The NFL Has a Problem with Stem Cell Treatments

barbara

Pioneer Founding member
http://www.technologyreview.com/news/533171/the-nfl-has-a-problem-with-stem-cell-treatments/

By Antonio Regalado on December 10, 2014

Professional athletes are getting injections of stem cells to speed up recovery from injury. Critics call it a high-tech placebo.

Elite athletes do whatever it takes to win. Lately, that’s meant getting an injection of their own stem cells.

The treatments, developed over the last eight years, typically involve extracting a small amount of a player’s fat or bone marrow and then injecting it into an injured joint or a strained tendon to encourage tissue regeneration. Bone marrow contains stem cells capable of generating new blood cells, cartilage, and bone.

Although the treatments have become a multimillion-dollar industry, some doctors say there’s only thin medical evidence they actually speed healing. In a report issued last week, public policy researchers at Rice University criticized the National Football League’s role in promoting “unproven” treatments to the public. Some players, including Peyton Manning of the Denver Broncos and Sidney Rice, who’s now retired but won a Super Bowl with the Seattle Seahawks last year, have reportedly gone overseas for stem cell treatments and others have acted as spokespeople for U.S. clinics offering them.

The Rice researchers, Kirstin Matthews and Maude Cuchiara, say the NFL should create an independent panel and fund research on whether stem cell treatments actually work, similar to what it did after facing questions around concussions and brain injury. “I think they should be more proactive. They should get ahead of this one,” says Matthews.

Sports Illustrated reports that hundreds of football players have gotten stem cell treatments, with many travelling abroad for types of therapy not offered in the United States. But it’s not only football players trying them. The tennis player Rafael Nadal is reportedly undergoing stem cell treatments for back pain, and the injections are also being sought out by soccer players and high school athletes.

The NFL didn’t respond to questions from MIT Technology Review. Doctors offering the treatments say they’re promising and should be given a chance. Others say there’s not enough data. “Any of these injections have a placebo effect,” says Freddie Fu, an orthopedic surgeon who is chairman of sports medicine at the University of Pittsburgh Medical Center and top doctor for the school’s sports teams. “We don’t know what we are putting in. We don’t really know what exactly what it does, biologically.”

Orthopedic surgeons hope one day to use stem cells to regenerate cartilage and other lost tissue. But wishful thinking, and profits, have gotten ahead of the facts, says Fu. “There’s a lot of marketing in orthopedics right now. I would say 15 to 20 percent of treatments are not effective,” he says.

Unlike a drug, which gets tested for years and is then weighed by experts and the U.S. Food and Drug Administration before hitting the market, the bone marrow treatments offered in the U.S. aren’t regulated.

At many private sports clinics and some academic medical centers, such treatments have become routine. Kenneth Mautner, director of primary care sports medicine at Emory University and team physician for its athletics department, says he performs about two to four bone marrow injections a week. “I’ll be the first one to tell you it’s a new procedure,” he says. “The evidence from human studies is really weak at this point.”

Still, Mautner says he thinks he’s seeing success in some patients, and there is plenty of demand. “We have patients who have the financial means, and who want to get back faster, before the literature can back it up,” he says. An injection of bone marrow for a sports injury costs about $6,000 and isn’t covered by insurance.

“Demand is exploding,” says Mitchell Sheinkop, a Chicago-area physician who says he’s injected bone marrow into the knees and hips of 400 patients in the last two years, in connection with a company known as Regenexx that is based in Colorado. He says he thinks the treatments are allowing some patients to postpone getting hip or knee replacements.

Chris Centeno, the doctor behind Regenexx, says it’s a mistake to apply the same standards of evidence to bone marrow treatments as is asked of new drugs. “The university approach has the obvious advantage of evidence first but the obvious problem of a glacially slow and hyper-expensive process to translate therapies to patients,” he says.

But, Fu asks, what if the injections don’t really work? They could gobble up huge amounts of money for years until doctors gradually move on to something else. He notes how many NFL players used to suck oxygen by the sidelines, until they realized it wasn’t really doing anything. Now oxygen tanks are rarely seen at sports events.


The Rice authors say what bothers them is the role that NFL players have had in promoting unproven treatments. One U.S. clinic, SmartChoice Stem Cell Institute, says it has signed former NFL linebacker Tom McManus as a spokesman. Meanwhile, clinics offering overseas procedures, like Precision Stem Cell, use images of players including Rolando McClain, now of the Dallas Cowboys, and promote media reports of players who have had treatments.

“Our patients are reading that and saying ‘We want what this guy got,’” says Shane Shapiro, an assistant professor of orthopedic surgery at the Mayo Clinic in Florida.

Shapiro is now carrying out a test of the bone marrow treatment in about 25 older people with arthritic knees. The process is similar to that being offered by private clinics. After obtaining bone marrow through a biopsy, it’s spun in a centrifuge to concentrate cells. He says he ends up with about 40 million cells—a tiny fraction of which are stem cells. To create a scientifically controlled situation, each patient gets two injections: bone marrow in one knee and a placebo of salt water in the other.

It will take another year to know the results. In the meantime, Shapiro says he’s turning away athletes who want to pay for the injections. “I have not felt comfortable charging for it without knowing if it really works,” he says.
 

barbara

Pioneer Founding member
Dr. Centeno replies

http://www.regenexx.com/2014/12/the-nfl-sports-figures-and-stem-cells/

NFL Stem Cell Treatments…

NFL athletes have been getting stem cell treatments in order to try and heal difficult injuries more quickly. We’ve treated our share of them through the years. Recently a Rice University professor penned an article that focused negative attention on this issue. So what gives?

My thoughts on the topic are “nuanced” as usual. The Rice professor (Kristin Matthews) wrote a article on the stem cell treatments that NFL players are receiving, painting those in a negative light. The word “unproven” was used. I first became aware of her paper when I was contacted by a reporter for the MIT Technology Review site. My back and forth with that reporter is illustrative of the issues. In the end, the writer, Antonio Regalado, wrote a very balanced piece on the topic.

First, for Matthews to place stem cells used for sports injuries into the “unproven” category, the other side of the coin must first exist in sports medicine-i.e. proven therapies with high levels of research evidence to support their efficacy. Anyone that has read my recent post on how the evidence base behind traditional orthopedic surgery is falling part at the seams knows that the second category really doesn’t exist. To put a finer point on it, this was my position:

“Is it in society’s best interest to only support medical innovation through the university-pharma pathway where high levels of evidence are required before use or is it better to also support physician based innovation where observation of efficacy followed by increasing levels of evidence are the norm? On the one hand, the university approach has the obvious advantage of evidence first, but the obvious problem of a glacially slow and hyper-expensive process to translate therapies to patients. On the other hand, physician driven innovation has the advantage of much faster clinical translation that’s focused on addressing real world clinical needs and the disadvantage that sometimes the evidence base fails to support the care.

[Matthews] also begins with the thesis that it’s the norm in sports medicine to only use therapies that have high levels of evidence, yet this isn’t the case. For example, we have no high levels of evidence to support almost all common orthopedic surgical procedures used in sports medicine including menisectomy, arthroscopic micro fracture, rotator cuff repair, Tommy John elbow surgery, foot/ankle ligament reconstruction surgery, ACL repair, etc… While these procedures have been observed by physicians to work, they lack the type of evidence [Matthews] wants for stem cells…Stem cells in orthopedics have been following that same medical innovation pathway since the 90s when the first papers were published by Hernigou. Where is the evidence base right now for something like knee arthritis? About the same place it is for knee micro fracture. Our self-funded RCTs should hopefully take that level of evidence up a few notches. However, while the concept that level 1 evidence is required before a therapy is used may be a widely held university belief, it’s clearly not a widely held belief in the community of physicians treating orthopedic injuries.”

I also pointed to the wonderful thought experiment published by Cambridge researchers on why we don’t need randomized controlled trails on the use of parachutes to reduce gravitational induced trauma (this is Monty Python funny)! While this research paper obviously pokes fun at the quasi-religious fervor that many academics have when it comes to evidence based medicine, it also raises a very serious point. More evidence is wonderful to have, but as a physician, letting patients suffer because you’re paralyzed by a lack of evidence is also not right.

The upshot? The Matthews paper is based on a flawed thesis that sports injuries are commonly treated with surgeries that have high levels of scientific evidence to support their use. Hence the author uses the logic fallacy known as a “false dilemma”. A false dilemma is a type of informal fallacy in which only limited alternatives are considered, when in fact there is at least one additional option. That additional option here is that orthopedic care is frequently used when there is less than high levels of evidence based on the simple observation that it works. That reality certainly has it’s problems, like care that may not work may get purchased. However, it would be horribly misleading to let the public believe that the university conceptualization of medical evidence is a widely held belief in orthopedic care, as judging by results, it is not. As a result, placing orthopedic stem cell use in a separate category of “unproven” makes no common sense (or in academic speak-“has no face validity”). If you’re going to do that, you might as well place all orthopedic care in the “unproven” category.
 
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