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

Wednesday, May 24, 2017

Under Cover Terrorists




There's so much hatred doing the rounds lately - I guess it takes an act of violence on children, innocent children, to get people riled.

And rightly so.

Terrorist Salman Abedi, who carried out the abhorrent act in Manchester two nights ago has been condemned by many. He walked into a foyer knowing what he was about to do, he did so because, it is believed, he had taken the written word from an ancient scripture literally. He probably believes that his actions will be rewarded by some fairy in the sky. "Here you go, Salman, here's some virgins for you, great job."

Many people, including friends and family, hang their hat on the mythical, Let's face it, there's no concrete evidence that God, any God, exists, yet we see throughout history how many atrocities have been carried out in the name of God.

Personally, I'm an atheist. As such, I avoid being manipulated by indoctrination of fairy tales. Not having a God in my life suits me just fine.

The world I move in has seen many child killers, but the public apathy suggests it's okay to kill children and, indeed, adults, if the perpetrators are multi-billion dollar industries.

During the past two days Facebook has seen people voice their shock and horror over the Manchester atrocity. Folks who normally post photos of what they are about to eat or weather updates have been so shocked and moved that they have voiced their opinions and condemned the actions. The Manchester atrocity was enough to get people enraged.

What if I told you that back in 2012, a white coach driver by the name of Geert Michiels carried out an act or terrorism? What if I told you he had no affiliation to any terrorist cell? Michiels deliberately drove his coach into a tunnel wall killing 28 passengers, 22 of whom were children. Would you still be inclined to vent your outrage on Facebook or any other social network?

Geert Michiels, 34, didn't have a weapon of destruction strapped around his body, but he was driving one.

But hey, he had no motive, no indoctrination, no manipulation of the mind... or so we are led to believe.

What if indoctrination came in the shape of a pill, what if that pill changed your outlook on life, on society as a whole? Wouldn't such a pill be snapped up by terrorist organizations such as those responsible for the events in Manchester? If one can manipulate the mind of a 22 year-old by preaching quotes from an ancient book then such a gift as one simple pill could speed up the process of manipulating someone who was once normal into a mass killer.

A full investigation into the coach crash was carried out by Swiss Chief Prosecutor Olivier Elsig, the results of which were inconclusive. He ruled out the involvement of a third party, shortcomings in the road surface or the tunnel infrastructure. Excessive speed, alcohol or technical problems with the vehicle were also ruled out. He, at no point, could determine whether or not Geert Michiels carried out an act of homicide/suicide with the vehicle.

From the investigation, and subsequent independent investigations, it was learned that Michiels was taking or withdrawing from Seroxat at the time of the crash. Seroxat is better known as Paxil in the US and Canada and Aropax in Australia.

It's become widely known that Seroxat can cause suicidal thinking in some people who take it, it has also been proven, in US Courts, that Seroxat was responsible for, not only suicide but homicide too.

Seroxat, by the manufacturers own admission, can cause a symptom called akathisia, in a nutshell, akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Seroxat was Geert Michiels 'bomb'. The drug caused adverse reactions that triggered a series of events in his brain. It was his indoctrination by proxy that eradicated his normal empathy and induced atypical thoughts of killing his passengers and himself. This became his mission in a split second. We know from the recent Dolin Vs. GSK trial that akathisia can be switched on and off in a second. We also know that for persons experiencing akathisia death can be a welcome result. This statement was made by Dr. Roger Lane who, in a 1998 article on akathisia, said, "It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation than patients feeling that 'death is a welcome result' when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders." - At the time, Roger Lane was working for pharmaceutical giant, Pfizer.

Pfizer make Zoloft, an akathisia-inducing drug.

Yet we see no world-wide condemnation of pharmaceutical companies or indeed those who are supposed to regulate the drugs you and I take.

22 people died in Manchester. - Salman Abedi's mind has been manipulated by indoctrination.
28 people died in Sierre. - Geert Michiels' mind had been manipulated by Seroxat.

I anticipate that Facebook posters won't be spreading the Sierre story far and wide.

Bob Fiddaman

Back stories

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

Did the Sierre Bus Driver Have a Pre-Disposition to Seroxat?

What is akathisia?

Advocates Against Prescribed Akathisia

Guest Post: Let's Bring Akathisia Out of the Darkness







Friday, May 19, 2017

Guest Post by JulieAnn Carter-Winward





I've been traveling a lot lately and am very tired. A recent death of a dearly beloved aunt has meant that I'm putting blogging on hold for a while. Being apart from my partner, whom I love dearly, is also difficult to cope with but it's only for a short time so at least we both have something to look forward to when we meet again in a month or so.

Just as well that I have a guest post to offer readers today.

It mentions the "A" word, you know, the one that many doctors, regulators and industry insiders like to 'play down', like to pass off as nothing more than an 'inner restlessness'.

For once, it's not about SSRIs, it's about a drug that I am not totally familiar with.

The guest post is well worth the read, it's part one of two.

~ Bob Fiddaman


Train Wreck: How Mental Health Care Got Derailed
By JulieAnn Carter-Winward



Have you ever been punched in the gut? Or fallen, had the wind knocked right-the-hell outta ya? Yeah, me too. It can be a humbling experience. But if you know me at all, you’d know: I am anything but humble.

My name is JulieAnn Carter-Winward, and I live in the U.S. of A., where everything “right” comes from, (“herb,” pronounced “erb,” not “herb” with an “h,” you hoity-toity Brits.) I’m kidding, of course. I pronounce it like British folk because, well, there’s a “h” in it.

AH, but I digress: yes, “humility” is a virtue of which I possess very little—and that’s actually sort of ridiculous, because I have countless reasons to be humble. I mean…I suck at a lot of stuff. Seriously suck.

My lack of humility, we could even call it pride or—dare I say it? Hubris—yeah, okay so I’d thought the sin of hubris would be what would eventually buckle my legs and knock the breath clean out of me.

I could not have imagined that my nemesis would be an innocuous, little, round, white pill.

BUT, although Mr. Fiddaman’s blog has focused on SSRIs up until this point, I need to tell you: this little pill was not an SSRI. 

Just like “Charcoal gray is the new black” or “Spoken Word” is the new “Beat Poetry,” or “Fifty Shades of Gray” is the new “Housewife Porn,” (shudder), the new SSRIs are the “second-generation atypical anti-psychotics,” or AAPs. Why? Because drug companies are now claiming AAPs can do what SSRIs cannot, and have not done: treat depression.



Bob Fiddaman has diligently revealed the truth behind the smoke, mirrors, dollar bills and coins behind antidepressant clinical trials, research, (rabid) prescribing and use—all to shed light on the potential lethal consequences of these medications: drug-induced akathisia.

But SSRIs are merely one way to whack the backs of an unsuspecting public’s knees; people searching for the “Little Pill that Could.” The “I think I can, I think I can,” or, more aptly, the “I think it will, I think it will…” hmm, will what?

Make this constant sadness disappear from my life!

Help my son get his life back together. I want to see him smile--it’s been so long.

Get my husband back to his old, jocular self again.

When it comes to antidepressants, these are all wishful thoughts at best, placing hopes in an engine powered by promises, not proof. Thanks to people like Mr. Fiddaman and others, SSRIs have been exposed for what they truly are: engines that not only can’t get you over the hill of unhappiness, but won’t—and on top of it, could very well derail you emotionally or those you love, within days, weeks, or months.

Enter AAPs. Yes, there are some new pills in town, and they’ve been approved by the FDA for not only bipolar depression, but run-of-the-mill, #1-cause-of-disability-in-America-today depression as well. AAPs are the new “add-ons,” booster meds, or, as I like to call them, the caboose medication to add to your impotent drug train, traversing the uphill battle of depression. 

Yet, AAPs, like an errant caboose, can whip around and bite you in the ass when things go the wrong way—knocking you to the ground, breathless—that, or six feet under it.

I should know. I was tied to the tracks.

If you’ve read Bob’s blog long enough, you’ve read tragic, heartbreaking stories of Wendy Dolin as well as other survivors left behind in the wake of loss, after drug-induced akathisia drove their loved ones to take their own lives. I have read stories of people who have had akathisia (past-tense); I felt the horror of their experiences in their words, the utter agony they recall with dread, almost as if they fear it a specter, and to invoke the very name of it would recall its visitation upon them again. Yes, thanks to Mr. Fiddaman’s diligence, SSRIs, and those who manufacture, sell, and prescribe them, are getting an uncomfortable spotlight shined right in their faces.

Today, however, right here and now, you are reading the words of someone who has tardive akathisia; “tardive” means “late appearing,” and in the medical field, that means the side effect doesn’t manifest until after the drug has been discontinued.

I stopped taking the AAP, Latuda, (lurasidone HCl, made by Sumitomo Dainippon Pharma Co., Ltd., and marketed in the U.S. by Sunovion,) almost 11 months ago, and I still battle akathisia, daily. The emotional pain, the quivering muscles but along with the persisting akathisia, I have developed other neurological movement disorders, and they appeared nearly 7 months after discontinuing Latuda: tardive dyskinesia and tardive dystonia.

What makes me rather unique is that for some people, the drug masks “inner akathisia,” the emotional pain, while the patient is on it. Not always, but sometimes. For example, akathisia can also be a withdrawal symptom. Just ask anyone who has tried to get off benzodiazepines. But Latuda did not mask my pain, and it grew, over years, until I was frozen with pain almost every day. I have lived with inner akathisia pain, for over a decade. I have been SSRI-free for years. The only medication I took with akathisia as a known side effect was the AAP, Latuda.  

But I don’t know that “living” is the correct word to describe what my life had been, and some days still, is like. More accurately, I white-knuckle my way through most days. Before my diagnosis last summer in 2016, I lived with a pain with no name, a pain so relentless, there were days when I could barely walk upright. It was misdiagnosed as “agitated depression,” “treatment-resistant depression,” and “severe panic and anxiety,” but no medication gave me relief.

I knew, knew in my BONES, that it wasn’t psychological. This was not a job for my therapist. No, this was physical, biological, and my doctor and I knew it had to do with medication. But he had no idea what “inner akathisia” was. I not only wanted that train to derail, I almost derailed it myself, more times than I care to admit here.

Akathisia dogs my every step; places a pall over every feeling and thought I have, every day. My mind can’t wrap itself around the pain at times—a pain like akathisia should be fatal. At the very least, it should have the compassion to BE fatal and allow the sufferer to die a death that is not self-imposed. It is hell on earth, and it has nothing to do with gods or devils.

I get whacked, despite the drug’s absence, and no one knows why it persists, other than I was on AAPs for 13 years, or how to help me. Am I now, then, finally humbled?

Hell no. I’m pissed.

And as a wise man once wrote…well as the guy who made the magnet on my refrigerator wrote: “It is unwise to anger a poet.” Oh, it’s a little different than that. 

I’ll fix it.



There. All fixed.

When Bob invited me to write about my experience, I had to laugh a little. Write about it? Hell, I’ve been writing about it for years. Years and years—as in, I have so many poems and stories about the mysterious “Pain” that dogged my daily existence, that I have an entire BOOK of writings about akathisia, a book I’m compiling as we speak. So yes, Bob, I’ll write about it, and this is the intro.

If you’d like a broader spectrum/look-see into the history of antipsychotic medications, and the evolution of the drug companies with regards to mental health, as well as my personal take on it and my experiences that led me to this point, please visit my webpage at:


Hopefully, in and of Bob’s good graces, I’ll be writing a bit more next month to address and inform you all about an upcoming awareness project premiering at the end of June. It’s a short YouTube film. I hope you will not only find it engaging, but that you will all help me spread the film’s message like a wildfire across the info-kindling that is the ether.

Thank you for reading. It’s time for me to step away. The Pain-- it’s here. So familiar, and yet it feels fresh and new, every day. Like a wound that is never allowed to heal. A torture, where every day a masked man comes and gouges out the same place on my body. I’d beg him, beg him, to please, give me another pain, in ANY other place.

I often think about that. I think about him, agreeing, but giving me this choice:

 “All right, instead of gutting you in the bloody hole in the upper part of your stomach, I will slash your arms and legs to shreds. But here’s the catch: I will only do that if you let me slash your limbs for a decade. If you refuse, I will continue gutting the usual spot, but only for one more week. Choose.”

Truth be told? I don’t know what I would do. I think I would choose the decade of limbs being slashed. If it meant my gut would be spared one more blow? God help me, I’d consign to the former. The pain…I can’t describe in words. I am undone by it; but I have work to do, and I need to help those who I can help. I need to keep holding on, and I will.

 So yes, I’m sinking, here and now, down to my knees…

…but so help me God, I will not allow my chin to drop—  

not until the makers of Latuda KNOW ME BY NAME.
 
 
~J.A. Carter-Winward

Thursday, May 11, 2017

Guess Who's Being Sued Again?





Drug: Lamictal (lamotrigine)
Marketed and manufactured by GlaxoSmithKline.

According to the Daily Mail, the lawsuit, filed by Khaliah Shaw, 26, alleges that within a month of taking the drug, she had developed a rash on her face, while the skin on her lips had started to peel off. Although she visited her local ER, she was initially diagnosed with the flu.

Two days later, it is claimed, Miss Shaw woke up in excruciating pain, with the skin on her face, neck, back and chest falling off and her mouth covered in blisters.

The reaction left her skin permanently scarred, and she is slowly losing her sight.

Shaw, along with many others, are suing GlaxoSmithKline for promoting the product without warning of the risks, claiming more than $3.45 million in medical costs.

Shaw lost up to 90 percent of her skin.

More articles...

Woman's skin burned from inside out after dosage error, lawsuit claims

Wrong Treatment Melts Woman’s Skin Inside Out

Student, 26, who was almost blinded and lost 90% of her skin after taking common anti-seizure drug sues GlaxoSmithKline for more than $3 million


The GSK company mission statement is to, "help people do more, feel better, live longer."

Bob Fiddaman





Friday, May 05, 2017

Disdain Shown Toward Kids by Australian Medicines Regulator





dis·dain
noun

the feeling that someone or something is unworthy of one's consideration or respect; contempt.



So, Australia, a country I hold dear to my heart, apparently has a limp-wristed regulator in charge of it's drugs. Here's a news story from TodayTonight, a current affairs show broadcast in Adelaide, Australia, that may shock you. It was aired on Thursday May 4.

I can't find the words.

I know how Aropax (more commonly known as Paxil and Seroxat) can screw with your head. I know how it can make you feel like you want to kill yourself. I know the horrific withdrawal effects can make you feel like punching walls, and even people.

I know how GlaxoSmithKline wanted children to take it.

Also featured in this video is the story of a young girl who took Zoloft. Pfizer, it's manufacturer, don't seem to mind if kids take their drug either.

I honestly have never known an industry as sick as this one. It's difficult to put in to words because there seems to be such an incestuous relationship with pharmaceutical companies and global regulators. This relationship grows yearly and, it appears, not one medicine regulator seems to give a damn about children (as depicted in this video segment) being prescribed mind-altering drugs that aren't safe for adults, let alone 5 year-olds!


video


For more information on the SSRI problem in Australia join the Australian Antidepressants Class Action & Awareness Facebook group.


Bob Fiddaman

SSRI Deaths in Clinical Trials







Following on from MHRA Yell "Barracuda!", I have sent the following request (under the terms of the Freedom of Information Act) to the MHRA.

I can't see any reason why they can't answer, given they already confirmed to me, in writing, about the 22 deaths that occurred in Paxil clinical trials.

1. How many deaths occurred in the pediatric trials for Paxil/Seroxat. How many were by suicide and how many of those patients were taking Paxil/Seroxat at the time of their death?

2. How many deaths occurred in the pediatric trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

3. How many deaths occurred in the persons aged 24 or over in clinical trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

4. How many deaths occurred in the pediatric trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

5.  How many deaths occurred in the persons aged 24 or over in clinical trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

6. How many deaths occurred in the pediatric trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

7. How many deaths occurred in the persons aged 24 or over in clinical trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

8. How many deaths occurred in the pediatric trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

9. How many deaths occurred in the persons aged 24 or over in clinical trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

Bob Fiddaman








Thursday, May 04, 2017

Facebook Comments






I've managed to add a Facebook comments box at the end of each of my blog posts. I've been trying to figure out how to do this for a while. Much of my work gets shared or 'liked' on Facebook and now you can leave a comment by using the comment box below each post.

The comment feature on this old blog of mine has been problematic for many years. Hopefully, now, it will be easier for you all to leave a comment.

Bob Fiddaman.



Tuesday, May 02, 2017

MHRA Yell "Barracuda!"




I think 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!Matt Hooper - Jaws


The above photo and caption are from the movie Jaws. Power and money-hungry Mayor Larry Vaughn, played by Murray Hamilton, refuses to acknowledge that the residents of Amity are at risk of a shark attack. If Vaughn doesn't close the beaches, the shark could harm and kill citizens. Matt Hooper, played by Richard Dreyfuss, is an oceanographer with a special interest in the study of sharks. He uses his knowledge to try and convince Vaughn to protect the town, but Vaughn ignores him. Given the popularity of Jaws (it won an Oscar), I assume we all know the outcome of Vaughn's callous ignorance, right?

I'm not Matt Hooper, but lately, I feel like him. For years I've been at loggerheads with the MHRA as I seek answers to improve public health. Today's blog spotlights my latest correspondence to/from the MHRA about the increased risk of adult suicide posed by Paxil.

The MHRA and FDA know SSRIs are not recommended for consumers under the age of 24 because these products increase the suicide risk. In the US there is a black box warning, and in Europe, the patient information leaflet highlights this increased risk of suicide for any consumers under age 24. It is actually printed in bold face font. (See Doublespeak)

What we don't know is how and why regulatory authorities chose to highlight the product's dangers in consumers under 24 and not communicate the increased suicide risk for consumers over 24.

Let's look at the facts regarding Paxil clinical trials. (Paxil is known as Seroxat in Europe.)

In GSK's Paxil pediatric trials, which included more than 1,000 patients treated with Paxil, there were zero completed suicides. We know this because GSK's vice president for regulatory affairs, Dr. David Wheadon, admitted this in a written statement. What we don't know is how many of the children who were given Paxil developed suicidal thoughts and actions. MHRA and the FDA apparently feel this information is not important for the public's viewing.

In GSK's Paxil adult trials, we know 22 deaths occurred, 80% of which were people over age 30. (See here.) What we now know, thanks to the evidence made public in the Dolin vs. GSK trial, 42 people taking Paxil developed suicidal thoughts and actions.(See here)

So, to sum up: No deaths occurred in Paxil pediatric trials, and 22 deaths occurred in Paxil adult trials. Twenty of these deaths were completed suicides, and 80% of these were people over age 30.

Surely, the MHRA never had this information?

Wrong.

Here's a series of emails between myself and the MHRA. Spelling and grammatical errors from the MHRA are as received.


From: Bob Fiddaman
Sent: 31 March 2017 14:54
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

On the current Seroxat Patient Information leaflet (Revised 11/01/2017) it states, under the subheading "Thoughts of suicide and worsening of your depression or anxiety disorder"...

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

· If you have previously had thoughts about killing or
harming yourself.
· If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an
antidepressant.

Q: Could you please explain why "young adult" is in boldface type font and who made the decision to include "young adult" in a boldface type font?

--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 5, 2017 10:44 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman

The SPC for Seroxat includes the following:

A meta‑analysis of placebo‑controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old (see also section 5.1).

As the above suggests that this particular age group are most at risk, the MAH will have suggested the emboldening of the text within the PIL. There are fors and againsts the use of emboldening, but in this particular case it has been considered appropriate.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 16 April 2017 15:52
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Chris,

Just so you know.

Plaintiff’s Exhibit 347: Each picture depicts a real person who completed suicide while taking Paxil in a GSK-clinical trial. The red “Vs” mean their specific suicides were violent in nature. There were multiple suicides using firearms, including a murder suicide by one patient. There were also two deaths from people jumping in front of trains.

When it comes to suicide attempts, GSK did not keep track of all the attempted suicides in their clinical trials because, according to their company witness, it would be too burdensome.

My question.

The MHRA knew about these adult completed suicides, correct?


Attachment added to email
--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 19, 2017 12:03 PM
Subject: RE: Drug labeling

Dear Mr Fiddaman

I can confirm that the MHRA is notified of all serious adverse events, as laid out in the Pharmacovigilance Clinical Trial legislation.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 19 April 2017 17:08
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Dear Chris,

For clarification. Were the MHRA notified of the 22 deaths that occurred in paroxetine (Seroxat) clinical trials carried out by GSK (SmithKline Beecham) and that 16 of those deaths (80%) were attributed to adults over the age of 30?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Friday, April 21, 2017 5:19 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman,

As stated in the previous email from Chris Penny the MHRA is informed of serious adverse reactions occurring in clinical trials in compliance with current legislation.


The deaths that you are referring to took place between approximately 1983 and 2003. This data would have been submitted to European Competent Authorities and the suicidality risk of paroxetine was formally addressed at a European level in 2003/2004. Class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the SSRIs based on data reviewed in 2004.


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

From: Bob Fiddaman
Sent: 21 April 2017 16:29
To: Clinical Trial Helpline
Cc: Pharmacovigilanceservice
Subject: Re: Drug labeling

Thanks Rosalind.

One final question.

The MHRA have no plans to update the Seroxat label regarding Seroxat-induced suicide in adults over the age of 24, correct?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Tuesday, April 25, 2017 2:05 PM
Subject: RE: Drug labeling


Dear Mr Fiddaman,

As stated before, class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the Selective Serotonine Reuptake inhibitors (SSRIs) based on data reviewed in 2004. Paroxetine is an SSRI. Suicidal ideation and behaviour is already addressed in the Paroxetine Summary of Product Characteristic (SmPC).


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

So, there you have it, folks. The MHRA decided to highlight the increased risk of suicide among consumers under age 24, and they decided not to highlight the increased risk of suicide among consumers over 24.

Why didn't the MHRA feel the need to highlight the 22 adult deaths that occurred in the Paxil trials? It appears the MHRA believes Paxil isn't safe for children, but is safe for adults?

Why, in 2017, is the MHRA still not updating the Paxil warning label for adults?

Why do the MHRA continue to highlight the risk of patients under the age of 24?

I think I know why. GSK already knew that their ideal target market for Paxil was not going to be children. GSK is not allowed to promote Paxil to children (but they still did and were fined for their criminal behavior.)

But GSK was not about to lose Paxil profits when it came to capturing the adult market. MHRA helped them out by emphasizing in the patient information leaflet that the risk is only for consumers under 24. By intentionally printing these specific words, "young adults," in bold face type, MHRA is essentially telling older consumers: "Pay no attention to this increased suicide warning if you are over 24. This product poses no increased risk of death."

Obviously, MHRA should warn older adults by highlighting the 22 deaths and including older adults in the warning. Perhaps MHRA's CEO, Ian Hudson, doesn't want to do this because, whilst under oath in 2000, he stated he had seen no evidence to suggest that Paxil "caused any person, worldwide, to commit an act of homicide or suicide."

I'll leave the final words to Ian Hudson, um, Mayor Vaughn who, despite knowing about the risks created by keeping the Amity beaches open, had this to say...

"You yell barracuda, everybody says, "Huh? What?" You yell shark, we've got a panic on our hands on the Fourth of July."


Bob Fiddaman

Related

Former Glaxo Safety Officer Becomes Head of MHRA

EXCLUSIVE: Dr Ian Hudson: In Defence of the Suicide Pill (Full Video Deposition)

Paxil Suicide - The Way GSK Hid the Link

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users





Please contact me if you would like a guest post considered for publication on my blog.