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Pfizer suspends 3-Nitro sales for more research

By KEVIN WALKER
Michigan Correspondent

MADISON, N.J. — Pfizer, Inc. announced last week it was voluntarily suspending sales of an animal medication called 3-Nitro, or Roxarsone, after the federal government told the company it found elevated levels of inorganic arsenic in chickens that ate the medicine.

Those elevated levels of inorganic arsenic are about what a person consumes with an eight-ounce glass of water, according to Pfizer. Alpharma, a subsidiary of Pfizer, makes the medicine. It was originally approved for use in animal feed in 1944; it’s been reviewed a number of times since then.

The U.S. Food and Drug Administration (FDA) discovered what it described as “very low” amounts of inorganic arsenic in the livers of chickens, amounts which were nonetheless higher than that found in chickens that hadn’t consumed the product. 3-Nitro contains organic arsenic, which isn’t harmful.
The FDA used a new test and discovered that some of the organic arsenic could have been converted into inorganic arsenic, which can cause cancer.
“FDA detected increased levels of inorganic arsenic in the livers of chickens treated with 3-Nitro, raising concerns of a very low but completely avoidable exposure to a carcinogen,” said Michael Taylor, FDA commissioner for foods, in a statement released June 8. “We are pleased to announce that the company is cooperating with us to protect the public health.”

George House, executive director of Michigan Allied Poultry Industries, said the FDA is operating on the hypothesis that people could be harmed if farmers overfeed the medicine to their birds.

House described 3-Nitro as “very effective” in the prevention of coccidiosis, the most common infection in poultry. Inorganic arsenic is found in small amounts in foods such as meats, fish, vegetables, grains and legumes.
“My sense is that it might be of greater concern to the turkey and broiler industry than to the layer industry,” he said.

The reason for this, he explained, is it’s more cost-effective for those raising turkeys and broiler chickens to use 3-Nitro than to have the birds vaccinated, but for layers the same problems are solved through vaccinations.

House said it’s not clear that the product is going to be banned: The company and the FDA have agreed to a suspension of sales of 3-Nitro beginning early in July so the industry can have time to seek out a cost-effective alternative. According to the National Turkey Federation, Pfizer is not withdrawing the FDA approval for the product, leaving open the possibility of resuming sales at a future date.

“It’s my sense that on shelf, there’s no alternative to this product,” House said. “They might continue to allow it, but establish rules on how long it can be fed.”

A spokesman for the National Chicken Council, Richard Lobb, said not all flocks are given 3-Nitro. Those that are treated with it are given it in the proper amounts, he said. When asked how he knows this, he said that’s “just the way it is” but didn’t provide evidence that showed this is the case. He said the companies that sell 3-Nitro are responsible.

Scott Brown, senior director of metabolizing safety at Pfizer, said feed mills have to submit a sample once a year to an analytical laboratory to make sure the amount of medication in the feed is correct. He said he believes the suspension of sales “was the right thing to do.” He added a lot isn’t known about the science at this point and that he has a lot of work to do to understand the study the FDA used in reaching its finding.

6/15/2011