This week, Dr. Sydney Spiesel discusses the herbal remedy Airborne and the power of belief, how to prevent kidney stones, and whether 30 million more kids should get a flu shot each year.
Airborne: Why it really does work.
Product: For more than 10 years, the herbal remedy Airborne was marketed as a cold-fighting treatment by CEO Elise Donahue, a former second-grade teacher who created and marketed the product herself, working her way up to an Oprah endorsement. Donahue's company claimed that it had been tested, with remarkable success, in a "double-blind, placebo-controlled clinical trial of 120 patients" in the early stages of a head cold. About half the patients treated with Airborne reportedly didn't develop a full-blown cold, compared with 77 percent of placebo-treated patients who did.
Law suit: But then two years ago ABC News reported that the testing laboratory, GNG Pharmaceutical Services, was a two-man operation with "no clinic, no scientists, and no doctors," started up to generate the Airborne study. A class-action suit for false advertising followed, and the company just agreed to pay more than $23 million to settle it. Besides its lack of demonstrable efficacy (a little problem shared by virtually all cold medicines), there is the additional concern that Airborne might contain an unsafe amount of vitamin A.
Regulation: Why isn't some government entity, like the Food and Drug Administration, keeping track of products like this? The answer is simple: Basically, we don't want them to. In 1994, Congress passed the Dietary Supplement Health and Education Act, which essentially set aside the FDA's oversight of products marketed as dietary supplements or the ingredients of dietary supplements. The FDA can pull such products from the market if they carry a significant risk of injury or if they are advertised to "prevent," "cure," or "treat" some illness, but, otherwise, they are to be left alone. The legislation was enacted to satisfy people who believe in these products and manufacturers who want to sell them. Neither constituency thinks these products should be subject to the pre-market safety and efficacy testing required of real medications—and, frankly, the true believers probably wouldn't heed the results, anyway.
Question: Are people deluded, or do products like this work? My answer, surprisingly, is that they do work—but only if you believe and thus deceive yourself. When you take the medicine you believe in, you won't notice when your nose runs anyway, and if you forget to take it before flying, you won't remember that your trip ended in perfect health. That's why it is so important that real studies of efficacy and safety include both the medication under evaluation and a placebo that looks, smells, and tastes just like it.
Findings: A very nice recent piece of research illustrates both the powerful effect of expectations and the subtle forces that influence them. The research group offered the experimental subjects a "new pain-relieving drug"—actually a placebo—and measured how well it relieved the pain of an electric shock. The subjects were divided into two groups. Both were given the same placebo pills and both were exposed to the same painful shocks, but one group was told that the pills cost $2.50 each and the other group was told that the pills were discounted to 10 cents. (I suppose because no one in their right mind would believe that a real pharmaceutical manufacturer would sell something so cheaply.) Both pills worked to reduce pain, but the $2.50 pill worked a lot better than the cheaper one.
Conclusion: I'm betting that even though Airborne's settlement includes an offer of refunds to disappointed buyers, the company won't have to pay a lot of them. It's awfully hard to unbelieve.
Kidney stones and germ prevention?
Condition: Kidney stones are hard, usually minerallike objects made of a poorly soluble salt, calcium oxalate. Between 5 percent and 15 percent of the population has them at some point. Because they often cause severe pain, kidney stones frequently send sufferers to the hospital. The annual economic impact of those admissions in the United States has been estimated at about $2 billion. Preventing them could lead to savings of $2,500 per patient.
Question: Could we figure out how to prevent kidney stones if we understood why some people get kidney stones and others do not? Recent research in Boston suggests that the key may be the presence or absence of a slightly exotic bacterium in the intestines. This germ, called Oxalobacter formigenes, burns oxalic acid as its energy source, which, in theory, could make the compound less available for forming kidney stones.
Research: To test this theory, the researchers looked at about 250 adult patients with recurrent calcium-oxalate kidney stones and compared them with a roughly equal number of similar people without the stones. They cultured the stool of both groups, looking for colonization of Oxalobacter formigenes in the large bowel. They found that patients with this bacterium were at 70 percent less risk of developing recurrent kidney stones.
Conclusion: Whether this association is a coincidence or reflects actual causation remains to be established, but the finding is provocative. If this apparently safe and harmless germ eliminates oxalic acid and, in so doing, inhibits kidney stone formation, it could lead to new treatments. Perhaps we are looking for a new form of probiotic—a live-bacterium food additive that would prevent these painful stones from forming.
A flu shot for every kid
Recommendation: The Advisory Committee on Immunization Practices is charged with making recommendations on immunization practice to the Centers for Disease Control, which almost always follows its advice. A few weeks ago, the advisory group came up with a bold new recommendation about influenza immunization: that all children between 6 months and 18 years of age should be given an annual flu vaccination.
Obstacles: The logistic difficulties inherent in this recommendation are pretty impressive. Thirty million additional children would get a flu shot every year (current recommendations call for flu immunizations for children only through age 5). Manufacturers, which in past years have had some difficulties in keeping up with the annual demand for this vaccine, would be pushed to scale up dramatically. That could lead to production problems, as in previous years, which in turn throw off distribution schedules, pushing the time of immunization dangerously close to the flu season itself. The timing of the recommendation is also tricky because of the clear wide failure of this year's flu shot. Nasal-spray vaccine will probably be used more if the CDC accepts the recommendation to immunize more kids. It's easier to administer but may result in more side effects, since it should not be used for patients with asthma or certain other disorders. It is also somewhat more expensive than the injected version of the vaccine.
Rationale: Why did the ACIP choose to make such a controversial recommendation? First, even healthy children infected with flu are at risk for developing serious additional illnesses. (Last year, for instance, about 70 children in the United States died of influenza or its complications.) Children have also been identified as playing a significant role in the transmission of this disease to other children and to adults. Also, the economic cost is larger than one might imagine, since parents often need to take time away from work to attend to children who are ill.
Questions: Immunizing 30 million more children will probably be beyond the capabilities of pediatric and family-practice doctors and might be assigned instead to schools, pharmacies, and supermarket clinics. We don't know what this will mean. For instance, will it further weaken the relationship between patients and their usual health-care providers? Would that reduce the diagnosis of serious illness? Will the cost of more immunization take money away from other more important medical efforts?
Conclusion: In sum, the ACIP's recommendation is probably a good one, but only time will sort out whether the benefits exceed the disadvantages.
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