We’ve all heard that the practice of medicine is as much an art as it is an objective science. The complexities of human biology and disease, genetic disparities and the limits of our scientific knowledge and technical abilities make this so. This reality is nowhere more apparent than in the realm of patient safety and medical complications.
Underlying the treatment of each patient are the assumptions the clinician makes about the patient and her condition. These assumptions are based on learned knowledge, evidence-based information and a more complex and subjective gestalt doctors describe as "the clinical picture."
If the clinician's assumptions about the patient and her disease match the reality of the disease, there is a chance of achieving a cure or alleviating suffering. But if these assumptions are incorrect, at best, the disease remains untreated — at worst, harm can be done.
A poignant example of how incorrect assumptions could lead to great harm emerged in the specialty of gynecology last year. In December 2013, the Wall Street Journal reporter Jennifer Levitz recognized that the gynecological specialty worldwide, was assuming that tumors of the uterus, known as fibroids or leiomyomas, are non-cancerous or benign.
This "assumption of benignity" by minimally invasive gynecological surgeons had led to the development of a widely used, high revenue and well-marketed surgical methodology practiced on 50,000-100,000 American women with uterine fibroids each year. The practice is known as power morcellation and it minces up uterine tumors to get the enlarged tissue out of small "minimally invasive" skin incisions.
The "assumption of benignity" about uterine fibroids turns out to have been a major and deadly mistake. The cost was paid by the unsuspecting women whose hidden cancers were being morcellated, leading to their spread (or upstaging). The undeniable fact is that this totally avoidable complication significantly worsened these patients' prognoses and caused many premature or unnecessary deaths.
What's worse is that the practice had been ongoing for over two decades. Many hundreds of unsuspecting women and their families, both in the United States and abroad, had been unnecessarily subjected to deadly harm by their well-intentioned doctors because of their "assumption of benignity."
Following the Levitz report in the WSJ, other major news outlets joined in examining this previously unrecognized women's health hazard. And most recently, it was established that up to one in 156 women undergoing morcellation has a hidden sarcoma.
After a yearlong battle between patient advocates and the gynecological industry, the Food and Drug Administration (FDA) imposed some moderate, but insufficient, limits on morcellation. The FDA has yet to remove power morcellators from the marketplace and restrain the gynecological surgeons who refuse to abandon the dangerous practice. Since then, this regulatory failure has established the FDA's Center for Devices and Radiologic Health (CDRH) as being a "captured" agency, whose primary loyalty is to industry interests, not patient safety.
Doctors' assumptions dictate the course of the care their patients receive. It's not difficult to see that if these assumptions are based on sound evidence, honest introspection and ethical reasoning, great good can be done. But when the aforementioned are lacking, the adverse consequences to patients can be irrecoverable.
One thing is for certain, when incorrect assumptions are harnessed into corporate profitability, a monster is created. Professional responsibility and good government should duly prevent lives from falling victim to this beast. But the momentum created by the corporate take over of the medical establishment, unfortunately, often overrides or controls both.
Self-advocacy can, to a very limited degree, protect patients against damaging and unrestrained corporate forces in medicine. But only doctors' strict adherence to evidence-based practice and empathetic medical ethics can result in a climate that truly serves patient safety in our hospitals.
Our federal government and its agencies also have a critical responsibility to impose efficient regulatory safeguards to assure patient safety. When professional responsibility and cogent federal regulation are over-ridden by industry needs, avoidable patient safety hazards easily penetrate through the buffer of self-advocacy, we are left with immeasurable harm.
The morcellation disaster in women's health is a bellwether case. At multiple levels, professional responsibility and government regulation failed. The result of this failure was a tangible tragedy — for two decades women fell victim to a dangerous and avoidable procedure, resulting in irrevocable suffering for likely thousands of women and their families worldwide. Indeed, because of the continued FDA failure to act decisively and ban power morcellation from the healthcare marketplace, patients will continue to fall victim.
As responsible citizens, we must demand that leading doctors, healthcare institutions and our government representatives in the United States congress take serious note of the lessons learned from the morcellation disaster - it has not been a small one. We must demand an adherence to medical ethics and insist that federal regulations in the United States serve their intended purpose of protecting the public from harm.
Silence in professional or congressional leadership is no leadership at all.
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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