Sorting Fact From Fiction on Health Care By Jerome Groopman and Pamela Hartzband

Monday, 31 August 2009

From the WSJ:

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 suppose 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.

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.