Stem cell treatments in demand among athletes — is this cheating?
Stem cell therapy is starting to find a market in sports medicine. In fact, it is next only to the wildly popular platelet-rich plasma therapies.
Elite athletes, like Colts quarterback Peyton Manning and Yankees pitcher Bartolo Colon, who seek quick fixes to injuries in order to return competition may think they’re helping advance these advanced stem cell treatment options.
But they may also be courting danger, not only for themselves, but for many people who look up to them as icons and who see anything they do as tacit endorsements.
What’s more, unproven stem cell treatments cross the line between healing injuries and enhancing performance — sparking debate among health and sports experts about their efficacy and whether or not these constitute cheating or doping, especially if they involve the use of human growth hormones (HGH).
A check with ClinicalTrial.gov, run by the U.S. National Institutes of Health, shows that there are 14 ongoing clinical studies probing the safety and efficacy of treating degenerated discs with stem cells taken from bone marrow.
But apart from these, the United States Food and Drug Authority hasn’t approved any treatment of damaged discs or orthopedic injuries using stem cells.
Experts say it’s dangerous to try treatments that haven’t been approved and regulated, but a growing number of Americans have been traveling abroad, seeking experimental stem cell therapies in places beyond the long arm of the FDA.
Although no one has exact numbers for how many people — or athletes — seek stem cell treatments in other countries, CNN cites Deloitte Center for Health Solutions figures that project the global medical tourism industry as growing 35 percent annually. About 1.6 million American patients will be leaving the country for stem cell treatments this year, the center also says.
Besides orthopedic injuries like Manning’s, there are stem cell therapies available elsewhere aimed at heart disease and neurological conditions, even autism. Germany, Panama and Thailand are all popular countries for seeking these kinds of treatments, says Dr. Joshua Hare, Interdisciplinary Stem Cell Institute director at the University of Miami’s Miller School of Medicine.
The therapies are based on the basic idea that stem cells can form new tissues to regenerate damaged ones. Mesenchymal stem cells in particular are believed to be able to restore bone cells and cartilage cells.
These concepts are held to be generally true by the American medical community, Dr. Hare admits. But he points out that doctors agree patients should not try to seek experimental stem cell treatments outside the country, as there’s no telling if they have serious side effects or will even work at all.
“We believe that there’s merit to this approach, we just want to see it (carried out) well, ethically and rigorously,” he says, adding that medical evidence should be gathered through clinical trials to ensure that these treatments are safe and effective.
Is it cheating?
Manning’s trip to Europe last September (2011) to try to cure his ailing neck with an experimental stem cell therapy is the latest of many attempts by elite athletes to speed up recovery of an injury through a controversial medical procedure.
The 35-year-old Colts quarterback and four-time league MVP sought the stem cell therapy after two surgeries did not cure a painful bulging disk on his neck. He’s had three surgeries in 19 months, but still missed his team’s first two games and remained out of the game since September. On Feb. 3, his surgeon cleared him to start taking hits, after a long rehab.
Meanwhile, Colon, 38, resurrected his career late in 2011 after missing all of 2010 — and attributes this to a stem cell treatment he received on his pitching shoulder and elbow last year.
In the procedure, done in Colon’s native Dominican Republic at his request, doctors took stem cells from the pitcher’s fat and bone marrow and then injected them into his injured right elbow and shoulder.
The National Football League doesn’t prohibit stem cell therapy, “unless a banned substance is used as part of the procedure,” an NFL spokesman told Christian Red of New York Daily News, who reported on Manning’s stem cell treatment last September.
NFL was referring to HGH, the powerful anabolic hormone that many athletes abused for decades, together with steroids, to enhance their performance.
Occurring naturally in the human body, HGH is a hormone that is produced by the pituitary gland and stimulates growth of muscle, cartilage and bone.
First isolated by scientists in 1956, doctors began to use it to treat children suffering from stunted growth. Now synthetic HGH can be made in unlimited quantities in the laboratory, but its use in sports was banned in 1989 by the International Olympic Committee’s medical commission.
“It’s a dicey issue,” Dr. Ken Mautner a sports medicine physician at Emory University tells NY Daily News.
Mautner has been using PRP therapy for three years, but says he has never used HGH on his patients. “When you’re dealing with pro athletes, you can’t use (HGH) in any capacity. But with regenerative type of medicine, I think that’s where the whole sports field may be going.”
The main effect of HGH, and other “doping” products, is that they allow athletes to complete more and harder training, sports scientists say. By allowing athletes to sustain a larger overload without breaking down and becoming injured, the adaptations they make are larger—and this leads to better performance.
HGH also allows athletes to recover faster from punishing workouts.
Dr. Joseph Purita, who treated Colon, supports HGH use for non-athlete patients. Used together with stem cell procedures or PRP, Purita says, HGH speeds and improves healing. But at the same time, he swears he never used HGH or any performance-enhancing drugs on Colon.
Athletes who dope with HGH also run the risk of testing positive and being banned from their sport, because the substance is prohibited by the World Anti-Doping Agency, Major League Baseball, NFL and other professional sports leagues.
Olympic athletes are tested for HGH and baseball conducts blood tests for the drug in the minor leagues, since urine tests are ineffective in detecting it.
But some people fear that athletes could exploit loopholes in rules and seek a therapeutic use exemption (TUE) to circumvent doping rules.
“It’s not impossible to imagine a spike in TUEs for growth hormone given the appeal of PRP therapy and the potential of stem cell treatment, especially if physicians tout the benefits of adding HGH with those procedures,” Red of New York Daily News points out.
But then he counters his own question, saying “it would be a long shot for such a TUE to be granted,” since the number of medical conditions for which HGH is an accepted form of treatment are few.
“Although Manning isn’t engaged in an action that is clearly unethical, it sets a bad example,” says Dr. Ruth Macklin, bioethics professor at New York City’s Albert Einstein College of Medicine.
“It would, indeed, be a bad thing if injured pro athletes were to fly all over the world looking for cures when the procedure in question is unproven. It would not advance science. And there are plenty of quacks out there,” she said.
What’s worse, the procedure may not even work.
“We live in an era where physicians are encouraged to practice ‘evidence-based’ medicine,” Dr. Macklin tells ABCNews.com in an email. “However, a sports superstar has the money and ability to travel anywhere in the world to receive an experimental procedure that isn’t based on any evidence that it works for his condition.”
Dr. Lawrence Goldstein, University of California-San Diego’s Stem Cell Program director, says he’s unaware of any stem cell therapy proven to treat “any sort of spinal issue.
“There are many proposed therapies that are being tested in clinical trials, and there are more to come,” Goldstein says in an email. “But in the absence of reliable evidence, it’s impossible to know whether the ‘treatment’ will make Manning better or worse or merely financially poorer.”
Dr. Barth Green, whose Miami Project to Cure Paralysis has clinched FDA approval to treat spinal cord injuries with adult, peripheral nerve cells or Schwann cells tells New York Daily News that “there’s no evidence that stem cell treatment can help repair a bulging disk or help a patient recover from” that type of injury.
Dr. Goldstein is also particularly concerned about the message Manning’s choices send to the public.
“When a highly visible celebrity athlete chooses to undergo an untested/unproven therapy, and if they happen to get better without knowing whether the therapy is what caused the improvement, they encourage many other people to ignore scientific evidence and to substitute hope and blind trust for proof,” he said.
“The downside is that many people might be hurt by subjecting themselves to a risky procedure, or procedure with unknown risks, when there’s no evidence of benefit to be gained.”
Manning could have made a more socially responsible choice by instead seeking out and enrolling in a clinical trial using this or another intervention, Dr. Macklin says.
And then, there are also the dangers.
Even if the stem cells are your own—as is often the case in many therapies—there are still safety risks, FDA warns in an advisory on its page.
There are risks involved even when the cells are manipulated after removal, FDA says.
“There’s a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” says Stephanie Simek, Ph.D., deputy director of FDA’s Office of Cellular, Tissue and Gene Therapies in an advisory on the agency’s site. “Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else,” she warns.
The agency says patients should still find out if a stem cell therapy is FDA-approved or if it’s part of a regulated trial. And be wary of so-called treatments being offered in countries outside the U.S., the FDA warns American consumers.
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