As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the industries it regulates. Opinions about FDA ranged from awful to terrible, and doctors and industry fared no better. It seems a lot of people think user fees conscript FDA, and some see the agency, industry and physicians as some sort of malevolent troika that would have made the Kremlin of Leonid Brezhnev proud.

Maybe I'm too close to it all to appreciate the nefariousness, but I wonder how anyone comes to see things that way, not to mention how many see it that way. Here's the question, though: If those perceptions are widespread, why are such things allowed to fester? One can easily understand why FDA and device makers might dismiss this kind of prattle from a member of the trade press, but it's not just me who thinks this ought not go unaddressed.

I recently interviewed Bray Patrick-Lake, President/CEO of the PFO Research Foundation (Boulder, Colorado), who appeared at Transcatheter Cardiovascular Therapeutics. One of her remarks at TCT 2011 was some patients “actually believe that when [a drug or device] is FDA approved, the risks are zero.” As covered in the Nov. 30 edition of Medical Device Daily, Patrick-Lake also told the audience at TCT, “if we don't do a better job of educating patients … we will continue to see lawsuits and backlash” against agency and industry alike.

During our interview, Patrick-Lake said that some patients are “asleep at the wheel” where the risks and benefits of a drug, device or procedure are concerned. She indicated that a failure to appreciate the risks can leave a patient with one of those unintended consequences that seems a bad trade-off, even if their life was saved in the process. A better appreciation for those risks might change a few minds about which treatment to select, Patrick-Lake suggested, but at the very least would avoid the kind of psychological whiplash that goes along with finding out the ride wasn't free of risk after all.

All the same, Patrick-Lake was not inclined to let FDA, docs and industry off the hook. “What gets advertised or what ends up on 20-20 … is never what happens to the average patient,” she said of DTC ads and sensationalistic media coverage, making the argument that the gap between the two is where device makers and FDA need to put forth some effort.

Patrick-Lake acknowledged that all the data on patient sub-populations means that a lot of work will go into the production of disease-specific patient education material (not to mention updating that material as new data emerge), but she also said that a more general public information campaign might work wonders for those who are not yet patients, giving them the heads-up on what to look for once they end up under a doctor's care.

Patrick-Lake said a public service campaign intended to make the audience aware of risks “would be very simple to do, and I don't think it would be that expensive.” She also remarked, “I can't imagine industry would have anything to lose over patients being better informed,” stating that both industry and FDA bear some responsibility to do something along these lines.

“It can be done and it should be done,” she said.