January 14, 2012
National Vaccine Program Office
US Dept. of Health and Human Services
Attn: Healthcare Personnel Influenza Vaccination Subgroup c/o Jennifer Gordon
200 Independence Avenue, SW
Washington, DC 20201
Via Email: firstname.lastname@example.org
Dear HCPIVS staff and members:
We appreciate the opportunity to offer some brief comments on the draft document developed by the Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS) of the National Vaccine Advisory Committee (NVAC), with the charge of recommending ways to increase influenza vaccination rates among healthcare workers.
That is a charge we support. We are strong proponents of flu vaccination. We get vaccinated annually, and urge family and friends to do likewise. (Dr. Lanard, who often works in the southern hemisphere, sometimes gets vaccinated twice.) We think the downsides of flu vaccination are negligible, while its upsides are substantial – even though the vaccine is only 50–70% effective in healthy adults under 65 in years with a good match. We think healthcare workers (HCWs), like everyone else, should choose to get vaccinated against the flu.
We are not experts in vaccination, influenza, or health policy. We are experts in risk communication, and will try to focus our comments on risk communication issues raised by your proposed recommendations.
We see two such issues: the dangers of overstating flu vaccination benefits, and the dangers of requiring reluctant HCWs to get vaccinated.
The dangers of overstating flu vaccination benefits
As you know, the evidence that vaccinating HCWs against the flu reduces patient mortality and morbidity comes almost entirely from studies conducted in nursing homes. There is little if any evidence demonstrating the same effect in a general hospital setting, far less an outpatient setting. Since patients in nursing homes have fewer close contacts with persons other than HCWs than patients elsewhere, extrapolating from one to the other without data is insupportable.
Yet many public health agencies and others have implied or explicitly claimed that there is strong scientific support for the contention that flu vaccination of HCWs benefits patients. Typically they cite the nursing home studies without noting the questionable applicability of these studies to other healthcare settings. In a 2010 editorial, for example, the Editor-in-Chief of Vaccine, the Mayo Clinic’s Gregory Poland, wrote:
Further, studies have now demonstrated the relationship between levels of HCW influenza immunization and mortality among the patients they care for [3,4].
Dr. Poland’s two footnotes in support of this statement lead to articles showing that HCW vaccination protected elderly patients in long-term care facilities. He cites no studies showing a similar protective effect in the general hospital population. The title of Dr. Poland’s editorial is worth contemplating in the context of his own overstatement: “Mandating influenza vaccination for health care workers: Putting patients and professional ethics over personal preference.”
Here is another typical passage, from the very first paragraph of a March 2012 article entitled “Seasonal Influenza Vaccine Compliance among Hospital-Based and Nonhospital-Based Healthcare Workers,” analyzing influenza vaccine compliance among HCWs, and also advocating mandatory HCW vaccination:
Influenza vaccination of HCWs has been shown to not only decrease employee sick leave(2) but also decrease morbidity and mortality among patients.(3–5)
We have no quarrel with the first part of this sentence. There appear to be ample data that increased HCW vaccination reduces staff absenteeism. (When there are more vaccinated HCWs around, there may be more staff with “failed vaccinations” who catch vaccine-tempered mild cases of the flu – and are not sick enough to stay home. But that is a problem for another day.)
Almost needless to say, footnotes 3–5 in the latter part of the sentence refer to the usual long-term care and nursing home studies. Later in the same article, footnote 5 (relabeled footnote 21) is used in support of the statement that “Research indicates that vaccinating HCWs in these [long-term care and nursing home] settings can decrease patient morbidity and mortality and is preferable to vaccinating the frail elderly.” But nowhere does the article acknowledge that virtually no similar studies have been done in acute-care hospitals or outpatient settings.
Much more culpable, in terms of the misleading use of evidence, is this excerpt from the American College of Physicians’ position statement on mandatory HCP vaccination. We are going to examine two of the three “Evidence” paragraphs of this document in detail (we have bolded some words in the passage that follows):
Immunizing health care workers safely and effectively prevents a significant number of influenza infections, hospitalizations, and deaths among the patients they care for, as well as preventing workplace disruption and medical errors by workers absent from work due to illness, or present at work but ill.7,8,9
Influenza vaccination of HCWs lowers mortality among patients. A study of 20 hospitals found an overall 51% staff vaccination rate in hospitals where vaccine was offered vs. 5% staff vaccination rate in hospitals where influenza vaccine was not offered. Mortality among patients was 13.6% (102/749) in the hospitals providing HCW vaccination vs. 22.4% (154/688) (P = 0.01) in hospitals that did not.10 In another study of 12 hospitals, HCWs and patients were randomized to receive influenza vaccine. There was no difference in patient mortality between hospitals with patients who received vaccine and patients who did not. However, the mortality rate among patients in hospitals where HCWs got vaccine was 10%, compared with 17% among hospitals that did not immunize HCWs.11
Why is this so misleading? None of the five footnoted sources in these two paragraphs of “EVIDENCE” provides any evidence whatever that vaccinating HCWs protects patients in acute-care hospitals, outpatient clinics, physicians’ offices, or other non-long-term care healthcare settings.
The first paragraph cites three studies. “Effectiveness of Influenza Vaccine in Health Care Professionals” (footnote 7) showed that HCW vaccination “may reduce reported days of work absence and febrile respiratory illness,” but did not examine whether HCW vaccination reduces patient mortality or morbidity. “Effectiveness and Cost-Benefit of Influenza Vaccination of Healthy Working Adults” (footnote 8) showed reduced absenteeism among healthy adults in a manufacturing company. And “Prevention and Early Treatment of Influenza in Healthy Adults” (footnote 9) compares the effectiveness and cost-effectiveness of flu vaccines and antivirals.
None of the three citations in this first “EVIDENCE” paragraph substantiates the claim that HCW vaccination “prevents a significant number of influenza infections, hospitalizations, and deaths among the patients they care for.”
The second paragraph refers repeatedly to “hospitals” – citing one study of “20 hospitals” and another study of “12 hospitals” – but the two footnotes (10 and 11) refer to the usual long-term care hospital studies, not to hospitals in general (nor to other healthcare settings such as outpatient clinics).
The Immunization Action Coalition (supported by the U.S. CDC among others) lists an Honor Roll of organizations recommending mandatory HCW influenza vaccination. The American College of Physicians is on the Honor Roll. It would be enlightening to see how many of the other Honor Roll organizations’ position papers are similarly guilty of misleading evidentiary claims.
A crucial segment of the audience for these position papers is political leaders and institutional administrators trying to make decisions about mandatory HCW vaccination. These target audiences assume – and should be entitled to assume – that the evidentiary claims of these position papers are solid and meticulously honest. Many are not.
We are hopeful that you will avoid this type of misleading use of evidence. It would be enormously helpful if you would also document its frequency – we would be happy to provide as many examples as you require – and explicitly recommend against it.
Your current draft acknowledges that there are “significant gaps in understanding the impact of increasing vaccination rates on patient safety.” It stops short of conceding, as we believe it should, that there is virtually no evidence supporting the hoped-for benefits in settings other than nursing homes. The most relevant passage in the draft reads as follows:
Determining the overall effects of vaccination of HCP on patient outcomes is methodologically challenging and the outcomes measured often vary between studies. Findings specific to the effectiveness of HCP influenza vaccination in protecting patients vary by setting, year, and population studied and may lead to differing interpretations of the available data [21, 23–27]. Collectively, the impact of HCP vaccination on patient morbidity and mortality in the acute and long-term care settings requires continued investigation. While the working group discussed several scientific studies that evaluated the impact of HCP influenza vaccination on reducing health-care associated influenza infection among patients, evaluating the full merits of HCP vaccination was not included in the charge of the working group, and therefore is not directly addressed in this report.
This is far superior to the misleading evidentiary claims of many public health agencies and trade associations. But it seems to us that a recommendation on behalf of mandatory HCW vaccination would require you to explain why you believe that the recommendation would benefit patients, not just healthcare workers themselves. (The alternative is to explain why you believe healthcare workers should be coerced for their own benefit.)
Ethics aside, our concern here is for the credibility of public health as an institution. We have written at length elsewhere about the ways in which flu vaccination “hype” – partial truths misleadingly deployed – may undermine trust, not just trust in flu vaccination but trust in public health generally. See particularly our 2009 article on “Convincing Health Care Workers to Get a Flu Shot … Without the Hype.”
Using such hype on behalf of coercion is in our judgment especially dangerous. HCWs who resent being coerced have reason to look closely at the rationales being offered for the coercion. Those rationales should be able to withstand close scrutiny.
We are aware of one impressive-sounding tertiary care hospital study, “Preventing Nosocomial Influenza by Improving the Vaccine Acceptance Rate of Clinicians,” which documented decreased nosocomial influenza transmission during a 12-year period as HCW flu vaccination rates increased from 4% to 67%. We have probably missed other relevant articles. But it remains true that the main evidence routinely cited to support mandatory influenza vaccination of HCWs continues to be evidence from long-term care facilities – and the evidence is typically cited without acknowledgment of this significant limitation (unless the reader scrutinizes the footnoted sources).
We would not object to your saying that you think it’s plausible that vaccinating HCWs will provide some protection to patients in various healthcare settings, even though there is little if any evidence. That’s the frame the World Health Organization used when supporting the efficacy of the conventional “cover your cough” recommendation despite the lack of influenza-related evidence with regard to that precaution. The World Health Organization Writing Group report on “Nonpharmaceutical Interventions for Pandemic Influenza” makes the recommendation but concedes that it makes it “more on the basis of plausible effectiveness than controlled studies.”
We don’t know if plausibility is sufficient to justify coercion, but we are not ethicists and we will leave that question to others. But first, let us offer you this thought experiment. If a healthcare researcher were to propose a study in which HCWs in certain hospitals would be given influenza vaccinations against their will (or lose their jobs) in order to assess the health outcomes of patients, would this methodology pass human subjects review?
At least a claim to base the policy on plausibility would not lack integrity, as a claim to base it on “sound science” would.
Is it in fact plausible that mandatory HCW vaccination reduces patient morbidity and mortality in settings other than nursing homes? We realize that there have been complex modeling studies to address this question, such as a 2009 study by van den Dool et al. If the manifold assumptions in that study are valid, then it is highly plausible that mandatory HCW vaccination would reduce hospital patients’ influenza risk. (This assertion will nonetheless sound implausible to many HCWs. Your draft cites a CDC study indicating that “55.4% of unvaccinated HCP do not believe that vaccination better protects those around them from influenza infection.”)
The potential benefit of mandatory flu vaccination strikes us as thoroughly implausible in outpatient settings, where patients spend more time in close proximity to each other in the waiting room than in close proximity to any healthcare worker … and are spending the rest of the week immersed in their lives (unless they are sick at home): riding the bus, hugging friends, and going out to lunch with coworkers.
Perhaps your position is that “if mandatory HCW flu vaccination saves even one patient life, it’s worth doing.” If so, then that is what we think you should say. For obvious reasons, this is not normally the position of public health, which prioritizes health interventions based on their comparative benefits and costs. There are many interventions that might save a life here and there that public health wisely decides aren’t worth the expense, the opportunity cost, or (in this case) the interference with other people’s autonomy.
We don’t know how much patient mortality and morbidity a mandatory HCW flu vaccination policy needs to prevent in order to justify the downside of annual coercion. As a start, we would suggest that it needs to prevent at least enough patient mortality and morbidity to achieve robust statistical significance in studies conducted in the sorts of venues in which the policy will be implemented.
But we understand that there continues to be contentious debate over the questions of whether HCW flu vaccination benefits patients; and, if so, whether the benefits are sufficient to justify forcing reluctant HCWs to get vaccinated. You need not share our skepticism on these points to accept our more urgent contention that overstating the benefits or the evidence of benefits would be both dishonorable and dangerous.
You have an opportunity not just to avoid making any such misleading claims, but to add a strong recommendation that HCW flu vaccination programs – whether mandatory or voluntary – should also be careful not to overstate the benefits or the evidence of benefits of HCW flu vaccination.
The dangers of requiring reluctant HCWs to get vaccinated
The impact of coercion on the attitudes of those who are coerced is a complicated issue. There are two possibilities, both of them plausible.
One plausible outcome is that resentment of the coercion will exacerbate people’s negative feelings about what they are coerced into doing. Every parent has experienced this firsthand. Thus a healthcare worker who was initially skeptical about flu vaccination might become much more hostile to flu vaccination as a result of being forced to get vaccinated.
More broadly, mandatory HCW flu vaccination could lead to:
- increased opposition to flu vaccination;
- increased hostility to the management that imposes the policy;
- increased mistrust of public health prescriptions generally;
- increased inclination to misinterpret coincidences as adverse events; and
- increased willingness to express anti-vaccination attitudes to patients. (“They made me get the shot, but thank God you have a choice.”)
The other plausible outcome is that coerced HCWs will gain experience with and confidence in the vaccine, forget that they accepted it only because they were forced to do so, and end up more pro-vaccination than they started. There is evidence that mandatory seat belt laws, for example, led to increased attitudinal support for the efficacy of seatbelts.
Cognitive dissonance theory and research has largely reconciled the two plausible predictions.
People who choose to do something they’re not confident is wise experience cognitive dissonance, and seek out information that will resolve the dissonance by validating the questionable behavior. This is the basis for many foot-in-the-door persuasion strategies: First convince people to (voluntarily) do something; then teach them why it was a smart thing to do.
Might this be the way mandatory HCW flu vaccination works? Might HCWs reluctantly comply, wonder why they did so, seek out information to resolve the dissonance, and end up vaccination supporters? “I got the shot, so I must think it’s a good thing.”
We doubt it. HCWs in a mandatory flu vaccination program already know why getting vaccinated is a smart thing to do: because they’ll get fired otherwise! The coercion is intense. So there is likely to be no cognitive dissonance, and therefore no reason to seek out (or even accept) pro-vaccination information.
Then why did mandatory seat belt laws lead to more public support for seat belts? Because the coercion was weak. The laws were on the books, but not aggressively enforced. And the penalties were mild. Seat belt coercion was strong enough to increase compliance, but not strong enough to enable those who complied to tell themselves that “I did it because I had no choice.” So they experienced cognitive dissonance, which motivated them to seek out pro-seat belt information.
There will undoubtedly be some HCWs for whom mandatory flu vaccination will lead to increased vaccination support. We would expect that effect for HCWs who weren’t especially hostile to flu vaccination at the outset, and who didn’t find the coercion especially offensive either. HCWs who were busy or lazy rather than hostile or skeptical may well experience a mandatory policy as simply a useful goad. Once vaccinated, they would feel that much better about themselves … and about vaccination. Other healthcare workers may notice over time that they are not having the adverse reactions to the vaccine that they had feared, leading them to become increasingly supportive of flu vaccination.
There will undoubtedly be other HCWs for whom mandatory flu vaccination will have a negative effect on their attitudes toward flu vaccination, vaccination generally, public health, and the institution that employs them. We would expect that effect for HCWs who started out critical of flu vaccination, of coercive management policies, or both.
Which effect will be larger? We don’t know. We do think the latter effect will be burdensome. A policy that turns neutrals into mild supporters while simultaneously turning mild critics into bitter opponents doesn’t sound to us like a wise policy.
Your draft recommendations took note of some concerns similar to ours expressed by Dr. George Annas. You reference in particular Dr. Annas’s warning of “negative impacts including building opposition that could result in an unenforceable mandate if a significant number of HCP refuse vaccination.” (We are quoting your words, not his.) You point out in response that “[h]ospitals that have implemented mandatory influenza vaccination programs have not reported the backlash by HCP predicted by Annas.” The Children’s Hospital of Philadelphia survey you mention does show that HCWs can end up approving of a vaccination policy they know to be coercive. But this is a long way from showing how mandatory policies affect the vaccination attitudes of HCWs who start out as critics or opponents.
Hypotheses about the attitudinal impacts of mandatory HCW flu vaccination can easily be tested. If the impact of mandatory HCW flu vaccination on patient health turns out to be small, the greatest impact of a mandatory vaccination policy may well be on the attitudes of the HCWs themselves. Before expanding the initiative, it would be helpful to know more than we know today about its likely attitudinal impacts. At a minimum, surveys to assess these impacts should be part of the ongoing stewardship obligation of institutions that implement mandatory HCW influenza vaccination – another recommendation we urge you to consider adding.
The attitudinal impacts that most worry us aren’t just the result of coercion; they are the result of coercion on behalf of a policy that has little scientific underpinning and is less-than-candidly advocated (consistently overstating what is known about the potential benefits to patients by implying that “studies” have been done in settings other than long-term care facilities).
Put yourselves in the place of a HCW who knows the following:
- that there is little evidence of patient impact of healthcare worker flu vaccination except in nursing homes;
- that the flu vaccine “takes” only 50–70% of the time even in healthy adults under 65;
- that his/her institution is making no effort to protect patients from asymptomatic vaccinated HCWs whose vaccine didn’t take (for example, by instructing them to wear masks during flu season regardless of vaccination status);
- that his/her institution is making no effort to screen out unvaccinated visitors or require (or even urge) them to wear masks – or to require all visitors to wear masks regardless of vaccination status, given the high failure rate of influenza vaccination; and
- that none of this has been acknowledged in the rationale his/her institution has offered in support of the mandatory flu vaccination policy.
It would be understandable for such a HCW to conclude that the policy was hypocritical and that something other than patient health must be at stake – an effort to reduce absenteeism, perhaps, or even just an effort to assert control over obstreperous employees.
Risk communication aspects of mandatory flu vaccination are addressed in three website Guestbook entries by one or both of us. You may find these prior articles of interest:
- Mandatory vaccination for health care workers (October 2009)
- Making health care workers get vaccinated against the flu (March 2010)
- Mandatory flu vaccination for health care workers (again) (November 2010)
The following excerpts from these articles make points we would especially like you to consider.
As risk communication consultants, we know that control is one of the most powerful of the outrage components. Coercion arouses outrage even when the coerced behavior itself doesn’t. And when the coerced behavior is something as personally upsetting as a medical intervention you have decided you don’t want, the outrage is likely to be extremely high. The resulting stress on health care workers’ morale, on labor-management relations, and on patient-provider relations is an awfully high price to pay.
The bigger question for me is the rationale for requiring HCWs to get vaccinated against the flu.
If it’s for the HCW himself/herself, then it’s unconscionable coercion. Making employees do things for their own good is pretty obviously wrong. We don’t (yet) make other people get vaccinated against flu. Why coerce HCWs for their own good more than we coerce people in other jobs? When officials tell HCWs “this is for your own good,” I think they’re undermining their own case.
If it’s for the hospital, aimed at reducing absenteeism and thus the cost of health care, then one wants to see the data. How much is actually saved? Are there bigger savings available with less collateral damage that the hospital isn’t pursuing? Is the hospital including morale issues in its cost-benefit calculation? Does the benefit justify the coercion? Moreover, in a unionized setting battles between what’s good for the employer and what’s good for the employee are the classical venue of labor-management negotiation. It would save the hospital money to pay HCWs less, too, but that’s not enough reason to countenance unilateral pay cuts. If vaccination is for the sake of the hospital, it ought to be a contract negotiation issue.
If it’s for the patient, the rationale for mandatory vaccination is stronger. Hospitals are entitled to regulate employee behavior for the benefit of patients. But here we really need data. My impression is that there are pretty good data that HCW flu vaccination reduces hospital costs, but not very good data that HCW flu vaccination reduces hospital-acquired flu in patients. Patient health is the strongest rationale for coercing HCWs, but only if the evidence is strong. Is it? And as you pointed out, if HCWs really give lots of patients the flu, you’d expect different hospital mask policies too. So officials end up trying to argue that the impact on patients is enough to justify making HCWs get vaccinated, but not enough to justify masking them when there’s no vaccine (or when the vaccine is a bad match). That’s a pretty narrow window. Similarly, why aren’t hospitals requiring visitors to prove that they have been vaccinated? Unvaccinated family hang around the patient all day with impunity … but the orderly has to get vaccinated?
Sometimes my clients get into fights with their employees (or other stakeholders) that started out over a real substantive issue (usually a fairly small one) … and morphed into something that’s really more about power and ego. I wonder how much of that is playing out in the HCW vaccination battle. “Whose hospital is it anyway?” “How dare someone without an M.D. question my judgment that the vaccine is safe?” “If we let them win this fight, what other policies will they decide to flout?” Of course the same could be true on the other side of the battle lines. When HCWs insist on their right to go unvaccinated, they may be bringing to that fight animus that comes from other labor-management issues, from pay to parking.
It’s also worth examining how HCW flu vaccination programs address the problem of unsuccessfully vaccinated employees, as opposed to the problem of those who decline to be vaccinated. Since the CDC says flu vaccination is 70–90 percent effective in healthy young adults, let’s generously assume 80% for HCWs. So if a particular program gets 98% of employees vaccinated, the vaccination worked for 78.4 percent of all employees (80 percent of 98 percent). Who’s left to give patients the flu? The 2 percent who weren’t vaccinated and the 19.6 percent whose vaccinations didn’t take. In this hypothetical hospital, unsuccessfully vaccinated employees are more than nine times as dangerous to patients as unvaccinated employees. [Added January 2012: This point is all the more potent now that the CDC estimates only 50–70% effectiveness.]
Yet HCW flu vaccination programs typically ignore the former risk, while many such programs force employees who decline vaccination to wear masks or take antiviral prophylaxis during flu season. The discrepancy doesn’t necessarily mean the programs are hypocritical or punitive. Unvaccinated employees are lower-hanging fruit than unsuccessfully vaccinated employees. Identifying the latter would be difficult; making all employees wear masks during flu season or flu outbreaks would be burdensome (and would undermine the case for vaccination), while feeding all employees antiviral drugs at such times would be bad public health policy. Still, a hospital administration focused rationally on patient health would have to think hard about the wisdom of inviting a bitter controversy over forced HCW vaccination and forced masking of the holdouts, while leaving the much larger problem of unsuccessful vaccination unaddressed – and unacknowledged….
I am reminded of the 2003 U.S. smallpox vaccination campaign. (See “Public Health Outrage and Smallpox Vaccination: An Afterthought.”) Intelligence agencies pushed smallpox vaccination out of a concern that terrorists might acquire the ability to launch a smallpox epidemic. The public health establishment opposed the program, unconvinced about the risk of a smallpox attack and worried about the risk of the smallpox vaccine itself. The President compromised with a program of voluntary smallpox vaccination for health care workers and emergency responders. Forced to implement (and pretend to support) a program they had vigorously opposed, public health professionals found ways to undermine it, and achieved a much lower level of vaccination than proponents had sought. It’s hard not to see the failure of the smallpox vaccination program as a success (perhaps unconscious; certainly unacknowledged) for its public health opponents.
In much the same way, HCWs forced to get vaccinated against their will can find ways to undermine patient vaccination….
Vaccination has had a tough decade – not just flu vaccination; all vaccination. Anti-vaccination activism is up. Public skepticism is up. Trust in officials (including health officials) is down. Easy, automatic compliance is down.
Nearly all public health professionals (and hospital administrators) consider vaccination an obvious good. For many, it follows that prospective vaccinees who don’t think vaccination is an obvious good are obviously irrational, and so reasoning with them is obviously a waste of time. This isn’t a reasoned conclusion. In their calmer moments nearly all vaccination proponents will concede that it’s better (if you can) to win over the doubters than to coerce them. But in their more outraged moments, they don’t want to talk (far less listen). And over many years, their persuasion efforts have mostly failed. No wonder they want to coerce.
Deep in their hearts, many vaccination proponents would dearly love to make all recommended vaccines required for everyone, so they wouldn’t have to spend precious time and emotional energy trying to coax reluctant vaccinees. Their outrage makes them want to coerce everyone. But they can’t get away with coercing everyone, at least not yet (thank goodness). HCWs are one of the few groups they can try to coerce. Add to that the contempt of too many public health leaders and medical administrators for working-class HCWs, and the emotional appeal of making HCWs get their flu shots becomes even clearer.
Again, we thank you for the opportunity to submit these comments. We hope they are helpful to you in your deliberations.
Peter M. Sandman, Ph.D.
Jody Lanard, M.D.
Copyright © 2012 by Peter M. Sandman and Jody Lanard