American “big pharma” reached deep into psychiatric research through its influence on university psychiatrists even at my own alma mater, Emory University. In the span of two years, I saw Emory’s Department of Psychiatry go from the most distinguished on campus to the one with a most dubious distinction, all because of one thing: an unethical relationship with “big pharma.”
When I began my residency in 2005, Emory’s Department of Psychiatry was arguably one of the top programs in the Southeast and by 2007 our program was ranked highest nationally over all other medical departments at Emory University. That year a large banner congratulating our department hung on the crosswalk that led over the busiest street on Emory’s campus. This success was largely due to the leadership and research contributions of our chair and his ties to the pharmaceutical industry.
In 2008, Senator Charles Grassly led a congressional investigation which revealed that many well known university psychiatrists had violated federal and university regulations by accepting millions of dollars in undisclosed amounts from pharmaceutical companies. Through their research, these psychiatrists promoted the use of psychiatric drugs manufactured by the companies that secretly paid them loads of cash.
The chair of of our department was among these doctors. He later resigned from his position after failing to report a third of the $2.8 million in consulting fees he received from GlaxoSmithKline. Because of our departmental connections with the pharmaceutical industry, Emory banned pharmaceutical representatives from campus altogether.
Our psychiatry department, however, wasn’t the only one in bed with “big pharma.” A highly influential Harvard University child psychiatrist, Dr. Joseph Beiderman, was also investigated by Senator Grassley and was found to have violated conflict-of-interest policies for receiving millions in undisclosed funds from pharmaceuticals which he promoted to treat children. He was later disciplined by Harvard for these violations but not before significant damage had been done.
Despite the resulting increase in federal regulations regarding relationships between “big pharma” and research psychiatrists, the pharma puppetmaster continues to influence psychiatry today, though now in less obvious ways. The financial and professional links which now exist between psychiatry and pharmaceutical companies are protected for both the physician and the pharma company through the guise of “full disclosure.” Drug companies still fund much of the research conducted by psychiatrists, but now, the doctors “fully disclose” this relationship--in the fine print. Drug companies also advertise medication in psychiatric journals and at medical conferences, fund psychiatric and healthcare organizations, and send representatives to lobby influential physicians and politicians.
Before these new regulations went into effect, Dr. Beiderman and his team had been producing medical literature to raise awareness of Childhood Bipolar Disorder, as well as endorsing its treatment with atypical antipsychotics, for over a decade. His team suggested that because of a child's undeveloped brain, bipolar disorder has a different clinical presentation in children than is typically seen in adults. Supporters of Dr. Beiderman’s work lobbied enthusiastically for inclusion of Childhood Bipolar Disorder in DSM-IV, but the committee at that time found the scientific support unconvincing and refused to do so.
Despite the snub by DSM-IV, child psychiatrists and pediatricians throughout the US, highly influenced by Dr. Beiderman’s work, increased the diagnosis of childhood bipolar disorder and its treatment with atypical antipsychotics. Childhood bipolar disorder, once rare, then became common. In only fifteen years, rates jumped an astounding forty-fold. Much to the delight of manufacturers of antipsychotics, prescriptions written for their products soared as child after child began taking these medications.
Of all classes of psychiatric medication, antipsychotics arguably carry the most burdensome short term and long term side effects. Children taking them are more likely to suffer short-term effects, and in more severe ways, because of their immature brains. Long term side effects can also be severe in children. Because very little research has been done, the long-term risk, although estimated to be high, is unknown.
Antipsychotics are divided into two classes: typical (first generation antipsychotics) and atypical (second generation antipsychotics). Both classes carry some of the same side effects, but the atypical antipsychotics are widely known for their most problematic side effect--weight gain. Due to weight gain and the associated complications of obesity, a baseline weight, cholesterol panel, and blood glucose level should be obtained before use, and each should be routinely monitored.
Lack of knowledge of when and how to properly use antipsychotics, as well as an understanding of their side effects, has not stopped their increasing use in America’s children, especially the use of atypical antipsychotics. According to the 2011 report from Medicaid, “children taking antipsychotic medications receive an atypical antipsychotic 90 percent of the time and in the majority of patients the use is for an off-label indication. Frequent off-label uses include treating aggressive, disruptive, and hyperactive children. The FDA has not approved use of antipsychotics in any children under age five, although I have on several occasions discontinued these medications in five-year-olds.
Drug companies promoted unapproved uses for their products among child psychiatrists and pediatricians alike. Meanwhile, nonstop magazine, TV, and internet direct-to-consumer advertising reached families struggling with aggressive children. These families, once mystified by their child’s of out-of-control behavior, now had a medical model for understanding their child. This medical model not only benefited the drug companies, but also provided parents with a more acceptable explanation of, and solution for, their child’s problem.
Teachers also tend to exert pressure on parents to medicate their children rather than to collaborate with caregivers on non-medical therapies. So, who can blame these families for trying medication as an option for treating their child's aggression when they face so many pressures to do so? Their child's repeated aggressive actions in the classroom result in multiple calls from teachers. Continually being called to pick up a dysregulated child often goes far beyond simply trying a parent's patience. Especially in the case of single working mothers, of whom there are many, continual disruptions can affect their jobs, even to the point of being fired.
Teachers, though, may also feel pressured. They find that medicating takes less time and results in an improved learning atmosphere for the rest of the students. After all, they cannot continue to tolerate a child's aggressive behavior if it risks their safety or the safety of other students. When that point is reached, a child may be expelled, risk legal charges, or be transferred to an alternative school. Alternative schools group children with behavior problems together, hence producing a more stressful learning environment, a situation that only exacerbates an already aggressive child's condition. Neither temporary subdual nor bodily removal solves the child’s problem.
What can be done? A preschooler who bites and spends long periods of time struggling through raging meltdowns needs help. Too often, the available psychotherapeutic services are minimal and don’t fully meet the child's need for treatment. Driving to and from therapy is expensive and often waiting lists are full. Funding has been slashed for social safety nets such as county mental health programs that could connect kids to, and often pay for, psychotherapy or for skills groups such social skills training and anger management training or, more importantly, provide parent education on how to handle behavioral problems on their own through learning basic behavioral modification.
It's understandable that medication from a pediatrician would be considered if other treatments are not readily available. Pediatricians fill these holes in our social safety net by prescribing antipsychotics to aggressive children. However, most of these children have not even been diagnosed with a mental disorder by the pediatrician before being prescribed antipsychotics.
According to a study, “‘primary care practitioners provide a larger percentage of psychotropic drug visits than psychiatrists in every psychotropic class except lithium. In all therapeutic classes, when a psychotropic medication was prescribed, psychiatrists typically provided a mental health diagnosis, while primary care physicians did not.” Antipsychotics quickly prescribed to five-year-olds who are not psychotic and who have not been diagnosed with any mental health disorder is exploitation.
Antipsychotic medications have serious side effects and can oftentimes do more harm than good. These medications are known to increase the appetite, causing weight gain, raising blood glucose and increasing the risk of diabetes. They are also sedating, leaving a child asleep at his desk for most of the day. These are some shorter-term consequences; the long-term consequences are largely unknown.
In some cases, though, the side effects of these medications must be outweighed by the possible consequences of violent children who seriously injure others and face legal charges. Thoughtful doctors do use atypical antipsychotics appropriately in aggressive children after all other options have been considered.
I have used atypical antipsychotic in young children in severe situations, such as repeated violence towards others in acute psychiatric hospitals and in residential treatment facilities.The benefit of the medication can be likened to a band-aid in that its sedative effects provide only a temporary solution, but do not address the underlying problem, whatever it may be. Aggression is nonspecific in children and can result from many different things such as anxiety, extensive physical abuse histories, or having to continuously protect themselves from older children they encounter in the behavioral health care system.
Some adolescents and, less frequently, children do, indeed, have early onset bipolar disorder. Clearly, however, Dr. Biederman along with “big pharma” greatly changed mental health treatment for aggressive children by considerably increasing the use of antipsychotic medications and other bipolar medications, known as mood stabilizers. These medicines have proven effective for the treatment of bipolar disorder in adults and carry FDA indications of such. They have proven less effective for children. We do a disservice to our children when we treat them as “mini-adults.” Treatment considered effective for adults is not automatically effective for children because the range of normal behavior in adults is very different from the range of normal behavior in children.
Both on- and off- label use of psychiatric medication in children and adolescents have increased rapidly in the last ten years. Pediatricians and family care doctors are not experts at prescribing psychiatric medicine, yet they write most psychiatric prescriptions for children. Because they have not been trained in non-medicinal treatment options, they use what they know--medications. They are unaware of treatment alternatives to medications which might be a better solution for the child in the long run because they’ve never been trained in psychotherapy modalities.
And what became of pediatric bipolar disorder? Something similar debuted in the new DSM but has been labeled as a different disorder: Disruptive Mood Dysregulation Disorder. The debut of DSM-V and especially its changes in the classification of childhood disorders was met with much controversy. A major blow to the APA came when the National Institute for Mental Health (NIMH), the largest funding agency for mental health research, withdrew support of the document and declared that it would no longer fund research that relied solely on the DSM-V. The NIMH made it clear to the AMA and the rest of the world that the DSM-V didn’t have enough scientific evidence to fully support its use. The disorder most cited for DSM-V’s lack of scientific evidence is the new disorder for children, Disruptive Mood Dysregulation Disorder.
Because this is a newly named disorder, how could there possibly be enough evidence from valid research to support its inclusion? It’s been studied by only one group and for only six years. The clinical implications of this new disorder have been highly theorized, but remain to be seen.
Writing a script is easy and a lot less time consuming than doing a thorough psychiatric assessment or participating in psychotherapy. It also works faster and in some cases is even cheaper than psychotherapy. But is it safest and wisest choice for our children? The puppetmaster says, “Yes!”
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