Tuesday, November 10, 2009

Mandatory Vaccinations: No, we're not there yet, but why have we started going down that road?

"Once you start requiring doctors to get it, doctors are going to think it's reasonable to make patients get it. It starts you down that mandatory route, and I don't think we want to go there." So said George Annas, renowned bioethicist, NEJM columnist and department chair of Health Law at Boston University School of Public Health.

A ho-hum influenza pandemic appeared, and suddenly hospitals on the east coast, west coast and the heartland started demanding mandatory vaccinations of their employees. At first the hospitals didn't know whether they wanted mandatory seasonal flu vaccinations or swine flu vaccinations. There wasn't any seasonal flu virus around, and there wasn't any swine flu vaccine around, so what was the rush? [And it seems no one told these hospitals that they would be on the hook for all liability were their workers to be injured from a mandatory vaccine, like swine flu vaccine, subject to the PREP Act.] Simultaneously, an organization of infection control nurses popped up, demanding mandatory vaccinations and "accountability" from healthcare workers who considered refusing. New York State's Health Commissioner (not the Legislature or Governor but an agency appointee) demanded all healthcare workers in the state be vaccinated or fired. This was clearly orchestrated. But who was pulling the strings?

The federal government claimed it had nothing to do with mandates. On its flu.gov website the following appeared:
"In a few local jurisdictions, vaccination is being required for health care workers. That is a local decision, not a federal one."
However, DHHS's Health Resources and Services Agency instructed its grantees to:
"... strongly encourage health care workers to receive the Novel H1N1 vaccination. Grantees should employ strategies to increase the rates of vaccination for their health care personnel such as waiving administration fees for health care personnel, providing educational materials, sending reminder messages, holding informational staff meetings, monitoring employee participation in the vaccination initiative, and employing declination forms."
Okay, maybe the feds aren't mandating, but they sure are pressuring. Perhaps I'm missing something the experts understand. Did the demands for mandatory vaccinations come from thoughtful, well-informed medical people? Actually, no:

The infection control nurses didn't understand the rationale for mandated vaccines, claiming it was due to multiple strains circulating this year. (Multiple strains circulate every year, however.) NY state's health czar claimed that healthcare workers were already mandated to receive tuberculosis and rubella vaccines, to justify his flu vaccine mandate. However, since there is no tuberculosis vaccine in the US, it certainly isn't mandated.

If we mandate seasonal flu vaccines for healthcare workers and there is no seasonal flu this winter, as some experts have predicted, won't we be replicating the 1976 swine flu vaccine program, when 45 million Americans rolled up their sleeves for a nonexistent disease?

And now for a disclosure: I am less concerned about the danger of swine flu vaccines than I am about future vaccines, particularly those manufactured and used under a PREP Act declaration or an Emergency Use Authorization (EUA). Read the legislation and you'll see why I am worried. The EUA allows the use of unlicensed drugs and vaccines, including those that have never been issued an Investigational New Drug (IND) permit by the FDA. You require an IND to test a drug or vaccine in humans.

Do you see the implications? A drug or vaccine that was never given experimentally to a single human could receive an EUA and be rapidly administered to the whole country, under the legal justification that it "may be effective" for some "potential" emergency. Does that leave you feeling warm and fuzzy? Invoke the Public Readiness and Emergency Preparedness Act (PREPA) and if the drug injures or kills you, you are barred from seeking damages within the US legal system. Now consider that experimental adjuvants or other newfangled vaccine additives, biologics and drugs may be used.

Keep the program voluntary-- and with the assistance of a complaisant press, millions of Americans will line up for the new remedy with little understanding of the legal implications or risk. (Has the government advertised its use of PREPA for wholesale tort reform of drug and vaccine injuries during the current pandemic? Why would they do a better job informing us next time?)

Then again, next time that new drug or vaccine might be mandatory. That's where we seem to be headed and, like George Annas, "I don't think we want to go there."

1 comment:

Meryl Nass, M.D. said...

After I wrote this post, the US govt DID use a PREP Act declaration for swine flu vaccines. This waived liability for all of the vaccine manufacturers.

Then PREP Act waivers for antiviral drugs were issued.

Few recipients of these products were informed, ahead of time, that their right to sue the manufacturer if there was a resulting injury had disappeared.