Schumer, Clinton Urge VA To Implement Cutting-Edge Genetic Research Program At Ualbany - Program Would Make Capital Region A National Center In Biotech

In a letter to Department of Veterans' Affairs Secretary Nicholson, Senators Charles E. Schumer and Hillary Rodham Clinton today called on the VA to act on a previously agreedupon genebank program at the University at Albany's Center for Functional Genomics. The program, originally delineated in a contract signed by University of Albany and the VA in December of 2003, would establish a biorepository of blood samples for genomic and proteomic analyses. Since the 2003 agreement, despite several requests by University of Albany to have the program implemented, the Department of Veterans' Affairs has failed to act.

 

"It is absolutely ridiculous that this innovative and jobcreating program has been stalled for so long" said Schumer. "This project has the potential of not only accelerating the identification of genetic linkages to diseases and the development of new therapies, but also of significantly enhancing the medical research program at the VA and creating jobs in the Capital Region. I will continue to fight tooth and nail for its immediate implementation."

 

"New York State, SUNY Albany and the scientists involved have been working for the last four years to get this important project underway.  It is time for the VA to do the same and allow for this critical research to commence.  According to SUNY Albany, this project would represent the most comprehensive genebank in the United States. Continued delay by the VA risks having the United States advancement in biotech lag behind the world scientific community," said Senator Clinton.

 

[A copy of the letter sent to Secretary Nicholson follows]

 

Dear Secretary Nicholson:

 

We write to request your assistance with the implementation of a genebank program, which, as we understand it, would establish a biorepository of blood samples for genomic and proteomic analyses, and which was reportedly delineated in a contract signed by the Research Foundation of the State University of New York on behalf of the University at Albany and Department of Veterans' Affairs (VA) in December 2003.  According to the University at Albany, the genebank has been held in abeyance by the VA since that time, despite their anticipation that the program would begin shortly after the signing of the 2003 agreement. 

 

According to the University at Albany, in 2002, Dr. Paulette McCormick, a researcher at the University at Albany, and at that time the Director of Genomic Research for the Stratton VA Medical Center, submitted an executive summary proposal to the VA Central Office of Research and Development (ORD) in Washington, D.C.  After review by the Office of Research and Development, we are told, Dr. McCormick was asked to submit a full application, which she did in collaboration with senior staff at the Stratton Medical Center and VA VISN2 in April 2003. 

 

We have been informed that this agreement would authorize VA medical centers to begin to collect blood samples through an informed consent process, to remove identifying information about the donors, and then to send the samples to the University at Albany's Center for Functional Genomics for analysis.  The University at Albany would then provide DNA analysis of these samples to medical researchers focusing on VA approved medical research.  The University at Albany believes that this project holds the potential of not only accelerating the identification of genetic linkages to diseases and the development of new therapies, but also of enhancing significantly the medical research program at the VA and creating jobs in upstate New York through the establishment of a cluster of new research and manufacturing companies in the life sciences.  

 

The University at Albany has informed us that despite repeated requests to begin implementation of this project, the VA has not permitted it to do so.  The University at Albany believes that it has complied with all of terms of both the 2002 Cooperative Technology Administration Agreement (CTAA) and the 2003 Genebank Agreement, including by:

 

• Submitting semiannual reports to the VA;

• Receiving approval for HIPAA and Informed Consent protocols from the Stratton VA's Medical Research and Development Committee and Institutional Review Board;

• Receiving a Certificate of Confidentiality from the National Institute of Health; and

• Receiving approval from the VA Biomedical Laboratory Research and Development Service for the banking of blood samples and associated clinical data.

Additionally, it is our understanding that New York State has committed up to $10 million for start up costs associated with the genebank project and secure space has been reserved at the Cancer Center at the University at Albany for the effort. 

 

According to the University at Albany's, while they have made repeated requests to commence the project as well as complied with all existing agreements, the Department has not fully implemented this partnership.  In fact, the University at Albany has expressed concern that the Department may be using the concepts developed by Dr. McCormick to establish a gene bank in another location.  The ability to identify medically relevant genetic sequences from large populations could help ensure that many cutting edge initiatives in medical research will progress more rapidly. Given the advanced nature of the agreement between the VA and the University at Albany, we urge you to resolve the issues regarding implementation of the genebank program at the University at Albany, in short order.

 

Thank you for your consideration.  We look forward to hearing back from you. 

 

Sincerely,

Charles E. Schumer

Hillary Rodham Clinton