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.

Power: a true test of character

As I mentioned in a previous post, the Department of Health and Human Services has contracted with the American Association for Respiratory Care to do a count of ventilators available in the US hospitals. This step is necessary in order to understand the capacity for accommodating the potential 300,000 victims of H1N1-induced acute respiratory failure. The AARC web site gives this interesting disclaimer:

"The U.S. Department of Health and Human Services further secures the privacy of your institution’s data through participation in the Protected Critical Infrastructure Information (PCII) program administered by the U.S. Department of Homeland Security. Resulting from the Critical Infrastructure Information Act (CII) of 2002, the PCII program protects voluntarily submitted critical infrastructure information from public release through Freedom of Information Act (FOIA), state and local disclosure laws, and use in civil litigation. Additionally, PCII can not be used for regulatory purposes. Institutions and facilities sending important data into the Federal government can be assured of the highest commitment to confidentiality and security of their data."

Why might the AARC feel the need to include it in order to conduct a legitimately needed survey? Clearly, they must feel that the responders would be reluctant to disclose publicly their vent numbers. Should the number of available ventilators really represent classified information under the current circumstances? How much more difficult does such secrecy make the already Sisyphean task of preparing our nation for what may be coming? It is like preparing for a war without knowing the number of rifles available to the army. And if it is this difficult to get a vent count, how impossible is it then to come up with an integrated triage plan? If the CEOs do not want known the number of shovels they can contribute to this sandbox, I hardly think they are running to volunteer the information on more advanced equipment (bulldozers, e.g.) or personnel to any foreman. Yet this is a very complicated sand castle construction, with many turrets, moats and portcullises, which without central oversight could do a lot of damage if not put together properly.

Having exhausted the sandbox metaphor, I will move on to several other, equally over-used ones. It is obvious that there are all-out preparations underway at the state, county and municipality levels. Further, hospitals are working hard as well to make sure they can provide best care possible to the greatest number of people. And the DHHS is working tirelessly to keep abreast of all the current developments to have mitigation measures in place. Unfortunately, all of the parties are brilliant musicians playing at the same time without a conductor. Federal regulators are constrained by state laws, regional agencies are confined to their own regions, and single institutions are ultimately driven by what is in their best interest; and besides, they are also beholden to the anti-trust laws!

Thus, suggestions (they are called "recommendations") are made, but there is currently no mandate that they be followed. It is like a surgeon suggesting that anesthesia be given to the patient before the first cut -- it may or may not happen. The President's advisers recommended in their report that he appoint an H1N1 Czar to oversee our preparedness efforts. But what is a Czar without the power to demand accountability, but a deposed monarch?

To me this fragmentation of effort falls in line with the mounting public paranoia that the government is using H1N1 as an excuse for a wholesale take over of the healthcare system, described nicely in a recent musing by Dr. Rob Lamberts, one of the top medical bloggers. In reality this is about turf battles and assertion of powers more than it is about any real threats to them. I know I keep referring to the NEJM piece that I reviewed a few days ago comparing Israel's state of medical preparedness to ours. I do not have to tell you that Israel has one of the most effective crisis mitigation systems in the world. Their healthcare system has to be ready for a mass casualty situation at a moment's notice. One of the central differences between them and us is competition between hospitals (they don't have it, we do). In the current instance, this competitiveness may be getting in the way of even the most rudimentary efforts at readiness. Hospitals already stand naked before a firing squad, having to report errors and other quality measures. What's the big deal about quantifying preparedness?

Abraham Lincoln once said "Nearly all men can stand adversity, but if you want to test a man's character, give him power." Let's look at this as an opportunity to show off our character, and share the power for the greater good.

H1N1: Why we are unprepared

We just published a paper in PLoS Currents: Influenza estimating what our ICUs can expect this flu season in the US due to the H1N1 pandemic. The picture is not pretty: about 300,000 extra patients needing assisted breathing from ventilators, and some of them requiring advanced modes of ventilation available only in specialized centers! Herein lies the paradox of this flu: by and large it does not cause a particularly severe disease, save in a small proportion of its victims. However, its contagion potential is high, and large numbers of the US population are likely to be affected (about 46 million by our estimates), accompanied by a large number of critically ill, thus potentially overwhelming the ICUs.

Here is how it fits into the overall picture of critical care in the US. ICU beds are perennially occupied, personnel numbers are shrinking and the volume of the sickest of the sick is growing at a clip 6 times that of all hospitalizations. Not to mention that 1/3 of all hospitals are financially in the red, and ~1/2 of all EDs are on diversion at some point (and, by the way, in the majority of these situations the reason for diversion is lack of ICU bed availability). Given that there are about 1 million patients on ventilators in the US annually, we are talking about a 33% surge likely compressed into a few months of the flu season! So what do you think is going to happen?

My friends on the ground tell me that we are not ready. Jeremy Kahn, MD, MS, Assistant Professor of Medicine and Epidemiology at the University of Pennsylvania School of Medicine and Senior Scholar in the Leonard Davis Institute of Health Economics, who happens to be one of the foremost experts on ICU capacity and regionalization in the US, told me that "we are woefully under prepared" for this pandemic. He is very concerned that critical care bed and ventilator supply will be outstripped by demand. But what concerns him even more is that "most municipalities do not have resource allocation or disaster preparedness plans in place". What this means is that we do not have plans in place to use the available resources optimally.

There are other ways in which we are unprepared. One is manifesting itself in our current national discourse on healthcare reform. The level of immaturity and selfishness in this "debate" makes me worry that we are not prepared as a population to make the tough decisions that have to be made during a disaster, which is what this pandemic is promising to be. Canadian Critical Care investigators came up with a protocol for their ICU resource allocation in case of a mass casualty event. This is an explicit scheme spelling out how prioritization is to take place. (Oh, yes, there will be prioritization). In a Society of Critical Care Medicine's podcast Dr. Randy S. Wax, a co-author of the Canadian protocol to triage ICU care during a pandemic, talks about this scheme. He uses the phrase "distributive justice". What this boils down to is that in the face of a public health disaster a bedside doc is responsible to the society at large even more so than to an individual patient. It is critical to have an explicit and transparent prioritization protocol, developed and put into place with full participation of community members. This is necessary as much for clarity and community buy-in as it is for protection from liability. The Canadian scheme has been available for 3 years -- have we heeded the call? Clearly not. And what is the Society of Critical Care Medicine doing? Well, to be fair, they have offered some disaster management courses. Now, at the 11th hour, they are advertising a web cast on September 17 at a cost of $65.00 for individual non-members!

So, where does all this leave us? As I said before, with our pants down! Is this sad state of affairs another reminder why we need a healthcare system devoid of the profit motive? A few days ago I reviewed a paper in the New England Journal of Medicine comparing Israeli preparedness scheme to ours. Some of the pivotal differences between our two systems are the centralized nature of planing and enforcement functions (they have it, we don't), competition between centers (they don't have it, we do), and the profit motive (they don't have it, we do).

Since it is too late for this pandemic to benefit from a philosophical and infrastructural overhaul, we need to have a realistic national plan. We have to do as much as we can to put plans into place that optimize the use of currently available resources. At the same time, prevention is clearly going to be the cornerstone of this effort. I believe that we need to be exceedingly aggressive with preventive efforts, including school and business closures, travel restrictions and the like. In fact, this may be a great opportunity to test to its fullest our communications web. It is possible that if we handle this potential catastrophe with some measure of common sense, we may gain useful insights not only into who we are as a community, but how our vast technological resources can make us into a more compassionate and efficient work force.

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.

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.