Health: FDA decision harms consumers
Published March 25, 2004
I believe the Food and Drug Administration (FDA) has made a mistake by bowing to pressure from consumers. "Huh?" you say and with good reason. Just about every entry I have written about a health issue has been from a pro-consumer perspective. Have I decided it is time for me to befriend the megacorps that manufacture prescription drugs? No, not at all. This situation is rare because I believe the federal agency has made a decision to please a vocal minority of drug users that is actually anti-consumer.
WASHINGTON — Doctors who prescribe some popular antidepressants should monitor their patients closely for warning signs of suicide, especially when they first start the pills or change a dose, the government warned Monday.
The Food and Drug Administration asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels.
The drugs of concern are newer generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro, Luvox, which are called SSRIs or SSRI-like drugs, and Remeron, Serzone and Wellbutrin, which operate differently.
The pressure was brought by families of people who have committed suicide while using antidepressants. There was special pleading by parents of dead children that proved to be particularly effective. Though no studies have established a link between antidepressants and suicide, the British claim there may be a causal connection between being a minor on antidepressants and committing suicide.
British health authorities sounded the alarm last year, saying long-suppressed research suggests serotonin-affecting antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Excepting one drug, Prozac, that has been proved to alleviate pediatric depression, Britain declared the other six SSRIs or SSRI-like drugs unsuitable for depressed youth. Britain didn't mention the other three drugs in the U.S. notice.
The FDA issued a caution on pediatric use last year but says it doesn't have proof the drugs are to blame. Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. A total of 109 patients experienced one or more possibly suicide-related behaviors or attempts — but the studies varied dramatically in what was considered suicidal behavior. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding.
Though there is no conclusive evidence that any of the ten drugs cited has caused even one suicide, the FDA's recommendation will likely lead manufacturers to comply. They will not want the negative publicity that may ensue if they don't. Furthermore, by seeking a general warning, the FDA is applying the poorly researched claim to all users of antidepressants, minor and adult. For me, this is an easy call. The answer should have been 'No.' During the years I spent working on personal injury, product liability and wrongful death cases, I developed an appreciation for having a reason for holding defendants responsible for harms they legitimately cause. Allowing warnings on drug labels without a basis in research is the first step toward assigning liability without a reason in wrongful death cases involving suicidal users of antidepressants. I believe the irrationality of that will be a blow to plaintiffs with real reasons to sue and further fuel the drive for 'tort reform.'
- Health: FDA decision harms consumers
- Published: March 25, 2004
- Type:
- Section: Politics
- Writer: Mac Diva
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One of the first steps a lawyer takes in making a tort case is to establish duty. Part of duty is warning consumers of a danger. If a warning exists, it is assumed there is a reason for it -- the product is dangerous in X way. By urging drug manufacturers to warn without a reason, the FDA is providing an unfair basis for plaintiffs who have lost depressed family members who were using antidepressants to bring lawsuits. The suits might not make it pass the rest of the analysis -- breach and injury -- but this is a first step in the wrong direction.
I agree that treating children with emotional problems is a connundrum. That is why Britain, despite its ban on SSRIs, is continuing to allow the use of Prozac for children. They desperately need a remedy of some sort. New Zealand decided not to even pretend it has a better approach. Hopefully, objective studies of children using antidepressants will shed light on whether they are at a greater danger in the future.
Yeah, I hear you on the legal angle. And then the beginning of the pharmaceutical companies asking for a ban on lawsuits, just like the HMOs did.
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Good analysis. When you say "The drugs don't cause the deaths, their preexisting conditions do," though, I think that's the part that's still up for grabs. Not all depressed people are suicidal, so it is possible that the drugs can initially deepen the depresssion and lead to that end.
But no studies have proven anything, so your point is well taken, as is the point that the warnings could make people who need the drugs shy away from them, ultimately leading to more suicides.
The thing that concerns me the most is the link to pediatric patients. Children are very often given drugs that were tested on adults and NOT on children. So there are no protocols established for how to establish doses. Doctors usually "dumb down" the adult dose based on the child's weight and age. But children's bodies metabolize the medicine faster than adults, and kids often end up taking an adult dose.
And nobody knows what the long-term affect is on a child's growing body. So the kids on these drugs are like guinea pigs.
So I guess all of this is to say that parents need to educate themselves on the drugs they give their kids. And that I'm not so sure a warning on the drugs is a bad idea, given the potential danger.