publication date: Mar. 25, 2016

NEJM Editors: There Will Be No Clarification For Disputed Power Morcellation Story 

The New England Journal of Medicine said it stands by the story that has triggered investigations of a potential breach of patient confidentiality.

In a paper that criticized FDAs regulatory actions that effectively ended power morcellation in gynecology, Lisa Rosenbaum, an NEJM national correspondent, made a statement that some readers interpreted as suggesting that she had access to confidential patient information (The Cancer Letter, March 18).

Rosenbaum is a cardiologist at Brigham & Women’s Hospital, the institution where Amy Reed—a patient who brought national attention to the harm associated with the procedure—underwent her ill-fated hysterectomy on Oct. 17, 2013.

Reed, who is now suing the hospital, also alleged that the NEJM story had breached her patient privacy. Officials at Brigham said an audit found no evidence of improper use of records and the hospital’s radiology imaging archive system.

It is plausible that this explosion was sparked by an unfortunate choice of words by the author or, for that matter, editing or lawyering by NEJM. However, if that is the case, NEJM isn’t willing to make a clarification.

In her March 10 article, titled “N-of-1 Policymaking—Tragedy, Trade-offs, and the Demise of Morcellation,” Rosenbaum writes:

“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%.”

Was there an intermediate step that took Reed from stage I to stage IV?

Was that step power morcellation?

Or was Rosenbaum suggesting that Reed’s disease was already stage IV when she received the power morcellation procedure? If that’s the case, how would she know?

Michelle Meyer, an assistant professor of bioethics at Clarkson University and director of bioethics policy at the Clarkson-Icahn School of Medicine at Mt. Sinai, described Rosenbaum’s phraseology as “grammatically ambiguous” and suggested some edits in an article for Forbes:

“It would have been better for all involved—perhaps most of all for Rosenbaum herself—had she instead written something like this (changes in italics):

“‘Reed…underwent…morcellation for presumptively benign uterine fibroids…The masses turned out to contain…cancer that has a 5-year survival rate of 63% when diagnosed at stage I. 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%.”

NEJM editors aren’t taking suggestions. “We do not plan to publish a clarification of Dr. Rosenbaum’s article,” NEJM said in a statement to The Cancer Letter. According to NEJM editors, Rosenbaum did not report unpublished, confidential health information about Reed.

“Dr. Rosenbaum was not reporting that the cancer was stage IV before the time of the initial fibroid surgery. It would be impossible to know this,” NEJM officials said. “The stage of disease was widely reported in many news stories. It was reported so widely that we did not think it would be an area of dispute.”

In the statement, the journal cites news stories by The Boston Globe, The Wall Street Journal, Prevention Magazine, and the Boston NPR affiliate WBUR as evidence that the staging of Reed’s disease was widely reported.

NEJM initially declined to answer questions from The Cancer Letter about Rosenbaum’s sourcing, citing an “ongoing investigation.”

Contacted by Reed and her husband, Hooman Noorchashm, Rosenbaum said in an email that she didn’t access Reed’s records (The Cancer Letter, March 18).

 

Surgeon: A Clarification “Completely Reasonable”

Reed and Noorchashm said that the question of whether Reed had stage IV disease would likely figure in the couple’s medical malpractice lawsuit against Brigham.

This consideration prompted them to file complaints with federal and state authorities.

Paul Sugarbaker, director of the Center for Gastrointestinal Malignancies and chief of the Program in Peritoneal Surface Oncology at MedStar Washington Hospital Center, also noted the lack of clarity in Rosenbaum’s statement that “Reed’s LMS was stage IV.”

“It’s not clear to me,” said Sugarbaker, the surgeon who treated Reed’s disseminated leiomyosarcoma in an emergency procedure Nov. 21, 2013. “If multiple people have a question, I would think it’s completely reasonable that [Rosenbaum and NEJM] would clarify that issue.”

Sugarbaker spoke to The Cancer Letter with Reed’s permission.

“I don’t understand Dr. Rosenbaum’s thinking with that particular statement saying that it ‘was’ stage IV,” said Sugarbaker. “It doesn’t hang together for me.”

Sugarbaker’s report doesn’t specifically cite the stage of Reed’s disease.

“I guess [conventional staging criteria] would apply, Sugarbaker said. Five weeks after, when I saw Dr. Reed, it was established radiologically and histopathologically that there was sarcomatosis. I think that would meet the definition of stage IV.

“The evidence, based on radiologic studies done at Brigham & Women’s Hospital prior to her morcellation, was that the disease was confined to the uterus,” Sugarbaker said. “Now, how far had it progressed within the uterus, there’s no way to know, because that evidence was morcellated. My knowledge of the case was that it was an unknown sarcoma.

“The only documentation of sarcoma implanted outside of the uterus came from the radiologic workup and then the pathology reports that were generated here [in Washington],” Sugarbaker said. “Dr. Rosenbaum would have to provide the evidence for that [stage IV claim]. It’s not in any of Dr. Reed’s records as far as I know.”

Sugarbaker disagrees with Rosenbaum’s characterization of the demise of morcellation as “N-of-1 policymaking.”

“We’ve seen numerous patients, six patients that have had morcellation that ended up with peritoneal sarcomatosis,” Sugarbaker said. “I just don’t see how anyone can argue with the fact that scrambling up a malignancy within the peritoneal space is going to be an innocuous event.

“It seems to me that we should be able to do something better, that direct and conscious dissemination of a malignant process within the peritoneal space cannot be overlooked. There’s got to be a better way to get at uterine fibroids.”

Sugarbaker’s operative report, which Reed and Noorchashm made available to The Cancer Letter, documents the local dissemination of tumor tissue in Reed’s abdominal cavity:

“During the entire 90 minutes of the chemotherapy treatment, I used the curved Mayo scissors to remove several hundred small nodules from the small bowel surface, from the small bowel mesentery, from the ascending colon, and from the large bowel mesentery. I am not sure what these small nodules are. It is quite possible that some of them are sarcoma implants.”

 

Sophisticated Readers Admit Confusion

“I think the passage was inartfully worded,” tweeted Charles Ornstein, a senior reporter for ProPublica covering health care and the pharmaceutical industry. “I read it as ‘before,’ [Reed’s surgery] but NEJM said that was not the intention or implication.”

Rosenbaum’s note about Reed’s staging “could have been clearer in this sentence,” wrote Ornstein, who won a Pulitzer Prize for Public Service in 2005 while working for the Los Angeles Times, and was a finalist in 2009.

“I admit that I misread the NEJM piece,” Ornstein wrote, after he received an expanded response from NEJM. “But if others did too, should it be clarified?”

Clarity is especially important in this case because of the radioactive nature of the controversy, said Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics and director of the Division of Medical Ethics at New York University Langone Medical Center.

“You’re talking about something that’s dividing the surgical field and is even leading into federal action,” Caplan said to The Cancer Letter. “In describing Dr. Reed’s case, it is important that anyone writing on the case clearly note that she and her husband believe the morcellation caused the dissemination and subsequently the upstaging in the severity of her cancer. I think the firefight over the whole subject cries out for as much clarity as is possible.”

Ivan Oransky, vice president of the Association of Health Care Journalists, highlighted NEJM’s initial hesitance in explaining the meaning of Rosenbaum’s writing.

“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,” Oransky, vice president and global editorial director of MedPage Today, wrote in Retraction Watch. “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.”

When Oransky asked NEJM whether a clarification is in order, he received a similar response.

“NEJM’s other opportunity is, of course, to correct or clarify the actual piece, which they could do at any time,” wrote Oransky, a Distinguished Writer In Residence at New York University’s Carter Journalism Institute. “When we asked whether they would be doing so, however, a spokesperson said, ‘we don’t plan to change the article.’”

This would not be the first time NEJM has declined to correct the record when issues were brought to the journal’s attention, Oransky wrote.

“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,” Oransky wrote.

Roy Poses, a clinical associate professor at the Alpert Medical School at Brown University, said that Rosenbaum’s diction is vague.

“On re-reading the NEJM article, I find the sentence about cancer staging ambiguous,” said Poses, president of the Foundation of Integrity and Responsibility in Medicine. “I am not sure what it means, and I can’t really say whether it meant the cancer was stage IV initially, or whether the cancer became stage IV much later as is well known.”

On March 20, Poses published a blow-by-blow critique of Rosenbaum’s arguments on Health Care Renewal, a blog that advocates for “transparency, honesty and ethics.”

“I thought there were many points made in the NEJM commentary that were interesting, but somewhat concerning,” Poses said to The Cancer Letter. “That’s why I attempted to discuss my concerns in the blog post.”

 

The Anatomy of a Suspicion

Reed and Noorchashm said they filed complaints because Rosenbaum’s statement that Reed’s cancer “was” stage IV suggested that she may have had access to confidential information.

Here, it’s important to consider the facts of the case:

Reed’s early CT scans at Brigham revealed lung nodules that might suggest metastases at the time of morcellation in October 2013. This information was known to her Brigham physicians, Reed and Noorchashm said.

Subsequent biopsies found no evidence of malignant spread prior to the morcellation, according to Thomas Greene, the couple’s attorney:

“In the First Set of Dana Farber records—on page 12/50, Dr. [Suzanne] George’s Progress Note from 04/07/2014 states that Dr. Reed ‘underwent pulmonary resection of two small pulmonary nodules on the right. I personally reviewed the pathology with and reviewed this with our sarcoma team at our pathology conference. There was no evidence of malignancy of the sample or clear evidence of treated tumor.’”

On March 14, as a direct consequence of the NEJM story, Reed filed a complaint under the Health Insurance Portability and Accountability Act with the Office of the Massachusetts Attorney General and the HHS Office of Civil Rights.

“It is a fact that my case has been a high profile one within the BWH/DFCI system and in addition has been discussed in settings within the hospital, and in the press with my own permission,” Reed wrote in the complaint. “But the simple fact remains that the content of Dr. Rosenbaum’s article leads me to conclude that she, or a proxy not involved with my care, may have accessed my records illegally and in violation of HIPPA.

“This complaint is to request an immediate investigation…to determine…whether any of my immediate care team has, without my consent, exposed and misrepresented my medical information to Dr. Rosenbaum and the NEJM.”

Brigham completed an audit of Reed’s electronic medical record and radiology imaging archive system and determined that Rosenbaum did not access either system.

“I did not read Dr. Reed’s medical records, nor did I discuss her care with any of her treating physicians,” Rosenbaum wrote in a March 14 email to the couple.

Rosenbaum’s article also states that Noorchashm has given up his “promising surgical career for a mission of offering comfort to people undone by illness.”

Noorchashm disputed this, stating that no one at NEJM has fact-checked this statement with him. “It is simply untrue that I’m ‘abandoning’ my profession,” Noorchashm said to The Cancer Letter. “This is a disgusting defamation of my professional reputation from a very powerful place.”

Rosenbaum directed The Cancer Letter’s questions to NEJM, which declined to comment.

Reed and Noorchashm launched an aggressive campaign in late 2013 against power morcellation—over 300 patients and families have come forward claiming harm.

Their advocacy led to FDA restrictions and a black box label on the use of power morcellators, finding that one in 350 women undergoing hysterectomies or myomectomies have an unsuspected uterine malignancy. Hospitals banned the surgery, and the agency’s final guidance largely ended insurance coverage for the procedure.

George Demetri, the director of the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School, said FDA’s November 2014 decision on morcellators is valid.

In early 2014, NEJM rejected a paper co-authored by Demetri on how power morcellation worsens outcomes for patients with undetected uterine sarcomas.

“I believe that we have gotten to a valid place where this practice is not routinely performed nor considered as it once was,” Demetri wrote in an email that was shared with The Cancer Letter. “The [Rosenbaum] editorial should change nothing.”

Copyright (c) 2018 The Cancer Letter Inc.