A Leading Gynecologist’s Persistent Disregard For the Cancer Risk in Symptomatic Uterine Fibroids.
A few days ago, I received an email from Los Angeles’ Dr. William Parker — the self-proclaimed “king of Fibroids”.
But before I tell you about the Parker email, for those who do not know it….here’s some background…
It’s been nearly 8 years since my wife, Dr. Amy Josephine Reed, fell to a disaster created by the specialty of “mininally-invasive” Gynecology (MIG).
But as a result of her activism, millions of people across the United States and abroad learned that MIGs rely on a technique called “morcellation” to removed enlarged tumors of the uterus through small skin incisions.
Morcellation is, literally, a process through which enlarged fibroid tumors of the uterus are minced up inside women’s abdominal cavities to extract the overgrown tissues from small skin incisions. The trouble is that one in 100–400 of these tumors are cancerous — and when a cancer is minced up inside a patient’s body cavity, it spreads and dramatically worsens the patient’s prognosis.
Many women across the US and the world have, verifiably, died over the past 30 years because of careless morcellation of their missed cancer diagnoses by MIGs. Morcellation, especially when uncontained, causes the premature or unnecessary death of the women who fall victim to this error in Gynecological reasoning.
Of course, as expected, because morcellation harms “only” one in 100–400 women with symptomatic uterine fibroids, many Gynecologists continue to practice it upon women — and continue to downplay the risk.
After all, as we know, it is very easy for powerful professionals to wantonly disregard and downplay even deadly avoidable harm to citizens — especially when only a minority subset are catastrophically affected, the professionals are legally shielded — and when the majority benefit or remain unaffected.
So it’s a fact of medical history now that following Dr. Amy J. Reed’s successful campaign to curtail the practice of morcellation in Gynecology, a coalition of well-decorated Gynecologists rose in dissent — even going as far as to use concocted data to dispute the United States Food and Drug Administration’s (FDA) analysis and rare decision to put significant restrictions on this practice and its associated medical device.
Chief among the Gynecologists who downplayed the risk of morcellation in women with symptomatic uterine Fibroid tumors is a past president of the American Association of Gynecological Laparoscopists (AAGL), Dr. William Parker of Los Angeles.
You may read about Dr. Parker and his colleagues’ assault on Dr. Amy J. Reed’s campaign HERE.
Despite Parker’s concerted effort to negate Dr. Amy J. Reed’s public health campaign, and to be certain it had not made an error, FDA reconsidered its 2014 decision and reiterated the agency’s strong warning against use of morcellation in the “vast majority of women”.
You may read the FDA most recent warning about morcellation in Gynecology HERE.
Amy Josephine Reed MD, PhD died on May 24, 2017 from complications caused by morcellation of her missed uterine sarcoma diagnosis at Harvard Medical School’s Brigham and Women’s Hospital, using a Laparoscopic Power Morcellator device made by the German company STORZ. A remembrance of her is HERE.
It is now Autumn of 2020, as I write. My family’s grief over Amy’s death is now numbness. Her absence loud, daily.
So, I was surprised a few days ago to receive a somewhat incoherent email, bordering on belligerent, from Dr. William Parker. This email was addressed to the FDA’s director of the Center of Devices and Radiological Health (CDRH), Dr. Jeffrey Shuren.
Of course, Dr. Shuren is well familiar with Dr. Amy Reed’s women’s health campaign. A few years ago, before Amy died, he even took the time to meet with her and me in person, along with his staff at FDA. Of course, our interaction with him at the time was contentious, because Amy felt that FDA (and specifically Shuren) had failed in not totally banning the LPM device, responsible for the avoidable deaths of so many women in Gynecological operating rooms. To be sure, Shuren got good public feedback — and I know that he and his colleagues at FDA were listening.
Since then, and especially because I now know that Dr. Shuren did not buckle to the scientifically unsound pressures exerted by Parker and his colleagues, I recognize that CDRH’s actions were as strong as he could possibly muster — and that FDA held the line, despite its regulatory constraints, doing its best to prevent harm to women by Gynecologists. I wouldn’t say that I consider Shuren a friend, but I understand the balancing act that is required of him now — and I appreciate the fact that CDRH has seen through the charade Parker’s group attempted to pull on the agency in their attempt to “nickel and dime” the cancer incidence in uterine Fibroid tumors.
Still, I was astounded by the wanton disregard Dr. William Parker continues to exhibit in his approach to the cancer risk of symptomatic uterine fibroids — and towards myself, as a fellow physician whose family has been devastated by a loss he should fully grasp as a leading Gynecologist. But Parker is locked in — both in his incorrect absolutist view of the cancer risk of uterine Fibroid tumors and his unkind belligerence towards me and Amy, personally. It’s astonishing that a physician with a, presumably, panoramic view of Gynecology is still persisting in his failure to appreciate the scope of epidemiological hazard the FDA and public heath advocates have highlighted in a practice he performs thousands of times each year on unsuspecting women.
Below is the striking email Dr. Parker sent to Dr. Shuren, with me CC’d. For the record this email was sent to a public health official at FDA, and as such the public has the right to view it — I am therefore sharing this with the reader:
From: William Parker
Tue, Sep 22, 1:42 PM (1 day ago)
To: Jeff.Shuren@fda.hhs.gov, me
Jeff,
I just saw a woman with an 18 year history of fibroids who continues to be symptomatic, but has been told by 6 gynecologists over the years that her only option is a hysterectomy. She has a 10 cm fibroid causing symptoms, but it should be easy to remove laparoscopically. The chance that this fibroid, present with little growth over 18 years, is leiomyosarcoma is zero. She is 51. Her mother was 55 at menopause and she doesn’t want to wait that long to remove the fibroid.
She is also a healthcare scientist and smarter than the 3 of us put together. She researched and found out that laparoscopic myomectomy was possible.
Why does the FDA (or Norchashm) get to tell her that she can’t have laparoscopic surgery with morcellation? Why can’t she have informed consent like every other surgical procedure?
Jeff, I am happy to hear your response. Hooman, don’t bother, since your e-mail is still blocked.
Bill Parker, MD
This email demonstrates the characteristic defective reasoning and the wanton disregard for the malignant potential of symptomatic uterine Fibroid tumors in women, exhibited by many “minimally-invasive” Gynecologists — of whom William Parker is the most prominent and vocal representative.
Aside from the rude tone he generally exhibits towards me, as husband to a powerful and dignified woman physician killed by morcellation, the errors implicit in the arguments Parker is posing to Dr. Shuren should speak for themselves to any reasonable citizen or physician.
Here is point-for-point listing of Parker’s errors in his note to FDA’s Dr. Shuren — for the historic and public record:
- Parker uses an anecdote about a woman, whose symptomatic uterine Fibroid tumor he believes is benign. Of course, his persistent and overarching error is his belief/assumption that this tumor is benign WITHOUT any attempt at obtaining tissue biopsy.
- Parker asserts that “The chance that this fibroid, present with little growth over 18 years, is leiomyosarcoma is zero.” This is a terrible error in clinical (and ethical) judgement, because he has no medically acceptable basis for this assertion — it is simply an incorrect and irresponsible assumption: Parker’s “ZERO” chance. It is, however, true that most likely, this patient’s tumor is benign — as are most symptomatic uterine fibroid tumors. But, one in 100–400 symptomatic uterine Fibroid tumors are NOT benign. One in 100–400 are, in fact, cancerous. So Parker’s assertion of “zero chance” has ZERO logical grounds and ZERO basis in clinical/epidemiological facts!
- Parker asserts that this patient is 51 years old and that she has found out that a myomectomy is “possible”. Of course, yes, myomectomy is the gold standard uterine sparing operation for women who wish to retain their fertility. Whether in this particular pre-menopausal 51 year old woman, whose symptomatic uterine Fibroids require surgical intervention, family planning is a cogent option, of course, is up to her. Certainly, the fact that she is “a healthcare scientist and smarter than the 3 of us put together” does not obviate the need for the Gynecologist to render her with sound and unbiased professional services, as the “expert”. It remains the Gynecologist’s responsibility to inform this patient that myomectomy is, by definition, an oncologically dangerous procedure — and that symptomatic uterine Fibroid tumors have a one in 100–400 probability of being a cancer. Of course, a responsible surgeon would perform tissue biopsies of the tumor pre- or intra-operatively to establish a “reasonable assurance of benignity”, before offering this woman an oncologically hazardous myomectomy operation. But unfortunately, as I have written previously, “minimally-invasive” Gynecology has not yet evolved into a mature enough state to accept the critical importance of tissue biopsy in ruling out uterine soft tissue sarcomas. Parker’s error is that he cannot bring himself to accept that it is his expert responsibility to exert maximal effort towards identifying the one in 100–400 women with uterine soft tissue sarcomas, before offering them oncologically hazardous uterine operations, such as a myomectomy.
- Parker asserts “Why does the FDA (or Norchashm) get to tell her that she can’t have laparoscopic surgery with morcellation? Why can’t she have informed consent like every other surgical procedure?” This assertion is simply a falsehood. Because neither FDA, nor myself, have told this or any other women, that she “can’t” have laparoscopic uterine surgery. In making this silly statement, Parker has revealed his terrible misrepresentation that “minimally invasive surgery” is synonymous with morcellation. This is a terrible conflation. In fact, any minimally invasive surgeon worth his/her salt will readily attest that it is possible to perform laparoscopic-assisted operations without resorting to morcellating the enlarged tissue/tumor to extract them from the body. The trouble with Parker’s position is that he is, in truth, advocating for what amounts to “maximally invasive surgery” through small-incisions — NOT “minimally invasive surgery”. These are two distinct approaches to surgery: the former aiming to do the least damage possible, using the most delicate and technically refined methodology to achieve repair, patient safety and comfortable recovery; while the latter is purely a marketing and cosmetic gimmick, designed to sell “small-incisions” to women, despite its needing to use what amounts to a meat grinder device to extract the diseased tissues through as small an incision as is possible. But, again, the real issue that irks Parker’s folks is that in 2014 FDA recognized that the lives of one in 100–400 women were being devastated during Gynecology’s most commonly performed uterine operations — because these women’s cancers where being minced inside their bodies indiscriminately, while an assumption of benignity was made about their symptomatic uterine Fibroid tumors. In fact, this dangerous assumption is what caused the premature or unnecessary death of Dr. Amy J. Reed’s in 2017. Certainly Parker’s assertion that I, personally, have anything to do with preventing women from undergoing uterine sparing operations is ludicrous and demonstrates the utter intellectual weakness of his position on morcellation in Gynecology. Sadly, it is very clear that the Parker and his colleagues may prefer to accept the harm done to one in 100–400 women as the acceptable collateral damage and cost for serving the convenience of a “vast majority of women” — and their own lucrative “service lines”.
- Parker asserts,”Jeff, I am happy to hear your response. Hooman, don’t bother, since your e-mail is still blocked.” This, again, is emblematic of Parker’s lack of clarity. Being as I am not only an academic physician colleague with training and credentials that rival his own — AND because my wife fell to a disaster definitively caused by his specialty — one would think that a highly qualified physician of integrity would be capable of inviting real open discourse with decency, empathy and courage. Maybe Parker is qualified and decent, but certainly his interactions with me over the past several years have left a lot of questions about either contention. Forgetting myself for a moment, the reality is that minimally-invasive Gynecologists like Parker owe Dr. Amy J. Reed (and her family) a debt of gratitude — because through her suffering and death she identified and exposed a deadly and totally avoidable hazard in their specialty. But, again, Parker has no scruples about generating half-baked emails and rallying “inside-the-box thinkers” in his specialty to attack what will demonstrably be remembered as one of the most effective women’s health campaigns in the history of Gynecology. Too bad, he doesn’t have the clarity and foresight to see that he is falling on the wrong side of his profession’s history.
Of course, I did respond to Dr. William Parker’s email, with FDA’s Dr. Jeff Shuren CC’d, as follows:
From: Hooman Noorchashm <noorchashm@gmail.com>
Tue, Sep 22, 2:07 PM (1 day ago)
To: William Parker <wparker1248@outlook.com>, Jeff.Shuren@fda.hhs.gov
Right. Please biopsy it to establish a “reasonable assurance of benignity” and don’t use an uncontained power morcellator….
[St_pid!]
Hooman Noorchashm MD, PhD
In the end, what it comes down to is this: Gynecologists cannot assume that symptomatic uterine fibroid tumors are benign — especially not when the operations they perform on these tumors floridly violate every reasonable principle of safe surgery on potentially malignant tumors and can cause the premature or unnecessary deaths of the unsuspecting women, affected.
Parker and his friends have yet to grasp the magnitude of their error and the injustice they have allowed (and allow) to transpire against the minority subset of women affected by this problem, under their care. The numbers are not small. With millions of women undergoing these operations daily across the world by Gynecologists, devastating one in 100–400 of these lives by upstaging a missed cancer is a modern day, well-camouflaged, atrocity.
Maybe Parker will grow up soon and exhibit the intellectual and ethical gravity necessary in a dignified physician…or maybe Gynecologists of reason and integrity will rise up to silence belligerent “Parker-esque dysreason” in their ranks.
For now, the clock is ticking on the MIGs!
