02.15.09
Report on California Health Plans and Insurers
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The study showed just how hard it is to change the habits of older patients and their sometimes inflexible doctors. And it points up the challenges the Obama administration will face in trying to reform health care for an aging nation.
Most of the patients had serious, but common, age-related illnesses including diabetes, heart disease and lung disease. Programs were set up at 15 centers around the country. Only two cut the number of times these patients were hospitalized, and those are still in operation. None saved Medicare any money.
The authors of the study called the results "underwhelming." An editorial in the Journal of the American Medical Association, where the study appears Wednesday, used the term "sobering."
"The only way you can really do it is by changing patients' behavior and by changing physicians' behavior, and both things are really hard to do," said study author Randall Brown, a researcher at Mathematica Policy Research Inc., in Princeton, N.J., which was hired to evaluate the programs.
Often, these patients need to stop smoking, or lose weight, exercise more, eat healthier foods - a challenge even for generally healthy people. Those changes are especially tough for sick, older patients who often are set in their ways.
"The same thing with physicians," Brown said. "A lot of them feel like they know how to take care of patients, so why do they need a nurse calling up and asking them why the patient isn't on some certain medication?"
Many patients in the study had more than one chronic disease, a common Medicare scenario. In 2002 alone, half of Medicare patients had been treated for five or more ailments, and they accounted for 75 percent of Medicare spending, the study authors noted.
Seeking ways to reduce those costs and improve care, the Centers for Medicare & Medicaid Services selected 15 proposals for test-site programs in 2002. The sites developed their own programs, enrolling a total of 18,309 fee-for-service Medicare patients through 2006.
About half got the patients got the usual care. The others got more intensive, coordinated care. That often involved nurses who acted as go-betweens, helping doctors give patients clear, appropriate advice; counseling patients on changing bad habits and recognizing worrisome symptoms. The nurses were available on a regular basis by phone or in person to answer patients' questions.
Jim Reid, a 74-year-old retired Pennsylvania welder, was among study patients who got coordinated care.
When he enrolled in 2002 in a test program run by Health Quality Partners, a nonprofit group in Doylestown, Pa., he was obese, had high blood pressure, high cholesterol and pre-diabetes.
But Reid was a rare success story.
He actually took the advice offered in group sessions run by nurses. He learned how to read food labels and avoid salty, calorie-laden foods. He also started exercising, walking with a pedometer and building up to a few miles daily.
Now, he breakfasts on oatmeal or vegetable omelets instead of coffee and doughnuts He's lost almost 60 pounds. His blood pressure and cholesterol have greatly improved and his pre-diabetes is gone.
Sticking with the program "is hard," he acknowledged. "As you get older, you don't want to do it." But he said it has "put an extra 10 years in my life."
Reid credits his success to the personal attention of a nurse coordinator.
"I have to have somebody to own up to," he said.
That close, in-person contact with nurses was also a feature of the project's other more successful, still-operating program, at Mercy Medical Center-North Iowa in Mason City, Iowa.
In both programs, each patient had face-to-face contact an average of about once a month with a nurse. That was far more frequent personal contact than in other programs. Both reduced hospitalizations - 17 percent yearly compared with usual-care patients at Mercy, and by about 20 percent in the Pennsylvania program, but only among its sicker patients. That program worked with Doylestown Hospital and recruited patients from area physicians' offices.
Targeting sicker patients and providing frequent in-person contact show the approach has some benefits and that success with future reform efforts "is possible, but it's not easy," Brown said.
Peter Ashkenaz, a spokesman for the Centers for Medicare & Medicaid Services, said the agency is evaluating the Iowa and Pennsylvania programs to see if their positive results persist.
He said there are other approaches being tested, some that offer incentives to doctors who meet quality benchmarks, or who use electronic health records to improve quality.
But so far, Ashkenaz said, "as the study shows, we have not yet found broad success."
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On the Net:
JAMA: http://jama.ama-assn.org
Centers for Medicare & Medicaid Services: http://www.cms.hhs.gov
© 2009 The Associated Press.
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Millions of Americans spend billions of dollars on vitamins to boost their health. Research has focused on cancer and heart disease in particular because of evidence that diets full of vitamin-rich foods may protect against those illnesses. But that evidence doesn't necessarily mean pills are a good substitute.
The study's lead author, researcher Marian Neuhouser of the Fred Hutchinson Cancer Research Center in Seattle, offered this advice: "Get nutrients from food. Whole foods are better than dietary supplements," Neuhouser said.
The study appears in Monday's Archives of Internal Medicine.
Co-author Dr. JoAnn Manson said despite the disappointing results, the research doesn't mean multivitamins are useless.
For one thing, the data are observational, not the most rigorous kind of scientific research. And also, it's not clear if taking vitamins might help prevent cancers that take many years to develop, said Manson, chief of preventive medicine at Harvard's Brigham & Women's Hospital.
She said multivitamins may still be useful "as a form of insurance" for people with poor eating habits.
The study involved an analysis of data on women in their 50s and up who participated in long-running government studies on postmenopausal women. Almost 42 percent of the women said they used multivitamins regularly.
After about eight years, roughly equal numbers of vitamin users and nonusers developed common cancers, heart attacks and other cardiovascular problems. Overall, there were 9,619 cases of cancer, including cancers of the breast, lung, ovary, colon and stomach; and 8,751 cardiovascular ailments including heart attacks and strokes. In addition, 9,865 women died, also at similar rates in multivitamin users and nonusers.
Alice Lichtenstein, a Tufts University nutrition professor who was not involved in the research, said the study is important because it involved so many women.
"All the evidence keeps pointing in the same direction," Lichtenstein said.
Eric Jacobs, an American Cancer Society epidemiologist, said while his group doesn't advise vitamins to prevent cancer, it does recommend maintaining a healthy weight and eating at least five servings of fruits and vegetables daily while limiting red meat. Similar habits are also thought to help reduce heart disease risks.
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On the Net:
Archives: http://www.archinternmed.com
American Cancer Society: http://www.cancer.org
© 2009 The Associated Press.
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The Food and Drug Administration said Monday it has issued letters to companies that make 24 opioid drugs, including morphine, oxycodone and methadone. Opioids are drugs that simulate the effects of natural opiates, such as opium poppy.
The products targeted by FDA, which come in both pill and patch forms, generally feature extended-release formulas designed to give long-lasting effects. But regulators warned that potency carries serious risks.
"We're focusing on these products because they generally contain very high doses of the drugs and need to be used very carefully," said Dr. John Jenkins, FDA's chief of new drugs.
The drugs are typically used by people already taking narcotics, such as cancer patients, to treat severe flare-ups of pain. Despite their ability to relieve chronic pain the drugs can be highly addictive and are often abused for their euphoric effects.
The FDA has issued a number of warnings on prescription pain relievers in recent years and some companies already have plans to manage the drugs' risks.
"Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," said Jenkins. According to FDA, about 3.7 million patients were taking the drugs under scrutiny in 2007. A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.
"This is an ongoing problem that's getting worse," said Bob Rappaport, head of FDA's anesthesia drugs division.
FDA said it will meet with 16 drugmakers March 3 to discuss risk-management plans for the medications. Such plans can include bolstered warning labeling, restrictions on patients who can receive the drugs and cautionary letters to physicians.
Companies asked to attend include makers of generic pills as well as brand-name products, like Johnson & Johnson's Duragesic patch, King Pharmaceuticals' extended-releases Avinza pills and Purdue Pharma's extended-release OxyContin.
The risk-managing plans are unlikely to appear until later this year, as FDA said it hopes to hold a public meeting to gather opinions on the issue in the late spring or summer. Until then, regulators said physicians should be diligent about prescribing the drugs only where appropriate.
Regulators said continuing deaths from the drugs are due to both abuse by patients and inappropriate prescribing by physicians. The agency has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, an unapproved use. The FDA said patients will also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose of the drug.
The FDA only gained the power to require risk-management plans in 2007, after Congress passed a law designed to improve drug safety. Previously the agency negotiated any changes to drug labeling and promotion with manufacturers.
Regulators are reviewing two experimental painkillers designed to discourage abuse.
King Pharmaceuticals has asked the FDA to approve the drug Embeda, which it acquired through the purchase of Alpharma, as a tamperproof version of morphine for patients with chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Drugmaker Pain Therapeutics, based in San Mateo, Calif., is waiting for an agency decision on its own abuse-resistant version of oxycodone. The drug was developed in partnership with King.
FDA said its announcement Monday only applies to companies with drugs already on the market.
© 2009 The Associated Press.
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Or consider treatment for early breast cancer: Is saving the breast worth all the extra doctor visits for radiation or would you prefer the whole breast removed in one trip?
There's no single right answer for everyone yet patients often are ill-equipped to weigh increasingly complex medical options. Now there's a small but growing movement to get unbiased reports of the pros and cons of different tests and treatments into patients' hands before they fall back on, "Doc, just tell me what you'd choose."
"No matter how hard I tried" to be objective, "inevitably my personal biases got involved," recalls breast surgeon Dr. Dale Collins of New Hampshire's Dartmouth-Hitchcock Medical Center, which helped pioneer the concept that it calls shared decision-making.
Think of it as "informed consent 2.0," going a step beyond the brief patient education that doctors are required to provide. One state, Washington, has passed a law encouraging the trend. And it may get renewed attention in this era of health care reform because studies suggest that patients who get the full scoop frequently choose more conservative therapy than their doctors initially recommend.
Savvy patients today turn to places like the National Institutes of Health or American Cancer Society for advice. For the less savvy, some medical groups are developing what they call decision aids, plain-English guides that give equal voice to the advantages and disadvantages of options and include real patients explaining why they chose differently. They can be videos or pamphlets, but the goal is for patients to get the guides even before doctor appointments so they come armed with better questions.
Consider that PSA blood test. Most men over 50 have had one even though it's hugely controversial. Why? Most men who undergo a biopsy for an abnormal PSA test don't turn out to have prostate cancer at all. Of those who do, there's no proof yet that the early detection saves lives. But finding an early prostate cancer forces a decision about trying surgery or radiation treatments that can cause incontinence and impotence - known harm for unknown benefit.
In fact, health guidelines issues last year concluded men over age 75 shouldn't get a PSA test while younger men should make an individual choice after hearing the pros and cons.
But getting upfront objective information is rare, Dr. Michael Barry of Massachusetts General Hospital told a meeting of the nonprofit Foundation for Informed Medical Decision Making last week, where health workers gathered to debate how to spread "informed choice."
In a decision-aid video the foundation sponsored about PSA testing, one doctor says, "Is this a slippery slope that I really want to get on?" He decided not to have his own PSA level checked.
"It's a good way to diagnose a potentially fatal condition," says another physician on the video who did get tested.
At Dartmouth, every woman diagnosed with early-stage breast cancer now sees a similar decision-aid video before meeting a surgeon. They're also quizzed to be sure they understood that survival is equally good regardless of whether they choose removing just the tumor, followed by radiation, or removing the whole breast - but that there are valid reasons for either choice, such as anxiety about keeping the breast, the time radiation requires, how often more surgery is needed.
Patient choice is only one part of good health care; a separate problem is how often doctors fail to offer proven care, such as medications that improve survival after a heart attack.
But many other scenarios - back surgery, knee and hip replacement, enlarged prostates, especially end-of-life care - have no one-size-fits-all guidelines, and Dartmouth research suggests where patients live often is the biggest determinant of what they get. For example, elderly patients with chronic illnesses spend 11 days in the hospital in Bend, Ore., over their last two years of life - while those in Manhattan spend 35 days in the hospital, although the extra care doesn't lengthen life.
A new University of Michigan study of how 3,000 patients made common medical choices suggests patients frequently have misinformation. Fewer than one in five could name the most common side effect of cholesterol-lowering statin drugs they were considering, for example. Moreover, patients said their doctors discussed treatment advantages more than the disadvantages.
Whether decision aids or some other approach truly improves informed choice remains to be seen, but a handful of medical centers are trying the guides.
"You're getting so much information thrown at you at one time, it's hard to assimilate," says Alethea Cassidy, 53, of Erie, Pa., who was diagnosed with early-stage breast cancer in March 2007 and received a similar decision-aid video from Allegheny General Hospital. It helped her decide to keep her breast. "It alleviates any doubts."
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EDITOR'S NOTE - Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
© 2009 The Associated Press.
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