Spine Surgeons React to BMP-2 Cancer Data

By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today

CHICAGO -- Spine surgery patients who got a bone growth stimulating agent as part of a clinical trial were three to five times more likely to develop cancer two to three years after being implanted with the product, according to a new analysis reported here.

The report is the latest cautionary note involving Medtronic's bone morphogenetic protein-2, or BMP-2, a popular genetically engineered product used in spinal fusion surgery as an alternative to using a small amount of a patient's own bone.

The analysis led by Eugene Carragee, MD, a Stanford University orthopedic surgeon, who presented the findings at the North American Spine Society's annual meeting, echoes findings in a Journal Sentinel/MedPage Today investigative report earlier this month. That story showed an elevated cancer risk in the clinical trial of an investigative Medtronic product containing BMP-2.

If approved it would be marketed under the brand name Amplify. Medtronic currently manufactures another BMP-2 product under the brand name InFuse. That product is FDA approved.

"This is a provocative study that should make surgeons most concerned," said Dan Spengler, MD, a professor of orthopedic surgery at Vanderbilt University Medical School. "I can't see a justification for its use except in extreme cases."

Carragee's analysis drilled down into data from a pivotal trial in which 239 patients were treated with the Amplify product and 224 controls, who had spinal fusion using autologous hip bone grafts.

Among those who underwent follow-up about three years after the surgery, 5% of those who got Amplify, or 12 patients, were diagnosed with a new cancer, compared with 1.3%, or three patients, who got a graft of their own hip bone. The difference was statistically significant P=0.02.

After two to three years of follow up, Amplify patients were four to five times more likely to develop at least one new malignancy, the analysis found. Viewed another way, one extra patient would be expected to develop cancer out of every 20 to 25 treated with Amplify.

Cancer cases that were diagnosed after spinanl fusion surgery among 239 patients who were implanted with BMP-2 as part of the Amplify clinical trial.


The cancer findings were not discussed when the findings were initially published.

"Who do we believe?" asked John Jacquemin, MD, an orthopedic surgeon from Cincinnati in response to Carragee's presentation. "When the literature comes out, what's real and what is not?"

Jacquemin said he was especially troubled by allegations of bias in papers written by doctors with financial conflicts.

"That scares me and troubles me," he said.

Jerry Knirk, MD, an orthopedic surgeon from New Hampshire, said he was concerned that most funding for medical devices comes from corporations.

"Money corrupts," he said.

The authors of the 2009 paper mentioned the cancer link only in a table accompanying the paper. The text itself never addressed the concern of whether BMP-2 might fuel cancer.

It was written by six physician authors. The first three authors of the paper - or entities they are associated with - received about $10 million from Medtronic, mostly in royalties, in 2010 alone. The royalties were for other products, not for BMP-2.

While the authors failed to warn of the cancer concern, the Journal Sentinel/MedPage Today found a full airing of the cancer question in more than 1,000 pages of U.S. Food and Drug Administration records. That information included FDA reports and information filed with the agency by Medtronic as part of its application to win approval for Amplify.

At a 2010 Amplify hearing, for example, an FDA staffer said "the primary statistical concern is an apparent association with malignancy."

Since coming on the market in 2002, BMP-2 has become popular in spinal surgery. By stimulating bone growth, it can eliminate the need to harvest a small amount of a patient's own bone for use in a spinal fusion surgery.

The product was approved for a narrow use after an earlier clinical trial showed it worked about as well as a standard hip bone graft in a specific kind of spinal fusion surgery. But doctors quickly began using BMP-2 in other, unapproved ways, known as "off-label" use. That helped fuel annual sales of $700 million.

Carragee said only a small portion of BMP-2 use follows the protocols of how the product originally was approved by the FDA. Most of its use is in so-called off-label applications.

He noted the doses of BMP-2 as well as the carrier used in the Amplify clinical trial are commercially available and as such are used off-label by surgeons.

Carragee said he thinks BMP-2 may fuel existing cancers.

He said in theory as people get older they have more cancer cells in their body, which the immune system tries to keep in check.

The addition of BMP-2, especially in higher doses, may disturb that balance and allow a cancer to grow, he said.

"At higher doses in people who are older and who have less resiliency to cancer, it's more worrisome," he said. "I would say, why risk it?"

Chiropractic Care Contributes to Optimal Performance of Baseball World Series Champions 2011 St. Louis Cardinals and 2010 San Francisco Giants

Cardinal pitcher Jason Motte advocates chiropractic care
CARMICHAEL, Calif. – Nov.  3, 2011 – As the St. Louis Cardinals celebrate their 11th World Series title and the San Francisco Giants relive their 2010 championship, the Foundation for Chiropractic Progress points to the role of chiropractic care in promoting faster recoveries, reduced risk of injury and enhanced on-field performance.  Chiropractic team doctors Ralph Filson, D.C. of the Cardinals, and Michael Gazdar, D.C. of the San Francisco Giants, explain that regular chiropractic care provides baseball players with proper spinal function and balance to reduce the risk of spine-related injuries, enhance recovery time and improve overall performance.
Dr. Filson, who began providing care to the players in 1990 through its then manager, Joe Torre, Major League Baseball (MLB) legend, says, “Chiropractic care is always available for players of the Cardinals and the visiting team, it is utilized by many.  With chiropractic care, players report that they feel better and have better endurance.  Body mechanics are significantly improved, enabling better pitching, hitting and throwing.”
Jason Motte, relief pitcher for the St. Louis Cardinals, shares, "I had issues with my shoulder and arm for a long time.  I started seeing Dr. Filson this year. Since then, I have not had any arm problems. The whole team appreciates him and the work he did throughout the season. I know while being under Dr. Filson's care, I was able to feel 100 percent while on the mound.”
In 2006, Dr. Filson was awarded a World Series ring for his role with the Cardinals, and was proud to play a similar role in the 2011 championship.  He also treated David Eckstein, Most Valuable Player on the Cardinals 2006 World Series Team, citing the importance of chiropractic care in helping players to achieve optimal performance:  “I am proud to have provided chiropractic care to the Cardinals for so many years, and gratified that chiropractic has contributed to the players’ optimal performance during every game.  We are all excited about bringing home the 2011 World Series title.”
According to Dr. Gazdar, who began working with the San Francisco Giants in 2008, and was seen by millions celebrating at the pitcher’s mound with the players following the game-ending play that resulted in the Giants World Series title, “Chiropractic care was a significant factor in the San Francisco Giants 2010 victory.  One of the Giants’ pitchers relied upon chiropractic adjustments for all of his pitching starts, and virtually every player benefitted from chiropractic services.” 
Both doctors express their enthusiasm for the inclusion of chiropractic care for virtually every team participating in professional sports, including golf, football, hockey, basketball and baseball. 



This press release was sent yesterday by the Foundation for Chiropractic Progress to 10,000 newspapers/wire services. Accompanying the article was a picture of Dr. Filson between GM Joe Torre and coach Tony LaRussa.

Fewer 'meds' = better health

For a long time, people believed they could get healthy by taking medicines. Yet, in recent years there’s been a lot of publicity about the dangers of prescription and over-the-counter drugs. The result is a trend away from medicines and toward natural health care. Sadly, however, many people still take far too many pills.
In fact, according to the Kaiser Family Foundation, prescription drug usage in the United States is continuing to rise. A recent report finds the number of prescriptions filled each year increased by 39% between 1999 and 2009, and the amount of money spent was $234 billion in 2008. The average American fills 12 prescriptions each year!
It shouldn’t be this way, according to a new research study that concluded both lives and money would be saved if medical doctors prescribed FEW drugs. What’s surprising is that the research was conducted at the University of Illinois at Chicago (UIC) College of Pharmacy! The report appeared in the online edition of the Archives of Internal Medicine as part of that journal’s “Less is More” series.
According to Bruce Lambert, the paper’s co-author and UIC professor of pharmacy administration, several studies over the past decade have concluded that the use of many new and frequently prescribed medications was either harmful or not beneficial to patients.
Medical doctors need to move away from the mindset that they need to prescribe the “latest and greatest” new drugs. Instead, they should prescribe fewer and only time-tested medications, said Dr. Gordon Schiff, associate professor of medicine at Harvard University, who co-authored the report.
The top “principle of conservative prescribing” suggested by the researchers is one that doctors of chiropractic already practice: The report urged people and their doctors to: “Consider non-drug therapies such as diet, exercise or physical therapy; look for and treat underlying causes rather than just mask symptoms with drugs; emphasize prevention rather than treatment.”
Another research project, this one conducted in Great Britain and published by the British Medical Journal, found that general practitioners prescribed high-risk medications for thousands of patients who – because of their health history or status – should never have received them.
Researchers pointed out how improper prescribing can cause considerable harm, and noted that “adverse drug events [negative side effects] account for 6.5% of all hospital admissions, over half of which are judged to be preventable.”
Dr. Russ Altman, a professor of bioengineering, genetics and medicine at Stanford University said, "Many side effects from drug interactions (not all) are exacerbations of known side effects of the single drugs that are made worse by the two drugs together." Dr. Altman co-authored a study in the journal Clinical Pharmacology and Therapeutics that found a widely prescribed antidepressant used in conjunction with a common cholesterol-lowering medication caused unexpected increases in blood sugar levels.
When it comes to prescription and over-the-counter drugs, the medical journal’s right – less IS more!

Heal Your Headaches Naturally

By Mao Shing Ni, L.Ac., D.O.M., PhD

One in six Americans experience chronic headaches. Headaches are especially common at this time of year when allergies wreck havoc on your sinuses. Luckily, Chinese medicine has an arsenal of natural remedies to help soothe your aching head.

When you have a headache, your body is trying to tell you something. According to Chinese medicine, pain is your body’s signal that there is a blockage of energy and blood. Your body is asking you to notice, evaluate and change the behavior that caused the pain in the first place. For example, a headache may be pointing to improper diet. It is best to heal pain using natural methods, so you can avoid side effects and also become more aware of your body’s unique needs.

Heal With White Light
How often have you uttered these words in a stressful situation: “This is giving me a headache!” It turns out that the human brain is genetically programmed to translate physical and emotional stress into headaches. Headaches can typically be prevented by relaxation or stress-releasing techniques like meditation and tai chi. Here is a simple visualization meditation called White Light Meditation that I have taught to my patients to reduce stress and headaches:

1. Sit or lie down comfortably. Clear your mind, relax your body, and breathe deeply and slowly.
2. Inhale and visualize a white light or clear mountain spring water entering your body at the top of your head and flowing down to your abdomen.
3. Exhale and visualize the white light or water continuing its downward course from your abdomen to the bottom of your feet, where it drains out.
4. Repeat for 10 minutes.

Usually you will experience a quick reduction in symptoms right after this exercise.

Herbal Tea Helps Headaches
Sichuan lovage, or ligusticum, has for centuries, been a traditional Chinese remedy for agonizing migraines. The usual dosage is 300 to 500 mg daily, or it can be taken as tea, 2 or 3 cups a day. You can find ligusticum (not to be confused with European lovage) in health food stores, online, and at the offices of acupuncturists and Chinese herbalists.

Ginger, a natural anti-inflammatory, has been used for thousands of years by the Chinese to cure pain. To make ginger tea, you can cut up the root, boil it for 10 minutes, then strain the water and sip as tea; you can also use ginger tea bags available in health food stores.

Release headache tension with this simple tea recipe: Boil 5 dried plums (prunes), 1 tablespoon of green tea, and 2 tablespoons of mint in 3.5 cups of water for 15 minutes. Drink no more than 3 cups a day when you get a headache until the pain subsides.

Press Valley of Harmony for Headache Relief
Recently, a patient’s 8-year-old child was suffering from a headache.  I was able to bring her the benefits of acupuncture without the needles. I simply used my own fingers to administer acupressure on an acupoint in the web between her thumb and index finger called Valley of Harmony. Within minutes, her headache was gone.

Find the acupoint Valley of Harmony (Li 4) on yourself.  It’s in the web between the thumb and index finger on both hands. Apply steady pressure with your thumb until you feel soreness. Hold for 2 minutes. Repeat on the other hand.

Added to Alternative Medicine on Wed 08/24/2011