Book review: “Children of the Cure: Missing Data, Lost Lives and Antidepressants” by David Healy, Joanna Le Noury and Julie Wood. Samizdat Health Writer’s Co-operative Inc; 2020.
By Peter C Gøtzsche
Professor and Director
Institute for Scientific Freedom
Visiting Professor, University of Newcastle
Psychiatrist David Healy has written over 20 books that describe what is wrong with the way we research psychiatric and other drugs and the many ways in which the results from the randomised trials have been manipulated and misrepresented.
David has not run out of steam and the current book is important. It is about the 2001 infamous GlaxoSmithKline Study 329 that compared paroxetine with imipramine and placebo in 275 adolescents with depression. What is unique is that the Attorney General of New York State sued GlaxoSmithKline in 2004 for repeated and persistent consumer fraud in relation to concealing suicidality events on paroxetine, and, as part of a settlement, the company was mandated to make its internal study report for Study 329 publicly available.
Healy and his co-workers succeeded to get access also to the original case report forms, as they had been filled out by the investigators before they had been processed and coded by the company. I am not aware of any other drug trial in any area of medicine where independent researchers have had such access to data that are usually hidden deep in company archives.
The story that Healy, Le Noury and Wood tell in the book is one of organised crime to which drug regulators in the United States and the United Kingdom happily contributed, prioritising to protect the company’s commercial interests instead of the safety of the children. The FDA lied about what they knew and about what the trials had shown, and it prevented its reviewer from presenting incriminating data that showed an increase in suicidality with paroxetine at an Advisory Board meeting. When the FDA investigated the issue of suicidality for all the newer depression pills, it was done in a way that minimized the risk that the companies would come up with incriminating data, and the FDA believed flatly what the companies told them, with no checks.
The book should be read by everyone with an interest in drug safety. As the authors say, “Truth is stranger than fiction because fiction has to make sense … This is a true story about lies.” The published trial report is fraudulent; the manuscript was written by a ghost writer hired by the company; and emails show that GlaxoSmithKline deliberately misrepresented their findings in order to deceive the public. The so-called academic authors had little to do with the publication, and these “authors” and the medical journal were complicit in the fraud. The authors because they accepted the ghost-written paper without asking questions of GlaxoSmithKline, e.g. about what the company meant by “emotional lability,” a new construct that removed cases of suicidality from public view. The journal because it published the fraud and refused to retract the paper when the fraud had become indisputable.
The British Medical Journal (BMJ) also played a reproachable part. It published deeply flawed articles that denied that depression pills increase the risk of suicide and praised GlaxoSmithKline for its new “openness” even though this was enforced on the company. It also raised its demands along the way to absurd levels for acceptance of the restoration of Study 329 Healy and colleagues had carried out, which made it close to impossible for the authors to get it published. And its handling editor did not recluse herself despite her indirect conflicts of interest in relation to GlaxoSmithKline.
The original 2001 trial report concluded that paroxetine was well tolerated and effective whereas the restoration of the study showed the exact opposite, that paroxetine was unsafe and ineffective.
The book describes in detail how GlaxoSmithKline concealed suicidal events on paroxetine by miscoding them or leaving them out altogether, even from the comprehensive study report it submitted to drug regulators. Clearly, as the book states, we can have no confidence about drug harms without access to individual-level data.
I discussed this study in my 2013 book “Deadly medicines and organised crime” in a chapter called “Pushing children into suicide with happy pills.” Based on the many randomised trials that have now been carried out in children and adolescents, it is absolutely certain that “happy pills” do not make children happy. They don’t even work for depression but double the risk of suicide.
Can anything in healthcare be worse than pushing children into suicide while pretending that the pills are as attractive as candy? I don’t think so. These drugs are being widely used in children and young people. According to the book, aside from contraceptives, they have become the most commonly prescribed drugs in adolescent girls in Britain, and the usage is increasing. The fact that leading professors in psychiatry in most countries still claim that the drugs protect against suicide shows a profession in ethical free fall that has allowed itself to become corrupted by the siren songs from the drug industry.
These drugs should be banned for use in children and adolescents, but as the drug agencies would then need to admit that they have been horribly mistaken, this will never happen.
I need say no more. Read the book and be shocked.
Peter C Gøtzsche
Professor and Director, Institute for Scientific Freedom Copenhagen
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