The Truth About the Drug Companies: How They Deceive Us and What To Do About It
Marcia Angell. New York: Random House, 2004; 305 pp; ISBN: 978-0-375-50846-2, hardcover $24.95 US.
By William Bruneau
Prescription drug sales in the United States amounted to just over $200 billion in 2003. At the going exchange rate that figure exceeded the total 2003 budget of the Government of Canada.
Meanwhile, Standard and Poor’s industry-wide survey in 2004 put worldwide drug sales at $494 billion, well over the budgeted expenditures of all governments in Canada — national, provincial and municipal — with an American state government or two thrown in. By comparison, global military expenditure amounted to $900 billion in 2004, almost twice the amount the world spent on prescription drugs.1
These are stratospheric numbers. One may imagine such a capital-intensive activity may not always be carried on in the public interest and that the public interest should therefore be guarded with highest vigilance.
Marcia Angell’s The Truth About the Drug Companies is a well-written description of the drug colossus ending with proposals for moderate changes in public policy. The book does tell a “truth about the drug companies.”
I have only small criticisms to make of Angell’s methods or research and argument, but larger ones of her recommendations. She wants change in higher education, research, industrial development and government policy, but not much change. In short there is a mismatch between her factual findings and her proposals for reform in medical education and public regulation.
Angell agrees with innumerable other critics that the problem isn’t just the money. It is the safety of pharmaceutical products that worries her. The August 2007 edition of Common Ground, an organ of the alternate medicine/whole earth school of thought, included a bracing attack by Alan Cassels on government and industry practices.2 As Cassels notes, commercial distribution of the painkillers Vioxx, Celebrex and their relatives led indirectly (some would say directly) to a wave of heart attacks in a minority of users and eventual withdrawal of Vioxx in a flood of negative publicity.
The marketing of Vioxx without adequate advance research and testing might be explained by plain greed, but it also must have something to do with what Aristotle called akrasia, moral weakness, in this case the inability to resist temptation. The financial gain from Vioxx, it would seem, was irresistible to the denizens of certain boardrooms.
Cassels, in this article and elsewhere, insists on root-and-branch reform of whole systems of research and marketing. He agrees with Angell that it will not do to conduct simpleminded research with small sample populations, or “easy” research that compares a given drug with a placebo, but not with other similar drugs. His reasoned views lead him to recommend sustained change, including much more demanding standards of inspection and verification of drug company claims, and in some cases, public ownership of certain elements of the “system.”
Angell plays it a bit safer, perhaps because she knows, or thinks she knows what is practically possible in the U.S. As a former editor-in-chief of the New England Journal of Medicine, she is well placed to make judgements of that sort.
But North American readers rightly expect more of a book like this. Canadians have seen how the industry sometimes verges on the iatrogenic. The Olivieri Report (2001) and two years later, David Healy’s Let Them Eat Prozac — both from the CAUT monograph series — gave us wide-open windows on the pharmaceutical world. What we saw through those windows continues to haunt us.
If Cassels, Olivieri (or rather, Thompson, Baird and Downie, the authors of the Olivieri Report), and Healy are right, the dangers of prescription drug research and commercialization go well beyond corporate boardrooms. Those dangers are as much social, political, personal and moral in character as they are scientific. People and communities live and sometimes die because of decisions in boardrooms.
But more than that, expectations of what constitutes a healthy life are shaped in some degree by drug company policy. After all, they want and need us to think we’re not all that healthy and that we must need products of which we are only dimly aware.
At first glance, these several points justify significant change in the entire structure of the “industry.” Such change would involve social policy and law, not just improved methods of peer review, or better standards of laboratory technique, important as those are.
A number of books, including several by Americans, do go down that road. In 1999, there was Stephen Fried’s Bitter Pills, in 2001, Cynthia Robbins-Roth’s From Alchemy to IPO: The Business of Biotechnology, and almost immediately following Angell’s book, in 2004, John Abramson gave us Overdosed America: The Broken Promise of American Medicine. In 2005 it was the turn of Ray Moynihan and Alan Cassels’ Selling Sickness.
Angell’s book stands out only in its discussion of research practice, publication routines and university medical education. She gives a chapter to Marketing Masquerading as Education. She reminds us that $54 billion is called “education,” “because by so doing it (the pharmaceutical industry) can avoid legal constraints on its marketing activities.”
Doctors are encouraged by their experiences of “education” to prescribe drugs for off-label uses (prescriptions for treatment of illnesses that may have an underlying connection to the officially approved target of the drug). Since drug companies are not allowed to make overlarge claims in public advertising, this is one way to increase demand. Then there are the kickbacks — money, entertainment, goods and services offered to doctors so they’ll look fondly on Paxil, Prozac and all the rest. (p. 137)
Big Pharma’s version of “continuing medical education” goes on at medical conventions, universities and hospitals, and 60 per cent of its financing comes directly from drug industry budgets. Industry often works through third-party institutions (continuing education companies) claiming to have no interest in any one drug or drugs, but that are run by drug company executives and partners from the world of medical education. (pp. 140-141)
Angell gives us a believable picture, and it has extra weight because of her professional background. She shows just how continuing education can be a device for finding and paying doctors to become consultants, teachers and authors, often under the pretext they are all in the service of the public good.
And yet “(T)he head of Brown University’s Department of Psychiatry reportedly made over $US 500,000 in one year consulting for drug companies that make antidepressants. When The New England Journal of Medicine, under my editorship, published a study by him and his colleagues of an anti-depressant agent, there wasn’t enough room to print all the authors’ conflict-of-interest disclosures. The full list had to be put on the website.” (p. 143) Angell wrote an editorial asking if “academic medicine is for sale.” A correspondent wrote to say that no it wasn’t, as “the current owner is very happy with it.”
In her discussion of marketing masquerading as research, Angell recites a horrid list of drug company sins: bogus “trials” of drugs, non-existent safety studies, ghost-written research and encouragements to take many drugs when one would do (this is called polypharmacy). In subsequent chapters she shows the weakness and irrelevance of much government regulation, and finally (pp. 232-236) pinpoints the motives that make the companies so sinful: they must make ever greater profits to satisfy stockholders, but (a) don’t have a stock of blockbuster wonder drugs to push and (b) face increasingly strong resistance to the high prices of drugs.
David Healy’s work deserves another mention here. Healy had already pointed in 2003 to problems in research and medical education that receive attention in Angell’s 2004 book, yet Healy’s writings are absent in the Angell bibliography. This is bothersome, for one important problem raised by Healy was that of “ghost-written research.” Angell, who makes much of this problem, could have learned from Healy. Maybe she should have waited a little before going to print.
A September 2007 discussion of ghost writing by Sergio Sismondo of Queen’s University adds to Healy’s. Sismondo begins with the Vioxx example (compare Angell, pp. 108-109). He quotes the first author of a research article about that drug. That author, Jeffrey Lisse, a rheumatologist at the University of Arizona, said that Merck, “designed the trial, paid for the trial, ran the trial
. . . Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck . . . ” 3
But Sismondo argues we now have “ghost management (his emphasis) of medical research and publishing: when pharmaceutical companies and their agents control or shape multiple steps in the research, analysis, writing and publication of articles.” Ghost management is a “substantial business, employing thousands of marketers, writers and managers.” 4 It has undermined the system of peer review and made a mockery of the usual rules for disclosure of “interest” in research. Until there is some way to “sequester pharmaceutical company funding from research and publishing or from marketing,” Sismondo believes we must find journal editors who have the courage to refuse suspicious manuscripts and insist that “universities and academic health centres . . . prohibit contracts that allow sponsors to draft, edit, or suppress articles.”
All of these authors and every one of their books and articles come close to saying the industry is broken beyond repair and a market-based approach to the discovery and distribution of prescription drugs will never be effective. Angell makes a strong case that the industry is responsible for almost no innovation; it is natural scientists and social scientists and universities that innovate, not the drug companies.
Yet Angell insists “this is an important industry that should be saved — mainly from itself.” (p. 237) Of course she may, in an extremely narrow sense, be not entirely wrong. The American pharmaceutical industry and its analogues elsewhere in the world have indeed noticed (but not discovered) useful substances, have successfully merchandised a whole rainbow of such substances and have made immense profits for their stockholders.
But how do such achievements contribute reliably and fairly to the public weal, to widespread and deep understanding of health and to research and teaching in the health sciences? Angell soldiers on, recommending the drug industry goes back to finding innovative drugs, accepting that patents to established drugs should merely be allowed in most cases to lapse. She has every reason to think the industry is incapable of sustained innovation. Why then does she make this recommendation?
She asks that the U.S. Food and Drug Administration be made wholly and truly independent of the pharmaceutical industry and a new institute be built to oversee clinical testing of drugs. She calls for intensified competition between drug companies (and thus an end to monopolies). She wants Big Pharma out of medical “education.” She calls for complete transparence in drug company budgets, so that it will be easy to see how much “research” is actually marketing in disguise. She claims it is possible for the industry to become an engine of innovation. She hopes health insurance companies and state health departments can organize their drug purchasing to push down prices. (By the way, she makes the error of saying that Canadian medicare pays for all drugs prescribed in this country. But Angell’s half-dozen or so factual errors are small and inconsequential, so we may return to her broad argument.)
Based on the facts and argument Angell herself gives us, one would think she would want the education of doctors in Canadian and American universities to discourage future MDs from seeing their work as a business. She should want to ensure young MDs don’t confuse control of their workplaces with the public interest. She would want them to refuse to allow the drug industry to play opportunistic roles in their training and continuing education — even if that is the traditional way of things. At the end of their MD programs, undergraduate meds should surely be ruthless critics of the social and business practices and of the science practised at Glaxo-Smith-Kline et al.
Provinces and states should consider more than just the management of demand for drugs. Surely they should go on to contemplate a direct investment in the manufacture of prescription drugs. Angell says she wants competition. All right, then why not make the state a competitor, a direct competitor in the “business” of health?
Angell underestimates the degree to which pharmaceutical R&D has become a hydra-like beast, a single entity with many closely related parts. Those retail visits to MDs are tied to the system that is the modern pharmaceutical industry. The reform of one part of the entity will never be enough. Some people say we are a prescription-drug-addled society. Well, then, surely the appropriate response involves education and reform in schools, prisons, hospitals, community centres and elsewhere.
For part of the truth about the drug companies, you might want to read Angell’s work. But to Angell, I say, revise and take courage: the beast should be tamed and can be tamed. Why not show us how to do the job thoroughly and quickly?
1. Figures taken from Government of Canada web site and from Globalsecurity.org, the latter statistic accessed 2007 September 12.
2. Alan Cassels, “Prescription for a Drug Disaster,” Common Ground, 193 (2007 August): 16-17, 34.
3. Sergio Sismondo, “Ghost Management: How Much of the Medical Literature is Shaped Behind the Scenes by the Pharmaceutical Industry?” PLoS (Public Library of Science) Medicine, 4, 9 (September 2007): 1429-1433 (accessed 2007 September 27 at http://medicine. plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal. pmed.0040286&ct=1). Sismondo’s quotation comes from a New York Times report of 2005 April 24 by Alex Berenson; Berenson interviewed Jeffrey Lisse personally.
4. Sismondo, loc. cit., 1429, 1431.
William Bruneau is professor emeritus at the University of British Columbia and a member of CAUT’s Academic Freedom and Tenure Committee.