On July 10, 2015, Congressman Mike Fitzpatrick of Pennsylvania, remained steadfast as the lone voice of reason and ethics regarding a severe public health hazard in the medical device regulatory space in the United States.

A popular bipartisan bill, known as "21st Century Cures" (H.R. 6), passed through the House of Representatives on Friday. Fitzpatrick was supportive of this bill - because it funded the NIH to facilitate life-saving research.

But, there was also a major catch. The provisions in H.R.6 directed at the medical device industry made an unsafe regulatory environment even more unsafe for the public. And Fitzpatrick recognized this very clearly.

So he proposed 8 Amendments to this bill, aimed at making H.R. 6 a "Safe bill" when it comes to regulation of medical devices in the United States.

Fitzpatrick's amendments were proposed because he understood that the "power morcellator" disaster in the women's health was a bellwether case of failure by the Food and Drug Administration's Center for Devices and Radiological Health. A failure that had cost many unsuspecting American women and their families their precious lives. Mike Fitzpatrick got tuned into this horrific disaster and its root cause, and he activated a full scale warning to his colleagues in the House of Representatives.

But, in an astonishing assault, his patient safety Amendments were killed in the Rules Committee of the House of Representatives. The man responsible for this attack on the Fitzpatrick amendments was a Congressman from Texas, Dr. Michael Burgess - himself a gynecologist supposedly committed to women's health. You can read about his action against public health at this link.

After rejection of seven out of Fitzpatrick's eight amendments to "21st Century Cures", on July 10, 2015, Mike Fitzpatrick rose on the floor of the House and made a speech. You can watch it at the following link.

In this speech, he complimented the bipartisan co-sponsorship of this bill, which hold the promise of saving many lives based on its funding of research by the National Institutes of Health. Then he warned his colleagues, again, of a severe safety deficit in the medical device regulatory space at the FDA - a hazard that was fully exacerbated by the provision in H.R. 6.

Fitzpatrick's presentation to congress was strong but down-to-earth, articulate and respectful of his colleagues.

He stated that the medical device provisions in this bill did "more good than harm".

In a courageous move, and specifically because of the hazardous medical device safety provisions, Mike Fitzpatrick voted "NO" to "21st Century Cures" - he voted on principle, on ethics and on conscience. Because to this congressman, making a clear legislative public health hazard even more dangerous for the American people was not an option - no matter what the projected long-term benefits of this bill might have been.

In sharp contrast, the man who killed the Fitzpatrick patient safety amendments in the Rules committee, Congressman Michael Burgess, an Ex-Gynecological surgeon is beholden to the medical trade organizations and industry. He engaged in a diatribe, lecturing Mr. Fitzpatrick as a medical "expert", not a fellow congressman and federal regulator - as though his opinion as a doctor was sacrosanct and definitive.

Burgess' opinion revealed a lack of understanding of the systemic nature of the power morcellator disaster and a deep seated dereliction of congressional duty to the American people, in favor of industry.

Where Fitzpatrick was politely focused on bringing congressional attention to a regulatory public health hazard, Burgess was arrogantly and over-confidently proclaiming that congress and FDA had no role in ensuring medical device safety - and that FDA's current conduct is good enough.

Of course, Burgess' position is very consistent with his campaign coffers - the medical specialty trade organizations and industry. You can view Mr. Burgess' campaign contributors here.

Again, in sharp contrast, Mike Fitzpatrick's campaign contributors are diverse and he is a popular leader. He is a congressman because he walks the streets of his constituency and listens carefully to those whom he represents - he is not just a puppet to the industry puppeteer.

So, is it a surprise that Mike Fitzpatrick falls on the side of the people where Burgess falls on the side of the medical profession and its associated industries? Is it a surprise that Burgess chooses medical industry protectionism where Fitzpatrick chooses patient safety and public health?

You see, Burgess killed amendments that were designed to draw attention to and protect patients from flawed or dangerous medical devices because he favors industry interests over lives.

On the other hand, Fitzpatrick sees that in our nation the lives and fundamental rights of minority subsets of people cannot be sacrificed or ignored by the federal government for the "benefit of the majority" or for the sake of smooth business. And those, dear reader, are true conservative values - those are the true values of a republican, who understands the purpose of the republic.

So the question now is how many others in the United States congress are able to focus squarely on the voice of the people and those harmed over that of the medical device industry and trade organization lobbyists. How many Mike Fitzpatricks are there in the United States congress? and how many Michael Burgesses?

Mike Fitzpatrick has come to represent a core group of women from across the nation, fallen to a disaster that the United States congress can and must contain. He is working to demonstrate to his colleagues that these women are to be recognized as "The Guardians" - their battle codified in the law - so they can stand watch and prevent another catastrophe like the "power morcellator" disaster from rearing its head in America again.

Or, perhaps, ours is wishful thinking.


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