Pharmageddon (2 page)

While making many excellent points and calling for action to tackle the problems the pharmaceutical industry poses, these concerned critics, largely from the medical profession, typically portray medicine itself as fundamentally healthy. The serenity of these physicians stems from their perception that, in contrast to an earlier time, medicine is now secure behind the ramparts of science. This science is not the laboratory science that emerged at the turn of the century with doctors like Richard Cabot but rather a science of randomized controlled trials (RCTs) that stems from the 1950s. In these trials new drugs are pitted against dummy pills, or placebos, and it is only if the new drug “wins” that it is allowed into use.

These trials have laid the basis for what has come to be called “evidence-based medicine.” The results of RCT trials are also incorporated into evidence-based guidelines for the treatment of different diseases, and these guidelines, when embraced by particular agencies, constrain the prescriptions doctors can write. Many professionals involved in healthcare see such guidelines as keeping doctors within a straight and narrow path of therapeutic virtue, whatever the blandishments of pharmaceutical or medical equipment companies. Few suspect, as I will argue in
chapters 5
and
6
, that these guidelines in fact hand medicine over to the drug industry. Insofar as evidence-based medicine means that doctors stick to treatments that “work” and eliminate those that don't, many professionals involved in healthcare see it as offering the only possible basis for a universal healthcare system, if such a system were wanted. But as currently practiced, evidence-based medicine tolls a death-knell for the possibility of universal healthcare in the United States or its continued existence elsewhere.

Aware that something is wrong, we cast around for a villain and often settle on the insurance companies or other third party payers for our current woes. While many grievances against insurance companies are legitimate, they too have a diminishing grip on the healthcare agenda. Because only the drugs and the style of care that goes with them have been proven to work, insurance companies are trapped into reimbursing for these treatments and in the case of hospital stays often only for periods of time that permit little more than the institution of a drug treatment regimen. In doing this they are just following the guidelines drawn up on the basis of the best evidence by medical academics with no links to industry, guidelines that typically endorse the latest high-cost treatments over more effective, cheaper, and more humane forms of care.

The medical establishment, aware of problems in their interface with the pharmaceutical industry but not sure of the source of those problems, increasingly concedes there are senior figures and other opinion leaders in the field who have overly close links with the pharmaceutical industry or other conflicts of interest. But these academics are seen simply as the rotten apples that can be found in any barrel and the assumption is that their behavior will soon be put right by new rules on disclosure of links to pharmaceutical companies.

There is also an acknowledgment that pretty well all the trials that a new drug has to go through for approval are designed, and implemented, by pharmaceutical companies, and a growing awareness that rather than being written up in journals by the academics whose names appear on their authorship line, these papers have commonly been “ghostwritten.” But for most commentators these are simply more reasons to rein in the pharmaceutical industry, rather than reasons to consider the need for more far-reaching changes such as the nature of our current patents on drugs or the prescription-only status of many drugs, or for a close look at how these ghostwriting and other practices, as laid out in
chapters 4
and
5
, compromise clinical care itself.

Criticizing success is not a winning formula. In a market economy what company is going to try to be less successful? The door is left wide open for pharmaceutical companies to argue that the reason there are so many medical care problems is that the rest of the healthcare economy has not fully embraced the market.
¹⁰
The argument is so seductive that even left-leaning commentators, whether in the United States or Europe, concede some validity to proposals that the way forward in health must involve some embrace of the market.
¹¹

For the pharmaceutical industry, attacks from the medical community have turned into a version of rope-a-dope. Muhammad Ali-like, they let the medical George Foremans punch themselves out on issues like conflict of interest, the sponsoring of patient groups, and ghostwriting. Industry is happy to settle back on the ropes and take the punishment.

I will argue that the problems that give rise to attacks from the medical community and other commentators stem from three sources not acknowledged elsewhere. First, at the start of the modern era of medical practice, in the 1950s, the basis on which drugs are patented was changed, allowing companies to have monopolies on drugs in a way they hadn't had before. This permitted the development of blockbuster drugs, laying the basis for the marketing of drugs we now see. Second, also in the 1950s these drugs were made available on a prescription-only basis, putting a relatively small group of people with no training in or awareness of marketing techniques—doctors—in the gun sights of the most sophisticated marketing machinery on the planet. Third, having been under siege by industry for a century, in the 1960s we in medicine woke up to find a horse outside the gates of Troy in the shape of controlled trials and hauled it inside, not realizing that industry-designed trials provide wonderful evidence about the benefits of drugs but very little evidence of what might be best for patients.

Against this background, discussions of conflict of interest and ghostwriting, while important, only scratch the surface. We need to ask whether faith in controlled trials when we are not allowed to see the data from those trials can protect us against the biases introduced by commerce. Whether making drugs available on prescription-only status is appropriate in an age of blockbuster drugs. Whether the basis on which we now permit drugs to be patented is delivering the benefits to society that patents were originally designed to provide. As I will argue, every assault on industry paradoxically has instead reinforced the apparent need for controlled trials, prescription-only privileges, product patents, and further regulatory arrangements, and together these have bound the medical profession and government ever tighter to the pharmaceutical industry. These are the changes that among them laid the basis for companies to create blockbusters, and as long as these changes remain unquestioned industry is happy to settle back on the ropes and take a pounding.

At times of change, there is a temptation to extol the virtues of some former golden age. But while the dogs may bark, the caravan invariably moves on. Generations of us have put our faith and the lives of those we love in the hands of doctors offering the latest in medical developments. Progress may be slow in many areas, but when it comes to life, death, and disability most of us—like my father—will opt for those who offer us hope however slender the odds may be. Up till now, we have been correct to do so. Is there a reason to think an author raising the prospect of Pharmageddon should detain us any more than concerned critics from Alfred Worcester to Ivan Illich have done in the past? Can the best critique do anything other than ask us to give up hope?

Worcester, Illich, and others talked about losing our humanity and our ability to care. In part these critiques failed, even though no one wants to lose their humanity or ability to care, because there were no specifics about what it means to care nor how to recognize the moment at which our humanity is threatened. In part they failed because until recently, whatever the drawbacks to developments, there was little doubt that life expectancies were increasing. All this is now changing. We are in a world where increasingly we need protection from the latest miracle cure to ensure we do not die prematurely.

It would never be good care to withhold a cure. But traditional medical wisdom as practiced by Worcester to my father's doctor, Dr. Lapin, stressed the quintessential importance of being able to recognize when a treatment might make things worse rather than better. This philosophy was best expressed two hundred years ago by Philippe Pinel, a doctor looking after the mentally ill in Paris in the midst of the French Revolution: “It is an art of no little importance to administer medicines properly,” he said, “but it is an art of much greater and more difficult acquisition to know when to suspend or altogether to omit them.”
¹²

Cures almost by definition should lead to a fall in drug consumption, and good medical care as defined by Pinel should too. But instead we have seen an astonishing and relentless increase in the sale of supposed panaceas that do little or nothing to save lives or significantly improve their quality. The consumption of blockbuster drugs has grown from 6 percent of the pharmaceutical market in 1991 to 45 percent in 2006,
¹³
with the top ten drugs accounting for $60 billion in annual sales.
¹⁴
Where once the pharmaceutical industry made its money from drugs that cured, the big money now lies in marketing chronic diseases for which the current best-selling drugs in medicine offer little benefit. We are quite literally taking pills to save the lives of companies who have a greater interest in the vitality of the diseases they market drugs for than in our well-being. The only historical parallel we have here is the flourishing of patent or proprietary medicines in the late nineteenth and early twentieth centuries.

In 2010 the global market for pharmaceuticals was worth over $900 billion, more than the government bailout of the US economy following the 2008 financial crisis. Half of this came from sales within the United States and almost all came from treatments for chronic disease management rather than for life-saving treatments. Aside from treatments for cancer, in the global market for pharmaceuticals that year the best sellers were the antidepressants, mood stabilizers, and other central nervous system drugs ($50 billion), followed by the cholesterol-lowering statins ($34 billion), which along with other drugs for cardiovascular disorders were part of a $105 billion market, proton-pump inhibitors for acid reflux ($26 billion), the blood-sugar-lowering hypoglycemics ($24 billion), treatments for asthma like Advair (alone worth close to $8 billion), treatments for osteoporosis, and drugs like Viagra for sexual functioning.
¹⁵

These celebrity or blockbuster drugs have been showing growth in sales of 10 to 20 percent per annum worldwide; they grew even during the financial crisis. Once the markets in China and India come fully into play the profits can only grow larger, likely doubling. The markup on these drugs is on the order of several thousand percent, so they are now worth more than their weight in gold. There simply are no other goods in any other part of the economy that produce returns like these, and the profit margins of the companies that produce them far outstrip those of any other companies.

If this outlay of money saved our lives or restored productivity it would be readily justifiable, but in most cases when doctors talk about lowering our cholesterol levels with a statin they are not treating a disease, they are talking about risk management. They are not talking about saving our life but giving us a treatment for life. The statin prescribed for us may lower our cholesterol levels, but of even greater importance is the marketing by pharmaceutical companies that has changed both the doctors' and our perceptions so that lowering cholesterol has come to seem as important as treating a disease like tuberculosis.

This marketing is moving us steadily from what was the practice of medicine to a healthcare products limited market, and indeed not just a market but the creation of a new healthcare universe—a universe where the focus has shifted from medicine, in which progress occurred slowly but patients benefited, to a healthcare products market in which science and progress have become marketing terms and where benefits accrue to companies even while patients suffer harm.

It is easy to say that in the process we are poisoning our abilities to care. But what is care and where is the evidence that it is being poisoned? Care is what doctors bring to patients afflicted by something that threatens to take their life or leave them disabled. The ideal care will involve a cure. But what if the threat of disability and death comes from a treatment? Drug-induced injuries are now the fourth leading cause of death in hospital settings. They are possibly the greatest single source of disability in the developed world. The cost of drugs is often picked out in debates about the rising cost of healthcare, but healthcare providers spend more on remedying treatment-induced health problems than they do on drugs without any apparent effort to staunch this hemorrhage of lives or money. Why should this be? If we turn to the evidence base to care for and ideally cure this new disorder afflicting us, we find there is none—no guidelines, no studies, but instead close to a blanket dismissal of any evidence that things could be going wrong.

When it comes to care, the billions of dollars wrapped up in pharmaceutical sales only tell part of the story. Until recently in medicine there was vigorous debate on the appropriateness of various approaches to tackling disease and caring for patients, and medical meetings were filled with academics passionately arguing quite different points of view in discussions that often hinged on managing the risks of a treatment. But the money put into the marketing of pharmaceutical blockbusters is steadily silencing debate about differing therapeutic options and any discussion of the hazards that blockbusters pose. This is not just a problem in the United States—the silence is now being extended worldwide.

Fifty years ago many European countries put universal healthcare in place. Today, at a critical juncture in the history of healthcare, the United States is seeking to expand healthcare coverage. Fifty years ago it made sense to use taxpayer dollars to treat real diseases such as pneumonias and tuberculosis, for example, raising people from their deathbeds and putting them back to work, or taking them off disability lists and restoring them to productivity. This is an investment. If we can cure life-threatening or disability-producing diseases, the use of taxpayer dollars pays for itself—it would make the United States, for example, wealthier and better enable it to compete with China, Japan, and Europe. But treating raised cholesterol levels and other “number disorders” in an ever greater proportion of the population when medical necessity doesn't call for it is more likely to lead to a decrease in American productivity by increasing health anxieties and giving patients unpleasant side effects, if it doesn't actually kill them prematurely—and such pill dispensing is exactly what Americans do more than any other country on earth. This is an expense rather than an investment. Moreover, this is an expense that is crippling American industry, given that virtually everyone now has some set of numbers that pharmaceutical companies portray as needing “treatment.”