Archive for the ‘Entertainment’ Category
As Sports Medicine Surges, Hope and Hype Outpace Proven Treatments
GINA KOLATA Published: Sunday, September 4, 2011 at 3:30 a.m. Last Modified: Tuesday, September 6, 2011 at 12:14 a.m.
Until she tore her hamstring a year and a half ago, Tina Basle ran marathons. Since then, she has been on a desperate search for a cure.
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 Cleveland, 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.
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.”
As Sports Medicine Surges, Hope and Hype Outpace Proven Treatments
Tags: Pittsburgh Medical Center, boca raton, Sports Medicine, Allan MishraNatural Detoxification Gives the Addict the Best Chance to Recover
The first part of drug detoxification is the process that involves getting all of the drugs all the way out of the body. Many people report this as being the most intense and painful part of rehab because your body is so used to having the drug it becomes dependant on it in many ways. Since most abusers have an addictive mentality naturally, its best if the patient can go through this detoxification without the use of any other drugs. This natural process will give the patient the best chance to succeed in recovery. Here’s a bit more about what’s involved with this process.
The best drug detox rehab centers offer natural detox processes because it is what is the safest for their patients. Ensuring that the patient receives no more drugs even in the detox process means that it will put a stop to the damage drugs are going to do to their body. Sometimes the damage done to various parts of the body will be permanent. For example, many alcoholics have live irreversible liver damage that is a common problem. On the other hand, there are plenty of patients that can recover fully and their body will operate just as it did before it started abusing the drugs.
When going through the painful withdrawal process the body will hurt and your mind may even play tricks on you. Many people report seeing things and being extremely paranoid and on edge throughout the first part of withdrawal. Of course the symptoms will differ from each person depending upon what drug or drugs were abused and the length of time they were abused for. Other factors will come into play as well including the medical history of the abuser and the current shape they are in.
However, if the patient can make it through the withdrawal process drug free it will make their body stronger and give them a better chance to succeed with their recovery over the long-term. This natural process will only be allowed in certain circumstances and for certain people. The medical professionals in charge of the drug treatment facilities will know which route will be best to take for each individual case. Some people are just so far gone with dependency that they will need drugs to ensure that their body doesn’t go into shock or seizure.
Have a conversation with these medical professionals about the care for yourself or loved one to see which route will be best. Ask them about doing it naturally and get their opinion before ever trying to go through withdrawal with no help at all.
Natural Detoxification Gives the Addict the Best Chance to Recover
Tags: drug detox, medical professionals, Health Medical Pharma, drug treatment facilitiesWhat is my diagnosis?
okay,
i think i might have colon cancer, im a 14 year old female.
about a month ago when i started having bowl movements some of my stool would be solid and the rest would be diharrea. it has been like that since and sometimes i wont have a bowl movement for a couple days and then when i do it will be diharrea again. ive been having alot of gas as well, whenever i would try to have a bowl movement all i would do is pass gas.
i dont want to talk to my mom about it yet, because sometimes i just get paranoid. and ive already told her about the frequent diharra and she said it was normal.
but is there any chance i could have colon cancer?
Are you sick? Because it isn't normal for you to have diharrea for a month. Ask your mom if she could take you to see a doctor.
This type of cancer is extremely rare on the young and even rarer in the adolescent (e.g. 14 years of age). It is an elderly cancer.This could be several things as follows:
1) Stress. Are you stressed at all..about schoolwork….friends….especially boyfriends or even girlfriends? Parents hasseling you to do better at school…perhaps "grounding you" for some trouble etcetc.
2) Irritiable Bowel Syndrome. This is common and there is treatment for it.
3) Bowel Infection.(Viral or Bacterial) If you've been a month with it already and you are not particularly bothered by what is indicated in number one above.. you are not stressed…then it may be worth while to try the following;
Abstain from all solid food for 24 hours..drink liquids..water , fruit juice etc. but no dairy (e.g. milk, yoghurt, ice cream etc)Drink at least 2 litres of water a day gradually.This prevents dehydration.
After 24 hours..gradually come back on solid food..but take it easy …eat light meals for the next 3 or 4 days and no fat and no dairy (e.g. milk..yoghurt etc). If this will not resolve it and you remain the same…then it is not viral..it may be bacterial…and this means that you have to see a doctor for antibiotics. If after trying this…then process of elimination has come down to… either Irritiable Bowel Syndrome..or some other condition but not serious. It would be then a good idea for you to undertake a Colonoscopy in order to definitely establish a condition. I suggested trying the above prior undertaking a Colonoscopy as this procedure in itself is not major..but the preparation is quite hassling….you have to take PecoPrep for 24 hours…and you'll be on the toilet for that long cleaning yourself out..you cannot go out
Dietary issues, plain and simple.
Tags: human interest, alot of gas, bowel syndrome, pass gasIs it normal for my cat's foot pads to be dry and cracked?
He is an indoor cat, and is very clean, but his foot pads are dried out and cracked. Is it normal? Should i get him treatment?
Is it normal for my cat's foot pads to be dry and cracked?
Tags: human interest, Health Medical Pharma, foot pads, indoor catWellstat Grants U.S. Distribution Rights to its Investigational Antidote for 5-FU Overexposure to Specialist Healthcare Company BTG
Press Release Source: Wellstat Therapeutics Corporation On Wednesday July 6, 2011, 2:00 am EDT
GAITHERSBURG, Md.–(BUSINESS WIRE)– Wellstat Therapeutics Corporation announced today that it has granted U.S. marketing rights for the company’s investigational drug uridine triacetate to the specialist healthcare company BTG International Inc. for use as a potential treatment for accidental overexposure to the chemotherapy drug fluorouracil (5-FU) due to dosing errors or impaired clearance of 5-FU from the body. Wellstat has retained commercialization rights for treatment of 5-FU overexposure outside of the U.S. and for all other potential uses of uridine triacetate.
Under the terms of the agreement, BTG will have exclusive rights to market, sell and distribute uridine triacetate as a treatment for 5-FU overexposure in the US for up to 10 years from marketing approval. Wellstat will be responsible for completing development and regulatory filings and for product manufacture. BTG will pay Wellstat an upfront payment, milestone payments upon NDA acceptance and approval, and transfer pricing payments based on manufacturing costs and a significant percentage of net sales.
While uridine triacetate has not yet received marketing approval, it will continue to be available to patients in the US under emergency use INDs and an expanded access protocol. It is anticipated that the New Drug Application will be submitted during the first half of 2013. The compound has been granted orphan drug designation both in the United States and outside the U.S. Until approval, any inquiries or requests for uridine triacetate should be directed to Wellstat.
“We are delighted to be working with BTG to address this important unmet medical need. This transaction provides significant value to Wellstat and will help accelerate uridine triacetate’s movement towards approval and commercialization,” said David M. Wohlstadter, Vice President of Licensing and Business Development for Wellstat. “In addition, we look forward to further development and commercialization of uridine triacetate in territories outside the U.S. as well as in other indications worldwide.”
Louise Makin, BTG’s Chief Executive Officer, commented: “There is currently no available antidote for 5-FU overexposure, so uridine triacetate will meet a real need if approved. As an oncology antidote, it is an excellent fit with our existing US acute care business and will enable us to leverage the sales team and back office support infrastructure which we have already put in place.”
In use as a cancer drug for decades, 5-FU is a mainstay of various treatment regimens for solid tumors including those of the colon, stomach, esophagus, breast, and head and neck. The drug is most commonly administered by infusion pump at or near what is considered the maximum tolerated dose. Expected side effects of 5-FU include myelosuppression (a reduction in white-blood-cell counts and thus increased risk of infection), diarrhea, nausea, vomiting, and mucositis (a painful inflammation of the mucous membranes lining the digestive tract). Overexposure to 5-FU can lead to severe myelosuppression, gastrointestinal hemorrhage, septic shock, multiple organ failure, and death.
The incidence of 5-FU overexposure is low though difficult to quantify. Overexposure may result because patients vary in their capacity to break down 5-FU and eliminate it from the body and because infusions pumps can malfunction and be misprogrammed.
About uridine triacetate
Uridine triacetate is an investigational drug currently under development for use as a treatment for overexposure to 5-FU due to dosing errors or impaired clearance of 5-FU from the body. It is an orally active prodrug of uridine, meaning that uridine triacetate is converted to uridine in the body. Once uridine triacetate is converted to uridine it reduces the incorporation of 5-FU metabolites into non-cancerous cells. Because of the poor bioavailability of oral uridine, however, and because of complications associated with intravenously administered uridine, uridine itself is not a clinically viable treatment for 5-FU overexposure. Studies have demonstrated that uridine triacetate delivers about eight-fold more uridine into the bloodstream than does oral administration of uridine itself.
Wellstat is also investigating the potential use of uridine triacetate when given after high dose 5-FU administration to cancer patients, as well as for the potential treatment of neurodegenerative and mitochondrial disorders. Uridine triacetate does not have marketing approval for any indication.
About Wellstat
Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. Wellstat Therapeutics is part of the Wellstat group of companies. For more information, please visit the website at http://www.wellstat.com
About BTG
BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products. For further information about BTG please visit our website at www.btgplc.com.
Tags: united states, commercialization rights, drug application, net sales, regulatory filings