Let Them Snort Snot

Last week an FDA advisory committee recommended that the agency stop pharmaceutical companies from selling cough and cold remedies for children under 6. (The news accounts are unclear on this point, but I assume the recommendation also covers over-the-counter allergy medications, which contain some of the same antihistamines and decongestants that are the main cause of concern.) "From 1969 to 2006," the Los Angeles Times reports, "the FDA received 54 reports of child deaths associated with decongestants and 69 linked to antihistamines." That's about three deaths each year. Most involved children younger than 2, and manufacturers already have voluntarily removed cold medicines intended for babies and toddlers. More important, the deaths generally resulted from accidental ingestion or overdoses mistakenly administered by parents. The advisory panel faulted manufacturers for using inconsistent measurements and giving confusing dosage instructions. But if the FDA follows the committee's advice and bans cold remedies aimed at children younger than 6, it could make overdoses more likely, as parents estimate how much of a drug labeled for older kids should be given to a 3- or 4- or 5-year-old. 

Although fatal reactions are rare and for the most part can be avoided by storing medicine safely and following the dosage instructions, the FDA panel concluded that any such risk is unacceptable because the products have not been shown to work in very young children. They have been shown to work in adults, however, and parents' experiences with their own kids' symptom relief suggests they work in children as well. Jesse Joad, a pediatrician who served on the FDA committee, dismisses such parental impressions. "They really believe it works," she says. "But colds are diseases that get worse for a few days and then get better. You don't have to give them anything." You don't have to give them anything, of course, but parents who want to minimize their children's discomfort may very well choose to. And if a child's nose stops running and he can breathe better shortly after taking an antihistamine/decongestant combo that has been shown to work in adults, and if this sort of thing happens consistently with different children, it probably is not simply a matter of the cold running its course.   

Comments

Mr. Nice Guy | October 22, 2007, 1:21pm | #

Hear, hear! I've been waiting for some dissent about this move by the FDA. I have children and this is insane to not be able to give them anything. The "all chemicals is bad" crowd has been urging this kind of thing for a long time, but it is stupid for the FDA and its experts to do this and deprive children of these medecines. Keep it up Jacob.

Neu Mejican | October 22, 2007, 1:22pm | #

Somehow this relates to the logic JS uses in the second-hand smoking debate. Lack of evidence is tied up in both debates, but in different directions. Hmm....

Neu Mejican | October 22, 2007, 1:25pm | #

2nd hand smoke: evidence of harm not a good reason to ban, evidence too weak to prove significant risk.

Cold meds for young kids: no evidence of benefit, clear evidence of harm, but risk is too small to warrant denying the unproven benefit.

So what role does evidence play in these kinds of policies?

Just asking for clarification.

Dave Woycechowsky | October 22, 2007, 1:26pm | #

Maybe the industry can show that they do work in very young children. With, like, science and numbers and stuff.

SJE | October 22, 2007, 1:26pm | #

I don't see how JS is being inconsistent. In each case he says that the government should not legislate to prevent free choice unless there is very strong evidence of harm that can only be prevented by government action, and that such action will not create other, greater harms.

Neu Mejican | October 22, 2007, 1:31pm | #

SJE,
I wasn't claiming inconsistency.
Just clarification regarding, I think, what counts as "very strong evidence." Doesn't benefit play into the equation?

Cold Meds: Risk confirmed= overdose & death possible.
Benefit: unproven.

2nd hand smoke: Risk confirmed in certain contexts - increased illness up to and including cancers which can be fatal.
Benefit: mild narcotic effect for smoker.

Neu Mejican | October 22, 2007, 1:37pm | #

With, like, science and numbers and stuff.

That is the right approach.
I believe the FDA policy highlights the need for said research. What do you bet this leads to a request for research applications on that topic from NIH?(I bet that RFA is already out there, actually).

So what do you do while waiting for the evidence of benefit for a product with proven risk?

Mr. Nice Guy | October 22, 2007, 1:39pm | #

NM-Is it a proven risk? The link says that most harm came from wrong dosage.

SIV | October 22, 2007, 1:46pm | #

NM-Is it a proven risk? The link says that most harm came from wrong dosage.

You just answered your own question MNG.

Elf M. Sternberg | October 22, 2007, 1:47pm | #

All I can say is, if this produces One More Roadblock to getting my kid pediatric Sudafed, I'm going to freakin' go medieval on someone. It bad enough that I have to hand in my driver's license to buy the only over-the-counter medicine that actually works for her during allergy season.

Looking at these numbers, it's 1.5 deaths per year for decongestants. That's gotta be lower than the death rate for lightning!

What's next, banning water because it causes drowning?

Mr. Nice Guy | October 22, 2007, 1:50pm | #

Harm from taking too much of something does not mean the thing taken is itself risky. A person can drink too much water and die but that hardly shows water a "proven risk."

MP | October 22, 2007, 1:51pm | #

Cold meds for young kids: no evidence of benefit, clear evidence of harm, but risk is too small to warrant denying the unproven benefit.

There's no evidence of benefit because studies are few and far between. There are few studies because we're dealing with children. It's a catch-22.

And clear evidence of harm? Tylenol has clear evidence of harm...when you use it improperly. Same goes for these meds. Big deal.

This is probably the most asinine application of the precautionary principle in 2007.

Highway | October 22, 2007, 1:51pm | #

This fits in with the DEA's helpful hints for people who suffer excruciating pain: Deal with it without pharmaceuticals.

What's next, is the official government position for blown out knees gonna be 'walk it off'?

c | October 22, 2007, 1:51pm | #

Look, the dosing directions for most of these medications specifically state: For children under 2 - Consult a physician. Most of the time, what matters when dosing is the weight of the child. (If you call your doctor about this, the first question they ask is how much does the child weigh.)

I don't necessarily advocate giving these medications to children just because they have a minor cold, however, if you are talking about a child with a sinus infection that needs some relief from congestion, why should you be denied access to this type of medication?

Dave Woycechowsky | October 22, 2007, 1:51pm | #

So what do you do while waiting for the evidence of benefit for a product with proven risk?

Writing or phoning your drug company to encourage them to prove efficacy of all the drugs they make across all age groups, races and genders -- even before the federal government requires them to do so. Tell them that, as a customer, this something you would like to see to prevent any similar delays in the future. If you feel strongly enough, ask them how you to make a large cash gift to the corporate entity to expedite the research presumably now underway.

Reformed Republican | October 22, 2007, 1:56pm | #

And if children's medicines are unavailable, what do you think parents are going to do? They will use adult medicines. Perhaps at lower doses, but not necessarily. Those who currently do not follow directions when dosing children's medicine will not follow directions for the adult medicine. Considering adult medicines have a higher concentration of the active ingredient, the likelihood of overdose will be increased.

Presto | October 22, 2007, 1:56pm | #

If I had been the journalist, it would have been difficult for me not to punch Joad directly in her self-righteous gob.

And what is this "no proven benefit" pigshit? If our three-year-old with a cold doesn't get Dimetapp, she can't breathe through her nose; if she does, she can. That seems pretty damn empirical to me.

Fluffy | October 22, 2007, 2:00pm | #

I disagree, Neu Mejican.

I consider "evidence of harm" to be absolutely irrelevant to the second hand smoke debate. The only relevant question is who owns the property being smoked on. If I own it, and I want to let people smoke, you can either put up with the risk of second hand smoke or you can hit the bricks.

Similarly, if it's my kid and my direct experience is that an antihistamine helps clear his nose and help him breathe easier, the FDA should not be allowed to tell me that my perception of the risks and benefits involved doesn't matter. I've got money; the drug companies have cold medicine; we want to swap. GFY FDA.

In each instance the libertarian position, from my perspective, has absolutely nothing to do with the presence of absence of evidence. It has to do with the autonomy of individual parents and property owners.

[I actually prefer child's formula Vicks Vapor Rub and a humidifier myself, but that's not the point.]

Taktix® | October 22, 2007, 2:03pm | #

Looking at these numbers, it's 1.5 deaths per year for decongestants. That's gotta be lower than the death rate for lightning!

That's lower that the death rate for people being killed simultaneously by both a 747 and an Ice Cream Truck.

Strangely enough, however, 1.5 deaths per hour are attributed to excessive taint withering...

SIV | October 22, 2007, 2:04pm | #

Harm from taking too much of something does not mean the thing taken is itself risky.

Obviously yes, but we are talking Government regulation to avert risk. Truck chassis based SUVs don't rollover any easier than the trucks they are based on yet they do flip easier than the cars on which their owners learned to drive.
SUV rollovers are therefore a matter of driver error rather than an inherent risk but Govt focuses on the statistics rather than the behavior. Same thing with the snot meds for kids.

Minion of URKOBOLD | October 22, 2007, 2:06pm | #

TAKTIX.

SILLY MORTAL.

THE 1/5 D/H IS BALANCED BY THE 27.6 URKOBOLD GIGGLES, CHORTLES, AND CHUCKLES PER MINUTE WHILE WHITHERING TAINTS.

Troy | October 22, 2007, 2:08pm | #

Whoever says that there isn't a benefit, doesn't have kids. No, it didn't fucking CURE the cold. but it did alleviate her symptoms.

That is, it ameliorated her suffering. [/sarcasm] Oh, the humanity, kids not suffering. [/sarcasm].

I think that all these morons who are against givving kids relief should have to babysit all these sick chilren.

R C Dean | October 22, 2007, 2:10pm | #

So what role does evidence play in these kinds of policies?

Absent strong evidence of harm outweighing benefit (lacking in both policies), the State should leave people alone to make up their own damn minds.

There, was that so hard?

swillfredo pareto | October 22, 2007, 2:10pm | #

So what role does evidence play in these kinds of policies?

A piece of data in a stream of disparate information to be factored in when a free man makes a choice. There are risks and there are rewards; ultimately it is up to the individual (or the individual’s parent) to make the decision.

Taktix® | October 22, 2007, 2:10pm | #

In each instance the libertarian position, from my perspective, has absolutely nothing to do with the presence of absence of evidence. It has to do with the autonomy of individual parents and property owners.

Exactly. I don't have kids, but I personally don't take cold meds because I find the illness subsides more quickly when I don't suppress my immune system (see: treating the symptoms).

However, for me to take my opinion and tell everyone that's the way it is, M.D. after my name or not, is wrong...

Wrong, wrong, wrong...

T | October 22, 2007, 2:13pm | #

SUV rollovers are therefore a matter of driver error rather than an inherent risk but Govt focuses on the statistics rather than the behavior.

In part, that's because getting people to change their behavior is difficult and oft-times impossible. Meanwhile, citizens are demanding action from the gummint! Something must be done! The government can't, for some obvious reasons, tell middle America "You're fucking morons, and some people will die as a result. Deal with it." So we ban things to appease noisy pinheads who don't understand personal responsibility. Ain't democracy wonderful?

SIV | October 22, 2007, 2:15pm | #

The FDA, Neu Mejican, and REASONs Ron Bailey all worship at the Holy Temple of peer reviewed, double blind, SCIENCE. They don't care if your child's snot dries up because she is a statistical outlier, the placebo effect, sympathetic magic or whatever.

MP | October 22, 2007, 2:24pm | #

The FDA, Neu Mejican, and REASONs Ron Bailey all worship at the Holy Temple of peer reviewed, double blind, SCIENCE.

Oh really? Where's the pile of peer reviewed SCIENCE that shows that children's medicines are no more effective than a placebo? I know that the AAP Petition (which I can no longer find) mentioned one study which indicated this. It also stated that there was, in actuality, a complete lack of real evidence that showed anything, either plus or minus. And this is because studying this in children raises particularly tricky moral issues.

So there is no SCIENCE behind this drive. This is all Precautionary Principle.

Ethan | October 22, 2007, 2:26pm | #

The FDA, Neu Mejican, and REASONs Ron Bailey all worship at the Holy Temple of peer reviewed, double blind, SCIENCE. They don't care if your child's snot dries up because she is a statistical outlier, the placebo effect, sympathetic magic or whatever.

These two sentences seem to contradict one another. What am I missing?

Tym | October 22, 2007, 2:30pm | #

This has to be the most extreme overreaction.

1) 1.5 deaths per year, while tragic, is a minute risk.

2) Most of the risk is caused by improper dosing and thus preventable.

3) Children are not biochemically all that different then adults, since they work in adults, it is theoretically more likely that they do rather than don't work in children.

4) Overwhelming anecdotal evidence suggests they work.

5) Regardless of whether they actually cure anything in adults or children they do alleviate suffering at minimal risk.

5) This will result in more injury as parents try to give children reduced adult doses.

Taktix® | October 22, 2007, 2:41pm | #

Tym,

But they're trying to protect the children!

J.D. Tuccille | October 22, 2007, 2:44pm | #

My wife is a pediatrician and she's furious about the FDA recommendation. The problems she's encountered have all been with incorrect dosing -- a problem not likely to go away if parents switch to guessing how much adult remedy to give a toddler. Her practice is now stockpiling children's cough and cold remedies so that they can make them available to their patients at least for a while if/when the actual ban comes.

Russ 2000 | October 22, 2007, 2:55pm | #

So what is the recommended dosage for dwarves?

Reformed Republican | October 22, 2007, 2:55pm | #

Soon all medicine will be prescription only, and we will have to visit a doctor for every little thing.

And we bitch about the cost of health care and medicine now?

Reformed Republican | October 22, 2007, 2:59pm | #

Russ,

Surprisingly, it is about the same as for a human of comparable weight. Their +2 to Con gives them more natural resistance to disease, but their +2 to saves vs. poisons also makes the medicine less effective.

SIV | October 22, 2007, 3:00pm | #

the FDA panel concluded that any such risk is unacceptable because the products have not been shown to work in very young children

MP , Ethan

See above the FDA's science shows the drugs don't work in children
read the comments here from people with children who say the drugs do work.

Personally, I will side with individual choice over the FDA and their studies any time.

MP | October 22, 2007, 3:08pm | #

See above the FDA's science shows the drugs don't work in children

It does not. The FDA hasn't studied this. All they've presented was information regarding deaths related to usage.

C'mon SIV, if you believe the SCIENCE is out there, then go find it and bring it back to us.

Taktix® | October 22, 2007, 3:08pm | #

So what is the recommended dosage for dwarves?

Surprisingly, it is about the same as for a human of comparable weight. Their +2 to Con gives them more natural resistance to disease, but their +2 to saves vs. poisons also makes the medicine less effective.

Duh! It's a D-20, +1 if Merck, -1 if Proctor and Gamble...

Fluffy | October 22, 2007, 3:08pm | #

Ethan:

At issue is the difference between empirical evidence and a "scientific study".

If I see a car run over a man and kill him, I will conclude that getting hit by a car can be fatal.

This would seem to be common sense, but there are people in the world who will NOT conclude that unless and until a scientific study of the subject is made, peer reviewed, and signed off on by the state. Many of those people work for the FDA. Many of those people will also read the eventual scientific study and say, "All the cars in this study were Fords. This means that getting hit by a Chevy may NOT be fatal."

Rick Barton | October 22, 2007, 3:09pm | #

Gag me! I'm voting with my eyes. The title's too gross so I'm not even gonna read the article...

Ok ok. I'll read it but only cuz it's Jacob and Reason. Please, let's have no more gross titles.

Bingo | October 22, 2007, 3:13pm | #

So is there anything we can't legitimize banning by saying "its for the children"?

MP | October 22, 2007, 3:15pm | #

So is there anything we can't legitimize banning by saying "its for the children"?

Children.

SIV | October 22, 2007, 3:19pm | #

,i>So is there anything we can't legitimize banning by saying "its for the children"?

Children.

You can ban children "for the children" too See the Godless Chi-coms and their one child policy

SIV | October 22, 2007, 3:21pm | #

Bad Tags!

J sub D | October 22, 2007, 3:32pm | #

I have no kids. So all of you worry wart parents (I meam that as a compliment, really) can disregard my comments.

The FDA seemingly takes the position that parents are either too stupid, lazy, or both to make decision about medicine for their children. I disagree. As evidence I point to the 50 million+ copies of "The Common Sense Book of Baby and Child Care" by Dr Benjamin Spock, sold since 1945. Parents suck up info about kids. The information is out there for parents who want to find it. In ancient times, parents would have the unreasonable burden of "going to the library" to access this information. Of course now you can get a good start with a Google search. I suspect, family practitioners, still discuss children's medical needs with their parents as well.

Most parents I'm familiar with are well versed on their children's health issues. Those few who don't choose to be are neglecting their children, if not legally, ethically. Short of an Orwellian society, I don't see any way for the feds to change this.

Civic, non-governmental, organizations are likely the best approach to reaching the ignorant and irresponsible parents. I also submit that all of the governments help/interference reduces caring, cost effective assistance by private charitable groups. Read the comments on this thread and you realize that Big Nanny in D.C. doesn't know best, because one size does not fit all.

The FDA should just but out! More children are probably killed by family camoing trips. If they want to publish a synopsis of the available studies, I'll reluctantly concede that.

J sub D | October 22, 2007, 3:34pm | #

Make that camping, vice camoing, trips. I'm a suckass typist.

R C Dean | October 22, 2007, 3:40pm | #

This will result in more injury as parents try to give children reduced adult doses.

So, you mean to tell me that intrusive interference by a distant organ of the state will actually make things worse?

I can't believe it!

SIV | October 22, 2007, 4:04pm | #

It does not. The FDA hasn't studied this. All they've presented was information regarding deaths related to usage.

C'mon SIV, if you believe the SCIENCE is out there, then go find it and bring it back to us.

MP,

Do I have to spell it out with colored alphabet blocks for you?

the products have not been shown to work in very young children

That is the FDA's opinion of the "science" as stated by Sullum in his post.

MP | October 22, 2007, 4:13pm | #

Do I have to spell it out with colored alphabet blocks for you?

Yes. And with the oversized blocks too.

They also haven't been shown to not work. There is no definitive evidence one way or the other. Because there are few studies. Because tests of this nature on children are difficult and morally complicated. The FDA is not claiming that they are a placebo. The FDA is only stating that they don't know definitively how effective/ineffective they are for children. They are claiming that extrapolation of adult test is not sufficient to prove efficacy. And because there are 1.5 deaths/year, they are (idiotically) erring on the side of caution, because, you know, if it only saves one life...

Or didn't I say that already?

Ventifact | October 22, 2007, 4:18pm | #

Mr. Nice Guy --

Water does have (proven) risk. Libertarianism is a difficult sell precisely because most people believe risk is not an inherent component to life, and can instead through proper management be massaged out of life. Note that this makes for a really big undertaking. Only a big ol' government could possibly manage it, eh? This is where we are now.

SIV | October 22, 2007, 4:25pm | #

MP,

I think we are agreeing on this issue despite your (mis-)reading of my comments.The FDA requires that meds be proven "safe and effective". They have ruled that the kid snot meds are neither, based on the available studies.




The panel experts concluded that the few small studies conducted among children showed no evidence that the medications are effective for treating cough and cold for children under 12.


I'm in favor of abolishing the FDA and allowing individuals to make their own choices for themselves and their children.

Paul | October 22, 2007, 4:29pm | #

2nd hand smoke: evidence of harm not a good reason to ban, evidence too weak to prove significant risk.

Cold meds for young kids: no evidence of benefit, clear evidence of harm, but risk is too small to warrant denying the unproven benefit.

Neu, I think this makes these two issues worlds apart:

"From 1969 to 2006," the Los Angeles Times reports, "the FDA received 54 reports of child deaths associated with decongestants and 69 linked to antihistamines."

54 "reports" associated with decongestants. Fifty four. Five four. From, ahem, 1969 to 2006. In essence, you could almost just as easily say that no one is dying from decongestants. How many trillions of doses over thirty years were given for 54 deaths? I mean, please.

As the father of an under-six-year-old girl, I do admit I scratch my head in puzzlement at the "ineffective" label. Sure, we could all be bamboozled by this stuff the way people who believe that accupuncture "works"-- personal testiminials and such. But to say the stuff is ineffective? How many coughs my daughter has had that stopped-- STOPPED within fifteen minutes of an over-the-counter cough medicine? Frankly, I just don't get it.

Sure, everyone who reads a label knows that it's a very different thing to give these remedies for children under two. But a chile of 15 months is a very different thing from a five-year-old. And off the top of my head, I don't remember reading a label that didn't say "for children under 2, consult a physician".

Paul | October 22, 2007, 4:42pm | #

The FDA is only stating that they don't know definitively how effective/ineffective they are for children. They are claiming that extrapolation of adult test is not sufficient to prove efficacy.

MP, I'm on your side on this one, but it seems to me that the FDA is saying they're ineffective. The FDA does not seem to be shrugging their shoulders and saying "we just don't know". In my reading of the article(s) they seem to be indicating that it is a placebo effect. That we might as well be giving our kids acupunture or homeopathic remedies. Oh, and then there's this pinhead:

"I'm against giving medicine to kids," Ciment said. "It's too much for their little bodies."

Sylmar resident John Thornton, whose wife is an herbalist, said his daughter, who takes preventive herbal remedies, gets sick less often than her classmates who take over-the-counter medicine.

Herbalist. Hmm. Kay... These herbs I'm giving my daughter aren't "medicine". Nope, ignore their chemical content. Nothing to see here, move along.

Perhaps what Mr. Thornton means is that he's against giving medicines which have been manufactured in a controlled manner, mass produced using engineered chemistry and requiring FDA approval. Dumb-ass...

MP | October 22, 2007, 5:29pm | #

MP, I'm on your side on this one, but it seems to me that the FDA is saying they're ineffective. The FDA does not seem to be shrugging their shoulders and saying "we just don't know".

I'd love to see the FDA come right out and say "This medicine is definitively not effective" and have the research to back it up. But they won't because they can't. Here's what I dug up. From the meeting memo (pdf) (issued prior to the meeting where the conclusion was reached):

The Agency has only very limited data from clinical trials showing that the ingredients in nonprescription cough and cold products described in the monograph are effective for temporarily reducing cold symptoms in children including infants, toddlers, school-aged children, and pre-teens. The Agency has not required such studies because efficacy was extrapolated from adults [...], and conducting clinical trials on cough and cold products in children is difficult, especially in very young children, because self-reporting is difficult to obtain and unreliable in this age group.

The FDA also has on file this study (pdf) by the CHPA (an OTC trade group). It is well referenced and is a treasure trove of information. It also shows how there has been almost no research on efficacy of these medications in young children.

Again, what we're dealing with here is a lack of definitive research. The studies (what few there are) which hint at a placebo effect are far from definitive.

And none of this is to say that the medicines in question don't have proven effects on adults. And the safety of these medicines is hardly in question (except by that precautionary principle jerk-off Sharfstein in Baltimore). These are medicines that have a proven track record of safety for children. The lack of definitive efficacy research, research that's nearly impossible to produce, should never have been an issue.

This whole story pisses me off to no end. To have all this medicine removed from circulation on the basis of nothing but "if it only saves one life" logic is unconscionable.

Robert | October 22, 2007, 6:25pm | #

If someone were marketing cough & cold medicines specifically for some other sub-population, they'd have the same lack of data. But for children, the problem now is that they're unlikely ever to get the data, not because the drugs don't work on children, but because it may never be worth anybody's while to do the studies on children. It'll be hard to get permission to study on children, and because the drugs they'd be testing would be in the public domain, nobody would capture enough benefit from them to make it worth their while to do the studies.

Jennifer | October 22, 2007, 6:32pm | #

Things have become so ridiculous that I can easily imagine, in all seriousness, a situation where in medical terms, "need" is defined only as "you'll immediately die without it," and any medical care you don't "need" under this requirement is outlawed. Much already is: you don't "need" to live free of pain, so the DEA arrests people for using or prescribing drugs that aren't strictly needed, and you don't "need" to be able to breathe through your nose when you have a cold, so you can't take effective decongestants (which can be used to make that scary meth, anyway).

Paul | October 22, 2007, 6:45pm | #

But Jennifer, in our increasingly health-driven legislative environment, this is exactly where we're going. Anything can be banned based upon 'need', that need defined by an increasingly narrow group of regulators or legislators. As the amount of public monies paying for life's necessities, the amount of so-called public scrutiny on the 'need' of said necessities arises (and naturally so). If I'm paying for your lung cancer treatment, I don't want you smoking.

We have a society which is imprisoning itself...willingly. I want to pay for your healthcare, you say no. I say yes, because I love your children. Populist sentiment wins over (does it ever lose?) and I'm paying for your healthcare. Now I'm complainging about your lifestyle. No smoking, no drinking, no trans-fats, no narcotics-- and the legal ones will be scrutinized and precautionary principled to death- or just pulled from the shelves if I don't perceive a need or obvious effect.

Legalization of drugs will never...EVER occur because we've shifted from the concerns of crime and the typical conservative fear of an unproductive society to a universal focus on "health". If we're pulling a cold medicine from the shelves, you really think we're going to legalize heroin which, at my estimation, has negative effects which outweigh its positive effects?

J sub D | October 22, 2007, 7:13pm | #

If we're pulling a cold medicine from the shelves, you really think we're going to legalize heroin which, at my estimation, has negative effects which outweigh its positive effects?

And yet, this guy still lives, and has arguably led a productive life..

Ogre | October 22, 2007, 7:23pm | #

More, more! Faster! Faster! All drugs have the potential for misuse and harm from overdose! Take them all away, America! Make us suffer! Torture our children! Counteract the entire canon of medical advancements over the last 100 years!

Make people notice, so they will finally rise up and throw you down!

---

I'm only half kidding.

Ogre | October 22, 2007, 7:38pm | #

PS: The Pirate Rule applies here.

("If some activity causes fewer deaths per year than piracy, it's not worth worrying about.")

Neu Mejican | October 22, 2007, 8:16pm | #

MP, Paul, and other considered responders....

Thanks for taking on my meandering thoughts on JS's thought processes.

I still think there is something off with his variable response to evidence in these issues. If evidence is irrelevant, then it is irrelevant. If evidence matters, then policy should be based on the best available evidence.

JS seems to want evidence to be important when it supports his policy position and unimportant when it doesn't.

But maybe I misread him.

Tym | October 22, 2007, 8:24pm | #

And yet, this guy still lives, and has arguably led a productive life..

And this dude.

Neu Mejican | October 22, 2007, 8:27pm | #

RCDEAN,

Absent strong evidence of harm outweighing benefit (lacking in both policies), the State should leave people alone to make up their own damn minds.

There, was that so hard?

Your math seems off here.
Evidence of benefit = 0
Evidence of harm = certain (debate is over importance of the harm, not whether it exists = you term "stength").

In that equation harm outweighs benefit, so the policy is correct.

With smoking we again evidence of non-zero harm. And evidence of non-zero benefit (based on people's desire to smoke). Evidence is strong on both sides (in appropriate contexts). So it isn't about strength of evidence, but weighting of the elements in the equation.

I think you really want to argue the "evidence is irrelevant" case.

swillfredo pareto | October 22, 2007, 8:42pm | #

Evidence of benefit = 0...In that equation harm outweighs benefit, so the policy is correct.

If you know that to be true (inefficacy), what explains the market for the medicine in the first place? A number of people in this thread have explained that it is beneficial to them and their children. If you believe in self-determination and liberty then the policy is not correct.

Robert | October 22, 2007, 8:58pm | #

Thanks for taking on my meandering thoughts on JS's thought processes.

I still think there is something off with his variable response to evidence in these issues. If evidence is irrelevant, then it is irrelevant. If evidence matters, then policy should be based on the best available evidence.

JS seems to want evidence to be important when it supports his policy position and unimportant when it doesn't.

His thought process is like mine. There's no reason or evidence to believe second hand smoke from cigarets acts differently from smoke from other sources, and there's no reason or evidence to believe nose drops work differently in children from the way they do in adults.

SIV | October 22, 2007, 9:29pm | #

As I pointed out above Neu Mejican equates Science with some sort of divine authority.
The authority is to be trusted and obeyed
over individual choice and belief.

The proper attitude of a free people towards "science informed public policy" should involve pitchforks and torches.

crimethink | October 23, 2007, 12:46am | #

Neu Mejican,

If people's desire to smoke counts as a benefit of legal smoking, then why doesn't people's desire to give their kids cold medicines count as a benefit of legal kids cold medicines?

Neu Mejican | October 23, 2007, 1:08am | #

SIV,
Crimethink,

I actually haven't expressed my own thoughts on these issues here. I am trying to figure out JS's positions. Like I said, sloppy meandering thoughts...no claim that I buy into them.

He cites "evidence for" and "no evidence for" quite liberally in his posts, but it never seems to relate to the actual level of evidence.

To your point Crimethink ...if you take "people buy the product" to be equivalent to "is safe and effective" then there is evidence of benefit for any product that someone purchases. That is a coherent position, I guess. It certainly leaves the policy questions with a nice simple answer (very popular 'round here).

SIV, science is a process, not an authority.
But you are free to choose to believe and follow whatever you individually feel is the valid path towards the truth.

Robert,
there's no reason or evidence to believe nose drops work differently in children from the way they do in adults.

There is, in fact, quite a bit of evidence to suggest that children's bodies work quite differently than adult bodies. That is more true the younger they are. Metabolic process develop just as surely as bones and teeth. You don't start out with a finished product.

Neu Mejican | October 23, 2007, 1:14am | #

So far the group seems to be massing around the "evidence is irrelevant" position. I've got no problem with that as a position.

JS, however, seems to feel the evidence matters. But it is unclear what his metric for "valuable evidence" would be...his metric certainly doesn't line up with most guidelines for evidence-based practices.

http://www.cebm.net/index.aspx?o=1023

Neu Mejican | October 23, 2007, 1:24am | #

I love it when I get 69...

Anyway,

Here is a cut and paste of a review of evidence in this area (from here http://www.aafp.org/afp/20070215/515.html).

From "Table 2"

[looks like they are using a Cochrane review, which means it is systematic]

Overview of the Evidence for Cold Therapies in Children

Cochrane review [seven studies])5; one RCT10
Antihistamines
Two studies: no benefit
Antihistamine/decongestant combination
Two studies: no benefit
Codeine plus guaifenesin (Robitussin AC)
One study: no benefit
Dextromethorphan (Delsym)
Two studies: no benefit
Dextromethorphan plus guaifenesin (Robitussin DM)
One study: no benefit
Dextromethorphan plus salbutamol*
One study: no benefit
Mucolytic (e.g., Letosteine*)
One study: benefit
Other combinations
One study: no benefit
Congestion and rhinorrhea (Cochrane reviews [four studies]6)
Antihistamines
Two studies (one using astemizole†): benefit
Antihistamine/decongestant combination
Two studies: no benefit
Decongestants
No studies
RCT = randomized controlled trial.

*-Not available in the United States.

†-Withdrawn from U.S. market in 1999.

Neu Mejican | October 23, 2007, 1:27am | #

The RCT mentioned above

http://pediatrics.aappublications.org/cgi/content/full/114/1/e85

Conclusions. Diphenhydramine and dextromethorphan are not superior to placebo in providing nocturnal symptom relief for children with cough and sleep difficulty as a result of an upper respiratory infection. Furthermore, the medications given to children do not result in improved quality of sleep for their parents when compared with placebo. Each clinician should consider these findings, the potential for adverse effects, and the individual and cumulative costs of the drugs before recommending them to families.

PEDIATRICS Vol. 114 No. 1 July 2004, pp. e85-e90
Effect of Dextromethorphan, Diphenhydramine, and Placebo on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents
Ian M. Paul et al...

SIV | October 23, 2007, 9:24am | #

Neu,

I have no problem with science as a process.
Many-particularly in regard to policy and regulation-regard the current state of the process as settled truth.

In regard to the issue at hand, medicine is not science.

Jay | October 23, 2007, 10:56am | #

As the father of 2 boys, ages 13 and 11, I can assert that cold medicines do indeed work on children 6 and younger.

I'm stil struggling with how a placebo can cause an actual reduction in mucus production, as I observed many times with my kids.

I must be magic...

Neu Mejican | October 23, 2007, 11:16am | #

Jay,

Are you saying you observed your kids mucus production systematically reduce after giving them a placebo?

The important point of the review of evidence is that there is no strong evidence that these things work. Lack of evidence is not evidence of lack of effect. The trend, however, is against effectiveness in the studies done so far.

Some facts on the Placebo effect:
Annu Rev Psychol. 2007 Jun 5; [Epub ahead of print]
A Comprehensive Review of the Placebo Effect: Recent Advances and Current Thought.

Price DD, Finniss DG, Benedetti F.

Division of Neuroscience, Oral and Maxillofacial Surgery, University of Florida, Gainesville, Florida 32610-0416 [e-mail].

Our understanding and conceptualization of the placebo effect has shifted in emphasis from a focus on the inert content of a physical placebo agent to the overall simulation of a therapeutic intervention. Research has identified many types of placebo responses driven by different mechanisms depending on the particular context wherein the placebo is given. Some placebo responses, such as analgesia, are initiated and maintained by expectations of symptom change and changes in motivation/emotions. Placebo factors have neurobiological underpinnings and actual effects on the brain and body. They are not just response biases. Other placebo responses result from less conscious processes, such as classical conditioning in the case of immune, hormonal, and respiratory functions. The demonstration of the involvement of placebo mechanisms in clinical trials and routine clinical practice has highlighted interesting considerations for clinical trial design and opened up opportunities for ethical enhancement of these mechanisms in clinical practice. Expected final online publication date for the Annual Review of Psychology Volume 59 is November 30, 2007. Please see http://www.annualreviews.org/catalog/pubdates.aspx for revised estimates.


More
http://skepdic.com/placebo.html
http://www.jneurosci.org/cgi/content/full/25/45/10390
http://www.medscape.com/viewarticle/561425

Neu Mejican | October 23, 2007, 11:21am | #

SIV,

In regard to the issue at hand, medicine is not science.

Well, to be fair, it is not like there is NO science involved. Far from settled, sure, but the bulk of the science so far says "no benefit." Drug companies save lots of money if they get to market substances without proof that they work. These kinds of policy decisions drive the science to provide that proof.

rana | October 23, 2007, 11:36am | #

It seems all parents in this thread agree that the medicine works for their children. I am curious, are threre ANY parents here who have found the medicine NOT to be effective?
Its odd that research has failed to prove that the medicine works on young children when so many parents seem to find it relieves their children's symptoms...
Aparently this is an issue NOT of finding actual evidence supporting the medicine's ineffectiveness on children but a lack thereof.

Neu Mejican | October 23, 2007, 11:57am | #

rana,

Aparently this is an issue NOT of finding actual evidence supporting the medicine's ineffectiveness on children but a lack thereof.

You've got that backwards.
The issue is a lack of evidence for "effectiveness" not a lack of evidence for "ineffectiveness."

So far the evidence available supports "ineffectiveness," but there is not enough research done (only one RCT?) to call that evidence strong evidence.

Popular opinion that something is effective also proves that Astrology predicts the future. So, without dismissing parent's impressions, a popular impression that these things work by parents willing to express that opinion on a libertarian thread opposed to more regulation is hardly strong evidence.

rana | October 23, 2007, 12:19pm | #

"You've got that backwards.
The issue is a lack of evidence for "effectiveness" not a lack of evidence for "ineffectiveness."
I agree. As I reread my post I realized I did not make myself clear...

"So far the evidence available supports "ineffectiveness," but there is not enough research done (only one RCT?) to call
that evidence strong evidence."
I think this is where most people take issue with FDA's decision, NOT ENOUGH research has been done. So instead of doing the actual work (I understand it is not easy because we are dealing with children), they simply recommend stop selling cold remedies to children under 6 altogether to appease a few worriers who believe we need to be saved from ourselves.
While I am not saying that parent's impressions are evidence, I am still curious, ANYONE out there has found these remedies to be ineffective? (I am not trying to make a point here, it really just seems odd that soooo many parents find that the stuff actually works!)

sixstring | October 23, 2007, 12:41pm | #

It seems all parents in this thread agree that the medicine works for their children. I am curious, are threre ANY parents here who have found the medicine NOT to be effective?

The Sudafed that you have to sign for works, that shit they call Sudafed (CE?) and leave out on the counter has little effectiveness.

Paul | October 23, 2007, 1:07pm | #

Neu,

We're all pretty well aware of the placebo effect. Believe me, I've spent two decades making fun of acupuncture...

I've read and re-read this article several times, in addition to others and the situation is very schizophrenic. At some point the FDA is concerned about overdosing infants. Fine. Then they claim that the remedies are ineffective. Then they claim that it's not that they're ineffective, but they don't know if they're effective because data was extrapolated from adult studies in the seventies.

The nice thing about my five-year-old is that she doesn't have all the psychological baggage an adult has, so the placebo effect is, in my opinion, somewhat limited. Her response to medication is very..."honest".

I have observed varying effects when administering these remedies to my daughter. For instance, we can't give her anything with pseudoephedrine or she'll be up all night. Some of the remedies don't seem to have any effect. Some seem to do very well, but might make her drowsy during the day.

I'm just smart enough to know that there are other factors that my "personal testimonial" doesn't take into account.

Maybe I give her the remedy and make her settle down, and the settling down alleviates her cough.

In all honesty, I'm the last one to simply shout "but it works for my daughter". Believe me, if that's all it took, then what kind of an idiot would I be everytime I made fun of homeopathy or acupuncture.

Children are different and it takes effort, time and patience to find remedies that are effective for your child. But to simply say "none of them work" and pull them from the shelves? This is nuts.

They need to do a real study. My guess is they'll find that some are effective, some aren't.

rana | October 23, 2007, 1:16pm | #

"Children are different and it takes effort, time and patience to find remedies that are effective for your child. But to simply say "none of them work" and pull them from the shelves? This is nuts.

They need to do a real study. My guess is they'll find that some are effective, some aren't."

Absolutely agree.

Neu Mejican | October 23, 2007, 1:37pm | #

Paul,

They need to do a real study. My guess is they'll find that some are effective, some aren't.

I agree, but will emphasize that they need to do more than a study. Rather they need to systematically demonstrate effectiveness with a series of well controlled studies.

And to be clear, I am not sure I agree with the FDA on this, but I certainly can see the logic behind having the default position be that drug companies need to demonstrate effectiveness for a population when marketing a drug for that population, at least when the risk of adverse effects is clear.

And remember, this is a case where the dosage is the source of danger and it is exactly the dosage response that is not known because the studies haven't been done.

Frank | October 23, 2007, 1:52pm | #

They need to do a real study. My guess is they'll find that some are effective, some aren't.

I don't think it would be either legal or ethical to do a study involving children.

Neu Mejican | October 23, 2007, 2:05pm | #

Frank,

Not illegal.
Can be done ethically.

The current policies
NIH
http://grants.nih.gov/grants/funding/children/children.htm

FDA
http://www.fda.gov/cder/pediatric/index.htm#bpca

R C Dean | October 23, 2007, 2:39pm | #

NM, if you think that the evidence that harm outweighs benefits is "strong", then I have some Iraqi WMDs for sale, cheap!

Seriously, I don't think the FDA has made a case at all that cold medicines dosed appropriately are dangerous to children. No. Case. At. All.

And there is no reason to believe that cold medicines effective in adults would not also be effective in children. The physiologic mechanisms are the same in both populations.

The FDA is engaged in a classic bureaucratic Chicken Little maneuver here, displaying pathological levels of risk aversion that will almost certainly result in more harm due to people overdosing their kids with adult medicines once the children's versions are ashcanned.

atrevete | October 23, 2007, 3:25pm | #

I don't think it would be either legal or ethical to do a study involving children (Frank)

So how did they come up with vaccinations for infants?

sixstring | October 23, 2007, 4:36pm | #

Oh man! If you want the FDA to hang a number on effective, then we are going to have all kinds of fun when we turn our attention to vaccines.

Paul | October 23, 2007, 5:39pm | #

And remember, this is a case where the dosage is the source of danger and it is exactly the dosage response that is not known because the studies haven't been done.

From a standpoint of precaution, FDA and corporate culpability in a court of law... I'll tentatively agree.

But in reality, I disagree.

54 kids have died since 1969. That is such a fantastically small number when compared with the number of dosages given in that time, that to say that dosage response isn't known is... ignoring reality. Dosage response may not be codified in an Official(tm) document endorsed by the FDA and backed up by peer reviewed study. But to take the entire Western World's usage of these medications with the mind-boggling success of only having 54 deaths since 1969-- I think we can say that we're dosing this stuff pretty safely and with relatively known response.

As I say, in the controlled study laboratory of Paul's house, I have pretty clear data showing what the dosage response is for a given number of medicines included in my clinical trials. Daughter: Healthy, alive and well. Oh, she came down with a cold yesterday. So this subject is particularly timely for me. I'm using Safeway's self-branded off-the-shelf cold and cough supressant. It seems to be working well. Her persistant cough shut down pretty quick last night within an hour of administering a 3/4 dose.

Paul does not layer medications during a cold so response to said dosage is isolated from other medicinal factors. Paul never doses over the recommended amount, but often doses at less than what is recommended on the label. Response usually occurs within one (1) hour of dosage. Dosages are given in the morning before school, and about 1 to 2 hours before bed, or during the day as needed.

Paul | October 23, 2007, 5:43pm | #

Neu:

Think of it this way (upon further reflection), it's like saying that we don't know what the danger of eating candy-corns is because no study involving children consumption of candy-corn has ever been done. Therefore, we should pull candy-corn from the shelves until further studies are done. This basically goes down the same road as the genetically modified crop issue.

Neu Mejican | October 23, 2007, 8:45pm | #

RC, Paul,

A pedantic response.

It is not 54 deaths. It is 123 (not that that makes much of a difference to your argument).

I don't think the FDA has made a case at all that cold medicines dosed appropriately are dangerous to children. No. Case. At. All.

Not only that. They haven't tried to make that case. They have made the case that inappropriate dosing of these medicines is a danger-with 123 confirmed deaths (certainly a fraction of the actual deaths, but what fraction is unknown).

The physiologic mechanisms are the same in both populations.

An incorrect assumption. Keep up.

The physiological differences between children and adults are most pronounced during the first 12 months of life. Specifically, physiological differences have the most impact on toxicokinetics. For example, processes such as detoxification (e.g., metabolism and excretion) might be significantly lower than in adults (De Zwart et al., 2002, De Zwart et al., 2004 and Scheuplein et al., 2002), Establishing the link between internal dose and effects probably is the most difficult step. Sensitive periods due to growth and development could cause different dose–response relationships compared with the relationship in adults. The question is, however, how to quantify these differences.

From
Regulatory Toxicology and Pharmacology
Volume 42, Issue 1, June 2005, Pages 83-95

Neu Mejican | October 23, 2007, 8:48pm | #

Paul

Candy corn has as good an evidence base as a treatment for your daughter's cough as the stuff you so carefully administer, when it comes right down to it.

I wonder how many candy corn overdoses are on record since 1969...

Paul | October 24, 2007, 2:53pm | #

Candy corn has as good an evidence base as a treatment for your daughter's cough as the stuff you so carefully administer, when it comes right down to it.

Mmmno. I would argue that there is some evidence that they work, it just hasn't been put into an Official(tm) FDA report and codified as such. I would argue that a substance with an antihistamine shown to be effective in adults has a high liklihood of being effective on some level in children under six. Making a flip comparison of evidence between candy-corn and a substance with a known effect in a large percentage of the population, then declaring it ineffective because there's no study for, oh, black femal midgets with lesbian tendencies who smoke more than two but less than seven cigarettes in any month with an "r" in it is a stretch. And we have to slow down here on the "children" moniker. I'm still generally referring to kids under age six, but I'm not generally referring to infants. To wit:

The physiological differences between children and adults are most pronounced during the first 12 months of life.

Keyword: most. These differences diminish dramatically after the first 12 months. So to say my daughter who is within 3 months of age six as having significant differences between my physiology and hers is...questionable.

If I were a betting man (meaning most of my wealth wasn't "intangible") I'd bet that once studies are done, toddler aged children up to age six will show positive response similar to adults with most cold remedies.

I wonder how many candy corn overdoses are on record since 1969...

Funny you should mention this. According to some sources, candy corn contains substances which contribute to...wait for it... obesity which has, according to these same "respected" sources, killed more than 123 people since 1969. You may be on to something. The FDA might want to have these little orange and yellow suicide pills pulled from the shelves.

So according to the blunt FDA "positives outweighing negatives" litmus test, I'd say candy-corns are on the short list for a ban.

Neu Mejican | October 24, 2007, 8:46pm | #

I would argue that a substance with an antihistamine shown to be effective in adults has a high liklihood of being effective on some level in children under six.

No one said otherwise.

There is a difference between this and there being evidence. So far the studies done show no improvement over placebo. A candy corn would be a good item to use as your placebo (being pretty close to the typical sugar water used in these kinds of studies).

Of course the real solution is to read more carefully the FDA recommendations that say more precise dosing information should be provided. I can see all sorts of ways for precise dosage to be marketed to reduce the overdose risk (liquid gells rather than free flowing liquid).

And to re-iterate--I never said I agreed with the FDA policy. But if evidence is important, policy should be crafted in ways that encourage companies to get that evidence prior to marketing.

But please continue with your spinning of lesbian strawmen.

Paul | October 25, 2007, 2:34am | #

I would argue that a substance with an antihistamine shown to be effective in adults has a high liklihood of being effective on some level in children under six.

No one said otherwise.

You must have a highly nuanced definition of "otherwise". The FDA seems to be saying just this.

A federal drug advisory panel concluded yesterday that over-the-counter cough and cold remedies should not be given to children under 6 because of safety concerns, and found no evidence that the remedies are even effective in children under 12.

Now, as I've said before, I find this a bit dubious and...broad. Again, agreeing to limit the discussion to the exclusion of infants, antihistamines of certain types have shown significant effectiveness. Again, I reiterate that I'll bet that if a broad enough study is done, they'll find all manner of antihistamines which are safe and effective for this block of children:

The effectiveness of antihistamines in the common cold
JE Crutcher and TR Kantner


A randomized, double-blind, placebo-controlled study was done on 106 volunteers to assess the effectiveness of chlorpheniramine maleate against the common cold. The results suggest that this antihistamine is significantly effective in relieving the symptoms of a cold if used four times daily for one week, and that relief was gained with no significant increase in side effects.

http://jcp.sagepub.com/cgi/content/abstract/21/1/9

As I say, upon reading the press accounts, the whole thing is highly schizophrenic. They seem to swerve between dosing issues, infants, toddlers under six, then twelve, then shrug their collective shoulders and say "bah, not effective anyway".

Maybe the problem is in the press accounts.