Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Suicide. Show all posts
Showing posts with label Suicide. Show all posts

Thursday, January 25, 2024

Families Lodge Complaints Over Seroxat, Citing Adverse Reactions Leading to Tragic Outcomes

 


Romain Schmitt, 16

Last week, Radio France ran a heartbreaking story about two young men who tragically died after taking the controversial antidepressant paroxetine. Paroxetine is more commonly known by its brand names, including Seroxat (UK), Paxil (US & Canada), and Aropax (Australia & New Zealand). The bereaved families are fighting to establish the link between the taking of Seroxat and these two suicides.

The story, investigated by journalists Par Rozenn Le Saint and Benoît Collombat, can be read in full here. 

Vincent Schmitt and Yoko Motohama, parents of Romain, who was 16 years old when he tragically ended his life in September 2021, are now seeking justice. Convinced that their son's death is linked to the use of Seroxat, they have filed a complaint for involuntary manslaughter, focusing on the potential connection between the young man's suicide and the Seroxat he was prescribed.

The parents assert that their son's behavior underwent a transformation between 2-3 months after taking Seroxat, an SSRI marketed and manufactured by GSK, which exacerbated his anxiety. "It was hell," Vincent Schmitt recounted. Adding that Romain began engaging in gambling and obsessively focused on football games. His behavior became increasingly worrisome, and he directed anger towards them.

Most notably, the teenager seemed to lose all sense of danger. "One day, he impulsively swam in a lake without regard for safety. His rescue came thanks to a pedal boat," Vincent Schmitt recalled.

Around 3 months after being on Seroxat, Romain's sleeping cycle was completely reversed. His parents complained to the prescribing doctor, and bizarrely, his Seroxat dosage was increased. What started as a 10mg daily dosage, ended (by 31/2 months) to 40 mg/day. The prescriber then added Tercian to the mix before taking a 1-month vacation. Tercian, also known as Cyamemazine or cyamepromazine, is a typical antipsychotic drug. When combined with SSRIs, it increases the risk of extrapyramidal adverse effects. Extrapyramidal effects refer to involuntary movements that cannot be controlled. An example of this is akathisia.

For years, GSK has steadfastly denied any connection between their best-selling SSRI and suicide completion. Despite reaching numerous out-of-court settlements with victims' families, they maintain that Seroxat is safe and effective. 

Over the years, this blog has extensively documented Seroxat-related suicides, with particular emphasis on the tragic case of Sara Carlin, a young Canadian girl who tragically took her own life. Sara's story also holds a prominent place in my book, 'The Evidence, However, Is Clear...The Seroxat Scandal.'

Sara's death at the hands of Seroxat prompted a series of recommendations at her inquest, a list that can be read here.

I reached out to Romain's mother, Yoko, to learn more about her son, Romain and what happened on that fateful day. She told me:

"I was sitting on the bench at the entrance of the station, enjoying the end of the summer's sun while waiting for Romain. It is such a tiny station, not even 10 meters away. Little did I know that Romain was already on the platform.

"From where I sat, I could see the school's entrance. It was after school, and all the kids were leaving. I heard a loud noise, possibly a train, followed by a strange silence and people reacting oddly. I started to worry that we might be late for our appointment with the psychiatrist for Romain.

"Teachers rushed to the station, and I noticed signs indicating that the train was delayed. Concerned about our appointment, I decided to call Vincent to request a car pickup. As I dialed his number, I began searching for Romain and approached a teacher to inquire about my son's whereabouts. The teacher asked for his name, and I replied, 'Romain Schmitt.' To my surprise, she abruptly left without saying a word, which struck me as strange.

"Soon, ambulances arrived, and a sense of unease began to intensify. Many firefighters gathered around me, and a man in a white coat approached. He delivered the devastating news that Romain was dead.

"For me, this marked the beginning of a profound sense of despair and loss. This is my story of that tragic day, a day that would forever be associated with suicide."

I asked Yoko what Romain was diagnosed with, she told me:

"That is also part of the question we are asking. Actually, no doctor gave us any official diagnosis. Romain liked sports and was very healthy. He liked footballers, like Christian Ronaldo. So, like many other boys of his age, he started muscle training. At the same time, he started doing a kind of special diet.

"Getting quite escalated and obsessed, his eating habit became painful to our family. Removing all fat parts, juice, sauce on the plate, and requesting a specific product, etc. But I could not really discuss with him, and he did not listen to me. He also needed to take a shower before football. He was not good at waking up in the morning to prepare for school and was always late for dinner because he needed to do muscle training just before eating, etc.

"Anyway, witnessing his new eating habits, we started seeking some help from specialists. But nothing was helpful. At the same time, I was searching on the internet what a disease could be. And we found that it can be an obsessive-compulsive disorder.

"The first psychiatrist we saw didn't believe Romain had OCD so we took him to see another. Within 20 minutes of seeing the 2nd psychiatrist, we were told that Romain's habits were a "serious disorder". Romain was then started on Seroxat."

Approximately one month later, Romain's eating habits seemed to level out, he became less obsessed with his previous dietary regime. However, he seemed to be sleeping most of the time. This, according to Yoko, was during the Covid lockdown. Things became estranged between Yoko and Romain and shortly after his dietary obsession returned.

Romain, nor his parents were informed by the prescribing psychiatrist about Seroxat's propensity to induce suicidal thinking. His father, Vincent, did, however, read the patient information leaflet where, hidden amongst the minor side-effects, was the warning about increased suicidality when taking Seroxat, particularly for patients of Romain's age.

Yoko told me, "On Friday, the morning prior to his death, he planned with his good friend to participate in some sports, and then do some homework together over the weekend. At the canteen, Romain had lunch with many friends and laughed a lot while sharing a banana."

Hours later, Romain, at the age of 16, tragically ended his life by stepping in front of a moving train.

After his death Romain's parents researched the link between Seroxat and suicidality, it was then they learned of many others who had taken their lives whilst taking GSK's powerful, mind-altering antidepressant.

Too little, too late for them but they want to warn others.

--

Gilles and Giusiana Mannoni have, along with Yoko and Vincent, also filed a complaint after their 20-year-old son, Florian, hanged himself. His father told the France Bleu website, “We learned on Thursday evening around 10 p.m. that Florian had hanged himself."

"A week later, when we gained access to the apartment, we found a prescription with a drug based on paroxetine. Florian's psychiatrist explained to us that he did not have a problem with his family or his friends, but just a problem with a rumbling in his stomach, that he was not depressed. I asked her why she prescribed the antidepressant, and she told us she prescribed it to everyone.”

Florian was due to go on a skiing trip with his parents.

Both Giles and Giusiana contacted GSK after the death of their son. They were, somewhat, callously told, adverse effects, such as suicidality, appear in the medication leaflet.

Maître Jean-Christophe Coubris, the lawyer representing both families, issued the following statement:

'Like most of us, I will never read a notice in its entirety.' He laments that most people prescribed antidepressants will not have the correct information regarding the increased risk, possibly triggering an irreversible action, which is two to three times higher. 'It's a gigantic umbrella that the laboratories open. You could even call it a parasol. I fear that no one is informed about the risks of over-suicide while taking antidepressants in all age categories."

--

Commentary

Since 2006, I've been researching GSK and Seroxat. In the case of Romain, GSK will argue that Tercian, also known as Cyamemazine, caused the changes in his behavior. This is a classic move that drug companies, and even prescribers, make when their products come under fire. They will blame anything and everything other than the product they are defending. They, along with the prescribing psychiatrist, might even suggest that Romain's apparent OCD pushed him over the edge, along with his strained relationship with his parents.

If this case goes to trial, attorneys will focus on Romain's parents and their friends, attempting to imply that Romain took his life due to their parenting skills. This situation bears a resemblance to what happened to Wendy Dolin when she filed a lawsuit against GSK. Below is an excerpt from an exclusive interview I conducted with Wendy:

"I knew when I filed this lawsuit, it was going to be a very difficult process. But I was unprepared for the sheer number of depositions and subpoenas GSK demanded. I was told this was a record number of requests. I understood the need for certain information, but it became very clear early on that GSK's goal was to send a powerful message to me: That is, when you have the audacity to challenge GSK, all attempts will be made to harass everyone you care dearly about. GSK also repeatedly tried to humiliate me. For example, depositions that should have been a few hours became eight hours in an attempt to wear people down. GSK asked the same question over and over and over again hoping to manipulate, confuse and take people's comments out of context.

"Some of the irrelevant but personal questions GSK asked me included, "How many times do you go to temple? Are you dating anyone? Who are my partners at work?" They even requested Stewart's high school transcripts. All were totally irrelevant and useless questions posed by attorneys from King and Spalding and Dentons. They were calling my friends, not identifying themselves and trying to get people to somehow say terrible things about my relationship with Stewart. There was nothing to say, of course, and GSK's attorneys just embarrassed themselves. It became a joke amongst my friends as to who would be called next and who did GSK think they were dealing with that they thought their sweet talking female attorney was somehow going to get information?"

There is a substantial amount of publicly available history regarding Seroxat on the internet, offering abundant resources for family lawyers to investigate. Unfortunately, such resources were not accessible to other families who lost loved ones to Seroxat over the years. This blog has covered many of these cases, and I'm aware that Yoko has downloaded a significant portion of my work here. It's encouraging to know that Yoko has also reached out to David Healy, who is an expert in SSRI-related issues and has historically been a thorn in GSK's side.

To be frank, I'm astonished that Seroxat is still being prescribed, given its atrocious track record of ruining lives. To give a 16-year-old 40mg of this mind-altering drug is, in my opinion, tantamount to gross negligence.

The journey ahead for both families is bound to be lengthy and filled with numerous obstacles. This endeavor is not driven by a pursuit of financial gain; rather, it's about raising public awareness so that no family has to endure the suffering that the Mannoni's and Schmitt's are currently experiencing.

No parent should ever have to bury their child, especially when such a tragedy could have been prevented, as in both of these cases.

I'd like to thank Vincent and Yoko for helping me clarify the events. It can't have been easy for them reliving such a traumatic experience.

It's worth noting that no formal case has been filed against GSK at this point. Both families have lodged complaints of involuntary manslaughter and these complaints are now being investigated.

If successful, the families could pursue lawsuits against the prescribers, the French regulatory authorities, and even GSK. The complaints are currently in the hands of the prosecutor.

--

Yoko has now created a website that you can view here (https://antidepeffects.wordpress.com/)

A photo album of Romain can also be viewed here (https://romainschmitt.wordpress.com/)

For updates and to offer your support, please follow Yoko's Twitter (X) account here (https://twitter.com/antidepeffects)


Bob Fiddaman

Sunday, July 26, 2020

Akathisia - The Taboo Terminology




Earlier this week the Royal College of Psychiatrists (RCPsych) published an updated report on suicide prevention. The report was put together by a so-called 'Patient Safety Group' (see image above) and other 'contributors', one of whom is the current President of RCPsych, Dr Adrian James.

The report focuses on adult suicides and, according to RCPsych, "provides new, practice-focused guidance for psychiatrists and other mental health professionals on suicide and self‑harm that examines what interaction is now needed between these topics."

Woe Is Me

I found the following finding quite striking. It's a contradictory statement that, on one hand, highlights the failings of the psychiatric profession's choice of treatment, whilst on the other hand calls for more help for those prescribers who experience patients dying by suicide whilst under their care:

"There is evidence that most psychiatrists have experienced the death of a patient by suicide during their career, a large number of them more than once. Half of them described increased stress in the weeks following the suicide, and a sizeable minority reported a change in their practice, including more referrals to colleagues and requests for admission. The evidence suggests that there is a lack of structured support for psychiatrists and psychiatric trainees following a death by suicide."

It's remarkable isn't it. A report on the prevention of suicide highlighting the stress of prescribers who may have contributed to the suicide by prescribing antidepressants that increase the risk of suicide.

What RCPsych seem to be doing here is telling their members, "don't worry, we have your backs and we will help you through the tough times when one of your patients kill themselves whist on the 'life-saving' antidepressant you prescribed them."

Akathisia - The Taboo Terminology

Whilst the new report references the apparent safety and efficacy of antidepressants, it makes no mention of their role in inducing self-harm, suicidal thinking and suicide completion, all three of which that appear on current patient information leaflets as 'warnings'.

There is also no mention of the taboo word, 'akathisia', a condition caused by the very same drugs that RCPsych members prescribe to patients.

They Know About Akathisia 

Last July (2019) Wendy Dolin, founder of The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin (MISSD), flew from Chicago to London to present suicide prevention information to the then President of RCPsych, Wendy Burn, and RCPsych audience members. The presentation highlighted akathisia and included a promotional video on how to spot signs of akathisia. Dolin wasn't the only safety advocate there that day who spoke about akathisia. Dr Lade Smith also spoke about this mind-crippling condition, she was even promoted by Burn who tweeted the following:



It seems a tad strange that the latest Suicide Prevention Report fails to mention akathisia, so I asked one of the 'Patient Safety Group members, Alys Cole-King, why. Cole-King had tweeted, back in March 2020, that "akathisia matters too."

Here's her reply to me (in two parts)



Appleby Ever After

The current UK Suicide Prevention expert is Prof Louis Appleby, he too is referenced throughout the new report although I am unsure of his input.

Appleby, to me at least, is a strange one. He has blocked many voices of the #PrescribedHarm community on Twitter (myself included) but back in October last year made a startling revelation regarding akathisia and the suicide prevention plan. According to Appleby he claimed, "When we came to update the strategy a few years ago, the Government wanted as few changes as possible. We were keen to add something about antidepressants after hearing from families who felt strongly about this."

What actually ended up the the suicide prevention strategy was "There are also risks in the early stages of drug treatment when some patients feel more agitated." (page 27).

Nothing about akathisia, surprising given Appleby's own personal thoughts that akathisia "can make people feel desperate and suicidal."

So, no suicide prevention warning about akathisia in a prevention strategy and no suicide prevention warning about akathisia in RCPsych's new Patient Safety Report.

Something is amiss here.



Why are Appleby and RCPsych, seemingly, afraid to address this elephant in the room?

Answers on a postcard please.

Bob Fiddaman

Tuesday, March 03, 2020

UK NATIONAL SUICIDE PREVENTION STRATEGY: An Open Letter





Between us all, we look back now on years and years of trying to raise awareness of the risks associated with SSRI/SNRI drugs - and all that seems to have happened is that prescribing of these drugs has continued to soar exorbitantly. Many of us have lost family members and friends and have seen for ourselves the terrible consequences of the effects of SSRI/SNRIs. Others have experienced for themselves the horrific adverse effects of these drugs and are desperately trying to warn others and to pass on their own expert experience. Many of us have voluntarily undertaken huge amounts of research and made significant contributions - and want to share what we have learned and are learning. Peter Gordon's 'Timeline of |Missed Opportunities' film summarises what has happened since 2002 - and how the National Suicide Prevention Strategy is deeply flawed by the flagrant disregard for the known (and heavily suppressed) risks of these mass-prescribed drugs.

Having been repeatedly ignored, 'blocked' and fobbed off by those with whom we have tried to communicate - we felt a need to share what we now can, and however we can, as a means of public safety education. If those in authority won't do what they are ostensibly employed to do - then we will do whatever we can do ourselves.

Lead author, Marion Brown, is a retired psychotherapist & mediator. Her late husband was a GP, who ran into severe medication difficulties himself (after 20+ yrs on Seroxat) and ended his life in 2011.



OPEN LETTER TO UK GOVERNMENT DEPARTMENTS OF HEALTH & SOCIAL CARE & ALL THOSE RESPONSIBLE FOR PUBLIC HEALTH & SAFETY
ENGLAND, SCOTLAND, N IRELAND & WALES


3 March 2020

UK NATIONAL SUICIDE PREVENTION STRATEGY:  SSRIs/SNRIs and AKATHISIA risks

We write to express extreme alarm at the way our concerns – expressed over more than a decade to a considerable number of individuals and groups, representing various committees, specialities, institutions and departments in the UK – have been, and are being, apparently quashed.

Current ‘expert’ advice on suicide prevention, which is now accepted government policy, is that SSRI/SNRI drugs are prescribed to any patient who indicates they may be feeling suicidal or have suicidal thoughts. Our concern is that SSRI/SNRI drugs can themselves cause such suicidal thoughts/impulses - and also a very serious adverse drug reaction called AKATHISIA, the symptoms of which are so unbearable that they can lead people to end their own lives. This fact is not recognised by governments, the NHS or the public, and is not mentioned in the national ‘Suicide Prevention Strategy’, despite our efforts to draw this important issue to the attention of responsible individuals and departments. Many people ARE INDEED dying avoidable deaths by iatrogenic suicide – when suffering known and/or extreme and unrecognised adverse prescribed drug effects.

Our efforts have been extensive, and most recently resulted in the online publication of a short film compiled by Peter Gordon, retired NHS psychiatrist, with input from several contributors: ‘A Timeline of Missed Opportunities’. This has already been widely shared on Social Media.

Please watch this short film - and also read the Replies/Comments section (found at the foot of the blogpost) where further correspondence has been added, including a letter dated 28 Feb 2020 from the UK Department of Health and Social Care (Ref: DE-1204751).

We are sharing this open letter on social media and with the press as we consider this to be a very serious matter indeed – where the lives of countless people are being knowingly and recklessly put at risk by national ‘Suicide Prevention Strategy’ and ‘Policy’. The public – and indeed prescribers - are being cruelly misled. 

We ask specifically that the KNOWN RISKS of SSRI/SNRI drugs in particular (and indeed other medications which can cause akathisia) be fully recognised NOW - and action taken by Governments cascaded to EDUCATE all prescribers, healthcare professionals and the public on how to avoid or mitigate these risks.

Examples of our appeals can be found in this collection of letters published by the BMJ a few months ago. https://www.bmj.com/content/366/bmj.l5102/rapid-responses 

Signed
Marion Brown, Beverley Thorpe Thomson, Peter Gordon, Millie Kieve, Jo Watson, John Read, Peter Gotzsche, Catherine Clarke, Janette Robb, Stevie Lewis, James Moore, Bob Fiddaman, Dierdre Doherty, Kristina Gehrki, Fiona French, Alyne Duthie

--


Further Reading

UK Suicide Expert: Akathisia Can Make People Suicidal

Louis Appleby Knew About Prescription Drug-Induced Akathisia in 2004

Suicide Expert Embroiled in Twitter Controversy

Akathisia Accredited 101 Course (Free sign-up and course)

MISSD (The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin)

Akathisia Alliance

SSRI - Induced Extrapyramidal Side-Effects and Akathisia (J Psychopharmacol.1998;12(2):192-214.review)



Wednesday, December 04, 2019

Turning Something Bad Into Good (Spin)



Jacob Polete (16)

Sean Polete shared his concerns about antidepressants and whether a prescription contributed to the suicide death of his 16-year-old son, Jacob Polete, on Nov. 30, 2018.

Jacob's Dr didn't inform him about the black box warning. He didn't inform him that he was prescribing it off-label' and that it wasn’t approved to treat depression in teens.

Jacob's father told the Dayton Daily News:

“I didn’t do the research because I felt like, well, I’m just happy to have somebody giving us some advice. These antidepressants and things have significantly different effects on a child’s brain and it’s much different than the adult brain.”

Step forward the spin doctors.


V. Grace Matheson, MD, PhD


In the same article, Dr. Virginia Grace Matheson, a child psychiatrist at Dayton Children’s Hospital, said:

“For most children, the drugs work. We don’t want them to be afraid of the medicine. The vast majority of cases, the medication will really help the child feel better and if they are having suicidal thoughts as part of their depression, it will relieve those in most cases. But there are those kids who have the adverse effects.”

Matheson added:

“Most of them [antidepressants] work in a very similar way, so we can sort of extrapolate from the adult data. It doesn’t mean that it’s not safe or it doesn’t work. Sometimes a child prescribed antidepressants actually has a form of bipolar disorder that wasn’t detected.”

T.J. Grimm, retail and ambulatory director for University Hospitals in Cleveland, and president-elect of the Ohio Pharmacists Association, added:

“There are people who, because they’ve heard about increased suicides, they’ve heard these medicines don’t work, (they’ve been) scared off. ”

Jacob Polete was just 16-years-old. Part of his online obit reads:

He attended Fairhaven church where he volunteered at Celebration Place, a program serving children 5 to 13 years old coping with life’s tough issues. Jacob was an avid naturalist, a fan of bushcraft, and wilderness survival. He enjoyed hiking in the woods, biking riding, and exploring large cities like New York and rural areas like the Metro Parks. He was not a fan of suburbs. He had recently started working as a bagger at Dorothy Lane Market, and was very proud of himself for saving his earnings to buy himself a new bicycle. Jacob loved food challenges, cooking, and pushing the limits of his taste buds with strong flavors and strange foods. He was fearless and impulsive, and never backed away from a challenge. He had great compassion and love for his furry friend Athena and an intimate circle of friends. His loving yet mischievous personality, combined with his intelligence and innate wisdom, gave the sense of being in the presence of an old soul. He was captivated by Lord of the Rings, both the books and the movies, and the band Pink Floyd. He was a curious experimenter and delved deeply into chemistry and botany. Since early childhood, Jacob was a skilled “deconstructive engineer,” and took apart every object he could get his hands on.

Read the full vomit-inducing spin by the 'experts' here.

In the meantime, this is for Dr Virgina Grace Matheson.


Bob Fiddaman

Wednesday, November 06, 2019

Louis Appleby Knew About Prescription Drug-Induced Akathisia in 2004



Louis Appleby Knew About Prescription Drug-Induced Akathisia in 2004

Following on from my previous post, UK Suicide Expert: Akathisia Can Make People Suicidal, it has come to light that the UK's 'expert' on suicide prevention, Prof. Louis Appleby, was warned about prescription drug-induced akathisia many years ago. Just as he does today, he ignored the akathisia and suicide links.

In 2004, Millie Kieve, founder of the APRIL Charity, called the Manchester Coroner's office as there has been a recent Roaccutane suicide. Millie was, and still is, concerned about the reaction of Professor Louis Appleby and why he fails to warn about medicines causing akathisia and suicide risk for some people. Back in 2004, Millie had written to Appleby but he had pretty much ignored her.

Millie recorded the conversation with the Manchester Coroner's office and tells them of her struggles with Louis Appleby. She also tells them that the 2004 suicide strategy plan, headed by Appleby, had no mention of prescription drug-induced suicides or indeed prescription drug-induced akathisia. She tells the Manchester Coroner's office that Appleby's office 'fobbed her off', claiming that "people might get more energy to kill themselves when they take antidepressants."

The call to the coroner sees Millie raise concerns about Appleby, SSRI drugs and other drugs, including Roaccutane, Dianette and Lariam.

This is a huge concern, so much so that MISSD (The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin) an American non-profit organization dedicated to honouring the memory of Stewart Dolin and other victims of akathisia, has now reached out to Appleby on Twitter and have urged him to save lives.


Listen to the 14-minute phone conversation here

Bob Fiddaman


Tuesday, September 10, 2019

PHE Review Dilutes SSRI Problem




Firstly, I'd like to thank everyone who worked hard to get this review to the table. The list is extensive, you all know who you are.

This post is dedicated to three warriors who were active within the prescribed harm community, they all recently died by prescription drug-induced suicide.

Thank you for fighting the cause:



Jo Dennison
Kata Balint
Shelley Johnson 

This post is in two parts. Part one is about the recent PHE review regarding the evidence for dependence on, and withdrawal from, prescribed medicines in the UK. Part two is about the current suicide 'expert' in the UK, Prof. Louis Appleby, and the president of the Royal College of Psychiatrists, Wendy Burn. Both parts are intertwined, one is about dependency, the other is about self-harm fatalities. I'll also be calling upon the current suicide prevention minister, Nadine Dorries, to carefully consider the serious issues raised here.

Report of the review of the evidence for dependence on, and withdrawal from, prescribed medicines.

Today is World Suicide Prevention Day and Public Health England (PHE) released a public health evidence review of available data and published evidence on the problems of dependence and withdrawal associated with some prescribed medicines.

Coincidence?

PHE review expert reference group members included Yasir Abbasi, Navjot Ahluwalia and Louis Appleby.

Abbasi has received honorarium for advisory board meetings or travel and accommodation for conferences from Indivior Pharma, Martindale Pharma, Bite Medical Pharma and Mundi Pharma.

Indivior market and manufacture Opioid addiction treatment drugs. Martindale, now known as Ethypharm, manufacture a whole host of drugs, including, but not limited to, painkillers. A Google search of Bite Medical Pharma shows no such company, but Bite Medical Consulting do exist. It appears as though they are a communications company. Safe to say that this means they ghostwrite. Some of their clients include Abbot and Lilly, both drug companies who market and manufacture brand and/or generic antidepressants. Mudi manufacture and market addiction medicines.

Ahluwalia carries out expert witness work and is the Executive Medical Director and Consultant Psychiatrist for Rotherham, Doncaster and South Humber NHS Foundation Trust

Appleby is a Professor of Psychiatry who leads the National Suicide Prevention Strategy for England and directs the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness. More about Appleby later.

The Review

The review covered many aspects of prescription drugs, in particular, the withdrawal and dependency problems people face when trying to come off them. There was, however, a mixed message for the SSRI family of drugs.
Benzodiazepines, z-drugs, opioid pain medicines and gabapentinoids are associated with a risk of dependence and withdrawal.
Antidepressants are associated with withdrawal
PHE found that dependency exists on benzos, z-drugs, opioids and gabapentinoids but not antidepressants (SSRIs).

The 152-page review includes a definition of dependence. PHE writes:
Dependence ~ An adaptation to repeated exposure to some drugs and medicines usually characterised by tolerance and withdrawal, though tolerance may not occur with some. Dependence is an inevitable (and often acceptable) consequence of long-term use of some medicines and is distinguished here from addiction.
I'm confused?

Are SSRIs addictive or do people become dependent upon them, or is it neither?

On withdrawal, PHE defines it as: Physiological reactions when a drug or medicine that has been taken repeatedly is removed.

I'm still confused.

Confusion aside, it's nice to see they recognised the daily stigma patients, former patients and drug safety advocates face on a daily basis whenever they publicly share their adverse experiences withdrawing from SSRIs.


The recommendations made by PHE are as follows:

1 ~ Increasing the availability and use of data on the prescribing of medicines that can cause dependence or withdrawal to support greater transparency and accountability and help ensure practice is consistent and in line with guidance.

2 ~ Enhancing clinical guidance and the likelihood it will be followed.

3 ~ Improving information for patients and carers on prescribed medicines and other treatments, and increasing informed choice and shared decision-making between clinicians and patients.

4 ~ Improving the support available from the healthcare system for patients experiencing dependence on, or withdrawal from, prescribed medicines.

5 ~ Further research on the prevention and treatment of dependence on, and withdrawal from, prescribed medicines.

(1) You don't have the data, the drug companies have it. You will never be allowed to see any of the raw data.

(2) You cannot guide if you don't have the data


(3) Where will this information come from?

(4) Improving? This would imply that support is already in place and just needs tweaking. It isn't. It never has been!

(5) Research is meaningless without the raw data


For what it's worth, recommendations are meaningless words. I've written about this terminology before, it gives people false hope and allows those in charge to continue as they were, so to speak. It's not a law, it's not a rule, it's not punishable if prescribers fail to adhere. Call me cynical, but I dare say meaningless recommendations also serve to help systems stall buy some more time to avoid real action.

Back in 2010, a jury at the inquest of Canadian teen, Sara Carlin, returned a list of 17 recommendations. Sara died a violent, akathisia-induced death after ingesting an SSRI known as Paxil in Canada, better known as Seroxat in the UK. These iatrogenic deaths from drug-induced delirium and self harm are typically labeled suicides by coroners. So it is possible Prof. Appleby and organizations purported to reduce suicides could recognize the loss of Sara today. But it is improbable that will happen given Sara's death doesn't help them promote more drugs ("treatments").

Today, nine years after Sara's death, guess how many of those 17 recommendations have been implemented?

None.

Nada.

Zilch.

Sara's death was a kick in the butt for me personally. It made me rethink why I became an advocate/activist. People are dying as a result of taking SSRIs and whilst withdrawal/dependency/addiction (delete where necessary) are important topics, I feel iatrogenic deaths also need to be immediately addressed.

The SSRI withdrawal issue will never be resolved as long as there is no alternative drug in the pipeline waiting to be promoted. In the meantime, the public will continue to be informed of recommendations that are little more than token gestures. These gestures may serve to keep some advocates quiet and give med organizations and rampant prescribers a break from public scrutiny and accountability. As I tweeted early this morning, barbiturates were viewed as having no problems until benzos arrived on the scene. Benzos were viewed as having no problems until SSRIs arrived on the scene. SSRI risks will be played down until a different class of drug arrives on the scene to take a lucrative centre stage.

Don't worry, folks, that may happen sooner than you think. A new way of administering depression treatment is already on the market. Spravato (esketamine) is used as a nasal spray to treat treatment-resistant depression (TRD)

TRD is basically a term used when all else fails or when the drugs a person is currently taking stop working. Janssen, the drug manufacturer, provided the FDA with modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. Now get this, three patients who received the drug died by suicide during the clinical trials, compared with none in the placebo group. But hey, this never stopped the FDA from granting it a licence.

Come back to this blog of mine in 10 years and you'll probably see me writing, "I told you so."

Eventually, and if they have their way, drugs like esketamine will flood the market. Then, and only then, will prescribers speak out en masse about the terrible dependency SSRIs cause.

The Apple That Burns

Earlier I mentioned the three PHE review expert reference group members. The third, Louis Appleby, leads the National Suicide Prevention Strategy for England. He is failing on a grand scale.

A few weeks ago Appleby chastised a member of the prescribed harm community on Twitter. Appleby was soon joined by the Royal College of Psychiatrists leader, Wendy Burn in the condemnation of the website host of antidepaware. The website promotes awareness of the dangers of antidepressants and includes links to reports of inquests held in England and Wales since 2003. The antidepaware author lost a son to SSRI-induced suicide in 2009 and since the creation of the website, in 2014, has tried to make the public aware of the dangers that are, in the main, dismissed by prescribers.

Appleby and Burn were wrong to target a fellow-advocate, particularly given antidepaware has done more than what they have to reduce the ever-increasing rate of suicide in the UK. Many other advocates threw their support behind antidepaware. Appleby, the man who apparently takes all forms of suicide seriously, responded by blocking them. He even blocked parents whose children have died as a result of SSRI-induced suicide.

With this in mind, I threw out a question to both Appleby and Burn on Twitter, a straightforward question that neither has answered despite being asked by me in nine repeated tweets. I have also sent both an email, and both have failed to respond. Here's the question they refuse to answer, or even acknowledge: "Can SSRIs induce death by self-harm?"

One has to ask why Appleby and Burn are refusing to answer a simple, relevant question. Burn in the past has claimed how important informed consent is but when push comes to shove she cannot provide me, or the public for that matter, with an answer regarding whether SSRIs can induce death by self-harm. Instead, Burn's Twitter timeline has been full of Lithium promotion, cat photos, and Play-Doh images.

Both Appleby and Burn need to resign. Appleby's treatment of those who inquire about SSRI-induced deaths has been abhorrent to watch from the sidelines. Burn's failure in recognising the SSRI withdrawal problem also needs to be condemned, as does both of their silence stances surrounding informed consent.

Shortly, I'll be writing to the current suicide prevention minister, Nadine Dorries, to voice my concerns regarding Appleby and Burn. I've written to ministers before and they've been pretty useless in their responses. I don't expect Dorries will intervene but I have an ethical obligation to try.

Suicide Prevention Day is about prevention. By refusing to speak with safety advocates and the bereaved just because their children, wives, husbands, brothers or sisters died iatrogenic deaths does nothing to reduce suicides and increase awareness of adverse drug effects that precipitate these violent, avoidable deaths.

If you want to prevent something from happening, you cover all bases and not just the ones that suit your blinkered views. Shame on Burn and shame on Appleby for keeping me, and others, in the dark regarding informed consent. Informed consent is a basic human right. Without accurate info, there can be no real medical freedom of choice.

On a final note, I want to also condemn Wendy Burn's college in general. On the day when suicide prevention was the paramount message they tweeted the following:


Those online resources they refer to include medications that are associated with suicidal thoughts and suicidal completion. Shame on them.

If you think all of the above is just the rantings of a conspiratorial mad man then read how Wendy Burn and her colleagues treated a fellow psychiatrist when he brought to their attention the dangers of Seroxat, a drug, that after many years he is still trying to withdraw from.

"You’d think that my colleagues would be generally sympathetic. However, I have been marginalised, ignored and vilified as a troublemaker — and a leading member of the RCPsych even wrote to my employer questioning my sanity." ~ Peter Gordon, Psychiatrist

Full story here

Bob Fiddaman








Wednesday, June 19, 2019

I'll Just Leave This Here






I salute everyone involved in the making of 'Letters From A Generation RX', the filmmaker, the parents and children featured throughout the movie, the narrator.

"These are vital issues that speak to our morality as a nation, as a people. How can you turn your back on this?" ~ Kevin P. Miller -  Award-winning filmmaker

I really don't know what else to say other than watch and share this powerful segment.

I am in tears...again.



Bob Fiddaman


Monday, May 06, 2019

UK Seroxat Litigation - 12 Years





The UK Seroxat litigation continues later this week.

Today is a day of rest. Today is also the anniversary of the death of 18-year-old Candian Sara Carlin who died by hanging in 2007. Today, but for Paxil, she would have been 30.

I will never forget Sara, even though I never met her I have an affinity with her and her family.

I always will.



Bob Fiddaman

Back Stories










Tuesday, January 08, 2019

Supreme Court Analyzes Merck's Ambiguous Wording




I'll admit it: I'm a legalese geek. But unlike certain companies peddling certain products, if I was too self-conscious to admit such, my failure to do so wouldn't hurt anyone.

Lately, I've been keeping a close eye on the court proceedings regarding Merck's Fosamax. Fosamax is a drug used in the treatment and prevention of postmenopausal osteoporosis. Ironically, Fosamax has been causing bone fractures in some consumers just as SSRIs can and do cause "depression," anxiety and akathisia in some consumers. But many Fosamax lawsuits haven't been heard by juries because Merck claims the company informed the FDA regarding bone fractures and the FDA failed to act by changing, or agreeing to change, the labeling.

The Merck case which was heard yesterday by the Supreme Court bears striking similarities to the GSK vs Dolin case. GSK also argued that it informed the FDA about the suicide links related to its Paxil product. (Paxil is an SSRI "brain pellet" that wreaks havoc among users while reaping billions in GSK profits. GSK claims it did everything to warn the public and doctors about Paxil-induced suicide risks. However, just as in the Fosamax case, GSK claims the FDA failed to agree to update the label.

Reading yesterday's Supreme Court transcript is fascinating and I highly recommend you download the 50-page transcript which is linked at the foot of this post. It provides an up-close look at how drug companies use the FDA's impotence to their advantage. Not only does the FDA fail to protect consumers, it proactively protects drug makers by serving as a revolving-door employment agency between pharma, the FDA and back again. Drug companies and the FDA create ambiguity and seem to enjoy a mutual understanding that this ambiguity will later be used to avoid lawsuits, protect shareholders and keep consumers in the dark regarding adverse drug effects.

Déjà vu: Dolin vs GSK

Wendy Dolin filed suit after her husband, Stewart, died when he jumped in front of a Chicago train. Stewart was taking a generic version of Paxil made by Mylan Pharmaceuticals, but GSK, the original manufacturers of Paxil, was responsible for the labeling and any subsequent label updates.

GSK tried to weasel its way out of a trial by citing the circumstances that Merck is now using as a defense in the Fosamax trials. GSK failed and the Dolin trial was heard by a jury who found for Dolin. Not only did the jury find that GSK was responsible for failing to warn consumers of the increased suicide risks created by Paxil, the jury also recognized that Paxil caused Stewart to suffer from akathisia, an adverse drug effect, prior to his death. Dolin was awarded compensation for both Stewart's Paxil-induced death and for Stewart's Paxil-induced suffering prior to his prescribed demise.

The Dolin trial, which lasted six weeks, ended with the jury awarding Wendy Dolin $3 million. But GSK appealed and the jury's decision was later overturned by the Seventh Circuit Court of Appeals. The overturned ruling didn't relate to the jury's finding that Paxil caused Stewart's death. Rather, it related to whether the label and failure to update the label, was the responsibility of GSK or the FDA. Dolin appealed but the Seventh Circuit refused to reconsider its decision to overturn the verdict. Dolin has taken her case to the Supreme Court where attorneys representing victims of Fosamax were yesterday.

A bit confusing, perhaps, but in short: Dolin won and GSK appealed. GSK won and the Dolin case is now in the hands of the Supreme Court.

Dolin's attorneys, Baum Hedlund, likely kept tabs on yesterday's proceedings given Merck's defense is similar to GSK's. The pharmafia conveniently blames its buddies at the FDA because partners in crime don't squeal on each other. Their silent pact sometimes helps both legally avoid responsibility for harming and killing unsuspecting consumers.

Like GSK, Merck is attempting to blame the FDA. Both companies try to adeptly muddy the legal waters so much so that jurors-even those who find the product causes adverse effects-become confused about who, exactly, should be accountable for faulty labeling and related tragic outcomes.

In cases such as Dolin vs GSK, it seems the amount awarded to plaintiffs is sometimes reduced not because the jury doesn't believe the product causes harms, but because the jury is effectively confused by pharma's legal strategy to "blame" its FDA pals. At the end of the day, pharma execs and FDA regulators likely slap each other on the back over dinner and drinks and cryptic "atta boy" correspondence. The end result is that consumers harmed by pharmaceutical products are further harmed by these cozy corporate/FDA ties.

Stress Fractures vs Emotional Lability

Merck is claiming that the FDA denied Fosamax label updates after it was learned a large number of atypical femoral fractures occurred among Fosamax users. Merck claims it proposed a change to the label but the FDA told them the wording in Merck's new proposal was inadequate. The FDA's complete response letter, in essence, said it didn't believe Merck had done a decent job with their proposal to change the label. Therefore, the FDA covers itself by responding to pharmaceutical companies and pharmaceutical companies understand they are essentially off the hook given the FDA won't follow up regarding proposed label updates and pharma won't either.

Merck did indeed inform the FDA about Fosamax related fractures but Merck labeled them stress fractures and not atypical femoral fractures. Thus, when the FDA read Merck's proposal for a label change they may have assumed these stress fractures were a relatively minor adverse drug effect. The FDA tends not to include extensive risk info in patient information leaflets because doing so might prevent consumers from seeking drugs as "treatment."

GSK used the same Merck tactic with its Paxil product after it was forced to acknowledge the number of suicides related to Paxil that occurred during Paxil clinical trials. GSK didn't tell the FDA that Paxil can cause adults to end their lives when suffering from a terrifying Paxil-induced condition called akathisia. Instead, GSK labeled suicidality as "emotional lability" just as Merck labeled atypical femoral fractures as simply "stress fractures."

Tossing the Egg

Imagine the CEO of an egg factory learns that many eggs contain bacteria that can cause serious harm and/or death to consumers. The CEO contacts a government regulator and says they have a problem. The government regulator doesn't think it's a severe problem and simply tells the egg factory to monitor the situation. But the egg CEO only told the regulator part of the story, stating that many eggs were cracked. The CEO didn't mention the bacteria inside the eggs that had grown as a result of said cracks.

It's a win-win for the egg factory. They can continue to sell eggs that are cracked, further, if a wrongful death lawsuit is brought against them, they can deny liability by stating, "We warned the government regulator but they decided not to do anything about the problem."

Both GSK and Merck had secrets hidden in their cracked eggs. The eggs were never fully opened by either company and the FDA only took a sneak peek through the cracks. GSK and Merck don't believe a jury should decide whether the FDA would have approved a label update had either company submitted an updated label change after receiving a first response from the FDA. Both companies claim the FDA wouldn't have sanctioned a second proposed label change. These companies are making assumptions, assumptions they aren't entitled to make despite that the CEO's likely have learned what to expect from their FDA friends.

Why nobody has thought to subpoena the current FDA Commissioner, Dr. Scott Gottlieb, is beyond me. Put Gottlieb on the stand, make him take an oath and ask him the very same questions the judges and legal teams are fighting over. Then again, Gottlieb would probably side with the drug companies given the FDA's incestuous relationship with pharma.

GSK, Merck and the FDA enjoy having their cake and eating it, too. But I doubt they use cracked eggs when together they cook up their half-baked legal excuses.

Bob Fiddaman



Merck Supreme Court Transcript

Wendy Dolin Petition to Supreme Court


Friday, October 26, 2018

MISSD October Akathisia Awareness Month



October: National Akathisia Awareness Month?

It’s no secret many health-related organizations deploy special awareness months to gain media coverage that promote strategic goals. It seems autumn is a particularly busy time of the year for such given September was Suicide Prevention Awareness month and October is American Pharmacists month.

There’s no shortage of advocacy organizations and months designated to wellbeing, but few are specifically focused on adverse drug effects despite that they are a leading cause of death. One reason this public health concern is barely an audible whisper is because safe patient and consumer advocacy organizations seldom have big corporate donors and large marketing budgets.

While public health and safety organizations don’t readily attract corporate sponsors, there is something authentic advocacy increasingly does have: a growing network of concerned citizens, caregivers, healthcare professionals, patient advocates, and friends and family dedicated to creating positive change. Recently I was fortunate to see old friends and hundreds of new faces at the MISSD annual fundraising event. I’ve noticed every year the turnout increases and MISSD might soon need a larger event space. This is one challenge nonprofit foundations surely welcome.


MISSD, which stands for the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin, has had a busy year filled with worthy accomplishments. For all the below reasons, MISSD gets my vote for October as National Akathisia Awareness month.

Making Akathisia A Household Word

To better educate the public about akathisia, this year MISSD:
·        Created a free, accredited Akathisia 101 continuing education course available to all at missd.learnupon.com
·        Rolled out a strategic public awareness campaign to include large signage on Chicago buses and trains 
·        Presented at several national and local conferences, universities, veteran’s groups, etc.

·        Released a public service video to help illustrate what Akathisia sometimes looks like, particularly in severe cases 

Wendy Dolin (right) with her sister, Marcy

At their annual conference in Toronto last week, the International Society for Ethical Psychology and Psychiatry (ISEPP) announced Wendy Dolin, MISSD Founder, is the recipient of this year’s ISEPP Special Achievement Award. The award is intended for a professional or non-professional who has made a significant specific contribution to challenging the conventional mental health system.

It’s great to see efforts to create akathisia awareness and education are valued. Far too many people have learned about akathisia the hard way, but through public education and increased awareness we can prevent avoidable suffering and deaths.

ISEPP Special Achievement Award Citation:


Wendy Dolin is a therapist and activist who founded MISSD, which is an acronym for Medication Induced Suicide in Memory of Stewart Dolin. Stewart was Wendy’s husband of 36 years and a successful senior member of the international defense firm, Reed Smith in Chicago. In July 2010, one week after being prescribed paroxetine for work stress, Stewart ended his life by jumping in front of an oncoming train. This started Wendy’s painful search for an answer and her mission to educate the community about medication-induced suicide. She discovered that the drug company GlaxoSmithKline had been concealing the suicide risk associated with paroxetine and so launched a lawsuit. In March 2017, a jury concluded that the drug manufacturer failed to warn about the suicide risk and awarded Wendy $3 million in damages. However, an appeal court just recently overturned the ruling. Wendy will be petitioning the U.S. Supreme Court to review the case. Wendy’s outstanding efforts to uncover the harmful effects of psychiatric drugs and her devotion to her husband’s memory is inspiring and warrants the receipt of ISEPP’s Special Achievement Award.”

Kristina Kaiser Gehrki






Monday, October 22, 2018

GSK Study 356 - The Truth is Out - 25 years Too Late!




Regular readers of the Fiddaman blog may have been keeping a close eye on an old study from the early 90's (08 Apr 1993 – 25 Oct 1994) that I've recently found via GSK's clinical trial registry website.

The study, known as GSK Study 356, reported 7 suicide attempts (2 of which were completed suicides). However, these attempts at suicide are not mentioned within the documents GSK has made public. Moreover, the actual number of suicide attempts in Study 356 was 9. (2 of which were completed suicides)

How do we know this?

Documents obtained from the Australian drug regulator, the TGA, show us this but strangely do not tell us in which group the attempts at suicide occurred...until now.

For those who are unfamiliar with the study, it was, to my knowledge, an attempt at finding which of the two antidepressants, namely Prozac and Paxil, were better at treating major depression. The study was sponsored by GSK.

After posting two blogs on the subject, GSK Study ID - 29060/356 - The Missing Suicide Attempts and No Action to be Taken Against GSK for Hiding Suicide Data, the TGA have written to me in efforts to clarify what was revealed by me last month.

However, rather than trying to add clarity to my previous two blogs, the TGA has opened a pretty big can of worms.

In asking them why GSK failed to report the missing suicide attempts they told me the following. It makes for very interesting reading.

Good Afternoon Mr Fiddaman

I have followed up your enquiry about the presentation of information about the Clinical Trial - GSK Study ID - 29060/356 on the GSK study website.

The nine events you have referred to were discussed with investigators at a meeting on November 26th 1993, whilst the study was still ongoing and blind.  Seven of those same events were also included in the Dear Investigator Letter which went out to investigators in August 1993. Of the nine events that were discussed with the investigators five events were subsequently coded to the WHO preferred term of drug abuse, through the methodology applied at that time. On the trial summary these are presented as cases of “Drug Abuse (Overdose)”. There were two of these recorded for paroxetine (patients 139 and 147) and three of them recorded for fluoxetine (patients 18, 76 and 144) 

The remaining four cases were coded to the WHO preferred term of “Suicide Attempt”. On the trial summary two of these events are listed as “Suicides” (in the fatal SAE section) with one for paroxetine (patient 92) and one for fluoxetine (patient 122). The two other cases are presented as “Suicide attempt”, both for fluoxetine (patients 87 and 142).

The information as presented in the clinical trial summary accords with the safety information as provided in the full study report.

I trust that the information provided is of assistance.

Regards

Bernadette Barton 
Assistant Director
Adverse Event and Medicine Defect
Pharmacovigilance and Special Access Branch

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia

--

So, there you have it, folks. The missing suicide attempts were coded as "drug abuse." They did this, according to the TGA, because this was the preferred term, at the time, used by the World Health Organisation (WHO)

So, breaking down the 9 who attempted suicide we have 6 from the Prozac group and 3 from the Paxil group. (1 patient from each of the groups completed suicide)

It's a head-scratcher for me - why would WHO use such a system?

The medical definition of "suicide attempt" and "drug abuse" differ somewhat.

Suicide Attempt
A non-fatal, self-directed, potentially injurious behavior with an intent to die as a result of the behavior; might not result in injury

Prescription Drug Abuse
Taking medication in a manner or dose other than prescribed

This begs the question: How many other GSK sponsored studies buried suicide attempts in the drug abuse category?

Study 356 was carried out in the early 90's. By the late 90's there was growing concerns regarding Prozac, the concerns surrounding Paxil came later.

Here's a Guardian article from 1999. I'll just post the sub-heading and the link:

It was too good to be true. Prozac, the wonderdrug hailed as the answer to the war against depression and taken by some 37 million people worldwide, is not as harmless as we've been led to believe. Disturbing evidence has now emerged, showing that, after the initial relief and euphoria of the first dose, Prozac can push some patients into so agitated a state of mind that they are a danger not only to themselves, but to others, too. (Full Article)

One has to remember here that Study 356 was sponsored by GSK, the manufacturers of Paxil who, at the time, wanted Paxil to be the blockbuster drug that Prozac already was.

Would doctors have prescribed Prozac knowing that there was a high ratio of suicides in a clinical trial - personally, I think they would have. The marketing for these two drugs was heavy and included incentives for doctors to prescribe them. Eli Lilly reps dining and dashing', whilst GSK reps would persuade doctors at strip bars, amongst other places.

Now we know. It's taken the best part of 12 months to get to the bottom of this study, a study that is almost 25 years old!, and I couldn't have done it without the help of Kathy, who is the moderator of the Facebook page,  Australian Antidepressants Class Action & Awareness and an administrator for the Australians For Safe Medicines Facebook page.

Special thanks to the TGA too. They seem a little bit more transparent than their counterparts, the FDA and MHRA.

The British, American, and, indeed, Australian media are disinterested.

Bob Fiddaman







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