One of the hopes of this blog is to create a repository of maneuvers through which clinical trials can be gamed to get results. The series of posts laying out some of the less well known tricks are filed under the Hiding the Bodies blog category. To be more generally useful, this repository needs others to contribute further maneuvers to make it comprehensive and to contribute examples from areas of medicine other than mental health to help people more generally to spot what is going on. I will add to the lists below as examples come in.
After this post, (and after a pharma-myth and personal account), the next series of posts will tackle the notion that randomized controlled trials (RCTs) offer a Gold Standard when it comes to determining what drugs cause. The argument in brief will be that RCTs provide something close to an ultimate, and at present unrecognized, bias behind which companies can hide bodies. These posts will be filed under the Spin & Data blog category.
Here is a variant on maneuver 1 outlined in Drug companies use studies the way a drunk uses a lamppost where the placebo washout was used by Lilly, GSK, and Pfizer to hide suicidal acts. When reviewing the issue of antidepressants and suicide in 2003, the MHRA asked for, but didn’t get, all trials and asked companies not to repeat this placebo washout maneuver.
Unable to move bodies from the washout phase, GSK instead took three suicides from the post-trial period and filed them under placebo – see Figure 1.
A good case can be made for excluding one, or two, or all three of these suicides. But part of the mystery is this: when there was only one suicide on Paxil and none on placebo in these trials, one suicide in about 34,000 months of study, why should three turn up in this withdrawal month, all from the placebo group? It is a statistical freak.
In the face of this freak why did the regulator (MHRA) include these suicides in the mix, helping in the process to hide the risks not just on Paxil but on all SSRIs?
Did the MHRA think that just because they had told companies not to import suicides from the washout period that this would bring an end to all efforts to find bodies elsewhere?
Why did David Gunnell, Julia Saperia, and Deborah Ashby, who produced an article for BMJ (19 February 2005) on the data from antidepressant trials and suicide, include these three placebo suicides?
When details of the suicides were drawn to their attention, why did DG/JS/DA do nothing about it?
Why did no one at BMJ spot the issue?
Copyright © Data Based Medicine Americas Ltd.
CITATION DISTORTION IS ANOTHER TRICK.
Most people are now aware how the academic literature on medications is undermined, (perhaps fatally for some drug classes such as antidepressants ), by publication bias and selective reporting. To these, we must now add citation distortion or “unfounded authority”. Unfortunately, much consensus in psychopharmacology is based on unfounded authority.
Citation distortion [2,3] is the process whereby, in a field with ambiguous primary data, studies showing the desired outcome are preferentially cited. Over years and generations of reviews, this distortion is amplified with exponential increases in supportive citation, facilitated by increased citation of papers that do not contain primary data (ie, one review cites another). At the same time, there is no parallel increase in citation of critical reviews.
Errors accumulate in this process of reiterative citation; for example what is acknowledged as hypothesis in cited articles is misrepresented as fact in reviews.
An example from this week’s academic literature is an article from Australia’s MJA . Amongst the numerous self-citations (count them), note the disingenuous citation of the discredited Gibbons et al paper (see David’s blog at https://davidhealy.org/coincidence-a-fine-thing) as though it supported ‘The importance of managing anxiety and depression in young people to minimise functional, medical and psychological complications’.
 Ioannidis JP. Effectiveness of antidepressants: an evidence myth constructed
from a thousand randomized trials? Philos Ethics Humanit Med. 2008 May
 Greenberg S. How citation distortions create unfounded authority: analysis of a citation network. BMJ2009;339doi: 10.1136/bmj.b2680 (Published 21 July 2009) http://www.bmj.com/content/339/bmj.b2680.full
 Slawson DC, Shaughnessy AF. Obtaining useful information from expert based sources. BMJ. 1997;314(7085):947-9. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2126390/pdf/9099121.pdf
 Scott EM et al. Targeted primary care-based mental health services for young Australians. MJA 2012; 196: 136-140 http://www.mja.com.au/public/issues/196_02_060212/sco10481_fm.html
[…] The tricks that drug companies do live after them, their patients are oft interred with their trials […]
I’m not sure where this post might rightly belong but it’s something I believe should be seen by everyone interested in the actions of Big Pharma – especially women. http://www.youtube.com/watch?v=TUY-iTf2T1A is the URL for the trailer for a hilarious but terrifying documentary about the development of Cialis and the creation of yet another disease – female sexual dysfunction. The film, called “Orgasm.inc” is available on Netflix in the US. The DVD is on Amazon. If you want to laugh while crying and cringing, please watch it. The trailer alone is worth a viewing.