Profitability for drug companies is high. Nine percent of the income of Fortune 500 drug companies went for profits in 1970, 18 percent in 2002. To keep profits up, the industry strives for “vertical integration” to control drug production, from research idea to consumer purchase. Along the line, companies bend the results of scientific research.
Writing for medical journalists in the Nieman Reports (Summer 2003), John Abramson, a family physician turned writer, passes on some tips for accuracy. In the process he provides a glimpse into the world of commercialized scientific research.
His subject is a November 2002 New England Journal of Medicine (NEJM) article that advocates testing for the C-reactive protein (CRP) – usually a test for inflammation – to identify people at risk for cardiovascular disease. The study of 28,000 women suggests that women with the highest CRP levels – the top 20 percent – face a 2.3 times greater likelihood of suffering heart disease than the 20 percent with the lowest levels.
The media reported the study as a scientific breakthrough, enabling physicians to identify people at cardiac risk through CRP measurements and then treat them with cholesterol-lowering drugs. Abramson believes that reporters jumped the gun.
He notes that the NEJM article makes no mention of the fact that the high-risk women – the top 20 percent – suffered only 2.3 episodes of cardiovascular disease per 1,000 women, per year, compared to one episode per 1,000 among the 20 percent at lowest risk. Terminology used in the article – “2.3 times more likely” – greatly exaggerates the actual findings.
Further, Abramson recommends, reporters should consider authors’ affiliations with industry. Manufacturers of drugs and medical products fund 70 percent of current clinical research. Studies show that findings published by researchers with company connections are almost four times more likely to favor industry products than research done independently. The lead author of the NEJM article holds patents on tests for inflammation used to identify cardiac risk.
He says reporters should search out scientists’ undisclosed conflicts of interest. Two of the NEJM article’s authors turn out to have conducted research funded by a manufacturer of a drug for lowering cholesterol. Four days after publication, the AstraZeneca company announced a project designed to find out whether its new cholesterol-lowering drug would be effective in protecting people with elevated CRP levels from heart disease. The lead author had already been hired by AstraZeneca to direct the study.
The NEJM is often described in the press as “prestigious” or “august.” For U.S. physicians, its respectability is unquestioned. The possibility that an article in that journal is tainted places the NEJM’s reliability in doubt.
Abramson, looking at the tip of an iceberg equivalent, hints that the big problem is baleful collusion between money interests and medical research.
The 1980 Bayh-Dole Law set the stage for medical centers to farm out research to corporations by allowing university recipients of federal grants to secure patents for their discoveries and to market them. Industry support for university research doubled between 1980 and 2001. Financially strapped university hospitals seek out stipends from drug companies in return for exclusive access to, or a first look at, their research. Recently, drug companies have established “contract research organizations” to conduct clinical trials and hire researchers, including university scientists, as direct employees.
Concerned medical leaders complain that with industry pulling the strings, research findings may be doctored. For example, negative results go unpublished, and data may not be shared with the scientific community. Companies hire prominent scientists to ghostwrite reports of other researchers’ work. Research findings that suggest possible harm to patients has been lost, or reinterpreted, or withheld from publication. Drug companies promulgate favorable research findings without scientific validation. Hired scientists design skewed research projects to produce findings that meet company needs. Academic researchers take in generous fees, receive stock options, and sit on company boards. Review boards set up by public agencies and specialty societies to provide physicians with unbiased treatment recommendations are now populated by physicians in the pay of drug companies.
Commenting on the general state of U.S. health care, in an interview with Harvard Magazine, Abramson says we “tend to treat disease downstream, at the end stage – [which] happens to be the most profitable one. If you have a disease that is profitable to treat, the best place in the world to be is the United States …The medical enterprise pretends to care about our health, but it cares much more about corporate well-being.” Abramson notes that profiteering “is the job of private enterprise. But we’re expecting private enterprise to do something it can’t do and doesn’t want to do.” Karl Marx would agree.
What then about people’s needs, about science in the public interest? Medical scientists, practitioners, even company executives, have to work under the prevailing rules of capitalism. But choices are available. They can leave the field entirely, or remain captive to an ethos based on greed, or they can opt for rules that promote equity, indeed for a new set of principles that serve people rather than profit.
W. T. Whitney Jr. is a part-time pediatrician in rural Maine. He can be reached at firstname.lastname@example.org