Soldiers lose fight to avoid anthrax immunizations

Court upholds FDA certification of anthrax vaccine - Rempfer v. Sharfstein, --- F.3d ----, 2009 WL 3076118 (D.C.Cir. Sep 29, 2009) - good discussion of the standard for reviewing an agency determination of a factual or scientific matter:

http://biotech.law.lsu.edu/cases/vaccines/08-5117-1208566.pdf (vaccine law)
 
This is a long standing lawsuit to block the military from requiring anthrax vaccinations. The anthrax vaccine is an old, safe vaccine, widely used in persons at risk of anthrax infection, such as persons who work with wool or livestock. (Despite claims by the media during the anthrax letter scare that anthrax is very rare, it is a common occupational medicine problem in at risk populations.) The anthrax vaccine controversy is part of the larger attack on vaccines by members of plaintiff's bar. They capitalize on the fears of the public, and encourage those fears in their promotional materials and through the anti-vaccination WWW sites they help support.

Standards of Care in Disasters

Guidance for Establishing Crisis Standards of Care. for Use in Disaster Situations: A Letter Report, NAP

There has been a lot of concern over legal standards for medical care in disasters. This presupposes that there are significant legal problems with disaster standards, but there is no evidence for this in the case law. The tort law has always started with the premise that standards are governed by conditions at the time of the event. This proves to be a very powerful disincentive to bring legal challenges to emergency actions. The one exception was related to medical care and allegations of mercy killings in an New Orleans Hospital during Katrina. The facts there were sui generis, as well as very ambiguous, which is a poor footing for standards.

This report addresses disaster legal standards, along with useful information about how providers might plan better for what they will do in disasters. As with the whole disaster preparation effort, it ignores the core premise of disaster response - if the system is not working before the disaster, it is not going to work during the disaster. While the feds and private groups continue to push the idea that we can make overloaded and dysfunctional health care systems - look at any urban ER on a random busy night - work in disasters, the reality is that we must address their underlying needs.

Proposed Revision to ADA Regulations

EEOC Notice of Proposed Rule to Revise ADA Regulations

This will bring the current rules into compliance with statutory revisions passed in 2008.

New State Secrets Policy

Memorandum from Attorney General Holder, “Policies and Procedures Governing Invocation of the State Secrets Privilege” (Sep. 23, 2009)

WASHINGTON -- Attorney General Eric Holder today issued a memorandum instituting new Department of Justice policies and procedures in order to ensure greater accountability in the government’s assertion of the state secrets privilege in litigation.

“This policy is an important step toward rebuilding the public’s trust in the government’s use of this privilege while recognizing the imperative need to protect national security,” Holder said. “It sets out clear procedures that will provide greater accountability and ensure the state secrets privilege is invoked only when necessary and in the narrowest way possible.”

FTCA discretionary authority does not extend to TVA green house gas case

Discretionary authority does not protect TVA from green house case claims - Connecticut v. American Elec. Power Co., Inc., --- F.3d ---- (2nd Cir.(N.Y.) Sep 21, 2009)

This follows on the United States Supreme Court case - Massachusetts v. E.P.A., 127 S.Ct. 1438 (2007) - that found that the global warming was a real problem and allowed the states standing to contest the EPA refusal to issue regulations on green house gas emissions.

Jurisprudentially, this is a classic public health nusiance case, with global warming being the outcome of the nusiance.

Mandatory Adult Immunizations - Health Care Workers

Immunization policy in the U.S. is directed at children, and is primarily enforced by school exclusion rules. While there are guidelines for adult immunizations, this has been left as a personal health care choice since the end of the smallpox vaccination programs more than 30 years ago. There are a few adult vaccination requirements tied to jobs where individuals work with specific infectious agents, but no general, legally mandated immunizations for adults. This has been very controversial in health care, because a frightening number of health care providers do not believe in immunizations and refuse to get basic immunizations such as flu shots and vaccinations for measles.

New York State, through regulations promulgated by the state health department, requires health care workers to get routine immunizations, including seasonal flu. The health department, through an emergency rule, has now made it clear that the H1N1 vaccine is included in these requirements, and has also clarified the exceptions to the requirements for health care institutional employees who do not deal with patients:

health_care_personnel_influenza_vaccination_requirements.pdf

archive link

The 1976 Swine Flu Immunization Campaign

In 1975, some epidemiologists at the CDC became concerned that a newly identified flu strain - a swine flu - was threatening to be become pandemic. A vaccine was developed, and a massive vaccine campaign was launched in 1976. Tens of millions were vaccinated, but the flu never materialized. Worse, it was believed at the time that the vaccine caused a severe neurologic disease. The decisionmaking behind this vaccination campaign was the subject of a report to the then Department of Health, Education, and Welfare by Richard E. Neustadt and Harvey V. Fineberg, DHEW: The Swine Flu Affair: Decision-Making on a Slippery Disease. This is a classic analysis of public administration decisionmaking. The National Academy Press has now reissued this as a PDF, available here: http://www.nap.edu/catalog/12660.html.

A scan of the original report is available on my WWW site, and includes the index that is ommited from the NAP publication:

The Swine Flu Affair: Decision-Making on a Slippery Disease, Richard E. Neustadt and Harvey V Fineberg, DHEW, 1978