10.27.2006

Informed Consent

I was talking with a guy yesterday afternoon about the project and how I was doing. This guy happens to be a doctor, but to me, he is much more than that - he is a good friend. As I was describing the pain I was feeling and my anger toward the drug that made me this way, he stopped me. He asked me straight out, “was it worth it for you?” I wasn’t sure how to answer this – I knew exactly what he was talking about but I struggled to answer the question. I immediately wanted to say no – but as I thought about it, I remembered that ten years ago, when I started taking Paxil, I desperately wanted to find a way to deal with my anxiety and mood swings. After about a year on the drug, I could have even been the poster child for Paxil - I remember praising the drug as “giving me my life back.” But something happened along the way, as the years passed, I realized that I didn’t really get my life back, the effects of the Paxil simply substituted my life with a watered-down version – one that was easily tolerated, but not real.

So, back to the question – was it worth it… As my friend pointed out – it’s like in most all areas of medicine, it is a question of informed consent. In my case, the question is, did I agree to take Paxil based upon an appreciation and understanding of the facts and implications of that action? (I know it sounds like legal speak – that’s because it is). Looking back, I’m ashamed to say, no – I did not make my decision knowing what I was getting in to. I wanted the Paxil. I wanted a quick fix for my problems. The commercials depicted exactly what I was feeling – so the decision was way too easy – give me the pill and let me conquer the world!


Image filmed by Phil Lawrence.

Now, ten years later, as I sit alone and cry my eyes out for no reason – and face the daunting task of reestablishing my sense of self – the answer to the question, “was it worth it?” should seem incredibly clear – but it’s not. The ten years I spent under the influence of Paxil happened - good or bad - and they are now a part of me. The withdrawal process I’m going through right now is hell, but it’s also going to be a part of me. So, in the end, was it worth it for me? I guess only time will tell.


6 Comments:

At 2:36 PM, Anonymous Anonymous said...

That's a heartbreaking picture I have to say. It's good to hear you're thinking in a clear and articulate fashion though about the whole experience and not just seeing it in some black and white extreme terms. I wonder if you're getting exercise and how that might be helping to alleviate your distress. Also are any nutritional tricks working -- omega-3 oils or anything like that? Let us know.

 
At 3:15 PM, Anonymous Anonymous said...

Phil - surely the point about informed consent is that it can only be given if we are told ALL THE FACTS about a drug.

There is no way that any of us could have given real informed consent... every few months new data comes to light that GSK has kept from the regulators and patients for years - in May this year GSK made the monumental admission that depressed adults treated with paroxetine might be six times more likely to exhibit suicidal behaviour than matched adults treated with placebo.

This new, improved analysis of the risk of adult suicidality is mostly of data from clinical trials conducted 10 years ago or more. 10 YEARS AGO! The main thing new is that this was the first independent analysis based on a blinded re-evaluation of the raw data. When the UK drug regulators, the MHRA, ran their ‘independent’ investigation of SSRI antidepressants, in 2003-4, they relied not on the raw data, but on summaries and analyses the manufacturers had prepared.

The Patient Information Leaflet that you and I saw ten years ago when we started to take the drug bears little resemblence to one that GSK prints today.

Prescribers have it little better: in the UK there was a sneaky revision of the paroxetine/Seroxat SPC ("Summary of Product Characteristics") on 13 September 2006 – the sixth change in the last three years. Haven’t checked, but this must be some sort of record for a drug that’s been on the market for 15 years. Needless to say, the overwhelming majority of Seroxat prescribers will be unaware of the changes; they’d need to tackle the small print with a nit comb to take it all in.

The major change seems to be a very belated contraindication against concurrent use of paroxetine and pimozide. Why did Canadian doctors get a Dear Doctor letter about the same problem, more than a year ago?

If you look hard enough, you’ll also find some glaring inconsistencies, plus a number of niggling changes in the text of the new SPC – many of them softening warnings previously given. One notable example qualifies the advice that "paroxetine should not be used in the treatment of children and adolescents". The new SPC has dropped the statement that "efficacy has not been adequately demonstrated", replacing it with a sop for prescribers who decide to treat anyway: "If based on clinical needs, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms …" How on earth are prescribers expected to keep up to date with stuff like this?

Informed consent? - don't talk to me about that. GSK are out to lie and confuse - just so long as Seroxat continues to make money for them.

GSK - their wealth or our health?

 
At 3:32 PM, Blogger Phil Lawrence said...

roger, thank you for your comments - i was not aware of some of the information you have presented.
phil

 
At 4:14 PM, Anonymous Anonymous said...

Thanks Phil -
I can't take all the plaudits for this info – check out a great UK site at www.socialaudit.org.uk run by Charles Medawar.

It's very UK/MHRA focused, but Charles' book 'Medicines out of Control' is one to get hold of. It's a great essay detailing the way we've been sold snake oil for all too long. SSRIs are just another in a long list of wonder drugs that turn out not be quite so wonderful with hindsight. But never mind - just let the marketing boys sell, sell, sell.

And do you know why GSK "re-analysed" their 10 year old data and came clean in May this year?

Maybe it had something to do with Dr Peter Breggin and what he was able to make public back in February!

Suppressed Paxil Suicide Data Released:
www.breggin.com/courtfiling.pbreggin.2006.html

 
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