June 6, 2002

ACTION: Provide written or online comments to the Centers for Disease Control (CDC) regarding their proposal to: 1) enforce quarantine and isolation on confirmed, probable and suspected cases of smallpox infection, 2) engage police powers, 3) implement government surveillance of patients all year long, and 4) vaccinate individuals for smallpox. (see website link below) To publicly testify, attend four hearings are held June 6 - 11 (see http://www.cdc.gov/nip/smallpox/News.htm#Forums).

DEADLINE: Wednesday, June 12, 2002, 5 p.m. (EDT)

SUGGESTION: Use CCHC's 8-point Summary of Concerns to formulate your comments to the CDC proposal (find below). Remember: the CDC has encouraged the public to provide other options for action than the ones they provide on the web site comment page.

Twila Brase, R.N.
President
Citizens' Council on Health Care

The CDC Proposal Includes:

1) GOVERNMENT HEALTH SURVEILLANCE ENCOURAGED: Year-around reports to state health officials of all patients with illness that includes fever and vesicular/pustular rash (could be chicken pox). (Surveillance, Contact Tracing, and Epidemiological Investigation, Guide A, pg A-1)

2) GOVERNMENT DATA COLLECTION: Data to be reported after the first report of a case of smallpox includes name, birth date, social security number, race, occupation, address, prior medical conditions, phone number, date of fever onset, vaccination status, date and place of medical examination, and final diagnosis, including not smallpox. Data is reported on each suspected/probable/confirmed smallpox case. (Surveillance, Contact Tracing, and Epidemiological Investigation, Guide A, pg A-9)

3) MANDATORY QUARANTINE AND ISOLATION: Requirement that all individuals with confirmed, probable and suspected cases of smallpox infection be placed in a "Type C" facility (place to house probable or actual cases of smallpox). (Isolation and Quarantine Guidelines, Guide C, page C-4 and C-5) NOTE: those who are only probable or suspected cases (without confirmed smallpox infection) could become infected by being placed in the same facility as those who are infected.

4) MANDATORY VACCINATION: Requirement that all persons entering a Type C facility must be vaccinated with smallpox vaccine. NOTE: individuals who do not have confirmed cases (but probable or suspected) must be placed in Type C facilities. This signifies compulsory vaccination of those individuals. (Isolation and Quarantine Guidelines, Guide C, page C-5) NOTE: Small pox can cause severe side effects including death.

5) MIXING POTENTIALLY NON-CONTAGIOUS PERSONS WITH CONTAGIOUS: Although officials are to set up "Type X" facilities to house those with "uncertain diagnoses" (those who are vaccinated, have a fever, but no rash), they propose to allow these patients to be placed in Type C facilities. This may expose these individuals to smallpox, endangering their lives. NOTE: Type C facilities may arguably also house individuals with uncertain diagnoses (those with probable and suspected, but not confirmed smallpox). (Isolation and Quarantine Guidelines, Guide C, page C-5 and C-7)

6) POLICE POWERS: Security staff must have the capacity to "Detain persons for examination and quarantine" and "Enforce of [sic] mandatory isolation of contagious patients." The proposal asks public health authorities to identify in advance those personnel "who can enforce these isolation and quarantine measures, if necessary." (Guidelines for Smallpox Vaccination Clinics, Annex 2, page A2-10 and A2-17 and Isolation and Quarantine Guidelines, Guide C, page C-17)

They note that three factors are needed for successful quarantine: 1) identification of legal authorities to enforce, 2) public trust and compliance, and 3) assured vaccination of personnel required to implement and enforce quarantine. (Isolation and Quarantine Guidelines, Guide C, page C-17)

7) ENDANGERMENT OF INDIVIDUALS?: "Medical Screeners", responsible for interviewing citizens to be vaccinated, determining exposure risk, ascertaining risks of vaccination, doing risk-benefit analysis and assessing medical contraindications need not be a physician or nurse. An undefined "paraprofessional" is allowed. A physician or nurse can also be considered a screener. Training is not described. If screeners feel uncertain, they can ask a physician consultant to make a final determination regarding vaccination risks. (Guidelines for Smallpox Vaccination Clinics, Annex 2, page A2-9) NOTE: What if screeners don't have enough knowledge to ask for help, or if there is pressure to keep the vaccination process moving?

In addition, "Vaccination Administrators" also need only be "paraprofessionals," although doctors and nurses qualify. The CDC provides a video for training vaccine administrators, and if time permits, the proposal encourages a mock vaccination clinic. "Vaccinators" must also "be prepared to respond to medical emergencies that may occur within the vaccination area (Guidelines for Smallpox Vaccination Clinics, Annex 2, page A2-10 and A2-11) ." NOTE: In a panic situation, how will the public be assured that qualified people know how to evaluate health risks and not expose the vulnerable to danger?

8) EXPERIMENTAL VACCINE WITHOUT CONSENT?: It appears that only those volunteering for the vaccination would be required to give their consent to vaccination "if the vaccine is still on Investigational New Drug status". Medical screeners are to ensure that the consent form is "read, understood and signed" by each recipient. (Guidelines for Smallpox Vaccination Clinics, Annex 2, page A2-9). For individuals who are sick, but may or may not have smallpox, it appears the vaccination would be mandatory, regardless of the risks. (Isolation and Quarantine Guidelines, Guide C, page C-5)

NOTE: If an individual who is not sick, but is considered to be exposed, refuses to be vaccinated, they would be required to enter a "Type R" facility, which can be their own home. They can continue daily routine activities, but may not wander beyond 20 miles of their city of residence. If "logistical difficulties or potential societal unacceptance" occur, these individuals can be placed in other Type R facilities (hotels, motels, or other facilities with beds, heating, air conditioning, running water and toilet facilities). Daily reporting to health officials would be required and daily visits by public health personnel may occur if resources permit. Those who become sick would then be transferred to either a Type C or Type X facility--after they are vaccinated. (Isolation and Quarantine Guidelines, Guide C, page C-4 and C-7)

PROVIDE PUBLIC COMMENTS:

Online: http://www2.cdc.gov/nip/smallpox/comments.htm

By Mail: Send them to the following address.

ACIP-NVAC Smallpox Working Group
Mailstop E-05
1600 Clifton Rd., N.E. Centers for Disease Control and Prevention
Atlanta, GA 30333

Deadline: Wednesday, June 12, 2002 (5 p.m. EDT)