The past is a foreign country: they do things differently there.
—L. P. HARTLEY, THE GO-BETWEEN
In the wee small hours of a perfect May night, I made my way home from the high-school graduation party of a close friend’s granddaughter. Then, blissfully wilted from a night of champagne, dancing, and laughter, I sprawled in the backseat of the cab to check my BlackBerry and was rewarded by a flurry of congratulatory messages from my writers’ group, all directed at Katherine Russell Rich, whose riveting book Dreaming in Hindi had just been published to worshipful reviews and radiant profiles in the New York Times, auguring certain literary success. This would have been a thrilling achievement for anyone, but it is an especially joyous triumph for Kathy, who, just a few years earlier, had cheated death via a harrowing bone-marrow transplant.
As I exited the cab, I mused that thriving, not just surviving, after breast cancer is a modern miracle. For that matter, so is living long enough to watch your grandchildren grow up. We are living lives that have been extended and transformed by medical research.
But, as pharmaceutical companies constantly remind us, these modern miracles are also modern luxuries, and they have not come cheap. Drug companies miss no opportunity to remind us that ours is money well spent, pointing out that by quelling major killers, by controlling infectious disease, and by providing the eternal vigilance of monitoring tests, modern biotechnological research has bestowed upon us more than decades of healthy life—it has also changed those lives.
Illnesses like polio, mumps, measles, diphtheria, and whooping cough used to fill parents with dread and carry off our children with regularity, but today even doctors have forgotten what they look like. We have swept polio and smallpox from the medical landscape, at least in Western industrialized nations. We have tamed, if not conquered, tuberculosis and syphilis while developing treatments that save the lives of most who suffer from childhood leukemia and testicular cancer. The discovery and refinement of insulin has transformed diabetes from a fatal mystery into an utterly controllable disorder. Drugs have tempered HIV from a feared scourge into a controlled virus, at least in the affluent West, and have reduced a constellation of other ailments from killers to annoyances.
Aging has been transformed as well. New knees, new hips, new hearts, newly sculpted eyes, and bodies and bones shored up by osteoporosis prophylaxis have enabled vigorous new adventures and careers that begin at sixty, an age most of us didn’t even reach a century ago. Before 1900, U.S. life expectancy was only 49.2 years.
Pharmaceutical companies take credit for these advances by claiming a single-minded pursuit of human health and happiness. “Life is our life’s work,” Pfizer declared for years, before replacing this with “Pfizer. Working for a healthier world.” Sanofi-Aventis exists “Because health matters.” GlaxoSmithKline’s mission? “Do more, feel better, live longer.” Merck is “Where patients come first,” and Germany’s Schering declares that it is “Making medicine work,” while Poland’s Polpharma consists of “People helping people.” Seemingly, these companies have no thought except for our better health and greater happiness.
But their research laboratories forge their miracles at great costs, which separate many of us in the United States and abroad from the medicines and medical care that we need. The price we pay is not only economic but also cultural: as Deadly Monopolies will reveal, medical culture itself has been transformed in the upheaval of the last thirty-plus years, as the university has been made into a partner of, or even an arm of, for-profit corporate entities. Unaffordable medications are merely the tip of this iceberg.
To understand what these costs are and why they have burgeoned, this book begins by revisiting the pivotal year 1980, when the Government Patent Policy Act, commonly known as the Bayh-Dole Act, catalyzed a proliferation of arrangements between universities, researchers, and private U.S. biotechnology companies. Now universities sell and license patents developed with taxpayer dollars to privately held firms, including biotechnology and pharmaceutical companies, which underwrite the cost of drug research and development.1
Another paradigm-shifting legal decision fed the proliferation of these biotechnology firms and pharmaceutical companies. In June 1980, the Supreme Court decided, in a 5–4 vote, to officially permit the patenting of living things, ruling in Diamond v. Chakrabarty that Dr. Ananda M. Chakrabarty’s “oil-eating” bacterium was not a product of nature, but rather a man-made invention that deserved patent protection.2 Life joined university patents on the auction block, and living entities were now viewed as patentable commodities.
What resulted from this newly cozy relationship between the university and industry, and from the newfound ability to patent living tissues, animals, bacteria, viruses, and even—especially—genes? As we will see, there were many and varied consequences, some of them unintended. We’ll examine the case of the surveyor John Moore, who discovered that his doctor had patented the unusual products of his oversized spleen, built a lab to commercially exploit them in partnership with Sandoz, and then concealed these acts from him. Moore was first in a long line of people who have lost control of their own tissues and body parts as the courts consistently ruled against them and for university and corporate patent holders.
Deadly Monopolies lays out the malign consequences of these developments in detail. Researchers who had habitually valued collaboration and sharing of data found that such collegial warmth threatened the exclusivity upon which the patent applications were based. Now such behavior is considered risky or worse: researchers have even been jailed on suspicion of sharing information with the wrong scientists. In an attempt to maximize patent profits, a zeal for devising derivative “copycat” or “me too” drugs instead of truly novel medications has come to dominate the medical-research landscape. The processes of medical research and publication have been distorted by the corporate agenda as pharmaceutical companies instruct researchers to withhold damaging data from studies and hire ghostwriters to package their marketing messages as scientific studies. With their eye on the bottom line, pharmaceutical companies even fund and oversee studies whose goal is to directly increase sales rather than to generate reliable scientific data.
Drug prices have soared as for-profit companies have assumed the direction of much medical research and have tended to place patent protection and profits above patient welfare. Companies and their university partners have even thwarted the work of some medical researchers, who have been forced to stop studies of needed medications because companies feared they would not be profitable enough or become the next billion-dollar blockbuster.
As profit potential has come to rule the research agenda, medications for common but relatively trivial ailments such as gastric distress and erectile dysfunction continue apace, but the killers that decimate poor developing nations—such as tuberculosis, cholera, and malaria—go largely ignored. As we’ll learn, pharmaceutical makers slight the medical issues of the Third World, even as its populations constitute huge pools of laboratory subjects who save the corporate-university research consortium a great deal of money and time. U.S. medical research is exported to poor developing nations in India, Africa, and even Eastern Europe, where research is completed far more rapidly and cheaply than it could be in the United States, amid practices and risks that American citizens are not asked to accept.
Corporations, notably pharmaceutical companies, now work closely with universities and their researchers in order to stimulate research, innovation, and profitability. But we’ll examine the deep inequalities of this alliance, with corporations holding the purse strings after a patentable entity has been developed, often with federal funds. The company that pays for R&D chooses which university’s and scientists’ candidate treatments to support, which to ignore, and which to abandon. Thus the legislative movement of the 1980s has created a medical-industrial complex that eventually robbed universities of their independence and seized control of medication design, costs, and even its evaluation in medical journals. This marriage, coupled with an American penchant for patenting an ever-wider range of living things, has not encouraged the production of important new cures, but rather has stymied it. The easy maximization of patent profits, not the arduous production of new drugs, has become the new corporate focus.
We’ll also examine the cultural revolution in medical research. Before the sea change of 1980, most twentieth-century medical researchers tended not to work for corporations but for universities or sometimes for private research organizations, including their own. Thus scientists were insulated from the commercial zeal of corporations. Scientists did seek recognition for their work, but their energies were more focused on reaping the honors of fame, influence, and academic advancement, along with the glowing satisfactions of altruism and being hailed as benefactors.
In the thirty years since Bayh-Dole, however, medical-research culture has been rendered unrecognizable to those raised in an earlier, less venal culture. The laws that fostered corporate-university partnerships in 1980 blurred the line between the two, and now the university has lost pivotal values that protected the public’s interests because they interfere with the profitability at the core of corporate missions.3
Valuable patents have been granted for living organisms, genes, biological processes, medically important animals, and even for human embryos. We’ll see how this expansion of patentability was sold to the American public as a strategy to stimulate creativity, to reward ingenuity, and to spark the development of important new therapies. Some hail this post-1980 medical-research paradigm shift as an unquestioned success, pointing to the more than five thousand biotechnology and other companies, based on university research, that have generated more than 2,500 patents since 1980.
But we’ll also see how, from the perspective of the medical consumer, medical innovation based on widely commercialized patents has raised prices, limited access to medicines, catalyzed the conscription of tissues, and has been associated with harmful effects of expensive new medications, many of which are withdrawn from the markets within a few years of FDA approval. By quelling competition, our monopolistic research models retard the development of important new diagnostic tests and medicines.
The medicines that do emerge from laboratories are expensive, and the pharmaceutical industry is quick to justify the sticker shock. For each experimental modality that reaches drugstore shelves, we are told, many others fall by the wayside after years of very expensive research and tests. As a result, the firms say, research and development today causes the cost of each new medication to soar from $800 million to as high as two billion dollars—and beyond. This stratospheric cost, the industry assures us, explains why medications are so expensive: the companies must recoup the costs of R&D while they cover the costs of the many experimental treatments that fail to attain perfection and approval. To paraphrase a quote often attributed to the late Senator Everett Dirksen, “$800 million here, $800 million there, pretty soon you’re talking about real money.” During the twenty years that a patent gives a company to profit from exclusive sales of the medication it developed, the industry claims, it must charge a price high enough to support the wider expense of saving our health.
Glaring inaccuracies cripple these arguments, most notably that the $800 million to $2 billion estimate for each new medication is wildly inflated, as I explain in Chapter 2. The high prices reflect not a need to recoup R&D costs, but the drive to shore up mammoth wealth for the $310 billion pharmaceutical industry, which was until 2006 the most profitable industry on the globe. (It has since slipped to the number-three spot, behind network and other communications equipment, and internet services and retailing.)4
Deadly Monopolies explains why most expensive “new” drugs touted by the pharmaceutical manufacturers and approved by a cooperative FDA are not new at all, but “copycat” versions of older drugs that are often not only cheaper but also safer. The industry has been getting away with a staggeringly high markup on today’s duplicates of yesterday’s medical miracles.
Experts in intellectual-property law disagree about the degree to which patents stymie innovation, raise prices, and discourage the production of new cures. These experts also disagree about what should be done. Should life and medication patents be done away with in some arenas? Should they be more strictly regulated, less strictly regulated, or should we adopt some new, more equitable model for rewarding drug innovation? I am indebted to a number of intellectual-property experts on every side of the issue for generously helping me illuminate these problems, as I survey the effects of patent laws and policies on everyday people and ask, cui bono—who benefits?
Do current laws and policies on treatment and research benefit only pharmaceutical firms at the expense of the everyday people who serve as consumers and research subjects? Are governments and agencies such as the FDA also responsible for such inequities, and to what extent? This book examines everything from the testing of patients without informed consent to the shadowy appropriation and marketing of Americans’ tissues to the biocolonialism that governs the appropriation of everything from seeds and plants to genes from poor people in the developing world. Many of these issues have lurked below the ethical and media radar or are not usually considered in the light of pharmaceutical economics.
Pharmaceutical companies have always been faced with the perhaps insurmountable challenge of serving both medicine and Mammon—an inevitable tension in a capitalist economy. But the marriage of corporations and academia subjected the university medical centers, publicly supported and with a very different agenda, to the same pressures. Within these pages, I explore what happens when formerly public institutions and advocates become minions of Big Pharma. I do so through the personal experiences of patients, research subjects, and even of researchers whose tugs-of-war over patents have landed them in jail, or who may have spent decades on a promising drug only to have a pharmaceutical company pull the plug over fears of market competition.
I detail how unwitting tissue “donors” such as Henrietta Lacks and John Moore lost control of their bodies when their tissues were appropriated and exploited for profit by the physician-researchers to whom they entrusted their medical care. Their betrayal has been compounded by a string of rulings in which the U.S. courts proved unsympathetic to Americans’ claims to their own body parts—but honored the claims of medical researchers to these same tissues. What role does the patent rush and the post-1980 university-corporation partnerships that catalyzed it play in today’s transformed research landscape? Almost none of us possess the unusually valuable and unique tissue of Lacks and Moore, but as we’ll see, value today lies in harvesting large numbers of healthy normal tissues, so we are all at risk of the type of non-consensual appropriation that befell them. For example, at some hospitals, surgery patients are routinely asked and sometimes required to surrender the right to their excised cells, blood, and tissues before undergoing the procedures they need.
The devastation that medical monopolies have visited upon Westerners has a face, and that face does not differ much from you the reader: it cuts a swath across nationality, economic status, race, gender, and sometimes even class.
But most people in the developing world lack the health-care infrastructure and drug availability that we enjoy, so they experience medical damages at a heightened level. New cures are often generated from biologicals found among poor native peoples and are often tested in Third World clinics. But once perfected, these medications tend to be priced out of the reach of the communities that made them possible.
We shall see how often sick, medically desperate people of the Third World are used as the laboratory subjects of the West as pharmaceutical companies impose on them all the risks of medical research but withhold the benefits of the approved medications. I’ll describe how the children of Kano, Nigeria, were victimized when Pfizer descended in the midst of a meningitis epidemic to test its newly patented but unapproved remedy—without, by many doctors’ accounts, informed consent. Pfizer left in its wake dead and injured children, lost records, outraged local physicians, and mourning parents who stormed courts on two continents to seek justice for their children who were sacrificed on the altar of an unapproved drug.
And why are tuberculosis, smallpox, and polio conquered only in the affluent West? In poor developing nations, these scourges are still untamed because their people lack money for vaccines and medications. Why are important diseases that strike poor people abroad (and sometimes here as well) so devoid of attention and resources that they are called “orphan diseases”? Because it is well known that no pharmaceutical company will take them on. Most of these diseases, such as malaria and African sleeping sickness, predominantly strike the developing world. The biological and pharmaceutical patents did not create this situation, but their wide deployment and other forms of medical monopolies have escalated it dramatically. In Deadly Monopolies, I describe how this escalation has come about.
Leaving aside for the moment the moral unacceptability of withholding medicine from poor people in order to maximize profits for one of the world’s most profitable industries, we must consider the global extent of drug makers’ control over our medical fates.
Most discussions treat Third World medical-access issues as if they were completely separate from those of developed nations, but I will argue that we in the United States share with them a common vulnerability at the hands of drug makers. I would not trivialize the suffering of the Third World by suggesting that our problems in the West are comparable to theirs in degree: this is why I devote separate chapters to their medical treatment at the hands of the pharmaceutical industry. But our medical interdependence has a common cause that may share common solutions.
E. Richard Gold, a professor of intellectual property at McGill University, validated this view when he commented on “Toward a New Era of Intellectual Property: From Confrontation to Negotiation,” a report published by his International Expert Group: “We found the same stumbling blocks in the traditional communities of Brazil as we did in the boardroom of a corporation that holds the patent to a gene that can determine the chance a woman will develop breast cancer.”5
Many economists, activists, patient-consumers, and scientists have decided that our monopolistic medical model is doing more harm than good. Already the first successful shot across the bow has been fired, by a coalition whose lawsuit effected the repeal of seven patents on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics. Their patents made genetic testing painfully expensive and blocked access to other tests. In January 2005, the European Patent Office had also rejected the essential points of BRCA1 gene patents. In July 2011, as this book went to press, the U.S. Court of Appeals for the Federal Circuit restored most of these patents on appeal,6 but future appeals will probably reach the Supreme Court. Which culture’s model will triumph? That of the patent-hungry United States or of the relatively parent-wary Europe? As we will see, the U.S. courts may be adopting a more European point of view because both the Obama administration and thousands of geneticists and other scientists support this lawsuit to bring down gene patents.
Breast cancer is only one of the many diseases with a prominent genetic component whose detection, treatment, and cure may be stymied, not abetted, by the drug industry’s myopic focus on protecting their patent profits. Deadly Monopolies explores ethical and therapeutic questions as it traces the growing dissent from the corporate “ownership” of human genes.
Gene patents are only the beginning. Increasingly, legal experts, medical leaders, lawmakers, and outraged citizens are calling for patent restraint in all quarters. Outright rebellions against life patents in the form of editorials, proposed laws, lawsuits, and political lobbying have begun to emanate from around the globe as scientists and advocates realize that monopolies on life threaten rather than serve public health, human freedom, and dignity.
Medical researchers, economists, and philanthropists have also joined to create imaginative models that provide wider access to drugs and preserve patent profits without exploitation. They dream of a world where access to medical miracles is not limited by accidents of birth, money, or land of origin: not a world devoid of corporate profits, but a world no longer in thrall to them. A world where lives depend not upon a patent but upon a passion for healing.
My friend Kathy shares this global vision in Dreaming in Hindi, her poignant memoir of traveling in India with stage IV breast cancer. Her wrenching realization that poor women in remote Indian villages have no access to mammography or standard chemotherapy, to say nothing of $3,400 gene tests or $25,000 bone-marrow transplants, forces her—and us—to confront the naked truth about medical monopolies, the profit motive, and the merciless geography of survival reflected in the eyes of a lone dying woman.
At a time when unemployment, the lack of adequate insurance, and a simple inability to afford medications are common burdens, even in the affluent United States, that woman could be any of us. This may be the best argument for restoring the patient, not the patent, to the center of the medical-research universe.