naked!…

Posted on Wednesday 31 October 2012

The British Medical Journal announcement that they will not consider publishing Clinical Trials without full patient level data is ever so welcome here in 1boringoldmanville [God Save the Queen!…]. Ever since GSK announced it would make data available by approval of an independent panel [need to hear more…], I find myself seeing loopholes – ways a marketing executive could slither around the thrust of CEO Andrew Witty’s announcement. The British Medical Journal solution is, to my way of thinking, perfect. If the peer reviewers can’t do the job with the actual numbers in front of them, we need some new peer reviewers. I realized that when an old psychoanalyst [namely me] could do enough with the Paxil Study 329 patient level data to see clearly how corrupted Sally Laden’s analysis really was [the final lesson of Study 329: epilogue…]. I know the Emperor’s New Clothes is the most over-used metaphor in this and many other blogs, but it just fits like a glove. Somebody is finally shouting "Naked!" Treating Clinical Trial data as proprietary, like it’s a state secret, is absurd at first glance. I claimed I was going to run down how that got started, and I tried but failed to pick up the scent. It’s even more absurd than the Direct-to-Consumer drug ads on television [and whatever logic was used there is pretty damned absurd].

Having lived in the UK for three years in the early 1970s, I remain something of an anglophile, and I admire the BMJ taking the lead here. I also like Ben Goldacre as our unlikely looking Knight-Errant [something of value…]. So I looked at the British Journal of Psychiatry, wondering if they will pick up the challenge and follow suit with the BMJ, but the November issue isn’t out until tomorrow. Perusing the editor’s comments, however, I ran across the comment below and thought I’d pass it on as a sterling example of why my anglophillia persists. It is, after all, the King’s Queen’s English. I call it Five Easy Syllables:
DSM-free and ICD
by Peter Tyrer
The British Journal of Psychiatry. 2012 201:334.

Some authors who write papers about the DSM classification system and submit them to the Journal are possibly a little surprised when I write back reminding them that the UK is a ‘DSM-free zone’. The influence of DSM is strong but some see it as an example of American colonialism, and we in the UK, being sensitive about our history, detect this a little more than most. But a lot of jockeying for position has taken place in the past few years as the DSM-5 manual will be published in May 2013 and it is natural that many have sought to influence its final form, which has come under heavy criticism. But I hope that this new version can be left to earn its spurs in practice once it is published and we will now move on to the other kid on the block, the International Classification of Diseases [ICD], the 11th revision of which is forthcoming, which we will doubtless see subjected to at least as much criticism as praise. Already we are seeing likely differences between this and the DSM-5 system in critical areas of classification, and so harmonisation may be difficult to achieve. But as we all know, forced agreement harks back to co·lo·ni·al·ism, and we would like its five syllables tinkered with a little so it is changed to col·la·bo·ra·tion.
As Dr. Frances points out [“but this is ridiculous”…], the DSM-5 people need to be in col·la·bo·ra·tion with more groups that just the British and ICD people. There are plenty of groups right here in the colonies who need to be in the mix too…

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