Overdosed America (4 page)

The illusion that newer is better and consumer autonomy is more important than a relationship with a trusted physician is leading to medical care that is often less effective and, at the same time, more expensive. Mr. Black’s Celebrex cost about $90 per month, while offering little if any advantage over drugs that cost one-third to one-seventh as much (as we’ll see in
Chapter 3
). In contrast,
the four medications
that kept Sister Marguerite alive for seven years cost a total of $38 per month at today’s prices. Nonetheless, the best way to serve my patients within this disordered medical system often called for me to accede to seemingly unreasonable demands, like Mr. Black’s.

As it happened, about a year after Mr. Black came in to request Celebrex for his elbow pain, he returned for another visit. As I walked into the exam room, I noticed that he looked tired and sad. When I asked him how he was doing, he said he was having trouble sleeping and asked if I would prescribe a sleeping pill. I asked him what was going on. With an uncharacteristic demeanor of defeat, he told me about a series of business setbacks that might force him to lay off several of his longtime employees. He shared his frustration and fears about the future. Just to be sure, I asked him if he was thinking about ending his life. He said no, but I sensed that he was relieved that I was taking his distress seriously.

I suggested a low dose of trazodone, an older, non–habit-forming antidepressant drug that has a side effect of sleepiness—just what Mr. Black needed. I reminded him how important it was to resume his regular exercise, which he had given up. I also made sure that he had at least one person with whom he was sharing his real feelings. I asked him to make an appointment to come back in two weeks so I could check on his progress, and to call me in the interim if he felt worse. At the end of the visit, Mr. Black thanked me for listening to his problems.

I was glad that Mr. Black had not simply demanded one of the expensive new antidepressant drugs or sleeping pills, neither of which would have unburdened him of his real-world problems. Mostly he needed to be heard and understood—and he needed more sleep and exercise and time to work through his business difficulties. I was glad that he trusted me enough to let me help. The difference between this visit and his earlier one illustrated the difference between commercially distorted medical care and old-fashioned (yet up-to-date) primary care.

When the history of this era of American medicine is fully written, there is no doubt that many of the scientific and technological advances will stand as great achievements. But I hope that the erosion of the healing alliance between doctors and patients will be looked back upon as a cultural aberration, a consequence of the unrealistic belief that good health is primarily a product of medical science rather than primarily the natural consequence of a healthy lifestyle and environment. Often the breakthroughs and sophisticated technology themselves weaken doctors’ ability to help their patients by drawing attention away from real encounters between real people working together to arrive at the best approach to each situation. As these relationships become less important, not only are we spending inordinate amounts of money on therapies that don’t provide commensurate value, but our health is actually suffering. This was the biggest surprise for me as I began to understand the real truth about the “scientific evidence” upon which I was basing my medical decisions.

By the time
all the morning patients had been seen, phone calls returned, nurses’ questions about patient care answered, and administrative issues addressed, I would be ready for some time alone to eat lunch and relax. I enjoyed reading through the current medical journals during my short break, looking for articles that might be relevant to my practice.

In August 2000, I was reading the
New England Journal of Medicine
(NEJM) over a typical lunch in my office when I noticed an article titled
“Pravastatin Therapy and the Risk of Stroke.”
This caught my attention because stroke is a fairly common problem among my elderly patients, and though most strokes are minor, some are tragic, leaving patients trapped in a permanent state of severe disability. I remembered one patient in particular, Mrs. Rose, who had spent the last year and a half of her life in a nursing home, wheelchair-bound, unable to feed herself or take care of her basic needs independently. Even though the stroke had left Mrs. Rose with garbled, almost incomprehensible speech, she managed to make it painfully clear to me each time I went to see her in the nursing home that she would much rather have died from her stroke than be stuck living that way.

I was certainly interested in decreasing other patients’ risk of suffering the same fate. But as I started to read the abstract (a brief summary of the study’s design, findings, and conclusions that precedes most articles in medical journals), I became a bit suspicious when I realized that the title itself was misleading. The study did indeed examine the effect of pravastatin, a cholesterol-lowering statin drug (more commonly known by its brand name Pravachol), in decreasing
the risk
of stroke, but it only included people who had already suffered a heart attack or unstable angina (chest pain that may precede a heart attack). The reduction in the risk of stroke reported in the study did not apply to Mrs. Rose or to other patients who did not already have heart disease, as might be reasonably assumed from the article’s title. Still, the abstract went on to report a statistically significant reduction in the risk of strokes among post–heart attack patients given Pravachol compared with those given a placebo, and concluded that “pravastatin has a moderate effect in reducing the risk of stroke.”

In the few minutes I had left before it was time to see my afternoon patients, I noticed that when the pre-study differences in conditions that predisposed a person to stroke (such as diabetes, high blood pressure, smoking, atrial fibrillation, and previous strokes) were taken into account, the reduction of stroke in the people who took Pravachol was not even large enough to be statistically significant.
*
This was the first time I had seen an article published in a major journal that reported results that did not reach statistical significance. I paused for a moment to register this fact and then read on.

The NEJM article reported an impressive-sounding 19 percent reduction in the risk of stroke in people who had taken Pravachol compared with those who had been given the placebo. This came down to 16 percent when the results were corrected for pre-study differences in factors that predispose to stroke. This way of expressing the effect of taking Pravachol is called the “relative risk reduction.” But
relative
risk tells only part of the story and often conveys an exaggerated impression of the benefit of the new drug or therapy. The far more important result is the amount of disease that is prevented by a given drug or therapy, called the “
absolute
risk reduction.”

The research skills I had learned as a Robert Wood Johnson Fellow served me well in critically reading articles in medical journals. Occasionally I would take out a pencil and calculator to do the arithmetic when the findings were confusing or their importance was not clear. And that is what I did with this study.

Over the course of this six-year study, 4.5 percent of the patients who took the placebo had strokes, compared with 3.7 percent of the patients who took Pravachol. The ratio between 4.5 percent and 3.7 percent provides the relative risk reduction of 19 percent. However, the actual number of strokes prevented by taking Pravachol, or the absolute risk reduction, is calculated by subtracting 3.7 percent from 4.5 percent. So over the six years of the study there were 0.8 percent fewer strokes among the people who took Pravachol. In other words, if 1000 post–heart attack patients took Pravachol for a year,
there would be about one less stroke
. This didn’t sound to me like a major finding. I called the local pharmacy to find out the cost of Pravachol 40 mg per day (the dose used in the study) and calculated that the cost of each stroke thus prevented was $1.2 million, not even including the cost of the extra blood tests and doctor visits to monitor for potentially dangerous side effects of the medication.

My curiosity about the rest of this article was now piqued, but it was time to start the afternoon clinic session. I took the article home to continue the time-consuming process of careful analysis. One of the benefits of a faculty appointment at Harvard Medical School is access to the school’s digital library, which provides access to virtually all the important medical journals. I wanted to dig around a little to see if I could find more information about statins and strokes.

The better I understood the details of this article, the more misleading its conclusion appeared to be. The biggest problem was the disparity between the people included in the study and the people most at risk of stroke. The people in the study averaged 62 years of age, but the
age at which most strokes
occur in the general population is much older: half of the men who have strokes are 71 or older, and half of the women who have strokes, like Mrs. Rose, are 79 or older. This is important because the patients in the study age 70 and older who had been treated with Pravachol actually had 21 percent
more
strokes than the patients given a placebo.

I kept going.

Eighty-three percent of the people included in the study were men, but
three out of five stroke victims in the general population are women
. The fact that only one out of six people in the Pravachol study were women turns out to be important because the women in the study who were given Pravachol experienced 26 percent
more
strokes than the women who were given a placebo.

And five out of six patients in the study were taking aspirin routinely to decrease their risk of having more heart trouble. But in the general population, the vast majority of people, like Mrs. Rose,
do not take aspirin routinely
. This is important because among the people in the study who were not taking aspirin, those taking Pravachol had 20 percent
more
strokes than those taking placebos.

My patient, Mrs. Rose, was a typical stroke victim: female, in her early eighties, and not taking aspirin. According to the results of the study,
her risk of stroke would have been increased
, not decreased, by treating her with Pravachol. It seemed to me that the only conclusion that could be reasonably drawn from the data presented was that men under the age of 70 who had suffered a heart attack and were taking aspirin might lower their risk of stroke by taking Pravachol.

When I finished analyzing the article and understood that the title didn’t tell the whole story, that the findings were not statistically significant, and that Pravachol appeared to cause
more
strokes in the population at greater risk, it felt like a violation of the trust that doctors (including me) place in the research published in respected medical journals. More than anything else in medical training, doctors are taught that good medical care is based upon a foundation of scientific evidence. I can remember well as a medical student, intern, and resident the daily exchange of photocopied journal articles as we went from patient to patient on hospital rounds. The latest articles from respected journals were accepted as the undisputed authority, defining good medicine and defending the decisions that had been made. A big part of becoming a doctor is learning to trust this scientific evidence enough to let it guide decisions that can have profound effects on vulnerable patients.

The Pravachol article seemed likely to have the effect of exploiting this deeply ingrained trust. Had the purpose of the study truly been to assist doctors in reducing their patients’ risk of stroke, it certainly would have mentioned other proven approaches to achieve that goal. Even taking at face value the article’s claimed 19 percent reduction in the risk of stroke—just to make this point—other more effective ways to decrease the risk of stroke had been well documented at the time the article was published. For example,
simply eating fish once a week
reduces the risk of stroke by 22 percent.
Controlling high blood pressure
reduces the risk of stroke by 35 to 45 percent. And even
moderate exercise for less than two hours
a week reduces the risk of stroke in an elderly population by about 60 percent.

The purpose of this article seemed incontrovertible: to establish “scientific evidence,” legitimized by the prestige of the
New England Journal of Medicine,
that would lead doctors to believe that they were reducing their patients’ risk of stroke by prescribing Pravachol. The collateral damage in establishing this belief is the diversion of doctors’ and patients’ attention away from far more effective ways to prevent stroke and achieve better health. But there is no profit to be made from these nondrug approaches, and therefore they receive much less attention than profitable and expensive drugs.

My instinct was to write an article for a medical journal explaining to doctors how to avoid being misled by the pro-drug spin in the pravastatin article and others like it that might appear in the future. I was confident of my analysis but thought that teaming up with an academic expert would make an even more powerful paper. I went over the problems I had identified in the article with a recognized authority. He found no fault with my analysis. I asked if he would be interested in writing the article with me, assuming that a university-based expert would welcome the opportunity to help correct the commercial bias that was creeping into the medical literature. He politely declined, explaining that he did “some consulting for the drug companies.” Stunned by his response, I quickly realized how naive I had been about the growing commercial influence in academic medicine. Nonetheless, this expert had generously taken the time to go over the article with me, so I did my best not to show my dismay.