Evidence-based medicine? Overdosed America: The Broken Promise of American Medicine

Evidence-based medicine? Overdosed America: The Broken Promise of American Medicine

Thu, 17 Mar 2005

Dr. John Abramson is a physician who spent more than twenty years as a clinician treating patients in Appalachia and Massachusetts before writing “Overdosed America: The Broken Promise of American Medicine.”

“When I first read of the poor performance of the US health care system I was incredulous. But as I confirmed these findings with data from multiple sources and began to understand the underlying causes, my skepticism gave way to a sense of vindication. I had been trained to believe that carefully reading the medical journals, following experts’ recommendations and keeping up with continuing education would ensure that I was bringing the best possible care to my patients.” Dr. Abramson discovered that belief in the excellence of American healthcare is a myth–more so since the commercialization of American medicine.

He examined the research literature, tracked down the unpublished data submitted by drug manufacturers to the FDA, and found that the unpublished data does not support the claims made about the safety and effectiveness of widely used medicines. Dr. Abramson calls into question the integrity of the scientific journals–such as the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM)-for publishing biased reports that physicians and the public have relied upon as a trusted source of “evidence-based medicine.” Harmful, even lethal drugs became blockbuster sellers, thanks to the tacit complicity of the journals.

In his review of the book, Dr. Thomas Bodenheim picked the chapter on osteoperosis as an example of how Dr. Abramson analyzes the information not disclosed in published reports and reviews. The chapters on the anti-inflammatory COX-2 drugs and the cholesterol cash cow, shed further light on how the commercial intrusion of drug manufacturers is evident in distorted reports published in JAMA and the NEJM. And because journal editors have done nothing to restore the integrity of their publications, such as retracting fraudulent reports, those reports continue to be cited, and continue to influence clinical practice.

Evidence-based reality:

Dr. Abramson debunks the myths about the excellence of American medicine, noting the paradox between the staggering cost of health care in America and the embarrassing poor outcomes. Health care spending reached $6100 for every man, woman and child in the US–that’s 42% more than other industrialized countries spent, this excess is (in essence) a tax of more than $1800 for each US citizen.

Despite the huge expenditure for health care, the US is the only industrialized country that fails to provide universal health insurance for its citizens, leaving 43 million Americans without insurance.

Furthermore, notwithstanding the high expenditure, the relative performance of US health care–measured in terms of improvement in citizens’ overall health–has declined since 1960. In other industrialized countries health care performance has improved. Overall life expectancy in the US ranks 29 among nations. Our healthy life expectancy ranks 22 among 23 industrialized countries: a baby born in the US can expect 69.3 healthy years of life, whereas a baby born in any one of 22 countries can expect 71.8 years of healthy life, and a baby in Japan can expect 75 years.

Americans’ health has not improved and we are clearly not getting our money’s worth: Americans pay 70% more for prescription drugs than Canadians or Western Europeans. Drug manufacturers would have us believe that Americans pay for and benefit from new breakthrough medicines. The facts don’t bear out that claim.

“From 1991 to 1999 pharmaceutical companies in the US did not develop more than their share of new drugs on a per capita basis compared with Western Europe or Japan. Furthermore, according to the FDA, of the 569 new drugs approved in the US between 1995 and 2000, only 13% actually contain new active ingredients that offer a significant improvement over already available drugs and therapies.”

Overdosed America examines how the commercialization of medicine is undermining health by pathologizing normal human experiences into medical problems, and how the inappropriate uses of drugs and interventions of uncertain safety are exacerbating minor problems into chronic disabilities.

Contact: Vera Hassner Sharav
212-595-8974

Health Affairs, Vol 24, Issue 2, 562-563
Book Reviews
Is Evidence-Based Medicine Evidence Based?
Overdosed America: The Broken Promise of American Medicine
by John Abramson
(New York: HarperCollins, 2004), 352 pp., $24.95

According to the U.S. Centers for Disease Control and Prevention, of the 2.4 million U.S. deaths in 2000, 400,000 were associated with unhealthy diet and lack of physical activity. These are deaths related to the particular way in which civilization has “progressed” upon this planet: high-fat, high-carbohydrate fast foods devoid of fruits and vegetables; a vast multitude of automobiles that make self-propulsion (walking) obsolete as a standard life routine; and couch-potato-creating television sets that not only replace the neighborhood kickball game and hide-and-seek activities that amused me when I was a kid, but also badger us to purchase those same automobiles and eat those same fast foods.

How has the trillion-dollar-plus enterprise we call the health care system responded to this pervasive undermining of our health? By offering more inventions, which-like those cars, fast-food chains, and TV sets-are capable of making money for a small stratum of society. Instead of approaching the health effects of modern civilization through community-wide and public health interventions-banning cars and creating greenbelts within cities, spending more dollars on health education than the food industry spends on advertising, and creating more neighborhood physical activity programs than the auto industry creates cars-we have chosen to address those 400,000 deaths with a few rushed minutes in a sterile exam room populated by a highly trained physician, a passive patient, and a prescription pad.

John Abramson is a physician who spent more than twenty years in those exam rooms, filling out thousands of those prescription pads. But something happened to him that, sadly, happens to few physicians. He began to study epidemiology and research methodology, expanding his viewpoint from a close-up focus on the individual patient to a panorama of the entire population. Carefully reviewing the research literature, he found that spin doctors had been doctoring the evidence. The conclusions he reached from his careful literature review differed from the conclusions published by the authors of the universally accepted clinical practice guidelines-the “evidence-based medicine”-that are the yardsticks against which physicians’ quality of care is measured.

Abramson’s book, Overdosed America, provides detailed arguments on the false conclusions reached from research on such topics as the prevention of coronary heart disease and hip fractures. He explains why those conclusions are distorted: the web of interlocking monetary relationships among the pharmaceutical industry, academic research physicians, the Food and Drug Administration, leaders within the National Institutes of Health, and some of the hallowed organizations that promulgate evidence-based medicine-with the nation’s prestigious medical journals often serving as unwitting collaborators in the distortions.

Overdosed America presents a strong indictment of the evidence that dictates medical practice, a challenge that is credible only because Abramson backs up his statements with detailed analyses of the prevailing evidence. It is beyond the purview of this review to judge whether each of Abramson’s conclusions are scientifically and statistically valid. What can be said, however, is that the seriousness with which he explores clinical issues merits a major debate on those issues within the world’s leading medical journals-untainted by the almost ubiquitous monetary distortions. To give a sense of Abramson’s approach, it is worth summarizing his treatment of an important clinical problem: osteoporosis.

Twenty percent of women over age fifty have osteoporosis, and another 40 percent have osteopenia, thinning of the bones that puts women at risk for osteoporosis. Osteoporosis increases the risk of a serious medical event-hip fracture. Osteoporosis is diagnosed with a bone mineral density (BMD) test. About half of all American women who have a BMD test will be diagnosed with osteoporosis by age seventy-two. The market for pharmaceutical products to manage this condition is enormous. Accordingly, based in part on the work of an expert panel funded by drug companies, current practice guidelines recommend that all women have a BMD test at age sixty-five, or earlier if at greater risk for osteoporosis.

The drug Fosamax (alendronate), which improves BMD, was found to reduce the risk of hip fractures for postmenopausal women with osteoporosis by 56 percent. Here, Abramson does what every journal article, newpaper report, and TV airing of a medical advance should do: report the absolute risk instead of trumpeting the relative risk. If, in a hypothetical example, 2 of every 10,000 women with osteoporosis sustained a hip fracture in a year, a relative risk reduction of 50 percent would mean that 1 of every 10,000 women would be spared a hip fracture-a very small improvement. If four of every ten women with osteoporosis sustained a hip fracture in a year, then a relative risk reduction of 50 percent would mean that two of every ten women would be spared a hip fracture-a very large improvement. Relative risk by itself can be highly misleading. Abramson reports the more illuminating facts: 81 women would have to take Fosamax for 4.2 years to prevent one hip fracture, and for women ages 70-79, Actonel (risedronate), a medication similar to Fosamax, had no effect on the number of hip fractures.

What is going on? Why do drugs that improve bone mineral density have little effect on hip fractures? It turns out, according to Overdosed America, that BMD is not a good test to predict hip fractures. BMD mainly measures the outer layer of bone (cortical bone), whereas much of the strength of bone lies in the inner structures of trabecular bone. Drugs such as Fosamax primarily strengthen cortical rather than trabecular bone, which improves the BMD score but may not contribute as much to fracture prevention.

Finally, women age sixty-five and older who engage in regular exercise enjoy twice the reduction in hip fractures achieved with Fosamax. Exercise not only increases bone density but improves muscle strength and balance, thereby preventing falls, the proximate cause of hip fractures. Yet physicians who prescribe drugs such as Fosamax for at-risk women, while ignoring or downplaying the greater importance of exercise, are viewed as “evidence-based” physicians.

Why this lengthy exposition of a clinical issue in a health policy book review? Because readers who might be inclined to view Overdosed America as simply another in the growing number of diatribes against drug companies should be aware that this book makes its arguments in a detailed, well-referenced manner. Moreover, responsibility for the overdosing of America goes far beyond the drug industry, resting equally with the nation’s physicians. I beg all of my physician colleagues to read this book and to think deeply about how we are practicing our chosen profession.

Thomas Bodenheimer
Editor’s Notes
Thomas Bodenheimer was a private primary care physician for twenty-two years and is now on the faculty of the University of California, San Francisco.

Copyright C 2005 by Project HOPE
DOI: 10.1377/hlthaff.24.2.562

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