5/26/2009 12:00:00 AM

The NIH (National Institutes of Health) has released draft guidelines that present a serious set-back to human embryonic stem cell research.

The “Connecticut Stem Cell Research Advisory Committee” has been working on a response to this problem but many were unaware of this issue until their meeting this past Tuesday.

This is a call to help support the progress made in human embryonic stem cell (ESC) research over the past eight years that could be lost due to the way that the NIH (National Institutes of Health) has presented the draft guidelines. The deadline for comments by the public is Tuesday May 26.

A. The Problem - Why your help is needed immediately:

On March 9, 2009 President Obama lifted former President Bush’s executive order restricting federal support to research with human embryonic stem cell lines created before August 9, 2001. At the same time President Obama charged the National Institutes of Health (the NIH is the primary funding agency for stem cell research) to draft a new set of ethical guidelines for use with an expanded set of cell lines by July 2009.

The NIH has issued its draft guidelines and asks for public comment no later than Tuesday May 26, 2009. Acceptance of the NIH draft guidelines in their present form represents a serious set-back to human embryonic stem cell research and an obstacle to building on past research. This is why your commentary on the NIH draft guidelines is requested no later than Tuesday May 26, 2009.

The draft guidelines are very restrictive. The NIH draft guidelines render ineligible for NIH-funding those stem cell lines formerly eligible under the Bush administration. Continued use of these well-researched lines is important. Also many stem cell lines derived in the United States and other countries after 2001 under standard guidelines would remain ineligible for use with federal money. These cell lines are a valuable resource.

The draft guidelines also restrict eligible lines to those derived from embryos created by IVF (Invitro Fertilization) for reproductive purposes and no longer needed for that purpose. Lines created through the alternative process of parthenogenesis (a technical term for a technique that would take too long to explain) are currently a valuable research tool but not supported by the draft guidelines.

B. Solution – How to Support Human Embryonic Stem Cell Research:

Step 1. Go to the NIH Public Commentary Website:

http://nihoerextra.nih.gov/stem_cells/add.htm (copy and paste to address bar if necessary).

Step 2. Copy and paste the following message, part of the message, or an alternate message no later than Tuesday May 26, 2009:

“I urge the NIH to adopt alternative criteria for the acceptable derivation of stem cell lines that will allow federal money to be used with stem cell lines currently approved for NIH-funding. Eliminating federal support for use of these lines would seriously undermine current research programs. I recommend that the alternative criterion for acceptable derivation be oversight of embryo donation by an Institutional Review Board (IRB) or its equivalent for stem cell lines created before 2009. The IRB should ensure that the informed consent process conformed to accepted regulations and guidelines at the time and place of donation. This alternative IRB criterion for informed consent continues support for current research programs and supports use of an expanded set of valuable stem cell lines.

Also, I support the use of NIH-funds with stem cell lines derived through parthenogenesis as long as they meet standards for ethical derivation. These lines are a valuable research tool."

Additional Comments:

It was also reported at Tuesday’s meeting, of the Advisory Committee, that the opposition that wants Embryonic Stem Cell Research further restricted or at least no changes to the draft guidelines is running far ahead with Inputs to the NIH. Their input may very well sway the NIH to stay with the restrictive version.

The current inputs for restriction are contrary too many polls that were for easing the restrictions that the Bush administration placed on ESC Research. I am quite sure that this contrary vote is being driven by Conservative (Right Wing) Talk Radio.

It is important that the inputs to the NIH are by individuals and not from a group. This apparently is a numbers game by NIH. For example 10 individual comments are worth almost 10 times as much as one comment from a group that carries 10 names.

Last, please forward this to people / organizations that you know, across the country for broader support as my distribution list is primarily geared to Ct. and Mass. (I know it is late in the game)

Thanks Dave Menaker

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