Drug Money and Scientific Objectivity

A study published in the Canadian Medical Association Journal (CMAJ) confirms what we all suspected.  Drug money sullies the objectivity of medical journals.

Medical journals run the gambit from purely funded by subscription to those that are funded solely by advertising.  Some journals have both kinds of revenue.  The ad-supported journals get most of their business from pharmaceutical manufacturers.  These drug money supported journals are typically sent free to doctors around the world and have much larger circulation than the subscription supported journals.  These free journals are also less likely to be peer reviewed.

The CMAJ study examined 11 medical journals with distributions in Germany in 2007.  In addition they surveyed Canadian general practitioners to find what journals they rely on for up-to-date data.  The write-up states, “Our study shows that the tendency to positively recommend the use of a drug depends on the source of a journal’s funding . . . Free journals almost exclusively endorse the use of the selected drugs, whereas journals that rely exclusively on subscription fees for their revenue are more likely to recommend against the use the same drugs. . . . More than half of the doctors surveyed had used free journals as a source of information during the previous months.”

This kind of bias can be critical when adverse reaction to prescription medication is the sixth leading cause of the death, at least in the US (reported in JAMA several years ago).  This study was not specific to psychiatric drugs but it certainly has salience in the psychiatric field where many medicinal treatments have questionable benefit.  If the risk-benefit calculation is skewed, then neither doctors nor patients are making truly informed decisions.

We now know that people with severe mental illness have life spans that are 20 years shorter than the general population.  How much of that is a result of our pharmaceutical treatments?


Reference: Becker, Anette; et al.  Canadian Medical Association Journal (2011, March 1).  The influence of advertising on drug recommendations.

Is that Thorazine in the Baby's Bottle?

One of the most disturbing trends in mental health today is the increasing use of powerful antipsychotic medication to treat behavioral problems in children, even very young children. According to a 2009 report by the Food and Drug Administration, there are 500,000 children in the United States being administered regular doses of antipsychotics. Medicaid data shows public health monies spent on antipsychotic drugs for children exceeding $30 million in New Jersey and topping $90 million in Texas. It is a trend that has built relentlessly for the past ten years and continues unabated.

I find the use of these drugs on children to be appalling almost beyond words. Having worked as a mental health professional for many years, I am well acquainted with these medications. This class of drugs, sometimes referred to as neuroleptics, are major tranquilizers and are primarily used and intended for controlling hallucinations and delusions in cases of psychosis and schizophrenia. For an adult with severe schizophrenia, these medications may be a glimmer of hope, but it is always a difficult risk-benefit analysis because there are potentially severe side effects and reactions. Depending on the individual, these medications can cause tremors, involuntary spasms and movements, severe sedation, muscles of the face become rigid, and loss of pleasure sensation, just to name a few. Permanent neurological damage can occur in the form of tardive dyskenisia, and sudden death can occur from a reaction called neuroleptic malignancy syndrome. With newer forms of antipsychotics, these type of side effects are less frequent and less severe, but continue to be a risk depending on the reaction of the individual’s body. However, newer, “atypical,” antipsychotics present new dangers to the patient, metabolic changes that result in a dramatic increase in the instances and severity of diabetes and heart disease. The result is that adults on antipsychotic medications have a life span that is 20 years shorter then the average person.

We know these medications have the potential to cause permanent harm to an adult’s brain, but they are still used because it is considered by many to be worth the risks to control just some of the symptoms of debilitating disorders, and, except in the most severe cases, where a person’s legal rights have been taken away due to impairment, it is ultimately up to the patient to decide whether or not to take that risk.

What then will these medications do to a child’s developing brain? The jury is out, but it can’t be a good thing. Who makes the decision and why? Certainly not the child who will live the rest of his or her life with the consequences of that decision.

The New York Times ran a recent article on the subject, highlighting the case of one child who was started on an antipsychotic at 18 months old. This helps to highlight the human side of this tragedy:

At 18 months, Kyle Warren started taking a daily antipsychotic drug on the orders of a pediatrician trying to quell the boy’s severe temper tantrums.

Thus began a troubled toddler’s journey from one doctor to another, from one diagnosis to another, involving even more drugs. Autism, bipolar disorder, hyperactivity, insomnia, oppositional defiant disorder. The boy’s daily pill regimen multiplied: the antipsychotic Risperdal, the antidepressant Prozac, two sleeping medicines and one for attention-deficit disorder. All by the time he was 3.

He was sedated, drooling and overweight from the side effects of the antipsychotic medicine. Although his mother, Brandy Warren, had been at her “wit’s end” when she resorted to the drug treatment, she began to worry about Kyle’s altered personality. “All I had was a medicated little boy,” Ms. Warren said. “I didn’t have my son. It’s like, you’d look into his eyes and you would just see just blankness.”

Today, 6-year-old Kyle is in his fourth week of first grade, scoring high marks on his first tests. He is rambunctious and much thinner. Weaned off the drugs through a program affiliated with Tulane University that is aimed at helping low-income families whose children have mental health problems, Kyle now laughs easily and teases his family.

Ms. Warren and Kyle’s new doctors point to his remarkable progress — and a more common diagnosis for children of attention-deficit hyperactivity disorder — as proof that he should have never been prescribed such powerful drugs in the first place.

As to what’s driving this latest treatment fad?  I think there are a number of factors.  The easiest and most popular target is Big Pharma.  The pharmaceutical industry has the largest profit margin of any major industry, and do you know what their most profitable line of drugs are?  Yes, that’s right, antipsychotics.  This class of drugs brought in a staggering $14.6 billion in 2009.  Antipsychotics are marketed as heavily as any other product line, and the marketers are always looking for new markets.  Antipsychotics have been marketed for depression, for instance, and they are actively promoted to pediatricians for use on children, but, for the most part, marketing efforts keep within the limits set by the FDA and the risk-benefit decisions made industry lawyers.  The FDA approved Risperdal for use on children as young as 5, but most antipsychotics are only approved for children 10 or older.

Yet, in spite of the FDA guidelines, these drugs are being given to much younger children. Who then is to blame? The other popular targets of finger pointing are the parents (and, I would add, teachers and childcare workers). Perhaps it is helped along by marketing campaigns, but the fact is, parents are increasingly choosing to pathologize and medicate their children in lieu of other, more traditional, parenting strategies. Childcare and educational professionals add to the stampede by pressuring parents to go to the doctor when the child’s behavior puts a strain on the professional. I think we can objectively state, unequivocally, the nature of childhood needs and behaviors has not changed in recent generations, yet more and more parents go to their pediatricians insisting there is something wrong with their child and demanding some pill they can give the kid to fix the problem. Parents just want to do right by their child, I’m sure, but they fail when the don’t take the time to research what they are doing and the possible consequences.

The final responsibility, however, rests on the shoulders of the professionals who prescribe these medications. Physicians are free to prescribe off label use of drugs and are under no legal obligation to stay within FDA approved guidelines, and some physicians seem more then willing to exercise this discretion in spite of the very serious risks they are exposing the child to. Regardless of shameless marketing by drug manufacturers and the irrational pressures of frustrated parents, the physician is supposed to be the final gate keeper and is responsible to safeguarding the health and wellbeing of the young patients. Physicians who push antipsychotics on children clearly fail in their responsibilities.

The issue is further complicated by shifting diagnostic categories. Schizophrenia is a disorder of adulthood. Age of onset is typically late adolescence or early adulthood. There is no defined criteria and very little in the way of scientific data to justify giving this diagnosis to younger children, yet we are seeing it, now, younger and younger, usually tied to a prescription. Another expanding diagnosis is bipolar. This disorder is very loosely defined and as a result, unscrupulous or simply confused professionals can see it everywhere. It too used to be a disorder of adulthood but has mushroomed as a child diagnosis in the last decade. The other big diagnosis linked to antipsychotics is autism. This is a very serious and real childhood disorder and children who suffer from this take a lot of care and present a lot of challenges. However, the autism diagnosis has become hugely popular and its working definition has expanded infinitely. As in the case of Kyle Warren, just about any child can get the diagnosis at this point. It is now virtually meaningless, yet it is the justification for giving these very serious drugs to young children.

The big picture is we have an expanding culture of psychopathology in which more and more facets of human behavior are being defined as disorders and sicknesses. This extends even to the point of defining childhood tantrums as a sickness that we have to treat with a powerful drug. The pathologization of childhood started probably in the 1980’s with attention deficit disorder and this became hugely popular in the 1990’s. In the first decade of the new millennium, we saw a significant expansion of clinical depression, bipolar and even schizophrenia into younger and younger populations with related drug therapies. Additionally the autism diagnosis has been opened up into a “spectrum” disorder so now parents of children with any kind of perceived interpersonal or behavioral challenges can have an autism label slapped on ‘em at bargain basement prices.

The bottom line is that young children are being harmed by antipsychotic drug treatment and it’s no laughing matter. The trend line is very disturbing. I hope I am not one of a few lone voices in the wilderness. Is anybody listening?

Drug Culture

from False Advertising: A Gallary of Parody

A funny but poignant comment on the modern family and our increasing dependence on Prozac, anti-depressants, and psychoactive medications in general just in order to cope with the irritations of daily life.