By Todd Neale, Staff Writer, MedPage Today
Published: July 01, 2010
Patients seeking stem cell treatments for various conditions now have an online resource to help them evaluate the claims of clinics and companies around the world.
The recently launched website -- http://www.closerlookatstemcells.org/ -- set up by the International Society for Stem Cell Research (ISSCR), provides information about stem cell biology as well as questions to ask clinics offering these often-experimental treatments.
The site will eventually contain a list of clinics that did -- or did not -- provide information to the ISSCR on issues such as whether a medical ethics committee is involved in a treatment to protect patients' rights, or whether there is oversight from a regulatory body like the FDA or the European Medicines Agency.
The website is the brainchild of a task force convened by Irving Weissman, MD, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine in California, during his tenure as president of the ISSCR, which ended earlier this month.
Reporting in the July 2 issue of Cell Stem Cell, members of the task force -- researchers, clinicians, ethicists, jurists, and patient advocates -- said they have become increasingly aware of misleading direct-to-consumer advertising touting expensive stem cell therapies.
Exploiting patients' hopes and fears, these ads often make exaggerated claims of efficacy, underestimate the potential risks, fail to disclose methods, and leave out information on whether the treatment is conducted with regulatory oversight, according to the authors.
"These so-called therapies therefore fail to meet minimum ethical, scientific, and medical standards that such oversight entails, including appropriate support through preclinical data; commensurability of risks and benefits; phased, structured assessment of safety, efficacy, dosing, or appropriate administration; and independently assessed and approved informed consent," Weissman and his colleagues wrote.
They said such unethical marketing "could place individual patients at risk and also jeopardize the progress of legitimate stem cell clinical translation."
The website set up by the ISSCR aims to give patients and their physicians the information needed to assess clinics' claims and decide whether to proceed with treatment.
Using a brief form, patients are able to submit websites for investigation by the ISSCR. The results of the inquiries will be posted on the ISSCR website.
According to the task force, any of the clinics investigated by the group should be able to provide evidence of adherence to a translational pathway from basic science to clinical applications.
For treatments deemed experimental or innovative -- and thus not needing a history of clinical testing in humans -- there will be the following note on the ISSCR website accompanying a clinic listing: "The position of the ISSCR Task Force is that the provision of an untested experimental or innovative therapy to more than two participants is a departure from recommended practice and should be tested in a regulated and authorized clinical trial prior to being offered for sale."
Weismann is a co-founder and director of StemCells Inc. and owns more than $10,000 stock in Amgen for services on their scientific advisory board from 1981 to 1988. His co-authors reported relationships with iPierian, Cellerant Therapeutics, and Tacere Therapeutics.
Primary source: Cell Stem Cell
Source reference:
Taylor P, et al "Patients beware: commercialized stem cell treatments on the web" Cell Stem Cell 2010; 7: 43-49.
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