The people profiting from food allergies.

Health and medicine explained.
Aug. 31 2009 1:44 PM

Nuts to That

The people profiting from food allergies.

Illustration by Mark Alan Stamaty. Click image to expand.

In a recent Wall Street Journal article titled "Save the Children (and Make Money)," fund manager James Altucher suggests investing in an "autoimmune index," a mix of stocks that have "good, lower multiples and that will supply the arms in our ongoing war against autoimmune diseases." I thought the article was a joke—until Altucher recommended buying stock in Novartis AG because its allergy drug Xolair was going into Phase II trials to see whether it could be useful in suppressing peanut allergies.

Altucher is on to something: Anybody who comes up with a new food allergy drug stands to make a boatload of money. The annual cost of allergies is estimated at $7 billion, according to the Asthma and Allergy Foundation of America, and the School Nutrition Association reports that about 35 percent of schools have some kind of allergy-related food ban in place. Every time I read something about Xolair or food allergies, I am reminded that our fear of children's food allergies is so very disproportionate to the likelihood of serious harm. Many more children die in car accidents on the way to school than from food allergies in the lunchroom; lightning strikes kill more people every year than do food allergies. It raises the question: Are we so afraid of food allergies because they represent a clear and present danger, or have our fears been exaggerated by the vast amounts of money we've thrown at the issue?

Most of what we know about food allergy danger, from the medical literature and in the popular press, comes from a single source: the Food Allergy and Anaphylaxis Network, a nonprofit located in Fairfax, Va. It was started in 1991 by Anne Munoz-Furlong, the parent of a formerly food-allergic child and a onetime researcher at Time-Life Books. FAAN has a substantially pedigreed medical advisory board, including Hugh Sampson and Scott Sicherer, both of whom are highly regarded allergists at the Jaffe Food Allergy Institute at Mount Sinai hospital in New York.

Sampson and Sicherer are excellent clinicians and biomedical researchers, and Munoz-Furlong is undoubtedly one of the most influential parent-advocates of the last 20 years. Their statistical work, however, is problematic. Sampson and Sicherer (who are medical doctors, not statisticians or epidemiologists) co-authored a 2004 paper in the Journal of Allergy and Clinical Immunology with Munoz-Furlong (who is not a statistician, an epidemiologist, or a medical doctor) on their attempt to determine how many people in the United States are allergic to seafood. They concluded that "physician-diagnosed and/or convincing seafood allergy is reported by 2.3% of the general population, or approximately 6.6 million Americans. … [S]eafood allergy represents a significant health concern."

Consistent with the journal's policy to disclose conflicts of interest, the statement attached to the paper read, "Funding sources paid for administrative costs and use of the company that performed the actual survey. The same funding sources have ties to the authors in other ways, but the authors do not perceive a conflict of interest on these accounts, and the relationships are public knowledge."

The authors may not have perceived a conflict of interest, but a close look suggests that a problem may, in fact, exist.

The funding sources for the paper include FAAN, the organization run until recently by Munoz-Furlong and her husband, and the Food Allergy Initiative, a private foundation that finances Sampson and Sicherer's research and clinical practice. Like many social causes, the food allergy movement depends on the assistance of a few wealthy patrons. Elliot and Roslyn Jaffe, who made their fortune with the Dress Barn women's clothing stores, became concerned about their granddaughter's food allergies in the late 1980s. That concern was magnified by an article that Sampson—himself the anxious parent of a food-allergic child—published in the New England Journal of Medicine in 1992. The article sent ripples of alarm through the food allergy community. The Jaffes have helped a wide variety of social causes over the years, so they directed their considerable philanthropic resources toward what they saw as a worthy effort. There wasn't a nationally renowned research center for food allergies, so they established the Elliot & Roslyn Jaffe Food Allergy Institute at Mount Sinai. The family also put $500,000 into the Food Allergy Initiative to help fund the research center at Mount Sinai. Sampson was drafted from Johns Hopkins to run the new Jaffe Food Allergy Institute.

FAI has given millions of dollars to Mount Sinai in the years since. In 2004, the year of the seafood allergy paper, FAI donated $1.6 million, specifically earmarked for salaries and clinical efforts at the Jaffe Food Allergy Institute—basically, to pay the salaries of Sampson, Sicherer, and/or their staff. Munoz-Furlong has also received substantial contributions from FAI for her organization's projects. Sampson currently heads the FAI medical research board, a position for which he receives a $10,000 honorarium. (Under Mount Sinai's institutional guidelines on conflicts of interest, any amount over $10,000 constitutes a "significant" conflict of interest: $10,000 is not reportable, but $10,000.01 is.) He also has financial interests in two allergy drug development firms and holds several peanut-allergy-related patents, including one for a Chinese herbal treatment that, as an "herbal supplement," is not subject to conventional FDA regulations.

Asking Sicherer, Sampson, and Munoz-Furlong to perform an objective study about national rates of seafood allergies is like asking a cigarette company to determine national rates of lung cancer.

If you want to influence the answers in a survey, how you ask a question matters as much as what you ask. In the seafood study, pollsters dialed random numbers and asked whether any household members were allergic to seafood. This kind of phrasing yields a far greater number of "yes" responses than the question "has a medical professional diagnosed you with a seafood allergy?" Criteria for "convincing self-report" in the study were highly subjective, bumping up the numbers a bit more.

Sicherer and Sampson are both on the editorial board of the journal that published the paper. Also, the journal's editor, Donald Leung, serves with Sampson on the FAI medical advisory board and has been rewarded as much as $10,000 a year for his service. The peer review process breaks down in this kind of situation because of a cognitive error called confirmation bias, where erroneous information goes unnoticed because it seems to validate what the reviewer thinks he already knows. Or, as Harvard psychologist Daniel Gilbert pointed out in the New York Times several years ago, "doctors, judges, consultants and vice presidents strive for truth more often than we realize, and miss that mark more often than they realize. Because the brain cannot see itself fooling itself, the only reliable method for avoiding bias is to avoid the situations that produce it."

The seafood study wasn't just used to legitimize food allergies inside the medical community. It also became a handy political weapon. In 2004, FAI hired a consulting firm to devise a plan to include specific ingredient information on food labels. Tax forms show that those expenses "included mailings to the public to help support the proposed legislation." Food allergy legislation was soon proposed by Rep. Nita Lowey, D-N.Y., and passed into law. We experience it now as the Food Allergy Labeling and Consumer Protection Act, the law that requires cream cheese to bear the label "contains milk."

That same year, thousands of producers and journalists received a press release FAAN sent out about the new seafood study, announcing, "Seafood allergies are much more prevalent than once thought. … [F]requent, severe reactions are reported by sufferers. … In all, about 11 million people—roughly 1-in-25 Americans—are now believed to be affected by one or more food allergies, a disease triggered by the ingestion of certain foods that may cause life-threatening reactions, or anaphylaxis."

Had the authors' financial ties been known, these dramatic results may have met with more skepticism. But the media found the story irresistible, in part because of the tantalizing way FAAN packaged the story. The press release was written in a way that practically guarantees a story will get picked up by the media: It required the journalist to do very little work. The release included the news hook, quotes from the authors of the survey, useful statistics, and a link to an unaffiliated group's prior estimate about the prevalence of seafood allergies. The facts and quotes were reproduced (almost verbatim) in an L.A. Times piece (subscription required), which was then syndicated and reproduced in other papers like the Houston Chronicle and the Milwaukee Journal Sentinel. The stats formed the backbone of a terrifying—yet factually wrong—2005 piece in Consumer Reports suggesting that fatal seafood allergies could strike anyone, anytime, without any prior warning.

The final piece stacking the deck in favor of food allergy paranoia came from FAAN's biggest media coup of 2004: a video news release FAAN produced with Dey Pharmaceuticals, the maker of the Epi-Pen. It's common for corporations to send out prepackaged releases that shill for products under the guise of news. The TV station is not required to state where it got the material it runs. FAAN used fake news "reported" by video news release voice-over actor Danielle Addair to promote its commissioned research. FAAN's annual report states that the video news release was extremely successful: "In total, the VNRs aired more than 300 times in approximately 207 US markets. Overall, we reached more than 30 million viewers—the most successful VNR outreach in FAAN history."

A small group of people is manipulating the scientific perspective on food allergies, exaggerating the perception of risk, and profiting from the flood of sympathetic private and government money. It's time to re-examine the statistics and question the media spin on food allergies. This time, we need to be hyperaware of potential bias and exaggeration. Food allergies deserve respect and awareness, sure—but we make unwise decisions when we're guided by fear. We should avoid telling one another horror stories about worst-case scenarios, or devising elaborate food bans. We should stop scaring ourselves based on manufactured evidence and remind ourselves that the vast majority of food-related allergic episodes are treatable. And when we look at proposed legislation like the Food Allergy and Anaphylaxis Management Act of 2009, we should look at the fine print—which allocates tens of millions of dollars to food allergy education—and wonder exactly whose pockets will be lined with that money.

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