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Stem cell therapies need better regulation

By Jann Bellamy
8/16/2012 Special to Health News Florida

The recent deaths of two Florida patients following stem cell therapy highlights the need for greater regulation of these medically controversial treatments.

In 2011, the Florida Board of Medicine imposed an emergency license restriction on Bonita Springs cardiologist Dr. Zannos Grekos after a patient died following an injection of stem cells to treat complications of breast cancer therapy. Although the restriction prohibited Grekos from performing more stem cell treatments, another patient died after Grekos performed a stem cell injection for pulmonary hypertension and fibrosis. This prompted the Medical Board to issue an emergency suspension of Grekos’s license to practice medicine in March of this year. Further proceedings are pending before the Board.

While any death following a medical procedure is unfortunate, these are all the more so because, according to the Department of Health’s complaints against Grekos, these stem cell treatments “had no substantial medical and scientific value” for the patients’ conditions.

Variants of the stem cell treatments performed by Grekos are offered in clinics throughout Florida. What’s behind these treatments?

The International Society for Stem Cell Research, a non-profit with over 3,500 international stem cell researchers as members, explains the theory behind stem cell therapies in a patient handbook, available on its website. Stem cells have two important properties that make them attractive candidates for therapies to replace or repair a patient’s damaged cells or tissues. First, they can divide, making more stem cells of the same kind. Second, they can differentiate into specialized cells that carry out certain functions in the body. All of us carry stem cells in our bodies which can be harvested, allowed to divide and make more cells, and then injected back into the body.

While these therapies hold great promise, the problem is that very few have been through adequate clinical trials to show that they are safe and effective for a particular condition. For example, blood stem cell transplantation to treat diseases of the blood and immune system, such as bone marrow transplants, are well established. And there are ongoing clinical trials to establish safety and effectiveness for other conditions. The University of Miami medical school is running clinical trials on the use of stem cells for treatment of heart conditions and chronic wounds.

But for now these uses remain experimental. Yet Florida clinic websites advertise stem cell therapies for a wide range of conditions, such as joint problems, autism, hair loss and erectile dysfunction. Because certain stem cell therapies are legally questionable in the U.S., some patients are sent to clinics outside the country for treatment.

Foreign clinics also advertise on the internet, which has led to a troubling trade in what’s become known as “stem cell tourism.” These clinics attract desperate patients with currently incurable diseases like ALS and multiple sclerosis.

Treatments can cost tens of thousands of dollars plus incidental expenses like travel. Except for those few treatments proven safe and effective, insurance will not pay.

Fortunately, more effective regulation is on the horizon. A federal district court in Washington, D.C., ruled last month that certain types of stem cell therapies, where the cells go through more than “minimal manipulation” outside the body, are drugs subject to FDA jurisdiction. This means that rigorous clinical trials must precede their use. However, the Colorado company sued by the FDA in this case has simply moved these treatments to a clinic in the Cayman Islands, thereby skirting FDA regulation.

In April, the Texas Medical Board enacted rules requiring that stem cell therapies not being offered as part of a properly conducted clinical trial be approved by a local review board. Some Board members, however, thought the rules didn’t go far enough. Board member William Smyth voted against the rules. He told The Texas Tribune that, “if Texas wants to be a leader in this area, there are other ways to do this. You want to add a layer of protection? Put a moratorium on the use of these agents until they are proven.”

For anyone contemplating stem cell therapy, the International Society for Stem Cell Research offers valuable information in a format easily understandable to the layperson. As its patient handbook says, “stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.”

Good advice. It would be even better for the state of Florida to take a more proactive stance, like Texas, in protecting patients. Had it done so earlier, it might well have saved the lives of two people.

-- Jann J. Bellamy, a Tallahassee attorney, is founder of the Campaign for Science-Based Healthcare (www.sciencebasedhealthcare.org). For previous columns, click HERE.



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