Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, September 13, 2011

MHRA Go Hi -Tech

To be honest, I can't tell them apart.


Pharmalot's Ed Silverman is reporting that the British drug regulator, the MHRA, are considering using Twitter and Facebook as a way of reporting adverse reactions to medicine.

Silverman writes:


The MHRA is now “actively working on introducing other ways of reporting to make it easier and encourage more reporting,” Mick Foy, the MHRA group manager for vigilance and risk management of medicines, tells GP. “Applications for smartphones, improved web reporting forms and the use of social media such as Twitter and Facebook are being carefully considered as potential routes for reporting.”
But this is not a slam dunk, because the MHRA wants reports to contain info on drug reactions, the patient and the person conveying the info. And the agency must be able to conduct follow-ups. “It is important to consider the structure of the information for inclusion on our database, something Twitter and Facebook do not easily lend themselves to,” he says.

Forgive me for my cynicism for a moment but don't you think the MHRA have rather more important matters to address first?

Their Chairman [I still don't know what he actually does] Alasdair Breckenridge is a stout defender of Seroxat, he is also a former employee of GlaxoSmithKline.

Their Head of Licensing, Dr Ian Hudson, is former World Safety Officer of GlaxoSmithKline.

The current UK Seroxat litigation sees both GSK and the claimants call upon expert witnesses. GSK have called upon Rashmi Shah. Shah's former positions at the MHRA were Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor. He worked for them for 17 years. [Back story]

To be honest, it would appear that this is just another token gesture by a regulatory authority who really don't have any authority at all when it comes to making decisions on whether a drug should or shouldn't remain on the market.

Their four and a half year investigation into GlaxoSmithKline's suppression of pediatric clinical trial data resulted in the MHRA's CEO, Kent Woods, sending the, then Head of Glaxo, JP Garnier, a "Whose been a naughty boy" type of letter. Glaxo were not criminally charged because the MHRA claimed there was a loophole in the EU law. It took them four and a half years and millions of pounds before they came up with that particular excuse.

I can't imagine for one minute that the MHRA actually believe that they have an untarnished image. Anyone who has ever wrote to them with simple requests will find that they either don't hold the information you request any more, can't give it to you because of some exclusion clause in their rules and regulations or, worst of all, they will label you vexatious if you debate with them about their ethics.

The current reporting system is called the Yellow Card Scheme. Their webpage proudly boasts, "This site can be used to report suspected side effects to any medication including vaccines."


If they do decide to move with the times and enter into the world of social networking, I'm sure the increase in reporting will rise. What I'm unsure of is that the MHRA will do nothing but log the adverse reports then claim that the benefits still outweigh the risks.

To be honest, I've heard it all before. I wouldn't trust the MHRA if my life depended on them...much like the poor souls who have died, and who continue to die, at the hands of antidepressant type medication that the MHRA continue to claim does more good than harm.

By the way Kent, there's still an SSRi withdrawal problem. You still haven't done anything about it. [Notes of meeting with Kent Woods 2008]

You can read more about the MHRA on the excellent Social Audit website. The author, Charles Medawar, was trying to convince the MHRA back in 1997 that there was an SSRi problem. As history unfolded and more children and adults suffered at the hands of these drugs, the MHRA stood firm. It's abundantly clear, to me at least, that the MHRA will never budge, it is, after all, the pharmaceutical industry that pay their wages.

I ceased communication with the MHRA back in 2009. I've sent them the occasional Freedom of Information request since. My reasons for ceasing communication with them is clearly marked out in my book, The evidence, however, is clear...the Seroxat scandal. Basically, the MHRA won't admit that Seroxat is a teratogen neither will they accept any such evidence that points to Seroxat being a teratogen.

I'm bored writing about them...they always leave a bitter taste in my mouth.



Fid 


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