Medical Device Approval vs F.D.A. Whose Side Are You On?

Last week, I attended a 2 day medical conference in Cleveland on obesity. It was a heavy seminar, which I would rate 8 on a (bathroom) scale of 1-10. Interestingly, the majority of the speakers appeared to have BMIs (body mass indices) within the normal range. Coincidence? I suspect discrimination against rotund academicians. I’m sure that if any attorneys were in attendance, that a proper legal response would have been promptly initiated. They would take the matter on a contingency fee basis, or in a more novel approach, fees could be linked to excess body weight so that each pound that was unfairly discriminated against would be fully and fairly compensated. I’ve been told that I think like a lawyer. Is this a compliment I should graciously accept or a slur that warrants a lawsuit for defamation?

The conference was excellent and I hope to incorporate what I have learned into my practice. My community gastroenterology practice is ever expanding, and I don’t mean my patient volume.

There were lectures on exercise, nutrition, commercial diets, bariatric surgery, medications and medical devices. There was a fascinating lecture given at the conference’s conclusion by a banker who works with venture capitalists. He lamented that the F.D.A. was a major impediment against product innovation and delivering products to market. Investors and companies pour millions of dollars into start-ups or toward medical device research and are frustrated by what they believe are unreasonable governmental obstacles or migrating goal posts. He stated that this was not simply his personal view, but was a widespread view across the industry. Some of the consequences of this policy include:

• Suffocation of of many small device companies and entrepreneurs
• Diminishing competition to foreign device companies
• Loss of investor confidence resulting in scarcer funds to fuel research and development
• Encourages corporations to pursue ‘safe’ projects where F.D.A. approval is achievable but medical benefit is marginal
• Harms the public by preventing or delaying new medical treatments from reaching them

A senior Cleveland Clinic physician offered a spirited rebuttal of the banker’s view stating that the system, while imperfect, is fundamentally sound. He pointed out various examples where recent medical devices were found to be seriously flawed which have cost millions of dollars and patients’ lives. Failing metal on metal hip appliances is the most recent example of the risk of under regulation. Indeed, it sounds horrendous for patients to have to undergo repeat hip surgeries because their new metal hips will soon be out of joint.

Earlier this year the Institute of Medicine (IOM) advised the F.D.A. that the system for approving medical devices should be scrapped, as it was too lax. The F.D.A., who commissioned the study, didn’t accept the IOM’s recommendations. Perhaps, they believe the agency can reform itself from within, always a dicey prospect.

Of course, a proper balance needs to be established between protecting the public and stimulating vigorous innovation. It seems to me that we are out of balance. We must recognize that no system will be perfect and please all players in the game. While we all strive to protect the public, if we tolerate no risk, then there will be no new products, devices or medications coming to us. How much risk is reasonable? There is no single answer here as most of us would tolerate more risk depending upon the circumstances. We accept more risk as the stakes increase.

While industry and the government have different interests and agendas, ultimately they both hope to serve the public good. Failed devices harm patients and harm industry by eroding the public trust.

All of us accept risk in our daily lives. Should the federal highway speed limit be lowered to 35 miles per hour? Why not? Wouldn’t this save lives? Wouldn’t this be worth some added travel time for all of us?

The political aspects of the medical device approval controversy were discussed in a New York Times article earlier this week which is worth a perusal.

Do you want more civil liberty protections or do you favor more power for intelligence gathering? Do save wildlife and forests or promote development and job creation? Do you want more public safety or do you want more medical innovation? It’s vexing to navigate through these tortuous conflicts.

We are being presented with a version of Trick or Treat. Each side claims to offer the treat and disparages the other as a trickster. It’s not quite that simple, is it?

Whose side are you on?