Desperate patients need help separating legitimate researchers from quacks, said representatives the biggest organization for stem cell researchers, who announced that they’d decided to draft guidelines for how basic research on stem cells can be responsibly “translated” to research on human patients. The guidelines will cover embryonic stem cells plus those collected from cord blood and adults, as well as stem cells induced from differentiated cells.
At a press conference in Half Moon Bay, California, a panel of highly influential officials and researchers in stem cell science said they were alarmed at “medical tourism” in pursuit of questionable and potentially harmful stem cell procedures. The only established stem-cell treatments are for a handful of blood diseases, they said, but advertisers promise cures for every imaginable disease. Story Landis, head of the National Institute of Neurological Disorders and Stroke and George Daley, president of the International Society for Stem cell Research said their organizations were besieged by patient queries about treatments whose risks and benefits are unknown. The ISSCR plans to produce guidelines to help such patients and their families assess whether practitioners’ claims are credible.
“It’s clear from those letters that there’s desperation with a complete lack of sophistication” in the ability to assess procedures, said Landis, head of the NIH Stem Cell Task Force. “Without that people will do things that are not in their own best interest.” Patients don’t know (or necessarily care) about established standards for clinical research, particularly that patients are rarely asked to pay for experimental procedures, and that they must be adequately informed of potential risks and benefits and the questions a trial will answer.
Patient desperation is “an invitation for exploitation,” said Daley, president of ISSCR and an associate professor at Harvard University, adding that one has to be very suspicious when asked to pay thousands of dollars to pay for treatments thousands of miles away. Patients should be asking questions such as whether researchers are affiliated with established medical centers and have published in scientific journals.
(Coincidentally, NPR recently aired a show on this very topic: American patients traveling to China for procedures that are not legal in the United States.)
Patients should also ask what evidence has been collected in animal models. Landis said that the NINDS put together a preclinical strategy to assess treatments that were getting a lot of general press. For example, some patients with spinal cord injury have had their sites of injury stuffed with tissue removed from behind the nose (which generates neuron-like cells used to smell). Landis said that of three “hyped strategies” submitted to this evaluation, none were borne out in animal models.
The panel also said that the guidelines could also help practitioners. Some desperate patients will always take huge risks in search of treatments, Olle Lindvall, chair of the task force that will draw up the guidelines and a professor of clinical neurology at University Hospital in Lund, Sweden. The guidelines are not intended to prevent clinical research but to guide researchers who are working toward clinical research “in a serious way” he said.
Panelists admitted that drafting the guidelines would require a balancing act to promote valid research. Some scientists are also worried about legal liabilities if they point fingers at specific procedures or institutions.
No one commented when asked on whether ISSCR members would be required to adhere to the guidelines once drafted. “We have yet to decide how to put teeth in the guidelines,” Daley said, adding that when his organization drafted ethical guidance for how pluripotent stem cells and embryos could be used in the laboratory, the organization asked scientific journals not to publish articles on research that didn’t comply.
Daley said that ISSCR does not have the mandate or the infrastructure to approve every clinical trial or procedure involving stem cells. The more-immediate goal is to educate patients so that they are not preyed upon. “The real message is caveat emptor,” he said. “We want to provide the sort of information so that people can come to their own judgements.”
A draft of the guidelines for clinical translation will be made available this June at the society’s annual meeting, and a final version is expected at the end of the year.
Regional stem cell organizations are also taking up this mandate. Though risks to patients are minimal, stem cell banks have come under similar criticism.