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The Shady Business Of Experimental Stem Cell Treatments

Medic in the process of separating out stem cells
Medic in the process of separating out stem cells
Catherine Mary

GENEVA — At the Geneva University Hospitals, pneumologist Jean-Paul Janssens receives patients suffering from Amyotrophic Lateral Sclerosis (ALS). This rare disease is caused by the degeneration of motor neurons and kills patients within a few years. It is incurable.

And yet patients often receive invitations from private clinics or doctors promising a miracle cure using stem cells, which can be multiplied in specialized settings or surfaces. "Patients are ready to enter into any protocol or clinical trial rather than stay inactive. Even if it means overstepping clinical research rules," says Janssens.

The pneumologist tries to warn patients about the illegal nature of the untested stem-cell treatments. Some listen. But others, usually those with more money to spend, try their luck anyway. Janssens remembers one patient, a few years back, who accepted an offer from a clinic in Tel Aviv in Israel. The treatment cost him 35,000 Swiss francs (a little under 33,000 euros). The plan was to remove some of his cells in French-speaking Switzerland, send them for isolation and cultivation in Israel, and then send the cells back to Switzerland for injection.

"We realized this was a bad procedure when the Swiss clinic refused to remove the cells," the doctor recalls. "So the patient had to go to Israel, but his condition prevented him from making the trip. A family member went instead to give his cells. The Swiss clinic then withdrew from the protocol, so the stem cells were injected into the patient at home." He died a short while later, for reasons "unrelated to this treatment," says Janssens.

A global affair

That kind of desperation on the part of patients is boosting a growing market for clinics that offer non-approved stem-cell treatments for conditions such as ALS, multiple sclerosis, Parkinson's disease, diabetes or heart attacks. Already well established in some developing countries, these kinds of clinics are now — despite the presence of powerful health agencies regulating the pharmaceutical market —gaining a foothold in places like Switzerland, Australia, Italy, Japan or in U.S. states like Florida or California.

In an article published last June in the review Cell Stem Cell, bioethicist Leigh Turner of the University of Minnesota counted 570 clinics illegally offering such treatments, a number big enough to exert economic power and bend laws in the sector's favor.

The clinics often look very respectable.

In Switzerland, investigations led in recent months by the Swiss Agency for Therapeutic Products (Swissmedic) led to authorities to ban two clinics, Med Cell Europe and Swiss Medica, from offering these treatments, and to identification of Intercare as a brokering service. While Stem Cell Europe has ceased all activity in Switzerland, Swiss Medica continues to recruit patients in its premises in Saint Gall, whence they are sent to affiliated centers in Serbia or Russia to undergo treatments banned in Switzerland.

Networking between patients, brokers, clinics and doctors is "what is making things difficult" says Christian Schaerer, head of investigations at Swissmedic. He says such treatments are not in any case offered by well-known clinics, and "can be done in a hotel room" where a foreign guest has brought in a doctor. "It's quite a global affair through international websites where a patient can search for a treatment or doctor, or choose a clinic of interest from among various proposed worldwide," he says.

No reliable data

Clinics like to wrap themselves in legitimacy by stating — with the backing of scientific references — that their treatments work. Doctors practicing them are raised to the level of pioneers of the new age of regenerative medicine, all in a discourse that tends to ignore the lack of reliable clinical data, not to mention documented and serious risks to patients, like pulmonary embolism, heart attacks, tumors or blindness.

Leigh Turner says the clinics often look very respectable. They cite studies published in scientific journals, he says, and provide guarantees on the doctors they employ. But unless patients make the effort to actually look at those studies, they don't know that the only research done "is on mice," the University of Minnesota bioethicist explains.

In the United States, this illegal market draws strength from the libertarian discourse elaborated since the 1970s by several winners of the Nobel Prize in Economic Sciences and adopted today in business papers like the Wall Street Journal. Its partisans say the U.S. Food and Drug Administration impedes innovation and access to medicines by making the evaluation process too long and costly.

Doug Sipp, a political science researcher at the Riken Institute in Japan, says that with regards to stem cell research, supporters of deregulation see "an opportunity to make their discourse heard and apply their theories."

The lack of reliable clinical data is only one of the serious ethical questions surrounding stem cell treatments. People with serious illnesses, as Turner points out, will go to desperate lengths to find a treatment. Which is "understandable," he adds. "But does that mean we should allow a market that profits from that despair and vulnerability?"

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