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By Brian Vastag
Posted May 1, 2008
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."
“It's not enough to create magic. You have to create a price for magic, too. You have to create rules.” Eric A. Burns
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