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Thread: CAMR Calls for Bush's Help in Fully Implementing Stem Cell Policy

  1. #1

    CAMR Calls for Bush's Help in Fully Implementing Stem Cell Policy

    Patient Groups Take Stock of State of Stem Cell Research One Year Later; CAMR Calls for Bush's Help in Fully Implementing Policy


    WASHINGTON, Aug. 5 /U.S. Newswire/ -- One year after President Bush announced his decision on whether or not to allow federal funding for embryonic stem cell research, the Coalition for the Advancement of Medical Research (CAMR) examined the state of the research -- the successes achieved in implementing the President's policy and the major challenges that remain-and proposed potential solutions. In a letter to the President, CAMR will call on the Administration to meet with leading stem cell researchers, cell line owners, and patient groups so that the obstacles to implementing the policy can be addressed. CAMR, comprised of leading patient groups, universities, and scientific societies, led the charge to support federal funding of stem cell research and has led the efforts opposing a ban on therapeutic cloning.

    "When President Bush announced his decision on federal funding for embryonic stem cell research on August 9, 2001, we expressed concern that while we believed some research could be carried out on the limited cell lines available, the policy was too limited over the long-term to successfully move embryonic stem cell research forward," said Michael Manganiello, president of CAMR.

    "One year later, we can say that there has been some good research under the policy, the promise of stem cell research continues to be proven every day, and good faith efforts have been made in implementing the President's policy.

    However, we still do not have the 60 cell lines promised, only 17 (footnote) are available for researchers, and we believe that only one line owner is actually sharing its line with research labs. The Administration has not created a sufficiently positive environment for embryonic stem cell research to flourish, nor have they been as aggressive in implementing their policy as they should have been. The political climate surrounding stem cell research has steered many scientists away from pursuing the research and many companies away from investing in it -- this only further delays vital cures for patients," added Manganiello.

    Some of the successes in implementing the President's policy over the past year include:

    -- The National Institutes of Health (NIH) has developed the Stem Cell Registry, initiated support for 13 administrative supplements for embryonic stem cell research, issued a program for "Career Enhancement Awards" as well as a program to help researchers with stem cell research techniques, negotiated four material transfer agreements for NIH intramural investigators to obtain access to human embryonic cell lines, and issued numerous program announcements and requests for proposals.

    -- The Department of Health and Human Services (HHS) has been helpful in clearing administrative red tape so that the NIH's implementation activities can proceed, and Secretary Thompson in particular has played a critical role in urging private owners to share lines. A few stem cell lines holders have signed agreements with the NIH, and one in particular, WARF/WiCell has shared its line with researchers more than fifty times already. In addition, universities are beginning to develop institutional policies and plans on embryonic stem cell research.

    However, some of the critical challenges that remain are:

    -- The number of stem cell lines available, only 17 (footnote), is far less than the 60 originally promised.

    -- The NIH still does not have full information up for many lines on the Stem Cell Registry, its promised funding targets are far from being met, and most stem cell lines holders have not signed agreements with the Department.

    -- The number of stem cell research applications is less than expected as some researchers may be concerned about entering the field due to visibility and/or potential difficulty in obtaining embryonic stem cell lines.

    -- The focus of HHS on embryonic stem cell research policy implementation was diverted by the very necessary response to events of September 11, but it has never fully regained momentum. This has led the Department to have difficulty aggressively implementing the Administration's policy and in maintaining pressure on more than a few stem cell line-owners, especially foreign owners.

    -- Congress has also provided less oversight post-September 11 and more is needed on the Administration and stem cell line holders.

    -- University planning has been slower than expected and the political climate at the state level is hindering some universities from entering the stem cell research field.

    In a letter to the President, CAMR will propose the following solutions:

    -- The President should call for a meeting to review the state of embryonic stem cell research, which would include as participants our nation's leading embryonic stem cell researchers, university and industry representatives, federal research agency leaders, stem cell line owners, and patient groups to hear first-hand the successes achieved, the problems that remain with implementation, and to discuss ways to speed the process.

    -- The NIH should work with the American Society for Cell Biology (ASCB) and other relevant parties to determine what information is needed for the registry, demand such information from line owners, and post such information on the Web site expeditiously.

    -- The NIH should also hold a stem cell research workshop for scientists in the field to promote the availability of funding support for additional grantees; convene a National Academy of Sciences (NAS) panel to solicit recommendations on whether scientific needs require a modification to current federal policy; and encourage additional private investment in stem cell research and additional derivation.

    -- Secretary Thompson should meet with any stem cell line holder which has not yet shared its lines to work out appropriate terms that encourage them to share.

    -- The Secretary should also call for a meeting between the NIH and research advocates to discuss implementation issues and prioritize needed responses; organize a working group with representatives from other departments, including State and Commerce, to discuss ways to encourage transfer of foreign stem cell lines to U.S. researchers; and use his position and stature to promote a more positive research environment, encourage resolution of intellectual property issues, and increased sharing of cell lines.

    -- Congress should hold hearings on oversight and other major issues, introduce legislation or provide resources if needed to remedy obstacles, and hear directly from stem cell line holders.

    -- Scientific societies and research universities should promote the availability of federal funding and encourage applications for grants.

    "In the end this all comes back to the 100 million Americans suffering from life-threatening diseases and conditions who could be helped from advances in embryonic stem cell research. The stakes are high, and the potential benefits could mean the difference between life and death for the families we represent," added Manganiello.

    Footnote: We believe there are 17 lines currently available though estimates range from 5 to 24.

    The Coalition for the Advancement of Medical Research (CAMR), is comprised of nationally-recognized patient organizations, universities, scientific societies, foundations, and individuals with life-threatening illnesses and disorders, advocating for the advancement of breakthrough research and technologies in regenerative medicine -- including stem cell research and somatic cell nuclear transfer -- in order to cure disease and alleviate suffering. For more information on CAMR, visit the Web site: http://www.camradvocacy.org

    http://www.usnewswire.com

    Contact: Julie Kimbrough, 646-734-6091, or Maggie Goldberg, 973-379-2690, ext. 115, both of the Coalition for the Advancement of Medical Research

    08/05 10:20

  2. #2
    Good article. Something we should all pay very close attention to.

    Onward and Upward!

  3. #3
    Super Moderator Sue Pendleton's Avatar
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    At 17 lines CAMR is being optimistic IMO. Last I heard from NIH it was 2. No one else would share lines for federally funded research.

  4. #4
    Super Moderator Sue Pendleton's Avatar
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    I was wrong. There are 3.

    Stem Cell Research Not Yet Booming
    Some Scientists Blame Political Controversy

    By Justin Gillis and Rick Weiss
    Washington Post Staff Writers
    Tuesday, August 6, 2002; Page A01


    One year after President Bush told the nation he had resolved one of the toughest dilemmas facing his young administration -- whether the federal government should fund human embryo cell research -- the research boom that scientists hoped would follow has yet to materialize.

    In Bush's televised address on Aug. 9, 2001, and in a news briefing the next day, the president and his top aides said the new policy, allowing limited federal funding, would give scientists access to more than 60 different colonies of precious human embryonic cells. Federally funded studies could probably get underway by the beginning of 2002, the aides said.

    Twelve months later, only three colonies of embryo cells are readily available to researchers. Moreover, despite the field's widely acknowledged medical potential, only nine research laboratories applied for the first round of federal grants -- evidence, some say, of a "chilling effect" from the lingering political controversy over embryo research.

    By contrast, embryo cell research is speeding ahead in several other countries, threatening U.S. dominance in a realm of biology that many believe is poised to revolutionize medicine.

    "I'm absolutely amazed at how little has been accomplished with human embryonic stem cells in this country following the president's announcement last August 9," said Paul Berg, Stanford University Nobel laureate and a critic of the Bush administration's policy. "If you look at what's happening elsewhere, in Australia, Israel and England, you get the feeling that they are rushing into this area of science because they see its promise. But here there's just no evidence of urgency."

    Yet the field is not completely static, and some scientists say they are satisfied with progress under the Bush plan. It takes time to create the apparatus to support an entirely new arena of research, some experts said. And while progress in the past year may have been slow, it is gaining momentum.

    "I think it is up to us to show what we can do with the cells that are available, then we can see if the policy needs to be debated or changed," said Savio Woo, who recently began work with some of the previously off-limits cells at Mount Sinai Medical Center in New York. "The important thing now is for the scientists to deliver the beef."

    Still others see the slow pace as a victory. Bush's compromise may have quieted last year's political fight, but some of his core supporters in the antiabortion movement remain as opposed as ever to the research.

    At issue is work on human embryonic stem cells, a class of cells nestled in the core of microscopic, 5-day-old human embryos. Isolated late in 1998 by privately funded U.S. scientists, the primordial cells have the potential to morph into mature human cells -- making them attractive as raw material from which replacement tissues or organs to treat a host of ailments might be grown.

    The nation's corps of federally funded scientists sought permission to work on the cells, which had been retrieved from spare fertility-clinic embryos slated for disposal. Federal funding is a critical factor in whether a new scientific field moves forward, because basic research in this country is overwhelmingly financed by the federal government. Generally, industry funding kicks in when a field is more advanced and begins to produce experimental treatments.

    Under the Clinton administration, the National Institutes of Health had been moving toward awarding federal research grants for a broad array of embryo cell studies. Bush halted that process and, after months of deliberation, decided to fund research only on cells taken from embryos already destroyed by Aug. 9, 2001, the date he announced the policy to the nation. More than 60 self-regenerating colonies, or "cell lines," had already been derived from such embryos, he declared, saying that was more than enough to give the field a robust launch.

    Scientists were surprised by the high number, the product of private inquiries the administration made of research labs, and Bush's aides were pressed repeatedly on the issue last August. "I would expect that an overwhelming number, and perhaps all, of the existing lines will be available in short order" to the scientific community, Jay Lefkowitz, a top administration lawyer, said last Aug. 10.

    For various reasons, that prediction has proved overly optimistic. A year later, few of the cell lines are actually available to scientists.

    The Sept. 11 terrorist attacks and the subsequent anthrax scare distracted the entire administration. NIH, which had to administer Bush's policy, didn't produce a definitive list of laboratories with approved stem cells until November. And of the first nine applications for grant money to study embryo cells, only "a couple" received funding, said Wendy Baldwin, who oversees the NIH office that is serving as facilitator between federally funded researchers and stem cell suppliers.

    Of the 14 potential suppliers now listed on an NIH registry, only two -- WiCell Research Institute Inc. of Wisconsin and Australian company ES Cell International Pte. Ltd. -- are shipping cells on a regular basis. And they are regularly shipping cells from only three of the 78 colonies that meet Bush's criteria.

    They and a few other laboratories have distributed cells from additional colonies on a limited basis to select collaborators. At least two labs -- BresaGen Inc., an Australian company with operations in Athens, Ga., and the University of California at San Francisco -- are gearing up to ship cells this fall. They are among five outfits, including WiCell and ES Cell, that have received NIH money to hire workers and develop the necessary procedures.

    "These are not the easiest cells in the world to grow," said Allan Robins, chief scientific officer of BresaGen.

    WiCell, of Madison, Wis., is the furthest along in establishing itself as a major supplier. The nonprofit enterprise, affiliated with the University of Wisconsin, handles requests for the five stem cell colonies derived by James Thomson, the UW scientist who discovered human embryonic stem cells in 1998.

    WiCell is focusing on just one of those colonies. As of last week, it had shipped cells to 57 researchers. Including those, WiCell has executed agreements with 90 researchers at 78 institutions in 12 countries, spokesman Andrew Cohn said.

    "We now have a national research project of a scale that is, I think, extremely impressive given the short period of time," said Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, WiCell's parent organization.

    But many scientists say they need to work with an array of cells to ensure progress. That should, in theory, be possible given that the Bush policy covers at least 78 colonies. But for every BresaGen and WiCell that has embraced the role of supplier, there are several other labs showing only halting progress.

    For instance, the biggest single cache of stem cells in the United States that meet the Bush guidelines is a group of nine colonies in San Diego, 12 percent of the world total claimed by the Bush administration. Those cells have been in deep freeze -- literally -- over the past year while two companies battled for control of them. A compromise was struck recently. But Lutz Giebel, chief executive of one of the companies, CyThera Inc., acknowledged that virtually no work has been done on the cells and it would be at least a year before any could be shipped.

    Baldwin said one condition of being included on the NIH registry was an expressed willingness to share information with other scientists. But NIH cannot insist on much more, she said.

    "It's one thing to be willing to work collaboratively with other scientists. It's another thing to say you're willing to be the Amazon.com of stem cells and click here and we'll ship," Baldwin said.

    A senior administration official, who would speak only on condition of anonymity, acknowledged roadblocks, but added that many of them -- including wrangling over patents -- have been outside White House control. He argued that the administration is pushing the policy forward as quickly as it can.

    It's hard to predict how the science will progress in the coming few years. Some scientists say they still have so much fundamental work to do, such as learning to control the development of stem cells and turn them into desirable tissues, that even the few available colonies are sufficient for now.

    "In terms of basic science, it doesn't make a big difference that there are only a few lines available," said Wisconsin's Thomson.

    For research opponents, such as Richard Doerflinger of the U.S. Conference of Catholic Bishops, there are ethical reasons, too, why the slow pace is fine. "It is controversial research and I think rightly so," Doerflinger said. "And it is one factor that scientists and investors do and should take into account." He and other critics note that scientists appear to be making rapid progress developing stem cells derived from adults, which they hope will eliminate the need for embryonic cells.

    Many scientists, though, say both lines of research should go forward because it is still unclear which may work best. They contend the stakes are nothing less than potential cures for Parkinson's disease, diabetes and other ailments. They argue that the lingering opposition is a reminder that, even a year after Bush laid out his policy, stem cell science is still subject to political winds.

    "Normally this would be a situation in which many young people would be diving into this field," said Keith Yamamoto, vice dean for research at the University of California at San Francisco. "We're not seeing that influx. It's clear to me there's been a chilling effect."



    © 2002 The Washington Post Company

  5. #5
    Bush Admin. Loosens Stem Cell Rules

    .c The Associated Press

    WASHINGTON (AP) - In a little-noticed ruling this spring, the Bush administration made it a bit easier for federally funded researchers to use embryonic stem cells that do not meet the president's strict test for federal funding.

    Researchers do not have to set up separate laboratories for research on stem cells that do not qualify for funding, the National Institutes of Health said in March.

    A year ago, President Bush ruled that federal dollars could support limited research using stem cells that are derived from human embryos. It was a controversial matter: The research holds enormous promise to treat and cure disease, but in order to get the cells, days-old human embryos must be destroyed.

    Bush said he would allow federal funding only on stem cell lines that were already in existence on Aug. 9, the night of his nationally televised speech on the issue. That way, he said, the government would not be providing an incentive for researchers to destroy more embryos to gather new stem cells.

    Researchers have always been free, however, to use private dollars to pay for their work. There is no law banning any of this research; the only issue was who pays for it.

    Still, until March, some researchers believed they had to physically separate their work using embryonic stem cells that do not qualify for federal funding from the rest of their taxpayer-subsidized lab work. Some established privately funded, separate laboratories to conduct the stem cell work.

    In March, the administration told researchers that this is not necessary as long as they keep their private money separate from their government funding. In a question-and-answer document, the National Institutes of Health explained that researchers who plan to derive new stem cell lines do not need to work in separate labs.

    ``You may do the derivation in your university supported laboratory as long as: 1) you carefully and consistently allocate all costs of doing the derivation a non-federal funding source; and 2) your university or research center has in place a method of separating the costs of supporting your laboratory so that any of the facilities and administrative (F&A) costs allocable to your new stem cell line work are excluded from the federal share of the organized research cost base,'' the document said.



    08/07/02 10:29 EDT

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