, 2005

LINCOLN, Neb. (AP) -- Human embryonic stem cell research using federally approved stem cell lines could begin as soon as next month at the University of Nebraska Medical Center in Omaha.

The research, which would be the first of its kind at the medical center, involves Dr. Stephen Rennard's work on emphysema and Dr. Ira Fox's work on the liver.

Each study using the embryonic stem cells will cost between $50,000 and $100,000. Rennard will use some of the money from his endowed professorship, created by a private donation. The medical center will fund Fox's research with some of the payments it receives from patients.

Regent Randy Ferlic of Omaha has said he opposes the research and he believes adult stem cells are as scientifically useful as embryonic stem cells. Ferlic said Thursday he doubted anything would be done to stop it, however.

"I've always thought this wasn't the most optimal path for the science to follow but I'm just one person in the wheels that turn," Ferlic said.

Medical center officials stressed Thursday that the research complies with President Bush's 2001 federal guidelines for stem cell research.

Bush approved a policy that includes using only existing stem cell lines that no longer could develop further as a human being.

Lincoln Journal Star
Associated Press

Couple may file wrongful-death suit. Embryos at clinic were destroyed.

February 6, 2005

CHICAGO – A couple whose frozen embryo was accidentally destroyed at a fertility clinic has the right in Illinois to file a wrongful-death lawsuit, a judge has ruled in a case that some legal experts say could have implications in the debate over embryonic stem cell research.

In an opinion issued Friday, Cook County Judge Jeffrey Lawrence said "a pre-embryo is a 'human being' . . . whether or not it is implanted in its mother's womb."

He said the couple are as entitled to seek compensation as any parents whose child has been killed.

The suit was filed by Alison Miller and Todd Parrish, who stored nine embryos in January 2000 at the Center for Human Reproduction in Chicago. Their doctor said one embryo looked particularly promising, but the Chicago couple was told six months later the embryos had been accidentally discarded.

In his ruling, Lawrence relied on the state's Wrongful Death Act, which allows lawsuits to be filed if unborn fetuses are killed in an accident or assault. "The state of gestation or development of a human being" does not preclude taking legal action, the act says.

Lawrence also cited an Illinois state law that says an "unborn child is a human being from the time of conception and is, therefore, a legal person."

"There is no doubt in the mind of the Illinois Legislature when life begins," Lawrence wrote.

Another judge had thrown out the couple's wrongful-death claims, but Lawrence reversed that decision, partly because that judge did not explain his decision at the time.

An attorney for the fertility clinic said an appeal would probably be filed.

The decision could curb reproductive research, said Colleen Connell, executive director of the American Civil Liberties Union in Chicago.

Connell expects the ruling to be overturned on appeal.

"It may be groundbreaking, but it's the wrong decision," Connell said. "No appellate court has ever declared a fertilized egg a human being in a wrongful-death suit."

Stem cells can potentially grow into any type of human tissue. Many scientists believe they could someday be used to repair spinal cord injuries and treat some diseases. Anti-abortion groups oppose such research because it involves destroying embryos, and the Bush administration has severely restricted funding.

Although the ruling probably is too narrow to affect abortion law, it increases legal risks for fertility clinics, said John Mayoue, a family attorney in Atlanta and specialist on in-vitro law.

ASSOCIATED PRESS

Sheep cloner turns to human embryos
Britain issues 2nd license in battle against disease

February 9, 2005

LONDON – The scientist who attracted the world's attention by cloning Dolly the sheep is about to take another major step for medical research: cloning human embryos and extracting stem cells to unravel the mysteries of muscle-wasting illnesses such as Lou Gehrig's disease.

Ian Wilmut, who led the team that created Dolly at Scotland's Roslin Institute in 1996, was granted a cloning license yesterday by British regulators to study how nerve cells go awry to cause motor neuron diseases.

The experiments do not involve creating cloned babies, but the license has nonetheless stirred fresh controversy over the issue and prompted abortion foes and other biological conservatives to condemn the decision.

"Are we supposed to be appeased by Professor Wilmut's declarations that the human embryos will be destroyed after experimentation and that his team has no intention of producing cloned babies?" asked Julia Millington of the London-based ProLife Alliance.

"All human cloning is intrinsically wrong and should be outlawed. However, the creation of cloned human embryos destined for experimentation and subsequent destruction is particularly abhorrent."

Wilmut, speaking after the announcement in Edinburgh, Scotland, defended the move.

"We all take for granted the very much healthier life that we have now compared with people 100 years ago," he said. "I think that the majority of people support this type of research and hope it will be successful in helping to bring useful treatment for diseases like motor neuron disease."

The license is the second one approved since Britain became the first country to legalize research cloning in 2001. The first was granted in August to a team that hopes to use cloning to create insulin-producing cells for transplant into diabetics.

In the latest project, Wilmut and motor neuron expert Christopher Shaw of the Institute of Psychiatry in London plan to clone cells from patients with the disease, derive stem cells from the resulting embryo, make them develop into nerve cells and compare their evolution to that of cells derived from healthy embryos.

The cloning technique, called cell nuclear replacement, is the same as that used to create Dolly. It has already been applied to humans by scientists in South Korea, who created the clone to extract stem cells.

Dr. Brian Dickie, director of research at the London-based Motor Neuron Disease Association, said the experiments could revolutionize the future treatment of motor neuron disease, which afflicts about 350,000 people worldwide and kills about 100,000 each year.

The status of cloning varies widely across the world, and most countries have no laws or regulation in place. In the United States, federal government money cannot be used for cloning projects, but there are no restrictions on privately funded research.

The United Nations is deadlocked over the issue and is scheduled to take it up later this month. The United States and Costa Rica are leading a bid to ban all forms of cloning, while Belgium is heading a faction that wants to allow it.

By Thomas Wagner
ASSOCIATED PRESS

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