Sorting Fact From Fiction on Health Care

In recent town-hall meetings, President Barack Obama has called for a national debate on health-care reform based on facts. It is fact that more than 40 million Americans lack coverage and spiraling costs are a burden on individuals, families and our economy. There is broad consensus that these problems must be addressed. But the public is skeptical that their current clinical care is substandard and that no government bureaucrat will come between them and their doctor. Americans have good reason for their doubts—key assertions about gaps in care are flawed and reform proposals to oversee care could sharply shift decisions away from patients and their physicians.

Consider these myths and mantras of the current debate:

• Americans only receive 55% of recommended care. This would be a frightening statistic, if it were true. It is not. Yet it was presented as fact to the Senate Health and Finance Committees, which are writing reform bills, in March 2009 by the Agency for Healthcare Research and Quality (the federal body that sets priorities to improve the nation's health care).

The statistic comes from a flawed study published in 2003 by the Rand Corporation. That study was supposed to be based on telephone interviews with 13,000 Americans in 12 metropolitan areas followed up by a review of each person's medical records and then matched against 439 indicators of quality health practices. But two-thirds of the people contacted declined to participate, making the study biased, by Rand's own admission. To make matters worse, Rand had incomplete medical records on many of those who participated and could not accurately document the care that these patients received.

For example, Rand found that only 15% of the patients had received a flu vaccine based on available medical records. But when asked directly, 85% of the patients said that they had been vaccinated. Most importantly, there were no data that indicated whether following the best practices defined by Rand's experts made any difference in the health of the patients.

In March 2007, a team of Harvard researchers published a study in the New England Journal of Medicine that looked at nearly 10,000 patients at community health centers and assessed whether implementing similar quality measures would improve the health of patients with three costly disorders: diabetes, asthma and hypertension. It found that there was no improvement in any of these three maladies.

Dr. Rodney Hayward, a respected health-services professor at the University of Michigan, wrote about this negative result, "It sounds terrible when we hear that 50 percent of recommended care is not received, but much of the care recommended by subspecialty groups is of a modest or unproven value, and mandating adherence to these recommendations is not necessarily in the best interest of patients or society."

• The World Health Organization ranks the U.S. 37th In the world in quality. This is another frightening statistic. It is also not accurate. Yet the head of the National Committee for Quality Assurance, a powerful organization influencing both the government and private insurers in defining quality of care, has stated this as fact.

The World Health Organization ranks the U.S. No. 1 among all countries in "responsiveness." Responsiveness has two components: respect for persons (including dignity, confidentiality and autonomy of individuals and families to make decisions about their own care), and client orientation (including prompt attention, access to social support networks during care, quality of basic amenities and choice of provider). This is what Americans rightly understand as quality care and worry will be lost in the upheaval of reform. Our country's composite score fell to 37 primarily because we lack universal coverage and care is a financial burden for many citizens.

• We need to implement "best practices." Mr. Obama and his advisers believe in implementing "best practices" that physicians and hospitals should follow. A federal commission would identify these practices.

On June 24, 2009, the president appeared on "Good Morning America" with Diane Sawyer. When Ms. Sawyer asked whether "best practices" would be implemented by "encouragement" or "by law," the president did not answer directly. He said that he was confident doctors "want to engage in best practices" and "patients are going to insist on it." The president also said there should be financial incentives to "allow doctors to do the right thing."

There are domains of medicine where a patient has no control and depends on the physician and the hospital to provide best practices. Strict protocols have been developed to prevent infections during procedures and to reduce the risk of surgical mishaps. There are also emergency situations like a patient arriving in the midst of a heart attack where standardized advanced treatments save many lives.

But once we leave safety measures and emergency therapies where patients have scant say, what is "the right thing"? Data from clinical studies provide averages from populations and may not apply to individual patients. Clinical studies routinely exclude patients with more than one medical condition and often the elderly or people on multiple medications. Conclusions about what works and what doesn't work change much too quickly for policy makers to dictate clinical practice.

An analysis from the Ottawa Health Research Institute published in the Annals of Internal Medicine in 2007 reveals how long it takes for conclusions derived from clinical studies about drugs, devices and procedures to become outdated. Within one year, 15 of 100 recommendations based on the "best evidence" had to be significantly reversed; within two years, 23 were reversed, and at 5 1/2 years, half were contradicted. Americans have witnessed these reversals firsthand as firm "expert" recommendations about the benefits of estrogen replacement therapy for postmenopausal women, low fat diets for obesity, and tight control of blood sugar were overturned.

Even when experts examine the same data, they can come to different conclusions. For example, millions of Americans have elevated cholesterol levels and no heart disease. Guidelines developed in the U.S. about whom to treat with cholesterol-lowering drugs are much more aggressive than guidelines in the European Union or the United Kingdom, even though experts here and abroad are extrapolating from the same scientific studies. An illuminating publication from researchers in Munich, Germany, published in March 2003 in the Journal of General Internal Medicine showed that of 100 consecutive patients seen in their clinic with high cholesterol, 52% would be treated with a statin drug in the U.S. based on our guidelines while only 26% would be prescribed statins in Germany and 35% in the U.K. So, different experts define "best practice" differently. Many prominent American cardiologists and specialists in preventive medicine believe the U.S. guidelines lead to overtreatment and the Europeans are more sensible. After hearing of this controversy, some patients will still want to take the drug and some will not.

This is how doctors and patients make shared decisions—by considering expert guidelines, weighing why other experts may disagree with the guidelines, and then customizing the therapy to the individual. With respect to "best practices," prudent doctors think, not just follow, and informed patients consider and then choose, not just comply.

• No government bureaucrat will come between you and your doctor. The president has repeatedly stated this in town-hall meetings. But his proposal to provide financial incentives to "allow doctors to do the right thing" could undermine this promise. If doctors and hospitals are rewarded for complying with government mandated treatment measures or penalized if they do not comply, clearly federal bureaucrats are directing health decisions.

Further, at the AMA convention in June 2009, the president proposed linking protection for physicians from malpractice lawsuits if they strictly adhered to government-sponsored treatment guidelines. We need tort reform, but this is misconceived and again clearly inserts the bureaucrat directly into clinical decision making. If doctors are legally protected when they follow government mandates, the converse is that doctors risk lawsuits if they deviate from federal guidelines—even if they believe the government mandate is not in the patient's best interest. With this kind of legislation, physicians might well pressure the patient to comply with treatments even if the therapy clashes with the individual's values and preferences.

The devil is in the regulations. Federal legislation is written with general principles and imperatives. The current House bill H.R. 3200 in title IV, part D has very broad language about identifying and implementing best practices in the delivery of health care. It rightly sets initial priorities around measures to protect patient safety. But the bill does not set limits on what "best practices" federal officials can implement. If it becomes law, bureaucrats could well write regulations mandating treatment measures that violate patient autonomy.

Private insurers are already doing this, and both physicians and patients are chafing at their arbitrary intervention. As Congress works to extend coverage and contain costs, any legislation must clearly codify the promise to preserve for Americans the principle of control over their health-care decisions.

By Drs. Jerome Groopman and Pamela Hartzband for the Wall Street Journal. Dr. Groopman, a staff writer for the New Yorker, and Dr. Hartzband are on the staff of Beth Israel Deaconess Medical Center in Boston and on the faculty of Harvard Medical School.

Posted by: Scott W. Yates, MD, MBA, MS, FACP

'Macho' men visit doctors less - and die younger. Are these related?

It's no secret that men don't like to go to the doctor, but new research finds they're especially likely to stay home if they're big on being macho.

Middle-aged men who are most devoted to traditional beliefs about masculinity are half as likely as other men to get routine medical care, researchers report.

It's not clear whether feelings about masculinity directly make men avoid doctor visits; the study only indicates that a cause-and-effect link might exist. Nor do researchers know what this might mean for men's health.

Still, the findings suggest that "we could help men's health if we could dismantle this idea that manhood and masculinity is about being invulnerable, not needing help and not showing pain," said study author Kristen W. Springer, an assistant professor of sociology at Rutgers, the
State University of New Jersey.

Previous research has suggested that "men are less likely to go to the doctor than women, across the board," Springer said - a notion she finds surprising because men are wealthier overall, potentially giving them better access to medical care.

Springer and a colleague launched their study to determine the role that ideas about masculinity play in the decisions men make about their health care.

Springer said she defines masculinity as a "stereotypical, old-school, John Wayne- and Sylvester Stallone-style" approach to life.

The researchers examined the results of surveys taken in 2004 by 1,000 white, middle-aged men in Wisconsin. The men answered questions about their beliefs regarding masculinity and disclosed whether they'd gotten recommended annual physicals, prostate checks and flu shots.

After adjusting the results to reduce the chance they would be thrown off by such things as a high number of married participants, researchers found that men who were the highest believers in masculine standards were 50% less likely to get the recommended care than other men.

Springer was unable to provide statistics about the percentage of men in each group who got the recommended care. Overall, though, fewer than half of all men did, according to the study.

There was one exception to the rule: Blue-collar workers who had a high attachment to masculinity were more likely to get the recommended health care.

The study has limitations. All participants were white and all had completed high school. And Springer said unanswered questions remain, such as whether spouses play a role through "support or nagging." The findings were to be presented Monday at the American Sociological
Association annual meeting in San Francisco.

Howard S. Friedman, a professor of psychology at the University of California at Riverside, said his research has found that less masculine men live longer than masculine men. But the new study doesn't show anything like that because it doesn't examine long-term effects on health, he said.

As for the gap between men and women when it comes to living longer, he said, "it would be a stretch, going beyond the data, to link it closely to men's increased mortality risk as compared to women."

By Randy Dotinga, HealthDay, USA Today

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

H1N1 is back

H1N1 Swine Flu has killed at least four Dallas County residents in the past month.

Of the four known deaths, three occurred in people who had other medical problems (their ages were 3, 37 and 52 years). However, an 11 - year old girl who died earlier this week was previously healthy. We have identified two cases of H1N1 influenza this week. Both patients are being treated and are doing well.

The H1N1 vaccine should be available in the next few weeks and as soon as we receive vaccine, we will contact patients to schedule administration. For more information about H1N1 as well as additional preventive measures, please see this list of posts.

Have a safe weekend!

Posted by: Scott W. Yates, MD, MBA, MS, FACP

Saving Your Bones: Hard Choices

Osteoporosis Drugs Prevent Fractures, but Patients Worry About Side Effects; Weighing the Risks.

Osteoporosis has haunted my family for generations, as it has many other families.

My great-grandmother was bent nearly horizontal from collapsed vertebrae. My grandmother lost a foot in height as her spine deteriorated, and broke her hip just pushing a grocery cart. I made her a new backbone out of papier-mâché when I was 4.

My mother did everything she could to avoid the family curse, but she also suffered painful collapsed vertebrae. All three women died, directly or indirectly, as a result of osteoporosis.

That was before the bone-building drugs called bisphosphonates became widely available in the mid-1990s. Thanks in part to them, the number of hip fractures has dropped significantly in the U.S. and Canada in recent years.

Osteoporosis remains a serious health problem for the 10 million Americans who have it and the 34 million who are at risk due to low bone mass; 80% of sufferers are women. It's estimated that one half of women and one-quarter of men over age 50 will suffer an osteoporosis-related fracture.

But reports of scary side effects from bisphosphonates-including Fosamax, Actonel and Boniva-are circulating on the Internet and in medical journals. Hundreds of lawsuits allege that the drugs cause a rare condition in which part of the jaw bone dies. The first case to be tried against Merck & Co.'s Fosamax ended in a hung jury last week in federal court in New York City. And some critics say the drugs-with sales of $8.3 billion a year in the U.S.-are being oversold to women who may never need them.

All that leaves women facing a difficult dilemma: Powerful osteoporosis drugs known to prevent future debilitating injuries are also suspected of increasing the risk for other terrible conditions. Balancing the risks and benefits is different for every woman, and depends on factors such as genetic history, diet and lifestyle. Figuring out how to proceed also requires having a very careful discussion with a qualified physician.

A good place to start is with your family tree. Having a parent with osteoporosis raises your own risk significantly. Caucasians, Asians and Hispanics also have higher rates of osteoporosis than African-Americans. So far, scientists have identified 15 related genes-but there isn't likely to be a predictive genetic test anytime soon.

That's because environmental factors also play a big role. The more bone you build up during the peak building years before age 30, the more reserves you'll have when net bone loss sets in. For women, that happens very rapidly after menopause when estrogen levels decline. Men lose bone far more slowly, although hormone-deprivation drugs for prostate cancer can also set them up for osteoporosis, as can a very strong hereditary load.

A diet rich in calcium (from dairy products and vegetables), plenty of exposure to vitamin D and weight-bearing exercise all help to build strong bones. Too little of those can weaken them, as can smoking, drinking alcohol, and a taking a variety of medications, including corticosteroids, anticonvulsants and antidepressants. Excessive dieting and exercising and being very thin-with a body-mass index of less than 20-can also leave your bones with little reserve. Being obese actually lowers your risk, though it can overstress your joints.

But some people can do everything right and still develop osteoporosis if they have a strong genetic predisposition.

A bone-mineral-density test can give you one indication of how strong your bones are. Women with several risk factors should have one at menopause; or at least at age 65. The most common such test, called a DEXA (for dual-energy X-ray absorptiometry) is quick and painless and measures the amount of bone in your hip, spine or wrist. Results, called T-scores, compare that density with an average peak at age 30.

A T-score of minus 2.5 or below indicates osteoporosis. A T-score between minus 1 and minus 2.4 is considered osteopenia-meaning low bone density but not full-blown osteoporosis.

You and your doctor can also assess your risk by using an online tool developed by the World Health Organization called FRAX, for Fracture Assessment Risk Tool. (www.shef.ac.uk/frax) It asks your sex, age, weight, height, hip-bone density and factors such as smoking, drinking, and parental hip fractures. It computes your chances of suffering a major bone fracture in the next 10 years.

What to do with that information is still somewhat controversial. "If you already have severe osteoporosis, you don't need a FRAX score to tell you you need treatment," says Bess Dawson-Hughes, director of the Bone Metabolism Lab at Tufts University, who has advised many of the drug makers. "Where we have struggled is what to do with that large group of healthy people who have low bone mass."

The National Osteoporosis Foundation's latest guidelines say that women who have a 3% risk of developing a hip fracture or 20% risk of other major fracture in the next 10 years are candidates for treatment, on cost-effectiveness grounds. In studies of older women with osteoporosis, Fosamax has been found to reduce the chance of hip and spine fractures as much as 50% . But it's less clear to what extent such drugs can prevent osteopenia from becoming osteoporosis.

Experts say that individual patients should never be treated based on T-scores or FRAX probabilities alone. Many other considerations apply.

"You need to consider the unique characteristics of this lady in front of you," says Ethel Siris, director of the Toni Stabile Osteoporosis Center at Columbia Presbyterian Medical Center, who has also consulted for the drug makers. For example, a 50-year-old woman with osteopenia may not be a candidate for treatment based on her FRAX alone. But if she falls a lot and her mother suffered spinal fractures, which the FRAX doesn't ask about, it may make sense to treat her for a few years and see how her bone density does, Dr. Siris says. Meanwhile, a 70-year-old who has the same T-score probably started out with better bone density, but she has had 20 more years for her bone architecture to erode, so her bones are more fragile, even though they weigh the same.

The official guidelines also don't take into account potential side effects of the bisphosphonates, which are also highly individual. Gastrointestinal upsets are the most common; the oral medications aren't recommended for patients who can't sit upright for at least a half-hour because these drugs can irritate the esophagus. Gastro-esophageal reflux disease (GERD) can make such discomfort worse. A woman with severe GERD might fare better on Reclast, a once-a-year injection of bisphosphonate.

Some patients have also reported severe bone and muscle pain while taking bisphosphonates. The Food and Drug Administration alerted doctors last year that they might see this and consider discontinuing the drugs at least temporarily. Who is most affected and how long it lasts seems unpredictable. "I treat a gazillion patients and I see this rarely," says Dr. Siris. "When I do, we stop and re-evaluate."

Cases of osteonecrosis of the jaw (ONJ)-in which parts of bone become exposed during dental work and don't heal-are more serious but very rare. No one knows the exact incidence. Estimates range from 1 in 1,000 to 1 in 100,000 patients taking bisphosphonates for osteoporosis. (It's far more common in cancer patients on much higher doses.) Merck and other manufacturers say there is no evidence that the drugs cause ONJ at doses used for osteoporosis, but some dentists have become wary of doing invasive dental work on women taking bisphosphonates.

"We often advise patients who need extensive, invasive dental work to get that done first, then start the drugs and the issue disappears," says Ian Reid, a professor at the University of Auckland in New Zealand who has written on biosphosphonate safety.

A few doctors have reported unusual fractures of the thigh bone in women taking bisphosphonates for many years. One theory is that because the drugs inhibit the breakdown of old bone, they may be maintaining bone that is unusually brittle. Here too, the incidence seems extremely rare and the link remains unproven. But experts agree that it warrants further study-and that patients and doctors should investigate any unusual thigh pain which has preceded several of the fractures.

On balance, most experts say that women with confirmed osteoporosis face a much higher risk of fractures if they don't treat their condition than if they do. "These horrible cases are incredibly rare, whereas hip fractures are not rare in the aging population and they can kill you," says Dr. Siris. She notes that there are still many unknowns about drugs, including how long it is safe for women to stay on them. Many doctors are using them with patients only about five years at a time and then re-evaluating.

Other osteoporosis drugs on the market work differently and carry different risks. Evista (raloxifene) acts on estrogen receptors and can cut the risk of breast cancer as well as spinal fractures in some women, although it doesn't prevent hip fractures. Forteo (teriparatide) is a daily injection for women with severe osteoporosis, but has been linked with bone malignancies in rats. Last month an advisory panel recommended that the FDA approve denosumab, a biological agent that blocks the production of osteoclasts that break down bone. It would be a twice-yearly injection.

Estrogen-replacement therapy can also help women postpone the rapid loss of bone mass that occurs after menopause. It's no longer recommended for bone protection alone-in part because of the added risk of heart disease and breast cancer found in older women in the Women's Health Initiative studies. But the risk-benefit profile seems more favorable for younger women who want relief from menopausal symptoms like hot flashes. "If you hate your life without estrogen, you can go back on it and that's your bone-loss drug as well," says Dr. Siris.

Some clinics urge women to fight osteoporosis with lifestyle changes rather than pharmaceuticals. Many experts agree that sufficient calcium (at least 1,200 mg per day from food or supplements) and vitamin D (800 to 1,000 IUs per day) and weight-bearing exercise (at least 30 minutes, three times a week) are critical for building and maintaining strong bones, but they may not be sufficient for reversing serious bone loss once it's set in.

All camps agree that the very best way to strong bones is to build them well to begin with. Nearly 90% of bone mass in females is built by age 18, yet few adolescent girls are getting the recommended amounts of calcium and vitamin D.

By: Melinda Beck
From: The Wall Street Journal. Health Journal - September 15, 2009

Posted by: Scott W. Yates, MD, MBA, MS, FACP

Selling out doctors to pay off lawyers

Civil justice reform, which is sometimes referred to as “tort reform,” is not addressed in any health reform bill now being considered by Congress. As a matter of fact, civil justice reform is rarely being discussed even though it should be a critical component of every discussion and in every legitimate health reform bill.

Physicians understand its importance. And so do the American people. Many are beginning to wonder why it’s not in any bill.

Howard Dean, former chairman of the Democratic National Committee, at a town hall meeting in Virginia last week said, “Tort reform is not in the bill because the people who wrote it did not want to take on the trial lawyers. And, that is the plain and simple truth.”

Unfortunately, the “plain and simple truth” is that Democratic leaders in Congress and President Obama are selling out the doctors to pay off the trial lawyers.

In a recent poll, 90 percent of physicians agreed that health reform will not succeed in bringing about substantive reform without addressing tort reform. Sermo, an online community of over 100,000 physicians, reports that while reasonable people might disagree on the specifics of tort reform, the fundamental principle remains that defensive medicine is a byproduct of the current tort system.

The “plain and simple truth” is that leaving the tort system “as is” ignores more than $200 billion in potential savings annually in health care. If the fundamental driving force behind any national health reform proposal is improving care and reducing costs, tort reform should be contained in every rational approach to health reform.

Defensive medicine is one of the largest contributors to wasteful spending, and it can manifest in many forms: unnecessary CT scans, x-rays, MRIs, cardiac testing and inappropriate hospital admissions. A 2005 survey in the Journal of the American Medical Association found that 93 percent of doctors reported practicing defensive medicine. These unnecessary and expensive tests and procedures are not ordered to advance the care and treatment of a patient or help the physician diagnose a medical problem. These tests and procedures are ordered exclusively to protect a physician from a potential and likely frivolous lawsuit.

In a recent speech before the American Medical Association, even President Obama said that doctors shouldn’t “feel like they are constantly looking over their shoulder for fear of lawsuits.” The president recognized that defensive medicine is “a real issue” but there is nothing in the bill to protect physicians from frivolous lawsuits. And, there is nothing in the bill to help stop defensive medicine.

While the White House and the Democratic leaders in Congress don’t want “to take on the trial lawyers,” they are apparently willing to fight with the doctors, the hospitals, the drug companies, the health insurance industry and even the American people on health reform. But they feel compelled to placate to the trial lawyers? Protecting trial lawyers at the expense of physicians is not in the best way to address health reform and it is not in the best interest of the American people.

At the Center for Health Transformation, we have developed several solutions which would advance patient safety and provide for fair and effective compensation for individuals who have legitimate claims. Our solutions establish accountability and encourage the disclosure of adverse medical events so future medical errors can be avoided.

For example, we believe that physicians should be shielded from liability if they demonstrate the use of clinical best practices in the care and treatment of patients. Shielding physicians from liability when they use best practices would reduce defensive medicine and minimize the loss of competent health professionals driven out by the high cost of litigation insurance.

We also support the creation of specialized health courts to address medical malpractice cases as a rational civil justice reform. Even some Democrats have rallied around the health court solution. Former Sen. Bill Bradley (D-N.J.), in a recent New York Times column, said “Malpractice tort reform can be something as commonsensical as the establishment of medical courts – similar to bankruptcy or admiralty courts – with special judges to make determinations in cases brought by parties claiming injury.”

We believe it’s time to stop selling out the doctors to pay off the trial lawyers. The president must include civil justice reform in any successful health reform proposal.

Former House Speaker Newt Gingrich is the founder of the Center for Health Transformation. Wayne Oliver is director of the Center’s civil justice reform project.

By: Newt Gingrich and Wayne Oliver

Posted by: Scott W. Yates, MD, MBA, MS, FACP