Maryn McKenna

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NDM-1: The World Health Organization warns governments

August 20, 2010 By Maryn Leave a Comment

The World Health Organization released a statement this afternoon, prompted by news of the NDM-1 multi-resistance gene. It’s worth taking a look: The agency recommends that countries around the world pay serious attention to the emergence of this resistance factor.

WHO calls for  broad action within countries, from hospital infection-control and antibiotic-stewardship programs, to increased surveillance for the emergence of resistance, to legislative control of over-the-counter sales. Those sound like (and are) minimal and rational suggestions — but they have the potential to be quite controversial in some countries, from India where OTC antibiotic purchases are a major economic sector, to the US where best practices for hospital control of resistant organisms continue to be, umm, vociferously debated.

The WHO says:

Those called upon to be alert to the problem of antimicrobial resistance and take appropriate action include consumers, prescribers and dispensers, veterinarians, managers of hospitals and diagnostic laboratories, patients and visitors to healthcare facilities, as well as national governments, the pharmaceutical industry, professional societies, and international agencies.

WHO strongly recommends that governments focus control and prevention efforts in four main areas:

  • surveillance for antimicrobial resistance;
  • rational antibiotic use, including education of healthcare workers and the public in the appropriate use of antibiotics;
  • introducing or enforcing legislation related to stopping the selling of antibiotics without prescription; and
  • strict adherence to infection prevention and control measures, including the use of hand-washing measures, particularly in healthcare facilities.

The WHO has been working on antibiotic resistance for a while now, though the effort seems to be continually obscured by urgent news of outbreaks such as SARS, H5N1, H1N1 and so on. Here’s their short fact sheet, detailed program page,  and Global Strategy for Containment of Antibiotic Resistance (sadly 9 years old, so it predates the emergence of community MRSA, not to mention NDM-1).

Filed Under: India, NDM-1, stewardship, surveillance, WHO

Incentives for making new antibiotics: What would it take?

May 21, 2010 By Maryn Leave a Comment

Let’s play a thought experiment. Imagine that you’re a major pharmaceutical company, a public company, with shareholders that you answer to, and market analysts looking over your shoulder to see whether this quarter’s earnings are up to projections. Imagine that you want to make a new drug. Let’s make it an antibiotic, because — as we talk about here all the time (and SUPERBUG explores in detail) — new antibiotics that can leapfrog over existing drug resistance are very needed. Thus, you imagine, a new antibiotic ought to sell well, even though any individual course of that antibiotic will only be a few weeks by mouth, or maybe a few months by IV if the patient is very sick. You know there’s a big market out there.

But: Imagine — as is generally accepted to be true — that it will take about 10 years, and about $1 billion dollars, to get that novel antibiotic through the development pipeline and into the marketplace. And then imagine that — as has been shown for a number of drugs, most recently the new antibiotic daptomycin — bacteria begin developing resistance to your drug within a year of its deployment in patients. And after that, imagine — as has been cited in a number of papers — that once local resistance to your antibiotic appears in approximately 20% of isolates, physicians will cease prescribing your antibiotic, for fear their patient will be one of that 20%.

So, to recap: 10 years, $1 billion; short course; short market life; rapid obsolescence.

Would you make that investment? Or would you, if you were a pharma company, opt instead to make insulin, which Type 1 diabetics will take every day for the rest of their lives? Or statins, which at this point we’re practically ready to put in the water supply? Or a cancer drug that costs $10,000 per dose? Or Viagra, or Cialis?

If you’re a company that is responsible to its shareholders, or listening to its analysts — or even capable of doing basic math — the answer’s obvious: Antibiotics lose. Which goes a long way to explaining why so many companies have backed off from making antibiotics, and why many of the few antibiotics in the pipeline are “me too” formulations, rather than new compounds with truly new mechanisms of action.

How to respond to this impasse has been an active debate for a while, largely focused on proposals to give market incentives, changes in tax credits, or patent extensions to pharma companies to persuade them to stay in or re-enter the marketplace. The Infectious Diseases Society of America, the specialty society for infectious-disease physicians (many of whom are also academic researchers), has been addressing this through its campaign “10x 20”, which has a goal of getting 10 new compounds into if not through the pipeline by the year 2020.

But, as a new article in the British Medical Journal points out, good incentivizing demands complexity — not just in developing both “push” and “pull” mechanisms (say, tax incentives to fund research v. prizes and wildcard patent extensions), but also in making sure that the incentives can be taken advantage of by companies of all sizes, not just the international mega-pharmas:

The characteristics of an ideal incentive mechanism and the desire for an equitable approach that engages developers of all sizes would suggest that neither push, pull, nor lego-regulatory mechanisms would be optimal to spur the desired investment in antibiotics …. Rather, elements of each should be combined. The exact shape of the ideal package is, however, as yet unclear. (Morel et al.)

 And an accompanying editorial emphasizes that new antibiotics are not the only things needed; new diagnostic tests, for instance, need funding as well:

Catchy as 10×20 sounds, the public sector strategy for funding such research and development must prioritise among different health technologies, such as diagnostics and vaccines, to combat antibiotic resistance. For example, three million children die each year from acute respiratory bacterial infections in developing countries, but penicillin sensitive pneumococcal strains have declined to a half, even a quarter, in some countries. A diagnostic test for bacterial pneumonia would save an estimated 405 000 lives a year, by targeting treatment and avoiding overprescription of antibiotics. New vaccines may also reduce reliance on drugs as the use of pneumococcal vaccine has suggested. (So et al.)

This is a hard discussion. I confess, as a longtime reporter, I flinch reflexively at the thought of handing more money to the pharmacos. At the same time, the state of the market demonstrates that the current model is not working. And though I would much prefer we focus on the ecological model of preserving antibiotics as a resource — dialing back on overuse and encouraging rigorous stewardship — it’s clear that we’ll always need new drugs for the most serious, most resistant infections.

So some sort of incentivizing seems necessary. And the multi-layered approach recommended in the BMJ, with appropriate attention paid to incentivizing the development of tests and vaccines as well, seems worth heeding.

Filed Under: antibiotics, drug development, IDSA, stewardship

News round-up!

January 19, 2010 By Maryn Leave a Comment

As promised, lots to catch up on — so here’s a quick round-up of some great reading that I have been stashing and that you may have missed in the past few weeks.

BBC News: Disinfectants may train bacteria to resist antibiotics
The BBC Health page (bookmark it!) translates a paper from the journal Microbiology on Pseudomonas aeruginosa’s newly recognized ability to pump the active ingredient in disinfectants out of its cells — and then to apply that same ability to the antibiotic Ciprofloxacin, even when it has never been exposed to Cipro before. Money quote: “... Residue from incorrectly diluted disinfectants left on hospital surfaces could promote the growth of antibiotic-resistant bacteria.”

Associated Press:  Solution to killer superbug found in Norway
In the latest installment in a 6-month series, AP writers Martha Mendoza and Margie Mason examine Norway’s success in forcing down rates of hospital MRSA. chiefly by extremely strict control of antibiotics dispensed in hospitals. I have some disagreements with this story; I don’t think they account for how much easier it is to do antibiotic stewardship, as it’s called, in a single-payer health system such as Norway or their second example, England, compared to the extremely complex US system. But I’m very glad to see the AP (and the Nieman Foundation at Harvard, where Mason was a fellow) support public exploration of antibiotic resistance, which I obviously feel gets insufficient attention. (Stay tuned for SUPERBUG’s discussion of one US stewardship program that has worked and may be replicable.)

Time: Should weight factor into antibiotic dosage?
Time.com looks at a provocative new paper in the Lancet that questions whether standard prescribed dosing of antibiotics isn’t really a form of inappropriate use. Money quote: “Dosage according to body mass is standard in anesthetics, pediatrics, oncology and other fields, [but] when it comes to antibiotics and antimicrobials the dosing guidelines are too broad… and may undermine a medications efficacy. …In the face of both widespread obesity and the increasing prevalence of antibiotic-resistance, tailoring dosage for optimal results is increasingly important.“

And finally, new today:
Science Daily: Bacteria Are More Capable of Complex Decision-Making Than Thought
University of Tennessee researchers explore the ability of a bacterium (the soil bacterium Azospirillum brasilense) to sense changes in its environment, process that information and make surprisingly complex decisions in response.

Filed Under: antibacterial, MRSA, Norway, stewardship

It’s (European) Antibiotic Awareness Day

November 18, 2009 By Maryn Leave a Comment

UK and EU readers can hug themselves with self-congratulation this morning (OK, admittedly, for you it’s afternoon already): It’s Antibiotic Awareness Day across the European Union, featuring a slate of public-awareness activities, public-service announcements, educational efforts, and random appearances by the charming little hedgehog above (kicking antibiotics, don’t you see). It’s all meant to convince people that antibiotics are a precious resource and that misusing them encourages antibiotic resistance.

The campaign is organized by the European Centre for Disease Prevention and Control (the EU equivalent of the US CDC) and is being carried out by an enviably long list of national agencies within the EU. It’s accompanied by the publication in the journal Eurosurveillance of an article setting out the challenges of controlling antibiotic resistance across such diverse nationalities and geographies.

There are materials on the site that would be useful for anyone attempting to get the message of antibiotic stewardship across to physicians, family members or friends: There’s a fact sheet for the general public, one for physicians and other experts, and one that specifically addresses the temptation to take antibiotics in cases of H1N1 flu.

There’s also a short film explaining the genesis of Antibiotic Awareness Day and the basics of antibiotic resistance, and a marvelous set of pull-no-punches short video spots. This one — comparing antibiotics to a lightbulb slowly burning out — is my favorite.

Filed Under: antibiotics, Europe, stewardship

Antibiotic-resistant infections: millions in cost to hospitals, families, all of us

November 3, 2009 By Maryn Leave a Comment

Folks, I mentioned that I’m way behind in working down a stack of great articles. Here’s a very good one that I missed when it came out two weeks ago and is well worth your time.

A team from John H. Stroger Hospital (the new location of the iconic Cook County Hospital, public hospital for downtown Chicago) and from the Alliance for the Prudent Use of Antibiotics at Tufts University (headed by Dr. Stuart Levy, dean of antibiotic resistance scholarship in the US) has analyzed the direct and distributed costs of resistant infections, and their results are stunning. They took a random sample of patients seen at the hospital, sorted out a subgroup that suffered from resistant infections, and computed the costs that those infections imposed: in medical costs, increased length of stay, and excess deaths. Those sort of calculations have been done before at other institutions (cf. for instance the excellent work of Susan Cosgrove of Johns Hopkins), but what makes this Chicago study striking is an additional layer of analysis that computes the “social cost” to the families of those infected.

In the study’s words:

In a sample of 1391 patients, 188 (13.5%) had [antibiotic-resistant infections]. The medical costs attributable to ARI ranged from $18,588 to $29,069 per patient in the sensitivity analysis. Excess duration of hospital stay was 6.4–12.7 days, and attributable mortality was 6.5%. The societal costs were $10.7–$15.0 million.

(Just to underline: These are almost certainly underestimates of the current problem and its current costs — because to get very solid data, the Stroger team went back in their database to patients who were treated in 2000. That’s before the emergence and dominance of CA-MRSA USA300 nationwide, and its subsequent movement into hospitals. Since 2000, the MRSA epidemic has gotten worse.)

An accompanying editorial takes the next step in logic, stressing that if we’re not going to work to reduce ARIs because it is good medicine to do so, we should do it because it is critically cost-saving:

…[T]he findings of Roberts et al [11] are significant, making a strong case for both the medical and financial benefits of reducing antimicrobial resistance. This is an important and timely question, considering the national focus on the prevention of health care–acquired infections, a significant proportion of which are caused by antimicrobial-resistant organisms, and the call for institutions to develop antimicrobial stewardship programs. These data should help inform decisions regarding the structure and implementation of health care initiatives designed to improve patient care while controlling unnecessary costs.

The cite for the study is: Rebecca R. Roberts, Bala Hota, Ibrar Ahmad et al. Hospital and Societal Costs of Antimicrobial‐Resistant Infections in a Chicago Teaching Hospital: Implications for Antibiotic Stewardship. Clinical Infectious Diseases 2009 49:8, 1175-1184.

Filed Under: antibiotics, cost, hospitals, stewardship

Despite stewardship efforts, antibiotic use increasing

November 11, 2008 By Maryn Leave a Comment

Well, this is bad news.

I hope we can all agree that antibiotic use creates antibiotic resistance. (Proof, if any were needed, that the universe has a captious sense of humor; but then it has had millennia to practice. OK, sorry for the anthropomorphizing.) The more pressure bacteria are placed under, the more resistant mutants emerge and survive. So the challenge in using antibiotics is to use them sufficiently and not too much: enough to quell infection and save lives, but not so much that the benefit of successful treatment is outweighed by the cost of increased resistance.

That’s the theory, anyway. In practice, according to a paper published today in the Archives of Internal Medicine, we’re not living up to the plan.

Amy L. Pakyz, Pharm.D. and colleagues at Virginia Commonwealth University surveyed antibiotic use at 22 academic medical centers — tertiary care teaching hospitals, ones that would be most likely to have high awareness of the dangers of resistance and good antibiotic stewardship programs — between 2002 and 2006. And found: Despite all that awareness, antibiotic use is going up, and the use of broad-spectrum agents and vancomycin, MRSA’s drug of last resort, is going up most of all.

The third significant observation is the marked increase in vancomycin use during the 5-year period such that it became the single most commonly used antibacterial in this sample of hospitals from 2004 to 2006. …
The reasons for the continued increase in vancomycin use are likely multifactorial, including the increasing numbers of hospital-acquired infections caused by MRSA and the emergence of community-associated MRSA, all of which encourage greater empirical use of vancomycin.

With only a few new drugs of comparative effectiveness on the market, and none that are significantly better, this is bad news, the authors underline:

Vancomycin use is a risk factor for emergence of vancomycin-intermediate S aureus and vancomycin-resistant S aureus, although these strains are rare in the United States. Of greater concern may be the emergence of low-level resistance in MRSA to vancomycin, referred to as minimum inhibitory concentration (MIC) “creep,” and this is far more common. Strains of MRSA having vancomycin MICs of 2.0 μg/mL are associated with longer median times to clearance of bacteremia compared with strains having MICs of 1.0 μg/mL or less, as well as frank treatment failures.

The cite is: Pakyz, AL et al. Trends in Antibacterial Use in US Academic Health Centers 2002 to 2006. Arch Intern Med. 2008;168(20):2254-2260.

Filed Under: antibiotics, drug development, evolution, hospitals, stewardship, vancomycin

CDC educational campaign on antimicrobial resistance

October 2, 2008 By Maryn Leave a Comment

The Centers for Disease Control and Prevention has a long-running educational campaign called “Get Smart: Know When Antibiotics Work.”

But with flu season starting, the agency has decided to make an extra push, hoping to prevent parents from asking pediatricians to prescribe antibiotics for colds and flu. (Which are, all together now: Viruses! And are not affected by: Antibiotics! Gold stars all ’round.) So it has named next week, Oct. 6-10, as “Get Smart About Antibiotics Week.”

There’s a website page specifically for the campaign, which seems to be aimed mostly at health-care institutions and public agencies — places that would mount campaigns and plan activities to reinforce the stewardship message. (The campaign has 14 health-agency and professional-association partners.) If you’re in any of those roles, there are scripts, ads, PSAs, pre-written “articles” and web graphics and widgets. Find them here.

If you’re looking for more general information that you can, for instance, share with friends, this page has explanations in everyday language.

Here’s a question: Are there any readers who are health-care professionals (doctors, nurses, NPs, PAs etc.) who feel you are pressured to prescribe antibiotics? If so, please get in touch via the comments or the email address in the right-hand bio box. I would love to hear from you.

Filed Under: antibiotics, CDC, children, stewardship

We pause in our goggle-eyed convention watching to bring you…

September 3, 2008 By Maryn Leave a Comment

[I’m sorry, faithful readers. It’s the most compelling election of my voting lifetime. I’m riveted. Also, I spent hours in the ER Sunday getting stitched up from a bike crash. A very clean ER … I hope.]

… an intriguing paper on controlling antibiotic prescribing within health care institutions.

Limiting inappropriate use of antibiotics is one of the central goals of the movement to control MRSA. Often, that’s interpreted as getting primary-care docs and pediatricians to resist pressure from consumers, especially parents with busy lives who need to limit their sick child’s illness so they can get back to work (or put the child back in day care) and stubbornly insist that antibiotics will help even when the illness is viral. But it’s just as important, possibly more important, to control inappropriate use in hospitals, where sick patients with depleted immune systems who are getting lots of drugs provide a fertile breeding ground for resistant strains.

So how to do that? If possible, you want the intervention to be systematized, not exceptional; you want it to be a routine occurrence, so clinicians don’t feel singled out for their prescribing choices, and you want it to be not face-to-face, so that the encounter remains about the patient and the drug, not about a clash of personalities.

A team at Johns Hopkins’ children’s hospital seems to have hit it whang in the gold. In the Sept. 15 issue of Clinical Infectious Diseases, Allison Agwu, Christoph Lehmann and colleagues describe a Web-based system that they instituted that significantly reduced inappropriate dosing and saved more than $370,000 in a year while making clinicians and pharmacists happier than they were with the previous system (which involved pagers and was face-to-face).

By chance, the Wall Street Journal ran a story this morning looking at such intervention programs, though not the Hopkins one — a story I missed because, in my normal reading time, I was interviewing Agwu and Lehmann. (H/t Joanne Kenen for alerting me to it though.)

Filed Under: antibiotics, hospitals, lame excuses, stewardship

Oh no they *didn’t*…

August 1, 2008 By Maryn Leave a Comment

The Environmental Protection Agency will allow apple growers in Michigan to spray the human antibiotic gentamicin on apples to control an apple-tree disease, fire blight.

This because the disease had already become resistant to a previously used, different human antibiotic, streptomycin.

The Infectious Diseases Society of America tries to get them to see reason:

“At a time when bacteria are becoming increasingly resistant to many of our best antibiotics, it is an extremely bad idea to risk undermining gentamicin’s effectiveness for treating human disease by using it to treat a disease in apples.” (IDSA President Donald Poretz, MD in a press release.)

Gentamicin is used against staph and against a range of Gram-negative bacteria, and is an important drug for bloodstream infections in newborns. In a bizarre irony, the EPA bans its use on imported fruits/vegetables — because of fears of fostering resistance.

The decision in the Federal Register here. The original EPA proposal here. A Clinical Infectious Diseases article about human antibiotic use in plant agriculture here. And somewhere in the immediate vicinity, me clutching my head and wandering away muttering.

Filed Under: antibiotics, EPA, food, resistance, stewardship

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