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22% of medical device follow-up studies left undone

Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior regulator who has launched a campaign to improve the ratio.

"It's not a pretty picture," said Daniel G. Schultz, director of the FDA's office of device evaluation, earlier this month at a conference in Waltham. Too many of these studies are treated as "an afterthought," he said.

At a time when the FDA is under fire for its oversight of drugs like Vioxx and Celebrex, which prompted health concerns after they were approved, Schultz's comments show how companies that make products such as pacemakers and hearing aids can also expect more scrutiny.

Since Schultz has been pressing for more follow-up studies for over a year, his plans to improve the situation through public disclosure or bureaucratic reforms could be a model for the way the FDA treats drug companies in the future.

Exactly how much oversight the FDA has given to approved products is becoming a political issue. Post-approval studies are routine in theory and rare in practice, an open secret in the healthcare industry.

In a report to Congress in March, for instance, the FDA said companies had agreed to conduct 1,338 post-approval drug studies.

But 65 percent of them had not begun and just 33 percent were on schedule or had been completed.

"I am concerned that if companies do not comply with their responsibility to conduct post-market studies, then the public will never know if the products . . . are no better than sugar pills or even dangerous to their health," wrote US Representative Edward J. Markey, Democrat of Malden, in a Dec. 20 letter to the FDA.

The issue wasn't as great in the past when devices were introduced to the market more slowly than drugs, giving producers time to make small changes. But now big marketing campaigns mean thousands of people might begin a treatment like an artificial hip or pacemaker within weeks of its approval.

This can lead to widespread concerns, especially in the devices world where treatments can cause fast reactions. Earlier this year, for instance, Boston Scientific Corp. had to take 165,000 new drug-coated cardiac-stent systems out of inventory after a manufacturing flaw was linked to three deaths and more than 40 injuries. In 2003 the FDA notified doctors that a similar product from Johnson & Johnson was linked to more than 60 deaths, though the agency later determined the death rate was within an expected range.

Citing those examples, Schultz said in an interview after his speech to the Massachusetts Medical Device Industry Council that "When you have such incredible market penetration in such a short time, we need to make sure we're asking a lot of questions about both products early in the process."

Schultz cited an internal FDA study tracking devices from the start of 1998 to the end of 2000. It found that during that period the FDA approved 127 applications to market new medical devices, and in 45 cases required their makers to conduct post-market reviews.

But in ten of the 45 cases, or 22 percent, no follow-up results were submitted, said FDA spokeswoman Sharon Snider. The internal study didn't specify what drug studies weren't finished, or how many patients were supposed to be included, she said.

Joseph J. Leghorn, a Nixon, Peabody attorney who often represents the makers of devices, said another reason might be that many devices tend to treat just tens or hundreds of patients, fewer than most drugs, and that devices often are used only for a few years before they are replaced by newer therapies. Both factors leave fewer patients for follow-up studies, he said.

"There may be various reasons why studies don't get completed," Leghorn said. "I doubt people are ignoring their responsibilities."

Other reasons might include a lack of funding from devices companies, which on average are much smaller than the multi-billion dollar companies that dominate the drug industry, or that patients aren't interested in participating once they've been treated, Schultz said.

To improve the response rate, Schultz said he plans a shake-up, putting post-market studies in the hands of different staffers, and to try to improve the quality of work the FDA requests. For instance, an agreement with Johnson & Johnson to follow up on the use of its stents lacked precision on how it would be initiated and a timetable for its completion. "That was something we learned and corrected," he said.

Schultz said the FDA also might start publicly reporting the status of all studies that have been required. So far the agency is not compelled to name companies that haven't met obligations to complete follow-up studies, and its public affairs office declined to do so this month.

There are limits to how much the agency might lean on companies, however, Schultz said.

"As far as the sticks are concerned, one of the things that has always been difficult to conceive of is the idea that we would pull a product off the market just because a study wasn't completed, absent a health risk," he said.

Ross Kerber can be reached at kerber@globe.com.

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