‘Stem cell tourism’ – how to lose the hype, not the hope

 Medical tourism – travel to another country for medical treatment – is popular for financial reasons: cheaper treatment, even after flight, accommodation and living costs are considered. These days, a motivating factor is availability: experimental therapies  not offered, or proven safe, in one country, are often available, untested, elsewhere in the world. Stem cell therapy is a prime example. It has spawned 'stem cell tourism' among desperate patients and their families who want to believe the therapy is magical. In this Newswise report, University of Wisconsin-Madison law and bioethics professor Dr Alto Charo says it's a prescription for significant risks, legal and ethical issues, and premature death. MS

Desperate patients are easy prey for unscrupulous clinics offering untested and risky stem cell treatments, says US law and bioethics professor Alta Charo

Stem cells are cells that can form many types of cells in the body, which makes them inherently promising — and dangerous, says the University of Wisconsin-Madison's Charo, who is studying "stem cell tourism". The term refers to people traveling both within their home country and abroad for advertised but untested stem cell therapies to treat a variety of medical conditions.

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

"Patients are being hoodwinked, but there are dilemmas about tackling 'treatments' at regulatory or political levels."

Outrage over failures in stem cell tourism is limited, Charo says. Patients may pay tens of thousands of dollars for procedures that 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," she  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 untested products alongside approved and unapproved treatments in the US, and stem cell clinics outside the US, including 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 (FDA) regulation, says Charo, who served as senior policy advisor in the FDA Office of the Commissioner 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", then reinsert the cells into the same patient, says Charo.

"There has been a long-running battle over whether that's a tissue transplant akin to organ transplantation and thus the practice of medicine, or a tissue transplant  acting like drug," she says. "If the latter, then it's subject to FDA (regulation), so you have to prove your product is safe and effective, which almost always requires expensive clinical trials."

In early February, a US appeals court upheld the FDA's ability to regulate manipulated stem cells as drugs, Charo notes. The victory may be hollow: "Each case takes a tremendous effort to bring suit, prove the facts and win the appeal; many other clinics may open up in the meantime."

In some countries, pretty much anything goes, Charo says. Almost half of stem cell treatments occur in China, but Mexico and Russia have growing sectors.

"Some clinics advertise brain injury treatment for patients who are in no condition to travel," she says. "Patients, and especially parents of children with injury or disease, are often desperate. One child went to Russia and had raw bone marrow injected into the brain. It's horrifying."

Research by Dr Paul Knoepfler of the University of shows  that most clinical trials occur in Europe and especially the US, where regulation is strictest, "but so-called 'therapeutic' clinic locations are mostly in China, Mexico and Costa Rica", Charo says.

It's unclear how much harm unregulated treatments causes to medical tourists because in the absence of comprehensive regulation, there is no comprehensive follow-up data.

"We've had two reported deaths of children, and there are probably more people injured than anybody would imagine," Charo says.

Limiting advertising could slow medical tourism to unscrupulous clinics, but is legally troublesome.

"The International Society for Stem Cell Research tried to list effective and ineffective clinics, but received letters charging business defamation. They did not have money for the litigation, and  took down the posting. It was tremendously frustrating."

US consumers could raise these issues with the Federal Trade Commission, which is charged with regulating false or misleading advertising. Scientists can work with fellow scientists, patient-advocacy organisations and regulatory authorities such as the FDA.

Charo says "stem cells have become a magic word. Often new areas of science get that reputation; in 19th century medical devices, everything with electricity or magnetism was magic. Today it's stem cells and nanotechnology. It is time to lose the hype without losing the hope." Newswise