Spotlight

CLS Releases Public Statement on Stem Cell Ruling

Today, Dr. Keith Yamamoto, Chair of the Coalition for the Life Sciences, issued a strong statement in response to Federal District Court Judge Royce Lamberth’s preliminary injunction blocking President Obama’s 2009 executive order expanding funding for human embryonic

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Legislative Alerts

Comments Needed on NIH Stem Cell Guidelines

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In March, President Obama issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research. NIH released its draft guidelines, and the public now has a short opportunity to comment on them.

NIH will review the content, as well as the volume/number, of the comments it receives as it drafts the final guidelines.

It is critical that the NIH hear from members of the scientific community during the comment period, because the opponents of stem cell research will submit tens of thousands of negative comments.

Please follow the instructions below to submit your comments to ensure that the final guidelines are crafted in a way that allows federally funded scientific research to proceed without undue impediments.

How to submit your comments:

Click here to access the NIH comment form.

Provide your name and select "self" for "Affiliation."

Insert comments into the comment box, provide the security check ID on the form, and click "submit comments."

You may wish to consider the following sample comments as you compose your remarks. This is very similar to the letter the ASCB submitted to the NIH. If your time is limited so that you cannot write original comments, please submit this material rather than no comments at all.

Sample text:

Two critical changes need to be made to the current draft guidelines. First, I believe that a major flaw exists in section II. B, "Eligibility of Human Embryonic Stem cells for Use in Research". While this section provides a reasonable standard for the eligibility of human embryonic stem cell lines derived in the future, it does not recognize the existence of hundreds of stem cell lines currently in use in research labs across the United States. While these existing lines were derived according to the most ethical standards recognized at the time of derivation, they may not meet in every detail the new, more rigorous standards set forth in the NIH draft guidelines. To prohibit their eligibility for federal funds under this new policy would do great harm to the field of stem cell research. Federally funded researchers would be forced to stop their work and wait for a yet unknown number of new embryonic stem cells that comply with the new NIH guidelines to be derived. Such a halt to research would be detrimental to the scientific community's progress and devastating to patients around the world who might benefit from this important research.

Therefore, I urge the NIH to include a provision within Section II to allow human embryonic stem cell lines previously and ethically derived to be eligible for use in federally funded research under these guidelines. Instead of requiring previously derived cell lines to comply with either the National Academy of Sciences (NAS) guidelines or the guidelines by the International Society of Stem Cell Research (ISSCR), I ask the NIH to consider a different standard. I recommend that the final guidelines allow NIH funding for any lines derived prior to the implementation of the new policy that had been derived: a) with informed consent, b) without undue inducement, and c) with oversight by an ethics advisory committee, such as an Institutional Review Board.

Second, I also urge the replacement of section II C, "Prior to the Use of NIH Funds". The requirement that each recipient of federal funds ensure the compliance of the cell lines to be used would be administratively burdensome and unnecessarily restrict research. Under the draft guidelines, each investigator who wishes to use a cell line in his or her research must provide assurances that the cell line complies with the NIH Guidelines. This repeated reauthorization of the same cell lines seems unnecessary. It is also possible that different institutions might judge the eligibility of the same cell line differently. This lack of uniformity threatens the free flow of scientific investigation.

To avoid bureaucratic and legal confusion, I ask the NIH to establish an NIH registry of human embryonic stem cell lines available for federally funded research. When a cell line is first used in federally funded research, assurance documentation should be submitted to an NIH-run registry. The registry would allow researchers to review the cell lines that meet the NIH guidelines and then apply to use those stem cells lines.

 

Dr. Martin Chalfie, Nobel Laureate, Presents on Groundbreaking Research at CRBC Briefing

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Molecules to Spy on Cells

The Coalition for the Life Sciences (CLS) was honored to welcome Nobel Laureate Dr. Martin Chalfie as he presented on his ground breaking research during a Congressional Biomedical Research Caucus Briefing on Capitol Hill on May 20, 2009.

Dr. Chalfie is the William R. Kenan, Jr., Professor of Biological Sciences at Columbia University, where he is also chair of the Department of Biological Sciences. He shared the 2008 Nobel Prize in Chemistry with Osamu Shimomura and Roger Y. Tsien for the discovery and development of the green fluorescent protein, GFP.

Dr. Chalfie’s discussion, Molecules to Spy on Cells, highlighted his prize-winning research. He and colleagues revolutionized how scientists study the mechanics of cells by getting a visual fix on how organs function. GFP is a small, inert, and relatively nontoxic molecule, easily diffused through living tissue. Researchers now have the ability to follow various cells with the help of GFP. They can study nerve cell damage during Alzheimer's disease, how insulin-producing beta cells are created in the pancreas of a growing embryo, or how cancer cells spread. In one spectacular experiment, researchers succeeded in tagging different nerve cells with a kaleidoscope of colors in the brain of a mouse.

The Congressional Biomedical Research Caucus provides a forum where Members and staff can interact directly with preeminent researchers responsible for important scientific discoveries. Many of the stunning advances, made possible by NIH funding, highlighted in these presentations have led to improved understanding of the cause, treatment, and prevention of human disease.

 

Kathleen Sibelius Confirmed as Head of HHS

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Kansas Governor Kathleen Sebelius has been confirmed by the Senate to be the next head of the Department of Health and Human Services (DHHS).

The DHHS was the last unfilled cabinet-level secretary position, in part because Obama's first choice for HHS chief, former Senate Majority Leader Tom Daschle (D-SD), withdrew from consideration on February 3rd amid controversy over tens of thousands of dollars in federal income taxes that he failed to pay on time.

DHHS is arguably one of the more important departments in the federal government. The DHHS critical mission includes protecting our nation’s health and providing essential human services. In addition, it oversees such agencies as the Food and Drug Administration, Centers for Disease Control, Centers for Medicare and Medicaid Services, and of course the National Institutes of Health.

 
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