Medical Device Daily Washington Writer

WASHINGTON – Although the Senate voted on Tuesday to pass a bill to expand federal funding for embryonic stem cell research, President George Bush is likely to stop the measure in its tracks.

The administration has issued a formal veto threat, a move applauded by opponents of the controversial research, and Bush's official rejection could come as soon as today. Neither congressional chamber appears to have enough votes for an override. A veto would represent a seminal move by the president, as he has yet to exercise such power since coming to office 5-1/2 years ago.

But proponents of the bill, the Stem Cell Research Enhancement Act, have made noteworthy progress in advancing it this far. Labeled H.R. 810 and S. 471, the measure would allow federal money for research on excess embryos produced at in vitro fertilization clinics.

It was approved last spring in the House of Representatives by a 238-194 margin, and took another 14 months before the 63-37 Senate vote. Bipartisan backers in both chambers come from liberal and conservative persuasions, and the issue has received support from almost every National Institutes of Health (NIH; Bethesda, Maryland) division head and other leading scientists. Embryonic stem cell research also enjoys wide public popularity, as evidenced by a recent poll showing that 72% of respondents view the science favorably.

That kind of backing indicates that the issue won't disappear, although the expected veto relegates the matter to a future congressional session and perhaps even another executive administration. That kind of slowdown is disturbing for many academic researchers, as well as those within the biotech industry.

“It's extremely disappointing,” said William Caldwell, CEO of Advanced Cell Technology (Alameda, California). His publicly traded firm is on the verge of human studies of three stem cell therapies for macular degeneration, cardiovascular disease and skin repair, with clinical trials likely to begin next year and in 2008.

Underscoring the importance of funding from the NIH for nascent research, Caldwell noted that such support effectively “incubates” early science until private backers enter with further investments to progress discoveries into therapeutic products. “That has been the American prescription for success.”

Echoing similar sentiments, Novocell (Irvine, California) President and CEO Alan Lewis called the likely veto “a shame.” But casting an optimistic eye toward that future, he pointed to the visibility around the issue these days, as well as the mounting pressure on Bush “to reconsider at some point, and hopefully sooner rather than later.” Privately held Novocell is planning its first clinical trial of an embryonic stem cell-derived diabetes treatment in 2009.

Lewis, who conceded that broader NIH funding for academic researchers wouldn't directly impact his company, nonetheless told Medical Device Daily's sister publication, BioWorld Today, that H.R. 810's passage would provide “more opportunities for us to in-license technologies and connect with key stem cell experts” who would be conducting wider lab work. “I think everything would be speeded up and made easier if Bush signed 810,” he added, “but I think we're going to have to wait for a while for that.”

The president does not appear willing to back off his policy that limits federal funding to research on embryonic stem cell lines created before Aug. 9, 2001. That, Caldwell said, “is an absolute travesty,” adding that election-year politics appears to have a hand in influencing the debate that many charge has caused the U.S. to lag behind other countries in terms of embryonic stem cell research capabilities.

“From our standpoint,” Caldwell said, “we would benefit from monies that would come in from the NIH for several of our major research projects that would enhance and/or accelerate the processes that we currently have.”

Still, information released by the White House indicates that more than $90 million has been poured into this research since the five-year-old policy went into effect. In addition, the administration has refuted worries that the remaining 22 stem cell lines eligible for federal support have been contaminated.

Nevertheless, the clamor for more funding for more stem cell lines is loud, and Bush's expected veto goes against many with whom he is typically allied.

As Senate Majority Leader Bill Frist (R-Tennessee) wrote in a Washington Post oped piece on Tuesday, “We cannot ignore the promise these cells hold.” His colleague, Sen. Arlen Specter (R-Pennsylvania), said Monday that “no sensible reason” exists for withholding the nation's estimated 400,000 unused embryos for research, adding that “a large delegation of senators” would urge the president to sign the bill.

Frist added: “I hope that we can redeem this loss of life in part by using these embryos to seed research that will save lives in the future.”

Almost a year after throwing his support behind H.R. 810, Frist carved a path for the Senate vote alongside two other stem cell-related bills, S. 2754 and S. 3504. They also cleared the Senate, by unanimous 100-0 tallies, and the president is expected to sign both into law. Senate Minority Leader Harry Reid (D-Nevada) criticized both as politically rooted to placate conservative constituencies.

The former, from Specter and Sen. Rick Santorum (R-Pennsylvania), encourages research into obtaining pluripotent stem cells without destroying embryos through methods such as altered nuclear transfer. The latter, from Santorum and Sen. Sam Brownback (R-Kansas), makes it illegal to perform research on embryos from fetal farms where they could be created specifically for research.

Brownback, who has been a leading opponent of H.R. 810 and “the use of young humans as raw material,” used this week's debate to push for further research on adult and cord blood-derived stem cells. Flanked by patients treated with such therapies at a press conference Monday, as well as so-called “snowflake children” born from excess in vitro fertilization embryos, he said 72 diseases have been treated with adult and cord blood-derived stem cells.

Opponents have scoffed at the scientific validity of that claim, but nonetheless, few dispute the potential value of that research as well. Still, it's clear that many in the biotech industry would like to pursue all forms of stem cell therapies, unimpeded by restrictions on federal aid.

“Any sort of technology improvement to the human condition must be embraced,” Caldwell said. “So there's no reason in the world to make this an either-or situation. Let's have it all.”

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