Mandatory vaccination programs are seldom without controversy. Since the early 1900’s when public health workers went door-to-door inoculating people against smallpox and authorities blocked unvaccinated children from attending school, these widespread campaigns have been met with court challenges and public opposition. The underlying issue has always been that mandates threaten medical liberty—the freedom for individuals to choose which medical interventions they want and which they don’t want. But when it comes to vaccines and infectious disease, in the eyes of the law, protecting public health often trumps individual choice.
It was predictable then, that these same tensions would surface when New York State and some large hospital systems in other areas made H1N1 vaccines mandatory for health care workers. In New York, health care workers like nurses, aides, emergency room clerks, food service workers, etc. are all required to get both the seasonal and the swine flu vaccines by Nov. 30, or risk losing their jobs. The idea is that without being vaccinated, these workers pose a threat of infection to vulnerable patients, and also, in the event of a widespread outbreak, they are more likely to get sick and be unable to work when needed most.
Opposition to the mandate from health care workers is growing. Several groups of health care workers have launched “Stop the Shot” efforts, including a legal challenge to the licensing of the swine flu vaccine that was filed in federal court and contends that the vaccine was approved without appropriate safety and effectiveness testing. The workers (joined by the anti-vaccine groups Natural Solutions Foundation and the Foundation for Health Choice) have asked a judge to block the distribution of the vaccine and halt mandated flu shots in New York.
The mandate is also facing a legal challenge in NY state court where a lawsuit (which includes some of the same plaintiffs as the federal suit) has been filed against Richard Daines, the state health commissioner, in hopes of halting the required flu shots. Yesterday, a state judge denied a request for a temporary restraining order barring the state from mandating flu vaccines for health care workers, but left open the possibility of another hearing on the issue next week.
Health authorities have flirted with making seasonal flu shots mandatory for years—currently the shots are only required at a handful of hospital systems. But without mandates or—in many cases—effective voluntary efforts like offering free shots and having roving vaccination carts that make the process more convenient, studies show that barely 40% of health care workers nationwide get seasonal flu shots. Immunologists believe that this vaccination rate has to reach 90% before protection is really complete.
According to a 2004 report issued by the National Foundation for Infectious Diseases, widespread vaccination of health care workers reduces influenza rates in nursing home patients by 43% and mortality rates by 44%. It also cuts down on staff illness and the resulting problem of absenteeism. Not surprisingly, vaccination of health care workers saves money—both in costs of treating hospitalized patients and in lost work time.
This same report provides some insight into how many health care workers and patients were sickened in the Asian flu pandemic of 1957—a harbinger for this year’s bout with H1N1. At the Oklahoma City Veteran’s Hospital, for example, 39% of patients in the neurology ward were infected with the flu and all but one physician on the ward was sickened. At New York Hospital, some 62% of unvaccinated staff contracted influenza in 1957. The report contains many similar examples of hospital outbreaks from other years when flu was not considered pandemic but still exacted a heavy toll on patients and workers.
Dr. Thomas R. Frieden, the new CDC head and past Commissioner of the New York City Department of Health and Mental Hygiene said in August that “even though he expected a surge in swine flu deaths this winter and even though C.D.C. guidelines give health care workers first priority for the new vaccine, he would not push to make vaccinations mandatory.
‘This is just not the right flu season to take this on,’ said Dr. Frieden.
C.D.C. experts said there was just too much confusion this year, with the logistical difficulties of getting both seasonal and swine flu vaccinations to workers and the fact that the swine flu vaccine is still being tested, to risk a fight over the issue now.”
Clearly that view is not shared by everyone. Arthur Caplan, the director of the Center for Bioethics at the University of Pennsylvania doesn’t mince words on how he feels about health care workers who refuse to get vaccinated:
“Enough already with the whining, moaning, demonstrating and protesting by health care workers. Doctors, nurses, respiratory therapists, nurses’ aides, and anyone else who has regular contact with patients ought to be required to get a flu shot or find another line of work.”
How does Caplan feel about the argument that mandated vaccination infringes on the rights of health care workers, on their “medical liberty?”
“Excuse me? What rights might those be? The right to infect your patient and kill them? The right to create havoc in the health care workforce if swine flu hits hard? The right to ignore all the evidence of safety and efficacy of vaccines thus continuing to promulgate an irrational fear on the part of the public of the best protection babies, pregnant women, the elderly and the frail have against the flu? Those rights?”
Caplan is clearly expressing the frustration that has surrounded the influenza vaccination issue for years. All the evidence points to real benefits in terms of protecting patients from illness and death when workers are vaccinated. Health care workers are already required to be vaccinated against measles, mumps, and polio and to undergo regular tuberculosis testing. Why the worry about flu vaccines?
Fears persist about the safety of influenza vaccines—even though there is no evidence that today’s shots cause illness or have any other side-effects beyond a “pinch” on delivery. Of course, fear and distrust of vaccines runs deep within our society and misinformation is rampant and spread irresponsibly by celebrities and some media outlets.
And, in fact, there are a fair number of Americans who, like the disgruntled health care workers, feel equally wary of the H1N1 vaccine. Some of them, like Bill Maher, are famous and reach a wide audience. On a recent show, Maher debated the merits of the vaccine with Senator Bill Frist—who ended up looking like the reasonable one on a health care issue while Maher sank to the level of anti-vaccine zealot in his opposition to the flu shot. Maher starts off the interview with Frist by asking:
"Conservatives always say about health care, especially, you know, are you going to let the government run health care? They screw everything up. So why would you let them be the ones to stick a disease into your arm?"
At one point Maher—who said he would never get the swine flu vaccine “or any vaccine,”—says he believes that pregnant women (considered by the Center for Disease Control to be high-priority for the shots because they have a higher risk of serious illness and death from H1N1) shouldn’t get H1N1 vaccinations. He provided no scientific basis for his statement and later, sent out a message to his 60,000 Twitter followers that those who decide to get the swine flu shot are “idiots.”
A significant portion of Americans seem to agree—or at least feel confident that H1N1’s return this season in a milder form is not a serious enough threat to their health or to that of their children. In fact, a recent AP poll found that 38% of parents said they would be unlikely to give permission for their kids to be vaccinated at school. A Consumers Report survey found that only about half of all Americans say they are planning to get the swine flu vaccine, and many of those are senior citizens, the ones least likely to actually get the disease.
The swine flu experience is, in the end, the latest example of how Americans react to public health crises. Last April when reports of serious infection and thousands of deaths from a ne
w flu virus were at the forefront of the news, fear of an epidemic reached a high level. Daily reports from the CDC tracked the virus and schools closed in infected areas for a week at a time. People wore masks on the subways and sales of antibacterial gels sky-rocketed. The hope was that the government would come up with a safe, effective vaccine as soon as possible that would protect us from the next wave of virus in the autumn.
As it turns out, that effort was mostly successful: In June, Congress appropriated $7.65 billion for agencies to use to respond to the H1N1 pandemic, and much of that has already been spent or committed to public health programs. Some $2 billion went to vaccine makers like MedImmune, Novartis, Sanofi-Aventis and GlaxoSmithKline who geared up to produce adequate supplies of “Flu-Mist” and shots. Then came the good news that adults and children over 10 only needed one vaccine to have protection.
This week the first deliveries of vaccine were reaching state health authorities. They are being sent supplies free of charge to distribute to doctors, school nurses and elsewhere. The CDC has a goal of providing 195-250 million doses of the vaccine—enough to protect those at highest risk (asthmatics, pregnant women, children, parents of children under 6 months of age, and those who are medically fragile) and then some.
Will vaccination efforts ultimately be successful? So far, doctors and health care facilities are being inundated with requests for shots from worried parents and elderly folks (who are actually at lowest risk for this particular variety of influenza) so the problem is too much demand for limited supply. But what about when that initial demand is gone? Will the government be stuck with a lot of extra vaccine as this year’s swine flu—at least in the short term—proves to be a mild version?
I think it would be shortsighted to be complacent about swine flu. According to the CDC, so far this season 147 children have died from Type A influenza—the type associated with swine flu; 19 died last week alone. The virus has now been confirmed in 39 states and tens of thousands have been sickened. People with asthma, diabetes, heart disease, and those who are obese—along with pregnant women, young children and other groups—are at greater risk of serious illness and death. The vaccine will soon be available; it’s safe, cheap and very effective. Where’s the downside?
For health care workers and many others who being urged to get the shot, the real issue is once again, the “greater good.” Massive immunization campaigns are ultimately less about individual risk and more about “herd immunity;” reducing the pool of virus in a population to such low levels that those at greatest risk of serious illness or death are protected. With this particular shot, the benefits of mandated vaccination greatly outweigh any risks to health care workers—and the population as a whole.
I come down on the side of NO.
We rely way to much on vaccines and other bio-medical interventions-some not fully proven to be effective or safe.
Prize wining health journalists Shannon Brownlee and Jeanne Lenzer wrote a remarkable piece in Nov issue of The Atlantic entitled “DOES THE VACCINE MATTER?”- see http://www.theatlantic.com/doc/200911/brownlee-h1n1#
Also this H1N1 strain has yet to prove its lethality.
As one of the most emminent voices in this area Anthony Faucci said, just because we produce a large quantity of vaccine we DO NOT have to use it.
And forcing anyone to take it is a whole different question filled with many mine-fields.
Dr. Rick Lippin
Southampton,Pa
PS TO MY FIRST POST- My biggest fear, by far,is that this so far “H1N1 NON-EVENT” (one in a series of many NON-EVENTS predicted and botched by our CDC)
will divert our attention from US Health Care reform
Dr. Rick Lippin
Southampton,Pa
Only half in jest, I would suggest a compromise – do not mandate vaccination, but impose mandatory furloughs on those who refuse, to remain out of work until the H1N1 incidence in their community has declined to low levels.
In truth, as someone familiar with the H1N1 virus, its lethality, and the nature and safety of the vaccine, I favor mandatory vaccination, although I’m pessimistic about the prospects of overcoming political opposition. The result of unvaccinated healthcare workers continuing to remain in contact with patients is that some patients will die. We don’t know who, or how many, but we already have enough epidemiologic data to know there will be some. Most at risk are young adults, children, and individuals with underlying medical conditions.
In another blog, a writer posted an indignant recapitulation of a recent news story about two parents in the Midwest who watched their 11-year old daughter die from uncontrolled diabetes without calling for medical assistance, while they prayed for her recovery in accordance with their belief in faith healing. The response to the blog item was extraordinary – outrage expressed with such fury it was almost palpable. Some claimed the action of the parents was “premeditated murder” and demanded the severest penalties possible. It is sadly ironic, however, that in the U.S., and possibly even within that group of bloggers, the false and potentially lethal faith in the evils of vaccination has already cost far more lives than the follies of a few misguided believers in faith healing. What drives both types of persistent and at times intractable unwillingness to relinquish false beliefs is a combination of factors – the viral dissemination of false information via the Internet, and the inevitable availability of testimonials to alleged examples supporting the belief system, even when an objective analysis shows the beliefs to be falsified.
I have seen one reassuring figure, recently, reported in the journal Nature, that mitigates slightly my alarm about the H1N1 issue. A poll showed that of those who stated they did not want the vaccine, 60 percent also said they would change their mind if given further evidence of safety and need. In that sense, some of the onus now falls on the scientific and healthcare community to educate the public in time to avert needless tragedies.
Keep in mind that we do not mandate seasonal flu vaccine for physicians, which will kill nearly 40,000 Americans this year. I do not favor mandatory vaccination, although, unlike the above commenter, I do believe that the H1N1 vaccine is safe and effective. I think that physicians, nurses and other health care personnel should be strongly encouraged to get vaccinated as a public health measure. I feel that if the vaccine were mandated, that it would lead to other health care mandates, many of which may be of lesser or questionable value. I intend to get the H1N1 vaccine. I don’t need the government to make me do it. I already know that it’s the right thing to do.
http://www.MDWhistlelblower.blogspot.com
Rick,
I also read the Atlantic article and agree that it raises interesting and new points to consider in terms of stemming influenza epidemics. But, I don’t think the issues it raises warrant changing the current public health response to the H1N1 epidemic. Many studies have shown that vaccinating health care workers against influenza reduces illness and death among patients from influenza and pneumonia (see the report I reference in my post). It seems reasonable that those who are in close and regular contact with these vulnerable patients should be vaccinated if a safe and effective shot is available. I have seen no studies or evidence that the current vaccine is unsafe. Mandating shots is, admittedly, a different kettle of fish–especially if misinformation and suspicions about safety have not been adequately addressed. But public health has a long history of mandates and, yes, coercion in the face of epidemics. If the mandate for health care workers stands, New York might end up being part of an unplanned experiment in determining just how effective the shots are in reducing death and illness among patients.
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Naomi is correct that the scientific literature demonstrates the significant efficacy of influenza vaccination in reducing deaths from influenza-like illness in the elderly, including one placebo-controlled study. Until peer-reviewed data appear that convincingly refute these conclusions, we would be prudent to act on the assumption that the life-saving potential of vaccination that we would expect in theory is actually realized in practice. Here is an abstract from one meta-analysis on the topic:
1: Ann Intern Med. 1995 Oct 1;123(7):518-27.
The efficacy of influenza vaccine in elderly persons. A meta-analysis and review of the literature.Gross PA, Hermogenes AW, Sacks HS, Lau J, Levandowski RA.
Department of Internal Medicine, Hackensack Medical Center, NJ 07601, USA.
OBJECTIVE: To quantify the protective efficacy of influenza vaccine in elderly persons. DATA SOURCES: A MEDLINE search was done using the index terms influenza vaccine, vaccine efficacy, elderly, mortality, hospitalized, and pneumonia. Appropriate references in the initially selected articles were also reviewed. STUDY SELECTION: Only cohort observational studies with mortality assessment were included in the meta-analysis. In addition, 3 recent case-control studies, 2 cost-effectiveness studies, and 1 randomized, double-blind, placebo-controlled trial were reviewed. DATA EXTRACTION: Vaccine and epidemic virus strains, age and sex of patients, severity of illness, patient status, and study design were recorded. Upper respiratory illness, hospitalization, pneumonia, and mortality were used as outcome measures. DATA SYNTHESIS: In a meta-analysis of 20 cohort studies, the pooled estimates of vaccine efficacy (1-odds ratio) were 56% (95% Cl, 39% to 68%) for preventing respiratory illness, 53% (Cl, 35% to 66%) for preventing pneumonia, 50% (Cl, 28% to 65%) for preventing hospitalization, and 68% (Cl, 56% to 76%) for preventing death. Vaccine efficacy in the case-control studies ranged from 32% to 45% for preventing hospitalization for pneumonia, from 31% to 65% for preventing hospital deaths from pneumonia and influenza, from 43% to 50% for preventing hospital deaths from all respiratory conditions, and from 27% to 30% for preventing deaths from all causes. The randomized, double-blind, placebo-controlled trial showed a 50% or greater reduction in influenza-related illness. Recent cost-effectiveness studies confirm the efficacy of influenza vaccine in reducing influenza-related morbidity and mortality and show that vaccine provides important cost savings per year per vaccinated person. CONCLUSION: Despite the paucity of randomized trials, many studies confirm that influenza vaccine reduces the risks for pneumonia, hospitalization, and death in elderly persons during an influenza epidemic if the vaccine strain is identical or similar to the epidemic strain. Influenza immunization is an indispensable part of the care of persons 65 years of age and older. Annual vaccine administration requires the attention of all physicians and public health organizations.
PMID: 7661497 [PubMed – indexed for MEDLINE]
Related articles
The efficacy and cost effectiveness of vaccination against influenza among elderly persons living in the community. N Engl J Med. 1994 Sep 22; 331(12):778-84.
[N Engl J Med. 1994]
ReviewVaccines for preventing influenza in the elderly. Cochrane Database Syst Rev. 2006 Jul 19; 3:CD004876. Epub 2006 Jul 19.
[Cochrane Database Syst Rev. 2006]
Effectiveness of influenza vaccine in the elderly. Gerontology. 1996; 42(5):274-9.
[Gerontology. 1996]
The efficacy and effectiveness of influenza vaccination among Thai elderly persons living in the community. J Med Assoc Thai. 2005 Feb; 88(2):256-64.
[J Med Assoc Thai. 2005]
ReviewVaccines for preventing pneumococcal infection in adults. Cochrane Database Syst Rev. 2003; (4):CD000422.
[Cochrane Database Syst Rev. 2003]
Finally, the above literature properly focuses on elderly individuals because they are the age group most at risk for the usual seasonal influenza. The current H1N1 appears to be less dangerous for them than for younger groups. Although the exact reason is conjectural, it is plausibly attributable to both immunization and natural exposure of the elderly in much earlier years to other H1N1 strains, thereby providing some modest immune protection to this age group that is absent in younger individuals whose immune systems had not previously been exposed to H1N1 strains.
There is a parallel to hospital requirements for PPD and/or CXR for PPD positive physicians. All the hospitals that I have privileges at require either PPD or CXR.
Personally, I have no problem with hospitals requiring flu vaccines. I get one every year anyway. I would think that a health care worker that comes into contact with those that could have flu would want to be vaccinated for their own protection.
Caplan is right, I believe. Healthcare workers are obligated to be vaccinated and should only be able to opt out when an acknowledged risk such as egg allergy, is known.
Lawyers will get savvy about this, and I foresee lawsuits accusing healthcare workers of manslaughter should patients die as a direct result of being infected by a healthcare worker.
The idiocy of the California Nurses Association and other unions in demanding no mandatory vaccination only points up the folly of using non-nurse led unions braying wrong headed health messages which are based on sensationalism, shoddy science and illogic.
I think people in healthcare jobs know what they are getting into when they take their positions. If any vaccine or other precautions become mandatory to make sure they are able to do their jobs and able to do their jobs without causing more harm to the people they are helping, they should comply. With any type of employment you face the parameters, risks, and also enjoy the benefits that come with the job.
Naomi- With utmost respect I would like to BROADEN THIS GOOD with this “rant”-The September 2009 letter below from the New York State Health Commissioner Dr Richard Daines invokes the principle repeatedly that health care professionals must put interests of their patients before themselves as one of his justifications for mandatory Swine flu vaccine for health care workers in the State of New York.
I have studied the health of US health care workers recently and it is not a pretty picture. Actually it is a national paradox and tragedy. When a health care worker gets sick (more often than not from work stress and working conditions- not the flu) it has a leveraging effect on all those who might have been taken care of by that health care worker
Why aren’t we making healthcare worker stress “immunization” mandatory? Why aren’t health care worker working conditions including even for God-sake their own health care benefits being improved! (Answer- because contemporary bio-medicine is in a state of severe denial at the highest levels)
ethically I have witnesses firsthand the culture of healthcare professional martyrdom and outright masochism in military medicine where one is expected to readily give one’s own life for the patient.
At the risk of offending the great ethical traditions of medicine from Hippocrates to Maimonides to William Osler to contemporary medical ethicists I posit that we must heal medicine “from the inside out”.
By that I mean we must improve working conditions thus the health of healthcare workers at ALL levels
This goes way beyond the providing protection against the swine flu which has yet to prove its lethality
Dr.Rick Lippin
Southampton,Pa
Should health care workers be required to get flu vaccines?
http://www.polladium.com/poll.php?poll_id=346&location_id=1
Deaths from the H1N1 flu strain are increasing. Of much concern is the unusual age distribution, such that mortality in children is higher than with seasonal flu.
http://www.cdc.gov/h1n1flu/update.htm
Conversely, the elderly, who are typically most at risk for deaths related to influenza, appear to be relatively protected, probably at least in part because of immunity to a related H1N1 virus they acquired much earlier from vaccination or natural exposure.
The only “idiot” is Bill Maher. As a supposed champion of the downtrodden. He probably killed more people with his statement about vaccines than he has ever saved. He wants to talk about fairy tales and rational thought when talking about religion, but it comes to life and death matter, he’s living the fairy tale. As a group the antivaccine zealots are much more dangerous than the birthers, the truthers or any other group you can think of. You can’t be for comparative effectiveness and data driven medicine, then totally toss it in the waste basket because you are friends with Jim Carrey.
There is a solution. Those workers that don’t want to take the vaccine have to wear a masks from parking lot to parking lot for the next 6 months, are banned from the cafeteria and must all use a designated H1N1 bathroom.
“Those workers that don’t want to take the vaccine have to wear a mask …”
In fact that is exactly the policy at one of the hospitals I work at. If a healthcare provider does not wish to get the vaccine, he/she is required to wear a mask when around patients.
I have never gone for a flu shot–but I’m not a healthcare worker.
And I don’t work with young children who might be at risk.
If I did, I would certainly get the shot.
But I’m afraid we can’t rely on people to “do the right thing.”
I agree with Naomi. The vaccination should be mandatory for health care
workers unless they can show some medical or perhaps religious reason why they shouldn’t be required to get the shot.
But then they should be re-assigned so that they are not working with a vulnerable population.
I’m disappointed–but not entirely surprised–by how the California Nurses Association has reacted.
This is a group that too often puts its own interests first–not what healthcare professionals are supposed to do.
What is the truth concerning use of squalene as an adjuvant in the H1Ni vaccine and whether this adjuvant was present in the vaccines used to determine safety and tolerability? Are there existing trails/studies utilizing this adjuvant showing safety and effectiveness?
I’ll be interested if you do a follow up since Bill Maher dug himself into an even deeper hole on his season finale. For a “man of science” he looks like a complete fool on this issue. If Rush Limbaugh and Bill Maher are on the same side of an issue, you should probably run in the other direction.
No liability to the drug companies so how many doctors will be sued who give the H1N1 shot with sqailene and thermerosal in the H1N1 shot? None of the trials included these dangerious ingredients. I guess the order of the day is to just trust the drug companies and the World Health Organization.
“I also agree that a health care worker who doesn’t get vaccinated is acting unethically and unprofessionally, like one that doesn’t wash his hands between patients.”
This is not a good analogy. Washing your hands has no side effects. If you look at the insert for the h1n1 vaccine, the list of side effects and contraindications is quite long and scary. The vaccine also depresses the immune system which would make the health care workers more susceptible to infections such as MRSA. Ultimately the precedent set erodes the freedom of choice.
I have been a good boy and have gotten both the seasonal and the H1N1 vaccine this fall. I usually get the flu vaccine anyway.
Interesting article in the most recent issue of the Atlantic. The article questions the efficacy of the flu vaccine and the anti-viral meds we have. I recommend it to those who are interested.
Maybe the flu vaccine is a placebo anyway!?
In my just posted comment, I mentioned a very recent NEJM article on H1N1 vaccination, but in looking through my previous discussions, I didn’t immediately find a reference to it. Here it is:
http://content.nejm.org/cgi/content/full/NEJMoa0907413
Note that immunologic efficacy can be confirmed by studies such as these, but clinical efficacy can only be presumed based on the known efficacy of seasonal flu vaccines that are equally immunogenic. We will need much more time and data for more direct assessments of the H1N1 vaccine’s ability to prevent illness or reduce its severity.
Very Interest Article Thanks
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Are you people nuts. Because everything comes down to the mighty dollar. What right does anyone have to tell you that you have to take a drug.They dont tell you how many people died from these vaccines do they ? I have worked in the health field for over 20 yrs and have not needed to take any kind of flu vaccines. This is ridiculous to mandate drugs to be taken. This is as bad as having fingerprinting for health care workers . Wise up people it is the younger generation that says ok do what you want with me. In Pennsylvania they say you must be fingerprinted to work with childred but you have to be fingerprinted just to get a job anymore. This is disgusting Wake up people. This is not the land of the free anymore.