Last week, a clinical trial ended and the spinning began as Cordis Corp., a Johnson & Johnson company, released the results of the first head-to-head comparison of its Cypher drug-eluting stent with its sole competitor on the U.S. market, Boston Scientific Corp.'s Taxus stent.
The study-primarily aimed at comparing efficacy in preventing restenosis, or re-clogging of the coronary arteries-failed "its endpoint," finding the two devices equally effective, said Eric Simso, Boston Scientific's vice president of cardiology marketing. However, the study also found that the Cypher was associated with the development of fewer blood clots, a result that Cordis emphasized in its news release. But Simso said Cordis was "cherry-picking the data" by stressing a result "which the study was not powered to study."
"Yes, the primary endpoint was restenosis and (the study) found both products very efficacious (on that point). But it also found a difference in thrombosis," said Terri Mueller, a Cordis spokeswoman. "When the data suggests a potential safety issue with one product, one cannot really ignore it. It's the investigators' obligation to present data as it is."
Such bruising battles for market share sometimes can make it difficult for physicians and consumers to differentiate science from spin, but at least one medical device company has been quietly lobbying in recent months for greater data transparency in an effort to resolve the ambiguities.
Cook Group, the world's largest privately held medical device manufacturer, is proposing a policy that calls for full disclosure of the results-good or bad-of all pivotal studies used in determining the safety and effectiveness of a product. "Cook is taking a leadership position because (the industry trade groups) are not acting on it. Their participants are not all in agreement on a policy," said Neal Fearnot, president of MED Institute, a Cook company.
Objectively evaluating medical devices can be a complex and murky endeavor that in recent months has been lost in the controversy over the Food and Drug Administration's oversight of clinical drug trials. Late last month, consumers applauded the introduction of bipartisan legislation in Congress that would mandate public disclosure of results from all new clinical drug trials. But no mention was made of devices.
Still, HHS' inspector general's office last year warned medical device makers that it was watching industry business practices. The threat seemed to materialize last month with the subpoena of Advanced Neuromodulation Systems for documents related to the company's sales, marketing and other business practices (Feb. 21, p. 16). The federal probe could be related to a 2001 initiative in which the company offered physicians $1,000 per patient to refer patients for a five-day test of the company's spinal cord stimulator. The doctors were reportedly compensated for "data collection and management of the trial process."
That investigation raises questions as to when some device studies are merely marketing ploys and when they are scientifically valid methods for gathering data on a product's safety and efficacy. Cook's proposal calls for an industrywide data-reporting standard that would provide physicians and patients with "an unbiased presentation," Cook President Kem Hawkins said earlier this year. "What no one wants to see is what I term `gaming the system,' " he said. Some companies exercise wide discretion in which studies or parts of studies they make public based on whether they like the results. "They can cherry-pick the data-that's gaming the system," Hawkins said.
By Cook's standards, a high quality, well-controlled study is unbiased, complete and accurate, Fearnot said. Cook posts such studies on its Web site, cook-inc.com, regardless of the results. "The patient or doctor needs to know how much monitoring and FDA oversight a study has had," Fearnot said.
Cook also is trying to persuade government, industry and professional medical societies to also distinguish between so-called marketing studies and scientific studies. Not to say that Cook plans to forgo marketing studies, only that the company would not publicly post them as scientific studies, he said. Ultimately, the goal is to develop a policy that makes it clear "if it was a high quality study or not," Fearnot said.
The idea may be commendable, but "with the complexity of devices, it's hard to have one standard that makes sense for everything," said Susan Foote, associate professor and division head of health-services research and policy at the School of Public Health at the University of Minnesota. For drugs, the double-blind randomized controlled trial is the gold standard, but "you can't always randomize with an implant." Drug trials are often a matter of giving a patient a pill, but studies of some devices could require major surgical procedures, which would necessarily involve surgeons, who can't be blinded. "That doesn't mean by any long shot that you can't develop reliable data and you can't demand reliable data, but you have to be more creative in your thinking," Foote said.
Officials at industry trade groups said they solidly support transparency, but the devil is in the details. "This is an issue we're taking a look at, and certainly we want to ensure that patients and physicians have important information to make determinations," said Mark Leahey, executive director of the Medical Device Manufacturers Association. Advanced Neuromodulation Systems President and CEO Christopher Chavez is chairman of the association's board.
"The transparency is important to follow through, but we still have to work to reform the (group purchasing organization) marketplace," Leahey said. GPOs too frequently evaluate devices only to disregard those evaluations when it comes time to negotiate contracts with vendors, he said, which is a long-standing dispute between small-device manufacturers and the GPO industry.
Officials at Novation, the joint GPO of VHA and University HealthSystem Consortium, said the Cook policy couldn't hurt. "My opinion is that having readily available clinical information would assist Novation's member councils with their efforts to evaluate new technologies," Cathy Denning, Novation's senior director of contract and program services, said in an e-mail.
Boston Scientific's Simso said the company has no arguments with the scientific design of J&J's trial, just with how it's getting spun. "What's happening now is hype. It's purely biased," he said. "I think it's ridiculous, but we're not innocent in that either."