‘Stem Cell Tourism’ Takes Advantage of Patients, Says Law Professor

Posted: March 25, 2014 at 8:42 am

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Newswise MADISON, Wis. Desperate patients are easy prey for unscrupulous clinics offering untested and risky stem cell treatments, says law and bioethics Professor Alta Charo of the University of Wisconsin-Madison, who is studying stem cell tourism.

Stem cells are cells that can form many types of cells in the body, and that makes them inherently promising and dangerous. Stem cell tourism refers to people traveling, both within the U.S. and abroad, in pursuit of advertised stem cell therapies to purportedly treat a variety of medical conditions.

The evidence for therapeutic use of stem cells is very limited, except for bone marrow stem cells, but patients all over the world are convinced stem cells will cure their disease, says Charo. While there are some very promising results in the early clinical trials for stem cell therapies using embryonic and other kinds of stem cells, the treatments being advertised by these clinics are dubious, mostly ineffective, and sometimes positively harmful.

Patients are being hoodwinked, but there are dilemmas about tackling (the treatments) at regulatory or political levels.

The outrage over failures in stem cell tourism is limited, Charo says. Patients may pay tens of thousands of dollars for procedures that may carry no promise of success or carry grievous risks of failure. Most people have no reason to pay attention, and those who are paying attention are sick, so they are focused on trying anything, Charo says. If it does not work, they are already in a bad position with plenty to think about.

During a search for stem cell therapies on the web, Charo found products that supposedly enhance the natural formation of stem cells in the skin alongside approved and unapproved treatments in the United States, and stem cell clinics outside the United States, like a stem cell treatment for spinal conditions that might be innocuous, but is probably useless.

Some American operators are trying to slip through Food and Drug Administration regulation, says Charo, who served as senior policy advisor in the Office of the Commissioner of the FDA between 2009 and 2011. The FDA regulates medical devices, tissue transplants and drugs, but not organ transplants or the way medicine is practiced.

To sell a product that can heal without claiming it is a drug, some clinics remove stem cells from a patient, grow them with minimal manipulation, and then reinsert the resulting cells back to the same patient. There has been a long-running battle over whether that is a tissue transplant akin to organ transplantation and thus the practice of medicine, or a tissue transplant that is acting like drug, Charo says. If the latter, then what you do is subject to FDA [regulation], so you have to prove that your product is safe and effective, which almost always requires expensive clinical trials.

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'Stem Cell Tourism' Takes Advantage of Patients, Says Law Professor

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