Pharmageddon (41 page)

Furthermore, the ability to have an exclusive patent on a drug creates conditions suitable to blockbuster marketing. As drugs have increased in celebrity status in the 1990s and 2000s, any independent assessments made of the therapeutic advantages offered by new drugs have consistently indicated that these have been minimal at best. Indeed, pharmaceutical companies now seem to be able to make blockbusters out of drugs that are virtual carbon copies of already available and cheaper drugs—Nexium out of Prilosec, Lexapro out of Celexa, Lyrica out of Neurontin. These are companies who are masters at generating and maintaining wants rather than companies who are any good at making drugs. Indian and Chinese pharmaceutical companies are today more innovative when it comes to producing novel and needed drugs than are the Western pharmaceutical manufacturers. As long as our companies can make their money from our wants there is no need for them to meet our needs.

It is far from clear that we need any patents on medicines. Asian companies have produced innovative compounds profitably without the protections of a product patent system. And as the makers of generic drugs show, a great deal of money can be made from drugs that are offpatent or sold over the counter. If patents are needed, one option is to reduce the length of protected time companies get for their patents—this was the option favored by Kefauver in 1962. Another option is to return to a system that offers patents on processes rather than products—a system that worked well in Germany for a century and led to the greatest rate of discovery of therapeutically useful drug treatments ever. If product patents are retained, at the very least we should insist on a return to the spirit of the law—namely that we, the community, will offer your company certain privileges in return for a genuine benefit.

Companies argue that the high cost of developing drugs, put at up to a billion dollars per drug, means they need the returns they get from the current system. But the greater part of these costs come from clinical trials that are in fact part of marketing and these costs escalate the weaker and less needed a drug is. The current patent system is central to both drug development costs and drug prices, and if we want to reduce drug prices the patent system has to change.

We have in fact engineered a lose-lose scenario. The current arrangements underpin the development of blockbusters that have become so important to the health of companies that they are prepared to conceal trials or adverse events that might pose problems for their marketing, ghostwrite such trials as are published, and aggressively counter attempts by doctors to describe problems that arise in the course of therapy. This is a situation that is as toxic to good medical care as it is possible to have.

THE FACTORIES OF POSTMODERNISM

In the 1990s a dispute blew up that has since been called the Science Wars.
¹⁸
At its most extreme, scientists who viewed the products of science as real were faced with radical skeptics, postmodernists from the humanities, who appeared to deny the reality of anything. Everything, including scientific articles, the postmodernists claimed, were just texts whose truth value was uncertain.

Postmodernism is linked to modern science. Once we in the West had seen God's revelation as coming in two books, the Bible and the Book of Nature. The rise of science led on to a radical or modernist doubt about the events portrayed in the text of the Bible. For a period, science remained immune to the crisis of belief in the biblical text, or indeed became a substitute for the lost certainties produced by viewing the Bible as simply a text. But as scientific advances began to show that older scientific “truths” were far from true, science itself faced a new radical doubt, postmodernism, that contested its claims to possess any revelation.

The response of science has been that any attempt to restructure science along postmodernist lines would produce a cargo cult. In the course of World War II, US Air Force planes flew into islands in the Pacific, disgorging all sorts of goods. Some of the islanders were so impressed by the appearance of these flying cornucopias that long after the US military left they maintained the runways and control huts, beside which they continued to fly the American flag, in the apparent belief that the right appearances would lead to the right results. These were the cargo cults. For scientists reality is not a text that can be read one way today and another tomorrow. The ultimate defense of science has been that its planes fly, whereas having postmodernists in a laboratory would reproduce the airstrips and the US flag—and leave us waiting forever for results.

The new drugs developed from the 1940s to the 1970s, based on breakthroughs in biology, pharmacology, and other medical sciences, meant the pharmaceutical industry of the time was about as far removed from a cargo cult as it was possible to be. In the face of such advances there was very little place for radical doubt. The first darkening of the medical horizon came in the 1960s with concerns about the emergence of a technological society, concerns that were applied to medicine by Ivan Illich in the 1970s. Illich's critique of medicalization came at a time when many had sensed the first intimations that not all was well with medicine.
¹⁹
The criticism at the time was directed at medicine itself, an apparently all-powerful institution, increasingly arrogating to itself the right to pronounce on life, death, and disability—not at industry.

Illich's critique crystallized battle lines already emerging between a medical sciences camp and a social sciences camp over “the medical gaze,” discussed in
chapter 6
. For one side this gaze was good, for the other it was dehumanizing. Some critics saw an overlap between scientists, physicians, and capitalism on the one side, and social scientists and socialism on the other. The degree of identification here is not important and it varied widely. But the key point is that there was an opposition, issues were contested, and the debate was open to a wider public. At its extreme it spawned an antipsychiatry that contested the legitimacy of any mental illnesses. Three decades on, debate has all but ceased.

The turn to quantification in medicine has transformed social scientists, medical anthropologists, and others into Stepford handmaidens of the establishment who embrace the New Biology. A medicopharmaceutical complex has triumphed; everyone seemingly accepts that it would be irrational to do anything but act in accordance with the “evidence.” Any sustained attempt to critique current trends is now likely to be dismissed as not evidence-based or as an advocacy of postmodernism that denies the reality of disease or scientific progress—in just the way that critics of psychoanalysis were once deemed ipso facto to have an unresolved neurosis.

But, while we now have in branches of medicine the appearances of science—controlled trials, a relentless quantification, and a sometimes stupefying recourse to statistics—the health care planes aren't flying any more, in the United States especially. In fact quite the opposite, over the past two decades the figures for life expectancy in developed countries show the United States falling progressively behind other developed countries, despite spending more money on healthcare than any other nation on earth—falling behind as well in terms of any ability to care, as the expectation that we will be rescued by magic has led us to neglect many of the caring skills we had.
²⁰

Meanwhile, the marketing departments of pharmaceutical companies are the postmodernists par excellence. They rewrite the text that is the human body from year to year with afflictions such as osteopenia, erectile dysfunction, and pediatric bipolar disorder that appear out of nowhere, creations of ghostwriters who practice to deceive.

Take Donna, for example. In marketing Zyprexa for bipolar disorder, in 2002, Lilly produced Donna, “a single mom, in her mid-30s appearing in your office in drab clothing and seeming somewhat ill at ease. Her chief complaint is ‘I feel so anxious and irritable lately.' Today she says she has been sleeping more than usual and has trouble concentrating at work and at home. However, several appointments earlier she was talkative, elated, and reported little need for sleep. You have treated her with various medications including antidepressants with little success…. You will be able to assure Donna that Zyprexa is safe and that it will help relieve the symptoms she is struggling with.”
²¹

In the 1960s and 1970s Donna would have been seen as anxious, a poster case for treatment with Valium. In the 1990s, presenting with the same symptoms, she would have been seen as depressed, and in need of treatment with Prozac. Neither neuroscience nor any aspect of clinical science had moved forward by 2002 in a manner that might justify rediagnosing Donna as bipolar. But this doesn't stop companies who are quite happy to read the vast majority of our problems one way today and quite another tomorrow.

And when it comes to the hazards of Zyprexa Donna may suffer from, just as with the hazards of the Lipitor she may have to take because Zyprexa has raised her cholesterol levels, or the Celebrex she may be on because of arthritis linked to Zyprexa-induced weight gain, or the Avandia she needs because Zyprexa has caused diabetes, Donna and her doctor will find themselves up against a radical skepticism. When it comes to the hazards of a pharmaceutical company's drug, the rules of science do not apply and causality, it seems, can never be proven. A more succinct definition of the arch-skepticism of postmodernism cannot be found than the phrase “doubt is our product.”

Almost the only critique left in town is limited to attributing all our problems to conflict of interest—the reason things are going wrong is that companies can hire academics to proselytize on their behalf. Somewhat ironically the champion of this charge has been a Republican senator, Chuck Grassley, rather than anyone from academia or the “left.”
²²
While Grassley has been nothing if not magnificently persistent in pursuing academics with links to pharmaceutical companies, forcing a number of eminent figures
²³
to resign from their university posts, and in proposing a Sunshine Act,
²⁴
his activism risks creating the impression that our problems stem primarily from a few rotten apples in the academic barrel rather than from anything more deep-seated. This is postmodernism for the twenty-first century—the text gets written according to the interests of the piper who pays the tune.

This superficial conflict-of-interest critique helps industry by focusing attention away from their unwillingness to allow access to the data. It is ignorant of the history of science, forgetting that John Snow's case for removing the handle on the Broad Street Pump was only aired because it was in the interest of the owners of local abattoirs and other businesses who were being blamed for the cholera epidemic to provide a platform for these views that supported them.
²⁵
It appears to imply that the State rather than private companies will need to run clinical trials or fund the academics who will present the results of these trials but this forgets that the specter of conflict of interest in science was first raised by another Republican—Dwight Eisenhower—concerned that public funding of research might lead to a military-industrial complex: “In holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy itself could become the captive of a scientific and technological elite.”
²⁶
If there is no access to the data, it is immaterial if the funding for science comes from private or public sources.

Eisenhower caught a glimpse of a world in which both the market and science might become forces for alienation rather than liberation. We have arrived there. This is a failure of historic proportions—seen rarely before except in the former Soviet Union. In the face of this failure, some belated critiques of practices such as ghostwriting or concerns about conflict of interest are profoundly inadequate.

In the face of the industrial postmodernism we see today, we need to recapture the ability to say that an increase in mortality is an increase in mortality and blockbuster drugs cause adverse events. We need to be able to recognize that little that glistens with statistical significance is therapeutic gold, and refuse to allow companies, their experts, and regulators to stand common sense on its head. Speaking out would be a way for doctors and scientists to demonstrate the “right stuff.” In addition to helping remedy our current difficulties, doing so might engage a wider public in the task of making real progress possible, rather than have us lulled into quiescence by fantasies of progress.

We need our media studies and other university departments to deconstruct industry rhetoric. But we also need to recover a belief in real progress and a faith in the biological sciences that would explain what lies behind the correlations thrown up by controlled trials. At present, in part because it suits industry, doctors are being taught that the controlled trials of evidence-based medicine are the answer to medicine's problems rather than being taught that they are a first step on the road to an answer—just as John Snow's isolation of the Broad Street Pump as a source of the cholera epidemic in London in 1856 was the first step on the road to an answer rather than itself the answer. It was Robert Koch's discovery of bacteria rather than Snow's researches that explained the cluster of events in Broad Street. Koch's work opened the way to a raft of inputs from the laboratory sciences into medical care that flourished in the work of clinicians like Richard Cabot a few years later.

THE FUTURE OF MEDICAL CARE

The juxtaposition of markets and health produces shudders, jolts, and every so often quakes as the tectonic plates of production, efficiency, equity, and choice collide. Americans embrace markets because they want choice—they don't want to be dictated to. Europeans have steered away from markets in medicine, seeing both equity and strength in the musketeer's one for all and all for one.