MHRA Meeting April 29th 2008 - My thoughts Part I

Below are my thoughts regarding the MHRA Meeting April 29th 2008 with patient representatives.

I'm not particularly bothered about the investigation into GSK - It took four years to investigate something has been publicly available for years previous to the investigation!

I'm not going to argue whether Seroxat can cause suicide in adults - The MHRA's position, or at least the position of their CEO, Kent Woods, will remain the same as GlaxoSmithKline's.

What I will argue the toss about though is Seroxat's addictive qualities and the failure of the MHRA to recognise this. I will also touch upon the whole antidepressant v placebo argument.

I will be using quotes from the transcript of the MHRA meeting, a transcript drawn up by the MHRA themselves... or a third party hired to do such a task. A copy of the transcript can be obtained via this link.

My comments in blue

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This from page 12 on the subject of addiction.

Patricia Martin (Patient Rep [PR]) - Discontinuation syndromes and symptoms and whatever else. But your average patient who's looking at the patient information leaflets that he gets with his drug would look for words that they would recognise immediately. Such as, is this addictive, is this an addictive drug?

Derek Scott [PR] - It actually made me suicidal.

Janice Simmons [PR] - But GSK removed that statement, didn't they? In 2003, this drug is not addictive. I wonder why?

Kent Woods [MHRA] - Well, there is a medical problem here in terms like `addictive'. Because they do have quite a precise meaning, and they're not generally understood in the sort of lay sense. The worry… if you label a drug as addictive that isn't actually addictive, you can have the undesirable effect of actually discouraging people from using a treatment they actually need. And one of the problems that I faced in clinical practice over and over again, where patients clearly needed medical treatment for severe depression, the question would be asked of me, `Is this an addictive drug?'

Not understood in the sort of lay sense? I find that statement quite insulting. Okay, I may not have the CV of Kent Woods but I DO KNOW what an addiction is. I experienced it! Or is he assuming that I and the thousands of others are liars or just not able to grasp the terminology because we are mere 'laymen'/women? How patronising!

He continued... 'If you label a drug as addictive that isn't actually addictive, you can have the undesirable effect of actually discouraging people from using a treatment they actually need...'

Yes - I agree. But at the same time you can say that this drug has been reported to be addictive and patients may struggle for months, and in some cases years to wean [taper] from it. There is no balance here. Once again you are going on the word of the manufacturer and NOT the patient. It's ironic to go on the word of a manufacturer you recently found to be not as forthcoming as you wanted them to be. Where is the logic in this. Once bitten Kent.

Further down on page 12 Derek Scott challenges Kent Woods with:

"recent studies that showed that antidepressants, all of them, were no better than placebo."

Derek was corrected by Janice Simmons when she added: "Except in severe depression."

Kent Woods reply was:

What that showed was… and it was a study that wasn't above criticism, it was criticised at the time, it certainly showed that the effectiveness of antidepressants was difficult to demonstrate in anything less than severe depression. But if you look at the marketing authorisation for antidepressants it always says, `indicated for major depressive disorder'. It's not for minor depression, it's not for unhappiness, it's for major depressive disorder. And what that study actually showed was to confirm the licensing authorisation; these are not drugs to be used for trivial indications. They really are not.

This statement makes me angry and expletives are used in the following comment.

Is shyness a fucking major depressive disorder Kent? That's how GSK marketed this drug or are you oblivious to this? It's all well and good pointing to your marketing authorisation but the fact is Seroxat was marketed for shyness and YOU did nothing. If the marketing authorisation were such a powerful tool then why the fuck didn't you use it to tell GSK that they couldn't market a drug for shyness? Why have you sat in silence whilst this drug has been prescribed to patients who didn't fall into the category of someone with a major depressive disorder? You surely must have known? If you didn't, it begs the question what the hell you are doing as CEO of a medicines regulator!

Pg 13

Patricia Martin comments:

"But if you just look at the figures though, the total number of SSRIs that have been prescribed, you know you're not dealing… these are not being prescribed just for severe depression."

Janice Simmons adds:

"Yeah, what I was going to say is that therefore that proves surely the point that the drug companies have given false information to health professionals regarding the drugs. Oh, they'll be okay for shyness, they'll be okay for this and that. And doctors have just prescribed them so willy-nilly."

Kent Woods responds with:

The company, by law, is not allowed to promote its product outside the terms of its licensed authorisation. And that's why we ploughed through these million pages of documents to see whether the company showed any documented evidence that it had encouraged its sales force to push their product for indications that they didn't have a licence for.

Now, there are two other players in this. Okay, there's the company which would quite like to sell its product. There's the prescriber who's trying to find the best solution for a patient, and there's the patient who wants the best treatment going. And I think there's this complex triangular relationship. And we shouldn't only focus on the push factor from the company, although that is sometimes taken to the limit. But there is the pull factor from patients and there's the pull factor from doctors who really want to do something useful for the patient. And I contrast the example of antidepressant treatment with the example of anti- hypertensive treatment or lipid load treatment. You don't see the same…

Now hold fire just a second here Kent. You have not answered the question have you? You are beating around the bush. Fuck Glaxo wanting to sell it's product, fuck the doctors wanting to find a solution to the poor sod sitting in front of them with mild depression. The patient wants and expects the best treatment available to them and YOU gloss over the fact that they have been prescribed a drug that will not work for their particular level of depression? What kind of logic is this?

Here, I have a drug here that won't work for you, Take it twice a day now kindly fuck off! NEXT!

In essence you are condoning this... that's the way I read it anyhow.

For crying out loud Kent WAKE UP! Protect the fucking patients and NOT fucking the product!

pg 14

Janice Simmons tells Kent Woods:

My husband was prescribed them because his first marriage went wrong. I mean, and seventeen years later he's still on them.

How does Kent Woods respond to this?

I guess the real problem is there is no one size fits all. And every patient is different and there has to be, if you like, a negotiation between the patient and the prescriber as to what is the best way forward. We don't have the powers, and we probably shouldn't have the powers, to dictate what the individual patients, individual prescribers, decide to do in that situation. We regulate the company, we don't regulate the prescriber or the patient.

Err, excuse me Kent, did you not hear what Janice Simmons just said? You answered like a politician - totally avoiding the real issue.

I will come back to this at another time. The stubbornness of the regulator just gets me to a point where I want to pull my hair out and as I hit the age of 44 I don't have much left to pull out!

Part two coming soon.

Fid




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