With the MHRA recently rolling out their SSRi Learning Module [Links at bottom of post] and once again buck-passing the emphasis of safety onto healthcare professionals and pretend "specialists" it got me thinking why the MHRA would do something like this.
They refuse to debate with me any more about the fake specialists they conjured out of thin air so, once again, they wish to play by their rules. Sorry guys, that just does not happen in my world.
In the news recently is the Diabetes type 2 drug, Actos.
Actos is manufactured by Japanese pharmaceutical giants Takeda Pharmaceuticals and was seen as a direct competitor to GlaxoSmithKline's diabetes drug Avandia.
Avandia was shelved after it was learned that patients taking it increased their chances of having a stroke and heart attacks. This was known for some time but nobody did anything about it. GlaxoSmithKline, after years of denial, eventually paid out settlements to those harmed by Avandia.
Actos has been reviewed by the European Medicines Agency [EMA]. After reviewing recent data as well as old data they found that there is an increased risk of bladder cancer in patients who take the drug longer than a year.
How do the MHRA respond to the findings?
Advice for patients Patients should not stop taking pioglitazone without consulting their doctor. Patients receiving pioglitazone should immediately report any visible blood in their urine or bladder problems such as pain while urinating or urgency to urinate, to their doctor. Patients receiving pioglitazone will have their treatments evaluated by their doctor at their next scheduled appointment. [LINK]
Were British doctor's privy to the investigation carried out by the EMA? Nup.
Of course, many British healthcare professionals will play down the bladder cancer risk in Actos because they won't want to alarm those patients already on it. Well, they need to and the MHRA should make sure that they do and not just send out warnings, many of which will probably find the bin in the doctor's office.
It's not enough to send out a warning letter. They should be warning the patients taking it and not those prescribing it. A full-page advertisement in the mainstream media papers and a series of radio and TV commercials warning of the dangers would be a start. Alas, the MHRA much prefer to campaign about buying fake drugs over the Internet. A series of cinema and TV commercials saw them team up with pharma giants Pfizer to promote that particular safety issue - so why not do the same with Actos?
At the start of the year California lawyers Baum, Hedlund, Aristei & Goldman, P.C filed a lawsuit in the Los Angeles on behalf of three couples whose lives have been turned upside down due to taking a drug that should have made their lives more comfortable.
The 12 point cause of actions include failure to warn, defective design and civil code violations. It's also alleged that Takeda Pharmaceuticals knew about the bladder cancer risk but concealed that information from the public. I doubt if a lawsuit will be launched here in the UK, going up against the pharmaceutical industry here one has to overcome many hurdles.
The MHRA won't help if you have been harmed from a drug, in fact, they seem to do everything but help. The on-going Seroxat litigation here in the UK is evidence of that - one only has to look at GlaxoSmithKline's expert witnesses in that case, one being an ex-employee of the MHRA.
So folks, always remember to take your medication, if you feel that you are having trouble with it or that your bladder cancer, heart strokes or suicidal thoughts may be a result of the drug you are taking then you could always talk to your doctor about it. The very same doctor that prescribed it to you in the first place!
More about the Actos bladder cancer link HERE
MHRA To 'Re-educate' UK Doctor's on SSRi's Part I
MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"
MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine
MHRA In Buck-Passing Specialist Cahoots
MHRA - More on the Mysterious "Ghost Specialists"
MHRA Wishing To Call The Shots
ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE
AUSTRALIAN ORDERS HERE