Foreign Clinics Lure Americans With Unproven Treatments

On a slick Web page, a hale, gray-haired man held a little girl's hand in a lush green field. "Adult Stem Cell Therapy. New Hope. New Life," the page beckoned, encouraging heart patients to plunk down $35,000 to travel to Bangkok, Thailand—for an unproven treatment.

Tammy Henderson, 37, of Garden City, Mich., heeded the call. In March, she became the latest of nearly 300 mostly American heart failure patients to have the procedure offered by Thera-Vitae, the company behind the website. It's too early to tell if stem cells taken from Henderson's blood and injected into her heart are repairing that severely weakened organ, but, she says, "I'm praying for a miracle."

The stem cell treatments offered by overseas clinics like TheraVitae aren't available in the United States, except in small clinical trials. Other treatments considered experimental here, such as high-intensity focused ultrasound for prostate cancer and new drugs for in vitro fertilization, can also be found abroad. But even if a treatment is approved somewhere else, that's no guarantee it's worth seeking out.

TheraVitae's medical director, Thein Htut, claims that 75 to 80 percent of patients improve significantly. "We are their last resort," he says, noting that Thai officials are aware of his activities. However, the company has not published its data, drawing harsh criticism. "It's just not ethical, in my opinion," says Warren Sherman, a cardiologist at Columbia University Medical Center. He's one of dozens of researchers testing adult stem cells in heart patients, and such trials have yet to show conclusive benefits, he says. An analysis published in the Journal of the American Medical Association in February concluded that the evidence to date indicates few risks but only a "modest benefit." Other stem cell treatments offered abroad for various illnesses are entirely untested in humans.

Henderson's medical history made her ineligible for a trial. So when she discovered TheraVitae, she sought advice from her cardiologist, who happened to have some experience with the company. Barbara Czerska of Henry Ford Hospital in Detroit told Henderson she had nothing to lose. "We don't know the long-term outcomes for these patients," Czerska says. "But if patients have the money, I tell them, 'Why not?' They don't have many options left." Henderson borrowed $13,000 and raised the rest through spaghetti dinners, bottle drives, and poker nights.

The International Society for Stem Cell Research is drawing up guidelines to help patients sort promising therapies from quackery. For now, the group's vice president, Irving Weissman, suggests that patients work with their stateside physicians to demand three types of information: evidence that the regulatory agency in the clinic's home country has stamped the treatment as safe and effective; medical journal articles describing the therapy and its effectiveness in human trials; and certificates of approval from the clinic's institutional review board, which is supposed to provide ethical guidance. If any is lacking, steer clear, he says. "Your assumption must be that they are part of a fraudulent enterprise until they prove otherwise."