Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label Brigham and Women's Hospital. Show all posts
Showing posts with label Brigham and Women's Hospital. Show all posts

Thursday, May 25, 2017

Dr. Amy Reed Dies at Age 44, Mother of 6 Children and Advocate for Safe Medical Devices





By DENISE GRADY
MAY 24, 2017  (FiDA highlight)
Dr. Amy J. Reed, a physician and cancer patient who turned a personal calamity into a crusade to spare other women from the medical procedure that harmed her, died on Wednesday night at home in Yardley, Pa. She was 44.



Dr. Amy J. Reed and her husband, Dr. Hooman Noorchashm, in 2014. (MATTHEW CAVANAUGH FOR THE NEW YORK TIMES)

Her husband, Dr. Hooman Noorchashm, said the cause was leiomyosarcoma of the uterus, a type of cancer.
Dr. Reed and her husband fought for years to ban the use of a surgical tool called a power morcellator, which has a spinning blade that slices up tissue so it can be extracted through small incisions. Though the device is regarded as a great boon to minimally invasive surgery, if a patient has cancer, as Dr. Reed did, morcellation can spread the disease.
Dr. Reed and Dr. Noorchashm (pronounced NOOR-chasm) won some notable victories. Because of their efforts, the Food and Drug Administration studied morcellation and in 2014 recommended that it not be used in the “the vast majority” of women having surgery for uterine fibroids, a common tumor that is usually benign but that can hide a dangerous type of cancer.

Some insurers began declining coverage for morcellation, and one major manufacturer took its morcellators off the market. Use of the technique dropped.

Dr. Reed, an anesthesiologist and the mother of six children, underwent surgery involving morcellation in 2013, when, at 40, she had her uterus removed because of fibroids. The operation was performed at Brigham and Women’s Hospital in Boston, which is affiliated with Harvard Medical School, where both Dr. Reed and Dr. Noorchashm had teaching positions. A biopsy after the operation found that Dr. Reed had a hidden leiomyosarcoma, an aggressive type of cancer.
Only then were Dr. Reed and her husband told that her surgeon had used a power morcellator to slice up her uterus. The device allows doctors to work through small slits rather than big, open incisions, so that patients can heal faster and run less risk of bleeding and infection.
At that time, morcellation was performed on 50,000 women a year in the United States to help remove fibroids, or to remove the entire uterus.
The device had sprayed malignant cells around inside Dr. Reed’s abdomen, leaving her with an advanced, Stage 4 cancer.
As physicians, Dr. Reed and Dr. Noorchashm knew at the time that her morcellation procedure could be a death sentence. As a surgeon himself, Dr. 
Dr. Reed quickly embarked on a series of aggressive treatments, but she still suffered one recurrence after another, in her abdomen, lungs and spine. She had several major operations and received arduous courses of chemotherapy, radiation, immunotherapy and experimental treatment.

The couple fought the medical establishment as fiercely as they did the cancer, seeking to ban morcellation. They sent thousands of emails to the F.D.A., device makers, hospitals, legislators, professional societies and individual doctors, and they reached out to news organizations to publicize their cause.
Dr. Noorchashm also collected the names and histories of women whose cancer had spread after morcellation, enlisting them, or their survivors, in the crusade.

































Dr. Amy Reed with her husband, Dr. Hooman Noorchashm, and their children in their backyard in Yardley, Pa., in the summer of 2015.
JENNIFER CAPOZZOLA
Their activism, alienating some colleagues and aggravating administrators, came at a price. Dr. Noorchashm had been a rising star in cardiothoracic surgery at Brigham and Women’s, where his wife had the operation, but as he continued to criticize its gynecology department, his career there began to stall.
He and Dr. Reed were both hired by the University of Pennsylvania, and moved there in 2014. Both had extended family in and around Philadelphia.
They had apparently burned their bridges at Harvard. At one point, when Dr. Reed needed to return to Brigham and Women’s for a medical procedure, she and Dr. Noorchashm were stunned to find that the hospital had assigned a guard to inspect their bags and escort them at all times, for security reasons. Dr. Noorchashm called a lawyer. A judge put a stop to the escort, issuing a restraining order against the hospital.
The gynecology profession also fought back against Dr. Noorchashm and Dr. Reed, insisting that leiomyosarcoma was so rare that the benefit of morcellation — the ability to have minimally invasive surgery — far outweighed any risk.

Before 2013, the F.D.A. had received no reports of uterine cancers being spread by morcellators. But after Dr. Reed and her husband went public — interviewed by newspapers, magazines and TV news shows — reports began to pour in. Dr. Reed, with her hair gone and her youngest child sometimes climbing onto her lap during interviews, was a sympathetic figure.

The couple’s efforts gained traction. The F.D.A. responded by studying published and unpublished medical data on morcellation. Before then, estimates of how many women with fibroids would have undiagnosed leiomyosarcomas or other uterine sarcomas were based on studies of varying reliability, and ranged from 1 in 10,000 to in 1 in 500. But the F.D.A. concluded in April 2014 that hidden sarcomas were more common than earlier estimates had stated — and probably occurred in about one in 350 women with fibroids. The tumors are extremely difficult to detect without surgery.
Soon after the F.D.A. issued its findings, one maker of morcellators, Johnson & Johnson, pulled its devices off the market. But others remained.
In November 2014, the F.D.A. went further, recommending that power morcellators not be used in the vast majority of women having fibroid surgery. Using the device in women with undetected sarcomas, it said, “may spread cancer and decrease the long-term survival of patients.” The F.D.A. portrayed the statement as a “safety communication,” not as an announcement of a new regulation.
Morcellator use dropped significantly, but many gynecologists still favored it, and the devices remained available. Dr. Noorchashm and Dr. Reed would not settle for less than a complete ban, and continued to agitate. They prodded legislators to ask the Government Accountability Office to investigate morcellation.
In a report issued in February, the G.A.O. criticized the F.D.A.’s method of collecting data on problems stemming from morcellation, noting that the system was dependent on voluntary reports from doctors, who frequently fail to report bad outcomes.

The F.D.A. said it agreed that it needed a better system to detect harm to patients. By September 2016, the agency had received 285 reports of uterine cancer being spread by morcellation.

Amy Josephine Reed was born on March 22, 1973, in Bristol, Pa. Her mother, the former Joann Tunis, was a pharmacist and executive at the drug company Pfizer. Her father, William Reed, was a health insurance consultant.
Dr. Reed graduated from Pennsylvania State University in 1995 and went on to the University of Pennsylvania, where she earned a Ph.D. in immunology and a degree in medicine. She specialized in anesthesia and critical-care medicine.
She and Dr. Noorchashm met as graduate students and married in 2001. In 2011, both were offered teaching posts at the Harvard Medical School and clinical positions at its affiliated hospitals — Dr. Noorchashm at Brigham and Women’s and Dr. Reed at Beth Israel Deaconess. She treated victims of the Boston Marathon bombing in 2013, as well as the surviving bomber.

Besides Dr. Noorchashm, Dr. Reed is survived by her parents; her daughters, Nadia and Ava; her sons, Joseph, Joshua, Luke and Ryan; and seven siblings: Alison Perate, Andrea Kealy, Amber Trainer, Matthew Reed, Justin Reed, Daniel Trainer and Sarah Trainer.
https://mobile.nytimes.com/2017/05/24/us/amy-reed-died-cancer-patient-who-fought-morcellation-procedure.html?_r=0&referer=http%3A%2F%2Fm.facebook.com

Tuesday, July 1, 2014

OOOPS! Study: One third of all total knee replacements are 'inappropriate'.



Monday 30 June 2014 - 12am PST
One third of total knee replacements in the US are "inappropriate" when applied to a Spanish patient classification system, according to a study published in Arthritis & Rheumatology, a journal of the American College of Rheumatology.
Figures from the Agency for Healthcare Research and Quality show that more than 600,000 knee replacements are performed each year in the US. This surgery has become increasingly more common over the past 15 years, with studies showing a 162% annual volume increase in Medicare-covered knee replacement surgeries during 1991-2010.
Experts are divided on the reasons for this growth, with some maintaining it demonstrates that the procedure is effective, while others argue the surgery is being overused. One concern of the critics who believe total knee arthroplasties (TKA) are being overused is that the procedure "is highly reliant on subjective criteria."
For the new study, researchers from Virginia Commonwealth University in Richmond examined the criteria that is used to determine appropriateness for TKA.
The authors point out that the investigated criteria have not been studied in the US and have been developed in other countries.
"To my knowledge, ours is the first US study to compare validated appropriateness criteria with actual cases of knee replacement surgery," says lead author Dr. Daniel Riddle from the Department of Physical Therapy at Virginia Commonwealth University.
Dr. Riddle examined a modified version of an appropriateness classification system developed in Spain and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Physical Function scale.
In the study, Riddle and colleagues note that the Spanish criteria are considered by many experts in the field to be "among the most powerful tools for improving quality of care and controlling costs."

The classification systems were used to assess participants enrolled in the Osteoarthritis Initiative - a 5-year study of 4,796 people partly funded by the National Institutes of Health.
Looking at a sub-set of 175 people who underwent TKA surgery, Dr. Riddle's analysis found that 44% of surgeries were classified as "appropriate," 22% were "inconclusive," and 34% were "inappropriate."
The mean age of knee replacement patients in the study was 67 years old, and 60% of them were female.
"Our finding that one third of knee replacements were inappropriate was higher than expected and linked to variation in knee pain [osteoarthritis] severity and functional loss," says Dr. Riddle. "These data highlight the need to develop patient selection criteria in the US."

"I agree with Riddle and colleagues," writes Dr. Jeffery Katz - from the Orthopedic and Arthritis Center for Outcomes Research at Brigham and Women's Hospital in Boston, MA - in a linked editorial.
"We should be concerned about offering total knee replacements to subjects who endorse 'none' or 'mild' on all items of the WOMAC pain and function scales."
The new study also highlights that there are many variables involved in the decision to undergo TKA surgery. Severity of symptoms and the psychological readiness of the patient are two important factors, but in addition to the variables examined in the study, there are a wide range of variables specific to the patient that a surgeon will consider when making the decision for or against TKA surgery.

Saturday, June 7, 2014

J&J Morcellation Surgery Device May Unleash Deadly Cancer


 Morcellation Surgery: When CuttingEdge Kills

How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown  Photograph by Jamie Young  FiDA Highlight

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.

Sunday, August 19, 2012

Knee Replacement and Cheesecake Factory


 ANNALS OF HEALTH CARE
BIG MED
Restaurant chains have managed to combine quality control, cost control, and innovation. Can health care?      by Atul Gawande
AUGUST 13, 2012      New Yorker                  (FiDA bold and highlight added)
         
Medicine has long resisted the productivity revolutions that transformed other industries. But the new chains aim to change this.
 It was Saturday night, and I was at the local Cheesecake Factory with my two teen-age daughters and three of their friends. You may know the chain: a hundred and sixty restaurants with a catalogue-like menu that, when I did a count, listed three hundred and eight dinner items (including the forty-nine on the “Skinnylicious” menu), plus a hundred and twenty-four choices of beverage. It’s a linen-napkin-and-tablecloth sort of place, but with something for everyone. There’s wine and wasabi-crusted ahi tuna, but there’s also buffalo wings and Bud Light. The kids ordered mostly comfort food—pot stickers, mini crab cakes, teriyaki chicken, Hawaiian pizza, pasta carbonara. I got a beet salad with goat cheese, white-bean hummus and warm flatbread, and the miso salmon.
The place is huge, but it’s invariably packed, and you can see why. The typical entrĂ©e is under fifteen dollars. The dĂ©cor is fancy, in an accessible, Disney-cruise-ship sort of way: faux Egyptian columns, earth-tone murals, vaulted ceilings. The waiters are efficient and friendly. They wear all white (crisp white oxford shirt, pants, apron, sneakers) and try to make you feel as if it were a special night out. As for the food—can I say this without losing forever my chance of getting a reservation at Per Se?—it was delicious.
The chain serves more than eighty million people per year. I pictured semi-frozen bags of beet salad shipped from Mexico, buckets of precooked pasta and production-line hummus, fish from a box. And yet nothing smacked of mass production. My beets were crisp and fresh, the hummus creamy, the salmon like butter in my mouth. No doubt everything we ordered was sweeter, fattier, and bigger than it had to be. But the Cheesecake Factory knows its customers. The whole table was happy (with the possible exception of Ethan, aged sixteen, who picked the onions out of his Hawaiian pizza).
I wondered how they pulled it off. I asked one of the Cheesecake Factory line cooks how much of the food was premade. He told me that everything’s pretty much made from scratch—except the cheesecake, which actually is from a cheesecake factory, in Calabasas, California.
I’d come from the hospital that day. In medicine, too, we are trying to deliver a range of services to millions of people at a reasonable cost and with a consistent level of quality. Unlike the Cheesecake Factory, we haven’t figured out how. Our costs are soaring, the service is typically mediocre, and the quality is unreliable. Every clinician has his or her own way of doing things, and the rates of failure and complication (not to mention the costs) for a given service routinely vary by a factor of two or three, even within the same hospital.
It’s easy to mock places like the Cheesecake Factory—restaurants that have brought chain production to complicated sit-down meals. But the “casual dining sector,” as it is known, plays a central role in the ecosystem of eating, providing three-course, fork-and-knife restaurant meals that most people across the country couldn’t previously find or afford. The ideas start out in Ă©lite, upscale restaurants in major cities. You could think of them as research restaurants, akin to research hospitals. Some of their enthusiasms—miso salmon, Chianti-braised short ribs, flourless chocolate espresso cake—spread to other high-end restaurants. Then the casual-dining chains reĂ«ngineer them for affordable delivery to millions. Does health care need something like this?

Big chains thrive because they provide goods and services of greater variety, better quality, and lower cost than would otherwise be available. Size is the key. It gives them buying power, lets them centralize common functions, and allows them to adopt and diffuse innovations faster than they could if they were a bunch of small, independent operations. Such advantages have made Walmart the most successful retailer on earth. Pizza Hut alone runs one in eight pizza restaurants in the country. The Cheesecake Factory’s major competitor, Darden, owns Olive Garden, LongHorn Steakhouse, Red Lobster, and the Capital Grille; it has more than two thousand restaurants across the country and employs more than a hundred and eighty thousand people. We can bristle at the idea of chains and mass production, with their homogeneity, predictability, and constant genuflection to the value-for-money god. Then you spend a bad night in a “quaint” “one of a kind” bed-and-breakfast that turns out to have a manic, halitoxic innkeeper who can’t keep the hot water running, and it’s right back to the Hyatt.
Medicine, though, had held out against the trend. Physicians were always predominantly self-employed, working alone or in small private-practice groups. American hospitals tended to be community-based. But that’s changing. Hospitals and clinics have been forming into large conglomerates. And physicians—facing escalating demands to lower costs, adopt expensive information technology, and account for performance—have been flocking to join them. According to the Bureau of Labor Statistics, only a quarter of doctors are self-employed—an extraordinary turnabout from a decade ago, when a majority were independent. They’ve decided to become employees, and health systems have become chains.
I’m no exception. I am an employee of an academic, nonprofit health system called Partners HealthCare, which owns the Brigham and Women’s Hospital and the Massachusetts General Hospital, along with seven other hospitals, and is affiliated with dozens of clinics around eastern Massachusetts. Partners has sixty thousand employees, including six thousand doctors. Our competitors include CareGroup, a system of five regional hospitals, and a new for-profit chain called the Steward Health Care System.
Steward was launched in late 2010, when Cerberus—the multibillion-dollar private-investment firm—bought a group of six failing Catholic hospitals in the Boston area for nine hundred million dollars. Many people were shocked that the Catholic Church would allow a corporate takeover of its charity hospitals. But the hospitals, some of which were more than a century old, had been losing money and patients, and Cerberus is one of those firms which specialize in turning around distressed businesses.
Cerberus has owned controlling stakes in Chrysler and GMAC Financing and currently has stakes in Albertsons grocery stories, one of Austria’s largest retail bank chains, and the Freedom Group, which it built into one of the biggest gun-and-ammunition manufacturers in the world. When it looked at the Catholic hospitals, it saw another opportunity to create profit through size and efficiency. In the past year, Steward bought four more Massachusetts hospitals and made an offer to buy six financially troubled hospitals in south Florida. It’s trying to create what some have called the Southwest Airlines of health care—a network of high-quality hospitals that would appeal to a more cost-conscious public.
Steward’s aggressive growth has made local doctors like me nervous. But many health systems, for-profit and not-for-profit, share its goal: large-scale, production-line medicine. The way medical care is organized is changing—because the way we pay for it is changing.
Historically, doctors have been paid for services, not results. In the eighteenth century B.C., Hammurabi’s code instructed that a surgeon be paid ten shekels of silver every time he performed a procedure for a patrician—opening an abscess or treating a cataract with his bronze lancet. It also instructed that if the patient should die or lose an eye, the surgeon’s hands be cut off. Apparently, the Mesopotamian surgeons’ lobby got this results clause dropped. Since then, we’ve generally been paid for what we do, whatever happens. The consequence is the system we have, with plenty of individual transactions—procedures, tests, specialist consultations—and uncertain attention to how the patient ultimately fares.
Health-care reforms—public and private—have sought to reshape that system. This year, my employer’s new contracts with Medicare, BlueCross BlueShield, and others link financial reward to clinical performance. The more the hospital exceeds its cost-reduction and quality-improvement targets, the more money it can keep. If it misses the targets, it will lose tens of millions of dollars. This is a radical shift. Until now, hospitals and medical groups have mainly had a landlord-tenant relationship with doctors. They offered us space and facilities, but what we tenants did behind closed doors was our business. Now it’s their business, too.
The theory the country is about to test is that chains will make us better and more efficient. The question is how. To most of us who work in health care, throwing a bunch of administrators and accountants into the mix seems unlikely to help. Good medicine can’t be reduced to a recipe.
Then again neither can good food: every dish involves attention to detail and individual adjustments that require human judgment. Yet, some chains manage to achieve good, consistent results thousands of times a day across the entire country. I decided to get inside one and find out how they did it.
Dave Luz is the regional manager for the eight Cheesecake Factories in the Boston area. He oversees operations that bring in eighty million dollars in yearly revenue, about as much as a medium-sized hospital. Luz (rhymes with “fuzz”) is forty-seven, and had started out in his twenties waiting tables at a Cheesecake Factory restaurant in Los Angeles. He was writing screenplays, but couldn’t make a living at it. When he and his wife hit thirty and had their second child, they came back east to Boston to be closer to family. He decided to stick with the Cheesecake Factory. Luz rose steadily, and made a nice living. “I wanted to have some business skills,” he said—he started a film-production company on the side—“and there was no other place I knew where you could go in, know nothing, and learn top to bottom how to run a business.”
To show me how a Cheesecake Factory works, he took me into the kitchen of his busiest restaurant, at Prudential Center, a shopping and convention hub. The kitchen design is the same in every restaurant, he explained. It’s laid out like a manufacturing facility, in which raw materials in the back of the plant come together as a finished product that rolls out the front. Along the back wall are the walk-in refrigerators and prep stations, where half a dozen people stood chopping and stirring and mixing. The next zone is where the cooking gets done—two parallel lines of countertop, forty-some feet long and just three shoe-lengths apart, with fifteen people pivoting in place between the stovetops and grills on the hot side and the neatly laid-out bins of fixings (sauces, garnishes, seasonings, and the like) on the cold side. The prep staff stock the pullout drawers beneath the counters with slabs of marinated meat and fish, serving-size baggies of pasta and crabmeat, steaming bowls of brown rice and mashed potatoes. Basically, the prep crew handles the parts, and the cooks do the assembly.
Computer monitors positioned head-high every few feet flashed the orders for a given station. Luz showed me the touch-screen tabs for the recipe for each order and a photo showing the proper presentation. The recipe has the ingredients on the left part of the screen and the steps on the right. A timer counts down to a target time for completion. The background turns from green to yellow as the order nears the target time and to red when it has exceeded it.
I watched Mauricio Gaviria at the broiler station as the lunch crowd began coming in. Mauricio was twenty-nine years old and had worked there eight years. He’d got his start doing simple prep—chopping vegetables—and worked his way up to fry cook, the pasta station, and now the sautĂ© and broiler stations. He bounced in place waiting for the pace to pick up. An order for a “hibachi” steak popped up. He tapped the screen to open the order: medium-rare, no special requests. A ten-minute timer began. He tonged a fat hanger steak soaking in teriyaki sauce onto the broiler and started a nest of sliced onions cooking beside it. While the meat was grilling, other orders arrived: a Kobe burger, a blue-cheese B.L.T. burger, three “old-fashioned” burgers, five veggie burgers, a “farmhouse” burger, and two Thai chicken wraps. Tap, tap, tap. He got each of them grilling.
I brought up the hibachi-steak recipe on the screen. There were instructions to season the steak, sauté the onions, grill some mushrooms, slice the meat, place it on the bed of onions, pile the mushrooms on top, garnish with parsley and sesame seeds, heap a stack of asparagus tempura next to it, shape a tower of mashed potatoes alongside, drop a pat of wasabi butter on top, and serve.
Two things struck me. First, the instructions were precise about the ingredients and the objectives (the steak slices were to be a quarter of an inch thick, the presentation just so), but not about how to get there. The cook has to decide how much to salt and baste, how to sequence the onions and mushrooms and meat so they’re done at the same time, how to swivel from grill to countertop and back, sprinkling a pinch of salt here, flipping a burger there, sending word to the fry cook for the asparagus tempura, all the while keeping an eye on the steak. In producing complicated food, there might be recipes, but there was also a substantial amount of what’s called “tacit knowledge”—knowledge that has not been reduced to instructions.
Second, Mauricio never looked at the instructions anyway. By the time I’d finished reading the steak recipe, he was done with the dish and had plated half a dozen others. “Do you use this recipe screen?” I asked.
“No. I have the recipes right here,” he said, pointing to his baseball-capped head.
He put the steak dish under warming lights, and tapped the screen to signal the servers for pickup. But before the dish was taken away, the kitchen manager stopped to look, and the system started to become clearer. He pulled a clean fork out and poked at the steak. Then he called to Mauricio and the two other cooks manning the grill station.
“Gentlemen,” he said, “this steak is perfect.” It was juicy and pink in the center, he said. “The grill marks are excellent.” The sesame seeds and garnish were ample without being excessive. “But the tower is too tight.” I could see what he meant. The mashed potatoes looked a bit like something a kid at the beach might have molded with a bucket. You don’t want the food to look manufactured, he explained. Mauricio fluffed up the potatoes with a fork.
I watched the kitchen manager for a while. At every Cheesecake Factory restaurant, a kitchen manager is stationed at the counter where the food comes off the line, and he rates the food on a scale of one to ten. A nine is near-perfect. An eight requires one or two corrections before going out to a guest. A seven needs three. A six is unacceptable and has to be redone. This inspection process seemed a tricky task. No one likes to be second-guessed. The kitchen manager prodded gently, being careful to praise as often as he corrected. (“Beautiful. Beautiful!” “The pattern of this pesto glaze is just right.”) But he didn’t hesitate to correct.
“We’re getting sloppy with the plating,” he told the pasta station. He was unhappy with how the fry cooks were slicing the avocado spring rolls. “Gentlemen, a half-inch border on this next time.” He tried to be a coach more than a policeman. “Is this three-quarters of an ounce of Parm-Romano?”
And that seemed to be the spirit in which the line cooks took him and the other managers. The managers had all risen through the ranks. This earned them a certain amount of respect. They in turn seemed respectful of the cooks’ skills and experience. Still, the oversight is tight, and this seemed crucial to the success of the enterprise.
The managers monitored the pace, too—scanning the screens for a station stacking up red flags, indicating orders past the target time, and deciding whether to give the cooks at the station a nudge or an extra pair of hands. They watched for waste—wasted food, wasted time, wasted effort. The formula was Business 101: Use the right amount of goods and labor to deliver what customers want and no more. Anything more is waste, and waste is lost profit.
I spoke to David Gordon, the company’s chief operating officer. He told me that the Cheesecake Factory has worked out a staff-to-customer ratio that keeps everyone busy but not so busy that there’s no slack in the system in the event of a sudden surge of customers. More difficult is the problem of wasted food. Although the company buys in bulk from regional suppliers, groceries are the biggest expense after labor, and the most unpredictable. Everything—the chicken, the beef, the lettuce, the eggs, and all the rest—has a shelf life. If a restaurant were to stock too much, it could end up throwing away hundreds of thousands of dollars’ worth of food. If a restaurant stocks too little, it will have to tell customers that their favorite dish is not available, and they may never come back. Groceries, Gordon said, can kill a restaurant.
The company’s target last year was at least 97.5-per-cent efficiency: the managers aimed at throwing away no more than 2.5 per cent of the groceries they bought, without running out. This seemed to me an absurd target. Achieving it would require knowing in advance almost exactly how many customers would be coming in and what they were going to want, then insuring that the cooks didn’t spill or toss or waste anything. Yet this is precisely what the organization has learned to do. The chain-restaurant industry has produced a field of computer analytics known as “guest forecasting.”
“We have forecasting models based on historical data—the trend of the past six weeks and also the trend of the previous year,” Gordon told me. “The predictability of the business has become astounding.” The company has even learned how to make adjustments for the weather or for scheduled events like playoff games that keep people at home.
A computer program known as Net Chef showed Luz that for this one restaurant food costs accounted for 28.73 per cent of expenses the previous week. It also showed exactly how many chicken breasts were ordered that week ($1,614 worth), the volume sold, the volume on hand, and how much of last week’s order had been wasted (three dollars’ worth). Chain production requires control, and they’d figured out how to achieve it on a mass scale.
As a doctor, I found such control alien—possibly from a hostile planet. We don’t have patient forecasting in my office, push-button waste monitoring, or such stringent, hour-by-hour oversight of the work we do, and we don’t want to. I asked Luz if he had ever thought about the contrast when he went to see a doctor. We were standing amid the bustle of the kitchen, and the look on his face shifted before he answered.
“I have,” he said. His mother was seventy-eight. She had early Alzheimer’s disease, and required a caretaker at home. Getting her adequate medical care was, he said, a constant battle.
Recently, she’d had a fall, apparently after fainting, and was taken to a local emergency room. The doctors ordered a series of tests and scans, and kept her overnight. They never figured out what the problem was. Luz understood that sometimes explanations prove elusive. But the clinicians didn’t seem to be following any coördinated plan of action. The emergency doctor told the family one plan, the admitting internist described another, and the consulting specialist a third. Thousands of dollars had been spent on tests, but nobody ever told Luz the results.
A nurse came at ten the next morning and said that his mother was being discharged. But his mother’s nurse was on break, and the discharge paperwork with her instructions and prescriptions hadn’t been done. So they waited. Then the next person they needed was at lunch. It was as if the clinicians were the customers, and the patients’ job was to serve them. “We didn’t get to go until 6 P.M., with a tired, disabled lady and a long drive home.” Even then she still had to be changed out of her hospital gown and dressed. Luz pressed the call button to ask for help. No answer. He went out to the ward desk.
The aide was on break, the secretary said. “Don’t you dress her yourself at home?” He explained that he didn’t, and made a fuss.
An aide was sent. She was short with him and rough in changing his mother’s clothes. “She was manhandling her,” Luz said. “I felt like, ‘Stop. I’m not one to complain. I respect what you do enormously. But if there were a video camera in here, you’d be on the evening news.’ I sent her out. I had to do everything myself. I’m stuffing my mom’s boob in her bra. It was unbelievable.”
His mother was given instructions to check with her doctor for the results of cultures taken during her stay, for a possible urinary-tract infection. But when Luz tried to follow up, he couldn’t get through to her doctor for days. “Doctors are busy,” he said. “I get it. But come on.” An office assistant finally told him that the results wouldn’t be ready for another week and that she was to see a neurologist. No explanations. No chance to ask questions.
The neurologist, after giving her a two-minute exam, suggested tests that had already been done and wrote a prescription that he admitted was of doubtful benefit. Luz’s family seemed to encounter this kind of disorganization, imprecision, and waste wherever his mother went for help.
“It is unbelievable to me that they would not manage this better,” Luz said. I asked him what he would do if he were the manager of a neurology unit or a cardiology clinic. “I don’t know anything about medicine,” he said. But when I pressed he thought for a moment, and said, “This is pretty obvious. I’m sure you already do it. But I’d study what the best people are doing, figure out how to standardize it, and then bring it to everyone to execute.”
This is not at all the normal way of doing things in medicine. (“You’re scaring me,” he said, when I told him.) But it’s exactly what the new health-care chains are now hoping to do on a mass scale. They want to create Cheesecake Factories for health care. The question is whether the medical counterparts to Mauricio at the broiler station—the clinicians in the operating rooms, in the medical offices, in the intensive-care units—will go along with the plan. Fixing a nice piece of steak is hardly of the same complexity as diagnosing the cause of an elderly patient’s loss of consciousness. Doctors and patients have not had a positive experience with outsiders second-guessing decisions. How will they feel about managers trying to tell them what the “best practices” are?
In March, my mother underwent a total knee replacement, like at least six hundred thousand Americans each year. She’d had a partial knee replacement a decade ago, when arthritis had worn away part of the cartilage, and for a while this served her beautifully. The surgeon warned, however, that the results would be temporary, and about five years ago the pain returned.
She’s originally from Ahmadabad, India, and has spent three decades as a pediatrician, attending to the children of my small Ohio home town. She’s chatty. She can’t go through a grocery checkout line or get pulled over for speeding without learning people’s names and a little bit about them. But she didn’t talk about her mounting pain. I noticed, however, that she had developed a pronounced limp and had become unable to walk even moderate distances. When I asked her about it, she admitted that just getting out of bed in the morning was an ordeal. Her doctor showed me her X-rays. Her partial prosthesis had worn through the bone on the lower surface of her knee. It was time for a total knee replacement.
This past winter, she finally stopped putting it off, and asked me to find her a surgeon. I wanted her to be treated well, in both the technical and the human sense. I wanted a place where everyone and everything—from the clinic secretary to the physical therapists—worked together seamlessly.
My mother planned to come to Boston, where I live, for the surgery so she could stay with me during her recovery. (My father died last year.) Boston has three hospitals in the top rank of orthopedic surgery. But even a doctor doesn’t have much to go on when it comes to making a choice. A place may have a great reputation, but it’s hard to know about actual quality of care. Unlike some countries, the United States doesn’t have a monitoring system that tracks joint-replacement statistics. Even within an institution, I found, surgeons take strikingly different approaches. They use different makes of artificial joints, different kinds of anesthesia, different regimens for post-surgical pain control and physical therapy.
In the absence of information, I went with my own hospital, the Brigham and Women’s Hospital. Our big-name orthopedic surgeons treat Olympians and professional athletes. Nine of them do knee replacements. Of most interest to me, however, was a surgeon who was not one of the famous names. He has no national recognition. But he has led what is now a decade-long experiment in standardizing joint-replacement surgery.
John Wright is a New Zealander in his late fifties. He’s a tower crane of a man, six feet four inches tall, and so bald he barely seems to have eyebrows. He’s informal in attire—I don’t think I’ve ever seen him in a tie, and he is as apt to do rounds in his zip-up anorak as in his white coat—but he exudes competence.
“Customization should be five per cent, not ninety-five per cent, of what we do,” he told me. A few years ago, he gathered a group of people from every specialty involved—surgery, anesthesia, nursing, physical therapy—to formulate a single default way of doing knee replacements. They examined every detail, arguing their way through their past experiences and whatever evidence they could find. Essentially, they did what Luz considered the obvious thing to do: they studied what the best people were doing, figured out how to standardize it, and then tried to get everyone to follow suit.
They came up with a plan for anesthesia based on research studies—including giving certain pain medications before the patient entered the operating room and using spinal anesthesia plus an injection of local anesthetic to block the main nerve to the knee. They settled on a postoperative regimen, too. The day after a knee replacement, most orthopedic surgeons have their patients use a continuous passive-motion machine, which flexes and extends the knee as they lie in bed. Large-scale studies, though, have suggested that the machines don’t do much good. Sure enough, when the members of Wright’s group examined their own patients, they found that the ones without the machine got out of bed sooner after surgery, used less pain medication, and had more range of motion at discharge. So Wright instructed the hospital to get rid of the machines, and to use the money this saved (ninety thousand dollars a year) to pay for more physical therapy, something that is proven to help patient mobility. Therapy, starting the day after surgery, would increase from once to twice a day, including weekends.
Even more startling, Wright had persuaded the surgeons to accept changes in the operation itself; there was now, for instance, a limit as to which prostheses they could use. Each of our nine knee-replacement surgeons had his preferred type and brand. Knee surgeons are as particular about their implants as professional tennis players are about their racquets. But the hardware is easily the biggest cost of the operation—the average retail price is around eight thousand dollars, and some cost twice that, with no solid evidence of real differences in results.
Knee implants were largely perfected a quarter century ago. By the nineteen-nineties, studies showed that, for some ninety-five per cent of patients, the implants worked magnificently a decade after surgery. Evidence from the Australian registry has shown that not a single new knee or hip prosthesis had a lower failure rate than that of the established prostheses. Indeed, thirty per cent of the new models were likelier to fail. Like others on staff, Wright has advised companies on implant design. He believes that innovation will lead to better implants. In the meantime, however, he has sought to limit the staff to the three lowest-cost knee implants.
These have been hard changes for many people to accept. Wright has tried to figure out how to persuade clinicians to follow the standardized plan. To prevent revolt, he learned, he had to let them deviate at times from the default option. Surgeons could still order a passive-motion machine or a preferred prosthesis. “But I didn’t make it easy,” Wright said. The surgeons had to enter the treatment orders in the computer themselves. To change or add an implant, a surgeon had to show that the performance was superior or the price at least as low.
I asked one of his orthopedic colleagues, a surgeon named John Ready, what he thought about Wright’s efforts. Ready was philosophical. He recognized that the changes were improvements, and liked most of them. But he wasn’t happy when Wright told him that his knee-implant manufacturer wasn’t matching the others’ prices and would have to be dropped.
“It’s not ideal to lose my prosthesis,” Ready said. “I could make the switch. The differences between manufacturers are minor. But there’d be a learning curve.” Each implant has its quirks—how you seat it, what tools you use. “It’s probably a ten-case learning curve for me.” Wright suggested that he explain the situation to the manufacturer’s sales rep. “I’m my rep’s livelihood,” Ready said. “He probably makes five hundred dollars a case from me.” Ready spoke to his rep. The price was dropped.
Wright has become the hospital’s kitchen manager—not always a pleasant role. He told me that about half of the surgeons appreciate what he’s doing. The other half tolerate it at best. One or two have been outright hostile. But he has persevered, because he’s gratified by the results. The surgeons now use a single manufacturer for seventy-five per cent of their implants, giving the hospital bargaining power that has helped slash its knee-implant costs by half. And the start-to-finish standardization has led to vastly better outcomes. The distance patients can walk two days after surgery has increased from fifty-three to eighty-five feet. Nine out of ten could stand, walk, and climb at least a few stairs independently by the time of discharge. The amount of narcotic pain medications they required fell by a third. They could also leave the hospital nearly a full day earlier on average (which saved some two thousand dollars per patient).
My mother was one of the beneficiaries. She had insisted to Dr. Wright that she would need a week in the hospital after the operation and three weeks in a rehabilitation center. That was what she’d required for her previous knee operation, and this one was more extensive.
“We’ll see,” he told her.
The morning after her operation, he came in and told her that he wanted her getting out of bed, standing up, and doing a specific set of exercises he showed her. “He’s pushy, if you want to say it that way,” she told me. The physical therapists and nurses were, too. They were a team, and that was no small matter. I counted sixty-three different people involved in her care. Nineteen were doctors, including the surgeon and chief resident who assisted him, the anesthesiologists, the radiologists who reviewed her imaging scans, and the junior residents who examined her twice a day and adjusted her fluids and medications. Twenty-three were nurses, including her operating-room nurses, her recovery-room nurse, and the many ward nurses on their eight-to-twelve-hour shifts. There were also at least five physical therapists; sixteen patient-care assistants, helping check her vital signs, bathe her, and get her to the bathroom; plus X-ray and EKG technologists, transport workers, nurse practitioners, and physician assistants. I didn’t even count the bioengineers who serviced the equipment used, the pharmacists who dispensed her medications, or the kitchen staff preparing her food while taking into account her dietary limitations. They all had to coördinate their contributions, and they did.
Three days after her operation, she was getting in and out of bed on her own. She was on virtually no narcotic medication. She was starting to climb stairs. Her knee pain was actually less than before her operation. She left the hospital for the rehabilitation center that afternoon.
The biggest complaint that people have about health care is that no one ever takes responsibility for the total experience of care, for the costs, and for the results. My mother experienced what happens in medicine when someone takes charge. Of course, John Wright isn’t alone in trying to design and implement this kind of systematic care, in joint surgery and beyond. The Virginia Mason Medical Center, in Seattle, has done it for knee surgery and cancer care; the Geisinger Health Center, in Pennsylvania, has done it for cardiac surgery and primary care; the University of Michigan Health System standardized how its doctors give blood transfusions to patients, reducing the need for transfusions by thirty-one per cent and expenses by two hundred thousand dollars a month. Yet, unless such programs are ramped up on a nationwide scale, they aren’t going to do much to improve health care for most people or reduce the explosive growth of health-care costs.
In medicine, good ideas still take an appallingly long time to trickle down. Recently, the American Academy of Neurology and the American Headache Society released new guidelines for migraine-headache-treatment. They recommended treating severe migraine sufferers—who have more than six attacks a month—with preventive medications and listed several drugs that markedly reduce the occurrence of attacks. The authors noted, however, that previous guidelines going back more than a decade had recommended such remedies, and doctors were still not providing them to more than two-thirds of patients. One study examined how long it took several major discoveries, such as the finding that the use of beta-blockers after a heart attack improves survival, to reach even half of Americans. The answer was, on average, more than fifteen years.
Scaling good ideas has been one of our deepest problems in medicine. Regulation has had its place, but it has proved no more likely to produce great medicine than food inspectors are to produce great food. During the era of managed care, insurance-company reviewers did hardly any better. We’ve been stuck. But do we have to be?
Every six months, the Cheesecake Factory puts out a new menu. This means that everyone who works in its restaurants expects to learn something new twice a year. The March, 2012, Cheesecake Factory menu included thirteen new items. The teaching process is now finely honed: from start to finish, rollout takes just seven weeks.
The ideas for a new dish, or for tweaking an old one, can come from anywhere. One of the Boston prep cooks told me about an idea he once had that ended up in a recipe. David Overton, the founder and C.E.O. of the Cheesecake Factory, spends much of his time sampling a range of cuisines and comes up with many dishes himself. All the ideas, however, go through half a dozen chefs in the company’s test kitchen, in Calabasas. They figure out how to make each recipe reproducible, appealing, and affordable. Then they teach the new recipe to the company’s regional managers and kitchen managers.
Dave Luz, the Boston regional manager, went to California for training this past January with his chief kitchen manager, Tom Schmidt, a chef with fifteen years’ experience. They attended lectures, watched videos, participated in workshops. It sounded like a surgical conference. Where I might be taught a new surgical technique, they were taught the steps involved in preparing a “Santorini farro salad.” But there was a crucial difference. The Cheesecake instructors also trained the attendees how to teach what they were learning. In medicine, we hardly ever think about how to implement what we’ve learned. We learn what we want to, when we want to.
On the first training day, the kitchen managers worked their way through thirteen stations, preparing each new dish, and their performances were evaluated. The following day, they had to teach their regional managers how to prepare each dish—Schmidt taught Luz—and this time the instructors assessed how well the kitchen managers had taught.
The managers returned home to replicate the training session for the general manager and the chief kitchen manager of every restaurant in their region. The training at the Boston Prudential Center restaurant took place on two mornings, before the lunch rush. The first day, the managers taught the kitchen staff the new menu items. There was a lot of poring over the recipes and videos and fussing over the details. The second day, the cooks made the new dishes for the servers. This gave the cooks some practice preparing the food at speed, while allowing the servers to learn the new menu items. The dishes would go live in two weeks. I asked a couple of the line cooks how long it took them to learn to make the new food.
“I know it already,” one said.
“I make it two times, and that’s all I need,” the other said.
Come on, I said. How long before they had it down pat?
“One day,” they insisted. “It’s easy.”
I asked Schmidt how much time he thought the cooks required to master the recipes. They thought a day, I told him. He grinned. “More like a month,” he said.
Even a month would be enviable in medicine, where innovations commonly spread at a glacial pace. The new health-care chains, though, are betting that they can change that, in much the same way that other chains have.
Armin Ernst is responsible for intensive-care-unit operations in Steward’s ten hospitals. The I.C.U.s he oversees serve some eight thousand patients a year. In another era, an I.C.U. manager would have been a facilities expert. He would have spent his time making sure that the equipment, electronics, pharmacy resources, and nurse staffing were up to snuff. He would have regarded the I.C.U. as the doctors’ workshop, and he would have wanted to give them the best possible conditions to do their work as they saw fit.
Ernst, though, is a doctor—a new kind of doctor, whose goal is to help disseminate good ideas. He doesn’t see the I.C.U. as a doctors’ workshop. He sees it as the temporary home of the sickest, most fragile people in the country. Nowhere in health care do we expend more resources. Although fewer than one in four thousand Americans are in intensive care at any given time, they account for four per cent of national health-care costs. Ernst believes that his job is to make sure that everyone is collaborating to provide the most effective and least wasteful care possible.
He looked like a regular doctor to me. Ernst is fifty years old, a native German who received his medical degree at the University of Heidelberg before training in pulmonary and critical-care medicine in the United States. He wears a white hospital coat and talks about drips and ventilator settings, like any other critical-care specialist. But he doesn’t deal with patients: he deals with the people who deal with patients.
Ernst says he’s not telling clinicians what to do. Instead, he’s trying to get clinicians to agree on precise standards of care, and then make sure that they follow through on them. (The word “consensus” comes up a lot.) What I didn’t understand was how he could enforce such standards in ten hospitals across three thousand square miles.
Late one Friday evening, I joined an intensive-care-unit team on night duty. But this team was nowhere near a hospital. We were in a drab one-story building behind a meat-trucking facility outside of Boston, in a back section that Ernst called his I.C.U. command center. It was outfitted with millions of dollars’ worth of technology. Banks of computer screens carried a live feed of cardiac-monitor readings, radiology-imaging scans, and laboratory results from I.C.U. patients throughout Steward’s hospitals. Software monitored the stream and produced yellow and red alerts when it detected patterns that raised concerns. Doctors and nurses manned consoles where they could toggle on high-definition video cameras that allowed them to zoom into any I.C.U. room and talk directly to the staff on the scene or to the patients themselves.
The command center was just a few months old. The team had gone live in only four of the ten hospitals. But in the next several months Ernst’s “tele-I.C.U.” team will have the ability to monitor the care for every patient in every I.C.U. bed in the Steward health-care system.
A doctor, two nurses, and an administrative assistant were on duty in the command center each night I visited. Christina Monti was one of the nurses. A pixie-like thirty-year-old with nine years’ experience as a cardiac intensive-care nurse, she was covering Holy Family Hospital, on the New Hampshire border, and St. Elizabeth’s Medical Center, in Boston’s Brighton neighborhood. When I sat down with her, she was making her rounds, virtually.
First, she checked on the patients she had marked as most critical. She reviewed their most recent laboratory results, clinical notes, and medication changes in the electronic record. Then she made a “visit,” flicking on the two-way camera and audio system. If the patients were able to interact, she would say hello to them in their beds. She asked the staff members whether she could do anything for them. The tele-I.C.U. team provided the staff with extra eyes and ears when needed. If a crashing patient diverts the staff’s attention, the members of the remote team can keep an eye on the other patients. They can handle computer paperwork if a nurse falls behind; they can look up needed clinical information. The hospital staff have an OnStar-like button in every room that they can push to summon the tele-I.C.U. team.
Monti also ran through a series of checks for each patient. She had a reference list of the standards that Ernst had negotiated with the people running the I.C.U.s, and she looked to see if they were being followed. The standards covered basics, from hand hygiene to measures for stomach-ulcer prevention. In every room with a patient on a respirator, for instance, Monti made sure the nurse had propped the head of the bed up at least thirty degrees, which makes pneumonia less likely. She made sure the breathing tube in the patient’s mouth was secure, to reduce the risk of the tube’s falling out or becoming disconnected. She zoomed in on the medication pumps to check that the drips were dosed properly. She was not looking for bad nurses or bad doctors. She was looking for the kinds of misses that even excellent nurses and doctors can make under pressure.
The concept of the remote I.C.U. started with an effort to let specialists in critical-care medicine, who are in short supply, cover not just one but several community hospitals. Two hundred and fifty hospitals from Alaska to Virginia have installed a version of the tele-I.C.U. It produced significant improvements in outcomes and costs—and, some discovered, a means of driving better practices even in hospitals that had specialists on hand.
After five minutes of observation, however, I realized that the remote I.C.U. team wasn’t exactly in command; it was in negotiation. I observed Monti perform a video check on a middle-aged man who had just come out of heart surgery. A soft chime let the people in the room know she was dropping in. The man was unconscious, supported by a respirator and intravenous drips. At his bedside was a nurse hanging a bag of fluid. She seemed to stiffen at the chime’s sound.
“Hi,” Monti said to her. “I’m Chris. Just making my evening rounds. How are you?” The bedside nurse gave the screen only a sidelong glance.
Ernst wasn’t oblivious of the issue. He had taken pains to introduce the command center’s team, spending weeks visiting the units and bringing doctors and nurses out to tour the tele-I.C.U. before a camera was ever turned on. But there was no escaping the fact that these were strangers peering over the staff’s shoulders. The bedside nurse’s chilliness wasn’t hard to understand.
In a single hour, however, Monti had caught a number of problems. She noticed, for example, that a patient’s breathing tube had come loose. Another patient wasn’t getting recommended medication to prevent potentially fatal blood clots. Red alerts flashed on the screen—a patient with an abnormal potassium level that could cause heart-rhythm problems, another with a sudden leap in heart rate.
Monti made sure that the team wasn’t already on the case and that the alerts weren’t false alarms. Checking the computer, she figured out that a doctor had already ordered a potassium infusion for the woman with the low level. Flipping on a camera, she saw that the patient with the high heart rate was just experiencing the stress of being helped out of bed for the first time after surgery. But the unsecured breathing tube and the forgotten blood-clot medication proved to be oversights. Monti raised the concerns with the bedside staff.
Sometimes they resist. “You have got to be careful from patient to patient,” Gerard Hayes, the tele-I.C.U. doctor on duty, explained. “Pushing hard on one has ramifications for how it goes with a lot of patients. You don’t want to sour whole teams on the tele-I.C.U.” Across the country, several hospitals have decommissioned their systems. Clinicians have been known to place a gown over the camera, or even rip the camera out of the wall. Remote monitoring will never be the same as being at the bedside. One nurse called the command center to ask the team not to turn on the video system in her patient’s room: he was delirious and confused, and the sudden appearance of someone talking to him from the television would freak him out.
Still, you could see signs of change. I watched Hayes make his virtual rounds through the I.C.U. at St. Anne’s Hospital, in Fall River, near the Rhode Island border. He didn’t yet know all the members of the hospital staff—this was only his second night in the command center, and when he sees patients in person it’s at a hospital sixty miles north. So, in his dealings with the on-site clinicians, he was feeling his way.
Checking on one patient, he found a few problems. Mr. Karlage, as I’ll call him, was in his mid-fifties, an alcoholic smoker with cirrhosis of the liver, severe emphysema, terrible nutrition, and now a pneumonia that had put him into respiratory failure. The I.C.U. team injected him with antibiotics and sedatives, put a breathing tube down his throat, and forced pure oxygen into his lungs. Over a few hours, he stabilized, and the I.C.U. doctor was able to turn his attention to other patients.
But stabilizing a sick patient is like putting out a house fire. There can be smoldering embers just waiting to reignite. Hayes spotted a few. The ventilator remained set to push breaths at near-maximum pressure, and, given the patient’s severe emphysema, this risked causing a blowout. The oxygen concentration was still cranked up to a hundred per cent, which, over time, can damage the lungs. The team had also started several broad-spectrum antibiotics all at once, and this regimen had to be dialled back if they were to avoid breeding resistant bacteria.
Hayes had to notify the unit doctor. An earlier interaction, however, had not been promising. During a video check on a patient, Hayes had introduced himself and mentioned an issue he’d noticed. The unit doctor stared at him with folded arms, mouth shut tight. Hayes was a former Navy flight surgeon with twenty years’ experience as an I.C.U. doctor and looked to have at least a decade on the St. Anne’s doctor. But the doctor was no greenhorn, either, and gave him the brushoff: “The morning team can deal with that.” Now Hayes needed to call him about Mr. Karlage. He decided to do it by phone.
“Sounds like you’re having a busy night,” Hayes began when he reached the doctor. “Mr. Karlage is really turning around, huh?” Hayes praised the doctor’s work. Then he brought up his three issues, explaining what he thought could be done and why. He spoke like a consultant brought in to help. This went over better. The doctor seemed to accept Hayes’s suggestions.
Unlike a mere consultant, however, Hayes took a few extra steps to make sure his suggestions were carried out. He spoke to the nurse and the respiratory therapist by video and explained the changes needed. To carry out the plan, they needed written orders from the unit doctor. Hayes told them to call him back if they didn’t get the orders soon.
Half an hour later, Hayes called Mr. Karlage’s nurse again. She hadn’t received the orders. For all the millions of dollars of technology spent on the I.C.U. command center, this is where the plug meets the socket. The fundamental question in medicine is: Who is in charge? With the opening of the command center, Steward was trying to change the answer—it gave the remote doctors the authority to issue orders as well. The idea was that they could help when a unit doctor got too busy and fell behind, and that’s what Hayes chose to believe had happened. He entered the orders into the computer. In a conflict, however, the on-site physician has the final say. So Hayes texted the St. Anne’s doctor, informing him of the changes and asking if he’d let him know if he disagreed.
Hayes received no reply. No “thanks” or “got it” or “O.K.” After midnight, though, the unit doctor pressed the video call button and his face flashed onto Hayes’s screen. Hayes braced for a confrontation. Instead, the doctor said, “So I’ve got this other patient and I wanted to get your opinion.”
Hayes suppressed a smile. “Sure,” he said.
When he signed off, he seemed ready to high-five someone. “He called us,” he marvelled. The command center was gaining credibility.
Armin Ernst has big plans for the command center—a rollout of full-scale treatment protocols for patients with severe sepsis, acute respiratory-distress syndrome, and other conditions; strategies to reduce unnecessary costs; perhaps even computer forecasting of patient volume someday. Steward is already extending the command-center concept to in-patient psychiatry. Emergency rooms and surgery may be next. Other health systems are pursuing similar models. The command-center concept provides the possibility of, well, command.
Today, some ninety “super-regional” health-care systems have formed across the country—large, growing chains of clinics, hospitals, and home-care agencies. Most are not-for-profit. Financial analysts expect the successful ones to drive independent medical centers out of existence in much of the country—either by buying them up or by drawing away their patients with better quality and cost control. Some small clinics and stand-alone hospitals will undoubtedly remain successful, perhaps catering to the luxury end of health care the way gourmet restaurants do for food. But analysts expect that most of us will gravitate to the big systems, just as we have moved away from small pharmacies to CVS and Walmart.
Already, there have been startling changes. Cleveland Clinic, for example, opened nine regional hospitals in northeast Ohio, as well as health centers in southern Florida, Toronto, and Las Vegas, and is now going international, with a three-hundred-and-sixty-four-bed hospital in Abu Dhabi scheduled to open next year. It reached an agreement with Lowe’s, the home-improvement chain, guaranteeing a fixed price for cardiac surgery for the company’s employees and dependents. The prospect of getting better care for a lower price persuaded Lowe’s to cover all out-of-pocket costs for its insured workers to go to Cleveland, including co-payments, airfare, transportation, and lodging. Three other companies, including Kohl’s department stores, have made similar deals, and a dozen more, including Boeing, are in negotiations. Big Medicine is on the way.
Reinventing medical care could produce hundreds of innovations. Some may be as simple as giving patients greater e-mail and online support from their clinicians, which would enable timelier advice and reduce the need for emergency-room visits. Others might involve smartphone apps for coaching the chronically ill in the management of their disease, new methods for getting advice from specialists, sophisticated systems for tracking outcomes and costs, and instant delivery to medical teams of up-to-date care protocols. Innovations could take a system that requires sixty-three clinicians for a knee replacement and knock the number down by half or more. But most significant will be the changes that finally put people like John Wright and Armin Ernst in charge of making care coherent, coördinated, and affordable. Essentially, we’re moving from a Jeffersonian ideal of small guilds and independent craftsmen to a Hamiltonian recognition of the advantages that size and centralized control can bring.
Yet it seems strange to pin our hopes on chains. We have no guarantee that Big Medicine will serve the social good. Whatever the industry, an increase in size and control creates the conditions for monopoly, which could do the opposite of what we want: suppress innovation and drive up costs over time. In the past, certainly, health-care systems that pursued size and market power were better at raising prices than at lowering them.
A new generation of medical leaders and institutions professes to have a different aim. But a lesson of the past century is that government can influence the behavior of big corporations, by requiring transparency about their performance and costs, and by enacting rules and limitations to protect the ordinary citizen. The federal government has broken up monopolies like Standard Oil and A.T. & T.; in some parts of the country, similar concerns could develop in health care.
Mixed feelings about the transformation are unavoidable. There’s not just the worry about what Big Medicine will do; there’s also the worry about how society and government will respond. For the changes to live up to our hopes—lower costs and better care for everyone—liberals will have to accept the growth of Big Medicine, and conservatives will have to accept the growth of strong public oversight.
The vast savings of Big Medicine could be widely shared—or reserved for a few. The clinicians who are trying to reinvent medicine aren’t doing it to make hedge-fund managers and bondholders richer; they want to see that everyone benefits from the savings their work generates—and that won’t be automatic.
Our new models come from industries that have learned to increase the capabilities and efficiency of the human beings who work for them. Yet the same industries have also tended to devalue those employees. The frontline worker, whether he is making cars, solar panels, or wasabi-crusted ahi tuna, now generates unprecedented value but receives little of the wealth he is creating. Can we avoid this as we revolutionize health care?
Those of us who work in the health-care chains will have to contend with new protocols and technology rollouts every six months, supervisors and project managers, and detailed metrics on our performance. Patients won’t just look for the best specialist anymore; they’ll look for the best system. Nurses and doctors will have to get used to delivering care in which our own convenience counts for less and the patients’ experience counts for more. We’ll also have to figure out how to reward people for taking the time and expense to teach the next generations of clinicians. All this will be an enormous upheaval, but it’s long overdue, and many people recognize that. When I asked Christina Monti, the Steward tele-I.C.U. nurse, why she wanted to work in a remote facility tangling with staffers who mostly regarded her with indifference or hostility, she told me, “Because I wanted to be part of the change.”
And we are seeing glimpses of this change. In my mother’s rehabilitation center, miles away from where her surgery was done, the physical therapists adhered to the exercise protocols that Dr. Wright’s knee factory had developed. He didn’t have a video command center, so he came out every other day to check on all the patients and make sure that the staff was following the program. My mother was sure she’d need a month in rehab, but she left in just a week, incurring a fraction of the costs she would have otherwise. She walked out the door using a cane. On her first day at home with me, she climbed two flights of stairs and walked around the block for exercise.
The critical question is how soon that sort of quality and cost control will be available to patients everywhere across the country. We’ve let health-care systems provide us with the equivalent of greasy-spoon fare at four-star prices, and the results have been ruinous. The Cheesecake Factory model represents our best prospect for change. Some will see danger in this. Many will see hope. And that’s probably the way it should be.

I