E-mail Communications With the American Society Anesthesiologists’ (ASA) Leadership Regarding Gynecological Morcellation

Hooman Noorchashm
Aug 28, 2017 · 9 min read
Following my July 26, 2017 open letter to the ASA, I received a promise from ASA president, Dr. Plagenhoef, that the ethics committee on OB/Gyn anesthesia will review the role of anesthesiologists in restraining GYN morcellation.

(My e-mail communications with the ASA leadership are appended at the end of this article.)

On July 26th, 2017 I wrote an open letter to the leadership of the American Society of Anesthesiologists (ASA). You can view this letter, here.

In this letter, I informed the ASA leadership that despite the demise of power morcellators, a vast number of GYN surgeons continue to perform morcellation of potentially malignant uterine tissues and tumors in women — some even recklessly morcellate known cancerous tissues, as you can see here.

I was encouraged to see that within the span of a few days my Open Letter to the ASA was read by well over 20,000 readers. I was even more happy to find out that many anesthesiologists in remote corners of the country had read it and thought about it carefully.

I even got emails from leading anesthesiologists at large academic medical centers around the country encouraging me and expressing their agreement with my request of the ASA.

Incredibly, the AAGL, ACOG and some decorated academic press outlets continue to maintain that morcellation is “safe and sound” and that the anti-morcellation women’s health campaign was nothing more than a “publicity stunt” by “availability entrepreneurs”.

This dismissive lack of professional insight by GYNs, systemically, is putting even more women at risk worldwide.

So, without a doubt all professionals, from anesthesiologists to perioperative nursing staff, have an ethical duty to restrain GYNs from morcellating uterine tissues and tumors with malignant potential.

Dr. Jeffrey Plagenhoef, current President of the American Society of Anesthesiologists.

So, it was a sign of strong leadership from the ASA when I received an email from the Society’s president, Dr. Plagenhoef, informing me that my call to duty “warrants consideration by ASA’s Committee on Ethics and Committee on Obstetric Anesthesia (although not an obstetric issue, this committee holds formal liaison to ACOG) and we will plan to pass it along for their review.” And “please accept our sincere thanks for bringing this important issue forward.”

I was particularly impressed by the response from Dr. Plagenhoef, because it came in a setting where many leading anesthesiologists, some friends and mentors of Amy’s, have taken a defensive corporate posture or remained silent in the face of my simple and correct call to duty in the aftermath of her passing— this is tragic, especially, because most of these individual anesthesiologists have a detailed view of the iatrogenic complication and clinical course that caused her death (and many others’) on May 24, 2017.

Of course, I am certain that Dr. Plagenhoef’s response comes because he understands the leadership role he could play in protecting women from harm. I can only assume that the ASA president is 100% cognizant of the fact that anesthesiologists have a definitive duty to protect their patients from iatrognic harm inside operating rooms.

In fact, when a woman with potentially malignant symptomatic fibroid tumors undergoes a gynecological operation, it is an anesthesiologist who enables that operation. Therefore, it stands to reason that when that woman (i.e., one in 350) is exposed to an avoidable mortality risk from cancer upstaging, the entire operating room team, not just the GYN, bears the ethical and liability burden.

I responded to the ASA president in a public email — requesting that the ASA advise documentation of a formal preoperative checklist query for all anesthesia practitioners involved with enabling minimally invasive uterine resection operations by GYNs:

  1. Is this uterine tissue/tumor known not to be malignant?
  2. Is any form of morcellation or tumor disruption planned?

The answers to these questions will allow the anesthesiologist to determine if he/she is willing to participate in a minimally invasive uterine resection or myomectomy, which might spread or upstage an occult or missed uterine cancer.

ASA attorney Jeremy Lewin and Florida Society of Anesthesiologists president, Jonathan Slonin, at the 2015 ASA meeting — promoting “Safety in Anesthesia”.

In my email, I also pointed to the legal liability burden incurred by anesthesiologists who are participating in the ongoing GYN practice pattern. So, it was not surprising when I heard back from the ASA’s chief counsel, Mr. Jeremy Lewin, whose job it is to ensure that the ASA guidelines operate within ethical, legal and safety standards.

I have no doubt that the anesthesiologists and attorneys studying the iatrogenic morcellation disaster in women’s health from a systemic, legal and ethical perspective will not fail where the GYN leadership has.

For the public record, and so as to provide the many anesthesiologist and lawyers following the outcome of the ASA president’s focus on the question of ethical duty to restrain harm, I have published my email communications with the ASA leadership below.

Let this record serve as a reminder that strong and responsible leaders do exist in American medicine — and that one group of physicians does have the power and duty to restrain another, when avoidable iatrogenic harm is defined on a systemic level, especially when it is not treated with the acuity it deserves by so-called specialists.

Time will tell if the ASA and individual leading anesthesiologists have the ethical and legal integrity to parse through the facts of this disaster and rise to definitively protect unsuspecting women from cancer spread and upstaging by GYN morcellation — contain or uncontained, power or manual. In the name of one of their own, fallen to this disaster: Dr. Amy Josephine Reed (and the many other mothers, daughter, sisters and friends).

__________________________________________________________________

Hooman Noorchashm <noorchashm@gmail.com>Fri, Aug 25, 2017 at 12:15 PM

To: Jeremy Lewin <J.Lewin@asahq.org>

Cc: “Jeffrey Plagenhoef, M.D.” <J.Plagenhoef@asahq.org>, Michele Campbell <m.campbell@asahq.org>, Paul Pomerantz <p.pomerantz@asahq.org>, Lawrence J Saidman <LSaidman@stanford.edu>, medicinex <medicinex@stanford.edu>, “Floyd, Thomas” <Thomas.Floyd@stonybrookmedicine.edu>, “Fleisher, Lee” <lee.fleisher@uphs.upenn.edu>, “Savino, Joseph” <Joseph.Savino@uphs.upenn.edu>, “maurizio.cereda@uphs.upenn.edu” <maurizio.cereda@uphs.upenn.edu>, “Lane-Fall, Meghan” <Meghan.LaneFall@uphs.upenn.edu>, “emily.gordon@uphs.upenn.edu” <emily.gordon@uphs.upenn.edu>, Alan Slobodin <Alan.Slobodin@mail.house.gov>, “Knowles, Joseph” <joseph.knowles@mail.house.gov>, Brian Fitzpatrick <BriFitz8@gmail.com>, “Lurie, Peter” <Peter.Lurie@fda.hhs.gov>, CDRH Ombudsman <CDRHOmbudsman@fda.hhs.gov>, Josh Sharfstein <joshua.sharfstein@jhu.edu>, “Rita.redberg@ucsf.edu” <Rita.redberg@ucsf.edu>, “Luigino,M.D.,Ph.D. Nascimben” <LNASCIMBEN@partners.org>, “Carabuena, Jean Marie,M.D.” <JCARABUENA@partners.org>, “arthur.caplan@nyumc.org” <arthur.caplan@nyumc.org>, Michael Paasche-Orlow <Michael.Paasche-Orlow@bmc.org>, “Sean P. Tracey” <stracey@traceylawfirm.com>, Thomas Greene <tgreene@greenellp.com>, “François M. Blaudeau” <Francois@southernmedlaw.com>, “Nepps, Mary Ellen” <Mary.Ellen.Nepps@ogc.upenn.edu>, “ddriscoll@obgyn.upenn.edu” <ddriscoll@obgyn.upenn.edu>, “Beshara, Mathew” <mbeshara@obgyn.upenn.edu>, “Levitz, Jennifer” <jennifer.levitz@wsj.com>, “Sutton, Charlotte” <csutton@philly.com>, “jon.kamp@wsj.com” <jon.kamp@wsj.com>, “mark.maremont” <mark.maremont@wsj.com>, “weintraubkaren@gmail.com” <weintraubkaren@gmail.com>, “Singer, Patti” <psinger@democratandchronicle.com>, “Lowes, Robert (Bob)” <rlowes@medscape.net>, “grady@nytimes.com” <grady@nytimes.com>, Matthew Ong <matthew@cancerletter.com>, “Cajigal, Stephanie” <scajigal@webmd.net>, Gilles Frydman <kosherfrog@gmail.com>, “gerard.baker@wsj.com” <gerard.baker@wsj.com>, “howard.bauchner@jama-archives.org” <howard.bauchner@jama-archives.org>, Charles Ornstein <Charles.Ornstein@propublica.org>, “cdeutschman@northwell.edu” <cdeutschman@northwell.edu>, “mmccullough@phillynews.com” <mmccullough@phillynews.com>, “Stark, Karl (kstark@phillynews.com)” <kstark@phillynews.com>, “cawtrey@bidmc.harvard.edu” <cawtrey@bidmc.harvard.edu>

Dear Mr. Lewin,

I appreciate your response as the ASA’s counsel.

You are correct. There are serious liability and ethics questions involved here, which should restrain all reasonable anesthesiologists from participating in GYN operations involving morcellation of potentially malignant tumors and tissues.

Frankly, my purpose in generating the Open Letter to the ASA leadership and members was to formally warn the ASA’s leadership against the legal and ethical liability anesthesiologists are incurring by enabling morcellation operations in women across the United States. This is not a theoretical patient safety hazard or liability risk.

Please consider this email, as the ones prior, formal statements of public health/ethics warning to the ASA from a physician-advocate and a friend to your organization and members — many of you are colleagues, close friends and mentors to myself and Dr. Amy Reed (accomplished member of the ASA and one of your own).

My respectful suggestion is that you guide the ASA leadership, as an ethical attorney, to generate the necessary guidelines to defend against the ethical and legal liability anesthesiologists are incurring every time they facilitate a women’s occult or missed uterine cancer being morcellated in a GYN operating room.

Yours sincerely,

Hooman Noorchashm MD, PhD.

On Fri, Aug 25, 2017 at 11:56 AM, Jeremy Lewin <J.Lewin@asahq.org> wrote:

Dear Dr. Noorchashm,

I am General Counsel for the American Society of Anesthesiologists (“ASA”). Thank you for your email and for providing this additional background.

As the issues you raised involve legal matters, I will be your sole point of contact at ASA going forward. Please direct all communications to me and I will include others as appropriate.

Please also note that ASA does not disclose its internal business, scientific, or legal considerations to outside parties. However, I respect that you have a wealth of knowledge in this area and will reach out to you for guidance if appropriate.

Sincerely,

Jeremy Lewin


From: Hooman Noorchashm <noorchashm@gmail.com>
Sent: Friday, August 25, 2017 9:08:52 AM
To: Jeffrey Plagenhoef, M.D.
Cc: Jeremy Lewin; Michele Campbell; Paul Pomerantz; Lawrence J Saidman; medicinex; Floyd, Thomas; Fleisher, Lee; Savino, Joseph; maurizio.cereda@uphs.upenn.edu; Lane-Fall, Meghan; emily.gordon@uphs.upenn.edu; Alan Slobodin; Knowles, Joseph; Brian Fitzpatrick; Lurie, Peter; CDRH Ombudsman; Josh Sharfstein; Rita.redberg@ucsf.edu; Luigino,M.D.,Ph.D. Nascimben; Carabuena, Jean Marie,M.D.; arthur.caplan@nyumc.org; Michael Paasche-Orlow; Sean P. Tracey; Thomas Greene; François M. Blaudeau; Nepps, Mary Ellen; ddriscoll@obgyn.upenn.edu; Beshara, Mathew; Levitz, Jennifer; Sutton, Charlotte; jon.kamp@wsj.com; mark.maremont;weintraubkaren@gmail.com; Singer, Patti; Lowes, Robert (Bob); grady@nytimes.com; Matthew Ong; Cajigal, Stephanie; Gilles Frydman; gerard.baker@wsj.com; howard.bauchner@jama-archives.org; Charles Ornstein;cdeutschman@northwell.edu; mmccullough@phillynews.com; Stark, Karl (kstark@phillynews.com); cawtrey@bidmc.harvard.edu
Subject: Re: Response to Inquiry: Sent on behalf of Jeffrey Plagenhoef, M.D.

Dear Dr. Plagenhoef,

I would greatly appreciate your organization keeping me abreast of any developments on the promise you’ve made of ASA action on the issues I’ve raised with you — vis-a-vis the deadly iatrogenic complication associated with gynecological morcellation:

https://medium.com/@noorchashm/an-open-letter-to-the-american-society-of-anesthesiologists-amy-j-reed-md-phd-1973-2017-2c46d98e907d

My respectful recommendation — as a physician and public health advocate with intimate understanding of this iatrogenic women’s health hazard — is that the ASA consider recommending the following 2 questions as a formal preoperative checklist to all anesthesiologists involved with enabling fibroid operations in GYN operating rooms:

1) Is a malignancy definitively ruled out?

2) Is any form of tumor disruption/morcellation planned?

These two simple questions should allow the individual anesthesiologist determine whether he/she is willing to participate in a gynecological operation that might harm women with occult or missed uterine malignancies.

As you know, many public health organizations, several federal bodies, trial advocacy groups, a vast number of plaintiff’s attorneys and trusted press outlets are looking at this issue with extreme care — these facts have serious regulatory and liability implications for all health care providers and hospitals involved with these operations, including anesthesiologists.

Furthermore, several high profile civil malpractice and product liability cases against morcellator manufacturers and GYN providers are currently underway across the nation — and will likely demonstrate negligence and liability in cases of morcellation. In several of these case, the participating anesthesiologist has also been named as a defendant.

There’s no doubt that anesthesiologists are equal participants in every one of these operations and must, therefore, serve as THE internal restraint on this hazardous practice to both protect the safety of unsuspecting patients and to limit professional liability — as such there is a definitive role for your organization expressing a formal guideline to all its members, to prevent anesthesiologists from rote participation in an operation that could spread dangerous cancers with deadly consequences in women.

As it stands, you should know, that many GYN surgeons, and even the ACOG and AAGL leaderships, consider the oncological risk of morcellation to be negligible and Dr. Reed’s public health campaign to have been an effective “publicity stunt”:

http://www.medscape.com/viewarticle/837932

http://www.jmig.org/article/S1553-4650(16)30083-8/abstract

http://www.jmig.org/article/S1553-4650(17)30230-3/abstract

http://www.prnewswire.com/news-releases/on-abc-news-today--arizona-surgeon-survives-cancer-to-invent-and-perform-world-record-setting-cancer-surgery-300492609.html

Therefore, many GYNs are continuing the practice of tumor morcellation unrestrained with and without a power morcellator — especially in private and community practice settings, but also in some prominent academic settings.

I ask that, as ASA president, you consider this message a formal request for immediate action by your organization, for the record — because as you know, every day, somewhere in the nation and across the world women may be confronting a similar complication and fate as Dr. Amy J. Reed because of gynecological morcellation. This is an undeniable epidemiological fact about an historic iatrogenic catastrophe in women’s health — one in which no ethical anesthesiologist could have a hand.

Yours with respect,

Hooman Noorchashm MD, PhD.

On Wed, Aug 2, 2017 at 1:28 PM, Michele Campbell <m.campbell@asahq.org> wrote:

Dear Dr. Noorchashm,

Thank you for your letter, detailing not only the tragedy of your wife’s experiences, but also her heroic efforts to look past her own suffering to campaign for the health and safety of others. I am sure that you and your family are extremely proud of your wife’s legacy, and you certainly should be.

In your letter, you raised two very important questions: 1.) is morcellation a safe gynecological surgical procedure?; and 2.) does an anesthesiologist have an ethical duty to intervene regarding medical procedural decisions made by surgeons? The first question is outside the scope of ASA’s operations. The second question, however, warrants consideration by ASA’s Committee on Ethics and Committee on Obstetric Anesthesia (although not an obstetric issue, this committee holds formal liaison to ACOG) and we will plan to pass it along for their review. My instinct is this is a topic that would be best presented in our setting with a broader scope than the individualized narrative you provided, but I also recognize the powerfully emotional nature of your wife’s journey. Either way, please accept our sincere thanks for bringing this important issue forward.

Best regards,

Jeffrey Plagenhoef, M.D.

ASA President

Hooman Noorchashm MD, PhD

C: 215–593–0596

)

Hooman Noorchashm

Written by

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.

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