This article was originally published in The Cancer Letter, May 26, 2017.
When Amy Reed enrolled at the University of Pennsylvania medical school in 2001, she could not have possibly imagined that she would save more lives as a patient than as a physician.
The final phase of her medical education began on Oct. 17, 2013, when Reed, then 41, checked in at Brigham & Women’s Hospital—her husband’s workplace at that time—to undergo a common gynecological procedure that would fundamentally redefine her career, and, ultimately, consume her life.
Reed, a Pennsylvania native, died May 24 from complications stemming from disseminated uterine cancer. She was 44.
“I always wanted to be a doctor when I was little,” Reed said to me on a sweltering July afternoon in 2015. “I wanted to go into medicine and be a doctor and fix things, and cure the world.”
Reed’s dream came true, albeit not in the way she envisioned.
Weeks after her “minimally invasive” surgery at Brigham, Reed learned that dozens of nodules of uterine sarcoma were growing throughout her abdominal cavity.
Upon confronting her surgeon, Reed learned that a handheld device—a power morcellator—was used during the procedure. At first glance, the morcellator might be mistaken for a steampunk rendition of a glue gun, except for the long cylinder of spinning blades that protruded from the main body. It was designed for the purpose of slicing fibroids and uterine tissue into easily removable fragments.
Staring at her pathology report and subsequent scans, Reed and her husband, Hooman Noorchashm, put two-and-two together. She was an anesthesiologist, and her husband, a cardiothoracic surgeon. They both earned PhDs in immunology from the University of Pennsylvania.
Reed wasn’t the first woman to be mortally wounded by this device, but she and Noorchashm were the first to publicly make the connection between the mechanical shredding of uterine tissue and the dissemination of previously undiagnosed malignancies—a conclusion that they would’ve most likely missed had they not been physicians.
By connecting the cause and effect and going on to the next step—waging a high-profile public health campaign—Reed and Noorchashm changed the standard of care in gynecology, saving an uncounted number of lives.
Reed’s doctors at the time said that her case was an exception. It was improbable: she turned out to be an extremely rare statistic: one in 10,000. You are really, really unlucky, Amy, they said.
We are very sorry, Brigham officials said, in response to Reed’s concern that upstaging of malignancies might be a systemic occurrence, that some of the 50,000 to 100,000 women who were undergoing power morcellation every year were being gravely harmed. Over 80 percent of black women and nearly 70 percent of white women develop fibroids at least once in their lifetime.
“Do you know if this has happened to other women?” Reed and Noorchashm asked. “You need to stop this surgical procedure if this is happening.”
No, Amy, it’s bad luck, she was told. It’s like being struck by lightning.
But the Harvard-affiliated hospital didn’t let on that another of its patients, Erica Kaitz, was dying from the same disease that afflicted Reed—aggressive leiomyosarcoma—at the same time that Reed and Noorchashm were confronting the Boston hospital’s administrators.
The lightning, it turned out, had struck twice—in the same city, at the same hospital.
Reed never met Kaitz. They were both living in Boston, and they were young. Neither knew, then, that their stories would change medical practice—or that they would share a similar fate.
“The medical story was almost a carbon copy of Erica’s, including the complications at the end,” said Erica’s husband, Richard Kaitz. “They were exactly the same: tumor blocking the kidneys, abdominal tumor that couldn’t be controlled. It’s exactly the same story. Those seeds were planted through the morcellation, clear as day.”
One thing set the women apart: Erica underwent morcellation at Brigham slightly over a year before Amy wanted her uterus and symptomatic fibroids removed.
“If, by some twist of fate, Amy had been diagnosed before Erica and their paths reversed, I am confident Erica would have been spared morcellation and would still be here with us,” Kaitz said to me when I called to talk about Reed’s life. “Whether Amy and Erica could’ve successfully lived with leiomyosarcoma on a long-term basis like so many others that we know without the morcellation, we’ll never know.
“But I think the likely answer to that is, yes. Would they have had a cancer to manage? Yes. Could they have lived a life of 10, 20, 30 years managing that cancer and even awaiting breakthroughs and treatment? Yes.
“That was taken away from them by morcellation. It was never discussed with us, it was never discussed with Amy, and none of us have ever really heard of it at the time. It’s just an overwhelmingly sad day.”
It is, of course, perilous to hypothesize about what might have been. By the same token, it’s hard to characterize the whirring power morcellator as the right tool for extraction of sarcomas.
It’s a question of assumptions. Should the surgeon assume that the fibroids are benign? Or should they be assumed to be cancerous?
Erica died on Dec. 7, 2013. Reed lived for three years seven months and eight days after her surgery.
Amy Josephine Reed was born in Bristol, PA. She had seven siblings. Her mother, the former Joann Tunis, was a pharmacist, and her father, William Reed, was a computer programmer.
As a child, Amy was, in her words, a “very enthusiastic-for-life kind of kid.”
“I always wanted to have a lot of kids when I was little. I imagine I’m someone who likes to build and create. I was always interested in building things,” Reed said to me on that July afternoon, nearly two years after her cancer diagnosis.
By then, I was deep into covering the power morcellation controversy Reed had brought to light. A video of our conversation is posted here.
After graduating from Pennsylvania State University in 1995, she went on to pursue her PhD at the University of Pennsylvania.
“I applied to the University of Pennsylvania, among other schools, and I interviewed at Penn. I enrolled there in the fall, and that’s where I met Hooman. We were classmates.”
Reed and Noorchashm married in 2001.
“When I was in college, I wanted to go to medical school, but my advisor, he said, ‘It’s really difficult to get into medical school. You probably won’t get into medical school,’” Reed said. “Four years later, I decided towards the end of my graduate school tenure that I really didn’t want to work on mice the rest of my life.
“I finished my MD and PhD in a total of 10 years, which wasn’t bad,” Reed said. “I applied for a residency in anesthesia and got a spot at Penn, which was nice, because Hooman, at that point, was a surgical resident. Then, Hooman proceeded to match as a cardiothoracic fellow at Brigham & Women’s Hospital. So, we went up there.”
In 2011, Reed was offered a teaching job at Harvard Medical School and a clinical position at Beth Israel Deaconess Medical Center, another Harvard-affiliated hospital.
Reed and Noorchashm described their initial years in Boston as challenging, but rewarding. They felt that they could achieve anything, that they were invincible—unaware that acrimony would soon emanate from the same hallowed halls they had dedicated their lives to.
Reed credits her maternal grandmother’s family with instilling in her a robust work ethic.
“She was a farmer, and I would work summers at her sister’s farm,” Reed said. “There was a roadside stand, and we’d sell fruits and vegetables. I think those were my formative years for work ethic.
“I remember, once—mind you, this was a roadside vegetable stand—I had shown up to work and I was putting up my hair, just in ponytails. I was walking up to the stand and I got yelled at, because they weren’t paying me to do my hair.
“That was just kind of the approach, like, I didn’t get paid to sit down. You were always expected to be working hard, and working on doing something. It wasn’t about you.”
These same principles would hold true three decades later, when Reed committed her remaining time to saving other women from the hazardous practice that hastened the end of her life.
Reed and Noorchashm told me that they quickly became disillusioned with Brigham. In numerous interviews, they described how their disappointment quickly morphed into outrage.
Instead of setting an example by ending the practice of power morcellation, one of the most prestigious medical institutions in the world—their very own workplace—seemed to be trying to convince them to accept the bad-luck explanation or, perhaps, go away.
No, this is not how it ends, Reed and Noorchashm decided. We won’t stop until we get to the bottom of this matter, the couple said.
They started a national campaign by first engaging The Wall Street Journal in December 2013, alerting the public, for the first time, to a health issue that would prove to encompass much more than a single medical device and a single institution.
I first met Reed and Noorchashm on June 30, 2014, after corresponding via phone and email for two months.
“This interview is very important, you know why?” Noorchashm said to me at the time. “Partly because of the topic, but partly because these are the first few hours in our new house.”
The couple had moved into an 18th century farmhouse in Yardley, PA. They left Boston to continue their careers in Philadelphia.
Noorchashm had resigned from Brigham, and Reed was recuperating from surgery and chemotherapy. They were chin-deep in a polarizing war against Brigham, device manufacturers, and the gynecology establishment.
Reed was now at the University of Pennsylvania and Noorchashm at Thomas Jefferson University.
Their campaign against power morcellation was getting results. In April 2014, FDA issued an advisory, concluding that the risk for dissemination of occult uterine sarcoma via morcellation was one in 350—almost 30 times higher than the rate touted by pro-morcellation advocates and gynecology professional societies.
That first story evolved into a three-year investigation at The Cancer Letter, which resulted in a series of stories, “How Medical Devices Do Harm.”
In the years I’ve known him, Noorchashm has fired off thousands of scathing emails to Brigham administrators, FDA officials and House and Senate members—anyone he considered a friend or foe—always copying the press. I believe his nickname, The Hoomanator, was coined by a friend.
The vast majority of Hoomanograms were anything but polite, and the acidic content of these emails was often prefaced by provocative subject lines: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”
Academic decorum was the least of their concerns—what Reed and Noorchashm went on to learn in 2014 and 2015 horrified them:
- They learned, for example, that Reed wasn’t the first woman to be harmed at Brigham. Erica Kaitz had been harmed earlier and had died. Almost immediately, Kaitz’s Brigham surgeon, Jon Einarsson, had started a registry trial designed to enroll 400 patients across several partner institutions to test an experimental “bagged” method for performing power morcellation. The study was suspended in November 2014, after The Cancer Letter reported that Brigham did not apply for an FDA exemption to conduct the high-risk study. The authors ultimately reported that leakage was observed in 9.2 percent of the cases.
- J&J subsidiary Ethicon, the primary manufacturer of power morcellators, was informed of the dangers of the device in 2006 by Robert Lamparter, a retired pathologist from central Pennsylvania. Ethicon dismissed Lamparter’s report, and did not pull the devices from the market until July 2014.
- Michael Muto, the Brigham physician who referred Reed for the procedure, had authored a 2012 study finding that four out of 1,091 patients—or about one in 273—showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. The couple said they felt betrayed: Muto did not communicate these findings prior to referring Reed for morcellation. My efforts to contact Muto were unsuccessful, and Brigham ultimately stopped communications with The Cancer Letter on the subject of power morcellation, citing legal advice.
- Brigham did not report the harm caused to Kaitz or Reed to FDA, as required by federal patient safety laws. In fact, until Reed filed her report in December 2013, no one had informed the agency of any adverse events resulting from power morcellators for the over 20 years that the device had been on the market. Since then, hundreds of patients and families, at least 300, have since come forward claiming harm. FDA has logged at least 285 reports.
It was a perfect systemic failure ushered into existence by negligence at every level, Noorchashm would often say to me. A multi-headed demon had entered our home, he would say.
Reed and Noorchashm made many enemies.
In August 2014, Karl Storz threatened to take legal action against Reed and Noorchashm for their aggressive campaign. The following year, when Reed sought treatment at Brigham, hospital administrators declared the couple a security threat, subjected them to a physical search, and mandated that they be followed by a security detail while Reed was being treated for her distant metastatic tumors at Brigham.
Brigham’s executive vice president, Ron Walls, called Reed and Noorchashm’s advocacy a “campaign of distortions.” The New England Journal of Medicine published snide commentary by Lisa Rosenbaum, a Brigham cardiologist, who labelled the couple “availability entrepreneurs.” Reed engaged in “N-of-1 Policymaking,” Rosenbaum wrote, and exploited “reporters eager to break stories of transgression.” Noorchashm gave up his “promising surgical career for a mission of offering comfort to people undone by illness,” Rosenbaum wrote.
But the couple also made many friends and allies: the patient advocacy and cancer community rallied to their cause, and scientific consensus was largely on their side. Minimally invasive gynecologists continue to dispute FDA’s risk estimate, but as far as the larger medical community was concerned, the case was settled. One high-powered study after another provided a critical mass of evidence that bolstered the FDA estimate.
A Boston judge issued a restraining order against Brigham, forcing the hospital to lift all security requirements against its own patient—a truly unusual event. Former Rep. Mike Fitzpatrick (R-PA) pushed for stricter patient safety and adverse event reporting laws. A Congressional subcommittee, FDA, the Federal Bureau of Investigation, and the Government Accountability Office launched investigations.
An argument can be made that Reed and Noorchashm were, for the most part, victorious:
- In November 2014, within a year of the couple’s campaign, FDA severely restricted the use of power morcellators, declaring that the devices should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures. The use of power morcellators dropped by nearly 80 percent after FDA’s guidance document, according to Columbia University researchers.
- In December 2015, FDA initiated inspections at 17 hospitals—including Brigham—to review their compliance with medical device adverse events reporting requirements. The agency found that the vast majority of those hospitals did not file timely reports of injuries and deaths caused by medical devices. The agency decided against taking punitive action.
- In June 2016, Fitzpatrick and Rep. Louise Slaughter (D-NY) introduced legislation to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices. The legislation wasn’t folded into the 21st Century Cures Act.
- In February 2017, the GAO released a 49-page report concluding that FDA’s passive reliance on self-reporting by hospitals and device manufacturers allowed harm caused by power morcellators to go unnoticed for over two decades—likely contributing to injury and deaths of hundreds of women. “I think it’s a failure because reports were not being filed … I’m hoping this was a wake-up call,” Marcia Crosse, director of the health care team at GAO, said to me.
But victory wasn’t complete, Reed and Noorchashm said.
They did not succeed at getting the procedure banned, and gynecologists can continue to perform power morcellation at their discretion, deterred only by the threat of medical malpractice lawsuits if harm is caused. Also, a sizable number of gynecologists believe that the campaign was a publicity stunt, and that the risk was overblown, Noorchashm said. Reed, Noorchashm, and Kaitz sued Brigham, and dozens of women around the U.S. sued their local hospitals.
“Amy was such a passionate, dedicated, and selfless advocate for the anti-morcellation campaign,” Kaitz said. “She took so much time away from her family and other professional pursuits as well to make the world a safer place for others. That’s really an incredible legacy that she’s left, and the progress that she and Hooman made is just astronomical on a relatively short time.
“They moved mountains and basically stopped a major medical practice. On top of that, she was obviously an incredible mother, physician, compassionate caregiver, and wife to Hooman.”
Fitzpatrick was stunned when he found out about Reed’s death.
“Dr. Amy Reed was the most impactful of any constituent I met or had the duty to represent,” Fitzpatrick said. “She taught and she cared. She fought and she made incredible change. Some of my former colleagues castigated basic truths that she brought to their attention, but she never gave up. At the same time, other colleagues only privately acknowledged but could not find the strength to support the truth publicly.
“And so, Amy was the strength not only in her own struggle, and the struggle of public health, but for numerous public and elected officials across the country. They would be well advised to attempt to follow the courage of her life and the impact of her convictions.
“There are so few in life who live their lives with such dignity and compassion and selflessness, and who, at the same time, dedicate every waking hour to care for their family, all while serving such a noble public purpose: saving lives, and righting wrongs.”
His voice cracked.
“Dr. Amy Reed has been, very publicly, a health care hero for our nation and, privately, nothing short of inspirational.”
Reed’s sarcoma remained largely manageable for about three years.
During the first year, her cancer appeared to be in remission. In 2015 and 2016, she underwent multiple surgeries and radiotherapy to treat a growing number of metastatic lesions. Noorchashm played a significant role in her care, testing immunotherapeutic agents with the hope that they might find one that would work.
On April 3, a large, recurrent abdominal tumor that could not be excised had ruptured and hemorrhaged when she showed up for a routine CT scan at a Penn Medicine community radiology center in Bucks County.
Reed suffered cardiac arrest and remained in a coma for five days.
Noorchashm worked frantically to revive her. “Fuck, not like this, Amy. Not like this!” he recounted in an email. “Need to say goodbye. Need to tell her I’m sorry we weren’t able to cure this. Need to tell her I’m sorry for all the things I could’ve been to her and done for her but hadn’t.”
Reed was flown to the Hospital of the University of Pennsylvania, where she stayed for eight weeks, before returning home on May 19. She was last conscious the morning of May 24.
“We’ve been at this for four years,” Noorchashm said to me that afternoon, a few hours before her death at 8:09 p.m. “We’ve had time to adapt and adjust to what is to come. We will miss Amy dearly. Amy has been the center of my existence since I met her. We’re going to miss her all the time. But Amy’s death is a warrior’s death. It’s not a tragedy where we want people to feel sorry for us.
“She has lived life with passion, and she’s fought when she has seen things that are wrong. There’s really no mourning going on here, there’s sadness, but we are not going to become victims of our circumstance. Amy Reed is someone who rose to the very top of what she was doing and she fell to arrogance, hubris, carelessness, and she fell to a natural disaster.
“But then she fought. This was her fight. I wrote a lot, but she was my muse for the past three years. This was her voice, this was who she was.”
On that humid July afternoon in 2015, in her new house, Reed paused to listen to the sky. Her six children, Nadia, Ava, Joseph, Joshua, Luke and Ryan, were playing in the backyard pool.
“Is that thunder?” she asked me. “Do you mind if I kick the kids out of the pool for 15 minutes?”
She opened the kitchen door and stepped away from the camera.
“Hey guys, that’s thunder.”