Yesterday we had a review of Malcharist by Gary Schwitzer. Today’s review is by Leemon McHenry – see below.
Malcharist, by Paul John Scott, is a fictional account of one of psychiatry’s most influential key opinion leaders (KOLs), his ghostwriter, and a journalist on the trail of a big scandal in the world of Big Pharma. The story didn’t happen in reality, but Scott has done his homework in such a way that one of medicine’s darkest secrets is exposed in all of its sordid detail.
For those of us familiar with industry-sponsored clinical trials such as GlaxoSmithKline’s studies 329 and 352, it doesn’t take much imagination to draw analogies to an all-too-common theme: a psychiatrist and a ghostwriter who helped create an illusion. He takes all the credit for her labors and she disappears into the background. What is presented to the medical community, however, is a story of pharmaceutical marketing masquerading as science.
The narrative begins with a terrifying description of a patient suffering drug-induced akathisia, a side-effect of antidepressants that often ends in suicide. Chapter by chapter, Scott then introduces the central characters, journalist Griffin Wagner, ghostwriter Shivani Patel, and key opinion leader Dr. Jeremy Elton, and then weaves together the plot, in which the drug maker manipulates clinical trial data to hide the dead bodies in the statistics.
In the novel, Jeremy Elton, M.D, PhD, Director of Clinical Research, University of Dallas, Institute of Brain Studies is America’s psychiatrist—overseeing $36 million in NIMH grants, co-author of 10 textbooks, author of 600 medical journal articles, paid consultant for six Fortune 500 pharmaceutical companies, and recipient of royalties from 16 pharmaceutical patents and 13 medical devices. (101) He pushes the blockbuster drug, the antidepressant Serotonal, that is fictional drug maker Krøhn-McGill Pharmaceutical’s goose that lays the golden egg, sold to prescribers and patients to correct the elusive chemical imbalance in the brain.
Vice President for Clinical Research Seamus Cole and ghostwriter Shivani Patel lure the KOLs on board with Krøhn-McGill with lavish gifts delivered at vacation venues such as ski and tropical resorts, golf getaways, and first-class hotels in the big city. Cole’s job is to make the physicians feel a little less like prostitutes and a bit more like heroes conquering debilitating illness as they assume their role as product champions for drug sales. (31) With a disingenuous self-depreciation and flattery for his new crew, he delivers a well-rehearsed message:
“I am not an expert in psychiatry but I know that every one of you are destined for the very top of your profession, and more importantly, that we can learn a lot from you. We know your peers can learn from you, as well, especially when we arm you with cutting-edge scientific presentations to deliver at forums hosted by Krøhn-McGill Psychiatric. I think you will find Krøhn-McGill KOL status is not just an invaluable contribution of your expertise to the advancement of medical practice, but a reliable and generous second revenue stream and a feather in your cap that will elevate your profile within the community of professionals…. Some of the most welcoming resorts in the world have opened their doors to those courageous professionals willing to leverage their authority in the service of eradicating mental illness.” (31-32)
They always buy it―hook, line and sinker.
When it comes to the issue of how the whole ghostwriting business works, Scott nails it in one purple passage, when Griffin says:
“… the pathway to market for everything you find at the pharmacy begins in medical journals, as scientists publish their findings on the experiments that broaden our understanding of human health….. So, I learned a great deal about how much these papers are the work of hired guns…. science written by marketing professionals posing as clinical researchers. It’s troubling. This process of creating evidence for the FDA seems to have become a pantomime of science…. What I mean by pantomime of science … is that we want to make sure these articles are written by scientists, not salesmen. And it turns out that they are almost entirely written by salesmen.… It’s not against the law or even the ethical codes that govern practice in the various specialties. Think of it as a loophole big enough to drive through with a bus wrapped in vinyl humping Bioferex.” (237)
Bioferex, in the story, is the name for a bone drug which treats stress fracture risk syndrome, but the journalist discovers it is really the antidepressant Serotonal, with the same fatal side-effects. (273)
In Scott’s novel, the coding of adverse events in the ghostwritten Study 463 publication, “Serotonal in the Treatment of Major Depressive Disorder,” Jeremy Elton et al., made Serotonal appear safe compared to placebo by hiding completed suicides in the study drug under the code “Suicidal Events” whereas suicidal nightmares, thoughts, and acts of self-harm were also coded as “Suicidal Events” in both the drug and the placebo groups. (126) The suicidal events that occurred in pre-randomization were also inappropriately included in the placebo group. “By inflating suicidal events in the placebo arm,” as Griffin explained the process to a confused KOL, “Makes normal life look more dangerous, and that makes the problem on the drug look more like normal life.” (274)
This general coding strategy is not fiction. Drug makers do it all the time and are caught only when there is discovery due to legal action.
The word, “malcharist,” the publisher’s flyer informs us, is a neologism for “bad power,” “bad sacrament,” or “bad spirit.” Like many real-life ghostwriters who went public with their story, Shivani Patel suffers a guilty conscience from her participation in malcharist activities—namely, knowingly misrepresenting the science and misleading doctors and patients. (289) She seeks salvation by teaming up with Griffin to expose Krøhn-McGill’s fraud. Gaining access to “bad data” stored in off-shore locations out of reach of the U. S. legal system, Patel finds the motherlode—but it comes at a price. (288-289)
This book is published by Samizdat House, the fiction imprint of Samizdat Health Writer’s Co-operative. The brainchild of David Healy, Samizdat (Russian: самиздат, self-publishing) is the name for the underground publishing industry that arose from forbidden literature of the former Soviet Union. Healy’s Samizdat House does for medicine what Samizdat did for the Eastern Bloc countries in the twentieth century. By recognizing the need for freedom of thought and freedom of the press, this enterprise dares to take on the pharmaceutical industry and avoids the censor of corporate lawyers working on behalf of the mainstream publishing industry.
Scott’s book, published in this co-operative venture, is the first fiction title. It is a well-written, well-researched, cleverly-crafted novel―a must-read for medical professionals, and especially aspiring key opinion leaders.
Leemon B. McHenry is Professor Emeritus of Philosophy at California State University, Northridge and a consultant in medical ethics to the Los Angeles law firm of Baum, Hedlund, Aristei & Goldman. He is co-author, with Jon Jureidini, of The Illusion of Evidence Based Medicine: Exposing the Crisis of Credibility in Clinical Research (Wakefield Press, 2020).