Coalition for the Advancement of Medical Research

Patient Groups Take Stock of State of Stem Cell Research One Year Later

Coalition for the Advancement of Medical Research Calls for President’s Help in Fully Implementing August 9, 2001 Policy on Embryonic Stem Cell Research

“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* 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*, 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 11th , 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 11th 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 website 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 US 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.