Monday, January 09, 2006

Airborne: Created by a schoolteacher, so it must work!


I was perusing the New York Times yesterday and trying to avoid working on a talk that I have to give on Tuesday (to give you an idea of why, of what a monster I've created thus far, the PowerPoint file is up to about 45 MB of image files of TIFF files of Western blots, graphs, and multicolored confocal microscopy photos, all of which is great in that it means that I have a lot of data to present but all of which also means a lot of work to organize), when I came across this article in the New York Times Magazine. At first, it didn't start out promising. I was half-expecting a gushing, credulous article based on this beginning:
Packages of Airborne, found in the cough-and-cold aisle of major chains like CVS, Rite Aid and Wal-Mart, proudly proclaim that the product was "Created by a School Teacher!" This seems a little odd. Don't we want to fight our seasonal ailments with things created by, for instance, doctors and scientists? Apparently not all of us do; Airborne is extremely successful, and its creation by someone without the slightest medical expertise or qualification is almost certainly a factor in its success.

For one thing, it makes for an excellent creation story. In the late 1990's, Victoria Knight-McDowell, an elementary-school teacher in Spreckels, Calif., grew weary of picking up colds from her students and began "researching Chinese and holistic medicine and the use of herbs and vitamins to boost the immune system," an official company history explains. She and her husband then decided to market her "natural formula of 17 ingredients" in 1997. They used the money her husband had made selling a television script. They handed out samples in malls and gradually got distribution in various stores. Kevin Costner became one of many celebrities to declare his confidence in the product. In 2000, Knight-McDowell gave up her teaching gig, and by 2004 annual sales hit $90 million. Along the way, Knight-McDowell appeared on "Dr. Phil," and Airborne was discussed on "Live With Regis and Kelly" and other shows.

In March 2005, Airborne brought in Elise Donahue, a former executive for Prestige Brands and Procter & Gamble, as C.E.O. She says that Airborne buyers feel that "if a schoolteacher who's around germy little kids all the time can find something that keeps her from getting sick," then her solution should work for them too. Similarly, the cartoon characters on the package lend a friendly, almost nonmedicinal aura to the product that stands out in the cough-and-cold aisle.
Oddly enough, I had never seen this product in the drugstore, supermarket, or anywhere else, much less advertised on TV or in any magazine or newspaper. I must lead a sheltered life. After all, back in the summer, when I spent a rare weekday afternoon home waiting for the cable repairman to come and fix the crappy connection to our upstairs TV, that was the first time I ever came across Kevin Trudeau's infomercial and later found out that this obvious scammer had a best-selling book chock full of quackery. (P. T. Barnum was definitely right.) This particular article on Airborne seemed as though it would be just another puff piece about an entrepreneur without any medical experience who nonetheless made it big, complete with the tale of how she overcame various challenges and odds. But then the article continued:
People also must use Airborne because it works, or rather because they believe it works. Technically, Airborne is a dietary supplement (you're supposed to take it "at the first sign of a cold symptom or before entering crowded environments"), meaning that it does not require Food and Drug Administration testing and approval. As the package disclaimer notes, it is "not intended to diagnose, treat, cure or prevent any disease." As with many supplements, there is no independent scientific evidence of Airborne's medicinal value. But many people continue to buy the herbal supplement echinacea, despite many studies (including one in The New England Journal of Medicine) saying it does nothing to ward off or treat colds.
Indeed, I noted this very phenomenon when I wrote about echinacea a few months ago. If people somehow come believe these "remedies" work, no amount of studies or data showing that they are no better than placebo seem able to convince them otherwise. Of course, since colds are generally self-limited within a couple of weeks anyway, because of confirmation bias it's very easy for it to appear as though taking these supplements decreases the duration and severity of colds. Unfortunately, although it would be great if these remedies could actually achieve this, there's seldom any hard evidence to suggest that they do. Airborne is no different. In case I was wrong about Airborne, though, out of curiosity, I checked out Airborne's website to see just what was being claimed and whether there was any evidence presented that this stuff worked. First, here are the claims:

Victoria Knight-McDowell, an elementary school teacher who was sick of catching colds in class and on airplanes*, spent over five years developing AIRBORNE with a team of health professionals. AIRBORNE was created by combining seven herbs** (each with a specific function in Eastern medicine) then putting them through a patented extraction process, and THEN combining them with a unique formulation of amino acids, anti-oxidants and electrolytes. An effervescent carrier was used, as a way to deliver the nutritional benefits of AIRBORNE to the system immediately, and without the bulk of conventional pills. There’s nothing else like it!
I'm sure there is "nothing else like it," but one could say that about almost any concoction. So far, this sounds pretty science- and data-free, don't you agree? Of course, curmudgeon that I am, I can't help but wonder why Ms. Knight-McDowell advertises "invented by a schoolteacher," thus appealing to her customer's mistrust of "conventional medicine," but then says that she developed Airborne with a "team of health professionals." She seems to want to have it both ways, appealing to homespun "practical" knowledge while at the same time appealing to the authority of "health care professionals." (Of course, the blurb above doesn't say just who these "health professionals" are or whether they're even doctors or scientists; they could well be alties like Hulda Clark for all we know.) Also, her experience as a teacher has to be the lamest argument from authority with respect to a health product that I've seen in a long time. Sure, kids are germ factories, and working with children as a teacher is a great way to be regularly exposed to the latest bug going around, but how does that give Ms. Knight-Dowell the expertise to come up with an herbal/supplement concoction to prevent or fight colds? I might buy it if she claimed to have figured out a method of hand-washing that kids can actually do correctly, which would probably go much farther in decreasing the spread of colds in schools than any herbal remedy, but don't see how her experience as a school teacher suddenly qualifies her as a expert in herbal medicine. And, of course, there isn't one whit of scientific evidence or studies from clinical trials to support her claims for Airborne.

Another interesting point to consider is that it is recommended that people take Airborne "at the first sign of a cold symptom or before entering crowded environments." However, "at the first sign of a cold symptom" is a fairly vague criterion, one that's tripped up any number of studies looking at, for example, whether zinc prevents or decreases the severity of colds. Some people cough once or twice and think they're coming down with a cold; if they take Airborne and don't get any further symptoms, they're likely to attribute it to the Airborne rather than to a different cause for their coughing, another example of confirmation bias. Ditto if people take Airborne before going into a "crowded environment" or an airplane and happen not to get a cold.

The pseudoscience gets even worse, though:

There is no known bacterial, viral, or fungal "resistance" to complex herbal formulas. Some of these formulas have been used for thousands of years with no evidence of waning efficacy. The Chinese medicine text, the "Nei Ching" is estimated to have been drafted in 200 a.d., and contains formulas that are still used effectively for infections today. The "resistance to resistance" of Chinese and other herbal formulas, is thought to occur because there are several herbs in each formula, and each herb has many complex plant alkaloids. This complexity is believed to be too much for the "bugs" to process; it is much easier for them to adapt and "outwit" the simpler "one item" pharmaceuticals. According to certain health experts in America and abroad, traditional herbal medicines may soon be our only weapon against bacteria, like staphylococcus--"staph"--that are fast becoming resistant to antibiotics!

Please refer to Wall Street Journal Article 5/8/03: "New Respect for Chinese Herbal Medicine.
Ah, nothing like that noted medical journal, the Wall Street Journal, to set me straight! I rather suspect that the reason there has been no "waning efficacy" over thousands of years is probably because there was never all that much efficacy outside of confirmation bias and placebo effects in the first place. For one thing, there's very little evidence that Chinese herbal formulas have clinical utility against serious (or even not-so-serious) viral illnesses, other than as an adjuct that might help symptoms. What little evidence there is out there is, for the most part, of low quality. However, there is evidence to suggest that some herbal preparations can decrease the levels of antiretroviral drugs and put AIDS patients at risk for recurrence if they use the wrong herb. That is not to say that some herbs or combination of herbs don't have some utility in combatting infectious diseases, but there is simply no scientific basis at present to make such broad and general claims as above, particularly the ridiculously overblown claim that "traditional herbal medicines may soon be our only weapon against bacteria, like staphylococcus--'staph'--that are fast becoming resistant to antibiotics." Natural products derived from herbs or other plants will likely have a role in developing new antibiotics, if efficacy can be demonstrated, but, even if they do, it's unlikely that they will be "our only weapon" (or even our most important weapon) against bacteria.

So what exactly is in this wonder compound? Here's the list:

Serv size 1 tablet. Servings, 10. Amount per serving: Calories 5, Total Fat 0g, Sodium 230mg (10% DV*), Total Carb 0g, Sugars 0g, Protein 0g. Vitamin A (Palmitate) 5,000 I.U. (100% DV*), Vitamin C 1,000mg (1,670% DV*), Vitamin E (Acetate) 30 I.U. (100% DV*), Riboflavin 2.8mg (170% DV*), Magnesium (Oxide & Sulfate) 40mg (10% DV*), Zinc (Sulfate) 8mg (55% DV*), Selenium (Amino Acid Chelate) 15mcg (20% DV*), Manganese (Gluconate) 3mg (150% DV*), Potassium 75mg (2% DV*), Proprietary Blend of Maltodextrin, Lonicera, Forsythia, Schizonepeta, Ginger, Chinese Vitex, Isatis Root, Echinacea 350mg (DV**), Amino Acids (Glutamine as L-Glutamine, Lysine as L-Lysine HCl) 50mg (DV**).
Ah, echinacea is in there. Why am I not surprised? I'll give her a pass on the echinacea, though, since her product was developed before the latest research showing that it doesn't do anything for colds. Let's see. What else is in there? Ginger? No evidence of benefit for colds. Chinese Vitex? No evidence found on PubMed that it does anything for colds Isatis root? No evidence found on PubMed that it does anything for colds. Ditto maltodextrin, lonicera, forsythia, and schizonepeta.

All of the above doesn't necessarily mean that Airborne doesn't work as claimed or have some mild symptomatic benefit in colds, but the onus is on Ms. Knight-McDowell to show that her product does what it says it does. So far, she has not, aside from unsupported claims and celebrity testimonials. She has claimed to have started a small clinical study, but, as this New York Times article from last year states:
Knight-McDowell commissioned a small clinical trial, and the results suggest that the product can fight colds, said Rider McDowell, a co-founder of the company. But the study has not been published in a medical journal. McDowell would not disclose where the study was done.
Anyone want to make a bet that that study still hasn't been published?

Products like Airborne are yet another indication of a gaping hole in the laws dealing with how we regulate medicines. Ms. Knight-McDowell is clearly making a medical claim for her product, namely that it can prevent or diminish the severity of colds. If I make a claim for a a compound that I develop, I'll have to prove it through clinical studies before I could ever get FDA approval to market it, which takes many years and costs hundreds of millions of dollars. Ms. Knight-McDowell can throw together a concoction of a bunch of vitamins and herbs and make millions. Certainly I'll give her props for her entrepreneurial spirit and willingness to risk everything for her business, but I only wish she could produce some actual evidence that her product does what she claims it does. A randomized, double-blinded study (preferably more than one) would, of course, be the gold standard, but in lieu of that I'd settle for lesser levels of evidence (or, for that matter, any credible evidence at all from a well-designed study, even a preliminary one) to give me some indication that Airborne is something other than a rather elaborate placebo. Medically, it's probably harmless, although we don't know even that for sure, given that some herbal medicines can interact with conventional medicines such as coumadin or anti-HIV retroviral drugs in potentially harmful ways.

But why should she bother? Her success has made it unnecessary to prove her product works, and here's one big reason why:

Apart from the power of the placebo effect, this consumer indifference to scientific proof brings up the critical issue of trust and, perhaps more important, distrust. . . And let's face it, the current reputation of the people who do have expertise in the concoction of remedies is not so great. The astonishing onslaught of consumer advertising for pharmaceuticals in recent years has more recently been followed by an onslaught of safety concerns and lawsuits. Merck, a heroic company just a few years ago, now calls to mind Vioxx lawsuits and trials. Consumer groups paint the pharma giants as shameless profiteers. "We're losing the battle for consumer trust," a top Bayer executive confessed to The Wall Street Journal last year.

Airborne - which, Donahue points out, is positioned as a mainstream product, not as an "alternative medicine" - is not against pharmaceutical companies or anyone else. It is simply for something that happens to have been invented by a nonexpert. But it probably benefits from distrust of medical authority and faith in a certain kind of folk wisdom just the same.

Of course it does. That's what much of alternative medicine relies on, a distrust of "conventional" medicine. Unfortunately, as was pointed out, the pharmaceutical industry and conventional medicine haven't always done as good a job as we should of earning that trust.

But what do I know? I'm just one lone pseudonymous skeptical blogger in the lower reaches of the blogosphere. I'm an anomaly in expecting a bit of supportive evidence, even if it's not the gold standard of a double-blind randomized trial, before I'll take a claim seriously. I don't stand a chance against Oprah, who did a puff piece on Ms. Knight-McDowell and Airborne or Knight-McDowell's other other celebrity boosters, such as Howard Stern or Kevin Costner (although I can't help but think that, if Tom Cruise were a booster, I might have a small chance convincing people that Airborne is probably a waste of money). With them on her side, Ms. Knight-McDowell probably doesn't even need to make the pretense of doing a clinical trial to test Airborne's efficacy in preventing colds after exposure or decreasing the severity of a cold after it starts.

20 example(s) of insolence returned:


At 1/09/2006 9:32 AM, Anonymous magista said...

I'd be interested in your opinion of the Canadian product "Cold-FX", which does claim (very small-scale, and therefore of questionable reliability, IMO) double-blind testing has been done. I've got teacher colleagues who swear by it, but I know what you say about anecdotes...

The Cold-FX website is here.

 

At 1/09/2006 10:37 AM, Anonymous TheProbe said...

None of the references re Cold-FX support the claims.

 

At 1/09/2006 10:47 AM, Blogger Nathan Williams said...

I'm curious if you're more annoyed by the fact that a product like Airborne can be sold with such dodgy claims, or that FDA-classified drugs are so much more restricted. I don't like the status quo, but I think I'd be happier with either more regulation of all such claims, or vastly less regulation of medical drugs; does it serve a lot of common good to restrict the distribution of, say, Lexapro?

 

At 1/09/2006 10:59 AM, Blogger beajerry said...

I'd be interested in a study that compares people sucking on any "cold prevention" lozenge with people sucking on Jolly Ranchers.

My hypothesis? The act of keeping your mouth closed and breathing mostly through your nose (because of the sucking action), added to the constant coating of the throat with swallowing is fairly effective in disrupting the establishment of a virus or bacteria infection.

 

At 1/09/2006 11:18 AM, Anonymous Skeptico said...

Funnily enough I saw this product with its "Created by a School Teacher!" label for the first time last Friday in Trader Joe’s and thought exactly the same thing – “so what?”.

 

At 1/09/2006 11:31 AM, Anonymous Bruce Small said...

If they don't come down with a cold, the remedy worked.

If they do come down with a cold, it was because they didn't take the remedy soon enough.

If the cold was mild, well obviously the remedy stopped the worst part of the cold.

The charlatans can't lose.

 

At 1/09/2006 11:45 AM, Anonymous HCN said...

I must hang out at pharmacies more often than you people (possibly because I have a kid with multiple health issues), but I have seen this stuff next to their pick-up counter often. I use that occasion to snicker at it.

Actually, just last month at my daughter's music lesson her teacher had a terrible flu bug. The teacher said that it came on quickly the previous weekend, and she tried the Airborne and "It did nothing!".

 

At 1/09/2006 12:00 PM, Blogger Joan said...

Along the same lines as beajerry's hypothesis, I wonder how much of the "benefit" from taking Airborne actually is from being properly hydrated? If I recall correctly, you're supposed to take it several times a day, which requires drinking several glasses of water. A lot of people are going to benefit from just being properly hydrated, especially if they're fighting off a cold.

Any proper testing of this supplement would have to compare it's effects to the effects on subjects who drank a similar quantity of fizzy drinks that weren't supplement-laden. I'm betting the results would be close to identical.

 

At 1/09/2006 1:01 PM, Anonymous JY said...

What was P.T. Barnum right about? If it's that "[t]here's a sucker born every minute", he may have thought it, but he never said it. It was said by David Hannum.

 

At 1/09/2006 1:26 PM, Anonymous Mary said...

The Cold-FX site (http://tinyurl.com/8b8xo) claims that several double blind studies using placebos and the real medication have been done, but they didn't provide links. However, via PubMed, I found this CMAJ study which looks like decent evidence for some reduction in frequency and duration of colds via the use of Cold-FX: http://tinyurl.com/7khmh

The article also references this other double blind study with placebos: J Am Geriatr Soc. 2004 Jan;52(1):13-9. (online at http://tinyurl.com/auvft )

Are there known issues with these studies?

 

At 1/09/2006 2:48 PM, Anonymous DawnCNM said...

I hadn't heard of this till I went to a conference last week; one of the nurses had a terrible cold and said she had tried to use the Airborne but has trouble drinking things like that so it didn't help her; another one of the nurses swore that her colds are shorter and less severe since she's been using it. I wanted to know--how do you quantify a cold vs postnasal drip due to weather changes vs allergies--and how long is "shorter" and how to you qualify "less severe"--she told me she "just knew it worked for her"...I thought...can you say placebo effect?

 

At 1/09/2006 3:48 PM, Anonymous dn said...

What double standard or gaping hole in the laws? Their advertising is plainly illegal. If you care, file complaints with the Federal Trade Commission and FDA. They routinely shut down and fine companies that do stuff like this. Or if you prefer private action, buy a box of the product and then sue the company (fraud, false advertising, assault by means of adulterated drug, etc.)

 

At 1/09/2006 9:52 PM, Anonymous Chris said...

Is it just me, or does the packaging bear more than a passing resemblance to the "...for Dummies" series of books? Glad to see someone confirm what I suspected when someone offered me some of this snake oil (okay--more like "fruity Alka-Seltzer") when I had a head cold. I'd never heard of it before a couple of weeks ago

 

At 1/10/2006 12:15 AM, Blogger Prometheus said...

This is great stuff! If you take it at the first sign of a cold, your symptoms will be gone in seven day - if you don't take it, your symptoms will linger for up to a week!

Now, could someone please give me a hand - my tongue seems to have gotten stuck in my cheek.


Prometheus

 

At 1/10/2006 1:05 AM, Blogger Ali said...

I hadn't heard of this either. I'll never understand why parents who want their kids to grow up to be doctors don't trust medicine.

 

At 1/10/2006 11:00 AM, Blogger Mrs. Coulter said...

Yay, you deep-sixed the circuit-board background.

I find the appeal of alterno-medicine products to be very fascinating. I think people are particularly vulnerable to these claims with regards to the common cold, simply because it makes you so miserable and we can only treat the symptoms (I have taken echinacea and was very disappointed when I saw that studies that say it doesn't help)...

But all this reminds of me an ad that drives me crazy. I think it's for Excedrin, and it features a testimonial in which a headache sufferer says basically, "I don't care about any scientific information about what works. I like this product because I think it makes me feel better." Excedrin isn't alternative medicine, but the ad pitches it based on an emotional appeal and dismisses scientific knowledge as irrelevant in the face personal experience. It's appealing to the same sort of people who keep taking echinacea even after they've been told it doesn't work.

 

At 1/10/2006 11:05 AM, Blogger Mrs. Coulter said...

LOL, one of the trackbacks to this article is a splog promoting herbal supplements. It's sucking up the text and reprinting it, surrounded by ads for herbal medicine.

 

At 1/10/2006 6:44 PM, Blogger Orac said...

Yeah, that is hilarious. It's the main reason that I haven't deleted the backlink yet.

 

At 2/03/2006 3:22 AM, Blogger nikki said...

This evening I felt the ever-familiar tickle, and before hopping out to the store to pick up what I knew would be essentials in the coming days (liquids, liquids, and more tolerable liquids), I punched "airborne a teacher created it" into a blank google window...

Your post came up first. I'll save my money for the co-pay.

 

At 2/09/2006 9:51 AM, Anonymous Anonymous said...

I found this on another site that I read - the poster said it was sent to her by Airborne when she requested the clinical research data.

Clinical Trial Summary for Airborne


In 2003 Airborne Health hired the services of GNG Services, a company specializing in the clinical trial management of pharmaceutical compounds and drug development. A protocol, which is a document that patients must follow in order to maintain consistency throughout the trial, was developed and implemented during the cold season of 2003 (fall/winter) in order to attract patients suffering from cold symptoms.

The protocol called for approximately 100 patients suffering from acute (meaning the onset of symptoms were within 24 hours of randomization) symptoms of an upper respiratory infection (or the common cold). Additional cold, allergy, pain medications were not permitted throughout the study. This allowed us to look at the results without other medications impacting the study.

Patients were randomized on a 1:1 ratio (placebo and active treatment) using a pre-determined randomization schedule determined by a computer. Placebo was made to look, taste and feel the same as the active treatment or Airborne. No one involved in the trial, including the patients, had access to the randomization codes. This meant none of the patients knew whether they were taking Airborne or a placebo.

Patients were required to take treatment 6 times daily for 5 consecutive days. Patients reported various outcomes such as a cold symptom on a scale (this scale would rate several cold symptoms such as cough/sore throat/etc) and adverse events. The combination of outcomes determined whether patients were responders (did well), partial responders (did average) or non-responders (did worse). .

Fourty-Four (44) patients were randomized/completed to the placebo arm. Over 77% of these patients did not respond any better than they would have expected to (without treatment). Nearly 14% of the patients were partial responders meaning they improved somewhat within these 5 days. Only 9% responded well while on placebo treatment.

Forty-Eight (48) patients were randomized/completed to the active arm. An amazing 49% responded well while on Airborne, meaning they felt better in 5 days. Nearly 32% of the patients were partial responders. Thus, combined, 81% either improved somewhat or made a full recovery in 5 days. Only 20% of these patients did not respond any better than they would have expected to (without treatment).

Clearly from a clinical study standpoint these results are very positive. In summary 4 out of 5 patients on Airborne either improved somewhat or made a full recovery in the 5 day treatment period compared to that of 1 of 5 patients who responded while on placebo.

---

That's the whole thing.

 

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