Drugs, money & kids: a dangerous mix

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In a recent post, I discussed the consequences of the massive conflicts of interest that exist between researchers, doctors and the pharmaceutical industry in the U.S. and abroad.

On June 8th the New York Times published an article underscoring these consequences and illuminating the risks that inevitably come with financial ties between researchers and drug companies.

The article revealed that Dr. Joseph Biederman, a world-renowned child psychiatrist at Harvard, accepted at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but did not disclose any of this income to university officials. By failing to report this income, Dr. Biederman and colleagues may have violated both federal and university research rules designed to prevent conflicts of interest.

Dr. Biederman is one of the most influential researchers in child psychiatry. Although many of his studies are small and often financed by pharmaceutical companies, his work has nevertheless directly contributed to a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a concurrent rise in the use of powerful antipsychotic medicines in children.

We know from my previous post that it has been shown that studies funded by pharmaceutical companies are more likely to show positive results for the drug. We also know that the veracity of clinical trials which are the basis of approval of new drugs by the FDA has been called into question in recent studies because of three major flaws: conflicts of interest on the part of investigators (like Biederman); inappropriate involvement of research sponsors (drug companies) in study design and management; and publication bias in disseminating results (if a study has negative results, the drug company doesn’t publish it).

When a researcher like Dr. Biederman is paid millions by a drug company to study it’s product, we must wonder whether we can expect his work to be objective and accurate. But when that researcher repeatedly lies about the money he received, the integrity of his work should be in serious doubt.

In one revealing example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with Harvard University. When asked to check again, he said he received $3,500. But Johnson & Johnson told Congressional investigators that Mr. Biederman was paid $58,169 in 2001.

The consulting arrangements of Dr. Biederman’s entire research group at Harvard were already controversial because of the researcher’s advocacy of unapproved (“off-label”) uses of psychiatric medicines in children. Dr. Biederman and his colleagues have promoted the aggressive diagnosis and treatment of childhood bipolar disorder with antipsychotic drugs – although these drugs have never been approved for such use. In fact, neuroleptic drugs have not been approved for use in children at all.

As a result of Dr. Biederman’s promotion of both the diagnosis and treatment for childhood bipolar disorder, antipsychotic drug use in children has exploded. Roughly half a million children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

The dramatic increase in antipsychotic prescriptions in children has occurred despite the lack of evidence that these medication improve children’s lives over time. On the contrary, it is well known that children are susceptible to the weight gain and metabolic problems caused by the drugs. Children typically gain twice as much weight in the first six months on atypical neuroleptic drugs (risperidone, olanzapine, etc.) as they should through normal growth, adding an average of 2 to 3 inches to their waistline. This is mostly abdominal fat, which also increases their risk of diabetes and heart disease.

There is also some evidence which suggests that these drugs may cause permanent changes to the structure and function of the brain (Breggin 1997). In other words, they cause brain damage.

The research of Dr. Biederman’s group, which has served as the basis for the rise in bipolar diagnoses and antipsychotic use in children, has been widely criticized by other psychiatrists and researchers.

The studies published by Dr. Biederman’s group were so small and “loosely” designed that they were largely inconclusive. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale, which is well below the 50 percent change that most researchers use as the standard.

Controlling for bias in these types of studies is particularly important, given that the scale is subjective and depends on reports from physicians, parents and children.

More broadly, psychiatrists have said that revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”

I couldn’t have said it better myself.

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  1. eric says

    Thank you for your article. I, too, am seriously pissed off at Biederman and Wilens for their behaviour. If nothing else, it casts a huge shadow over the world of pediatric behavioural medicine. As a pediatrician actively involved in the practice of pediatric psychopharmacology, however, I am also seriously pissed off at the notion, advanced by this article, that these actions of the Harvard group somehow taint the actions of the entire field.
    I am also disturbed by the notion of this and many other anti-Biederman blogs that “pediatric bipolar” and other pediatric behavioural diagnoses are somehow imaginary. You are correct that they require a large degree of subjective impression in making the diagnosis, and the closest thing we have to a “test” is often parent-rating scales. You are correct that there has been a large increase in the recognition of childhood behavioural diagnoses, and you are correct that the scientific literature does not yet have a consensus on the best treatments, and certainly the FDA lends no guidance. You are correct that these medications have a number of adverse effects (All drugs do–Tylenol, antibiotics, cough medicine, you name it–all need to be handled with care.) You did not resort to the comment that these drugs are ‘powerful,’ which is often used in other blogs to discredit them; yes they are kinda powerful, they work pretty good, but parents come in wanting something that works (i.e., “powerful”) rather than something that doesn’t.
    I am disturbed by the biased tone of your article. Your criticisms of Biederman are correct, with regard to the conflict of interest. However, for example, the use of the word ‘controversial’ appears to be used several times only for the purpose of implying falsity. Another example is the Breggin paragraph which goes from stating a possibility in the first sentence to an assertion of fact in the second.
    Mostly though, I am disturbed about the notion that these are false diagnoses. You have a perfectly good thesis in your discussion of Biederman’s misbehaviour, but this does not support in any logical way your assertion that bipolar or any other childhood mental illness is invalid. We will probably be looking for a new terminology over the next several years, and we will probably have better objective measures, but that does not invalidate the notion that these children have a real problem. They hurt other children, they kill their pets, they curse their parents, they kill themselves. We aren’t talking about the kid who pushed your child down at day-care, we’re talking about a group of children who are very, very ill.
    When I read Breggin’s work, sorting out the polemics from the meat of his writing, he basically promotes a psychotherapeutic approach (talking) instead of pharmacotherapuetics (meds). Anyone competant in this field would agree that therapies such as cognitive-behavioural therapy is an excellant approach for mild to moderate problems, and remains a cornerstone of therapy of severe disease. The logic extrapolating that this negates the value of medical therapy does not hold.
    I wish I could invite you to sit in the exam room with me, and do a history and physical and tell me that bipolar (or whatever you want to call it–really bad ADHD, intermittent explosive disorder, opposition-defiance– is fake. If you are going to promote that notion, you have the responsibility of working to find a better solution that works for unhappy, violent, lonely, school-failing children.

  2. admin says

    Eric,

    Welcome to the blog and thank you for your comment.

    I am absolutely outraged by the behavior of Biederman and Wilens, and that certainly influenced the tone of the article. It would be one thing if their behavior was unusual or unique. Unfortunately, it is all too common in the medical field. If you disagree, I urge you to read my recent article on the rampant conflicts of interest between researchers, doctors and pharmaceutical companies.

    I am obviously not alone in pointing this out. The editors of thirteen of the most prominent medical journals have written an editorial detailing these conflicts of interest and calling for more stringent guidelines to prevent them.

    The use of the word “controversial” in the article is accurate. There is considerable controversy over whether 1) childhood bipolar disorder is anywhere near as prevalent as it is currently being diagnosed, 2) whether childhood bipolar disorder is caused (or treated successfully) by an “chemical imbalance” in the brain, 3) whether neuroleptic drugs are safe and effective treatments. In fact, if you remove Biederman’s studies which were small, poorly designed and obviously biased, then the consensus in the scientific community about using antipsychotics with children is that in many cases the benefit does not outweigh the risk.

    I don’t believe I said anywhere in the article that childhood mental illness is invalid. I said that the 40-fold increase in the diagnosis of childhood bipolar disorder has been influenced by Biederman’s aggressive promotion of the diagnosis, which he supports with studies that are by most accounts invalid. My argument is that childhood bipolar disorder is overdiagnosed – not that it doesn’t exist.

    I completely agree with you that these children who come to see you have a serious problem. However, I have not seen any convincing evidence that such problems are caused by imbalances of chemicals in the brain that would in turn be corrected by antipsychotics. I’ve read several reviews of the evidence by highly qualified researchers and authors, and this is the conclusion they have reached. If you haven’t already, I highly recommend you read “Blaming the Brain”, by Elliot Valenstein Ph.D.; “Rethinking Psychiatric Drugs”, by Grace Jackson M.D.; and “The Myth of the Chemical Cure”, by Joanna Moncrieff.

    As far as I know, Breggin does not negate the value of medication in certain cases. What he disagrees with is the notion that all children with behavioral problems or depression should be medicated without first trying other proven interventions. In some cases medications may be necessary or useful, but only as a last resort.

    Finally, there are many other ways to approach working with “unhappy, violent, lonely, school-failing children”. How have we come to the point where drugs are the first option we turn to? Clearly if a child is having behavioral problems like you describe there is something very wrong in either the home or school environment or both. Our system of education does not respect and honor differences in learning style, interest, or temperament. Obviously, family dynamics can also contribute significantly to a child’s distress.

    I also believe that poor nutrition is a contributing factor to behavioral problems with children. High fructose corn syrup and refined carbohydrates are the #1 and #2 sources of calories for kids, and the effect of sugar on mood and behavior is well-established in the scientific literature. It is also likely that these kids are deficient in micronutrients that play a role in maintaining good mental health. For example, both vitamin D and Essential Fatty Acids (EFAs) have been shown to be effective in relieving depression in some cases.

    The changes I am suggesting, of course, are beyond the power of a single physician to implement. Addressing family dynamics would likely require family systems therapy or a similar approach. It would also probably include addressing whatever issues the parents might have (depression, alcoholism, etc.) individually that are contributing to the dynamic. The problems with our educational system are even more systemic and difficult to change, but options there include choosing a school with a philosophy that is in alignment with the child’s needs or even home-schooling. Finally, I know firsthand how hard it can be to introduce nutritional changes with kids. But I also know that it is possible and can lead to dramatic changes in behavior.

    I’m not saying any of this is easy. Indeed, it is far easier to simply give a child a drug. But the lack of evidence of efficacy of these drugs, combined with their significant side effects and risks, does not support their prescription in most cases.

    Did you see the recent series of articles in USA today about the dangers of psychiatric medication in children?

    http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm

    Did you know that Biederman used an inactive form of St. John’s Wort in his “study” that “demonstrated” that the herb isn’t effective in treating ADHD? The study was also very small, with only 54 subjects. 40% of them had taken psychiatric medication in the past, which has been shown to alter brain structure and function. Third, males children are known to be more susceptible to the behaviors known as “ADHD”, but in the study the placebo group consisted of 50% males while the St. John’s Wort group consisted of 75% males. This created a bias toward placebo.

    I bring this up to illustrate how bias (Biederman’s, in this case) can prevent valid alternatives from becoming widely known.

    Thanks again for your comment Eric.

    Chris

  3. Elanne Marie says

    There is a mantra repeated often by people who wish to take a moderate view of the role of pharmacological treatments of the mind. It goes something like this, “Drugs have their place.” I think this statement is true, but incomplete. In order to reflect reality it needs to continue, “Drugs have their place in a society that worships technology, power and money, in which family and community systems have fallen apart, education is a joke, and meaningful contact with nature is absent.” Indeed in such a society drugs fit like a glove and may be necessary in order to survive.

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