The crisis of credibility in clinical research

Multicoloured pills

How big pharma manipulates data to sell us drugs we don’t need

The Illusion of Evidence-Based Medicine is a new book co-authored by IASH alumnus Prof. Leemon McHenry. Grounded in trial evidence that resulted in billion-dollar payouts by the pharmaceutical industry, the book reveals the disturbing tactics used by big pharma to prove that their products are safe, effective and necessary – regardless of whether this is true. During this time of Covid-19, as the world watches the race for a vaccine, it’s more important than ever that we think critically about medical research.

“The pressure of Covid and the research opportunities it throws up mean that the standards of scientific integrity are tested more than usual, and are likely to be found wanting,” says co-author Jon Jureidini. “We want to give people the tools to think about their medical treatments more sceptically. Not cynically, but with a healthy scepticism.”

Jureidini and Leemon B. McHenry were employed by US law firm Baum Hedlund to critically examine two infamous studies into the use of SSRI antidepressants to treat childhood and adolescent depression. Child psychiatrist Jureidini had long been sceptical of using antidepressants to treat children and adolescents, but when he read Study 329, which concluded that GlaxoSmithKline’s paroxetine (Paxil in the US, Aropax in Australia, and Seroxat in the UK) was safe and effective for this purpose, he at first thought he’d been proved wrong. “But then I re-read the paper a couple of times and thought, there’s something not right about this.”

He co-authored a letter, with pharmacologist Anne Tonkin, (now president of the Medical Board of Australia), to the Journal of the American Academy of Child and Adolescent Psychiatry, who had published the study, outlining their concerns. At a Newcastle conference, Skip Murgatroyd, a lawyer from Baum Hedlund who’d read the letter, told Jureidini, “You’ve picked up some problems with this study, but you haven’t seen the half of it.” He hired Jureidini to work alongside McHenry, a disillusioned academic philosopher he’d recruited as a high-level researcher after meeting him in the surf at Malibu. Together, with access to thousands of previously confidential industry documents, Jureidini and McHenry helped prove that Study 329, and Study CIT-MD-18, another industry-sponsored SSRI drug trial for adolescent depression, had misrepresented data about the safety and effectiveness of these drugs to treat children and adolescents – including suppressing data showing an increased suicide risk. Jureidini calls their findings “fascinating and horrifying”.

The worst thing? “There is nothing extraordinary about these two trials,” say Jureidini and McHenry. “In one way or another, they exemplify what is wrong with a system that allows industry to test its own products. When the profit motive dominates research agendas, there can be little confidence in the results.” Drug trials are run by the pharmaceutical industry. Their reports are published in medical journals that depend on their advertising, and peer-reviewed by academics whose best financial and career prospects come through close ties to industry, particularly as government funding of universities continues to plummet. Though officially authored by expert academics (“honorary authors”), the content is often ghostwritten by marketing professionals, hired by the pharmaceutical companies to best represent their marketing objectives, through the “key messages” they supply.

This book brings together all they’ve learned, to provide an inside look at how the pharmaceutical industry conspires to manipulate us, and calls for change. “Our dream is that regulators do a better job of regulating, and data becomes broadly available for scientists to interpret for themselves, rather than what medical journals serve up.”

The book is available from Wakefield Press.