Make A Stand - Call out the Financially-Driven FDA

 

With mainstream media outlets, seemingly, ignoring severe conflicts of interests between FDA Panel members with financial ties to vaccine manufacturers, Pfizer, it's no surprise that parents across the world will be soon telling their 5-11 year-old children to roll their sleeves up to be injected with a vaccine that, if government figures are to be believed, the majority of adults have already taken.

We can go one step further and quote the President of the United States, Joe Biden - president's don't lie, right, they never have, they never will.

“You’re not going to get COVID if you have these vaccinations.” Biden added, "This is a simple, basic proposition: If you’re vaccinated, you’re not going to be hospitalized, you’re not going to be in an ICU unit, and you’re not going to die."

These two statements by Biden will serve to put the US public at ease. Thanks' Joe. Nothing like reassurances from a world leader.

You'd have to be from the Planet Zog not to challenge Biden's claims, either that or be totally brainwashed by the leaning-left political media.

I shake my head at times, not at Biden, not even at CNN, my head shakes in disbelief at members of the general public whom have been so taken in by this absurd narrative.

Biden is wrong when he says ,“You’re not going to get COVID if you have these vaccinations.” Biden is also wrong when he claims, "This is a simple, basic proposition: If you’re vaccinated, you’re not going to be hospitalized, you’re not going to be in an ICU unit, and you’re not going to die."

Nonetheless, many of his voters will stand by these claims because, well, they elected him and he's much better than the other guy who was President.

I've seen nothing to suggest that he is, just a load of support on various social media outlets in the shape of various memes.

Biden has doubled-down and dangled a huge 'come gobble me carrot' in front of the FDA. Telling them, and the rest of the world, that the Administration has procured enough vaccine to support vaccination for the country’s 28 million children ages 5-11 years old, this before the FDA panel of 'experts' gave it the thumbs up. More about this decision below.

When something is wrong, say it's wrong. Biden isn't personally going to visit your home and condemn you for your lack of support. Trump isn't going to phone you up in the middle of the night and tell you, "I told you so."

This political allegiance baffles me. Just because you give someone your vote does not mean that you can never publicly chastise them for making such absurd claims as Biden has made regarding a virus and injections.

More people (that voted for him) need to call him out. They need to drop this false sense of loyalty they hold, they need to stop deflecting this misinformation by changing the subject to Biden's predecessor.

I don't care what you think about the opposition - it's history, let it go and focus on the bullshit staring you in the face. You're not being disloyal if you do this, you're part of the problem, however, if you don't.

Fast forward...

Last Friday (Oct 29) the FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age, despite protestations from  an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.

The 8 hour meeting between interested parties can be viewed here.

Remarkably, we had one either side of the fence, a party representing reasons for and reasons against. Those in the reasons for camp, namely the FDA’s Vaccines and Related Biological Products Advisory Committee, have financial ties and/or relationships with Pfizer.

These include a former vice president of Pfizer Vaccines, a recent Pfizer consultant, a recent Pfizer research grant recipient, a member who runs a center that gives out Pfizer vaccines, the chair of a Pfizer data group, a member who was proudly photographed taking a Pfizer vaccine, and numerous people who are already on the record supporting Coronavirus vaccines for children.

It's also important to note that the former FDA Commissioner ,Scott Gottlieb, is on Pfizer’s board of directors.

It was pretty obvious how they would vote in favour, imagine if they didn't, Pfizer would have asked some serious questions about their loyalty.

Any such 'deliberation' between consumer safety advocates and FDA panels is therefore, surely, compromised by such a conflict of interests.

Those safety advocates faced an uphill battle from the get go given Biden had already told the heavily influenced Pfizer/FDA Panel that his Administration had already procured enough vaccine to support vaccination for the country’s 28 million children ages 5-11 years old.

This incestuous relationship between regulators and drug/juice manufacturers is clearly there to be seen yet it's only independent journalists and safety advocates that seem to be highlighting this. For this, they are labelled 'anti-vax' or other anti-narrative slurs.

Panel members with clear financial ties to manufacturers. Hey, no problem, no bias to see, right?

One of the most insidious mutterings I've heard in a long time came from Infectious disease specialist, and current editor-in-chief of the New England Journal of Medicine, Dr Eric Rubin, who said, “We’re never going to learn about how safe the vaccine is unless we start giving it. And that’s just the way it goes." 

Meantime, millions of parents will be telling their 5-11 year-olds to roll up their sleeves in one of the biggest child experiments the world has ever seen.

This is absurd and its only a small proportion of people speaking out about it. 

Even if you've had the juice, this cannot sit right with you. 

Coming full circle

As Biden supporters stand by idly and don't condemn his misinformation, we now have two other sides of the fence. Those who have been juiced and those who haven't. The juiced, in the main, won't see the conflict of interests as an issue, they won't see the fact there is no long-term safety data for 5-11 year-olds as an issue either. The won't see any problems with the FDA and, indeed the CDC, not having access to Pfizer's clinical trial case report forms (Raw data). Even if they did take issue with any of the above it would be highly unlikely that a majority would say what an utter disgrace this was. Thinking it is and uttering to oneself that kids need and should be protected from financial bias isn't good enough, it won't take you to those pearly gates as 'good people', quite the opposite if you believe in Heaven that is.

Weighing up benefits and risks should be about benefits and risks to the intended recipients and not about the benefit and risks of making a financially driven decision, which is clearly what has happened here. It's political, it's money-driven, it's utterly repugnant.

Finally, if none of the above stirs any kind of response other than a shrug of the shoulders, one should study the following slide. Correlation will never equal causation if we have data collecting agencies who don't follow up any adverse reaction reports.

Slide presentation from Roundtable discussion with vaccine injured and medical experts on federal vaccine mandates and the importance of health care freedom. Nov 2, 2021

Bob Fiddaman

Special thanks to independent journalist Maryanne Demasi, PhD for her piece, 'A 'one size fits all' approach to vaccinating kids aged 5-11yrs?

Here is a Roundtable discussion with vaccine injured and medical experts on federal vaccine mandates and the importance of health care freedom.

Guest Post: Irresponsible Reporting Harms Parents & Children

Kristina Kaiser Gehrki

Irresponsible Reporting Harms Parents & Children 

By Kristina Kaiser Gehrki

In 1987 I was an optimistic college student earning my first degree in journalism from a top 10 university program that was then, and remains today, highly ranked by the Associated Press.

I vividly remember class discussions about the Washington Post—a newspaper that had diligent reporters such as Bob Woodward and Carl Bernstein who exposed wide-scale corruption to include President Nixon’s Watergate scandal. Back then, venerable Washington Post reporting was often seen as a public service for the greater good. It was good journalism about which Academy Award-winning movies like “All the President’s Men” were made. 

Flash forward to the present decade and it appears journalism ethics and responsible reporting has gone the way of the dinosaurs. Yesterday’s article in the Washington Post titled, “Your Child is Nervous About the New School Year, Which May be Normal—or Not,” is just one of a long string of examples.

In an effort to sell and publish articles, journalists often write stories called “evergreens.” Such articles have a long shelf life and keep their leaves when autumn arrives. I suspect the “Your Child is Nervous” article by Jill U. Adams was likely written as an evergreen, and the back-to-school marketing headline was later crafted to catch the attention of concerned parents who want to ensure their kids are happy and healthy.

As a parent, trained journalist and former teacher, Adams’ article caught my attention because of what she claims and what she chooses to omit.

Jill Adams -  freelance science journalist

Former Pharma Employee-Cum-Reporter Promotes Risky Drugs for Kids

Adams states kids with anxiety can benefit from cognitive therapy—and certain drugs. She specifically asserts: “Medications can help, too, particularly the class of antidepressant drugs known as selective serotonin reuptake inhibitors, or SSRIs.” 

Really? Given that Adams is also a trained pharmacologist, one presumes she is aware of research that finds SSRIs are neither safe nor effective for children. Adams neglects to mention such nor does she inform her Washington Post readers that she studied psychoactive drugs for Johnson & Johnson. 

I can’t help but wonder, was Adams working for Johnson & Johnson when the company criminally marketed Risperdal for unapproved use by children? More than 30 children died and more than 1,000 reported serious complications. The US Dept. of Justice effectively forced Johnson & Johnson to pay more than $2.2 billion to resolve these criminal and civil charges. 

Parents Denied US FDA Black Box Warning Info

US FDA Black Box Warning

While promoting SSRIs to reduce childhood anxiety, Adams also fails to mention that SSRIs carry the US FDA’s most serious Black Box warning. (Above image). She doesn’t note SSRIs cause akathisia which often causes psychosis and unwanted deaths. Reporters are not legally required to communicate FDA Black Box warnings with the readers who trust them. Doctors are not legally required to share FDA Black Box warnings with the parents who trust them. But that doesn’t mean it is ethical for either to withhold such life-saving information.

Failure to Share Conflicts of Interest

Adams also neglected to inform readers that her quoted source, psychiatrist John Walkup, has several potential conflicts of interest to include taking free drugs and money from many pharmaceutical companies.

Adams’ Health and Science section article is simply the latest of many accountability and ethics problems found in mainstream newspapers. Years ago after my teenaged daughter died a prescription-drug-induced death, I contacted the Washington Post about similar omissions and reporting errors. My valid concerns backed up by published data were met with a virtual pat on the head and false promises to contact me should they ever again cover this topic.

A Constant Pattern of Zero Accountability

Systemic errors of omission don’t just occur in newspaper articles; they also rear their ugly heads in the Letters to the Editor and Op-Ed pages.

The Washington Post Letters to the Editor section requires writers to “disclose any personal or financial interest in the subject matter of their letters.” However, in 2014, the newspaper published a letter that appeared to be written by your average Joe, a man named David from Vermont. David’s letter was in response to a Washington Post article about SSRIs, depression and children. His letter expressed concern for children who are depressed and supported the use of pharmaceutical products as effective treatment.

I noticed the letter writer’s last name was “Fassler” and realized this seemingly average Joe from Vermont was Dr. David Fassler, a child psychiatrist and frequent testifier to the FDA in support of the pharmaceutical industry. Fassler describes himself on his LinkedIn page as a specialist in “child and adolescent psychiatry” and “forensic psychiatry” and notes he’s worked with the Executive Director of NAMI-Vermont. NAMI, is the National Alliance for the Mentally Ill and has been the subject of Congressional investigations into its deep financial ties to the pharmaceutical industry. 

Fassler testified at the 2004 FDA SSRI hearings in support of prescribing SSRIs to children. Specifically, “David Fassler of the American Psychiatric Association cautioned that the FDA should not scare patients away from treatment.” Ironically, this was a quote from the Washington Post.

The FDA also heard testimony from many family members who carried photos of their dead loved ones while recounting the torturous SSRI Adverse Drug Reactions they suffered before dying. After the hearings, the FDA responded, albeit far too late, by placing the Black Box suicide warnings on SSRIs.

Fassler’s more recent FDA testimony supported prescribing atypical antipsychotics to children.

Who “Works” for Whom?

But back to 2014. I contacted Fassler to inquire why his Washington Post letter to the editor didn’t disclose his medical credentials nor any personal and financial interests in the subject matter. Our correspondence is below:

On 7/11/14 12:32 PM, Kristina G. wrote:
--------------------
Hi David,

I read with interest your letter to the Washington Post. I was wondering why you didn't share your expertise as a child psychiatrist, experience testifying, and work with pharmaceutical companies? If you write the Post again, perhaps you should include your background so readers can better respect and understand your viewpoints. 

Regards,
Kristina Gehrki

--

On 07/11/14 5:36 AM, David F. wrote:
--------------------
Hi Kristina

I did tell the Post I was a child psychiatrist, but they chose not to include any identification. 

I don't do any work w/ pharmaceutical companies.

David

--

It’s important to note Fassler stated: “I don’t do any work w/pharmaceutical companies.” Perhaps he also has no personal or financial interests in the subject matter he wrote about? What is not debatable is that Fassler is an active member of The American Academy of Child and Adolescent Psychiatry (AACAP) and ran for their national position as AACAP Treasurer in their 2013 election. It must be an important position considering AACAP states that in 2012 their “60th Annual Meeting Sponsorships” included “Pharmaceutical sponsorships” that “totalled $175,000.”

I can’t help but wonder if Fassler sat next to Dr. John Walkup at this annual conference when Walkup was a featured speaker at AACAP’s 2013 Psychopharmacology Update Institute. I also wonder if Fassler read AACAP’s 2013 Report to the Council that stated:

“August 14, 2012 Informed on August 4 that Wayne Batzer, M.D. resigned as a member of AACAP stating, “The Academy is clearly reliant on continued pharmaceutical industry funding and I am no longer able to accept this.” 

Looking back on it, I’ve come to accept Fassler’s statement “I don’t do any work w/pharmaceutical companies” at face value. To me, its relevancy depends upon how one first personally defines the word “work.”

Experience is the Best Teacher

Today I’m no longer an optimistic college student. While I’ve earned more advanced degrees and certificates, the most important knowledge I’ve gained since my daughter, Natalie's, prescribed demise comes from experience and research. Independent research and unbiased “journalism” uncovers unimaginable fraud, collusion, corruption and ethical violations in nearly every nook and cranny—from university medical schools to medical associations, from pharmaceutical headquarters to neighbourhood pharmacies, from national papers to your hometown rag, and right on down to your local doctors.

As a former high school marketing teacher, I understand parents want their children to start the school year off right. Parents want to believe things that will provide comfort. Seeking comfort is a basic human trait. But I implore parents who might read yesterday’s Washington Post dribble or another newspaper’s misleading article tomorrow: Remember, just because something sounds comforting doesn’t mean it is true.

When Natalie was 10, I took her to a therapist because of concern about mild school anxiety. I wanted the best for my child. Unfortunately, what we anticipated would be talk therapy soon turned into drug “therapy” prior to the FDA’s SSRI Black Box warning. It’s tragic that misinformed parents who read such articles might unwittingly go down the same dangerous drug path from which there may be no return. I speak up simply because I don’t want to see other trusting parents caused permanent discomfort when later they find themselves visiting their children’s graves.

Natalie’s prescribed demise is featured here & here. Like Anne Frank, Natalie's diary documented her torture and it is hoped society can learn from these systemic atrocities.

Kristina Kaiser Gehrki is a public health and safety advocate and educator. She holds degrees in crisis and strategic communication, journalism and education but feels her most relevant knowledge stems from personal experience. Her teenage daughter, Natalie, died a prescription-drug induced death after suffering SSRI Adverse Drug Reactions and SSRI withdrawal that was undiagnosed by her doctor and improperly treated with SSRI dose increases.

Masterfully Harming Kids for Profit

eu·phe·mism (noun)

1. the substitution of a mild, indirect, or vague expression for one thought to be offensive, harsh, or blunt.

"Part of my job is to create ‘masterful’ euphemisms to protect Medical and Marketing." -- Guess Who?

If you think the above quote is from a sleazy character in the hit TV series Mad Men, you'd be partly right. It is indeed uttered by a sleazy character, but in this case, it's a real person, a mad woman named Amy Rubin. When you learn what Rubin did, you'll understand why this woman can't accurately be called a lady.

As a Regulatory Affairs Manager for Forest Pharmaceuticals, Rubin proudly used her marketing skills to help pull the wool over the FDA's eyes regarding Forest's dangerous, ineffective drug, Celexa, which carries the generic name of citalopram. Rubin made her self-aggrandizing declaration in a memo sent to Dr. Charles Flicker, Senior Medical Director of Forest Laboratories as the two concocted ways to stretch the truth so that more doctors would prescribe Celexa for children and adolescents.

Spin Doctors At Work

Forest Pharmaceuticals conducted the MD-18 study involving Celexa, an SSRI now owned by Allergen. MD-18 was supposed to be a double-blind, placebo-controlled clinical trial of pediatrics. According to unsealed documents and testimony, MD-18 was only able to achieve a positive result by including nine patients in the study that were, as Forest’s medical director stated, “automatically unblinded” due to a supposed dispensing error. (Blinded means that a study's investigators are not supposed to know who consumed the product and who consumed the placebo.) The MD-18 investigators did know who was consuming Celexa and who was consuming placebo. And Forest Pharmaceutical execs knew this, too. The MD-18 study was flawed and biased.

The company then whitewashed the data in a draft letter to the FDA stating that incorrectly dispensed pills could have “potentially unblinded the study,” - After the draft was passed around Forest Labs they decided to rephrase the term and acknowledged that the wrongly dispensed pills could have the  “potential to cause bias.” By omitting the word 'unblinded' Forest was deliberately trying to hoodwink the FDA and create the false impression of positive results.

Forest then actively promoted the MD-18 study to encourage doctors to prescribe Celexa for children. The company later used the flawed MD-18 study to gain FDA approval for its other SSRI, Lexapro (escitalopram) and promoted it for adolescents. The result: Forest made money peddling snake oil to doctors knowing that unsuspecting parents would likely later make funeral plans for their children.

Last month Los Angles law firm, Baum, Hedlund, Aristei & Goldman, wrote a letter to Greg Shapiro, Chief of the Affirmative Civil Enforcement Unit, regarding a series of agreements that Forest made in 2010 with the United States Attorney’s Office for the District of Massachusetts. (USAO). Baum Hedlund points out that the 2010 settlement agreement missed some crucial evidence.

Baum Hedlund states:

"Over the past several years, our litigation has revealed that the scope and extent of Forest’s fraud was not honestly disclosed to the USAO (or, to the Food and Drug Administration) and that Forest misrepresented material facts underlying the USAO’s prosecution.  Documents and testimony obtained in our litigation have been unsealed, over Forest’s objection, and we have prepared a detailed memorandum outlining Forest’s misconduct and fraud with the hope the USAO will consider reopening its investigation."

The unsealed correspondence between Rubin and Flicker shows how pharmaceutical companies intentionally and routinely put the public--including children and teens--at great risk of harm and death from their products.

Wreckless Endangerment of Children

I tried to find a photo of Amy Rubin to show you what an evil spin doctor looks like, but it seems Rubin is camera shy. For her role in creating a medical holocaust that harms and/or kills thousands of innocent children, I've chosen a makhsheyfe or Baba Yaga photo to represent Rubin. If today Rubin is a mother, I imagine the reckless endangerment she helped unleash in neighborhoods across the globe isn't something she'd want to do to her children or grandchildren. But harming children is merely business as usual for Amy Rubin and her pharma colleagues.

So, as Forest's Rubin once wrote that it was part of her job to "create ‘masterful’ euphemisms to protect Medical and Marketing", it's part of my job to protect children and adolescents.

I hope Amy Joyce Rubin, age 64, has no contact with the innocent children in her Paterson, New Jersey neighborhood.

There are many appropriate adjectives we could use to describe Rubin, most of which are four-letter words. I'll leave it to you to fill in the blanks.

Bob Fiddaman

Baum Hedlund's letter to the Chief of the Affirmative Civil Enforcement Unit can be read here.

BBC Newsround: Antidepressants

BBC flagship programme, 'Newsround', a children's news show, are looking to hear from families in the UK whose children (17 or under) have had good or bad experiences on antidepressants.

I'm promoting this as I feel education regarding these drugs really should start at a grassroots level, namely, our children.

Here's what lead researcher Oliver Newlan wrote me.

BBC Newsround are interested in speaking to any families of children currently aged 17 or under who have had good or bad experiences of being prescribed antidepressants.

If there are any experiences you feel you would like to share please could you email oliver.newlan@bbc.co.uk by Thursday 8th February 5pm.

We will deal with your experiences sensitively and will not make anything public without your explicit consent.

Bob Fiddaman 

Targeting Young Minds With Mythical Fairytales

I've found a cause for depression and other related 'mental health' issues. It came to me last night. I've cracked this age-old question.

I witnessed it myself, so I know it is concrete evidence.

Okay, so this is what happens.

Whilst a normal person is sleeping bad fairies visit and sprinkle bad dust on their heads. This destructive dust seeps into the heads and makes people have dark thoughts. These fairies are 6-inch creatures from the planet Zog; they are sent down as part of an intergalactic experiment created by more bad fairies who are higher in authority than the 'visitors'. Their leader, Major Larry Junk, created these 'bad dust' experiments in the 10th century and has been sending down visitors ever since. He was born in the late 950's and was great friends with Burchard of Worms, the bishop of the Imperial City of Worms, in the Holy Roman Empire. He died in the year 1025 but was resurrected a year later in 1026.

Of course, I have no proof of this, but you'll just have to accept it. Depression is caused by bad fairies sprinkling bad dust.

If you don't believe my fairy tale, here's another by YoungMindsUK

Compare my theory to the one touted by YoungMinds UK, a charity, according to their website, that, "champion the wellbeing and mental health of young people."

They claim, amongst other things, that depression is caused by a chemical imbalance in the brain. Not only do they know the cause of depression they also know a good treatment for it. They write...

There is help and treatment available for people with mental health problems. Usually, they’ll see their GP first, who’ll arrange for them to see a specialist like a psychiatrist, counsellor or psychotherapist. They’ll decide together on the best treatment for them. This can include:

Medication – these can help to address chemical imbalances and make someone feel more ‘normal’

So, the opposite of normal is abnormal, correct? So, in essence, YoungMinds UK are telling its target audience (children) that having a 'mental health problem' is abnormal, furthermore the person experiencing the 'mental health problem' is abnormal.

Major Larry Junk doesn't do that.

YoungMinds UK go much further than I do though. They have a health care professional who oversees all their claims and she, along with her colleagues, have checked all the claims made by Young Minds UK and found them to be factual. YoungMinds UK apparently doesn't understand that fairy tales are supposed to entertain children, not end their lives.

Their brochure specifically thanks "Dr Andrea Gnanadurai and her colleagues at the Child and Family Public Engagement Board, Royal College of Psychiatry for fact checking this booklet."

I disagree with Dr Andrea Gnanadurai and her colleagues because I know that depression is caused by bad fairies sprinkling bad dust.

Dr Andrea Gnanadurai (pictured below) holds a Bachelor of Medicine, Bachelor of Surgery. Safe to assume then that she knows a lot more than I, or indeed Dr Larry Junk, Head of the Intergalactic Bad Dust Fairies Operation Unit on planet Zog.

Dr Larry Junk is over 1000 years-old. Judging by Dr Andrea Gnanadurai's Twitter profile photo she is considerably younger. I tweeted her the following earlier...

@andreagee Can you provide me with evidence that backs up the claims that depression is caused by a chemical imbalance?

— BOB FIDDAMAN🐦 (@Fiddaman) July 10, 2017

Depression, they claim, is caused by a chemical imbalance and, according to them, is treatable with either talking therapy or medication, or indeed both.

I find this bizarre. If my drain was blocked, for example, would talking to it unblock it or would I need to pour a chemical into it to unblock it?

If a chemical imbalance was present in the brain then how would talking about it make it go away?

YoungMinds UK don't stop there. Their website is calling for 'Youth Activists' to raise awareness of mental health. They write...

If you’re aged 14 to 25 and have experience related to mental health – including caring for someone with a mental health problem – then you can apply to become an activist.

Amongst its partners are Heads Together, an initiative spearheaded by The Duke and Duchess of Cambridge and Prince Harry. Other partners/supporters include the National Lottery, but gambling addiction doesn't seem to be addressed by YoungMinds UK.

On the subject of ADHD they claim, "Children under 5 shouldn't be given ADHD medication." So, okay if you are 5 years of age or older then?

Regarding a BMJ publication, 'Suicidality and aggression during antidepressant treatment', YoungMinds UK offer the following...

This new report is very worrying and its very concerning that some clinical trials have been misreported or poorly designed. Children and their parents must have solid and comprehensive information about the effects that antidepressants can have, so they can make informed decisions about treatment.

Ironic considering their website claims medication "can help to address chemical imbalances and make someone feel more ‘normal." Apparently, YoungMinds UK is worried about misreported clinical trials, but they aren't worried about their own unproven claim regarding "chemical imbalance" marketing.

If YoungMinds UK can provide evidence that a; depression is caused by a chemical imbalance and b; antidepressants address a chemical imbalance, then, I'm sure, both children and parents will be able to make informed decisions about treatment.

The booklet, 'Young Minds: Mental Illness In Your Family', can be downloaded here.

I spoke with Major Larry Junk earlier, he told me that, just like his surname, the chemical imbalance claims made by Young Minds UK are 'junk science.'


Bob Fiddaman

Disdain Shown Toward Kids by Australian Medicines Regulator

dis·dain
noun

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



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

I can't find the words.

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

I know how GlaxoSmithKline wanted children to take it.

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

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

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

Bob Fiddaman

Glaxo's Paxil Kids Down Under

It's not uncommon to think that only in America lawsuits against pharmaceutical companies are filed, settled and/or won. For many years I was under the impression that it was nigh on impossible to get GlaxoSmithKline into court in the UK. Stumbling blocks, legal wrangles and funding just being some of the hurdles those of us involved in the UK group action against GSK have had to endure over the past ten years or so. Thankfully, against GSK's wishes, the group has now been granted access to trial by the presiding Judge (Back Story)

So, what about other countries? We rarely hear of pharmaceutical companies getting hauled in front of Judges outside of America (and now the UK)

Canada, for example, sits on the border of America yet, to my knowledge, no class action lawsuit has ever been brought against any pharmaceutical company where antidepressants are concerned. Maybe I'm wrong or maybe the Canadian media just don't want to report on any such action?

Step forward Australia. A country I hold dear to my heart.

Drayton Sher, a Sydney based law firm,  are now working on a group action on behalf of people who, as children and adolescents, were prescribed the antidepressant drug paroxetine, known as Aropax in Australia.

It's a brave move and they should be applauded.

Aropax, which is known as Seroxat in Europe and Paxil in the US and Canada, has been the subject of many lawsuits ranging from it inducing suicide, homicide, birth defects and severe withdrawal reactions for a large number of people who have taken it.

The proposed class-action lawsuit comes on the back of recent findings that Glaxo played down the risk of Aropax use in children.

Last September a damning reanalysis of GlaxoSmithKline's infamous Study 329 went public. (Back story)

The original 329 study showed that...

"Paroxetine is generally well tolerated and effective for major depression in adolescents."

However, after reanalyzing the study, it was found that the claims and subsequent support of the claims were misleading and, in actual fact, false.

Glaxo have remained tight-lipped regarding 329 for many years, on the odd occasion (slip-up) they have drawn attention to the abhorrent scale of those who could have been at risk but, as usual, those risks have either been spun or played down.

In 2003, GSK's then Head of Psychiatry, Alastair Benbow (pictured above) went on national television and claimed that, "less than a small class size would have these suicidal thoughts." 

For those of you interested in Benbow's actual class size please feel to read Alastair Benbow: The Devil is in the Details - it makes interesting reading.

In the meantime, Glaxo will no doubt defend the allegations. The Sydney Morning Herald reached out to them for comment. None was forthcoming.

Drayton Sher can be contacted here.

A Facebook page has also been created where you can learn more about other lawsuits in the pipeline - here.


Bob Fiddaman.

Glaxo Collaboration With CISNC - A Cause For Concern?

I'm often sent tips by followers and friends of my blog. This one was of particular interest to me, sent to me by a fellow Facebooker, who shall be known as "Susan."

It seems GlaxoSmithKline have teamed up with Communities In Schools of North Carolina (CISNC)

The reason? Well, it's kinda difficult to read between the lines because, as usual, any funding aimed in the direction of children's well-being is vague where pharmaceutical companies are concerned.

A press release from Education North Carolina (EDNC) shows us that GlaxoSmithKline and CISNC have "joined together to announce tools and training to ensure that students in the state’s lowest performing schools have access to high quality wraparound services to propel success in school and beyond."

Tools and training?

The press release goes on to say that...

Yesterday at CISNC’s “2015 Impact Training: Mission Possible” event in Cary, GSK announced a $360,000 grant to enable Communities In Schools of North Carolina to put high quality, research-based interventions in schools to increase attendance, improve behavior, enhance coursework, and engage more parents and families.

Should we be concerned about this or should we be applauding Glaxo?

Exactly what are research-based interventions that will improve behavior? Sadly, the press release doesn't elaborate.

I did some digging.

Glaxo, who have a HQ in Research Triangle Park, N.C, seem to be caring a lot about their community in North Carolina. On the surface, this looks good for GSK.

In 2013, GlaxoSmithKline and Community Care of North Carolina (CCNC) announced the initiation of a new approach to analyzing health information that allowed healthcare providers and payers, with the touch of a button, to analyze patients' medication challenges in real time to determine "effective ways to overcome barriers to delivering quality care."

In a 2013 press release, Glaxo announced...

The service utilizes "prescriptive analytics" to analyze the data and determine suggested interventions that are most likely to facilitate better patient engagement and ultimately, improved patient outcomes.

They added...

... the goal of the project is to assist these healthcare professionals in determining – and responding to medication-related problems that often lead patients to use their medicine incorrectly, or to not adhere to the treatment regimen prescribed by their doctor. 

Hmm.

So, I'll ask again, exactly what are research-based interventions that will improve behavior?

A quick glance of CISNC's page shows that Lisa Benna of GlaxoSmithKline is a board member. Benna is Human resources vice president at Glaxo.Previously she worked for Wyeth in a range of roles in both organization development and HR roles in R&D, Manufacturing and Commercial.

Eric Hall (Pictured above), who is the president and CEO of the Communities In Schools of North Carolina, was previously National Director of Educational Services where, according to his LinkedIn page, he managed and supported a network of over 50 non-traditional schools for students at-risk of dropout across nine states. In his role, he worked to establish value-added models of teacher evaluation, implement common core standards, develop teacher and school leader professional development pathways, and also worked closely with state and local policy-makers to ensure effective practices for serving at-risk students.

I understand that there are problem students, what I can't quite grasp here is why CISNC would team up with a pharmaceutical company who has a pretty poor record when it comes to the safety of children. Is it just purely about the $360,000 grant GSK have given them?

Will they be influenced by GSK's kind offering, will those children with behavoral problems, who, after being offered one-to-one adult supervision, be then sent down the mental health road and prescribed GlaxoSmithKline drugs such as Wellbutrin, Paxil, Lamictal, all medicines used to treat mood disorders?

Maybe I'm clutching at straws here. Maybe GlaxoSmithKline have turned a corner and are trying to make amends for their previous abhorrent treatment of children with Paxil. Maybe it's just a huge PR exercise or maybe Glaxo have ulterior motives?

Whatever way you slice it, GlaxoSmithKline have pleaded guilty for promoting medicines to kids, medicines that were unsafe for kids. Why would any organisation connected with children wish to have GSK on board?

It's a head scratcher for me.

I Tweeted the following to CISNC - they never replied.

So, I fired off an email to Jill Cox, who is the Communities In Schools of North Carolina contact. I basically want to know what these research-based interventions are and whether or not they involve the use of psychiatric medication.

Dear Jill, 

I read with great interest that CISNC have recently joined forces with GlaxoSmithKline and announced tools and training to ensure that students in lowest performing schools have access to high quality wraparound services to propel success in school and beyond.

The press release, I read, also states that "Yesterday at CISNC’s “2015 Impact Training: Mission Possible” event in Cary, GSK announced a $360,000 grant to enable Communities In Schools of North Carolina to put high quality, research-based interventions in schools to increase attendance, improve behavior, enhance coursework, and engage more parents and families."

Exactly what are research-based interventions that will improve behavior?

I'd be grateful if you could let me know the answer to this at your earliest convenience.

Sincerely,

--
Bob Fiddaman

I will, as usual, keep you updated if Jill responds.

Now, here's something that I bet you all thought you'd never read, from me at least.

I think it's safe to say that I am probably one of Glaxo's biggest online critics but I have to take my hat off to them and, probably for the first time ever, give them praise, particularly for looking after the residents of North Carolina. Credit where credit is due, I guess.

The North Carolina GlaxoSmithKline Foundation offers grants to various organisations and charities across the state of NC. Since 1986 they have awarded $65 million in grants to North Carolina nonprofit organizations. I do applaud them for that. However, this should not, nae should never, detract from the fact that GlaxoSmithKline have caused a lot of harm to a lot of people with their antidepressant Paxil - there are other prescription medications manufactured by Glaxo that have also caused death and heartache, Avandia for one.

When we balance up the good that they have, it appears, done for these nonprofit organizations in North Carolina against the bad they have done with drugs such as Paxil and Avandia we still see a company that is almost Jekyll and Hyde-like. It's almost as if grants such as the above are handed out to ease the conscience of their abhorrent history. It would be far better, in my opinion, if GlaxoSmithKline were seen to hand out cash awards to those they have harmed and not make them, or their families, have to jump through legal hoops in Paxil suicide litigation, Paxil withdrawal litigation and Paxil birth defect litigation. Glaxo will only ever settle when they know they cannot win trials. It seems absurd, therefore, that they seem to paint themselves whiter than white when handing out cash awards to nonprofit organizations across North Carolina. For families affected by Paxil, be they families who have suffered a loss of a child or adult due to Paxil induced suicide or mothers who have given birth to children with heart defects due to Paxil ingestion during pregnancy or for those affected by the horrendous withdrawal problems Paxil has caused them, seeing Glaxo hand out $65 million to organizations must be a kick in the teeth.

On one hand they giveth, on the other hand their drug, Paxil, taketh away.

And that just doesn't sit right with me. It never will.





Bob Fiddaman.

The Seroxat Scandal - 2007

Following on from my previous posts regarding BBC TV's Panorama and their coverage of GlaxoSmithKline's Seroxat.

In 2007 they aired their 4th and final installment into the whole Seroxat scandal. 'The Secrets of the Drug Trials' focused on the infamous Paxil 329 study and showed how bosses at Glaxo knew about the suicide link with children and teenagers taking their blockbuster antidepressant - they knew yet still paid highly ranked psychiatrists to spread the word to colleagues that Seroxat was safe and effective for use in children and teenagers. Even more worrisome, GSK paid key opinion leaders huge amounts of money for writing about the benefits of Seroxat in children and teenagers, yet these same key opinion leaders didn't actually write the material - GSK hired an outside agency to ghostwrite the articles for the key opinion leaders. In essence, GSK just paid for leading psychiatrists in the field of pediatrics to add their name to the ghostwritten material and to make believe that it was their work.

The previous three Seroxat specials can be seen here, here and here.

Here's The Secrets of the Drug Trials (Starts 50 seconds in)

Bob Fiddaman.

Is This The World That We Created?

       An article in the Wall Street Journal from Feb this year was recently brought to my attention. The article in question reports on how psychiatric drugs are now being given to infants and toddlers in unprecedented numbers.

       The article refers to an analysis of 2013 IMS Data. (the world’s leading health information and analytics company) The WSJ writes...

"An analysis of 2013 IMS Data, found that over 274,000 infants (0-1 year olds) and some 370,000 toddlers (1-3 years age) in the U.S. were on anti-anxiety and antidepressant drugs. This report also found over 1,400 infants were on ADHD drugs."

       I find this report quite alarming given that the majority of these class of drugs have never been proven to work in these age groups. More alarming, for me at least, is the fact that parents are allowing their children to take these mind altering drugs. Okay, look, I understand how difficult it can be if your child is acting up or crying all the time, I'm a father of three myself so I kinda know the score. But I cannot for the life of me think why any parent would allow these dangerous and addictive mind altering drugs to be taken by these little vulnerable people.

       Let just look at the paragraph again.

       "274,000 infants (0-1 year-olds) were on anti-anxiety and antidepressant drugs."

       Now imagine London's iconic Wembley Stadium being filled three times by 0-1 year-olds. The photo below really shows you the scope of this problem. Put a 0-1 year-old on each of the red seats, give them each a diagnosis (a guess at what's wrong with them) them - treat them with powerful drugs purely based on that guess. Remove the 0-1 year-olds from each of the seats then fill the stadium again with other 0-1 year-olds - same process - have a man in a white coat diagnose them (guessing what is wrong with them) allow the same man in white coat to prescribe them mind-altering drugs. Repeat the process a third time.

The modern world

       Now, here's the hypocrisy of it all. If we substituted the 0-1 year-olds for psychiatrists and we put a giant screen in the middle of the pitch with a slide show of a bunch of symptoms, the psychiatrists would diagnose and offer not only different illnesses but they would treat with different drugs too.

       It's not science, it's purely profit driven and pimped by these idiotic bufoons in white coats who think they know how the brain works, when in actual fact they just don't have a clue.

       "No conferring please, just write down what you believe the patient has then write down, once again with no conferring, how you would treat that illness."

       Oh, by the way, here's what they mean when they say 0-1 year old's

Estimated age - between 0 - 1 years old

       Who in their right mind would prescribe drugs to such a bundle of joy as the one above? Moreover, what parent, of sound mind, would agree to such lunacy?

       What are medicine regulators doing about this? Well, in a nutshell, nothing. They claim that there are warnings on the drugs that state that they are not recommended for children - maybe so, but the word 'recommended' means jack-shit, even if you stick the word 'not' in front of it.

       Will we see top executives of pharmaceutical companies speaking out about this lunacy? Of course not - these same executives have, in the past, devised clever marketing schemes to target this very same age-group.

       So, what can be done? Do we just shrug our shoulders and do nothing and continue to post photographs of fluffy bunnies on Facebook or do we actually reach out to help these kids?

       It's pretty shameful that so many kids are being diagnosed and treated with this vast cocktail of mind-bending addictive medications. It's pretty shameful that parents could neglect their own flesh and blood in such a manner and that the adults who look after the health and safety of consumers who take these drugs (FDA, MHRA, TGA etc) sit back and do nothing.

       As for the pharmaceutical executives who have, in the past, told their reps to promote these drugs to this vulnerable age group, fucking shame on you.

       Shame on us all for standing back and getting on with our own lives when these kids are targeted by the maniacs in white coats.

       Here's the full WSJ article

Bob Fiddaman.

Celexa and Lexapro Refunds

A federal judge has ruled that parents, whose children were prescribed the antidepressants Celexa [citalopram] and/or Lexapro [escitalopram] are entitled to refunds.

Forest Laboratories and its subsidiary Forest Pharmaceuticals, have agreed to shell out up to $10.4 million in refunds.

Back in 2010 Forest  pleaded guilty to federal charges that its sales force team illegally marketed Celexa and Lexapro for use in children and teenagers when they knew that both drugs were only approved by the FDA to treat depression in adults. According to the charges, Forest bribed doctors with cash, meals and travel in efforts to persuade doctors to prescribe the drugs to children.

Why aren't we surprised by this anymore?

Once again we are seeing a pharmaceutical company quietly settle matters, once again there is no jail time for any of the executives, once again money is thrown at the problem.

The 2010 charges also allege that Forest covered up the negative results of their pediatric trials.

So they knew their drugs were no better than placebo yet still targeted doctors to prescribe them to kids.

Anyone familiar with the story Hansel and Gretel?

Dr. Greg Mattingly with his wife Judi

Dr. Greg Mattingly, a psychiatrist in St. Charles, was also named in court documents as one of the country’s top prescribers of Celexa. Evidence shows notes made from a phone call with Mattingly and a Forest sales representative where he agreed to include information about Celexa for children into his talks. Mattingly is alleged to have received more than $107,000 from Forest Pharmaceuticals in meals, travel and speaking fees in 2012 and close to $38,000 in 2013, according to trial documents.

Dr. Brian D. Barash

Dr. Brian Barash, a Kansas City psychiatrist and chief medical officer of the Marillac Children’s Psychiatric Treatment Center, was paid “thousands of dollars to give dozens of speeches to Missouri doctors about Celexa,” according to trial docuuments.

Take a good look at the photos above. Both have, it seems, been promoting drugs that not only don't work in children but drugs that are dangerous for children.

Forest has already agreed to pay out $313 million to settle allegations with the government and millions more in dozens of personal injury lawsuits.

• 13-year-old Andrew Tradd of Massachusetts, who died of a brain injury days after he tried to hang himself in 2004, two years after being prescribed Celexa. 
• The family of Danielle Henrikson, 15, sued the company after she hanged herself in her Idaho home the same year, weeks after starting the drug. 
• Alex Kim of Georgia, hanged himself in 2004 after his dosage of Lexapro was doubled.

Full article, 'Parents can get refunds for some anti-depressant drugs given to kids', here.

Celexa is known in the UK as Cipramil. Lexapro uses the brand name Cipralex in the UK.

Both drugs are also under scrutiny for causing birth defects.

More on the settlement agreement here.

Bob Fiddaman.

Stop State Kidnapping by South Dakota

Last week it emerged that Justina Pelletier had been taken [by force] from her parents and put into care. Back stories here, here and here.

Justina's case has hit the newswires globally, her case has even been reported in British newspapers.

Justina, is one of many...

Last night I was alerted to a video that shows that Justina's case is just the tip of the iceberg. The video, entitled, Hearts On The Ground, can be seen in its entirety below. Every parent should watch it regardless of the age of your children.

While watching the video bear this in mind...

Every year, the Department of Social Services of South Dakota removes about 750 Lakota children from their families. [1]

While Lakota children make up only 13% of the child population of South Dakota, nearly 60% of the children in foster care are Lakota. [2]

Hearts on the Ground focuses on Native American families being ripped apart by the Department of Social Services of South Dakota who have, for one reason or another, removed children from the family home. This despite laws in place designed to protect Native Americans. Laws that the Department of Social Services of South Dakota have blatantly ignored.

According to the Indian child welfare act (ICWA) passed by Congress in 1978, Native American children are legally required to be placed with relatives or tribal members. [3]

A Native American child cannot be placed in non-native foster care facilities unless there are no relatives, tribal members or members of other tribes willing to take the child. [4]


In other words, the actions of the Department of Social Services of South Dakota is in complete violation of the Indian Child Welfare Act...yet they are allowed to get away with it.

Not only are kids taken away from their Native American surroundings, many of them are put into foster care homes and psychiatric units where they are prescribed medication without their parents consent. [5]

The video highlights just how these families are being torn apart by these white-coated morons who claim they have a unique ability that sets them apart from your average human-being. These knuckleheads can see things going on inside a child's brain that no other person...or man-made machine for that matter, can see.

Here's just a snippet of the transcript...

ZANE: They were giving me these uh drugs like you know Prozac and two other ones I didn't know the names of, which scared me because I didn't even know what I was taking, and they just basically said, “Take this,” and if you didn't take it they would physically restrain me and throw me in my room and not let me out you know for an extended period of time, until I wanted to take the meditation.

Zane was only twelve years old when he was placed in the Canyon Hills Psychiatric Facility and forced to take psychiatric drugs.

ZANE: I don’t remember any doctor you know sitting down saying this is what you’re taking, or anything they just kind of conveniently come up to me and said this is the new court ordered medication you have to take because of such and such whatever, you know behavioral report or whatever and they’d be like this is what you’re taking now. I didn't see a doctor I didn't have consent, my mom didn't have consent. they basically just said you take this or you’re in trouble.

Now here's the video. If, after watching, you feel compelled enough to do something about this, then a petition, Free the Lakota Children, can be signed here. If you are outside the US then there's a petition to sign here.

Let's put a stop to this utter madness.

Bob Fiddaman



[1] Administration for Children and Families, Child Welfare Outcome Report 2008-2011, page 311

[2] Administration for Children and Families, Child Welfare Outcome Report 2008-2011, page 310

[3] The Indian Child Welfare Act of 1978

[4] United States Code Title 25 - Indians Chapter 21 - Indian Child Welfare

[5] Internal Document

Child Medication [ADHD] Linked to Sexual Organ Abnormalities

So, we know about Risperdal causing breast enlargement in boys. Janssen's own clinical trials, with just 1,885 children, showed that 43 of them developed abnormal breasts. [1]

Now we learn that boys, such as the four year-old who developed a breast on one side and began producing milk, are at further risk. This time, we are told, it's priapism, a condition that can permanently damage a patient's penis.

So, let's just get this straight.

Using psychiatric medication in children can cause suicidal thoughts, completed suicide, abnormal breasts in boys and now permanent penis damage.

If that wasn't enough we already know that these drugs, when taken by pregnant mothers, can cause birth defects. If your child is lucky enough not to develop birth defects in the womb then they can die from overdose when ingesting breast milk from their mother.

That some huge net pharma have cast out.

Psychiatry and Pharma must be very proud of themselves.

Who needs birth control pills when psychiatric medication does pretty much the same thing.



Priapism story here


Bob Fiddaman


[1] The New Drug Of Choice - CBS Video - May 2009

So, Do You Care About Children?

Every now and again something comes along that really needs no introduction. Something as simple as a two minute video kinda sums up the needless over-prescribing of powerful antidepressant-type medications to the most vulnerable.

This two minute video was put together by the Citizens Commission on Human Rights [CCHR]. They've been banging the drum for years regarding the dangers of these types of medications.

I've wrote about the CCHR before on this blog [here and here] and in my book. They are an organisation who pretty much kick ass and an organisation that recognise that others kick ass too.

Any healthcare professional with a conscience should see that handing out powerful drugs to kids whose brains have not yet fully developed is wrong on so many levels.


Here's the video and also the accompanying message I put on Facebook too.

"Check it out. If it moves you then share it. If it doesn't then continue posting fluffy kittens or bunnies to your Facebook wall. Truth is 280,000 babies, from 0 to 12 months of age, are being prescribed psychiatric drugs. Truth is almost 200,000 children, under the age of 5, are taking ADHD drugs. Truth is.... well, just watch the video."

Please share.

Bob Fiddaman

Why Was the Japanese Paxil Pediatric Study Terminated?

Regular readers of this blog will know how I broke the news back in 2009 regarding GlaxoSmithKline's attempts to push Paxil [known as Seroxat in UK] on kids in Japan.

I was so outraged at this that I wrote to the Japanese Embassy and the Japanese Ministry of Health, more or less to give them a detailed view of how GSK had previously claimed Paxil was safe for kids to take...when in actual fact they knew that it wasn't.

I never heard back from either one of them.

I also contacted GlaxoSmithKline in 2010, you can see the email I sent to them here.

In 2008, one year before I broke the news, Glaxo were recruiting kids for a clinical study. I say Glaxo, they, in actual fact were sponsoring the study.

The study was designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.

Oral paroxetine is a sickly orange syrup, I've been on it myself. It was the only safe way to taper from this highly addictive antidepressant.

And just who were being used as the guinea pigs in Japan?

One look at the inclusion study criteria would have showed you.

Ages Eligible for Study:7 Years to 17 Years.

Yup, that's right folks. Despite being dragged through numerous courts in the US where evidence was shown that Glaxo manipulated previous clinical trials in children, here they were again back in 2008 recruiting more kids.

A marketing campaign went out in the form of a poster... which I just happened to obtain from a source at Medwatcher Japan. Medwatcher were also furious at this particular clinical trial involving kids and Paxil.

Take a good look at the imagery used in the recruitment poster.

If a picture paints a thousand words, eh?


Well, folks... **drum roll** - the trial has been terminated.

**Cue a spectacular display of fireworks**

According to GSK's clinical trial database the study was terminated in 2011. They give no reasons as to why this study was terminated.

What we do know is that 56 kids were enrolled. 29 were in the Paxil group whilst the remaining 27 were in the placebo group.

The study results claimed that there were 3 reports of suicidal ideation in the placebo group but none in the Paxil group. [More about this later]

The subjects enrolled had to have a diagnosis of a depressive disorder before being allowed into the study.

So, it would appear that 3 of the kids taking placebo had suicidal ideation. Not one report in the Paxil group. Glaxo must have loved this.

Unfortunately for the Glaxo sponsored trial, Paxil didn't really show much efficacy.

Open the Outcome Measures on the Clinical Trials website and it tells us how Paxil failed.

Paxil didn't reduce the depression scores of the children sufficiently to be considered effective and the primary purpose of this study was efficacy. In this study all participants had to have a depression score of 45 or greater to be included. A 50% reduction on the CDRS-R is required to consider children have responded to treatment.

So, not only did Paxil not reach the standard for efficacy but in comparison to, let's say, fluoxetine, it would be seen to be less effective.

In the Fluoxetine studies [1] [2] the average decrease was 28.9%. In this Japanese study, the decrease was only 16.9% therefore the kids would not be considered to have responded to Paxil treatment.

No wonder the study was terminated, right?

It would appear that GlaxoSmithKline didn't want to expose the fact that Paxil is less effective than that of their competitor.

Another interesting finding from the Japanese study was the participants only had to have been free from any antidepressant for 1 week prior to the trial commencement.

Anyone who's anyone will know that one week off an antidepressant is hardly a time to get the champagne corks popping and decorate rooms with bunting and balloons. Any number of these participants could have been suffering withdrawal even before they were entered into the Japanese trial. Any of these patients suffering withdrawal, which remember can mimic depression, would have had immediate relief if they were selected for the Paxil arm of the trial. As the phases of the trial progressed they would have, obviously, reaped the benefits of Paxil but not for their apparent depression, their benefits from Paxil would have merely meant they would not be going through withdrawal anymore.

Take the three patients from the placebo arm of the study who, according to the results, suffered suicidal ideation, and we may just find that these three were also taking antidepressants a week or so before they entered the Japanese study.

Could their suicidal ideation have been caused by the withdrawal effects of the medication they were taking prior to the Japanese study?

Glaxo pretty much shot themselves in the foot with this study, a study that should never have taken place given the findings of the Paxil 329 study.

So, once the Japanese trial was over did the sponsors, GlaxoSmithKline, do any follow-up to see if these kids were okay? The doses used in the study were between 10mg and 40mg, the latter being enough to put a horse into a coma.

The withdrawal phase of the Japanese study lasted three weeks. Two weeks later the participants were contacted to see how they were.

Can you imagine a 7 year old child on 40mg of Paxil a day just having three weeks to taper? Even if the 7 year old was on a lower dose it's still mind-boggling how one adult human could give someone so young a pill known to increase suicidal thoughts, known to increase completion of suicide.

What on earth were GlaxoSmithKline thinking by using kids in a study for Paxil?

The Japanese public, particularly the children and adolescents, just don't know what a lucky escape they've had from this truly awful abomination of an antidepressant.

Bob Fiddaman

[1] Psychometric Properties of the Children's Depression Rating Scale–Revised in Adolescents - J Child Adolesc Psychopharmacol. 2010 December; 20(6): 513–516.
[2] Early Prediction of Acute Antidepressant Treatment Response and Remission in Pediatric Major Depressive Disorder - J Am Acad Child Adolesc Psychiatry. 2009 January; 48(1): 71.

Back stories:

Thursday, January 15, 2009 - Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan

Friday, May 21, 2010 - Email To GlaxoSmithKline Re; Paxil Study In Children

Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE

Friday, May 13, 2011 - Glaxo remain tight-lipped on new Japanese Paxil study in children.


Wednesday, May 18, 2011 - GSK Japan, Paxil Study in Kids Update