Lawsuit Highlights State Role in Regulating Regenerative Medicine

New York Attorney General Letitia James (D) filed a lawsuit in early April against a Manhattan clinic and its managing doctor for allegedly engaging in fraudulent and illegal advertising, accusing them of deceiving “New Yorkers into paying thousands of dollars for unproven and potentially harmful stem cell procedures.”

The clinic advertised that it could use patients’ own stem cells to treat conditions such as urologic illnesses, erectile dysfunction, neurological disorders such as Parkinson’s and Lou Gehrig’s disease, and orthopedic conditions—claims with “no adequate scientific substantiation,” according to the attorney general’s complaint. In court filings, the clinic has denied any wrongdoing.

Although the federal government has primary jurisdiction over medical products and clinical research, state governments play a complementary role in protecting residents from being injured or defrauded by unscrupulous businesses selling unproven medical interventions. Many of these businesses appear to be trying to capitalize on the legitimate promise of regenerative medicine—a field that includes stem cells, bioengineered tissues, and gene therapies—by offering potentially dangerous and often expensive interventions. Typically, these products are not covered by insurance and have not been proved to work in rigorous clinical trials. As of 2016, at least 21 clinics were advertising such interventions in New York state, with 14 in New York City.

Attorneys general in 2 states have stepped in to protect patients

The New York suit seeks an injunction to stop the Manhattan clinic from marketing its treatments, which the complaint says start at $3,995 per procedure. “Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral,” James said in a statement, pledging to continue investigating clinics that “shamelessly add to the suffering of these consumers.”

Last year, the North Dakota attorney general’s Consumer Protection Division launched an investigation into allegedly misleading claims made by a clinic in that state and the clinic’s failure to disclose possible negative consequences to patients. The attorney general’s office did not pursue a formal filing at that time, saying that the clinic had fully cooperated with the state’s investigation, stopped offering stem cell injections not approved by the Food and Drug Administration, and provided refunds to patients. This spring, however, ProPublica, the investigative journalism nonprofit, reported that the clinic’s website said it would resume offering stem cell treatments “soon” and that the attorney general’s office was reviewing the matter.

Legislatures have acted to strengthen oversight

State attorneys general are not the only authorities taking action. Lawmakers in California and Washington have enacted measures  that require providers to alert patients that the stem cell interventions they are receiving are not approved by FDA. California is considering legislation to establish a committee within the state Department of Public Health to recommend ways to better regulate the more than 115 clinics operating in the state.

Lawmakers in Florida,  home to at least 104 clinics, have introduced but not yet acted on two measures aimed at tightening oversight of stem cell clinics. The most recent would make it illegal to purchase or sell stem cells, among other provisions aimed at reforming regulation.  

Not all state legislation under consideration would strengthen oversight. In 2017, lawmakers in Texas passed a bill that allows patients to access unapproved stem cell therapies outside of the FDA regulatory process; Alabama is considering comparable legislation. These measures are similar in several key respects to the federal Right to Try Act signed last year by President Donald Trump. However, it is unclear if such laws would withstand challenge in court, as they are in conflict with federal statutes governing clinical research and patient access to experimental therapies. 

The role of state medical boards

State medical licensing boards also can help ensure that clinics operate within the boundaries of the law and that patients are protected from fraudulent or dangerous interventions. Last May, the Federation of State Medical Boards published best practices for regulating physicians’ use of regenerative therapies and recommended actions that state boards can take to ensure that providers are not exposing patients to undue risk. At least one state board has since taken steps to enhance oversight: In November, the California medical board announced formation of a task force to investigate claims made by stem cell providers in the state.

State boards also can use national databases established by the Department of Health and Human Services and the Federation of State Medical Boards that track information about providers, including past malpractice suits and formal complaints against them. These databases were established to facilitate the background checks that state boards are supposed to conduct as part of their licensure process. However, a recent investigation found that state medical boards vary substantially in how often they consult these data sources. Only a dozen—out of 63 boards nationwide—have subscribed to receive regular updates on the providers they license.

Despite the concerns, various regenerative “treatments” continue to be widely available. As of May 2017, an estimated 716 clinics in the U.S. offered stem cell therapies, but that number has likely grown. To effectively safeguard consumers, additional actions by FDA will be required, as will steps by other oversight bodies charged with protecting public health or protecting consumers from fraud. State attorneys general, lawmakers, and boards of medicine are among the state-based entities that can play an important role in this broader effort.

Liz Richardson directs The Pew Charitable Trusts’ health care products project.