Hope Slips for Disc Implants

Measuring Success

Swiss device maker Synthes, which already controls more than 10% of the U.S. spine market, hopes to gain FDA approval to sell an artificial disc in this country next.

UBS analyst Martin Wales last month started recommending the company's stock, which trades mostly in Europe, in part because of that new opportunity. Wales is looking for the company's ProDisc to secure the FDA's blessing and rack up sales of $40 million in 2006 before going on to generate $400 million annually by the end of the decade.

But at least one ProDisc recipient fears that problems with the disc could be getting buried and hopes the device never gains approval at all. Patricia Kennedy says that her own ProDisc surgery failed to work -- even though documents for the FDA trial suggest otherwise.

"I'm filling out a questionnaire and saying that my pain level is an '8' on a scale of one to 10," with 10 being the worst, Kennedy says. "And my doctor is writing down that I have 'mild pain.' I don't think so."

Kennedy is suing her Pennsylvania surgeon -- a lead investigator for the ProDisc trials -- as well as Spine Solutions, a division of Synthes, for damages. The former competitive skater says she has gone from taking Tylenol to morphine for her pain and can no longer work for a living.

Synthes declined to comment on the discs. But Kennedy's surgeon, Richard Balderston, says patients recorded their own pain scores in paperwork for the clinical trials. Moreover, he insists that at least 90% of his ProDisc recipients now feel better instead. Balderston has implanted nearly 100 of the devices so far and looks forward to a favorable ruling from the FDA so that other patients -- outside of clinical trials -- can enjoy the benefits as well.

Meanwhile, Kathy Machado wishes she had never participated in a clinical trial, either.

Five years ago, Machado received an artificial disc -- known as the AcroFlex -- that Johnson & Johnson had been banking on before major problems led the company to focus on the Charite instead. Machado, who says she has lost her ability to work and most of her assets after undergoing expensive treatments, now feels like a forgotten casualty of the company's success.

"Johnson & Johnson just wanted to get a disc on the market first," she says. "And I was an easy target. I was the perfect victim."

To be fair, Johnson & Johnson has won praise from others for its conduct during clinical trials. Like Kennedy, however, Machado feels misled about the risks involved with her artificial disc and -- even worse -- worried that her poor results have been excluded from the already scarce reports available on her device. She now looks at studies of the Charite with skepticism as well.

Machado is hardly alone. Critics believe that Johnson & Johnson carried out a flawed study -- using guidelines that better suited the company than the patients themselves -- and has since plowed forward with the Charite despite clear evidence of poor outcomes. For its part, Johnson & Johnson has readily portrayed Charite operations as complex but has also launched an extensive surgeon training program to help make sure that the procedures ultimately succeed.

In the meantime, however, even the medical journal Spine has published an editorial citing multiple concerns about the clinical trial that led to the disc's approval in the U.S. TheStreet.com first highlighted similar problems seven months ago.

For starters, the Spine editorial noted, Johnson & Johnson simply set out to prove that the Charite worked at least as well as a competing procedure that -- because of its high failure rate -- has been abandoned by most surgeons. It also excluded pain relief, a primary goal of back surgery, from its definition of success. Moreover, it fell short of proving that the disc successfully preserves motion even though it promotes the product -- with catchy slogans such as "natural motion is back" -- as an attractive alternative to spinal fusion for that very reason.

In the end, the editorial concludes, Johnson & Johnson simply managed to show that just 57% of Charite recipients -- carefully chosen and treated by highly trained surgeons -- met "modest" measures for success.

"If well informed, how many patients will accept an improvement chance no better than a coin toss?" back surgeon Sohail Mirza asked in the editorial. "Contrary to optimistic marketing, the data provided to the FDA and published in this issue of Spine argue for caution by patients and surgeons. Hopes for a cure of back pain and a marketing bonanza must be held in check by principles of fairness and responsibility, and by the end results."