Saturday, November 24, 2012

Testing testing - Why the costs and benefits of some cancer screenings stir such controversy - 2012 FALL - Stanford Medicine Magazine - Stanford University School of Medicine

OTIS BRAWLEY, MD, IS ADMITTEDLY A SKEPTIC OF THE MEDICAL SYSTEM. An African-American, he was raised among people who had a deep distrust of doctors and hospitals, believing they could cause as much harm as good. 
And that is how Brawley has come to view screening for prostate cancer with the long-established blood test. He believes it causes as much — if not more — harm as good. It's an issue on which he has become a crusader.
Brawley, the medical director of the American Cancer Society, opposes routine, widespread screening using the prostate-specific antigen test, or PSA, as a way to detect prostate cancer in healthy men. He argues that men have been misled into believing that prostate cancer screening saves lives, when science has never definitively shown that to be the case. Rather, he believes large-scale PSA screening has resulted in great suffering from needless and potentially damaging treatments, with uncertain benefits.
Brawley is among the many health-care leaders calling attention to the problem of overscreening — not just for prostate cancer, but for conditions from breast cancer to heart disease — which adds billions of dollars to health-care costs annually. Screenings and the medical procedures that may result, such as biopsies following a high PSA reading, feed the U.S. medical spending juggernaut. The Institute of Medicine reported in September that $750 billion is wasted by the U.S. health-care system each year. Unneeded care amounts to $210 billion of that total.
Nonetheless, the PSA screening controversy, which has persisted for more than a decade, shows how dilemmas in medical practice can impede change.

OVERDOSING ON SCREENING?

Millions of men in the United States now take the PSA test, which measures the level of a protein produced by the prostate gland that can be an indicator of prostate cancer — the second-leading cause of cancer death for U.S. men. This year, it will take the lives of 28,000, estimates the American Cancer Society. A man's lifetime risk of dying of prostate cancer is 2.8 percent among Caucasians and 3.5 percent among African-Americans. The cancer society had recommended in 1993 that men receive a PSA blood test annually starting at age 50 — age 40 for African-Americans and others at higher risk — though it backed off in 1997, saying men should talk with their doctors first about the benefits and drawbacks of the test and make an informed decision before being screened.
A big limitation of the PSA test is that it is imprecise, unable to effectively distinguish between slow-growing, harmless cancers, which are most common, and more aggressive, deadly ones. And high levels sometimes don't indicate cancer at all, but instead more benign conditions such as an enlarged or inflamed prostate.
A high PSA result often leads men down a path to surgery, radiation or hormone therapy which may — or may not — be of benefit and which can have lifelong complications, including impotence, incontinence and problems of bowel control. Unfortunately, no better method for detecting potential prostate cancer exists. It has become entrenched in the medical care system, with many vested interests involved, including doctors, hospitals and pharmaceutical firms.
"Prostate cancer is a poster child for the problem of overdiagnosis," says H. Gilbert Welch, MD, MPH, with the Dartmouth Institute for Health Policy and Clinical Practice and author of Overdiagnosed: Making People Sick in the Pursuit of Health.
"We have done it for 20 years because some people thought it might save lives," says Brawley, professor of oncology and epidemiology at Emory University. "But we told people — we in medicine — that it saves lives and you should get it. My own American Cancer Society recommended every man over 50 get prostate cancer screening — every black man over 40 — back in 1993 without adequate scientific data. Everybody is so brainwashed into thinking that prostate screening is the right thing to do," adds Brawley, who has been both praised and vilified for his views on the highly divisive issue. (To be clear, however, he and other critics of the test endorse its use to track the growth of cancer once it has been identified.)
In a May article in the British Medical Journal, health journalist Ray Moynihan, a senior research fellow at Bond University in Australia, and two co-authors identified prostate cancer as one of a dozen commonly overdiagnosed conditions. The others included breast cancer, asthma, osteoporosis and attention deficit disorder, according to the researchers, who said medicine's ability to heal the sick is becoming overshadowed by its capacity to harm the healthy.
"Screening programmes are detecting early cancers that will never cause symptoms or death, sensitive diagnostic technologies identify 'abnormalities' so tiny that they will remain benign, while widening disease definitions mean people at ever lower risks receive medical labels and lifelong treatments that will fail to benefit many of them," the researchers write.
Next fall, the Dartmouth institute is hosting an international conference on the wider problem of overdiagnosis, partnering with Bond University, BMJ and Consumer Reports.
The costs to the system are enormous. In one study, published this April in theJournal of the American Medical Association, Donald Berwick, MD, former chief of the U.S. Centers for Medicare and Medicaid, and colleague Andrew Hackbarth of the Rand Corp. estimated that between $158 billion and $226 billion was wasted in 2011 in the United States on care that can't help patients, including some end-of-life care and surgical treatment when simple monitoring of a condition would have sufficed.
Americans have embraced the concept of medical screening in the belief that more knowledge is better, says internist Randall Stafford, MD, PhD, a professor of medicine at the Stanford Prevention Research Center who studies the adoption of disease prevention practices. But sometimes that knowledge sends patients down a path to more testing and more treatments, which are not only costly, but harmful.
"While some screening tests have limited utility, patients often expect that a full evaluation will include them, including an EKG, urinalysis or blood count," says Stafford. "We now recognize that there is tremendous overuse of those diagnostic tests."
The problem is that the tests not only cost money, but also can lead to more unneeded health-care activities. "An EKG that is suspicious for coronary artery disease leads to a stress test, which leads to a catheterization, which in turn leads to a bypass surgery, all of which might not have been necessary," says Stafford. "These tests are not specific. That is, a suspicious test result may not always represent actual disease."
Cancer screening is particularly controversial. In 2009, the U.S. Preventive Services Task Force set off a firestorm when it recommended women start getting routine mammograms at age 50, rather than 40, and switch from annual checks to every other year. The organization, which reviews the scientific justification for clinical preventive services, found evidence lacking for earlier and more frequent screenings.
When the decision came out during the national debate over President Obama's health-care reform legislation, opponents decried it as health-care rationing. Many physicians' groups also denounced it, as did some breast cancer research and treatment advocacy groups. Congress went on to undermine the recommendation by writing a requirement into the health-care reform law for insurers to cover mammograms for women ages 40 to 49 despite the task force's conclusion.
Then this spring, the task force added further fuel to the debate when it gave the PSA test a "D" rating and recommended against it for the general population. In its report, the panel noted that a large percentage of men who are screened opt for treatment, with various ill effects.
Among 1,000 men screened, as many as five will die within a month of prostate cancer surgery and between 10 and 70 will have serious complications, the panel reported. At least 20 to 30 percent of men undergoing radiation therapy or surgery will have long-term side effects, including urinary incontinence, erectile dysfunction and bowel dysfunction, while hormone therapy may lead to erectile dysfunction, breast enlargement and hot flashes, according to the report, published in May 2012 in theAnnals of Internal Medicine.
"Based on this work, the task force concludes that many men are harmed as a result of prostate cancer screening and few, if any, benefit," concludes the task force on its website.
 AMERICANS HAVE EMBRACED THE CONCEPT OF MEDICAL SCREENING IN THE BELIEF THAT MORE KNOWLEDGE IS BETTER.
The recommendation provoked outrage in the urology community, with the American Academy of Urology calling it "inappropriate and irresponsible." The group notes prostate cancer mortality has significantly declined in the United States, which it believes is largely due to the advent of widespread PSA screening. In June, the American Medical Association voted to officially express concern over the task force's recommendations on both mammography and PSA testing.
"In the United States, death rates from prostate cancer have decreased by 40 percent, and the percentage of men who present with metastases has decreased by 80 percent," says Northwestern University urologist William Catalona, MD, a screening advocate whose early studies helped validate use of the test. "So we are detecting prostate cancer earlier and detecting it in a curable stage more often. Screening has fallen victim of its own success. Now we have people saying we are detecting it too early and treating it too often."

THE TEST'S HISTORY OF CONTROVERSY

Overdiagnosis' "poster child," the PSA, first came into vogue following a 1987 report in the New England Journal of Medicine by Stanford's Thomas Stamey, MD, now an emeritus professor of urology, which suggested it could be useful as a marker in the blood for the disease. Men rushed in, eager to know their status, leading to an immediate spike in prostate cancer diagnoses. These men would go on to have their prostates biopsied, with doctors sampling tissue though a needle from a dozen spots in the gland, which is about the size of a golf ball. Biopsies are not only uncomfortable, but can cause bleeding, infection and, in 1 percent of cases, hospitalization.
In those days, if any one bit of biopsied tissue came back positive, the patient would usually go on to have the entire organ removed, and possibly radiation therapy. Because the prostate is located deep in the pelvis, surrounded by other organs and hard to access, it is difficult for surgeons to avoid damaging the nerves that control vital functions, such as ejaculation and urination.
By 2004, Stamey himself began to question the test, saying it was turning up far too many cases of small, low-grade tumors that were unlikely to spread and cause any harm, yet were subjecting men to unwarranted treatment. His paper that year in the Journal of Urology highlighted a major flaw in the test — its inability to distinguish between slow-growing tumors that may never be troublesome and the more aggressive, potentially deadly ones. His conclusion, that the test was of limited value, caused a furor among urologists.
Two major studies have been completed since then, yet neither has been sufficient to settle the controversy.
A large U.S. study, known as the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, enrolled men at 10 centers around the country over six years. The results, published in January 2012 in the Journal of the National Cancer Institute, showed no difference in mortality among men in the screening group versus controls. Unfortunately, many men in the control group could not restrain themselves from being tested, so the results were considered contaminated.
A separate study, published in 2009 in the New England Journal of Medicine and involving 162,000 men in seven European countries, showed a 20 percent relative reduction in mortality among men receiving the test, though the authors noted that screening is associated with as much as a 50 percent risk of overdiagnosis. The study is often cited by patient advocates and others favoring PSA screening as clear evidence of the value of the test. In August, Dutch researchers published a follow-up to the European study, saying whether or not to screen depends on how an individual patient feels about the possible harms and benefits. 

UNCOUPLE SCREENING AND TREATMENT

James Brooks, MD, a professor of urology at Stanford and prostate cancer expert, says a moratorium on testing, as recommended by the task force, is akin to "throwing the baby out with the bathwater." He still believes the PSA is useful, recommending annual tests for men ages 50 to 75.
"Elevated PSA is a marker of risk, much as high blood pressure is a marker of risk for death from heart disease," says Brooks, chief of urologic oncology at Stanford Hospital & Clinics.
He says the task force ignored the fact that death rates and the incidence of metastatic disease have significantly declined, with studies suggesting the decline is related to screening and treatment of localized disease and less so to improved treatments of advanced disease, as some critics argue.
He also believes the task force erred in directly linking screening to treatment. If, for instance, a man has a high PSA, he can go on to have a biopsy, and that may show that he has low-grade disease, in which case the cancer would just be monitored, not treated.
"We have learned that low-grade cancers can be watched safely. Because of that I uncouple screening and treatment.  Men with low-risk cancer are watched, and men with aggressive cancer are treated," he says. "There are two randomized trials that show that operating on men with intermediate and high-risk cancers, rather than doing nothing, improves their life expectancy and decreases their chance of developing metastatic prostate cancer. Those are the patients to whom we offer treatment."
 'PEOPLE ARE SCARED BECAUSE THEY HEAR THE WORD, "CANCER." DOCTORS ARE SCARED BECAUSE THEY HEAR THE WORD "CANCER." TOGETHER THIS PROMPTS TREATMENT.'
At the core of the problem with PSA screening is the fear inflamed by a diagnosis of cancer. "People are scared because they hear the word 'cancer.' Doctors are scared because they hear the word 'cancer.' Together this prompts treatment. It does not help that there are monetary incentives that drive those decisions," says Brooks.
Brawley, who recently authored the book How We Do Harm: A Doctor Breaks Ranks about Being Sick in America, says he is particularly concerned about free mass screenings at county fairs, shopping malls, churches and other public venues that are sponsored by special interests seeking to attract new patients but that don't provide men the opportunity to make informed decisions. (One past sponsor has been Kimberly Clark, the maker of Depend diapers for adults, he notes.)
"There's a lot of publicity out there — some of it by people who want to make money by recruiting patients — that oversimplifies the issue by saying that prostate cancer screening clearly saves lives. The truth is if you are concerned about prostate cancer, understand there are proven risks and possible benefits.... Every man needs to decide for himself," says Brawley.

LIVING WITH UNCERTAINTY

Often the first reaction among men is to have the cancer removed until they learn about the serious side effects surgery can cause, Brooks says. Once he describes them, he says, many become open to the idea of active surveillance, in which they are monitored with periodic PSA tests, biopsies and physical exams.
"In 1997, virtually all of our patients who were diagnosed, even if the tumor was small and low-grade, got an operation," he says. "Now, one-third of those patients are in active surveillance."
Bill, a 70-year-old Oakland, Calif., resident, is one such patient. Since 2002, he had been getting annual PSA tests, and while the numbers bounced around, they showed a gradual upward trend. So in 2008, at the suggestion of a Berkeley, Calif., urologist, he had a prostate biopsy, which detected something suspicious. The urologist then launched into a discussion of his various treatment options. "My mind said that if I had some kind of cancer, I want to take care of this. This was based on ignorance," says Bill, who asked that his last name not be used to protect his privacy.
He went home and talked to his wife and then began asking more questions of his urologist. "We started talking about side effects — impotence and incontinence, that sort of thing. I kind of felt I was getting different stories at different times."
He decided to get a second opinion and came to Stanford, where he learned that he actually had very little, very low-grade cancer and was a good candidate for active surveillance. Brooks has continued to measure his PSA levels quarterly and do a biopsy every 18 months. Bill's PSA has been trending down.
"On the whole, I'm glad I'm getting the PSAs, and I'm glad I didn't rush into treatment because there are lots of side effects from the treatment," he says. "The cancer is small and doesn't cause me any problems. Treatment would probably cause more problems than having the cancer. So I'm really feeling good about the decision."

THE NEW ATTITUDE

While the PSA test remains widely used, medical associations, including the American College of Physicians and the American College of Preventive Medicine, have begun to advise caution, saying men need to have a detailed conversation with their doctors before proceeding with the test and possible follow-up treatment. Even the conservative American Academy of Urology, in its 2009 Best Practice statement, recommends that men be informed of the risks of screening and of the option of active surveillance for newly diagnosed patients; the organization is currently revising its guidelines to reflect the state of the science.
Which begs the question, what is the state of the science? One unfortunate aspect of the debate over the PSA test is that valuable time has been lost, when scientists could have been looking for other alternatives, Brawley says.
"The urologic industry has been so fixated that they've delayed finding something better than PSA. So what's a man to do since we've been so foolish," he asks.
In fact, efforts are now under way to find a better option, with researchers using genomics, new imaging techniques and other strategies to develop more reliable indicators of the disease. Brooks is involved in several of these studies, including one in which 700 men are under active surveillance, undergoing periodic testing in an effort to develop a marker that can distinguish aggressive tumors from non-aggressive ones.
In another study, he is collaborating with Sanjiv Sam Gambhir, MD, PhD, professor and chair of radiology at Stanford, in using nanotechnology to measure proteins in the blood that may be better indicators of the disease than PSA. And at least two Bay Area companies have alternatives in clinical studies that aim to single out those cancers most likely to progress and require treatment.
"There are certainly plenty of men who are getting treated who don't need to be," says Brooks. "So we have to move the ball down the field. We just need better tests."

http://stanmed.stanford.edu/2012fall/article6.html

Against the odds - A band of rebels fights to save health care - Stanford Medicine Magazine

Manali Patel, MD, had dark circles under her eyes after a rough week battling tumors at the Stanford Cancer Institute. Patel, 33, doe-eyed and 99 pounds soaking wet, looked more like a college freshman than an oncology fellow six years out of medical school. Lately, she had seen a lot of bad endings. Several patients who wanted to die at home said their last goodbyes from a hospital bed, tethered to machines with tubes and wires. Another patient was referred to the hospital without knowing why. It was Patel's job to deliver the grim news: He had incurable lung cancer and only a few months to live.
Then, as she hung up her white coat for the day, she received the worst call of her life – her mother had breast cancer.
This began Patel's journey down the patient side of cancer treatment, away from the traditional career path of a working doctor. She joined a small, idealistic band of physicians, engineers and management scientists with an ambitious goal – to battle the waste and perverse financial incentives in America's increasingly unaffordable medical system.
Her mother's call also brought a personal urgency to a nagging problem that is easy to ignore while working 80-hour weeks and managing the treatments of 100 or so cancer patients a month: Few oncologists have the time to talk to cancer patients anymore.
Less than a third of oncologists have end-of-life discussions with terminal cancer patients. As a result, cancer patients are left out of the decisions that determine how and where they spend their last days. Recent studies show that when cancer patients understand the big picture — treatment side effects, survival odds and pain-relief options – they live longer and enjoy a better quality of life.
Listening to her mother's voice over a bad cell phone connection 3,000 miles away, Patel realized that her mother was about to be rushed off to chemotherapy.
"Wait. We need to talk first," said Patel, as she started to formulate her plans to try to bring compassion and affordability back into cancer care, for mother and country.

Patel grew up with her parents and two siblings in Shelby, N.C., the rural Appalachian town where The Hunger Games was filmed. Her parents, who emigrated from India in 1973, worked hard to give their three children a good education in a community of primarily cotton farmers and textile workers. Patel's mother held two jobs and her father ran his own textile design company. They bought only books, never toys, for the children. And ultimately, all three were accepted into a competitive science high school near Duke University and the University of North Carolina's medical school.

Around town, Patel's mother is known as "Mrs. Patel with the long hair," because of the long, dark braid that comes down to her knees. Though Patel and her mother look very much alike – petite with caramel-colored skin ‐ their cultural backgrounds are very different.
"My daughter is the protector of the family, aggressive and outspoken," says Mrs. Patel, who asked that her first name not be used.
Patel's mother, whose marriage was arranged by aunts and uncles in Gujarat, India, was raised to follow elders' and doctors' orders without question.
When Mrs. Patel's local physician first diagnosed her with cancer, he immediately sent her to a local oncologist for chemotherapy. "Once my doctor said the word 'cancer' I started crying and heard nothing," says Mrs. Patel. "I thought it was the end of the world."
Patel, the daughter-oncologist, was upset that her mother hadn't gotten a second opinion. She told her mother to put everything on hold until she could talk to a breast cancer specialist at Stanford. And, for the first time, she experienced "the cancer talk" from the other side of a physician's desk.
"This Stanford breast cancer specialist, who had never met me, called me back at 10 p.m. that same day," says Patel. "He spent an hour on the phone with me, reassuring me, telling me what I needed to know about my mother's cancer and teaching me how to be her caregiver."
Patel flew her mother out to meet with the Stanford specialist, who then spent two hours with her mother discussing her condition and wishes. The deciding factor in her mother's treatment plan came at the very end of the meeting: "My mother said she didn't want chemotherapy because she didn't want her hair to fall out," says Patel. "Back in India, her family had a tradition of never cutting hair. None of her American children had realized that this was so important to her."
Instead of chemotherapy, Patel's mother was given six weeks of daily radiation, followed by a five-year course of a non-chemo drug that doesn't cause hair loss.
"Going through this with my mother made me a better doctor. And it made me realize that these cancer discussions take time," says Patel.
Though she worried about whether her mother had made the right choice, she realized the importance of letting this be her mother's well-informed decision, not hers.
As she finished her oncology training, she decided to take action on what she had learned. So she hit "pause" on that $380,000 median oncologist's salary, buying a house and starting a family. Instead, she joined the Clinical Excellence Research Center at the Stanford School of Medicine.

LEAP OF FAITH

The CERC is led by Arnold Milstein, MD, the center's director and a professor of medicine. The 2-year-old center's mission is to find more affordable ways to deliver better medical care to the sickest of our population who consume the bulk of the country's health-care spending.
The CERC team takes aim at the unintentional wastefulness of the U.S. medical system, which is by far the most expensive in the world, yet is ranked 37th in quality of care. In Milstein's opinion – forged after 25 years as a health-care advisor to Fortune 100 companies, three White House administrations and Congress – there is no quick fix. Our country needs to safely improve the value of its health-care system by at least 2.5 percent per year, every year, in order to align health spending with national income growth. Anything less means more uninsured people, higher taxes and, eventually, fiscal Armageddon.
Milstein, a soft-spoken Midwesterner with a fondness for corduroy jackets, is building a pipeline for creating and testing innovative health-care delivery methods.
AS SHE FINISHED HER ONCOLOGY TRAINING, SHE DECIDED TO TAKE ACTION ON WHAT SHE HAD LEARNED. SO SHE HIT 'PAUSE' ON THAT $380,000 MEDIAN ONCOLOGIST'S SALARY, BUYING A HOUSE AND STARTING A FAMILY.
"To anchor our process, we recruit very smart postdoctoral and master's-level research fellows with a history of fresh thinking and successful doing," says Milstein. "We expose them to successful health-care innovators, pair them with Stanford faculty and Silicon Valley mentors to formulate better health-care models, then recruit health-care organizations and insurers to test the effectiveness of their concepts."
Over the years, Milstein has won a number of epic battles in health-care redesign. He co-founded the Leapfrog Group, which defined hospital patient safety goals that became the de facto standard across the nation. He was the force behind Congress' decision to stop paying hospitals for the cost of treating preventable patient complications. He launched an outpatient care delivery model for medically frail patients, called the "ambulatory-care ICU," which improved health and lowered annual per-patient spending by more than 15 percent. And he's the founding medical director of the Pacific Business Group on Health, the nation's largest regional health-care improvement coalition of large employers, whose members include Chevron, Safeway, Walmart, Boeing, HP, Cisco, Facebook, CalPERS and Stanford University.
For the fellows' first year, Milstein targeted four of the most debilitating and expensive medical conditions in the U.S. system – chronic kidney disease, morbid obesity, colon cancer and poor-prognosis cancer, which was Patel's area of focus.
PHOTO BY JAMIE KRIPKE 
The Clinical Excellence Research Center's fellows and Terry Platchek, fellowship director. From left: Sarah Adler, Graham Abra, Manali Patel, Platchek, David Moore and Sundeep Singh.
Though the fellows have diverse backgrounds, all have had personal experiences that have motivated them to join this small group of reformers.
For example, Graham Abra, MD, a nephrology fellow, was curious about why some medical institutions provide better patient care than others, and whether innovative approaches could make health care more affordable. Psychologist Sarah Adler, PsyD, became interested in obesity after researching the mental health underpinnings that may contribute to overeating. Sundeep Singh, MD, a gastroenterology fellow with a bachelor's degree in industrial and systems engineering, sought to develop systems-based solutions to health-care delivery. Kimberly Stone, MD, a surgery resident, wanted to see if making low-cost bariatric surgery more widely available might extend life for morbidly obese patients. And David Moore, PhD, an industrial engineer and consultant, became interested in the redesign of health services after working on a system to improve efficiency in surgical suites.
Abra, who worked on the chronic kidney disease and cancer care models, spoke about his first impressions: "It was pretty risky signing up for a new type of fellowship program. There's this professor with the crazy idea that better health care can cost much less. But he was giving us a chance to fix the medical system at a higher level. So I joined." And he adds with a smile, "It was a leap of faith."

VALLEY OF DESPAIR

The team got to work in August 2011 with a month-long "Innovation Bootcamp." It started with almost 50 briefings by eminent health-care economists, biostatisticians, futurists, clinical specialists, faculty, information technology experts, human factors gurus and behavioral scientists. They also met with leaders from efficient health systems, such as the Permanente Medical Group in California, ThedaCare in Wisconsin, Intermountain Healthcare in Utah, and government-run health systems in British Columbia and Sweden.
"I was star-struck, and I even felt a little guilty about how many top national experts met with the six of us," says Patel.
Optimism was high among the fellows as they began their clinical research and observations. To help structure their search for solutions, the center adapted the Stanford Biodesign Program innovation methodology, which has spawned more than 300 patents and 26 medical technology companies. This training teaches inventors to identify the most pressing unmet needs within a medical system, so that the resulting solutions improve clinical outcomes and save money. The team spent two months immersed in clinical settings, observing patients, families and physicians. They interviewed care delivery innovators in the United States, Canada, Sweden and other countries. And they gathered new ideas from scientific literature and medical experts.
Fast forward two months: It was almost 11 p.m., and the fellows were in a conference room cluttered with marker-scratched white boards, fast food carnage and stacks of studies. The fellows had fallen into the "valley of despair," the ugly, chaotic middle of the innovation design process.
"We were all so exhausted and suffering from information overload," says Patel. "That was the low point. We couldn't imagine how we were going to make sense of everything we'd learned."
That was where the Biodesign process helped – as well as its credo: "Given enough time, sugar and caffeine, you will invent something."
At this stage of the project, the fellows had a list of about 200 unmet needs (a.k.a. problems to fix) for each target condition. The needs were entered into a database and ranked by characteristics such as importance to patients and clinicians, and potential cost savings. This helped the team narrow the best ideas to those that addressed the most critical "needs clusters." Then, during the late winter and spring, Patel and the other fellows began assembling their care models, folding in feedback from faculty and mentors.
When Milstein reviewed the first round of care models, he was worried. He felt that some of the fellows had fallen prey to "anchoring bias," the human tendency to fixate too early on one piece of information when making decisions.
"That's where David Moore, our operations researcher, really helped the team," says Milstein. "He created the economic and analytical framework for each of the care models, and in the case of Patel's plan, the biggest cost-benefit in cancer care came from an unexpected line item – rapid symptom relief."

TALK IS CHEAP

The side effects of cancer treatments – pain, seizures, debilitating headaches and nausea – can easily overwhelm patients at night or during weekends, when oncologists are difficult to reach. Suffering patients often end up in crowded emergency rooms, waiting hours for relief. Sometimes they're hospitalized overnight, waiting until the oncologists arrive the next morning, accruing thousands of dollars in unnecessary medical bills.
Patel's model provides patients with 24-hour telephone access to nurses trained in cancer care. They guide patients' use of symptom-control medications, pre-positioned at home or delivered within hours.
"Quick symptom relief is not only more humane, but it literally saves thousands of dollars per year for these cancer patients," says Patel.
'WE WERE ALL SO EXHAUSTED AND SUFFERING FROM INFORMATION OVERLOAD. THAT WAS THE LOW POINT. WE COULDN'T IMAGINE HOW WE WERE GOING TO MAKE SENSE OF EVERYTHING WE'D LEARNED.'
Another component of her care model is providing patients with more convenient local access to chemotherapy infusions, giving patients with low-risk treatments the option of receiving the drugs at home, via home health nurses, or at nearby infusion centers, such as those operated by Walgreens across the country. These treatments would be monitored by experienced nurses and pharmacists, and remotely guided by expert oncologists. Patel discovered that this approach is already working well for the Nebraska Veterans Administration hospital.
Perhaps the most important aspect of her model is earlier cancer patient counseling, institutionalizing shared decision-making well before a patient is on the brink of death and emotions overwhelm the decision-making skills of patients, their families and clinicians.
According to a recent study, end-of-life discussions typically take place only 33 days before death. With Patel's new cancer care model, patients would be thoroughly briefed on the survival odds and side effects before being rushed off to surgery or chemotherapy. Many months before the family is gathered around a loved one's deathbed, a person's final wishes – resuscitation, feeding tubes, assisted breathing and whether a person wants to die at home – would be well-informed and documented.
"Eighty percent of all cancer patients express a desire to die at home, yet only 10 percent do," says Patel. "These conversations, which typically take two hours in the beginning and require many follow-on conversations, are too hard, time-consuming and draining for a busy oncologist to do well."
These conversations would automatically occur whenever the probability of death is 30 percent or more within three years, based on oncology survival tables.
After months of scenario building and faculty critiques, the team's care models crystallized for each of the four conditions, and three-year health spending reductions were projected.
Based on a conservative financial model, Patel estimated that her team's new care model would lower the $123,000 annual per-capita health spending of poor prognosis cancer patients by 30 percent – even after paying for its new services.
The problem? Clinics, hospitals and insurers have to be convinced that paying for these additional services on the front end will pay off on the back end. And this was Patel's challenge as the academic year came to a close – to find partners willing to test her plan, so she could gather and publish evidence on effectiveness.
Finally, after 10 months Milstein and the other faculty decided that the fellows' care models were ready for their first public airing.

THE PITCH

It was June, six days before the Supreme Court announced its ruling on whether the Affordable Care Act would stand. Patel and her colleagues were about to present their new care models to about 100 health benefit plan leaders of the Pacific Business Group on Health at its annual strategy retreat. The meeting was in a conference center, once a turn-of-the-century mansion, now landlocked in a sea of San Jose tract homes. The conference room walls were papered in easel notes from the previous day, filled with ideas on how to provide the best possible medical care to their employees in the face of escalating health-care costs.

Patel was second up in the presentation, a little nervous and barely tall enough to be seen behind the podium. She stated the problem in her target area: Cancer is the second-leading cause of death in the United States, with costs estimated to be $173 billion by 2020. These rising costs are unsustainable.Milstein introduced the Stanford fellows and summarized the writing on the wall: "The only way we're going to bring per-capita health-care spending in line with revenue growth is to create a continuous flow of more efficient ways of delivering health care. Today, our research fellows will illustrate the first wave of Stanford-designed care models, and we ask that you to consider testing our ideas."
And what do many poor-prognosis cancer patients get for all the money spent? "Horrible treatment," she said, citing a statistic that silenced the room: Seventy-three percent of terminal cancer patients never have an end-of-life discussion with their oncologists. "Many patients are rushed off to chemotherapy without understanding the big picture. And when predictable treatment side effects happen at night and on weekends, patients who are unable to reach their oncologist end up in misery in emergency rooms and hospitals. Later in their illness, many die painfully in intensive-care facilities that bankrupt their families emotionally – and sometimes financially."
During her presentation, Patel's eyes became dark pools that threatened to overflow. A few people in the audience wept silently, perhaps remembering loved ones who had similarly suffered.
"Overall, these added services improve the quality of life of patients, giving them what they need and want without delay," she added after describing her model. "And best of all, we lower health insurance costs … simply by doing the right thing."
Afterward, leaders from Disney, Tesla, Boeing and Safeway asked Milstein and the fellows for more details on implementing their models.
The following week, however, some of Patel's conference calls to health-care providers and insurers didn't go as well.
At a large clinic in the Midwest, the medical director said to Patel, "Our cancer center is one of the few areas where we're profitable. Thanks just the same, but we'll pass."
A representative from a large national private health insurer said, "We can't afford to alienate any more of our oncologists by lowering their income."
Another health-care insurer in Seattle referred to her proposal, only half-jokingly, as a "death panel," using the Tea Party's misnomer for the counseling sessions on end-of-life cancer care and hospice that were to be reimbursed under the Affordable Care Act. This provision, which was misinterpreted as government committees encouraging seniors to forgo treatments to save money, was pulled from the act before it passed.
By the end of the second week of presentations, Patel was deflated. Her care model was dead last in attracting test sites, and she began to realize that a major flaw in her plan was that it threatened the livelihood of the plan's most important participants – oncologists.
The near-term savings from her care model would come off the bottom-line revenues of oncology practices and cancer centers. Unlike other medical specialties, private-practice oncologists earn most of their money through selling drugs – 65 percent of total revenues come from drug sales and another 21 percent from fees associated with drug infusions, imaging and radiation services, according to the National Oncology Practice Benchmark 2011 Report published in the Journal of Oncology Practice.
This report goes on to show that only 8 percent of a typical private-practice oncologist's earnings, strictly speaking, comes from "patient time," the revenues earned through conversations about cancer, treatments, side effects, outcomes and end-of-life issues.
"Current incentives are often misaligned to reward doing the most aggressive and expensive actions, as long as patients are satisfied, because this leads to the highest return to the practice," says Thomas J. Smith, director of palliative care at Johns Hopkins, in a 2010 article in Oncologist. "Some consequences include U.S. cancer treatment costs that are twice that of any other nation with no or minimal differences in survival, late referrals (if at all) to hospice, and 14 to 20 percent of patients receiving chemotherapy within 14 days of their death, when it is highly likely to harm and cause complications."
Private-practice oncologists, on the other hand, argue that they are losing money because Medicare reimbursement rules don't cover overhead costs for drug administration, inventory and bad debt. They understandably want to fight the erosion of their revenue base, which has fallen 33.5 percent in the last six years. But as the Affordable Care Act seeks to wean the medical system away from the fee-per-service structure, Patel hopes her model can be the bridge from the old compensation model to a new one, based on shared savings from more humane and effective treatments.
After the first two weeks of sales pitches, Milstein organized an expert panel to critique the fellows' presentations, prepping them for more presentations over the summer. Milstein was joined by Rob Rebitzer, a CERC consultant and a former partner in Accenture's health-care consulting group. Together, they offered advice on speaking more simply and slowly, "like Mr. Rogers," to certain groups. And they suggested clarifying that the substantial savings from each new care model would be shared by employers, physicians and patients within large health insurance groups.
For Patel's plan, they recommended that criticism of oncology compensation structures be replaced with ideas on oncology profit-sharing incentives. And overall, Patel should stress the win-win aspects of her model – better care that saves the system money.
At the end of the session Milstein spoke from the heart to his fellows: "I know it's difficult to offer advice to a room full of senior health-care professionals who are all older than you, but think back on all the knowledge that you've gained over the last year. And remember, you represent hope to these people."

IN THE WAITING ROOM

By the end of July – after dozens of presentations on her advanced-cancer-care model, Patel got good and bad news. The good news was that five groups expressed interest in piloting her program. One large hospital in California agreed to test most of her new care model. A large employer agreed to offer financial incentives to fully implement her care model with a health system serving a large number of its employees. Three others were leaning toward implementation but had not given the final go-ahead.
The bad news: Patel's mother came back to Stanford for a follow-up appointment with her oncologist to make sure her breast cancer hadn't recurred. The mammogram showed no tumors, but the bone scan showed an anomaly, and now Patel and her mother were going through the tortuous process of waiting for results.
"My mother is my best friend," says Patel. "I talk to her about everything. Except my worries about her cancer."
Watching the compassionate handling of her mother's case by the veteran Stanford breast cancer specialist forever changed Patel's view of how physicians should talk to cancer patients and their families. It impressed her with the need for a calm, experienced, neutral coach to talk a patient through the life-changing experience of a cancer diagnosis. She realized that there are thousands of factors, seen and unseen, involved in cancer treatment decisions. And that an informed patient – with the support of friends, family, counselors and oncologists – needs to be at the center of those decisions. Now she wants to share what she's learned with others.
Mrs. Patel recently spoke about how proud she is of her daughter: "Four years after my cancer, I'm still here. I thank my daughter for that. I can't wait to see how she will make a difference in helping other cancer patients."
As Patel sat in the waiting room with her mother, she mentally ran through worst-case scenarios of other cases she's seen, and she worried. But she understood that her mother needed to be able to make these decisions on her own.
Then Patel was handed her mother's bone scan report. She looked it over and breathed a sigh of relief. It was clear. And at that moment, she took off her white coat and tried to simply be a supportive daughter.