Recently, UnitedHealth the largest health insurer in the United States made a very dramatic move. This insurance provider joined a chorus of others around the country by announcing its decision to sharply curtail and scrutinize its coverage of uterine resection operations performed by gynecologists across the nation.
Indeed, the gynecological industry finds itself "externally regulated".
Why is that? Simply put, because the gynecological leadership failed to appropriately "self-regulate" when faced with the reality of a catastrophic public health hazard.
The recent move by UnitedHealth was triggered by our yearlong campaign to enforce a ban on a widely used gynecological practice, known as morcellation. Because for over 2 decades, minimally invasive gynecologists across the world, had been spreading and upstaging unsuspected and deadly cancers by using this practice. Out of the Hundreds and thousands of women undergoing uterine resection for symptomatic fibroids annually worldwide, somewhere around one out of every 150-350 were falling victim to a deadly hazard.
Why? Because the specialty of gynecology was assuming that tumors of the uterus, widely known as fibroids, are benign.
We highlighted and publicized this severe and negligent error in practice using the free press to inform the populace – because almost all our colleagues in medicine stood on academic ceremony and failed to fight alongside us. Certainly most gynecologists fought back and characterized our alarm as an "overblown publicity campaign". And leading gynecological industry trade groups mounted a vigorous defense, which continues to date.
Why? Because, an entrenched and well-marketed practice was generating a large revenue-stream for many a gynecological practice across the nation. Of course it hurts to be forced into giving up such a comfortable thing – it is tough to give up "steak off one's plate". So the professional defense was vigorous, and it continues straight from the top, draped in false claims of "majority benefit", "women's choice" and even "patient safety".
But the simple and powerful truth is that this avoidable practice has led to the unnecessary or premature deaths of many hundreds of unsuspecting women.
It is a pure truth that men and women of common sense, reason and ethics see with clarity - but not the professionals who are fully invested in making a living from this practice. And, very certainly, not the FDA regulators who see these professionals as equal stakeholders to the American patient, to the consumer and to those harmed.
So in November 2014 the Food and Drug Administration, after what was likely a significant internal battle, only managed to put a "black-box" label on this power morcellator device - despite overwhelming evidence of avoidable harm to many women.
The FDA commissioner, Margaret Hamburg, was too soft and failed to protect the public from a very clear hazard. This failure of Dr. Hamburg's was a result of two factors: 1) her own inability to act with urgency in the face of a clear women's health hazard and 2) corruption of mission at the FDA's Center for Devices and Radiological Health (CDRH). This federal failure to protect patient safety in the medical device space will be remembered as a historic one on the part of FDA commissioner, Hamburg. And we believe it will soon lead to the ouster of the current CDRH leadership by Congressional oversight – certainly Dr. Margaret Hamburg, herself, is now gone.
But most remarkably for us as believers in free-market economics and responsible federal regulation, the recent move by UnitedHealthcare points to the capacity of our economy to self-correct and heal – where both professional and federal regulation have failed the people. But such effective market self-regulation only results when the people's voice interacts with the free press with efficacy – as did the campaign to end morcellation. After all, as is widely known to the agents of our free press, "the light of day is the best disinfectant".
Incredibly, where gynecological surgery trade organizations have failed to effectively self-regulated to protect their patients, where a group of medical device manufacturers have failed to protect their costumers and where federal public health agents failed to protect public health – a third industry is regulating them all.
Why? Because the insurance industry "bean-counters" looked in their databases and came face-to-face with a terrifying reality: That for over 2 decades our limited insurance dollars have been funding a practice that devastates one in 156-350 unsuspecting women. Every upstaged cancer not only represents an irrecoverable human loss, it triggers a large downstream cost of care for the harmed patient. Neither cost is acceptable to insurance actuaries and the industry's executives – or to any people of reason and ethics.
The beauty of free market capitalism interacting with the free press and democratic forces in America is that when an industry ethically misbehaves or fails, it is regulated actively – either by our federal government or by other industries!
The gynecological surgery industry has brought this level of external regulation, over its most commonly performed procedure, upon itself. Gynecological surgeons and their leaders failed to take measure of our warnings in November 2013 from Boston, when the avoidable upstaging of cancer was made visible beyond a doubt. So their vociferous objections over this external restraint and oversight are akin to those of a 2-year old.
We know that soon, the United States Congress will act with definition - to Protect and to serve, the people from ethical, corporate and FDA failures - as is its framing purpose.
But for now, our kudos and high cheers go to UnitedHealth and its executives for acting in the best interest of public health.
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.
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