Maryn McKenna

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New Analysis Says FDA Farm Antibiotic Reduction Won't Work As Planned

December 3, 2014 By Maryn Leave a Comment

Epsos.de (CC) on Flickr

Epsos.de (CC) on Flickr

A brand-new analysis of the Food and Drug Administration’s plans to restrict agricultural overuse of antibiotics brings some needed clarity to the subject — and calls into question how effective those plans will be.

The analysis, published by the Pew Charitable Trusts, examines whether the FDA’s request to veterinary pharma companies — to observe voluntary curbs on the antibiotics they sell — is actually going to make much difference in quantities of antibiotics that are used. And concludes: Maybe not.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: antibiotics, FDA, growth promoters

Update on the Found Vials: There Weren't 6; There Were 327. (Not All of Them Were Smallpox)

July 16, 2014 By Maryn Leave a Comment

Variola, CDC

Variola, CDC

I was away reporting most of today, and while I was out, a few federal emails landed in my mail with what probably sounded like a  thud. One was an official announcement from the Food and Drug Administration; the others were copies of FDA and NIH emails that people there thought I should see.

They all said the same thing: The six vials of smallpox virus found in an FDA cold-storage room on the National Institutes of Health campus July 1 and announced by the CDC last week had company. A lot of company: 321 other vials. Some of them contained other “select agents,” infectious pathogens considered serious enough — for the illness they create, or the lack of a vaccine to prevent or drugs to treat them — to be considered potential bioterror agents.

(If you’ve missed this story so far, catch up here, here, here and here.)

Here’s the gist of the FDA’s external announcement:

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: CDC, FDA, NIH, smallpox

The Leader of the Smallpox Eradication Effort Speaks About the Virus' Rediscovery

July 14, 2014 By Maryn Leave a Comment

Variola, CDC

Variola, CDC

Those of us who write about infectious diseases faced a conundrum last week, when the news broke that 60-year-old vials containing viable smallpox virus had been found on the National Institutes of Health campus. A responsible reporter always wants to talk to the experts in any subject. But when it comes to smallpox, experts can be hard to find.

Smallpox was one of the world’s worst killers, from prehistory through the first half of the 20th century. Yet there has not been a case of the dreadful disease anywhere since 1978, so few physicians working today have seen one. The virus is supposed to exist in only two highly secure stockpiles, so few scientists do research on it. And the aggressive campaign that chased the disease from the globe — the only human infection for which that claim can be made — ended 34 years ago. Many of the men and women who led it are in retirement, and a number have died.

Fortunately, the physician who headed that international campaign — 85-year-old Donald Ainslie Henderson, universally known as D.A. — is still working in public health, as a distinguished scholar at the bioterrorism-focused Center for Health Security of the University of Pittsburgh Medical Center. Henderson literally wrote the book on smallpox — twice, in fact: He co-authored the World Health Organization’s definitive 1,500-page reference, Smallpox and its Eradication (known in public health as the Red Book), and in 2009 wrote a personal reminiscence of the global battle, Smallpox: The Death of a Disease. Just last month, he published a lengthy, closely argued essay in the journal he co-edits, Biosecurity and Bioterrorism, urging the WHO to finally consent to destroying the last stocks of smallpox virus. (A decision the international agency declined to take; instead, for the sixth time in a row, it postponed a vote on destruction in favor of more study.) There are only a few people working in public health — not just in the United States, but in the world — who possess equivalent knowledge of smallpox, its eradication, and the persistent fears afterward that it could be used as a bioterror agent.

Last week, I talked to Henderson about the live-virus discovery and whether it will affect calls for all stocks of smallpox to be destroyed. He had some surprising things to say, particularly about the availability of smallpox vaccine. I edited our conversation for clarity and length.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: CDC, FDA, NIH, smallpox

Virus in Found Tubes of Smallpox Is Viable

July 11, 2014 By Maryn Leave a Comment

Variola, CDC

Variola, CDC

Here’s an update on the vials found on the National Institutes of Health campus last week that were labeled smallpox, and transported earlier this week to the Centers for Disease Control and Prevention: The CDC and NIH have both confirmed that the virus in two of the tubes is viable.

That is, if the vials had broken, and someone had come in contact with the dried contents, the result could have been a smallpox infection — something that has not been seen in the world since 1978.

NIH director Dr. Francis Collins made the announcement in an email sent to staff today, which was shared with me. Simultaneously, CDC director Dr. Thomas Frieden announced in a press briefing that the CDC lab studying the vials, which earlier had identified the contents as smallpox virus based on PCR of the contents’ DNA, had induced growth of the contents in a tissue culture, and confirmed that the growing material is smallpox virus.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: CDC, FDA, NIH, smallpox

What the Forthcoming White House Report on Antibiotic Resistance Will Ask For

July 11, 2014 By Maryn Leave a Comment

e-Magine Art (CC), Flickr

e-Magine Art (CC), Flickr

Among the groups that work on awareness of antibiotics resistance — which include major medical and public health organizations as well as nonprofits trying to direct attention to antibiotic misuse in medicine and agriculture — there has been a lot of anticipation of a forthcoming report by the President’s Council of Advisors on Science and Technology. The report, which has been in the works for months, will be published shortly, possibly as early as next week. Today, the council — known as PCAST for short — held a public meeting to discuss the report’s contents and vote as a group to accept or rejected. The meeting was webcast, and as far as I could tell, the vote was unanimous.

Though the report itself won’t be out for a bit, the meeting gave a good sense of what the report will say. For accessibility, PCAST runs live voice-recognition transcription of its meetings; so while the meeting was proceeding, I grabbed a transcript to review later. Here’s what seems to be coming.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: agriculture, antibiotics, FDA, Resistance

Found: Forgotten Vials of Smallpox

July 8, 2014 By Maryn Leave a Comment

Variola, CDC

Variola, CDC

Headline-making news today from the Centers for Disease Control and Prevention: Workers clearing out an old storage room on the Bethesda, Md. campus of the National Institutes of Health have found a forgotten box of vials that contain smallpox.

Yes, smallpox. The “most terrible of all the ministers of death,” as Thomas Babington Macaulay called it in his 1848 History of England — a disease that was the world’s most dreadful killer, until it was declared eradicated in 1980. A disease caused by a virus that now is supposed to reside in only two highly secure laboratories on the planet, in Russia, and at the CDC.

Smallpox is the only human disease ever successfully eradicated — pursued to elimination by a relentless dragnet that closed nooses of vaccination around every identified case. After the last natural infection, in Somalia in 1977, the World Health Organization launched a second dragnet, scouring lab freezers and storage rooms for any remaining samples of the virus, and consolidating them in Siberia and Atlanta.

Somehow, these six tubes of freeze-dried virus evaded the search. They were found in the storage room of a lab that now belongs to the Food and Drug Administration but was ceded to that agency by NIH in 1972. They may date back to the 1950s.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: CDC, FDA, NIH, smallpox, Who

Report: FDA Documents Show Decade of Unsuccessful Attempts to Control Farm Antibiotics

January 28, 2014 By Maryn Leave a Comment

Image: gina pina/Flickr

Image: gina pina/Flickr

A nonprofit group that has been using the courts to pressure the Food and Drug Administration into exerting more control over farm antibiotic overuse has done a deep review of FDA documents prised loose through Freedom of Information Act requests — and concludes that by allowing the drugs to remain on the market as formulated, the agency isn’t meeting its own internal safety standards.

Instead of only making that assertion, the Natural Resources Defense Council took the unusual step of showing its evidence in detail. NRDC published its analysis, Playing Chicken with Antibiotics, alongside a selection of the raw documents it received from the FDA. You’ll have to be a document-obsessive to take it on: The file (cached in a Dropbox and requiring download to view) is 306 mb and 971 pages. But even without considering its content, the file’s heft makes clear how much discussion there has been at the FDA over this issue, and suggests how much evidence has been accumulating over the problem of antibiotic resistance emerging from livestock production. Also telling: The FDA has been attempting to put some controls on livestock production since 1977; these documents cover only reviews of antibiotic feed additives that were conducted between 2001 and 2010.

NRDC’s conclusion, in its report:

FDA’s scientific reviewers’ findings show that none of these products would likely be approvable as new additives for nontherapeutic livestock use if submitted today, under current FDA guidelines. Eighteen of the 30 reviewed feed additives were deemed to pose a “high risk” of exposing humans to antibiotic-resistant bacteria through the food supply, based on the information available. The remainder lacked adequate data for the reviewers to make any determination and their safety remains unproven. In addition, FDA concluded in their review that at least 26 of the reviewed feed additives do not satisfy even the safety standards set by FDA in 1973.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: animals, antibiotics, FDA, food policy, food safety, growth promoters, NRDC, Resistance, Science Blogs

Can Antibiotics User Fees Force Down Drug Mis-Use and Overuse?

January 7, 2014 By Maryn Leave a Comment

image: NeilT (CC), Flickr

Happy new year, constant readers. Here’s the most urgent thing I have to say today: Stop reading and go set your DVRs for 8pm ET tonight. The fantastic The Poisoner’s Handbook, written by Wired colleague and dear friend Deborah Blum, has been adapted by PBS and airs tonight on The American Experience. It’s going to be superb.

Back? OK, on to business. Just before the holidays, the Food and Drug Administration finalized its long-aborning plan to ask the meat-production industry to reduce its use of routinely administered antibiotics. (My posts on the move here and here.) The FDA’s guidance to industry, as it is called, is not a regulation but rather a request for voluntary action on the part of veterinary-drug companies. It has met with skepticism and concerns that manufacturers will redefine the uses of their drugs in such a way that nothing will change.

The FDA action is aimed at the routine use of antibiotics for what is called growth promotion — causing animals to gain muscle faster than they would without the drugs being used — and is modeled on a ban on growth promoters enacted by the European Union in 2005. The goal, as in the EU, is to reduce the drugs’ use, and therefore the antibiotic-resistant bacteria that use stimulates.

In a recent New England Journal of Medicine, University of Calgary economist Aidan Hollis suggests though that a ban may not be the most useful or practical approach to the problem of drug overuse. In its place, he suggests the pocketbook persuasion of having to pay a fee.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: antibiotics, drug development, FDA, IDSA, Resistance, Science Blogs, stewardship

Re-Examining the FDA Antibiotics Decision: Banning Growth Promoters Won't Be Enough

December 27, 2013 By Maryn Leave a Comment

USDA Photos by Lance Cheung/Flickr

In my first take on the news of the FDA finalizing its request to agriculture to stop using growth-promoter antibiotics, I promised to come back for a more thoughtful reaction. And then this happened, and this happened, and the holidays happened, and, well, it’s been a busy few weeks.

So, finally getting back to it: When the news broke, a number of people, including me, said that this was a long-awaited first step on the part of the FDA, but of uncertain ultimate impact because it asks for voluntary action and does not address whether the drugs simply can be relabeled. I still agree with both those points, but think the possibly most important issue — which I raised briefly in the first post  — is that merely removing antibiotics, without changing the system in which those antibiotics have been administered, may cause significant animal-welfare problems, without having any real effect on human health.

(If you’d like the short version of this, listen to my chat with NPR’s Weekend All Things Considered.)

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: animals, antibiotics, FDA, food, food policy, food safety, growth promoters, Resistance, Science Blogs

FDA Scrutinizes Antibacterial Products for Hormonal Disruption, Bacterial Resistance

December 16, 2013 By Maryn Leave a Comment

Image: Jim Belford (CC), Flickr

More news today out of the Food and Drug Administration — so while I’m still writing my follow-up to last week’s news on growth promoters, I want to toss this up first. The latest: The FDA has announced that it is formally reconsidering “antibacterial” soaps and other personal-care products, charging that the antibacterial ingredients confer no benefit over regular soap and water while carrying extra risks.

In a draft rule that will be published Tuesday in the Federal Register, the agency calls for manufacturers of consumer antibacterial products to begin providing data that shows the ingredients are both safe for daily use, and also more effective than plain soap and water. Deep in the 137-page rule, it also raises the issue that’s most interesting to me: whether the routine use of these products causes bacteria to develop resistance against the active ingredients, and against antibiotics as an unintended side effect.

Antibacterial products are a vast market; according to the FDA there are more than 2,000 currently for sale to consumers. (NB: This rule does not cover antibacterial hand-sanitizers; neither does it include the kind of washes and wipes used in healthcare.) The announcement today opens a 6-month comment period that ends next June. It will be interesting to see where this goes.

[Read more…]

Filed Under: Science, Science Blogs, Superbug Tagged With: antibiotics, EPA, FDA, Resistance, Science Blogs

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