J&J's New Device for Spine Surgery Raises Questions

Artificial Disk Aims to Help Body's Natural Movement; Some See Risk if It Slips

'Big Money Riding on This'

June 7, 2005; Page A1

It sounds like an excellent answer for persistent back pain: an artificial disk, placed between the bones of the spine, that helps the body move naturally. After decades of research by doctors, Johnson & Johnson became the first to market an artificial disk in the U.S. last October, and surgeons are flocking to a J&J training center in Cincinnati to learn how to implant it.

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 -- more so, they say, than the repairs when fusion surgery goes wrong.

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.

"With proper patient selection and good surgical technique, the patients are generally very happy," Dr. Toselli says. "We're confident this is a definite improvement over fusion."

Fixing back pain has long stymied doctors. Many cases seem to stem from problems with the disks, which are like spongy shock absorbers between the bones of the spine. Thanks to the disks, people can bend and twist their backs in many directions. But sometimes disks slip out of position, bumping into nerves and causing pain. They can also degenerate with age or from the stress of repetitive motions.

When rest, exercise or painkillers don't relieve the pain, the traditional solution has been fusion surgery. Surgeons extract the troublesome disk or disks and fuse spinal bones together -- aiming to reduce pain at the expense of some flexibility. Low-back fusion surgery is performed nearly 200,000 times annually in the U.S.

Just as knee-fusion surgery has mostly been phased out in favor of knee replacements that allow people to walk almost normally, the artificial disks are designed to keep the spine moving in its natural way. 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.

The Charité artificial disk is implanted between the bones of the lower back.


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.

"I am lucky to be alive now," says Ms. Whittaker, a 52-year-old golfing enthusiast. During the nine-hour removal surgery, she lost a lot of blood. "I almost died on the table, twice," she says.

When spinal fusion fails, doctors can generally access the problematic spot from the patient's back, avoiding damage to vital organs. But to remove an artificial disk, surgeons must go through a patient's abdomen. Because scar tissue sets in after the initial surgery, it's more difficult the second time to move the major veins and arteries that block access to the spine. That is why patients such as Ms. Whittaker are at risk of severe bleeding.

J&J's Dr. Toselli says that of 11 patients who needed repair surgery for Charité in a key clinical trial only two had to have the disk removed. The others were able to get by with supplemental fusion surgery and didn't need to have their abdomens opened a second time. Dr. Toselli says fixing fusion surgery may also occasionally require a second abdominal cut.

Unanswered Questions

Joseph Riina, an Indianapolis surgeon who performed Ms. Whittaker's disk replacement and emergency surgery, says he still thinks the Charité may be right for some people but patients need to know there are unanswered questions about it. One of those questions is why Ms. Whittaker's disk slipped out of place. "We've sent films to surgeons all over the country," says Dr. Riina, who has instructed other doctors about the device. "No one has been able to give a reason for what happened." Ms. Whittaker hasn't sued anyone over the problems. J&J declined to comment on her case, citing incomplete information about it.

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 trial 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. He says he has spent considerable time reviewing European studies, FDA transcripts and other data on the Charité's safety. Dr. Rosen wrote a letter to the FDA last month demanding that the agency rescind its approval.

An FDA spokeswoman said the potential risks of the Charité, including the possibility of it getting dislodged, were considered during the review process. She said all back procedures have risks and benefits, and the agency is monitoring the academic debate.

Many surgeons are aggressively promoting disk replacement on their Web sites and in articles for specialist journals and the popular press. The promotions describe the new treatment with terms such as "revolutionary" and say it's suited to young, otherwise-healthy people who want to stay active. Many depict spinal fusion as problematic because it allegedly puts strain on the body's surviving natural disks. Whether that is so has yet to be proven, and Johnson & Johnson hasn't shown that Charité avoids this risk.

Some of Charité's critics predict that future artificial disks will be better. Medtronic Inc. of Minneapolis and Synthes Inc. of Switzerland both have artificial disks in U.S. clinical testing. John Peloza, a spine surgeon in Dallas, calls the Charité "a nightmare to fix" but thinks other devices using different materials might survive longer in the body. "I'm not trying to wreck spinal arthroplasty," he says, referring to artificial disks. "I'm trying to save it from a big black brush when [the Charité] goes bad."

At a packed Canadian meeting of spine specialists in January, Dr. Peloza accused Fred Geisler, a Chicago surgeon and J&J consultant, of hyping the Charité by suggesting in a presentation that it is superior to fusion surgery. Dr. Geisler says that is what his analysis of the clinical-trial data shows using multiple statistical tests, although J&J's own marketing describes Charité as an alternative to fusion rather than as a superior procedure.

"Peloza is aligned with Medtronic, so he thinks the Medtronic disk is better," says Dr. Geisler. "There is big money riding on this. Where there is big money, there are no disinterested people." Dr. Peloza confirms he is a Medtronic consultant, but says that doesn't affect his view of the Charité.

The idea of implanting artificial disks has been around for more than 30 years. The original version of the Charité was developed by orthopedic surgeon Karin Büttner-Janz, a former East German Olympic gymnast, and Kurt Schnellnack. It was named after the Charité hospital in Berlin where it was introduced in the 1980s. There are many other designs for artificial disks including some that would be implanted in the neck. Only Charité, which is designed for the low back, is FDA-approved.

The technology began to take off when big global medical-device companies began buying up small disk makers. In 2003 J&J's DePuy unit acquired Link Spine Group, owner of the Charité.

Treatment Overseas

Before the Charité was approved, Americans suffering from back pain journeyed to spine centers in France, Germany and Australia to get artificial disks. Mark Mintzer, a 48-year-old former computer consultant, said his back pain forced him to live like a "shut-in" for two years before he went to the Alpha Klinik in Munich in 2002. He mortgaged his house in Fountain Valley, Calif., to cover the $22,000 cost of disk replacement surgery plus about $6,000 in travel expenses for himself and his wife.

Three months after surgery, he was playing tennis. Later he resumed scuba-diving and flying planes. Today, he runs a small business out of his home to link prospective patients to U.S. and European spine surgeons.

John Regan of Los Angeles has performed nearly 200 Charité surgeries and says patients "do consistently better than patients of any other surgery we do." He says he receives royalty payments from J&J in connection with his work on Charité but they don't influence his professional judgment. Dr. Regan's patients were treated at Cedars-Sinai Medical Center in Los Angeles, which promotes artificial disk replacement in radio advertisements.

A leading critic of artificial disks, André van Ooij of University Hospital Maastricht in the Netherlands, warns against judging from early results. "Most patients will be happy for the first years, but the big problem will arise in later years," says Dr. van Ooij. "I am very negative about disk prostheses in general and the Charité disk in particular."

Dr. van Ooij has tallied 58 cases of Charité complications, including 27 that he reported in the Journal of Spinal Disorders & Techniques in August 2003. In many cases surgeons did a bad job inserting the device or chose the wrong size for the patient. More worrisome: Some problems occurred even when surgeons did everything right. Dr. van Ooij believes that artificial disks, rather than allowing the body to move naturally, instead promote "bad motion" in the spine.

Dr. van Ooij sent eight devices that had been surgically removed to Steven Kurtz, principal engineer at Exponent Inc., a scientific consulting firm in Menlo Park, Calif. 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. Such longevity is acceptable in elderly patients, the typical recipients of artificial hips, but may be a problem for the younger patients who often have surgery for back pain. 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.

Johnson & Johnson disagrees. It says its tests showed Charité's plastic core can withstand 80 years of wear and tear, far more than the typical hip implant. The company points to the results of a leading French spine surgeon, Jean-Philippe Lemaire, who has reported that 90 of the 100 patients he followed for 10 years had good or excellent results. Only two had complications involving the disk itself.

Even supporters of the Charité agree that inadequately trained doctors could botch implantation of the disk. At a training center and surgical laboratory in Cincinnati, J&J has given intensive instruction to more than 2,000 surgeons. By the fall, that number is expected to grow to 3,000.

At a recent training session, 24 doctors split up into two-man teams to practice implanting disks in calf spines. Each table had a TV screen so the doctors could watch and imitate the instructor as he operated on another calf spine. At one operating table, Dr. Toselli, the J&J spine-research chief, cut through ligaments covering the front of the spine to reveal the calf's glistening, whitish disk. He removed it methodically with long-handled gouges. After determining the proper size and angle for the implant, Dr. Toselli pried the spine bones apart with a pair of forceps and drove the implant into place with a steel hammer.

The visiting doctors also received instruction on how to get paid for the surgery, including tips on appealing thumbs-down verdicts from insurers. The instructors included J&J employees and veteran surgeons who tested Charité in clinical trials.

During a question period, doctors peppered the lecturers with questions about the durability of the disk and the kind of patients who could be treated. Some wondered whether fusion surgery could offer superior results. "Physicians, in general, are suspicious of new technology, and, as a company, we want them to be," says Dr. Toselli. He said he's confident doctors will appreciate Charité's merits once they try it.

Some doctors say they're worried they will lose business if they don't offer the Charité option to patients. "There's a feeling that it isn't adequately proven, but there's anxiety about being left behind," says Bernard Guiot, director of the spine program at the University of South Florida. Dr. Guiot went to the Cincinnati center in April to get credentialed, and praises J&J for its research and commitment to training. He says he might use Charité in some patients but hasn't done so yet.

Insurers have taken a mixed view of the device. Kaiser Permanente, the California-based health maintenance organization, endorsed the Charité last November after requests by its doctors but the Blue Cross and Blue Shield Association concluded there isn't enough evidence that the device works. Most of the nation's 40 independently owned Blue Cross and Blue Shield plans are following that advice.

One exception is Horizon Blue Cross Blue Shield of New Jersey. It decided the Charité is right for some patients and doesn't cost much more than spinal fusion, says senior medical director Stanley Harris. He puts the cost of the procedure, including doctor and hospital fees, at $67,000 per patient. J&J says a more typical figure is $35,000 to $45,000.