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). 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) and Stryker ( SYK) 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.
"Any time you do a study, there are certain data that are considered outliers," Gupta acknowledges. "However -- and this is a big 'however' -- in almost all good studies, that is a very small percentage of the total sample size. ... Whenever a significant percentage is excluded, for any reason, it leaves a reviewer skeptical of the data analysis." Colamarino says those patients spent more time in the operating room, lost slightly more blood and suffered a higher rate of adverse events than other participants in the study. However, she says, they actually had better clinical outcomes than the other patients based on two measures. She also stresses that Johnson & Johnson supplied the FDA with safety data on the training patients during the approval process. Still, Brent Blumenstein -- a voting member of the FDA advisory panel -- specifically complained about omitted patients during the Charite hearing. "The sponsor's definition of the ITT (intent-to-treat) population ... is incorrect because it deletes randomized patients," Blumenstein said. "To modify the definition of ITT or analysis by arm by deleting patients is tantamount to saying someone is only partly dead." Like the rest of the panel members, Blumenstein nevertheless went on to vote for approval of the device anyway.
"Revision surgery to remove the implant ... will be potentially life-threatening in every case," he explained. "And at present, there is no consistently successful strategy to deal with a failed implant." Thus, he said, the implants -- studied for just two years in the U.S. -- should be designed to last four decades. But Paul McAfee, a Johnson & Johnson consultant with a financial interest in the discs, indicated that he would be satisfied with far less. "Well, I hope they will last 40 years," McAfee said during the hearing. But "honestly, to talk to the patients, 10 years is (a) pretty good outcome." McAfee then went on to undermine one of the central arguments favoring implants over traditional -- and highly successful -- spinal fusions. Fans of the device say that it preserves motion and, in turn, reduces wear on nearby parts of the spine. But McAfee confessed that he "cannot find a single study on any motion-preserving device" that proves this theory. Meanwhile, Andre van Ooij -- a Danish surgeon who has tracked hundreds of the operations in Europe -- later offered evidence about the implant's drawbacks. He noted "retrograde ejaculation and erectile dysfunction" in men. He also cited leg complications in others and pointed to joint degeneration as an especially big problem. "All of these patients have really terrible leg and back pain," said van Ooij. And "revision is dangerous and sometimes impossible." Van Ooij went on to cite a 17-year study showing that more than half of Charite recipients wound up with fair or poor results. Moreover, he said, spinal fusion -- which could have been employed in the first place -- rarely offers relief to failed patients down the road. "There was a fusion done, and this is the only one of the re-operations (among those studied) that the patient is satisfied" with, he said. "So I really would stress that it is not a good solution for the problem" in the end.
Of course, Johnson & Johnson itself has been busy marketing its new offering as well. The company is currently targeting orthopedic surgeons, including Rosen, with offers of specialized training courses. As soon as the implants won FDA approval, in fact, the company was already pledging to intensively train orthopedic surgeons -- at sites all over the country -- so that they could begin doing the new operations as soon as possible. But Rosen, for one, will not be among them. "I think there are going to be thousands and thousands of people who suffer failures and wind up in chronic pain with no solution for it," he says. "I don't know how anyone, in good conscience, could put these things in knowing the past history and the potential for so many failures. ... It's just money over everything else, and it's just cruel."