Several conspicuous academics have sent letters to prestigious British medical journal The Lancet, claiming prominent psychiatric Professor Ian Hickie had a serious conflict of interest in his review of a new drug, Valdoxan. Professor Hickie, who is from Sydney’s Brain and Mind Institute and one of eight new national mental health commissioners, says he is the victim of a campaign to discredit his work.
Hickie has also been accused of down playing the side effects of Valdoxan, an antidepressant marketed for the treatment of major depressive disorder. So far six letters, in response to the Hickie review, have been published in The Lancet, all of which are critical. Hickie and his co-author Naomi Rogers have both replied to the criticism.
One of Professor Hickie’s detractors says the group is simply being scientifically critical. Critics slammed Hickie for not revealing his ties – conflict of interests – in the review, something which he has since changed with his response to the critics. Since the question has been raised, The Lancet has published the following disclaimer:
Hickie was previously Chief Executive Officer and Clinical Adviser of beyondblue, an Australian National Depression Initiative. He has led projects for health professionals and the community supported by governmental, community agency, and drug industry partners (Wyeth, Eli Lily, Servier, Pfizer, AstraZeneca) for the identification and management of depression and anxiety. He has served on advisory boards convened by the drug industry in relation to specific antidepressants, including nefazodone, duloxetine, and desvenlafaxine, and has participated in a multicentre clinical trial of agomelatine effects on sleep architecture in depression. IBH is also supported by a National Health and Medical Research Council Australian Medical Research Fellowship. He is a participant in a family-practice-based audit of sleep disturbance and major depression, supported by Servier, the manufacturers of agomelatine. NLR [Rogers] has received grant support from Vanda Pharmaceuticals, Servier, Pfizer, and Cephalon, and has received honoraria for lectures from Pfizer, CSL Biotherapies, and Servier. She has previously received research funding from Vanda Pharmaceuticals, manufacturers of tasimelteon. She has also received an unrestricted educational grant from Servier. Research studies done by IBH and NLR are mainly funded by NHMRC project and programme grants.
The latest stoush began when Professor Hickie was commissioned by The Lancet to write about new anti-depressants. Hickie says he declared his links to the drug company concerned, but the article drew letters of complaint from 11 people.
Among the critics was Professor Jon Jureidini of the University of Adelaide who says The Lancet should have had someone else do the study. ”The authors had financial and other relationships with the manufacturer of the drug,” Jureidini said. ”There are concerns about the misrepresentation of the effectiveness of the drug, about the clinical usefulness of it, about its adverse effects and about conflicts of interest.”
Jureidini’s letter to The Lancet outlines with clarity his concerns: “Ian Hickie and Naomi Rogers’s paper illustrates substantial problems prevalent in reviews of psychotropic drugs: unjustified and misleading conclusions in the summary (abstract), withholding of information about serious adverse effects, citation misrepresentation, and possible conflicts of interest. First, there is a serious discrepancy between the summary and the body of the paper. The summary claims that “fewer patients on agomelatine relapse (23·9%) than do those receiving placebo (50·0%)”. But that was only one trial. The body of the paper admits that two other trials did not find lower relapse with agomelatine. Unfortunately, many will only read the summary, and will be misled.”
Jureidini’s letter is scathing of Hickie’s approach to research and raises serious questions about Hickie’s credability, calling the paper flawed and bring into question The Lancets motivation for publishing the paper. “The Lancet‘s publication of this flawed paper will undoubtedly validate marketing of Valdoxan, and we are curious to see how many paid Valdoxan advertisements will be published in Elsevier journals. We also wonder how many reprints of the paper Servier has purchased, but Elsevier will not tell us, claiming that it is – strictly company-confidential. “ Jureidini wrote.
In a second letter to The Lancet, it’s author Bernard J Carroll writes “This paper seems to break new ground for sponsored writing in medical journals, with conflicts of interest hidden in plain sight while bias continues.”
Professor Hickie walks a fine line at the best of times, his work with groups such as EPPIC - The Early Psychosis Prevention and Intervention Centre – an integrated and comprehensive mental health service aimed at addressing the needs of people aged 15-24 prior to or just as a first episode of psychosis takes place, these early treatments call for some clever diagnoses as well as cutting edge drugs.
Hickie has rejected that claim, saying he disclosed his connection to the drug company and that it was The Lancet who approached him to write the article. ”I absolutely reject the allegation that we misrepresented in any way the data available,” Hickie said. ”That is a slur on us, it’s a slur on the journal and its editorial processes to suggest that. Professor Jureidini may say that, it doesn’t make it at all true.
“We took all the available evidence, we showed that. The article itself is not limited to a discussion of the drug agomelatine but is really about a focus on circadian systems as a new target for treatment in depression. The first new target in 50 years at a time when we need new anti-depressants that might work better and have less side effects.” Hickie said.
Hickie says this is part of a long campaign to discredit him. ”The reason I use the word campaign is not just related to this particular article but in fact issues that Professor (Patrick) McGorry and I have been dealing with over the last few years from similar groups in South Australia and sometimes Western Australia, attacking not just individual academic publications like this one but our general work in relation to expanded treatments for depression, the efficacy of anti-depressants, the expansion of youth studies and most importantly national mental health reform,” Hickie said. ”So I think this is a classic case of trying to attack the messengers of reform and trying to do that on the grounds of our personal credibility rather than responding to the really serious issues.”
Professor Jureidini says there is no campaign. ”What is being criticised is the science and indeed The Lancet’s decision to publish this article,” Jureidini said. ”To try to reduce that to attributing it to personal attacks on him is, I think, an attempt to distract from the very substantial criticisms that are being made of the scientific merit of the article.”
Professor Jureidini thinks youth mental health has hijacked the sector at the expense of other areas. He says too much of the federal funding goes to the Headspace and The Early Psychosis Prevention and Intervention Centre.
But he says he is not against all the reforms put forward by the National Mental Health Commission. ”Some of them I agree with, some of them I disagree with,” Jureidini said. ”I think that would be true of most psychiatrists and I would like to think that we all should have the opportunity to express our points of view and … that the capacity to express an opinion is not restricted to a few powerful psychiatrists.”
Professor Jureidini says the federal minister should carefully examine the allegations against Professor Hickie, who has been defended by Dr John Mendoza, former chair of the Federal Government’s Advisory Council on Mental Health. ”Ian is very mindful of these things,” Dr Mendoza said. ”I mean you don’t get asked to write pieces for The Lancet unless you have a high standing in terms of your scientific rigor and approach.
“I think … people need to look for, well, if there is a material benefit that is accruing to him and his family. I’d be surprised if there is. He drives a small Japanese car and a 10-year-old four-wheel drive, lives in a modest apartment in Redfern.” Dr Mendoza said
Dr Mendoza says it has been evident for a while that there has been a vicious personal campaign against Professor Hickie. ”It is not that they are pushing any reform agenda,” Mendoza said. ”What many of these people are doing is trying to undermine reform efforts which have really started in Australia at a national level way back in the early ’90s, and there are still people who do not believe that the community-based approach to mental health is valid. ”They still want to hold onto old 19th century-style institutional beds.”