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J&J Discs Face Backlash

Normally, Charles Rosen embraces scientific advances in back surgery. But the university-based spine surgeon can't imagine using one now being promoted by Johnson & Johnson (JNJ - Get Report).

The company's Charite artificial discs last year became the first to hit the American market, offering a long-awaited alternative to complex spinal fusion surgery. Rosen, recently filmed by PBS performing another new procedure, likes to provide his patients with cutting-edge services.

So he set out to learn about the treatment. Specifically, he wanted to know if the discs could safely reduce chronic back pain while, unlike typical surgery, preserving motion. Charite backers say the new discs do just that and therefore offer the "potential to revolutionize spine surgery."

But Rosen says he found that the devices have regularly failed in Europe, leaving patients with life-threatening complications. He says he finds it "unbelievable" that the Food and Drug Administration ever approved the devices.

"Any prudent person, who does not have a financial conflict or industry tie, would reasonably conclude that their safety and effectiveness has not been proven by the FDA," says Rosen, an associate clinical professor of spine surgery at the University of California at Irvine. "These artificial disc replacements should be recalled by the FDA to protect the American public."

For its part, Johnson & Johnson portrays the implants as "the best solution for the appropriate patients" while stressing that "patient selection is key." In any case, banning the implants could hurt Johnson & Johnson and its competitors, who see the market as a lucrative growth opportunity.

Within years, some experts believe, the market for spinal discs could top $1 billion. Goldman Sachs analyst Lawrence Keusch says that Johnson & Johnson itself hopes to rake in $150 million on its brand-new spinal offering in 2005 alone. Meanwhile, companies like Medtronic (MDT - Get Report) and Stryker (SYK - Get Report) are busy designing artificial discs of their own.

In this last of five articles exploring potential conflicts of interest in the drug and medical device business, TheStreet.com examines how a potentially lucrative treatment can reach the market even as questions linger about its safety and effectiveness.
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