Antibiotic use in animals: The feds move, a little

This is an addition for archival purposes of a post that originally appeared at Scienceblogs.

(You leave the country for a few days -- I spoke at a conference in Brussels, which was was lovely, thanks for asking -- and all kinds of news breaks out. So, sorry to be late on this, but it's an important issue.)

Last week, the Food and Drug Adminstration took the first (baby, mincing, tentative) steps to address the problem of antibiotics being used in animal agriculture, not to treat disease, but to make animals grow up to market weight faster. This practice -- variously called subtherapeutic dosing, growth promotion, and "for production purposes" in the FDA's exceedingly careful language -- has been fully banned in the European Union for 4 years, and some aspects of the practice have been banned longer.

The simple reason for the ban: There's decades of good science and real-world experience showing that it contributes to the development of drug-resistant organisms in farm animals and the farm environment, organisms that leave farms in the animals and in their manure, and also contaminate the environment beyond farm borders via leakage into groundwater and dust blowing off manure lagoons.That movement off the farm is critical because many of the drugs used in agriculture are the same, or close analogs, of drugs used in human medicine; so resistance that develops on the farm endangers human health as well. (MRSA ST398, livestock-associated MRSA, is the latest example of this. Find a long archive of posts on ST398 here.)

Just to be clear, growth-promoters don't treat disease; they're given to healthy animals solely for the purpose of getting them up to sale weight and to market faster. The ways in which antibiotics are given to livestock to treat or prevent disease have their own issues, but those are not part of the FDA effort. (Historical note: The growth-promoting effect of trace amounts of antibiotics was first recognized in 1947, when scientists at Lederle were looking for something to do with the leftover fermentation mash from the manufacture of chlortetracycline, fed it to chickens, and discovered they thrived on it. Stuart Levy's The Antibiotic Paradox tells this story in detail.)

In human medicine, when we give antibiotics to people who are not sick with a bacterial illness, we call it inappropriate use -- and aim massive education campaigns at the practice in an attempt to dial it down. In contract, the animal side has had a free pass for a long time, to the extent that it remains unclear how many antibiotics are used in farming in the US (best estimate: about 70% of all antibiotic use in the US per year), and there is no organized surveillance that would look at what organisms are emerging in animals from that use.

The FDA has been trying to put curbs on growth promoters since the 1970s, always without success; the lobbying against it, by agriculture and also by pharmaceutical interests, is reliably intense. There's been a parallel effort in Congress to limit the use in animals of drugs that have close analogs in human medicine, via the Preservation of Antibiotics for Medical Treatment Act, or PAMTA, authored by Rep. Louise Slaughter (D-NY), Congress's only microbiologist. PAMTA has been introduced in several Congresses but this year finally gained some traction. Last year, the Obama administration signaled, in testimony by then-new assistant FDA commissioner Joshua Sharfstein, that it might be friendly to the idea of dialing back on growth-promoter antibiotic use, and it looked as though the long logjam might finally be broken.

Well, OK: Not broken, exactly. Just shifted a little, and maybe showing a tiny bit of light.

On Tuesday, the FDA released a "draft guidance" that proposes animal ag do two things: stop using growth-promoting subtherapeutic dosing, and administer antibiotics to animals under the supervision of a veterinarian. That's the good news.

The bad news: It's only a guidance, not a regulation. In other words, it has no force in law. It's more like a request -- though in a press conference last week, Sharfstein suggested it might also be a shot across agriculture's collective bow:

We have the regulatory mechanisms and the industry knows that. But we are also interested in what things can be done just voluntarily that they would do them. And I think it'll be interesting to see how the industry responds to this and how - what direction their comments take. ...We're not handcuffed to the steering wheel of a particular strategy at this point. We really want to understand what people think. And but we're also - I'm not ruling out anything that we could do to accomplish these important public health goals. (Transcript)

Reactions to the FDA announcement were predictable -- effectively "No science, more research needed": Here's the National Cattlemen's Beef Association, the National Pork Producers Council, and a standing statement by the Animal Health Institute. (Supporting the FDA move: the Pew Charitable Trusts, the New York Times.)

The draft guidance stays open for public comment for 60 days, until Aug. 30. The required Federal Register posting is here, with the mailing address. Electronic comments can be left at Regulations.gov; the docket number for the guidance is FDA-2010-D-0094; 33 comments have been posted already.

Quick alert: Congressional hearing Wednesday

Constant readers, I'm on the road again: Georgia Center for the Book tonight in Decatur, 7:15 p.m. But if you can't make that, take a look at this: The Energy and Commerce Subcommittee of the US House of Representatives has announced a hearing for Wednesday on "Antibiotic resistance and the threat to public health."

This is not a hearing on PAMTA, but apparently a broader hearing on the whole issue, featuring two VIPs: Dr. Anthony Fauci of NIH and Dr. Tom Frieden of the CDC. To my eye, this indicates that official, policy interest in this issue is (finally, at last) ramping up.

The hearing page is here and the preliminary memo on it is here.

Guest Q&A: Dr. Brad Spellberg and RISING PLAGUE

I'm thrilled today to present another guest blogger: Dr. Brad Spellberg, associate professor of medicine at the David Geffen School of Medicine at UCLA and author of the new book Rising Plague: The Global Threat from Deadly Bacteria and Our Dwindling Arsenal to Fight Them (Prometheus Books). This new book is important reading for anyone concerned, as all of us are here, about the narrowing pipeline for new antibiotics against MRSA and other resistant pathogens. That pipeline problem is something Dr. Spellberg knows well: He is not only a practicing infectious-disease physician, but also a member of the Antimicrobial Availability Task Force of the Infectious Diseases Society of America, the specialty society that produced the "Bad Bugs" reports that I've posted on before.

Below, Dr. Spellberg thoughtfully answers some questions about the difficulties of treating resistant infections and of developing drugs to control them.


From your point of view as a practicing ID physician, why is it so difficult to prevent resistant infections?

It's difficult to prevent all infections period. Not more difficult to prevent infections caused by resistant organisms than any other organisms. However, also difficult to prevent the spread of resistance among bacteria that are causing infections.

So, why is it difficult? People have this crazy belief that hospital acquired infections are the result of sloppy medicine. Not so. They are the result of very sick people with tremendously sophisticated levels of intensive medical care being delivered in a concentrated environment (i.e., a hospital). Crowd a bunch of sick people together with plastic catheters, mechanical ventilators, and nasty bacteria, and such infections are inevitable. What we are learning is that we have to go above and beyond normal to stop these infections from happening. Research is needed on how best to do this. It's not as simple as people think.

You can't stop the spread of the resistance itself. It is inevitable.

You say in Rising Plague that physician misuse and overuse of antibiotics is not the cause of antibiotic resistance. What do you consider the primary driver?

This is by far the biggest misperception among the public. Let's start from first principles. Who invented antibiotics? Who invented antibiotic resistance? When were both invented?

Humans did NOT invent antibiotics. Bacteria did...about 2 billion years ago. And they invented antibiotic resistance at the same time. So, bacteria have been creating and defeating antibiotics for 20 million times longer than humans have even known that antibiotics exist (about 78 years, as the original sulfa compound was developed in late 1931 by Gerhard Domagk). Over the past 2 billion years, bacteria warring among themselves have learned to target virtually every targetable biochemical pathway with antibiotics, and have learned to create defense mechanisms to defeat virtually all such antibiotics. They are already resistant to drugs we haven't even developed yet. It is bacteria that cause antibiotic resistance, not humans.

What humans do, is we apply natural selection when we use antibiotics. We kill off susceptible bacteria, leaving behind already resistant bacteria to replicate and spread their resistance genes.

This may seem like a subtle distinction: We don't create antibiotic resistance, we just increase its rate of spread. But, from the perspective of effective response planning, this is a critical distinction. If inappropriate antibiotic use caused antibiotic resistance, all we would have to do to defeat resistance is never prescribe drugs inappropriately. Unfortunately, that won't work. All antibiotic prescription, even appropriate antibiotic prescription, increases selective pressure, which increases the rate of spread of resistance.

Eliminating inappropriate antibiotic use, and always using antibiotics appropriately is indeed critical, because it will slow the spread of resistance, buying us time to develop new antibiotics. But if 100% of our efforts are focused on antibiotic conservation, all we will achieve is a slowing of the inevitable exhaustion of the antibiotic resource. What is needed is to marry antibiotic conservation with antibiotic restoration. That is, we need new drugs to be developed. Just conserving what we have is not enough.

Why are "antibiotic stewardship" policies not a sufficient remedy for controlling resistance?

See above. Stewardship leads to conservation. That is half the battle, but by itself it will only lead to a slowing of the inevitable exhaustion of the resource.

Furthermore, the initial calls for stewardship were made by people like Max Finland in the late 1940s and early 1950s. This is not a new call. It's more than a half century old. It just doesn't work very well. An analogy is the temptation to say that we don't need condoms to stop the spread of STDs, we just need abstinence. It is true that abstinence will stop the spread of STDs. But, an abstinence-only policy just doesn't work. You've got to have the condoms too. Well, stewardship, by itself, just hasn't worked after more than 60 years of calls for it. It is too hard to change behavior, and the pressures on physicians not to be wrong about their patients' illnesses is too great.

What do you consider the chief impediments to developing newer/better antibiotics?

The two major impediments are: 1) economic, and 2) regulatory.

The primary economic impediment is that antibiotics have a lower rate of return on investment than other classes of drugs. You make a lot more money back on your R&D investment if the drug is taken every day for the rest of the patient's life (e.g. cholesterol, hypertension, dementia, arthritis) than if it is taken for 7 days and then the patient stops because he/she is cured.

The regulatory problem is a startling degree of confusion at the FDA regarding what types of clinical trials should be conducted ot lead to approval of new antibiotics. There has been a total rethinking of antibiotic clinical trials at the FDA over the past 5 years. Right now, companies don't know what trials they are supposed to do to get drugs done, and increasingly the standards are calling for infeasible study designs that simply can't be conducted. This revisionist thinking is being driven by statisticians who know nothing about clinical medicine or patient care. They are asking for things to be done that can't be done to human beings. The balance of clinical and statistical concerns is totally out of whack, and must be restored if this problem is to be solved.

What types of policies are needed to kick-start development of new antibiotics?

Simple. Solutions follow the problems above.

For the economic problem, we need Congress to pass legislation that creates special economic incentives for companies to re-enter the antibiotic R&D market. The return on investment calculation must be changed. Antibiotics are a unique, critical public health need. Congress should recognize this. Examples of programs that would work include increase in funding to scientists (e.g. via NIH) who study bacterial resistance and antibiotic development. Increased small business grants to help translate basic science discoveries to lead compound antibiotics. Tax credits, guaranteed markets, patent extensions, and prizes to serve as pull strategies to help companies improve the return on investment for antibiotics.

For the regulatory problem, Congress needs to stop hammering the FDA into a state of paralysis, where fear permeates every decision to approve a drug. We should be encouraging a balance between statistical concerns and clinical concerns, and we need to restore a sense that the agency is regulating drugs used by physicians for patients, and that trials showing those drugs are safe and effective must be feasible to conduct and relevant to how the drugs will be used in clinical medicine after they are approved.

Wednesday a.m.: Congressional briefing on antibiotics in livestock - live-tweeted!

Folks: On Wednesday 2 December, at 9:30 a.m. EST, Rep. Louise Slaughter (D-NY) will host a Congressional briefing about antibiotic use in food animals. As a reminder, Rep. Slaughter is an MPH and Congress's only microbiologist, and the chief sponsor of PAMTA, the Preservation of Antibiotics for Medical Treatment Act that proposes restricting antibiotic use in animals to therapeutic uses under the guidance of a veterinarian and phases out "growth promotion" with sub-therapeutic doses, which consumes millions of pounds of antibiotics every year, many of them close analogs to human drugs.

Appearing at the briefing along with Rep. Slaughter are leaders of efforts that have produced an important string of reports on antibiotic overuse — the Pew Commission on Industrial Farm Animal Production and the Extending the Cure project of Resources for the Future:

• Michael Blackwell, DVM, MPH–former Vice Chair, Pew Commission on Industrial Farm Animal Production; Assistant Surgeon General, USPHS (ret.); Former Dean, College of Veterinary Medicine, University of Tennessee, Knoxville, TN.
• Robert Lawrence, MD–Director, The Johns Hopkins Center for a Livable Future, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
• Ramanan Laxminarayan, PhD, MPH–Senior Fellow, Center for Disease Dynamics, Economics, and Policy, Resources for the Future, Washington, DC
• Robert Martin–Senior officer, Pew Environmental Group; former Executive Director, Pew Commission on Industrial Farm Animal Production, Washington, DC
• Lance Price, PhD– Director, Center for Metagenomics and Human Health, Translational Genomics Research Institute, Flagstaff, AZ

Here's a post explaining the importance of this issue from the blog of the Center for a Livable Future, a Johns Hopkins University research group that has produced some of the most mportant papers on leakage of antibiotic-resistant bacteria and antibiotic residues from CAFOs ("confined" or "concentrated" "animal-feeding operations" — very, very large-scale farms). And here's some video on the issue from last summer from Lou Dobbs Tonight.

Because the event Wednesday is an informational briefing, not a hearing, I can't find any link for a live webcast. (I'll update if I find one.) But the hearing will be live-tweeted by the staff of the Center for a Livable Future (@LivableFuture) at the hashtag #CLF09. BLOGGERS: They will take tweeted questions toward the end of the hearing, ~10:45 a.m. — use the hashtag.

Two good reports published elsewhere

Some holiday reading:

• Mike the Mad Biologist, who often blogs about MRSA, has an analysis up about the varying degrees of attention that the Senate and House healthcare reform bills give antibiotic resistance and healthcare infections
• And Jacob Goldstein at the Wall Street Journal's WSJHealth blog describes and links to a program at UCLA Medical Center that uses volunteer undergraduate observers to make sure healthcare staff wash their hands. (h/t @ePatientDave)
  

Antibiotic misuse in animals - one example

Via the Minneapolis Star Tribune and the excellent blog Fair Food Fight comes the story of two cows, from two Minnesota farms, that have been reprimanded by the US Food and Drug Administration for bringing cows to slaughter that turned out to have been massively overdosed with antibiotics.

From the Strib:

In a rare move, federal officials sent stern warning letters to two central Minnesota dairy farms, which were among only 30 farms nationwide reprimanded so far this year for violating the rules governing how animal drugs can be used.
J&L Dairy, in Clarissa, Minn., sent a dairy cow to slaughter in March, even though it was drugged with 129 times the amount of penicillin allowed under federal regulations.
Another farm, Evergreen Acres Dairy, LLC, in Paynesville, Minn., was warned by the FDA last month, after one of its cows was found to have more than four times the allowed amount for a certain type of antibiotic. Further inspection found that the farm had misused 10 other drugs. (Byline Lora Pabst)

From one of the FDA's reprimand letters, to J&L Dairy of Clarissa, Minn.:

Our investigation ... found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. ... Our investigation found that you routinely administered penicillin G procaine to dairy cows without following the daily dosage amount or dosage amount per injection site as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a), and your extralabel use of penicillin G procaine resulted in illegal drug residue, in violation of 21 CFR 530.11(d).

From the other reprimand letter, to Evergreen Acres Dairy of Paynesville, Minn.:

Our investigation ... found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
...The investigation ... found that you adulterated the new animal drugs neomycin sulfate, sulfadimethoxine oral solution, oxytetracycline injection, oxytetracycline hydrochloride injection, ceftiofur hydrochloride, ceftiofur crystalline free acid, ceftiofur sodium, penicillin G procaine aqueous suspension, florfenicol, tetracycline hydrochloride soluble powder, and tylosin. Specifically, the investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs contrary to their approved labeling is an extralabel use.

There are some important points to make here.

As we've talked about before, many of the antibiotics used in food animals are effectively over-the-counter drugs; farmers can buy them in feed stores and administer them without a veterinarian's supervision. (Putting an end to OTC animal antibiotics is the goal of Rep. Louise Slaughter's legislation, the Preservation of Antibiotics for Medical Treatment Act (PAMTA), supported by the Obama Administration supports; post here.) Without such supervision, it is easier for a farmer to make a mistake in dosing, or to give the drugs too close to animal's slaughter time, so that the drug's don't wash out of the animal's system but remain in its meat after death.

A second important point is that we talk a lot here about the dangers of industrial-scale farming, in which antibiotics are given to animals that are not sick, either in small doses as growth promoters or in treatment-size doses to prevent illness spreading through a flock or herd. Antibiotic misuse has become linked in the public mind with the enormous animal-raising operations known as CAFOs. But both these reprimanded farms were family farms, not CAFOs. These reprimands underline that inappropriate antibiotic use is not a function of farm size — it's a by-product of market pressure.

Antibiotic resistance: international news

Constant readers, we've often talked about MRSA and other resistant pathogens as a global problem (cf. these posts for resistance issues in Europe and these for resistance around the world).

But now there has been formal recognition that resistant bacteria respect no borders. On Nov. 3, the US government and the European Union signed an agreement to form a joint task force to investigate and combat antibiotic resistance. From the Joint Declaration, posted on WhiteHouse.gov:

[We therefore agree}... To establish a transatlantic task force on urgent antimicrobial resistance issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities, prevention of both healthcare- and community-associated drug-resistant infections, and strategies for improving the pipeline of new antimicrobial drugs, which could be better addressed by intensified cooperation between us.

You may not have heard much about it here, but in Europe, this declaration was big news. Here's a story from the Swedish newspaper Arbetarbladet (Sweden currently holds the EU Presidency) and another from the Irish Times. But while it merited barely a blink in the US mainstream media, US nonprofits were deeply involved in the declaration, notably the Infectious Diseases Society of America and the Pew Charitable Trusts:

"Antimicrobial resistance and the lack of new antimicrobial agents to effectively treat resistant infections are problems that no country can deal with alone -- they threaten the very foundation of medical care," said Richard Whitley, MD, FIDSA, president of the Infectious Diseases Society of America (IDSA). "Without effective antimicrobial drugs, modern medical treatments such as operations, transplants, intensive care, cancer treatment and care of premature babies will become very risky if not impossible." Dr. Whitley joined with Javier Garau, MD, president of European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Shelley A. Hearne, managing director of the Pew Health Group in welcoming the multi-country initiative.
..."Antibiotic resistant bacteria respect no political borders, so we must work together to combat them," Dr. Hearne said. "Resistance takes a terrible toll on health worldwide and is measured in lives lost, greater suffering and higher health care costs. One way that U.S. leaders can demonstrate their commitment to solving this issue is by immediately joining the EU in banning non-judicious antibiotic uses in food animal production." (Pew press release)

This fresh focus on the problem of resistance will be sharpened in Europe this week with the celebration of European Antibiotic Awareness Day. (We should be so lucky.) More on that on Wednesday.

Guest Q&A: Jeanine Thomas and World MRSA Day

I want to introduce you all to a MRSA campaigner, Jeanine Thomas of Chicago. Jeanine — whose story will be told in SUPERBUG — is the founder of World MRSA Day, a worldwide event of activism and grieving that will take place Friday, Oct. 2. There will be simultaneous observances in the UK, and a candlelight vigil in Salt Lake City that evening.

Tomorrow, Oct. 1, Jeanine will be at Loyola University in Chicago to lead a press conference, commemoration for MRSA victims, and award ceremony for notable MRSA campaigners, and to urge those harmed by MRSA to observe October as MRSA Awareness Month.

In advance of the observances, I asked Jeanine to talk to SUPERBUG about her experience and her activism.

Tell us about your personal experience with MRSA.
I was infected with MRSA after ankle surgery in 2000. I came back to the ER — my incisions were black and oozing a large amount of pus and I was in teribble pain — and was admitted. Three days later my culture came back positive for MRSA. I was not put on the right antibiotic; the infection went into my bloodstream and bone marrow and I went into septic shock and multiple organ failure in the middle of the night. The night nurses were able to pull me back and save me. I had seven more surgeries to save my leg from amputation, spent a month in the hospital, and then was confined to bed on a cocktail of antibiotics for 5 more months. I also contracted C. difficile. I now have a destroyed ankle joint and a severely compromised immune system.

You started a MRSA patients' group. Tell us about the group and why you did that.
I started MRSA Survivors Network in 2003 to give support, raise awareness and educate others. There was so little out there about this disease. I never wanted anyone else to go through what I had.

You used your experience with MRSA to help pass patients-rights legislation in Illinois. Please talk a little about the bill.
In 2003, I helped push the "Hospital Report Card Act" that then-state senator Obama introduced, to have infection rates reported. As the consumer representative on the state board for the HRCA, I saw that state health officials and doctors did not even want to have MRSA reported as a disease. So I decided I must take action and in 2006 we introduced the "MRSA Screening and Reporting Act." It passed in 2007, the first in the country, and mandated that all ICU and other at-risk patients be screened for MRSA and infection rates reported. Since then, the Illinois Hospital Association has reported that inpatient infection rates have dropped, but they see many more CA-MRSA cases because of the screening.

How and why did you come up with the idea for World MRSA Day?
In January of 2009 I was thinking of ways to raise awareness and the idea of launching World MRSA Day and a MRSA Awareness Month popped into my head. There are awareness days for every other diisease and as MRSA is pandemic, we need global awareness. I did not know how successful I could be the first year during a recession, but the response was surprising, and I was able to launch the campaigns.

Tell us what you hope will change in the aftermath of having had this worldwide event.
I hope that awareness of MRSA as an epidemic in the US and a pandemic sweeping the globe will be revealed, and that action from the World Health Organization, Department of Health and Human Services, the CDC, governments and health departments will happen. I want all of them to declare MRSA an epidemic. This should have happened years ago, but let's move forward now. Their inaction has caused this disease to proliferate. I also want the public to be aware of MRSA as we are all in this together and every single person on this planet is at risk. Prevention is key to saving lives.

Antibiotic overuse in animals: Obama administration comes out against

For anyone who cares about the overuse of antibiotics in food animals, and the resistant bacteria that overuse has been shown to produce, this is important news.

In testimony today, new FDA Commissioner Dr. Joshua Sharfstein announced the administration's opposition to the use of growth promoters: sub-therapeutic doses of antibiotics used not as disease treatment, but to encourage animals to put weight on rapidly. Further, he also came out against the administration of antibiotics in food animals without the involvement of a veterinarian — a common situation out here in farm country, where veterinary antibiotics are freely available over the counter. (We discussed Scott Weese's proposal to end that practice here.)

Both of these practices have been repeatedly linked to antibiotic resistance, and for the administration to come out against them is highly significant — not just for the struggle against resistant bacteria, but also for the movement to reduce industrial-scale agriculture, which relies on antibiotics to keep food animals healthy while they are in the close confinement of CAFOs.

Sharfstein made the announcement while giving testimony on behalf of Rep. Louise Slaughter (D-NY)'s Preservation of Antibiotics for Medical Treatment Act of 2009, which has been introduced (and opposed into nonexistence) multiple times over the past decade. (Earlier post on the legislation, including its text, here.) He said:

To avoid the unnecessary development of resistance under conditions of constant exposure (growth promotion/feed efficiency) to antibiotics, the use of antimicrobials should be limited to those situations where human and animal health are protected. Purposes other than for the advancement of animal or human health should not be considered judicious use. ...
Important factors in determining whether a prevention use is appropriate include evidence of effectiveness, evidence that such a preventive use is consistent with accepted veterinary practice, evidence that the use is linked to a specific etiologic agent, evidence that the use is appropriately targeted, and evidence that no reasonable alternatives for intervention exist. FDA also believes that the use of medications for preventino and control should be under the supervision of a veterinarian. ...
FDA supports the treatment of ill animals according to appropriate veterinary practice within a valid veterinary-client-patient relationship.

Also on the docket at Slaughter's hearing:

• Margaret Mellon, PhD, of the Union of Concerned Scientists (who specifically discussed MRSA ST398): "As long as the massive use of antibiotics continues, animals ... will remain a fountain of resistant pathogens, dangerous to both animals and humans. The straightforward solution to the problem is to reduce the use of antibiotics in animal production and thereby diminish the pool of resistant organisms and traits."
• Robert Martin of the Pew Environment Group (Pew Charitable Trusts): "The present system of producing food animals in the United States is not sustainable and presents an unacceptable level of risk to public health, damage to the environment, as well as unnecessary harm to the animals we raise for food."
• And statements of support from the Chipotle restaurant chain and the Bon Appetit Management Company (which operates catering services in corporations and universities).

Of note, the Pew Commission on Human Health and Industrial Farming, which supports Slaughter's bill, said after the hearing that Sharfstein's proposals are only necessary but not sufficient: "“The proposed FDA position does not go far enough in this regard and would allow the continuation of conditions that necessitate the improper use of antibiotics in the first place."

MRSA legislation in Congress

Readers, on Monday, Rep. Jackie Speier (D-CA, 12th District) introduced a bill: HR 2937, the MRSA Infection Prevention and Patient Protection Act.

It requires:

• hospitals to screen all patients entering high-risk units for MRSA infection
• adoption of best practices including contact precautions among health care professionals to prevent MRSA’s spread within hospitals.
• patients testing positive for MRSA be informed of the result and given instructions on how to prevent the spread of their infection when discharged.
• hospitals to report the number of cases of hospital-acquired MRSA that occur within their facilities.

In other words, it seeks to enact nationally what advocates such as Jeanine Thomas, Carole Moss, Michael Bennett and others have done in individual states. (Find their organizations in the right-hand column.)

Speier's announcement is here and the text of the bill is here.

World MRSA Day, coming in October

Folks, MRSA activist Jeanine Thomas, who helms the group MRSA Survivors Network and was substantially responsible for getting Illinois to pass its MRSA reporting legislation, is heading the movement to observe World MRSA Day on Oct. 2, 2009.

Jeanine has been tireless in pressing for reform despite her own MRSA injuries. Please consider visiting her site and checking out the network and the October observance.

Consumers Union: 18% of Americans have had a hospital infection in self or family

Constant readers: You may not be aware that Consumers Union (yes, the nonprofit that publishes the magazine Consumer Reports) has a marvelous project called Stop Hospital Infections that has been instrumental in pushing for hospital-infection reporting and MRSA-control laws, offering support to citizen activists who want change in their states and offering text of a model MRSA-control act. (Stop Hospital Infections is in the blogroll at right.)

They have just released a survey — of more than 2,000 U.S. adults, performed March 12-16, 2009 — that gives us an excellent, and very sobering, look at what is happening with hospital-acquired infections. The news is not good:

• 18% reported that they or an immediate family member had acquired an infection owing to a hospital stay or other medical procedure.
• 61% of those who acquired an infection said it was "severe" and 35% characterized it as "life-threatening."
• The risk of an infection increased 45% if a patient spent the night in the hospital.
• 53% of Americans polled said these infections required additional out of pocket expenses to treat the infection.
• 69% had to be admitted to a hospital or extend their stay because of the infection.

The press release describing the poll — undertaken with the American Cancer Society, American Diabetes Association and the American Heart Association in advance of a Congressional briefing on healthcare reform — is here. The full results of the poll are here.

Reporting MRSA - a few places see results

Happy New Year, constant readers. I hope you had relaxing holidays; I myself have been pounding the keyboard, forging through a chapter. (I hope to post pieces at some point, but I need to talk to my editor about when is the right time in the process.)

While I was out, there were a few interesting developments on mandatory reporting of MRSA infections, which we have talked about here, among other posts.

First, the Canadian province of Ontario has launched an amazing website that reports MRSA rates for all its hospitals and allows you to search all its hospitals by name or map location. This is part of an initiative launched last May by the provincial Ministry of Health and Long-term Care that created mandatory reporting for eight indicators of patient safety: C. difficile, MRSA, VRE, standardized mortality rates, ventilator-associated pneumonia, central line infections, surgical site infections, and hand-hygiene compliance. C. diff reporting began in September; MRSA, VRE and mortality rates rolled out on Dec. 30; and the other four will be reported from April 30.

When I look at the very incomplete patchwork of reporting we have achieved state by state in this country, I find the Ontario achievement just stunning.

But, some good news from the US also: Over the holidays, Virginia made its first report of invasive MRSA infections, acting on an emergency order written by Gov. Timothy Kaine following the death of a teen named Ashton Bond in 2007. Strangely, there is no sign of the report on the website of the Virginia Department of Health (if anyone knows where it has been posted, please let me know).[UPDATE: The Virginia DOH very kindly got in touch to say that the numbers are drawn from a set of spreadsheets that are hosted here.] The Virginian-Pilot said:

There were 1,380 invasive MRSA cases reported from Dec. 1, 2007, through the end of this November. The rate for this region of Virginia was 15 per 100,000 people, slightly less than the state rate of 18.
People 60 and older had the highest rate of incidence, and blacks had higher rates than whites. ...
Only about 30 percent of the cases reported to the Virginia Health Department listed a known outcome. Of those, there were 35 deaths.
The data do not distinguish between whether MRSA was acquired in a hospital or in the community. The state also doesn't require reporting of the less serious forms of MRSA that involve skin and tissue infections. (Byline: Elizabeth Simpson)

I especially applaud this caution, attributed to Dr. Christopher Novak, an epidemiologist with the Virginia DOH:

"Just because you're reporting it doesn't mean it's under control."

UK: Hospitals' MRSA deaths could bring manslaughter charges

Last Wednesday was the first day of the new federal fiscal year, and therefore the day on which HHS's new "non-reimbursement for medical errors" rule went into effect. Under this new rule (blogged here and here and covered in this New York Times story), the Center for Medicare and Medicaid Services will no longer reimburse hospitals for the increased care that a patient needs after an extreme medical error has happened. While infecting a patient with MRSA is not specifically disavowed in the rule, it outlaws reimbursement as of this year for infections associated with vascular catheters and coronary artery bypass graft surgery, and next year (Oct. 1, 2009) for surgical site infections following orthopedic procedures. (Disappointingly, CMS rejected requests to define staph septicemia and nosocomial MRSA infection as "never events.")

Now, however, it seems that the UK government is willing to go much further than our own. According to a story in The Independent (first flagged here by ace flu blogger Crawford Killian), "tough new manslaughter laws" will allow corporations — including healthcare institutions — to be held accountable for deaths in which corporate behavior plays a role:

Maria Eagle, the Justice minister, told a meeting of more than 100 chairs and non-executive directors of NHS trusts that where managers ignore warnings of health risks, prosecutions may follow. She said: "Putting the offence into context, imagine that a patient has died in a hospital infected by MRSA and the issue of corporate manslaughter has been raised. Could the organisation be prosecuted and convicted? The answer is 'possibly'. (Byline: Robert Verkaik, law editor)

Public attitudes in the UK are ripe for this change. In July, there was significant protest after it emerged — via a government report — that 345 patients died of Clostridium difficile infection at three hospitals, after government warnings, with no punishment to the hospitals. In fact, according to The Independent, the chief executive of the trust that operated all three was allowed to resign with $150,000 in foregone pay, and is now suing for additional compensation.

So far, US protests and citizen action over nosocomial MRSA infections have been within individual states (see this recent post on the new Nile's Law in California). But isn't it interesting to see what coordinated national action — granted, in a smaller country — can do.

Good news from California

Last night, California Gov. Arnold Schwarzenegger signed an extremely important bill, California SB 1058. The new law, formally called the Medical Facility Infection Control and Prevention Act, requires California hospitals to do MRSA screening on high-risk patients (such as in ICUs, admitted from long-term care facilities, or known to have a previous MRSA infection) and to report their rates for hospital-acquired infections including MRSA to a newly created body with the state Department of Public Health.

This new law puts California in the vanguard of states who are requiring healthcare institutions to count and track MRSA infections. (For a complete list, visit the database maintained by Consumers' Union's Stop Hospital Infections project.) This is vital not only for controlling MRSA, but also simply for helping us to understand how much MRSA is out there. Because MRSA has not been a reportable disease, and is not subject to any national surveillance, state counts like these are one of the best ways of assembling a fuller picture of the bug's spread.

The most important reason to hail the passage of this law, though, is that it represents a memorial to a MRSA victim, and a determination by his survivors that no one else should meet the same fate. SB 1058 is also known as "Nile's Law." Nile is Nile Calvin Moss, who died in 2006. In response, his parents Carole and Ty Moss founded Nile's Project and became tireless advocates for MRSA surveillance and screening. Among other efforts, Carole was appointed by Schwarzenegger to a state commission on hospital-acquired infections, where she is the sole voting member representing health-care consumers.

It is no small thing to step out of your grief and make your loss into a force for change. Carole and Ty Moss deserve congratulations.

News round-up

I'm deep into writing again and therefore slipping on posting; apologies to regular readers! But here are some items of importance from the past week:

• Wednesday (Aug. 20) marked the first anniversary of Illinois' signing and immediately enacting the MRSA Screening & Reporting Act, the first state law to mandate that hospitals screen all ICU and other high-risk patients for MRSA colonization and to isolate and treat them until they are clear. This law would never have been passed without the extraordinary advocacy of MRSA survivor Jeanine Thomas, founder of the MRSA Survivors Network (site here and in the blogroll).
• Also as of Wednesday, California came within one step of passing its own MRSA laws, SB 1058 and SB 158. They await the signature of Gov. Arnold Schwarzenegger — but with California's budget in a $15.2 billion deficit freefall, new legislation there may be held hostage until a budget deal is agreed. Important addition: SB 1058 is also called "Nile's Law," after Nile Calvin Moss, who died of MRSA in April 2006. His parents Carole and Ty have pushed relentlessly for a MRSA law in his memory.
• Plus, a great find thanks to Carole Moss: The Washington State Department of Health has put together an excellent pamphlet, Living with MRSA, that explains MRSA infection, colonization, decolonization and infection-control care at home in excellent everyday language.
• And finally, another blog worth knowing about: GERMblog, written by Dr. Harley Rotbart, professor and vice-chair of pediatrics at University of Colorado School of Medicine and author of Germ Proof Your Kids: The Complete Guide to Protecting (Without Overprotecting) Your Family from Infections. I interviewed Dr. Rotbart recently for a magazine story and his advice was clear, science-based and sensible. His blog is now in the blogroll.

One more on MRSA in meat

It turns out that European governments — in contrast to the United States — are taking very seriously the emergence of MRSA in food animals and its potential for transfer to humans. (For background, posts here, here, here and here.)

How seriously? They're doing a sampling survey of pigs on farms across the European Union, at a cost of about $3 million in EC funds, with matching funds expected from each government.

The MRSA survey piggybacks (sorry) on a year-long survey of Salmonella incidence that the EC called for in September 2007. But in December, following publication of several significant papers about the ST 398 MRSA strain in pigs and pig farmers, the EC Directorate-General for Health and Consumer Protection pushed for an addition to the Salmonella study: a same-time sampling for the presence of MRSA strains in pig operations across 29 countries.

The sampling is taking place from January to December of this year, with results mandated by mid-2009, though individual country authorities may release data earlier if they choose. (In the wake of the finding of three ST 398 cases apparently caused by retail meat in the UK, the Soil Association has called on the British government to release whatever data it has ASAP. Before the EC decision, the UK government had refused to test its pigs; cf. these House of Lords minutes.)

Of note: The Soil Association is pressing the argument that ST 398 has developed in the setting of widespread use of antibiotics in food animals, and contends the strain's arising in the Netherlands is especially alarming because they have some of the lowest animal-antibiotic use rates in the EC it illustrates the difficulties that even a society conscientious about antibiotic overuse can have keeping track of veterinary applications. The Netherlands has been successful limiting overuse in humans, but has found controlling veterinary use much more of a struggle. (Thanks to the Soil Association for correcting my misunderstanding!)

Hospital gives patient MRSA. Should Medicare reimburse?

You have until June 13th to tell the government what you think. Details of how to comment at the end of this post because they are complicated.

Here's the back-story: Until recently, hospitals were reimbursed by the Center for Medicare and Medicaid Services (part of the US Department of Health and Human Services) whenever they provided care to Medicare or Medicaid patients, even if that care included a mistake, error or hospital-acquired infection. Thankfully, that is beginning to change. Last December, CMS proposed a rule change. In the agency's language:

Beginning October 1, 2008, Medicare will no longer pay hospitals at a higher rate for the increased costs of care that result when a patient is harmed by one of several conditions they didn’t have when they were first admitted to the hospital and that have been determined to be reasonably preventable by following generally accepted guidelines. (Quoted from this press release.)

In other words: Hospitals, you break it, you bought it.

These are the conditions for which, as of Oct. 1, 2008 (the first day of federal fiscal year 2009), Medicare will not reimburse:

• Object inadvertently left in after surgery
• Air embolism
• Blood incompatibility
• Catheter associated urinary tract infection
• Pressure ulcer (decubitus ulcer)
• Vascular catheter associated infection
• Surgical site infection - Mediastinitis (infection in the chest) after coronary artery bypass graft surgery
• Certain types of falls and trauma.

Note: MRSA is not on that list. But: At the same time, CMS proposed a second set of error-related conditions for which it will consider not-reimbursing, based on public comment. Some of those conditions are MRSA-related. The conditions are:

• Surgical site infections following certain elective procedures.
• Legionnaires’ disease (a type of pneumonia caused by a specific bacterium)
• Extreme blood sugar derangement
• Iatrogenic pneumothorax (collapse of the lung)
• Delirium
• Ventilator-associated pneumonia
• Deep vein thrombosis/Pulmonary Embolism (formation/movement of a blood clot)
• Staphylococcus aureus septicemia (bloodstream infection)
• Clostridium difficile associated disease (a bacterium that causes severe diarrhea and more serious intestinal conditions such as colitis)

CMS will decide whether or not to include any or all of those additional events by Aug. 1. The non-reimbursement would start at a later date that the first list.

This a complex topic and there is a long paper trail attached to it. Fact sheets are here. Definitions of the conditions, as accepted by CMS and the CDC, are here. The records of the Dec. 17. 2007 hearing in which this was discussed, including complete transcripts, is here.

Directions for how to comment electronically and by mail and hand-delivery (faxes are not accepted) are contained in this long Federal Register entry. Here is how to do it electronically:

• Go to http://www.regulations.gov
• Under "Comment or Submission," enter this file-code: CMS–1390–P
• Click on "Send a comment or submission" in the left-middle of the page.
• Fill out the form that comes up (you may have to page-down to see the full form).

Rumors of the blog's death are only slightly exaggerated (3d ed.)

Apologies for the non-appearance: I am deep into writing (and also continuing research travel) and it's hard to carve out the extra hour a day. But here is something new that is worth posting on. Jeanine Thomas, MRSA patient and prominent activist, has put up a site, blog and online community for MRSA stories and activism. Thomas, who lives in Chicago, contracted and almost died from a MRSA infection following ankle surgery in 2000 and went on to lead one of the first successful efforts to enact state legislation for MRSA control.

Find the MRSA Survivors Network in the blogroll and here.

HAIs: Congress weighs in

Today, the House of Representatives Committee on Oversight and Government Reform held a hearing on hospital-acquired infections, led by committee Chairman Henry Waxman (D-Calif.).

The witness list is here. A Government Accountability Office report that was presented during the hearing is here. Its title captures the committee's point of view: "Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections."

In opening the hearing, Waxman said:

[HHS] is not providing the necessary leadership. It has not identified for hospitals the most important infection control practices, and it is not coordinating the collection of data from hospitals in order to avoid duplication and unnecessary burden.
The failure of HHS leadership is particularly regrettable because these illnesses, deaths, and costs are preventable. Moreover, the preventive measures don’t require new technologies or large investments.

The witness list includes links to testimony, including some very powerful remarks delivered by HA-MRSA survivor Edward F. Lawton:

We possess the knowledge and capabilities to fight this enemy; we possess the educational and professional expertise to overcome and destroy it. The only question is whether we have the will to fulfill the mission!

(And BTW, apologies to loyal readers for disappearing for a week. I was speaking at the American Society of Journalists and Authors, and doing book-related research in New York. Back now.)