Healthcare workers in New York State are subject to new regulations requiring that they be immunized against seasonal and H1N1 influenza.
To get a better idea of the ethics of this regulation, I contacted George Annas, JD. He is the Edward R. Utley Professor, and Chair, Health Law, Bioethics & Human Rights, of Boston University School of Public Health. He is a prolific writer and publishes regularly in the medical literature and lay press, including a recent appraisal of the Supreme Court's decision in Wyeth v. Levine, on whether federal law preempts state torts claims imposing liability on drug labeling that the FDA had previously approved, and an opinion piece in Newsday, entitled "Don't force medical pros to get H1N1 vaccine."
Q: As an Emergency Medicine physician practicing in New York State, I am subject to the new regulations requiring that all healthcare workers be immunized against regular seasonal flu, and the swine flu, when vaccines are released. While I have gotten the flu vaccine for each of the last ten years, and I intend to get it again this year, I deeply resent that immunization is now a requirement of the state, and therefore a condition of my employment. Is there any precedent in recent US history for forced immunization of autonomous populations?
A: Not for adults. The closest probably is the old Massachusetts statute that permitted cities to mandate smallpox vaccine in the late 1800s and early 1900s under penalty of a $5 fine. The US Supreme Court upheld this statute in 1905, and hasn't revisited the issue since, even though adults now have constitutionally recognized rights to refuse treatment, even life-saving treatment. The only major group of adults who now get mandatory vaccinations are members of the US military.
On the other hand, private employers can put reasonable requirements on their employees as a condition of continued employment, and the state can require facilities that they license to do the same. It IS legal, but it is at best dubious public policy that I think can only infuriate physicians and nurses (and not only those opposed to the vaccine, but
especially those who were planning to take it voluntarily) and confuse the public (who will reasonably ask, if this is such a good vaccine, why do public health officials have to force doctors and nurses to get it?)
Q: Part of the reason that I think that this mandate is a mistake is that it relies on the concept that immunizing all health care workers will prevent spread of the flu to patients, when this concept has not been proven, and has been challenged in the medical literature. The flu is not like the measles, which is an unchanging virus that is transmitted in a linear or tree-like fasion, and for which a single person is usually identified as the index case in an outbreak. Rather, the flu is constantly changing, yearly vaccines frequently fail because the local strain does not match the strain in the vaccine, and index cases are rarely identified, indicating that transmission is not as linear as one might think. How might this information impact ethical considerations?
A: It makes the ethical argument for flu vaccination (at least for the seasonal flu where the vaccine is based on an educated guess concerning what strains will be around during the following season) more difficult than for vaccines, like measles, which have been proven safe and effective, are given only once, and can predictably prevent the spread of a serious disease to patients. Patient safety should be the primary concern here, but it should be based on evidence of effectiveness.
Q: Would the ethical considerations of forced H1N1 immunization be different if the requirement targeted populations at highest risk of life-threatening illness, such as pregnant women and the severely obese?
A: No one has seriously suggested mandatory vaccination for any patient population, even those at greatest risk. One could make an argument that obstetricians have a higher ethical responsibility to take the H1N1 vaccine than other physicians who have no pregnant patients, but making distinctions among physicians who care for patients--at least in a situation where there is enough vaccine for all such physicians--doesn't seem to make much sense.
Q: I know a healthcare worker who intends to ask his doctor to "fake" his immunization, by drawing up and disposing of the dose without injecting it, and then providing him with the lot number to give to his employer. What is your take on this?
A: Not a good practice, but whenever rules are put into place that people believe are unfair or put them in jeopardy, people will predictably do what they can to avoid them.
Q: How would you recommend a health care worker, who strongly objects to being personally vaccinated but wants to continue employment, ethically proceed?
A: That's a great question to which I don't have a great answer. Basically there are two choices:(1) organize opposition and try to get the Department to rescind its regulation, and/or get your institution not to try to enforce; or (2) examine the language of the medical exemption carefully and see if you can find a physician who takes mental health risk as seriously as physical health risk.
Q: Thank you very much for helping us to understand this important bioethical issue.
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