(Health Secrets) So far the largest single pharmaceutical fraud settlement in history occurred in 2012, when GlaxoSmithKline (GSK) plead guilty and paid $3 billion in criminal and civil fines for a list of bad behavior that included bribery of doctors with luxury vacations and lucrative engagements, fabrication of drug safety data and lying to the FDA, defrauding Medicare and Medicaid of billions of dollars, and using deceptive practices to sell potentially dangerous drugs. Now this appears to be just the tip of the iceberg, as the whistleblower in that case recently revealed that GSK and other pharmaceutical companies preyed on the most vulnerable among us, the children of the extremely poor and foster children.
Underprivileged children seldom benefit from psychotropic drugs
Whether it be a teacher, counselor, social worker, school psychologist or other expert, the awareness is there that both children of the extremely poor and foster children struggle to cope with trauma that psychotropic drugs cannot heal. Yet the push has been on at GSK and other members of Big Pharma, such as Eli Lilly and Pfizer, to drive sales of antidepressants, antipsychotics and other psychotropic drugs to this group, often for uses never approved by federal regulators.
A Denver Post investigation released in April found that foster children were prescribed the potent mood altering drugs at a rate 12 times higher than the rate they were prescribed to other children on Medicare in Colorado during 2012. Dosages and rates of multi-drug prescriptions were also elevated among underprivileged children in the state.
In Colorado, nine of the top 10 most prescribed drugs for foster children in the Medicaid program were psychotropics. In contrast, only one psychotropic drug was among the top 10 drugs most prescribed to the general pool of Medicaid children.
“A variety of psychotropic drugs — some simultaneously — are used by many children in the foster-care system. Olanzapine, sold under brand names including Zyprexa, is used to treat schizophrenia and acute mixed or manic episodes, while Seroquel, or quetiapine, is used to treat nervous, emotional and mental conditions such as schizophrenia, and symptoms of bipolar disorder or manic-depressive illness. All of these drugs are atypical antipsychotics”, writes Helen H. Richardson for the Denver Post. Other atypical antipsychotics are Ability and Risperdal.
The use of such drugs on underprivileged children attending inner city schools has drastically increased over the past several years as well. These children are often labeled as special education material and are grouped away from those in the mainstream, with their only intervention being psychotropic drugs.
A Rutgers University study found that at least three-quarters of the children prescribed antipsychotics through Medicaid took them for issues beyond FDA approved uses for the drugs. The drugs are often prescribed for dubious classifications such as attention deficit hyperactivity disorder (ADHD), learning disability, emotional disturbance, anxiety, and depression. They may be prescribed for a student classified as mentally retarded, or even for one who just can’t stand the tedium of today’s public schools.
Side effects from psychotropic drugs include:
- Dopamine hypersensitivity – an outcome that can actually heighten incidence of the behaviors in question.
- Weight gain
- Prolactin elevation – This leads to lowered levels of estrogen in girls resulting in infertility and lowered bone mineralization. In boys it leads to development of breasts (gynecomastia) sexual dysfunction and infertility. In both sexes it leads to lowered levels of testosterone resulting in under development of the heart muscle.
It’s all about the money!
Antipsychotics are among the big money makers at Big Pharma, with sales of over $18 billion in 2011, triple the amount spent on antipsychotics in 2002. According to a 2009 Food and Drug Administration advisory committee study, more than one million children in America now take antipsychotic drugs annually, and tens of thousands of these are younger than age 5.
One in 25 children in the U.S. between the ages of 12 and 17 took antidepressants in 2011, says the Centers for Disease Control and Prevention, while use of antipsychotics in Americans of all ages increased by 400 percent in the past two decades.
The FDA has warned that antidepressants increase suicidal behavior and thinking in children and adolescents.
Pharmaceutical companies say the explosive growth of psychotropic drugs fills a need, and they deny that growth was driven by inappropriate marketing. But many child health experts warn that this increase comes at high cost to public health programs and at great risk to children.
“We really don’t know enough about the safety and effectiveness of these drugs,” said Dr. Tobias Gerhard to the Denver Post. He is an assistant professor at Rutgers University who has studied the growth in prescribing of antipsychotics to children and adolescents.
Doctors are free to prescribe psychotropic or other drugs for any symptom whether they are approved for that symptom or not. However, it is against the law for pharmaceutical companies to encourage doctors to prescribe off-label.
The threat of fines for prescribing off-label and other bad behavior has not deterred Big Pharma. Since 2008, drug companies have paid out $13 billion in fines, a number that has not fazed their shareholders due to their stratospheric profits.