Stem-Cell Rules Criticized: Federal Policies Restrict Funding

By Jason Gertzen, The Kansas City Star, Mo.

Apr. 15–CHICAGO — The scientist who once touted stem cells’ tantalizing promise on Time magazine’s cover is sounding an alarm about the future of his field.

James Thomson, the Wisconsin biologist who was the first to grow human embryonic stem cells in a laboratory, and Kevin Eggan, an up-and-coming Harvard University scientist supported by the Stowers Institute for Medical Research, joined a chorus of concern this week about federal policies restricting stem-cell research funding.

They were among 19,000 researchers, executives and investors at BIO 2006, the biotechnology industry’s major annual gathering.

Those in attendance reported advances in the quest to produce cures for paralysis, diabetes and other maladies from stem cells. Work relying on stem cells to test new drugs or reveal important secrets of diseases also appears to be gaining notable traction.

Yet they contend that the pace of progress has been impeded by President Bush’s 2001 decree that restricted funding to research involving only limited batches of the cells.

Thomson addressed the issue in uncharacteristically forceful terms in an interview with The Kansas City Star.

“People are keeping their heads down,” Thomson said. “It (federal funding) is not proportional to the need right now.”

Embryonic stem-cell research, widely seen as a source of the most promising potential medical breakthroughs, now gets just 0.1 percent of the primary source of federal research funding. International stem-cell scientists are racing ahead of those in the United States in publishing research.

Thomson, Eggan and others warned that the pre-eminent position of U.S. researchers has been slipping, uncertainty has hindered private-sector investment, and not enough scientists have been seeking to answer fundamental questions about cells that offer such intriguing possibilities.

“The federal lockdown is having a fairly profound effect,” said Eggan, who attracted $5.9 million in backing from Stowers, a privately funded institute in Kansas City.

Others counter that different forms of stem cells offer greater potential for near-term medical treatments, troubling moral concerns continue to envelop human embryonic stem-cell research, and the federal government already is devoting plenty of money to the field.

“We all have a duty to protect the innocent, and stem-cell research that destroys embryos kills young human children,” said Sen. Sam Brownback, a Kansas Republican, who does not want to see the 2001 policy reversed.

“To expand taxpayer funding of human embryo destructive research is wrong and cruelly plays on the hopes and fears of those suffering from illness and disease,” Brownback said. “We should shift taxpayer funds to nondestructive, ethically sound research that is resulting in real treatments and real benefits for real people.”

In Missouri and Kansas, much of the recent attention garnered by stem cells has been over divisive questions of whether research involving cells derived from human embryos should be banned or even criminalized. Missouri voters are to consider a proposed constitutional amendment in November that would grant legal protections for this work.

Although resolution of such controversies could be a major factor determining what work takes place in individual states, the national debate over research funding could have a greater effect.

The National Institutes of Health devoted $40 million to human embryonic stem-cell projects last year. This was less than a tenth of the $569 million for other stem-cell research. The agency’s overall research budget was about $29 billion.

Considering the Bush administration’s views on the matter, few administrators in the agency that is the nation’s premier supporter of basic science are likely to press the case for more funding, said Thomson.

In 2001, Time trumpeted Thomson as “the man who brought you stem cells.” While researchers had been working for decades with these cells from animals, Thomson in 1998 became the first to isolate human embryonic stem cells.

The cells start as blank slates and, with coaxing, are able to transform into any other cell type in the body. Their discovery spawned hopes that one day they could work as repair kits for ailing hearts, damaged spinal cords, or brains ravaged by Alzheimer’s disease.

Their use, however, has generated intense controversy because some stem cells are obtained with unused embryos donated from fertility clinics. The embryos are destroyed during the process.

Bush sought a compromise with a decision that will mark its fifth anniversary this summer. While leery of supporting research leading to the destruction of additional embryos, the president agreed to fund work involving human embryonic stem cells already in existence.

Some had feared a ban on the research, so the decision wasn’t seen at the time as a devastating setback.

“It opened the window,” Thomson said. “President Bush could have shut this down.”

Thomson said he has been reluctant to become a vocal critic of the policy before now, largely because the compromise was crafted with the help of Tommy G. Thompson, a former Wisconsin governor who had championed the stem-cell researcher’s work. In 2001, Thompson was secretary of health and human services.

The 2001 policy allowed research to get started. Now, however, scientists need new batches of stem cells not eligible for federal funding with the current policy, Thomson said.

“The president’s compromise is a bad compromise, and it does not represent good public policy,” Thomson said. “Now is the time to change it.”

In the frenzy over the research, some hyped its potential and set unrealistic expectations about how quickly any advances would emerge. But research so far shows that the work is worthy of expanded support, Thomson said.

“If you look at the early days of any technology, it takes a while to get going,” Thomson said. “There was a lot of enthusiasm early on, then it waned and hit this lull. Then it comes back and turns into being real. We are getting close to the point where it is going to be real.”

Difficulties confront researchers who have some federally funded projects and also wish to work with stem cells ineligible for government grants, said Eggan. Obtaining private funding exclusively for highly expensive lab operations is impractical for most scientists. As a result, some scientists have avoided the field.

Stanford University researchers recently showed that U.S. stem-cell scientists were being outpaced by international peers in the journal articles published since the 2001 funding decision.

“Things are going frustratingly slowly,” Eggan said. “It is just taking longer to get there because there are fewer people doing the research, there are fewer resources and limited resources we can leverage.”

Even so, work is progressing.

John A. Kessler, a physician and stem-cell researcher at Northwestern University, played video at the conference of mice with spinal cord injuries that regained partial use of paralyzed legs after stem-cell therapy.

Other researchers are pushing ahead in finding ways for stem cells to produce insulin for diabetics, improve neurological function for Parkinson’s patients, and bolster diseased hearts.

“The promise is still there,” Eggan said.

Some states, most notably California and its voter-approved $3 billion initiative, have sought to fill the gap created by the limited federal funding for some forms of stem-cell research. While helpful, even the most ambitious state initiatives are eclipsed by the resources of the NIH, said Michael Werner, president of the Washington-based Werner Group, which has lobbied for expanded stem-cell funding.

“There really is no substitute for the NIH jumping in,” Werner said.

Stem-cell research supporters are no different than other disease-fighting groups seeking more government money, said Carrie Gordon Earll, a spokeswoman for Focus on the Family in Colorado Springs, Colo. The federal government has a big budget to support research, but it is not unlimited, she said.

“Go talk to the AIDS people, the cancer people,” Earll said. “There is never a big enough piece of the research funding pie to make them happy.”

A lack of government money apparently isn’t the only factor slowing stem-cell advances.

The uncertainty and social controversy surrounding stem-cell research has discouraged many biotech companies and investors from embracing the technology, said Gareth Williams, a patent attorney with London-based Marks & Clerk.

In a report, Marks & Clerk showed that private-sector investment in stem-cell technology has stalled. Universities continue to dominate with stem-cell-related patents, though the technology is mature enough that private firms otherwise would be expected to be doing more to develop therapies and products by now, Williams said.

Academic researchers typically answer the fundamental scientific questions and then hand off to commercial researchers to apply the findings to patient treatment.

“If private investment isn’t there, the technology isn’t going to be commercialized,” Williams said.

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To reach Jason Gertzen, call (816) 234-4899 or send e-mail to jgertzen@kcstar.com .

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Copyright (c) 2006, The Kansas City Star, Mo.

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