(Guest post by Greg Forster)
I am an angry man this morning.
My daughter, who just turned three, can’t talk much yet. (For the record, that’s not her picture at the top of the post.) Of all the difficulties she goes through because of her very limited ability to speak, one of the worst is that when she’s scared or in pain, she can’t tell us what’s wrong. She’s accustomed to communicating with us (through sign language, by pointing, by pulling us over to something, and through the limited set of words she can use), so when she desperately needs to communicate that her throat hurts or her head hurts and she doesn’t know how, she panics. Ordinary illnesses are terrifying to her. And of course that makes them doubly painful for us.
We thank God for the medicine companies that have produced the pain relievers and other medicines that get our daughter, and us, through these ordeals. I can only imagine what my daughter’s life would be like if she couldn’t take medicine to relieve her pain, and her terror.
On page B8 of your Wall Street Journal this morning, you will find a story about how the medicine companies that make children’s cold and cough remedies are “voluntarily” relabeling their products at the “request” of the FDA. These medicines will now be (mis)labeled with the warning that they shouldn’t be given to children under four.
These medicines are known to be safe for small children when used as directed. The FDA doesn’t dispute this. If the FDA had a legitimate reason to act, it wouldn’t make a request, it would make a rule, and enforce it.
These medicines were even marketed for children under age two until last October, and that change was also made “voluntarily” at the “request” of the FDA.
When the FDA requests that medicine companies voluntarily do something, it’s like when Vito Corleone summons the undertaker to the morgue and asks if he’s prepared to do him a favor.
So what justification was given for this request? Well, it seems that two-thirds of ER visits associated with these medicines come from children under four accidentally ingesting them. Different sources are saying either 6,000 or 7,000 ER visits are associated with these medicines, meaning that we’re talking about roughly 4,000 visits. [UPDATE: It appears to be 6,000 visits by children under 6, 7,000 visits total. It’s not surprising that most of the visits are by children under 6 given that these are medicines specifically marketed to young children. But that only makes it worse. The FDA is alarmed because, out of all ER visits by children under 6, two-thirds are by children under 4. Think about that. It’s like the old Dilbert cartoon where the boss is enraged that 40% of all sick days are taken on Monday or Friday.]
Most of the ER visits presumably don’t result in death or even long-term health impacts. If these medicines killed 4,000 children a year, the FDA would have acted against them openly rather than by subterfuge, and it would have done so a long time ago.
Who gets to speak for the millions of children who will suffer, over and over again, suffer every moment of pain that an untreated illness causes, because a relatively tiny number of parents can’t be bothered to store their medicines properly and as a result they have to endure one lousy ER visit? No one.
I am an angry man this morning.
Why would the FDA do such a moronic thing? We all know the answer. I don’t even have to say it. (Check the title of the post if you’ve forgotten it.)
Now, I know that in reality, many parents will keep on using these medicines. But some won’t. Lots of parents trust the FDA, more fool they. And what about future parents, who aren’t paying attention to what the FDA does today because they’re not parents yet? No dobut some will hear the truth, but others won’t. And what if the drug companies decide that now that these medicines are labeled for kids over four only, they can up the dose? We can watch for that, of course, but it’s one more obstacle between children and pain relief.
By tomorrow I will have resigned myself to this latest injustice. By now I ought to know better than to get this mad. I’ve spent my career fighting a government school monopoly that systematically destroys children’s lives so that the unions can make the gravy trains run on time. I can write about that without getting mad; if I got mad every time I contemplated the injustice of the system, I couldn’t do what I do. Why am I mad when it’s my daughter and not somebody else’s?
Because I’m human, I guess.
Jay P. Greene's Blog 
I’m with you, Greg. They make decisions for all based on median outcomes when there is obviously a distribution of outcomes. For example, even the notorious Vioxx, which had marginally positive median effects for pain relief and potentially fatal side-effects for some, had significantly positive benefits for some at almost no -risk of side-effect. That is, someone could know that they were at little risk for heart disease and try Vioxx to see if they received exceptional pain relief. If they did, they could continue to enjoy that relief from chronic pain with little or no risk to their heart. But the FDA doesn’t allow people to figure out whether they are on the tail of the distribution with significant benefits and little risk. The FDA makes the same decision for everyone.
And on being angry … A little anger can be a good thing. It can be motivating to write an excellent post like this.
(corrected to say Greg, not Matt)
Excellent post, Greg. The FDA, like the public schools, primarily serves those who are employed by it and who manipulate it, not the public it’s supposed to protect. Unfortunately, this is what we get when too many people are willing to trade their liberty for false government promises of security.
Thanks, both of you. But when you say a little anger can be a good thing, you don’t know how angry I was when I started writing the post!
Please see the update – now with even more outrageous FDA looniness!
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