Back Fire: J&J’s New Device for Spine Surgery Raises Questions; Artificial Disc Aims To Help Body’s Natural Movement; Some See Risk if it Slips; ‘BIG MONEY RIDING ON THIS’

Wall Street Journal

June 7, 2005

Patients need to know there are unanswered questions.

John Peloza, a spine surgeon in Dallas, calls the Charité “a nightmare to fix.”

Now a vigorous debate has emerged among doctors about the durability of the J&J device and its effectiveness compared with older “fusion” surgery, in which the bones of the spine are fused together. Some surgeons are predicting that a wave of patients will suffer complications over the next 10 to 15 years and need to have the device, called Charité, removed. That’s particularly worrisome because the surgery to take it out can be dangerous.

J&J says malfunctions are rare. About 5% of Charité patients need a new operation to fix problems, in line with older surgeries, says Richard Toselli, vice president for research and development at J&J’s DePuy Spine subsidiary. He says in most cases repair surgery doesn’t involve big risks.

The Charité—a plastic core sandwiched between metal plates—is implanted between the bones after the patient’s own disk is removed. About 2,500 people have received the Charité disk since it was approved last year by the Food and Drug Administration.

By 2010, the market for artificial disks, including Charité and others still being studied, could approach $1.7 billion a year, according to a recent estimate by J.P. Morgan. Charité’s list price is $11,500. Spine surgery also brings in big money for hospitals: A single operation, whether for an artificial disk or spinal fusion, can cost $50,000 or more including all fees.

Susan Whittaker of Indianapolis sought relief from back pain with everything from Pilates exercises to cortisone shots, to no avail. So when a surgeon told her that she was an ideal candidate for an artificial disk, she decided to go under the knife in January.

The surgery went smoothly, her recovery was swift and her pain almost disappeared. But one morning a month later, she woke up with a hugely swollen leg. Tests showed that her Charité had slipped from its place between bones of the spine. She needed emergency surgery to remove the disk, which had become intertwined with blood vessels.

Charité’s critics, including some insurance companies that are refusing to cover the procedure, focus on the key trial of 304 people that J&J used to win FDA approval of the device. They say the two-year trail was too short to prove that the artificial disk can sit in the spine indefinitely without falling out of place or causing other problems. What’s more, Charité was compared in the trial with a then- standard version of fusion surgery that is now outdated and it worked no better in relieving pain after two years.

In older forms of fusion surgery, doctors chop out a chunk of the pelvic bone to use in fusing the spinal bones. Today, surgeons often use a biologic material called bone morphogenetic protein to stimulate bones to fuse.

The FDA approval of Charité “puts the American people potentially at great risk for receiving operations that could fail at a high rate and result in untreatable pain and disability”, says Charles D. Rosen, a surgeon at the University of California at Irvine’s spine center.

Dr. Kurtz concluded that the disks wear out in a manner similar to artificial hips and knees that generally last up to about 10 years. Dr. Kurtz, who has consulted for Medtronic and other medical- device makers, says many younger patients who are getting artificial disks may need a life-threatening operation to remove a worn disk in 10 years or less.