publication date: Nov. 15, 2019

Trials & Tribulations

Noorchashm: “Biopsy your tumors”—with failed fibroid guidelines, gynecologists might as well be reading tea leaves

Hooman Noorchashm

By Hooman Noorchashm, MD, PhD

 

write, again, compelled by emerging scientific facts regarding a serious systemic error of negligence on the part of the main American gynecological societies, AAGL and ACOG, and their member practitioners—though the problem I highlight here also affects overseas gynecological counterparts, specifically the RCOG in the United Kingdom.

As you well know, in 2014 and then in 2016, FDA issued several stern warnings regarding the iatrogenic cancer mortality risk caused by morcellation of symptomatic uterine fibroid tumors. Since then, gynecological surgeons and their professional associations across the world have made a concerted effort at damage control—and legal defense.

It remains true that not a single corporate entity, or GYN leader, has had the courage to extend an apology to the hundreds, if not thousands, of families whose loved ones’ lives were lost to catastrophic iatrogenic abdominal sarcomatosis or carcinomatosis—catastrophes caused by the careless morcellation of these women’s “missed” uterine cancers.

This lapse is, of course, a striking professional ethical failure and an error in surgical judgment on the part of the gynecological industry leaders. Not to mention that from a historic perspective, it will remain a dramatic demonstration of how business interests in health care delivery can override reason, sound ethical conduct, and even human decency in the practice of medicine in the United States.

It is quite clear, from The Cancer Letter’s past reporting and others’, that many an individual gynecologist and some high-caliber health care corporations understood the systemic nature of the deadly morcellation hazard to women, but failed to do anything at all to prevent the harm, until the 2014 FDA action (The Cancer Letter, How Medical Devices do Harm, 2014-2017; When Surgical Innovation Kills, 2018-2019).

Notwithstanding, since 2014, AAGL, ACOG, and RCOG have attempted to create “guidelines” that might help identify the women whose fibroid tumors are at “higher” risk of being malignant, preoperatively—all this under the guise of “patient safety,” but in truth, in a desperate attempt to preserve the practice of morcellation for small-incision surgery, in the revenue-rich practice of “minimally invasive” hyster-ectomy and myomectomy.

“Minimally invasive” gynecological reasoning in concocting these preoperative “guidelines” goes something like this: “If we could come up with a series of clinical features that would allow us to identify the one in 200-400 women at high risk of having a sarcoma, we can continue our lucrative morcellation business as usual in the vast majority of women.”

To date, AAGL, ACOG and RCOG have contrived a series of seemingly “common sense guidelines” to identify the so-called “high risk” women—using criteria like age, tumor size, growth rate, the need for blood transfusion, central necrosis on imaging, etc.

This all sounds reasonable! But only if these so-called “guidelines” can actually help identify the women at high risk with adequate sensitivity and positive predictive value.

Unfortunately for the AAGL, ACOG and RCOG, in July 2019, a reputable group of GYNs from California’s Kaiser Permanente Health system, led by Dr. Scott Lentz, demonstrated that their “guidelines” have virtually no positive predictive value in identifying women with uterine sarcomas.

This means that all the guidelines AAGL, ACOG and RCOG have thus far elaborated, to justify the continued use of morcellation as an oncologically safe and risk-mitigated practice algorithm, are simply USELESS!

Of course, most cogent clinicians will recognize a glaring deficit in the gynecologists’ pre-operative risk stratification “guidelines”: NONE of them include the routine use of tumor biopsy to characterize the potentially cancerous uterine tumors. This is in striking contrast to the routine use of tissue biopsy as a gold-standard methodology used by virtually every other surgical specialty— except gynecology—to assess the malignant potential of soft tissue tumors.

Without the use of tissue biopsy to obtain at least a reasonable assurance of tumor benignity, the gynecologists who use the AAGL, ACOG or RCOG “guidelines” might as well be reading tea leaves to determine which women are at high risk of carrying a sarcoma in their uterine fibroid tumors.

Most gynecologists defend this failure to use biopsy by making excuses about limitations in sensitivity or specificity of biopsy techniques—and the nuanced technical challenges routine biopsy of fibroid tumors would pose to these surgeons’ already well-oiled hysterectomy/myomectomy money machines.

I know that any reasonable surgeon and pathologist would immediately recognize that these excuses are a result of technical, intellectual and ethical lassitude, and are contrary to well established facts about a method used by all other surgical disciplines in evaluating the biology of various tumors in the human body for malignancy.

Granted, all biopsies do have diagnostic limitations and are subject to “sampling error,” but it is a certainty that the gynecologists’ insistence that biopsy of uterine tumors has no or little role in ruling out cancer is absurdly incorrect and negligent.

I am compelled to write this editorial now, because this week, the Journal of Minimally Invasive Gynecology (JMIG), the press arm of the AAGL, published a disturbing podcast video interview with the Kaiser Permanente authors, Drs. Scott Lentz and Eve Zaritsky.

Screen-Shot-2019-11-14-web

Peter Movilla, a minimally invasive gynecologic surgical fellow at Newton-Wellesley Hospital, interviews Scott Lentz and Eve Zaritsky of Kaiser Permanente about their study in a video podcast published Nov. 10 by the Journal of Minimally Invasive Gynecology.

The Lentz et al. study concluded that, “when incorporated into a prediction model,” multiple clinical features associated with the present of a uterine sarcoma “fail to provide significantly more information about women who may have an unrecognized sarcoma and only marginally improve the certainty about women who are not likely to have sarcoma.”

 

You may view this video here.

In this interview, the authors admit their study demonstrates that the current “guidelines” for identification of high-risk women have no predictive value. The interview is striking for the dispassionate way the interviewer, Dr. Peter Movilla of Partners Health System in MA, discussed the series of criteria used to establish the “guidelines” put in place to presumably protect a one in 200-400 subset of women—in a population of over 500,000 American women undergoing uterine operations.

The gynecologists in the video rather nonchalantly conclude that the current “guidelines” carry no predictive value in protecting women. But, it is shocking to witness the interviewer fail to extend the implication of the Lentz et al. findings and call for an urgent, nay, emergent, re-evaluation of the preoperative diagnostic algorithm for the management of symptomatic uterine fibroids—as if the Lentz et al. paper is simply a rhetorical academic exercise for these gynecologists, and is not directly identifying a major systemic error that is certain to devastate even more unsuspecting women’s lives somewhere in a gynecological operating room in the U.S. or abroad.

Of course, I know the sad reality is that most gynecological “leaders” will interpret the Lentz et al. results to imply that uterine soft tissue sarcomas are, in fact, unidentifiable and are truly “occult,” thus, they are not “missed” diagnoses at all—what a testament articulating such a position would be to the intellectual rigidity and inability of the specialty to be self-critical about a serious deficit in its clinical acumen and reasoning; what a testament to the house of cards the gynecologists have built to defend morcellation of potentially malignant tumors.

Without any attempt at biopsy, uterine fibroid tumors will continue to be “assumed benign” as a rule by gynecologists, and when found post-operatively to be cancerous, will be labeled an unfortunate case of an undiagnosable, “occult” malignancy—thereby removing any burden of ethical or legal responsibility for a “missed” cancer diagnosis from the treating gynecologist.

Such is the nature of the rhetorical game gynecological leaders and their associations (AAGL, ACOG, and RCOG) are playing with women’s lives in the year 2019. And, a whole generation of young gynecologists are being trained in such cognitive blindness.

Of course, it is notable to consider an analogous situation in the management of breast masses in women, where the incidence of malignancy in women who present with palpable breast masses is considered to be on the order of one in 200-400—virtually identical to the incidence of cancer in the case of women with symptomatic uterine fibroid tumors.

But unlike the average gynecologist, the typical breast surgeon NEVER assumes a breast mass to be benign without tissue biopsy—and even when a biopsy shows a benign fibroadenoma, the women are offered an oncologically sound resection.

Why is gynecological thinking about the malignant potential of uterine fibroid tumors so primitive and careless, by comparison?

They will claim, of course, that the breast mass and uterine tumors are anatomically distinct and not comparable—but, of course, this retort misses the point about the gynecologists’ unsafe cognitive approach to the management of potentially malignant uterine tumors.

Notwithstanding, for those health care professionals, risk managers, defense attorneys and regulators who have any degree of clarity on the implications of the Lentz et al. study in JMIG, there are now only three potentially logical options for gynecological associations to consider, in thinking about and managing the deadly morcellation hazard to women:

  1. They can attempt to argue that the one in 200-400 risk of creating an iatrogenic disaster in this minority subset of women is ethically justified by the “majority benefit” imparted to the over 99% of women—most of whom undergo small-incision surgeries with morcellation without an oncological complication. This utilitarian argument has been made by many a so-called gynecological leader (e.g., Professor William Parker of UCLA, Dr. Jubilee Brown of AAGL, and their band of “expert” colleagues). These gynecologists are of the opinion that, so long as the woman gives consent and accepts the risk of morcellation, the one in 200-400 cases of deadly cancer upstaging are acceptable. But this argument does not pass medical ethical muster—because it is only a utilitarian argument designed to secure corporate revenue and patient convenience metrics, not the ethical or patient safety metrics every physician and hospital must have as their primary objectives.

  2. They can admit that, because the women at risk of deadly cancer upstaging cannot be identified pre-operatively using their current “guidelines,” EVERY woman is being exposed to an unacceptable iatrogenic mortality risk—because ANY woman with a symptomatic uterine fibroid tumor could be the one whose tumor is malignant. Thus, non-oncological uterine operations should NOT be offered to any women—that is, a total abandonment of morcellation practices of any kind in women with symptomatic uterine fibroids.

  3. They can accept that it is possible to establish a “reasonable assurance of tumor benignity” using the gold-standard technique of tissue biopsy—as most surgical disciplines rely on to diagnose soft tissue malignancies. In particular, in young women undergoing uterine-sparing myomectomy operations, it is of paramount importance to perform such biopsies to rule out a malignancy with a reasonable degree of certainty—because these operations are, by definition, non-oncological.

Most reasonable clinicians would consider option 1 to be totally invalid from a medical ethical perspective. Of course, option 2 is not entirely feasible, because a large number of young women with symptomatic uterine fibroids wish to retain their fertility and must have the option of undergoing a myomectomy.

So, every effort must be made to offer these women uterine-sparing operations in an oncologically safe manner. Therefore, the only reasonable approach AAGL, ACOG, and RCOG have remaining in re-orienting their current “guidelines” for the pre-operative evaluation of uterine fibroid tumors, is a combination of options 2 and 3.

That is, AAGL, ACOG and RCOG must establish a set of revised “guidelines” for pre-operative evaluation of symptomatic uterine fibroids, which include the use of tissue biopsy as a centerpiece—in order to establish a “reasonable assurance of benignity” before proceeding with ANY non-oncological uterine operation in women. Furthermore, all total uterine resections (i.e., hyster-ectomy) must be performed en bloc, in an oncologically sound manner, with an adequate-sized incision to remove the organ, when necessary.

It goes without saying that it is critical for gynecologists to grasp that tissue biopsy of uterine fibroid tumors does not provide a guaranteed diagnosis of benignity. In fact, tissue biopsy could only render a reasonable assurance of benignitynot a guarantee.

But neither the sensitivity/specificity limits of tissue biopsy, nor the limitation introduced by “sampling error,” ought to pose a barrier to the use of biopsy as a means of establishing a reasonable assurance of benignity—in order to protect one in 200-400 women from the catastrophic iatrogenic spread and upstaging of uterine cancers.

To reiterate, for the record, from a patient safety and ethics perspective, only women requiring uterine sparing operations (or, high risk operative candidates, who require small incision surgery) should ever be subjected to non-oncological uterine operations—and, this, only after tissue biopsy has established a reasonable assurance of benignity.

On the other hand, low to moderate-risk operative candidates, who require a total uterine resection, must be offered oncologically safe operations, without the possibility of tissue/tumor disruption—either transvaginally, or via an adequate abdominal incision.

AAGL, ACOG and RCOG remain at a self-imposed crossroads, where the cost of their continued error in ethics and clinical judgment can be (and has been) measured in the number of iatrogenic casualties their member practitioners are continuing to cause in women with fibroid tumors across the U.S. and abroad.

I will say again, as I have in the past, that gynecological morcellation and its handling since the 2014 FDA action is a historic error in professional ethical integrity and judgment by leading gynecological associations. This error will be remembered in the archives of medical history—because it has harmed and killed hundreds, likely thousands, of unsuspecting women, prematurely or unnecessarily, for several decades across the world.

Finally, to be clear, “missing” a uterine cancer diagnosis and then spreading the “missed” cancer by morcellating it, is not an acceptable iatrogenic complication to be justified, even by patient “consent,” when one in 200-400 women are being exposed to a catastrophic risk.

No unsafe and negligent medical practice is ever justifiable by invoking the medical ethical principle of “patient autonomy” (i.e., “informed consent”)—especially when the gynecologist obtaining the consent is geared towards downplaying the risk by blindly reassuring the patient, whose own tendency it is to trust her doctor, when he tells her that: “the vast majority of women, in fact, do NOT have cancerous uterine fibroid tumors, and you likely don’t either.”

One in 200-400 do, indeed—and the woman being consented has not been reasonably ruled out as being the one at risk!

For the record, here I ask The Cancer Letter and other public health media outlets, all cogent public health regulators, and any wise gynecological leaders reading this editorial, to urgently and carefully interrogate the dangerous oncological implications of the Lentz et al. study.

The current AAGL, ACOG, and RCOG “guidelines” for pre-operative risk stratification of potentially malignant uterine fibroid tumors have been formally invalidated. They provide no risk-mitigation buffer towards oncological safety.

But the radically simple solution is staring at the gynecologists’ blind spot: “Biopsy your tumors!”


For Amy, and the others.

Copyright (c) 2019 The Cancer Letter Inc.