After years of suffering from an aching back, 49-year old fork-lift driver Calvin Timberlake opted for surgery on December 14, 2006. With the help of his doctor, he chose a rigorously tested and FDA-approved procedure. The clinical trails boasted that it was the best procedure out there. The surgery was smoother. The recovery times were quicker. The benefits were greater. So, when he went under the knife he had good reason to think his troubles would soon be behind him.
Little did he know that doctors would be scrambling to save his life just months later…
Like many back sufferers, Timberlake had tried it all. Injections… medications… physical therapy… Anything to relieve that aching pain. But nothing had worked.
That’s when he heard about a state-of-the-art procedure that seemed like it could change all that. The procedure replaced busted discs with implanted artificial ones called ProDisc. All the reports sounded great: the procedure had been thoroughly tested by several doctors and the studies showed great results…
Best of all, it was approved by the FDA. Timberlake consulted with his doctor to get his advice and he got the thumbs up.
Nervous but assured of a good outcome, Timberlake submitted to surgery. His busted discs were removed and the new disc was inserted into his spine. The surgery went smoothly. The medical advice seemed good. Timberlake was hopeful he’d be back to work in no time.
But just five days after his surgery the x-rays suggested something was wrong. His surgeon had concerns. And that was the beginning of his nightmare…
Over the next few weeks his pain increased. His back felt worse than ever! Instead of healing, he was getting worse. Over the next couple of months, the ProDisc dislodged and literally fell to pieces inside of him!
Three months later, he was back in surgery again. This time it was an emergency operation to remove the collapsing ProDisc. When the doctor opened him up, the disc was in pieces… And the disc insert had separated from the metal end plates and was now attached to his iliac vein.
Timberlake was in a battle for his life. The surgeon worked desperately to remove the disc and staunch the bleeding vein. But three hours later he was still in danger. The doctor desperately called for a second surgeon. Together they battled to stop the bleeding… contain the damage… and try to save Timberlake’s life.
Finally, they wrestled control over the operation. They staunched the bleeding and removed the ProDisc.
But the nightmare still wasn’t over… There were so many complications that the surgeons couldn’t complete the fusion. Instead, they had to do a second surgery after Timberlake had had time to recover. And so six days later they went in again… They fused vertebras and inserted new hardware.
They had removed the ProDisc and saved his life. But the damage was done. The ProDisc had created bilateral fractures in his spine… meaning permanent disabling pain for Timberlake.
Timberlake’s story is completely true. And it’s not a one-off incident. In the months ahead, Timberlake and others would find out more about ProDisc. And the truth reveals a frightening new trend in the whole backache business…
Offering False Hope
ProDisc seems like the solution that back sufferers are seeking. It replaces busted discs with artificial ones. If busted discs are the cause of back pain – and there are plenty of experts who say they are not – then replacing them with new ones makes sense.
Plenty of leading spine surgeons supported the ProDisc. And a study was conducted on 240 patients to test the procedure. The clinical tests went well. They reported smooth operations… quick recoveries… better back benefits.
Heavily involved in the study, leading spine surgeon Dr. Jack E. Zigler voiced his support. “Patients recover function more quickly than after fusion and return to their normal activities easily,” he said.
The study was led by an army of spine surgeons and conducted at 17 centers around the country. The glowing results were passed to the FDA for review… and quickly got the stamp of approval.
Thousands of back-sufferers paid for the procedure… and at a cost of about $10,000 they had good reason have faith in it. But if they knew the truth behind those studies… the motivation behind the doctors’ claims… they’d have kept their money – and their backs – away from ProDisc.
Patients who had the surgery and suffered adverse reactions – like Calvin Timberlake – couldn’t understand how the trials could be so wrong. And it’s only after they took legal action that the truth started to emerge.
And it revealed a frightening money chain that raises questions about the ethics and motives of the doctors involved. Here are the disturbing facts that came out of the ProDisc court documents.
The Truth behind the Trials
A start-up company in New York founded Spine Solutions in 1999. The company was a partnership between a German medical device maker and a New York investment firm called Viscogliosi Brothers. Spine Solutions developed ProDisc within its first 12 months of operation.
Enter Dr. Zigler – a spine surgeon at the Texas Back Institute. He performed the first U.S. ProDisc surgery in 2001. He must have liked what he saw… or recognized the potential profits. He invested over $25,000 to fund Spine Solutions.
The Texas Back Institute invested another $75,000. And several other doctors at the Institute invested a further $70,000.
Benefitting from Backache
Many other spine surgeons jumped on the bandwagon…
Spine surgeon Frank P. Cammisa, Jr. kicked in $250,000. His hospital also bought stock. Dr. Richard A. Balderston, Dr. Thomas J. Errico, and Dr. James Zucherman each invested over $100,000.
And what’s scary is… they were all heavily involved in the clinical trials. It’s their tests that the FDA approved.
Dr. Balderston kicked in closer to $500,000. He was a heavy investor by the time the FDA recruited him for the studies.
According to court records, he never mentioned this when he filled out the investigator form. He didn’t see any reason why he’d need to disclose his investment, according to his court statement.
“There were a lot of people who invested,” he said. “My small number was not significant.”
Here’s another piece of the puzzle… When the “Brothers” sold Spine Solutions to Swiss medical device maker Synthes, they received $175 million. Synthes promised them another $175 million if ProDisc got regulatory approval.
So when Synthes submitted the ProDisc study to the FDA, they used partial results from patient trials.
They chose not to include 50 ProDisc patients who they considered “training cases.” They explained them away as surgeries performed while doctors learned the procedure. Another 21 patients were also left out from the results.
Taking It to the Courts
Many patients were unhappy with the results of the ProDisc procedure. Several brought cases against Synthes. Timberlake is one of those patients. Patricia Kennedy was another who said the procedure left her worse off than before.
According to her court record, she said her surgeon was “more concerned with the prospects for the ProDisc than her medical care.”
Her surgeon was none other than Dr. Balderston. She settled on undisclosed terms out of court. Both she and ProDisc representatives have remained tight-lipped since.
Doctors and Devices
The ProDisc debacle reveals the financial relationship between doctors and devices. It shows that surgeons have a financial stake in expensive treatments… And that they are often same doctors who are conducting tests to show that the treatments are effective.
“American medicine is riven with financial conflicts of interests,” says Dr. Nortin Hadler, a professor at the University of North Carolina. “Surgeons are rewarded by [the makers] of the gizmos [they] advocate.”
There’s an obvious danger in having doctors financially linked to the drugs or devices they prescribe to patients. Plus, the whole purpose of clinical testing gets clouded. Researchers are no longer just looking out for the safety of a drug or procedure. They are also caught up in the money that can be made from it.
“Even the patients of spine surgeons see no problem if they are offered a device [made] by a manufacturer for whom their surgeon is a paid consultant,” says Dr. Hadler.
While patients are left with the damage of these procedures, the ProDisc scientists are already looking at new opportunities. Dr. Zigler is researching a spine-stabilizing machine for Applied Spine Technologies. And Dr. Errico is investigating a new spinal implant for Paradigm Spine.
The Wider Scope of Pain
The ProDisc procedure is just one aspect of back surgery that’s in doubt. Many leading experts question whether there are ANY benefits from drugs and spinal surgery.
“Medicine is no longer a cottage industry,” says Dr. Hadler. “It is a complex industrial enterprise.”
Experts like Dr. Hadler call into question the effectiveness of surgery, medication, and devices. They say back surgery is not the answer… that there isn’t enough evidence to support it.
“Back pain has little to do with ruptured discs or any other form of spinal pathology,” says Dr. Hadler.
Rather than opting for surgery, a safer bet is to explore natural options that can ease your back pain.
What You Can Do
Plenty of physical therapists believe that simple lifestyle adjustments can relieve pain and repair back problems.
Dr. Jeffrey Wock – who operates a chiropractic wellness clinic in Minnesota – says diet and exercise are critical factors in improved back health.
“Exercise improves muscle function and circulation,” he says. This is important because it ensures a flow of blood to your back muscles. That blood carries essential oxygen and nutrients and removes irritants like lactic acid.
A balanced diet ensures that your back muscles get the energy, vitamins, and minerals they need to work properly.
Dr. Wock also promotes proper stretching exercises to restore back health. Remember when you were a child? You had no problem touching your toes. There aren’t too many children with back problems… so it’s logical that increasing your flexibility is essential to back health.
Here’s one simple stretching exercise that you can try:
Stand up straight in a doorway. Grasp the door frame with one hand at waist level. Holding onto the door frame, gently push back and away from it.
Push away until you are bent over at a 90 degree angle, making sure your knees are not locked. Your arm, shoulder, and back should form a straight line. Bend your knees. Hold the position for five seconds, and rotate your body slightly to one side to get the best stretch possible. Slowly come up and repeat with the other hand.
Repeat both stretches 5-8 times at least once per day.
Experts like Dr. Wock recommend taking your flexibility to the next level. Stretching is a great option for relieving back pain… but yoga and Pilates can actually realign your posture and may be able to permanently ease your back problems.
Look for an in-depth article on yoga, Pilates, and stretching for back health in an upcoming edition of Natural Health Dossier.
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To your health,
NHD “Health Watch”
About Dr. Hadler:
Nortin M. Hadler, MD, is the professor of medicine and microbiology/immunology at University of North Carolina School of Medicine. He is also the attending rheumatologist at University of North Carolina Hospitals, Chapel Hill. He has written several best-selling books on medicine including Worried Sick and Stabbed in the Back.