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| Objective The following review was instigated in response to criticism that the marketeers of Airborne give Capitalism a bad name (instead of the class action lawyers and defendants; who are coming out of the deal with over $20 million to divvy-up amongst themselves) [Heavily-adapted from its Wiki-entry] Structure-Function Disclaimer ====================== Although it is recommended that Airborne be taken "at the first sign of a cold symptom, or before entering crowded environments, like airplanes and offices," the package explicitly states that Airborne is "not intended to diagnose, treat, cure, or prevent any disease." ====================== Trumped-up Trial ====================== "GNG Pharmaceutical Services Inc.", claims to have conducted this study with 120 people, and reported that 47% of Airborne recipients showed little or no cold or flu symptoms, whereas only 23% of the recipients of a placebo pill showed equal results.[2] However, in February of 2006, ABC News discovered that GNG Pharmaceutical Services has no official clinic, scientists, or even doctors. In fact the company comprises only two men, who started the company just to perform this study. Because of the bad publicity that this controversy has brought forth, Knight-McDowell Labs has removed all references to the study from their packaging and web site.[3] ====================== The Medical Letter Executive Summary ====================== "... First, there is no conclusive evidence that this product or any of its ingredients prevents colds or shortens their duration. Second, the adult tablet contains 1 g of vitamin C, and the directions for use advise taking 1 tablet at the first sign of a cold and repeating the dose every 3 hours as necessary. Vitamin C in doses higher than 1 g increases oxalate and urate excretion and may cause kidney stones (EN Taylor et al, J Am Soc Nephrol 2004; 15:3225). Third, the safety of this herbal extraction combination has not been established. And with herbs and dietary supplements in general, we only have the manufacturers’ word on the label for what’s in them."[4] ====================== 2006 Class Action Suit alleging unlawful advertising as "cure" for the common cold ====================== A class action lawsuit was filed that alleges that Airborne Health, Inc. (and other defendants) (“Airborne”) falsely advertised certain therapeutic properties, including the ability to cure or prevent the common cold, when marketing products under the Airborne brand name. Defendants denied any wrongdoing or illegal conduct but have agreed to settle the litigation. ====================== Supplement Facts panel ====================== Each tablet: Vitamin A (Palmitate) 5,000 IUs Vitamin C 1,000mg Vitamin E (Acetate) 30 IUs Riboflavin 2.8mg Magnesium (Oxide & Sulfate) 40mg Zinc (Sulfate) 8mg Selenium (Amino Acid Chelate) 15mcg Manganese (Gluconate) 3mg Potassium 75mg Amino Acids (Glutamine as L-Glutamine, Lysine as L-Lysine HCl) 50mg Proprietary Blend 350mg: Maltodextrin, Lonicera, Forsythia, Schizonepeta, Ginger, Chinese Vitex, Isatis Root, Echinacea ====================== 2008 CNN Money News Article ====================== "There's no credible evidence that what's in Airborne can prevent colds or protect you from a germy environment," said CSPI Senior nutritionist David Schardt. The site says Airborne "boosts the immune system with seven herbal extracts and a proprietary blend of vitamins, electrolytes, amino acids and antioxidants." Airborne changed their advertising campaign when a plaintiff filed suit against the company in March 2006. That came after an ABC News report disclosed that the company's clinical trials were not conducted by doctors or scientists, but instead carried out by two laypeople. Advertisements stopped mentioning the study and cold-curing claims and instead touted claims that it helped boost the body's immune systems. In late 2006 the CSPI joined the suit as co-counsel against Airborne and in 2007 the Federal Trade Commission and an assembly of state attorney generals began investigating the firm's cold-curing claims professed since its creation in 1999. ====================== Airborne Health Website FAQ ====================== General Information 3. Is Airborne a cure for the common cold? There still is no cure for the common cold. Airborne helps to boost your immune system to help fight germs and viruses that abound in offices, classrooms, airplanes and other public places. Product Information 7. Should I be concerned about any of the levels of vitamins in Airborne? Airborne is meant to be taken in short duration. If used properly, there is no concern of the higher dose vitamins. For further guidance, or if you are taking other medications, please consult with your family physician. Company Information 3. Is there scientific evidence to support that Airborne really works? The law requires that we have competent and reliable scientific evidence to support the claims for our product. The science demonstrates that our product helps to boost your immune system, and have confirmed this fact through independent scientific experts. ====================== ====================== ====================== ====================== Recap: There are 3 points of contention regarding Airborne and its marketing: (1) whether it's known to work ... a) whether any valid studies on it show so ... b) whether any valid studies on its ingredients show so (2) whether it's safe (3) whether it's been unlawfully advertised Evidence on whether it's unlawfully adverstised ====================== The first note to make is that -- when examining contention point 3 -- it doesn't matter what the answers were to points of contention 1 & 2. Current law states rigid rules on advertisement, rules which have to do with a whole class of products -- regardless of their investigated safety or effectiveness. This rule states that structure-function claims are allowed -- such as: "helps boost your immune system" -- as long as there is a concurrent disclaimer on the bottle stating that the product hasn't been tested by the FDA and is "not intended to diagnose, treat, cure, or prevent any disease." If Airborne is guilty of breaking this rule, then the class action lawsuit against them is valid. If it isn't, then it isn't (and it's just another frivalous lawsuit; an inverted morality of the punishment of producers for being productive). I am not privy to whether Airborne is guilty of breaking this rule in the past (though none of their current ads break this rule). ====================== Note: The following points are mute with respect to the legality issue of the class action suit. Evidence on whether it works ====================== Re-quote (from above): "There's no credible evidence that what's in Airborne can prevent colds or protect you from a germy environment," said CSPI Senior nutritionist David Schardt. Comprehensive, Evidence-Based Refutation of Schardt (and any horse that he may ride on): 1999a "The dose may also affect the magnitude of the benefit, there being on average greater benefit from > or = 2 g/day compared to 1 g/day of the vitamin. In five studies with adults administered 1 g/day of vitamin C, the median decrease in cold duration was only 6%, whereas in two studies with children administered 2 g/day the median decrease was four times higher, 26%." -- Med Hypotheses. 1999 Feb;52(2):171-8. 1999b "In three trials of subjects under heavy acute physical stress, common cold incidence decreased by on average 50%, and in four trials of British males common cold incidence decreased by on average 30% in the vitamin C groups. ... In the four largest studies the duration of colds was reduced only by 5%. In two of these studies, however, absence from school and work was reduced by 14-21% per episode, which may have practical importance. Three controlled studies recorded a reduction of at least 80% in the incidence of pneumonia in the vitamin C group ..." -- Int J Tuberc Lung Dis. 1999 Sep;3(9):756-61. 2000 "Vitamin C in doses as high as one gram daily for several winter months, had no consistent beneficial effect on incidence of the common cold. For both preventive and therapeutic trials, there was a consistently beneficial but generally modest therapeutic effect on duration of cold symptoms. This effect was variable, ranging from -0.07% to a 39% reduction in symptom days. The weighted difference across all of the studies revealed a reduction of a little less than half a symptom day per cold episode, representing an 8% to 9% reduction in symptom days. There was no clear indication of the relative benefits of different regimes or vitamin C doses. However in trials that tested vitamin C after cold symptoms occurred, there was some evidence that a large dose produced greater benefits than lower doses." -- Cochrane Database Syst Rev. 2000;(2):CD000980. 2002 "One hundred sixty-eight volunteers were randomized to receive a placebo or a vitamin C supplement, two tablets daily, over a 60-day period between November and February. They used a five-point scale to assess their health and recorded any common cold infections and symptoms in a daily diary. Compared with the placebo group, the active-treatment group had significantly fewer colds (37 vs 50, P<.05), fewer days challenged virally (85 vs 178), and a significantly shorter duration of severe symptoms (1.8 vs 3.1 days, P<.03). Consequently, volunteers in the active group were less likely to get a cold and recovered faster if infected." -- Adv Ther. 2002 May-Jun;19(3):151-9. 2004a "A subgroup of six trials that involved a total of 642 marathon runners, skiers, and soldiers on sub-arctic exercises reported a pooled RR of 0.50 (95%CI 0.38 to 0.66).Thirty comparisons that involved 9,676 respiratory episodes contributed to the meta-analysis on common cold duration during prophylaxis . A consistent benefit was observed, representing a reduction in cold duration of 8% (95% CI 3% to 13%) for adult participants and 13.5% (95% CI 5% to 21%) for child participants.Fifteen trial comparisons that involved 7,045 respiratory episodes contributed to the meta-analysis of severity of episodes experienced while on prophylaxis. The pooled results revealed a difference favouring those on vitamin C when days confined to home and off work or school were taken as a measure of severity (p = 0.02), and when restricting to studies which used symptom severity scores (p = 0.16), and for the both measures of severity combined (p = 0.004)." -- Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000980. [an update of 2000 above] 2004b "Five small trials found a statistically significant 45 to 91% reduction in common cold incidence in the vitamin C group. These trials were short and the participants were under heavy exertion during the trial. Furthermore, three other trials found a statistically significant 80 to 100% reduction in the incidence of pneumonia in the vitamin C group." -- Mil Med. 2004 Nov;169(11):920-5. 2005 "CONTEXT: The term "sufficiently important difference" (SID) refers to the overall amount of benefit that people consider sufficient to justify the costs and risks of treatment. ... The hypothetical benefit of reduction in length of illness was traded off against best estimates of costs and risks. First, the authors briefly described costs, risks, and possible symptomatic benefits of 4 treatment scenarios, based on evidence regarding vitamin C, echinacea, zinc, and pleconaril, an antiviral. Hypothetical benefit (reduction of illness duration) was then varied until the cold sufferer indicated that the treatment was minimally desirable. ... For the scenario based on vitamin C, mean SID was estimated as 26.1 h (95% CI, 23.2 to 29.3), with 142 of 460 (31%) saying they would take it regardless of duration benefit, and 22 of 460 (5%) saying they would not take it, regardless of duration benefit. For the echinacea-based scenario, mean SID was estimated at 36.8 h (33.4 to 40.2), with 105 (23%) favoring and 41 (9%) rejecting treatment, regardless of duration benefit. For the zinc lozenge-based scenario, mean SID was estimated as 64.8 h (61.0 to 67.9), with 42 (9%) favoring and 109 (24%) rejecting treatment. For the prescription antiviral-based scenario, mean SID was estimated as 82.6 h (78.7 to 86.7), with 29 (6%) favoring and 223 (48%) rejecting. Severity of illness at the time of interview did not appear to significantly influence responses. Possible side effects, treatment type (tablet v. lozenge v. liquid), monetary costs, and opportunity costs (e.g., getting to the doctor or pharmacy, dosing frequency) did appear to be important in influencing these preference patterns. CONCLUSIONS: Our study suggests that, on average, people want the duration of their colds to be reduced by between 26 and 65 h to justify potential harms of popular cold treatments. A prescription antiviral would require a greater benefit (83 h) to justify larger perceived risks." -- Med Decis Making. 2005 Jan-Feb;25(1):47-55. 2006a "Intervention: Daily vitamin C supplementation of 50 mg (low-dose group) or 500 mg (high-dose group). RESULTS: Total number of common colds (per 1000 person-months) was 21.3 and 17.1 for the low- and high-dose groups, respectively. After adjustment for several factors, the relative risks (95% confidence interval (CI)) of suffering from a common cold three or more times during the survey period was 0.34 (0.12-0.97) for the high-dose group." -- Eur J Clin Nutr. 2006 Jan;60(1):9-17. 2006b "A large number of randomized controlled intervention trials with intakes of up to 1 g of vitamin C and up to 30 mg of zinc are available. These trials document that adequate intakes of vitamin C and zinc ameliorate symptoms and shorten the duration of respiratory tract infections including the common cold. Furthermore, vitamin C and zinc reduce the incidence and improve the outcome of pneumonia, malaria, and diarrhea infections, especially in children in developing countries." -- Ann Nutr Metab. 2006;50(2):85-94. ====================== Evidence on whether it's safe ====================== One claim that Airborne's unsafe involves the fact that we have to trust them. This claim is stated in a manner which implies that we don't have to trust other producers -- which is clearly false, a telling point which fully invalidates this claim. Another claim that Airborne's unsafe involves the fact that it contains a high-dose of vitamin C -- and that that increases risk of kidney stones. About 5% of the population are categorized as "stoneformers" and about 40% -- of that initial 5% -- are "oxalate-responders" to high-doses of vitamin C (J Nutr. 2005 Jul;135(7):1673-7). That means that 2% of the population would be at risk -- if everyone started taking high-dose vitamin C. More importantly, there are other lifestyle factors that outweigh the potential risk of stones from vitamin C. Obesity, for instance, can more than double the risk of stones (a 100% increase)! -- and vitamin C has never been shown to ever have that large of an effect. Here are lifestyle-related risk factors and their respective, expected effects on background stone risk: -high animal protein intake (except in heavy men) counterintuitively reduces risk by about 16% -high beer intake reduces risk by about 40% -high body weight increases risk by about 33-109% -high calcium intake counterintuitively reduces risk by about 27-50% -high coffee intake reduces risk by about 60% -high fluid intake reduces risk by about 29-38% -high grapefruit juice intake increases risk by about 44% -high lemon juice intake reduces risk up to 100% -high magnesium intake reduces risk by about 29-48% -high phytate reduces risk by about 37% -high potassium intake reduces risk by about 46% -high sugar intake increases risk by about 31% -high vitamin B-6 intake reduces risk by about 34% -high vitamin C intake increases risk by about 6-41% -high wine intake reduces risk by about 59% ====================== Evidence on whether I'm cool ====================== See above. ====================== ;-) And now I am prepared to take any questions that any of you may have ... Ed | ||||
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