Would you go outside the US for Unapproved diabetes treatment?
For those Football fans among us, we know about the Mega star NFL’s Indianapolis colts quarterback Peyton Manning. Well Peyton Manning was an Iron Man starting every game for the team for the past 10 years or so, Until he got hobbled by a neck Injury this past off season that has so far defied 3 surgeries. His latest surgery was last month and he is expected to miss 2-3 months recovering.
That’s not the Interesting part though. On Sunday a report on Fox’s NFL pre-game show by Jay Glazer sent the sports world ablaze. It was on decision by Manning to fly to Europe to take advantage of an FDA-unapproved stem cell treatment for his neck. (the treatment was unsuccessful)
Beyond the obvious:
Sport analogies of competitive advantage such a treatment would present. (Think blood doping in cycling)
or The ethics behind such a decision.
Dr. Lawrence Goldstein, director of the University of California-San Diego Stem Cell Program, said he was unaware of any stem cell approach that is proven to help “any sort of spinal issue. “There are many proposed therapies that are being tested in clinical trials, and there are more to come,” Goldstein said in an email. “But in the absence of reliable evidence, it is impossible to know whether the ‘treatment’ will make Manning better or worse or merely financially poorer.”
Or The Perception
Dr. Ruth Macklin, professor of bioethics at the Albert Einstein College of Medicine in New York City, called Manning’s reported action “an act of desperation.
Macklin added that Manning could have made a more socially responsible choice by instead seeking out and enrolling in a clinical trial using this or another intervention.
“Although Manning is not engaged in an action that is clearly unethical, it sets a bad example,” she said. ”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.”
Or even about the message Manning might be sending to the general public with regard to unproven treatments.
“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 is no evidence of benefit to be gained.”
One Of the most contentious issues we as diabetics have with the FDA is the fact that they are slow to action, when it comes to approving desperately needed devices or therapies for the US market. (check out the DSMA chat on diabetic’s thoughts about the FDA)
Think Cellnovo’s Recent CE Mark Approval for World’s First Mobile Diabetes Management System. not yet approved in the US though or the fact that the FDA is still not completely Banning Avandia after it was Banned In Europe.
This CNN article from Sept 2010 details why the FDA never if rarely bans a drug once its on the market.
Yet Many believe that the FDA is dragging its feet on Approvals for the Artificial Pancreas project.
Standards of care is a just political term when it comes to non third world countries so its not as if we are talking about witchcraft or black magic here. If it is good for the Europeans why is it good enough for the US?
Peyton Manning is so desperate to play football again that he will do whatever it takes so OK he is also a gazzilionare who can afford the best treatments available.
“To say I am disappointed in not being able to play is an understatement,” Manning said in a statement released by his team earlier this month. “I simply am not healthy enough to play, and I am doing everything I can to get my health back.”
That Man must really love his Job. I would like to ask you guys or Jay Cutler (Chicago bears quarterback and type1 diabetic) for that matter If you would consider hopping the Pond for an artificial pancreas or any other deemed necessary diabetes therapy that is not approved in the US by the FDA?