BOOK REVIEW by Susan Taney, MSN, NP

Over Dosed America: The Broken Promise of American Medicine
Author: John Abramson, M.D.

The American health care system is a trillion dollar industry and it is not practicing doctors (the one's taking care of the patients) who are making that money. Read this book to better understand the medical-pharmaceutical industrial complex, how that kind of money is generated and where it is going.

Dr. Abramson has spent over twenty years practicing medicine in exam rooms not corporate board rooms. He's practiced medicine in Appalachia and Hamilton, Mass. He also teaches at Harvard. Years ago, as a Robert Wood Johnson fellow and research assistant, he came to understand research methodology and epidemiology. Over the years his view expanded and he has the unique ability to remain focused on the individual patient while also holding a clear and enlightened understanding of health issues and health care phenomena within the entire population. He has carefully reviewed research evidence and in many instances his conclusions differ from those of the authors reporting their research findings in the medical journals, which in turn become the basis of traditional medicine's clinical practice guidelines. These guidelines are the “evidence based medicine” referred to as best practices in health care. It is against this that the quality of a health care provider's practice is evaluated in this and many other countries.

Dr. Abramson explains with credible detailed analysis why some conclusions reached in the reports of drug and other therapeutic intervention research are distorted. He details the onset and progression of the sticky web in which many in the health care industry find themselves. This web of financial interdependence encircles not just those on the payroll of the pharmaceutical industry, but research scientists (about 90% of drug research is supported by drug company money), leaders at the Federal Food and Drug Administration (FDA) and those serving the revered organizations on the forefront of developing and publishing the guidelines on which medical practice is based. Many of these are the physician leaders of their profession. The nations prestigious medical journals report the “findings” and their resultant guidelines, becoming collaborators in the perpetuation of the distortions by placing them alongside reports of credible evidence.

Medical students, intern and resident physicians are trained with the information from these respected journals, “accepted as the undisputed authority, defining good medicine and defending the decisions that had been made”, says Dr. Abramson. So do nurse practitioners and physician assistants who also can prescribe drugs and are held accountable to the same standards. Trusting the science reported in these journals guides decisions that can and does have a profound impact on patients who entrust their doctors, NP's and PA's with their care.

Dr. Abramson explores and evaluates these issues with skill and rigor. A major debate on this subject within the profession of medicine and a reporting of that debate in those very journals could begin with this one book. The rest of the health care system's direct providers of care as well as the consumers of traditional medical care should demand that debate and attend it with tough love encouragement. There's just too much at stake to sit back and not speak out. I implore with earnest supplication that all health care providers, particularly allopathic physicians, read this book. The wise patient will read it too.

Examples from OVERDOSED AMERICA of manipulations of research statistics distorting the true picture:

#1

Prevastatin Therapy and the Risk of Stroke, THE NEW ENGLAND JOURNAL OF MEDICINE, April 2000, Volume 345:317-326.

Reported Results: Among the patients given placebo, the risk of stroke was 4.5 percent, as compared with 3.7 percent among those given pravastatin [Pravacol®] (relative reduction in risk 19 percent; 95 percent confidence interval, 0-34 percent; p=0.05).
After adjustment for significant base line factors, treatment with pravastatin was associated with a reduction of 16 percent in the overall risk of stroke (95percent confidence interval, -3 to 31percent; p=0.10)
This risk reduction corresponds to the occurrence of strokes in 8 fewer patients for every 1000 patients treated with pravastatin instead of placebo for six years.

This sounds promising and would lead one to believe that anyone who meets risk criteria for developing atherosclerotic cardiovascular disease (ASCVD) that can lead to heart attack and stroke should be on this drug or one like it. But on closer inspection the title and reported results are misleading as all of the subjects ALREADY HAD ASCVD and had unstable angina or had already suffered a myocardial infarction (MI or heart attack). Still a 19 percent reduction in stroke in this population is significant if that were the true picture but it is the relative risk that only tells part of the story. Dr Abramson points out in his book that relative risk “often conveys an exaggerated impression of the benefit of the new drug or therapy”. More importantly is the “absolute risk reduction” that is the amount of disease prevented by a drug or other therapy.

In his meticulous dissection of this study, Dr. Abramson found and describes that over the six years of the study there were actually 0.8 percent fewer strokes among the people that took the pravastatin which by the way is not available as a generic. Another way to say this would be that there would be one less stoke if 1000 post MI patients with a ratio of 6 men to 1 woman took Pravacol® and each prevented stroke would cost $1.2 million, a significant portion of this money going to Bristol-Myers Squibb Company, manufacturer of Parvacol® and financial supporter of this Australian study.

What is particularly striking is what is omitted in the reporting. The 756 women of the 4512 on Pravacol® in this study had an increase in overall stroke risk when compared to the 760 women of the total of 4502 in the placebo group. Even more alarming is the diversion of attention away from more effective ways to prevent stroke and prolong better health. Perhaps the reason for this is too obvious. There is little money to be made from these non-drug interventions. These are downplayed as not significantly attainable in many circles in medicine because it takes effort for people to achieve change and abandon unhealthy lifestyle habits. The medical pharmaceutical industrial complex doesn't consider as a rule the general population capable of significant change. People do indeed frequently want a pill instead of having to change their habits. This combination of views coupled with the ever shrinking public funding of medical research spells increased use of expensive medications and big profits for drug companies. The public health suffers.

#2

Effect of Alendronate on Risk of Fracture in Women With Low Bone Density but Without Vertebral Fractures: Results From the Fracture Intervention Trial, JAMA – THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, Dec 1998; 280: 2077 - 2082.

Alendronate, better known as Fosamax®, was brought onto the market in 1995 and was the first of a new kind of drug approved by the FDA for the treatment of osteoporosis. Considering the fact that 20 percent of women over the age of 50 have been diagnosed with osteoporosis, and another 40 percent meet criteria for osteopenia, bone loss that has not progressed to osteoporosis, this drug had promise to capture a large share in the drug market. By 2020, about 14 million Americans will have the diagnosis and 47 million will have low bone mass.

Osteoporosis is the result of a silent band of thieves, including smoking, alcohol, carbonated beverages, a diet low in vitamins and minerals, drugs that deplete vitamins and minerals or compete for and win - blocking their absorption, and lack of weight bearing exercise. The resultant bone loss increases the risk of hip fracture, which is a major medical event that has a mortality rate of 15 - 20 percent within the first year. It is recommended in the guideline criteria developed by a WHO study group funded by three drug companies, that women have a bone mineral density (BMD) screen by dexascan at age 65 or sooner if they meet the criteria for increased risk.

In this study of women with an average age of 68 and a dexascan reading in the osteoporotic range, those who took Fosamax® for four years were reported to be 56 percent less likely to suffer hip fracture than the ones in the control group. But this is the relative risk. Analysis of the data reveals that as usual the relative risk reported alone is misleading. The absolute risk as reported by Dr. Abramson looks like this. If 81 women with the diagnosis of osteoporosis as defined by the BMD dependent criteria took Fosamax® for 4.2 years, one hip fracture would be prevented. The cost to prevent this one hip fracture in 81 women over a four-year+ period of time cost $300,000. There was no reduction in less serious fracture.

#3

Effect of Risedronate on the Risk of Hip Fracture in Elderly Women, NEW ENGLAND JOURNAL OF MEDICINE, Feb 2001; 344:333-340.

Risedronate, better known as Actonel®, was given randomly to half of the 9331 women 70 to 79 years old who participated in this study, the control group received placebo. Here 5445 of the women 70 to 79 years old had the diagnosis of osteoporosis and 3886 women at least 80 years old who had at least one nonskeletal risk factor for hip fracture or low bone mineral density at the femoral neck. The primary end point was the occurrence of hip fracture or three years.

For the newer drug in this class, Actonel®, there was no effect on the number of hip fractures. Of the 40 percent of the total number of the women who already had one spine fracture at the onset of this study, 100 of them would have to take Actonel® for about one year to prevent one hip fracture. The remaining 60 percent who had no preexisting spine fractures, Actonel® did not significantly reduce the risk of hip fracture according to Dr. Abramson's absolute risk analysis of the data.

So what is going on in study examples number 2 and 3? Why do drugs that improve BMD fail at preventing more hip fractures on an absolute basis? Dr. Abramson explains that BMD is not a good predictor for hip fracture because it analyzes cortical bone, the outer layer of bone and not trabecular bone, the inner structures of bone. Drugs in the class of Fosamax® and Actonel® only strengthen cortical bone which does improve BMD but does nothing to trabecular bone, seemingly more important for necessary strength to avoid hip fracture.

So what does it all mean?

Dr. Abramson points out that reporting only the misleading relative risk and influencing clinical guidelines, forces the hand of health care providers to take pen to prescription pad where other interventions may be more effective, at least at first. Women 65 years of age and older who engage in regular exercise have half the actual number of hip fractures as women of the same age who are sedentary. Exercise increases bone density and also increases muscle strength and coordinates balance so that falls are more easily avoided. Other more promising combinations of interventions to improve the strength of bone in this age group of women would be welcomed. Health care providers can present to the younger women and men in their care the lifestyle habits that promote lifelong strong bones.