Your Friday Dose of Woo: Created by a schoolteacher, so it must work! (from the vaults)

i-e7a12c3d2598161273c9ed31d61fe694-ClassicInsolence.jpgWhile I am on vacation, I’m reprinting a number of “Classic Insolence” posts to keep the blog active while I’m gone. (It also has the salutory effect of allowing me to move some of my favorite posts from the old blog over to the new blog, and I’m guessing that quite a few of my readers have probably never seen many of these old posts, most of which are more than a year old.) These posts will be interspersed with occasional fresh material. This post originally appeared on January 9, 2006 and seems to fit in with the whole “Friday Dose of Woo” thing; so I’ll repost it as such. Enjoy!.

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.

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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.