We all know about the placebo effect. But a Harvard Medical School professor has applied the same theory to antidepressants and his findings are likely to rile drugmakers. Why? He filed Freedom of Information Act requests to obtain unpublished clinical trial data and found that, when combining results with published data, the various antidepressants were no better than dummy pills.
“These are the studies that show no benefit of the antidepressant over the placebo. What they did was they took more successful studies – they published most of them – and they took their unsuccessful studies, and they didn’t publish that…. If they were mildly or moderately depressed, you don’t see a difference at all. The only place where you get a clinically meaningful difference is at these very extreme levels of depression,” Irving Kirsch tells 60 Minutes. “…The reason they get better is not the chemical in the drug. The difference between drug and placebo is very, very small, and in half of the studies, non-existent… You can get the same benefit without drugs.”
As 60 Minutes notes, Kirsch is “dropping a bomb” on a big business – some $11 billion in annual sales. PhMRA and Eli Lilly, the only drugmaker to respond to the news program, disputed his findings.
See Why Most Published Research Findings Are False Ioannidis JPA (2005) Why Most Published Research Findings Are False. PLoS Med 2(8): e124. doi:10.1371/journal.pmed.0020124 ‘… There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research…’
See A key player in stoking this Swine Flu hysteria was Dr Iain Stephenson, a Consultant at University Hospital of Leicester NHS Trust who has been found guilty of vaccine research fraud on a grand scale by the General Medical Council (GMC).
See Thirteen per cent of scientists or doctors have said they know of colleagues who have fabricated data in order to get research published. More than one in ten (13%) scientists or doctors have witnessed colleagues intentionally altering or fabricating data to get published or during their research, a poll suggests. The survey of almost 2,800 experts in the UK also found 6% knew of possible research misconduct at their institution that has not been properly investigated. The poll, for the British Medical Journal (BMJ), is being presented at a meeting aimed at tackling research misconduct in the UK. 13 January 2012
See Mental scores decline precipitously at 30 months after anthrax vaccine, but CDC spins study to say vaccine safe Thursday, January 12, 2012
See http://www.theoneclickgroup.co.uk/news.php?id=6732#newspost Patient No. 28665 was helping a Chesterfield company test a drug dubbed the “female Viagra” but stopped showing up for exams in December 2007. That didn’t stop a staffer of the company, PPS Clinical Research STL, from claiming that six months later the patient came in for an exam, was diagnosed with medical conditions, had undergone tests and even had given a urine sample. That admission was made in the company’s guilty plea to a federal felony charge of obstructing a proceeding of a federal agency. The drug the company helped test, aimed at women who suffered from an unexplained lack of sexual desire, never made it to market. As part of the plea, PPS admitted that it “corruptly influenced, obstructed, and impeded” an inspection by the Food and Drug Administration by providing false patient records in May 2010. During the trials, the drug’s manufacturer faulted PPS for failing to have a trained investigator conduct some exams, for back dating records and for failing to properly oversee one patient’s selection for the study, according to prosecutors. Boehringer did not respond to emails seeking comment.
See http://www.theoneclickgroup.co.uk/news.php?id=6610#newspost A well-known psychologist in the Netherlands whose work has been published widely in professional journals falsified data and made up entire experiments, an investigating committee has found. Experts say the case exposes deep flaws in the way science is done in a field, psychology, that has only recently earned a fragile respectability.
See Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. Michelle Roseman, BA; Katherine Milette, BSc; Lisa A. Bero, PhD; James C. Coyne, PhD; Joel Lexchin, MD; Erick H. Turner, MD; Brett D. Thombs, PhD. JAMA. 2011;305(10):1008-1017. doi: 10.1001/jama.2011.257