What Are the Chances?
Back in November, there was a little article about Amy in the Philadelphia Inquirer. She’d bought a package of organic grapes at BJ’s and found a black widow spider inside. Amy recognized the potential danger. She and Hooman alerted the local media. A TV station sent a reporter. That made the couple laugh. “It took three months to get the media onto the morcellation story,” Hooman told the Inquirer. “We call them about a spider, and they’re here.”
The only reason the media “got onto” the morcellation story was because of Hooman’s barrage of emails. He knows that a rare cancer spread by a gruesome process—he makes me watch a YouTube video of morcellation—isn’t an easy sell. “There are plenty of nut jobs out there making phone calls and sending emails,” he says. But he sensed that he could use what had happened to Amy—a smart, beautiful, young mother of six—to push for what he wanted: to have power morcellators banned, so that no other woman would ever go through what his wife was going through.
Along the way, he made some amazing discoveries. He found, for example, that there hadn’t been any pre-market testing of the morcellator in women with fibroids; the FDA didn’t require it. Morcellators had been grandfathered into use in the early 1990s via an expedited process in which devices deemed similar to ones already on the market are approved for other purposes without clinical trials. Morcellators became popular mostly because they made it easy for doctors to chop up fibroids inside the body and vacuum out the pieces.
There had been reports, in the years since the morcellator’s approval, that the devices sometimes scattered the tissue they were decimating. In the video Hooman showed me, a big hunk of fibroid breaks off from the whirling blades and lands atop the morcellator itself, perched like a cup of Dunkin’ Donuts on the roof of a car. In 1998 a medical journal reported on a scrap of morcellated fibroid that landed near a woman’s liver, requiring major surgery. There were other reports of bits and fragments that landed and grew. When morcellators are used for other types of operations, doctors regularly add an attached surgical bag to catch the cut-up tissue, so it doesn’t spread infection or something worse. But the FDA didn’t require the use of such bags. Johnson & Johnson, until recently the largest morcellator manufacturer—though it didn’t make the one used on Amy—recommended using a bag with the device when a malignancy was suspected. But it never manufactured such a bag, and it didn’t feature bags in its training. What are the chances of a woman with a fibroid having a hidden cancer? Ten thousand to one?
Still, there had been hints the risks might be greater. In 2006, a pathologist in Lewisburg, Pennsylvania, contacted Johnson & Johnson expressing concern about cancerous cells he was finding in morcellated uterine tissue. His report fell through a crack in the system; because he didn’t cite an experience with a patient, it was labeled a “complaint” and didn’t trigger a review. A South Korean study in 2011 showed that morcellation of leiomyosarcoma more than doubled the death rate in patients compared with removing the tumor whole, but it looked at only 56 patients. Further studies confirmed those results, though. And then there was that peer-reviewed study by Brigham doctors, including Michael Muto, that examined 1,091 morcellation procedures and found the rate of sarcoma was much higher than previously believed—the study that got Hooman upset.
Hooman was proud to be a Brigham doctor. That and his Harvard teaching appointment were the culmination of a long, strange life’s journey. In the 1960s, his parents were part of “a generation of Iranian kids who got subsidized to get their educations here in the U.S., go back to Iran, and build the country,” he says. Hooman was born here before his parents returned to their homeland; when they did, they got stuck there, “under duress,” as he puts it, for 10 long years. He and his parents finally got out and back to the U.S. when he was 13.
“Iran was a country run by thugs,” he says now. “There was no concept of individual rights.” His life experience taught him to honor dissent. When he found out how dangerous morcellation was, “The way it played out in my head was, I’ll tell them and they’ll shut it down. This is Harvard! This is the most powerful medical establishment in the country.” If Harvard stopped using morcellators, everybody else would, too.
But it didn’t go that way. When the couple went through what Amy calls “the kumbaya sessions” at Brigham, she says the doctors and administrators were soothing but noncommittal, saying, “Well, we’re having a conversation with our malpractice insurers.” The liability experts had looked at the odds. The gynecological surgeons didn’t want to stop using the easier morcellation technique. They insisted it cut down on infections and complications—that it was safer for patients. Except, of course, for those one in—what? Ten thousand? One thousand?—for whom it proved deadly instead.
A Boston physician who was a friend of the couple, Michael Paasche-Orlow, combed through medical journals and studies, searching for sarcomas that showed up after hysterectomies for fibroids. He found a lot more than he expected. When he analyzed 10 studies, he found that while a woman’s general risk of having a hidden uterine sarcoma morcellated is one in 10,000, among women whose fibroids caused symptoms severe enough for surgery, it was one in 415.
That number, plus Brigham’s reluctance to curtail the use of morcellators, convinced Hooman to go nuclear.
There’s a framed photo on a windowsill in Amy and Hooman’s living room from the day of their 2001 wedding. She’s in lacy white; he stands behind her, looking over her shoulder with a grin. When he first started with the emails, she wasn’t exactly on board. She thought his energy and time would be better spent on their children. And she worried about the effects of his campaign professionally. “This had huge implications for him,” she says. “I look at myself and wonder—would I have stood by me? I don’t know. People are just trying to make it in life, you know? Even our good friends… ”
“Everyone was standing on ceremony,” Hooman says.
“Doctors are very protective of other doctors,” Amy explains.
Hooman kept the emails flying. He wrote to morcellator manufacturers, medical societies, doctors at Brigham. He threatened to quit his job. He pulled his diplomas off the wall. Colleagues considered him mad with grief.
Amy, meanwhile, was examining her options. She did her own searches of medical literature, looking for the most aggressive treatment of her cancer she could find. In November 2013, she underwent an unusual seven-hour operation known as a “Sugarbaker procedure,” named for the oncologist who developed it. Doctors sliced her open, removed bits of uterine tissue that had adhered to her bowel, cut out a leiomyosarcoma from her bladder (its presence showed the disease was already spreading), scraped away suspicious-looking tissue from her other organs, then poured a heated chemotherapy mixture into her abdomen and sewed her shut. (Also removed: her gallbladder, appendix, ovaries, and some supporting membranes.) After the mixture had sloshed around in her abdominal cavity for an hour and a half, doctors opened her back up and drained it away. She was hospitalized for more than a week, then had a brief respite before a six-month regimen of standard chemotherapy began.
And just then, finally, one of Hooman’s emails rooted, took hold. In December 2013, the Wall Street Journal published a front-page article about morcellation that included Amy’s story. In January 2014, a British medical journal took note of her case in a piece on the process of approval for medical devices. The following month, Michael Paasche-Orlow submitted his research paper to the FDA. The paper called for a moratorium on morcellator use, stating that its risks were “too high to be accepted as a standard of care.” With the publicity, more and more cases were coming to light. The Journal of the American Medical Association published an editorial on the dangers of morcellation. Temple University Hospital in Philadelphia became the first U.S. hospital to tightly limit the use of morcellation, requiring containment bags. Other hospitals, including Brigham, soon did the same.
Also around that time, the FDA disclosed that it had been investigating whether the advantages of morcellation outweighed the risks. In response, gynecologic surgeons who relied on the procedure started a campaign of their own. The American College of Obstetricians and Gynecologists and the American Association of Gynecologic Laparoscopists argued that laparoscopic procedures were safer than abdominal surgeries because there were fewer complications and infections. Morcellation proponents considered Hooman to be overreacting. The vice president of ACOG, inadvertently hitting “Reply All” to one of Hooman’s mass emails in March 2014, wrote, “As we have repeatedly said, nothing is going to create any ‘peace’ in this man.”
Then, in April 2014, the FDA issued an advisory opinion that discouraged the use of morcellators for fibroid surgery. Its own review of the data showed the risk for undetected uterine sarcomas in women seeking fibroid surgery was one in 350. In July, Johnson & Johnson withdrew its morcellators from the market. Insurers, including Blue Cross Blue Shield, began refusing to pay for hysterectomies performed with the devices. In November, the FDA for the first time in its history flexed its “Immediately in Effect” authority, which bypassed public comment to put a black-box warning—its strongest possible—on morcellators and declare them contraindicated for removal of fibroids or uterine tissue. “The FDA decision today is based on what we believe is best for patients,” the agency’s chief scientist declared.
Hooman and Amy had won.