On the Take: How Medicine's Complicity With Big Business Can Endanger
By Jerome P. Kassirer • Oxford University Press • 288 pages • $28.00
The $800 Million Pill: The Truth Behind the Cost of New Drugs
By Merrill Goozner • University of California Press • 297 pages • $24.95
Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs
By Jerry Avorn • Alfred A. Knopf • 448 pages • $27.50
Could we finally be seeing a backlash against the pharmaceutical industry? After all those headlines about Medicaid fraud, research abuse, data suppression, class-action lawsuits, recalled drugs, conflict-of-interest scandals, corporate whistleblowers, ghost- written research papers, and kickbacks to physicians -- not to mention the video clips of elderly New Englanders hauling their walkers onto chartered buses to fill their monthly prescriptions in Canada -- is the American public finally getting wise to Big Pharma? According to a Harris poll reported in the British Medical Journal, public confidence in drug companies has plunged faster than for any other industry, putting it on a par with the oil business and even Big Tobacco. The proportion of Americans who believe that the pharmaceutical industry is “generally honest and trustworthy” now stands at a mere 13 percent. And if the raft of books on drugmakers published this year is any indication, the approval rating among academic authors is even lower.
In fact, a reader of Jerome Kassirer's alarming new book, On the Take, might be forgiven for concluding that the Americans who say that the pharmaceutical industry is honest must be getting kickbacks themselves. Kassirer, a physician and former editor in chief of The New England Journal of Medicine, has taken on the daunting task of documenting the varied and ingenious ways in which his fellow physicians have managed to accept money and gifts from pharmaceutical companies without calling the practice “bribery.”
Some of his story is depressingly familiar -- fancy dinners, dressed-up “consulting fees,” expense-paid conferences at Caribbean resorts and Alpine ski lodges. But there is plenty of novelty here, too. We hear of corporate-funded journal supplements, in which marketing propaganda comes disguised as peer-reviewed scientific literature; of expert panels where all the experts are on the industry payroll; of journal articles ghostwritten by industry-funded medical writers and signed by industry-funded academics; and of the scandal of what is politely called “continuing medical education,” 60 percent of which is now funded by the pharmaceutical industry. Big Pharma spends about $21 billion a year on marketing; 88 percent of that staggering sum is directed at doctors. According to Kassirer's calculations, that amounts to more than $30,000 per physician.
One virtue of this fine book, at least as a muckraking exhibit, is that its author, a physician of the old school, has been around long enough to see a lot of unraked muck. Although he does not tell the story here, Kassirer was reportedly ousted as editor of The New England Journal of Medicine because of his unwillingness to allow the Journal's name to be used as a marketing device. He was also one of the enlightened figures who instituted the Journal's policy (now rescinded) of refusing to publish editorials and review articles by authors with a financial interest in the topics they were addressing. As Kassirer points out, this editorial policy, while rare among medical journals, is standard at other publications. Kassirer quotes from a policy developed by the wine writers of The Wall Street Journal (who do not accept free wine, free trips, or free meals), from the editorial policy of The New York Times (which prohibits staff members from having any financial interest in the topics or industries they cover), even from that trusted friend of the global backpacker, the publishers of the Lonely Planet travel books (whose policy is not merely to refuse gifts and payment from potential beneficiaries of their recommendations but also to refuse advertising). Kassirer asks, quite reasonably, why should doctors set their own ethical bar so much lower?
If nothing else, you have to admire Kassirer's willingness to call a spade a spade -- and, in at least one case, to call a doctor a “marketing whore.” The problem with the book is that after reading about so many of these marketing scams, your eyes start to glaze over. It is hard to sustain moral outrage when corruption seems so pervasive. After awhile you start to marvel at the sheer ingenuity of the industry in figuring out so many ways to buy off doctors while disguising it as education, research, or some other benevolent activity.
If Kassirer is a reluctant muckraker, Merrill Goozner is an enthusiastic debunker. The title of his new book, The $800 Million Pill, comes from a much-hyped study from the industry-funded Tufts University Center for the Study of Drug Development, which in 2001 estimated the average cost of developing a new drug at $802 million. Big Pharma now routinely invokes that figure (“with the force of an incantation,” as Goozner puts it) to justify its enormous profits. Americans may pay dearly for their medicine, the industry argues, but that's the cost of innovation.
Goozner does not buy it. The Tufts economists claimed that the cost of drug development has risen so dramatically because of the rapidly growing cost of testing drugs in human clinical trials (as opposed to earlier stages of development). They also argued that development costs have risen because the pharmaceutical industry has turned its attention to treatments for chronic and degenerative diseases. But if this is true, asks Goozner, why haven't development costs risen dramatically in the public sector, which has managed to develop new drugs for AIDS and cancer at a fraction of the cost of industry trials? At least one answer (among many) is that the drug industry pours vast sums of money into human trials whose sole purpose is marketing. According to one credible estimate, the drug industry spent $1.5 billion in 2000 testing medicines that had already been approved by the Food and Drug Administration. Some of these studies are conducted merely to give drug representatives and advertisers ammunition to market the drugs. Others, known as “seeding trials,” are conducted mainly to make community doctors familiar with new drugs. (If you pay doctors to enroll their patients in a clinical study of a new drug, they will be more likely to prescribe that drug in the future.)
Goozner points out that the watchdog group Public Citizen used different accounting methods and came up with a figure of only $71 million to develop a new drug. The Global Alliance for TB Drug Development, despite using methods similar to those of the Tufts researchers, estimated the cost of developing new tuberculosis treatments at $115 million to $240 million.
Goozner, now a staff member at the Center for Science in the Public Interest (and a Prospect contributing editor), was formerly chief economics correspondent at The Chicago Tribune, and it shows. The $800 Million Pill is an authoritative, elegantly written, thoroughly researched book. Despite its title, the bulk of the book is not about the Tufts studies. Goozner's real aim is to draw back the curtain on the drug and biotech industries and give a more complete account of how drugs are developed. He begins with the story of Eugene Goldwasser, the University of Chicago biochemist who isolated erythropoietin, an enzyme produced in the kidney that signals bone marrow to make red blood cells. Goldwasser shared his research with the company that later became Amgen. When Goldwasser retired in 2002 after a 47-year career, he did it without riches or glory. Yet Amgen transformed Epogen, the recombinant-engineered version of the enzyme Goldwasser isolated, into the most profitable biotech drug in the world. At a time when biotech entrepreneurs get rock-star treatment from the press, stories like this do not get told very often. Yet again and again, Goozner shows how private-sector developments, touted as pure products of the market, would have been impossible without the work of publicly funded scientists.
Powerful Medicines is a harder book to characterize. Jerry Avorn is neither a muckraker nor a debunker. He is equal parts teacher and reformer. An internist and pharmacoepidemiologist at Harvard, Avorn has set about explaining how drugs are developed, tested, priced, approved, and prescribed -- and at each step of the way, how things can go badly wrong. We hear about the FDA, about drug-industry promotion, about recalled prescription drugs, and also about patients themselves. Much of the book is explanatory -- say, what a randomized clinical trial is and why it is such a powerful tool. In some hands this approach could become tedious, but Avorn also happens to be very funny. Powerful Medicines is not just a highly successful book; it is an ambitious one. Unlike many writers, Avorn proposes solid ideas about how to build a more rational system of drug evaluation. He argues, for example, that we desperately need a new kind of “information-transfer organization” aimed at providing doctors with the unbiased information they need to prescribe drugs in a cost-effective way. This may sound obvious, but as Avorn powerfully demonstrates, we are nowhere close to it now.
Some seasoned readers may know Avorn as the pioneering force behind the concept of “academic detailing” (sometimes known as “counter-detailing”), in which academic physicians deploy the marketing techniques of the drug industry in order to promote scientific, evidence-based prescribing. (Drug representatives, known in the old days as “detail men,” are the salespeople that the industry employs to make sales pitches to doctors.) Academic detailing is a gimmick, and it will never come close to matching the actual detailing that the drug industry employs, but it rests on a powerful idea that runs through Avorn's book: Why shouldn't drug prescription be based on scientific and economic evidence, rather than our current irrational mix of advertising, public relations, and bureaucracy?
There are faint signs of improvement on the horizon. Congress has taken an interest in the conflict-of-interest scandal at the National Institutes of Health. The American press (many years after the British) has started to give serious coverage to a possible association between antidepressants and suicide. Medical editors are calling for a clinical-trial registry that would make it harder for the drug industry to hide unfavorable trial results. Many people are calling for the repeal of the Prescription Drug User Fee Act, which has made the FDA financially dependent on the very industry it is supposed to be regulating. Marcia Angell, another former editor of The New England Journal of Medicine, argues in her new book, The Truth About the Drug Companies, that the FDA should require pharmaceutical companies to test all new drugs not merely against placebos but against currently available treatments -- a measure that would not only be far more useful to clinicians but would discourage the development of me-too drugs. Angell writes that the government should set up an institute to oversee the design and analysis of clinical trials, in order to prevent Big Pharma from manipulating research results to suit its own marketing needs. Time will tell whether any of these initiatives will take hold.
Carl Elliott is the author of Better Than Well: American Medicine Meets the American Dream and co-editor with Tod Chambers of Prozac as a Way of Life.