Clarity, Conciseness Important in Research Findings

The following commentary does not necessarily reflect the views of AgWeb or Farm Journal. The opinions expressed below are the author's own.

Here at Farm Journal’s PORK, we receive a lot of articles and news releases every day. We look at the sources and decide first if the information is important to our audience. If it is, then we determine if we can run the news articles on the site as it is, or if we need to add more sources and modify it, or if we need to run it as a “company news” release, or if we need to let it pass (if it’s purely promotional). We try to label articles with an appropriate byline so you know what you’re reading. For example, since the National Pork Board and the National Pork Producers Council are trusted sources, we often use those releases as they are, with NPB or NPPC as the respective authors.

The reason for this long explanation is that we recently received a news release reporting research about impurities in injectable iron. It was edited, but it still contained far-reaching statements that went beyond the research associated with the release.

Industry stakeholders are concerned about the potential negative impact that the release and published research study could have on the pork industry, due to the implications made regarding the use of iron products on pig and food safety. The research study was first reported on the website for the American Association of Swine Veterinarians, which only publishes peer-reviewed articles, hence, our confidence in the information.

Representatives of Ceva Animal Health wrote a response, indicating these concerns:

  • Included unproven statements regarding potential exposure of humans to elemental impurities based upon inappropriate correlations between humans and swine.
  • Failed to consider the long-term safety record of the products in question.

“Numerous incorrect worst-case assumptions fail to consider normal physiological parameters, and misapplication of USP elemental impurity limits are introduced in this article to suggest a lack of safety and lack of food safety for the human that consumes a treated pig,” the sources said. “Considering just excretion elimination, no toxicology or safety concerns would be expected,” the company said, in regard to the research study.

The sources continue: “The CVM website has published a list of cumulative Adverse Drug Experience Reports (ADEs) for 26 years spanning from 1987 to April 30, 2013, which are categorized by active ingredient, species and route of administration for all approved drug products including the ‘iron actives’ administered in a pig by injection. For gleptoferron injectable products administered to pigs, only 13 AEs were reported to CVM and only 166 AEs were reported for iron dextran products. It has been clearly demonstrated over many years that this class of products are unequivocally safe for use as indicated in baby pigs. Any speculation to the contrary particularly without controlled data is irresponsible and harmful to the industry.”

In conclusion, the company stated: “This article is troubling in multiple aspects. However, the most troubling is that the authors are strongly implying iron products approved by the CVM are unsafe for their intended use in piglets and the meat from the pigs may be unsafe for human consumption,” the sources said. “The effort to differentiate and promote one product may have put the entire industry’s reputation at risk. By suggesting one product is safe, but other approved products are unsafe, the confidence consumers can have in the pork they are purchasing and consuming is undermined.”

The Authors Respond
As a result of the concerns expressed regarding the interpretation of the findings in the study, the study authors provided the following statement for inclusion in the AASV e-Letter:

"In response to the recently published article "Elemental impurities in injectable iron products for swine" in the Journal of Swine Health and Production, concern has been raised regarding product and food safety. To clarify any misconceptions, the article does not state that any of the products available in the United States were or are considered unsafe for use in swine by any regulatory authority in the United States. The objective was to evaluate a number of different parenteral/injectable veterinary iron products for the presence of impurities with the hope that the findings would be used to potentially improve the already stringent quality production standards implemented by manufacturers. While the study clearly revealed new information concerning differences in the levels of detectable impurities (e.g., arsenic, chromium, and lead) amongst the injectable iron products evaluated, the quantities of such impurities (measured in micrograms per 200 mg dose of iron) need to be kept in context to their use as a one-time dose or two-half doses to a neonatal pig. Detection of these elements does not indicate that the products are unsafe and should not be used. All products available in the United States have maintained an adequate safety record according to FDA adverse event reporting records for the duration of their availability as FDA approved products. Thus, caution should be used in interpreting data from this publication to avoid over interpretation about the safety of injectable iron products. The data reported in the article is scientific in nature and should not be used to conclude that there is a food safety issue with pork or pork products.”

Increased Diligence
Hopefully more research will be conducted, because the study does brings up some interesting findings that should be further explored. Farm Journal’s PORK hopes the original article, in its edited form, didn’t mislead readers. This situation is a good reminder to be even more diligent in reviewing the information we share with our most important resource: you.