Democracy Gone Astray

Democracy, being a human construct, needs to be thought of as directionality rather than an object. As such, to understand it requires not so much a description of existing structures and/or other related phenomena but a declaration of intentionality.
This blog aims at creating labeled lists of published infringements of such intentionality, of points in time where democracy strays from its intended directionality. In addition to outright infringements, this blog also collects important contemporary information and/or discussions that impact our socio-political landscape.

All the posts here were published in the electronic media – main-stream as well as fringe, and maintain links to the original texts.

[NOTE: Due to changes I haven't caught on time in the blogging software, all of the 'Original Article' links were nullified between September 11, 2012 and December 11, 2012. My apologies.]

Saturday, December 24, 2011

FDA Withdraws Proposal To Limit Livestock Antibiotic Use, Raising Public Health Concerns

The U.S. Food and Drug Administration announced Thursday its withdrawal of a decades-old proposal to limit the use of antibiotics in animal feed, a move experts say could have dire implications for public health.

Experts warn the common and often unnecessary practice is decreasing the effectiveness of antibiotics in human medicine and increasing the deadly threat of Methicillin-resistant Staphylococcus aureus (MRSA) and other difficult-to-treat infections.

"This is a step backwards in protecting the public from the rise in antibiotic resistance," said Avinash Kar, a staff attorney for the Natural Resources Defense Council.

Earlier this year, the NRDC filed a lawsuit to compel the FDA to fulfill a commitment it made in 1977, when the agency first acknowledged the mounting public health threat posed by the use of antibiotics in healthy livestock for growth promotion and disease prevention. A recommendation from an advisory committee at the time addressed two major classes of antibiotics that are used in both human and animal medicine: penicillin and tetracycline. The FDA was told to "immediately withdraw approval" for subtherapeutic uses of the drugs in livestock.

According to Thursday's FDA notice, Congress stepped in before the FDA could move forward with industry hearings -- a necessary step before imposing a ban. They asked the agency to refrain from taking any action until there was more research on public health risks.

"The evidence was there way back in 1977, actually before then," said Steve Roach, public health program director for the advocacy group Food Animal Concerns Trust. "They made a political decision. And since then, the FDA has failed to act."

"We think this is bureaucratic maneuvering to try to get around the lawsuit," added Kar. "If anything, the science showing the threat to public health has only gotten stronger."

Overall, livestock receive an estimated 80 percent of the nation's antibiotics. According to the FDA, about 90 percent of those antibiotics are consumed by the animals through their feed or water -- usually at very low doses.

The use of small amounts of antibiotics for large groups of animals over long periods of time, Roach said, creates ideal conditions for bacteria to develop resistance to the drug. What doesn't kill the bugs can make them stronger -- and more likely to defeat medicine's current range of weaponry.

What's more, recent research has found that the resistance issue isn't limited to the antibiotics given to livestock. "The use of any one antibiotic can lead to a drug resistance to multiple antibiotics," said Kar.

The FDA now says that it will move forward with voluntary guidance first issued in 2010, which offers suggestions to industry rather than imposing a ban. The FDA could not provide The Huffington Post with a timeframe for when that guidance will be finalized.

Roach suggested that this voluntary approach goes against the agency's "legal mandate" to only license drugs in the U.S. that are proven to be safe. "If they are shown to be unsafe," Roach told HuffPost, "then they need to withdraw it."

"Right now, there is no economic incentive for drug companies to cut back on their sales," he added. "To think they would do so voluntarily is absurd."

In a press conference on Wednesday with the USDA's Food Safety Working Group, both USDA Secretary Tom Vilsack and Mike Taylor, deputy food commissioner for the FDA, noted the intent of both organizations to work collaboratively, as well as with veterinarians, drug companies and producers, to address the antibiotics issue. They did not mention inclusion of the public health community.

Ellen Silbergeld, a professor at Johns Hopkins School of Public Health, noted her disappointment with the FDA's latest decision. "The agency has been dithering about this for over 30 years," she said.

"There is no real impact on the industry from this notice, but it did affirm FDA positions that prevention and control of animal diseases are considered therapeutic uses and are judicious," said Richard Carnevale, vice president for regulatory, scientific and international affairs at the Animal Health Institute, which represents pharmaceutical companies.

Some members of Congress also expressed displeasure with the FDA withdrawal. "Every year, 100,000 Americans die from bacterial infections acquired in the hospital," said Rep. Louise Slaughter (D-N.Y.), the author of legislation that seeks to preserve the effectiveness of antibiotics for the treatment of human disease, in a statement.

"Seventy percent of these infections are resistant to drugs commonly used to treat them. I wonder how many lives could have been saved if these proposals were adopted in 1977 as they should have been. We need to get our head out of the sand and start taking public health advice from scientists rather than industry lobbyists.”

The Preservation of Antibiotics for Medical Treatment Act, the legislation Slaughter proposed, was originally introduced in 2007. Since re-introduced, the act currently has over 300 endorsing organizations -- from the American Medical Association and the Natural Resources Defense Council to the Humane Society.

Kar said the NRDC will continue fighting with legal action. In the meantime, Kar said, consumers can look for certain seals to ensure antibiotics weren't used in livestock upbringing: USDA Certified Organic, American Grassfed Certified, Animal Welfare Approved and Certified Humane.

Original Article
Source: Huff 

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