One of the more unusual sports medicine stories in recent memory involves the best quarterback on the planet, a freak injury, and a subtle bit of legalese.
Peyton Manning, first forehead of the NFL and adopted son of Nebraska, injured his neck in a game against the Washington Redskins on October 22nd, 2006 after his helmet was ripped off by Andre Carter. Manning played relatively pain-free the next few years but reinjured the neck in 2010 and soon found himself without his characteristic arm strength. Ultimately, Manning decided to go under the knife in May of 2011 to have surgery on a herniated disk that was thought to cause the pain and weakness. In the weeks following the operation, the NFL's most marketable player appeared to be on the road to recovery1 but he suffered another setback in the summer of 2011 necessitating a second, far more serious operation: cervical spinal fusion.2 But before he had the procedure, Peyton Manning did something truly bizarre.
Shortly before the spinal fusion, Manning travelled to Europe to have stem cells harvested from his fat tissue so they could be injected into his injured neck. Upon learning of this unusual procedure, I had two questions: 1) Why did he do this? and 2) Why was it done in Europe?
Stem cells are those undifferentiated cells that, like Daniel Day-Lewis, can seemingly turn into anything. They can be harvested from bone marrow, the umbilical cord, blood, or fat tissue – plucking them from fat happens to be technically easy and relatively painless – and through the secretion of growth factors can aid in cartilage and bone regeneration. There's no definitive evidence that stem cell injections actually work for the kind of neck injury Peyton Manning had, so when it was leaked that the quarterback had undergone the procedure, there were more than a few skeptics.
A professor of bioethics at the Albert Einstein College of Medicine called Manning's decision "an act of desperation" and Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego said, "It is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer."
Well, at age 37, Peyton Manning just had the best season for a quarterback in the history of the NFL. But was it because of the stem cells or in spite of them? It's still unclear. Proponents of the procedure call Manning a poster child for stem cell therapy, while critics say he required a subsequent neck operation precisely because the stem cells didn't work. (Manning has not commented.) While that argument plays out, a more interesting question remains: Why did Manning have to go to Europe for the procedure? The answer has to do with the FDA and how one defines risk.
A patient can either be consented individually (by signing a form, typically) for a medical procedure—like neck surgery—or exposed to an unconsented risk where regulatory assurances are already in place, like the FDA ensuring that your painkiller is potent, safe, and pure. But where do stem cell injections fall on the consent/risk spectrum? Is the injection of your own cells more like having a surgical procedure or more like taking a drug? Because there is no mass production or distribution involved, many doctors think the risk of stem cell injections is more like having surgery; it can only be estimated by the clinician who is providing the therapy, and it's up to the patient to weigh and ultimately accept the risk and provide consent. The FDA disagreed with this line or reasoning and in 2006 ruled that a patient's own cells should be subject to the same regulation as mass produced drugs. Peyton's stem cells were essentially no different than a medication you'd pick up at the pharmacy.
The outcry from medical organizations was swift, and included critical statements from the American Red Cross and the American Society of Clinical Oncology, which objected, "in the strongest terms to FDA's proposed regulation of stem cell transplants. This misguided proposal is unnecessary...and exceeds FDA's legal authority...stem cell transplants are medical procedures. Their use is the practice of medicine, not the manufacturing of a drug as FDA asserts."
The FDA's ruling meant Peyton's own stem cells fell under the purview of the FDA and were suddenly wrapped in red tape. To avoid any possible bureaucratic delay, he simply went to Europe to have the procedure done there. Manning didn't have time to wait for the FDA or more testing of the procedure, he needed to get back on the field before he was too old. Now the presumptive MVP may be headed for the Super Bowl after a record-setting season. Was it because of the stem cells? Who knows, but the likelihood is that many more people—not just pro athletes, but weekend warriors—will want to go to Europe to have this done, and Peyton won't just be the face of junk pizza and DirecTV, but of an unproven medical procedure and skirting FDA regulation abroad.
1 The Colts signed him to a $90 million contract extension two months after the operation
2 The procedure linked two of the vertebrae in his neck together and caused him to miss the entire 2011 season.
Image via Getty Images
Matt McCarthy is board-certified in internal medicine. You can follow him on Twitter here.