The drag queens of the conservative right

(I apologize in advance to my drag queen friends for putting them in the same sentence as the conservative extremists -- I merely do this to make a point) 

Who among us can forget the 1980s? I would guess that most of my readers were conscious adults during that glorious decade. Having come to this country as a young teen in the late '70s, I enjoyed the '80s as my time of initiation into the American culture. It was then that I became aware of such iconic symbols as the Brady Bunch, The Doors, and... drag queens. Yes, drag queens. As the struggle for gay equality permeated our collective consciousness, I began to notice a plethora of drag queens in the press's coverage of gay pride events. And a lot of very tough women in leather jackets on motorcycles. Just like most people in that era, I was not aware of any gay people in my immediate circle, so I had to assume that these flamboyant and memorable images were representative of the gay community at large. 

Well, my views grew up. As I learned more, I realized that the lovely drag queens and the charming biker lesbians were but the tip of the gay iceberg, images that in those days had sure shock value and sold news. The vast majority of the gay community, as it turned out, was virtually indistinguishable from heterosexuals. And for this reason, they were not newsworthy. 

I find the attention-grabbing efforts of the conservative extremists at hijacking our national healthcare discussion akin to the coverage of gay pride during the '80s: just the drag queens (though not nearly as charming and genuine) and no average gay people. Does Sarah Palin really represent the entire Republican party? Don't tell me that the hatred spewed hourly by the likes of Rush, Glenn and Bill does not make an average Republican cringe! Where are the voices of reason?

Another group that amazed and surprised my immigrant sensibilities in the 1980s was The Moral Majority. I remember finally someone coming out with the slogan "Moral Majority is neither". Today we have the extreme right purporting to represent the Republican majority and fiscal conservatism. In fact, they do neither. This emperor has no clothes.      

Absence-of-evidence based medicine

The term evidence-based medicine has made it into our colloquial language over the last decade. David Sackett, considered one of the founding fathers of the movement, defined it as

... the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research." (Sackett D, 1996)

The reality is that only about 5% of all medical practice recommendations have good quality evidence behind them, and perhaps another quarter have some evidence. The rest of medicine is practiced by "the seat of the pants" approach, or "the 15 years of experience" method. Clearly, this is not wrong when there is absence of evidence.

It is a fallacy, however, to confuse this absence of evidence with the evidence of absence of an association or an effect. What I mean by this is that in the former no one has bothered to generate the evidence, whereas in the latter there is evidence that does not support an association between the exposure and outcome. The latter is in fact evidence, while the former is absence of any evidence.

The distinction may be subtle, but is worth making. Take some of our environmental policies, for example. There are 80,000 potentially toxic chemicals on the market, including household cleaners, pesticides, etc., of which only 200 have been evaluated for toxicity by the government agencies. Does this represent the evidence of absence of any harm to human health? Of course not! This is a clear case of absence of evidence -- we have not deemed it fit to put resources into investigating the association between exposures to these chemicals and health. So to say that these chemicals are harmless would be a fallacy in the absence of a concerted effort to study them in the context of public's health.

Similarly, because our adverse drug reactions reporting system has traditionally been voluntary, the absence of reporting does not equal the absence of adverse events. Again, a classic situation of absence of evidence and NOT evidence of absence of these events.

So, given what I have just said, it is in fact difficult to practice evidence-based medicine or evidence-based public health. Unfortunately, even the evidence that exists is slow to wend its way into practice. As the RAND researchers demonstrated several years ago, the median penetration of evidence into practice is on the order of 50%, which is no better than a coin toss! So, we can certainly do better than that. When there is evidence. But, let's not be fooled: most of the time what we end up practicing is absence-of-evidence based medicine. Question your doctors closely to distinguish between the two, as this distinction is the key to rational decision making.

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

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

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

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

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

Additionally, the IOM committee concludes that

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

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

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

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

 

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.

My study covered on Reuters Health hosted on thedoctorschannel.com

Here is a story from Reuters Health covering my recent study in Chest. There is a video there too!

NEW YORK (Reuters Health) – Patients on prolonged acute mechanical ventilation face an increased risk of Clostridium difficile-associated disease, according to a report in the September Chest.

“C. difficile is frequent in this population, and we need to be vigilant in our prevention efforts,” Dr. Marya D. Zilberberg from University of Massachusetts, Amherst told Reuters Health by email. “Once present, it is critical to contain the spread of C. difficile to other patients.”

Dr. Zilberberg and colleagues used 2005 data from the Health Care Utilization Project/Nationwide Inpatient Sample to examine the rates and outcomes of C. difficile-associated disease among 64,910 hospitalized adults who received prolonged treatment with acute mechanical ventilation.

Among these patients, 5.3% had a concomitant diagnosis of C. difficile-associated disease at death or discharge.

On unadjusted analysis, the primary outcome of the study – hospital mortality – was 32.6% in patients with C. difficile-associated disease and 33.0% in patients without it. In the adjusted analysis, there was “a small but statistically significant difference” in mortality risk, with patients who had C. difficile-associated disease “somewhat less likely” to die in the hospital (adjusted relative risk, 0.89).

In addition, C. difficile-associated disease in patients with prolonged ventilation was associated with substantially greater median hospital length of stay, higher median costs, a greater likelihood of being discharged to a skilled nursing facility, and a lower likelihood of being discharged to home.

“This infection rate of 530 cases per 10,000 hospital admissions is strikingly high compared with that noted in the general hospitalized population (11.2 cases per 10,000 hospitalizations,” the investigators say.

“The most important thing is to minimize the use of antibiotics as much as possible, particularly the classes that are known to select for C. difficile (e.g., quinolones, etc.),” Dr. Zilberberg said. “We are finding that there is a fair bit of community-acquired C. difficile, which may act as a reservoir for hospital-acquired disease. So limiting antibiotics should be a community-wide effort, not just that in the hospital.”

Reference:
Chest 2009;136:752-758.

What should we do with scientific ghost writing?

Ghostwriting in peer-reviewed healthcare literature has been gaining quite a bit of attention. PLoS has even created a public web site to document this deplorable practice by one pharmaceutical manufacturer. But what is this really all about? Is it another tempest in a teapot or a dire threat to scientific integrity? The answer is probably a little bit of both.

Before going further, a couple of disclaimers. I have published a number of studies supported with research funding from manufacturers. In only two instances I had manuscript preparation assistance from a medical writer, and each was acknowledged in the paper. I generally do not like having someone else draft the paper, even a co-author, and prefer to do so myself (control issues, clearly). I also agree that having a paper written by a medical writer and slapping an academic's name on it willi-nilli is an indefensible practice. To be sure, it is indefensible on the parts of both the sponsor and the academic, and as such should be systematically routed out.  

Now that we have gotten that out of the way, let's focus on the topic at hand. Here is the definition of a ghostwriter from my favorite populist source, Wikipedia:

A ghostwriter is a professional writer who is paid to write books, articles, stories, reports, or other texts that are officially credited to another person. Celebrities, executives, and political leaders often hire ghostwriters to draft or edit autobiographies, magazine articles, or other written material. In music, ghostwriters are used in film score composition, as well as in pop music such as Top 40, country, and hip-hop. The ghostwriter is sometimes acknowledged by the author or publisher for his or her writing services. [emphasis mine]

Clearly, ghostwriting is a pervasive and acceptable practice in literature, music, politics and even journalism. So, why is there such a furor over it in medicine? Well, the answer is "bias". Here is an example cited by the PLoS editors of an illustrative correspondence between a sponsor and the medical writing company:

An email from a writer employed by the medical writing company, DesignWrite, to employees of Wyeth, the company that performed the study, and Parthenon (another medical writing company) on November 10, 2003 concerning manuscripts on Totelle (a brand of hormone replacement therapy manufactured by Wyeth) tells the story concisely. “Thanks to all who have reviewed and approved the manuscripts… I have received no word on authors for the Totelle 2 mg bone manuscript P3(2), and need input on this matter before this manuscript can move forwards.” [our emphasis added]

On its own, the quote is damning on the one hand, but totally explicable on the other: in large trials not all investigators are listed as authors on the paper, and this my be what the e-mail is querying. I do not think that this was the case here, however. As for generating review papers with authorship to be determined at a later date, the case is less clear. Should the manufacturer be able to be the originator of an idea on what information gaps need to be filled? Or should these always come from academics?

Consider this: manufacturer organizations are not monolithic. It is unfortunate that sales and marketing departments are usually oversized, powerful and most visible. Less visible are R&D groups, Clinical Affairs divisions responsible for Phases 1-3 work, and Medical Affairs departments, whose role is to shepherd the post-approval clinical development. It is the Medical Affairs, staffed by healthcare professionals including physicians, pharmacists and others, that primarily interacts with academics to develop ideas that presumably have both, academic integrity and strategic merit for the company. Smart companies understand the importance of having a firewall between the sales and marketing organizations and the Medical Affairs in order to safeguard against marketing abuses couched as science. Under these circumstances, even if a paper starts out within the walls of the company, there has been a heavy imprimatur of the academic collaborators, who ultimately, along with the company authors, take full responsibility for the content of the publication. My point is that not all papers "commissioned" by the industry need to be thrown out.

But what is the role of a medical writer in these endeavors? In my experience, medical writers develop an outline and the first draft of the manuscript based on the data at hand. The quality of this draft can be quite variable depending on the writer's experience. An ideal medical writer is not only knowledgeable about the particular field of investigation, but also knows how to write. Unfortunately, these two criteria are rarely met either singly or together. So, the draft that the authors get usually goes from incoherent to rambling and requires a great deal of intervention at both the scientific and the writing levels. So, if the implication is that the papers get accepted into high impact journals as written by the medical writers without much shaping and editing by the academics, there is something very wrong with these journals' review practices: it is easy to spot an unedited piece of hired writing a mile away! 
      
The World Association of Medical Editors defines ghostwriting thus:

Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. WAME considers ghost authorship dishonest and unacceptable. Ghost authors generally work on behalf of companies, or agents acting for those companies, with a commercial interest in the topic, and this compounds the problem. For example, a writer employed by a commercial company may prepare an article, then invite an expert in the field to submit the work, perhaps with minor revisions, under his or her own name. The submitting author may be paid, directly or indirectly, for this service. In other circumstances, investigators may pay a professional writer to help them prepare their article but not mention this assistance, gaining credit for writing they have not done. Although editors seek to avoid publication of ghost written articles, these articles are often very difficult to detect.

Again, I have to say that ghost writing that I have been privy to as a reviewer is really not that hard to spot. But of course this view may be the result of misclassification on my part, as those papers that are well written do not elicit the same suspicion from me. I guess to be more accurate I need to state that at least some ghost written papers are easy to spot.

So, what is the sum total here? So long as there is a profit motive on the part of the manufacturers (sorry, but this is the way capitalism works today, right or wrong), they will have a hand in what gets funded. Short of scrapping the pharmaceutical business model as it exists today, we need to come up with transparent best practices that everyone can live with. Companies do and will commission papers. It is unwise for the sales and marketing departments to be the originators of these ideas because of the unmitigated conflict of interest. It is best for Medical Affairs professionals, insulated from sales and marketing, to interact with the academic experts to develop and execute studies and reporting of the data. Medical writers should be used as such only if they bring writing and content expertise to the table, and they need to be acknowledged either as a co-author (provided they meet the criteria) or as someone who has made a contribution to the drafting of the manuscript. If they are unable to contribute usefully, they should be used only for such administrative tasks as formatting the manuscript and references, collating comments and submitting the paper.

On their part, journals need to set higher standards for the reporting, disclosure and reviewers' comments. Editors and reviewers should be on alert for poorly written review papers with a marketing message -- from what I have seen, these are just not that subtle. Ultimately, the responsibility for the integrity of scientific discourse lies with all of the stakeholders. Lest we blow our scientific reputations with the public, we have got to fix what is wrong and come up with a solution incorporating those pieces that work and do not compromise our professional ethics. We do not need to throw the baby out with the bath water; a rational solution may be much closer than we think.    

 

H1N1 pandemic and gut superbug

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

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

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

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

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

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

Is our political discourse suffering from a psychiatric disorder?

When I was a kid in Odessa my Dad and I went to see The Sound of Music at least 17 times in the span of 3 months. Remember that song sung by the nuns when Maria is late for the vespers, "How do you solve the problem like Maria?" One nun says "She's an angel", another one counters "She's a demon", when the voice of reason from Mother Superior repositions the whole argument with "She's a girl!" I always saw this as a bit of splitting nipped effectively in the bud by the Mother Superior -- good for her!

The press are doing exactly this to President Obama: the right makes him out to be a demon promoting a big government take-over within the US while ruining our reputation abroad, and the left canonizes him as the do-no-wrong president. I am struck by how effective this borderline personality approach has been at overtaking our political discourse. A borderline personality is a psychiatric diagnosis highlighted by a black-and-white view of the world, resulting in splitting behaviors. Sound familiar? Right: Obama bad, we good! Left: Obama good, them bad! I learned in medical school that a borderline personality disorder is a psychosis. Therefore, conservative and liberal alike, in lemming-like fashion we are following a psychotic analysis of reality.

In this grey world, neither the black nor the white bent seems intellectually honest. Granted, everything I understand about politics I learned from the "West Wing", so I am by no means an expert pundit. But I have also learned some valuable lessons from my own life, including that life is all about compromises whenever possible. This, I believe, is what Obama is after, which makes him neither evil nor a saint, but a reasonable leader and diplomat.

Let's take his approach to the Middle East. Yes, he is making an effort with the Iranians, the nation perceived to carry a substantial threat to the US security. Does it not make sense to establish constructive relationships with their leaders so as to avoid a potential nuclear confrontation? You know that expression about "an eye for an eye" and being blind -- this seems like the perfect application for it: time to turn around our eight-year bully posturing on Iran and start exploring real long-term solutions.

Domestically, the biggest sticky wicket is the healthcare reform. And even here Obama is showing himself to be a compromiser. This is not appreciated by the extreme right or left (myself included), but the realist in me understands that this is a chess match with far-reaching implications. And while I would like to see quality single payer healthcare for all Americans in my lifetime, I appreciate that mine is considered to be an extreme point of view.

More important to me than getting my own way is to see our country brought together. We need to get away form the psychotic hegemony and end the divisiveness of the deliberately polarizing rhetoric. We must engage in an honest intellectual exercise and effect changes that are best for all people.    

Repairing the world

Today is Friday. Eight years ago, when our world fractured, it was Tuesday. I was away in Chicago for a meeting. I was eating breakfast when my cell phone rang, and a distraught voice on the other end told me that we were under attack: a plane had just struck one of the World Trade Center towers. It would not be long before the second tower and the Pentagon got hit, and another plane went down in a Pennsylvania field.

My meeting was at the Westin in Chicago. Throngs of guests crowded around the television in a small bar to bear witness to the surreal events. Rain of airplanes and people, falling, jumping... The vivid images of billowing smoke and dust caught in my throat. No one was sure what would get hit next -- Los Angeles? Boston? Chicago? I recall the wave of relief upon seeing a colleague in the bar who had just flown in from New Jersey that morning. I recall ghostly emptiness of Chicago streets, police cars parked, with their lights spinning.

I recall getting myself back to Boston, into Logan, terminal B, where my car was parked, close to midnight on the 12th. Another dark and silent ghost town, police car lights throwing blue and red splashes on buildings and sidewalks. It was hard to remember where I had left my car.

In subsequent days it was impossible to drag myself away from CNN -- I survived on a steady diet of anger, conjecture, analysis, voyeurism. When the names of passengers came out, I realized that one was a former colleague with whom I had recently sat down to lunch: he had been on his way to a Continuing Medical Education program in San Diego.

I did not fly for the rest of the year; I drove everywhere and avoided journeys too far away from home. Despite being requested to do so by the leader of the free world, I did not go shopping. I spent time with my kids, family, friends. I fasted on Yom Kippur and stood up for the mourners' kaddish. I began to cultivate an organic understanding of Tikkun Olam (Repairing the World).

As days, weeks, months and years are whisking me farther away from that day, I am finding myself washed up on the doorstep of the world that is more broken than it was on that day of darkness. We are broken by poverty, wars, hatred and greed, by lies told by politicians in the name of expediency, by divisiveness of power grabs, by denying our human drive to help one another. The current devastations are more gradual and muted, and therefore less viscerally shocking. They are not the in-your-face acts of terror, but they are nevertheless leading us down the path of societal destruction. Compared to the self-inflicted collapse of our financial institutions one year ago, the fears for terrorist attack-caused economic upheaval were but a weak tremor. The tens of thousands of people dying every year here in the US because they either do not have access to needed healthcare or are trapped in a healthcare system that is fraught with errors and harm dwarf the magnitude of the loss of life of 9/11. Millions of children coming home from school to an empty house to sit inside for hours in front of the most effective sales and marketing machine, to drink soda and eat chips and become diabetic and hypertensive before graduating from middle school, is the result of terror far more egregious than anything perpetrated or contemplated by our acknowledged enemies.

As our President pointed out the other night, "the time for bickering is over". Now more than ever in my lifetime we need to engage in repairing the world. Out of respect for those who perished that day and those who have given their lives since, Tikkun Olam!                  

Healthcare reform: so much more than costs

The opposition to healthcare reform is fanning fears of rationing as a way of controlling escalating costs and broadening access. A better use of our collective energies would be to identify and eliminate the waste and harm produced by the current healthcare system. We are well aware of over 1 million hospitalizations and the nearly 100,000 deaths associated with hospital-acquired infections, at a cost of approximately $40 billion annually. We have this information partly because the data infrastructure within hospitals exists to track these events. Many more potential adverse consequences of healthcare remain unrecognized and unquantified, particularly those that occur outside of hospitals, where the majority of healthcare takes place. We hear distant echoes of alarms sounded by researchers, but because there is no integrated picture of the full magnitude of the harm, we remain complacent. We must admit that harm exists, develop systems to track and quantify it, and finally eliminate it. The time for this is now; here is why.

Why would harm be pervasive in what has been called by some “the best healthcare system in the world”? Theoretically, risk aversion, by promoting a culture of over-testing, over-diagnosis and over-treatment, is fraught with paradoxically noxious potential. Beyond theory, an example of how the “better-safe-than-sorry” approach can be detrimental plays out in screening mammography. Despite the fact that the US Preventive Services Task Force says to commence breast cancer screening at the age of 40, the risk and benefit balance of this recommendation is unclear. A recent study from Europe, for example, noted that for every 2,000 women screened over a 10-year period, one cancer death is averted. The trade-off is that 2-10 other women receive invasive and toxic treatments for a cancer that would not have become life-threatening. What is even more disturbing is that we do not know how many of these 10 women are consigned to life-long illnesses or an early death due to the complications of this unnecessary treatment. Similar concerns exist for prostate cancer screening and for many other diagnostic and therapeutic modalities we employ every day: the drug and device approval process focuses more on short-term benefits and less on long-term risks. Therefore, the full extent of the harm remains unknown.

Until recently, the heretical talk of harmful effects of healthcare was relegated to the fringes of the medical world. Fortunately, this conversation has now penetrated into the mainstream, with a paper in a recent issue of The New England Journal of Medicine laying out the research framework to explore this problem. Unfortunately, the research agenda, which still requires much clarification and planning, though harnessing the will to fill this knowledge gap, will be hard-pressed to find a way. This is because of the heterogeneous and still mostly paper-based medical record-keeping by the majority of US practitioners, precluding meaningful recognition and aggregation of relevant data.

This lack of knowledge gives the public a rosy view of healthcare: high benefits with virtually no harms. Getting a handle on the full picture of the balance of benefits with harms and waste, however, is critical for optimizing outcomes. Although data to quantify it are presently scant, the timing of the emergence of this research agenda, coincident with the major push to adopt electronic health data platforms along with the recent allocation of funding to the comparative effectiveness research (CER), is fortuitous. Electronic data, if captured accurately and uniformly, are a robust source of complete information on long-term outcomes, and the well-established framework for CER is a natural fit for incorporating these data to inform policy decisions.

If healthcare reform is to achieve its goals of universal access to good quality healthcare at a reasonable price, we must not miss this opportunity to align the research into harm with our ability to generate useful data from electronic sources to feed smart policy decisions through CER. Although historically our healthcare system has enjoyed very little integrated planning, this is an opportunity to draw up a sensible blueprint for a successful future. If we do it right, we will be not only saving money, but also addressing such an important societal concern as human lives. 

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.

Is breast cancer really the WORST enemy?

I got a chain e-mail from a good friend of mine urging me to get my screening mammogram done. The message contained cute comics about mammography (mostly about the lasting effects of squishing the boobs, you can imagine), and at the end it had the following message:

Mail this to 13 other women. Now, don't break the chain! One female broke the chain, her plumbing became so bad, she now has an outhouse! OK gals, now that you have had your laugh, remember... Breast Cancer Awareness... Go have those boobs checked out and stay healthy! Pass the message on to your mothers, sisters, daughters, aunts, cousins, friends, and even your enemies. Because the WORST enemy is Breast Cancer.

Now, by now you,my reader, know that I am a great skeptic of over-diagnosis and over-treatment; I think it causes more harm than good, though we have not really bothered to quantify the harm yet. But a recent study from Europe fueled my fires on the mammo front. This study, a systematic review of the literature on the subject, concluded that about 1 in 3 cancers in a screened population is an over-diagnosis. In an accompanying editorial, H. Gilbert Welch from Dartmouth, a perennial skeptic of the "more is better" approach, provided a sober view of the dilemma:

Mammography is one of medicine’s "close calls"—a delicate balance between benefits and harms—where different people in the same situation might reasonably make different choices. Mammography undoubtedly helps some women but hurts others. No right answer exists, instead it is a personal choice. (emphasis mine)

Dr. Welch, one of the foremost experts on over-diagnosis in mammography, in fact provided this very useful, in my opinion, table:

Draft balance sheet for screening mammography in 50 year old women*

Credits Debits 1 woman will avoid dying from breast cancer 2-10 women will be overdiagnosed and treated needlessly 10-15 women will be told they have breast cancer earlier than they would otherwise have been told, but this will not affect their prognosis 100-500 women will have at least one "false alarm" (about half of these women will undergo a biopsy)

*For every 1000 women undergoing annual mammography for 10 years

This tally is chilling, given that the end-result is that, to avoid 1 breast cancer death, 2 to 10 women will be treated unnecessarily with disfiguring surgery, toxic chemo and radiation therapies, and 100 to 500 others will be subjected to follow-up testing, some of it invasive. Now, you may be saying that it is all worth it to avoid dying from breast cancer. Unfortunately, what we do not have a solid idea about is how much harm, in the form of complications and deaths from the unnecessary work-up and treatment, comes from this "better-safe-than-sorry" approach. We also have very little knowledge of the long-term effect of the radiation exposure from mammo. 


So, the bottom line is that, if a woman decides against the current dogma to have annual screening mammography, don't make her into a pariah -- she is exercising her good judgment. Peer pressure in this situation is not only unwarranted, but may be detrimental. We as the medical and public health profession need to start developing a much more nuanced message about cancer screening in general, and mammography in particular. There is too much evidence now that one size does not fit all. 

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.

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. 



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.