Dr. Purita in New York Times


As Sports Medicine Surges, Hope and Hype Outpace Proven Treatments

Published: September 4, 2011


It took her from doctor to doctor, cost her thousands of dollars and led her to try nearly everything sports medicine has to offer — an M.R.I. to show the extent of the injury, physical therapy that included ultrasound and laser therapy, strength training, an injection of platelet-rich plasma (or P.R.P.), a cortisone shot, another cortisone shot.

Finally, in February, she gave up.

“I decided this is never going to heal, so let’s get on with it,” she said.

And so Ms. Basle, a 44-year-old digital media consultant who lives in Manhattan, started running anyway. She has lost a lot of speed and endurance. And, she added, “the stupid hamstring is really no better.”

Medical experts say her tale of multiple futile treatments is all too familiar and points to growing problems in sports medicine, a medical subspecialty that has been experiencing explosive growth. Part of the field’s popularity, among patients and doctors alike, stems from the fact that celebrity athletes, desperate to get back to playing after an injury, have been trying unproven treatments, giving the procedures a sort of star appeal.

But now researchers are questioning many of the procedures, including new ones that often have no rigorous studies to back them up. “Everyone wants to get into sports medicine,” said Dr. James Andrews, a sports medicine orthopedist in Gulf Breeze, Fla., and president-elect of the American Orthopaedic Society for Sports Medicine.

Doctors love the specialty and can join it with as little as a year of training after their residency, as compared with the more typical two to four years for other specialty training. They see a large group of patients eager for treatment, ranging from competitive athletes to casual exercisers to retirees spending their time on the golf course or tennis court.

The problem is that most sports injuries, including tears of the hamstring ligament like Ms. Basle’s, have no established treatments.

Of course, some remedies for certain injuries do work: putting a cast on a broken bone or operating to repair a torn Achilles tendon. But patients whose injuries have no effective treatment often do not know that medicine has nothing to offer. And many expect cures.

“They watch ‘Grey’s Anatomy’ and think we can do anything,” said Dr. Raymond Monto, a sports medicine orthopedist in West Tisbury, Mass. “And to a certain extent, we allow that.”

Added to that is the effect of sports stars and their doctors. Patients “see a high-profile athlete and say, ‘I want you to do it exactly the same way their doctor did it,’ ” said Dr. Edward McDevitt, an orthopedist in Arnold, Md., who specializes in sports medicine.

The result is therapies that are unproven, possibly worthless or even harmful. There is surgery, like a popular operation that shaves the hip bone to prevent arthritis, that may not work. There are treatments, like steroid injections for injured tendons or taping a sprained ankle, that can slow the healing process. And there are fads, like one of Ms. Basle’s treatments, P.R.P., that soar in popularity while experts debate whether they help.

All this leads Dr. Andrew Green, a shoulder orthopedist at Brown University, to ask, “Is sports medicine a science, something that really pays attention to evidence? Or is it a boutique industry where you have a product and sell it?”

“For a lot of people it is a boutique business,” he said. “But are you still a doctor if you do that?”


A Theory Becomes a Fad

If ever anyone wanted to know how untested sports medicine treatments come into use, they would need only look at platelet-rich plasma, medical experts say. They joke that it is the perfect example of what is a tried-and-true path to popularizing a new treatment. It is what Dr. John Bergfeld, an orthopedic sports medicine specialist at the Cleveland Clinic, calls the Orthopedic Triad: famous athlete, famous doctor, untested treatment.


While there are no official statistics on P.R.P. treatment, all agree that it has exploded on the scene, propelled by testimonials from celebrity athletes.


Part of its appeal was that it made sense. Blood contains platelets that secrete growth factors that, in turn, can help tissue heal. So if a patient’s own platelets are injected into the injury site, they might speed recovery. And since it is the patient’s own platelets, the treatment is unlikely to be harmful.


It is easy to extract platelets. A doctor spins a tube of a patient’s blood in a centrifuge and then removes the middle layer of cells. Those are the platelets.


The claims by athletes and their doctors that brought the treatment to the fore began in the winter of 2009. Two leading football players for the Pittsburgh Steelers — Hines Ward, who sprained a ligament in his knee, and Troy Polamalu, who strained his calf — had P.R.P., recovered quickly and went on to play in the Super Bowl.


Earlier that year, a doctor for a pitcher for the Los Angeles Dodgers, Takashi Saito, said P.R.P. let the pitcher avoid surgery, which would have put him out of commission for about a year. Soon afterward, Tiger Woods reported that he had had four P.R.P. injections after knee surgery.


His doctor, Anthony Galea, who was later investigated for providing performance enhancing drugs to athletes, told The New York Times in December 2009 that within two days after his first treatment, Woods sent him a text. “He said he couldn’t believe how good he felt,” Dr. Galea said. “He’d joke and say, ‘I can jump on the kitchen table.’ ”


Having an athlete report that a treatment worked “is almost like direct-to-consumer advertising,” said Dr. Fred Azar, a sports medicine orthopedist in Memphis.


Of course, researchers say, testimonials from athletes and their doctors are a far cry from credible evidence. Most injuries eventually get better on their own, so if a patient has a treatment and then gets better, would the person have gotten better at the same time anyway? Or did the treatment actually slow the healing process? There is no way to know without a study that compares people who were randomly assigned to have a treatment with those who were randomly assigned not to have it.


But testimonials, especially from celebrities, had an effect.


Patients began asking for the treatment, and sports medicine doctors responded, offering it to speed healing of tissue and muscle injuries, mend broken bones and even help with arthritis.


(This reporter tried P.R.P. in 2009 for a torn hamstring and wrote in an article about the experience that it was impossible to know if it helped; her hamstring eventually healed.)


The number of commercially available kits for obtaining the platelet-rich plasma in a doctor’s office more than doubled, to 16 from six, in the past five years. Some journals devoted entire issues to the treatment, even though most of these papers fall far short of scientific rigor. Interest among orthopedists is so intense that the orthopedists’ association devoted a daylong session to the procedure before its annual meeting, something the group had never done before.


Prices varied widely from hundreds to thousands of dollars per injection. The cost of the equipment — tubing, test tubes — is about $150 to $200. The rest goes to the doctor and the hospital.


If an injury fails to heal, doctors often inject again and again. Insurers usually do not pay, so patients, like Ms. Basle, pay out of their own pocket — she paid $1,500 for an injection.


P.R.P. has gotten so popular, in fact, that there is sort of a price war. In some places, doctors who were charging more than $1,000 two years ago charge about $500 today.


In the meantime, sales representatives from equipment makers urge doctors to use it, telling them, said Dr. Marc Schneider, a sports medicine orthopedist in Cincinnati, that “there is no downside.”


But, Dr. Schneider asked, “is there an upside?”


Those who say no to requests for the treatment often lose patients.


“Patients come in and say, ‘I want the same thing that Tiger Woods had,’ ” said Dr. McDevitt, the sports medicine orthopedist in Maryland. “I say, ‘It really hasn’t been proven.’ And they say, ‘Well, I don’t care.’ ”


And when he refuses to provide the treatment to patients, Dr. McDevitt adds, “They usually say: ‘No offense, Doctor. You seem like a nice guy, but I will go to see one of the many, many other doctors who will do it.’ ”


As the editor of a newsletter put out by the orthopedics society, Dr. S. Terry Canale wanted to give doctors some guidance about P.R.P. There were lots of studies, but most were not rigorous, Dr. Canale said, and they came to contradictory conclusions. To further complicate matters, there were four different ways of preparing the treatment, and doctors asked if the different results reflected different preparations.


“It went on and on,” Dr. Canale said. “There was no obvious conclusion.”


Some of the best studies, though, were disappointing. For example, one found that the treatment was no better than saline injections for people with Achilles tendinopathy, a painful injury that often afflicts athletes like runners or tennis players and resists treatment.


Maybe, some said, the problem is that P.R.P. diffuses after it is injected.


Dr. Scott Rodeo of the Hospital for Special Surgery in New York addressed that in a new study. His patients had torn their rotator cuffs, a tendon in the shoulder, a painful injury affecting tennis players and swimmers, among others.


During surgery to sew the tendon together, Dr. Rodeo added P.R.P. directly to the injury, embedding it in a fibrin matrix that, he said, “is sort of like chewing gum” to ensure it stayed in place. The procedure did not help.


There was one rigorous study — of tennis elbow — that did have a positive result. But it compared P.R.P. with cortisone injections, which can impede healing. Critics said the treatment should have been compared with saline injections, which could serve as a placebo. A new study comparing it with saline found that it was no better than the salt water.


In February — when some of these studies were released, and others were still under way — Dr. Canale decided it was time to try to sort things out. He invited about 50 leading experts on P.R.P. to meet, review the data on the treatment and reach some sort of consensus on whether it worked.


They included Dr. Allan Mishra, an orthopedist in private practice in Menlo Park, Calif., who is supported by and gets royalties from one of the P.R.P. equipment makers, Biomet, and is on the board of directors and owns stock in another company, BioParadox, which is exploring the treatment for cardiovascular disease.


Dr. Mishra says more research is needed but offers the treatment for a variety of injuries. His Web page includes a TV news video that claims P.R.P. cured a Stanford football player, James McGillicuddy, with a torn knee tendon. On the program, Dr. Mishra says that, in general, 90 percent of the patients he treats “get better and stay better” after the treatment.


Dr. Canale, who says he receives no support from the P.R.P. industry, said: “The bottom line is that most think it works. The operative word is ‘think.’ They don’t know if it works. They have a feeling it does.”


Dr. Rodeo, who also reports having no conflicts of interest, said he understood that response. “Unfortunately in our field, there often is acceptance and use before there is data,” he said.


The Next Big Thing?

As orthopedists and other sports medicine doctors argue about this particular treatment, another popular treatment is forming. It leapt to the public and medical world’s attention this year when Bartolo Colon, a pitcher for the New York Yankees, made an astonishing comeback from elbow injuries and a torn rotator cuff that had plagued him for years and had kept him from pitching for all of 2010.


In May, Mr. Colon and his doctor, Joseph R. Purita, an orthopedic surgeon in Boca Raton, Fla., reported that Mr. Colon was treated with P.R.P. and “stem cells” — his own fat and bone marrow cells, injected into his shoulder and elbow. Dr. Purita worked with the Harvest Technologies Corporation, a Massachusetts company that also supplies equipment for P.R.P.


The opening scenes seem familiar to those who followed the saga of P.R.P.


Once again, there is a rationale behind the treatment, said Rocky Tuan, director of the Center for Cellular and Molecular Engineering at the University of Pittsburgh Medical Center.


The reasoning began with questions about why P.R.P. is not clearly effective. The problem may be that growth factors released from platelets need cells that can respond. But most tissues in joints and tendons have very few cells.


“That’s where stem cells come in,” Dr. Tuan said. Fat and bone marrow contain stem cells that might grow into joint or tendon if they were placed in the right environment. And if a patient also gets an injection of P.R.P., a tendon or joint might actually heal.


The key word, of course, is “might.”


For now, Dr. Tuan said, “no systematic study has been done.”


Original Article