Taylor-Weiner & Zivin. Medicine's Wild West — Unlicensed Stem-Cell Clinics in the United States. N Engl J Med 2015; 373:985-987.
Excerpts:
..... Although stem-cell therapy may hold great potential, the field is less advanced than the public has been led to believe. Stem-cell clinics in the United States and abroad have capitalized on this confusion by selling treatments that are not approved by the Food and Drug Administration (FDA), supported by clinical studies, or covered by insurers.....
..... The FDA has approved few treatments involving stem cells. The approved therapies use hematopoietic stem cells to treat diseases of the blood and immune system....
...... Since insurers don't cover unapproved stem-cell treatments, patients pay out of pocket for procedures that cost anywhere from $5,000 to $50,000....
..... Apart from directly harming patients, the activities of unlicensed clinics could hinder advances in the stem-cell field, if a tragedy resulting from unapproved treatment makes the public and regulators suspicious of stem-cell technologies in general......
....... In recent years, the FDA has issued warning letters and audited some stem-cell clinics to enforce the rules for stem-cell treatments .......
...... Although it's difficult to determine the number of unlicensed stem-cell clinics in the United States, there are strong indications that the FDA's actions to date are insufficient to enforce its regulations. ......
....... New policies are clearly needed to prevent for-profit human experimentation and protect patients......
....... The FDA can address the proliferation of clinics selling unapproved treatments by first establishing clear guidelines defining what procedures physicians may not perform in the absence of regulatory oversight. Then the agency may need to change its procedures for identifying and penalizing clinics that are out of compliance......
...... The FDA might increase its enforcement capabilities by coordinating with state medical boards, which have authority to revoke the licenses of physicians performing these procedures. By sharing the results of its investigations, the FDA could make it easier for these boards to penalize doctors who are defrauding patients. The added risk of an audit by a medical board might even be enough to discourage many physicians from offering unapproved procedures in the first place......
...... The Federal Trade Commission (FTC) may also be able to help reduce the misinformation in stem-cell-clinic advertising. Although clinic websites say the therapies are not FDA-approved and not proven to be effective, they suggest the procedures are based in scientific research and that there's hope for curative outcomes.....
....... In other health care areas, the FTC has worked in coordination with the FDA to combat such deceptive advertising — for example, filing complaints challenging claims made by the supplement industry...... In regulating dietary supplements, the FTC has extensive guidelines regarding the amount and quality of evidence that must be collected before a claim can be advertised. It may be able to write similar guidelines requiring stem-cell clinics to consider the totality of the evidence, rather than individual studies, before making claims about a treatment's chances of success......