Healthcare

Taming the Wild West: Florida’s Stem Cell Therapy Industry

By January 20, 2020 No Comments

If you watch CBS after Sunday Night Football, you may have seen a segment or two about “unscrupulous” stem cell providers/clinics falsely preaching about the miraculous healing power of stem cell therapy. These providers market to unsuspecting patients peddling treatment for a range of ailments like sore knees or failing hearts with no true evidence the treatment is safe or effective. These treatments, which are not usually covered by insurance, will cost patients thousands of dollars and, in the worst cases, potentially exacerbate the affliction they are attempting to treat.

Florida can and must stop these unethical providers. In doing so, Florida would be a bellwether state, demonstrating a new approach to regulating cellular therapy.

Of course, I’m not saying that reputable providers with treatment options aren’t demonstrating promise. In fact, there are plenty of public and private entities demonstrating this treatment as one of the latest frontiers in modern medicine. The largest and most respected names in healthcare, from universities and hospital systems to private entities and pharmaceutical companies, are involved in medically substantiated non-embryonic cellular treatment with excellent track records.

While this industry is no longer in its infancy, it’s not yet fully evolved, either. If anything, the cellular therapy industry is still in its adolescence − dare I say it − A millennial! Therein lies the problem. How does Florida create boundaries in this industry without stifling innovation? How does Florida eliminate the bad apples?

Initially, we need to understand what kind of providers are operating in Florida. Therefore, Florida should require all stem cell clinics and cord blood banks to register with the state. It’s not unusual for healthcare providers to do this and it’s inexpensive for the state and the provider.

The second step is to require accreditation for facilities providing this treatment. Accreditation allows for an independent third party to objectively determine if there are consistent safety processes. This patient safety check doesn’t happen once; most accrediting bodies have ongoing surveys and inspections to ensure that patient safety processes are being upheld.  And there are plenty of entities for providers to choose from including, but not limited to, the Joint Commission, AABB, or the Foundation for the Accreditation of Cellular Therapy (FACT).

Crucially, the information must then be made public. At the moment, unlike most health care facilities, laboratories, or physicians’ offices, the consumer cannot find a complete list of those providing treatment. The answer is simple: the state should create an accessible customer database. Such databases already exist. For instance, the Agency for Health Care Administration (AHCA), has a wonderfully efficient database on Florida Health Finder.

To clarify, I am not recommending a licensure program. Licensure programs are expensive for both the state agencies responsible for licensing AND the providers being licensed. Besides which, both the AHCA and Department of Health are already surveying thousands of entities; licensure is a time intensive process. Instead, these recommendations are a far simpler, cost-effective approach to consumer protection and patient safety.

Stem cell therapy is one of the newest and most exciting sectors of health care. In many ways, it can sound like science fiction, taking us into a transformative future of wellbeing. Like many who have seen the positive results, I am eager to watch this treatment step into maturity. However, we cannot let dishonest individuals stain the industry, nor can Florida allow a “Wild West” where there are no standards for patient safety.  Florida must act, and by adopting these commonsense ideas to protect patients and eliminate the bad apples, the state will encourage safe growth in this new frontier.

Contributed by Strategos Group Principal, Orlando Pryor. Orlando is based in Tallahassee, Florida and can be reached via email at opryor@strategosgroup.com.