On May 1, Utah’s law SB 199, Placental Tissue Amendments, goes into effect. Despite the innocuous-sounding name, this law puts the people of Utah at risk by promoting the sale of unproven placental “stem cell” products that are not approved by the Food and Drug Administration (FDA). The Legislature thus endorsed the idea that the safety and effectiveness of medical products need not be proven before sale to the people of Utah.
This law opens a door for bad actors seeking to sell fake stem cell products. No placental stem cell product has ever been proven to be effective for the treatment of any medical condition in controlled clinical trials. Moreover, illegally-marketed unproven stem cell therapies have harmed consumers.
There are hundreds of companies in the United States that illegally market “stem cell therapies” that have not been shown to be safe and effective in clinical trials. Often these companies make broad claims about the ability of these products to cure many conditions. However, there is no one-size-fits-all stem cell therapy that can cure a wide range of medical conditions involving different tissues. Such claims are not only unsupported by clinical data, they are often not even biologically plausible.
As stem cell biologists, we know that very few medical conditions can currently be successfully treated using stem cells. These conditions mostly involve the transplantation of blood-forming stem cells, such as in a bone marrow transplant. This is done to treat certain blood cancers as well as rare genetic conditions, such as sickle cell disease. However, these therapies can only be safely and effectively administered in major medical centers and can have life-threatening side effects. Most other kinds of stem cells have never been shown to be effective for the treatment of anything.
Sadly, there are now several examples of healthcare providers who preyed on desperate patients by selling fake stem cell therapies. Utah’s SB 199 could lead to a boom in the sale of snake oil in Utah.
Federal regulations represent the main protection against fake stem cell therapies. The FDA prohibits the marketing of stem cell products whose safety and effectiveness have not been proven in clinical trials. The Federal Trade Commission enforces laws against misleading advertising. Both agencies have brought successful cases against companies that sold unproven stem cell therapies, including placental products. However, the growing number of such companies has created an escalating problem akin to a game of Whac-A-Mole.
Utah’s S.B. 199 not only makes it legal for companies to sell unproven placental stem cell products in Utah but it attempts to undermine federal regulation by explicitly stating that “A health care provider… may perform a stem cell therapy that is not approved by the United States Food and Drug Administration.” The FDA not only examines the evidence supporting safety and effectiveness, it also examines the manufacturing process to ensure consistent quality. Companies that do not follow FDA regulations sometimes also cut corners on quality control, leading to products that are contaminated with pathogens.
Stem cell research is likely to yield more cures in the future; however, it takes decades to develop safe and effective new therapies. There are many different types of stem cells, with different biological properties that must be precisely matched to the condition being treated. Years of pre-clinical research is required in animal models, followed by early-stage testing in patients and concluding with larger scale testing in controlled clinical trials. A number of stem cell therapies are currently being tested in this pipeline. Other therapies were once considered promising but were found to be 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 products. While SB 199 requires that providers disclose that products are not FDA approved, this is already done by many companies that sell unproven therapies. This does not dissuade consumers from buying such therapies when the disclosure is coupled with misleading claims about effectiveness. “Buyer beware” is not an effective strategy when it comes to experimental medical products. The people of Utah 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. Morrison, Ph.D., is Public Policy Committee Chair and former President of the International Society for Stem Cell Research. He is a stem cell biologist and is Director of Children’s Medical Center Research Institute at the University of Texas Southwestern Medical Center. He is a member of the FDA Cellular, Tissue, and Gene Therapies Advisory Committee. 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. Spangrude, Ph.D., is Emeritus Professor of Internal Medicine at the University of Utah. He is a stem cell biologist and Adjunct Professor at the Institute For Stem Cell Biology and Regenerative Medicine at Stanford University. His views do not necessarily reflect the views of his institutions.
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