Irving Wesissman, M.D., is a physician scientist who directs Standord's Institute of Stem Cell Biology and Regenerative Medicine. This is a major stem cell program and Weissman is therefore a major figure in stem cell research. He recently became president of the International Society for Stem Cell Research (ISSCR) an independent, nonprofit that promotes the field and offers professional and public education in all areas of stem cell research and application.
Weissman promises an activist term as president, urging vigorous research but tempered with reality. One area he plans to tackle is the spread of stem cell clinics overseas. At his urging, ISSCR formed a new committee, Task Force on Unproven Stem Cell Therapies.
Here's what he told the journal Nature recently:
"I can't tell you how many phone calls and letters I get every week that start of with "I have blank untreatable condition and I'm going to blank for stem cell therapies. Tell me it's okay.' And of course I can't tell them it's okay. It's time to have a professional body do it.
Weissman urges that ISSCR publish a 'blacklist' of rogue stem cell treatments
" ... we need to list unproven therapies. To do so we need to get from the practitioners of potentially unproven therapies a statement that would allow anyone to look at the peer-reviewed papers from independent investigators that give the evidence that the putative stem cell therapy should work for the disease specified. If they lack peer-reviewed demonstrations of the discovery behind the therapies and IRB and FDA-type approvals, I would recommend that they be put on a list of unproven therapies."
Herewith the requirements, once again:
(1) The provider or clinic must be able to send peer-reviewed papers from independent practitioners that establish the therapy as possible.
(2) The provider must send evidence of approval from an independent committee, such as an institutional review board (a document from the clinical entity where the therapy is being practiced that shows the steps taken to protect the patient and justifying the experimental or approved therapy for their specific disease).
(3) The provider must send a document from an agency equivalent to the Food and Drug Administration showing the approval of the experiment or the therapy for human subjects with their disease.
Says Weissman, without all three, patients "must assume they are receiving an unproven therapy and that [he or she] is in danger of risking their life or health, of losing their money, of being away needlessly from home, family, and friends, and of course, of not being therapeutically improved."
An international task force of physicians, lawyers and advocates has been formed at ISSCR to deal with the blacklist idea:
Chair: Patrick Taylor, JD
Children's Hospital Boston;
Roger A. Barker, PhD, MRCP
Cambridge Centre for Brain Repair;
Elena Cattaneo, PhD
Univ of Milano Dept of Pharmacological Sciences;
Alan Colman, PhD
Singapore Stem Cell Consortium;
Hongkui Deng, PhD
Peking University;
Harold S.H. Edgar, JD
Columbia Law School;
Claude Gerstle, MD
Ophthalmologist and Advocate;
Lawrence S.B. Goldstein, PhD
University of California San Diego;
Andrew Lyall,
Stem Cell Network;
Fernando Pitossi, PhD
Leloir Institute;
Douglas A. Sipp,
Riken Center for Developmental Biology;
Alok Srivastava, MD, FRACP, FRCPA
Christian Medical College;
Susan Stayn, JD
Stanford University;
Gary Steinberg, MD, PhD
Stanford School of Medicine;
Amy Wagers, PhD,
Joslin Diabetes Center;
Irving L. Weissman, MD - Ex Officio Member,
Stanford University.
Mad
