Livestock production has long been suspected as a key incubator of antibiotic resistance in the United States. Credit: Bigstock

By Carey L. Biron
WASHINGTON, Mar 27 2014 (IPS)

Pharmaceutical companies have overwhelmingly agreed to new U.S. government guidelines aimed at decreasing the use of antibiotics in the raising of livestock, new data shows.

In December, the U.S. Food and Drug Administration (FDA), the federal government’s main regulator for these sectors, unveiled a new, voluntary programme to reduce the use of “medically important” antibiotics, the hundreds of drugs considered important for human health."Any time antibiotics are used for routine disease prevention, that’s a sign that something else is wrong with the livestock system.” -- Sarah Borron

The agency targeted 26 of the world’s largest manufacturers of livestock antibiotics, requesting their compliance. On Wednesday, the FDA announced that all but one of those companies, accounting for more than 99 percent of the supply, had agreed to the new guidelines.

“As of March 26, [25 companies] have agreed in writing that they intend to engage in the judicious use strategy by seeking withdrawal of approvals relating to any production uses and changing the marketing status of their products from over-the-counter to use by [veterinary] prescription,” the FDA stated Wednesday.

“FDA is encouraged by the response thus far and will continue to monitor ongoing participation and provide public updates on a periodic basis.”

The only targeted company not to agree to the new guidance is PharmaqAS, a Norwegian manufacturer of drugs used on farmed fish. A spokesperson for the company told IPS that its products are only used to treat diseased fish rather than to promote growth in livestock, and Pharmaq “interpreted the proposed voluntary program not to be relevant for our products.” However, it is currently reviewing the FDA request.

The U.S. meat industry has come under increased criticism in recent years over the widespread practice of feeding low levels of antibiotics to healthy livestock over an extended period, as a way of forcing animals to put on weight more quickly. Motivated by surging reports of antibiotic-resistant “superbugs” around the world, public health officials have increasingly looked for ways to decrease this practice.

At base, the new guidance offers a simple tweak to labelling requirements for antimicrobial drugs intended for livestock. These 25 companies will no longer include reference to their drugs’ growth-enhancing potential on their labels, in effect outlawing the practice by farmers.

The use of antibiotics for truly sick animals will still be allowed, but only with a prescription from a registered veterinarian.

While public interest groups are supportive of the fact that U.S. regulators are finally taking action over growing antibiotic resistance, many are concerned that the FDA’s guidelines are too weak.

“We did some analysis of the drugs being affected by the guidance and found that of the drugs that will stop being used for growth promotion, 63 percent can still be used for disease prevention,” Sarah Borron, a researcher with Food and Water Watch (FWW), a watchdog group, told IPS.

“The problem is, that’s a very similar type of use. Farmers still give low doses of antibiotics to entire herds for long periods, and that still promotes the development of antibiotic resistance. Any time antibiotics are used for routine disease prevention, that’s a sign that something else is wrong with the livestock system.”

Concerns over the possibility of antibiotic resistance have been around almost since the discovery of antibiotics themselves. Credit: Bigstock

Some U.S. lawmakers are expressing similar concerns.

“This voluntary pro-industry approach is a step in the wrong direction,” Rosa DeLauro, a member of the House of Representatives, said when the plan was announced in December.

“Companies will either disregard the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention. For the good of public health, FDA should step up and implement tighter restrictions on antibiotic usage.”

DeLauro said that 80 percent of the antibiotics sold in the United States are given to healthy animals, often to “overcompensate for crowded and unsanitary conditions”.

23,000 deaths annually

Concerns over the possibility of antibiotic resistance have been around almost since the discovery of antibiotics themselves, a breakthrough that many say is among the most important of the modern age. Yet such reports have spiked in recent years.

While this resistance is a growing problem in countries on every continent, governments outside of the United States have taken more proactive steps. The European Union, for instance, has banned the use of antibiotics to fatten livestock since at least 2006.

Data from E.U. countries suggest that overall antibiotics use for livestock can be reduced fairly easily, through simple yet often cost-ineffective changes to farming practice.

The United States, meanwhile, has seen major outbreaks of food-borne illness with resistance in recent years.

In 2011, for instance, the U.S. company Cargill was forced to recall 36 million pounds of ground turkey, over concerns that it may have been contaminated with an antibiotic-resistant form of salmonella. Hundreds more became sick from similar infections this past October, reportedly traced to a chicken farm in California.

Also last fall, the Centers for Disease Control and Prevention (CDC), a federal agency, estimated that some two million people in the United States are getting sick from antibiotic-resistant infections every year, causing some 23,000 deaths. Further, the agency cautioned that those numbers were minimum estimates based on conservative assumptions.

In April, CDC director Dr. Tom Friedman told the U.S. House of Representatives that antibiotic resistance constitutes one of the country’s “most serious health threats”.

Livestock production has long been suspected as a key incubator of antibiotic resistance in the United States. Yet the FDA ultimately decided to make its new programme voluntary rather than mandatory.

The agency says it took this decision in order to speed up what would otherwise have been a long and likely contentious regulatory process. But analysts like FWW’s Borron say this is cause for concern.

“Whenever there’s voluntary guidance, we worry about whether companies will follow,” she notes. “In this instance, there’s the sense that the FDA has been working on something that the industry can accept.”

In this approach, the FDA appears to have been successful. Both the animal pharmaceuticals manufacturers and the meat industry appear to be backing the new guidelines, though some express some reservations.

“The response to FDA reflects the shared commitment of those who raise poultry and livestock to the judicious use of medicines for the care and well being of healthy animals,” Keith Williams, a spokesperson for the National Turkey Federation, a trade group, told IPS.

The pork industry, meanwhile, is warning that the new guidelines will mean “real changes” for producers. Liz Wagstrom, the chief veterinarian at the National Pork Producers Council, told IPS that “farmers will need to work with their veterinarians to come up with alternative strategies to keep their animals healthy.”

Pharmaceutical manufacturers will now have three years to phase in the new labelling requirements.

The EU logo for organic food, which became obligatory in 2009. Credit: Simon Leufstedt/cc by 2.0

By Carey L. Biron
WASHINGTON, Apr 24 2013 (IPS)

A decades-long push to require the labelling of foods containing genetically modified ingredients in the United States received a significant boost Wednesday, when bipartisan bills on the issue were simultaneously proposed in the House and Senate.

Advocates of such measures are reacting with excitement, noting that the new bills appear to be far better positioned than previous such attempts, in terms of both public and Congressional support. If the bills pass, the United States would join 64 other countries that have already put in place similar laws or regulations.“The fact of the matter is that, for far too long, the FDA has been playing politics over science.” -- Colin O’Neil of CFS

The legislative moves mark the first time that such a bill has been proposed in the U.S. Senate in more than a dozen years, a period during which the use of genetically modified crops has expanded exponentially.

Further, while that earlier iteration, from 2000, was the work of just a single Democratic senator and was unable to attract any additional co-sponsors, the new bill has already received official support from nine senators and 21 representatives, including two Republicans.

“Americans have the right to know what is in the food they eat so they can make the best choices for their families,” Senator Barbara Boxer, a key sponsor of the new bill and author of the 2000 proposal, said Wednesday.

“This legislation is supported by a broad coalition of consumer groups, businesses, farmers, fishermen and parents who all agree that consumers deserve more – not less – information about the food they buy.”

Indeed, public opinion on the matter appears to be overwhelmingly on the side of the new proposal, which would direct the Food and Drug Administration (FDA), the main government regulator on food-related issues, to require food producers to clearly label their products if they contain genetically engineered (GE) components.

According to multiple polls in recent years (including here and here), more than 90 percent of people in the United States favour the FDA requiring the labelling of foods containing genetically modified ingredients.

Yet for years, the FDA has pushed back against such requests, despite having the legal authority to mandate such a change. Rather, today’s policy continues to be informed by 1992 guidance in which FDA administrators stated that GE foods were not “materially” different from conventional foods.

The rationale for this stance was simply that consumers were unable to physically sense the difference between conventional and genetically modified foods.

“Unfortunately, the FDA’s antiquated labelling policy has not kept pace with 21st century food technologies that allow for a wide array of genetic and molecular changes to food that can’t be detected by human senses,” according to a press release put out by the bill’s main sponsors, Senator Boxer and Representative Peter DeFazio.

Further, such a test appears inconsistent with regard to the 3,000 other substances for which the FDA does require labelling.

“The fact of the matter is that, for far too long, the FDA has been playing politics over science,” Colin O’Neil, the director of government affairs at the Center for Food Safety, a Washington advocacy group, told IPS.

“Corn that produces its own insecticide, or a fish that grows twice as fast as normal, or an apple that doesn’t turn brown for 30 days – we know these are material changes and that those are novel foods.”

Choice, not science

Over the past decade and a half, consumers in the United States have been eating more and more GE foods, almost always unlabelled. According to some estimates, nearly two-thirds of processed foods sold in the U.S. today contain genetically modified grains, particularly corn or soybeans.

And although the use of these materials started in the United States, they have since spread throughout the world, with genetically modified crops now covering more than 10 percent of all farmland. In 2010, more than 80 percent of all soybeans were reportedly grown from modified seed.

Even as public concern has spiked on the issue in recent years, the debate over genetic modification has often become bogged down in discussions of what the science has or hasn’t found. Due in part to the need for long-term studies and the relative newness of this widespread use, findings are available to back up both advocates and opponents of genetic modification.

The new U.S. legislative proposal, however, sidesteps the science entirely, to hinge solely on issues of public information and consumer choice.

“The government doesn’t label dangerous foods – they take them off market,” O’Neil notes.

“Food doesn’t have to be dangerous to be labelled. When the FDA required that irradiated foods be labelled, for instance, it explained its reasoning based not on the ‘material change’ to the food but simply on whether consumers felt that the absence of that knowledge would deceive them.”

As for the new bill, O’Neil says it marks a “very significant step forward” for the labelling movement.

“Given the number of original, bipartisan co-sponsors, there is very good indication that this bill could have legs,” he notes.

“There was a lot of fear-mongering by industry when Senator Boxer introduced her first bill [in 2000], but the dialogue has changed dramatically since then. It’s no longer a matter of if but when labelling will be required.”

Groundswell

The new proposal was almost certainly helped along not only by widespread public backing but also by growing support from corporations and state-level governments. Just this year, over 50 bills in 26 states have introduced proposals on GE food labelling.

In addition, more than 100 companies have already publicly backed the new federal bill. Others have moved unilaterally – for instance, the grocery chain Whole Foods pledged earlier this month to label all GE foods it carries by 2018.

Farmers unions too have expressed support, highlighting in part the export obstacles that have cropped up as the United States has fallen behind the international curve on labelling. In fact, if it passes, the new bill would simply require food producers to do for U.S. consumers what they’re already doing for many export markets.

“Pepsi, Kraft – major producers have already been labelling U.S. products in accordance with foreign laws,” O’Neil says. “This experience has shown that doing so is not a barrier to trade, does not increase costs for consumers – and those in the U.S. would no longer have to live in the dark over what’s in their food.”

Patients, doctors and international aid groups are calling on donors and governments to support measures that would make treatment of drug-resistant tuberculosis more effective and accessible.

The demands are being made amidst the recent or imminent approval of two new drugs, bedaquiline and delamanid. Advocates say the drugs present an historic opportunity to tackle the notoriously difficult-to-treat disease.

“As we know with all infectious diseases, we need to seize this opportunity before an airborne infectious disease gets too out of control,” Dr. Jennifer Cohn, a policy advisor with Medecins Sans Frontieres (MSF), an aid group, told IPS.

On Monday, MSF released a manifesto, signed by TB patients and their doctors in 23 countries around the world, noting that “after close to five decades of insufficient research and development into TB … Research is urgently required to determine the best way to use these new drugs so that treatment can be made shorter and more effective.”

It also warns that “If measures to tackle MDR-TB are not immediately expanded, rates of the disease will continue to increase worldwide, and a historic opportunity to improve abysmal cure rates will have been squandered.”

The call to action comes on the heels of a World Health Organisation (WHO) statement on the wide spread of drug-resistant tuberculosis – and warnings over an anticipated funding gap of 1.6 billion dollars needed to both identify new cases and combat existing strains.

An additional 3.2 billion dollars, according to WHO estimates, could be provided by governments. If the combined 4.8 billion dollars is funded, treatment could be provided for 17 million TB and drug-resistant TB patients.

“We have gained a lot of ground in TB control through international collaboration, but it can easily be lost if we do not act now,” Dr. Margaret Chan, the WHO director-general, said in a statement.

Twenty pills a day

While the overall incidence of tuberculosis has fallen in recent years, drug-resistant strains have increased. In a 2009 resolution to the World Health Assembly, the WHO noted that the highest levels of multidrug resistance reported in the agency’s lobal report “pose a threat to global public health security”.

The spread of resistant strains is particularly alarming because their long and difficult treatment process makes them significantly more difficult to cure than traditional strains.

The MSF manifesto makes reference to regimens that require up to 20 pills a day along with daily injections that make it painful to sit or lie down. The treatment is also known for strong side effects, including severe nausea and even deafness.

MSF is calling for universal access to diagnosis and treatment for patients suffering from drug-resistant tuberculosis, as well as the development of “more tolerable” drug regimens, and additional financial support from international donors and governments for research.

Perhaps the most serious obstacle to filling the 1.6-billion-dollar funding gap is the massive federal budget cuts that went into effect here in Washington in early March. These are slated to cut deeply into development assistance, including international health.

For instance, the United States will reduce its contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria alone by 300 million dollars, according to figures revealed by Secretary of State John Kerry.

“The United States is the number one donor to the Global Fund, and the Global Fund is the number one donor for treating multi-drug-resistant TB,” Cohn says. “So budget cuts are definitely a concern.”

Still, she notes, one of the biggest challenges lies in fostering cooperation among manufacturers.

“We need to see manufacturers engaging in trials on the different [anti-TB] drugs together, to determine their efficacy and to develop a regimen that works as strongly and safely as possible,” she says. “Unfortunately, we have not seen a lot of progress on this.”

Drug reservations

One of the drugs being lauded in the manifesto is bedaquiline. But some watchdog groups here are sounding alarms about the drug’s safety.

“I don’t have any problem with looking for more drugs to treat disease that is a terrible problem in many countries, but it has to be done very carefully and cautiously,” Dr. Sidney Wolfe, the director of the Health Research Group at Public Citizen, a Washington-based advocacy group, told IPS.

In a letter to the U.S. Food and Drug Administration sent in December, Public Citizen strongly opposed any accelerated approval of bedaquiline, noting that the drug has been shown to be highly dangerous in clinical trials. The letter referenced findings that patients taking bedaquiline in addition to standard TB treatment were five times likelier to die than those who took a placebo.

Despite these concerns, bedaquiline was approved in December.

“There are two possibilities,” Wolfe says. “Either [MSF] didn’t read the report [about the five-fold increase in death rate], or they did and decided that since the FDA approved it, it must be ok. Either one of these explanations is unacceptable. How can you be enthusiastic about a drug that is killing so many people?”

Cohn at MSF stresses the need to be vigilant about any new medication, and notes that the drug will now go through an additional phase of testing.

“Any new drug that comes to market we want to watch closely,” she says. “We are looking forward to data that will tell us more about the Phase 3 side effects of bedaquiline.”