Payton Manning’s Remarkable Comeback Story: Why the FDA is against stem cell research

For the Superbowl this year, even though I like and admire both teams, the defense of the Seattle Seahawks, and the offense of Payton Manning on the Broncos—it is the Broncos that I will be rooting for.  During the football year of 2011, Manning was forced to sit out the entire year and watch from the booth in Indianapolis as his football career appeared to be over with a neck injury that appeared irreparable.  Yet Manning, with the same resiliency he shows in all of his football games was determined to never say die even when the odds were very much against him.  He calmly made arrangements to have his injury fixed with stem cells returning a year later to a new team with the Denver Broncos having a strong season.  The very next year, he has taken that franchise to the Superbowl—a feat they would not have achieved without him.  Payton Manning singlehandedly cared the team on his back and with leadership that is very unique.  He took a team that would otherwise be average—to the most coveted sports event of the entire year—a Superbowl.

There was a wonderful article on this stem cell procedure which I thought was of interest to my readers here at Overmanwarrior’s Wisdom.  As my frequent readers know, I am very excited about the cures for cancer, the regenerative growth technology that is happening in the medical industry, and other exciting developments in stem cell research that are currently underway.  If Manning had followed the rules in The United States dictated by the FDA, Payton would have found his NFL career over two years ago.  He would not be playing in a Superbowl, and Denver would still be struggling to find an identity after their experiments with Tim Tebow.

The entirety of that article can be found at the end of this article for cross-reference but the gist of it is this–Peyton Manning, first 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 or unrelated entirely? 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 is 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 from 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 be wanting 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.

http://regressing.deadspin.com/what-the-hell-did-peyton-manning-inject-into-his-neck-1502352128

The American government is killing people because of their intense regulations and causing many millions of others to be ill when they don’t need to be.  The Peyton Manning story should be a lesson to us all of what kind of medical potential exists, but aren’t options because they threaten the power of the pharmaceutical lobby.  As the world watches Peyton Manning in the Superbowl finalize a 2013 season remember that Manning would not be able to play that game if he had followed the recommendations of the American government and the ridiculous rules of the FDA.  Look at your own aches and pains and remember the loved ones who painfully left your life through death and illness and answer your own question………………………..why?

The answer is because the FDA wants people sick—so they can stay relevant and keep everyone buying drugs at a pharmacy protecting the drug companies.  The option of stem cell research threatens those drug companies by making it so that people could be healthy, instead of always sick.  There is more money to be made off sick people than healthy ones.

For all those reasons……………….I am rooting for Payton Manning…………….one more time.

Rich Hoffman

 www.OVERMANWARRIOR.com