A “profile in courage”: Congressman Mike G. Fitzpatrick (R-PA)?

by Hooman Noorchashm, MD, PhD, and Amy J. Reed, MD, PhD

Published Feb. 23, 2015, 10:41 a.m. ET

We live in a complex world. That means that the truth is not always immediately visible. There's so much complexity in our world today that a lot of people have given up on the concept that there is such a thing as truth. Everything seems to be relative these days. Everything is about compromise and consensus – about being polite.

But, there remain fundamental truths and injustices in this world worth fighting for. The trouble is that in our relativistic world of "consensus and compromise" very few leaders are willing to really fight for the truth – even when truths and justice are being clearly violated.

Courage seems lacking in American leadership in almost all quarters today – and this may be a systemic problem. We are pretty sure American leadership has become too comfortable and too blunted – punch drunk on our society's financial success and meaningless cliches.

That's why when you come across a leader who seems to see the truth and stands up to defend it, you've got to take notice and see if they're for real.

Based on our recent personal experience with a deadly medical hazard known as "morcellation", we've been highlighting and fighting to eliminate a very grave public health hazard in the United States. Amazingly, we discovered that the vast majority of medical devices cleared for marketing by the United States Food and Drug Administration (FDA) are neither safety tested, nor subjected to post-market surveillance of adverse outcomes. The "power morcellator", cleared for marketing by our FDA and used by a large number of gynecologists in the United States and abroad, is one such medical device. It is responsible for, likely, thousands of avoidable, premature or unnecessary deaths of women across the world.

We vocally reported this unacceptable patient safety hazard to the FDA and several prominent United States senators after our own family was hit by it - including senators Lamar Alexander, Bob Casey, Elizabeth Warren, Jeanne Shaheen, Marco Rubio, Chuck Schumer, and Kristen Gillibrand among others. They all heard the problem and expressed their regret. A few wrote letters to the FDA commissioner. Senator Warren even sent a letter of query to the FDA commissioner. That was all good and we are grateful. But in the face of what history will certainly judge to have been a massive public health hazard and catastrophe, caused by a specific industry and the federal agency regulating it, their responses have been like squirting a water-pistol at a five-alarm fire. It's just not enough – because many American lives are in deadly harm's way and many have been irreversibly damaged and lost.

But recently we came across a Pennsylvania congressman who seemed to listen just a little bit more intently. On an icy Saturday morning in his Bucks County office, he listened very carefully for about 2 hours and seemed to see what we were telling him. The few words that he did say included, "that's not right" and "I'm going to write a letter to the FDA commissioner and I'm going to talk to my colleague on the House Energy and Commerce committee – this may need a hearing" – and then, he wrote a letter!

In this letter to the FDA commissioner, who seems to be retiring, and her interim replacement, he writes: "Since its creation, the 510(k) process has come to dominate the path to market for virtually all Class I, Class II, and some Class III medical devices despite the fact that consumer protection is severely lacking."

He also writes: "The FDA's primary focus should be to ensure patient safety."

He then asks: "Does the CDRH consider the medical device industry as equal stake-holder to patients and consumers in the United States?"

He goes on to write, "The reporting of adverse outcomes associated with the use of medical devices is a requirement set forth in the Code of Federal Regulation, Title 21, Section 803. This requirement was not followed by the manufacturers, practitioners, hospitals, or specialty organizations."

But, perhaps most remarkably, he concludes his letter by asking the FDA's commissioner: "Is there any role for the FDA, the HHS Office of Inspector General or the United States Congress to inquire and hold FDA, the device manufacturers or the gynecological specialty organizations accountable for the loss of life in the United States?"

Mike Fitzpatrick's congressional letter to the FDA commissioner is no water pistol on a 5-alarm fire – it's a cannon. It's a pointed and specific letter from a legislator that has risen to protect the lives of real people across the United States from his seat in our congress.

We wonder if Mike is alone in the House of Representatives – and we very sincerely hope not.

After having fought for a year to move our federal government and congress to pay attention to a severe public health hazard in the medical device industry, we were about to conclude that our congress lacks courage – some very powerful senators have certainly been equivocal or silent, almost as if our alarm is a theoretical one. Then we came across Fitzpatrick.

You see, it's very easy for senators and congressmen, to speak of protecting the rights and lives of minority subsets of citizens in harm's way by corporate and government failure – especially when their target of criticism doesn't get them elected. It's very easy to write polite, watered-down letters to protect political "tails" from future criticism for not having spoken out. Its quite another thing to roll up your sleeves, take off your gloves and start slugging when you see the truth violated. And we think Mike may just be aiming to give a few supposed "public servants and healthcare providers" a bloody nose or two. That's the way this question sounds like to us anyway: "Is there any role for the FDA, the HHS Office of Inspector General or the United States Congress to inquire and hold FDA, the device manufacturers or the gynecological specialty organizations accountable for the loss of life in the United States?" Mike has asked, and we think he means it – we think his gloves are off.

You see, it would be very easy for a pro-business republican congressman from Bucks County, PA to just fall in line with industry advocates and kiss up. PA does have a pretty sizable medical device lobby. Some of his colleagues probably think he should. Instead, Fitzpatrick has looked with care and sees his over-arching responsibility as a federal representative to protect the very lives of the American people across our nation. And we think he is poised to remind and convince his colleagues on both sides of the aisle in congress of this basic truth.

Don't get us wrong, Fitzpatrick is a pro-business republican for sure - but he seems to clearly recognize that the medical device industry in our country has a massive problem and has caused unforgivable harm to subsets of unsuspecting Americans from all walks of life. Ultimately, this systemic hazard not only harms people, it harms our health insurance infrastructure, and it will ultimately damage the device industry itself.

These days, it takes courage to stand before the establishment, money and corporate lobby power to protect individual lives. John F. Kennedy described a few "Profiles in Courage" in his book. We will soon see if Mike is a "Profile in Courage" in the United States House of Representatives – we think he just may be.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.