Antidepressant drugs and suicide

Safety for Sale

It’s rare to get a glimpse of the inner workings of the FDA. But the growing controversy surrounding suicides among minors taking antidepressant drugs reveals disturbing priorities when the issue of safety comes into conflict with the agency’s close relationship with the drug industry.

And now Congress is turning up the heat. The U.S. House of Representatives Energy and Commerce Committee has launched an investigation to determine if FDA officials acted in a timely manner in demanding warnings about the association between antidepressants and suicide among the young.

As the old saw goes: Where’s there’s smoke, there’s fire.

Strike a match

Last month the FDA asked manufacturers of several prominent antidepressant drugs to include in the product labeling, “a warning statement that recommends close observation of adult and pediatric patients for worsening depression or the emergence of suicidality.”

But as CBS reports, the full FDA statement implies that there is really no strong evidence that these drugs prompt suicide among the young, even though a safety analysis by an FDA medical officer revealed that just the opposite is true.

Here’s the sequence of events, as described by CBS News:

In the summer of 2003, reports from GlaxoSmithKline (GSK – maker of Paxil) indicated an association between antidepressant use and suicide among minors in clinical trials. An FDA internal document stated that the information, “had us worried.”

In response to the GSK data, Dr. Andrew Mosholder, an FDA medical officer and child psychiatrist, performed a safety analysis, reviewing 20 studies that examined the outcomes of more than 4,100 children who used eight different brands of antidepressants. The San Francisco Chronicle reports that Dr. Mosholder’s analysis found a clear risk of increased suicidal behavior among children taking antidepressants.

Asking the hard questions

CBS News states that the Mosholder analysis indicated two times as many suicide-related events occurred among those children who took antidepressants, compared to those taking placebo. (This simple observation sidetracks a prevalent theory that it’s not the drugs prompting the suicides but rather the fact that depressed minors already have a tendency toward suicidal thoughts.)

Although Dr. Mosholder characterized these findings as “difficult to dismiss,” FDA officials removed his report from the agenda when a special panel reviewed evidence about antidepressant use among minors last February.

One FDA insider asked this question when interviewed by the San Francisco Chronicle: “Why is the agency sitting on its hands and acting as if there isn’t a risk when their own scientists have looked at the data and concluded that there is?”

Excellent question.

And all the more important because it comes from within the agency.

Just say, “No!”

The FDA makes a big deal out of protecting minors with the absurd ban of ephedra products. But when it comes to some of the best-selling drugs on the market today, who is the FDA protecting?

The CBS report quotes Vera Hassner Sharav, the president of the Alliance for Human Research Protection, who stated simply that officials at the FDA are watching out for the drug industry, not consumers.

But the fact is, we don’t need further FDA warnings. For one thing, we’ve already got the important information we need from Dr. Mosholder (thank you, CBS News). And for another thing, just how effective can warning labels really be? Antidepressant drug use among minors is quickly approaching adult usage rates in spite of existing labels. Is an additional warning really going to put a dent in those sales?

Besides, we already know exactly what to do: Stop drugging our children!

These kids should be getting one-on-one counseling, altering their diets, and, if need be, trying safe, non- pharmaceutical means of controlling depression (such as St. John’s Wort) before a single drug prescription is ever written.

In the meantime, the House Energy and Commerce Committee may decide to step over the FDA and issue requirements for more explicit warnings on the labels of antidepressant drugs. Frankly, this strikes me as election-year posing – a little saber-rattling for the constituents back home. But if it serves to help keep this controversy alive, that’s a positive step. When this sort of thing becomes water-cooler conversation, the public gets a better education than any number of mandated warning labels could provide.

Sources:
“FDA Mum on Suicidal Side Effects?” Sharyl Attkisson, CBS News, 3/30/04, cbsnews.com
“Drug Report Barred by FDA – Scientist Links Antidepressants to Suicide in Kids” Rob Waters, San Francisco Chronicle, 2/1/04, sfgate.com
“Panel Probes FDA Moves on Antidepressant Risks” Reuters, 3/24/04, reuters.com
“Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medications” FDA Public Health Advisory, 3/22/04, fda.gov
“Most Low-Carb Dieters Eat Too Many Carbs – Study” Reuters Health, 4/5/04, reutershealth.com