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Wednesday, April 09, 2008

GlaxoSmithKline Investigation... Some Answers...

... from the MHRA. Obtained under the Freedom of Information Act

After the recent publication of the MHRA investigation into GlaxoSmithKline, I was prompted to write the MHRA and ask a series of questions under the Freedom of Information Act.

Yesterday I received the answers to all but one question.

It makes interesting reading and of course leaves the door open for more probing questions.

I asked:

1. Were the MHRA right to think Seroxat was not authorised for use in children?

The MHRA replied:
In 2003 Seroxat did not have an indication for treatment of children. Prior to June 2003, the Summary of Product Characteristics at the time stated that 'The use of Seroxat in children is not recommended as safety and efficacy have not been established in this population.'.

2. Is there, or has there ever been, a document called a marketing authorisation making it clear Seroxat is only licensed for use in adults?

The MHRA replied:
When a marketing authorisation is issued, the terms for use of the product (including licensed indications and information about use in different populations) are laid out in the Summary of Product Characteristics which is approved by the competent authority. After authorisation the SPC cannot be changed without the approval of the originating competent authority. As stated above, prior to June 2003, the Summary of Product Characteristics at the time stated that 'The use of Seroxat in children is not recommended as safety and efficacy have not been established in this population.'.

3. If Seroxat wasn't licensed for use in children, as the MHRA are now saying, and if the normal conditions of use means simply licensed use, as the MHRA's lawyers seem to have concluded - how come the MHRA had power to vary the authorisation?

The MHRA replied:
We are still awaiting advice on the third of those questions and will answer it as soon as we can

4. Why were MHRA enforcement investigators unable to question GSK staff?

The MHRA replied:
Under UK criminal law suspects in criminal investigations can not be compelled to answer questions, they have a right to remain silent. Lengthy negotiations were conducted with solicitors acting for individual members of GSK staff and for GSK itself with a view to persuading them to attend interviews under caution. The conclusion of the correspondence was that all the potential interviewees indicated that they would not attend an interview under caution.


The individual suspects (as opposed to the corporate entity GSK) could have been arrested and required to attend an interview under caution. However they could still not be compelled to answer questions and, given that their solicitors had clearly indicated that they would not answer questions, the investigation team concluded that there was nothing to gain by carrying out arrests.

5. Does the MHRA have the powers it needs to properly regulate pharmaceuticals industry?

The MHRA replied:
The Medicines Act and associated legislation provide the framework through which the pharmaceutical industry are regulated, this legislation sets out a number of criminal offences and provides a number of powers to enforce the legislation. The enforcement duty is undertaken by authorised officers at MHRA on behalf of the Secretary of State and Health Ministers using powers available under the Medicines Act. These include rights of entry, powers to inspect and take samples, and to demand production of any books or documents from those carrying on a business which consists of or includes the manufacture of medicines from any person engaged in that business. The MHRA may seize any articles or documents which may be required as evidence in proceedings under the Act.

Offences under medicines legislation are criminal and where appropriate, prosecutions are brought before the Courts.

6. When interviewed on BBC TV's Panorama, MHRA Chairman, Alasdair Breckenridge was asked whether or not criminal charges would be brought against GSK. He answered 'That is a possibility'. Are we now to assume that this was a lie?

The MHRA replied:
At the time of the Panorama programme, the case was still under investigation and therefore the statement by Professor Breckenridge that a criminal prosecution was a possible outcome of the investigation was correct.

To be fair I think the MHRA are trying to be as transparent (as they can) here. I do, however, find their answer to question 4 quite baffling.

I asked: Why were MHRA enforcement investigators unable to question GSK staff?

Their answer does not sit right with me.

"Under UK criminal law suspects in criminal investigations can not be compelled to answer questions, they have a right to remain silent."

I am aware of this but surely an individual has a right to remain silent AFTER an arrest?

"Lengthy negotiations were conducted with solicitors acting for individual members of GSK staff and for GSK itself with a view to persuading them to attend interviews under caution. The conclusion of the correspondence was that all the potential interviewees indicated that they would not attend an interview under caution."

Well, did you honestly expect them to?

In layman's terms if I was a police officer as part of an ongoing investigation and I wanted to interview a 'suspect' - I would not listen to their solicitor, I'd bring them in for questioning regardless of what their solicitor said. We are all innocent until proven guilty so an arrest would have at least gave the MHRA Enforcement Officers a chance to cross examine these 'individuals'.

If I was alleged to be part of a plot to rob a bank and the investigating team of a police unit wanted to interview me, do you think they would 'brush that idea aside' because my solicitor had told them that it would be a waste of time because I would not answer any questions?

It would be interesting to learn of the 'individuals they asked - maybe that can be another Freedom of Information request? Whether they answer or not remains to be seen.

"The individual suspects (as opposed to the corporate entity GSK) could have been arrested and required to attend an interview under caution. However they could still not be compelled to answer questions and, given that their solicitors had clearly indicated that they would not answer questions, the investigation team concluded that there was nothing to gain by carrying out arrests."

Really? This handling with kid gloves justifies public concern about the MHRA does it not?

How can an investigation be thorough if there are no interviews with those you are investigating? This is absurd, dare I say it... OUTRAGEOUS.

Basically... and do tell me if I am wrong. The MHRA Enforcement Officers asked 'Can we interview you under caution?'

GlaxoSmithKline's Lawyers answer, on behalf of their clients was 'NO'

So the MHRA Enforcement Officers thought, Okay then... no problem.

C'mon, a little bit of interrogation wouldn't have gone amiss here. We are talking about a plot to keep silent about the safety of a drug here are we not?

You've let them off lightly and you know it.

Maybe the only reason there were no arrests made was because you didn't want the mud to stick with these 'individuals'?

I think my opinion is fair on these matters and hopefully if the MHRA are investigated at a later date over this GlaxoSmithKline investigation then 'individuals' in the Enforcement Team won't be given the privilege of answering 'I don't want to be interviewed so na na na na na'

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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