by Marion Nestle

Currently browsing posts about: Antibiotics

Dec 27 2013

More on “profligate” use of antibiotics to promote growth in farm animals

The New England Journal of Medicine has an editorial on why we need to stop using antibiotics to promote the growth of farm animals and make sure they are only used for therapeutic purposes.

Otherwise, bacteria will become resistant to them and the antibiotics won’t work in us.

This figure from the article illustrates the problem:

As writers in the Journal wrote a year ago, we know what to do about the problem: Ban antibiotic use for everything other than disease treatment.

The FDA is taking baby steps in this direction.  How about a new year’s resolution to speed up the process?

Dec 17 2013

The FDA issues guidance on animal antibiotics–voluntary, alas, but still a major big deal

I was in Washington DC last week when the FDA announced  that it was taking significant steps to address antibiotic resistance, a problem caused by overuse in raising animals for food.

The FDA called on makers of animal antibiotics to:

  • Voluntarily stop labeling medical important antibiotics as usable for promoting animal growth or feed efficiency (in essence, banning antibiotics from these uses).
  • Voluntarily notify the FDA of their intent to sign on to these strategies within the next three months.
  • Voluntarily put the new guidance into effect within 3 years.
  • Agree to a proposed rule to require a veterinarian’s prescription to use antibiotics that are presently sold over the counter (the proposal is open for public comment for 90 days at www.regulations.gov.   Docket FDA-2010-N-0155).

Voluntary is, of course, a red flag and the Washington Post quoted critics saying that the new guidance falls far short of what really is needed—a flat-out ban on use of antibiotics as growth promoters.

  • Consumers Union is concerned about the long delay caused by the 3-year window.
  • CSPI is worried about all the loopholes.
  • NRDC thinks the FDA is pretending to do more than it’s really doing and “kicks the can significantly down the road.”
  • Mother Jones points out that the meat industry can still “claim it’s using antibiotics ‘preventively,’ continuing to reap the benefits of growth promotion and continue to generate resistant bacteria.”
  • Civil Eats reminds us that the Pew Commission on Industrial Farm Animal Production (on which I served) recommended a ban on nontherapeutic use of all antibiotics.

Yes, the loopholes are real, but I view the FDA’s guidance as a major big deal.  The agency is explicitly taking on the antibiotic problem.  It is sending a clear signal to industrial farm animal  producers that sooner or later they will have to:

  • Stop using antibiotics as growth promoters.
  • Stop using antibiotics indiscriminately, even for disease treatment.

I think the FDA is dead serious about the antibiotic problem.  If the FDA seems to be doing this in some convoluted fashion, I’m guessing it’s because it has to.  The FDA must not have been able to find any other politically viable way to get at the antibiotics problem.

I see this as a first step on the road to banning antibiotics for any use in animals other than the occasional treatment of specific illnesses.

As the New York Times puts it,

This is the agency’s first serious attempt in decades to curb what experts have long regarded as the systematic overuse of antibiotics in healthy farm animals, with the drugs typically added directly into their feed and water. The waning effectiveness of antibiotics — wonder drugs of the 20th century — has become a looming threat to public health. At least two million Americans fall sick every year and about 23,000 die from antibiotic-resistant infections.

Still not convinced antibiotics are worth banning for promoting growth?

The best explanation is the Washington Post’s handy guide to the antibiotic-perplexed.  Here, for example, is its timeline of development of microbial resistance to antibiotics.  The bottom line: the more widespread the use of antibiotics, the greater the onset and prevalence of resistance.  And it takes practically no time for bacteria to develop resistance to antibiotic drugs.

nchembio.2007.24-F1

Resources from FDA

Sep 26 2013

CDC’s thoroughly convincing report on the threat of antibiotic resistance

The CDC has produced a major study on antibiotic resistance and how it works. 

The report provides convincing evidence that use of antibiotics in farm animals must be restricted to therapeutic purposes—and not used to promote growth.

Apr 24 2013

FDA vs EWG: Report on antibiotic-resistant superbugs in meat oversimplified, misleading?

Earlier this month, the Environmental Working Group (EWG) issued a report on antibiotic-resistant bacteria in meat: Superbugs Invade American Supermarkets.

Its message:

Consumers have a right to know that federal scientists are finding antibiotic-resistant bacteria on retail meat in high percentages.

The report must have struck a nerve.  The FDA has now posted a rebuttal on its website, along with the agency’s interpretation of data in the 2011 Retail Meat Annual Report of the National Antimicrobial Resistance Monitoring System (NARMS).

The EWG, says FDA, “oversimplifies the NARMS data and provides misleading conclusions.”

The FDA particularly objects to EWG’s use of the term “superbugs.”

We believe that it is inaccurate and alarmist to define bacteria resistant to one, or even a few, antimicrobials as “superbugs” if these same bacteria are still treatable by other commonly used antibiotics.

The FDA says the NARMS data show:

  • No fluoroquinolone resistance in Salmonella from any source (the drug of choice for treating adults with Salmonella).
  • Resistance to trimethoprim-sulfonamide is also low (0% to 3.7%).
  • Fluoroquinolone resistance in Campylobacter has remained essentially unchanged since it was banned for use in poultry in 2005.
  • Macrolide antibiotic resistance in retail chicken isolates remains low (this is the drug of choice for treating Campylobacter)
  • Multidrug resistance is rare in Campylobacter except that gentamicin resistance increased from 0.7% in 2007 to 18.1% in 2011.
  • Resistance to third-generation cephalosporins, which are used to treat salmonellosis, increased in Salmonella from chicken (10 to 33.5%) and turkey (8.1 to 22.4%) from 2002 to 2011.  FDA has already taken action by prohibiting certain extra-label uses of cephalosporins in cows, pigs, chickens and turkeys.

The EWG’s response to the FDA’s rebuttal:

This is the best the agency can do?

It has been failing to protect the public health on this issue for 40 years, only recently issuing a voluntary guidance to scale back on the worst antibiotic abuses.

What are we to make of this dispute?

Beyond questions about how best to frame antibiotic resistance, some facts are clear.

  • Most antibiotics in the United States are used as growth promoters for raising meat animals, not as treatment for infections in animals or people.
  • Frequent use of antibiotics selects for and promotes the growth of antibiotic-resistant bacteria.
  • Infections with antibiotic-resistant bacteria are difficult to treat, and sometimes very difficult to treat.

It would be better for public health to end the use of antibiotics as growth promoters.

The FDA’s current stance on use of animal antibiotics appears to be more about protecting the meat industry than about protecting public health.

While waiting for the politics to get better (and this might be a long wait), the EWG has some tips for avoiding antibiotic-resistant bacteria in meat.  I can’t think of a single good reason not to follow these recommendations, except that they place the burden of avoiding antibiotic-resistant bacteria on you rather than on the meat industry.

That’s why EWG’s advice to Be Vocal makes especially good sense:

Be vocal: 

  • When you’re eating out: ask if the meat was raised without unnecessary antibiotics. 
  • „At the doctor’s office: don’t press for unnecessary antibiotics. 
  • With your friends: share this tip sheet or a wallet guide with them. 
  • „Make your voice heard: Go to ewg.org/antibioticsaction to find out how you can help preserve the effectiveness of antibiotics [Try www.ewg.org--the link given here doesn't seem to work].
Apr 12 2012

The FDA takes action on animal antibiotics, at long last

Yesterday, the FDA proposed long-awaited action against use of antibiotics for non-therapeutic purposes in animal agriculture.

From the outside, this might look more like inaction.  The agency is asking drug companies to voluntarily cut back on producing antibiotics for non-therapeutic purposes and to require veterinary oversight of use of these drugs.

The announcement comes in the form of three documents in the Federal Register.

  • Final Guidance for Industry: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.
  • Draft Guidance for Industry aimed at assisting drug companies in voluntarily removing from FDA-approved product labels uses of antibiotics for production rather than therapy, and voluntarily changing the marketing status to include veterinary oversight.  This is open for public comment.
  • A draft of a proposed Veterinary Feed Directive regulation,  also open for public comment, outlining how veterinarians can authorize the use of antibiotics in animal feed.

In an FAQ on the announcement, the FDA answers some obvious questions:

4. What is “judicious use” and what are FDA’s recommendations?

“Judicious use” is using an antimicrobial drug appropriately and only when necessary;

Based on a thorough review of the available scientific information, FDA recommends that use of medically important antimicrobial drugs in food-producing animals be limited to situations where the use of these drugs is necessary for ensuring animal health, and their use includes veterinary oversight or consultation.

FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use (my emphasis).

5. Why did FDA decide to do this now?

FDA has worked with many stakeholder groups and the U.S. Department of Agriculture (USDA) to develop a strategy that will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agricultural industry.

In June 2010, FDA released a draft guidance document explaining its recommendations for change and in the interim period sought and received input from various stakeholders, including the animal pharmaceutical industry, animal feed industry, veterinary and animal producer communities, consumer advocacy groups and USDA.

Translation: this has been in the works for a long time and is the result of extensive discussions with the relevant industries.

As Food Safety News explains, the reaction of just about everyone to this announcement has been tepid.

  • Food safety advocates object to voluntary, because it never works.
  •  The meat industry insists that non-therapeutic antibiotics are essential for producing cheap meat under crowded conditions.

For example, the National Pork Producers make the usual industry arguments:

Harm to small farmers: The guidance could eliminate antibiotics uses that are extremely important to the health of animals…And the requirement for VFDs [veterinary oversight] could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.

Voluntary equals regulation: The guidance, which does not have the force of law but may be treated as such by FDA, is a move to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on the use of antibiotics in livestock and poultry production.

The science is “junk”: But numerous peer-reviewed risk assessments, including at least one by FDA, show a “negligible” risk to human health of antibiotics use in food-animal production.

My interpretation:

The FDA’s position on non-therapeutic use of antibiotics in animal agriculture is quite clear.  The agency recognizes that based on the science, the use of antibiotics as growth promoters in animals poses a serious risk to human health.

I’m guessing this is the best the FDA can do in an election year.

This move looks to me like a direct challenge to drug companies and meat producers to clean up their acts and take some responsibility for the effects of their misuse of animal antibiotics on public health.

It’s also a challenge to food safety advocates to make sure that the FDA monitors the effects of its voluntary guidance and, if the industries don’t cooperate, that the FDA gets busy on real regulations.

Addition: The account in today’s New York Times explains why the FDA is starting with voluntary efforts:

The reason for the reliance on voluntary efforts is that the F.D.A.’s process for revoking approved drug uses is lengthy and cumbersome, officials said. The last time the F.D.A. banned an agricultural use of a medically important antibiotic against the wishes of its maker, legal appeals took five years. In this case, hundreds of drugs are involved, each with myriad approved uses in various animals.

“You and I and our children would be long dead before F.D.A. could restrict all of these uses on its own,” Ms. Rogers [of the Pew Foundation]said.

Apr 6 2012

Tired of hearing about beef processing? Try chicken.

Apparently as a result of a need to cut costs, the USDA is changing the way its inspectors oversee chicken processing.

As Dana Milbank of the Washington Post puts it, this is

a proposal to allow chicken slaughterhouses to inspect themselves — eliminating those pesky federal monitors who have the annoying habit of taking diseased birds out of the food supply.

Even if the Obama administration were inclined to bring down capitalism with an orgy of overregulation, there isn’t enough money in the budget to enforce the rules on the books.  That’s what the chicken fight is about: Spending cuts…are a form of de facto deregulation (my emphasis).

The New York Times account of this policy change notes that inspectors:

had observed numerous instances of poultry plant employees allowing birds contaminated with fecal matter or other substances to pass. And even when the employees try to remove diseased birds, they face reprimands….

The Agriculture Department proposal allows poultry plants to speed up their assembly lines to about 200 birds per minute from 140, hampering any effort to examine birds for defects.

But that’s not all.  The Center for Livable Future at Johns Hopkins  reports that meal made from chicken by-products (in this case, feathers) contains arsenic and antibiotics such as fluoroquinolones that have been banned by the FDA for use in poultry.

A study published in Environmental Science & Technology found fluoroquinolone antibiotics in 8 of 12 samples of feather meal collected from six states and China.

A second study found arsenic in every sample of feather meal tested.

These findings indicate that poultry producers are using these drugs, even though they are not allowed to.

The U.S. poultry industry raises about 9 billion chickens and 80 million turkeys for human consumption each year.  Meal made from their feathers is commonly added to feed for chickens, pigs, cattle, and fish.  This could be a reentry route into the human food supply for such drugs.

Nicholas Kristof explains in the New York Times that these studies also found feather meal to contain

an antihistamine that is the active ingredient of Benadryl…[and] acetaminophen, the active ingredient in Tylenol.  And feather-meal samples from China contained an antidepressant that is the active ingredient in Prozac.

Poultry-growing literature has recommended Benadryl to reduce anxiety among chickens, apparently because stressed chickens have tougher meat and grow more slowly. Tylenol and Prozac presumably serve the same purpose.

Such findings indicate some of the worst problems with industrial poultry production.  They result from pressures to produce chickens cheaply.  The faster chickens can be pushed to grow, the less feed they consume and the cheaper they are to raise.

I don’t know what the best system for inspection might be, but I’m quite sure that leaving food safety oversight to the discretion of the packers is not a good idea.  Neither is speeding up the line.  And neither is feeding chickens drugs that can affect human health.

Here is even more evidence for the need for an overhaul of our food safety system.

A single food safety system anyone?

Jan 10 2012

Antibiotics in farm animals: FDA issues weak rule

By this time everybody knows—or ought to—that the non-therapeutic use of antibiotics in farm animals is a threat to human health. 

Using antibiotics to promote animal growth or reduce feed requirements is a bad idea.  Widespread use of these drugs induces microbial resistance, making the antibiotics ineffective against human disease.

So you would think that public health agencies would be falling all over themselves trying to reduce antibiotic use in farm animals.  No such luck.  Proposals to restrict use of antibiotics for therapeutic purposes runs up against the interests of meat and poultry industries. 

The best the FDA can do falls far short of what is needed.  Witness its pussy footing on cephalosporin drugs.

On January 4, the FDA proposed a final rule on use of cephalosporin drugs in animal agriculture.

The rule bans some “extralabel” (i.e., unapproved) uses of cephalosporin antimicrobial drugs in some food animals—cattle, swine, chickens, and turkeys. 

As the FDA’s press release explains, it is banning use of cephalosporins:

  • At unapproved dose levels, frequencies, durations, or routes of administration
  • In forms that are not approved for use in cattle, swine, chickens, and turkeys because they are intended for humans or companion animals
  • For disease prevention

These are all good things but should do much more. 

Cephalosporins are used in humans to treat pneumonia, skin and soft tissue infections, pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

If bacteria are resistant to cephalosporins, doctors have fewer options for treatment and these are less effective or more harmful.

 What is troubling is that the FDA proposed a more restrictive ban in 2008 but reversed the decision under pressure from industry veterinarians.

As Food Safety News reports, the new order, which is scheduled to go into effect in April, follows a couple of previous notices published last year. 

In November, the FDA turned down consumer petitions calling for a ban on the non-therapeutic use of a broader range of antibiotics in farm animals. 

In December, the FDA admitted that it had given up a plan first announced in 1977 to withdraw approval for penicillin and tetracyclines in animal feed.

Apparently, the FDA has decided to try to get drug companies and the meat and poultry industries to reduce the use of antibiotics voluntarily.

Good luck with that. 

Philip Brasher writes in the Des Moines Register that the new restrictions will hit hardest on the chicken industry, which uses the drugs for disease prevention. 

He says the FDA’s 2008  proposal would have blocked hog producers from treating illnesses that aren’t listed on the label.   He quotes the chief veterinarian for the National Pork Producers Council:

We are pleased that FDA balanced the need to protect animal health with their concerns about resistance.

This is not about animal health.  Nobody is trying to stop the use of antibiotics to treat animal disease.  At issue is their use as growth promoters or feed savers.

Congresswoman Louise Slaughter (Dem-NY) understandably views the FDA’s action as “tepid.”  She has introduced the  Preservation of Antibiotics for Medical Treatment Act to deal with the problem of non-therapeutic antibiotic use.  Of the FDA’s proposal, she said:

This is a modest first step by the FDA…but we’re really just looking at the tip of the iceberg. We don’t have time for the FDA to ploddingly take half-measures. We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs. We need to start acting with the swiftness and decisiveness this problem deserves.

We do indeed.  Her bill deserves much support.   Public health should not be left up to the meat, poultry, and drug industries to decide.

Addition, January 12: I missed the New York Times editorial on this issue:

It’s time for the F.D.A. to consider the public’s health as carefully as it considers the interests of intensive agriculture and pharmaceutical companies.

Dec 29 2011

Food safety: it’s déjà vu all over again

In preparation for the holiday season, Secretary of Health and Human Services Kathleen Sebelius and Agriculture Secretary Thomas Vilsack held a press conference  to promote the departments’ efforts on food safety.

They announced release of the administration’s progress report from its Food Safety Working Group.

They also highlighted additional places to get government information about food safety at home:

I didn’t pay much attention to these announcements until I read the slightly snarky account in Food Chemical News (December 22). 

The Obama administration patted itself on the back today with a new report that both lists the accomplishments over the past three years of its Food Safety Working Group (FSWG) and identifies the group’s top priorities for the coming year.

Released just minutes before a short media call that served as more of a pep rally, The Federal Food Safety Working Group Progress Report, a 31-page document, summarizes for stakeholders a host of activities that have taken place at government agencies over the past three years related to detecting foodborne pathogens, enhancing surveillance, responding to food safety problems, improving food safety at the retail level and educating consumers.

The list of the administration’s food safety accomplishments is long and detailed, and many are impressive.

But what the report does not say is telling.  Neither the USDA nor FDA have the resources or power to require the industries they supposedly regulate to produce safe food.

As Mark Bittman explains in his Opinionator column in the New York Times, politics defeats even the most rational and thoroughly science-based safety measures, leaving the FDA unable to do much more than politely request “voluntary guidance” of industry.

Bittman focuses on the political barriers to doing what the FDA has been asking for since 1977:  a ban on the use of antibiotics for non-therapeutic purposes, in this case to make food animals grow faster.   The result: “Bacteria 1, FDA 0.”

Here’s the nut: The F.D.A. has no money to spare, but the corporations that control the food industry have all they need, along with the political power it buys.

That’s why we can say this without equivocation: public health, the quality of our food, and animal welfare  are all sacrificed to the profits that can be made by raising animals in factories….Animals move from farm to refrigerator case in record time; banning prophylactic drugs would slow this process down, and with it the meat industry’s rate of profit.

Lawmakers beholden to corporate money are not about to let that happen, at least not without a fight.

For more than 20 years, the Government Accountability Office has called for creation of a single food safety agency that unites the safety oversight functions of the FDA and USDA and has the authority to require food to be produced safely.

In this Congress?  Hopeless.

But Congress can be changed—and that’s a worthy thought for the new year.

 

 

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