The New Epidemics 5
Jon Jureidini and Leemon B. McHenry tell us in their excellent work, The Illusion of Evidence-Based Medicine:
“Conflicts of interest and the failure to disclose industry relations that bias the results of medical research have been the dominant themes in the medical literature since the 1990s. The level of cynicism reached an all-time high when, in response to Marcia Angell’s (2000) editorial “Is Academic Medicine for Sale?” in the New England Journal of Medicine, Thomas J. Ruane responded with the quip: “No. The current owner is very happy with it.” The pharmaceutical industry largely controls academic medicine by engaging academic physicians as third-party promotional agents for their products. The result is a crisis of credibility.”
“Pharmaceutical companies have gained unprecedented control over the testing of their own drugs (Angel, 2008). The companies select for publication the trials that show the drugs have passed a minimal test, often using a flawed design that favors their drugs, and then conceal those trials with negative results. Since the companies have intellectual property rights to the data they generate, they control the dissemination of information. Prescribing physicians are the exposed to a distorted profile of drugs. The companies hire contract research organizations (CROs) to conduct the clinical trials, academic researchers to design the trials and act as clinical investigators, medical communication companies to ghostwrite the publications, and public relations firms to create positive images of the drugs for prescribing physicians and the public. All are eager to serve their client’s best interest, irrespective of whether the drugs being evaluated are the latest miracles of science. Almost always, they are not. There is an idea that because industry-sponsored clinical trials are very expensive, the science must be sound. This is deeply flawed.”
“The academic physicians who serve as clinical investigators in the trials and are named as ‘authors’ of the publications are selected by the sponsor company to become key opinion leaders (KOLs in marketing parlance) for their influence in the prescribing habits of physicians and for the prestige that their university affiliation brings to the branding of the company’s products. As handsomely paid members of pharmaceutical advisory boards and speakers’ bureaus, the key opinion leaders also present the results of the trials at medical conferences and in continuing medical education lectures. Instead of providing a critical evaluation of the performance of drugs, they are carefully vetted by drug companies on the basis of their loyalty and willingness to become what marketing executives refer to as ‘product champions’ (Amsterdam et al., 2017, 996).”
“Because the companies invest enormous sums to bring new drugs onto the market, failure is not an option. Aside from suppression of negative data in publication results, the very design of the trial is often manipulated in subtle ways that escape detection in the peer-review process. Common strategies for ensuring success include conducting the trial drug against a treatment known to be inferior, testing it against too low (or too high) a dose of the competitor drug, and excluding placebo responders in the pretreatment, wash-out phase of the trial. When it comes to publishing the results, the sponsor company’s marketing department contracts with the medical communication firm to produce the manuscript. This typically involves the production of several manuscript drafts that are subsequently inspected by the key opinion leader “authors” and the sponsor company’s marketing, medical and legal departments for approval. The marketing department and the medical communication firm also select the target journal and the ‘authors’ whose names will appear on the by-line of the published article well in advance of the trial results. They will also draft responses to criticism from the peer-review process and from letters to the editor post-publication and organize the distribution of the journal re-prints to the pharmaceutical sales force (Forest, 2003).”
“Whenever message-driven models of public relations strategy dominate the production of medical journal articles, corporate marketing has usurped science; the results of biased clinical trials reports have polluted the peer-reviewed literature and misinformed physicians about the true harms and benefits of medication. In this regard, the much-esteemed peer process that ensures the reliability of the medical literature has, in the words of The Lancet editor, Richard Horton, ‘devolved into information-laundering operations for the pharmaceutical industry’ (Horton, 2004a, 9). Medical journal articles reporting on industry-sponsored clinical trials have become little more than expensive drug advertisements.”