‘Change has come to America’

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The Test

NEWYORKER.COM, November 4-10th 2008, by Steve Coll – In 1934, President Franklin Roosevelt asked Frances Perkins, his Secretary of Labor, to draft a plan that might help Americans escape poverty in old age. “Keep it simple,” he told her. “So simple that everybody will understand it.” On August 14, 1935, after bargaining in Congress, Roosevelt signed the Social Security Act at a White House ceremony. The law “represents a cornerstone in a structure which is being built but is by no means complete,” the President said. He continued:

It is a structure intended to lessen the force of possible future depressions. . . . It is, in short, a law that will take care of human needs and at the same time provide the United States an economic structure of vastly greater soundness.

Roosevelt hoped that the elderly would also receive health insurance; Congress balked. It took thirty years—until July 30, 1965, when Lyndon Johnson signed the Medicare bill—to protect older Americans from the ravages of sickness as well as poverty. These were Democratic initiatives, but they gradually became national compacts: Ronald Reagan defended Social Security, and George W. Bush expanded Medicare. They, too, came to recognize that a sound system of social insurance enabled by government makes capitalism and its splendid innovations (the iPhone, the Cartoon Network, the Ultimate Fishing Tool, etc.) more balanced and sustainable.

Last week, the Department of Commerce reported that the economy is shrinking. Almost certainly, the United States has entered its twelfth official recession since Roosevelt’s death. Most of the past eleven recessions have been short and mild, in part because of the “automatic stabilizers,” as economists call them, created by New Deal-inspired insurance and regulatory regimes. The current financial crisis, however, has already proved so severe and so volatile that it has smashed or bypassed a number of important shock absorbers. Some economists fear that this downturn may therefore be atypically long and painful.

The country is fortunate in one respect: the sudden buckling of financial safeguards has put just about everyone in touch with his inner New Dealer. Even Alan Greenspan recently confessed to Congress a crisis of faith in self-regulation. Meanwhile, former free-market true believers in the Bush Administration have tossed out money from the public vault like looters, and just as untidily; if they can sort out exactly what they have done, the Treasury’s mandarins must soon prepare PowerPoint presentations to document for their successors the most expansive nationalizations undertaken in the United States since the Second World War. The Administration seems giddy with a discovery familiar in the palaces of certain despots: yes, you can just print the bills on your own presses and hand them out to your friends.

Embedded in this festival of emergency measures, however, is an important and possibly durable ideological shift. Last week, in an op-ed in the Washington Post, Martin Feldstein, the chairman of the Council of Economic Advisers in the Reagan Administration, and, more recently, an adviser to John McCain, endorsed large-scale spending on public works as a way to stimulate economic recovery. This was a bit like Al Gore embracing coal. The essay’s appearance indicated that a broad coalition is emerging, where none existed a year ago, in favor of New Deal-style expenditures on roads, bridges, broadband lines, alternative energy, and the like, to support economic recovery and future growth. Such investment could strengthen the economy for a generation, as Eisenhower’s Interstate Highway System did.

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It’s not enough, of course, just to be like Ike. The campaign of 2008 was notable for its misleading narratives about how Presidents are tested. From the wacky competition over 3 A.M. phone calls to McCain’s alleged campaign suspension, it was suggested repeatedly that Presidents are best measured by their day-to-day crisis-management skills. Of course, sound judgment under pressure is essential to a successful Presidency, and its absence can prove disastrous (see Bush, post-Afghanistan; see Bush, post-Katrina). Coolheadedness on its own is sometimes enough to earn lasting gratitude (see Kennedy, Cuban missile crisis). Yet, great Presidencies can arise only from great causes. To define them and deliver on them is the truer test of the officeholder.

The next Presidency has within its reach at least two generation-spanning causes: the need to jump-start a new energy economy, and, in so doing, help to contain climate change; and the need to enact a plan to provide quality health care to all Americans, and, in so doing, complete the project of social insurance that Roosevelt described in 1935. Each of these projects is urgent, but it is health-care reform that speaks more directly to the economic and human dimensions of the present downturn.

The accumulating failures in the country’s health-care system are a cause of profound weakness in the American economy; unaddressed, this weakness will exacerbate the coming recession and crimp its aftermath. A large number of the country’s housing foreclosures in recent years appear to be related to medical problems and health-care expenses. American businesses often can’t afford to hire as many employees as they would like because of rising health-insurance costs; employees often can’t afford to quit to chase their better-mousetrap dreams because they can’t risk going without coverage. Add to this the system’s moral failings: about twenty-two thousand people die in this country annually because they lack health insurance. That is more than the number of Americans who are murdered in a year.

Presidents who help right a wrong of this character are generally immortalized in granite, but to succeed they require a transformation-minded Congress, too. The next Congress will likely be without the active leadership of its great lion of social reform, Ted Kennedy. There is only one senator with the wonky expertise, work habits, and political stature to fill Kennedy’s place: Hillary Clinton. The psychology she would bring to this inheritance would surely be complex, but no health-care-reform bill will pass without her. Lyndon Johnson, also a person of complex psychology, understood this politics of legacy well. At the Medicare signing ceremony, he invited Jimmy Roosevelt, F.D.R.’s eldest son, and the aging Harry Truman, who had pushed hard for health-care reform, to share the glory. Johnson, in his remarks, linked them (and himself, of course) to the Social Security Act and its “illustrious place in history,” and he carefully recited an “honor roll” of fifteen congressional leaders who contributed to the bill’s passage. It was, Johnson said, a “time for triumph.” It is, even more so, today.

New Online Network Improves Patient Safety; Reduces Paper and Medical Liability.

PharmaLive.com, October 31, 2008 — The newly launched Health Care Notification Network (“HCNN”) has just delivered the first online drug alerts to U.S. physicians. The alert focused on a widely manufactured and commonly used class of antibiotics and was sent immediately via the HCNN to health care providers, who are no longer forced to wait days or weeks for a traditional “Dear Doctor Letter” to arrive via U.S. mail.

“The HCNN dramatically improves the process of notifying physicians of time-sensitive and important patient safety information,” said Nancy Dickey, M.D., former president of the American Medical Association (AMA) and chair of the iHealth Alliance, the not-for-profit board that governs the HCNN service. “With the success of this first notification, the HCNN is well on its way to moving patient safety into the Internet Age.”

“We applaud the efforts of Dr. Dickey and the HCNN in improving the speed and efficiency of patient safety alerts,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Email notification offers significant advantages over traditional mail delivery, and helps ensure that we can adequately protect the health and safety of Americans.”

In just six months – and as a result of the joint efforts of the AMA, state and specialty medical societies, health plans, consumer advocacy groups, government leaders and industry – the HCNN already reaches physicians across the country. The HCNN is promoted by these organizations, as well as most medical liability carriers and many university medical centers, because it significantly reduces delays in notifying physicians of important medication and device safety alerts, which dramatically improves patient safety.

“As an early partner of the HCNN with a longstanding commitment to patient and product safety, Johnson & Johnson is pleased to see the successful use of this important network,” said Adrian Thomas, M.D., chief safety officer and global head Benefit Risk Management, Johnson & Johnson. “The HCNN provides timely, effective and efficient delivery of important medical safety information to the nation’s physicians, and we are encouraged that other manufacturers recognize the importance of this groundbreaking new system.”

The HCNN replaces traditional U.S. mail delivery of urgent drug warning and recall letters to physicians. Physicians not yet enrolled in the HCNN will receive the Alert in paper via U.S. mail later in the month. Free to all licensed U.S. physicians and their staff, the HCNN is used solely for FDA-mandated Patient Safety Alerts, fulfilling the recently-updated FDA guidance for the electronic delivery of these Alerts. It is not used for advertising or marketing.

Physicians and health care providers can register to receive electronic alerts at www.hcnn.net or through participating medical societies and other HCNN partners. The HCNN is also a “green” initiative because it reduces paper and mail, thereby saving trees and fuel.

For more information about the HCNN and online Patient Safety Alerts, visit www.hcnn.net.

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About the HCNN The HCNN is the new online service that delivers important FDA-mandated and product-related Patient Safety Alerts to physicians and other health care professionals via email. Currently, these alerts (also known as “Dear Doctor Letters”) are sent to physicians on paper via traditional U.S. mail – a slow, error-prone process. The HCNN may also be used to notify physicians in the event of national public health emergencies or bio-terror events. The network is governed by the not-for-profit iHealth alliance with network operations provided by Medem, Inc.

About the iHealth Alliance The iHealth Alliance is a not-for-profit organization with a mission to protect the interests of patients and providers as health care increasingly moves online. The iHealth Alliance governs the Health Care Notification Network (HCNN) and ensures that the network is used only for patient safety alerts. The iHealth Alliance is chaired by Nancy W. Dickey, M.D., past president of the AMA, president of Health Science Center and vice chancellor for Health Affairs for Texas A&M University. The Board of Directors is comprised of industry leaders from medical societies, liability carriers, patient advocacy groups and others dedicated to protecting the interest of patients and providers.

About Johnson & Johnson Caring for the world, one person at a time…inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our 119,400 employees at more than 250 Johnson & Johnson companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Creating an at-home blood dialysis industry has been a struggle.

Forbes Magazine, FORBES.COM, November 17, 2008, by Robert Langreth

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NxStage’s Jeffrey Burbank & client Vanessa Evans

Software engineer Colin Mackay was 32 when a mysterious autoimmune disease destroyed his kidneys in 2001. By last year two transplants had failed; doctors told him he would have to go on dialysis three times a week for the rest of his life. Mackay, now 39, would arrive at work at dawn on dialysis days so he could leave in time for the four-hour treatment. The treatment was so exhausting that he went straight to bed as soon as he got home. On the off-days toxins built up, making him bloated and twitchy. He slept badly and rarely had the energy to entertain his kids.

Then his wife heard about a home dialysis treatment from University of Pennsylvania nephrologist Joel Glickman. It uses a new portable machine from NxStage Medical in Lawrence, Mass. that allows patients to treat themselves at home in six shorter sessions per week. Mackay started the home treatment in September and had more energy almost immediately. His blood pressure sank to normal because he didn’t have so much fluid buildup. For the first time in years he can play soccer with his 7-year-old and 5-year-old. “This is a breath of fresh air. I feel infinitely better,” he says. “My kids have gotten back a father.”

Kidney dialysis is that rare medical procedure that hasn’t changed much in decades. More than 300,000 Americans with renal failure, often caused by diabetes, trudge to dialysis centers on a rigid thrice-weekly schedule. A kidney transplant is salvation, but organs are scarce. Dialysis keeps patients alive by removing excess fluid and toxins with expensive blood-filtering machines. It can be an unpleasant existence. Patients often gain a lot of weight, and the ups and downs in fluid buildup stress the body and heart. A fifth of dialysis patients die in their first year, a number that hasn’t improved since the early 1990s.

“We provide a very expensive therapy with high mortality and poor quality of life. We should be saying this is unacceptable,” says Michael Kraus, a nephrologist at Indiana University School of Medicine. He is one of a small group of doctors allying with medical device firms hoping to shake up the status quo. They are arranging dialysis treatment schedules to be followed at home, either in short daily sessions or longer ones overnight. The goal is to better mimic the function of the kidneys, which work continuously.

Kraus started a home dialysis program in 2004 and now has 65 patients on treatment. With daily treatment, “people will live better and will live longer,” he predicts. “There is no question about it, patients feel better,” says Glickman.

Both doctors use NxStage’s $21,000 machine, approved for home use in 2005. (Glickman and Kraus are NxStage scientific advisers.) The appliance, the size of a microwave, replaces behemoths the size of filing cabinets. A key innovation is that all of the sophisticated filtration is done in a disposable cartridge, eliminating the need for elaborate cleaning. “You slide the cartridge in, close the door, and away you go,” says patient Mackay.

So far only 1% of blood dialysis patients are being treated at home. NxStage hopes to get this up to 15% someday but faces formidable obstacles selling its device through dialysis centers. Medicare won’t routinely pay for more than three treatments a week, which comes out to $2,000 a month. NxStage charges dialysis centers $1,500 a month to lease its machine with supplies to the patient. That leaves centers limited profit, unless they plead for extra payments. Patients need 20 days of training and a partner to be on hand. There’s also no proof from randomized trials that more frequent treatment saves lives or prevents hospitalizations. “I don’t think there is sufficient evidence to justify a widespread change to six-times-a-week dialysis,” says Stanford University nephrologist Glenn Chertow, who is running a big, randomized trial on more frequent in-center treatment.

NxStage is unprofitable, and its shares have dropped 70% this year. Another firm supplying home dialysis equipment went bust last year. “The average nephrologist is cynical whether patients really want to do this at home. It is so much easier to send them to the dialysis center,” admits NxStage Chief Executive Jeffrey Burbank.

But interest in home machines is rising. Baxter International already sells supplies for peritoneal dialysis, an older nonblood method that pours dialysis fluid into the belly via a catheter and uses the abdominal lining itself as a filter. Last year it started working with noted medical-device inventor Dean Kamen to devise a home blood dialysis machine. Baxter kidney unit president Bruce McGillivray won’t reveal details but predicts “a big transformation of the industry” if home machines catch on. Between both blood and peritoneal methods, a third of patients could benefit, he says.

Home Dialysis Plus in Portland, Ore. has an all-in-one dialysis machine that is half the weight of NxStage’s and uses ink-jet technology from Hewlett-Packard to continuously mix small amounts of dialysis solution on the fly. “This will improve patient lives and lower costs,” says company founder Michael Baker. Meanwhile, UCLA researcher Martin Roberts is designing a wearable artificial kidney. His six-pound machine uses peritoneal dialysis but has catalysts and enzymes that remove the toxins from dirty solution so the liquid can be reused. Human trials for both are two years off.

Thirty-six-year-old Vanessa Evans has been on dialysis for a decade and switched to NxStage in 2005. On a conventional schedule she got pounding headaches and puffed up so much between treatments that her clothes would no longer fit, despite a long list of dietary restrictions. Now she eats what she wants and does dialysis with her two toddlers while they watch cartoons at night. “I never want to go back,” she says, even though she admits managing all the supplies “can be daunting.”

Home dialysis was fairly common in the 1960s, when the treatment was new and extremely expensive. Congress’ decision in 1972 to cover dialysis gave rise to chains of outpatient centers that now treat 90% of U.S. patients. Two companies, DaVita in El Segundo, Calif. and Germany’s Fresenius Medical Care, dominate the in-center market. NxStage has partnered with DaVita. Fresenius sees the home market remaining small, but it is working on a wearable artificial kidney.

Interest in home treatment perked up in the 1990s when University of Toronto doctors reported good results with overnight treatments on conventional machines. Toronto’s Andreas Pierratos says 85% of his overnight patients are still alive after five years, double the rate with traditional treatment. It is unclear whether the populations are comparable; those on the home method tend to be younger and more capable. Last year a University of Calgary trial found that people on overnight dialysis (with traditional machines) needed fewer hypertension drugs and their thickened heart muscles shrank, according to the results in the Journal of the American Medical Association.

But that study had only 52 patients. A much bigger government trial could prove that more frequent dialysis prevents serious health problems, but results won’t come until 2010. “We suck up a lot of money in this field. [The feds] want outcomes data before they will pay” for more sessions, says Kaiser Permanente nephrologist Victoria Kumar. She has found that her NxStage patients save the HMO money because of fewer hospital days.

Harvey Wells, a 56-year-old programmer in Texas, has been using NxStage since 2007. This summer he took his machine, two grandchildren and a nephew on a cross-country trip in his motor home. “It befuddles me why more people don’t try it,” he says.

FORBES.COM, by Allison Van Dusen — About six years ago, Sharon Gutterman hit a rough patch. Gutterman, then 60, a West Hartford, Conn.-based consultant who teaches wellness workshops for resident physicians, went to the doctor’s office to discover that her blood pressure was high. On top of that, she was feeling a lot of anxiety, so her physician wrote her a prescription for an anti-depressant.

But, before getting the prescription filled, Gutterman did some reading and decided she could probably start feeling better not by popping pills, but through practicing yoga.

Gutterman’s experience is becoming increasingly common, experts say, as patients continue to feel dissatisfied with the effectiveness of conventional medicine and look for new ways to take control of their health. In 2004 the Centers for Disease Control and Prevention estimated that up to 62% of U.S. adults had used some form of complimentary and alternative medicine in the previous year, including yoga, most often to treat problems such as back pain, colds, neck problems, joint stiffness and anxiety or depression.

But medical research that’s been accumulating over the past 10 to 15 years is showing that yoga can provide health benefits that many people may not realize, positively affecting conditions such as heart disease and the symptoms of menopause. “As far as preventive medicine, it’s as close to one-stop shopping as you can find,” says Dr. Timothy McCall, a board-certified specialist in internal medicine and author of Yoga as Medicine: The Yogic Prescription for Health and Healing.

McCall’s own interest in yoga grew slowly. At first he attended classes every other week or so but had trouble finding time to practice yoga at home and didn’t see great results. It wasn’t until he resolved to get up every morning for one year to do it that he began seeing changes. In a few months, his slouching posture was improving, knots in his upper back were disappearing and he wasn’t getting injured as often as he used to when playing tennis and basketball.

He also wasn’t worrying as much. McCall, who now does yoga poses, breathing exercises, meditation and other practices just about every day, eventually left his medical practice and began investigating yoga’s therapeutic potential.

One of the more surprising things McCall has found is that yoga can improve levels of cholesterol and triglycerides. He points to a controlled trial conducted at the Yoga Institute of Santacruz, India, near Mumbai that examined the effects of yoga on 113 patients with coronary artery disease who were taking prescribed medication.

The study showed that those who received instruction on yoga techniques, lifestyle recommendations and a healthy diet had a 23% drop in cholesterol–from 247 to 185–compared with 4% among those who did not. The yoga-practicing group also had a 26% drop in low-density lipoprotein, known as bad cholesterol, compared with 3% in the control group.

The mechanism, McCall says, may be connected to yoga’s effect on stress, which can boost cholesterol levels and worsen the ratio of total to high-density lipoprotein, or good cholesterol. The weight loss and conditioning that come with regular yoga practice also tend to lower triglyceride levels and boost HDL, high levels of which protect against heart attacks.

Comfort for Cancer Sufferers

Yoga is also getting more attention nowadays for its ability to improve the quality of life of women being treated for breast cancer. A small study at the University of Texas M.D. Anderson Cancer Center in 2006 showed that women with breast cancer who participated in yoga classes twice a week at or around the time of their radiation appointments reported better general health after just one week, including a slight improvement in their ability to function socially and less overall fatigue.

Researchers are currently looking at how yoga might affect levels of the stress hormone cortisol, as well as the immune system of cancer patients, says Lorenzo Cohen, director of the Integrative Medicine Program and professor in the department of behavioral science at the Anderson Cancer Center.

A new, small study out of Temple University earlier this year also demonstrates the role yoga can play in keeping people on their feet as they age. Researchers found that women enrolled for nine weeks in an Iyengar yoga program designed for people over 65 had faster strides, increased flexibility in their lower extremities and more confidence in their balance and ability to walk. The results are important because falls are the leading cause of nonfatal injuries and hospital admissions for trauma among those 65 years and older, according to the CDC.

“If an individual has a fear of falling they may tend not to move as much,” says Roberta Newton, professor in physical therapy at Temple University. “Unfortunately, by not moving, they really increase their chance of falling. Yoga makes individuals feel more comfortable, more confident.”

If you’re thinking of starting a yoga program for its medicinal purposes, experts recommend doing some research and, before signing up, talking to an instructor about what his or her class entails and what you hope to get out of it. It’s also worth it to check in with your general practitioner. McCall suggests that on your visit you bring along a book illustrating the poses you’ll be doing, just in case your doctor isn’t a yogi.

Yoga, of course, can’t do everything. For instance, while Gutterman improved her outlook, lost weight and never ended up taking antidepressants, she still had to go on medication to control her blood pressure.

McCall says he gets particularly annoyed when some teachers overstate the practice’s benefits, since it turns off skeptics and promotes disbelief of the proven effects, which are impressive on their own.

“The line I like to use is that by itself yoga isn’t a cure for many things,” says McCall. “But there’s almost nothing it can’t help.”