MHRA 'No Comment'

A while ago I wrote to the MHRA to ask them if they would like to comment on the recent report in The New England Journal of Medicine which said the makers of popular antidepressants published only 14 percent of their unconvincing clinical results.

I provided them with 28 newspaper stories from around the world.

Here's the email I got back from them:



----- Original Message -----
From: MHRA
Information Centre
To: fiddaman64
Sent: Friday, January 25, 2008
5:10 PM
Subject: RE: Effectiveness Of Antidepressants Questioned


Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.

We have no comment to make on the links referred to in your email. You might be interested to check the link below:


http://www.instituteofclinicalresearch.org/id621EMWA.asp


Please contact us again if you need further assistance with this, or any other queries.


Kind Regards,

Central Enquiry Point

-----

No comment? Why?... and why on earth send me a link to a ICR/EMWA Joint Symposium?

ICR is the Institute of Clinical Research, EMWA is the European Medical Writers Association, their blurb being:

The European Medical Writers Association was founded in 1989 by a small group of professional biomedical communicators with academic, industrial and journalistic affiliations. Their aim was to provide a forum to promote standards of excellence in medical writing by furthering the professional development of members and increasing awareness of medical writing throughout Europe.

This is all very confusing to me, I was merely asking the MHRA to comment on the recent report in the New England Journal of Medicine and they respond by sending me a link to some sort of seminar full of psychiatrists and ghost writers!

Now with some help from a colleague of mine we have found an interesting thread of discussion on the British Medical Journal (BMJ) Website. The thread is entitled 'Ghost writers need to be more visible'. Interesting because two names pop up - Wager and Jacob.

So who are Wager and Jacob?

They are involved in EMWA (sponsors of the symposium the MHRA referred me to) and their involvement in the actual meeting as hosts and moderators. As hosts you would expect a modicum of transparency. It seems Wager and Jacob are about as transparent as the MHRA if this particular response is to be believed (See 'Poachers & Gamekeepers HERE)

The response, by John Stone, reads:

I am getting ever more confused:-

Challenged by me just over two years ago in Rapid Responses Adam Jacobs was unwilling to name a single article which he had co-authored and also defended practices which make my hair stand on end [1]. He remains shy about declaring which pharmaceutical companies he works for but in Journal of American Physicians and Surgeons he noted: "AJ's company regularly provides services to a variety of pharmaceutical companies, some of which make vaccines, including SmithKline Beecham and Aventis-Pasteur' [2]. There is no client information on his website [3].

Stone continues...

...Liz Wager lists as clients on her website Fujisawa, GlaxoSmithKline, Janssen-Cilag, Ortho-Biotech and the Royal Brompton Hospital [4] but not here. She is also a member of the BMJ Ethics Committee [5].

The Nordic-Cochrane study, just published Gøtzsche et al 'Ghost Authorship in Industry-Initiated Randomised Trials' is full of citations of Jacobs and Wager, and lists intriguingly 'Liz Wagner' as academic editor [6].

"Elizabeth Wager is a medical writer and trainer for a variety of organizations, including pharmaceutical companies. She is a coauthor of the European Medical Writers Association guidelines for medical writers and Good Publication Practice for pharmaceutical companies, and occasionally receives payment for speaking about or providing training on publication ethics." [7]

Now let's see Jacob's position on the study of clinical trial data and publishing - just so you can all paint your own picture of him.

The thread is entitled 'In defence of medical writers' . This particular sentence grabbed my attention - ... In my own experience of writing papers on behalf of investigators, the named authors always have access to the summary tables and graphs, which is far more important than access to the raw data.

You getting the picture people?

The summary tables and graphs are far more important than access to the raw data?

Far more important to earn a fast buck rather than safeguard human health you mean?

Do I really need to remind Jacob's of the Paxil Study 329? Do I really need to throw names around such as Prof. Martin Keller? Read about him here

Most readers of this blog will already know about Paxil Study 329 - most will already know of Prof. Martin Keller.

I do hope word gets around to Messrs Wager & Jacobs - I do hope that they visit this blog.

I have some questions for them.

1. Exactly what is the EMWA?

2. Why is the EMWA 'supported' by the MHRA?

3. Do you believe scientific fraud is a good thing?

4. Jacobs thinks authors should not have to verify results, is this the position of EMWA as well?

Dr Aubrey Blumsohn has a great article entitled ' Who is the beast? The merger of medical journals and ghostwriters'

He writes: With publication last week of a strange article about the Gillberg affair by the British Medical Journal (BMJ), the dumbing-down is increasingly obvious (read the article and the responses - or at least those which were allowed). The upshot of this BMJ commissioned piece is that researchers faced with questions over the integrity of their data analysis should simply destroy that data. Great advice! News today adds to the concerns. The BMJ have apparently (yet again) declined to publish a paper (about ghostwriting and data misrepresentation of Paxil study 329) involving one of their advertisers (GSK) because "they feel they don't have the resources for the legal work required to check it all". That seems to have become a regular excuse.

I'm still scratching my head at the MHRA for sending me the link. Did they want me to attend the symposium?

It all smacks of one big game for the boys and it's high time this game was put to an end.

Fid

**This article will be sent to the MHRA.

I don't expect them to make any sort of comment on this either!