The FDA seems reluctant to warn parents about the dangers of ADHD drugs

Erring on the Side of Caution

Recently, FDA officials urged caution. And what prompted this urge for caution?

The answer to that question reveals the true FDA – the one that remains mostly hidden from the average consumer who still holds the sweet belief that the agency keeps a diligent watch on his behalf.

If only…

Timid watchdog

Here’s how a headline from Medscape neatly summed up the FDA’s concern: “FDA Urges Caution in Interpreting Study Linking Stimulants to Increased Risk for Sudden Death in Children”

Yep! Classic FDA.

Does the agency do parents the huge favor of warning them that a new study reveals an increased risk of sudden death in ADHD children who take Ritalin and other stimulant medications?

No. The agency would rather have parents not jump to any WILD conclusions, even though the study found that Ritalin may increase risk of sudden death by as much as SIX TIMES!

Here’s how FDA officials put their position: “Given the limitation of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile…”

See how it works? It’s the study that’s a problem, not the drugs.

And are you ready for the kicker? The study was funded by the National Institute of Mental Health and…the FDA. It’s their study! They own it! But when the results revealed potential dangers of a blockbuster drug, they threw the study to the wolves and questioned its methodology.

Gee, if they were dropping a big chunk of taxpayer cash on a study, you would think they would check that methodology BEFORE the study got underway.

And of course, I’ve got to ask: If the results had shown that Ritalin PROTECTS kids from sudden death, would the agency urge caution about interpreting the results? Would the methodology be questioned? Would mainstream pediatricians be rejoicing in the streets?

Answers: No, no, and absolutely YES!

Drawing attention

The FDA had to be concerned about how this study would make news, so they hit the ground spinning the message. They called a press conference where Robert Temple, M.D. (FDA director of medical policy for the Center for Drug Evaluation and Research) had this to say about the very troubling results: “I don’t think it makes the case that there is real risk here.” He doesn’t think that, and so you shouldn’t think that either. Now go on home and have a nice day!

Even the team that conducted the research hedged a bit – although they hedged, then stood their ground. In the 6/15/09 issue of the American Journal of Psychiatry they started off by throwing a bone to the agency party line: “While the data have limitations that preclude a definitive conclusion…” And then, a cold blast of reality: “…our findings draw attention to the potential risks of stimulant medications for children and adolescents.”

And really, that’s all we want from the FDA. Just do the most basic thing we expect you to do: Draw attention to potential risks. Is that too much to ask?

Apparently it is when drug sales are at stake.

For more information about heart health risks linked with ADHD medications, see the e-Alert “Too Much of a Good Thing” (5/6/08).

Sources:
“FDA Urges Caution in Interpreting Study Linking Stimulants to Increased Risk for Sudden Death in Children” Barbara Boughton, Medscape, 6/18/09, medscape.com
“Study Shows Possible Link Between Deaths and ADHD Drugs” Shankar Vedantam, Washington Post, 6/16/09, washingtonpost.com