Clinics offering stem cell “treatments” often use advertising and other materials that almost certainly will confuse patients, according to a new guidance on informed consent for stem cell-based interventions.1
“Longstanding therapies, clinical trial interventions, and wholly novel and as-yet-untested interventions are all discussed in the same few paragraphs,” says R. Alta Charo, JD, a member of the International Society for Stem Cell Research (ISSCR) task force that developed the guidance.
According to Charo, patients need to understand what is offered, whether a governmental authority has asserted its legislative right to regulate, and whether the intervention has complied with all applicable regulations. Further, patients need to understand the risks of adverse effects (and where those data come from), the probability of good outcomes (and of which type) and where that prediction comes from, and if the clinic personnel are medically qualified. Also, patients need to know their options for alternative treatments or enrollment in clinical trials.
“The FDA has recently increased its enforcement efforts and its success in the courts when clinics attempted to challenge FDA’s regulatory authority,” says Charo, professor of law and bioethics at the University of Wisconsin.
It is important to distinguish between stem cell therapies that have been shown to be beneficial and sufficiently safe and those that still are experimental, says Philip M. Rosoff, MD, MA, professor emeritus of pediatrics and medicine at Duke University and former chair of Duke Hospital’s ethics committee.
For example, some kinds of bone marrow transplantation for relapsed leukemia now are considered to be the standard of care. “This does not mean that informed consent is not required, simply that the additional features demanded by human investigation are not needed,” Rosoff cautions.
The level of information and the manner in which it is presented can be problematic, regardless of whether the proposed therapy is under investigation in a clinical trial or is standard treatment. “However, the former at least has the assurance of IRB oversight. The latter is pretty much unregulated,” adds Rosoff, noting that an apt analogy is the use of “off-label” drugs given for non-FDA-approved indications.
As it stands now, if stem cells are removed from a person’s body and then put back in the same person, there is scant regulation over what can be done to them. “The FDA finally seems to be aware of the problem after a number of patients have been injured or died as a result of these unregulated clinics,” Rosoff says.2
The ethical concerns, says Rosoff, “are similar to those situations where vulnerable, desperate persons are being taken in by hucksters and crooks.”
Charo says that the ISSCR guidance was published “in the hope that clinics not yet subjected to FDA scrutiny will nonetheless think it is good medical practice to ensure patient consent is truly informed.”
If the clinics fail to do this, says Charo, the paper’s description of what constitutes good informed consent can serve as a benchmark against which state medical societies can evaluate disciplinary actions. “Judges and juries can measure the behavior of any clinic that is sued for malpractice,” Charo says.