ADHD Drug Warnings Come Too Late For Many
ADHD Drug Warnings Come Too Late For Many
By Evelyn Pringle
The makers of drugs used to treat attention disorders have known about the serious health risks associated with the medications for years but instead of warning the public, the industry has consistently focused its efforts on expanding the market and colluding with FDA officials to keep warnings off the labels of ADHD drugs.
On February 21, 2007, the FDA finally directed the drug companies to develop Patient Medication Guides to inform patients about the adverse psychiatric symptoms associated with Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate CD, Methylin, Ritalin, Strattera, and the extended-release, patch and chewable versions of these drugs.
An FDA report titled, "Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data," by Kate Gelperin and Kate Phelan, was presented at the March 22, 2006, Pediatric Advisory Committee meeting and stated in part:
“The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD.”
Between January 2000, and June 30, 2005, the FDA identified nearly 1,000 cases of psychosis or mania linked to the drugs in its own database and those from the drug makers themselves. A substantial proportion of the cases occurred in children age ten years or less, a population in which hallucinations are not common, the authors said.
"The occurrence of such symptoms in young children," they wrote, "may be particularly traumatic and undesirable, both to the child and the parents."
"The predominance in young children of hallucinations, both visual and tactile," it stated, "involving insects, snakes and worms is striking, and deserves further evaluation."
But the fact that these drugs cause psychosis is not news. The rate of psychotic events was reported in a 5-year Canadian study of children diagnosed with ADHD, by Cherland and Fitzpatrick in 1999. Among the 192 children studied, 98 had been placed on stimulant drugs, mostly methylphenidate, and psychotic symptoms developed in more than 9% of the children and ceased as soon as the medication was stopped.
Researchers reported no psychotic symptoms in children who did not receive stimulants and the authors noted that due to poor reporting, the rate of drug induced psychosis and psychotic symptoms was probably much higher.
Dr Chris Griffith testified at the March 26, 2006, hearing on behalf of the industry funded front group, known as CHADD, and as much as said, kids would burn in hell without ADHD drugs. "What happens when a child loses all hope and ambition;" she asked the panel, "what happens when it is easier to find a vial of crack cocaine or 40 ounces of beer as opposed to a park or community recreation center?"
According to psychiatrist, Dr Stefan Kruszewski, the opposite is true. “Children who are medicated early," he says, "do not learn to develop coping strategies that work as they move through different developmental stages."
"Instead," he says, "they learn to rely on drugs to solve problems, rather than their creative potential to solve problems on their own or with the help of family, friends, schooling, music and the arts, church, social outings, recreation and sports."
Dr Griffith also asked the advisory panel to think about:
"What happens to a future generation of minority youth, African-American, Latino males who disproportionately populate our juvenile justice system? What happens to a teenager's sense of fun when we are dealing with high rates of teen pregnancy, sexually transmitted diseases and even abortions?
"Finally, what does it say about all of us? We turn on the news each night and we tragically see young drivers, teenagers, killed in automobile accidents--so many that we forget their names, their faces and their stories. We develop a sense of apathy."
"This may all seem like drama," she stated, but “it is the untold story of what happens when we fail to recognize and treat ADHD.”
According to Dr Griffith, depriving kids of legalized speed leads to every sin known to man. "With untreated ADHD,” she told the panel, “we see higher rates of school and occupational failure; greater rates of incarceration; juvenile delinquency; substance abuse; teen pregnancy; sexually transmitted diseases; more problems with depression and self esteem and, finally, greater numbers of automobile accidents and fatalities."
This is a drama all right, but it's the other way around. A study in the February 2006, Journal of Drug and Alcohol Dependence, examined data from a 2002 survey of about 67,000 households, and reported that more than 7 million Americans have misused ADHD stimulant drugs, and “substantial numbers of teenagers and young adults appear to show signs of addiction, according to a comprehensive national analysis tracking such abuse.”
The researchers found that in one 12-month period, about 1.6 million teens and young adults had misused the drugs and that 75,000 showed signs of addiction.
In addition, for years there have been reports of suicide and violence in persons on ADHD drugs. For example, back on January 30, 1999, Adderall use resulted in the death of 5-week-old, Tyra Ehlis, in Grand Forks, North Dakota, when Ron Ehlis killed his daughter ten days after his doctor wrote the a prescription for Adderall.
In this case, Ron had been on Ritalin as a child, and when he went to a psychiatrist at age 26, because he was having difficulties with his college studies, without conducting any tests whatsoever, the doctor prescribed Adderall.
A few days later, Ron doubled the dose per his doctor's instructions, and he began experiencing delusions, hallucinations, and out-of-body experiences, including talks with God and his dead grandfather.
Shortly thereafter, acting under a belief that he was carrying out God’s orders, Ron shot Tyra, and then himself in the stomach, but he survived.
Ron went on trial for the murder of his daughter, but the charges were dismissed after several doctors testified that Ron suffered from an Adderall-induced psychosis. The infant’s mother also testified that Ron had not acted like himself from the first day that he began taking the Adderall.
Adderall also caused the violent death of 8-year-old, Jessica Curry, in Spokane, Washington. In late September 1999, she was a happy little third-grader sitting on her mother's lap in a Mustang convertible telling mom what she wanted to wear for Halloween.
After saying she wanted to be a princess, Jessica's mother, who was on Adderall at the time, stabbed her daughter 5 times and then stabbed herself. Here too, the mother lived but child did not. A short time later, a policeman came across mother and daughter still sitting in car in the driveway all covered in blood.
Jessica’s mother was also found not guilty by reason of insanity brought on by the Adderall after doctors for the prosecution and the defense agreed that her mental state was so acute that she could not have distinguished right from wrong at the time that she killed her daughter.
The death of 3-year-old Nathaniel Branson must also be classified as an Adderall fatality. On March 18, 2000, Nat's mother Dawn was driving in Scottsdale, Arizona with her son in the car when she suffered a psychotic episode while under the influence of Adderall.
According to court documents, Dawn heard a voice saying: "Let go of the steering wheel and gas. God will drive the car don't you trust him?"
Dawn did as she was told and a car accident caused the death of her son and serious injuries to herself. She had never been psychotic before taking Adderall and she has had no more psychotic episodes since she quit taking the drug.
So when the FDA reported that the agency had received hundreds of reports of aggressive behavior in children taking ADHD drugs, and up to 20% resulted in a significant injury or hospitalization, this was not news either.
Experts say to expect more of the same as the prescriptions for these drugs continue to multiply. At the advisory meeting, Dr Gelperin noted the expansion of the customer base stating: "Drug treatment of ADHD is increasing in all age groups ... and also drug treatment for ADHD can now potentially be life-long."
It hard to imagine how sales could go higher. In 2005, according to Research and Markets, the value of the ADHD market was $2.6 billion and is now the 9th largest segment of the CNS market by sales with growth of 8% year-on-year.
Attorney, Barry Turner, a lecturer in law and medical ethics at Leeds Law School in the UK, warns about of dangers of "pathologising" children's behavior. He says psychiatric drugs have a disinhibitory effect on children and those who grow up disinhibited become psychopathic.
"Psychopaths," he explains, "are unable to benefit from guilt, fear or empathy and pray on victims without inhibition."
“ADHD drugs are creating a generation of psychopaths,” he warns, “not because it is real, but because children are being brainwashed into believing they are sick."
"It becomes a self fulfilling prophecy,” Mr Turner says.
By disrupting the brain development of small children, he explains, drug makers are manufacturing a small army of “artificial psychopaths.”
When testifying at the hearing, FDA scientist, Dr Mosholder, told the advisors what all parents deserve to know. "There are no pathognomonic physical or laboratory findings," he said, "and there is no psychological testing that can make the diagnosis for certain."
The panel was informed that children are being stigmatized for life by being wrongfully diagnosed and put on drugs. Sue Parry, a school-based occupational therapist from New Mexico, testified that parents are not aware of the future harm that may result from an ADHD diagnosis, as described by Dr William Carey who states:
“The label may be stigmatizing and harmful in the long term in ways that are only dimply appreciated today. The diagnosis of brain malfunction, which seems so useful and comforting today, may at a later time come back to plague the person.
“We have not yet had sufficient time to observe fully the possible consequences it may have for education opportunities, employment, the military service or security clearances. Labels stick firmly, especially when they involve neurological disability.”
Allen Jones, speaking on behalf of the Alliance for Human Research Protection, told the advisors that the FDA should instruct the pharmaceutical industry to advise the FDA of all adverse events that have been reported on the drugs immediately, and demand that all clinical trials be turned over so that independent researchers can review them.
"We don't have the luxury of time to wait for the future trials," he said, “children are dying.”
Having lost her son to the side effects of Zyprexa before a warning was added to its label, Ellen Liversridge, testified on behalf of parents who lost children. “I grieve particularly today,” she said, “for the 51 dead of ADHD drugs that were announced by the FDA.”
“I guess my up-front message, front and center,” she told the panel, “is that you know that these drugs can cause serious side effects and death, including sudden death, hypertension, myocardial infarction, stroke, and possibly bipolar disorder.”
“This being the case,” she stated, “I urge you to recommend that these drugs have an appropriate black box warning placed on the label starting immediately.”
A grieving mother, Jacqueline Bessner, told the story of her 15-year-old daughter, Leanne, a high school sophomore who she said, was popular, beautiful, acted in school plays, loved sports, played baseball, and was on the varsity basketball team.
Ms Bessner informed the panel that Leanne "will not run another base, or shoot another free throw or tease her little sister, or share memories with her own children because on October 9th 2005, she took her life."
This family's nightmare began when Leanne complained to her mother about problems concentrating and she took Leanne to a counselor, who diagnosed her with ADD and sent a recommendation to their family doctor to prescribe Concerta.
On September 18, 2005, the doctor doubled the dose after Leanne told her mother she was not feeling any better, and 3 weeks later, Ms Bessner found her daughter hanging from a loft bed with a belt around her neck in her bedroom.
"Amongst my screams," she told the panel, "I recall her beautiful brown eyes partially open.”
The family has retained the Conshohocken, Pennsylvania-based law firm of, Pogust & Braslow, for the purpose of bringing a wrongful death claim against the manufacturer of Concerta, and attorney, Derek Braslow attended the hearings with Leeane's parents.
Mr Braslow says, "Leeane's story should be required reading for every pediatrician and child psychiatrist in the country."
According to WebMed on March 26, 2006, Dr Tom Laughren, head of the FDA's division of psychiatric products, said, the committee appeared "unimpressed" by more than 350 reports of suicidal thoughts or behaviors in treated children over the last five years.
"Up to 20% of middle and high school students," he stated, "already report such thoughts, and it was unclear that drugs other than Strattera led to increased risk."
Any street addict knows that crashing after taking amphetamines brings on the most severe depression, in large part, experts says, because speed almost always disrupts the appetite and sleep cycle. However, unwitting consumers of ADHD drugs would have no way of knowing this if they start feeling suicidal when they cannot eat or sleep as the speed wears.
According to Attorney Braslow, "Dr Laughren's comments are offensive and lack sympathy for those families in grief."
He points out that Leeane was not on Strattera, she was on Concerta, and she was not depressed or suicidal before she began taking the drug. "These drugs take the life out of children," he said.
"They do one of two things to children and teenagers," Mr Braslow explains, "turn them into zombies, making them passive and non-responsive or as they affected Leeane - turn them into hyperfocused, anxious kids who can't sleep and who become consumed with minor typical teen issues like friendships, boyfriends and school."
"I don't doubt that these drugs may help some adolescents or children," he notes. "But at what price?" he states, "Better grades? Quieter class rooms?"
"The FDA has finally admitted that these drugs can cause sudden death, serious cardiovascular events, hallucinations, psychosis, suicidality, mania and suppression of growth among others," he says, "but these warnings come too late for Leeane and her family."
And Mr Braslow points out that despite the new warnings, physicians continue to prescribe ADHD drugs in record numbers.
"These warnings are worthless," he says, "unless first, doctors inform families of the risks, so families can make informed decisions about these drugs and so they can look out for signs of suicidality or psychosis and second, doctors stop giving these drugs out like candy, stop giving samples of these drugs to families based upon the whim of a teacher or nurse."
Mr Braslow says, "doctors need to actually weigh the risks and benefits of these drugs before recommending them."
"While the newest warnings on these drugs are certainly necessary," he notes, "albeit many years late, these warnings still are not strong enough to adequately inform physicians about the true risks of these drugs."
"The FDA advisory committees," he states, "should stop worrying about frightening doctors with valid warnings and start giving doctors all the warnings so they can make fully informed choices."
"That is the job of the FDA," he states. "Our children deserve better."
The number of ADHD related deaths cited at the hearing does not reflect an accurate picture. There are many more deaths recorded in the individual states. For instance, according to the report, “Child Suicides In Florida Associated With Use Of Psychotropic Drugs,” by Ken Kramer, of the 252 cases of suicide in children under 18, between 2000 and 2004, thirty-six were on ADHD drugs.
Because the FDA system of reporting is voluntary, the agency admits that only between one and 10% of adverse reactions get recorded. Which means, because the FDA and Big Pharma intentionally delayed warning the public about the dangers of ADHD drugs, there are probably tens of thousands of ADHD victims who do not even know what happened.
Persons interested in more information on legal matters related ADHD drugs can contact the Pogust & Braslow law firm at 610-941-4204, or http://www.pogustbraslow.com/
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)
(This article is part of a series covering
litigation involving the pharmaceutical industry and is
sponsored by the Pogust & Braslow, LLC law