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A new law in Utah will lead to a boom in snake oil sales

Utahns are at risk of being harmed by a law that undermines federal regulation and promotes the sale of unproven therapies.

(Jacquelyn Martin | The Associated Press) This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Maryland.

On May 1, Utah's law SB 199, Placental Tissue Amendments, goes into effect. Despite its innocuous-sounding name, this law endangers Utahns by encouraging the sale of unproven placenta “stem cell” products that are not approved by the Food and Drug Administration (FDA). The legislature therefore supported the idea that the safety and effectiveness of medical products would not have to be proven before being sold to the people of Utah.

This law opens the door to criminals who want to sell counterfeit stem cell products. No placental stem cell product has ever been shown to be effective in the treatment of any disease in controlled clinical trials. Additionally, illegally marketed, unproven stem cell therapies have harmed consumers.

There are hundreds of companies in the United States illegally marketing “stem cell therapies” that have not been proven safe and effective in clinical trials. Often these companies make sweeping claims about the ability of these products to cure many medical conditions. However, there is no universal stem cell therapy that can cure a variety of diseases of different tissues. Not only are such claims not supported by clinical data, they are often biologically implausible.

As stem cell biologists, we know that currently only very few diseases can be successfully treated with stem cells. These diseases usually involve the transplantation of blood-forming stem cells, for example in a bone marrow transplant. This is done to treat certain types of blood cancers as well as rare genetic diseases such as sickle cell anemia. However, these therapies can only be delivered safely and effectively in large medical centers and can have life-threatening side effects. Most other types of stem cells have never been proven effective for treating anything.

Unfortunately, there are now several examples of healthcare providers taking advantage of desperate patients by selling counterfeit stem cell therapies. Utah's SB 199 could lead to a boom in snake oil sales in Utah.

Federal regulations provide the primary protection against counterfeit stem cell therapies. The FDA prohibits the marketing of stem cell products whose safety and effectiveness have not been demonstrated in clinical trials. The Federal Trade Commission enforces laws against deceptive advertising. Both agencies have successfully filed lawsuits against companies that sold unproven stem cell therapies, including placenta products. However, the growing number of such companies has led to an escalating problem that resembles a game of Whac-A-Mole.

Utah's SB 199 not only makes it legal for companies to sell unproven placenta stem cell products in Utah, but also attempts to undermine federal regulations by explicitly stating: “A health care provider…may administer a stem cell therapy that is not approved in the United States.” “Food and Drug Administration.” The FDA reviews not only the evidence of safety and effectiveness, but also the manufacturing process to ensure consistent quality. Companies that don't follow FDA regulations also sometimes cut corners on quality control, resulting in products contaminated with pathogens.

Stem cell research is likely to produce more cures in the future; However, developing safe and effective new therapies takes decades. There are many different types of stem cells with different biological properties that must be precisely tailored to the disease being treated. Years of preclinical research in animal models are required, followed by early-stage testing in patients, and finally with larger-scale testing in controlled clinical trials. Several stem cell therapies are currently being tested in this pipeline. Other therapies were once considered promising but proved unsafe or ineffective in clinical trials.

Individual patients and physicians rarely have the time, expertise, or data access needed to evaluate the safety and effectiveness of experimental medical devices. While SB 199 requires providers to disclose that products are not FDA-approved, many companies selling unproven therapies already do so. This does not deter consumers from purchasing such therapies if the disclosure involves misleading claims about effectiveness. “Buyer beware” is not an effective strategy when it comes to experimental medical devices. Utahns are at risk of being harmed by a law that undermines federal regulation and promotes the sale of unproven therapies.

(Photo courtesy of Sean J. Morrison) Sean J. Morrison

Sean J MorrisonPh.D., is Chair of the Public Policy Committee and former President of the International Society for Stem Cell Research. He is a stem cell biologist and director of the Children's Medical Center Research Institute at the University of Texas Southwestern Medical Center. He is a member of the FDA Advisory Committee on Cell, Tissue and Gene Therapies. His views do not necessarily reflect the views of his institutions and he does not speak on behalf of the FDA.

(Photo courtesy of Gerald J. Spangrude) Gerald J. Spangrude

Gerald J. SpangrudePh.D., is Professor Emeritus of Internal Medicine at the University of Utah. He is a stem cell biologist and associate professor in the Institute of Stem Cell Biology and Regenerative Medicine at Stanford University. Its views do not necessarily reflect the views of its institutions.

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Anna Harden

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