MASS KILLINGS IN PICTURES

If you're concerned about a family member or friend who you know is taking psychiatric medication, please inform yourself by taking the Akathisia 101 course.
It's FREE to take.

You just may be able to help someone in their hour of need.

Bob Fiddaman

Now watch the following.

 

Bob Fiddaman

Special thanks to Antidepaware, SSRI Stories, CCHR International and Murderpedia

When A Stranger Calls (Part One)

Guest post from Kristina Kaiser Gehrki

Halloween Isn't the Scariest Day in US Schools

Most people don't realize the Celts brought the first Halloween tradition to America. What started out as turnip carving in Ireland, morphed into pumpkin carving in America. In typical US fashion, Americans turned Halloween into a booming business. Nearly 70% of Americans are celebrating Halloween today with retail spending reaching $9 billion. 

The American version of Halloween excess is steadily crossing back over the pond given nearly 50% of all UK residents are celebrating Halloween. But while this holiday trend isn't scary, another US trend invading the UK is cause for concern: compulsory mental health education for children. Starting in 2020, all English children will receive mental health education lessons purportedly "to tackle the rise in mental health issues." 

Last year, I spoke with an Ohio parent who shared concerns about her son's school health curriculum. It was an important topic I planned to write about for some time as it prompted reflection on my own experiences as an educator and parent. I've worked on several national programs that benefited children and taught in one of America's largest and highly-rated school districts. Helping students identify their unique talents and develop resiliency needed to live happy, productive lives was a worthy endeavour I thoroughly enjoyed. I'm all for effectively alleviating children's stress and suffering to improve their future outcomes. Why then does England's new mandatory mental health education set off alarm bells in my head? 

Identifying Students At Risk for Mental Illness

Shortly before I retired from teaching, I noticed several changes in my district's annual mandatory teacher training. There were new requirements regarding mental health and suicide prevention. Being the mother of a teen who died an akathisia-induced death, I was initially pleased to see my suburban Washington DC school district was focused on improving children's wellbeing. Regrettably, I soon learned that much of what teachers and students were being taught about mental health was woefully inadequate. Some information was misleading and false. 

During one mandatory Fairfax County Public Schools (FCPS) teacher-training session, a school social worker gave a lecture about self-harming behaviors. I raised my hand and shared it may also be important for school personnel to know what, if any, drugs children have been prescribed given that research finds an increased risk of developing self-harming behaviors among children taking SSRIs. I mentioned akathisia and some of the physical components children suffering from akathisia might exhibit in the classroom. This includes frequently getting out of their chairs to walk around the room, rocking back and forth and incessantly swinging their legs while seated. The school social worker responded that this information was "too complicated" for teachers and that, basically, once teachers made student referrals, "mental health professionals" would take it from there.  

The next school year began with more training in which critical information was omitted. Teachers were instructed to informally assess students who were "at risk" of mental illness and start an intervention by referring these students to the school counselor. The counselor could then meet with the student, call the parents, refer the student to the school psychologist, who might then refer the student for services outside the school district. During the 2016-17 school year, FCPS made 4,415 consultations with "outside providers." Specific data regarding these 4,415 referrals isn't provided, but judging from the teacher training info, it's logical to presume many of these students were referred to psychiatrists.

While I had always planned to return to my communication career after my own children went to college, my retirement from teaching came at a time when teachers were very stressed trying to successfully do more with less. Many class sizes were increasing and curriculum was expanded to meet the new state testing requirements. When discussing the subject of student mental health referrals, some teachers were worried they might miss possible signs of at-risk student behaviors. Others felt that teachers were supposed to teach subjects, not recruit subjects. 

This isn't to say teachers didn't want to do their best to help children. We chose teaching because we cared deeply about children, so much so that we didn't want to unwittingly do something that might hurt children by starting a referral process that could lead to possible misdiagnosis, a mental illness label and prescribed harm. Teachers are well aware that most parents dread receiving a phone call from their child's school. To receive such a call from a stranger might be particularly distressing, especially if it was prompted by a teacher's misperception. As a result, we sometimes found ourselves in a difficult Catch 22. 

Who's Checking the Children? 

Thinking about my previous conversation with the Ohio parent who expressed shock when her son's health class provided instruction that specifically mentioned brand-name drugs to include the SSRI Prozac (fluoxetine), I decided to attend the annual FCPS Mental Health and Wellness Conference last month. I wanted to see if what is happening in my home state of Ohio is also happening in school districts across America, and perhaps soon, across the globe. The district-wide conference provided parents and community members with an array of sessions to include:

•  "Attention-Deficit/Hyperactivity Disorder (ADHD): Signs, Symptoms and Why Testing is a  Good Idea"
•  "Educate Before You Medicate"
•  "The Neurobiology of Stress & Anxiety: What Teachers, Parents and Students Need to Know"

In addition to the break out sessions, time was built into the schedule so attendees could visit with many of the conference exhibitors and obtain their organization's information. Exhibitors included the National Alliance on Mental Illness (NAMI) and Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD). 

I left the conference with many treats to include free pens, notepads and refrigerator magnets emblazoned with organizational logos similar to what doctors receive from drug companies. In the days that followed, I began thinking about a horror flick I saw as a teenager titled, "When a Stranger Calls." The storyline is about a high school girl who is traumatized during an evening of babysitting. A deranged man repeatedly calls her and asks, "Have you checked the children?" The police try to help her and soon discover the disturbing calls are actually coming from inside the house.

Part two of this blog post will discuss the scary details of the conference sessions I attended. I won't share them today because doing so might adversely impact one's ability to have a happy Halloween. 

Kristina Kaiser Gehrki is a public health and safety advocate who believes our most important knowledge stems from personal experience. She holds degrees in strategic communication, journalism and education. Her teenage daughter, Natalie, died a prescription-drug-induced death after suffering SSRI adverse drug effects that were undiagnosed by her doctor and improperly treated with SSRI dose increases.

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

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

Is GSK's Horlicks a Medicine, Asks Judge

I'm strong to the finish, 'cause I eats me Spinach

Following on from an earlier post of mine that the British and American media don't seem to be interested in, sees GlaxoSmithKline (GSK) lawyers in Bangladesh argue that GSK do not need permission to sell Horlicks in Bangladesh. Further, it sees the judge ask GSK if Horlicks, a malt drink marketed and manufactured by GSK, is a medicine, given the claims on the product label.

New Age Bangladesh is reporting that, on hearing both arguments, the judge asked GSK's legal team, "Is it a drug? Do you have drug administration’s permission?"

Several claims have been made on GSK's Horlicks, including that the consumption of it can "make you grow three times faster."

Glaxo Chairman and General Manager Failed to Show for Court Hearing

This from the New Age...

Prosecutor Kamrul Hasan said that on its label Horlicks contains words like ‘taller’, ‘stronger’ and ‘sharper’ next to the brand name, which may give rise to the idea among consumers that they needed to rely on the product for gaining the qualities. 

Kamrul said that the label further confirmed that their claim was proven ‘clinically’.

‘I challenge defence lawyer to prove its claim before the court,’ said Kamrul.

The label of Horlicks Classic Malt, Kamrul said, discusses about Horlicks drinkers showing five signs of healthy growth— ‘bone circumference’, ‘strong muscle’, ‘heightened concentration’, ‘healthy blood’ and ‘gaining weight rightly’. 

The label also listed numerous health benefits of drinking Horlicks, including the strengthening of bones and muscle, development of the brain, improving metabolism and ‘blood health’ necessary for a strong immune system. 

Kamrul said that the label even claimed that children might not get the necessary nutrition from regular food and their nutrition demand could be met by drinking Horlicks daily. 

Arrest warrants have been issued for GSK's chairman, M Azizul Haque, its General Manager, Prashanta Pandey and Azim Uddin Ahmed, chairman of Mutual Food Products Limited, the company responsible for processing and packaging of Horlicks in Bangladesh.

Haque and Pandey failed to show for the court appearance whilst Ahmed was present during the hearing and later granted bail.

It seems as though the longer a product stays on the market, the more manufacturers can make outlandish claims, as long as they add the words "clinically proven" next to the claim. GSK also claims Horlick's is 'clinically proven' to improve attention and concentration. Begs the question why they don't market it as an ADHD drug!

How on earth did we get from this...

...to this...

('clinically proven' to improve attention and concentration')

Nothing to do with the Beecham Group (now GSK) acquiring Horlicks in 1969, huh?

If one thing, it shows us how the power of marketing has improved over the years, even though it's all based around exaggeration as depicted in the popular Popeye cartoons of yesteryear. Glaxo has taken the Popeye cartoon and basically added to it a whole bunch of claims that they maintain are 'clinically proven.' I'm with the prosecutor on this one, "I challenge defence lawyer to prove its claim before the court."

Next thing we know, GSK will be claiming that their Lucozade sports drinks are better than water...Oh, hang on a minute, they already made that false claim (Source)

Or maybe that Ribena really is full of vitamin C, yup, they got busted for that too, by two pesky schoolgirls! (Source)

They may even claim that their popular antidepressant, Seroxat, also known as Paxil, is non-habit-forming - Oops (Source)


Bob Fiddaman

Back Story

Bangladesh: GSK Chairman & General Manager Could Face 7 Years in Prison

Breaking... Antidepressants cause Majority Withdrawal Symptoms

It's not often I write two blog posts in one day but as I hit the 'publish' button on my last post the following dropped into my Twitter feed.  - " a major new study suggests millions of patients are experiencing drug withdrawal. (LINK)

I just have this to say, for now:

SHAME on all those healthcare professionals, including GPs, NHS staff and psychiatrists, both on the NHS and Independent, who have, for years played down the severe withdrawal effects of antidepressants. Tonight, I hope you all sit down and read the study thoroughly. I hope every single one of you who have told your patients "It's the illness and not the drug" go on to social media websites tomorrow and apologize to all those you have ignored or dismissed over the years, I hope you can do this without spouting any irrelevant nonsense that "antidepressants benefit millions of people and they are life-saving."

You all need to apologize for being part of this wanton ignorance, you need to apologize for some of the abhorrent behaviours I have witnessed on Twitter this past week or so too.

I started this blog 12 years ago because I suffered severe withdrawal effects of the antidepressant Seroxat, known elsewhere as Paxil and Aropax.

12 long years of banging the drum only to be ridiculed online by medical 'professionals' - I've been labelled a 'smeary conspiracy theorist', a racist, a misogynist, a paedophile, and, more recently, a far-right Scientologist, all in efforts to silence me, all in efforts to stop people reading my work.

Other bloggers, most notably 'Truthman' have been doing the same - he too has been labelled by so-called medical professionals.

Shame on you, shame on you all.

The question now is - What are you going to do about it?

The Royal College of Psychiatrists President, Wendy Burn, has promised a meeting in November this year, although when asked to provide a list of those attending the meeting she has failed to respond. One tweeter summed this up with...

All a bit of a mystery - a meeting in November somewhere organised by someone to discuss something with some people.

— Fiona French (@benzosarebad) October 1, 2018

The new study found that over the past 20 years, "56 per cent of all patients on antidepressants suffer withdrawal symptoms, of which 46 per cent said their symptoms were severe."

Study researchers also found, "that it’s ‘not uncommon for patients to experience symptoms for several weeks, months or longer’, with some having debilitating symptoms for years."

One would expect me to be joyous about this new study. I'm not. For many years now patients who have struggled and continue to suffer because of long-term use of antidepressants, have been sneered at, ridiculed.

I am, in fact, very angry that it's taken this long to show healthcare professionals that they have been wrong for many years - they should have known they were wrong when faced with patients self-harming, showing signs of aggression, showing signs of memory loss - instead they chose to increase the dose or add another brain pellet to the mix.

Shame on you all, you uncaring, sociopathic bastards!

Bob Fiddaman.

Bangladesh: GSK Chairman & General Manager Could Face 7 Years in Prison

(Left) M Azizul Haque GlaxoSmithKline Chairman. (Right) Prakash (Prashant) Pandey GlaxoSmithKline General Manager

"For increasing sales, the accused adopted a host of heinous tactics."

It never rains but it pours.

Incidentally, I love rain.

None of the British media has picked up on this, or indeed any other country apart from Bangladesh.

The New Age of Bangladesh, a leading English language daily newspaper, is reporting that an arrest warrant against, M Azizul Haque, who is the chairman, and Prakash (Prashant) Pandey, who is the general manager of GlaxoSmithKline Bangladesh, has been issued for cheating consumers through deceptive advertisements of Horlicks.

Kamrul Hasan, who heads the Department of Inspection for Factories and Establishments in Bangladesh said, "For increasing sales, the accused adopted a host of heinous tactics."

GSK and heinous tactics, surely not?

This from the New Age:

Horlicks Classic Malt

On the label of Horlicks Classic Malt, Kamrul said, five signs of healthy growth are talked about — ‘bone circumference’, ‘strong muscle’, ‘heightened concentration’, ‘healthy blood’ and ‘gaining weight rightly’ — which are confusing and misleading.

The label also listed numerous health benefits of drinking Horlicks, including the strengthening of bones and muscle, development of the brain, improving metabolism and ‘blood health’ necessary for a strong immune system.

Kamrul said that the label even claimed that children might not get the necessary nutrition from regular food and their nutrition demand could be met by drinking Horlicks daily.

‘This is not medicine and a food item cannot ensure so many health benefits alone,’ observed Kamrul.

 Mother’s Horlicks

Staggeringly, on the label of Mother's Horlicks GlaxoSmithKline claimed, "it helps the baby grow in the mother’s womb."

GSK didn't just add these outlandish claims to the labels, Kamrul said, "GSK was seen making similar claims in adverts meant for television consumers and Facebook users."

This from the New Age:

GSK was cheating people by bringing to market a variety of Horlicks products, targeting different groups of consumers like women, children and mothers.

The verified Facebook page of Horlicks Bangladesh show mothers continuously interacting with its updates, mostly being similar advertisements, sharing their desire to feed Horlicks to their kids, often aged about three.

A warrant for the arrest of Azim Uddin Ahmed, chairman of Mutual Food Products Limited, the company responsible for processing and packaging of Horlicks in Bangladesh, was also issued.

If the allegations are proved, the accused will face seven years’ imprisonment or heavy fines, or both.

Here's an example of the misleading ad Glaxo have broadcast across Bangladesh.

A spokesperson for GSK said, "We have not received any notice on the mentioned issue from Bangladesh Food Safety Authority; hence are unable to comment on it now."

Bob Fiddaman

Spin Doctor or Bullying Victim?

David Baldwin Alleges Harassment

Spin Doctor

a person (such as a political aide) responsible for ensuring that others interpret an event from a particular point of view.

Extra, extra, read all about it!

Today's headlines in The Times and Daily Mail were designed to attract attention. Their headlines suggest their articles are about a government advisor being bullied online. Like many headlines, I believe these two are misleading.

The Times runs with, "Drugs adviser David Baldwin quits after being branded ‘worse than Hitler’ in online abuse row." The Daily Mail uses, "Government drugs advisor QUITS after sustained campaign of abuse that saw him branded 'worse than Hitler' over his stance on antidepressants."

It's important to note that both newspapers omitted the word "alleged."

They have stated Baldwin's claims as fact.

Baldwin's Hitler claim caught my attention as I was once threatened by GSK's attorneys when I wrote these exact words regarding a GSK employee back in 2008. Today I was struck by Baldwin's claim because 1.Baldwin quoted a phrase from 2008 that was identical to the one I said about a former GSK employee and 2. There is no evidence that anyone on social media or any blogger has said this about Baldwin.** (Update at foot of post)

Baldwin, who is no stranger to controversy, claimed pressure from bloggers and social media forced him to resign from the Prescribed Drug Dependence and Withdrawal Panel for the forthcoming Public Health England review. Baldwin would have represented the Royal College of Psychiatrists.

One would think Baldwin had a stronger backbone given his profession freely assigns labels to all and sundry. What's good for the goose, huh? I, and other advocates are often labelled "conspiracy theorists" and "pill-shamers" for speaking out about drug safety and efficacy. Apparently, we must have stronger backbones given we don't throw hissy-fits and quit.

What's worse, having your behaviour elicit the label "pharma-whore" or being subjectively labelled "mentally ill"? The first label suggests one takes money from drug companies to peddle their products, the second emphatically declares is not of sound mind. I know which label I find more offensive.

However, the alleged name calling isn't really the issue here. Baldwin's bullying claim is a sneaky tactic used by Baldwin and RCP to deflect attention from the real issue: Taking drug money while promoting the drugs. Undoubtedly, if Baldwin had been brave enough to sit on the panel he would defend these products to infinity.

Smoke & Fire

Did Baldwin really quit because he didn't like the names he was being labelled? In the field of public relations, false reasons are often given when a person resigns or quits. Perhaps, Baldwin quit because where there's smoke there's fire. It's bad enough his pockets are lined with unethical drug money. It's possible further enquiries would uncover more conflict of interest.

Bullying Those Who Suffer

Earlier this year, Baldwin and RCP President, Wendy Burn gaslighted all who have suffered adverse drug effects from the pills they promote as "antidepressants." They said, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment." (Fig 1)

(Fig 1)

Baldwin now claims this statement is supported by the National Institution of Clinical Excellence (NICE). It would be interesting to learn just how many patients NICE see on a daily basis.

To quiet the critics of this joint statement, Burn has somewhat retreated. She now claims in her "clinical experience" she has not seen problems with discontinuing drugs marketed as antidepressants. Burn states via Twitter she treats and prescribes these drugs to patients over the age of 60. She has received drug company money in the past but doesn't take it anymore. In a conversation with blogger, The Truthman, she told him, "I stopped taking money because I saw how it looked…" It's a pity she couldn't have relayed this to Baldwin.

The keywords in the above statement are "vast majority." Most people who suffer adverse drug effects don't appreciate having their prescribed harm diminished by doctors. Both Burn and Baldwin have had plenty of time to retract their statement and apologize. For whatever reason, they choose not to.

Super sleuth and podcaster James Moore queried the Times comment as it didn't tally with RCP's own study carried out and published on their own website. In that study, RCP learned that 63% of people suffered from antidepressant withdrawal. Once Burn was contacted by Moore, RCP removed the study from their website claiming, "It was out of date." However, due to the marvels of the Internet, the results of RCPs own study can be seen here.

Pharma-Whore

It is unknown when the term 'Pharma-Whore' was first introduced. It's been used many times to describe someone who takes money from drug companies and then promotes drug company products. Sometimes this promotion is through prescribing and sometimes it is through biased research and spin doctoring.

Why Baldwin feels his salary isn't enough for him to live on is beyond me. He is responsible for his unethical conflict.

In a 2003 article in The Guardian, Baldwin declared a personal interest in Lundbeck. The company makes the"antidepressant" called Citalopram, also known as Celexa in the US. Baldwin has also participated in advisory boards for SmithKline Beecham (Seroxat, Wellbutrin), and Eli Lilly (Prozac).

The Truthman wrote an interesting blog on Baldwin entitled, "Professor David Baldwin’s Lovefest With The Pharmaceutical Industry. Truthman said Baldwin was "instrumental in the promotion of Seroxat in the late 90’s." In 1998 Baldwin stated, "it (Seroxat) was one of the safest drugs ever made." Professor David Baldwin was also the lead coordinator of the European trial on paroxetine (Seroxat) for “social anxiety disorder.”

The Bloody Aftermath

Baldwin and Burn would have been wise to apologize and retract their joint statement. People are dying violent, bloody deaths that are due to drug withdrawal. This is not my opinion, violence against oneself and others is often precipitated by akathisia. There are four types of akathisia to include withdrawal.

After their joint comment in The Times, a formal complaint, headed by Dr John Read, a psychologist and mental health researcher, was lodged to the RCP. The complaint was dismissed by RCP without a full investigation and with no right of appeal. A new complaint was then sent to the new Secretary of State for Health and Social Care. It informed that “the Royal College of Psychiatrists is currently operating outside the ethical, professional and scientific standards expected of a body representing medical professionals.” It's presently unknown if the Secretary of State replied.

The spin-doctoring from Baldwin is regrettable when you consider human lives hang in the balance.


Bob Fiddaman

** The 2018 'worse than Hitler' claim reportedly came from a comment left on a blog post. (Not this blog, I hasten to add)

Back Stories

RCP Remove Damning Antidepressant Document From Website

Royal College of Psychiatrists - 63%

Scooby and Those Pesky Tweeters Rumble Psychiatry

Royal College of Psychiatrists Dig Deep Abyss

Royal College of Psychiatry: "Unprofessional Conduct"

Other "Conspiracy theorists" and "Pill-shamers" discussing David Baldwin can be viewed at the following links.

GSK Licence to [Kill]

Hole Ousia

Mad In America

Mad in the UK

No Action to be Taken Against GSK for Hiding Suicide Data

Earlier this month I posted previously unseen documents that clearly showed how GlaxoSmithKline (GSK) hid 9 suicide attempts from the results of a 1993 clinical trial posted on their website. See - GSK Study ID - 29060/356 - The Missing Suicide Attempts

The documents were sent to me by '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.

After publishing my findings, Kathy wrote to the Therapeutic Goods Administration (TGA) and asked if they would be taking action against GSK for failing to report the 9 suicide attempts in the Aropax clinical trials, known as GSK Study #356.

The TGA's response is staggering, to say the least.

Dear Kathy

Thank you for emailing the Therapeutic Goods Administration (TGA). I acknowledge your concerns about the GSK clinical trial (A double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability) that was conducted in 1993-1994.  However, the TGA is unable to comment about the clinical trial as it was completed twenty four years ago.

As has been explained to you previously, the TGA’s safety monitoring is based on rigorous pre-market assessment and then the post-market signal investigation area of the TGA monitors the safety of medicines, to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials.

Thank you for your interest in medicine safety.

Regards

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

--

On the 'About TGA' section of their website, they state: "TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products.

Just to be clear, the results of GSK Study #356 failed to mention 9 suicide attempts, moreover, they failed to say which group these 9 suicide attempts pertained to. Study #356 had two active drugs, namely paroxetine and fluoxetine, both of which are selective serotonin reuptake inhibitors (SSRIs). There was no placebo group in the study.

As a regulator who claims to "manage any risks associated with individual products" I am utterly gobsmacked by their response above.

Surely a regulator should be asking GSK why they failed to include these 9 suicide attempts. Surely they should be telling GSK to publish the correct statistics and not a watered down version of what actually occurred during the study.

In essence, the TGA is saying, we don't care if the public doesn't know how many suicide attempts occurred in either the paroxetine or fluoxetine group. We don't care that GSK failed to report that the percentage of suicide attempts was a staggering 11.11%. We don't wish to manage these risks, even though we claim on our website that we do. We don't care the public isn't armed with this information when visiting their doctor or psychiatrist. We don't think 9 suicide attempts in a clinical trial is important.

I find the last line of the email kind of ironic: "Thank you for your interest in medicine safety."

Are they taking the piss?

Bob Fiddaman

GSK Study ID - 29060/356 - The Missing Suicide Attempts

Fluoxetine - AKA Prozac
Paroxetine - AKA Aropax, Seroxat, Paxil

Study ID - 29060/356
A double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability.

Snapshot was taken 3rd September 2018

Study ID - 29060/356/_1
Extension phase for a double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability.

Both studies appear on the GSK Study Register website, the second study is a continuation (extension) of the first.

As you can see, both studies were double-blind, which means neither the patient or investigator knew what drug they were taking/prescribing. After the trials have been completed, GSK can break the code and find out on which drug the adverse events occurred. In this case, one suicide in the paroxetine group and one in the fluoxetine group; no suicide attempts in the paroxetine group, and; two in the fluoxetine group, one of which was a completed suicide. In both groups, there was one suicide each, both were women.

According to recently obtained documents from the Therapeutic Goods Administration (TGA), the #356 trial reported 7 suicide attempts* (2 of which were completed suicides). However, there is no mention of the 5 attempted suicides on the GSK Study Register website, at least not for paroxetine. They do, however, cite two suicide attempts for patients taking fluoxetine during the trial, one of which was a completed suicide.

*Further, more documents show that there were in fact 9 suicide attempts in Study #356, however, there is no mention of this on the GSK Study Register website.

Masking the suicide attempts
GSK report that there were 6 subjects with non-fatal serious adverse events (SAEs) in the paroxetine group and 10 in the fluoxetine group. A total of five (2 paroxetine, 3 fluoxetine) are in the Drug Abuse (Overdose) category.

Drug overdoses
Could these be deemed as attempted suicides or were the overdoses unintentional? If, indeed, they were attempts at ending one's own life, then why is it not reported as such? Well, according to recently obtained documents, no suicide attempts were made by overdose.

Therapeutic Goods Administration (TGA)
Who are the TGA?

The TGA  is Australia's regulatory authority for therapeutic goods. They carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. They are the American equivalent of the FDA and British equivalent of the MHRA.

The Previously Unseen Documents for Study ID - 29060/356
These were obtained under the Freedom of Information Act and forwarded to me by 'Kathy' who runs the Australian Antidepressants Class Action & Awareness Facebook page. Kathy copied me in on a lot of the correspondence between herself and the TGA. The process of obtaining the following documents took a considerable amount of time; I'd estimate the best part of a year. Kathy's tenacity and doggedness paid off.

After initially requesting payment for the documents, the TGA apparently had a change of heart and released many documents pertaining to Study #356, most of which make for very interesting reading. Before I publish them, it's important you understand the reasons why there are many redactions (black-outs) in the documents. According to the Australian Freedom of Information Act 1982, there are a number of exemptions where certain information may be redacted. They include: protecting patient privacy; irrelevant material; documents disclosing trade secrets or commercially valuable information and; documents subject to legal professional privilege.

Human Research Ethics Committees (Australia)
It may be unethical for a researcher to continue a trial if:

(a) there are or have been substantial deviations from the trial
protocol;
(b) side effects of unexpected type, severity, or frequency are
encountered

National Statement on Ethical Conduct in Research Involving Humans

You'll hear more about the Human Research Ethics Committees (HREC) in the documents below.

First off, the two suicides...

32-year-old female 
Causality: "Possible"
Outcome: Death, maybe drug

46-year-old female
Causality: "Possible"
Outcome: Death, maybe drug

Attempted Suicides

According to the study posted on the GSK website, there were only two suicide attempts, both of which occurred in the fluoxetine group. One of these was fatal. However, the documents obtained from the TGA say something quite different. There is a contradiction as to exactly how many suicides attempts occurred. Firstly, according to a Paroxetine Clinical Study Meeting, Dr Sykes claimed there were 9 reported suicide attempts, two of which were completed suicides.

The study meeting, according to the document, was held on Friday the 26th of November, 1993

However, 4 months prior to Dr Sykes' claims, GSK, then SmithKline Beecham, sent a letter to all investigators involved in the trial. They stated, "...we have now received reports of 7 suicide attempts (including two deaths) for the 356 study comparing paroxetine to fluoxetine."

The letter, below, goes on to state how confident they are that, "the number of suicide attempts in this study is within that expected as a consequence of the depressive illness per se."

In other words, it wasn't the drug, it was the illness.

In between these two letters, we have a document from a Professor (dated September 1993). The letter was sent to the Research Ethics Committee.

GSK had made contact and told him about the suicides and suicide attempts. Here it gets interesting because it gives us the number of those enrolled (63). The Professor states, "...there have been seven suicide attempts including two deaths in the first 63 patients included in this Australian multicentre study." (11.11%)

The letter,, signed off by an Associate Professor at the School of Psychiatry, goes on to say how he had researched data and had found no evidence that either paroxetine or fluoxetine increase suicide rate or ideation in depressed patients. Remember, this was 1993 - no lawsuits had yet revealed the extent of those who had died or attempted suicide on paroxetine, or indeed Prozac.

In November 1993, the Research Ethics Committee ceased enrollments for the study because of the "reported cases of suicidal gestures'.  A review of the attempted suicides was needed before #356 could proceed.

#356 was halted and, it seems, an independent review of the study took place one year later. The independent review clarifies that there were actually nine suicide attempts, two of which were successful. In all, according to the review, there were 100 patients enrolled. The review, however, found no reason why the study shouldn't continue. (Attempted suicides = 9%)

Of the 91 patients who did not attempt suicide, the review states, "26 either withdrew or were withdrawn prematurely from the trial."  No reason is given for this.

According to the review, no suicide attempts were made by means of a drug overdose.

Here is the 25-page Independent Report.

Comment

Where are these missing suicide attempts? Why are they not reported on the GSK Study Register website?

There were 7 suicide attempts when 63 patients were enrolled (11.11%) . Surely this figure should have raised a red flag?

There were 9 suicide attempts when 100 patients were enrolled (9%) . Even this figure is astronomically high.

Investigators and review panels didn't really have much to go on back in 1993/94, apart from, of course, GSK's own information and published literature that was mainly ghostwritten by PR companies hired by GSK.

From the early onset of this study, GSK made it abundantly clear to investigators (prescribers) that there was no supporting evidence that suggested paroxetine could induce suicidal ideation. The study was double-blind so the patients and investigators didn't know what drug was being used.

Today, on the GSK Study Register website we see that since the study completion, GSK broke the code (so they could see what patient took what drug). They admit to having one suicide in the paroxetine group and one in the fluoxetine group. What they don't do, and they've had 25 years to rectify, is show us what drug caused the suicide attempts. According to the findings, we see no attempts in the paroxetine group and 2 (one completion) in the fluoxetine group. This would suggest that they also broke the code for the suicide attempts but only showed 2 (both in the fluoxetine group) when the documents obtained from the TGA show that there were 7 attempts when 63 patients were enrolled and 9 attempts when the enrollment reached 100.

The 356 Study that sits on the GSK website today doesn't really raise any red flags in its current format. With documents I've published today should we have a need to be concerned?

It is unknown in what group the non-fatal suicide attempts occurred. For all we know they could have all occurred in the fluoxetine group. I'm unsure why GSK have omitted such important data but I can speculate.

It leaves me wondering that if such a trial was carried out today, would the review board still claim there is no link between either paroxetine or fluoxetine and suicidal ideation?

Since the year of this #356 study (1993) GSK has paid $390 million for suicides or attempted suicides said to be linked to paroxetine. This has included an average of $300,000 to resolve 300 attempted suicide cases and an average of $2 million for 150 suicide cases. (Source)

The most recent paroxetine suicide case involves former corporate lawyer Stewart Dolin, whose life ended when he jumped in front of a Chicago Transit Authority train on July 15, 2010, while taking a generic version of Paxil. On April 20, 2017, an Illinois federal jury found GSK liable for Stewart Dolin’s death and ordered the pharmaceutical company to pay $3 million to Wendy Dolin. However, on August 22, 2018, the Seventh Circuit Court of Appeals overturned the verdict claiming, "GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case. Therefore, they said, the lawsuit should have been dismissed." Further, they added, "Court judges erred when they allowed to go to trial a lawsuit brought by Stewart Dolin's widow (Wendy Dolin)"

By 2000, Eli Lilly had reportedly paid more than $50 million to settle more than 30 Prozac (fluoxetine) lawsuits related to murders or suicides. There were also undisclosed settlements. While Prozac suicide lawsuits spiked in the 1990s, Lilly faced less litigation after the drug lost patent in 2001 and generics flooded the market. An FDA-required black box warning for suicide ended all “failure to warn” lawsuits. (Source)


Bob Fiddaman

Special thanks to 'Kathy' of the Australian Antidepressants Class Action & Awareness Facebook Group

Kathy is also an administrator for the Australians For Safe Medicines Facebook page.

She is now in the process of requesting suicide information from Venlafaxine trials in Australia.