PRESS RELEASE

For Immediate Release

Tuesday, June 10, 2002

======================================

Citizens' Council on Health Care

1954 University Ave. W., Suite 8

St. Paul, MN 55104

CONTACT:Twila Brase, R.N., President

PHONE: 651-646-8935

======================================

CCHC PUBLIC COMMENTS ON FEDERAL SMALLPOX PROPOSAL: Recommends Ongoing Access to Smallpox Vaccine and Warns of Public Endangerment

St. Paul, Minnesota - Health care officials should not wait until an emergency to allow citizens to protect themselves against exposure to smallpox. In public comments to a federal proposal on smallpox vaccination and quarantine (SEE BELOW), the Citizens' Council on Health Care (CCHC) wrote that informing the public of all benefits and risks now, and providing ready access to smallpox vaccine, would help to prevent widespread panic if a case of smallpox is ever reported.

"Both the vaccine and the disease hold dangers for the public. Now is the time to prepare the public to protect themselves. Waiting until a crisis erupts is a surefire prescription for panic." says Twila Brase, RN, president of CCHC, a Minnesota-based health care policy organization.

Individuals Endangered; Rights Violated

Writing that the proposal may endanger individuals, CCHC notes that health officials are allowed to house together unconfirmed cases and confirmed cases of smallpox, mandatory vaccination may cause death and disability, medical screeners may be unqualified to evaluate risk of vaccination, and vaccinators may be unqualified to give the vaccine or handle medical emergencies resulting from administration of the vaccine.

CCHC notes that the death rate of smallpox is 1 percent - 30 percent, depending on whether the individual contracts variola minor, the mild form, or variola major, the serious form of smallpox. At the same time, the smallpox vaccine may cause serious adverse reactions, including death, in approximately 1 out of every 4,000 citizens vaccinated.

CCHC also makes it clear that the proposal violates various rights of individuals and medical ethics. Forcing individuals to submit to vaccination without their consent, requiring submission to physical examination, detaining individuals against their will, and collecting detailed health data without patient consent violates the individual's right to freedom of conscience, right to due process, right to preserve the sanctity of their home, right to confidentiality, and right to freedom of movement.

Public Trust Critical

The federal Advisory Committee on Immunization Practices are to send their recommendations to the Centers for Disease Control by Thursday, June 20, 2002. Public hearings are being held around the country through tomorrow, and public comments are due to the committee by Wednesday, June 12.

"Creating and sustaining the public's trust is critical to preventing panic and protecting the public in a time of crisis," says Brase. "Providing citizens with up-to-date accurate information and ongoing access to vaccine is key to building the public's trust now and in an emergency."

"If officials continue to plan a command and control strategy that ignores citizen rights and medical ethics, the resistance of the public during a crisis may thwart their best laid plans."

- 30 -

CCHC is an independent non-profit free-market health care policy

organization located in St. Paul, Minnesota

-------------------------------------------------------------------

June 10, 2002

ACIP-NVAC Smallpox Working Group

Mailstop E-05

1600 Clifton Rd., N.E.

Centers for Disease Control and Prevention

Atlanta, GA 30333

To Whom It May Concern:

We are responding to the request for comments on the CDC's Interim Smallpox Response Plan & Guidelines. Included in this response are our concerns regarding the entire proposal, our response to the Advisory Committee on Immunization Practices' three questions and a conclusion, that reiterates federal facts about side effects of the smallpox vaccine and death rate of those infected with small pox. Citizens' Council on Health Care supports the right of individuals to be informed and to take actions in advance of a bioterrorism attack to protect themselves and their families, which may include choosing not to be vaccinated against smallpox.

CCHC'S SUMMARY OF CONCERNS REGARDING THE ACIP PROPOSALMANDATORY QUARANTINE MAY INCREASE EXPOSURE: The requirement that all individuals with confirmed, probable and suspected cases of smallpox infection be placed in a "Type C" facility may expose the noninfected (the not yet confirmed) to smallpox, leading to an increase in smallpox infection. It also appears to be proposed without a court order. (Isolation and Quarantine Guidelines, Guide C, page C-4 and C-5).

MANDATAORY VACCINATION VIOLATES FREEDOM OF CONSCIENCE: The requirement that all persons entering a Type C facility must be vaccinated with smallpox vaccine exposes these individuals to the side effects of the smallpox vaccine. Most may be more than willing, but not all will agree to the vaccine. Small pox vaccine can cause severe side effects including death. This constitutes a state-imposed injection of a life-threatening substance, violating the individual's freedom of conscience and medical ethics. And, until proven otherwise, there is no guarantee that the vaccine will eliminate the risk of illness even for those who are vaccinated. In addition, unlike those who volunteer for vaccination, there is no requirement that these individuals read, understand and sign a consent form for the vaccination. (Isolation and Quarantine Guidelines, Guide C, page C-5)

MIXING POTENTIALLY NON-CONTAGIOUS WITH CONTAGIOUS: Although officials are to set up "Type X" facilities to house those with "uncertain diagnoses" they propose that these individuals may be placed in Type C facilities-with those who are confirmed to have smallpox. This requirement may expose these individuals to smallpox, endangering their lives. (Isolation and Quarantine Guidelines, Guide C, page C-5 and C-7)

LOSS OF FREEDOM OF MOVEMENT FOR NON-VACCINATED: Although the proposal states those refusing vaccination, who are assumed to be exposed, can be sent home ("Type R"), it allows government officials to detain them outside their home-without a court order. This permits state officials to impose a loss of freedom on those who choose to exercise their freedom of conscience. It also permits the livelihood of individuals to be threatend. Vaccination itself carries risks, including the risk of getting the disease from the vaccination, spreading the illness beyond the limited location of those actually diagnosed with smallpox through shedding of the vaccine, and death and disability as a side effect of the vaccination. Those who do not choose to get the vaccine are those who have chosen one risk over another. If the vaccine is effective-the only type of vaccine that should be given-those who are vaccinated need not fear those who are not. Those who choose not to be vaccinated should not be penalized for exercising their freedom of conscience.

POLICE POWERS VIOLATE DUE PROCESS: The proposal to provide "security staff " with the capacity to detain persons for examination and quarantine and the power to enforce mandatory isolation of contagious patients is cause for concern. As read the proposal would endow security staff with the power to enter homes and haul citizens away before there is any clear evidence of communicability or danger. This is a violation of due process rights and an individual's freedom of movement and security of home. And in the case of forced detention and vaccination, a violation of the person's right to a freedom of conscience. (Guidelines for Smallpox Vaccination Clinics, Annex 2, p. A2-10 and A2-17 and Isolation and Quarantine Guidelines, Guide C, p C-17)

With the implementation of such police powers, the agency should not expect to secure the second factor of the three factors noted as necessary for successful quarantine: public trust and compliance. (Isolation and Quarantine Guidelines, Guide C, page C-17)

ENDANGERMENT OF INDIVIDUALS THROUGH UNQUALIFIED STAFF?: Requirements for personnel are lax, leading to possible endangerment of human life. 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-perhaps someone who may not be held to a high standard of medical ethics. Training is not described. Although screeners can ask a "physician consultant" to make a final determination regarding vaccination risks, screeners may not have enough knowledge to know when to ask for help, or may be more liable to succumb to assembly line pressures during a crisis. (Guidelines for Smallpox Vaccination Clinics, Annex 2, page A2-9)

In addition, Vaccination Administrators also need only be paraprofessionals, although doctors and nurses qualify. Training is limited to a CDC video, and although practice and mock drills are encouraged, they are not required. So actual practice and experience are not necessary. Vaccinators must also "be prepared to respond to medical emergencies that may occur within the vaccination area." It is not clear that such vaccinators must be qualified in CPR, emergency training, first aid, IV insertion, anaphylactic shock, or any other emergency situations. There is little to assure that public that qualified people will be on hand to evaluate risks, and handle emergencies. (Guidelines for Smallpox Vaccination Clinics, Annex 2, page A2-10 and A2-11) .

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. This is a violation of medical ethics and freedom of conscience. (Isolation and Quarantine Guidelines, Guide C, page C-5)

GOVERNMENT HEALTH SURVEILLANCE ENCOURAGED: Year-around reports to state health officials of all patients with illness that includes fever and vesicular/pustular rash are proposed. There is no acknowledgement or requirement of patient consent. Neither is there a requirement that such patients be notified that their information may be disclosed, or has been disclosed. (Surveillance, Contact Tracing, and Epidemiological Investigation, Guide A, pg A-1)

GOVERNMENT DATA COLLECTION VIOLATES PATIENT CONFIDENTIALITY: Proposed is health and personal data collection after the first report of a case of smallpox. Data to be reported 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 without patient consent or notification. In addition, some of the data - social security number, birth date, race, prior medical conditions, and occupation - seem unnecessary for simple tracking of illness. If plans include additional research on these individuals, a specific research consent should be obtained. In addition, there is no clear rationale for collection of data on those who are not confirmed cases, leaving citizens vulnerable to arbitrary decisions regarding data collection. (Surveillance, Contact Tracing, and Epidemiological Investigation, Guide A, pg A-9)

RESPONSE TO SPECIFIC CDC/ACIP QUESTIONS:

QUESTION 1

With no known cases of smallpox worldwide, should there be any change in the current recommendation for not vaccinating members of the general public before there is a confirmed smallpox case or a confirmed bioterrorism attack using smallpox?

CCHC RESPONSE: In the absence of a confirmed smallpox case or confirmed smallpox bioterrorism attack, the ACIP recommends making small pox vaccine available to members of the public, provided the public is supplied in advance of vaccination with complete information on benefits and risks of vaccination, including whether the available vaccine is tested or experimental. Information on precautions to take once vaccinated (ex. to protect others against shedding of vaccine) and warnings regarding the expected effectiveness of the vaccine must be clearly explained prior to vaccination.

QUESTION 2

In addition to laboratory workers who work with viruses related to smallpox, are there other individuals in specific occupational groups who should be vaccinated to enhance smallpox preparedness? If so, what guidelines should be used to determine which individuals should be vaccinated before there is a confirmed smallpox case or a confirmed bioterrorism attack using smallpox?

CCHC RESPONSE: In the absence of a confirmed smallpox case or confirmed smallpox bioterrorism attack, the ACIP recommends making small pox vaccine available to medical personnel and first responders, provided these individuals are supplied in advance of vaccination with complete information on benefits and risks of vaccination, including whether the available vaccine is tested or experimental. Information on precautions to take once vaccinated (ex. to protect others against shedding of vaccine) and warnings regarding the expected effectiveness of the vaccine must be clearly explained prior to vaccination.

QUESTION 3

Should there be any change(s) in the recommendation that surveillance and containment ("ring vaccination") be the primary control and containment strategy in the event of a confirmed smallpox case or a confirmed bioterrorism attack using smallpox?

CCHC RESPONSE: The ACIP recommends that ongoing surveillance and surveillance after a confirmed smallpox case be done only with the specific consent of patients. In addition, the ACIP recommends that containment and mass vaccination of members of the general public be encouraged, but not mandated.

IMPORTANT CONSIDERATIONS/CONCLUSION

If the federal government has not allowed the public to make an informed vaccination decision before a smallpox crisis occurs, the news of a confirmed smallpox case or confirmed smallpox bioterrorism attack may not allow public health officials the luxury of limiting demand for the vaccine to a "ring." Particularly because health officials and the media have led the public to believe that smallpox is a sure death sentence. But smallpox comes in two versions: variola minor and variola major. Variola minor is milder with less than one percent of the cases leading to death. On the other hand, variola major is serious, with fatality between 20 and 30 percent.

However, the vaccine is not completely safe either. According to the Working Group on Civilian Biodefense "It has been estimated that if 1 million persons were vaccinated [with live vaccinia virus vaccine], as many as 250 persons would experience adverse reactions of a type that would require administration of VIG [vaccinia immune globulin]."

That's 1 in every 4,000 people who would experience a serious reaction.

According to the National Vaccine Information Center, "the CDC reports that one 10-state survey revealed that transmission of vaccinia virus infection occurred in 27 per million total vaccinations (1 in 37,000 vaccinations) and 44 percent of those contact cases occurred among children. Approximately 60 percent of contact transmissions in the survey resulted in the inadvertent inoculation of otherwise healthy persons."

And according to the World Health Organization "existing vaccines have proven efficacy but also have a high incidence of adverse side-effects. The risk of adverse events is sufficiently high that vaccination is not warranted if there is no or little real risk of exposure. Vaccine administration is warranted in individuals exposed to the virus or facing a real risk of exposure."

Despite this recommendation, the risk of exposure through bioterrorism is completely unknown. Therefore, the public should be given time and information now to make decisions about vaccination. The vaccine should be made widely available and all its risk and benefits known. If a high percentage of the public chooses to vaccinate themselves now, there will be less of a rush to vaccination if a case of smallpox ever emerges.Finally, those who choose not to be vaccinated should be allowed to follow their conscience without restriction of movement. Until and unless they develop a smallpox rash they are contagious to no one. If they become ill, they are contagious only to any other person who chooses to face the risk of the disease over the risk of the vaccine--others who have likely isolated themselves from exposure.

That is a choice the public should be allowed to make.

Sincerely,

Twila Brase, R.N.

President

**************************************************************

A free-market resource for designing the future of health care

**************************************************************

Citizens' Council on Health Care

1954 University Ave.W., Suite 8

St. Paul, MN 55104

651-646-8935 phone

651-646-0100 fax

**************************

NOTE: If you do not wish to receive this email,

contact CCHC to remove your name from the list.

Thank you.