The New England Journal of Medicine (NEJM) has no plans to change the wording of an article that led to allegations of breached patient confidentiality and caused a minor social media firestorm this past weekend, the journal told Retraction Watch.
The paragraph in question appeared in an essay by Lisa Rosenbaum chronicling the history of power morcellation, a technique to remove gynecological organs that the FDA has subjected to a “black box warning” because it can also spread tumors:
Practice changed after 2013, when Amy Reed, a 40-year-old anesthesiologist and mother of six, underwent a hysterectomy with intraoperative morcellation for presumptively benign uterine fibroids at Boston’s Brigham and Women’s Hospital (where I have since joined the faculty). The masses turned out to contain foci of leiomyosarcoma (LMS), a rare, aggressive cancer that has a 5-year survival rate of 63% when diagnosed at stage I. Reed’s LMS was stage IV, so her likelihood of surviving 5 years was only about 14%.
The Cancer Letter, along with Reed and her husband, Hooman Norchashm, who have been on a campaign to ban power morcellators, interpreted that passage to mean that Reed “had stage IV cancer at the time of her hysterectomy.” That would, presumably, weaken the case for the FDA’s warnings, as well as the legal cases Noorchashm and Reed have against the hospital and a power morcellator manufacturer.
In a story published late on Friday, The Cancer Letter reported that Reed, concerned that Rosenbaum had accessed her medical records without permission, had “filed a complaint under HIPAA, the Health Insurance Portability and Accountability Act, with the Office of the Massachusetts Attorney General and the HHS Office of Civil Rights.” Brigham and Women’s, the Letter reports, said an investigation had found Rosenbaum did not access Reed’s records.
It is easy to say, as some have, that The Cancer Letter jumped the gun on this story, given what we now know about what NEJM says they meant (more on that in a moment). But that would seem to ignore the fact that NEJM had several opportunities to clear up the confusion surrounding that sentence.
The first, which in hindsight seems likely to have nipped the whole controversy in the bud, was when The Cancer Letter asked NEJM for comment sometime before the story about the essay ran Friday. The journal’s response:
NEJM officials declined to respond to The Cancer Letter’s questions on sourcing, citing an “ongoing investigation prompted by a complaint filed with a government agency.”
The second, which they took advantage of after the story was being discussed on social media — but apparently while the investigation was still ongoing — was when Michelle Meyer contacted them for a post she published Saturday at Forbes. The essay, a NEJM spokesperson told Meyer,
was not reporting that the cancer was stage IV before the time of the initial fibroid surgery. It would be impossible to know this.
Meyer even offers a helpful rewrite of the sentence in question (italics mark changes):
Following—and likely as a result of—morcellation, Reed’s LMS was diagnosed as stage IV, so by then her likelihood of surviving 5 years was only about 14%.
The journal told ProPublica‘s Charles Ornstein the same thing it told Meyer, and answered other questions from him.
NEJM’s other opportunity is, of course, to correct or clarify the actual piece, which they could do at any time. When we asked whether they would be doing so, however, a spokesperson said “we don’t plan to change the article.”
This is not the first time in recent memory that NEJM has declined to correct the record when issues were brought to the their attention. The New York Times reported on one such case earlier this month, in which the journal published a letter without realizing it omitted critical data about anti-clot drug Xarelto. And to be fair, they are hardly the only journal that doesn’t jump to issue corrections, as a recent analysis showed. (Correcting the record, we hasten to note, does not necessarily mean retraction.)
The Cancer Letter, for its part, says a new story is coming in response to the journal’s comments over the weekend.
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Sounds like The Donald in making “factual” statements . . . a.k.a. slinging BS.
I was left with the impression that Rosenbaum had looked into Reed’s EHR, before writing this op/ed for nejm.
nejm should correct itself now, rather than later.
‘Black Box Warnings’ do no good unless the doctor believes in the possibility of this happening to patient before him.’Informed consent’ for an unsafe procedure, 1 out of 350, only seeks to protect the doctor and the hospital, not the patient.
Especially, when you read
‘A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA
Warning and Litigation’
Raquel Ton, BS, Gokhan S. Kilic, MD, John Y. Phelps, MD, JD, LLM
Received Date: 19 August 2014
Revised Date: 20 January 2015
Accepted Date: 21 January 2015
Quote:
‘This article is not meant to further deter gynecologists from using laparoscopic power
morcellators, but to provide an interpretation of the FDA statement as to which patients the use
of power morcellators may still be permitted under the FDA guidelines. This article also offers
protective measures from a legal perspective for those who choose to continue to use power
morcellators in the face of the recent FDA warning and litigation.’
I think the key phrases in the subject paragraph are “turned out to contain foci of leiomyosarcoma.” Combined with the previous “presumptively benign uterine fibroids” could only be interpreted that the stage IV diagnosis was made either during or after the procedure. “…turned out…” can’t mean beforehand unless stated so.
NEJM likely couldn’t change Rosenbaum’s wording because of the pending legal action, nor could they say they may, only that they had no plans to, which is noncommittal either way.
Morcellation is used in many procedures, gynecology is just one application of the technique. It’s not gruesome but may seem so to the uninitiated. Dentists grind teeth, GI doctors cauterize gastric ulcers and orthopedic surgeons use bone saws, chisels and screws in their work; all primitive but effective methods. Reed’s husband certainly has to be aware of cardiac electrophysiology, deadening misfiring cardiac nerves with electricity; the trauma of his wife’s situation must be understandably driving many of his actions.
J&J is a very risk averse company, I’ve worked for them; they are big, resilient and quite data driven. Morcellators represent a tiny portion of their business and pulling them from the market may mean nothing beyond avoiding scrutiny of a fairly mundane product.
Amy Reed’s first surgery was in October 2013. In November, a second surgery found a leiomyosarcoma (LMS) growing on her bladder, making her stage 4. Because only weeks had elapsed, I understood the NEJM article to mean that morcellation occurred and she was then stage 4.
Hooman Noorchashm, Amy’s husband, harasses people who disagree with him on morcellation. In an email to me personally and to others, he wrote: “The truth is the truth and wrong is wrong – no matter who commits it (a dying LMS patient, a leading advocate, a surgeon or an entire profession).” I hope NEJM will back Lisa Rosenbaum because I know what it’s like to be harassed for questioning him.
I don’t trust The Cancer Letter, which I consider biased toward Hooman & Amy. For example, it has tweeted: “Brigham Doc’s NEJM Paper Decries Morcellation’s Demise, But How Did She Get Confidential Patient Information?” This tweet suggests Lisa did indeed get confidential information, although there is no evidence to support that. Unfortunately, Arthur Caplan, head of the Division of Medical Ethics at New York University, and others retweeted this.
As if to prove Lisa’s point in the NEJM article, Boston Magazine has just come out with an article that quotes only Hooman & Amy. At least one statement is demonstrably false: The article refers to the 2012 Seidman study. It says that “the Brigham doctors found unexpected sarcomas in 10 out of 1,091 samples of tissue from women who’d undergone uterine morcellation.” This is incorrect. The study looked at 1,091 samples from 2005-2010 and found 7 fibroids that were unusual; 3 tumors of uncertain malignant potential; 1 endometrial stromal sarcoma and 1 leiomyosarcoma. The researchers also looked at surgeries done elsewhere and found disease was disseminated in 4 of the 7 LMS cases. Of those 4, three died. The other 4 survived, as did the women who had something other than LMS.
Suzie Siegel,
in remission from metastatic LMS
longtime patient advocate
bachelor of journalism degree from the U of Missouri
master’s in women’s studies from the U of South Florida
18 years as a reporter and editor at the Arkansas Democrat in Little Rock, the New Orleans Times-Picayune and the Tampa Tribune
——————-
Sources:
Boston Magazine: http://www.bostonmagazine.com/health/article/2016/03/20/amy-reed-morcellation/
My Tampa Tribune article & its comments: http://www.tbo.com/list/news-opinion-commentary/siegel-questioning-the-campaign-against-power-morcellation-20140709/
The Cancer Letter: https://twitter.com/search?f=tweets&vertical=default&q=Brigham Doc’s NEJM Paper Decries&src=typd
Seidman study: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3506532/
It took me a while to go through my email to find other articles in which Amy said she was stage 4, but here are a couple: “Now she also has stage 4 cancer, with an 85% chance of death within five years. … The morcellation spread those cancerous cells throughout Reed’s abdomen, turning a dangerous but treatable disease into a terribly lethal one.”
http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/
The New York Times wrote: “Morcellation had spread the tumor around inside her pelvis and abdomen, causing advanced, Stage 4 cancer.” http://www.nytimes.com/2014/04/18/health/fda-tells-doctors-to-stop-procedure-used-to-remove-uterine-fibroids.html?_r=0