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FDA Does Herbals Good?
October 26, 2007
This is a continuation of my rant against the FDA recommendation that OTC cough/cold medications. If you are sick of that, at least do the survey on the sidebar.
So here is the rationale of the decision of the FDA and cough and cold medication manufacturers:
- Cough and cold medications have not been proven to be of benefit for children with coughs and colds.
- There is a risk with these medications causing harm if used beyond the labeled directions.
- Since these manufacturers could not make claims of efficacy for children, there should not be marketing to children and should not be directions for children’s dosing.
- This does not affect the prescription cough/cold medication market (which is actually quite large).
What I find interesting about this ruling is that there are tons of unsubstantiated claims being made all of the time. I had a bowl of cereal yesterday, and on the box it said that its ingredients "help support a healthy immune system." I wonder if they have clinical trials backing up this claim.
If you walk down the aisles of a grocery store (not to mention a health-food store), you will see many claims of health benefits that are clearly unsubstantiated. Since these nutritional items are not regulated by the FDA in the same way, they can make unsubstantiated claims without fear of sanction. Here is information from the website of the product "Airborne:"
Airborne is easy to take and tastes great. It comes in three flavors of effervescent tablets - Original Zesty Orange, Lemon-Lime and Pink Grapefruit. Look for our newest products, Airborne Seasonal, Airborne Power Pixies, and Squid Soap by Airborne.
Airborne Seasonal comes in a delicious citrus blend flavor. It is a non-drowsy formula containing a nutritional blend that promotes normal histamine levels.
Airborne Power Pixies gives kids the immune-boosting formula of Airborne in a great-tasting, fun-to-take packet. It’s easy for moms because it’s fun for kids.
So what is the upshot of this? To the consumer it appears that legitimate medicine is not effective in an area where alternative/nutritional "medicine" is presumed to be effective. So standard medicine - which is held to a higher standard of truth in advertising - gets a black eye, while the non-standard medicine - which can claim whatever they want (as long as it is vague) - goes on making claims like "helps fight off colds." In doing so, the FDA has done a great favor to the area of healthcare with the least amount of evidence.
We have to explain to parents that these medications are not dangerous and that the medication was pulled because it has not been shown to be effective (which the majority of my patients don’t agree with). I have to spend extra time with patients discussing this while parents weight this against unsubstantiated claims of non-regulated medications.
Inadvertently, the FDA is doing harm to the medicine I practice.
(1 votes, average: 5 out of 5)
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Posted in American Medicine, Rants
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October 26th, 2007 at 10:37 am
I just think that parents are too quick to medicate. We had to hold off on medicating my eldest son because he was taking a number of proscribed medications until we could talk adding anything over with his cardiologist. By the time I got around to asking her about it he would not need the medication that I thought he may have needed. The one time we did give him something (he was gagging on his own snot and puking) the side effects were worse than dealing with the actual cold. Supportive care can do a whole lot for kids with out running the risk of side effects. We also have to be very careful about herbals so that has not been an option for us to turn to either, not that I would since I know that they are not all that effective either.
October 26th, 2007 at 1:32 pm
I think the biggest problem is that so many people are stupid and DON’T READ DIRECTIONS, or take the time to make a 10 minute call to their Ped. I can definitely see not medicating a six month old, but when my three year old has just a garden variety cold and isn’t complaining about his ears, but is stuffy and cranky and can’t sleep and generally miserable beyond words, Triaminic or other cold meds are going to make the symptoms hide long enough for him to get better on his own.
(Awesome mom, but I do agree that if my kids had any reason to not take cold meds, like another health condition or other medical problems, I’d not medicate them with anything at all without asking our doc. I used saline sprays and hot showers and the dreaded nasal bulb when they were too young to take OTC meds.)
Dr Rob, while I’m thinking about it, with kids that are nonverbal what are good ways to tell if they have ear infections other than the tugging or poking at their ears? I don’t have a ear-looking-inner thingy (otoscope? Is that right?) and I always feel like such a schmuck when I take them to the doctor and their ears are fine.
October 26th, 2007 at 8:13 pm
Why do products get approved to go on the market and then later get pulled? Did they not test adequately in the 1st place and get skewed results or is the testing now more disciplined and sophisticated giving more accurate results? I-buprofen is/has been a great drug for me (guess not for kidneys) but now they say can cause stroke or heart attack. Is profit the motivator for taking some otc medicines off the market? How does one know if it is safe to take anything? Just frustrating!
BTW - I think the children’s cold meds did help our sons when they were little. No they don’t cure anything but they did help make them more comfortable.
My husband and I love theraflu the yucky hot beverage kind. We actually acquired a taste for it (when sick) and seems to help before finishing half way. My husband never misses work and went to work with the flu (I know should not have) and theraflu made it possible. I know this product isn’t in the discussion but just another example of an otc product that works.
October 26th, 2007 at 8:31 pm
To be fair Dr. Rob, it isn’t just that they haven’t been proven to work. That is a little misleading. They have, in fact, been proven to not work in children. I think that this distinction is important. I agree with your overall point that it is a little silly for them to be focused on by the FDA when homeopathic remedies and herbal supplements exist with little to no regulation as to the claims that they can make. The only true non-placebo derived benefit from these medications is, depending on the particular product, either their sedative properties (diphenhydramine) or their stimulant properties (pseudoephedrine). The rest is bunk. So why not just give your child benadryl to help them sleep through a nasty cough, or caffeine to help them perk up when they are feeling sluggish, and forget all the unecessary pharmaceutical agents. I’m speaking as both a parent and a pediatrician on this topic and in case you haven’t heard, I like horsies.
October 26th, 2007 at 11:24 pm
I think it’s wise of the FDA to pull these OTC off the shelves for infants given the scientific research showing that they are ineffective for symptom control in URIs and there is a safety risk. The latter is particularly relevant because parents will inadvertantly give their children multiple OTC meds not realizing each product has one or more shared ingredients resulting in supra-therapeutic dosing. Given this is a $2Billion dollar industry… pharma is making a whole lot of $$ off of placebo– doesn’t seem right to me.
As for Dietary Supplements– the FDA recently passed (admittedly voluntary) regulations mandating QA programs and after 2010 will begin enforcing breaches in these guidelines in company wtih the FTC. Currently, the FTC is appropriately going after DS companies that are promoting misleading claims- admittedly they are short handed and have limited funding which limits their reach.
Brad Jacobs MD
Revolution Health
October 27th, 2007 at 6:58 am
What would a controlled trial of children’s cold medicine look like?
1) There appears an ad in the Sunday paper, or a poster in your ped’s waiting room, asking if you would like to participate in a study about children’s colds.
2) When your child has a cold, you bring him/her to a center (hospital?) where s/he can safely recieve various kinds of cold-busting meds or a placebo. The investigators monitor the child . . . s/he stays in the center overnight? Since overnight is when the child plus the rest of the family don’t get any sleep–the most troublesome symptom in many cases.
3) Or you use the medicine at home. Is the monitoring–including the dosing–the same? Is it as reliable? Will the home-care add uncontrollable variables, such as comforting the child in the rocking chair? Playing lullabies? Elevating the head of the crib? or???
Other things are pretty much the same–the cold is as bothersome and everybody is still losing sleep, and you cannot go–or if you go, you cannot function–to/at work the next day. And the daycare doesn’t want your kiddo to be there, exposing the other kids to the cold.
My point is that these controlled studies would be very difficult to carry out and control. Thus the efficacy and safety of the cold medicines are vague.
Let’s face it–we do a lot of experimental treatments on kids. I’ve worked in the NICU and have an ex-preemie at home. Think about the steroids-to-get-off-the-vent debacle over the years!!! We HAVE been experimenting on kids. I see this recall as falling into the same category: there haven’t been enough studies; we are now admitting this; we are now back-tracking.
In addition, we have a culture of denying ourselves time and extra rest in order to overcome our coughts and colds. Even healthcare professionals are somewhat proud of working sick. They say “I should have stayed home,” but there they are, on-site and slogging through the day. In this, we bypass the R & R benefit for adults and kids.
Parents who have to miss work to stay home with a sick child are in a terrible bind. They have to heed their use of their sick days for themselves, and perhaps double or triple the number of sick days for their kids’ illnesses. And I think a lot of us do this under the radar. We are not really playing by the rules of the game at work. We are fudging it, if we do stay home with our sick kids.
So to me, this is not as simple as Big Pharma making money–or taking a hit. It is our culture. It is “family values,” if you will. And it is experimentation on kids.
I know your head was “Herbals,” Dr. Rob. You can bet your sweet bippy that now, with the recalls, even more alternative remedies will be tried in order to bring relief to the child, in order for everyone in the household to get some sleep.
Oh, and since we are losing SCHIP, parents will bring kids in to the peds even less, and make even more decisions on their own. And if grandma says to try herbals, or vaporize camomile tea, or overdose on Vitamin C and Zinc, you bet some parents will try these things. Can you blame them?
October 27th, 2007 at 5:19 pm
This seems not entirely irrelevant.
(Is it just me, or are your arithmetic problems getting harder?)
October 27th, 2007 at 5:27 pm
Ooops, sorry. Just visited a place where you seem to have noted that link yourself…
October 27th, 2007 at 6:06 pm
CAK,
I’m having trouble finding the article but I know that the January 2005 Chest had such a study.
October 28th, 2007 at 12:30 pm
In the Milw Sunday paper, there were coupons for Pedia Care Cold Relief medicine. Likewise, in the print section of the paper, there were ads for Pedia Care . . . How did this med escape recall? Does anybody know? (No, I haven’t gone to the store to read the label–maybe that would contain the answer.)
June 29th, 2008 at 8:25 pm
The fact that you kind find herbal crap in an “health store,” doesn’t bother me as much as seeing homopathic crap next to the OTC in the drug store. It is one thing to see primrose tea sold by the vitamins, but seeing some random potentially dangerous chemicals with a fancy name like “flu-ease” in the cough and cold section is just dangerous. I cannot believe that a retail pharmacy would do this. I think the pharmacists at these stores should be ashamed of themselves.