publication date: Dec. 18, 2015

 

 Two Docs Who Broke the Code

Hooman Noorchashm sends out several scathing emails each day.

Consider the subject lines of some recent emails that went to hospital administrators, with copies to members of Congress and the press: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”

“The time for diplomacy has passed,” Noorchashm said to The Cancer Letter. “I have no time to play politics. I have a wife with advanced cancer and six young children.”

His wife, Amy Reed, is battling advanced leiomyosarcoma. Since her undetected cancer was spread via power morcellation performed at Brigham & Women’s Hospital in October 2013, Reed has been in treatment for metastatic disease.

“Every time I see her go through these different phases and I think about the implications of it, it gives me a little bit more resolve to look at the root cause of this thing and hit it as hard as I can,” Noorchashm said.

Noorchashm’s blistering, in-your-face tactics abandon the decorum of academic debate usually expected of Harvard physicians. He says his indignation grew in response to what he describes as the initial stonewalling he received from his former employer, Brigham & Women’s Hospital—and the medical community at large—for speaking up.

“It’s probably fair to say that we went from being straight-laced professionals on a certain path, to becoming activists,” Noorchashm said. Reed was formerly employed as an anesthesiologist at Beth Israel Deaconess Medical Center, and Noorchashm was formerly employed as a cardiothoracic surgeon at Brigham.

Angered and disillusioned, Reed and Noorchashm turned to the press, regulators and legislators.

“It took heroic measures on mostly Hooman’s part to be heard,” Reed said to The Cancer Letter. “They weren’t reaching out to us. You know the number of emails alone that he sent, and the number of phone calls—it was like three full-time jobs, what he was doing to get the FDA to move in that direction. And that’s not even thinking about the 20 years that this was on the market with no recourse for these patients.”

Within a year, FDA published a guidance to severely limit the use of power morcellators in the vast majority of women getting these procedures. An analysis by the agency found that one in 350 women who undergo hysterectomy or myomectomy for fibroids have an unsuspected uterine sarcoma (The Cancer Letter, Nov. 26, 2014).

The FBI and the Government Accountability Office have launched investigations. And now, members of Congress are writing letters to determine who knew what, and when.

“The reality is, this succeeded because there were two things: there was a fundamental truth underlying it, and because the press engaged it,” Noorchashm said. “The Wall Street Journal and The Cancer Letter did a great public health service, and I think in both professional domains, both outlets got recognition by their colleagues that this was something significant that was accomplished.

“The third was because we were hitting this problem from inside the establishment.”

Having undergone two surgeries in November and December, Reed is focusing on recovery, and her family.

“What’s immediately next is, for me, what’s immediately in front of me,” Reed said. “As Hooman said, we’re working hard to make a cure or at least turn this into a chronic condition.

“I’m lucky that I started off this in relatively good health, so hopefully I’ll be able to withstand all the treatments that are thrown at me, and you know, raise the kids, dog, chickens.

“The biggest lesson I’ve learned this year is that this is just one example of many. We always come across things in life that don’t seem right. There were countless times when people could’ve intervened in the past 20 years that wouldn’t leave us sitting here.

“It’s very easy to stand by or look the other way. That’s very easy; that’s the default—but you can really make a difference to one person by not doing so. It’s not always pleasant, and it certainly doesn’t win you any popularity contests or help keep any mainstream jobs, but it can really make a difference to people.

“I hope I’ve done true to my word and stayed to the cause and spoken up.”

 

 

 

What Did Brigham and J&J Know?

In the initial months after Reed’s October 2013 hysterectomy at Brigham, the couple was stunned to discover that upstaging of Reed’s disease was not an unlucky, statistical anomaly. Other women must have been similarly harmed.

Power morcellators have been on the market for about 20 years, and were used to perform routine hysterectomies and myomectomies on about 100,000 women a year in the U.S. (The Cancer Letter, July 4, 2014).

At the time of Reed’s surgery, no one had publicly made the connection between the mechanical shredding of uterine tissue and the dissemination of hidden malignancies.

It was a painful discovery for Reed and Noorchashm, and it happened only because of the couple’s medical expertise—both physicians have PhDs in immunology, and Noorchashm, now a cardiac surgeon at Thomas Jefferson University Hospital, has a working understanding of medical devices.

The couple immediately alerted Brigham to the problem, believing that the Harvard-affiliated hospital would ban the procedure, set an example, and thereby protect women across the world from avoidable harm.

Their concerns were met with silence in the beginning, Reed and Noorchashm said, not only from Brigham, but also professional gynecological societies and device manufacturers.

Noorchashm and Reed are suing Brigham, claiming medical malpractice.

Hospital officials declined to comment. “We will not be answering any further questions,” a spokesperson said.

As media across the country picked up their story, letters and phone calls from other patients and their families poured in, confirming the couple’s suspicions.

In the past two years, over 300 patients and families have come forward claiming harm, and at least 50 lawsuits have been filed.

Reed and Noorchashm subsequently learned that Brigham doctors—as well as the Johnson & Johnson leadership—knew of the dangers and risk estimates of power morcellators prior to Amy’s surgery.

But no one, it appears, had informed FDA as per Title 21, Section 803 of the Code of Federal Regulations, which mandates adverse outcomes reporting by user facilities and manufacturers.

“Failures in many domains had created this monster that was sacrificing one in 300 to 400 women to the altar of corporate medicine,” Noorchashm. “An individual who has been hit by this and is dying in your hospital and you don’t take any real steps to protect others in your own hospital? You’re criminally negligent.”

The press started asking questions, and the momentum reached the House Subcommittee on Oversight and Investigations (The Cancer Letter, Nov. 20), which launched an inquiry focused on reporting of adverse outcomes.

In a statement to The Cancer Letter, J&J subsidiary Ethicon said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20).

In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging Erica Kaitz’s leiomyosarcoma via power morcellation performed in 2012. Kaitz died on Dec. 7, 2013, nearly two months after Reed received her cancer diagnosis at Brigham (The Cancer Letter, Nov. 26, 2014).

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 patients—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.

Responding to questions at a House subcommittee hearing, Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said FDA wasn’t informed of Kaitz’s death or any other adverse outcomes prior to Reed’s report in December 2013 (The Cancer Letter, Nov. 20).

 

“Campaign of Distortions”

In August 2014, Karl Storz, a German manufacturer of power morcellators, warned Noorchashm to cease his campaign against power morcellation or face legal action (The Cancer Letter, Aug. 27, 2014).

“Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s or any other women’s uterine cancer, and/or any aggravation of their cancerous situations, we would not hesitate to take appropriate legal actions to protect our good name and our rights,” the letter states.

A scuffle erupted in November 2015, when a Brigham administrator declared Reed and Noorchashm a security threat and subjected them to a physical search.

Noorchashm had to submit to being tailed by a security guard while his wife was undergoing an urgent cancer surgery (The Cancer Letter, Nov. 3).

“Do you know what it’s like to have a hospital administration threaten your health care proxy with being forced out of the hospital, when you are six hours from home and family, and could potentially be left without anyone to speak for you in person, because of some arbitrary hospital rules that have been made up and apply only to them?” Reed wrote in a Nov. 13 letter to Brigham COO Ron Walls. “Threatening? Yes. Terrifying. You should be ashamed of yourselves for penalizing patients and their families for speaking up. For saying something’s wrong. For saying that there was a real patient safety issue, and when no one listened, called them on it.”

The couple sought a restraining order against Brigham for engaging in “retaliatory action”—the next day, a Boston Superior Court judge ordered the hospital to lift all security requirements, finding that “both plaintiffs will suffer irreparable harm.”

In a Nov. 5 letter to Brigham, Rep. Mike Fitzpatrick (R-Pa.) wrote that he was “deeply concerned about what appears to be an effort to retaliate against [Reed and Noorchashm’s] advocacy and silence their First Amendment Rights.”

Walls replied, saying that the hospital stands by his decision, because of Noorchashm’s “disturbing and threatening” emails to hospital faculty and staff.

“I undertook these precautions with full knowledge that he would use them to distort the truth and once again publically criticize the hospital,” Walls wrote to Fitzpatrick Nov. 10. “Responding to the safety and security needs of our faculty, staff, our patients and their families is far more important to me than the impact of Dr. Noorchashm’s campaign of distortions.”

 

Top Gynecologists Challenge FDA Guidance

Many prominent gynecologists and some patient advocates are opposed to FDA’s restrictions on morcellation, saying that more invasive open surgeries would harm more women than power morcellation.

That exchange was sparked by a recent study, led by William Parker, director of minimally invasive surgery at UCLA Medical Center, and published by The American College of Obstetricians and Gynecologists in the December 2015 issue of Obstetrics & Gynecology.

Titled, “U.S. Food and Drug Administration’s Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?” the study, authored by top gynecologists in the nation, disputes FDA’s estimate that one in 350 women getting a hysterectomy or a myomectomy have unsuspected uterine malignancies.

The authors, representing a 46-member review group, “disagree with the FDA’s methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery.”

A letter from the group to FDA is posted here.

A recent and “more rigorous analysis”—the authors argue—of 133 studies determined that the risk of finding leiomyosarcoma among women having surgery for presumed fibroids was one in 1,960, or 0.051 percent. Another estimate puts the risk at one in 4,320, or 0.023 percent.

“There are serious gaps in the studies used [by FDA] to estimate the frequency of finding unexpected LMS where the device might be used,” said Matthew Siedhoff, director of minimally invasive gynecologic surgery at the University of North Carolina, Chapel Hill. “Our research suggests that, rather than abandon the clear benefits minimally invasive surgery affords women, future research efforts ought to focus on better preoperative identification and new techniques, such as placing specimens in bags before removing them.”

Ironically, another study published in the same issue of the journal produces estimates that wildly differ from those in the Parker et al. paper.

That study, titled “Occult Uterine Sarcoma and Leiomyosarcoma: Incidence of and Survival Associated with Morcellation,” identified 125 hysterectomies with occult uterine sarcomas among 34,728 hysterectomies performed for leiomyomas. The study finds that the incidence of occult uterine sarcoma and leiomyosarcoma is one in 278 and one in 429, respectively—numbers that fall within range of FDA’s estimate.

“Morcellation is associated with decreased early survival of women with occult leiomyosarcomas,” the authors conclude.

In 2014, Brigham launched a controversial study that combined power morcellators with “containment bags” intended to capture tissue during the minimally invasive procedure. The study was led by Jon Einarsson, the Brigham surgeon who performed the “open”—unbagged—version of the procedure on Erica.

Designed to enroll 400 women, the study was suspended after The Cancer Letter reported that the hospital did not seek an FDA Investigational Device Exemption—the agency’s license allowing clinical testing of potentially high-risk devices.

In July 2014, several panel members of the FDA Obstetrics and Gynecology Devices Advisory Committee said that the safest way to perform a hysterectomy or myomectomy would be to remove the specimen intact, i.e. via the vaginal route, to preclude the need for a containment system (The Cancer Letter, July 25, 2014).

Responding to the Parker et al. paper, an FDA spokesperson said that the agency’s recommendations have not changed.

“Prior to issuing recommendations concerning the use of power morcellation for the treatment of presumably benign uterine fibroids in November 2014, the FDA convened a public meeting of the Obstetrics and Gynecology Medical Device Advisory Committee,” FDA said in a statement to The Cancer Letter. “At the meeting, patients, family members, health care providers, researchers, device manufacturers and other stakeholders—including some of the authors from the recent paper—presented information and provided their perspectives.

“The FDA’s November 2014 recommendations considered these perspectives and that of the Advisory Committee. At this time, the Agency’s recommendations have not changed.

“We continue to believe that inclusion of a boxed warning and contraindications to the use of power morcellation for uterine fibroid removal in the majority of women is both appropriate and necessary.

“We welcome the continued scientific dialogue concerning the available evidence about benefits and risks associated with power morcellation and will notify the public if our recommendations change.”

FDA’s November 2014 guidance preserves the use of power morcellators for younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks.

“By recommending these labeling changes, the FDA believes it will reduce the risk of unsuspected cancer spread,” the spokesperson said. “But, even for that very narrow patient population who are not included in these contraindications, doctors should thoroughly present the risks of such surgery to these patients.

“There is evidence to show that women over 50 years old have a higher risk of having underlying cancer, and morcellation carries a higher risk than previously thought of spreading and upstaging such cancer. According to the medical literature, women 50 to 54 years old are five times more likely to have uterine cancer compared to women under 40. That risk continues to increase with age.”

Power morcellators should not be used in younger women, Noorchashm said.

“The FDA says that power morcellators have a role in younger women hoping to preserve their fertility. This is a misrepresentation by the gynecological industry,” Noorchashm said. “There is absolutely no reason for why young women wishing to undergo a fertility-preserving myomectomy should need a power morcellator. When you can’t rule out a cancer for sure, the power morcellator would still pose a danger.”

Noorchashm was infuriated by the Parker paper, sending out what might be called a Hooma-gram to over 50 people. His subject line: “Ethical/Legal Lapse in Gynecology—Do Read With Extreme Care.”

“Dr. Parker and company, your position stands as ethically and legally compromised and weak,” Noorchashm wrote.

Responding, Parker said that he had blocked Noorchashm’s emails for over a year.

“Please be advised that, for more than a year, I have my server reject all of his email before it is delivered or read,” wrote Parker, hitting “Reply All.”

In the same exchange, Carla Dionne, executive director of the National Uterine Fibroids Foundation, said she would report Noorchashm to Google.

“On May 5, 2014, you and your wife were explicitly asked to cease and desist all email communication to me,” Dionne wrote Dec. 14. “These latest 2 emails sent from you to me (and others) today is a direct violation of that request. At this point, I will be reporting your breach to abuse @ gmail. Cease and desist and STOP attempting to email me for ANY reason whatsoever immediately.”

“Feel free, Ms. Dionne,” Noorchashm replied. 

 

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