Frankly, I am sick of people taking credit for chance events. One such chance event is the less-than-expected severity of the H1N1 pandemic. Several organizations, and even nations, have invoked a broad conspiracy by the WHO, among other agencies, to pad the pockets of Pharma companies with a large stake in this disease. Some are feeling proud and vindicated for their assertions as early as last summer that the threat of the pandemic is overblown. Politically, however, it does not seem enough just to gloat; these clairvoyants want further recognition by spreading stories of malfeasance by people they love to hate.
These conspiratorial concoctions are in line with our national psychology, in my opinion. The Republicans' refrain of the last 30 years that government is not to be trusted has taken root. (Parenthetically, it seems that it is through the very GOP members' efforts that this assertion has been fulfilled famously!) Lumping the WHO and the HHS in this equation is but a small stretch.
But what is the reality? The reality is much less news-worthy. In reality, all of the estimates of havoc that H1N1 was expected to reek were just that, estimates. Those estimates were based on the best data available at the time that decisions had to be made. Those data, by necessity, were limited, and the urgency to prepare precluded further waiting to accumulate more information. So, everyone did the best they could. To assign a malicious motive to these decisions is sophomoric. This self-congratulatory stance has blinded its backers to an obvious flaw in their logic: since pharmaceutical industry is a for-profit business, it is child's play to assign profit as the sole motive to these decisions retrospectively. The logic goes that, since Pharma is interested in the potential profit, there can be no other legitimate motive for declaring this pandemic. Well, it makes about as much sense as saying that the only motivation to treat a heart attack is to make money for the manufacturer. To be sure, there are several motives, one of which, from the perspective of the manufacturer, is profit. Still, I hope that a concern for immediate survival and better health of the patient are the prevailing reasons for treatment.
So, let's not distract from other important issues of our day by creating false controversies. Although for the moment it looks like many of our predictions were much graver than what is coming to pass, it is counter-productive to spread rumors of a conspiracy, when the evidence used to generate the projections is there for examination. On the other hand, I am glad that we can continue to engage in this pointless blame game, rather than having to clean up from what could have been.
Showing posts with label swine flu. Show all posts
Showing posts with label swine flu. Show all posts
Wednesday, January 13, 2010
Tuesday, October 6, 2009
Shaky evidence for flu vaccination policies
This in the British Medical Journal from a Cochrane Center -- evidence for policies is shaky at best.
BMJ 2006;333:912-915 (28 October), doi:10.1136/bmj.38995.531701.80
Analysis and comment
Public health
Influenza vaccination: policy versus evidence
Tom Jefferson, coordinator1
1 Cochrane Vaccines Field, Anguillara Sabazia, Roma 00061, Italyjefferson.tom@gmail.com
QUOTING:
Summary points
(A hat tip to @cebmblog)
1 Cochrane Vaccines Field, Anguillara Sabazia, Roma 00061, Italyjefferson.tom@gmail.com
QUOTING:
Summary points
Public policy worldwide recommends the use of inactivated influenza vaccines to prevent seasonal outbreaks
Because viral circulation and antigenic match vary each year and non-randomised studies predominate, systematic reviews of large datasets from several decades provide the best information on vaccine performance
Evidence from systematic reviews shows that inactivated vaccines havelittle or no effect on the effects measured
Most studies are of poor methodological quality and the impact of confounders is high
Little comparative evidence exists on the safety of these vaccines
Reasons for the current gap between policy and evidence are unclear, but given the huge resources involved, a re-evaluation should be urgently undertaken
(A hat tip to @cebmblog)
Thursday, September 24, 2009
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
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!
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!
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.
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.
Friday, September 4, 2009
Nearly random thoughts on holding hands
I was listening to Sylvia Boorstein's podcast yesterday while driving in my car. The title of the talk was "I talk to my friends". This was said in the context of what one does when one is discouraged. She also spoke of holding hands as a manifestation of our human need for connectedness.
I started to think about what this means for us as communities struck by the swine flu and social isolation as a preventive measure. Some officials are even asking us to modify the way we greet each other in order to minimize the chances of exposure. I myself have advocated for low thresholds for keeping us socially contained by school and business closures in favor of distance learning and working.
But what are the implications of this for our human need to be a part of the community, to talk to our friends and to hold hands? Do I really want to forgo contact in order to reduce the chances of contracting the illness to near-zero? And more importantly, what kind of a message will the government be sending by advocating this behavioral modification?
It feels to me that now more than ever before in human history we as individuals are isolated from one another. This is facilitated by our computer-centric culture, our fear of being outdoors, our apprehension of appearing weak, and a host of other factors that people far smarter than I can recount. So, do we really need to feel that our neighbors present an even greater danger to us now than before H1N1? Do we need to erect better fences in order to make even better neighbors and lose all sense of community?
I will be honest: I do not have the answers to these questions. Perhaps I just need to keep in mind that the isolation will be temporary, and that afterwards we will get back to talking to our friends and holding hands. It just seems like this pandemic is conspiring to drive us humans even farther apart than we are now.
Crisis is difficult, but it is also an opportunity: communities can choose to fall apart or to become stronger. It is up to us to choose the latter.
I started to think about what this means for us as communities struck by the swine flu and social isolation as a preventive measure. Some officials are even asking us to modify the way we greet each other in order to minimize the chances of exposure. I myself have advocated for low thresholds for keeping us socially contained by school and business closures in favor of distance learning and working.
But what are the implications of this for our human need to be a part of the community, to talk to our friends and to hold hands? Do I really want to forgo contact in order to reduce the chances of contracting the illness to near-zero? And more importantly, what kind of a message will the government be sending by advocating this behavioral modification?
It feels to me that now more than ever before in human history we as individuals are isolated from one another. This is facilitated by our computer-centric culture, our fear of being outdoors, our apprehension of appearing weak, and a host of other factors that people far smarter than I can recount. So, do we really need to feel that our neighbors present an even greater danger to us now than before H1N1? Do we need to erect better fences in order to make even better neighbors and lose all sense of community?
I will be honest: I do not have the answers to these questions. Perhaps I just need to keep in mind that the isolation will be temporary, and that afterwards we will get back to talking to our friends and holding hands. It just seems like this pandemic is conspiring to drive us humans even farther apart than we are now.
Crisis is difficult, but it is also an opportunity: communities can choose to fall apart or to become stronger. It is up to us to choose the latter.
Thursday, September 3, 2009
CDC's H1N1 public engagement dialogue, day 2
On August 31 and September 1, the CDC in conjunction with the Keystone Center and WestEd held a web based discussion centering around implementation of and communication about H1N1 vaccination efforts. In addition to the sponsors, over 150 members of the public from different regions of the US participated. The discussions were structured around 3 distinct approaches to vaccination:
1. With the "go easy" approach a few extra sites for vaccination are planned. The goal is to meet an expected low public demand for vaccine and to do so throughout the flu season without rushing to vaccinate early on.
2. The goal of the "moderate effort" approach is to raise the expected low public demand for vaccine by promoting vaccination to eligible groups, setting up extra vaccination sites, and vaccinating relatively quickly a large number of the eligible groups.
3. The goal of a "full throttle" approach is to create and respond fully and speedily to significant public demand for vaccination even if the severity of the illness is initially perceived to be low.
The discussions were guided by the following questions/points:
--What are your questions and concerns about each approach?
--As you weigh the pros and cons for this approach what values influence your thinking?
--What additional pros/cons do you think should be considered?
--If you feel this option is the best for the assumptions and circumstances, talk about why.
--If this option is not acceptable to you, share why not.
Here is the summary of day 1 as kindly provided by the conference organizers.
Day 1 notes can be found here.
PANELISTS:
Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
Prevention
John Iskander, Senior Medical Consultant, CDC
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC
............................................................
FOCUS POINT DISCUSSION SUMMARIES:
Exploration of Poll Results
Participants will explore the preferences registered through the
poll. The goal is to explore the reasons behind the choices made and
the underlying values and assumptions that may have influenced those
choices. This conversation will provide a richer, deeper view into
participants' choices and will help the CDC better understand the
reasons behind the numeric poll results.
Now that you have completed the poll and can view the results so far,
what are your initial responses? If you liked them, why do you like
them? If you favored an alternative that didn't get majority support,
what are the most serious difficulties that you would face if the CDC
didn't adopt your favored alternative? Can you live with the results
even if you disagree with them? If the CDC takes the approach chosen
by the majority of participants, what important perspectives will
they be missing? If the pandemic were more or less severe than you
had expected, how would that change your perspective on the poll
results?
While poll results do not reflect a statistical representative sample
of the US population, they provide insights into the views and
preferences of individuals who choose to participate in the online
discussion and polling process. Like the comments in the previous
days' discussions, the polling data provides additional information
and perspectives for CDC to consider as it plans its approach to H1N1
vaccination. It also allows participants to learn what one another
might be thinking and toward what approach they might be more or less
inclined, which may help us to explore implementation challenges and
issues.
Highlights of participants' comments on the Exploration of Poll
Responses discussion follow.
* The Moderate Effort approach was favored because it has a timeline
that permits the flexibility to ramp up or down as the situation
changes (more or less severe flu). Since the current H1N1 strain is
less severe, the moderate approach allows us to complete additional
testing and monitor how the virus changes.
* The Moderate Effort was preferred because it is aimed to lower the
public need for vaccine.
* The Full Throttle approach was favored because the majority of
Americans are uninformed about why this virus is a problem and how
widespread it will be. The crush of "worried well" or mildly ill
people who will break our already broken health care system is
worrisome.
* Taking a Full Throttle approach is troubling because it is going to
cause people to panic. Those who thought they had a choice not to
vaccinate will have to get vaccinated to protect themselves from
those who receive live vaccine.
* One participant advocated: (1) intensive education about the
pandemic, including the evolving risks, (2) a low threshold for
social containment actions, and (3) intensive education on the
vaccine, including full disclosure of what we do not yet know.
* Participants noted the strong preferences of individuals who seek a
flexible, balanced approach that prevents the maximum number of
deaths and hospitalizations and that preserving life is more
important than the costs associated with it. Additionally, the
preference for wanting "more time for educating the population and
raising awareness about H1N1 virus" would be nice, but the disease
itself may not allow for that.
* A discussion of the vaccine and whether or not it is "experimental"
led to an explanation of the two sets of trials that are underway
being conducted by the manufacturers and the National Institute of
Allergy and Infectious Diseases. The trials comply with Good Clinical
Practices, which includes many provisions to prevent results from
being "invented". While the H1N1 vaccines are not experimental and
will be licensed like all strain changes, it was noted that H1N1 is a
novel strain and there is a risk that the vaccine may need two shots
in older people.
* It was noted that poll results appeared inconsistent. For example,
even though the moderate approach was favored in question #7, the
opposition to vaccination program came in first at 31% on question
#7.
* Disapproval was expressed about CDC's "in-humane" vaccination
program. Concern was voiced for innocent individuals who could die,
become chronically ill, or acquire a lifelong neurological disorder
as a result of unstudied vaccine.
Implementation issues -- a look into the future
The H1N1 vaccination program that is ultimately chosen will involve
specific features (e.g., resources, number of vaccination sites,
speed of vaccination, recall methods for the second dose) and
activities (e.g., communication, volunteer involvement, partnerships,
safety monitoring, disease surveillance, coverage monitoring,
security). The level of effort for these features and activities will
vary depending on which program approach is implemented.
When considering the poll results, what thoughts or issues come up
for you regarding implementation of the vaccination program? What do
you think implementation will look like? How do you think the
vaccination program will really work? What implementation issues do
you foresee given the poll results? What concerns do you have?
Highlights of the discussion of implementation issues follow.
* The dominant theme of the implementation discussion covered
elements of a Public Information Campaign: audience, media, and
content. Overall, participants advocated for a communication program
that is based in fact and repeats the same message clearly and
consistently in easy-to-understand language. The goal of the campaign
would be to raise awareness of the H1N1 virus and to promote
prevention and containment of the disease. Other considerations:
employ images for visual learners, use multiple languages, and
provide information so that people can make an informed decision
based on facts. Vaccination education needs to be implemented full
throttle, talking about the risks of the virus as well as the
unknowns of the vaccine.
* The target audience includes, among others, seniors/over 64 years
old, young adults (the "bullet proof" generation), parents, pregnant
women, adolescents, those at risk for complications, employers,
health care workers, families, etc.
* Media should be selected based on the target audience's typical
preferences for receiving information. For example, seniors are
likely to listen to the radio and watch TV, while young adults are
inclined to use FaceBook, Twitter, and cell phones. Other media
outlets included billboards, signage in public places like airports,
the Internet (reputable sources), newspapers, posters, text
messaging, MTV, YouTube, MySpace. Community organizations such as
schools, PTAs, church groups, senior centers, and libraries were also
suggested as forums for disseminating the H1N1 message. Public
service announcements, commercials, infomercials, peer-to-peer
discussions, and word-of-mouth could be used to broadcast the H1N1
message.
Concerns were expressed about using live vaccine particularly in
schools, potential for disease spread by shedding, risks of
thimerosal and adjuvants, how well patients are being informed, lack
information about vaccine ingredients (e.g., on VIS pages),
absenteeism due to illness, unsafe vaccines, harming our healthcare
and other priority groups with an unsafe vaccine, and more. The
Public Information Campaign plan needs to address these concerns in a
straightforward, factual way. Some examples of the type of content
participants want include the following.
* Explain to seniors why they are not in the initial priority group:
one of the benefits of their age is that they have some immunity to
H1N1. However, they are still susceptible to seasonal flu and need a
seasonal flu vaccine.
* Explain the types of vaccines (live and killed, preservative-free
and preservative-containing vaccines), reasons for having multiple
types (e.g., greater supply), and the target population for each
vaccine. Spell out the risks and benefits of the vaccine and its
ingredients. Include warnings about side-effects, adjuvants,
preservatives, and shedding. Note availability of thimerosal-free
vaccine.
* List the ingredients contained in the vaccine including their
side-effects.
* Explain the reasons why the CDC is following the approach it is
following. Spell it out: (1) Pregnant women are at X times more
likely to be hospitalized and X times more likely to die from this
virus. (2) If 30% of the population is ill, these are the
ramifications (detail the impact on the health care system, the
impact on the economy, lost opportunity to protect the public).
* Explain practices for good hygiene (cough into your elbow, don't
share drinking glasses and eating utensils). Provide personal
preparedness information: necessary supplies, how to care for loved
ones, how to care for children when schools close, utilize "tribes of
three" for high-risk children, describe disease prevention tactics.
Include information on the serious complications, hospitalizations,
and deaths that have occurred in children with certain chronic
medical conditions. Inform parents of the danger signals that mean
their child needs medical attention.
* Describe the relative risks and benefits of getting the vaccine
versus not getting it.
* Clarify the rationale regarding the prioritization of groups and
individuals.
Additional implementation issues included the following.
* If the outbreak is more severe than anticipated and the "full
throttle" approach is chosen, then health care workers will be in
greater demand. Strengthening existing volunteer networks and
encouraging volunteer participation through communication campaigns
might help. Recently retired health care workers might be an
excellent group to target for assistance since that age group is less
susceptible to the H1N1.
* To effect containment, there should be very low thresholds for
closing schools and work places. This will test our distance learning
and working capabilities, and could serve as a pilot public health
measure. Travel should also be limited; business travel may be
effectively replaced by web-enabled communications.
Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
Prevention
John Iskander, Senior Medical Consultant, CDC
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC
............................................................
FOCUS POINT DISCUSSION SUMMARIES:
Exploration of Poll Results
Participants will explore the preferences registered through the
poll. The goal is to explore the reasons behind the choices made and
the underlying values and assumptions that may have influenced those
choices. This conversation will provide a richer, deeper view into
participants' choices and will help the CDC better understand the
reasons behind the numeric poll results.
Now that you have completed the poll and can view the results so far,
what are your initial responses? If you liked them, why do you like
them? If you favored an alternative that didn't get majority support,
what are the most serious difficulties that you would face if the CDC
didn't adopt your favored alternative? Can you live with the results
even if you disagree with them? If the CDC takes the approach chosen
by the majority of participants, what important perspectives will
they be missing? If the pandemic were more or less severe than you
had expected, how would that change your perspective on the poll
results?
While poll results do not reflect a statistical representative sample
of the US population, they provide insights into the views and
preferences of individuals who choose to participate in the online
discussion and polling process. Like the comments in the previous
days' discussions, the polling data provides additional information
and perspectives for CDC to consider as it plans its approach to H1N1
vaccination. It also allows participants to learn what one another
might be thinking and toward what approach they might be more or less
inclined, which may help us to explore implementation challenges and
issues.
Highlights of participants' comments on the Exploration of Poll
Responses discussion follow.
* The Moderate Effort approach was favored because it has a timeline
that permits the flexibility to ramp up or down as the situation
changes (more or less severe flu). Since the current H1N1 strain is
less severe, the moderate approach allows us to complete additional
testing and monitor how the virus changes.
* The Moderate Effort was preferred because it is aimed to lower the
public need for vaccine.
* The Full Throttle approach was favored because the majority of
Americans are uninformed about why this virus is a problem and how
widespread it will be. The crush of "worried well" or mildly ill
people who will break our already broken health care system is
worrisome.
* Taking a Full Throttle approach is troubling because it is going to
cause people to panic. Those who thought they had a choice not to
vaccinate will have to get vaccinated to protect themselves from
those who receive live vaccine.
* One participant advocated: (1) intensive education about the
pandemic, including the evolving risks, (2) a low threshold for
social containment actions, and (3) intensive education on the
vaccine, including full disclosure of what we do not yet know.
* Participants noted the strong preferences of individuals who seek a
flexible, balanced approach that prevents the maximum number of
deaths and hospitalizations and that preserving life is more
important than the costs associated with it. Additionally, the
preference for wanting "more time for educating the population and
raising awareness about H1N1 virus" would be nice, but the disease
itself may not allow for that.
* A discussion of the vaccine and whether or not it is "experimental"
led to an explanation of the two sets of trials that are underway
being conducted by the manufacturers and the National Institute of
Allergy and Infectious Diseases. The trials comply with Good Clinical
Practices, which includes many provisions to prevent results from
being "invented". While the H1N1 vaccines are not experimental and
will be licensed like all strain changes, it was noted that H1N1 is a
novel strain and there is a risk that the vaccine may need two shots
in older people.
* It was noted that poll results appeared inconsistent. For example,
even though the moderate approach was favored in question #7, the
opposition to vaccination program came in first at 31% on question
#7.
* Disapproval was expressed about CDC's "in-humane" vaccination
program. Concern was voiced for innocent individuals who could die,
become chronically ill, or acquire a lifelong neurological disorder
as a result of unstudied vaccine.
Implementation issues -- a look into the future
The H1N1 vaccination program that is ultimately chosen will involve
specific features (e.g., resources, number of vaccination sites,
speed of vaccination, recall methods for the second dose) and
activities (e.g., communication, volunteer involvement, partnerships,
safety monitoring, disease surveillance, coverage monitoring,
security). The level of effort for these features and activities will
vary depending on which program approach is implemented.
When considering the poll results, what thoughts or issues come up
for you regarding implementation of the vaccination program? What do
you think implementation will look like? How do you think the
vaccination program will really work? What implementation issues do
you foresee given the poll results? What concerns do you have?
Highlights of the discussion of implementation issues follow.
* The dominant theme of the implementation discussion covered
elements of a Public Information Campaign: audience, media, and
content. Overall, participants advocated for a communication program
that is based in fact and repeats the same message clearly and
consistently in easy-to-understand language. The goal of the campaign
would be to raise awareness of the H1N1 virus and to promote
prevention and containment of the disease. Other considerations:
employ images for visual learners, use multiple languages, and
provide information so that people can make an informed decision
based on facts. Vaccination education needs to be implemented full
throttle, talking about the risks of the virus as well as the
unknowns of the vaccine.
* The target audience includes, among others, seniors/over 64 years
old, young adults (the "bullet proof" generation), parents, pregnant
women, adolescents, those at risk for complications, employers,
health care workers, families, etc.
* Media should be selected based on the target audience's typical
preferences for receiving information. For example, seniors are
likely to listen to the radio and watch TV, while young adults are
inclined to use FaceBook, Twitter, and cell phones. Other media
outlets included billboards, signage in public places like airports,
the Internet (reputable sources), newspapers, posters, text
messaging, MTV, YouTube, MySpace. Community organizations such as
schools, PTAs, church groups, senior centers, and libraries were also
suggested as forums for disseminating the H1N1 message. Public
service announcements, commercials, infomercials, peer-to-peer
discussions, and word-of-mouth could be used to broadcast the H1N1
message.
Concerns were expressed about using live vaccine particularly in
schools, potential for disease spread by shedding, risks of
thimerosal and adjuvants, how well patients are being informed, lack
information about vaccine ingredients (e.g., on VIS pages),
absenteeism due to illness, unsafe vaccines, harming our healthcare
and other priority groups with an unsafe vaccine, and more. The
Public Information Campaign plan needs to address these concerns in a
straightforward, factual way. Some examples of the type of content
participants want include the following.
* Explain to seniors why they are not in the initial priority group:
one of the benefits of their age is that they have some immunity to
H1N1. However, they are still susceptible to seasonal flu and need a
seasonal flu vaccine.
* Explain the types of vaccines (live and killed, preservative-free
and preservative-containing vaccines), reasons for having multiple
types (e.g., greater supply), and the target population for each
vaccine. Spell out the risks and benefits of the vaccine and its
ingredients. Include warnings about side-effects, adjuvants,
preservatives, and shedding. Note availability of thimerosal-free
vaccine.
* List the ingredients contained in the vaccine including their
side-effects.
* Explain the reasons why the CDC is following the approach it is
following. Spell it out: (1) Pregnant women are at X times more
likely to be hospitalized and X times more likely to die from this
virus. (2) If 30% of the population is ill, these are the
ramifications (detail the impact on the health care system, the
impact on the economy, lost opportunity to protect the public).
* Explain practices for good hygiene (cough into your elbow, don't
share drinking glasses and eating utensils). Provide personal
preparedness information: necessary supplies, how to care for loved
ones, how to care for children when schools close, utilize "tribes of
three" for high-risk children, describe disease prevention tactics.
Include information on the serious complications, hospitalizations,
and deaths that have occurred in children with certain chronic
medical conditions. Inform parents of the danger signals that mean
their child needs medical attention.
* Describe the relative risks and benefits of getting the vaccine
versus not getting it.
* Clarify the rationale regarding the prioritization of groups and
individuals.
Additional implementation issues included the following.
* If the outbreak is more severe than anticipated and the "full
throttle" approach is chosen, then health care workers will be in
greater demand. Strengthening existing volunteer networks and
encouraging volunteer participation through communication campaigns
might help. Recently retired health care workers might be an
excellent group to target for assistance since that age group is less
susceptible to the H1N1.
* To effect containment, there should be very low thresholds for
closing schools and work places. This will test our distance learning
and working capabilities, and could serve as a pilot public health
measure. Travel should also be limited; business travel may be
effectively replaced by web-enabled communications.
Tuesday, September 1, 2009
CDC's H1N1 public engagement dialogue, day 1
On August 31 and September 1, the CDC in conjunction with the Keystone Center and WestEd held a web based discussion centering around implementation of and communication about H1N1 vaccination efforts. In addition to the sponsors, over 150 members of the public from different regions of the US participated. The discussions were structured around 3 distinct approaches to vaccination:
1. With the "go easy" approach a few extra sites for vaccination are planned. The goal is to meet an expected low public demand for vaccine and to do so throughout the flu season without rushing to vaccinate early on.
The discussions were guided by the following questions/points:
--What are your questions and concerns about each approach?
1. With the "go easy" approach a few extra sites for vaccination are planned. The goal is to meet an expected low public demand for vaccine and to do so throughout the flu season without rushing to vaccinate early on.
2. The goal of the "moderate effort" approach is to raise the expected low public demand for vaccine by promoting vaccination to eligible groups, setting up extra vaccination sites, and vaccinating relatively quickly a large number of the eligible groups.
3. The goal of a "full throttle" approach is to create and respond fully and speedily to significant public demand for vaccination even if the severity of the illness is initially perceived to be low.The discussions were guided by the following questions/points:
--What are your questions and concerns about each approach?
--As you weigh the pros and cons for this approach what values influence your thinking?
--What additional pros/cons do you think should be considered?
--If you feel this option is the best for the assumptions and circumstances, talk about why.
--If this option is not acceptable to you, share why not.
Here is the summary of day 1 as kindly provided by the conference organizers.
PANELISTS:
Roger Bernier, Senior Advisor For Scientific Strategy and Innovation,
National Center for Immunization and Respirat, CDC
Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
Prevention
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC
Eleanor Peters, Epidemiology Specialist, St. Louis County Department
of Health
............................................................
FOCUS POINT DISCUSSION SUMMARIES:
Pros and cons of a "GO EASY" approach to a vaccination program
With the "go easy" approach a few extra sites for vaccination are
planned. The goal is to meet an expected low public demand for
vaccine and to do so throughout the flu season without rushing to
vaccinate early on. Program activities in the areas of communication,
volunteer involvement, partnerships, safety, disease, and coverage
monitoring will be slightly increased over those undertaken during a
regular flu season.
What are your questions and concerns about the "go easy" approach? As
you weigh the pros and cons for this approach what values influence
your thinking? What additional pros/cons do you think should be
consider? If you feel this option is the best for the assumptions and
circumstances, described in the Discussion Guidelines, talk about
why. If this option is not acceptable to you, share why not.
Some pros of the Go Easy approach
* Given the fairly low complication and case fatality rates in New
Zealand, perhaps the "go easy" approach is the most rational one.
This seems sensible particularly because the vaccine development and
approval are such a rush job, and we will be learning about their
efficacy and safety once they are on the market.
* We need to be developing risk stratification schemes for who is
likely to develop complications. If we can risk-stratify, we may not
need to have a shotgun approach to vaccination.
Some cons of the Go Easy approach
* It's just a matter of time before a severe pandemic will happen. If
we fail to respond appropriately to this, it could have far more
lasting, more adverse effects.
* Although a pandemic of some sort is a foregone conclusion, it's not
clear if this is the one. In looking at the Southern hemisphere, so
far it is not as bad as predicted. If the second wave does not
materialize this season, this may give us time to test the vaccines
more extensively for both efficacy and safety before advocating the
full throttle vaccination approach.
* Other effective, inexpensive health strategies have been overlooked
as we have a medical system that seems focused solely on the idea of
vaccination to deal with disease. I would suggest the CDC look at the
research on the use of probiotics and Vitamin D supplementation to
enhance immunity and incorporate that into any level of approach to
the H1N1 response.
* I believe the time has passed for Go Easy approach. The Go Easy
approach gave way to the Moderate Effort approach over the summer. If
we fail to respond Moderately now, we may not be able to respond more
aggressively later, say in October when we will have a clearer
picture of what we are dealing with.
* The Go Easy plan would make it too hard to find and get the flu
shot, even for those who would really like to get it.
* If the Go Easy approach were applied, there is no possible way to
provide vaccination to those who would want it, or in time to
minimize hospitalization and death. Resources would be stretched
beyond their capacity and fatalities would increase.
* I prefer the Go Slow option where everyone that wants a vaccine can
have it, and people who do not want it do not have to take it. I do
not feel any schools should be centers for administering the vaccine
(if the live form) because of possible shedding to the unvaccinated
children.
* A public health crisis is not the time for our government to "Go
Easy." We have had the benefit of buying time since H1N1 showed in
May to learn about the virus and of watching the Southern hemisphere
go through their influenza season. If we Go Easy and wait, I think
there will be a devastating impact.
* The government has already committed so much to the study and
development of the vaccine that to treat this virus as if it's a step
above a seasonal influenza will undercut the government's perceived
competence. Truth be told, this isn't the same as seasonal influenza
nor are all the parameters known--it could end up being much ado
about nothing.
Pros and cons of a "MODERATE EFFORT" approach to a vaccination
program
The goal of a "moderate effort" approach is to promote vaccination to
eligible groups, set up extra vaccination sites beyond those used in
a regular flu year, and to vaccinate relatively quickly a large
number of the eligible groups. An aim of the program is to raise the
expected low public demand for vaccine. Regular program activities
are considerably enhanced to accomplish this especially in the area
of communication, but other program areas such as volunteer
involvement, partnerships, and program monitoring are also
intensified.
What are your questions and concerns about the "moderate effort"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros and cons for do
you think should be considered? If you feel this option is the best
for the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.
Some pros for the Moderate Effort approach
* Given history, and the events that have transpired since the Novel
H1N1 appeared last Spring, the most logical and practical approach is
the moderate approach. The current virus, appears to resemble the
effects of the 1957 Asian Bird Flu Pandemic rather than the 1918
Swine Flu Pandemic. The Moderate approach provides a balanced,
credible avenue for dealing with a mild to moderate pandemic.
* The moderate effort could be the best approach. Getting the
infrastructure in place and working at some capacity will allow
either scaling back or ramping up as the situation unfolds. According
to the Discussion Guide, enhanced communication is part of the
Moderate approach. Providing sufficient, accurate and timely
information so that the public, government, and health care providers
can make informed decisions should be a fundamental activity,
regardless of the approach taken.
* I am advocating the Moderate Effort approach. People who are
staunchly against vaccination won't agree to be vaccinated (or have
their kids vaccinated), no matter how much time is put into studying
the safety and efficacy of a vaccine. The vast majority of people
will want to know the costs/benefits of the vaccination and will
weigh if it's worth taking the risk in a situation where everything
can't be known. A moderate approach communicates the seriousness of
the H1N1 threat without suggesting that people should be panicked.
* Moderate effort is the best choice overall for the reasons already
indicated. Additionally, it places you in the middle of preparedness
making it easiest to respond appropriately to developments, which can
result in de-escalation or escalation. Flexibility in the plan is a
must.
There were no cons for the Moderate Effort approach.
Pros and cons of a "FULL THROTTLE" approach to a vaccination program
Significant additional federal, state, and local funds are invested
in creating numerous extra vaccination sites in both the public and
private sectors. The aim of a "full throttle" approach is to create
and to respond fully and speedily to significant public demand for
vaccination even if the severity of the illness is initially
perceived to be low. Extensive communication activities are
undertaken to stimulate public demand, and extensive networks of
volunteers and partners are identified and ready to spring into
action. Monitoring of the program activities is carried out
aggressively to collect timely data and take any corrective actions
needed to improve the ongoing program or to protect public safety.
What are your questions and concerns about the "full throttle"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros/cons do you
think should be considered? If you feel this option is the best for
the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.
Some pros of the Full Throttle approach
* The only real positive for the Full Throttle approach seems to be
the Rapid Response feature to vaccinate the population quickly should
the severity increase.
* I favor the Full Throttle approach. The H1N1 virus is here to stay.
Those who want to vaccinate will, those who don't, won't. Another
consideration to the vaccination strategy is the economy. If 40% of
the population is sick, how is this country going to continue to get
out of this economic recession?
Some cons of the Full Throttle approach
* A full throttle approach that would inject mercury into pregnant
women and young children is not safe. Any approach that fails to warn
the general public about these hazards is not taking into
consideration the health and welfare of the whole person.
* We shouldn't go full throttle unless we have the vaccine supply to
cover the top tier.
* Use of resources during an economic hardship. Given the resources
are for the safety of the people and the fact that they have spent
far more bailing out businesses elsewhere - this is a non-issue for
me. The people of the United States of America are worth the
investment.
* Less possible for the U.S. to donate vaccine elsewhere. Not
necessarily true. If it turns out to be less severe here and more
severe elsewhere, we will of course send what we have.
* Risk of reaction. This is a legitimate concern - expressed
emotionally and at length by others here. I would prefer to have
factual studies cited to read for myself, however. This is too
serious a subject to be laced with subjective opinion and conjecture.
* If we go full throttle, and it turns out to be a mild flu season,
we will have lost a lot of public credibility by "crying wolf" and
people will be less willing to gear up the next time there is the
possibility of a pandemic.
* I am not in favor of a full-throttle response because increased
subjective demand for a vaccine is not necessarily correlated to
increased objective need for a vaccine in order to protect vulnerable
people. As long as the media reports on H1N1 in the sensationalized
and alarmist way it did this spring, people will not get the
information they need to know whether they should be demanding a
vaccine. Therefore, I am in favor of the CDC going slow and using
their expertise to decide whether to ramp up the response.
* I am dis-inclined to support the Full-Throttle approach for the US
because of our recent experience with non-severe symptoms, low
mortality rate, and last swine flu episode. I agree with a strong
readiness posture concerning health education, vaccine production,
and vaccination for high-risk individuals, but would caution against
a Full Throttle initiative for the Nation at this time.
* I'm not sure that we need to start with the "full throttle" mode of
operation as the availability of the vaccine doesn't appear to be
able to keep up with the demand in this mode of operation.
Roger Bernier, Senior Advisor For Scientific Strategy and Innovation,
National Center for Immunization and Respirat, CDC
Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
Prevention
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC
Eleanor Peters, Epidemiology Specialist, St. Louis County Department
of Health
............................................................
FOCUS POINT DISCUSSION SUMMARIES:
Pros and cons of a "GO EASY" approach to a vaccination program
With the "go easy" approach a few extra sites for vaccination are
planned. The goal is to meet an expected low public demand for
vaccine and to do so throughout the flu season without rushing to
vaccinate early on. Program activities in the areas of communication,
volunteer involvement, partnerships, safety, disease, and coverage
monitoring will be slightly increased over those undertaken during a
regular flu season.
What are your questions and concerns about the "go easy" approach? As
you weigh the pros and cons for this approach what values influence
your thinking? What additional pros/cons do you think should be
consider? If you feel this option is the best for the assumptions and
circumstances, described in the Discussion Guidelines, talk about
why. If this option is not acceptable to you, share why not.
Some pros of the Go Easy approach
* Given the fairly low complication and case fatality rates in New
Zealand, perhaps the "go easy" approach is the most rational one.
This seems sensible particularly because the vaccine development and
approval are such a rush job, and we will be learning about their
efficacy and safety once they are on the market.
* We need to be developing risk stratification schemes for who is
likely to develop complications. If we can risk-stratify, we may not
need to have a shotgun approach to vaccination.
Some cons of the Go Easy approach
* It's just a matter of time before a severe pandemic will happen. If
we fail to respond appropriately to this, it could have far more
lasting, more adverse effects.
* Although a pandemic of some sort is a foregone conclusion, it's not
clear if this is the one. In looking at the Southern hemisphere, so
far it is not as bad as predicted. If the second wave does not
materialize this season, this may give us time to test the vaccines
more extensively for both efficacy and safety before advocating the
full throttle vaccination approach.
* Other effective, inexpensive health strategies have been overlooked
as we have a medical system that seems focused solely on the idea of
vaccination to deal with disease. I would suggest the CDC look at the
research on the use of probiotics and Vitamin D supplementation to
enhance immunity and incorporate that into any level of approach to
the H1N1 response.
* I believe the time has passed for Go Easy approach. The Go Easy
approach gave way to the Moderate Effort approach over the summer. If
we fail to respond Moderately now, we may not be able to respond more
aggressively later, say in October when we will have a clearer
picture of what we are dealing with.
* The Go Easy plan would make it too hard to find and get the flu
shot, even for those who would really like to get it.
* If the Go Easy approach were applied, there is no possible way to
provide vaccination to those who would want it, or in time to
minimize hospitalization and death. Resources would be stretched
beyond their capacity and fatalities would increase.
* I prefer the Go Slow option where everyone that wants a vaccine can
have it, and people who do not want it do not have to take it. I do
not feel any schools should be centers for administering the vaccine
(if the live form) because of possible shedding to the unvaccinated
children.
* A public health crisis is not the time for our government to "Go
Easy." We have had the benefit of buying time since H1N1 showed in
May to learn about the virus and of watching the Southern hemisphere
go through their influenza season. If we Go Easy and wait, I think
there will be a devastating impact.
* The government has already committed so much to the study and
development of the vaccine that to treat this virus as if it's a step
above a seasonal influenza will undercut the government's perceived
competence. Truth be told, this isn't the same as seasonal influenza
nor are all the parameters known--it could end up being much ado
about nothing.
Pros and cons of a "MODERATE EFFORT" approach to a vaccination
program
The goal of a "moderate effort" approach is to promote vaccination to
eligible groups, set up extra vaccination sites beyond those used in
a regular flu year, and to vaccinate relatively quickly a large
number of the eligible groups. An aim of the program is to raise the
expected low public demand for vaccine. Regular program activities
are considerably enhanced to accomplish this especially in the area
of communication, but other program areas such as volunteer
involvement, partnerships, and program monitoring are also
intensified.
What are your questions and concerns about the "moderate effort"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros and cons for do
you think should be considered? If you feel this option is the best
for the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.
Some pros for the Moderate Effort approach
* Given history, and the events that have transpired since the Novel
H1N1 appeared last Spring, the most logical and practical approach is
the moderate approach. The current virus, appears to resemble the
effects of the 1957 Asian Bird Flu Pandemic rather than the 1918
Swine Flu Pandemic. The Moderate approach provides a balanced,
credible avenue for dealing with a mild to moderate pandemic.
* The moderate effort could be the best approach. Getting the
infrastructure in place and working at some capacity will allow
either scaling back or ramping up as the situation unfolds. According
to the Discussion Guide, enhanced communication is part of the
Moderate approach. Providing sufficient, accurate and timely
information so that the public, government, and health care providers
can make informed decisions should be a fundamental activity,
regardless of the approach taken.
* I am advocating the Moderate Effort approach. People who are
staunchly against vaccination won't agree to be vaccinated (or have
their kids vaccinated), no matter how much time is put into studying
the safety and efficacy of a vaccine. The vast majority of people
will want to know the costs/benefits of the vaccination and will
weigh if it's worth taking the risk in a situation where everything
can't be known. A moderate approach communicates the seriousness of
the H1N1 threat without suggesting that people should be panicked.
* Moderate effort is the best choice overall for the reasons already
indicated. Additionally, it places you in the middle of preparedness
making it easiest to respond appropriately to developments, which can
result in de-escalation or escalation. Flexibility in the plan is a
must.
There were no cons for the Moderate Effort approach.
Pros and cons of a "FULL THROTTLE" approach to a vaccination program
Significant additional federal, state, and local funds are invested
in creating numerous extra vaccination sites in both the public and
private sectors. The aim of a "full throttle" approach is to create
and to respond fully and speedily to significant public demand for
vaccination even if the severity of the illness is initially
perceived to be low. Extensive communication activities are
undertaken to stimulate public demand, and extensive networks of
volunteers and partners are identified and ready to spring into
action. Monitoring of the program activities is carried out
aggressively to collect timely data and take any corrective actions
needed to improve the ongoing program or to protect public safety.
What are your questions and concerns about the "full throttle"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros/cons do you
think should be considered? If you feel this option is the best for
the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.
Some pros of the Full Throttle approach
* The only real positive for the Full Throttle approach seems to be
the Rapid Response feature to vaccinate the population quickly should
the severity increase.
* I favor the Full Throttle approach. The H1N1 virus is here to stay.
Those who want to vaccinate will, those who don't, won't. Another
consideration to the vaccination strategy is the economy. If 40% of
the population is sick, how is this country going to continue to get
out of this economic recession?
Some cons of the Full Throttle approach
* A full throttle approach that would inject mercury into pregnant
women and young children is not safe. Any approach that fails to warn
the general public about these hazards is not taking into
consideration the health and welfare of the whole person.
* We shouldn't go full throttle unless we have the vaccine supply to
cover the top tier.
* Use of resources during an economic hardship. Given the resources
are for the safety of the people and the fact that they have spent
far more bailing out businesses elsewhere - this is a non-issue for
me. The people of the United States of America are worth the
investment.
* Less possible for the U.S. to donate vaccine elsewhere. Not
necessarily true. If it turns out to be less severe here and more
severe elsewhere, we will of course send what we have.
* Risk of reaction. This is a legitimate concern - expressed
emotionally and at length by others here. I would prefer to have
factual studies cited to read for myself, however. This is too
serious a subject to be laced with subjective opinion and conjecture.
* If we go full throttle, and it turns out to be a mild flu season,
we will have lost a lot of public credibility by "crying wolf" and
people will be less willing to gear up the next time there is the
possibility of a pandemic.
* I am not in favor of a full-throttle response because increased
subjective demand for a vaccine is not necessarily correlated to
increased objective need for a vaccine in order to protect vulnerable
people. As long as the media reports on H1N1 in the sensationalized
and alarmist way it did this spring, people will not get the
information they need to know whether they should be demanding a
vaccine. Therefore, I am in favor of the CDC going slow and using
their expertise to decide whether to ramp up the response.
* I am dis-inclined to support the Full-Throttle approach for the US
because of our recent experience with non-severe symptoms, low
mortality rate, and last swine flu episode. I agree with a strong
readiness posture concerning health education, vaccine production,
and vaccination for high-risk individuals, but would caution against
a Full Throttle initiative for the Nation at this time.
* I'm not sure that we need to start with the "full throttle" mode of
operation as the availability of the vaccine doesn't appear to be
able to keep up with the demand in this mode of operation.
Wednesday, August 26, 2009
H1N1 predictions demystified
The President's Council of Advisors on Science and Technology report on the US preparations for the 2009 H1N1 influenza estimate of 90,000 fatalities is getting a lot of heat from an unlikely source: the Centers for Disease Control and Prevention. According to a New York Times story, there is disagreement with this prediction. Anne Schuchat, the director of the National Center for Immunization and Respiratory Diseases is quoted as saying "We don't necessarily see this as a likely scenario". A CDC press officer apparently confirmed that no one at the CDC "expects anything like 90,000 deaths".
If you look at the report itself, even the authors hedge on this point: they prefer to present is as a "planning scenario", rather than a prediction. OK, I'll buy this but what is a prediction but a planning scenario? True, it could be fewer. But if we sit around and simply argue about the number, it could be a lot worse.
Let me tell you a little bit about why and how we create these predictions (or planning scenarios, your choice). The why is pretty self-evident: we want to be prepared. Preparation entails having an idea, vague though it may be, of what's to come. Why do you care about tomorrow's weather forecast? So that you can plan what to wear, how long to allocate to your commute, or whether or not to cancel that trip to Florida during the hurricane season. Similarly, policy makers need to have some idea of how to allocate resources in the future. So, we make predictions, create forecasts or planning scenarios.
The irony is that all this future planning is built on past events as we know them in the present. (So you can see how a rapidly-evolving pandemic can throw a monkey-wrench into any estimates.) What makes us think that there are likely to be 30,000-90,000 fatalities associated with H1N1 in the US this flu season? Its past behavior, of course -- we look at what has happened to date, both in the US, and, in this case, in the Southern hemisphere, where the flu season is in full swing, and we apply those numbers to our population. The result is a mathematical formula which, when populated with these carefully evaluated assumptions, spits out the desired estimate. Now, it is also possible to include some other assumptions into the model, such as what happens at different levels of vaccine availability, efficacy and penetration. However, since all of these factors are to date unknown, putting them into the model would create a tremendous amount of uncertainty, and the model would be useless.
But even without introducing conjecture around potential modifiers, these estimates are prone to a large degree of uncertainty. This is why whenever you hear a report of a single number as the estimate derived from a prediction model, ask for more: there is usually a confidence interval calculated around that number based on varying the assumptions across some justifiable range. Generally, the tighter the confidence interval, the more useful the prediction. For example, in our recent study we estimated that on average we can expect ~300,000 cases of acute respiratory failure associated with H1N1 in the US, with the confidence interval ranging from ~225,000 to ~450,000. Now, this is a wide range, and it betrays our uncertainty about assumptions that went into the model.
One final note. The estimates provided by the White House advisors and the ones derived by us do not necessarily account for the effect of an all-out effort at prevention. So, if we sit by and wait for the virus to hit, and if it does not get more or less virulent than its current incarnation, we will have the predicted number of fatalities. That is a lot of "ifs", some of which are certainly within our control -- aggressive education, prevention, containment, to name a few.
So, with all of the pitfalls of planning scenarios, they are necessary for us to appreciate the potential magnitude of the problem and to plan for it rationally. Sweeping them under the rug and throwing their creators under the bus is just playing politics with an uncertain situation: these numbers evolve, and we need to acknowledge that. After all, as that populist philosopher Yogi Berra once pointed out: "Predictions are very hard, especially about the future".
Tuesday, August 25, 2009
How technology can help contain H1N1
It makes sense to put a lot of resources into trying to prevent at least some of the estimated 46 million cases, 2.7 million hospitalizations, 300,000 cases of respiratory failure and 200,000 deaths expected this flu season from H1N1 in the US. I believe that technology can be leveraged to mitigate this epidemic. Here is how.
The obvious solutions are already here. We are using social media outlets, Twitter, Facebook, to keep up with the galloping epidemic. Making sure that the majority of the population has access to this relevant information could help local health departments to broadcast latest recommendations. The availability of remote learning and work environments should make it much easier to make sensible decisions about work and school closures without major adverse consequences to the economy, at least in the non-production sectors. Webcasting technology can be a good substitute for remote meetings, thus obviating the need potentially for many people to travel across the country or the world.
And there are other, less obvious ways, in which technology can be useful. We can leverage the thriving possibilities of geographic information systems (GIS) not only to track the epidemic as it spreads, but to plan sensible triage on the ground. Another engineering approach, discreet event simulation, can be used to help avoid the much anticipated bottlenecks in the hospital emergency departments and ICUs. And I am sure there are other opportunities that this vast web of communication can offer us that I am not even aware of, but someone is! I sure hope that we are firing up these technologies and learning how to simulate this epidemic, so that we have at least a little more idea of what we are doing when it descends upon us full force. It is heartening to me that the Department of Health and Human Services has commissioned a count of all the mechanical ventilators in the US hospitals -- this basic activity will certainly help. What I have not heard anything about is what efforts are underway leveraging the sophisticated 21st-century technologies to optimize our approach. My guess is that these efforts, if they exist, happen at the local level and are quite fragmented and haphazard.
I think that it now takes very little imagination to foresee the potential fall out from this virus. So, let's use our imagining energy on how we can mitigate the epidemic. The DHHS, if it has not done so yet, should convene a panel of docs, EMS professionals, engineers and IT experts to develop contingencies and test them virtually. This way, when the full epidemic strikes, we will not have to blame our collective lack of imagination for not preventing a catastrophe.
Sunday, August 9, 2009
Medical ethics in the era of H1N1: A need for a national conversation
In the UK the H1N1 pandemic is bringing to the forefront the public's concerns for healthcare rationing. In a recent article for the BBC news, Daniel Sokol, a medical ethicist, discusses the issue with frightening lucidity. He cites several probable scenarios and asks how they should be handled. For example, when 5 critically ill patients are "competing" for a single ICU bed, how should the allocation decision be made? Should it be on the basis of viability? Age? Value to society (that is, should a healthcare worker take precedence over another patient?) While he argues for transparency in such choices, he acknowledges the uncertainties inherent in our understanding of disease. Thus, a patient who is 99% likely to die may still surprise us 1% of the time and survive.
These are very thorny issues that we very well may get confronted with in this coming flu season. How will we handle them? The Brits at least appear to have the emotional maturity to start the discussion in explicit terms, so that they can wrestle with some of these issues before the 11th hour. Are we? In the US we cannot even seem to get beyond the demagoguery of grandma killings at this most important healthcare juncture. What will we do when we are actually confronted with having to make these very real and concrete choices? The culture of "me-me-me" will only impede us from electing the rational path.
The time to think through these conundrums is now because come fall and winter it will be too late. Revolts have been fomented over lesser issues; do we really want to leave this to the last minute? As a nation we need to take a deep breath, arm ourselves with courage and open our eyes and ears. Not everyone will be pleased with everything, but at least we will have a clearer idea of what we can expect and, perhaps, in turn this clarity will allow for better personal and societal choices. The press needs to help lead this discussion in a measured non-sensationalized way. This is our opportunity to grow up as a nation. If we do not take it now, the results may be more devastating than we can imagine.
Friday, August 7, 2009
Caught with our pants down by H1N1
I am still on vacation and my brain is too mushy to do a good new post. So, am recycling an old one. By the way, I modeled the potential number of respiratory failures we can expect in association with this winter's flu season, and now I am more sure than ever that we may be in deep doo-doo. This is made even more relevant by the story in the WaPo yesterday discussing the challenges of the vaccine development and distribution.
Got an e-mail today from a Bloomberg reporter asking about my thoughts on the state of US preparedness for H1N1. Specifically he was interested in the ICU capacity as it applies to dealing with the more severe respiratory failure that has been reported in association with this infection. You might wonder why he called me of all people. Well, this is because I published a bunch of papers recently (that have been dutifully ignored by policy makers) that quantify the expected stress to the healthcare system in the US posed by the sky-rocketing increase in the population of patients requiring ventilators to assist them with breathing. How naïve I was to think that our numbers might be used for planning purposes, so that we could be better prepared for this growth!
A year since we first started to come out with the numbers, there are still no reliable estimates, or even attempts to derive them, as far as I can tell, of the US ICU surge capacity. And this information is more critical now than ever, as we are faced with the potential for untold numbers of H1N1-related hospitalizations accompanied by severe respiratory failure. It is shocking to me that we are leaving these infrastructure issues to chance.
But wait, why am I so shocked? This is just another byproduct of our fragmented healthcare "system". There is no one either to take or to designate responsibility for planning. While our professional organizations are doing the best they can, their approach is usually siloed and somewhat distracted: in case you have not heard, we are also tackling the most rampant pandemic of antibiotic resistant infections, which affects ICUs disproportionately.
So, who will take charge of this hot potato? The CDC? Homeland Security? FEMA (chuckle-chuckle)? Press your representatives to tackle this thorny issue, because if you are worried about planned rationing now, wait until you see what unplanned bedlam looks like. Condi Rice said that the US intelligence community just did not have the imagination necessary to anticipate the 9/11 terrorist attack. Let us not have to resurrect this tired excuse this flu season.
Friday, July 31, 2009
Swift-boating the healthcare reform in the month of August*
Do you know the kids' book "Officer Buckle and Gloria" by Peggy Rathmann? It is a story of a police officer and his dog Gloria, who, as a team, go around the local schools giving such useful safety tips as "do not stand on a swivel chair". They are a big hit: they teach and make kids laugh, and their popularity soars to the point where a news team films one of their presentations. Watching it that evening on TV, officer Buckle has an epiphany about the etiology of their popularity: it is Gloria's charming antics, acting out his tips while standing behind him on the stage! Naturally, officer Buckle feels like a fool and slips into a depression and refuses further engagements, but it's OK, because Gloria is the real attraction, and she is still invited to talk, and she fails miserably without her buddy to the point that both she and her audience are depicted in the auditorium in a peaceful slumber. Z-z-z-z-z...
This is how I am beginning to feel about this whole healthcare "debate": z-z-z-z-z. The public is bogged down with worsening economy, the press are colluding with the Republicans in spreading mis-information, a la the Swift Boat gate. Members of Congress are day-dreaming about their summer recess, and the President is busy chugging Bud light at a teachable summit. So, among these doldrums, in walks Paul Krugman with his Nobel Prize in economics, and in a few computer strokes says as much as Tolstoy could say in a novel, and just as eloquently: Get your facts straight, you anti-government conspiracy-theory bile-spewing idiots! You owe whatever small amount of success exists in our current healthcare debacle to government regulation. Between Medicare and Medicaid, caring for the elderly and the indigent, respectively, and tax incentives for employers to cover their employees, while taking away their ability to cherry pick the healthy ones and rescind those with "pre-existing conditions", the government is already responsible for the parts that work.
This over-$2-trillion behemoth, and many of those feeding at its trough and promoting inefficiency, inequity and overuse, needs to be reined in! With the economy in the slump, and the US index of production, the GDP, continuing its nose-dive, our healthcare spending is continuing to increase, and I would not be surprised if it came in around 25-30% of the total GDP by the end of 2009. This would be a good investment, if the health of the population was improving. But with the rates of obesity on the rise, the threat of a tough flu season ahead that we are ill-prepared for, and fully 40% of the population carrying a chronic disease diagnosis, this does not appear likely.
So, let me reiterate a few points. If you worry about reduced incentives for innovation, don't: manufacturers' own risk-averse attitudes in response to market pressures have already squelched innovation. If you worry about the government getting into your affairs, don't: the role of the government will be well defined and limited to providing the funding and the tools necessary to make rational care decisions. If you worry about rationing, don't: we have a long way to go in cutting away the fat of unnecessary care before we get to the lean mass of what is useful and effective. And please, do not confuse "rational" with "rationing". Rational is what you will get if comparative effectiveness research is allowed to do its job. Rationing is what you are getting now from the suits in the boardroom who refuse to pay for your care.
So, as any doldrums, these too will pass. In the "Officer Buckle and Gloria", as you can imagine, officer Buckle sees the light and understands that he and Gloria are a team, and without him the schtick does not work. So, in the all's-well-that-ends-well fashion of children's books, the two friends get back together to the delight of their fans. Will our reality end well? I do not know, but what I do know is that without our involvement this healthcare schtick will not work. So, during the August recess we need to resist the slumber of summer and continue to pressure our elected officials to do the right thing: bring us quality equitable healthcare that will not bankrupt our children's future.
*I cannot take credit for this "Swift-boating" terminology, which I have respectfully borrowed from the Chairman of the DCCC, Chris Van Hollen
Tuesday, July 28, 2009
Imagination and H1N1 preparedness
Got an e-mail today from a Bloomberg reporter asking about my thoughts on the state of US preparedness for H1N1. Specifically he was interested in the ICU capacity as it applies to dealing with the more severe respiratory failure that has been reported in association with this infection. You might wonder why he called me of all people. Well, this is because I published a bunch of papers recently (that have been dutifully ignored by policy makers) that quantify the expected stress to the healthcare system in the US posed by the sky-rocketing increase in the population of patients requiring ventilators to assist them with breathing. How naïve I was to think that our numbers might be used for planning purposes, so that we could be better prepared for this growth!
A year since we first started to come out with the numbers, there are still no reliable estimates, or even attempts to derive them, as far as I can tell, of the US ICU surge capacity. And this information is more critical now than ever, as we are faced with the potential for untold numbers of H1N1-related hospitalizations accompanied by severe respiratory failure. It is shocking to me that we are leaving these infrastructure issues to chance.
But wait, why am I so shocked? This is just another byproduct of our fragmented healthcare "system". There is no one either to take or to designate responsibility for planning. While our professional organizations are doing the best they can, their approach is usually siloed and somewhat distracted: in case you have not heard, we are also tackling the most rampant pandemic of antibiotic resistant infections, which affects ICUs disproportionately.
So, who will take charge of this hot potato? The CDC? Homeland Security? FEMA (chuckle-chuckle)? Press your representatives to tackle this thorny issue, because if you are worried about planned rationing now, wait until you see what unplanned bedlam looks like. Condi Rice said that the US intelligence community just did not have the imagination necessary to anticipate the 9/11 terrorist attack. Let us not have to resurrect this tired excuse this flu season.
Subscribe to:
Posts (Atom)