Injections of Hope
Tuesday, September 2, 2008
A vast human experiment is afoot. And no one is taking good notes.
Fueled by demand from desperate patients, dozens of companies around the globe are peddling stem cell injections for $15,000 to $50,000 and more. Based merely on the claims made by these companies, at least a few thousand patients from the United States have paid for stem cells overseas.
Patients dart across the border to Mexico or jet to the Caribbean, India, China and elsewhere for injections of stem cells from embryos, fetuses, umbilical cords and the patients' own fat, blood and bone marrow. These shots would be illegal in the United States, where the Food and Drug Administration has yet to approve any such treatments.
Online ads promoting this therapy target people with spinal injuries, Lou Gehrig's disease, heart failure and other tough-to-treat conditions, promising improvements and even cures.
"Diseases and conditions such as diabetes, multiple sclerosis, cerebral palsy . . . are all being successfully treated," claims one site, returninghope.com. When asked to support the claims, Brian Dardzinksi, who operates the site from Bangkok and Hong Kong, provided one medical journal article describing the treatment of incontinence with muscle stem cells, an Austrian study now under investigation for possible ethics problems.
Dardzinski has no medical background and acts as a broker, matching U.S. patients with stem cell providers overseas. "Several hundred patient inquiries a month is not uncommon," he said. "I'm just a businessman trying to do some good."
Because the companies operate offshore, they are not subject to the FDA's strict safety regulations. And because they collect little, if any, data, it's impossible to assess whether their treatments work.
The business is drawing sharp concern from academic researchers.
"It's almost evil, because it preys on the fears and the hopes of the most vulnerable people," said Evan Snyder, a stem cell researcher at the Burnham Institute in La Jolla, Calif.
"There are a lot of scams out there," said Wise Young, a spinal cord injury researcher at Rutgers, the state university of New Jersey. "People should be very careful."
Barbara Hanson and Jeannine Richardson discovered the risks after a trip to a stem cell clinic in Tijuana, Mexico, last year.
The women, who met in an online support forum for people with chronic obstructive pulmonary disease, learned of a company called Stem Cell Biotherapy, which has offices in Agoura Hills, Calif., and advertised online. Hanson says one of the company's doctors, Burton Feinerman, told her he had taken 10 COPD patients to Tijuana and all had improved enough to discard their portable oxygen tanks.