ICBS Everywhere

Posted June 28, 2009

In search of a report on green tea and its alleged cancer fighting properties for a recent blog post, I went to our local ABC station’s news website and clicked on the “your health” section link. I did not find the green tea story, but I did find several misleading reports about recent research.

I contend that, since most people get their information about the latest research from media reports, those reports have the potential to cause great harm. Simply misunderstanding the relationships among variables is harmful because it creates and/or feeds superstitious or misguided beliefs.

In my last post, I discussed misleading reporting of the relationship between snoring and diabetes in pregnant women. In this post, I will discuss a rather bad study examining the relationship between stimulant medication and sudden death in children.

FDA cites limits of ADHD drugs study

The headline is misleading; the study the FDA is hesitant about has nothing to do with the efficacy of ADHD medications, but rather the risks, and they should be hesitant. The first line of the article states:

Federal health regulators are urging parents to keep their children on attention deficit drugs like Ritalin and Adderall, despite new evidence from a government-backed study that the stimulants can increase the risk of sudden death.

The FDA is urging parents to continue medications because the study is NOT new evidence that stimulants can increase the risk of sudden death. Saying there is evidence of sudden death is fraud of the worst kind because it results in withholding treatment from fear produced by irresponsible warping of the truth by journalists.

The research, to be published in the American Journal of Psychiatry, is a seriously flawed archival study (archival studies are one of the worst designs possible). It involved examining death certificates, coroner reports, and interviews of family members of 564 children whose deaths were sudden and somewhat unexplained. They then compared the number of children taking stimulant medication to the number of a group of 564 children, matched by age and gender, who died in motor vehicle accidents. Ten in the unexplained group was significantly more than 2 in the accident group. They claimed these findings as evidence of an association between taking stimulant medication and sudden death.

I don’t think so.

The comparisons made in this study are unbalanced in many ways, but the most important is that they did NOT control for the number of ADHD diagnoses among the groups. In fact, they specifically chose car accidents because it has been established that the rate of ADHD diagnoses in this group does not differ from the general population, but they did not establish this same base rate comparison in the unexplained death group.

If there are more ADHD diagnoses, of course there will be more who take stimulant medication! Anything related to ADHD may be responsible for the discrepancy. They controlled for a number of conditions which may or may not be related to ADHD by simply excluding those individuals from the study, but they did not control for behavioral variables such as poor impulse control.

The way to find out if stimulant use is related to sudden death is to compare rates of such deaths among those children with ADHD taking stimulant medication to those with ADHD who are not. The fact that it is nearly impossible to conduct such a study due to the rarity of sudden death is extremely important. It shows clearly that the risk of sudden death while taking a stimulant is so low that knowledge of whether the medication contributes to that risk is of no practical value.

I would not find it difficult to believe that such an association exists if the research was strong. It would not be at all surprising that the use of ANY medication carries such a risk. The question doctors ask themselves before prescribing is always “Do the benefits greatly outweigh the risks?” They certainly do in this case.

Although this study began with a different question, I find myself wondering why it was conducted at all. The FDA’s 2005 study examined the rate of sudden deaths over the course of 13 years and found that rate to be no greater among those taking stimulants than in the general population. The American Academy of Pediatrics also stated that there was no evidence of increased risk. The only criticism the authors of the present study offered of the FDA finding was that the information MAY have been inadequate, resulting in under-reporting of stimulant use. However, that would not explain the findings. To do that, one must give a reason for such under-reporting that is likely to covary with sudden death.

Many people simply dislike the idea of giving children stimulants and search for reasons to discourage the practice. This leads to scaremongering, not knowledge. I cannot know if the researchers in this case were motivated by such views; this is pure speculation. It is, however, an important thought for all of us to consider. We cannot ignore truths because we do not like them, and we cannot search exhaustively for support for our views. We must consider that those views may be unfounded. Scientists must be skeptics; we must be open-minded and seek answers as objectively as possible.

2 Comments:

Time Out on October 4th, 2009 at 18:03:
Have you ever seen how this makes kids react after they come down from these drugs?
Barbara Drescher on October 4th, 2009 at 19:27:
Kids do not “come down from” stimulant medication, but yes, I know exactly what kids are like on them and off of them. I also know how they work, how long they stay in the system, how they are metabolized, and what kids who need them but do not take them suffer through. DO YOU?
The scientific literature, which gives us FACTS about these questions, is pretty clear.

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