Tuesday, December 31, 2013

I Had My DNA Picture Taken, With Varying Results - NYTimes.com

I like to plan ahead; that much I knew about myself before I plunged into exploring my genetic code. I'm a healthy 28-year-old woman, but some nasty diseases run in my family: coronary heart disease,rheumatoid arthritisAlzheimer's and breast cancer.

So I decided to read the tea leaves of my DNA. I reasoned that it was worth learning painful information if it might help me avert future illness.

Like others, I turned to genetic testing, but I wondered if I could trust the nascent field to give me reliable results. In recent years, a handful of studies have found substantial variations in the risks for common diseases predicted by direct-to-consumer companies.

I set out to test the tests: Could three of them agree on me?

The answers were eye-opening — and I received them just as one of the companies, 23andMe, received a stern warning from the Food and Drug Administration over concerns about the accuracy of its product. At a time when the future of such companies hangs in the balance, their ability to deliver standardized results remains dubious, with far-reaching implications for consumers.

My experiment ran into hurdles from the start. After I ordered 23andMe's saliva test kit, which for $99 promised a report on more than 240 health conditions and traits, it turned out that I could not legally send it in; the New York State Health Department forbids any labs that lack a state permit to accept specimens from a health-related test. Luckily, my in-laws mailed it from their home in New Jersey.

Then I learned that the other two companies I planned to approach were no longer offering genetic testing. Additional research led me to two more: Genetic Testing Laboratories and Pathway Genomics. G.T.L. charged $285 for a report on 25 disease risks, and required a professional sample collector to draw blood; Pathway charged $399 for a report on 24 disease risks. (In 2010, Pathway planned to sell its saliva test kit at Walgreens, but abandoned the idea after the F.D.A. challenged the sales. Now Pathway requires a doctor to order a kit on a patient's behalf.)

After my tests had been sent, I braced myself for the revelations about my DNA. It took about two months to receive all the results, and when I did, the discrepancies were striking.

23andMe said my most elevated risks — about double the average for women of European ethnicity — were for psoriasis and rheumatoid arthritis, with my lifetime odds of getting the diseases at 20.2 percent and 8.2 percent. But according to Genetic Testing Laboratories, my lowest risks were for — you guessed it — psoriasis (2 percent) and rheumatoid arthritis (2.6 percent).

For coronary heart disease, 23andMe and G.T.L. agreed that I had a close-to-average risk, at 26 to 29 percent, but Pathway listed my odds as "above average."

In the case of Type 2 diabetes, inconsistencies on a semantic level masked similarities in the numbers. G.T.L. said my risk was "medium" at 10.3 percent, but 23andMe said my risk was "decreased" at 15.7 percent. In fact, both companies had calculated my odds to be roughly three-quarters of the average, but they used slightly different averages — and very different words — to interpret the numbers. In isolation, the first would have left me worried; the second, relieved.

Medical ethicists and other experts have a different kind of worry about results like these: a lack of industry standards for weighing risk factors and defining terminology.

"The 'risk is in the eye of the beholder' standard is not going to work," said Arthur L. Caplan, director of medical ethics at the New York University Langone Medical Center. "We need to get some kind of agreement on what is high risk, medium risk and low risk."

Several other problems may account for my discrepancies. The genetic testing that these three companies offer is premised on reading segments of DNA called SNPs (pronounced snips), for single nucleotide polymorphisms. But these segments, which have been linked to diseases in research studies, vary among people.

Scientists have identified about 10 million SNPs within our three billion nucleotides. But an entire genome sequencing — looking at all three billion nucleotides — would cost around $3,000; the tests I took examined fewer than a million SNPs.

"Imagine if you took a book and you only looked at the first letter of every other page," said Dr. Robert Klitzman, a bioethicist and professor of clinical psychiatry at Columbia. (I am a graduate student there in his Master of Bioethics program.) "You're missing 99.9 percent of the letters that make the genome. The information is going to be limited."

Companies choose which SNPs to read. By comparing the technical reports provided with my results, I found that my tests sometimes relied on different SNPs to assess the same condition, like coronary heart disease. Each test studied four to 15 markers, with almost zero overlap, though two tests reached similar conclusions about my odds.

In the case of rheumatoid arthritis, though, the tests examined the same five markers, plus a few others, and delivered contradictory interpretations.

J. Craig Venter, chief executive of his namesake institute and of Synthetic Genomics, was a pioneer in sequencing the human genome in 2000. Though he issued recommendations to genetic testing companies four years ago to help them improve their predictions, he remains skeptical of their clinical value.

"Your results are not the least bit surprising," he told me. "Anything short of sequencing is going to be short on accuracy — and even then, there's almost no comprehensive data sets to compare to."

Another source of variation was in the estimates of average risks. For example, 23andMe listed the typical odds of obesity at 59 percent, while G.T.L. listed them at 30 percent.

But the major issue, experts say, is that the causes of most common diseases remain unknown. Genes account for just 5 to 20 percent of the whole picture.

"Even if they are accurately looking at 5 percent of the attributable risk, they've ignored the vast majority of the other risk factors — the dark matter for genetics — because we as a scientific community haven't yet identified those risk factors," said Dr. Wendy Chung, an associate professor of pediatrics and medicine and the director of clinical genetics at Columbia.

Environmental factors play a role. A study published in 2007 demonstrated this link: After pregnant mice were exposed to various levels of a chemical, their genetically identical offspring were born obese and yellow or small and brown.

There are only 23 diseases that start in adulthood, can be treated, and for which highly predictive tests exist. All are rare, with hereditary breast cancer the most common. "A small percentage of people who get tested will get useful information," Dr. Klitzman said. "But for most people, the results are not clinically useful, and they may be misleading or confusing."

23andMe declined to comment for this article. Jim Bentley, the chief operating officer of General Genetics Corporation, which owns G.T.L., said test results should be interpreted with professional guidance: "Because of the complexity of genetic testing results and other factors that have a role in determining the long-term potential health risks a person may face, such as environmental conditions and personal health habits, G.G.C. requests its customers provide information that would allow us to send the results of our predisposition test to a physician."

The chief medical officer of Pathway, Dr. Michael Nova, said: "Pathway Genomics is accredited by the College of American Pathologists, and accredited in accordance with the U.S. Health and Human Services' Clinical Laboratory Improvement Amendments of 1988. As such, we are held to a higher standard for report accuracy than our unaccredited competitors."

To be sure, my tests did provide some beneficial information. They all agreed that I lack markers associated with an increased risk of breast cancer and Alzheimer's.

That said, they were testing for only a small fraction of the genetic risks for these diseases, not for rare genetic variants that confer much of the risk. I could still develop those diseases, of course, but I don't have reason to pursue aggressive screenings as I age.

In June, the Supreme Court prohibited the patenting of genes that exist in nature. But the ban did not apply to DNA created in the laboratory, leaving the door open to additional patents in the field. That will encourage the industry to gather big bio-banks of people's genomes — the more, the better.

In the wake of the F.D.A. warning, 23andMe has stopped providing data on health risks, and a class-action lawsuit alleges that the company's results are "meaningless." The company's supporters have launched a petition to protest the warning.

Until and unless the predictive science improves, experts advise consumers to take most of their results with a grain of salt.

The tests "may be interesting as a kind of entertainment," Dr. Caplan said, "but do not take them seriously yet in driving your health care or your lifestyle."

He added: "If you want to spend money wisely to protect your health and you have a few hundred dollars, buy a scale, stand on it, and act accordingly."



http://www.nytimes.com/2013/12/31/science/i-had-my-dna-picture-taken-with-varying-results.html?src=me&ref=general&pagewanted=print

Roughed Up by an Orca? There’s a Code for That - NYTimes.com

Know someone who drowned from jumping off burning water skis? Well, there's a new medical billing code for that.

Been injured in a spacecraft? There's a new code for that, too.

Roughed up by an Orca whale? It's on the list.

Next fall, a transformation is coming to the arcane world of medical billing. Overnight, virtually the entire health care system — Medicare, Medicaid, private insurers, hospitals, doctors and various middlemen — will switch to a new set of computerized codes used for determining what ailments patients have and how much they and their insurers should pay for a specific treatment.

The changes are unrelated to the Obama administration's new health care law. But given the lurching start of the federal health insurance website, HealthCare.gov, some doctors and health care information technology specialists fear major disruptions to health care delivery if the new coding system — also heavily computer-reliant — isn't put in place properly.

They are pushing for a delay of the scheduled start date of Oct. 1 — or at least more testing beforehand. "If you don't code properly, you don't get paid," said Dr. W. Jeff Terry, a urologist in Mobile, Ala., who is one of those who thinks staffs and computer systems, particularly in small medical practices, will not be ready in time. "It's going to put a lot of doctors out of business."

The new set of codes, known as I.C.D.-10, allows for much greater detail than the existing code, I.C.D.-9, in describing illnesses, injuries and treatment procedures. That could allow for improved tracking of public health threats and trends, and better analysis of the effectiveness of various treatments.

Officials at the Centers for Medicare and Medicaid Services declined to be interviewed about the new codes. But a spokeswoman said that the agency was "committed to implementing I.C.D.-10 on Oct. 1, 2014, and that will not change."

In a letter in November, Kathleen Sebelius, the secretary of health and human services, told Senator Jeff Sessions, Republican of Alabama, that the Medicare and Medicaid officials were working diligently to help doctors get ready. "I.C.D.-10 is foundational for building a modernized health care system that will facilitate broader access to high quality care," she wrote.

Still, the troubles with HealthCare.gov have given new ammunition to those urging a go-slow approach on I.C.D.-10 and have made it harder for the government to stand behind assurances that the transition will go smoothly.

"Failure to appropriately test I.C.D.-10 could result in operational problems similar to what the Department experienced with the rollout of HealthCare.gov," the Medical Group Management Association, which represents the business managers of medical practices, said in a letter this month to Ms. Sebelius.

The Medicare and Medicaid office now appears to be open to greater testing of the system. Also this month, the Obama administration relaxed some deadlines for parts of the health care law, and some deadlines under a separate law for enacting electronic medical records.

"I think that people at C.M.S. understand the stakes with respect to I.C.D.-10 in a heightened way as a result of HealthCare.gov," said Linda E. Fishman, senior vice president for policy at the American Hospital Association.

Dr. John D. Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston, said the need to prepare for I.C.D.-10 and the Affordable Care Act and to achieve so-called meaningful use of electronic health records all at once could overwhelm computer staffs throughout the health care industry.

"It's just this collective sum of activities that exceeds the capacity of the system to absorb it simultaneously," he said.

He said his hospital was spending $5 million this year on I.C.D.-10, $7 million for the Affordable Care Act, $2 million on meaningful use, and $3 million to comply with a federal health care privacy law. "Basically, I'm not doing anything but federal regulatory mandates," he said.

I.C.D.-10 has already been postponed by a year. It was originally scheduled to go into effect this past Oct. 1, which would have coincided with the rollout of the insurance website.

Some health care executives say predictions of a fiasco next Oct. 1 will prove as erroneous as those that said civilization would collapse on Jan. 1, 2000, because computers could not handle years beginning with a 2 instead of a 1 — the so-called Y2K issue.

"It's not going to be a shock to the industry to confront this," said Christopher G. Chute, professor of biomedical informatics at the Mayo Clinic. "We've literally had seven or eight years to anticipate it."

survey by the American Hospital Association this year found that about 94 percent of hospitals were moderately to very confident about being ready on time. Both the hospital association and America's Health Insurance Plans, which represents insurers, said that their members had spent a lot of time and money getting ready for I.C.D.-10 and that the changeover should not be postponed again.

I.C.D.-10 is the 10th revision of the International Classification of Diseases, which is issued by the World Health Organization, though countries can modify it.

Having a common global code allows for easier collection, comparison and analysis of the causes of death and illness. Most other countries have already adopted I.C.D.-10, at least for record-keeping and in some cases for reimbursement.

The classification was first issued in the 1800s. An early one listed "visitation of God" as one cause of death.

But as medical knowledge and technology have improved, more codes are needed. I.C.D.-9, which allows codes of up to five characters, has about 14,000 codes to specify diagnoses and 3,000 to specify inpatient procedures. The code, which has been used in the United States for medical statistics since 1979 and for billing since 2002, has run out of room to incorporate new knowledge and technology.

I.C.D.-10, with codes containing up to seven digits or letters, will have about 68,000 for diagnoses and 87,000 for procedures.

While I.C.D.-9 had a single code for certain repairs to blood vessels in the head and neck, I.C.D.-10 allows specification of the particular vein or artery and the particular procedure used. Extra codes allow recording of whether a patient was visiting the doctor for the first time or a subsequent time for a particular problem, and whether broken arms and some other injuries occur on the left or right side of the body.

There are dozens of codes dealing just with the big toe — contusion of the right great toe, contusion of the left great toe, with damage to the nail or without, initial encounter or subsequent encounter, blisters, abrasions, venomous insect bites, nonvenomous insect bites, lacerations, fractures, dislocations, sprains and amputation, not to mention the vague "acquired absence of unspecified great toe."

I.C.D.-10 has been the subject of jokes, however, for its catalog of possible injury causes, like those burning water skis. There are codes for injuries incurred in opera houses and while knitting, and one for sibling rivalry.

When it first proposed moving to I.C.D.-10, the Medicare and Medicaid Services office estimated it would cost the government and industry $1.64 billion over 15 years on training, software changes and lost productivity. But it also said the system would bring $4 billion in benefits over that time, from more accurate claims and improved health care.

Lee Browder, national director of the Professional Association of Healthcare Coding Specialists, said the transition should not be too hard for coders. He compared it to the introduction of the extra four digits on ZIP codes — there were many more codes, but the concept was the same as before.

The transition could be tougher for doctors, because they will have to be more specific in describing a patient's condition.

The government has said Medicare contractors will have a week of testing in early March during which doctors and hospitals can practice submitting claims. But the Medical Group Management Association and the American Hospital Association, among others, are pushing for more testing.

Rhonda Buckholtz, vice president for I.C.D.-10 education and training at the American Academy of Professional Coders, said postponing the deadline would just push the problem down the road.

"It doesn't matter what deadline we get," she said. "We'll find a way to not meet it."


http://www.nytimes.com/2013/12/30/technology/medical-billing-nears-a-new-era-of-ultra-specific-codes.html?src=me&ref=general&pagewanted=all&pagewanted=print

Sunday, December 29, 2013

Living Sick and Dying Young in Rich America - Leah Sottile - The Atlantic

We were standing at Target in an aisle we'd never walked down before, looking at things we didn't understand. Pill splitters, multivitamins, supplements, and the thing we were here to buy: a long blue pill box—the kind with seven little doors labeled "S M T W T F S " for each day of the week, the kind that old people cram their pills into when they have too many to remember what they've already taken.

My husband, Joe Preston, shook his head. "Do I really need this?"

I grabbed it off the shelf and threw it in our basket. And when we got home, Joe—then a fit and fairly spry 30-year-old man with a boss-level beard—stood at the kitchen counter, dropping each of his prescriptions with a plink into the container.

I guess it's true that life is full of surprises, but for the three years since Joe's crippling pain was diagnosed as the result of an autoimmune disease called Ankylosing Spondylitis, our life has been full of surprises like this one. Pill boxes, trips to the emergency room, early returns from vacation. Terms like "flare-up" have dropped into our vocabulary. We've sat in waiting rooms where Joe was the only person without a walker or a cane. Most of our tears have been over the fact that these aren't the kind of surprises either of us thought we'd be encountering at such a young age.

But here's the thing: We recently realized we weren't alone. Almost all of our friends are sick, too. When we met our friend Missy Narrance, Joe found solace in talking to her about his health. She's 29 and has been battling lupus and fibromyalgia for the past 10 years. She's been through chemotherapy twice, and her daily symptoms are so extreme that she was granted federal disability status when she was just 23 years old. In our close group of friends—who range from 25 to 35 years old—we know people with everything from tumors to chronic pain. Sometimes our conversations over beers on a Friday night turn to discussions of long-term care and miscommunication between doctors.

I thought this would be the time when we'd be preparing for the rest of our lives: earning money, going on fun vacations, having families, building our careers. And we are, but at the same time, we're doing it while we're trying to manage pain symptoms, chase down prescriptions, and secure stable health insurance. When I was in college, I remember being prepared to survive in the workforce, but I don't remember a class that told me how to do that if half of your household is in so much pain on some days that they can't get to work. I'm barely over 30. I thought I had so much more time before I had to think about this stuff.

I wondered if this was normal. Do we know so many people who are dealing with pain because people are just getting sicker in general?

I found out that they kind of are. It turns out that chronic conditions like what Joe and my friends are dealing with are one of America's biggest health emergencies. And it's one that many people say we're not prepared to deal with.

Despite the fact that America shells out more money on healthcare than any other country in the world, according to a report by the Centers for Disease Control and Prevention—and a hefty 75 percent of those dollars are going toward aiding people with chronic conditions—almost half of American adults had at least one chronic condition in 2005.

More ...

http://www.theatlantic.com/health/archive/2013/12/living-sick-and-dying-young-in-rich-america/282495/

Saturday, December 28, 2013

Anxiety linked to stroke risk | Reuters

Men and women with severe symptoms of anxiety may have a higher risk of stroke than their more relaxed counterparts, a new study suggests.

"The greater your anxiety level, the higher your risks of having a stroke," study co-author Dr. Maya J. Lambiase, of the University of Pittsburgh School of Medicine, told Reuters Health.

"Assessment and treatment of anxiety has the potential to not only improve overall quality of life, but may also reduce the risk of cardiovascular diseases, such as stroke, later in life," she said in an email.

Dr. Philip Muskin, a professor of psychiatry at Columbia University Medical Center in New York emphasized that the stroke risk identified in the study among overly anxious individuals was not vastly increased.

"What it's really saying is, you're a little more likely to have a stroke," said Muskin, who was not involved in the study. Still, he added, "I would like to be a little less likely (to have a stroke) in my life."

Stroke is one of the leading causes of death in the U.S., but few studies have looked at psychosocial factors other than depression or psychological stress or distress, that may contribute to a person's risk of stroke.

Yet, Lambiase and her colleagues point out, anxiety has been linked to increased cigarette smoking, alcohol abuse and physical inactivity - all of which are known to increase stroke risk.

To investigate the association between anxiety and stroke, the researchers analyzed data from 6,019 men and women who were enrolled in the First National Health and Nutrition Examination Survey in 1971-1975 and followed for about 16 years.

The participants were interviewed at the start of the study to determine the presence and severity of any anxiety symptoms, and stroke events were identified by examining hospital or nursing home discharge reports and death certificates.

A total of 419 strokes occurred throughout the study period, but the risk of stroke was higher among those who reported greater anxiety symptoms, including excessive feelings of worry, stress and nervousness, at the initial interview.

Overall, anxiety was linked to a 14 percent higher risk of stroke relative to participants who were not anxious, Lambiase and her co-authors report in the American Heart Association journal Stroke.

But stroke risk also appeared to rise in line with increasing severity of anxiety symptoms, the results suggest.

The link between anxiety and stroke risk remained even after the researchers took into consideration other factors that may have influenced cardiovascular health, such as alcohol use, physical activity and smoking. After those adjustments, men and women with higher levels of anxiety were 33 percent more likely to experience stroke than those with fewer anxiety symptoms.

Similarly, the link between anxiety symptoms and increased stroke risk remained when the researchers accounted for study participants' age, gender and symptoms of depression.

The researchers didn't analyze the reason for the connection between anxiety and stroke, but they speculate multiple factors are likely to be involved. These could include unhealthy coping behaviors people with anxiety indulge in as well as overactivation of the sympathetic nervous system, which controls fight-or-flight responses, such as the release of stress hormones.

"People with high anxiety levels are more likely to smoke and be physically inactive, possibly explaining part of the anxiety-stroke link," Lambiase said. "Higher stress hormones, blood pressure or sympathetic output may also be factors."

"However," she added, "future research is needed to determine the precise mechanisms whereby greater levels of anxiety increase a person's risk for stroke."

Dr. Muskin acknowledged that the study findings do point to a greater risk of stroke among overly anxious people, "but there are things you can do about that," he said.

Noting that "anxiety predicts bad health behaviors," Dr. Muskin cited the importance of stopping smoking and starting to exercise. He also described the importance of meditation and proper breathing techniques, which he teaches in his private practice with patients.

"Doing nothing leaves you at a higher risk (of stroke)," he said, but breathing exercises have "a psychologically beneficial effect," with no harm and no addicting qualities, he told Reuters Health.

Source: bit.ly/1ijtNye Stroke, online December 19, 2013.

http://www.reuters.com/article/2013/12/27/us-anxiety-stroke-idUSBRE9BQ0BK20131227

Thursday, December 26, 2013

Sunday, December 22, 2013

Health Care’s Road to Ruin - NYTimes.com

Having spent the last year reporting for a series of articles on the high cost of American medicine, I've heard it all. There was Fred Abrahams, 77, a skier who had surgery on both ankles for arthritis — one in New York for more than $200,000 and one in New Hampshire for less than $40,000. There was Matthew Landman, 41, billed more than $100,000 for antivenin administered in an E.R. after a small rattlesnake bite. There was Robin Miller, a Florida businessman, who needed to buy an implantable defibrillator for his ill brother, who was uninsured; the machine costs tens of thousands of dollars, but he couldn't get a price for a make or a model.

Extreme anecdotes, perhaps. But the series has prompted more than 10,000 comments of outrage and frustration — from patients, doctors, politicians, even hospital and insurance executives.

As of Jan. 1, the Affordable Care Act promises for the first time to deliver the possibility of meaningful health insurance to every American. But where does that leave the United States in terms of affordable care?

Even supporters see Obamacare as a first step on a long quest to bring Americans affordable medicine, with further adjustments, interventions and expansions needed.

There are plenty of interesting ideas being floated to help repair the system, many of which are being used in other countries, where health care spending is often about half of that in the United States. For example, we could strictly regulate prices or preset payment levels, as is currently done for hospital stays under Medicare, the national insurance program for people over 65, or at least establish fair price corridors for procedures and drugs. We could require hospitals and doctors to provide price lists and upfront estimates to allow consumers to make better choices. We could stop paying doctors and hospitals for each service they performed and instead compensate them with a fixed monthly fee for taking care of each patient. We could even make medical school free or far cheaper and then require service afterward.

But the nation is fundamentally handicapped in its quest for cheaper health care: All other developed countries rely on a large degree of direct government intervention, negotiation or rate-setting to achieve lower-priced medical treatment for all citizens. That is not politically acceptable here. "A lot of the complexity of the Affordable Care Act arises from the political need in the U.S. to rely on the private market to provide health care access," said Dr. David Blumenthal, a former adviser to President Obama and president of the Commonwealth Fund, a New York-based foundation that focuses on health care.

With that political backdrop, Obamacare deals only indirectly with high prices. By regulating and mandating insurance plans, it seeks to create a better, more competitive market that will make care from doctors and hospitals cheaper. But it primarily relies on a trickle-down theory of cost containment. The Princeton health economist Uwe E. Reinhardt has called it "a somewhat ugly patch" on "a somewhat ugly system."

With half a billion dollars spent by medical lobbyists each year, according to the Washington-based Center for Responsive Politics, our fragmented profit-driven system is effectively insulated from many of the forces that control spending elsewhere. Even Medicare is not allowed to negotiate drug prices for its tens of millions of beneficiaries, and Americans are forbidden by law to re-import medicines made domestically and sold more cheaply abroad.

And so American patients are stuck with bills and treatment dilemmas that seem increasingly Kafkaesque. The hopeful news is that American health care spending has grown at a slower pace over the past four years. While that is partly because of the recession, economists say, many credit the cost-containing forces unleashed by Obamacare with a significant assist. Even at that rate, many modelssuggest that nearly 25 percent of gross domestic product will be eaten up by health care in 20 years. That is not sustainable.

"It's like a diet you can't just stop, because it's starting to work," said Michael Chernew, an economist at Harvard Medical School. "And remember, we haven't even lost weight yet, we're just gaining weight more slowly."

Many health economists say we must move away from the so-called fee-for-service model, where doctors and hospitals bill every event, every pill, every procedure, even hourly rental of the operating room. Though insurers try to hold down costs by negotiating discounts or limiting reimbursement, this strategy has limited power because armies of consultants now advise hospitals on what is known as "strategic billing": Losing money from trauma patients? Hospitals can add on a $10,000-plus "trauma activation fee." Medicare not paying enough for a broken wrist? Add a separate "casting fee" to the bill.

"People in fee-for-service are very clever — they stay one step ahead of the formulas to maximize revenue," said Dr. Steven Schroeder, a professor at the medical school of the University of California, San Francisco.

Given that national or even regional rate-setting is out of the question, most health economists argue that the nation needs a new type of payment model, one where doctors and hospitals earn more by keeping patients healthy with preventive care rather than by prescribing expensive tests.

Such models exist: A number of hospital and doctors groups engage in so-called capitated care, where they are paid an annual fee by an employer or individual for all patient needs and must work within that budget. The Affordable Care Act promotes a strategy focused on accountable care organizations, in which similar networks can earn financial rewards for figuring out how to save money while meeting standards for good care. But such models are still far from the norm in a country where a majority of physicians are in business for themselves and doctors and hospitals bill separately.

The new law includes a number of incentives intended to nudge doctors, hospitals and insurers to join groups and focus more on value, "but we don't know how well they're going to work," said John Holahan, a fellow at the Urban Institute's Health Policy Center.

For example, the law will tax premiums for the most expensive insurance plans to keep luxury health care spending down. And Medicare, through a value-based purchasing program set up by the law, is providing bonuses to doctors and hospitals for meeting quality-care standards. But those are tentative steps. In fact, recent research published in the journal Health Affairs concluded that the magnitude of bonuses now offered to hospitals was too small to change behavior, noting that even supermarket coupons tended to offer benefits worth well over 10 percent of total value.

The Affordable Care Act generally requires patients to be responsible for more of their bills — copays and deductibles — so they will become more price-savvy medical consumers. But the deck is stacked against them in a system where doctors and hospitals are not required or expected to provide upfront pricing. Why not? They should tell and patients should ask. (In France, before a hip replacement on a private patient, doctors must sign a contract that includes a price.)

And policy makers need to address two of the biggest drivers of our inflated national health care bill: the astronomical price of hospitalizations and particularly end-of-life care.

Obamacare plans cap an individual's annual out-of-pocket spending at $6,350 a year. That (happily) prevents bankruptcy, but it also means that patients will still not be very discerning shoppers when it comes to major hospitalizations, since — in the United States — they've quite likely surpassed their out of pocket maximum by the time they've been formally admitted.

On the private side, some companies and employee health plans are experimenting with new payment models to limit these large bills. They may follow Medicare, which offers hospitals bundled payments for given procedures, or try a technique known as reference pricing, in which they pick a rate they think is fair for a procedure — say $32,000 for a knee replacement, all-inclusive. If a patient wants to go to a hospital with higher fees, the difference comes out of his pocket.

To rein in price increases, companies and insurers have begun offering patients narrower networks, already a major gripe about many Obamacare plans.

And as choices narrow while prices rise, I sense that many patients are no longer so devoted to a market-based health care system. Barbara Felton, 86, was "shocked" when she saw her $12,000 itemized hospital bill for a recent brief stay to repair a fractured femur in Pocatello, Idaho. "I've never been in favor of a single payer before, but now I am," she said, referring to a government-run health system.

The perfect recipe for containing medical costs remains to be written and must be tweaked thoughtfully. After all, the American health care system is a major part of the economy. As Dr. Blumenthal, the former Obama adviser, put it: "If you put our health care system on an island and floated it out into the Atlantic it would have the fifth-largest G.D.P. in the world. It's like saying you have to change the economy of France."

But after a year spent hearing from hundreds of patients like Mr. Abrahams, Mr. Landman and Mr. Miller, I know, too, that reforming the nation's $2.9 trillion health system is urgent, and will not be accomplished with delicate maneuvers at the margins. There are many further interventions that we know will help contain costs and rein in prices. And we'd better start making choices fast.

Elisabeth Rosenthal is a reporter for The New York Times who is writing a series about the cost of health care, "Paying Till It Hurts."

Friday, December 20, 2013

Aging and the Art of Losing - NYTimes.com

This is often how the story emerges: the cold, metal scale in the geriatrics clinic betraying a tightly held secret. "You've lost another four pounds," I say to my patient, an 85-year-old woman who layers multiple shirts against the season's chill and peels them off to reveal skin that hangs on her stooped frame. She wears an oxygen cannula and is mildly short of breath after this exertion. With some taps of the keyboard, I note a 22-pound weight loss in the past two years.

The true tally of her losses is more significant. First there was her husband, who died unexpectedly in the emergency room one winter day. She still will turn and expect to find him sitting in the chair beside her. Another loss was the home they shared. Her children moved her to a senior apartment building so she could be nearer to them. A fall resulted in a fractured pelvis, so that now she slowly negotiates a wheeled walker through the shrinking sphere of her life. It has all been an adjustment. She does not feel like eating when she is alone.

"The art of losing isn't hard to master," writes Elizabeth Bishop in her poem "One Art." "So many things seem filled with the intent to be lost."

In my third year as a geriatrician, a doctor who specializes in the care of older adults, I find these words are often in my mind as I listen to the stories of my patients. I've learned from them that aging is an emotional experience as much as a physical one. Doctors and nurses caring for the growing numbers of elderly need to recognize this.

I take histories from patients well versed in the art of losing: The widower who tries, unsuccessfully, to recreate his wife's pork chops, and instead sustains himself with whiskey and cigarettes in front of a flickering late-night TV. The Air Force veteran with swollen legs who can no longer walk to the bathroom and smells faintly of urine, swearing he would rather take a gun to his head than move to a nursing home.

Sometimes the metal scale is a cruel accomplice, uncovering lapses that can no longer be ignored. One woman, a wisp over 100 pounds and disoriented about time and place, has put plastic storage dishes in the oven and served raw hamburger to her husband. Both of them are shedding pounds, alarming their daughter, who accompanies them from the waiting room and gently, tearfully mentions the slips. Within the year, the husband will be dead and their children will have boxed up the contents of the three-story home where they lived for more than half a century.

One reason I chose geriatrics is that it offers the chance to help older adults have an excellent quality of life, in spite of disability and illness. And for sure, many of my patients continue to lead vibrant, joyous lives in their 80s and 90s — volunteering, traveling, remarrying, spending time with family. One is 97 and takes classes in memoir-writing, music and the Supreme Court. Another, 93, sings in his church choir, bowls in a league and dances the shag at the American Legion.

Still, I know there are some calamities I cannot fix, tragedies so ordinary and yet so singular: A patient, down nine pounds in the past year, who hits her face on the curb when she trips on the way to the store. Her daughter flies in from across the country and finds the refrigerator empty. The older woman misplaces the car keys, accuses the daughter of stealing, grows suspicious that people have been breaking into her house.

When I administer a short test of her memory and executive function, the ability to plan and organize behavior, she becomes flustered and annoyed. She looks at her daughter imploringly, but continues out of politeness. Young enough to be her grandchild, it feels cruel to ask her such ridiculous questions, but I know it is a necessary part of my assessment. I feel crueler still when she is unable to complete the task, and later, when I have to say, "You should not drive anymore."

I can only begin to imagine what it is like for her, and for other patients who lose spouses, confidants, homes brimming with memories. Mobility, independence, dignity. Their minds. Their identities. This is what I'm learning: Although I can't fix everything, I can ease suffering, and offer hope, understanding and dignity.

My patient's daughter has been taking notes in a spiral-bound notebook throughout the visit. I wonder if she will show them to her mother later, as proof of my conclusions and recommendations. When we are finished, the daughter returns the notebook to her tote bag, gathers their belongings – their role reversal an act of love that signifies how much has been lost. They walk down the hall away from here, the old woman taking small, cautious steps, heading out into the waning sunlight.


Ariel Green is a geriatric medicine fellow at the Johns Hopkins University School of Medicine in Baltimore. 


http://well.blogs.nytimes.com/2013/12/19/aging-and-the-art-of-losing/?ref=health

Tackling a Racial Gap in Breast Cancer Survival - NYTimes.com

MEMPHIS — After her doctor told her two months ago that she had breast cancer, Debrah Reid, a 58-year-old dance teacher, drove straight to a funeral home. She began planning a burial with the funeral director and his wife, even requesting a pink coffin.

Sensing something was amiss, the funeral director, Edmund Ford, paused. "Who is this for?" he asked. Ms. Reid replied quietly, "It's for me."

Aghast, Mr. Ford's wife, Myrna, quickly put a stop to the purchase. "Get on out of here," she said, urging Ms. Reid to return to her doctor and seek treatment. Despondent, Ms. Reid instead headed to her church to talk to her pastor.

"I was just going to sit down and die," she says.

Like many other African-American women in Memphis and around the country, Ms. Reid learned about her breast cancer after it had already reached an advanced stage, making it difficult to treat and reducing her odds of survival. Her story reflects one of the most troubling disparities in American health care. Despite 20 years of pink ribbon awareness campaigns and numerous advances in medical treatment that have sharply improved survival rates for women with breast cancer in the United States, the vast majority of those gains have largely bypassed black women.

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http://www.nytimes.com/2013/12/20/health/tackling-a-racial-gap-in-breast-cancer-survival.html?us

Sunday, December 15, 2013

Solving the Shortage in Primary Care Doctors - NYTimes.com

Again and again, we hear that the country has too few doctors, particularly for primary care. And Obamacare is supposed to make the shortage much worse in the coming years as more Americans become insured and try to shoehorn themselves into already crowded medical offices.

But why, exactly, are doctors in such short supply?

I had always assumed the culprit was medical school enrollment. But when I looked into those numbers, I found that they are actually increasing noticeably. Thanks to the opening of new medical schools and expanded admissions at existing ones, enrollment is projected to rise by 30 percent between 2002 and 2017, according to the Association of American Medical Colleges. That's in addition, mind you, to the swelling number of med students studying abroad, with the goal of eventually practicing in the United States.

It turns out that the real bottleneck is at the post-med-school step: residencies, those supervised, intensive, hazing-like, on-the-job training programs that doctors are required to go through before they can practice on their own.

There has been little growth in residency slots; they totaled 113,000 in 2011-12, from 96,000 a decade earlier. Exactly why residencies have not increased faster is a subject of great debate in the health care industry.

Hospitals, doctors and med students usually give the same explanation: Congress is too stingy.

After all Congress, through Medicare, subsidizes the vast majority of residency slots, at $10.1 billion annually, or an average of $112,642 per resident per year. Congress froze the number of subsidized positions in 1997, and hospitals argue that the best way to train more doctors is for Congress to open the spigot and fund more jobs.

Obviously Washington is not keen on doling out more money for anything right now, especially not for Medicare. But there's a bigger problem with that argument: It's not clear that hospitals actually need taxpayer money to pay for more residents, because those residents might actually be turning a profit for those hospitals right now. It's hard to know, though, because hospital accounting is so opaque.

Residents definitely impose a lot of costs, besides the salaries they earn. Those salaries are fairly low — about $50,000 to $65,000 a yearjust slightly more than hospital janitors on an hourly basis. The enormous number of hours they work — about 80 hours a week — is crucial in these calculations. Their 80 hours may not be as productive as 80 hours spent by their supervisors would be, but they're still providing some valuable services during that time, said Uwe E. Reinhardt, a health economist at Princeton and contributor to The Times's Economix blog. Relative to other personnel alternatives, like hiring more nurse practitioners or physician assistants, residents provide relatively cheap, skilled labor.

Costs are only part of the story. "Hospitals don't like to acknowledge that there's anything other than a cost part of the equation," said Gail Wilensky, a health economist who is a co-chairwoman of the Institute of Medicine'sCommittee on Governance and Financing of Graduate Medical Education.

Dr. Wilensky says that most likely, hospitals lose money on residents in the first year, when the doctors just out of med school waste a lot of time and money on unnecessary tests and treatments. But residents' value goes up rapidly because the learning curve is steep, while their salary increases are not.

In fact, one data point that suggests hospitals are currently making a lot of money on the more seasoned residents is the quantum leap in compensation on the day doctors convert their status from trainee to attending physician, under a new job contract. How can a doctor be worth paying only $60,000 on Friday and then at least twice that on Monday? Does the doctor's marginal revenue product — that is, how profitable the doctor is for the employer — actually surge that much?

We don't know exactly how profitable individual residents are for hospitals because the hospitals can't or won't do the complicated accounting to figure it out, at least not publicly. But we can guess, at least, where hospitals believe they make the most money, based on how they've allocated their residency slots (both those Medicare subsidizes, and the 17,000 additional jobs that health care organizations have managed to create through other funding in the last decade).

There's another problem. The types of residencies with the most growth are not necessarily the ones that are most critical for the country's public health needs. They're more often in the lucrative specialties that America's fee-for-service billing system rewards. Think anesthesiology and neurology, and not primary care or pediatrics, where hospitals are more likely to lose money for many years in training a resident because of America's crazy payment system.

"Under our current system, despite the fact that they're getting huge amounts of federal money, there is no requirement that hospitals bring on residents in any kind of work-force-accountable way," said Dr. Fitzhugh Mullan, a physician and health policy professor at George Washington University. "So they're doing what businesses do, by bringing in residents that are most valuable to them."

In other words, hospitals are behaving rationally according to the incentives set up by law. Which brings us back to what Congress can do to help shape the health care work force. Merely funneling more taxpayer money to the doctor training system, as hospitals and med schools hope is done, is not likely to solve the problem. The money needs to be directed in a more deliberate, intelligent way.

There are, of course, other ways to reorganize the health system to alleviate the primary-care doctor shortage. Lawmakers might allow nurse practitioners, pharmacists and other nondoctor clinicians to provide more services, for example. But reshaping the physician work force through targeted subsidies for residents might be a good first step.


http://www.nytimes.com/2013/12/15/business/solving-the-shortage-in-primary-care-doctors.html?hpw&rref=health&_r=0&pagewanted=print

Friday, December 13, 2013

The Art of Dying by Gayatri Devi - Roundtable | Lapham’s Quarterly

The phone rang on Tuesday afternoon, it was Jane.

"I am throwing up blood," she said.

"For how long?" I asked. "What color is it?"

"Since this morning," Jane said. "It is bright red."

Jane was eighty-four, and during the three years in which I'd been her neurologist she'd been having what she called the "dwindles". First one stroke, then the next, then a series of small strokes, each imprisoning her vibrant mind in her small body. Incapacitated, weighing no more than a hundred pounds but still in control of her thoughts, she was living in her apartment on Fifth Avenue, ten blocks from my office at Park Avenue and East 76th Street.

"Jane," I said, "do you want to go to the hospital?"

"No," she said.

"Alright," I said, "you know this is serious, it means you will bleed to death. If you stay home, you will die."

"I know," Jane said, "I'm done."

And I knew it too. Even if we successfully treated this new trauma, I knew that Jane herself would be further diseased, further decimated. I was relieved. The last three years had been a long and painful struggle for us both.

When I first met Jane in the autumn of 1998, I was struck by her abundant energy and formidable intelligence, a handsome woman fiercely committed to a variety of philanthropic causes, who dressed in tailored twill and drove, at high speed, a hunter green convertible with cream leather seats. I'm still not sure why she chose me to be her neurologist, a young woman not long out of her fellowship training, inexperienced as a practicing physician, low on the totem pole of the medical faculty at Columbia University.

Why me and not one at the department chairs, the hospital bigwigs? Maybe she regarded me as one of her causes, along the lines of an unconventional modern building that she thought deserving of landmark status. Soon after we were introduced, she had said, "You are going to be something special."

Three months later she said, "Can I have a copy of your book?"

"What book?" I said. And then, of course, I wrote one.

Jane had a way of making things happen, saving beautiful old buildings from the wrecking ball by browbeating donors into donating, legislators into legislating. On that Tuesday afternoon in August I hurried over as soon as I could. Sam, Jane's husband, opened the door. He was a slight man, courteous and old-worldly, dressed like a country squire, his gray hair neatly combed back, the lapels of his jacket lying flat against his chest.

"Steve is here," Sam whispered in the foyer, nodding toward the bedroom. "He wants Jane at the hospital immediately. He wants us to call 911."

"And you, Sam?"

"I am with Jane. She's been just as brave as can be." Sam eyes became watery. He cried each time she had a stroke. He cried when he laughed. In the last few months, just the mention of Jane was enough to get Sam crying. But Sam also cried when the stock market hit a new low and when he saw a beautiful piece of art. Tears came easily to Sam, and gloriously, unabashedly, rolled down his rosy cheeks as they must have doing since he was a child.

Steve was Jane's plastic surgeon. This being the Upper East Side of New York City, plastic surgeons were as important as neurologists, often more so. Jane, in her pragmatic, no-nonsense way, had had some "work" done in her later years. She saw no need to defend the mingling of the natural and the artificial. Her ability to combine disparate elements into a serene whole was one of her signature and inexplicably endearing features.

I went into Jane's bedroom, a large, high-ceilinged, draperied Fifth Avenue room overlooking Central Park, airy and light despite the period French furniture. Swirling around Jane in this room now was Marta, the maid, Lulu, Jane's silky, energetic terrier, and, of course, Steve. He was wearing a blue polo shirt and khaki slacks, his dark hair slicked back over a handsome, Slavic face upon which quite some "work" had at some time been done. Steve had the type of preternaturally taut, middle-aged body that only good surgical suctioning achieves.

Seeing the buzzing around Jane lying prostate in bed, I felt myself on the set of the Ars Moriendi, the small medieval manual featuring eleven woodcuts on how to die the Good Death. The scenes are more crowded than the main floor of Barney's at Christmas season, teeming with saints, devils and people. The devils slither around and under the dying person, the Moriens, while the saints hover above and around the bed. Relatives and friends run off with the horses in the stable and the fine wine from the cellar of the soon-to-be-dearly-departed.

In twenty-first century America, there is no such "how to" manual on dying. Nor does our state-of-the-art modern medicine offer much help.

Fact: Seven out of ten Americans wish to die at home, die the Good, the Valid, Death.

Jane abhorred whispering, so Steve and I included Jane in our discussion of the mechanics of her death.

Fact: Seven out of ten Americans die in institutions, intubated, infiltrated, invalidated.

"This is a treatable problem," Steve said.

"Yes," I said, "but she is going to be worse off afterward."

We went back and forth like this for half an hour. Jane and Sam listened intently, following the argument like spectators at a tennis match. In the end, Steve acquiesced even though his suggestions were in line with what my hospital colleagues would recommend. What I was proposing was not the medical norm.

I felt wobbly and unsure. Steve had decades more experience as a physician. What if he was right and I was wrong? What if it was wrong to agree with Jane and let her go, wrong to let her die? I had never helped anyone die before. How would I go about doing this? There were many colleagues I could ask to help me help Jane live, but I couldn't think of anyone to call to help me help Jane die. I could, of course, hand her off to a hospice team, an end-of-life, medical clean-up crew. But this felt like a shirking of responsibility, an abandonment of my patient in her time of need, so that I would be spared the discomfort. The opting out seemed to me cowardly.

I told Sam to alert everyone in the family. The time, I said, had come.

"How long?" Jane asked me. I didn't know how to answer the question.

I looked at Lulu, at her perky, twitching ears and her eyes shimmering in moist health. She lay on the pillow next to Jane, occasionally swishing her little tail the way dogs do when they are being looked at. I was trying to see if she knew, as dogs often know things that people don't, but Lulu just kept on peering mutely back at me.

"It could be in a few days," I said. "We will make sure that you stay comfortable."

We? Who was the "we"? In my tentative foray into this new territory of helping someone die, I was waving the flag of the larger medical establishment to reduce my vulnerability and make me feel and seem more authoritative.

"Okay," Jane said, squeezing my hand. The firm way Jane grasped my hand said in so many words that she was putting her trust in the specifics of me, not in the nebulous "we" of established medicine.

Steve's disapproval was like a thick fog in the room. I kept my posture erect as I left, walking very slowly, measuring the pace of my feet and breathing in and out. Once off stage, I sprinted to the elevator as if I was being chased.

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http://www.laphamsquarterly.org/roundtable/roundtable/the-art-of-dying.php?src=longreads

Thursday, December 12, 2013

A Doctor's Formula for Care - NYTimes.com

It was almost 15 years ago that I set my personal record, since equaled but never exceeded, of 18 patients seen in the course of a single afternoon. What I remember are not the details of that particular day — all days are hectic for one reason or another — but a conversation I had at a party a short time later.

With nothing much else to discuss with another guest, also a doctor, I modestly mentioned my record. He smiled indulgently and replied that he averaged more like 60 primary-care visits a day.

For some time afterward, I compulsively redid the math (he spent around eight minutes per patient, hour after hour) and idly fantasized about his office, which clearly included a small army of medical assistants, other capable souls to handle phone, fax and paperwork, and extraordinary data-retrieval abilities for labs and tests. And a lot of agreeably healthy patients. Or maybe they were too sick to talk much. Did the man eat? I wondered. Did he type? Perhaps a court reporter stood by.

Of course, when I heard a few years later that the state had closed his office and stripped him of his medical license, a whole new set of images came to mind.

I am hardly alone in these fantasies: Every medical administrator in the country has the same obsession with physician productivity, from the happy daydreams of smooth high-throttle operation to the nightmares of wipeout if the machine spins out of control.

For some medical metrics, the sky's the limit — we aim for zero complication rates, 100 percent adherence to various required annual screens. But performance statistics always come with a natural cap. The cheetah maxes out at 60 miles per hour or so, and no American cow has yet provided more than 7,000 gallons of milk a year. How fast, then, can a domestic physician move? How much health can one produce?

Everybody approaches the math a little differently, wielding different units of measurement. Some think only in dollars, with yearly income goals that are self-imposed or set by an employer. The less said about them the better.

A more legitimate unit of productivity is the number of patients in a doctor's practice — the patient panel, to use the technical term. American primary care providers have long been estimated to work smoothly if they care for about 2,300 patients each, at an average rate of 3.3 visits a year, which works out to 25 visits a day, including Saturdays.

Some authorities now worry this number may be much too high. Even without factoring in the exploding paperwork, the list of tasks each patient brings to the office is growing with body mass. The average American general practitioner is now estimated to worry about a total of 417 cases of uncontrolled cholesterol, 312 cases of uncontrolled high blood pressure, 91 cases of uncontrolled diabetes, a few hundred of these same problems under good control and then a variety of other chronic illness in various states of disarray.

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http://well.blogs.nytimes.com/2013/12/09/a-doctors-formula-for-care/?src=recg

Wednesday, December 11, 2013

Curb ‘weekend effect’ at hospitals to make Saturday or Sunday admittance less risky for patients: study

For 20 years, the evidence has piled up in study after study: Patients admitted to hospital on the weekend are more likely to die or have poor outcomes, as reduced staff levels cause delays in tests and treatment.

Yet the health-care system has done little or nothing to address the problem, say two Canadian doctors who have just published a call to action for hospitals to curb the so-called "weekend effect."

The problem is complex and the solutions would be no less so, but it is time for health care to "restructure the hospital work week" and make Saturday and Sunday just as safe for patients as any week day, they said.

Other doctors who have studied the problem echoed their appeal, suggesting that even relatively minor, inexpensive changes could save lives.

"It really is a pervasive thing that has happened in multiple aspects of medicine," said Dr. Chaim Bell, co-author of the new article in the journal BMJ Quality and Safety. "The problem has been trying to get a call to action. It's hard to change an ingrained approach to care and organizational structure."

One prominent patient advocate suggested Tuesday that achieving an overhaul of scheduling that resulted in more shifts on Saturday and Sunday might, in fact, be all but impossible.

"Health care is delivered primarily by middle-class people," said Sholom Glouberman, spokesman for the group Patients Canada. "Doctors tend to be upper middle-class people, and they tend to arrange their lives so they don't work on the weekend."

A representative for many of the country's hospitals, meanwhile, said he welcomed Dr. Bell's editorial, while calling for more study.

"This research is important," said Anthony Dale, interim CEO of the Ontario Hospital Association. "A first step will be to fully understand the facts behind the findings, such as prevalence and contributing factors, so that they can be properly examined and addressed."

In the meantime, patients should not fear going to hospital on the weekend, but ask caregivers if any delay in testing or therapy is safe, experts say.

Dr. Bell, an internal-medicine specialist at Toronto's Mount Sinai Hospital, along with colleague Dr. Donald Redelmeier of the city's Sunnybrook Health Sciences Centre, have been among the pioneers of research in the area. Their 2001 review of Ontario hospital data found patients admitted on the weekend were significantly more likely to die of 23 common, potentially fatal conditions, and no less likely to die from other ailments.

The medical literature over the past several years has been replete with similar papers, bearing titles like "Don't get sick on the weekend" and "Weekends: a dangerous time for having a stroke?"

A U.S. study published this year found a relatively modest 3% increase in mortality for patients admitted to hospital on the weekend. But that would translate into "thousands and thousands" of potentially preventable deaths, said Dr. Adam Sharp, a University of Michigan emergency-medicine doctor and co-author of the research.

"The day of the week should not predict whether you die or not, no matter how small the difference," he said.

A 2007 Canadian study suggested that stroke patients who landed in hospital over the weekend were 14% more likely to end up dead.

"If you look at how many cars are in the parking lot on weekends, versus the weekdays, you will realize the basic difference," said Dr. Gustavo Saposnik, a neurologist at Toronto's St. Michael's Hospital and the lead author. "And that is obviously translated into the care, the number of providers available to provide excellent care."

Researchers stress that they can only speculate about the reasons for the weekend effect. As well as fewer staff and the resulting delays, it could also be a function of less-experienced, more junior nurses and doctors being on duty, they say.

And the solutions are not as simple as they might appear. A wholesale scheduling change that allowed hospitals to function at the same level on the weekend as during the week would likely be prohibitively expensive and unnecessary, said Dr. Sharp.

It will be important to focus on specific areas where weekend care is proven to lead to poor patient outcomes, and address them directly, Dr. Bell said.

In the care of stroke patients, that does not necessarily mean having more people on duty, said Dr. Saposnik. Much could be done by ensuring weekend staff are trained to perform key tasks, he said. Those include swallowing assessments designed to ensure patients do not aspirate food into their lungs — a potential source of infection — and simply getting stroke sufferers to walk around, staving off potentially dangerous blood clots in their legs.

Mr. Glouberman suggested, however, that energy should be focused, not on beefing up hospital services on the weekend, but improving community-based care for people with multiple illnesses, partly by training more multi-skilled geriatricians.

That way, such patients would be less likely to have to be admitted to the hospital — on any day of the week, he said.


Tuesday, December 10, 2013

The Nastiest Injury in Sports - Grantland

To be honest, it doesn't look like much. It's short, just over an inch in length, and stubby, about half an inch wide. It is white, slick, and striated like a cluster of angel-hair pasta. It isn't rubbery, and it doesn't have much elasticity. In fact, you wouldn't give it a second thought — not until it self-destructed, which it occasionally does, always at the most inopportune of times. And then you wouldn't think about much else butthat gremlin that now sits at the center of so many of our games. It was there when Kansas City Chiefs safety Bernard Pollard dove at Tom Brady's knee on the 15th offensive snap of the Patriots' season in 2008. It was there in December 2011 when Adrian Peterson went up the middle for three yards in the third quarter. It was there when Derrick Rose landed awkwardly during the first game of the 2012 playoffs, making him grimace in agony and sending him to the sidelines for over a year. It was there two years ago when Mariano Rivera was shagging flies in Kansas City and tripped over the apron to the warning track, ending his season. It was there just this last weekend when Cleveland Browns safety T.J. Ward crashed into the knee of Patriots tight end Rob Gronkowski. It has been there for Mickey Mantle, Wes Welker, Jerry Rice, Ricky Rubio, Donovan McNabb, Craig Biggio, and Tiger Woods, to name just a handful. That gremlin is always there — just waiting to pop.

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An effective eye drug is available for $50. But many doctors choose a $2,000 alternative. - The Washington Post

The two drugs have been declared equivalently miraculous. Tested side by side in six major trials, both prevent blindness in a common old-age affliction. Biologically, they are cousins. They're even made by the same company.

But one holds a clear price advantage.

Avastin costs about $50 per injection.

Lucentis costs about $2,000 per injection.

Doctors choose the more expensive drug more than half a million times every year, a choice that costs the Medicare program, the largest single customer, an extra $1 billion or more annually.

Spending that much may make little sense for a country burdened by ever-
rising health bills, but as is often the case in American health care, there is a certain economic logic: Doctors and drugmakers profit when more-costly treatments are adopted.

Genentech, a division of the Roche Group, makes both products but reaps far more profit when it sells the more expensive drug. Although Lucentis is about 40 times as expensive as Avastin to buy, the cost of producing the two drugs is similar, according to scientists familiar with the drugs and the industry.

Doctors, meanwhile, may benefit when they choose the more expensive drug. Under Medicare repayment rules for drugs given by physicians, they are reimbursed for the average price of the drug plus 6 percent. That means a drug with a higher price may be easier to sell to doctors than a cheaper one. In addition, Genentech offers rebates to doctors who use large volumes of the more expensive drug.

"Genentech continues to maintain that Lucentis is the most appropriate medicine," the company said in a statement, adding that it costs "significantly" more to make and is tailored for use in the eye. The drug "has made an immense impact."

Many ophthalmologists, however, are skeptical that it provides any added value over the cheaper alternative.

"Lucentis is Avastin — it's the same damn molecule with a few cosmetic changes," said J. Gregory Rosenthal, a Toledo ophthalmologist who, outraged by the price, co-founded a group called Physicians for Clinical Responsibility to protest its use. "Yet Americans are paying a billion dollars every year for no good reason — unless you count making Genentech rich."


The story of Genentech's two drugs, Lucentis and Avastin, began with a scientific marvel — a breakthrough in biology that, thanks to the vast budgets of U.S. entitlement programs, has produced enormous financial returns.

Those profits have yielded benefits. By paying for such drugs without regard to cost, the Medicare system has helped stimulate investment in medical research that contributes to the development of more lifesaving technologies.

But the flow of cash also pushes up the health-care costs that are projected to deplete federal budgets. For while Genentech has aggressively marketed the more expensive drug and sought to restrict the use of the cheaper one, critics say, Medicare has been powerless to do anything but pay up.

That's because over the past seven years, despite pleas from the Food and Drug Administration and doctors groups, Genentech has maintained the barriers that make it harder for doctors to use the cheaper drug.

Avastin was not originally intended for use in the eye, and the company has refused encouragement from the FDA to seek official approval for using it to treat eye ailments, according to unpublished internal FDA documents. This forces doctors to use it "off-
label," or in ways not specified on the medicine's label.

The company also packages the drug, which was approved for cancer in 2004, in doses far too big for use in ophthalmology, meaning that the drugs must be repackaged by other companies for use in the eye, raising the risk of contamination.

Genentech has argued that Avastin may pose a greater danger of severe side effects than does Lucentis, although independent scientists say such worries are unsupported by the six trials that have been conducted.

In a statement, the company said that it has not sought FDA approval of the cheaper drug for use in the eye because it has already developed one drug for the ailment known as wet age-
related macular degeneration, or wet AMD.

"Genentech continues to maintain that Lucentis is the most appropriate medicine for wet AMD as supported by clinical and other scientific data," the statement said.

"We specifically designed Lucentis for use in the eye and to clear quickly from the bloodstream after leaving the eye to potentially minimize side effects," the statement said. "The two medicines were designed for different purposes and, we believe, may have different systemic and ocular safety profiles when used in the eye."

Genentech defended its pricing by noting that the Roche Group spends $9 billion annually on research and development.

"The price of Lucentis supports the research and development of new potential medicines, including the 92 percent of drugs that never make it to patients," the company said. "We re-invest a larger portion of our revenue into clinical research than most pharmaceutical companies. Genentech believes it is in the best interest of patients to continue to focus our efforts in ophthalmology on discovering and developing new potential medicines for other serious diseases of the eye."

Most doctors, however, prefer to use the cheaper drug. Despite the company's position, U.S. doctors have been using Avastin in about 56 percent of such cases, according to Medicare data analyzed by The Washington Post. In the most recent survey by the American Society of Retinal Specialists, about 61 percent of doctors preferred using Avastin for macular degeneration, with the rest of the market split between Lucentis and Eylea, a new drug made by Regeneron that is almost as expensive as Lucentis.

Because so many doctors continue to use Lucentis, Genentech has rung up more than $1 billion in U.S. sales of the drug for four years running. Roughly 80 percent of U.S. sales are paid for by Medicare and its beneficiaries.

The rising cost of U.S. entitlement programs such as Medicare has prompted outrage in Congress, but it is Congress that has made it difficult in this case and others for Medicare to limit such expenses.

To begin with, the Medicare agency is blocked from seeking better drug prices by negotiating directly with the drug companies, as health agencies in other countries do. Authorities in Britain, for example, have negotiated a price of about $1,100 per dose of Lucentis, and in the Netherlands a dose sells for about $1,300.

Moreover, in cases in which two equivalent options are available, such as Lucentis and Avastin, Medicare is forbidden from restricting payment to the amount of the less costly alternative. After it sought to do so in 2009, a federal appeals court said it lacked that authority.

It's often difficult, of course, to know when two drugs are equivalent. When the debate over the two drugs and their pricing erupted more than six years ago, Genentech asserted that its more expensive new drug was superior. At the time, it was hard to show otherwise. No one had tested them in side-by-side comparisons.

Since then, the six randomized clinical trials involving more than 3,000 patients have found the drugs to be largely equivalent.

Yet in 2012, the Medicare program and its beneficiaries spent $1.2 billion on Lucentis, according to The Post's analysis of Medicare data.

Medicare officials said they have no choice but to pay the bill when a doctor prefers to use Lucentis.

"We do not have the authority to dictate treatment based on cost," Tami Holzman, a spokeswoman for the Centers for Medicare and Medicaid Services, said in a statement. "Under current law, Medicare must cover treatment that is deemed reasonable and medically necessary by a physician or other provider."

Pharmaceutical firms argue that this is the way it should be.

The industry's main lobbying group, known as PhRMA, opposes allowing the government to negotiate prices with companies — a process it calls "price controls" — and similarly opposes attempts by Medicare to pursue a policy of paying only for the least costly alternative.

The industry has spent more than any other in the United States to have its voice heard in Washington. Over the past 15 years, the pharmaceutical industry has far outstripped any other in the money it has devoted to lobbying, according to data from the Center for Responsive Politics. Drug companies spent a total of $2.7 billion over that time.

"Proposals to change this system by imposing price controls or only giving patients access to treatments deemed the 'least costly alternative' by Medicare would have severe unintended consequences," Matthew Bennett, a senior vice president at PhRMA, said in a statement.

Such proposals could discourage medical progress, he said. Moreover, because every patient responds differently to a treatment, it may be difficult for the government to set rules for coverage.

"The cheapest option on average is not always the best option for many patients," he said.


What's the right price for a miracle?

Every year, about 200,000 people in North America are diagnosed with wet age-related macular degeneration, a chronic disease characterized by abnormal blood vessels that leak blood or fluid into the retina.

Sufferers lose clarity in the center of their field of vision, and among older people it has long been the leading cause of blindness.

Then came Avastin and Lucentis.

Both are the outgrowth of pioneering work done by Napoleone Ferrara, a Sicily-born molecular biologist.

Ferrara studied at the University of California at San Francisco and joined Genentech in 1988. First assigned to the company's efforts to develop a hormone called Relaxin, Ferrara devoted his discretionary research to a theory that blood vessel growth could cause cancer and other illnesses.

Over several years, Ferrara and his collaborators identified a protein called VEGF that causes blood vessel growth. They then linked that protein to cancer and macular degeneration. Finally, they developed an "anti-VEGF" drug that would attack VEGF, halting the harmful blood vessel growth.

The first anti-VEGF drug was Avastin, which won approval from the FDA in 2004 for the treatment of colorectal cancer.

Lucentis followed. It is a stripped-down version of the same molecule, and it can likewise attack VEGF and bind more closely to it. It won FDA approval in 2006.

"People weren't sure that VEGF would prove particularly important, but sometimes in science, you just follow your own ideas," said Ferrara, now a distinguished professor at the University of California at San Diego School of Medicine. "The magnitude of the benefit of these drugs far exceeded our expectations."


The company spent almost $1.4 billion on the development of Lucentis, which included 18 clinical trials, a Genentech vice president testified to Congress in 2011.

The company appears to have recovered those costs and quite a bit more.

In the first 2 1/2 years, it sold $2.1 billion worth of Lucentis in the United States alone. Another Swiss company, Novartis, in partnership with Genentech, sells billions more overseas.

Much of that is profit.

The company will not disclose how much it costs to manufacture a dose of Lucentis, saying only that it costs "significantly" more to make than Avastin. But scientists knowledgeable about manufacturing drugs of this kind say that the costs of making Lucentis are not much different from those of making Avastin.

Indeed, some scientists said that some aspects of Lucentis make it cheaper to produce.

The Avastin process begins with growing a culture from mammalian cells taken from the ovary of the Chinese hamster.

The Lucentis process begins with growing cultures of the common bacteria E. coli, and these are easier to produce.

The subsequent purification process with bacteria may be more complicated, but "production in bacteria is cheaper than in mammalian cells for several reasons," said Hervé Watier, a medical professor at the University of Tours in France who has studied the drugs.

While there are some "drawbacks" to the bacteria production method, Watier said, "the financial result still remains in favor of bacteria."

"I think the difference in cost in producing them is very modest. They cost almost the same, from what I can tell," Ferrara said.

If so, Genentech is making a lot on each dose. The manufacturing costs may account for 10 percent or less of the price of a Lucentis dose, according to a conservative calculation generated with industry experts.

The company declined to reveal how much it is making from Lucentis above the drug's manufacturing costs.

"Lucentis and Avastin are not the same medicine and should not be treated, nor represented, as if they are," the company said in a statement.


After the development of Lucentis in the early 2000s, it was the only drug known to have such effects.

It seemed to be in a class by itself and seemed poised to win even more in sales than it gathers today.

But then Philip J. Rosenfeld, a Miami ophthalmologist, made a discovery.

Rosenfeld was lead investigator on some of the Lucentis trials that Genentech had conducted, and he recognized how effective it could be.

After reading the research that some Genentech scientists had published, he realized that Avastin and Lucentis were derived from the same antibody and thus were functionally equivalent.

"I realized they would perform in the same way," he said.

Under a university-approved research program, he'd also learned that Avastin, injected into a patient's arm as is done with cancer patients, had the same effects as Lucentis. The trouble was, since the Avastin was going into the entire body, a large dose was needed, and that could produce dangerous side effects. He calculated that a much smaller dose injected into the eye would be just as effective as Lucentis.

In May 2005, Rosenfeld had a patient who was quickly losing her vision. A retired nurse in her 60s, she'd lost the use of one eye already, and none of the available remedies could slow the disease's progression.

Rosenfeld knew that Lucentis could help her, but it would be another year or more before the FDA would approve it.

With the patient's permission, he injected her eye with a small dose of Avastin — one milligram — and ordered her back the next week.

"We were astounded by the results," he said.

The billion-dollar drug Lucentis was about to be beaten to market, and by one of Genentech's own products.

In July 2005, Genentech held what amounted to a coming-out party for its new drug.

At the annual meeting of the American Society of Retinal Specialists, the company presented several detailed studies showing how effective it was in treating macular degeneration. With hundreds of ophthalmologists crowded into the room, speakers for Genentech described the marvel of Lucentis.

"Our jaws were on the floor," recalled Daniel F. Martin, chairman of the Cole Eye Institute at the Cleveland Clinic.

Right after, Rosenfeld presented his Avastin experiment on one patient.

"Phil showed one case report — no animal studies, no randomized trials," Martin said. "But after this meeting, every ophthalmologist on the planet was injecting it. The therapeutic effect was so powerful."

Because Lucentis had yet to win FDA approval and couldn't be sold, ophthalmologists quickly embraced Avastin, which had been approved the year before, albeit as a cancer remedy.

When Lucentis did go on sale, Genentech's blockbuster drug already had a competitor. How could the company convince doctors and hospitals that Lucentis had any major advantage over Avastin?

Over and over again, it sought to discourage the use of Avastin by raising concerns about its safety.

They told doctors that Avastin was not approved by the FDA for use in the eye — Lucentis was. They reminded doctors that if the repackaging firms cutting Avastin into smaller doses were careless, infection could be introduced. And despite the lack of conclusive evidence on the point, they said that Avastin patients might suffer more adverse events than Lucentis patients.

Sometimes, senior FDA officials said, these warnings stretched the truth.

In October 2007, the company announced a move that would severely restrict the supply of Avastin for ophthalmology: It would no longer sell the drug to the repackaging firms that were cutting it into eye-appropriate doses.

The company's president of product development at that time, Susan Desmond-Hellmann, explained in a letter that Lucentis was already available. Moreover, she said that during a routine FDA inspection of the company's Avastin manufacturing facility, "concerns were raised by inspectors related to the ongoing ocular use of Avastin because it is not designed, manufactured or approved for this use."

An FDA ophthalmology official, Wiley A. Chambers, told colleagues that the company had misconstrued the agency's position.

That routine FDA inspection at a Genentech plant, Chambers told his colleagues, was unrelated to the intrinsic safety of Avastin in ophthalmology. Instead, it showed that Avastin had been contaminated by glass particles, a danger that could have harmed cancer patients or eye patients.

"Genentech has found a way to blame FDA for their decision to limit the distribution of Avastin," Wiley wrote to colleagues in an e-mail. "The manufacturing problem at their facility that resulted in glass in their product would be an issue for either the on-label oncology indications or the off-label ophthalmology indications."

Genentech said in a statement: "We have never sought to restrict the ability of physicians to prescribe Avastin as they see fit for their patients. . . . Genentech did not blame the FDA and took the decision independently."

Eventually, after ophthalmologists and their professional societies strenuously objected to Genentech's move to limit Avastin sales — they even threatened lawsuits to make sure the flow of Avastin continued — Genentech backed down and continued to provide the drug to the repackaging firms.

About the same time, Genentech asked the FDA for permission to change the Avastin label to instruct doctors that it was not to be used for eyes. The FDA said there was no evidence to support such a change to the label.

The FDA believed "there was no safety-related basis adequately justifying that labeling change," according to an internal agency e-mail, and the label was not changed.

Today, millions of doses of Avastin have been administered successfully. Six randomized clinical trials around the world, beginning with one called Comparison of AMD Treatments Trials, have found its effectiveness equivalent to that of Lucentis. After the CATT study, the National Institutes of Health issued a news release headlined, "Study finds Avastin and Lucentis are equally effective in treating age-related macular degeneration."

The effort was funded by the NIH because Genentech had refused to test the drugs itself and, in a break from industry custom, had refused to provide the drugs to government researchers. An internal company document described the strategy of not performing a test or contributing the drugs as "in the interests of shareholders and the interests of patients," according to a Senate Aging Committee investigation memo from 2008.

Because it had developed Lucentis, the company said, "there was no need to invest substantial resources and years of clinical development to explore the safety and efficacy of another medicine."

Since the CATT study, five more head-to-head trials have been conducted. They also found Avastin just as effective as Lucentis.

"There have now been six randomized clinical studies that show no difference in the major areas of safety concern — deaths, heart attacks and stroke," said Martin, the Cleveland Clinic doctor who also led the CATT trial.

Indeed, Genentech has acknowledged that the drugs are similarly effective. But the company has argued that Avastin may be dangerous when used in eyes.

"The emerging data consistently show differences in safety — particularly in systemic serious adverse events — between Lucentis and Avastin," Anthony P. Adamis, global head of ophthalmology at Genentech, said in an interview.

These differences are "biologically plausible," Adamis said, because studies have shown that Avastin remains in the blood longer.

The main basis for Genentech's safety argument is a finding in the CATT trial that has not reappeared in any of the following five trials and that some scientists involved regard mainly as a curiosity.

The incidence of what are known as serious adverse events — a catchall category that includes hospitalizations for any reason — was slightly higher in the Avastin group: 40 percent vs. 32 percent. The adverse events included broken bones and urinary tract infections.

"The majority of the adverse events would be difficult to imagine being caused by the drug," Martin said. Martin noted that while small, probably random effects favored Lucentis in some cases and in others they favored Avastin. Neither should be viewed as conclusively related to the drug, he said.

It is very difficult for such trials to detect differences in rare safety events. To do so, a trial might need more than 10,000 patients. Running a trial of that size could cost billions of dollars.

To look for effects in large numbers of patients, researchers often turn to Medicare claims records, examining how patients fared on the treatments in question. It is this kind of review that Lesley H. Curtis, a Duke University medical professor, performed, looking at 146,000 patient claims.

After fully adjusting for patient and provider characteristics, Curtis and her colleagues found that there was no difference in the safety profiles in the drugs.

"In conclusion, we found no evidence of increased risks of mortality, myocardial infarction, bleeding, or stroke," their research paper said.

The other danger to using Avastin, however, has attracted a lot of publicity in recent years.
The fact that the drug needs to be repackaged into smaller doses introduces an element of risk because it opens the possibility that the drug could be tainted during the repackaging process. (Genentech says because the FDA has not approved it for use in the eye, the company cannot legally distribute Avastin in doses appropriate for the eye.

Indeed, in three cases that made the news — in South Florida, Nashville and Los Angeles — just such a problem has arisen. Several patients reportedly suffered vision loss as a result.

"I've never used Avastin because of the potential for contamination," Warren L. Herron Jr., a Pensacola, Fla., ophthalmologist, said after a morning in which he did 11 eye injections. "Is it a rare thing? Yes, it's a rare thing. But I can't stand the idea of ever telling my patients that they can no longer see because I used a tainted drug.

"Besides," he said, "I don't think the extra money being spent for Lucentis is totally wasted because it's going into research and development."

But as Herron noted, the likelihood of contamination is negligible. Globally, hundreds of thousands of injections are doled out every year without trouble, making the risk of contamination in repackaging smaller than the risks that doctors routinely ignore when deciding on a treatment.

Whether a patient gets Avastin, Lucentis or the new drug Eylea depends on an array of factors. Some doctors use only one of the drugs; some let their patients choose; many decisions are guided by whether the patient's insurance covers the entire cost or just a portion; and some doctors may consider how much they earn with each drug.

John Thompson, a Baltimore ophthalmologist who is president of the American Society of Retinal Specialists, noted that most doctors use Avastin and that even more would do so if the company sought FDA approval for using it in eyes and packaged it in appropriate doses.

"If Genentech decided to get FDA approval and make Avastin available in small quantities for the eye," he said, "the American Society of Retinal Specialists would applaud."

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