Medication Overload, Part II: The Explosion of Drugs for Kids

In the early 1960s, around the age of two, I experienced an accidental overdose. 

The pediatric drug I took was most likely purchased by my father at our family grocery store, which was located in the heart of our village community. St. Joseph Aspirin for Children was a trusted brand in our home and at our store, especially since it claimed to be “recommended 4 to 1 over any other by Children’s Doctors” and carried the name of the patron saint of families. This product was kept not in our bathroom medicine cabinet, hidden behind a mirror, but rather in our kitchen where we stored our drinking glasses.

The incident occurred after one of my preschool-age siblings managed to use a kitchen chair to retrieve the tasty but very toxic medicine, open the bottle, and then give it to me believing the “candy medicine” would help their baby sister feel better.

The drug that nearly took my life as a toddler was intentionally formulated to taste like candy. After its release in 1947, St. Joseph Aspirin for Children was aggressively marketed to parents, relying heavily on newspaper and magazine ads. The success of the pediatric drug spawned competition and by the 1950s, low-dose, flavored aspirin was the most profitable drug for kids, far outselling its chief competitor, penicillin. However, the drug companies failed to warn consumers of the potential harm their products could cause—and as profits soared for the drug companies, “candy aspirin” poisoning among young children increased dramatically during the ’50s and ’60s.

Despite evidence of the dangerous nature of this product, along with mounting pressure from the Food and Drug Administration (FDA) and child safety advocates, the aspirin industry denied any negligence on their part and instead blamed the reported safety concerns on poor parenting. It was not until after the passage of the Poison Prevention Packaging Act of 1970 that safety measures were improved. By the mid-’70s, the use of child-resistant packaging was associated with a significant reduction in the aspirin-related child mortality rate. Nonetheless, many children accidentally overdosed, and some lost their lives because corporate interest focused on remaining profitable at all costs, even if those costs meant a parent losing a child. 

For anyone who pays attention to the behavior of Big Pharma, none of this should be surprising. As readers of Mad in America know, the potential harms of psychiatric drugs are too often swept under the table or outright ignored, even in the face of devastating statistics on deaths and other forms of iatrogenic harm. With the explosion of more and more drugs in cabinets across the country, more and more children are dying—but still, pharmaceutical companies push their products, leading to yet more drugs and yet more deaths.

Which is exactly what happened with children’s aspirin. After the improvement in packing, the negligence in the children’s aspirin industry continued. According to a 1992 analysis published in The Lancet, the deaths of almost 1,500 children who died of Reye’s syndrome may have been prevented if the government had not waited five years to require warning labels on aspirin. Although doctors had reached a consensus in 1982 that the use of aspirin in young children could cause Reye’s syndrome, government documents show that corporate lobbyists worked to delay regulations requiring warning labels.

Clearly, I was one of the lucky ones. The only reason I lived is I grew up in a small, tightknit, caring community—this was a village in Central New York, back in the 1970s—where people took responsibility for each other. But the only reason I even know about my own candy aspirin overdose is because I heard my father recount the incident many times. My father was a true craftsman in many arenas, including mastering the art of storytelling. His stories would command the attention of his audience, no matter how large or small, as he knew how to weave together the details of the past with humor, suspense, emotion and meaning. I especially loved hearing this story because my dad was one of the heroes involved in saving my life. But by the end of the story, my dad would always have a solemn look on his face, holding back tears, staring at the floor, slowing down his tone, he would shake his head and say he thought that I was “gone.” 

When the incident occurred, my panic-stricken mother told my father to take me to the hospital right away. My father quickly realized I would never make it there and instead drove straight to our family doctor, whose medical practice was also his home, just a few blocks away. Dr. Fulmer quickly pumped the drugs out of my stomach and told my father I would not have lived if he had tried to get me to the hospital. He was more than just a doctor to my father, he was a friend, a neighbor, a patron of our local grocery store—and a lifesaver.

The Main Street Connection

For those of us who had the privilege of growing up in Main Street America settings, the proverb, “it takes a whole village to raise a child” reflects a social reality too often absent in the culture at large, particularly in the Corporate America that holds sway in the pharmaceutical industry. Business owners on our Main Street held pride in their neighborhood and took on leadership roles within our community. The majority were family-owned businesses whose owners, like us, lived in the village and raised their families in the same community they operated. 

While I would never claim things were perfect, our village community did its best to take care of each other, especially our most vulnerable. Our village was established with a family-friendly infrastructure, having shops, schools, churches, medical doctors, dentists, attorneys, social clubs and municipal services all within walking distance. Community safety was a concern for all, and when the sirens at the fire station went off, our volunteer firefighters would leave their homes or their jobs to jump into action. Without hesitation, they would put their own lives at risk to run into a burning home and save the lives of their neighbor’s children.

Unlike the pharmaceutical industry, in our village community the pain of losing a single child was felt by all. 

Still, things weren’t perfect. Like most any community, people living in our village had their fair share of differences and disputes. And despite the clutch of small, caring businesses in town, one outlier made its presence known in ways we could not ignore. Living in our village could really stink—literally stink. The stench came from the smoke billowing out of the stacks from the largest business in our village by far, Bristol Myers Squibb. The pharmaceutical facility was built in 1943 and made 70% of the penicillin produced in the world.

Bristol Myers, along with the many other manufacturing plants located in the surrounding area, helped to grow and strengthen our local economy. Unfortunately, living with their pollution came with a price we all had to pay. Even after years of repeated warnings and paying millions in fines for violating federal regulations, the drug company displayed a lack of social responsibility and continued to discharge toxins into our waterways and air. 

By the mid-2000s, because of cheaper costs to manufacture penicillin in foreign countries, the plant downsized considerably. But across the country, the towering influence of corporate culture—mass production, mass marketing, mass consumerism, and profit-driven healthcare—has eroded our Main Street America culture and negatively impacted many aspects of our society, including consumer behaviors and the drugs we purchase at our doctors’ recommendation. The number of pharmaceutical products in the home today is unprecedented—and drugs, both legal and illegal, continue to be the leading cause of child poisoning. A review of poisonings among children age 5 and younger found that opioids were the leading cause of fatal poisonings between 2005 and 2018. Over-the-counter pain, cold, and allergy medications were the second most common substance contributing to pediatric poisoning deaths. 

The contents of most medicine cabinets in the US have changed a lot since the days of “candy aspirin” poisoning, with more drugs being prescribed to kids: In 2009, children became the leading growth demographic in the pharmaceutical industry. The use of off-label medications in children has become a common practice for pediatric providers, and psychiatric medications are now the fastest-growing class of pharmaceutical agents for children. 

The Devil Is in the Details

As seen in tragic cases such as that of Rebecca Riley and Gabriel Myers, pediatric psychiatry, polypharma, and off-label prescribing have no age restrictions. Rebecca started seeing a psychiatrist at the age of two and was diagnosed with attention-deficit hyperactivity disorder and pediatric bipolar disorder. A nurse at Rebecca’s preschool warned her psychiatrist that Rebecca seemed overmedicated because she was so lethargic that she appeared like a “floppy doll.” After suffering horrible abuse, Rebecca died in 2006 from an overdose of psychiatric drugs. She was four years old. 

During her short life Rebecca was prescribed three medications to stabilize her mood: Seroquel, an antipsychotic; Depakote, an anti-seizure drug; and Clonidine, a blood pressure medication. Two months after Rebecca’s death, her parents were arrested and charged with first-degree murder. The circumstances surrounding Rebecca’s death led to Katie Couric’s segment on 60 Minutes, “What Killed Rebecca Riley?”—which questioned the rising cases of young children diagnosed with bipolar disorder. A wrongful death suit was also filed against her psychiatrist, Dr. Kayoko Kifuji. The civil case was settled in January of 2011 for $2.5 million. Prosecutors had already granted Dr. Kifuji immunity from criminal prosecution in exchange for her testimony in the trial of Rebecca’s parents.

The 2009 suicide death of 7-year-old Gabriel Myers prompted a statewide investigation into Florida’s foster care system, followed the Government Accountability Office conducting a federal investigation. In her series, “Generation Meds,” ABC World News anchor Diane Sawyer reported these findings: Many foster children, even as young as one year old, are being prescribed powerful mind-altering drugs at alarming rates—up to 13 times higher than that of other children. The investigations revealed thousands of children in foster care were prescribed psychiatric medications at doses higher than the maximum levels approved by the FDA. And hundreds of foster children received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together.

Gabriel, a victim of sexual abuse, was seen briefly by a psychiatrist who prescribed him the ADHD drug Vyvanse along with Symbyax, a combination of the antipsychotic Zyprexa and the antidepressant Prozac. Symbyax carries a “black box” warning that it might lead to suicidal behavior among children and adolescents, especially when first prescribed. Gabriel’s psychiatrist, Dr. Sohail Punjwani, was later “sanctioned for over-prescribing medications to patients and for the age-inappropriate prescription of medications to Gabriel Myers.”

Pediatric anxiety is currently a condition that pharma giant AbbVie is now marketing their drug Lexapro to treat. As reported on MIA by Peter Simons, in May, the FDA expanded the prescribing of Lexapro to include kids as young as seven years old who need help because they feel nervous. This drug gained FDA approval for children even though it did not work any better than a placebo—and increased suicidality sixfold! 

The Lexapro prescribing information expects parents to limit their child’s activities and pay very close attention to how their child reacts to this drug. The drug company instructs parents to:

Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.

The drug information packet also lists numerous adverse physical reactions, including life-threatening conditions, and has a “black box” warning regarding the increased risk of suicidal thoughts and behaviors in pediatric consumers. 

Therefore, the FDA, the drug company, and prescribers all expect parents to fully understand that a product they are purchasing to help their child cope with feeling nervous is, in fact, a very dangerous product that might not work at all or result in their child suffering a life-threatening adverse reaction. Or, worst of all, could cause their child to die by suicide. 

A “Safe and Effective Drug” That Leads to a Child’s Death

The 1999 filicide death of five-week-old Tyra E. truly epitomizes the callous nature of the pharmaceutical industry. Filicide is the deliberate act of a parent killing their own child. One study found such deaths occur about 500 times a year in the US, and researchers have different theories on why. In Tyra’s case, the cause was drug-induced. 

Ten days after Tyra’s father began taking the ADHD drug Adderall to help him with his college studies, he slipped into a psychotic fog, shot and killed his baby girl, and then shot himself in the stomach. The criminal court found Tyra’s dad innocent after expert testimony reported the “psychotic state” was caused by the Adderall.

I first learned of Tyra’s death from a small article that asserted: “Despite the slaying, Adderall remains a safe and effective drug.” That was the statement made by Shire Pharmaceuticals Group, the manufacturer of Adderall. While this case did not attract much media attention, those words hit me like a hurricane; exactly how many “slayings” need to occur before this product is deemed an unsafe and defective product?

At that time the internet was still in its infancy, and there was very little information available online about the court’s decision, so I went to the law library to learn more about the case and the drug company involved. Shire started out as a tiny company founded and funded in 1986 by four entrepreneurs in the UK. By 1997, their acquisitions facilitated access to the US drug market and the relaunching of Adderall. Their drug quickly became the fastest growing ADHD product in the US.

After Tyra’s death, her parents sued Shire for $100,000 to recover medical, legal, and funeral expenses. They claimed Shire failed to warn about the effects of Adderall and illegally marketed and advertised the drug. Their lawsuit was dismissed, as the court ruled a pharmaceutical manufacturer has a duty to warn a physician of the risks involved with a drug, and the physician acts as a “learned intermediary” between the manufacturer and the patient. “Thus, a warning to the physician is deemed a warning to the patient; the manufacturer need not communicate directly with all ultimate users of the prescription drugs.” So, even though Shire admitted their product caused a tragedy, they refused to accept any responsibility. And our courts sided with the drug company. 

Shire was later accused of violating the False Claims Act regarding the marketing and promoting of several products including Adderall. Among the allegedly unsupported claims was that Adderall would “normalize” its users, rendering them indistinguishable from their non-ADHD peers. The drug company also allegedly marketed its ADHD product based on unsupported claims that Adderall would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted diseases. In addition, Shire allegedly promoted Adderall for the treatment of conduct disorder without FDA approval. 

Shire agreed to resolve the civil allegations with a $56.5 million settlement. From the settlement, the federal government received $35,713,965, and state Medicaid programs received $20,786,034. The allegations arose from a lawsuit filed by Dr. Gerardo Torres, a former Shire executive, and a separate lawsuit filed by Anita Hsieh, Kara Harris, and Ian Clark, former Shire sales representatives. The lawsuits were filed under the False Claims Act’s whistleblower provisions, which permit private parties to sue for false claims on behalf of the government and to share in any recovery. Torres received $5.9 million. 

Follow the Money: Investors Banking on ADHD for All

For marketing purposes, the name Adderall was conceived from the contraction of the phrase “ADD for All” to intentionally convey the message that “it was meant to be kind of an inclusive thing.” Adderall has certainly lived up to its name. It continues to be a money-maker for pharmaceutical companies, with a whopping 41.4 million prescriptions dispensed in the US during 2021.

The drug is a formulation of amphetamine mixed salts, and the active pharmaceutical ingredients for production are primarily produced in China and India. Currently, Israel-based Teva Pharmaceutical Industries is the largest supplier of Adderall for the US. Shire has since been bought out by Japan’s Takeda Pharmaceuticals, a 242-year-old company that made the purchase in 2019 to strengthen its footprint in the US drug market. 

The irony: In Japan, the use, production, and import of any medicine containing amphetamines, including Adderall, is strictly prohibited. This issue came to light during the 2021 Tokyo Olympics with public concerns being raised over Simone Biles having access to her ADHD medication Ritalin. The ban on ADHD medications in Japan dates back to WWII, when amphetamines were used to keep soldiers from being fatigued, and high doses were given to kamikaze pilots before suicide missions. All stimulants, including Adderall, were subsequently banned by the government in 1951, after it was revealed that they were devastatingly addictive.

Here in the States, the government has reached the same conclusion—without the subsequent ban. Adderall and the amphetamines used to make it are classified as Schedule II controlled substances by the Drug Enforcement Administration (DEA). Last October, the agency expressed concern that “aggressive marketing practices” by telehealth companies may be contributing to the over-prescribing of ADHD medications; as a result, the DEA limited the production, contributing to a nationwide shortage.

While the DEA did not mention specific telehealth companies, it is believed the company Cerebral Inc. was one of their concerns. Cerebral’s prescribing and marketing practices resulted in triple investigations by the Federal Trade Commission, Department of Justice, and DEA. The company had launched in 2020 with five employees and became one of the digital mental health startups that reached “unicorn” status, which signifies a privately held startup company valued at over $1 billion.

Regulatory changes during the pandemic benefited the telehealth industry as potentially addictive medications—like Adderall—became more available online to patients. With the mental health market booming during the pandemic, both American and foreign investors poured major cash into start-up companies like Cerebral, who recruited social media influencers to target a tech-savvy generation desperately seeking psychiatric treatment. Cerebral quickly formed a partnership with Alto Neuroscience Inc., to launch the first-ever decentralized clinical study by recruiting app subscribers to participate in at-home clinical research utilizing Alto’s biomarker platform and targeted drug candidates. Field Trip Health also entered into a partnership with Cerebral to “lower the barriers of entry into ketamine assisted therapy for many people who have solely been exposed to generalized psychiatry.”

Simone Biles became a spokesperson for mental health issues after opting out of the Tokyo Olympics and was recruited by Cerebral as an investor and face of their brand, quickly helping it raise $300 million in venture capital—and take its value to $4.8 billion. After complaints surfaced and whistleblowers came forward about unethical practices and overprescribing, Cerebral announced last year that it would no longer offer stimulants such as Adderall or Concerta. Shortly after the allegations, Ms. Biles ended her partnership. 

While the company’s mission was based on what seemed like an altruistic goal to “end the stigma of mental illness,” in reality, it had a ruthless goal of generating extreme profit as quickly as possible by increasing the number of people diagnosed with mental illness—children included—and prescribed potentially harmful psychiatric drugs.

Granted, pharmaceutical companies are credited with being producers of life-saving drugs, but these companies have also proven that they are willing to aggressively market dangerous products under the guise of improving our mental health and wellbeing while showing a blatant disregard for human life. With the FDA’s stamp of approval and recommendations from prescribers, these companies act as if they are unstoppable because they believe we have become so mentally overwhelmed by the world around us that we are nothing but a quick-fix, drug-dependent society.

I believe we are better than that.

Our overreliance on the pharmaceutical industry to treat perceived psychiatric disorders should be seen as a societal problem that needs a collective response. Reducing our reliance on psychiatric drugs will only take place when we learn to listen with discernment, recognize alternative options, and stop listening to the party line of the medical model. 

Turning the Corner: Revitalization, Restoration, and Gradual Awakenings

Which takes me back, once again, to my childhood.

My father was a true pillar of strength, both in our family and in our community. During the recession of the early 1980s, when many businesses were hit hard, my father spearheaded creative projects to remodel our store, improve sales for our group of neighborhood supermarkets, and revitalize our village community through redevelopment projects. What was projected to be a very depressing economic forecast became a chance to engage in exciting opportunities that breathed new life and energy into our village community. Although many of the family-owned and operated businesses have since closed, the community is still fairly well-maintained, and the village government continues to host many engaging family-friendly events. 

After our store closed, the building was sold to the Rescue Mission Alliance and made into a thrift store. Our family was invited to the grand opening, and a plaque honoring my father was hung at the entrance. The money earned at the thrift store supports the homeless shelter in the nearby city. While it was heartbreaking to see our store close its doors, especially since so many within walking distance depended on it for essentials, it was heartwarming to tour the shelter and know a higher purpose is still being served in the building that my dad put his heart and soul into.

The building adjacent to our store was maintained by one of my siblings, who until their retirement a few years ago, operated a bottle and can redemption center. Although not easy work, my sibling enjoyed staying connected to the community. For low-income areas, this service is very valuable for extra income, it helps reduce neighborhood waste and also helps out many nonprofit organizations with fundraising. 

As for Bristol Myers, it spent tens of millions of dollars working with the state to implement a comprehensive plan for environmental protection to reduce and clean up toxic waste. A herculean effort under the supervision of state and federal regulatory agencies helped to clean up a heavily polluted lake that for decades was a dumping ground for Bristol and many of the industries in the area. For more than a century, sewage combined with industrial waste gave the lake the reputation of being one of the most polluted lakes in the world. 

On my last trip to visit family in my hometown, I was able to walk a trail at the lake with my childhood friend. We saw over 30 bald eagles as this lake, which was once considered a “cesspool”—but is now one of the largest winter roosting sites for eagles in the state. This was a sight that as kids, we never could have imagined. 

Over the past 15 years, I have had the opportunity to engage in volunteerism that supports various nonprofit organizations and elementary schools in the community I now live in. I have been blessed to meet and connect with dozens of individuals who are truly making a difference in this world, including working to advance consumer education on psychiatric drugs and alternative options. These are individuals who are quietly and persistently answering the call of caring for the needs of others in our community because it is their passion. Their contributions to grassroot efforts, dedication, commitment, and creative ideas of fundraising have blossomed into sustainable nonprofit organizations that are best described by those who know what goes on behind the scenes as “magical.” 

After seeing so much tragedy and injustices in the world directly related to the use of psychiatric drugs, it is heartwarming to know that small groups of thoughtful, committed citizens are truly making a difference. 

As Margaret Mead once said: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” 

Let’s keep at it.