How
Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
On good mornings, Hooman Noorchashm
wakes early, a relic of the days when he rose at 4:30 am for surgical rounds at
Brigham and Women's Hospital. He pads through the quiet house to pop a coffee
pod into the machine, then heads for his home office, where, over the course of
the day, he will calmly, deliberately compose and send dozens of emails.
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.
His wife, Amy Reed, sleeps till 6:30
am, when she slips on a red Phillies T-shirt, snugs a maroon jersey cap over
her stubbled head, and begins the work of getting six children under 12 ready for the day. An anesthesiologist at Beth
Israel Deaconess Medical Center, Reed was on the team that treated both the
Boston Marathon bomber and his victims. She is by nature even-keeled.
You'd want her as your anesthesiologist. You'd want her sharp intelligence and
steady presence with you in the OR. She and her husband aren't people who
"do drama," as they put it. They're experienced doctors who argue
logically rather than raise their voices or yell or cry.
On good mornings, then, in the face
of events that have devastated
their family, this composure seems both a gift and a burden. 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.
Reed's surgeon, one of the best in
the country, wasn't to blame for the catastrophe. Nor was this a random
disaster, the kind of bad-luck bolt from the blue that can strike anyone—the
brick falling off the building, the truck spinning on the icy highway. The
cancer upstaging was a preventable
consequence of a surgical technique, one that is still being used in operating
rooms around the country.
And this is what Noorchashm and Reed
can't bear. This is what keeps him doggedly online, in the research, on the
phone, whether he's home or sitting by Reed's hospital bed or driving her to
and from chemo. The effort has led to international attention, much of it
critical. Noorchashm's incendiary question: When new technology makes medicine
cheaper and more convenient, how many patients have to die to prove it's not
worth it?
"People
have faulted my husband's enthusiasm," Reed says of Noorchashm. "But
women are having this surgery right now."
On good mornings, his arguments land
as powerfully as his wife's even gaze. "People have faulted my husband's
enthusiasm," Reed says on one of those mornings. "But women are having this surgery right now.
Today. And they're going to have their lives destroyed, just like ours."
This year, more than half a million women in the United
States will undergo hysterectomies. The majority will be between 40 and 55
years old, and, like Reed, most will have the surgery for fibroids,
benign growths in the uterus that can cause pain, bleeding, and other symptoms.
Five years ago, only about 12% of these surgeries were performed
laparoscopically, done through incisions just big enough to fit a scope and
tiny camera. Last year, nearly 30% were done that way, and the numbers were
considered likely to rise.
Compared with traditional open
abdominal procedures, laparoscopic surgeries were said to result in shorter
hospital stays (and, therefore, lower costs for insurers), faster healing, less
pain, fewer infections, and smaller scars. Still, when Reed first discussed hysterectomy
with her surgeon, she
asked for an open operation, despite the larger incision and longer recovery
time. "I said, ‘I'm an anesthesiologist. I know how they operate. I'd
rather have them see what they're dealing with and not mess around with little holes,'
" she recalls. "Laparoscopic surgery's not all it's touted to be
sometimes."
She'd known about her fibroids
for a while, but the bleeding and pain had ramped up dramatically during her
last pregnancy. Her husband arranged a consult with a colleague, Michael Muto,
who directs the gynecological oncology fellowship at Brigham and Women's, which
is Harvard's teaching hospital and an industry standard-bearer. As Reed
remembers, Muto reassured her that the problem was "a no-brainer";
she'd have her uterus removed, and that would be that. "He told me, ‘This
is not cancer, it's not anything terrible, this is what fibroids do.' "
She says this quietly, matter-of-factly, 3 months later, sitting in the
sun-splashed living room of a white clapboard house on a narrow street in the
Boston suburb of Needham. From time to time she reaches under her cap to rub at
a spot where her hair is starting to grow back, white fuzz now laced through
the dark.
Muto
said no surgeon would do what she wanted. You're young and healthy, Reed
remembers being told; there's no reason in the world to have this done as an
open surgery. "Dr. Muto wears a nice white coat with the Harvard emblem on
it," says Noorchashm, sitting across from Reed. "He's my colleague,
and we trust our own establishment." He pauses, and then corrects himself.
"I trusted the establishment."
So
Reed had MRIs and biopsies to check for cancer, as is standard before a fibroid
operation, and went ahead with the laparoscopic hysterectomy. She went home
that afternoon, and everything was fine until the surgeon called 8 days later
to say that the pathology report showed leiomyosarcoma, a cancer in her uterus.
And nothing has been fine since then.
Imagine
a hive filled with angry bees flying this way and that, buzzing, darting,
stingers at the ready. Now picture that hive inside a woman's belly, where at
any moment the bees could explode through the body, wreaking the deadliest kind
of havoc. The hive, says Noorchashm, is a good metaphor for a
sarcoma, a kind of cancer that can grow anywhere in the body. He's operated on
sarcomas and knows that the way to handle them is to carefully remove them in one piece. Now
imagine inserting a long spinning saw—something like a handheld blender—into
the hive while it's still inside the woman's body and cutting it up into tiny
pieces. "What's going to happen," says Noorchashm, "is a million
bees are going to come out and you're dead."
That saw is called a
morcellator, and over the past 10 years or so, it's become standard procedure
in laparoscopic surgeries to remove fibroids, the uterus, or both. "Morcellation prevents you from having to make a larger
incision," says Larry Kaiser, dean of the Temple University School of Medicine.
"You couldn't take the uterus with fibroids out through these small ports
used for the camera and instruments."
The trouble is, some cancers—like
leiomyosarcoma—don't show up on biopsies or MRIs done before surgery. If
a woman's uterus is morcellated inside her body, cancer cells are spewed around
the abdomen, where they cling to internal organs and, inevitably, grow. Even benign tissue that's
morcellated can implant in the abdomen and trigger pain, bowel obstructions,
and other problems.
Morcellation is what Reed and
Noorchashm want to stop, arguing that it's unacceptable if there's any chance of hidden
cancer—and there's pretty much always a chance. "It's flawed surgical
procedure," says Noorchashm. Some ob-gyn surgeons say morcellation
is safe if it's done in a containment bag, something like the bag inside a
vacuum cleaner. Noorchashm disagrees. Bags can break, he says, especially when
you're using a rotating power saw. Instead, he and Reed want surgeons to remove the whole,
unmorcellated uterus vaginally when they can, and do the old-fashioned open
surgery when they can't.
On the day Reed got the bad news,
Noorchashm was down at Duke, preparing for surgery. After he got the call, he
scrubbed out, booked a ticket home, and left. In the cab on the way to the
airport, he called Muto, who told him what he'd already told Reed:
Leiomyosarcoma is so rare there are no protocols for treating it, no best
practices, no good survival statistics. Some doctors do nothing, waiting to see
if it comes back; some start chemotherapy
to try to stave it off; some schedule surgery to clean out anything that's
already growing.
Noorchashm was horrified, both by
the stark reality of the facts and by the offhand way he felt they were being
delivered. "In my mind, when
I hear sarcoma, and the sarcoma has been broken up inside, that's a five-alarm
fire," he says. "And here's a surgeon thinking, We have three
options, including watching and waiting. That's like taking a water gun and
shooting at a five-alarm fire."
That day in the Raleigh-Durham
airport, an advocate was born. Noorchashm began researching, making phone
calls, and sending hundreds of emails to anyone he thought might make a
difference—family, friends, colleagues, doctors, researchers, journalists,
editors of medical journals. He and Reed (who at the time felt physically fine
despite the cancer inside her) created a petition on Change.org calling for a ban on the
practice.
Doctors and administrators
maintained that what happened to Reed was unfortunate but incredibly rare and
that it didn't make sense to abandon morcellation—a convenient and widely
usable technique—because of such an unusual occurrence. The largest
professional organization for ob-gyn surgeons, the American Association of Gynecologic
Laparoscopists, issued an official statement disagreeing with putting
limits on the procedure.
Some ob-gyns pointed out that the
alternative laparoscopic techniques (removing tissue vaginally or morcellating
in a bag) aren't an option for women with large fibroids—and worried that
restrictions would lead to thousands of unnecessarily invasive open surgeries.
These can cause more blood clots and infections, both of which can be lethal,
says Joseph Ramieri, an ob-gyn surgeon and professor at Mount Sinai School of
Medicine. "I'm not defending morcellation—as a technique, it leaves an
awful lot to be desired," he says. "But it needs further study before
we put limitations on it."
Noorchashm and Reed were asking for a huge shift in medical
practice, and physicians, especially surgeons, can be slow to change,
says Brian Van Tine, a physician who heads the Sarcoma Program at Barnes-Jewish
Hospital in St. Louis. Part
of the resistance was likely financial. If, say, half of the women who
have hysterectomies have abdominal surgery rather than laparoscopy and must
spend an extra day or two in the hospital, that's a lot of extra costs for insurance
companies to cover. "Morcellation saves money," Van Tine says,
"and these surgeries
are a huge moneymaker."
As a result of the couple's efforts,
new information emerged about just how uncommon leiomyosarcoma really was. Reed
says that Muto, who
refused to comment for this story, told her the cancer affects 1 in 10,000
women, but that statistic was based on the population at large. Among women
with symptomatic fibroids, the number may be closer to 1 in 415, Noorchashm
discovered—incredibly, from a paper listing Muto himself as a coauthor. In
fact, Reed was the second woman within a year whose cancer was upstaged by
morcellation at Brigham and Women's Hospital alone. The first woman has since
died. Since Reed's surgery, at least five other women around the country whose
cancers were upstaged by morcellation have come forth. And there are certainly
others out there.
Though
Reed's odds of living to see her youngest son graduate from high school are
slim, she chooses not to focus on the numbers.
As the winter progressed, Reed
committed herself to doctors' visits and weighing treatment options—and
remaining an upbeat, present mom to her children. Noorchashm stayed up nights
writing strongly worded letters, posting comments on every website remotely
relevant to the cause, and having strategic conversations with anyone who would
talk to him. The only
resulting change he saw was in his own reputation. He'd gone from star surgeon
to social leper, shut out of the operating room at his own hospital (though he
can't prove it was because of the campaign) and avoided by colleagues and
former friends. "They closed ranks on me," he says now, with sadness
in his voice. "I broke the white code of silence; I hung out our dirty
laundry."
But he pushed on. He contacted
hospital executives, the FDA, legislators. In return, his bosses at Brigham emailed faculty and staff
warning them not to talk to Noorchashm and to speak to the hospital's chief
medical officer if contacted by Noorchashm. Gerald Joseph, vice president of
the American Congress of Obstetricians and Gynecologists, wrote to a colleague
about Noorchashm: "Nothing is going to create any peace in this man."
And then, in February, something
shifted. Kaiser (the dean at Temple) passed Noorchashm's materials to the head
of gynecology, who responded by making the institution the first to ban open morcellation,
requiring surgeons to use an isolation bag or not morcellate at all. Within
weeks, another hospital got on board: Rochester General Health System declared
that its surgeons wouldn't morcellate without a bag. Noorchashm wasn't
satisfied—the bags could break, he said. He carried on with his campaign.
At the end of March, 5 months after the surgery
that spread Reed's cancer, Brigham
and Women's—Noorchashm's own employer—did the thing no one expected. The
same administrators who had shaken their heads at this angry, disenfranchised
surgeon finally acknowledged his case. They banned fibroid morcellation without a bag. Then, in
mid-April, the FDA came out with a new analysis: A shocking 1 in 350 women
seeking the removal of symptomatic fibroids has a hidden cancer, it said. The
FDA issued an advisory strongly discouraging the use of morcellation,
crediting Noorchashm with bringing the issue to its attention. More
institutions, including the University of Pennsylvania Health System and
Cleveland Clinic, changed policies. And Johnson & Johnson, the
biggest morcellator maker in the United States, suspended production and sale
of the tool. Noorchashm's life was shattered, but he had achieved
much of his goal. "We have the privilege of being able to give meaning to
what's happened to us," he says. "That gives us strength."
But he and Reed aren't finished. The FDA will hold a hearing in July, and Noorchashm expects
it to be contentious. "That's when the likes of Gerald Joseph"—the
man who said that Noorchashm would never find peace—"will come in with
their suits and their lawyers and make arguments about the 'benefit of the
majority,' " he says. "But medicine is not a popularity contest. You have to practice in a way
that every single person matters."
Reed knows her chances of living to
see her youngest son graduate from high school are slim. She copes, in part, by
resisting the urge to focus on probabilities. The first time she Googled
leiomyosarcoma—the day the surgeon called her—was also the last. "If your chance
of living is 30% versus 70%—I don't even know what to do with that," she
says. "You don't live 30%. You live or die. And either way, today I could
be hit by a car."
She certainly wasn't the type to
wait around for her cancer to spread. She opted instead for a radical
procedure, performed by only a few surgeons in the country. The Sugarbaker operation,
named for its inventor, Paul Sugarbaker, is a brutal 9-hour surgery that removes all visible evidence
of sarcoma, as well as the patient's appendix, gallbladder, omentum (the fatty
covering of the intestines), and peritoneum. Once the organs are gone, surgeons
pour heated chemotherapy
into the abdominal cavity and let it sit for 90 minutes. Sugarbaker told
Reed that if the surgery went well, she'd have an 80% chance of having no
recurrence in her belly in 10 years. In other words, she'd be back to baseline,
back to where she would have been if the cancer had not been upstaged.
"That was the best number I'd heard," she says, her eyes a little
teary for the first time. So in November, she and Noorchashm flew to
Washington, DC, for the surgery. Before getting on the plane, she nursed her
youngest son, then 14 months old, for the last time and handed him to her
mother.
Reed's recovery was more grueling
than she'd anticipated. She couldn't eat for 10 days and lost 20 pounds. The
incision, which runs from her sternum to her pubic bone, was so taut she
couldn't stand up straight for weeks; even now she sometimes hunches to
minimize the pain. Once that healed, she started on a course of chemotherapy,
which just finished. And now comes the hardest part. "I'm afraid to be
done with chemo," she says one afternoon, her youngest son curled on her
lap under a blanket. "At least I was poisoning the cancer. Now what
happens? Now I wait?"
Her son sits up suddenly and grabs a
plastic hippo, making it clomp across the kitchen table. Reed holds the boy
loosely, one arm across his legs, and when he slides off her lap to chase a
squirrel from one window to another, she lets him go without hesitation. She's
started making plans for the near future, for the time when they can get back
to some semblance of normal life. She's maintained a research lab over the past
10 years, and she and Noorchashm are talking about working together to study,
and ultimately defeat, leiomyosarcoma. "We have the know-how, and we
certainly have the drive," she says.
At 2 am the house is quiet. Reed and
the children sleep upstairs, but Noorchashm is still awake downstairs. He sits
alone in a small pool of light, staring at a bronze statue on the mantel: St. George on his horse, his
magical spear poised to slay the dragon. In the story, George kills the dragon
to save not just the princess but also the rest of the town's children, who
were being fed to the dragon one by one to appease it.
It's a metaphor, Noorchashm thinks.
No, it's more than a metaphor; it's the new story of their lives, a fight to
the death with the powerful creature that has changed their world forever. The
horse is the media and doctors he's rallying to the cause; the shield
represents the status of being a cardiac surgeon at Harvard. In some versions
of the myth, the princess lives but George winds up dead; in others they get a
happily-ever-after ending.
Noorchashm is a realist; he knows
that odds are he will lose his wife sooner rather than later. He may also lose
his career, but he's not worried about that just now. He's focused on the
moment, the here and now. This fight he and his wife are immersed in, a fight
not of their choosing.
He taps his long surgeon's fingers against the metal,
sets the statue down on the desk, pulls the laptop closer, and opens a new
email. He is not just George but the spear itself, aimed at the dark and bitter
heart of the monster.
