A while back, I wrote about Airborne, the "herbal" concoction designed by a schoolteacher that is touted as preventing colds and the flu if taken preemptively or lessening their severity if taken early on in the course of a cold. I concluded that there was no evidence that it did what Victoria Knight-McDowell, a schoolteacher and the creator of Airborne, claims. Now the company itself seems to be admitting as much. It turns out that the company commissioned a study to "prove" Airborne's efficacy, and its results did seem to show a mild positive effect on colds. Unfortunately, the study was shoddily designed, mainly because the people doing the clinical trial appeared to have no clue how to design such a placebo-controlled double-blind study:
"Simply washing your hands during cold and flu season is a much more effective way of preventing colds," said David Kroll, a pharmacologist at Duke University Medical School.
Yet the Airborne box tells users to take the product at the first sign of a cold. An Airborne ad testimonial called it a miracle cold buster. And the company said in a news release Airborne would get rid of most colds in one hour.
"I'm not commenting on that particular press release," Donahue said. "I wasn't with the company then."
Airborne said that a double-blind, placebo-controlled study was conducted with "care and professionalism" by a company specializing in clinical trial management, GNG Pharmaceutical Services.
GNG is actually a two-man operation started up just to do the Airborne study. There was no clinic, no scientists and no doctors. The man who ran things said he had lots of clinical trial experience. He added that he had a degree from Indiana University, but the school says he never graduated.
"I would not define that then as a clinical trial," Kroll said.
Never let it be said that that a lack of evidence of efficacy ever stops the alties, though. They're just going to change the packaging to say something else:
Now, Airborne is phasing in new packaging. Before, the box said that Knight-McDowell had created it because she was "sick of catching colds." Now, it says she created Airborne because she "needed help supporting her immune system." The word "cold" no longer appears on the new package or in the advertising.
Interesting. If Knight-McDowell is so confident in the scientific soundness of study the company commissioned, then why is the packaging being changed? I wonder if they'll add the usual copout found on supplements that says something along the lines of "This product is not intended to diagnose or treat any illness...contact your doctor...blah...blah..."
Instead, the company is inserting the the usual vague altie claim of "boosting" or "supporting" the immune system, a completely meaningless statement, scientifically and medically speaking, at least the way it's used by alties. (Oddly enough, I was in Walgreen's the other night when I noted an Airborne knockoff called Wal-borne and noticed that Walgreen's at least is ahead of the curve on this. There were no claims on the Wal-borne package that it could prevent colds.) In any case, I'm betting these guys don't know an antibody from a T-lymphocyte, but now they're pushing a "boost the immune system" claim. What specific aspect of the immune system are they boosting? Cell-mediated immunity? What cell type? Neutrophils, T-lymphocytes, B-lymphocytes, natural killer cells?
Inquiring minds want to know. Show us the evidence.
Recently, I saw someone comment on the "boost your immune system" nonsense. He pointed out autoimmune disease as a good reason not to "boost your immune system" if you could.
I've been without my allergic responses long enough to forget about that little snag.
One of my classmates was talking about airborne when I was waiting in line. As someone who took an interest in herbal medicine when I was a teenager (no, not that kind of herbal medicine) I can say that some works, but what work doesn't work well. Though I held my tongue. If she wants to waste money on it, it doesn't hurt me.
If she wants to waste money on it, it doesn't hurt me.
Of course, I care about what hurts others. Otherwise, I wouldn't be spending my time commenting at a lot of these blogs.
They probably had to change the package wording as the FDA won't allow statements about treating diseases either on dietary supplements.
So probably Airbourne were sent a warning letter about mislabelling and misbranding.
There is more information on dietary supplement labeling regulations here:
http://www.cfsan.fda.gov/~dms/lab-hlth.html
That's perfect timing....I was just giving my mother a litany of reasons last night as to why the Airborn premise is bunk. (I have a cold / she said "take Airborne" / I said "not a chance in hell" / it went from there....)
FWIW, I also briefly discussed the airborne phenomenon in this post:
Bench scientists just don't get the AA ["average american"], and their detachment and/or arrogance belies this. For instance, if you're wondering why so many AA's buy a health product designed by an elementary schoolteacher, and why the marketing of that product exploits it non-expert origins, maybe it's a reaction to this arrogance.
Great follow-up post - you were the first to clue me in to this phenomenon on your old blogsite. Funny that you should mention your Walgreen's experience because I was just in our CVS and saw their own version too, again, right beside the Airborne.
My bigger complaint is that the stores stock this stuff right next to the antihistamines, decongestants, and analgesics, implying to the consumer that all OTC products are the same in terms of safety and efficacy. I'm almost cool with them putting these remedies over in the herbal aisle where they belong but there need to be way better disclaimers besides the microprint on the labels saying, "these statements have not been evaluated by the FDA, blah, blah." As Kevin wrote very insightfully, saying something hasn't been evaluated by the FDA will have the same promotional value to that AA subset as marketing a product developed by a schoolteacher.
My longstanding criticism of the chain drug store industry and NACDS (Natl Assoc of Chain Drug Stores) is that they clearly collude with many smarmy supplement manufacturers (as well as some reputable ones) to hawk their crap. Their practice in this regard is a disgrace to every community pharmacist and hospital Pharm.D. who truly stands for trying to keep pharmacy as a real profession, one meant to work hand-in-hand with the art and practice of medicine (and don't get me started on the pharmacists who refuse to dispense emergency contraception on religious moral grounds.).
Well, the solution's right there:
"Simply washing your hands during cold and flu season is a much more effective way of preventing colds," said David Kroll
Just make your cold prevention tablets really sticky so that users need to wash their hands afterwards. A 7-times-a-day dose should encourage a high enough hand-washing rate to have some effect on the number of colds caught, and also enable you to sell more.
Great... I can retire on this one. :)
GNG is actually a two-man operation started up just to do the Airborne study. There was no clinic, no scientists and no doctors. The man who ran things said he had lots of clinical trial experience. He added that he had a degree from Indiana University, but the school says he never graduated.
Sounds like a place where a certain ex-NASA official might want to seek employment.
I can't say how or why but, I was in a position to fight to keep Airborne out of a consumer entertainment product. I had to campaign pretty hard, going to the top of the company to do so but, I ultimately succeeded. I knew the stuff was pure pseud-oscience crap just by reading the ingredients on the label and knew that I could have no part in promoting their BS.
I also noted how the wording was written in just such a way that they weren't actually making the claim that their stuff prevented colds, they only implied the hell out of it. Obviously, some lawyer had made sure they straddled, but did not cross over that line of fraudulent claims.
I was the scientist interviewed in this GMA piece and was happy to see that my 40 minutes of taped interview ended up with my overall, scientifically-based views being represented despite only two short quotes. Many thanks to you, Orac, for covering this story.
JKVisFX, what a fascinating insight you have into the marketing machine behind this product. The rest of the botanical industry is scratching their heads as to how a company that came from nowhere could put up such big numbers. Hearty kudos to you for your tenacity in putting a stop to it in your neck of the woods.
The company very carefully skirted the 1994 DSHEA legislation that allows for this dichotomy between supplements and OTC medicines. Their old label claims that you probably saw were, in my opinion, in violation of DSHEA, but they were recently revised to be even softer. But, you can't negate the momentum built up by several years of marketing as a cold/flu preventive. Implications abound on all sorts of herbal products as long as there are no direct claims to "prevent, cure, or diagnose a disease." But, consumers obviously are getting the message.
Orac,
A most annoying aspect of junk science is that it is justified by many because "the placebo effect works and I do not care if the [homeopathic medicine|magnetic bracelet|etc] actually works: if it gives me placebo effect I am all in favour of it".
This thinking has just led to the British Prescription Pricing Authority authorisign magnetic bracelets for ulcer treatment. (The Guardian, p.15, "Bad Science", 4 March 06).
What arguments do I have against this? Personally, I do not want to be cheated even if it is in my own interest. Burning candles in church is no doubt equally effective, but I think a society run on that basis is wrong. What say you?
I have just finished reading all the results and arguements about Airborne. Here is my results after
using the product. Three weeks ago my daughter-in-law
called me long distant and told me that my son,grandson
and herself all were sick and needed my help. I purchased
soups,sprite,chicken broth and just happened to come across
Airborne and decided to try it myself. They all had
fever,colds,vomiting,and diarrhea. I sure didn't need all
of that so I started trying out the Airborne. Guess what
three weeks later I am still doing great. Whether it was the Airborne,the hand washing,keeping everything clean I
don't know. Most likely it was from all the praying I did
which was alot. I am just thankful to still be in good health.
I always thought that any "medicine" designed by a school teacher should be a cocktail of alka-seltzer and diazepam.