Category Archives: Healthcare

How to protect effective antibiotics: a conversation with Doc Ricky

MRSA

I believe that the rapid spread of antibiotic resistance should be recognized as an urgent public health priority – possibly the #1 priority. E.g., CRE [1].

After reading Betsy McCaughey [2] “U.S. Lacks Will to Fight Superbugs” [3] I tweeted the citation for her op-ed

CRE the “nightmare bacteria”: U.S. Lacks Will to Fight Superbugs j.mp/1au0EbR

Shortly Doc Ricky replied:

@stevedarden I’m kind of perplexed by the media repetition of “fighting superbugs” – what do ppl expect anyway? Some secret weapon?

What an excellent framing question! I replied with some suggestions:

  1. Transparency of hospital performance on sanitation standards.
  2. No excuses policy on resistance cases e.g. Israel
  3. Strict limitation of agriculture use to disease, no routine NTA dosing
  4. Transparency on physician prescribing by doctor

Shortly Doc Ricky replied:

“@drricky: @stevedarden but problem is most of these are preventative, what is expected when MDR {Multi Drug Resistance} is detected?”

I replied over several tweets: By #2. what I meant is that the CDC publishes “best practice” on procedures to execute upon every identified case of MDR[4]- beginning with effective quarantine and decontamination. The “best practice” level of response is mandated to be the minimum response. It should be the top priority of the hospital to eliminate the detected microbe from the institution. I appreciate that is a statistical goal, as we have no way to validate that “we killed it”.

For examples of such best practices consider the 2011 NIH Clinical Center response to a CRE outbreak [5], and of Israel 2006 (from Betsy McCaughey):

When CRE invaded Israel’s hospitals in 2006, public health authorities launched a military-style campaign requiring reports from all hospitals, which were ordered to test patients and undergo rigorous cleaning efforts. This reduced CRE by 70 percent in one year. Israeli researchers just announced a drug that may protect patients exposed to CRE from becoming infected.

My personal bias is that regulation is a blunt and ineffective tool in complex, fast-changing domains like this one. My question: How to incentivize hospitals to succeed?

Suggestion: first try transparency. E.g., if the Johns Hopkins data, such as MDR cases, hand hygiene and infection-control scores are published on the web every month – that is a powerful incentive to improve – to be ranked among the very best institutions globally.

Meanwhile Doc Ricky tweeted a critique of my first try on agriculture:

@stevedarden The agriculture issue is more nuanced than that, after all, how does one exactly limit the use?

Exactly:

@drricky Legislating detailed Rx rules not practical. How about transparency of farm usage per animal-KG? Is public shame effective?

I am thinking of the Denmark experience beginning 1999 where they succeeded to eliminate NTA use in agriculture. See my 2010 Denmark: results of stopping NTA (non-therapeutic antimicrobials)

Doc Ricky moves the discussion to the next level, biology:

@stevedarden only skirts around the real problem, which is biology. We culture animals with similar physiology to ours

The microbes shared by humans and pigs, chickens, beef are why we are so concerned about agricultural applications of antibiotics. Agriculture uses roughly 80% of the antibiotics effective in the human population – but in vastly larger quantities. If we were all vegetarians that would eliminate the whole worry about agriculture.

Doc Ricky is truly the expert in this topic – I’m looking forward to learning from him. We agreed to shift the conversation from Twitter to a long-form-friendly fora.

@stevedarden clearly a complicated topic, and hope you’ll continue to discuss.

NOTES:


  1. The CDC on CRE Carbapenem-Resistant Enterobacteriaceae.  ↩

  2. Betsy McCaughey founder of Committee to Reduce Infection Deaths  ↩

  3.  (…snip…) CRE was first uncovered in North Carolina in 1999. By 2008, it had spread to 24 states and was “routinely” seen in certain New York and New Jersey hospitals. But hospitals kept quiet. Now it’s in at least 43 states.
    (…snip…) Two months ago at a press conference, CDC Director Thomas Frieden dubbed CRE the “nightmare bacteria,” warning that “without urgent action now,” superbugs like CRE will prevent patients from getting joint replacements, cancer therapy and other treatments. The risk of incurable infections will make these treatments too dangerous. Yet, where’s the urgent action?
    The CDC doesn’t even have accurate data on how many CRE infections are occurring and where, because according to the director of the CDC’s Office of Antimicrobial Resistance, Steven Solomon, the government agency has never reached out to state officials to make CRE a reportable disease. Only 12 states require hospitals to report cases. Astoundingly, New York State did not require reports until July 2013, despite CRE menacing some of its hospitals for a decade.  ↩

  4. I am using the shorthand MDR to represent all the emerging multi-drug resistant microbes.  ↩

  5. This is what happened at the National Institutes of Health Clinical Center in Maryland in 2011. A 43-year-old woman known to have CRE was admitted from a New York City hospital. The NIH treated her, using CDC infection-control precautions, but three weeks later, a male cancer patient who had had no contact with her came down with CRE. Week after week, more and more patients contracted the infection introduced by the New York woman. Six of those patients ultimately died, one of whom was a 16-year-old boy. To stop the outbreak, NIH investigators double-cleaned rooms with bleach and misted hydrogen peroxide in measures far beyond what the CDC recommends.  ↩

John Cochrane on portable health insurance

This piece by Tyler Cowen on John Cochrane on portable health insurance is so good I'll just quote the whole thing:

The entire Op-Ed is interesting and noteworthy, but the part on health insurance is perhaps the cutting edge of the piece analytically:

Health insurance should be individual, portable across jobs, states and providers; lifelong and guaranteed-renewable, meaning you have the right to continue with no unexpected increase in premiums if you get sick. Insurance should protect wealth against large, unforeseen, necessary expenses, rather than be a wildly inefficient payment plan for routine expenses.People want to buy this insurance, and companies want to sell it. It would be far cheaper, and would solve the pre-existing conditions problem. We do not have such health insurance only because it was regulated out of existence. Businesses cannot establish or contribute to portable individual policies, or employees would have to pay taxes. So businesses only offer group plans. Knowing they will abandon individual insurance when they get a job, and without cross-state portability, there is little reason for young people to invest in lifelong, portable health insurance. Mandated coverage, pressure against full risk rating, and a dysfunctional cash market did the rest.Rather than a mandate for employer-based groups, we should transition to fully individual-based health insurance. Allow national individual insurance offered and sold to anyone, anywhere, without the tangled mess of state mandates and regulations. Allow employers to contribute to individual insurance at least on an even basis with group plans. Current group plans can convert to individual plans, at once or as people leave. Since all members in a group convert, there is no adverse selection of sicker people.

I suppose my worry is this. As individuals age, they will become greater health risks and that will hold even if Cochrane keeps Medicare going. That means a higher price for their individual portable insurance. It is not clear to me under what conditions premia can be raised legally (what does “unexpected increase” mean?), but it seems the result is much higher premia for sick people, or legally-mandated low premia, but then providers will restrict access and lower the quality of care, as another means of raising the price of course. Contractually speaking, price is verifiable but quality of care is not. The overall problem is not one of “adverse selection” but rather simply that the good information of the suppliers means that insurance is hard to sell at all for many conditions.

I do understand the option of letting the premia rise, and selling insurance against that event too, and maybe that could work. Still, it is surprising how many insurance markets don’t really blossom even if it seems they would make economic sense. Just ask Robert Shiller or look at the earlier history of failed CPI futures. I’d like to experiment with Cochrane’s idea, which I think has real promise, but on a trial basis first. The question is what such a trial might actually mean, and who would be willing to give up their current arrangements to make such an experiment possible. If the recent Obamacare reactions show anything, it is that status quo bias is getting stronger all the time in matters of health care.

The Affordable Care Act perpetuates a myth of health insurance

Is the Affordable Care Act perpetuating a myth? Yes according to physician Luis Collar (who is also a novelist, the author of A Quiet Death). Dr. Collar outlines very nicely why “health insurance” as practiced in America is a very Bad Idea. Since it’s origins as a pathway for employers to get around FDR’s wage fixing, these contracts have been shaped by their special tax treatment. Since the employer-paid coverage is not taxed as income to the employee it has been used as a competitive hiring tool for over sixty years. It is like the Zombies, very hard to kill.

The bottom line is the ACA, aka Obamacare, was formulated to satisfy progressive backers of the Obama campaign. The design of ACA carefully avoided addressing any of the real and serious structural defects of the American insurance scheme:

  1. The tax exemption for employer-paid coverage
  2. The lack of a national competitive market
  3. The bundling of pre-paid routine care with catastrophic insurance coverage
  4. The high administrative costs of erecting a whole system that intermediates between consumer and provider
  5. The complete isolation of the consumer from knowledge of pricing, and largely from any knowledge of the quality of services provided.

I could go on, but Dr. Collar does such a nice job I’ll just quote these excerpts: 

Whenever a discussion of health care policy is initiated, the importance of health insurance, of extending coverage, takes center stage. The need for insurance quickly becomes an undeniable truth, a universal imperative. And we never seem to question this premise enough before getting more patients fitted with shiny, new policies. This was precisely the case with the Affordable Care Act. But where is the evidence insurance plays any role in improving anyone’s health? Why is it assumed more coverage is always the answer, particularly for routine care? I would argue it is little more than a myth, one found nowhere else in our collective understanding of insurance.

Let’s consider our experience with insurance in other areas of our lives. In most states, it’s mandatory for drivers to carry automobile insurance. But it doesn’t reduce the incidence of accidents or extend the life of a vehicle, nor does it cover oil changes, car washes, flat tires, or any other form of maintenance or unfortunate mechanical reality. Similarly, homeowners insurance doesn’t cover the cost of repairs when your kids put a hole in the wall, the price of having your gutters cleaned, or the removal of mold due to leaky pipes or unsealed windows.

Why, then, do we expect health insurance to function any differently? There is no compelling evidence that insurance improves outcomes. In fact, of the few studies conducted, most have either failed to control for known determinants of health or shown, at best, a very tenuous relationship between the two. Access to health care matters, but we mistakenly assume more insurance is the best way to increase access. We believe coverage for routine medical care, for everything from checkups to preventive care procedures, improves our nation’s health. It does not; it only appears to because of numerous confounding variables.

What is known, however, is the total amount of money available for health care, generally some large percentage of our GDP. That number is static at any given time and cannot be magically increased. In fact, by definition, relegating any aspect of health care to insurance industry jurisdiction necessarily decreases the funds available at the bedside. These companies must extract a profit; that’s how capitalism works. Moreover, whenever the scope of coverage is increased, patients and physicians give up more control as to the nature, timing, and extent of the routine care provided.

All insurance, even health insurance, should be procured to protect one’s financial interests against catastrophic, unforeseen events. Engaging it for routine activities, including all but the most costly drug therapies and procedures, serves only to dilute valuable resources and relinquish essential control. Thankfully, Healthcare.gov offers some high deductible plans that encourage direct payment for routine care, but many of them are also HMO-type plans, plans where third parties determine the routine care that is or isn’t covered.

Physicians must regain the authority to decide what routine care patients need. Despite the increasingly popular, one-size-fits-all algorithms of evidence-based medicine, it remains a fact that, even for those of similar age, sex, race, and socioeconomic background, every patient is unique. We have conceded that the future of pharmacology points to personalized medicine, to therapies tailored to an individual’s unique genetic composition, and yet we continue to assume that generic algorithms should govern what is best for a particular patient.

(…snip…) We need to embrace a system where health insurance is procured only to protect patients’ financial interests against catastrophic injury or illness and routine, less expensive health care services are paid for directly by patients. This would require a fundamental change in how individuals view their responsibility for their own health, an increased awareness that routine care must be budgeted for like any other household expense. But this shift would help control costs and empower patients to purchase competitively priced services from independent primary care physicians free of unnecessary administrative burdens. 

Read the whole thing.

The File Drawer Effect

This is not an academics-only esoteric debate. It is about whether new, effective drugs are released. It is about how accurate is our knowledge of reality. Here is astronomer Phil Plait quoted in this excellent essay on Survivorship Bias:

For far too long, studies that fizzled out or showed insignificant results have not been submitted for publication at the same level as studies that end up with positive results, or even worse, they’ve been rejected by prominent journals. Left unchecked, over time you end up with science journals that only present the survivors of the journal process – studies showing significance. Psychologists are calling it the File Drawer Effect. The studies that disprove or weaken the hypotheses of high-profile studies seem to get stuffed in the file drawer, so to speak. Many scientists are pushing for the widespread publication of replication, failure, and insignificance. Only then, they argue, will the science journals and the journalism that reports on them accurately describe the world being explored. Science above all will need to root out survivorship, but it won’t be easy. This particular bias is especially pernicious, said Plait, because it is almost invisible by definition. ”The only way you can spot it is to always ask: what am I missing? Is what I’m seeing all there is? What am I not seeing? Those are incredibly difficult questions to answer, and not always answerable. But if you don’t ask them, then by definition you can’t answer them.”

We subscribe to the AllTrails network – I can’t recommend their work highly enough. See also Publication bias in Wikipedia and All Results Journals.

 

Meningitis Outbreaks Call for FDA Leadership. Don’t Hold Your Breath

Henry Miller:

 

Vaccination is one of the most important advances in public health in recent centuries, and hundreds of vaccines have all but eradicated many of the infectious disease scourges of the past. But two recent college campus outbreaks of Meningitis B (MenB), which is caused by serotype B of a bacterium called Neisseria meningitidis, or meningococcus, show that more needs to be done. What we need right now is not scientific or technological ingenuity, but more enlightened and responsive government oversight.

Since the first MenB cases were reported at Princeton University nine months ago, the federal government has taken insufficient and piecemeal steps to stem the further spread of the highly contagious and potentially deadly disease. The second outbreak has occurred at the University of California, Santa Barbara over the past month. Twelve students in all have been infected. Worldwide, there are 20,000-80,000 cases of MenB annually, with a mortality rate of about 10 percent. Of those who survive, about one-fifth suffer from devastating permanent disabilities such as brain damage, deafness, or limb loss. One UCSB case is a freshman lacrosse player whose feet had to be amputated.

As students and administrators at UCSB have learned to their dismay, there is no approved MenB vaccine in the United States although one called Bexsero, manufactured by Novartis, has been approved by regulators in the European Union, Australia, and Canada, and is available in those countries. The same vaccine is in clinical trials in the United States, but characteristically, the FDA has slowed the testing and approval process, so officials at the affected campuses have been forced to appeal to the federal government for special permission to import and administer it.

 

FDA: stop buying antibacterial soap products

Every day, consumers use antibacterial soaps and body washes at home, work, school and in other public settings. Especially because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks.

In fact, there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.

Moreover, antibacterial soap products contain chemical ingredients, such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven.

“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.

(…)

In addition, laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Such resistance can have a significant impact on the effectiveness of medical treatments.

Source

 

The Best Protection Against the Spread of Disease

Excerpt from today's ProMED bulletin from the International Society of Infectious Diseases.

Vaccine hesitancy is a global problem: coverage for many of the vaccines recommended for adolescents and adults in the US is low. While vaccine adherence rates for children in developed countries are typically above 90%, data suggest that nearly 12% of parents in the US are refusing and 30% delaying one or more of the recommended childhood vaccines. There appears to be decreasing confidence in immunization worldwide.

In 1988, the WHO launched the Global Polio Eradication Initiative with the goal of ending the disease by the year 2000. In 1996, Nelson Mandela launched “Kick Polio Out of Africa” that aimed to vaccinate 50 million children that year alone. Mass immunization drives included national immunization days, acute flaccid paralysis surveillance, training of local community health workers, and door-to-door campaigns. By 2003, however, a plan to immunize more than 15 million children in west and central Africa against polio was hobbled by a boycott in northern Nigeria that ultimately led to a resurgence of polio, not just in Nigeria, but globally. (You can find contemporaneous reports and links at ProMED Archive Number: 20040630.1742.)

FDA restricts antibiotic use in livestock

This is the best news in a long time.

WASHINGTON — The Food and Drug Administration on Wednesday put in place a major new policy to phase out the indiscriminate use of antibiotics in cows, pigs and chickens raised for meat, a practice that experts say has endangered human health by fueling the growing epidemic of antibiotic resistance.

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.

“This is the first significant step in dealing with this important public health concern in 20 years,” said David Kessler, a former F.D.A. commissioner who has been critical of the agency’s track record on antibiotics. “No one should underestimate how big a lift this has been in changing widespread and long entrenched industry practices.”

The change, which is to take effect over the next three years, will effectively make it illegal for farmers and ranchers to use antibiotics to make animals grow bigger. The producers had found that feeding low doses of antibiotics to animals throughout their lives led them to grow plumper and larger. Scientists still debate why. Food producers will also have to get a prescription from a veterinarian to use the drugs to prevent disease in their animals.

Federal officials said the new policy would improve health in the United States by tightening the use of classes of antibiotics that save human lives, including penicillin, azithromycin and tetracycline. Food producers said they would abide by the new rules, but some public health advocates voiced concerns that loopholes could render the new policy toothless.

Health officials have warned since the 1970s that overuse of antibiotics in animals was leading to the development of infections resistant to treatment in humans. For years, modest efforts by federal officials to reduce the use of antibiotics in animals were thwarted by the powerful food industry and its substantial lobbying power in Congress. Pressure for federal action has mounted as the effectiveness of drugs important for human health has declined, and deaths from bugs resistant to antibiotics have soared.

Under the new policy, the agency is asking drug makers to change the labels that detail how a drug can be used so they would bar farmers from using the medicines to promote growth.

The changes, originally proposed in 2012, are voluntary for drug companies. But F.D.A. officials said they believed that the companies would comply, based on discussions during the public comment period. The two drug makers that represent a majority of such antibiotic products — Zoetis and Elanco — have already stated their intent to participate, F.D.A. officials said. Companies will have three months to tell the agency whether they will change the labels, and three years to carry out the new rules.

Additionally, the agency is requiring that licensed veterinarians supervise the use of antibiotics, effectively requiring farmers and ranchers to obtain prescriptions to use the drugs for their animals.

“It’s a big shift from the current situation, in which animal producers can go to a local feed store and buy these medicines over the counter and there is no oversight at all,” said Michael Taylor, the F.D.A.’s deputy commissioner for foods and veterinary medicine.

 

The EHR Debate: Fighting the Last War?

Fighting the Last War?

…Yes, we’re having the wrong fight by focusing on old problems. The EMRs that are producing the studies we’re fighting about are the current equivalent of 1990s EPR implementations. In general they’re hard to use and require lots of money and training to produce halfway decent results. The real improvements from IT came when user-centered tools came to consumers and then to business with Web 2.0 and new devices like the iPhone.

It may take months of training on Epic or Cerner to get a doctor or nurse to be three-quarters as productive as they used to be, but my two-year-old daughter can fire up an iPad and play games and watch videos with no training.What we’re seeing every day at Health 2.0 is a whole new generation of data-driven applications and devices that are going to make the health care user experience much more like the one my daughter has.

When we get there, the real improvements in both productivity and safety, as well as in quality and even cost, will emerge and we’ll wonder why we ever were having this fight.

Ignorance Of Critical Medical Information Isn’t Bliss

Read this short Forbes essay by Vasilios Tsimiklis and Henry I. Miller. These statistics are shocking:

(…) Here are just a few shockingly common self-destructive behaviors that can lead to negative – and resource-wasting — health outcomes:

• One-third of mothers answering a survey released in 2010 said they did not plan to have their children vaccinated against the flu. Worse, more than a quarter of healthcare workers polled also said they intended to forgo immunization. Flu not only causes misery and economic losses, but it is a killer — of tens of thousands in an average year in the United States.

• An astonishing 40% of women who regularly take medicine that is considered by the FDA to be “contraindicated in women who are or may become pregnant” fail to practice birth control as prescribed. That puts them at high risk of having babies with birth defects.

• Women who have a high risk of breast cancer can reduce their risk substantially by taking either of two types of drugs — selective estrogen receptor modulators (such as tamoxifen) or aromatase inhibitors (such as anastrozole and exemestane) — yet only one-fifth or fewer of eligible women take one of the effective drugs.

• Hypertension, or high blood pressure, is a common but largely symptom-free illness that is a major cause of heart attacks, strokes and kidney disease, yet only 10% of patients take their blood pressure-lowering medications as prescribed for more than one year.

• Compliance with doctor-prescribed medicines overall is dismal. For every 100 prescriptions written, patients take only 50–70 to a pharmacy; 25–30 are taken properly; and 15–20 are refilled as prescribed. Asthmatics, diabetics and even AIDS patients sometimes arbitrarily reduce the dose or frequency of their therapy or skip it altogether.

We are continually surprised by the willingness of people to put their health and lives at risk by refusing to do the tried and true but at the same time trying unproven “natural” remedies and other quack cures advertised in magazines and on TV. Not unlike the 19th-century snake-oil preparations that were dangerous but had little (if any) efficacy, many herbal supplements, for example, are toxic, carcinogenic or otherwise unsafe; and a high proportion contain undeclared substances. Known side effects include blood-clotting abnormalities, hypertension, deadly allergic reactions, irregular heart rhythms, kidney and liver failure, exacerbation of autoimmune diseases and interference with critical prescription drugs.

At the same time that they indulge in such harmful behaviors that encompass errors of omission or commission, many of these same people evince concern over various negligible threats to their health. For example, a large number of people who neglect to take critical drugs or choose to expose their children to the very real dangers of preventable childhood infectious diseases at the same time are frightened of imaginary hobgoblins such as plasticizers in toys and shower curtains and pesticide residues in foods. (Not only are the permissible levels of chemical pesticides in food extremely low — and seldom exceeded — but 99.99% of pesticidal substances in food occur naturally.)