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Wednesday, June 10, 2009

Medicine Regulators Putting Lives At Risk

The reason I started writing this blog, SEROXAT SUFFERERS STAND UP AND BE COUNTED, was to highlight the ignorance of the Medicines Healthcare and Products Regulatory Agency [MHRA]. I, along with many others, were being stonewalled regarding questions about the antidepressant drug, Seroxat. My first post came on April 7th, 2006, I was concerned why Richard Brook had resigned from the Government's watchdog on antidepressants after it tried to cover up its own ten year failure to identify serious side effects of Seroxat.

At the time I was a member and moderator of the Online Seroxat Support Group [OSSG]. It was a sanctuary where like-minded people discussed their problems with Seroxat and generally chewed the cud about life in general. Sadly, the group was infiltrated by a couple of insidious characters who chose to berate the group owner then later other members of the group. These two characters still berate and criticize on various health forums and doppelganger blogs created, it seems, with the sole intention of slinging mud at everyone and anyone who has spoken out against Seroxat. A tactic Pharma have used on many occasions.

The OSSG is still online but I have not posted since the creation of this blog. Writing and researching takes up a lot of time and I feel blogging ones thoughts creates a bigger awareness. I think this has been justified over the three years or so I have been writing this blog. Online support groups have their place and without the OSSG many people would be left wondering why they are experiencing electric zaps ripping through their bodies, anger issues, suicidal thoughts and a whole host of other adverse reactions that accompany Seroxat and it's withdrawal.

Personally I have been accused by certain quarters of focusing on Seroxat when I should be 'banging the drum' about ALL SSRi's. I can only go by personal experience and if my critics [I prefer to call them stalkers] wish to create awareness about their particular gripe then my hat will be taken off and I shall applaud them.

I am aware that that this is an SSRi problem and not just a Seroxat one - my discussions with the MHRA over the years has involved the whole family of SSRi's and not just Seroxat.

The UK has a number of bloggers who write about Seroxat, all have played a major part in raising awareness to both the MHRA and the general public and hopefully some doctors too. Janice Simmons who runs the Seroxat User Group, has been banging the drum well before I started writing about the dangers of this particular antidepressant. Charles Medawar was creating awareness about Seroxat long before I and his webpage Social Audit is a great resource for anyone wishing to learn how writing publicly can get your voice heard.

In America, Seroxat is known as Paxil. Two websites that spring to mind regarding creating awareness are the now deleted 'Paxil Protest' and the online support forum, 'Paxil Progress'. Paxil Protest can still be accessed - learn how, here. There are also a host of personal blogs written by people who have experienced the horrific side effects of Seroxat - look in my sidebar for the various links.

Both Australia and Canada seem pretty less vocal regarding Seroxat, although 'Death By Paxil' is written by a Canadian who has experienced Seroxat first hand and often highlights failures in the Canadian medicine regulators, Health Canada. In Australia, Healthy Skepticism stands alone with it's hugely resourseful Paxil 329 documents.

Many other advocates from around the world often highlight stories that relate to Seroxat, these advocates [in many instances] write about their own experiences on SSRi's, Benzoes and many other mind altering prescription drugs. Each and every one should be applauded for their roles in creating awareness about the dangers of drugs and the corrupt practices of pharmaceutical companies, key opinion leaders and medicine regulators.

Book authors and the media also need to take a bow with their relentless work regarding exposing the truth about GlaxoSmithKline. Alison Bass, whose book, 'Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial' is, in the main, about a whistleblower and New York District Attorney who were not happy with the way Seroxat's dangers were being hidden from the general public by it's manufacturer, GlaxoSmithKline. Then we have Shelley Jofre, Panorama's own ankle biter who took on the might of the establishment with her series of programmes regarding Seroxat. In all, there have been four Panorama programmes regarding Seroxat, Shelley has exposed and shown the UK just how corrupt the whole system is. Both Shelley and Alison, along with many other authors and journalists, should take a bow.

An honourable mention also has to go to journalist, Evelyn Pringle, whose Seroxat articles, in particular, 'Drip, Drip, Drip, Paxil Info Leaks Out', have been instrumental in creating awareness.

With all that is mentioned above it came as no surprise that the MHRA should commission a Stakeholder Analysis. The aim was to provide an overview of the stakeholders who are influential in the debate surrounding the MHRA and Seroxat. 'Stakeholder' is basically a term given to people with an opinion, at least that's the way I see it.

A copy of the MHRA's 'Stakeholder' Analysis can be read here [HTML] or here [PDF]. This particular copy is hosted on Phil Dawdy's excellent website Furious Seasons.

This leads me perfectly into why I am writing this particular post 'Medicine Regulators Putting Lives At Risk'.

I have met with the MHRA on two occasions. I don't think it coincidental that I was granted my first meeting with them, I have, after all, written about them on many occasions on this blog, in many instances I have lampooned them for their failure to regulate the drugs we all take. My first meeting came many years after they were fist alerted to the dangers of Seroxat. In between they had met with other patient advocates to discuss Seroxat and, was themselves, the main focus of Panorama's excellent programme, 'Taken On Trust'.

The recorded minutes of my first meeting with them can be read here. As you will see, the issue was about withdrawal of SSRi's. I basically wanted them to know how difficult it was to taper off SSRi's and wanted them to speak with someone who was learned in the subject of SSRi withdrawal, Dr. David Healy. David had previously corresponded with the MHRA, alerting them to the dangers of fluoxetine, paroxetine, sertraline and other SSRIs. His correspondence with them started as early as 1999 - 10 years ago!

The MHRA agreed to meet with Dr. Healy but it took them 7 months to set up that meeting. I'm pleased to say that the meeting will now take place sometime later this month. It will be yet another occasion where the dangers of SSRi's are brought to the MHRA table and it will be interesting to see how they react to what is obviously a major problem in the UK medicine regulatory system.

Only last month, I met with the MHRA again, this time, Simon Gregor, the Communications Manager at the MHRA. Simon had contacted me some two weeks previous to invite me to share my thoughts about the fairly recent MHRA Strategy Plan, which can be downloaded HERE. A brief summary of that meeting can be read HERE.

I have to applaud the MHRA for at least showing they are willing to listen to patients and expert opinion. Where I think they are failing, presently at least, is in the amount of time it takes them to act upon patient concern. In fact had they have listened to Dr. Healy 10 years ago then they wouldn't be in this precarious position now of trying to satisfy patient needs whilst not upsetting the hand that feeds them - Pharmaceutical companies. 10 years is an awful long time to play around with patient safety, particularly when the effects of SSRi's are seriously affecting a large number of people that take them. The Risk/Benefit ratio needs to be looked at and also they need to ask themselves at what point do they pull a drug from the market. How many adverse reaction reports does it take, how many deaths or suicide attempts will it take [anecdotal or not] to protect the public from these types of antidepressants?

Where the MHRA stand out is that they DO at least listen to people. The Food and Drug Administration [FDA] seem to be a tougher nut to crack. In fact it would be easier, it seems, setting up a meeting with Barrack Obama than it would with the FDA. One only has to type the words "FDA FAILURE" into Google to see how incompetent they are at regulating prescription drugs. Their links to the industry [Pharma] are cancerous and as long as these ties remain, the American public will always be at a risk with the prescription drugs they take.

Health Canada seem about as useful as a chocolate kettle and have the morals of a French kiss at a family reunion! One only has to look at the cases of Sara Carlin and Vanessa Young. Two young girls who took prescription drugs that they [Health Canada] granted a licence to. Their complete lack of empathy and ignorance is abhorrent regarding these two particular needless deaths. Two girls leave behind two families to pick up the pieces. Grief never goes away, it just eases. It's bad enough to lose a child but to have to go through the ordeal of an inquest because someone failed to properly regulate is a nightmare. The suffering caused by Health Canada's incompetence will never die, unlike these two poor girls who took the drugs under faith that their regulatory system was working!

The Therapeutic Goods Administration [TGA] are the Australian agency set up to protect the public from harmful prescription drugs. They are so laid back and blasé about the SSRi problem that I just imagine them patting one another on the back at the end of each working week, commending one another for staying off the radar of patient advocates. I have wrote them on many occasions regarding the GlaxoSmithKline Australia web page where Seroxat [Called Aropax] in Australia, is still being touted as something that corrects the chemical imbalance. Basically they are promoting under a myth, a bit like you or I claiming that to step on an ant will bring rain!

I've corresponded with the TGA before. I wasn't happy that the Delphi Centre in Melbourne was blatently advertising Seroxat [Aropax] on their webpage. After emailing one another on numerous occasions, the TGA wrote me and said that the advertising had now been removed. It hadn't - so why lie to me? Was the distance of 10,000 miles the TGA's safety net or did they think I was just some patient pissed at the Delphi Centre? Eventually, the advertising was removed. [LINK]

With all of what you have read about patients and experts knocking on the doors of the regulators, you would have to think that embarrasment would bring them all into submission, or at the very least ignite some spark in them. Alas, that doesn't seem the case, at least not with Health Canada, The FDA and The TGA.

It remains to be seen exactly what the MHRA will do with this SSRi problem and whether other regulators follow suit.

All regulators speak of the Risk/Benefit ratio when taking prescribed drugs. As a public citizen I would like to know what the Risk/Benefit ratio is for regulators, who are funded by pharmaceutical companies, who have ex-pharmaceutical company employees on their staff, offering advice on the drugs you and I take. I can clearly see no benefit whatsover.