It’s been 50 years since Dr. Tom Fogarty invented the catheter-based treatment for blood clots that’s now the standard of care. At 80, it would be a cinch for Fogarty to retire to his California vineyard and bask in the reflected glory of his accomplishments.
But Fogarty, a serial entrepreneur with more than 30 medical device startups under his belt, told MassDevice.com recently that he has no plans to slow down until he’s 6 feet under.
In Part 3 of our 3-part series, Fogarty tells us about his concerns and criticisms of the FDA’s Center for Devices & Radiological Health, and explains why he signed on with the watchdog agency to help it improve.
When Fogarty invented his catheter in the 1960s, the FDA oversaw food and drugs only. Operating under the watchful eyes of his own physician mentors, Fogarty developed the technology, tested prototypes and hand-crafted catheters himself. He was able to take the device from concept to 1st human use for about $2,000, a process that he speculates would cost multiple millions today.
In an interview a few weeks before a "Celebration of Innovation" fund-raiser for the medtech incubator he founded, commemorating his 80th birthday, Fogarty told MassDevice.com that there would be no Fogarty catheter had he been forced then to contend with today’s FDA. But not because the agency might have rejected the device; instead, he told us, the process would likely have taken many years and come with very high costs. Fogarty has seen those hurdles spell the end for other companies that either ran into the ground or simply threw in the towel after going many rounds with regulators.
Asked if he would have put up with similar obstacles when he developed the balloon catheter, Fogarty flatly responded, "No way."
The federal watchdog agency is too focused on the science of medicine, rather than its practical application, Fogarty said. Rather than demanding hundreds or thousands of patients’ worth in clinical trials and dozens of points of data, the agency should limit its scope to the most important question: Does the technology help patients?
"What’s happened at the FDA, they want to be scientists. Well scientist means exploration of theory to prove or disprove a premise, that’s what science is," Fogarty said. "You want something that works in a human. It’s totally different."
Fogarty insists that he is a "technologist" rather than a scientist in his work with medical devices as well as with his patients.
"Surgery is all about technique. We have to know science, but it’s not what we practice. We are technologists," he said. "Surgeons don’t like to hear that, but it’s the absolute truth. You want a surgeon who’s done a whole bunch of cases; that means his technique is better. That’s the way it is.
"I get upset when people call me a scientist, because I’m not," he added. "I’m a technologist who happens to know science."
The FDA, he cautioned, often confuses the two. As a result the agency forces innovators to jump through unnecessary hoops to demonstrate aspects of a new technology that aren’t ultimately relevant to patient care. Fogarty worries that the delays prevent patients from getting care and prevent U.S. doctors from keeping up with those abroad, who may get a technology years earlier and have a huge head start in becoming expert practitioners. Perhaps most worrisome to Fogarty is that the delays rob patients of a choice that he thinks they should make: Whether to take a risk with their health.
"We as physicians can’t nail what’s a risk or what’s a benefit all the time. We think we know, we know better than most, but we’re wrong sometimes. We’re just flat-out wrong," Fogarty said. "When the FDA denies a technology, they’re denying a patient choice. I’ve had patients come to me over the years who say, ‘Cure me or kill me.’ That’s what a lot of patients feel, and it’s on the increase."
Patients, increasingly worried about quality of life, are willing to take a chance to ease their pain and suffering, even if it means they may die, he explained. When the FDA denies an experimental new device on the grounds that the benefits don’t outweigh the risks, they fail to consider how that scale may tip for the patients. Some patients would rather chance death than live without hope.
"If I had a stroke, if it paralyzed me and I had to be on a respirator or somebody had to feed me, I would prefer to be dead," Fogarty told us, saying that many of his patients feel the same way. "It makes sense to the patient, it makes sense for society, it makes sense for a lot of people. But when [regulators] take a technology away that has a pretty good chance of making the patient better and providing a better life for the rest of their life, and they want to accept the high risk, that’s their choice."
Fogarty’s been a staunch advocate for change at the FDA, but he’s not one to complain from the sidelines. He’s consulted for the FDA many times on issues relating to medical device review, and he views those contributions as a type of community service for future generations of inventors.
"I’ve been one of [the FDA’s] most egregious critics over the years, and they called me and asked me if I’d come back and help," Fogarty said. "I said, ‘Do you know who you’re talking to?’ And they said, ‘Yes.’ I said, ‘Do you know my attitude?’ And they said, ‘Yes, and we need to hear more.’ If I didn’t help them, I’m the bad guy."
Fogarty cedes that things have gotten improved a bit at the FDA and that some technologies are getting to patients faster, but says there’s still a long way to go. Devices are frequently available overseas long before they hit the U.S. market, taking innovation, jobs and patients along with them.
"I myself would go offshore for certain diseases," Fogarty said. "The technology is available and the physicians know how to use it. This is a truth – and it’s not a good truth, it’s a bad truth – but it’s reality."