Excerpts from Chapter 14

This is the mother of all sleights of hand: the transformation of medical science from a public good whose purpose is to improve health into a commodity whose primary function is to maximize financial returns. As a result of this sleight of hand, the gap is widening between the scientific evidence that impartial experts (not paid or threatened by the medical industry, not biased by other personal concerns, and granted unrestricted access to all of the evidence) would agree upon and the perceptions that actually drive American health care. This growing gap is at the core of the crisis in American medicine. And why are we surprised? The drug companies have no more responsibility to oversee the public's health than the fast-food industry has to oversee the public's diet.

The substitution of narrow corporate interests for medical progress has produced some dramatic excesses. When the manufacturer of Paxil performs nine clinical studies on the treatment of adolescents for depression and finds that Paxil is no more effective than placebos and, in fact, significantly increases the frequency of "emotional lability� (including suicidal thoughts and attempts), it's no problem. The company publishes one study that shows a benefit, fails to publish the other eight, and markets away. When British drug authorities spill the beans? No problem. A task force of the American College of Neuropsychopharmacolgy is convened, and concludes that the new antidepressants are safe for adolescents after all. Too bad the task force didn't have access to some of the information that was available to the British drug authorities. But perhaps that didn't seem like so much of a problem, because, according to the New York Times, "Critics of the medicines noted that 9 of the 10 task force members had significant financial ties to the pharmaceutical industry. . . .� (However, the task force insisted that no industry money financed their report.) What to do when the FDA epidemiologist in charge of analyzing all the antidepressant studies involving children concludes, just like the British drug authorities, that twice as many children treated with the new drugs (except Prozac, which is available as an inexpensive generic) became suicidal, and that the FDA should therefore discourage doctors from treating children with these drugs? Just bar the expert from testifying at the FDA's public hearing. Then don't make him available for an interview with the New York Times, which reported the story on April 16, 2004

You don't like the way the study of an expensive drug for blood pressure is going? A nonissue -- just stop the study before the results reach statistical significance.

Endovascular Technologies (a wholly owned subsidiary of Guidant, the company that manufactures implantable defibrillators) manufactured a $10,000 device to repair aortic aneurysms that dangerously malfunctioned in a third of the 7600 patients in whom it had been used. Did this frequency of malfunction stop Endovascular Technologies? No. The company reported 7 percent of these events to the FDA and sold on. According to a plea agreement entered into with the United States government in 2003, the company belatedly disclosed another 2628 serious malfunctions and 12 deaths. No problem. It agreed to pay $92 million to cover criminal and civil penalties and then picked up with business as usual on other products.

Your drug company just received an official warning letter from the FDA for the "false and misleading� marketing of Celebrex, Vioxx, Pravachol, or OxyContin? No problem. The FDA's corrective action is unlikely to displace the false information already firmly planted in the public's mind.

And the list goes on. Controlling medical costs in this near free-for all commercial grab is not just impossible, it is a contradiction in terms. Does it make sense to talk about reducing national expenditures for cars or clothes or beer? Medical care, by far the largest consumer commodity in the United States, is now no different.

Read more!

Excerpts From Chapter 13

In 1995, Fosamax, the brand name for alendronate, was the first of the new generation of drugs approved by the FDA for the treatment of osteoporosis. Fosamax works by attaching itself to the surface of bone, interposed between the osteoclasts and the bone the osteoclasts are trying to absorb. Randomized clinical trials of Fosamax published in medical journals show dramatic reductions in the relative risk of hip fracture for women with osteoporosis. In a study published in JAMA in 1998, for example, women with an average age of 68 and a T score of - 2.5 or less who took Fosamax for four years were 56 percent less likely to suffer a hip fracture than women in the control group.

This sounds like very good news for women with osteoporosis, but how many hip fractures were really prevented? With no drug therapy at all, women with osteoporosis had a 99.5 percent chance of making it through each year without a hip fracture -- pretty good odds. With drug therapy, their odds improved to 99.8 percent. In other words, taking the drugs decreased their risk of hip fracture from 0.5 percent per year to 0.2 percent per year. This tiny decrease in absolute risk translates into the study's reported 56 percent reduction in relative risk. The bottom line is that 81 women with osteoporosis have to take Fosamax for 4.2 years, at a cost of more than $300,000, to prevent one hip fracture. (This benefit does not include a reduction of less serious fractures, including wrist and vertebral fractures. Most vertebral fractures cause no symptoms.)

[. . . ]

What about using these drugs to prevent osteoporosis? Fosamax and Actonel were approved by the FDA to treat women with osteopenia based on studies that showed that they significantly increase the bone density of these women. It is important to remember, however, that bone density is only a surrogate end point; the real reason for taking these drugs is to reduce fractures, and hip fractures in particular. The study of Fosamax published in JAMA in 1998 (mentioned earlier) also included women with osteopenia. Did Fosamax reduce their risk of fracture? The results show that the risk of hip fractures actually went up 84 percent with Fosamax treatment.* The risk of wrist fractures increased by about 50 percent (that figure may be statistically significant -- but this can't be determined from the data as presented in the article).

How can it be that drugs approved for the prevention and treatment of osteoporosis succeed in increasing bone density but have such limited impact on reducing hip fractures? The answer can only inspire awe at Mother Nature's elegance. There are two types of bone. Eighty percent of the body's bone is made up of the hard and dense outer layer called cortical bone. In some areas of the body, bones also have an internal structure of trabecular bone, which works like an organic three-dimensional geodesic dome, providing additional strength in the areas of the skeleton most vulnerable to fracture, such as the hips, wrists, and spine.

The lacelike structure of trabecular bone creates a much greater surface area than the densely packed cortical bone and therefore allows the former to be more metabolically active when the body needs calcium. Its greater metabolic activity also makes trabecular bone more vulnerable than cortical bone to the changed balance between osteoclast and osteoblast activity. As a result, when bone mass starts to decline in women, trabecular bone is lost more quickly than is cortical bone. Once the architecture of these internal struts is lost, there is no structure left onto which calcium can be added. (See Figure 13-1.) The new bone, formed as a result of taking the osteoporosis drugs, is then formed primarily on the outer part of the bone, the cortical bone. This increases the score on the bone density test but does not necessarily contribute proportionately to fracture resistance.

Read more!

Introduction

Just before I left my practice to write this book, one of my longtime patients, Mrs. Francis, came in for a visit. I always enjoyed seeing Mrs. Francis, a widow then in her mid-eighties. Her greeting was warm and her presence made the exam room feel comfortable - an oasis in the midst of daily time pressures, multiple tasks, and complex patient challenges. During this visit, Mrs. Francis asked why I was leaving. This wasn't just a casual question, nor did I feel that she was prying. Over the years, we had enjoyed many conversations, and I felt as if she genuinely wanted to understand what had gone into my decision. I did my best to explain.

I told her that over the last few years a profound shift had been taking place in the culture of American medicine. I explained that tests unlikely to improve patient care were being routinely ordered and expensive drugs that had not been shown to be any more effective or safer than the older drugs they were replacing were being routinely prescribed. I told her that the research I had been doing at night and on weekends was confirming my sense that much of the �scientific evidence� on which we doctors rely to guide our clinical decisions was being commercially spun, or worse; and that many of the articles published in even the most respected medical journals seemed more life infomercials whose purpose as to promote their sponsors' products rather than to search for the best ways to improve people's health.

I told her that many of my patients were being drawn in by the growing number of drug ads and medical news stories; that patients were increasingly arriving for their visits with a firm (if not fixed) idea of the outcome they wanted instead of the expectation that the best medical care would emerge from open discussion of their symptoms, concerns, and exam and then mutual consideration of the options. I told her that when I tried to refocus patients on interventions proved to be safe and effective, many were reacting as if I were purposely trying to withhold the best treatment, making me choose between providing the best care and yielding to their demands in order to maintain the healing potential of our relationship. Finally, I told her that I had come to the conclusion that the best way I could help people to achieve better health was to find out what the scientific evidence really shows and explain this to the public - in much the same way that she and I had talked over the years - and to other medical professionals.

That was the best answer I could give Mrs. Francis at the time. I wasn't sure what I was going to find when I turned my full attention to these issues. But it was becoming clear that American medicine was like a runaway train picking up speed, fueled by the commercially generated belief that ever-increasing medical spending is necessary to achieve good health. It was also becoming clear that the train's brakes were failing. It seemed to me that, despite a few clear and brave voices, there was no effective counterbalance to the influence of commercially sponsored research. Nor was there even a way to determine whether all this expensive new care actually led to better health. And it as also clear that this crisis would soon come to a head when the burden of relentlessly increasing medical costs became more than many Americans could bear.

What I found over the next two and a half years of �researching the research� is a scandal in medical science that is at least the equivalent of any of the recent corporate scandals that have shaken Americans' confidence I the integrity of the corporate and financial worlds. Rigging medical studies, misrepresenting research results published in even the most influential medical journals, and withholding the findings of whole studies that don't come out in a sponsor's favor have all become the accepted norm in commercially sponsored medical research. To keep the lid sealed on this corruption of medical science - and to ensure its translation into medical practice - there is a complex web of corporate influences that includes disempowered regulatory agencies, commercially sponsored medical education, brilliant advertising, expensive public relations campaigns, and manipulation of free media coverage. And last, but not least, are the financial ties between many of the most trusted medical experts and the medical industry.

Excerpted from Overdosed America. Copyright © 2004 by John Abramson, M.D. All rights reserved. Harpercollins Publishers.

Read more!