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Researcher Shreds Industry Ties

Charles Rosen believes medical device research is riddled with conflict.

When Charles Rosen recently established the Association of Ethical Spine Surgeons and invited other doctors without financial ties to the industry to join, he didn't expect very much.

"I wasn't sure if I was going to be the only member or not," says Rosen, founding director of the spine center at the University of California at Irvine. "But I've got my first 50 members already. They can't believe all of the garbage that goes on."

Rosen counts his fellow AESS members among a silent majority of spine surgeons who quietly practice medicine free of the financial influence exercised by device-makers over so-called key opinion leaders in the field.

Rosen himself is more outspoken. Indeed, he has created quite a stir -- and more than a few enemies -- by criticizing powerful companies like

Johnson & Johnson's

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DePuy,

Synthes

and

Medtronic

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for the artificial discs that they make.

Rosen has questioned the safety of DePuy's Charite disc, in particular, since the device first hit the market nearly two years ago. He has seen the disc fail numerous times during that period.

Rosen blames a serious design flaw, saying that device-makers have mistakenly assumed that the spine's center of rotation lies in front of -- rather than behind -- the spinal canal. He believes that the discs should have never been approved by the Food and Drug Administration.

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"My greatest fear in all this is that thousands of people will have horrible outcomes that will result in chronic, severe pain that they didn't have before -- and the only solution at the moment is a surgery that risks death or loss of the use of their legs to walk," Rosen writes on his association's new Web site. "I believe the FDA should immediately recall the Charite disc" and order further studies of the device, he says.

DePuy claims that it thoroughly tested the Charite during formal clinical trials that showed the device to be safe and effective. The company now markets the Charite as an attractive alternative to fusion surgery for certain patients who suffer from degenerative disc disease.

But some industry critics cite an early study of the spine, published by the

Journal of Bone and Joint Surgery

some 28 years ago, as evidence that device-makers never should have invented lumbar discs at all. That article discusses spine function under normal physiological conditions, critics say, explaining that most loads are transferred in an off-center fashion and suggesting that artificial discs would need to defy gravity in order to allow the same.

For his part, Rosen says that the study also supports his theory about the spine's natural center of rotation.

"I think some people did figure out the problems a little bit in the past," Rosen says. "What our model does is delineate more extensively what that article was scratching the surface of" nearly three decades ago.

Rosen has become a critic over time. Early on, he thought he might even try Charites on some of his own patients. However, he first set out to learn more about the discs -- even poring over a transcript of the FDA hearing that led to their approval -- and wound up horrified.

"After my review of the Charite disc, I became concerned and began asking some very difficult questions to the FDA and DePuy," Rosen says on the AESS Web site. But "all I received in the end from DePuy was an invitation to attend one of their courses on how to implant the device and some very vague overviews on the complications -- which, of course, were of no help."

Rosen believes that DePuy won over some other surgeons, particularly the loudest promoters of the discs, with financial incentives. If so, those surgeons cannot join his new group.

AESS members cannot accept any compensation from device-makers for using their products. They cannot own stock in the companies, either.

Moreover, AESS guidelines state, members must believe that such financial perks are "unethical and immoral because they create inherent and irreconcilable conflicts of interest that result in patient care decisions being made on the basis of financial gain."

To publicize his new association and seek out members, Rosen sent emails to fellow doctors who belong to the North American Spine Society. However, he says, NASS -- which counts some high-profile surgeons with industry ties among its members -- immediately tried to distance itself from his organization.

"They sent out their own email about mine, saying, 'This is not from us,'" Rosen says. "That actually doubled the number of people who were interested in joining my group. Then, when I went to the big NASS meeting, everybody knew who I was!"