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Monday, August 31, 2015

MHRA: Double Standards







I first became aware of the British drug regulator, the MHRA, adding a copyright notice to Freedom of Information request responses some time ago.

They first did this to me in 2007. I had sent them a series of questions regarding the suicide link in GlaxoSmithKline's antidepressant Seroxat (known as Paxil in the US)

The copyright notice reads...

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder. 

I, as you would expect, took umbrage to this and let my feelings known via this blog (here)

Again, this time in 2014, the MHRA, once again saw fit to include a copyright notice to another response to a Freedom of Information request I had sent them. This was in response to an FOI request I had sent them regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury) Back story here.

Earlier this week I was contacted by Cheryl Buchanan who has, in the past, wrote a guest post for this blog. (here) Cheryl had requested an answer from the MHRA (under the terms of the FOIA) regarding SSRi use in pregnancy. It's important to note that Cheryl has been at loggerheads with the MHRA and citalopram manufacturers, Lundbeck, for some considerable time now.

The MHRA sent Cheryl a response and included a copyright notice. Cheryl wrote back the following to them.

Dear MHRA,
Thank you for responding to my request, I have some further questions which I will sent to you shortly but at the moment I am perplexed as to why you have put a copyright on the response you sent me?  I feel it is within pubic interest to have the data within the response available to anyone who would like to see it. Is every paragraph copyrighted or am I allowed to share any of the information which relates to myself and my own report?

The response from the MHRA was...

Copyright information is included in responses from the agency where data is presented to the requestor. Data given in these types responses has the potential to be taken out of context, and the agency would wish anyone who has requested information from us to include the context when sharing information.
The agency is happy for you to share information released under the Freedom Of Information Act, indeed from the agencies perspective the response is already deemed as being “in the public domain”. The copyright notice is included as the information should be able to be traced back to the MHRA as the source, and as mentioned previously, the context can be included.


So now I'm confused?

You see, when a pharmaceutical company apply for a licence for one of their drugs they are supposed to submit supporting evidence. They do this by cherry-picking the best results from clinical trials. The poor results (ie; those showing that efficacy has not been proven) are never sent to the MHRA.

Here's my take on the MHRA copyright notice.

Would it be fair to say that when pharmaceutical companies submit clinical trial results to the MHRA in support of drug licensing that they include the failed clinical trials...so the actual benefit of a drug isn't "taken out of context"?

Just a thought.

What's good for the goose is good for the gander, right?


Bob Fiddaman.







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