Lisa Reiss President, Connecticut Vaccine Information Alliance

Transcription

1 Lisa Reiss President, Connecticut Vaccine Information Alliance Written Testimony for the Connecticut Legislature s Public Health Committee March 5, 2003 Informational Hearing on Public Health Preparedness Thank you for inviting me to speak about Connecticut s Public Health Emergency Preparedness. This is a very important issue and we appreciate that the committee is thoughtfully and calmly analyzing this issue. As you know, this committee took up this same issue last session in the form of Bill 5286, An Act Concerning Public Health Emergency Response Authority. Before I begin, I want to be very clear that the Connecticut Vaccine Information Alliance is a pro-information organization. We are not anti-vaccine or pro-vaccine. Rather, we believe people should have all the information and make an educated decision. After September 11, 2001, when the Center for Disease Control (CDC) presented what was called the CDC Model State Emergency Health Powers Act (MSEHPA), we were very concerned. The initial version created a huge uproar, forcing it to be revised at the end of December The revised bill still caused concern among many groups for two reasons: unchecked emergency authority powers and controversy over its status as a model bill, since interested parties were not consulted. Bill 5286, which was presented last session, was partially based on the CDC MSEHPA. CTVIA understands the need for a public health emergency response bill but we strongly believe that it must be reasonable and humane. Otherwise, we fear mayhem will result if the public believes that the government is seeking too much authority and is not offering reasonable options. I understand the concern about a bioterrorism attack on the U.S., but it is important to note that the U.S. has previously experienced germ terrorism. It was detailed in the book Germs by Judith Miller, Stephen Engelberg and William Broad. In 1984, the citizens of The Dalles, Oregon were attacked in their local restaurants. Almost 1000 people reported symptoms of salmonella typhimurium that can cause food poisoning and 751 were confirmed to have salmonella. After an exhaustive search for the cause, it was finally confirmed that the food at salad bars in four restaurants were tainted with salmonella. Authorities suspected contamination in at least six other restaurants and one supermarket, and contamination in other parts of Oregon. The attack was done by a cult called the Rajneeshees who followed Bhagwan Shree Rajneesh. The authorities eventually learned that the Rajneeshees attacked The Dalles, Oregon because they were trying to seize control of the county government in the upcoming election. While salmonella is treated with antibiotics, it is interesting to note some other things that resulted from the investigation. First, it was very disturbing to see how easily pathogens had been ordered from germ banks. Authorities learned that Rajneesh Medical Corporation obtained dangerous pathogens from VWR Scientific and American Type 1

2 Culture Collection (ATCC). ATCC is a large private germ bank from which doctors, clinics and hospitals can obtain germs for research and testing. Of particular interest was that the Rajneeshees obtained Salmonella typhi, which causes typhoid fever, and Francisella tularensis, which causes tularemia. Experiments were also done at the lab with Hepatitis. Second, the lab never had to register with the state and serious problems resulted when scientists and law enforcement did not share their information. (1) While much of our present day concern is driven more by the fear of a smallpox attack, we must be cautious of three things. First, we must not overreact and expect the government to have a contingency plan for every single situation at the expense of common sense and public awareness. Any public health emergency plan must involve a cooperative public not a coerced public. Second, we must not focus only on more extreme situations such as potential smallpox attack at the expense of missing the easier terrorist opportunities, such as contaminating a salad bar. Any public health emergency plan must be flexible enough to deal with any potential situation. Third, we must be cautious about permitting officials, elected or unelected, excessive powers while not having reasonable safeguards or options in place for the public. Any public health emergency plan must not give unchecked powers to individuals. Before I address some provisions of a Public Health Emergency Response bill, I would like to point out some important facts about smallpox. According to the CDC, Smallpox is spread from one person to another by infected saliva droplets that expose a susceptible person having face-to-face contact with the ill person. (2) Clearly, this is not an easily transmissible disease. In fact, in the recent Morbidity and Mortality Weekly Report from February 26, 2003 it stated, Infection is transmitted by large-droplet nuclei and occasionally by direct contact or contact with fomites (e.g. clothes or bedding). Airborne transmission has occurred rarely. Epidemiologic studies have demonstrated that smallpox has a lower rate of transmission than certain other diseases (e.g. measles, pertussis, and influenza). The greatest risk for infection occurs among household members and close contact of persons with smallpox, especially those with prolonged face-to face exposure. (3) Therefore, the following are some provisions, which we believe should be included in any Public Health Emergency Response bill. First, we are very concerned with how a public health emergency would be defined. In Bill 5286, it was defined as an imminent threat or occurrence of a communicable disease that poses a substantial risk of death to a significant number of persons over a short period of time. It is our position that language such as imminent threat is far too broad. Clearly, everyone would agree that we are under imminent threat sitting here in this hearing of getting the flu from someone who may be infected. Should a public health emergency be called? No. Additionally, we believe any definition should be limited to bioterrorism, as the CDC MSEHPA is written. By limiting it to bioterrorism, it would permit action in extreme cases, such as a biological attack, but not for other communicable diseases, such as AIDS, once a vaccine is available to the public. Additionally, we believe that the communicable disease should be medically 2

3 documented. Invoking emergency powers without confirmation of a specific disease is extreme. What happens if emergency powers are invoked only to find out that it was not the disease they suspected? The public will lose faith in the government officials who are declaring the state of emergency. The CDC has the capabilities to confirm a disease within a short period of time. Second, any public health emergency powers bill will most likely deal with vaccination. Therefore, there should be provisions included for medical, religious and conscientious objector vaccination exemptions. Without a doubt, the majority of the population in an emergency situation will be more than willing to be vaccinated, but not everyone will be able or willing to be vaccinated. Some of the population will be medically contraindicated from getting the vaccine, meaning the vaccine could cause a serious reaction for the individual. Some will have serious opposition to vaccination due to religious reasons, such as a Christian scientist. Others will have serious opposition to vaccination due to conscientious reasons. In times of war, individuals are permitted to not serve in the military due to conscientious objector reasons, which can include moral reasons, according to the Selective Service System which conducts the draft during wartime. All three of these vaccination exemptions exist in the CDC MSEHPA language. Furthermore, during the 1947 smallpox outbreak in New York, there were no forced vaccinations as it was all handled voluntarily. Additionally, there should be no fine for individuals claiming one of the three vaccination exemptions, as was passed in the House last year. If these exemptions are not permitted, than two things will occur. First, the public will not trust the government if they feel they have no choice or voice. After all, if it is in the best interest of the public, no one should be forced. Second, the public may choose to not cooperate if there are not reasonable alternatives in place, which would create chaos for those trying to deal with a public health emergency. To illustrate this point, I would like to share from a speech given by Judith W. Leavitt, PhD. She is a professor of History of Medicine at the University of Wisconsin Medical School. Her presentation was entitled, Public resistance or cooperation? Historical experiences with smallpox and was given at a conference just recently entitled, The Public as an Asset, Not a Problem. A summit on leadership during Bioterrorism. In her presentation, she details two smallpox outbreaks: one in Milwaukee, Wisconsin in 1894 and one in New York, New York in Her presentation contrasted the two situations in which riots broke out in Wisconsin and people were calm in New York. Milwaukee had a strong Health Department also when it started out, some Health Department help, strong-arm tactics for everybody, not just drug companies, very discriminatory in its policies, limited information, mixed messages, no citizen activity, and consequently a raging epidemic. Whereas, New York City had also a strong Health Department, state and federal cooperation, information and respect for people shown at every stage, even-handed in its policy, a media blitz with a clear message despite what Lee just said. It wasn t just one person, but it was a clear message. Use of citizen groups and confined, very confined outbreak. 3

4 Ms. Leavitt, continued by explaining that coercion where it has been tried has not worked historically, and has led to more problems; whereas, cooperation with a strong education component has been much more successful. (4) Clearly, a far better situation would be to permit such exemptions and to provide a reasonable method of handling those who claim such an exemption after having been exposed to or infected with a communicable disease due to bioterrorism. Third, any public health emergency powers bill should have clear definitions of quarantine and isolation. We believe that quarantine should be defined as individuals who have been exposed to a communicable disease and who are physically separated and confined. Whereas, isolation should be defined as individuals who are infected with a communicable disease and who are physically separated and confined. Additionally, defining whether an individual has been exposed or infected should not be left to the Public Health Commissioner or Director of Health to believe the individual was exposed or infected because believing is to open to interpretation. What would constitute that belief? These definitions are significant because it is our position that people should only be quarantined or isolated if they are exposed or infected, not as a punitive measure because an individual claims a medical, religious or conscientious vaccination exemption. Limited definitions would provide for basic safeguards. For example, if someone in Salisbury (a town in the farthest northwest corner of the state) became infected with smallpox, a person in Stonington (a town in the farthest southeast corner of the state) who has never come in contact with the Salisbury individual should not be quarantined if he or she claims a vaccination exemption. In short, a person who has been exposed or infected should either agree to be vaccinated or placed into quarantine or isolation, but only if exposed or infected. Fourth, we are concerned that the length of time one is placed into quarantine or isolation is reasonable. Last year, the bill proposed placing individuals into quarantine for 30 days. This does not make sense for two reasons. First, every disease has a certain period of time in which it takes the disease to exhibit symptoms of the disease. This time period is called the incubation period. Every disease has a different incubation period and public health officials definitely know the incubation periods for the diseases. Appendix 1 is a list of possible bioterrorism diseases. As you can see, some incubation periods are one day and others are 17 days. Since I do not believe the purpose of any public health emergency powers bill is to punish the population in a worst-case scenario, any quarantine period should be limited to the incubation period of the disease, plus five days. Picking an arbitrary 30 days is not logical, and many individuals will feel the government is simply being punitive rather than seriously watching out for the public s best interest. With regard to the isolation period, an individual should be released once the individual no longer poses a substantial risk of transmitting the disease for which the individual is isolated. Fifth, any quarantine and isolation provisions should be in the least restrictive means necessary, including the individual s home. It makes no sense to take someone who has 4

5 been exposed or infected, who most likely will already have exposed other family members and place that person in a separate facility. Sixth, any public health emergency powers bill should include humane provisions for quarantine and isolation. Humane provisions would include, for example, the guarantee of food, water and shelter. It should not be permitted for individuals in quarantine and isolation to be punished simply for being placed in such a situation. Seventh, quarantine and isolation should include provisions for families in a residence to stay together, and parents should be permitted to stay with a minor child in isolation or quarantine if they sign a waiver documenting their prior informed decision and their willingness to assume full responsibility for any risks or consequences resulting from their decision. If provisions such as these are not included, then the government will face an uphill battle should the public learn, for example, that infants are being kept apart from their parents. Eighth, any public health emergency powers bill must contain informed consent provisions. Any medical procedure requires that an individual knows the risks and benefits of the procedure. Vaccines, even in an emergency situation, are no different. Dryvax, the current smallpox vaccine, was classified as an investigatory drug because the process of creating the smallpox vaccine does not meet current Food and Drug Administration (FDA) guidelines. Last October 25, 2002, the FDA approved a new label and different manufacturing supplement and declared that the vaccine was now licensed. (3) Ironically, the Dryvax vaccine package insert, please see appendix 2, clearly states, Dryvax should not be used after the expiration date regardless of whether it is in the dry or reconstituted form. When I contacted Wyeth Laboratories, the manufacturer of Dryvax and the company that donated Dryvax to the government, and I asked for the expiration dates, I was told they no longer have that information because it had been to so long. The only thing I could infer from that was that the expiration dates had long since passed. When I asked the gentleman how long most vaccines last, I was told that they generally last three years. How can vaccines, which clearly state not to use after the expiration date be declared licensed, yet the manufacturer no longer even has the information on the expiration dates? Additionally, there has never been a clinical trial of Dryvax on children. While many people received the smallpox vaccine for years, it is important to note that there was no reporting system for reactions years ago. In an emergency situation, if one wants to get the vaccine they should be permitted to do so, after informed consent is received but to mandate such a controversial vaccine with no informed consent provisions is not responsible. Furthermore, if any public health emergency response authority bill releases any government official, or medical professional administering the vaccine of liability, then there must be a provision in place where the person being vaccinated gives informed consent. Ninth, provisions should be made in a public health emergency powers bill to permit individuals to see their physician before they are vaccinated. Many individuals, 5

6 particularly adults, do not see doctors regularly. Such an individual may have a medical contraindication, such as eczema or some other serious skin condition, for which they should not receive the smallpox vaccine. Tenth, any emergency response plan should be submitted to the legislature. Based on situations I have witnessed and the seriousness of the issue, the legislature should retain their oversight of the Department of Public Health so that any plan is reasonable and humane. Additionally, since the public would be expected to participate in such a plan, they should be included in the discussion. One might argue that an emergency plan must be kept secret from the public so that any terrorist would not know how the situation would be handled. This argument is ridiculous. There are only so many reasonable options that could be ordered under such a situation. If a terrorist took the time to plan an attack on the population with smallpox, then they will probably have other plans following such an attack, most likely including getting out of the situation rather than getting caught. Furthermore, if an emergency response plan was ever utilized, the plan would be released to the public at that time, in which case if that terrorist was determined to create more terror, the terrorist could easily change their plans. Since learning of the CDC MSEHPA bill and Bill 5286 last year, I have spoken to many, many individuals. Without knowing what an individual s belief in vaccination was at the time of our conversation, whenever I discussed the provisions of Bill 5286 and our organization s concerns, all outlined above, it was acknowledged without hesitation that our requests seemed reasonable. In fact, I recently spoke to a nurse who, after making it clear to me that she was supportive of vaccines, acknowledged that all of the provisions we are seeking are more than reasonable. In fact, she was astonished, which is the common response once it is learned what Bill 5286 included and that the above measures were not included. In closing, I would like to point out two things. First, I would encourage you not to set up a situation whereby the public is treated as if they are children who are incapable of mature judgment. Work with us and be reasonable. Second, back in June 2001, the Johns Hopkins Center for Civilian Biodefense Studies, along with several other organizations, held a biological attack exercise at Andrews Air Force Base in Washington, DC. The exercise was entitled DARK WINTER. It was set up to see how the U.S. would respond to a fictional, covert smallpox attack. Former Senator Sam Nunn acted as the President. In the analysis of the lessons learned, one quote from a senior Dark Winter participant stood out: For one thing, the federal government has to have the cooperation from the American people. There is no federal force out there that can require three hundred million people to take steps they don t want to take. (5) I would respectfully argue the same at the state level. Once more, I appreciate the opportunity to speak to the committee and I am willing to work with you to draft reasonable language for a public health emergency situation. I am available to answer any questions you may have. Thank you. 6

7 (1) Miller, Judith, Stephen Engelberg and William Broad. Germs. New York: Touchstone, (2) Facts about Smallpox, (3) Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program. Morbidity and Mortality Weekly Report Dispatch, February 26, 2003, 52(Dispatch); (4) Leavitt, Judith, Ph.D. Public resistance or cooperation? Historical experiences with smallpox. The Public as an Asset, Not a Problem. A summit on leadership during Bioterrorism. /peoplesrole/leavitt/leavitt_trans.html (5) O Toole, Tara, MD, MPH, Thomas Inglesby, MD, and Johns Hopkins Center for Civilian Biodefense Studies. Shining Light on Dark Winter. 7