9/8/00

Stem Cell Update - Hearing

For your information, following is an account (from the American Society of Cell Biology) of today's Senate hearing on the NIH Stem Cell Guidelines. The hearing was basically a rehash of issues that have been aired in previous hearings on the topic of pluripotent stem cell research. Another hearing is planned for next Thursday and will feature celebrity panelists such as Michael J. Fox.

This morning the Senate Labor, Health & Human Services and Educations Appropriations Subcommittee held its sixth hearing on stem cell research. The intended focus of the hearing was the recently released NIH Guidelines for Research Involving Human Pluripotent Stem Cells. In fact, most of the hearing was a rehash of the debate over whether or not we need to work with embryonic stem cells. While not much new ground was covered, Senator Specter (R-PA) did reiterate his intention to move his bill S. 2015.

Senator Specter opened the hearing by giving a sense of the political history on the stem cell issue. He feels that although the NIH guidelines do allow for embryonic stem cell research under the current law, they are still too restrictive. He also took issue with the notion that adult stem cells are a sufficient alternative source for researchers. Specter reiterated the agreement he reached with Majority Leader Lott last year to bring this issue to the floor of the Senate. He feels the Subcommittee has laid the groundwork for a floor debate on his bill. He ended by stating his belief that stem cells may be a veritable fountain of youth.

Senator Harkin (D-IA) expressed his support for the NIH guidelines and said he thought their release was a "critical step forward towards improving the lives of millions." He equated stem cells to smart bombs used in the Gulf War and said that like our military we ought to put significant resources into this line of research.

Gerald Fischbach, M.D., Director of the National Institute of Neurological Disorders and Stroke was the first witness. He restated that the intent of the NIH guidelines was to ensure that stem cell research is conducted in a legal and ethical manner. He called the discovery of embryonic stem cells the most exciting of his career. He feels that embryonic cells have two properties that make them so important: 1) they can be used to create a large supply of particular cells and 2) they can be forced to differentiate into particular types of cells. As a nonscientist, his hope is to use these cells for transplantation purposes. Currently neural cells cannot regenerate, but stem cells may be able to do so. He ended by saying that much more work needs to be done on all types of stem cells, but he believes that embryonic cells have the greatest promise.

Allen M. Spiegel, M.D., Director of the National Institute of Diabetes and Digestive and Kidney Diseases was the next witness. He stressed the importance of the ethical oversight that the guidelines would provide. The guidelines spell out the assurances that the cells will be obtained from IVF [in vitro fertilization] embryos that are in excess of clinical
need. He feels the best example of how these cells will be used is the possible treatment of Type I diabetes. He mentioned the recent work in Canada transplanting islet cells from cadaver pancreases, but explained that there would not be enough cells from that source. Embryonic stem cells could instead be used to create a sufficient number of islet cells, the demand for which will grow exponentially. He stated that "now we may be able to fund research which may lead to a cure."

Specter asked Drs. Fischbach and Spiegel how many patients might be impacted by stem cell research if it is successful. After some back and forth, Sen. Harkin pulled out a chart showing the numbers of patients diagnosed with various disease which led the Senator to say this research has the potential to impact 128 million people nationwide. He asked the two NIH Directors about the viability of adult stem cell research, and they both said that line of research should be pursued, but not exclusively. With his questions, Harkin made the point that many federally funded scientists had been waiting to conduct embryonic stem
cell research, and that the private sector has already been moving forward with this research.

The second panel featured David Prentice, Ph.D, Professor of Life Sciences of the University of Indiana and Micheline M. Mathews-Roth, M.D., Associate Professor of Medicine at Harvard (though she made it clear she was not there on behalf of Harvard). Prentice was a strong witness, focusing his testimony on why embryonic stem cell research is unnecessary. He is clearly opposed to embryonic stem cell research because he feels that one should not end a life to cure another. Based on the recent scientific literature, he feels that research on adult stem cells will suffice and thinks there may be real problems with immunological rejection of embryonic stem cells. Mathews-Roth was not as strong a witness, and covered much of the same ground. She showed a graphic of a stem cell saying that she did not think a small human even at this stage should be killed for research purposes. She emphasized adult stem cells and called on scientists to use spontaneous abortions for this research. (It has been shown that not only are stem cells from spontaneous abortions very difficult to obtain, they usually are not a viable source because they had a defect of some kind causing the miscarriage). Mathews-Roth came off as an antiabortion foe [sic] and was not very compelling.

The hearing heated up a bit when Specter began asking questions of the second panel. He focused in on Mathews-Roth's willingness to use fetal tissue. He skipped over the clarification that that the tissue would be from spontaneous abortions. He also tried to pin both witnesses down on what they would do with the embryos that would be discarded anyway. Prentice said he thought an adoption system for excess embryos should be
developed, but when pressed, didn't know how that would work. Mathews-Roth and Prentice do not think embryonic cells should be used in any way despite the fact that they will be discarded, because it would be deliberately killing them.

In a somewhat unusual event Specter then asked Speigel and Fishbach to come back up to the table with Prentice and Mathews-Roth so they could respond to their adult stem cell claims. Prentice reiterated several recent adult stem cell studies. Fishbach and Spegiel said again that both types of research should continue, but that no adult stem cell research has showed enough results to convince them that embryonic stem cell research should not be pursued simultaneously. Specter gave each of them one final statement. Prentice made an odd addition at this point saying that "this is not a scientific question", but a question of ethics. Fishbach got the last word saying that these are exciting times in the field of research and that he felt the NIH Guidelines allow this important research to move forward under strict regulation.

8/4/00

APHIS Proposed Rule on inspection, licensing and procurement of animals

In today's Federal Register (65 FR 47908-18), the U.S. Department of Agriculture (USDA) Animal and Plant Inspection Service (APHIS) published an Advanced Notice of Proposed Rulemaking regarding inspections, licensing, and procurement of animals. APHIS is proposing to amend the Animal Welfare Act regulations (9 CFR Parts 1 and 2) to revise and clarify exemptions from the licensing requirements, the procedures for license applications and renewals, and restrictions upon the acquisition of dogs, cats, and other animals. APHIS is seeking public comments until October 3, 2000.

NABR (National Association for Biomedical Research) is currently analyzing this proposed rule change, and will report in detail how such changes could affect NABR members. NABR members are encouraged to review this proposed rule, and provide us with your comments and recommendations. For more information, please contact Barbara Rich.

6/20/00

Electronic Signatures Conference Report Approved

The California Institute for Federal Policy Research, California Capitol Hill Bulletin Volume 7, Bulletin 20--June 15, 2000 www.calinst.org

After months of negotiations between industry and consumer groups, the House gave overwhelming approval to the conference report to accompany S. 761, the Electronic Signatures in Global and National Commerce Act (ESIGN)," on Wednesday, June 14 by a vote of 426-4. All of the California congressional delegation supported the bill. The Act, which the President has indicated he will sign, gives the same validity to contracts executed electronically by so-called "electronic signatures" as to written ones. It is expected to make business-to-business and business-to-consumer transactions easier and more efficient.

The negotiations over the last few months, however, have centered on providing adequate consumer protections. The final language, for instance, requires specific consent from consumers to receive notices electronically and requires that notice of cancellation of utility services, health and life insurance, and mortgages may not be executed electronically. The bill also allows federal and state regulatory agencies to continue to require written filings of records if there is a compelling government interest. In most instances, however, the bill is intended to pre-empt state law and establish national standards for the validity of electronic signatures.

The Senate is expected to pass the bill and send it to the President shortly. The Conference Report can be obtained on the House Commerce Committee's web site at: www.house.gov/commerce.

House Judiciary Examines Webcasting of Copyrighted Material

The California Institute for Federal Policy Research, California Capitol Hill Bulletin Volume 7, Bulletin 20--June 15, 2000 www.calinst.org

The House Judiciary Subcommittee on Courts and Intellectual Property held a hearing on Thursday, June 15 to examine the issues surrounding the webcasting of copyrighted material. In his opening statement, Chair Howard Coble (NC) stated the goal of the hearing was to see how programming was being streamed to the public currently, and the impact that is having on copyright laws.

Mr. Jack Valenti, Chairman and Chief Executive Officer, Motion Picture Association of America, testified that individuals and organizations in the sports and entertainment industries have formed "The Copyright Assembly" because of their concerns over the future of creative works "in a digital world where theft is easy, protection hard to come by, and too many people are seemingly unaware that stealing is wrong." Mr. Valenti pointed out that intellectual property comprised 6.5% of the nation's Gross Domestic Product ($530 Billion) in 1997 and generates about $67 billion annually in international revenues, and produces new jobs at three times the annual rate of the economy as a whole. He urged the Committee to put intellectual property rights at the top of its agenda as it considers public policy issues related to new
technological advancements.

Ms. Hilary Rosen, President of the Recording Industry Association of America, also testified. She detailed some of the ways in which the industry is responding to webcasting of sound recordings, such as negotiating licenses with webcasters and working with them to develop more personalized programming for individuals. The challenges continue to remain substantial, however, according to Ms. Rosen, because no industry-wide standards have been developed as yet to guide the process. Nevertheless, she believes that the marketplace is working and the current course of action, negotiating with webcasters, is the correct one.

For the testimony of all the witnesses, click on the Committee's web site at www.house.gov/judiciary.

Mail Dina Pecceu with questions about Regulatory Reform. Last modified: September 11, 2000