Monsanto Roundup Lawsuit

About Me
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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Monday, December 28, 2015

2016: The Role of Others





Aside from Christmas Eve, Christmas Day, and Boxing Day, I spent this period of festivity alone. Great to catch up on House of Cards with the brilliant Kevin Spacey and Robin Wright, in between many episodes of Ghost Adventures (probably the best programme on TV) and trips down to the local bar with residents of the surrounding area, most of whom are pretty much oblivious to the work I do (and have been doing for almost 10 years)

April this year (2016) is the 10th birthday of this blog, it all started with a blog post of mine regarding the British drug regulator, the MHRA. Since then it's been a journey of learning, a journey of acceptance, a journey of grieving the loss of parents, children, husbands and wives - my grief shared in unison with those who are left behind to pick up the pieces that a death in the family brings.

10 years.

I've held meetings with the British drug regulator, been threatened by GlaxoSmithKline's lawyers, had online stalkers, doppelganger blogs, Facebook and Twitter pages. In between, I've lost my mother, Teresa, and my best friend, Benn (my 10 year-old Rhodesian Ridgeback/Boxer cross) I've had a number of relationships, none of which worked out. A book published and two human rights awards. I've even tried my hand at fiction writing, a manuscript that sits waiting to be finely tuned if or when I get the time.

It's been 10 years that has opened my eyes to the murky world of the pharmaceutical industry, psychiatry and apparent medicine regulators, all of whom have enlightened me, all of whom I have a lack of faith in.

Online advocates have come and gone. This kind of work can be mentally exhausting, it's akin to having your soul raped when you read about another teen who has killed themselves because their prescribing physician couldn't be bothered to research the brand of antidepressant. Or another child born with serious birth defects, again for the same reason. Big pharma denies individual suicide links, medicine regulators sit and shrug their shoulders believing that they have done everything in their power to warn and moderate reported side effects of antidepressants - in truth, they haven't, truth is, they never will.

2016

For me, this new year is about the role of others. There is a choir and has been for the past 10 years, since the conception of this blog, we sing the same hymns whilst others, for reasons unknown, sit and pretend to sing, they open their mouths but nothing comes out - they go home after the sermon and, well, leave the dirty work to the likes of HealyWhittaker(MIA), Fennell, Antidepaware, Lynch, Truthman, BuchananWitczak, Matthews, Ann Blake Tracy, the CCHR**, myself, hoping (in vain) that we can pull the rabbit out of the hat and bring a halt to these needless deaths, truth is, we won't, not alone at least.

What we, as advocates, can achieve is hampered by the shoulder shruggers, be they medicine regulators or family, friends and those faceless Facebook friends who "like" a post within seconds of you posting it on your page, the type that read a headline without reading the actual content. I don't blame them for not reading, this stuff is heartbreaking and can leave one carrying around the grief of many people, sometimes taking that grief to bed, sometimes allowing it to spill into our everyday lives - yup, we have lives too, we don't just sit at home writing and researching antidepressants and corruption, We, just like those who choose not to bang the drum, have our own lives and families, relationships to deal with. I think, sometimes, that people forget that.

It's a feeling of pride when I see my name mentioned with those above, they have each put thousands of hours of work into making sure that this problem reaches the masses. It's all voluntary, it's all down to doing what they believe is the right thing to do.

I'm unsure if Healy,Whittaker, Fennell, Lynch, Truthman, Buchanan, Witczak, Matthews, Ann Blake Tracy, the CCHR et al think along the same lines as me when it comes to the role of others? I don't know if they think that others should be playing a part in voicing their opinions, meeting with regulators, congress - doing unselfish acts for, in part, the people that sit back and prefer to post fluffy bunny pics on their Facebook walls or the latest Hollywood gossip on their Twitter walls.

An old friend of mine once told me that they don't read my work because it's upsetting. As a writer I understand the sentiment, as a human, I don't.

The problem of antidepressants cannot, nor should not, be sugar-coated. Sharing a link on Facebook or Twitter is all well and good, but it's debating with those who still disbelieve that there is a problem that is they key. I don't want people to agree with everything I write. I'm sure the same can be said for the advocates I mention above. Debate is good, it's healthy, it's a snowball that will get bigger and bigger as it gathers momentum but it needs more snow, different snow, not the same snow.

As parents we all have a duty to protect children - those who work within the fields of the pharmaceutical industry, regulators and psychiatry, collectively known as the Pharmafia, fail in this one simple duty. I don't expect anything but negativity from them - it is they who are the problem and it is us who are the solution.

The problem cannot be resolved by ignoring stories because "they upset you or spoil your day" - boo hoo - try stepping into the shoes of the parents who have lost kids to suicide then ask yourselves if you really think you are doing enough to help a future generation of children and their blinkered parents.

We all know it's Christmas because we were each told the story of Jesus Christ. Christmas isn't about him any more, it's about over indulging and debt (Bah Humbug).

He was a good guy, he spread love amongst his fellow humans... then again, he had no foe to deal with in the shape of the Pharmafia.

If you are going to make one New Year's resolution this year, spare a thought for those who have loved and lost, those who have probably spent Christmas crying because their son, daughter, mom, dad, husband or wife, isn't around any more, all because they were prescribed an antidepressant that induced their death. Then, spare a thought for the anguish and frustration they feel because all they see and hear day in, day out, is the same people banging the drum about this problem.

Let 2016 be the year that YOU make a change. Nodding your heads in agreement isn't enough. Get your hands dirty.

Your online presence is of the utmost importance.

Wordpress

Blogger

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Mayor Vaughn: I don't think either of one you are familiar with our problems. 

Hooper: I think that I am familiar with the fact that you are going to ignore this particular problem until it swims up and BITES YOU ON THE ASS! 

Scene from the movie, Jaws.



Bob Fiddaman



**Many more to mention, they all know who they are.



Sunday, December 20, 2015

Top 10 Posts for 2015





These are the top 10 most popular posts from my blog this year. Two guest posts make the number one and two spots which I'm very pleased about.



#10 - UK Serious Fraud Office and the GSK 3
I name the three individual GSK employees currently being interviewed by the UK Serious Fraud Office.

#9 - When Pharma Use the Defence of the FDA
I engage with Duchesnay's market analyst, Danny Martel regarding the Kim Kardashian promotion of Duchesnay's morning sickness medication, Diclegis.

#8 - Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash? 
My own investigation and take on the Sierre 2012 Bus Crash.

#7 - Psychiatry Taking the Biscuit
One sided media and the bizarre thoughts of media psychiatrists.

#6 - Kim Kardashian on the Pharma Payroll
Socialite promotes morning sickness pill with no mention of side effects.

#5 - Co-pilot, Andreas Lubitz Germanwings
My take on the Germanwings Flight 9525 disaster. This was written before we knew about the medication the co-pilot was taking.

#4 - Reanalysis of Glaxo's 329 Study Goes Public
My own take on the 2015 reanalysis of Glaxo's 329 Study by the RIAT team.

#3 - British Medical Journal Add to Glaxo's Woes
BMJ invite me along to a press conference regarding the reanalysis of Glaxo's 329 Study

#2 - Seroxat Withdrawal Diary (Guest Post)
This guest poster wishes to remain anonymous, his story is familiar. His story is a classic example of what is not being done to help people suffering Seroxat addiction.

#1 - Prozac Took My Child (Guest Post)
With almost 16,000 views this guest post by Stephanie Lynch is one that is both tragic and informative. It's also very sad.




Bob Fiddaman










Friday, December 11, 2015

Patricia Casey and Catholic Suicide






Two things that get my goat.

1. Irish psychiatrist, Patricia Casey.
2. The Catholic Church.

Raised as a Catholic and put through Catholic schools (until my expulsion) I learned that suppression is the key to the Catholic way of living. I pulled away from the whole idea of the Holy Trinity when I was old enough to, a) have a mind of my own, and b) see sense.

This post is not slamming those who choose to follow the Catholic faith, because, ladies and gentlemen, that's all it is, a faith, a belief based on stories that are centuries old.

Now, it appears, Irish psychiatrist, Patricia Casey, whose stance on antidepressant use is well known, has spoken out on the Irish Catholic website. Once again we see Casey lay claim that “medication is absolutely essential”.

To back her claim,Casey cites a study that found that two thirds of people who died of probable suicide were not taking prescribed medications when they died.

Talk about cherry-picking from that garden of Eden!

Her claim is bizarre, to say the least, particularly when we see daily inquests where depressed individuals have gone on to complete suicide... those individuals having been prescribed the very same medications that Casey deems "absolutely essential."

She can't have it both ways.

Casey's claim comes on the back of a recent article published in the New York Times. The article shows that almost 20,000 prescriptions for risperidone (commonly known as Risperdal), quetiapine (Seroquel) and other antipsychotic medications were written in 2014 for children 2 and younger, a 50 percent jump from 13,000 just one year before (US figures)

Do we see the Catholic church or, indeed, Casey, speak out regarding these appalling figures?

In fact (not faith) a report from the Centers for Disease Control and Prevention found that health care providers had given a diagnosis of attention deficit hyperactivity disorder to at least 10,000 children age 2 or 3 and then prescribed medications such as Adderall outside American Academy of Pediatrics guidelines.

If it's happening in America, then it's happening everywhere else folks, such is the stranglehold of the pro-medication psychiatry brigade that exists worldwide.

Casey has gone on record and claimed that "The evidence about suicide is that antidepressants do not cause suicide", a belief (faith) that she adheres to despite regulatory precautions put in place to warn patients that taking antidepressants may, indeed, cause suicidal thinking, abnormal behaviour and, despite Casey's belief, completed suicide.

I find it peculiar that Casey chooses to keep on banging the drum regarding antidepressant use given that global medicine regulators and even pharmaceutical companies warn about the antidepressant/suicide link. Furthermore, I find the Catholic church and their apathetic attitude to antidepressant use to prevent suicide nothing short of ignorant and, as per usual, as unexplainable as the Trinity they seem to hold close to their hearts.

In short, we have an Irish psychiatrist going against facts and a church publishing those views.

If you, like me, shake your head in wonderment at religious beliefs, then you'll probably understand that this recent offering by Casey via the Catholic Church is stuff of fairy-tales. The virgin birth, the resurrection, the miracle man who healed the sick and changed a measly meal into one that could feed thousands and, now, a claim that antidepressants are essential if suicide is to be prevented.

Last time I looked we were in the 21st century, we got this far using science and not because of some bearded guy. Catholics and even Christians may argue that I'm wrong, they would wouldn't they. Their Word, according to whatever denomination you speak to, is the "truth".

Don't get me wrong. Jesus Christ was a decent human-being, he, according to history, was a man of love, he had compassion. Whether or not he was actually the son of God is, and always will be, up for debate - after all, that's what God gave us isn't it, free will.

Casey's beliefs are, in my opinion, perfectly placed. They are published on a website that offers nothing but a personal belief and no scientific evidence whatsoever. Casey is entitled to her views as much as the next person, myself included. But her views must be backed up by scientific evidence and not with her own belief. The subject matter (suicide) and the precaution of it must not be taken as "Gospel" just because a psychiatrist believes it to be true.

Pharmaceutical companies and medicine regulators, in this case the Irish Medicines Board, have a duty too. They should politely ask Casey to show them where they are wrong, it shouldn't be left to bloggers, patients, parents, husbands or wives of victims who have died as a result of antidepressant induced suicide.

If you or I were to make claims that a drug we invented gave humans extra sensory perception, we'd be asked to prove it. If we couldn't prove it then medicine regulators would, more than likely, tell us to stop promoting it in such a way. They should, I believe, tell Casey to either provide them with evidence that antidepressants prevent suicide or to just shut up.

If you're a devout Catholic and you find this rant of mine offensive then please don't start quoting your mythical nonsense to me. I'm up for debate but refuse to engage in anything based on a belief borne out of control and Chinese whispers. That goes for any religion and not just Catholicism.

"Father, forgive them for they know not what they do."

Must fly. I have to get ready in preparation for Santa and his elfs.




Bob Fiddaman.

Related

Patricia Casey Sets the Hounds on Irish Blogger.













Wednesday, December 09, 2015

Glaxo: Made In England



Sing to the tune of 'Made In England' by Elton John (Video at foot of post)

I suggest you click play on video then read the lyrics. If you feel brave enough then sing-a-long :-)




"Made In England"

Lyrics by Bob Fiddaman

They was made in England out of SmithKline and Beecham
They've had a quit-me Frenchman, and a 'love-me' Witty
They've got lots of money and that pack of Paxil
Oh that sweet numbing drug and the KOL's to pay.

Oh, they was made in England
Oh, they was made in England

They was made in England out of SmithKline and Beecham
Sold shares in a market citing we are like no other
Saying 'transparent' for stocks and shares
Oh that sweet numbing drug and the KOL's to pay

Oh, they was made in England
Oh, they was made in England

They was made in England from a fierce Diablo
But some Yankee lawyers had a way about them
Glaxo denied all problems, and showed their middle finger
Found guilty of fraud with a 3 billion dollar fine.

Oh, they was made in England
Oh, they was made in England

If you're made in England, you're built to last
You can still say 'Glaxo' and everybody laughs
But the joke's on them, they never read the song
There's no secrets that time does not reveal.

Oh, they was made in England
Oh, they was made in England



Merry Christmas to Glaxo, their lawyers, and their Key Opinion Leaders!








Bob Fiddaman






Tuesday, December 01, 2015

Life After Antidepressants





If you, like me, have experienced life on antidepressants and you, like me, no longer rely on having to mask and paper over life's problems, then you'll know that life after antidepressants can be so much more fun and enriching.

Some months ago I looked up an old friend of mine (she'll kill me for using the word 'old' in this sentence - ah, sod it, that's twice I've mentioned it now)

She, like me, endured the harsh reality of being prescribed Paxil (known as Seroxat in the UK). Her body, however, was medically abused, her dosage being a staggering 90mg of Paxil per day.

Eventually she weaned herself off, more antidepressants and antipsychotics being added to the mix to substitute the weaning process of the Paxil. More withdrawing and withdrawal problems arose with these substitutes but she eventually managed to kick them all in to touch and move on with her life.

She, just like me, is a writer, she writes fiction and, unlike me, writes it brilliantly. Could she have written such powerful pieces whilst under the influence of psychiatric medication? I doubt it. Antidepressants do everything but make our minds clear, substituting life's problems with a fog where within lies a complete lack of compassion and empathy. To write well one must have both compassion and empathy. I'm pleased to say she has both.

She has since suffered yet more of life's problems, this time though she has battled through them and not gone down the route of medication. People who have experienced horrific withdrawal reactions to these types of drugs rarely go back to them. We are the fortunate ones because, through research, we learned that the withdrawal effects, bouts of sadness, insomnia, anger etc were not, as many professionals suggest, the "illness" returning.

I've been privy to a new novel she is writing, it's in its infancy yet already it's a work of art, particularly when I pay attention to the detail she uses, detail that under the influence of psychiatric medication, could not be seen yet alone described.

Her eyes are open, her mind has found its creativity again and because of that she is, I believe, on the right road. She is laughing again, she is giving as good as she gets again.

She's alive, her mind, body and soul.

The irony of this is that she was offered antidepressants recently. A recent life problem that, could seemingly be fixed with a drug that would merely numb her. Yes, it was tough in the beginning but months down the line, and without the aid of mind-altering drugs, she's fighting fit and telling a story in such a unique and gifted way that will, I'm sure, be ready for public consumption at some point in the near future.

My life after antidepressants turned out pretty much the same. I wrote a book about Seroxat, had it published then, some months ago, completed a fictional book about love, life, angels and demons. Sadly, I don't think, in its current format, that its good enough to be published but I can always go back to it - maybe my "old" friend can offer me some guidance?

Life after antidepressants is so much clearer. You can see the road ahead, a road that looks appealing when faced head on. There's no fog on the road but there's plenty of compassion and empathy, you pick both up as you walk along.

'Midge' is alive and kicking thanks to her horrific experience of psychiatric drug withdrawal, without which she'd probably be stuck in the middle of the mist, confused, feeling unloved, feeling guilt and feeling nothing but hopelessness, particularly if her recent offering of medication had been taken on trust.

Love, light and peace to all those who have broke free from the demons that are antidepressants, an extra dose of love, light and peace for those of you still trying to break free from the pharmaceutical shackles.

The timing is always right to look up friends from the past, if only to wish them well. You never know, your voice may just be what they need, theirs may just be what you need too.




Bob Fiddaman





Saturday, November 21, 2015

GSK: Motions Denied in Paxil Suicide Case






Earlier this year I reported on how GSK, via their team of highly-paid lawyers, had targeted four expert witnesses that were due to give evidence in (Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)

For those that don't know, Wendy Dolin had filed suit against GSK claiming that their antidepressant, Paxil, had induced the suicide of her husband, Stewart. Since filing, Wendy has, just like the four expert witnesses due to give expert opinion supporting her claim, has come under fire from GSK. In fact, Wendy Dolin has been sent more than 30 subpoenas from GSK, they have also made over 70 record requests and have shown the Dolin children their father's private medical notes. To top it all, GSK's lawyers have been asking (goading) Wendy about her love life since her husband killed himself.

Not satisfied with targeting a bereaved wife, GSK then turned their attention to four expert witnesses. One of those witnesses, Dr. David Healy, came under heavy fire from Glaxo's gunslingers, King & Spalding. They had accused Healy of being a radical activist who held an extreme bias against GSK (insert tears here). Furthermore, GSK had probed into Healy's private life and had, during a 10 hour deposition, talked more about his finances than the actual science behind Paxil and induced suicide.

The decision is in folks and.... (drum roll)..

GSK have been roundly trounced.

Judge James B. Zagel, in summary, said...

"I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable. My decision does not, however, mean that the reliable opinions of all four of these expert witnesses are correct—reliability is a measure of consistency of opinions, not necessarily a measure of correctness. Such a determination will be the job of a fact-finder at trial."

Healy, along with three other experts, namely; Dr. David Ross, Dr. Joseph Glenmullen, and Dr. Roger Grimson, will now be allowed to offer their expert opinions in the Dolin case, something that GSK have fought desperately hard to suppress and, as I suspect, may now be the factor in some sort of settlement being agreed upon.

This isn't the first time GSK have faced claims that Paxil induces suicides in adults. In 2001 a jury returned a verdict that Paxil was responsible for inducing homicide and suicide in Don Schell, who had, some years previous, shot to death his wife, daughter and granddaughter before turning the gun on himself.

Glaxo were ordered to pay $6.4 million to the remaining family members.To the layman, it beggars belief why Glaxo would oppose the claims of Wendy Dolin given that they have already lost one Paxil induced suicide case. The mud-slinging and goading of plaintiff and expert witnesses doesn't surprise me in the least, it's what I have come to expect of Glaxo and their defence lawyers. Wendy Dolin isn't the first plaintiff to have pressure put on her by Glaxo, she won't be the last. Healy et al aren't the first expert witnesses to have mud thrown at them, again, they won't be the last.

If anything, this ruling has shown Glaxo that no matter how hard they try to suppress those who wish to seek the truth, they will always fail.

I hope the Dolin case goes the whole hog and isn't settled. To put Paxil in the public eye (yet again) is something that needs to be done. The message that this antidepressant can cause homicidal and suicidal acts needs to be repeated. It is, in my opinion, a menace to society just as, I believe, GlaxoSmithKline are. Yeh, okay, we will have those that say Glaxo have saved millions of lives with vaccines and have helped millions of people with various respiratory diseases, fair enough, I guess, but that does not give them the right to market and manufacture drugs that can induce homicide and suicide - it's akin to the defence of a serial killer, 'He donated to charities every week your honour, so what if he killed a dozen or so adults, he's a decent man, at heart."

Glaxo need to step up to the plate. They need to compensate Wendy Dolin for her loss, they need to stop pussy-footing around and acknowledge that defending Paxil in suicide cases is a fruitless exercise, they know it, their shareholders know it and the general public know it. Paxil is a nasty drug that causes more harm than good. Glaxo claim Paxil has helped millions of people worldwide but just like the fictitious serial killer above, they throw a blanket over the darker side of Paxil, the induced homicide and suicide, the birth defects, the horrific withdrawal suffered by those trying to stop Paxil.

It will be interesting to see what Glaxo's next step is regarding the Dolin case. They've thrown pretty much everything at the grieving widow but she has stood firm and remained strong because she knows that the truth will, eventually, out.


Bob Fiddaman







Thursday, November 19, 2015

How to Polish a Turd, the GSK Way






A recent interview with Glaxo's Andrew Witty saw BBC journalist, Evan Davis, more or less told how to phrase questions. Davis had broached the subject of Glaxo's murky past - Witty, using the art of deflection, told Davis, "I think the bigger question is, where do you want to go forward?"

So, how do you polish a turd?

Well, you talk about what you have in the pipeline, (excuse the pun) thus eliminating tricky questions about the following...



6/4/2015 - India Meningitis Vaccine Market Collusion - GlaxoSmithKline, Sanofi-Aventis - $9,442,587

9/15/2014 - Clean Air Act Violation at Hamilton, MT Facility - GlaxoSmithKline - $172,900

8/11/2014 - Hazardous Waste Violations in King of Prussia - GlaxoSmithKline - $317,550

6/4/2014 - Multistate Illegal Marketing Settlement - GlaxoSmithKline - $105,000,000

5/13/2014 - China Bribery and Fraud - GlaxoSmithKline - $487,000,000

3/25/2014 - Mylan v. GlaxoSmithKline (Breach of Generic Paxil Agreements) - GlaxoSmithKline - $106,700,000

3/18/2014 - Contaminated Drug Ingredients at Ireland Plant - GlaxoSmithKline - FDA Warning Letter

12/17/2013 - Maryland Diabetes Drug Improper Marketing Lawsuit - GlaxoSmithKline - $15,000,000

7/24/2013 - Multistate Avandia Settlement (July 2013) - GlaxoSmithKline  - $184,000,000

6/14/2013 - Cappellino v. GlaxoSmithKline (Gender Discrimination) - GlaxoSmithKline - Complaint

4/19/2013 - OFT Paroxetine Antitrust Investigation - GlaxoSmithKline - U.K. Office of Fair Trading Press Release

2/5/2013 - Louisiana Off-Label Marketing Lawsuit - GlaxoSmithKline - $45,000,000

11/15/2012 - Multistate Avandia Settlement (November 2012) - GlaxoSmithKline - $90,000,000

11/15/2012 - Flonase Antitrust Litigation - GlaxoSmithKline - $150,000,000

7/9/2012 - Dolin v. GlaxoSmithKline (Paxil Wrongful Death) - GlaxoSmithKline - Complaint

4/17/2012 - Idaho Average Wholesale Price Lawsuit - GlaxoSmithKline - $2,600,000

2/7/2012 - Defrauding Louisiana’s Medicaid Program - GlaxoSmithKline - $10,000,000

1/11/2012 - Argentina Vaccine Trials Fine - GlaxoSmithKline - $93,000

11/3/2011 - Criminal and Civil Investigations Settlement - GlaxoSmithKline - $3,000,000,000

10/27/2011 - South Korea Antitrust Fine - GlaxoSmithKline - $2,651,737

10/7/2011 - Current Good Manufacturing Practice Violations at Worthing, UK Facility - GlaxoSmithKline - FDA Warning Letter

6/27/2011 - Nigeria Trademark Infringement - GlaxoSmithKline - $7,873,706

6/23/2011 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $40,750,000

5/17/2011 - South Carolina Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint

2/15/2011 - Louisiana Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint

11/17/2010 - Humana v. GlaxoSmithKline (Reimbursement for Avandia-Related Injuries) - GlaxoSmithKline - Complaint

11/9/2010 - Utah Attorney General Avandia Lawsuit - GlaxoSmithKline - $8,500,000

10/26/2010 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $750,000,000

10/6/2010 - Hawaii Average Wholesale Price Litigation - GlaxoSmithKline - $10,000,000

8/30/2010 - Kentucky Kytril and Zofran Average Wholesale Price Lawsuit - GlaxoSmithKline - $3,750,000

7/12/2010 - U.S. Senate Investigation of Avandia - GlaxoSmithKline - Senate Finance Committee Letter to FDA

6/23/2010 - Paxil Birth Defect Litigation - GlaxoSmithKline - Confidential settlement with 190 families 

4/19/2010 - FDA Review of Altabax Promotional Material - GlaxoSmithKline - FDA Warning Letter

10/13/2009 - Kilker v. SmithKline Beecham (Paxil Birth Defects) - GlaxoSmithKline - $2,500,000

10/1/2009 - Denture Cream Product Liability Litigation - GlaxoSmithKline - Complaint

12/23/2008 - Santa Clara County Drug Pricing Lawsuit - GlaxoSmithKline, Wyeth - Complaint

9/30/2008 - Paxil Class Action (National) - GlaxoSmithKline - $40,000,000

7/26/2008 - Medicines Australia Code of Conduct Violations - GlaxoSmithKline - $310,000

7/21/2008 - Relenza Litigation Settlement - GlaxoSmithKline - $19,500,000

5/19/2008 - Release of TCE in Scottsdale, AZ - GlaxoSmithKline - EPA Press Release

5/2/2008 - Wellbutrin Direct Purchaser Antitrust Litigation - GlaxoSmithKline - $49,500,000

2/27/2008 - Bartram v. GlaxoSmithKline (Paxil Birth Defects) - GlaxoSmithKline - Complaint

12/17/2007 - Avandia Marketing, Sales Practices and Products Liability Litigation - GlaxoSmithKline - $770,000,000

10/6/2006 - Paxil Class Action Litigation (Madison County, IL) GlaxoSmithKline - $63,833,148

9/11/2006 - Under-reporting Profits - GlaxoSmithKline - $3,400,000,000

7/10/2006 - Cunningham v. GSK (Paxil Wrongful Death) - GlaxoSmithKline - Complaint

3/28/2006 - Paxil Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $14,000,000

9/20/2005 - Zofran and Kytril False Claims Act Violations - GlaxoSmithKline - $150,000,000

4/1/2005 - Relafen Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $10,000,000

11/24/2004 - Relafen Consumer Litigation - GlaxoSmithKline - $75,000,000

8/26/2004 - Paxil New York Litigation - GlaxoSmithKline - $2,500,000

7/8/2004 - Augmentin Antitrust Litigation - GlaxoSmithKline - $92,000,000

2/6/2004 - Relafen Antitrust Litigation - GlaxoSmithKline - $175,000,000

4/16/2003 - Overcharging Medicaid - GlaxoSmithKline - $87,600,000

9/6/2002 - Average Wholesale Price (AWP) Drug Litigation - GlaxoSmithKline - $70,000,000

6/6/2001 - Tobin v. SmithKline Beecham (Paxil Wrongful Death) - GlaxoSmithKline - $6,400,000


**TOTAL - $10,057,614,485 (That's 10 billion, folks!)


**Federal Contractor Misconduct Database


There are many more missing from the Federal Contractor Misconduct Database, most notably the settlement (resolution) GSK made with over 3,000 Paxil plaintiffs who alleged the drug had caused them addiction problems, Also missing is the individual payment made to Pennsylvania mother Joanne Thomas who settled with GSK after losing her original case against them, see here and here.
The UK Seroxat Group Action is also missing from the list. The claim alleges that UK consumers become dependent upon the antidepressant, Seroxat. (Paxil)

Then, of course, we have the on-gong investigations of bribery and corruption in the following countries, United Kingdom, Iraq, Poland, Bahrain, Jordan, Kuwait, Lebanon, Syria, Oman, Qatar, and United Arab Emirates.

The mission of GSK, according to their website, is to improve the quality of human life by enabling people to do more, feel better and live longer.

(Insert laughter here)



Bob Fiddaman











Tuesday, November 17, 2015

Lariam Suicides - MHRA Respond




Back in September I wrote to the British drug regulator, the MHRA, under the terms of the Freedom of information act.

The question I put to them was in regard to reported suicides associated with Lariam (mefloquine) reported on their database. Their Drug Analysis Print (DAP) had shown that there were 9 completed suicides associated with the drug.

For those that don't know, Lariam, marketed and manufactured by Roche, is a drug used to treat the prevention of malaria and I wrote about it here back in August. It's used a lot by the military to treat soldiers who visit and train in countries that have a high risk of malaria.

Worryingly, it wasn't just the completed suicides that concerned me. There were a number of other psychiatric events associated with this drug, namely;


  • 18 reports of Abnormal behaviour.
  • 24 reports of Affect lability (rapid shifts in outward emotional expressions; often associated with organic brain syndromes such as intoxication.)
  • 61 reports of Agitation
  • 304 reports of Anxiety
  • 38 reports of Aggression
  • 82 reports of Paranoia
  • 11 reports of Personality change 
  • 67 reports of Confusional state 
  • 61 reports of Disorientation
  • 19 reports of Delusion
  • 341 reports of Depression
  • 10 reports of Depersonalisation
  • 14 reports of Dissociation
  • 28 reports of Irritability
  • 59 reports of Mood swings 
  • 15 reports of  Mental disorder
  • 11 reports of Mania
  • 162 reports of Panic attack
  • 119 reports of Abnormal dreams
  • 146 reports of Nightmares
  • 113 reports of Hallucinations
  • 19 reports of Acute psychosis* 
  • 76 reports of Psychotic disorder
  • 9 reports of Completed suicide
  • 33 reports of Suicidal ideation 
  • 12 reports of Thinking abnormal 

* Bizarrely, there has been one reported death of "acute psychosis" - This seems to have been omitted from the "completed suicide" category - unless, of course, the person died naturally?

The MHRA took approx one month to answer my question. Their full response is below.

They told me...

"Of the nine UK spontaneous suspected ADR reports of suicide associated with mefloquine, I can confirm that three of the cases were followed up by the MHRA with either the reporting doctor or family member. Two cases were reported to us by pharmaceutical companies and so follow-up was conducted by the Marketing Authorisation Holder.
"The remaining four cases were received between 1998 and 2002 and as such were previously stored in our legacy ADR database. We do not hold records of follow up letters to cases from our legacy database and can confirm that we have no record of any further communications regarding these cases."



The International Mefloquine Veterans' Alliance have taken an interest in my correspondence with the MHRA, their website makes claims that there have been denials by military officials, veterans’ affairs agencies, the ethically compromised medical establishment, the pharmaceutical industry and their lobbyists, which has resulted in  no support for veterans and their families experiencing the debilitating, chronic health effects of mefloquine toxicity, some of which are listed above.

Hopefully, this somewhat blasé response from the MHRA will help those campaigning, or, as I strongly suggest, get those campaigning to write to the MHRA to ask them why the follow-up rate has been so poor regarding the reported suicides and other psychiatric adverse events associated with this drug.

The MHRA can be contacted via email here.


Bob Fiddaman.











Thursday, November 12, 2015

Consumers Vs Pharmaceutical Companies - The UK System








It's kind of set in stone these days that Seroxat, the antidepressant manufactured and marketed by British pharmaceutical giant, GlaxoSmithKline, is a faulty product. It's been through the American court system in various types of litigation.

1. Suicide - GUILTY - APPEALED - SETTLED - Compensation paid
2. Birth Defects - GUILTY - APPEALED - SETTLED - Compensation paid
3. Withdrawal problems - RESOLVED - Victims compensated

To date, GlaxoSmithKline have not settled any cases that relate to Seroxat use and suicide, birth defects and withdrawal problems in the UK.

They are a British company yet, it appears, will only settle with American consumers of Seroxat (Known as Paxil in the US)

To go up against a pharmaceutical company in the UK is notoriously difficult. Many law firms prefer not to touch cases against pharmaceutical companies because they can drag on for many years, the risk is too high, they can either 'make' or 'break' the claimant's legal representation.

The UK Seroxat litigation is fast approaching 10 years since it was first filed. Glaxo, represented by Addleshaw Goddard, have not, at any point, expressed an interest in resolving the litigation. They, it appears, wish for the cases, involving just over one hundred claims, to go to trial... at least they do at this point in the proceedings.

The litigation has been laboriously slow - claimants have been dropped by law firms, despite those law firms attesting that their cases against GSK were strong. Public funding has been given, then put on hold, then taken away.

In America, the Seroxat withdrawal problems lawsuit involved over 3,000 claims against GSK. The whole process of filing and agreeing to resolve took as little as two years. Each of the 3,000 were awarded compensation. Each of the 3,000 had to sign confidentiality agreements - ergo, they could not tell anyone how much they were awarded by GSK.

Meantime, UK consumers who suffered Seroxat withdrawal problems, some who still do, continue to wait for their cases to be heard in trial. The date of which has yet to be determined.

Almost 10 years.

It's a showing of the iron fist by GlaxoSmithKline and it sends out a strong message to consumers of pharmaceutical products. That message being, "We won't bend over for British consumers, even though we are a British company."

Glaxo are denying that they knew there was a withdrawal problem with Seroxat, this despite settling the 3,000 or so case in America. This, despite public documents that have shown that hey did indeed know about the withdrawal problem in adults but 'hushed up' these findings.

Project 1059 revealed a series of emails between  Daniel Burnham of SmithKline Beecham and a ghostwriting company. In those emails, below, the Seroxat withdrawal issue was raised. Burnham became concerned and decided to pull the plug on Project 1059. There was no way that they could have this Seroxat withdrawal issue made public.

You can view the series of emails here.

Meantime, Glaxo CEO, Andrew Witty, continues to cover his company in garlands, he continues to refuse to meet with anyone who has suffered as a result if ingesting Seroxat. Irish blogger, the Truthman, who, like me, has been writing about GSK for almost a decade, perfectly dissects a recent interview between journalist Evan Davis and Glaxo's Witty here.

It's well worth the read, an edited version of the interview between Evans and Witty is also shared on the Truthman's post.

Glaxo, in my opinion, are psychopathic, it's hard to pinpoint who is the person behind the dodgy marketing and hiding of negative results, so, as a whole, Glaxo, to me at least are not only psychopathic but delusional too.

As for Witty, once again my opinion of him, is that he lacks compassion and empathy for those harmed by his company. He continues to harp on about how Glaxo (these days) are more transparent than any other pharmaceutical company. He fails to mention that they were forced to be more transparent by the recent $3 billion they paid the American Department of Justice for, amongst other things, a lack of transparency in sharing negative trial results.

Who knows if the UK litigation will ever see the light of day. I would love nothing more than a judge who sees through Glaxo's arguments and allows documents produced at trial to be made public and not sealed away.

The criticism of GlaxoSmithKline is warranted. As long as they continue to treat their consumers like lab rats then they will always fall under the spotlight.

We, as humans, have a desire to see more when something teasing is revealed, be that a woman in a sexy low-cut dress or a pharmaceutical company not disposing of emails that highlight how they ignored links of severe Seroxat withdrawal.

Glaxo are not sexy, in fact, the more that they reveal, the more sickened I become.

I'll eventually walk away from this blog, a change of direction and finding peace is, I feel, what I've earned over these past ten years or so. Until I feel that time is right I'll continue to cross swords with GSK - I guess that the Truthman will too.

Perfer et obdura; dolor hic tibi proderit olim. (Google it)


Bob Fiddaman.


Tuesday, November 10, 2015

Pfizer: The Scooby Gang Are On The Case.






If you still believe that pharmaceutical companies have opened their doors and are being transparent then look no further than a recent report from the lawyer-based website, Law360.

Your illusions delusions will be shattered.

Law360 are reporting on a recent investigation into Pfizer by the U.S. Food and Drug Administration (FDA)

Let me tell you folks, it's straight from the production team of Hanna Barbera. It's definitely a case for Scooby-Doo, Fred "Freddie" Jones, Daphne Blake, Velma Dinkley and Norville "Shaggy" Rogers.

It appears the FDA are being given the runaround by Pfizer officials who, it seems, are covering up manufacturing lapses at one of their sites in China.


According to the FDA, when Pfizer encountered "undesirable/suspect" test results, it simply performed new tests until satisfactory results were achieved.
"The original test results are not reported, and no laboratory investigation is initiated," the FDA wrote.
Agency officials also recounted fishy circumstances surrounding the availability of records. According to the report, investigators at one point noticed an 8-inch stack of documents in a room, then returned 10 minutes later to find that the stack had disappeared. When the investigators requested that the records be returned, only one-third of the papers were brought back, and the rest were later discovered stashed in a wooden crate in a construction area, the report said.
Subsequent analysis of those records revealed that Pfizer's internal documents contained conflicting data as well as references to possible use of expired ingredients, the 483 added.
Further, Pfizer's quality control unit lacked suitable oversight of records, and employees on occasion failed to document certain activities in a timely manner, according to the 483.

Never has the term "LOL" been more appropriate.

An 8-inch stack of documents that miraculously disappears into thin air, only to return somewhere else on the Chinese site... with two thirds of the stack missing! The likes of Dynamo, David Copperfield, Penn & Teller and even Paul Daniels must be quaking in their magical boots.

Scooby Dooby Doo, Where are you?
We've got some work to do now.

Scooby Dooby Doo, Where are you?
We need some help from you now.


Pfizer have responded in typical fashion...

"Materials and that drugs produced at the site met every national and international testing specification."

Thanks for clearing that up folks.


In other news, I recently bid on eBay for the complete series of Scooby Doo. I came so close to winning, but was outbid at the last second! I would have got away with it too, if it weren't for those meddling bids!

:-)

The FDA's 9-page warning letter to Pfizer below.




















































































PS - I'd still do Daphne.


Bob Fiddaman.





Wednesday, October 28, 2015

Andrew Witty: The Art of Deflection.






Sir Witty should have been a politician. Very adept at answering a question...with a question.

Here's a recent interview with Evan Davis, Presenter, Newsnight, BBC

Skip to 29.40. Transcript for this section is below video.




Transcript. 29.40

Evan Davis
I'm going to open it to the floor in a second, because we do want to leave half the session for the audience to ask questions. I'll just finish with kind of a general reflection, because it is interesting, and it's nice when you talk about the drugs and what they cure, what the treatments are. Don't you find it very interesting that the pharmaceutical industry has a bad reputation? We read about the China corruption, we read about profits, we read about profiteering. It is an industry that saves lives, no one can dispute that. It's an industry that produces pills that are completely transforming for people's welfare. Yet, it's actually not a terribly popular industry. I just wonder if you can explain that paradox. Is it that you've done bad things and that's been recognized, or is there somehow something the public don't understand about the industry that makes them feel negative about it? Or am I wrong in thinking there's a slight [indiscernible] around it?

Andrew Witty
No, clearly – first of all, I think we are, slightly alongside any big industry, or any big institution, there is a bit of that. We are big companies, we're global. Again, like any big organization, you're vulnerable to your weakest link in the organization. So if something goes wrong, particularly in today's social media world – I often think about what it must have been like to run a global company in the 1970s, where you had to wait for the ship to arrive to find out what happened on the other side of the world. Today, the Wall Street Journal calls you before you've even heard about something inside your own company. So I do think there is a certain phenomena where – and you see that across many, you look at it in politics, you look at it in newspapers. The hacking stories, all things like that. So I think it's a bit of that. I do think – let's be honest, nobody wakes up in the morning hoping that they're going to need a drug from GSK. You don't wake up in the morning thinking, actually, if it's a really good day, I might be diagnosed to be ill and I might need a drug. So we're not aspirational in that sense. So you start by saying, actually, I've got some bad news, because I've been told I'm not very well. They then said: we might have some good news, because there's something we can help you with. Then in some countries, I have to pay for it. Or in Britain, you might go to the doctor and they say: actually, I'd like to give you this, but NICE have said I can't. So then there's a whole series of reasonably negative concepts around pricing. So there's a bit of that. Then you've got – actually, we do occasionally make mistakes. Things go wrong. We have inevitably – of course, we go through all the processes with the regulators to get a drug to be as safe and effective as it can possibly be. But the reality is, every time a human takes a drug, it's like a clinical trial. You don't really know what's going to happen. Everybody can react a different way. So on the one hand, what is the story of the drug industry? The story of the drug industry is wonder drugs. On the other hand, it's danger drugs. Those are the two extremes that we have. It's kind of unavoidable.

Evan Davis
But you're saying there are bad apples, and it goes wrong. Is that right, or is it – for example, in the China case. Was it that there was a bad apple and it went wrong, or was it that that was normal behaviour in certain markets, and it just got called out in that particular case?

Andrew Witty
For obvious reasons, I'm not going to get into all the details of that.

Evan Davis
Was that behaviour actually something, or was it just a slight extension of behaviour that is normal?

Andrew Witty
I think the bigger question is, where do you want to go forward?

Evan Davis
No, but just answer that one.

Andrew Witty
There's no doubt, if you ask the more general question – so there have been concerns over the years of, is the drug industry transparent enough? What's the relationship of the drug industry with doctors? All of those are kind of concerns – let's call them concerns or reasons for anxiety, whatever they are. Sometimes they've spiked up into real issues. What we've really tried to do, and we're beginning to see some other companies, I think, following a similar direction, is we've said: you know what? We get that. We get that transparency is a cause of concern. People are worried that something is being hidden. We didn't think there was but people – perception is everything, right? So what did we do? We came out and said: we will publish every single bit of clinical data we have in the company. We are the only company to do that at this point. Every single thing. If a researcher wants to know exactly what the data was on patient number – all anonymized, but on Patient 1002, in Clinical Trial 87, from 2002, we will give them that information. All the way through, we'll do that. We've said we will stop all payments to physicians to speak on behalf of the company. It's a perfectly legal practice, everything the company has done – but we stopped it all.

Evan Davis
But this is a recognition – there is a lot you've done to present these things differently. But it is a recognition that it was pretty dysfunctional before, isn't it? Because publishing data, to me, honestly, doesn't seem like a great achievement. It just seems to me that that's what you should be doing with data. Not bribing doctors seems like a thing you would do.

Andrew Witty
I wouldn't say it's bribing doctors – it's perfectly legal to pay. If you went to a physician and said, would you expect to be paid for speaking on behalf of somebody, they will probably say yes. Actually, in most countries in the world, it's perfectly legal. However, there are risks it can be abused. People can make mistakes. And there are risks that there is a misperception. Just to your point on publication, do you think academics are mandated to publish their data? Do you think universities publish all their failed studies? They don't, but we do.


One box of chocolates for the first person to tell me how many times Witty deflects the questions put to him.

**Footnote

GSK were forced to be transparent, they didn't just decide one day that they were going to be the first pharmaceutical company to "open it's doors" (Halfway)

This from the Department of Justice/GSK agreement

"Among other things, the CIA also requires GSK to implement and maintain transparency in its research practices and publication policies and to follow specified policies in its contracts with various health care payors."

Also...

"Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse."


I think the bigger question is why did Witty fail to mention that his company were forced to be more transparent.

I'll leave the last words to Witty...

"It's a perfectly legal practice, everything the company has done..."




Bob Fiddaman.

Original video here.







Tuesday, October 27, 2015

Two Facebook Statuses That Say It All







Seroxat (Paxil) withdrawal...

If you, like many thousands, find difficulty when trying to wean yourself off Seroxat (known as Paxil in the US and Aropax in Australia) then you'll know that there is no guidance.

The manufacturers, GlaxoSmithKline, refuse to help - Any correspondence sent to them during your horrific withdrawal will be met with the bog standard replies of "We are not allowed to discuss individual cases blah, blah..."

Your prescribing healthcare professional will, more than likely, refer to the product monograph which really tells them that there isn't a huge problem when patients taper from Seroxat - the product monograph, if you didn't know, is crafted by the drug company.

The medicines regulator, be they the British MHRA, the American FDA or the Australian TGA, will shrug their shoulders then scurry back to their various rat holes in the hope that you don't disturb them again.

Internet forums will offer various tidbits of information, you'll show your prescribing physician and he/she will probably tell you that these types of forums are run by conspiracy theorists.

~Bob Fiddaman


--

As I was getting nowhere debating back and forth with the MHRA and Pharmaceutical company Lundbeck I decided to write to the Minister for Public Health, Jeremy Hunt, about my daughters death which I believe was caused by the SSRI Citalopram. She was fatally malformed, incompatible with life. I had been given a "prescribed overdose" (according to lundbeck) by my GP unwittingly throughout the pregnancy and thoroughly reassured that it was not a teratogen. I was on a prescribed dose of 60mg, this dosage was the maximum back in 2004, but was lowered a few years ago to 40mg by the manufacturer and the MHRA as it was known to cause the heart condition "Long QT syndrome" and sudden death in adults. Today I was very surprised to have received a response -

Dear Miss Buchanan,

Thank you for your correspondence of 5 October to Jeremy Hunt about citalopram. I have been asked to reply.

I was very sorry to read about the death of your daughter and the circumstances surrounding her cremation.

However, the Department of Health is unable to comment on individual cases.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided the following information.

Citalopram is a member of the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are used to treat depression in pregnant women in cases where there are no safer alternative effective treatments. The decision to prescribe SSRIs requires a careful evaluation of the need for treatment and any known risk of harm to the mother and/or foetus. Untreated depression during pregnancy is known to be harmful to the mother and foetus.

Some studies have suggested a small increased risk of birth defects with some SSRIs. Data has shown that paroxetine and fluoxetine are associated with an increase in risk of birth defects in the baby if the mother takes them in the first trimester. The background rate for birth defects is two to three per cent of all pregnancies. Current available data is insufficient to prove birth defects occur more commonly after taking citalopram than this background rate.

It is known that all the SSRIs can be associated with an increased risk of persistent pulmonary hypertension, a heart condition in the newborn, when taken later in pregnancy. Neonatal withdrawal and toxicity reactions have also been reported when SSRIs are taken in later pregnancy.

Several important changes to the citalopram prescribing information were introduced by the MHRA in 2011, including maximum dose restriction in adults after a detailed review of data showed citalopram was associated with a dose-dependent increased risk of abnormal heart rhythm.

The MHRA continues to monitor the safety of use of SSRIs in all patient populations very closely and all new data are rigorously assessed to evaluate the need for further regulatory action.

I am sorry I cannot be more helpful, but I hope this reply helps to clarify the situation.

Yours sincerely,

Malcolm Jones
Ministerial Correspondence and Public Enquiries
Department of Health

-------------------------------------------------------------------------------------------------------

I'm sorry to see that, once again, I have been given the usual spiel about the MHRA monitoring medications such as these, but what use is monitoring them if, when issues are flagged up, they chose to do absolutely nothing about it? I have never had once single invitation from the MHRA to converse with them or provide them with further information on my daughters death, this is despite me contacting them fairly regularly for over the past two years.

What else can I do? Is there anywhere else I can turn, anything I can try? I'm not giving up on this. I won't ever give up.


Cheryl Buchanan


--


Says it all really...



Bob Fiddaman


Wednesday, October 21, 2015

Antidepressant Induced Suicide - The Mothers and Wives






Watch.

Listen.

Learn.


They have the pharmaceutical industry, medicine regulators and psychiatry to thank for their grief.

There is nothing left for me to say.






Leonie Fennell - Ireland
For Shane
Causation: Cipramil (Celexa, citalopram)




--


Stephanie McGill Lynch - Ireland
For Jake
Causation: Prozac (fluoxetine)




--


Mathy Downing - USA
For Candace
Causation: Zoloft (sertraline, Lustral)





--

Wendy Dolin - USA
For Stewart
Causation: Paxil (paroxetine, Seroxat)





--


Kim Witczak - USA
For Woody
Causation: Zoloft (sertraline, Lustral)





Bob Fiddaman










Tuesday, October 20, 2015

MHRA: "We Now Consider This Request Closed"





It took me a while to get to the bottom of this. The MHRA are, and have always been quite vague when it comes to answering the simplest of questions put to them. None more so then when I asked a series of questions regarding their Yellow Card Reporting System. (YCRS)

For those that don't know, the YCRS is a way of reporting adverse events from the drugs you take to the British drug regulator, the MHRA. What they do with these reports has, to me at least, always remained a mystery.

A recent series of emails between myself and the MHRA leaves me somewhat perplexed, particularly as their last one to me finished with, "we now consider this case closed".

Hmm, I don't. So, where does that leave us?

My issue with the YCRS is that, I believe, it is a system designed to fail, moreover, it does not do as it suggests, ie; "Helping to make medicines safer."

After much hulabaloo of answering questions I put to them, I finally got the answer I needed. My question being, Do the MHRA actually follow up any Yellow card report sent in by the original reporter, i.e.; do they,or have they, ever contacted the patient who sent in the original yellow card?

Their reply...

"The MHRA regularly follows up Yellow Card reports with the original reporter. If permission has been given on the Yellow Card, we will contact the reporter to request any further information that we think would be helpful to enable assessment of the case."

Finally!

I followed up their reply with, what I thought, a simple question...

We seem to be getting somewhere.
The answer, however, is quite vague. Please define 'regularly' - give me some figures.
You may think I am publicly bashing the MHRA via my blog, in truth, I do when you respond with vagueness.
Can you give me actual figures, ie; how many yellow card reports have been followed up with the original reporter, you must keep a record of this, right?

Their answer left me bemused. Years ago it would have left me frustrated but I've come accustomed to such contradictory answers from the MHRA.

We do not record the number of follow-up requests that are sent out by the Agency as knowing this information does not help monitor the safety of medicines in the UK. Rather, it is the follow-up information received that is useful for assessment of a suspected Adverse Drug Reaction (ADR). This can either be in response to a request sent out by the MHRA, or follow-up information that has been spontaneously provided by the reporter.

They added the standard disclaimers and also, bizarrely, a request for money (minimum £600) if I wanted them to perform searches for "an actual figure for the total number of all Yellow Card follow-up requests that have been sent out."

Here's their full suggestion..

Therefore to provide you with an actual figure for the total number of all Yellow Card follow-up requests that have been sent out, we would be required to manually review the case folder for each individual Yellow Card report submitted to the agency.  Under the Freedom of Information (FOI) Act, a public body is only required to collate information that is already in a recorded form, rather than creating new information beyond basic collation. Furthermore, the agency has received over 600, 000 Yellow Card reports directly from healthcare professionals and members of the public to date, with approximately 16,500 Yellow Cards reported a year. The staff time and cost of extracting the requested information from this would far exceed the £600 limit for central government set by Section 12 of the FOI Act.

You can see my confusion. If they don't keep records of follow-up requests that are sent out then why are they asking for a minimum fee of £600 to search for records that, they have already said, don't actually exist?

Furthermore, how can they make the claim that "The MHRA regularly follows up Yellow Card reports with the original reporter", when they don't actually "record the number of follow-up requests that are sent out."

I'd like to ask them but at the foot of their final email to me they told me, "We now consider this request closed."

Ho hum.

To date, the Drug Analysis Prints on the MHRA website list the number of yellow cards submitted to them and also the nature of the events, they range from completed suicide to skin rashes. There has not, to my knowledge, been any statement from the MHRA that any prescription drug currently on the market in the UK has caused a patient to complete suicide.

This attitude, I believe, keeps poor, unsafe drugs in pharmacies and keeps the MHRA from coming under fire - remember, it is the MHRA who grant licenses to the medicines you and I take.

The MHRA recently went all 21st century on us by creating a phone app for the yellow card. I have to ask what is the point in sending in adverse reactions when they don't, and I assume, never will, blame the drug for the more severe adverse reactions, such as completed suicide, suicidal thoughts and/or self harm.

I have further requests pending that are not related to the above. I suspect, due to my asking questions to seek the truth, the MHRA will probably, sooner or later, consider those requests closed too.


Bob Fiddaman.








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