“Studies Show…”: Beware of Medical Bills of Goods

During this last week, I became upset when I heard doctors quoting from an article published in the journal Pediatrics, suggesting that the use of stimulants to treat ADHD in children is a safe practice and we do not need to screen them for heart disease.

Shortly afterward, I noticed that Medscape published an educational piece for doctors and other health professionals, using the same flawed study to support their view. The Medscape article is titled “No Increase in Cardiac Events or Death with ADHD Drugs.”

The article opens with this statement: “Children and adolescents who take medication for attention-deficit/hyperactivity disorder (ADHD) are not at increased risk for cardiovascular events and death, according to results of a large observational cohort study.”

That statement is just not true. That conclusion could not be asserted in the study, because the incidence of sudden death among study participants was very low; as a result, the authors concede that no final conclusions could be made.

Once again, industry-supported research fools the scientific and medical community.

This study is flawed, and its group sampling is, unintentionally or otherwise, biased to suggest that the medications are safe. The study compared populations of children who take stimulants to treat symptoms of ADHD with populations who do not. The purpose of this observational study was to measure if there is a higher rate of cardiac events in the stimulant-using group.

The major flaw in this study is that physicians and parents are hesitant to place children on stimulants, especially if there are indications of heart disease that would increase the risk of sudden death. As a result, many of the children at risk are placed automatically in the non-treatment group. This built-in bias would make it virtually impossible to prove that stimulants had any detrimental effect on at-risk patients. And what the study did purport to show was that more children died suddenly in the untreated group than in the group taking stimulant drugs.

For added perspective: We have millions of Americans being treated with stimulants. Amphetamines are being prescribed to children and adults alike. All too commonly, I hear from high school or college students, who happen to be my patients, that they are able to obtain these drugs illegally from friends. This time of year I hear it more often, as such stimulants are popular as illegal aids to promote wakefulness in students studying long hours for final exams. The dangers posed by such uncontrolled availability among young people are too obvious to require extended commentary from me in this column.

To summarize, administering a stimulant to children with an underlying disease like WPW, LONG QTC or HCM will increase their risk of sudden death. If we do not require childhood screening for those diseases (as well as others), then placing groups of children on these medications will almost certainly increase their incidence of sudden death.

The question is not whether the use of these stimulant drugs will increase the risk of sudden death for these patient groups, but whether that risk is acceptable to the parents, regardless of the attitudes now current in the pharmaceutical and medical communities.