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Big Pharma and Health Care: Unsolvable Conflict of Interests Between Private Enterprise and Public Health

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Big Pharma and Health Care: Unsolvable Conflict of Interests Between Private Enterprise and Public Health Isr J Psychiatry Relat Sci Vol 45 No. 2 (2008) 83–94 Big Pharma and Health Care: Unsolvable Conflict of Interests between Private Enterprise and Public Health Mayer Brezis, MD, MPH Center for Clinical Quality & Safety, Hadassah Medical Center & School of Public Health, The Hebrew University of Jerusalem, Israel . Abstract: A landmark paper on Game Theory showed that individual maximization of profit necessarily endangers the public good, and since the problem has no technical solution, “it requires a fundamental extension in morality” (1). We propose here that public health, as a public good, now emerges as a grave example of this problem. Recent events and reports increasingly suggest misalignment between the interests of the pharmaceutical industry and those of public health. Johnson & Johnson illegally and effectively promoted Propulsid off-label for children despite internal company documents raising safety concerns. Death in drug trial has been described as a “trade secret.” On Vioxx, Topol wrote: “Sadly, it is clear that Merck’s commercial interest exceeded its concern about the drug’s toxicity” (2). More and more concerns are raised by scholars and major journal editors about the type and the quality of published evidence, often biased towards efficacy of new products. The industry, funding over 80% of trials, sets up a research agenda guided more by marketing than by clinical considerations. Smart statistical and epidemiological tactics help obtain the de- sired results. Budget for marketing is by far greater than for research. Massive advertising to physicians and to the pub- lic gets increasingly sophisticated: ghost writing, professional guidelines, targeting of consumer groups and manipulating media for disease mongering. Pervasive lobbying and political ties limit the independence of regulatory bodies. Obligation to shareholders overriding public health considerations is not unique to the pharmaceutical indus- try. The chemical, tobacco and food industries share similar tactics: proclaiming doubts about safety issues, buying re- searchers, infiltrating universities, boards, media and legislative agencies. By contrast, powerful and cheap health promoting activities, poorly supported by industry because they are too cheap and not patented, are markedly underutilized: technologies for changing behavior (e.g., cardiac rehabilitation), palliative care and use of old, effective and safe drugs — all could benefit from industry’s tools of marketing and quality. As those most affected are the sick, the poor and the least educated, free market successes appear to pose unsolvable challenges to social justice in public health. Social Justice in Health Care health promotion, clinical quality and safety, or pal- liative care could in fact be more cost-effective. In recent consensus papers on modern physicians’ Given the profit motive that underlies industry’s ethics, social justice appears as a fundamental novel activities, a general question that emerges is: How principle, not present in the classical Hippocratic solvable is the conflict of interests between private Oath. The Ethics Manual, published by the American enterprise and public health? Adam Smith, who College of Physicians, declares (3): “Physicians (…) presciently viewed the modern free-market, claimed: should promote justice in the health care system and “bypursuinghisowninteresthefrequentlypro- should base allocations on medical need, efficacy, motes that of the society…” (5). More recently, how- cost-effectiveness and proper distribution of benefits ever, a landmark paper on Game Theory described and burdens in society.” “the Tragedy of the Commons” and showed that in- While the pharmaceutical industry has signifi- dividual maximization of profit necessarily endan- cantly contributed to therapeutic advances, in recent gers the public good, and since the problem has no years the exponential rising cost for medicine (4) is technical solution, “it requires a fundamental exten- not necessarily translated into far better health care sion in morality” (1). Health care is a public good or into increase in longevity. Investing this money in that induces market failure as it differs from other Address for Correspondence: Prof. Mayer Brezis, Center for Clinical Quality & Safety, Box 53, The Hebrew University — Hadassah Medical Center, POB 12000, Jerusalem 91120, Israel. E-mail: [email protected] 84 BIG PHARMA AND HEALTH CARE merchandisesuchascarsorfood:inhealthcare, While Merck’s CEO received over $30 million in there is a large information gap between consumers bonus and stock options in 2004, Topol was recently and vendors, there are many uncertainties related to fired from his position at the Cleveland Clinic. diagnosis or outcomes, the system is complicated by According to an inquiry by the U.S. Senate, John- insurance and indirect payments that allow gaming, son & Johnson had illegally promoted for children and, finally, when life itself is at stake, framing of is- the “off-label” use of Propulsid (a medication for gas- sues is often more emotional than rational. For these tro-esophageal reflux — now removed from the reasons, the health market is greatly susceptible to market because it may induce serious heart corruption, as recently reviewed by the organization arrhythmias)atatimewheninternalcompanydocu- Transparency International (6). We propose here ments were already raising safety concerns (11). that public health now emerges as a grave example of After dozens had died taking the medicine, sales conflict of interests with private enterprise. continued to surpass $1 billion per year with contin- ued promotion of use in infants: 20% in neonatal in- tensive care units were given it, while physicians Safety Concerns Dwarfed by Industry were never made aware of concerns about a drug Recent events and reports increasingly suggest mis- which had never been approved by the FDA for this alignment between the interests of the pharmaceuti- age group. cal industry and those of public health. Attempts by During a trial on duloxetine (an SSRI tested for companies to minimize, deny or hide adverse effects use in stress incontinence), a young volunteer with by COX-2 inhibitors have shed an important light on no depression committed suicide. The FDA investi- what may be in fact common tactics (7–9). In 2000, gation of the death was reported as a “trade secret” JAMA published the information that Celebrex (protected even under the Freedom of Information when used for six months is associated with lower Act). After medical investigative journalist Jeanne incidence of gastro-intestinal complications. In the Lenzer published the story (12), the FDA revealed unreported second six months of the study, nearly all that the rate of suicide attempts with duloxetine in serious complications occurred in people taking trials of stress urinary incontinence was double that Celebrex, negating the original conclusion (7). The of a placebo. Lenzer concluded: “The use of trade-se- JAMA editor said: “I am disheartened to hear that cret laws to conceal deaths and serious side effects they had those data at the time that they submitted linked to drugs has the obvious flaw of putting prof- [the manuscript] to us… We are functioning on a its before public health.” It appears as if the interests level of trust that was, perhaps, broken” (7). behind attempts to clear safety issues are by far stron- This year, similar concerns have been expressed ger than the data. Altogether, the events reported by the editors of TheNewEnglandJournalofMedi- above suggest, at the very least, that the systems in cine, commenting that an original article on Vioxx place provide the industry more incentives to hide did not accurately represent the safety data available safety concerns than to genuinely protect public to the authors. Since 2001 Merck has been denying health. the risk of myocardial infarction, spending around $160 million/year in advertising Vioxx. Merck sent a note to its sales representatives, ordering: “Do not Evidence B(i)ased Medicine initiate discussions on [this topic]” and instructing More and more concerns are raised by scholars and them to show doctors asking about Vioxx and myo- major journal editors about the type and quality of cardial infarction a pamphlet prepared by its market- published evidence, often biased towards efficacy of ing department, indicating that Vioxx was associated new products as systematic publication bias favors with reduced cardiovascular mortality (10). Topol the industry: Repeated analyses have shown that tri- concluded: “Sadly, it is clear to me that Merck’s com- alsfundedbytheindustryare2to5timesmore mercial interest (…) exceeded its concern about the likely to recommend an experimental drug com- drug’s (…) toxicity” (2). When fighting a pharma- pared with trials funded by nonprofit organizations ceuticalgiant,itmaynotbewisetobesooutspoken: (13–15). MAYER BREZIS 85 The industry, funding over 80% of trials, now sets devoted to research — allowing massive advertising up most of the research agenda, which is guided to physicians at a yearly cost of $5.5 billion in the U.S. more by marketing than by clinical considerations. alone, an amount greater than the entire budget of For instance, very few if any new antibiotic agents are medical schools to train physicians in the U.S.A. produced to treat short-term bacterial infections in- (10). Harvard Professor Arnold Relman, also former ducedbyemergingresistantbugs,whiledozensof Chief Editor at TheNewEnglandJournalofMedicine,
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