“The problem is that no [drug company]wants to fund it, because no one has the rights to it: It's the patient's own cells.”
Globetrotting cure shopping
The grey market in stem cells appears to be one of the first to thrive in what Jonathan Kimmelman describes as the post-global medical economy.
Dr. Kimmelman, a biomolecular researcher and ethicist at McGill University in Montreal, says the 1990s was the “pre-global era” of medicine. Despite the excitement around potential DNA-based treatments at the time, gene-therapy clinics did not spring up in far-flung locales the way stem-cell centres are now, says the former chair of the American Society of Gene and Cell Therapy.
“But it's a very different era now. Brazil, India, China are not inconsequential players in the medical economy,” he says. “There is more transit of expertise – people trained in North America who returned to their home countries, and run trials or do research in their less-regulated, lower-income settings that they could do not here.”
Within the past decade, medical tourism has ballooned into a multibillion-dollar international industry. Increasingly, patients are chasing high-priced treatments unapproved in their own countries. Most recently, for example, hundreds of Canadians with multiple sclerosis have sought out the controversial Liberation treatment in clinics around the world.
Meanwhile, the wide availability of unproven stem-cell treatments is so well established that an international network of brokers, clinic branches and fundraising efforts has sprung up to recruit and counsel potential patients.
Clinics market their treatments as forbidden fruit, Prof. Caulfield says, “with claims that they can sell these things that are severely restricted wherever you are: ‘But we can get you tomorrow's treatments today.’ ”
On the other hand, doctors and researchers offering stem-cell treatments, along with certain patient groups, allege that because big pharmaceutical companies are unlikely to profit from therapies involving a patient's own stem cells, industry-funded scientists and groups are trying to halt their spread.
“There is a kind of skepticism, a level of distrust that patients feel about the relationship between medicine and commerce,” Dr. Kimmelman says, describing a generation of savvier patients who know of the ties between drug companies, doctors and researchers. “Yet they see pharma is not jumping all over stem cells.”
Between the cracks
Both Health Canada and the FDA consider stem cells to be drugs under federal legislation, and as such, subject to the same regulations. But that's less clear when it comes to a patient's own stem cells being moved from the fat of, say, love handles to breasts, or blood to balding head.
The RIKEN Center's Mr. Sipp feels that “a fine balance” has to be struck between allowing patients the freedom to choose treatments for themselves and protecting them from harm.
If a clinic offers an experimental stem-cell treatment, a patient should not be charged for it, he says – “and money is a big problem here.”
He doesn't buy the argument that trials aren't possible, or that using a patient's own stem cells is necessarily safe. Doctors used patient stem cells for costly bone-marrow transplants in women with breast cancer for years, he says, until trials showed they could be more dangerous than the disease.
“With cosmetic procedures,” he adds, “patients are healthy. It's not the same as someone with a serious disease. For them, the benefits may not be as great as the risks.”
One satisfied customer
One day in May, 2009, as Mr. Lidstone ate sandwiches and watched Die Hard Again on the clinic TV, Mr. Satino's staff transplanted his hair follicles from one side of his head to another and injected his own, treated blood into the back of his numbed scalp.
“He had a $50,000 machine right there” to process the blood, Mr. Lidstone says. “So right there, on the spot, every follicle was soaked in my own stem cells. That was pretty neat.”
Today, he's thrilled with the transplant results. The follicles took like weeds, he says: “After 21/2 months, they were an inch long. … Not one of them has died.”
It may be that the stem cells helped their survival, he says. But the area that received only the plasma injections “isn’t doing very well ... about 17 new hairs” by the clinic's last count.
I ask Mr. Lidstone if he has had any safety concerns at all. “I'm shocked I didn't think more about it,” he says. “We knew it was very powerful stuff, but they were getting it from my own blood – I just thought of it as good fertilizer.
“When it came to my hair, I wanted to take a chance,” he adds. “I got all caught up in it, I guess.”
Some mornings, I know the feeling.
Carolyn Abraham is the medical reporter for The Globe and Mail.