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Sci Tech May 8, 2008, 5:00PM EST

The Doctor vs. Device Makers

(page 2 of 2)

Rosen anointed himself an industry watchdog in 2005. It was shortly after Johnson & Johnson (JNJ) subsidiary DePuy Orthopaedics (JNJ) launched an artificial disc called Charité. To decide whether to incorporate the device into his practice, he read up on the clinical trial results. He was surprised to discover that a key study the company used to gain approval from the Food & Drug Administration left out data from 26% of the patients who participated. Furthermore, some authors were paid consultants to DePuy. Rosen complained to the FDA. He even volunteered to serve on future FDA advisory panels as a surgeon who has no financial ties to industry. "They didn't call," says Rosen.

A spokesperson for DePuy said in an e-mail that data on the excluded patients were reported to the FDA, and that the company went out of its way to minimize any bias the investigators might have had. Rosen's complaints didn't trigger an investigation. But DuPuy was one of the companies involved in the recent DOJ settlement on hips and knees, and it did vow to make some changes. The company "has continued to refine and enhance our policies and procedures" for working with physicians, the spokesperson writes.

Rosen, meanwhile, continues to hound the FDA when he thinks there are lapses in the orthopedics area. On Apr. 23 he wrote to the agency asking for a list of surgeons who helped draft a new set of rules for approving artificial discs. He wanted to see if the physicians who are influencing the FDA's approval processes are paid by the companies whose products regularly come up for review. An FDA director wrote back saying Rosen would have to file a Freedom of Information request to get the list. He says it's just the latest example of the "transparency problem" in orthopedics.

Activism hasn't made Rosen particularly popular, either on campus or in industry. His soft-spoken manner belies a combative intensity and a desire to shine, which may have been honed during the years he spent as a competitive figure skater. Often, he has found himself at odds with other professors over the appropriate role companies and their physician consultants should play in training other doctors. Dr. Ranjan Gupta, U.C. Irvine's chair of orthopedic surgery, says new rules starting July 1 will restrict companies' activities on campus.

Undeterred by the controversies he has stirred up, Rosen now plans to run an ethics symposium at the university in June. He has already invited 11,000 spine surgeons and other health-care professionals. "Everyone will reveal in detail their industry connections, including the amount they receive, in what form, and what they do [for those companies] in return," says Rosen. The industry will have a chance to participate, he says. At the top of his list of invitees is none other than Zimmer.

Links

How to put medical studies under the microscope

Editors for The Journal of the American Medical Association were stung by the recent revelation that some of the scientists listed as authors of key studies may have done little of the actual research. And some failed to disclose financial support from pharmaceutical companies. The studies concerned Vioxx, the Merck (MRK) arthritis pill that was pulled from the market in 2004 after being linked to heart attacks and strokes. In response, JAMA's editors laid out a manifesto for all journals in its Apr. 16 edition. Among the 11 suggestions: Everyone named as authors of scientific papers should be required to tell the publications exactly how they contributed. And journal editors should seriously consider authors' conflicts of interest when deciding whether to publish a study. Disclosure might not stop unethical behavior, the editors write, but it may give pause "to authors who might reconsider lending their names and reputations to articles in which they did not meet requirements for authorship."

A graphic with "The Doctor vs. Device Makers" (What's Next, May 19) incorrectly put revenues for artificial spinal discs at $3.8 billion annually. That figure represents the market for all spinal devices.

Weintraub is a senior writer for BusinessWeek's science and technology department.

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