publication date: Mar. 18, 2016

Brigham Doc’s NEJM Paper Decries Morcellation’s Demise—Did She Get Confidential Patient Information? 

Update: The New England Journal of Medicine’s subsequent response after this article is published is appended at the end.

Clearly, Lisa Rosenbaum wanted to trigger a heated discussion—but not of the sort she ended up with.

Rosenbaum, a national correspondent at the New England Journal of Medicine, focused on the demise of power morcellation, a once widely used gynecological procedure, which in some cases ended up disseminating undetected uterine sarcomas.

In a paper published in the March 10 issue of the journal and titled “N-of-1 Policymaking—Tragedy, Trade-offs, and the Demise of Morcellation,” Rosenbaum alleges that Amy Reed, a high-profile opponent of power morcellation, had stage IV cancer at the time of her hysterectomy.

What was Rosenbaum’s basis for saying this with no equivocation? It is publicly known that Reed’s disease had metastasized after morcellation and is now stage IV. However, Reed and her husband Hooman Noorchashm said while an early scan might suggest metastases, further investigation found no evidence of malignant spread prior to the morcellation. Alas, Rosenbaum’s paper, which notes “stage IV” in the context of Reed’s initial surgery at Brigham, is mum on its sources.

The only footnote in vicinity of this bit of personal health information takes the reader to the American Cancer Society’s compilation of cancer statistics. Writes Rosenbaum: “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%.”

Had Rosenbaum been a cub reporter at a local newspaper, rather than a Harvard cardiologist writing for one of the world’s most esteemed general medical journals, her editor would have demanded that she either (1) cite her source, or (2) explain why the source couldn’t be revealed, and (3) be dead-sure of her facts.

Actually, appearances in this case are even more perilous. Rosenbaum practices at Brigham & Women’s Hospital, the very institution where Reed had her ill-fated hysterectomy, and which Reed is now suing. Of course, the question of staging is important to Rosenbaum’s article. If Reed indeed had stage IV disease at the time of her initial surgery, her “N-of-1” advocacy would be based on the wrong “1.” Presumably, the issue of staging would be important to lawyers, too.

Contacted by The Cancer Letter, Rosenbaum did not respond to questions.

On March 14, as a direct consequence of the NEJM story, Reed 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.

“Dr. Rosenbaum has written a recent article for the NEJM, which includes statements referring to medical care that I received explicitly at BWH in conjunction with DFCI,” Reed wrote in the complaint. “Based on the specific content of these statements, I am concerned that my medical records have been accessed by either Dr. Rosenbaum directly, as a Brigham physician, or by discussions she held with my treating physicians—both would be illegal because I never provided consent for such access to Dr. Rosenbaum.

“Again, Dr. Rosenbaum’s specialty falls outside of care that I received and she would have had no clinical reason to access any of my HIPAA-protected medical information—other than for the purpose of publicity,” wrote Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center.

Noorchashm, said Rosenbaum’s allegation that his wife had stage IV sarcoma in October 2013 is incorrect.

“This is an inaccurate misrepresentation, particularly because the clinical data—including a lung biopsy done to rule out metastatic disease by Dr. Scott Swanson [chief surgical officer at Brigham] in early 2014—proves otherwise,” said Noorchashm.

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.”

In a statement, Brigham officials said that “the hospital’s Privacy Office has concluded the audit of Reed’s record and has determined that Rosenbaum did not access Dr. Reed’s record.”

Noorchashm, formerly a cardiothoracic surgeon at Brigham, said that, based on his direct knowledge of the information systems at the institution, a person can access the radiology imaging archive system without leaving an electronic fingerprint. Cafeteria conversation, too, can come into play, he said.

“We hope this will be vetted by the [Massachusetts attorney general’s office] and the HHS OCR investigations,” Noorchashm said.

Reed and Noorchashm asked Rosenbaum directly whether she accessed Reed’s files.

“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. “The stage of her cancer has been reported in several media outlets.”

Reed said no news publication had reported the stage of her cancer at the time of her surgery at Brigham.

“She’s like, ‘Oh, you know, it was published.’ No, it actually wasn’t, because it’s not true,” Reed said. “At best, I think it’s irresponsible journalism, and that’s not even getting at what the message of this paper is.”

 

“Availability Entrepreneurs” and Media Hype

In the NEJM article, Rosenbaum characterized Reed and Noorchashm as “availability entrepreneurs” who “exploit reporters eager to break stories of transgression.”

Rosenbaum writes that FDA used “poor data” to engage in “N-of-1 policymaking,” because of public outrage from widespread media attention that “exaggerated the risk of LMS.”

FDA disagrees. In response to Rosenbaum’s allegations, the agency said it doesn’t use N-of-1 anecdotes, low-quality data, or media hype in its policymaking decisions.

Contacted by The Cancer Letter, the agency said it stands by its actions.

“No, the FDA’s primary concern is the safety and well-being of patients,” an FDA spokesperson said. “The FDA bases its decisions on what is in the best interest of public health, carefully balancing both the benefits and risks of a product. The FDA evaluated the available data at the time and determined that it was of sufficient quality and reliability to support our November 2014 decision.”

In her conflict-of-interest form, Rosenbaum disclosed her NEJM position as one of the “relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work.”

However, in the same section—Section 5 of the form created by the International Committee of Medical Journal Editors—she does not mention her relationship with Brigham.

This is fine, NEJM officials said. “In the interest of transparency, Dr. Rosenbaum discloses her employment as a BWH physician in the fourth paragraph of her article,” an NEJM spokesperson said to The Cancer Letter. “Readers do not need to visit a separate disclosure form to learn this.”

Rosenbaum and NEJM should have explicitly disclosed any potential conflicts or the appearance of one, 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.

“It’s a potential institutional conflict; she’s working in a place that’s getting sued,” Caplan said to The Cancer Letter. “You’d want to know about that, because of her special access to information or sources that may not otherwise be available to the general media covering this issue. I think the disclosure of those things should’ve been better than it was.

“There’s enough there that I think it belongs in a disclosure form, it should’ve been something that got broader attention in the piece, either by her or at the suggestion of the editor. When there are lawsuits flying, insider access is important to know—it’s something that readers or a reasonable person would want to know about. They should’ve done more to disclose, either the author or the editor. It could well get a note. In general, you’d want to say something about the source.

“Not everything demands disclosure by the reporter to the same degree, but this one—you’ve got to really think hard when half the American legal profession is suing each other.”

The NEJM editors have an obligation to insure the authenticity and accuracy of Rosenbaum’s information, said Meg Kissinger, an investigative health reporter for the Milwaukee Journal Sentinel, a 2009 Pulitzer Prize finalist for investigative reporting, and a two-time George Polk Award winner for medical and environmental reporting.

“For their own sake, they have to ensure that disclosures are made, so that there is no question for the readers about the point of view,” Kissinger said to The Cancer Letter. “Journalists have their code of ethics to follow; doctors, of course, have the medical code of ethics. This doctor-journalist has a double set of ethical considerations. What distinguishes her is that she technically does have access, that’s another reason why her association should’ve been disclosed.

“Sometimes, as journalists, sources give you stuff, but then it’s your job to verify their authenticity. For her own sake, she should have attributed her information. She could’ve saved herself some headaches there. It would seem to me an abuse of her position if she did indeed get the information by virtue of her being a doctor.”

The manner in which Rosenbaum notes her Brigham relationship is insufficient, said Roy Poses, a clinical associate professor at the Alpert Medical School at Brown University and president of the Foundation of Integrity and Responsibility in Medicine.

“In the article, the author, Dr. Rosenbaum, says that she ‘joined the faculty’ of Brigham, again, the hospital that is involved in this legal controversy,” Poses said to The Cancer Letter.

“I cannot tell from that simple phrase, whether Dr. Rosenbaum does some unpaid teaching at the hospital or voluntary unpaid care of indigent patients, or on the other hand, whether she works for the hospital for a salary. It would seem to me that whether she has in fact a significant financial relationship or not might be relevant to understanding whether she actually has a conflict of interest in writing this article,” said Poses, chief blogger of Health Care Renewal.

Rosenbaum’s financial relationship with Brigham is unclear—the hospital declined to provide information on Rosenbaum’s title and whether she is a full-time faculty member, citing personnel policies.

“I can see that the hospital would not want to reveal her salary, if in fact she has one, and that has privacy implications,” Poses said. “But I don’t understand why the hospital would not be able to simply tell you whether or not she is employed there and in what capacity.”

At least two suits claiming medical malpractice have been filed against Brigham—one by Reed and Noorchashm, and the other by Richard Kaitz, whose wife, Erica, died Dec. 7, 2013 from metastatic leiomyosarcoma, nearly two months after Reed received her cancer diagnosis at Brigham (The Cancer Letter, Nov. 21, 2014).

Kaitz and Reed are also in product liability litigation against Karl Storz, the manufacturer of the power morcellators used at Brigham. Of 100 or so lawsuits against Johnson & Johnson subsidiary Ethicon—which manufactured nearly three quarters of the devices on the market—about 70 have been settled, according to The Wall Street Journal.

Congress, FBI and the Government Accountability Office have launched probes into issues of hospital compliance with adverse outcomes reporting laws and patient safety regulations (The Cancer Letter, Dec. 18, 2015).

“The work has just gotten underway so it is very early in the process,” a GAO spokesperson said to The Cancer Letter. “Some of the first steps will be to determine the scope of what will be covered and the methodology to be used.”

 

Observers: Rosenbaum’s Confusing Arguments

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.

Rosenbaum’s characterization of FDA’s decision on power morcellators as based on an N-of-1 is inaccurate, NYU’s Caplan said.

“There’s been lots of allegations of safety issues,” Caplan said to The Cancer Letter. “Now, you could say this is a case of ‘N-of-1’ high visibility policymaking, in which Dr. Reed and her husband are both doctors, they’ve really lobbied hard to get attention to the issue and it’s a case that has played a prominent role, but I wouldn’t say it’s ‘N-of-1.’”

“I don’t think the FDA, in my experience, would do ‘N-of-1’ policymaking. ‘N-of-1’ would get their attention as to, ‘Is there a problem?’ but the agency always wants to push further and establish, ‘Is there a pattern, is there an outlier?’ They’re not just going to say, ‘Oh okay, we had an adverse event, and that puts us in a position to make policy.’ They are always going to examine and go further.

“I know in the fight that there certainly have been exchanges back and forth about other cases. There are certainly red flags flying around which say, ‘Maybe we don’t leave this to just doctor-patient negotiation, we’ve really got to establish what the risk profile is here.’ That’s the FDA’s job, and I think it’s all going to come out in litigation.”

Brigham physicians knew of at least three or four cases before Reed, said Kaitz, a Boston real estate attorney.

“N-of-1? That’s absurd. All you have to do is look at the collage of pictures of all the victims. That’s ridiculous. For the Brigham, it wasn’t an N-of-1,” Kaitz said to The Cancer Letter. “FDA listened to lots of different parties, lots of different experiences. I personally have been in touch with 20 to 30 victims, families in only the last year or two, so God knows how many there were before that—they’ve done the procedure for 15 to 20 years. No, it’s not N-of-1 policymaking at all.

“The media have not been exploited, absolutely not. I am an extremely reluctant participant in this public discussion, because it’s just not the way I operate. At the same time, articles like this and some of the actions that Brigham has taken, you can’t just sit back and watch them.

“I personally am happy with what FDA has said—the practice of morcellation as we knew it doesn’t exist today. Certainly Amy and Erica would not be subject to morcellation today.”

In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months. It is not publicly known where the four patients were treated.

Robert Lamparter, a retired pathologist, alerted Ethicon about potential problems with morcellators in 2006 (The Cancer Letter, Nov. 20, 2015).

Rosenbaum’s arguments about the data and about the efficacy and safety of power morcellation are “confusing,” because she doesn’t provide data about the benefits, said Poses.

“Where to draw a line to say a particular treatment is safe is not always easy; the FDA made a decision based on recent information that this device was not safe,” Poses said. “I’m not sure that the discussion of the data in Dr. Rosenbaum’s article helps with the decision.

“She talks about the data concerning the possible harms of power morcellation and argues that that data comes from relatively low-quality studies, not randomized, controlled trials, and that it is hard to tell the actual rate of harms, in particular, the dissemination of cancer. On the other hand, Dr. Rosenbaum implies that the benefits of power morcellation are well known.

“She writes initially that power morcellation allows the treatment of fibroids to be ‘done more efficiently and effectively,’ she later implies that power morcellation is less invasive, leads to quicker recovery, avoids income loss, and furthermore, reduces the likelihood of pulmonary embolus, wound infection, or hemorrhage.

“However, she doesn’t provide any data about these ostensible benefits. A quick search suggested that there are no good randomized, controlled trials that assessed benefits. Her argument that we have abandoned a beneficial treatment based on poor quality and perhaps exaggerated the data about its harms—that does not seem to be supported by any clear data about its benefits.”

Poses said he is surprised that the NEJM would publish Rosenbaum’s article at all.

“The NEJM is perhaps the most prestigious, most highly regarded English-language medical journal in the world,” Poses said. “It is, in many cases, viewed as the standard for scholarly medical journals. I am a bit surprised that it published a commentary by its own national correspondent that appears to make an argument—about benefits and harms of treatment and policymaking about treatment—that does not have a clear discussion of the data that support or fail to support either the benefits or the harms of the treatment.”

Rosenbaum’s parallels make no sense, Poses said.

“Toward the end of the article, the author, Dr. Rosenbaum, writes that ‘Noorchashm insists that it’s unethical to consider morcellation’s majority benefit when some individual patients may face such serious adverse consequences.’ The article by Dr. Rosenbaum never really goes over the data that does or does not suggest ‘majority benefit,’” Poses said. “Then, Dr. Rosenbaum goes on to say, ‘such reasoning could easily apply to giving ACE inhibitors to patients with heart failure…’ I fail to understand the parallel.

“There were multiple, large, reasonably well done randomized controlled trials of ACE inhibitors for heart failure,” said Poses, adding that he is familiar with research on ACE inhibitors. “These trials show clear survival benefits and relatively infrequent mild to moderate adverse effects. There is no parallel because, again, there were large trials, the benefits were clear, and they included increased survival, and the adverse effects were reasonably clear and did not appear to come close to outweighing the benefits.

“So I fail to understand the argument by Dr. Rosenbaum, and I feel it makes the article even more confusing.”

 

FDA: Media Hype, “N-of-1” not Factors in Policymaking

In a statement to The Cancer Letter, FDA said it relied on data that was of “sufficient quality and reliability” to support its final November 2014 guidance on power morcellation.

The full text of FDA’s response follows:

The FDA reviewed the related data, including adverse event reports, published and unpublished literature, product labeling and other materials to determine the nature and significance of this issue. As part of its review, the agency considered the benefits and risks of the use of these devices.

The FDA review concluded that there is a risk of spreading unsuspected cancerous tissue beyond the uterus when using laparoscopic power morcellation for hysterectomy or myomectomy in women with uterine fibroids.

The literature has reported that women are often told that the risk of having an unsuspected leiomyosarcoma is 1 in 10,000, a relatively small risk; however, based on the FDA’s analysis of available data, the FDA believes the estimated risk of unsuspected uterine sarcoma in women undergoing hysterectomy or myomectomy for the treatment of uterine fibroids is closer to 1 in 350. As a result, the FDA issued a safety communication in April 2014 discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women.

While others have produced different risk estimates, the general consensus among the clinical community is that the risk is higher than what was previously understood. The FDA also wants to ensure that women considering the procedure know that power morcellation can increase the risk of spreading cancerous tissue in women with undetected cancer in the uterus.

The FDA evaluated the available data at the time and determined that it was of sufficient quality and reliability to support our November 2014 decision. The FDA’s analysis of available information indicated that the risk of having an unsuspected uterine sarcoma, a type of uterine cancer, in a woman undergoing surgery for presumed fibroids is approximately 1 in 350 women. If laparoscopic power morcellation is performed in these women during the removal of the uterus (hysterectomy) or fibroids (myomectomy), there is a risk that the procedure will spread the cancerous tissue. An outside panel of experts also felt that the risk of unsuspected uterine cancer should be included in the product labeling, and that it was critical that doctors discuss the risks and benefits of all options with their patients.

The FDA’s primary concern is the safety and well-being of patients. The FDA believes that it is possible to reduce the risk of unsuspected cancer spread by warning against the use of laparoscopic power morcellation in the vast majority of women undergoing myomectomy or hysterectomy and clarifying the small patient population for whom morcellation may be an acceptable therapeutic option.

The FDA bases its decisions on what is in the best interest of public health, carefully balancing both the benefits and risks of a product. The Agency has recommended that health care providers thoroughly discuss the benefits and risks of all treatments with patients and be certain to inform the small group of patients for whom laparoscopic power morcellation may be an acceptable therapeutic option that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.

 

NEJM: Rosenbaum was Reporting Post-Morcellation Staging

“We do not plan to publish a clarification of Dr. Rosenbaum’s article. These are the questions we received, and our answers,” NEJM officials said in a statement March 21 to The Cancer Letter after this article was published. The NEJM previously declined to answer March 17 questions about sourcing from The Cancer Letter, citing an “ongoing investigation.”

The text of NEJM’s full statement follows:

1) Was there a privacy breach?

No. Dr. Rosenbaum has assured us that she never accessed Dr. Reed’s medical records, and an audit done by BWH’s Privacy Office determined that the records were not accessed by Dr. Rosenbaum.

2) Was Dr. Reed’s staging diagnosis previously published, and if so, do you have a citation?

The stage of disease was widely reported in many news stories. 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.

3) If not, why was it included in the article?

It was reported so widely that we did not think it would be an area of dispute. Sources include:

The Boston Globe (12/18/13): “Follow-up tests done on the tissue found that Reed had uterine leiomyosarcoma, a rare aggressive cancer. Later imaging tests showed that the cancerous tissue had been spread throughout her abdominal cavity during the surgery, giving her stage 4 cancer, her husband said.”

WBUR (12/18/13): “You are basically taking a procedure, which puts women basically in a collision course with a stage four cancer,” said Dr. Noorchashm, noting that this is what happened in his wife’s case.”

Wall Street Journal (2/26/14): “Dr. Reed is now being treated for stage 4 cancer. Although her outlook for long-term survival is much worse because her cancer has spread, she is actively fighting the disease.”

Prevention magazine (5/29/14): “Last fall, a routine hysterectomy seeded cancer throughout Reed’s abdomen. The hysterectomy didn’t cause the cancer, but it very likely transformed it from stage 1 disease, with a 60% 5-year survival rate, to stage 4 disease, with a grim prognosis. About 85% of women like Reed are dead 5 years after diagnosis.”

See also the subhed: “Doctor. Mother of six. Stage 4 cancer patient. Amy Reed may not have much time to live, but she’s making sure her death won’t be in vain.”

4) Was the couple contacted before the piece and given an opportunity to respond?

Dr. Rosenbaum interviewed Dr. Noorchashm prior to publication.

5) As a medical journal, does NEJM have a higher responsibility when it comes to individual patients’ privacy?

We are committed to the highest standards and most rigorous protection for patient privacy. Dr. Rosenbaum did not reveal anything that was not already in the public record.

Copyright (c) 2017 The Cancer Letter Inc.