Our PLoS H1N1 predictions: right so far (UPDATED)

In August we published a knol in PLoS Currents: Influenza, where, based on the data to date, we modeled hospitalization, respiratory failure and death rates from H1N1. Because "preditions are hard, especially about the future", we could not be sure that we got the numbers right, especially since they were quite staggering.

Well, yesterday, the CDC and ANZIC published the US experience with the first 272 hospitalized patients and the winter flu season Australian-New Zealand ICU experience with H1N1. Here is a table that compares our predictions to what the CDC they found:

	Zilberberg knol (base case)	CDC NEJM study	ANZIC study
ICU admission		25%
ARF (relative to ICU)			65%
Acute Respiratory Failure rate [ARF] (relative to hospitalization)	12%	25% x 63% = 16%
Mortality rate (relative to ARF)	58%	Not reported	17%/65% =26%*
Mortality rate (relative to ICU)			17%
Mortality rate (relative to hospitalization)	12% x 58% = 7%	7%

*Based on assumption that all deaths occurred in ICU patients
Clearly, we got it right at least partly right -- totally consistent with the CDC numbers, and slightly higher on mortality than ANZIC. Also of interest in the CDC study is the data on antibiotics use:

Of 260 patients for whom data were available regarding antibiotic therapy, 206 (79%) received antibiotics. Of 198 patients for whom the date of initiation of antibiotics was available, such therapy was started before admission in 30 patients (15%), on admission in 117 patients (59%), within 48 hours after admission in 44 patients (22%), and more than 48 hours after admission in 7 patients (4%). Patients received a median of two antibiotics (range, one to seven); 70% of the patients received more than one antibiotic. Commonly used antibiotics included ceftriaxone (in 94 patients), azithromycin (in 84 patients), vancomycin (in 56 patients), and levofloxacin (in 47 patients). Seventy-threepercent of patients who had radiographic findings that were consistent with pneumonia were treated with antiviral drugs, and 97% were treated with antibiotics.

It is not surprising that there was such a high rate if antibiotics use, as these patients represent a group with very high severity of illness, where you throw everything at them up front and ask questions later. The rate is also similar to what was reported in the Spanish study, though those patients might have been even sicker since they were all in the ICU.

What concerns me more, however, is the 15% rate of use of outpatient antibiotics in the setting of this viral illness. I am not pointing any fingers here, as it is a decision that has to be made individually in the office by the doctor and patient. But, as I have done in the past, I do want to caution about what indiscriminate use of antibiotics could do to the incidence of C. diff and other resistant infections. We need to be very judicious in our use of these therapies as the onslaught of the H1N1 pandemic continues.

»»  READMORE...

Our PLoS H1N1 predictions: right so far (UPDATED)

In August we published a knol in PLoS Currents: Influenza, where, based on the data to date, we modeled hospitalization, respiratory failure and death rates from H1N1. Because "preditions are hard, especially about the future", we could not be sure that we got the numbers right, especially since they were quite staggering.

Well, yesterday, the CDC and ANZIC published the US experience with the first 272 hospitalized patients and the winter flu season Australian-New Zealand ICU experience with H1N1. Here is a table that compares our predictions to what the CDC they found:

	Zilberberg knol (base case)	CDC NEJM study	ANZIC study
ICU admission		25%
ARF (relative to ICU)			65%
Acute Respiratory Failure rate [ARF] (relative to hospitalization)	12%	25% x 63% = 16%
Mortality rate (relative to ARF)	58%	Not reported	17%/65% =26%*
Mortality rate (relative to ICU)			17%
Mortality rate (relative to hospitalization)	12% x 58% = 7%	7%

*Based on assumption that all deaths occurred in ICU patients
Clearly, we got it right at least partly right -- totally consistent with the CDC numbers, and slightly higher on mortality than ANZIC. Also of interest in the CDC study is the data on antibiotics use:

Of 260 patients for whom data were available regarding antibiotic therapy, 206 (79%) received antibiotics. Of 198 patients for whom the date of initiation of antibiotics was available, such therapy was started before admission in 30 patients (15%), on admission in 117 patients (59%), within 48 hours after admission in 44 patients (22%), and more than 48 hours after admission in 7 patients (4%). Patients received a median of two antibiotics (range, one to seven); 70% of the patients received more than one antibiotic. Commonly used antibiotics included ceftriaxone (in 94 patients), azithromycin (in 84 patients), vancomycin (in 56 patients), and levofloxacin (in 47 patients). Seventy-threepercent of patients who had radiographic findings that were consistent with pneumonia were treated with antiviral drugs, and 97% were treated with antibiotics.

It is not surprising that there was such a high rate if antibiotics use, as these patients represent a group with very high severity of illness, where you throw everything at them up front and ask questions later. The rate is also similar to what was reported in the Spanish study, though those patients might have been even sicker since they were all in the ICU.

What concerns me more, however, is the 15% rate of use of outpatient antibiotics in the setting of this viral illness. I am not pointing any fingers here, as it is a decision that has to be made individually in the office by the doctor and patient. But, as I have done in the past, I do want to caution about what indiscriminate use of antibiotics could do to the incidence of C. diff and other resistant infections. We need to be very judicious in our use of these therapies as the onslaught of the H1N1 pandemic continues.

»»  READMORE...

H1N1 vaccine and the burden of proof

I am following with great interest all of the reports, both scientific and popular, on the reluctance to subject oneself to the H1N1 vaccine. Yesterday's WaPo reported that

A nationally representative poll of 1,042 adults released Friday by the Harvard School of Public Health found that only 40 percent were sure they would receive the vaccine and that about half were certain their children would. Recent research by the University of Michigan and by Consumer Reports yielded similar results.

Similarly, a CBS story reported that

Outside New York 's capitol building, health care workers - shouting "Give me liberty!" - vowed to fight an unprecedented order from state health officials: a requirement for every health care worker to get seasonal and H1N1 flu shots or face the possibility of being fired.

By some strange coincidence, the CBS story reports that, in any given year, the rate of voluntary vaccination against seasonal flu among healthcare workers is 40%. This begs the question: What is it about flu vaccination that engenders skepticism in over one-half of the population, whether healthcare professionals or lay people? And further, upon whom does the burden of proof in this argument fall? That is, does the government, who is mandating universal vaccination among NY healthcare providers, need to prove safety and efficacy to the satisfaction of the people or do the protesters need to prove to the government that their concerns are legitimate?

Let's take safety and efficacy. The mere fact that the vaccine has been approved by the FDA (and other regulatory bodies around the globe) should give us some comfort about its profile. Of course, we are all too aware of the recent debacles of removal of medications from the market due to safety signals, Vioxx being the most memorable of all. This drug, having undergone the FDA's scrutiny, was approved and then pulled because of an unacceptably high rate of cardiac events detected in treated patients in post-marketing studies. This has unquestionably colored the public's attitude toward drugs, even those receiving the FDA's blessing.

But is there something special about vaccines? From where I stand, vaccines are subject to an exaggerated suspicion on the part of the public, more so than other therapies. Well, my guess is that because most of the time the population for these injections consists of young and healthy individuals, the risk-benefit balance has to be much more weighted to the benefit side. What I mean is that the more seriously ill the person is, the more risk we are willing to accept for a small incremental benefit. Take cancer chemotherapy: when the alternative is certain death without a drug, the often severe side effects of that drug are acceptable given that it improves one's survival odds. Not so among the young and healthy. It would be absurd to accept the same risk profile from a vaccine that we would in a chemotherapy drug. OK, so there is the risk-benefit profile.

One important question that goes mostly unaddressed in safety discussions is that of time. That is, risk-benefit over what period of time? The flu vaccines, whether seasonal or H1N1, are developed annually and over a fairly contracted timeline. Can we possibly fathom the potential long-term risks of these vaccines in someone who is 20 years old today? Our drug approval process gives us a false comfort in that it only examines drug profiles in the short term. However, the human body is a complex network, and an exposure today may not make itself known until 20 or 30 years from now -- look at cigarettes and cancer. Further complicating this issue are several factors. First, we do not have a great system in the US for tracking adverse events, be it from drugs or from vaccines. The systems are voluntary, and for this reason incomplete and fraught with bias. Second, the task of connecting the potential exposure to an outcome separated by 20 or 30 years is a highly complex cognitive exercise. This task is made even more challenging if the exposure rate to the agent in question, here the vaccine, is very high. Under these circumstances, it may be difficult or impossible to connect the outcome to the exposure causally.

So, where does the burden of proof lie? The fact that even healthcare professionals have a hard time understanding this balance speaks to the complexity of the issue. As for the H1N1 mandatory vaccination of the healthcare workers, the added potential risk to the society may make the explicit risk-benefit balance easier to derive, given the immediacy of the outcomes. Nonetheless, I go back to my previous assertion that there is a dire need for better individual risk-benefit communication -- decision scientists and behavioral economists need to be recruited in droves to help with these dilemmas; we have the technology! In the long term, however, nothing will replace an educated consumer who is empowered to participate in this nuanced exercise.      

 

»»  READMORE...

H1N1 vaccine and the burden of proof

I am following with great interest all of the reports, both scientific and popular, on the reluctance to subject oneself to the H1N1 vaccine. Yesterday's WaPo reported that

A nationally representative poll of 1,042 adults released Friday by the Harvard School of Public Health found that only 40 percent were sure they would receive the vaccine and that about half were certain their children would. Recent research by the University of Michigan and by Consumer Reports yielded similar results.

Similarly, a CBS story reported that

Outside New York 's capitol building, health care workers - shouting "Give me liberty!" - vowed to fight an unprecedented order from state health officials: a requirement for every health care worker to get seasonal and H1N1 flu shots or face the possibility of being fired.

By some strange coincidence, the CBS story reports that, in any given year, the rate of voluntary vaccination against seasonal flu among healthcare workers is 40%. This begs the question: What is it about flu vaccination that engenders skepticism in over one-half of the population, whether healthcare professionals or lay people? And further, upon whom does the burden of proof in this argument fall? That is, does the government, who is mandating universal vaccination among NY healthcare providers, need to prove safety and efficacy to the satisfaction of the people or do the protesters need to prove to the government that their concerns are legitimate?

Let's take safety and efficacy. The mere fact that the vaccine has been approved by the FDA (and other regulatory bodies around the globe) should give us some comfort about its profile. Of course, we are all too aware of the recent debacles of removal of medications from the market due to safety signals, Vioxx being the most memorable of all. This drug, having undergone the FDA's scrutiny, was approved and then pulled because of an unacceptably high rate of cardiac events detected in treated patients in post-marketing studies. This has unquestionably colored the public's attitude toward drugs, even those receiving the FDA's blessing.

But is there something special about vaccines? From where I stand, vaccines are subject to an exaggerated suspicion on the part of the public, more so than other therapies. Well, my guess is that because most of the time the population for these injections consists of young and healthy individuals, the risk-benefit balance has to be much more weighted to the benefit side. What I mean is that the more seriously ill the person is, the more risk we are willing to accept for a small incremental benefit. Take cancer chemotherapy: when the alternative is certain death without a drug, the often severe side effects of that drug are acceptable given that it improves one's survival odds. Not so among the young and healthy. It would be absurd to accept the same risk profile from a vaccine that we would in a chemotherapy drug. OK, so there is the risk-benefit profile.

One important question that goes mostly unaddressed in safety discussions is that of time. That is, risk-benefit over what period of time? The flu vaccines, whether seasonal or H1N1, are developed annually and over a fairly contracted timeline. Can we possibly fathom the potential long-term risks of these vaccines in someone who is 20 years old today? Our drug approval process gives us a false comfort in that it only examines drug profiles in the short term. However, the human body is a complex network, and an exposure today may not make itself known until 20 or 30 years from now -- look at cigarettes and cancer. Further complicating this issue are several factors. First, we do not have a great system in the US for tracking adverse events, be it from drugs or from vaccines. The systems are voluntary, and for this reason incomplete and fraught with bias. Second, the task of connecting the potential exposure to an outcome separated by 20 or 30 years is a highly complex cognitive exercise. This task is made even more challenging if the exposure rate to the agent in question, here the vaccine, is very high. Under these circumstances, it may be difficult or impossible to connect the outcome to the exposure causally.

So, where does the burden of proof lie? The fact that even healthcare professionals have a hard time understanding this balance speaks to the complexity of the issue. As for the H1N1 mandatory vaccination of the healthcare workers, the added potential risk to the society may make the explicit risk-benefit balance easier to derive, given the immediacy of the outcomes. Nonetheless, I go back to my previous assertion that there is a dire need for better individual risk-benefit communication -- decision scientists and behavioral economists need to be recruited in droves to help with these dilemmas; we have the technology! In the long term, however, nothing will replace an educated consumer who is empowered to participate in this nuanced exercise.      

 

»»  READMORE...

Are vaccines safe?

The H1N1 pandemic is bringing into focus not only the world's vulnerabilities vis a vis the spread of an infectious disease, but also our complete lack of a framework in which to make rational choices about prevention. The cornerstone of preventive efforts for any significant infectious disease is vaccination of a large swath of the population. The rapid development and approval of the H1N1 vaccines is both a blessing and a curse, given the sophomoric level of discussion about its risks and benefits. By coincidence this discussion has extended into the world of HPV vaccination, with a high profile death of a 14-year-old girl in the UK one hour following inoculation with Cervarix, the GSK's HPV shot. Though upon a post-mortem examination it is clear that the girl's death was a result of a malignant tumor invading her chest and not of Cervarix, the level of panic and skepticism about the vaccine is illustrative of the polarization of public opinion on the very philosophy of vaccination itself.

Why do we even have vaccines? To put it simply, vaccines are there to prevent highly infectious agents from causing mass morbidity and mortality. In the US, states mandate that children undergo certain vaccinations as a prerequisite for attending school. In fact, save for a handful of states where parents can express intellectual objections to some vaccines, in most states, including my own, the only acceptable reason for not vaccinating a child is a religious objection. And this is an all-or-nothing situation, where you are forced to either get the entire panel of shots or nothing. These laws, written decades ago, have taken individual decision making out of the public's hands. They leave no room for engaging in an educated risk-benefit analysis for the individual situation.

Rabid vaccine advocates would argue that there is never a need to make individual decisions in diseases where a vaccine is available. Well, let's take the chicken pox vaccine. Here is a childhood disease that is indeed highly contagious, but only causes a self-limited nuisance illness with a very low risk of complications in the pediatric age group without underlying conditions. In the US the disease was associated with ~10,000 hospitalizations and on average 105 deaths annually in the pre-vaccine era. So, is this really a big deal? Well, yes, from the perspective of those families suffering the 105 fatalities. But what about the societal concern? This is well summarized in the recommendation rationale from the American Academy of Family Physicians: 

Because chickenpox is so contagious, a child with chickenpox shouldn't go to school or day care until all the sores have dried or crusted. Many parents miss work during the time their child has chickenpox. Because of the lost time from work, chickenpox can be a significant cost to parents of children who get the illness. [emphasis mine]

So, there is clearly an economic risk that drives at least some of the rationale for requiring this vaccine. This then begs the question: should economic considerations ever drive a government mandate for vaccination? Note, economic considerations do not fall into what I put forth as the rationale to vaccinate: to prevent spread of highly contagious disease that causes wide-spread morbidity and mortality. Now it becomes about the money. So, does it not stand to reason that I as a parent should be able to take into account my personal situation with respect my aversion to missing work days to stay home with a sick child and make this vaccination decision myself?

Unfortunately, I do not believe that most citizens are equipped with the skills to make these informed choices. Since we have broadly accepted the government's judgment as to who should get vaccinated with what, we have not been taught systematically to make these choices rationally. And here we are, in 2009, faced with the swine flu and HPV choices: to vaccinate or not?

Ignorance is fertile ground for breeding fear. Hysterical rhetoric on both sides, anti-vaxers and vaccine apologists, is promoting a climate of confusion. When a radio program polls its listeners on whether or not they believe the H1N1 vaccine is safe, what are they looking to accomplish? As scientists we know that the concept of safety does not exist in a vacuum. How do you define safe? Safe for whom? Is there a gradient of safety? And what do the loud and often non-sensical caller responses accomplish but to create more noise at the margins?

A more constructive approach in the short-term would be to present the populace with facts -- both risks and benefits of both the diseases and the vaccines against them. (And yes, the reality is that diseases AND vaccines will have risk-benefit profiles that differ for different people.) But this short-term tactic will not solve our general inability to make rational choices when faced with complex ideas. This shortcoming needs to be addressed in our educational institutions. This knowledge will serve us in far more ways than just deciding whether or not to vaccinate our kids against chicken pox.      

   

»»  READMORE...

Are vaccines safe?

The H1N1 pandemic is bringing into focus not only the world's vulnerabilities vis a vis the spread of an infectious disease, but also our complete lack of a framework in which to make rational choices about prevention. The cornerstone of preventive efforts for any significant infectious disease is vaccination of a large swath of the population. The rapid development and approval of the H1N1 vaccines is both a blessing and a curse, given the sophomoric level of discussion about its risks and benefits. By coincidence this discussion has extended into the world of HPV vaccination, with a high profile death of a 14-year-old girl in the UK one hour following inoculation with Cervarix, the GSK's HPV shot. Though upon a post-mortem examination it is clear that the girl's death was a result of a malignant tumor invading her chest and not of Cervarix, the level of panic and skepticism about the vaccine is illustrative of the polarization of public opinion on the very philosophy of vaccination itself.

Why do we even have vaccines? To put it simply, vaccines are there to prevent highly infectious agents from causing mass morbidity and mortality. In the US, states mandate that children undergo certain vaccinations as a prerequisite for attending school. In fact, save for a handful of states where parents can express intellectual objections to some vaccines, in most states, including my own, the only acceptable reason for not vaccinating a child is a religious objection. And this is an all-or-nothing situation, where you are forced to either get the entire panel of shots or nothing. These laws, written decades ago, have taken individual decision making out of the public's hands. They leave no room for engaging in an educated risk-benefit analysis for the individual situation.

Rabid vaccine advocates would argue that there is never a need to make individual decisions in diseases where a vaccine is available. Well, let's take the chicken pox vaccine. Here is a childhood disease that is indeed highly contagious, but only causes a self-limited nuisance illness with a very low risk of complications in the pediatric age group without underlying conditions. In the US the disease was associated with ~10,000 hospitalizations and on average 105 deaths annually in the pre-vaccine era. So, is this really a big deal? Well, yes, from the perspective of those families suffering the 105 fatalities. But what about the societal concern? This is well summarized in the recommendation rationale from the American Academy of Family Physicians: 

Because chickenpox is so contagious, a child with chickenpox shouldn't go to school or day care until all the sores have dried or crusted. Many parents miss work during the time their child has chickenpox. Because of the lost time from work, chickenpox can be a significant cost to parents of children who get the illness. [emphasis mine]

So, there is clearly an economic risk that drives at least some of the rationale for requiring this vaccine. This then begs the question: should economic considerations ever drive a government mandate for vaccination? Note, economic considerations do not fall into what I put forth as the rationale to vaccinate: to prevent spread of highly contagious disease that causes wide-spread morbidity and mortality. Now it becomes about the money. So, does it not stand to reason that I as a parent should be able to take into account my personal situation with respect my aversion to missing work days to stay home with a sick child and make this vaccination decision myself?

Unfortunately, I do not believe that most citizens are equipped with the skills to make these informed choices. Since we have broadly accepted the government's judgment as to who should get vaccinated with what, we have not been taught systematically to make these choices rationally. And here we are, in 2009, faced with the swine flu and HPV choices: to vaccinate or not?

Ignorance is fertile ground for breeding fear. Hysterical rhetoric on both sides, anti-vaxers and vaccine apologists, is promoting a climate of confusion. When a radio program polls its listeners on whether or not they believe the H1N1 vaccine is safe, what are they looking to accomplish? As scientists we know that the concept of safety does not exist in a vacuum. How do you define safe? Safe for whom? Is there a gradient of safety? And what do the loud and often non-sensical caller responses accomplish but to create more noise at the margins?

A more constructive approach in the short-term would be to present the populace with facts -- both risks and benefits of both the diseases and the vaccines against them. (And yes, the reality is that diseases AND vaccines will have risk-benefit profiles that differ for different people.) But this short-term tactic will not solve our general inability to make rational choices when faced with complex ideas. This shortcoming needs to be addressed in our educational institutions. This knowledge will serve us in far more ways than just deciding whether or not to vaccinate our kids against chicken pox.      

   

»»  READMORE...

Resource-constrained medical situations: What would a grown-up do?

Today the Institute of Medicine has released their "Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations". This report was specifically commissioned by Nicole Lurie, MD, MSPH, the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. The committee was charged with the following:
1). Identify and describe key elements to include in standards of care protocols to develop a framework for care in crisis situations.
2). Review roles and responsibilities as well as ways of integrating public opinion in the guidance.
3). Incorporate ethical principles into the guidance.

The committee admits that, due to an "accelerated time frame", they might not have examined the totality of evidence or included all relevant stakeholders. This begs the question of why the time line was so aggressive, given that we have been expecting an avian flu pandemic for years. Is this yet another failure of the previous administration or just the usual government inefficiency? I give Nicole Lurie credit for jumping into this morass with much needed alacrity.

Nevertheless, their conclusions are sobering (and not unlike what I have written in my previous posts on the matter). They state

... the committee recognizes that although some federal, state, municipality, territorial, and health-sector agencies and institutions have made considerable progress in developing protocols, many states have only just begun to address this urgent need. [emphasis mine]

Additionally, the IOM committee concludes that

... there is an urgent and clear need for a single national guidance for states for crisis events and is not specific to certain event. [emphasis mine]

The committee then goes on to define what they call "crisis standard of care", which is "the level of health and medical care capable of being delivered during a catastrophic event". The change in the level of care is to be declared by the state government. They then go on to develop ethical drivers for crisis standards, emphasizing fairness, equitability, community and provider education and communication, and the rule of law. Finally, the report makes specific recommendations for the states for the development of these standards of care.

Now, it is obvious that there is plenty of room for paranoia, similar to what we have witnessed recently in conjunction with our healthcare reform discussions, to hijack this very important topic. If that is the way we choose to handle the matter, the results are potentially disastrous. Instead, the press really need to step up to the plate and present a rational and nuanced discussion of the realities of the choices in the setting of a crisis. The lazy and insidious metaphors of fascism, socialism, communism, Hitler, Stalin, McCarthy, etc., accomplish nothing other than to promote chaos (we have to ask ourselves what the advantages of chaos may be for those who are working so hard to promote it).

The fundamental question is "What is the role of the government in a crisis situation?" I am certainly not a civics scholar, but it seems reasonable to expect the government to act in the best interest of all citizenry, to be a unifying force where there needs to be a concerted response, and to promote fairness and equity within some ethically accepted standards. In a potential mass casualty like H1N1 pandemic, the resource constraints are real. Instead of saying an outright "no" to any plans, be they from Washington, the states, or the healthcare institutions, let's engage in a logical public dialogue. Like grown-ups. As I've said before, we won't all agree, but we should all have our polite and considered say. That is, after all, what Democracy is all about!

 

»»  READMORE...

Resource-constrained medical situations: What would a grown-up do?

Today the Institute of Medicine has released their "Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations". This report was specifically commissioned by Nicole Lurie, MD, MSPH, the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. The committee was charged with the following:
1). Identify and describe key elements to include in standards of care protocols to develop a framework for care in crisis situations.
2). Review roles and responsibilities as well as ways of integrating public opinion in the guidance.
3). Incorporate ethical principles into the guidance.

The committee admits that, due to an "accelerated time frame", they might not have examined the totality of evidence or included all relevant stakeholders. This begs the question of why the time line was so aggressive, given that we have been expecting an avian flu pandemic for years. Is this yet another failure of the previous administration or just the usual government inefficiency? I give Nicole Lurie credit for jumping into this morass with much needed alacrity.

Nevertheless, their conclusions are sobering (and not unlike what I have written in my previous posts on the matter). They state

... the committee recognizes that although some federal, state, municipality, territorial, and health-sector agencies and institutions have made considerable progress in developing protocols, many states have only just begun to address this urgent need. [emphasis mine]

Additionally, the IOM committee concludes that

... there is an urgent and clear need for a single national guidance for states for crisis events and is not specific to certain event. [emphasis mine]

The committee then goes on to define what they call "crisis standard of care", which is "the level of health and medical care capable of being delivered during a catastrophic event". The change in the level of care is to be declared by the state government. They then go on to develop ethical drivers for crisis standards, emphasizing fairness, equitability, community and provider education and communication, and the rule of law. Finally, the report makes specific recommendations for the states for the development of these standards of care.

Now, it is obvious that there is plenty of room for paranoia, similar to what we have witnessed recently in conjunction with our healthcare reform discussions, to hijack this very important topic. If that is the way we choose to handle the matter, the results are potentially disastrous. Instead, the press really need to step up to the plate and present a rational and nuanced discussion of the realities of the choices in the setting of a crisis. The lazy and insidious metaphors of fascism, socialism, communism, Hitler, Stalin, McCarthy, etc., accomplish nothing other than to promote chaos (we have to ask ourselves what the advantages of chaos may be for those who are working so hard to promote it).

The fundamental question is "What is the role of the government in a crisis situation?" I am certainly not a civics scholar, but it seems reasonable to expect the government to act in the best interest of all citizenry, to be a unifying force where there needs to be a concerted response, and to promote fairness and equity within some ethically accepted standards. In a potential mass casualty like H1N1 pandemic, the resource constraints are real. Instead of saying an outright "no" to any plans, be they from Washington, the states, or the healthcare institutions, let's engage in a logical public dialogue. Like grown-ups. As I've said before, we won't all agree, but we should all have our polite and considered say. That is, after all, what Democracy is all about!

 

»»  READMORE...

Compilation: H1N1 and ICU prioritization plans resources

Here are some approaches that have been suggested for how to prioritize limited ICU resources in a case of a mass casualty/pandemic situation. Some of the key points are:
1. Need to codify these protocols prior to the actual event, so as to maximize efficiency and minimize chaos
2. It is desirable to get community buy-in
3. Broad adoption is also needed to avoid litigation downstream

Here are some resources:
1. The Canadian protocol
2. American College of Chest Physicians disaster preparedness presentation
3. Recent joint MA DPH and HSPH statement on altered standards during a pandemic
4. Critical care during epidemics
5. Allocation of vents in a public health disaster (from NYC DPH)
6. SCCM podcast from Dr. Randy Wax
7. Chest Journal supplement: Definitive care for the critically ill during a disaster
8. Canadian Pandemic Resources for Critical Care
9. NYS DOH draft document on ventilator allocation (hat tip to Scott Hensley)

And here are a few posts on this blog that have discussed some of the issues:
1. Imagination and H1N1 preparedness
2. A narrowing window of opportunity
3. H1N1: Why we are unprepared
4. H1N1 predictions demystified
5. Notes from a pandemic

This is by no means an exhaustive list, but just some stuff I could come up with off the top of my head. Please, feel free to suggest other relevant resources in your comments.

»»  READMORE...

H1N1 pandemic and gut superbug

Yesterday afternoon I was on a Society of Critical Care Medicine's webcast on the ICU and H1N1 preparedness. Despite my very busy day, I had paid my $50 bucks for the privilege, and, damn it, I was going to get my money's worth. So, I made it, albeit a few minutes late.

Breathless at my monitor, I was promptly reminded by Randy Wax that in the Mexican experience over 70% of the patients with respiratory failure received antibiotics prior to hospitalization. And these are just the ones that required breathing support, representing only 18% of all the hospitalized H1N1 cases. In the recent Spanish study of H1N1 victims requiring ICU care, on the other hand, all patients received initial empiric antibiotic therapy, with 63% being treated with a fluoroquinolone.

These numbers are concerning for several reasons. Granted, these were the sickest of the sick H1N1 patients, where the ICU ethos is rightly to throw the kitchen sink and ask questions later. And it is important to note that a number of patients in the Spanish group did have a superinfection with a bacterial pathogen. But what happens if in an onslaught of cases in our hospitals later in the fall and winter engenders prodigious overuse of antibiotics in these patients?

Before there was an H1N1 pandemic, there had already existed and established pandemic of antibiotic resistance in our communities and healthcare institutions. One of these superbugs is Clostridium difficile, affectionately called C diff, which causes florid diarrhea and potentially life-threatening inflammation of the colon. This bug gets very happy when its neighbors in the gut succumb to death from antibiotics. Unopposed by its foes, it proliferates out of control and elaborates a toxin which squeezes the large intestine of all its contents, causing cramping, distention of the colon and frequent watery bowel movements. What used to be thought of as a nuisance infection primarily in chronically ill hospitalized patients, in recent years,  has mutated into a much more virulent form and is now galloping in an epidemic fashion through nearly every state in the US. More ominous is the fact that, much like its brother-in-arms MRSA, C diff is now causing diarrhea in the community setting, among people without any chronic illnesses. Furthermore, this superbug is more likely to recur despite adequate treatment and to cause much more severe disease in its victims than the bug we used to know and love (well, not really love) a decade ago.

So, how is all this relevant to the H1N1 story? One word: antibiotics! And more specifically, fluoroquinolones. This new and improved C diff seems to love fluoroquinolones. The reason for this oversized affection is that is has developed resistance to them. Practically speaking, it now has a further survival advantage over its neighbors when fluoroquinolones hit the gut.

What does all of this amount to? Well, I go back to my previous assertion that an ounce of flu prevention is going to be worth far more than a pound of cure; we need to take prevention efforts at both the personal and public levels extremely seriously. Short of that, we, both healthcare professionals and its consumers, need to say an emphatic "no" to antibiotics unless we are sure that they will help -- after all this is no longer a "might help won't hurt scenario". Finally, physicians and hospitals need to put systems into place where a critically ill patient can still get the kitchen sink before any questions are asked. But this magnitude of therapeutic interventions, including antibiotics, must be assiduously de-escalated in the absence of evidence of a bacterial superinfection. These systems need to be in place before the predicted onslaught of flu season cases. Otherwise, we may be in a situation of "our treatment was successful, but the patient died". This kind of Pyrrhic victory we can all do without!

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