Generic Paxil Suicide Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Tuesday, January 08, 2019

Supreme Court Analyzes Merck's Ambiguous Wording




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

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

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

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

Déjà vu: Dolin vs GSK

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

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

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

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

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

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

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

Stress Fractures vs Emotional Lability

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

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

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

Tossing the Egg

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

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

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

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

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

Bob Fiddaman



Merck Supreme Court Transcript

Wendy Dolin Petition to Supreme Court


Tuesday, December 18, 2018

Brain Pellets On Tap in America




Tim Alexander is a film-maker. He is in the post-production phase of his groundbreaking, Legal Death - In Drugs We Trust,  a series of 12 one hour episodes that explore every aspect of why so many people are dying, killing and having their lives, families, and relationships ruined after they begin taking prescription medications, particularly Opioid Painkillers, Antidepressants, Psychotropic Drugs, Benzodiazepines, Fluoroquinolone Antibiotics, and Statins as prescribed by a psychiatrist and primary care doctors.

More on this in the future.

Tim's Facebook group, the Legal Death - In Drugs We Trust Group, is a page I've been following with interest, particularly as Tim uploaded a few clips of his mini-series.

Today, my jaw dropped.

Here's why, in Tim's own words.

THIS IS A IMPORTANT WARNING ABOUT DOCTOR VISITS!

I was just at the doctor's moments ago because my lovely wife Karen makes me go. I am 100% healthy never once with any drugs or other medical issues. The video posted below tells the story of what happened, watch it.

The most important question they had for me was how was my brain. First, the nurse asked them, and then the doctor walked in and asked them again. I asked the doctor why that was the first question, he said he was not sure but he thinks the Pharmaceutical Companies or the Government mandates that they ask, as it is on a federal level for Mental Health Evaluation.

I never sought that. I asked him if he went to school for Mental Health and was qualified in it, he smiled and said "No", but said he did have a little training. I asked him what would have happened if I had said yes to the questions, he said it would have automatically triggered more questions. I asked what would happen if I answered in a way that was yes, I was depressed, was he qualified to prescribe me a medication? He said "Yes". I said how if you were not trained in the brain? He said my answers would allow him to look them up and diagnose me and give me one of the few FDA approved medications for the symptoms I said I had, and that is the way the screening works. I asked him what kind of medications and what did they do? He told me they were FDA approved antidepressants and they worked on certain specific regions of the brain that he didn't understand, but that they effectively relieved the symptoms of depression, and said it with a smile.

He was maybe 32 at best, he didn't know snot. I saw it first hand with my own eyes and experience, I was just a few wrong words away from a major Pysch Drug being given to me from a man who was not trained in the brain, diagnosing me from a simple questionnaire, and who had no idea what they do or how they worked. This was the second time this happened to me, it happened last year with a different doctor the exact same way.

They are nationally PUSHING THESE DRUGS ON A FEDERAL LEVEL, these Mental Health diagnoses are promoted, not selectively given because of an apparent need at the doctor's judgement. If I had a bad job with stress or trouble in my relationship I could have been thrown down the drug rabbit hole for it by a doctor with no clue just by saying I have been down, or a bit depressed. That is what I am making this movie, to WARN PEOPLE WHO DON'T KNOW THIS YET, not to talk to the people who do know it. You must protect you, and that starts with being on guard and being careful how you answer any doctor's questions, it is almost as bad as talking to an arresting officer, your words can be used against you, but in this case TO DRUG YOU. 'Legal Death - In DRUGS WE TRUST' is a WARNING to protect your life from a few simple questions that could destroy it forever!

Tim Alexander

Top 20 Popular Posts From Fiddaman Blog 2018







Top 20 popular posts from 2018. '

Saturday, January 06, 2018
GSK Call In the Fireman

Monday, January 08, 2018
Who's Hiding the Clinical Trial Benefits of Antidepressants?

Friday, February 09, 2018
Masterfully Harming Kids for Profit

Friday, February 23, 2018
Media Frenzy - Antidepressants Are Safe!

Tuesday, February 27, 2018
RCP Remove Damning Antidepressant Document From Website

Wednesday, February 28, 2018
Guest Post: I’m Depressed about Antidepressants

Thursday, March 01, 2018
Royal College of Psychiatrists - 63%

Friday, March 09, 2018
Scooby and Those Pesky Tweeters Rumble Psychiatry

Tuesday, March 27, 2018
India: GSK Whistleblower Names and Shames - Part I

Sunday, April 08, 2018
The NYT Addresses Antidepressant Withdrawal Issues

Thursday, April 12, 2018
The Truth About SSRI Withdrawal/Dependence

Thursday, April 19, 2018
Stop It!

Thursday, May 10, 2018
We Speak For The Dead To Protect The Industry

Sunday, June 17, 2018
Dutch Court Rules for Plaintiff - Seroxat (Paxil) Psychological Damage

Tuesday, August 14, 2018
Guest Post: Irresponsible Reporting Harms Parents & Children

Friday, August 17, 2018
Psychiatry: A Faith-Based System?

Tuesday, September 04, 2018
GSK Study ID - 29060/356 - The Missing Suicide Attempts

Sunday, September 16, 2018
No Action to be Taken Against GSK for Hiding Suicide Data

Monday, October 01, 2018
Breaking... Antidepressants cause Majority Withdrawal Symptoms

Monday, October 22, 2018
GSK Study 356 - The Truth is Out - 25 years Too Late!


Merry Christmas to all the truth tellers out there!

Bob Fiddaman




Saturday, December 15, 2018

Hetlioz: The Body Clock Brain Pellet





It's been a while since I last blogged. GSK has, seemingly, been good boys and girls for a while and Twitter seems to be where all the action is these days regarding the defence of brain pellets and some shocking behaviour from the field of psychiatry. More on that if you follow me on Twitter.

Today, I'm going to revisit a 2014 blog post of mine that was recently brought to my attention by a reader. The post, Blind Date With Vanda's Hetlioz, can be viewed here.

Hetlioz (tasimelteon) is an FDA approved medication for the treatment of Non 24 Sleep-Wake Disorder in the totally blind and is marketed and manufactured by Vanda Pharmaceuticals.

What is Non 24 Sleep-Wake Disorder?

According to Vanda Pharmaceuticals Hetlioz webpage, it's a "serious, chronic disorder that disrupts a person's circadian rhythms. Non-24 affects up to 70% of people who are totally blind, whether you were born blind or became so later in life."

All seems to be above board until you peel back some of the layers.

The clinical trials for Hetlioz are surrounded in controversy:

 - The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

 - The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

 - Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

 - Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.

The marketing of Hetlioz has also come under close scrutiny too. Back in 2015, Stat News ran an article regarding the airtime that Vanda Pharmaceuticals had bought to advertise its sleep/wake disorder drug, $29 million worth of airtime to be exact.

Stat News posed a pertinent point, they pointed out that the target audience for Vanda Pharmaceuticals were blind members of the public, so why the heavy promotional push on TV?

Here's one of the ads they ran across America.



Stat News also claimed that the adverts helped Vanda Pharmaceuticals net a tidy profit of $73 million in revenue.

Hetlioz Indications

The product labelling for the drug does not specifically state that it is to be used by blind people only. This leaves the door open for Vanda Pharmaceuticals to target other patients (non-blind).

Public Citizen, a nonprofit consumer advocacy organization, has filed a petition asking the FDA to correct the labeling to indicate the drug is only for patients with the disorder and who are totally blind, a population numbering approximately 100,000. Public Citizen is concerned the existing labeling may encourage off-label use in people who are not blind and have some other type of sleep disorder.

A Concerned Citizen

A concerned citizen recently wrote to me and told me he, and others, were digging into recent activities of the promotion of Hetlioz. He told me, "We are extremely confused by what we are finding. First off, it appears they are targeting Medicaid patients for Hetlioz with an estimated 80% of revenue coming from Medicare part D. Second, how can they be seeing 2x-3x demand from sighted patients vs blind if non-24 affects mostly blind people and is rare in sighted patients? Third, Cafepharma and glassdoor posts seem to indicate that there is rampant off-label promotion of Hetlioz going on via the company's psychiatric initiative.  This is just a sampling of what we are finding."

Vanda Drug Reps

The same citizen sent me two videos in which we can see Vanda Pharmaceuticals drug reps target patients and not doctors, as is the norm for drug company reps. The first video sees two reps for Vanda speak with what appears to be a mixed audience of visually impaired and blind subjects at Lighthouse, an organisation that promotes the independence, equality and self-reliance of people who are blind or have low vision. What is striking is the Vanda rep at the beginning of the first video asks the audience to fill out the paperwork if they feel they have any symptoms and give it to her and she will contact their physician. I'm unsure of the legality of this. The second rep throws out the question, "How many of you have difficulty sleeping at night?" When 6 or 7 raise their hands he tells them that it could be because they have 'Non 24 sleep/wake disorder'. He then goes on to tell the audience how everyone has a "master body clock in their brains."

I have to point out that neither of the reps mentioned the drug Hetlioz.

One of the audience members tells the rep she has Non 24 and takes Seroquel for it. Hmm.

If anything, this video gives an insight into how drug company reps play their audience. I found it fascinating, I hope you do too.

PS - He's not very good.

**Raw copies of both videos have been downloaded.



So, just as brain pellets were promoted because people had a 'chemical imbalance', along comes another mystery brain anomaly, this time it involves some sort of ticking clock. If you watched the video above you'll note how many times the rep drums home the 'body clock' claim.

The second video is much shorter than the first and shows pamphlets left behind by the Vanda reps. The leaflets, although visible are also written in braille and direct readers to http://www.non-24.com/ - where there's more talk about the 'body clock.' Again, there doesn't seem to be any direct-to-consumer advertising of Hetlioz on the webpage but there's plenty of talk about patients going to see their doctor to explain they may have symptoms of Non-24.




I can only speculate that Vanda reps have already visited their doctors and planted the 'Non-24' seed and what new drug can treat it.

As I mentioned above, I'm not sure if drug company reps targeting patients is entirely ethical so I wrote to a former drug company rep turned whistleblower for her opinion. I asked her if this was legal. She replied:


"No, this is not legal in the U.S. but I cannot provide any documentation to this effect. We were just instructed by the companies that I worked for that it was illegal to interact with patients regarding care/drug regimens. Unless something has changed...I left the industry in the year 2000."

In my 2014 blog post I mentioned the link between Vanda Pharmaceuticals and The National Sleep Foundation (NSF). 

New information I've learned is that Charles A. Czeisler, an American physician and sleep researcher, was President of NSF and is/was on Vanda's scientific advisory board. Also, Dr. Stephen Lockley, the Harvard sleep expert overseeing the Hetlioz clinical trials, received grant support from Vanda Pharmaceuticals.

Blogger, 'Frugal Nurse', has also been investigating Non-24 and Hetlioz. She writes:

On January 31, the Food and Drug Administration announced its approval of tasimelteon for treatment of Non-24.
Approval was based on results of 2 trials: . . . a 26-week study that included 84 patients, . . . and a 19-week trial that included 20 patients . . .
Really? Market approval based on 104 patients over 6 months?
And what were they testing for exactly? Patients experiencing a better night’s sleep, or less daytime drowsiness? No, something called “entrainment” or re-setting of circadian rhythm, measured by melatonin byproducts in the urine.
Frugal nurse also has an opinion on the Non-24 website. She writes:

The informational website for Non-24 is classic pharmaceutical advertising.
It’s not about selling a drug—at least not directly. It’s about helping you understand what Non-24 is and why you might suffer from it. The site helpfully (and slyly) provides a sidebar of symptoms to aid self diagnosis:
Not being able to sleep when you want
Excessive sleepiness during the day
Daytime napping or dozing off during the day
Periods of poor sleep quality at night
Sleeping through the night, but not waking up feeling alert and refreshed
Problems with focus and concentration; trouble with memory
Difficulty with daily tasks
Feeling irritable
Oh my God, I’ve got Non-24!!
If you are “experiencing any of these symptoms,” you are invited to fill out your name and address and “give permission” for Vanda to send you “information about Non-24 and about medicines that treat Non-24.”
As an added incentive, when you sign up, Vanda will make a $24 donation to the “blindness community.”
We can see from her research that Vanda's marketing is widening the net. They don't just want blind or partially sighted people to ask for this drug, they want, it appears, people with insomnia too, a condition that Hetlioz is not indicated for.

Jet Lag

In March this year, Vanda Pharmaceuticals announced that Hetlioz demonstrated significant and clinically meaningful benefits in nighttime and daytime symptoms of jet lag disorder. The press announcement stated:
Vanda intends to seek marketing approval for the use of Hetlioz in the treatment of jet lag disorder.  Vanda believes that if Hetlioz is approved by regulatory authorities for the treatment of jet lag disorder it will potentially offer a therapeutic solution to many travellers and will likely represent an important commercial opportunity for the company. 

You're not kidding! According to drugs.com the cost for Hetlioz oral capsule 20 mg is a staggering $15,186 for a supply of 30 capsules, depending on the pharmacy you visit.

It's no surprise that Vanda are trying to tap into the market of jet lag. It is reported that more than 30 million US residents make trips abroad each year to overseas destinations. Of these, 60% (approximately 20 million) travel to destinations in Europe, Middle East and Asia. That's an awful lot of potential customers for Vanda.

Another market they will no doubt be persuading doctors to prescribe to is the insomnia market. Around 1 in 3 people have at least mild insomnia. Many poor sleepers have developed poor sleep habits.

So, the body clock drug that was initially aimed at blind people now has a much larger potential. Jet lag and insomnia will become the new 'Non 24 Sleep/Wake Disorder'. Sufferers will be spun the story about 'body clocks' and the importance of setting the timing of that clock back to normal.

What next?

Will we see Hetlioz pushed on kids who can't sleep because they have normal teenage worries, or perhaps the man or woman who are facing employment stresses and can't sleep? Remember, the FDA left the door wide open when they agreed that this drug could come to market. Hetlioz has not been studied in children and it is not recommended for use in children but history shows that drug companies always try to widen the net when selling to the public. One only has to look at the group of SSRIs that are currently prescribed off-label to children.

How Does Hetlioz Work?

Hetlioz works to enhance the effects of the receptors for melatonin. In particular, it binds and augments the MT1 and MT2 receptors within the brain. This induces sleep.

So, is Hetlioz merely another brain pellet then, one being sold on the back of a spinning story that involves body clocks in the brain, just as SSRIs were heavily promoted on the spinning story of a chemical imbalance in the brain?

Finally, last month the FDA issued a warning letter to Vanda Pharmaceuticals. The warning letter chastized Vanda for failing to warn Hetlioz users of its most common adverse reactions, namely; headaches, increased alanine aminotransferase, which is the term used for elevated liver enzymes, nightmares or unusual dreams, and upper respiratory or urinary tract infection. These are common adverse reactions, folks!

Nightmares or unusual dreams? Nothing like taking a drug to help you with sleep, huh.


Bob Fiddaman

Back Story




Saturday, December 08, 2018

NATALIE JULIA GEHRKI



Natalie would have been celebrating her 25th birthday today but for the intervention of prescribed brain pellets.

To honour her please take, and pass on, the accredited Akathisia101 course which was designed and created by Natalie's mother, Kristina.

I have a lot of anger toward those responsible for Natalie's death. The prescribers who kept adding brain pellets, despite obvious signs that the brain pellets were slowly killing this beautiful young girl. The drug companies, for not being truthful about those brain pellets. The mental health system, for basing its entire diagnostic model on guesswork. The regulators, for its limp-wristedness and incestuous relationship with the drug industry.

Today, Natalie's family should be celebrating, instead, they are going through the motions of what might have been. Only if you have buried a child will you know the pain and suffering this family are going through today, a pain that never goes away but is magnified on birthdays, anniversaries, Christmas, Easter, Thanksgiving etc.

Natalie's story can be read in two parts here and here, it's harrowing reading, nonetheless its compelling evidence that prescribers, drug companies, regulators and the mental health system all had a part to play in taking this young woman away from her family.

I never got to meet Natalie, I never got to meet any of the kids I have written about over the past 12 years - all share one thing in common - their lives were taken by a sick and twisted monopoly of greed, fraud and psychopathy. They all will sleep well tonight, they all will blame one another for the mistakes they have made over the years but none will take the gauntlet and say enough is enough. Instead, they continue to push these brain pellets, making excuses for those who died whilst on them, blaming the victims, blaming the illness, blaming everyone and everything but themselves.

Shame on all of the above who each played a part in creating the feeling of loss that Natalie's family are suffering today. Shame on them all for continuing to ignore the mess they created.

My thoughts are with Kristina today and also Natalie's family.

Bob Fiddaman





Friday, November 16, 2018

Truth or Fiction: What are Parents to Believe?



This post is the second in a series, from Kristina Kaiser Gehrki, that started with “When a Stranger Calls.” It explores the active role pharma-funded “patient advocacy” organizations play in creating and delivering school-based mental health education targeting children.

“The truth.” Dumbledore sighed. “It is a beautiful and terrible thing and should, therefore, be treated with great caution.” – Harry Potter and the Sorcerer’s Stone

Parents in Fairfax County, Virginia tend to be affluent and well educated. The 2016 US Census found the median household annual income is more than $114K, and 60% of adults age 25 and older hold a bachelor’s degree or higher.

Well-paying jobs and well-rated schools help attract families to the region. Every high school in the Fairfax County Public Schools (FCPS) district has been “designated among the most demanding public schools in the country” and the county’s magnate program, Thomas Jefferson High School for Science & Technology, ranks in the top ten of all US high schools. Fairfax parents often spend money for private services (music lessons, tutoring, counseling, etc.) in anticipation they might improve their children’s academic and emotional wellbeing. Therefore, I was unsurprised to see a large turnout at the 5th annual FCPS Mental Health and Wellness Conference.

My work with FCPS spanned more than a decade. The district first hired me as an independent communication consultant. Shortly after, I was hired “in-house” as a central office communication specialist. Later I became a marketing teacher coordinator because I missed working directly with children. I am very familiar with the inner workings of FCPS from district headquarters to individual schools. However, I had never previously attended this annual conference.

Before I discuss the instructional content taught at the conference, it is important to convey some background info that helped spark its creation. For decades, the school district had draconian disciplinary policies ranging from silly to tragic. FCPS made the national news in 2009 when a high school at which I taught suspended and sought the permanent expulsion of a teenage girl who took her birth control pill at lunchtime. The FCPS disciplinary actions made the national comedy show, the Colbert ReportAnother student was denied school attendance for nearly two months because she had her acne medication in her locker.

These FCPS disciplinary procedures received attention from the American Civil Liberties Union given that students who were suspected of wrongdoing were routinely interrogated by school administrators and police officers assigned to each school. When principals suspected students of possible wrongdoing, it was common practice to call students into the principal’s office, hold them for hours, deny them a phone call to their parents, and fail to explain any possible Miranda-type Rights. School administrators sometimes told students if they wrote and signed confessions of wrongdoing, the school district would “go easy on them.” Often the adults’ promises of leniency in exchange for students’ cooperation were never honored and many students who signed incriminating personal statements received the maximum district punishment allowable.

The consequences and related downward spiral for two other FCPS students punished for wrongdoing were tragic. The high school boys were suspended and expelled from their neighborhood schools and, understandably, struggled with the resulting shame caused by being ostracized and alienated from their friends. The Fairfax school district stated the boys could face possible arrest if they should ever step foot on their former school’s property at any time to include weekends. This meant the students, both football players and one who was described as a “model student,” could never again attend a sporting event, high school dance or any other social activity at their former school at which their friends would be. Both boys became depressed after their involuntary transfers and both later ended their lives. One of the sessions offered at the FCPS conference I attended was presented by the Josh Anderson Foundation, created in memory of one of these two FCPS students who died.

ADHD: A Sharp Increase in Diagnosis

Given FCPS' long history of severe punishments that failed to use restorative justice principles to help children learn and grow from mistakes, I really wanted to attend the session titled, "Resilience and Thriving: The Secret Power of Stress." But I just couldn't do it considering the ironic title in relationship to the district's not-so-distant past. Instead, I attended two other sessions both of which featured the National Alliance on Mental Illness (NAMI) and Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD). The first was titled, “Community Resources for Families and Youth.” Instructors included the Executive Director of the National Alliance of Mental Illness (NAMI) northern Virginia office, a representative from CHADD’s northern Virginia chapter and another representative from an organization for foster and adopted children.

Some information parents and teachers learned in this session included:
  •  ADHD is a serious disorder that has a neurobiological and neurochemistry basis.
  • If financial means is a deterrent to have children assessed for ADHD and other DSM disorders, parents can ask the school system for screening/services and some external services are free or provided at discounted rates depending upon family income.
  • ADHD diagnosis should not be based on children’s self-reporting of symptoms because “evidence” shows children’s perceptions don’t always correspond with the cognitive and functional disabilities professionals can best identify during objective assessment.
  • If teachers share with school personnel their concerns about students possibly having a disorder like, say, ADHD, the Individuals with Disabilities Education Act includes “Child Find” which federally mandates that schools locate, identify and evaluate all children with disabilities from birth to age 21.
  • CHADD publicizes ADHD as a life-span disorder. The presenter at this FCPS session repeatedly stressed ADHD is also an adult disorder. CHADD has a poster illustrating this life-span disorder approach. 
  • CHADD, which bills itself as the National Resource on ADHD, offers a Teacher-to-Teacher program purported to have “expert educators” to help teachers understand ADHD.

Some information parents and teachers did not learn from this session:
  • CHADD’s 2013/14 report states it is “increasing service related programs such as Parent to Parent and Teacher to Teacher. These strategies are focused on increasing revenues…” 
  • The number of US children and teens receiving a diagnosis of ADHD increased by 43% from 2003 to 2011. 
  • The chances of a child being diagnosed with ADHD and prescribed ADHD drugs are related to the state in which the child resides. For example, children living in Kentucky are three times more likely to be labeled with ADHD than are children living in Nevada.
  • Boys are three times more likely to be labeled with ADHD than are girls.
  • 25% of children in preschool who have been diagnosed with ADHD are being given drugs and receiving no talk therapy or other behavioral interventions. 
  • The United Nations International Narcotics Control Board (INCB) expressed concerns about CHADD’s active lobbying for the use of Ritalin for children labeled with ADHD while being heavily funded by the makers of Ritalin. INCB said this promotion of sales of an internationally controlled substance could be identified as covert advertising and charged CHADD with being a vehicle for marketing a controlled substance directly to the public in violation of the Controlled Substances Act of 1971. 
  • Ritalin maker, Ciba-Geigy (now Novartis) admitted CHADD was their conduit to the public. CHADD and National Institutes of Mental Health personnel were regular visitors at the Department of Education office of Special Education authoring ADHD materials.
  • American taxpayers are also funding CHADD given that two federal agencies, The Center for Disease Control (CDC) and the National Center on Birth Defects and Developmental Disabilities (NCBDDD) each donated $500,000 or more to CHADD this year.
Before this session ended, I asked the instructor how CHADD was able to offer so many parent and teacher programs, some of which include free dinner. She said CHADD operated through donations and grants. Pharmaceutical companies were never mentioned.

The reality is CHADD’s top corporate donors are pharmaceutical companies. Shire Pharmaceuticals, makers of several ADHD drugs, contributed a minimum of $100,000 to $299,999 in 2018. In 2014 the US Justice Department announced Shire pharmaceuticals paid $56.5 million to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs to include Adderall XR and Vyvanse, both marketed for ADHD. 

Next in line is Supernus Pharmaceuticals donating $25,000 to $99,999 to CHADD in 2018. Supernus began as a US subsidiary of Shire and is currently “developing multiple candidates in psychiatry to address significant unmet medical needs in the treatment of Impulsive Aggression (IA) and for the treatment of ADHD.” CHADD’s total pharmaceutical-related funding for 2018 is much more given that in 2009, CHADD took more than $1.5 million from pharmaceutical companies alone, roughly 36% of its total 2009 revenues. This includes pharma funds for advertising.

The third top CHADD corporate donor in 2018 is Akili Interactive, a company that develops video games marketed to help treat children diagnosed with ADHD. I’m including Akili’s $25,000 to $99,999 donation to CHADD as a pharmaceutical-related donor, however, because Shire is directly invested in Akili. In addition to the monetary investment, Shire worked closely with Akili to structure and launch the first clinical study of the Project: EVO™ billed as a cognitive measurement product in pediatric ADHD. This week in typical FDA and industry revolving-door fashion, Akili announced it has hired former FDA and Pfizer employee, Dr. Anil Jina, as head of medical affairs preparing to “launch its first digital medicine and drive the aggressive expansion of its pipeline.”

Educate Before You Medicate

Reading the description of the second session gave me some hope. Titled, “Educate Before You Medicate," the session description stated: “Prescription medication are being more widely used among children. However, medications alone will not improve the health of children. Learn about the proper use of common medications and lifestyle changes to help keep children healthy.” The instructor held a doctorate in pharmacy and his bio stated he is a healthcare consultant, entrepreneur and patient advocate.

We viewed the instructor’s PowerPoint which shared data about how to safely store medications, a brief overview of nutrition, and common prescription drugs that are sometimes abused by teens. I waited for some information about adverse drug effects, particularly data that pertained to children and teens, but this info wasn’t part of the presentation.

Some information parents and teachers learned in this session included:
  • “Most medications used to treat mental illnesses such as depression, bipolar and others take an average time of 4 to 6 weeks before these drugs are the most effective.”
  • Many mental illnesses have a biochemical basis.
  • People need to stick with their medication plan and should not stop taking their medication.
Near the end of class, the instructor asked attendees for questions or comments. A parent started asking questions about psychiatric drugs and side effects, specifically inquiring about Zoloft. Out of respect for privacy, I won’t share the gender of this parent or their child’s. The worried parent shared frustrations about the teen’s deterioration. The parent’s frankness surprised me a little given that publicly discussing mental health topics is sometimes seen as a cultural taboo in the parent's country.

The instructor-pharmacist responded to the parent’s questions with something to the effect of “it’s important to discuss these issues and possible side effects with your doctor.” I understood the reasons for his response. Unfortunately, I also understand far too well that doctors are often unable or unwilling to recognize their pharmaceutical interventions have destroyed those they professed to help.

I raised my hand and mentioned akathisia, serotonin toxicity and the FDA Black Box suicide warnings on all SSRIs. I shared the RxISK.org website where adverse effects are reported by actual users. The instructor went over to his laptop and accessed the RxISK website. He then returned to the lectern and shared with the class the Walgreens pharmacy website. He said parents can learn more about individual drugs on this website, adding it was “more reliable” presumably because it was from Walgreens. I replied that I had nothing against Walgreens. (My daughter was a college freshman and worked in the Walgreens beauty department at the time of her death). I pointed out that the Walgreens website likely only contains the drug info provided by drug makers and not by actual drug consumers. If parents look for information about Zoloft on the Walgreens website the instructor provided, they will not learn about akathisia. Further, the FDA Black Box warning is not readily apparent on the Walgreens Zoloft homepage and users must click an additional link to find this warning. Parents and teachers will also not find akathisia info on the CHADD and NAMI websites the FCPS conference instructors praised as valuable resources.

During his presentation, the instructor promoted NAMI. When class ended, he encouraged us to take a NAMI handout before we left.

Some information parents and teachers did not learn from this session:
  • US FDA Black Box warning info, suicidality as an adverse drug effect and Informed Consent was not part of the prepared instruction
  • A significant percentage of NAMI’s funding is from pharmaceutical companies. Exact funding amounts are obfuscated given NAMI’s broad donation categories of “$5,000 or more.” However, a US Senate investigation into NAMI’s conflicts of interest determined NAMI took $23 million from pharma between 2006 and 2008. It is reasonable to assume this year NAMI collected more of the same. 
  • NAMI’s 2017 annual report has a long list of pharmaceutical “corporate and foundation supporters.” They include Eli Lilly, AstroZeneca, Otsuka America Pharmaceuticals, Takeda Pharmaceuticals North America, Lundbeck, Bristol-Myers Squibb, Allergan and PhRMA (a trade group for the pharmaceutical industry). 
  • Pfizer heavily funded NAMI in 2009 when the company was busy illegally promoting the drug, Geodon, for non-approved use in children. Pfizer paid more than $2 billion in criminal and civil fines for pushing their antipsychotic drug onto pediatric, adolescent and geriatric patients for off-label uses. 
One Parent’s Search for Answers

After we left the session, the parent who bravely sought information about drug side effects started telling me about the child’s deterioration. I politely stopped the conversation and asked if it was okay if I tried to "guess" the sequence of events. I asked because I strongly suspected what was happening to this parent’s teenager is similar to what happened to mine. I thought if I could accurately tell this parent the “story” of their child’s demise before being told, it might better encourage the parent to seek out independent and accurate info that could save the teen’s life. I then recounted the adverse effects that ended with my daughter, Natalie’s, prescription-drug-induced death. The parent nodded in agreement as I was speaking.

The parent then shared their family’s lived experience. The teenager was prescribed Zoloft. After starting this SSRI, the teen changed dramatically and started self-harming. New drugs were added and the SSRI dose was increased. The teen subsequently attempted suicide. At the present time, it is unlikely this teen will be able to leave home for college. These symptoms were not part of the teen's original presenting challenges.

I recommended a list of books and online resources for the parent. I spelled out the word akathisia on a piece of paper so that the parent could seek critical mental health and wellness information upon returning home.

"The ancient study of alchemy is concerned with making the Sorcerer's Stone, a legendary substance with astonishing powers. The stone will transform any metal into pure gold. It also produces the Elixir of Life, which will make the drinker immortal.

You know, the Stone was really not such a wonderful thing. As much money and life as you could want! The two things most human beings would choose above all – the trouble is, humans do have a knack of choosing precisely those things that are worst for them." Dumbledore – Harry Potter and the Sorcerer’s Stone

The third post in this series highlights actions parents, teachers and schools can take to improve and safeguard children’s well-being.


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.







Friday, November 09, 2018

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

















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