In a classic case of the fox guarding the chicken coop, Alpharma, a former subsidiary of the major pharmaceutical company Pfizer, was recently found to be colluding with the Food and Drug Administration (FDA) behind closed doors to delay and downplay public release of important information about risks of one of its livestock drugs. Those closed doors have now been thrown wide open.
After filing a Freedom of Information Act (FOIA) request and having to sue the agency to get the documents, Food & Water Watch recently obtained internal documents ranging from formal letters to e-mails between Pfizer and the FDA. The trail of breadcrumbs reveals just how far Big Pharma will go to protect its interests, and just how easily the FDA gave in—at the expense of public health and food safety.
Here’s the deal: Decades ago, the FDA approved the use of drugs containing arsenic for use in chickens, turkeys and pigs. It says these drugs can be used for growth promotion and to treat and prevent disease. The catch is, the FDA recognizes the organic form of arsenic as safe, while inorganic arsenic is considered a carcinogen that may lead to health effects from lung, bladder or skin cancer, to heart disease, diabetes, neurological problems in children and more.
Alpharma produced and sold roxarsone, or “3-Nitro,” an arsenical animal drug, for use in animal feeds. And while roxarsone was deemed an organic, “safe” form of arsenic (and had been approved by the FDA since 1944), some scientists began to question its safety. The FDA caught on, and when Alpharma could not provide more information, the FDA sought to test the theory that roxarsone remains in the safer form after the chickens metabolize it—or when it moves to the chicken’s poop.
By 2009, the FDA began to test the theory using advanced technology, despite initial pushback from Alpharma. Here begins the long conversation between Pfizer and Alpharma, and the FDA, the former two working hard to keep roxarsone on the market and their coffers full.
Based on its study, the FDA found that levels of very harmful, inorganic arsenic were higher in chicks treated with the drug than in untreated chicks. Ah-ha! But when the FDA shared these results with Pfizer, noting that using inorganic arsenic in animal feed violates a federal ban on carcinogens in food (and should therefore be removed from the food chain), Pfizer put up all of its guards.
Food & Water Watch’s analysis of FOIA documents reveals that Pfizer initially disagreed with the adequacy of the study, and its representatives pressured the FDA to alter its public communications about it. FDA and Pfizer then agreed to work together on a strategy to release the results. And it turns out that the FDA not only allowed Pfizer to delay removal of the drug in the U.S. and continue its sale abroad, the agency also compromised with the company to delay the release of the report and avoid using language about how roxarsone threatens human health.
How could the FDA, the government agency responsible for protecting public health and food safety, allow a drug company to exert so much influence over it? Why would it let Pfizer write portions of its press release, change the headings and completely omit the term “arsenic” from the media materials all together?
Pfizer indeed agreed to (voluntarily) suspend sales of the drug, as the final title of the FDA’s press release (“Company Takes Action in Response to FDA Data”) benignly states. But it was only after a 2013 John Hopkins study that the FDA finally withdrew approval of the drug. For some not-so-strange reason, the FDA refuses to take action on similar arsenical drugs like nitarsone.
We cannot allow this kind of industry-driven PR game continue to dominate government regulators. Food & Water Watch, public health researchers and food advocates will continue to call for a ban of arsenic-based drug approvals for use in animal feed. We will also continue to expose these sketchy relationships because the people's health is more important than Big Pharma’s profits.
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