Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

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 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


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

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