COLUMN ONE : Devices Languish in FDA Limbo : Medical community says agency is threatening patients’ lives with protracted reviews. But U.S. is also winning support for flexing regulatory muscle.


Sam Sabolovich has not been to work in eight years, and daily chest pains are a constant reminder of his doctor’s advice: Just stay home and watch TV.

“I don’t do much. I don’t even cut the grass anymore,” said Sabolovich, 43, a decorated officer who retired in 1985 from the Detroit Police Department after undergoing quadruple heart bypass surgery.

Since the surgery, Sabolovich’s arteries have clogged again, forcing him to take daily dosages of nitroglycerin.

Returning to work would be possible, Sabolovich and his doctor believe, if only a diamond-tipped surgical drill could be sold in this country. The drill, proponents say, would permanently clear clogged arteries. An application for approval was made to federal regulators in August, 1990, but a final OK, if it comes, is up to two years away.


“There’s nothing we can do,” said Sabolovich’s physician, Dr. William W. O’Neil, director of cardiology at William Beaumont Hospital in Royal Oak, Mich. “It’s an idiot bureaucracy that is keeping him from getting well. Patients like him are being harmed.”

O’Neil’s complaint is a common one within the medical community, which is pointing an accusatory finger at the U.S. Food and Drug Administration and its increasingly difficult and drawn-out process for determining whether medical devices are safe and effective.

Echoing long-running debates about the approval process for drugs, the controversy over medical devices raises the issue of how much oversight, how much testing and how much delay are needed to protect patients who eagerly await anything that might save their lives.

Ironically, the longer review periods for medical devices come at a time when the FDA has taken steps to approve drugs more quickly, particularly those for AIDS patients.

Critics of the FDA, many of them firms within the medical technology sector of Orange County, cite people who need help immediately from new products while noting the competitive requirements of an industry known for remarkable growth. Those who endorse the agency’s regulatory vigor recite recent disaster stories involving medical devices.

Waiting in the wings are devices as wide-ranging as a heartbeat regulator, an artificial pancreas, an osteoporosis diagnostic machine that would help tens of thousands of elderly patients afflicted with bone disease, and devices that would help asthmatic children.

Last year, the FDA’s Center for Devices and Radiological Health approved 12 breakthrough medical devices, down from 56 approvals in 1989. Four devices were rejected for a variety of reasons, FDA officials said. The FDA received 65 applications during 1992 (compared to 84 in 1989), and as of March, 149 applications were awaiting attention by FDA reviewers.

The sheer bulk of the FDA workload--which also includes approving thousands of “me-too” products similar to ones on the market--has made the review process frustratingly slow, even by the agency’s account. The time required to review breakthrough applications rose from 12 months in 1989 to about 22 months in 1991, when 27 products were approved.


Although average review time for 1992 dropped back to about a year, critics say that figure is misleading because half of last year’s approvals were license transfers and not authorizations for new products. Some companies report delays of up to three years.

Even those who have been mostly concerned about dangerous medical products being put on the market are worried about the delays.

“At this point, I am perilously close to being convinced that the FDA is more dangerous to the patients than the manufacturers are,” said Joel Nobel, head of the Emergency Care Research Institute, a nonprofit group in Pennsylvania that collects data on faulty medical devices. “My first concern is the consumer, and they are being hurt by all this.”

But the FDA is winning support in some quarters for finally flexing its regulatory muscle.


Medical devices still have a shorter approval process than that for drugs--up to two-thirds shorter. Drugs--which require complicated tests involving large patient groups, placebos and attention to possible side effects--can take up to nine years in some cases. Medical devices, which rely on tests that are largely exercises in engineering, tend to take six months to three years for final approval.

About 15% of the FDA’s $726-million annual budget is earmarked for evaluating medical devices. The FDA created the Center for Devices and Radiological Health in 1976 under legislation that recognized differences in the underlying science behind drugs and devices.

The first product approved by the devices center was a catheter that is used to clear clogged arteries. Since then, devices have become more complicated, and FDA officials say they should be looked at more closely.

The greater scrutiny being given to devices comes within the context of still-simmering controversies over frightening failures of the Shiley heart valve and silicone breast implants.


About 300 of the 86,000 people who received the Shiley heart valve have died. The valves fail when metal struts that hold the valves in place crack.

In the case of the breast implants, which have been used by more than 2 million women, some doctors report a complication rate of about 40%. Sale of the silicone bags has been halted by the FDA.

In total, the FDA ordered 1,330 recalls of medical devices, including products as wide-ranging as ventilators and X-ray machines. Two in five of those recalls were for poor design; the remainder for poor manufacturing.

“The companies were snookering them,” said Dr. Sid Wolfe, head of Washington-based Public Citizen’s Health Research Group, a nonprofit consumer advocacy group founded by Ralph Nader. “The industry will survive just fine. I don’t buy into this whimpering.”


FDA officials predict that by 1995 there will be fewer reports of faulty devices and thus fewer recalls.

“If it’s a matter of being timely, anybody can do that,” FDA Commissioner David A. Kessler said. “But that is only half the equation. We are saying: ‘Our job is to assure the public is appropriately protected. It’s OK to have higher standards.’ ”

Elaine Levinson, 46, of Pittsburgh, Pa., knows all too well the result of low standards. She can feel it beating in her chest.

In 1981, Levinson was found to have a leaking heart valve that was causing her heart to enlarge dangerously. Her only chance of survival, her cardiologist said, was to implant an artificial valve. She chose the Bjork-Shiley valve, which took the FDA 5 1/2 months to approve in 1979.


“They said it was the Cadillac of valves,” Levinson said.

But like thousands of other Shiley valve recipients, Levinson later learned that a strut holding the valve in place occasionally broke, causing immediate death.

On one hand, Levinson is angry that the FDA did not take more time to review the device and did not adequately follow up on the manufacturing process--the struts broke because of faulty welds, not bad design.

Now, ironically, Levinson is hoping that the FDA will move quickly on another medical device--a new X-ray machine being developed in a Michigan hospital that should determine if her artificial valve is on the verge of cracking.


“It really is a Catch-22 situation,” said Levinson, who heads a Pittsburgh support group of Shiley valve recipients. “We want it on the market right away.”

At stake, FDA critics argue, is not only patients’ health but one of America’s most innovative and successful technology-driven industries. The Washington-based Health Industry Manufacturers Assn. reports that one in six of its members has established manufacturing operations overseas in the last two years--at times because they can sell products there that cannot be sold in the United States.

U.S. companies produce nearly half the world’s medical devices, and more than one in three such products are shipped offshore, creating a $3.2-billion global trade surplus. Firms spend heavily on research and development.

Together, the 11,000 medical device companies, employing about 249,000 workers, form a $33.9-billion-a-year industry. Nearly 80% of those companies are small businesses. The industry is growing at an average of more than 9% a year.


The industry is particularly strong in Orange County, where hundreds of small, start-up firms seemed to sprout out of the bean and cabbage fields of Irvine in recent years. Some of the industry’s largest medical device firms--Baxter International, Allergan and Beckman Instruments--also have plants in Orange County.

All things considered, Advanced Interventional Systems of Irvine considers itself one of the lucky ones.

In the foyer of the heart laser manufacturer’s offices is a foot-high stack of yellowing documents that is treated with all the reverence of a hunter’s trophy. Neatly bundled with a pink ribbon inside a museum-like glass case, the package of technical documents is testament to the six-year campaign on behalf of its device to help patients avoid heart bypass surgery. The device was approved for sale in January, 1992.

Company officials said that half the $30-million battle to get their product approved was devoted not to scientific study of the product, but to dealing with what it characterizes as bureaucratic ineptitude at the FDA.


Victor Ham, Advanced Interventional’s director of regulatory affairs, said the firm waited months for word on approval of the heart laser, only to learn that the application had been left on the desk of a reviewer who no longer worked there. Up to 180 days was added to the approval period each time a change in wording or grammar was ordered.

“It was chaos,” Ham said. “It seemed like they were paralyzed from the inside.”

Heart Technology Inc., based in Bellevue, Wash., views itself as an unfortunate victim. The maker of a diamond-tipped heart device, called a RotoBlater, is awaiting word from the FDA on whether it can sell its product in the United States. The company sells the RotoBlater throughout Europe and Asia.

Company President Alan J. Levy said the firm began designing and testing the RotoBlater in 1981. Doctors say the device can be used on damaged arteries more effectively than lasers. By 1990, the company had tested the device on 500 patients with a 1% mortality rate.


After applying for FDA approval in August, 1990, it received a unanimous recommendation from an FDA panel of cardiologists and had expected speedy approval.

“We’re still waiting,” Levy said.

He estimates that Sabolovich is one of about 200,000 heart disease patients waiting for the product to be approved for use. Few patients have enough money to travel to Europe or Asia for the procedure, Levy said. A vast majority, like Sabolovich, cannot afford the travel or the operation. (Insurance companies do not pay for overseas operations.)

Summit Technology in Waltham, Mass., has prospered by taking its products overseas while awaiting approvals from Washington.


Summit President David Muller said the company, which manufacturers a laser used for eye surgery, has sold its machine legally for almost four years in 38 countries in Europe, Asia and South America.

But in the United States, the application is held up because the FDA has not assembled a panel of ophthalmologists in more than a year to review the data. Although such a panel could reject the new laser, Muller said that his company for now is left in limbo, unable to plan the company’s domestic future.

In January, Alan H. Magazine, president of the Health Industry Manufacturers Assn., called for an overhaul of the review process, better communication and for cutting regulatory delays in half.

“Hobbled by barriers, new health care technologies have little hope of delivering their full promise to a troubled U.S. economy,” Magazine wrote in a report to the Clinton Administration.


FDA officials declined to address the specific issues raised by individual companies, but acknowledged that some charges are valid. “There has been an outcry, complaints,” said Deputy Commissioner Jane Henney, “and there is a bit of truth to it.”

Although FDA chief Kessler and other regulators believe that industry is overstating the problem--"Industry would really like to get back to the good old days, when a device just flew through,” one official said--the agency has taken steps to build bridges between the agency and industry.

The agency is developing a new computerized database that for the first time would allow companies to receive timely status reports. A recent FDA report suggests that medical device companies and the FDA meet more formally early in the process so that industry and FDA officials can jointly develop clinical trials.

Now, companies decide on their own how to study proposed products and receive an exemption that permits them to conduct clinical trials before approval. The FDA only adds its input after the clinical trials are done, when companies submit the application for approval.


Occasionally, FDA reviewers throw out the results of clinical trials, asking that more tests be done at extra cost to the companies. Jointly establishing rules for clinical studies would help speed up the approval process, FDA official said.

But to truly reduce the backlog and inevitable delays, the 300-person medical device review staff would have to be doubled at a cost of $50 million a year, Henney said--a highly unlikely prospect amid budget concerns in Washington.

Kessler has proposed that the agency charge device companies for having their applications reviewed as a way to pay for additional staff. Although drug companies pay such fees, medical device firms tend to be smaller and complain that the cost would be more than many could bear. Fees can reach $50,000 for reviewing one product.

One FDA official said he hopes to have physician advisory panels meet more frequently--once each quarter.


Congress may take steps on its own and, in a twist, one agitator is likely to be Rep. John D. Dingell (D-Mich.).

As chairman of the House subcommittee on oversight and investigations, Dingell pushed for investigations of industry when problems became evident with heart valves and breast implants.

But Dingell has been increasingly critical of the FDA and the process for reviewing medical devices. In a letter to Kessler in August, Dingell criticized the FDA’s device center for near anarchy in the approval process. He has scheduled hearings on the subject for this year.

“Virtually nothing is happening despite the fact that at least some pending approvals offer the only hope for people in need of lifesaving devices,” Dingell wrote. “The paralysis is unconscionable.”