Washington, D.C.— New documents released today by Food & Water Watch show that the U.S. Food and Drug Administration (FDA) colluded with the pharmaceutical company Pfizer to downplay the results of a study that links inorganic arsenic, a human carcinogen, to the U.S. food supply. The documents, obtained through the Freedom of Information Act, show the full reach of the pharmaceutical giant and its influence over the government agency charged with protecting public health, food safety and drug manufacture oversight.
Communications between FDA and staff from Pfizer and Alpharma, a former Pfizer subsidiary (now part of Zoetis), began prior to a 2011 announcement to suspend sales of the arsenic-based drug known as roxarsone for use in poultry feed. The decision stemmed from a 2007 study suggesting roxarsone could convert into the most dangerous form of arsenic in chickens, prompting the FDA’s Center for Veterinary Medicine to conduct their own 2011 follow-up study and report. The FDA report found that elevated levels of inorganic arsenic were found in the livers of chicken fed the drug as compared to chickens that never received it. In addition, continued approval of roxarsone violated the Delaney Clause of the Federal Food, Drug, and Cosmetic Act requiring the FDA to refuse approval of cancer-inducing additives in animal feeds. Despite the FDA report, internal documents reveal the agency allowed Pfizer to delay withdrawal of roxarsone in the U.S. and continue sale abroad, and that Pfizer collaborated with FDA on a media relations strategy for announcing the results.
“These documents reveal a highly inappropriate relationship between FDA and Pfizer, showing that the agency has not fulfilled its responsibilities under law to prevent avoidable human exposure to arsenic,” said Food & Water Watch Executive Director Wenonah Hauter. “Instead of acting decisively to protect public health, FDA let a drug company determine what and when the public learned about critical new information about the safety of the food supply.”
According to internal FDA documents, FDA and Pfizer also agreed to collaborate on a media strategy regarding the 2011 report and the company’s suspension of sales. Pfizer rewrote the agency’s draft press materials to downplay the danger of roxarsone and all arsenic-based animal feeds and to minimize the significance of FDA’s study.
“Chickens raised with arsenic-based drugs resulted in chicken meat that had higher levels of inorganic arsenic, a known carcinogen,” said Keeve Nachman, PhD, Assistant Professor and Director of Food Production and Public Health Program at The Johns Hopkins Center for a Livable Future and lead author of a 2013 study on arsenic in poultry. “It’s critical the FDA ensure its recommendations are issued in a timely manner, and are driven solely by science and a commitment to protecting the public’s health.”
“These documents paint a troubling picture for the U.S food supply and expose the true extent of Pfizer’s lobbying and public relations efforts. Since the FDA agreed to allow Pfizer to voluntarily stop using roxarsone in the U.S. and did not withdraw approval, it allows Pfizer to continue manufacturing and selling the drug overseas, putting other populations at risk,” added Hauter.
Arsenical drugs were first approved for use in chicken feed in 1944 and until 2013, were routinely used to aid in poultry growth and improve meat pigmentation. The drugs are also approved to treat and prevent parasites in poultry. Inorganic arsenic is a carcinogen, and long-term exposure has been associated with higher rates of heart disease, cancer, diabetes, neurological problems in children and adverse pregnancy outcomes. This has prompted many public health researchers and advocates to call for a complete ban of arsenic-based drug approvals for use in animal feed.
Contact: Kate Fried, Food & Water Watch, (202) 683-2500, kfried(at)fwwatch(org).
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