Pharmageddon (27 page)

Extrapolation from studies that demonstrated a benefit in men already ill to the rest of us has led to claims that “balancing” our lipids will reduce our future risk.
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This is a completely mythical balancing, rather like remedying a supposed imbalance of neurotransmitters with antidepressants. Several studies have suggested there may be as much if not more benefit to be gained from adopting a Mediterranean diet, which is more likely to increase than reduce cholesterol levels.
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For women in particular, the data suggests that attempting to reduce cholesterol levels may increase mortality.
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Alarmingly women without coronary artery disease now constitute almost a quarter of those taking statins with almost 10 percent of women over the age of seventy being on statins.
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More generally 40 percent of people taking a statin have no history of coronary artery disease.
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These developments have been driven by a series of studies designed to map out norms for cholesterol and lipid levels, the achievement of which would supposedly lead to minimal or no risk of cardiovascular events.
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There is a set of cholesterol levels that is linked to almost no cardiovascular events—levels found in teenagers or people in their twenties. But these levels are linked to no cardiovascular events because cardiovascular events almost never happen at this age. There is thus no particular reason to believe that cholesterol levels in this range protect against strokes. Nevertheless, it is just these values that have been set up as the normal range for adults of every age. According to norms like these, 94 percent of New Zealand's population has elevations of their lipid levels that carry some risk.
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It is a clear contradiction to set up as a normative standard a level according to which 94 percent of a population is abnormal. These may be optimal cholesterol levels but they are not normal levels. This is akin to what happened with the advent of drugs like Viagra, when impotence was reconfigured as erectile dysfunction. Impotence had been a disorder of men who were completely or close to completely unable to function. But the marketers have progressively redefined the target so that now even twenty-year-olds, who from time to time have an erection that falls in any way short of full rigidity, are invited to think of themselves as having a condition that could benefit from treatment and are encouraged to see a pill as a way out of anxiety.

In the case of cholesterol, the context in which any discussion of cholesterol levels made sense—where patients had a history of heart attacks in their family, smoked, were obese, and were also hypertensive—was progressively stripped away, so that the clinical gaze now focuses on the numbers themselves and their deviation from norms, partly because here is an area where a drug can be prescribed and a doctor can document that something has been done.

Just being constantly reminded of our own numbers on a scale of cholesterol norms can seduce. Even someone like me who knows better, who knows that cholesterol levels are for the most part meaningless in terms of overall health, when faced with his own lipid numbers, if these are thought to be even marginally too high, is likely to be unnerved or perhaps challenged. “I know there's no real need to get this marginally elevated level down, but hey, let's see what I can do.” Faced with an apparent deviation of our numbers from the norm, some of us can “feel” our arteries clog up on the spot and would find it almost impossible to do nothing.

Just as Sanjeebit Jachuk found his patients began suffering after a diagnosis of hypertension where they had been fine before (see
chapter 3
), so also many readers of this book would likely start to suffer from the effects they imagine excessive cholesterol brings if faced with their lipid levels. Once we only visited a doctor when we were suffering and we hoped to leave in a happier frame of mind about relief in the offing, often later grateful for an encouragement that we did not know at the time defied the numbers. Now we are much more likely to start suffering when some nonessential blood test, health program, or ad prompts us to visit a doctor, who is unlikely to counsel us to leave well enough alone.

At the epicenter of this are the companies who have cholesterollowering drugs to market. This is a market worth $35 billion per annum, with the best seller, Pfizer's Lipitor, making over $12 billion worth of sales in 2008. At the heart of the marketing of Lipitor have been a series of ads that have pulled no punches. One shows the soles of the feet of a corpse in the morgue, with a name tag on its left big toe, and a strap line on the side—Which would you rather have, a cholesterol test or a final exam? Another shows an open heart with its traceries of blood vessels and a strap line—Lipitor reduces risk of heart attacks by 36 percent. Behind claims like this, there is typically a study in which 3 percent of older men with a history of heart problems and other risk factors have a heart attack on placebo compared with 2 percent taking Lipitor or whichever drug—this is a 50 percent reduction in what is called relative risk in contrast to absolute risk. But even for consumers alert to this piece of trickery, there is nothing in the ad to let women or men with no history of heart problems know that these figures for risk reduction do not apply to them.

Pressure like this makes the idea of taking something that might lower lipids very seductive. So much so that even though using pills to lower cholesterol appears to increase mortality, the pill becomes a solution to the problem that attention to cholesterol levels has created. This follows the standard recipe for pulling a rabbit out of a hat—first put rabbit in hat.

A UNIVERSE TURNED RISKY

A remarkably similar dynamic has been playing out around another set of measurements. When I trained in the 1970s, osteoporosis was a rare disorder that involved an excessive thinning or weakening of bones, leading to an increased rate of fractures, which was diagnosed occasionally in older women who had unexpected fractures in response to minor traumas. It was also known that there was some loss of calcium in the bones of women after the menopause, but this was not seen as a particular problem.

In the 1970s with the marketing of hormone replacement therapy (HRT) for menopausal women the idea emerged that one of the benefits of treatment might be to keep women's bones young.
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When in the 1980s, pharmaceutical sales of HRT fell following suggestions that it might lead to breast cancer, Wyeth, one of the primary makers of HRT, helped sponsor a more aggressive marketing of osteoporosis, and it began to be portrayed as a much more ominous disorder. This promotional campaign featuring a benefit of HRT to counter attention to possible risks turned around the sales of HRT.
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But osteoporosis only properly came into vogue after 1988 and the development of DXA (dual energy X-ray absorptiometry) scans. Using minimal radiation these low-cost machines measure bone density, something that had not been done before. In one sense the findings came as no surprise—there was variation around different sites in the body and in older women there was some thinning compared to women in their twenties. Across the lifespan, though, while women in their twenties have denser bones, they are perhaps the most abnormal: if we take both children, who have the thinnest bones, and older women into account, then bone densities as found in women in their twenties are far from being the norm for females.

DXA scans offered a golden opportunity to redefine osteoporosis, just as weighing scales did with refashioning standards of beauty. Women now were said to have the disease if their scans showed that bones in some part of their body had densities that were a standard amount less than the densities found in women in their twenties. All of a sudden one-third of postmenopausal women found themselves diseased.
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A further large group of women—and their doctors—were faced with another problem. These were the women who fell in between the supposed optimal bone state of women in their twenties and the new diseased state. For women whose bones fell between these states a completely new condition was invented, osteopenia (literally, “less bone”). Women with osteopenia are at no increased risk of a fracture compared to their “normal” peers.

Two factors combined to ensure that the transformation in our perceptions to make room for this disorder would be particularly rapid.

One was that two companies, Merck and Procter and Gamble, were competing to be the market leader with products from a new drug group—the biphosphonates. Merck's Fosamax was up against Procter and Gamble's Actonel in a billion dollar battle. Both companies saw DXA scans as the way forward to increased sales and they competed to provide scanners for free to doctors—who of course could charge a fee for scanning.
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The biphosphonate drugs conveniently provided an answer to the image of bone thinning—offering, at least in popular understanding, to remineralize bones. Given to women with severe reductions in bone densities, the biphosphonates can reduce what are called fragility fractures—hairline fractures primarily of the vertebrae that are picked up on X-ray without the person ever being aware they have had anything wrong. However, there is no difference between those on the drug and those not in the number of women who present to their doctors with an obvious fracture. Somewhere between 80 and 90 percent of women to whom biphosphonates are now given are unlikely to get even the X-ray changes in the rate of hairline fractures, and in some of those with minimal reductions in bone densities the biphosphonates have been linked to increased rates of fractures of long bones such as the femur.
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Aside from increased risks of fractures, up to one-third of women given biphosphonates will have significant gastric distress, a small number (1 in 10,000) will get osteonecrosis (bone death) of the jaw or other bones, and an unknown number will develop generalized pain syndromes, or eye problems including blindness, or cardiac problems that may increase the risk of a stroke.
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The difficulty in knowing how many will suffer from these complications is that the company trial data is almost unbelievable—in the company trials that have been released the rates of gastric problems are the same on the active drug as for the placebo.

These risks might be worth running for those rare women who have a clinically established form of osteoporosis if there were good evidence that medication could help or help as much as getting fit. There is good evidence that factors such as levels of a person's physical fitness are better predictors of fractures than are bone densities, and good evidence that encouraging women to improve their fitness will reduce their fracture rates.
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But fitness clinics don't distribute articles with the results of controlled trials demonstrating such benefits of good exercise, whereas doctors are bombarded with articles in which an artful use of statistics appears to confirm a benefit to drug treatment, and women are subjected to ubiquitous advertisements on the benefits of the drug. And just as with the statins, for both doctor and patient prescribing a pill can seem easier than changing a lifestyle.

From the 1990s onward magazines for teenage girls began to feature discussions of osteoporosis. While none of these adolescents will have been the direct target of marketing by Merck and Procter and Gamble, still the change in culture these companies have created feeds through to all women, reinforcing the message in ads that are directly aimed at older women. Messages such as those in a Merck ad showing a very attractive woman apparently emerging from the bath, with a towel discreetly held to her upper chest but displaying enough of her body for the ad to be confident you will give a positive answer to its first question, “See how beautiful sixty can look?” This is followed by a further question, “See how invisible osteoporosis can be?” The sidebar then tells us that one in two women sixty and over have osteoporosis, and that while it may be invisible it leads on to broken bones and a dowager's hump. This Merck ad is not for Fosamax by name; instead it asks women to ask their doctor if a bone density test might be right for them.

The numbers that come from bone density scans and blood tests for cholesterol set up a new normality. If our numbers are abnormal, we almost immediately begin to feel at risk—dis-eased. And here we come to a key point. Whereas for centuries medicine had almost exclusively been about the treatment of diseases in the sense of biological disorders that posed an immediate threat to our lives, and still is in much of the world, Western medical practice now is increasingly about the management of risks—and this increasingly creates dis-ease.

When it came to treating diseases, epidemics aside, usually only a relatively small number of people had them. In the West much greater numbers are at risk as now defined. There are thousands of women with technical osteoporosis now for every one with clinical osteoporosis in the past, thousands with checklist depression now for every one with melancholia in the past, and entire populations with lipid abnormalities where hypercholesterolemia had been a rare disorder in the past.

In early twentieth century, we were rescued from the problems of a previous generation of celebrity drugs by the laboratory work of scientists and doctors from Robert Koch to Richard Cabot and others. Many physicians today remain confident that mapping of the human genome and other scientific developments will save us from the ravages of disease tomorrow. But there is a critical difference: the bacteriology of Koch alerted us to an external threat such as cholera, anthrax, or tuberculosis that we could mobilize against, whereas the mapping of the human genome promises to extend the riskiness of our universe. There are likely to be a much greater number of genetic markers for small degrees of risk than there will be genes for diseases. How do we mobilize against the uncertainties of the human body itself?