SENATE HEALTH, EDUCATION AND SOCIAL SERVICES COMMITTEE February 12, 1996 9:04 a.m. MEMBERS PRESENT Senator Lyda Green, Chairman Senator Loren Leman, Vice-Chairman Senator Mike Miller Senator Johnny Ellis Senator Judy Salo MEMBERS ABSENT All members present. COMMITTEE CALENDAR SENATE BILL NO. 185 "An Act relating to immunization records for children under the age of seven." PREVIOUS SENATE COMMITTEE ACTION SB 185 - No previous action to record. WITNESS REGISTER Sherman Ernouf, Staff Senator Kelly State Capitol Juneau, Alaska 99801-1182 POSITION STATEMENT: Read sponsor statement. Elmer Lindstrom, Special Assistant Department of Health & Social Services PO Box 110601 Juneau, Alaska 99811-0601 POSITION STATEMENT: Discussed concerns with SB 185. Mead Treadwell Anchorage, Alaska POSITION STATEMENT: Supported SB 185. Sandy Mintz Anchorage, Alaska POSITION STATEMENT: Supported SB 185. Harry Gregson Anchorage, Alaska POSITION STATEMENT: Discussed his experience. Dr. Archie Kalokerinos RMB 218 ZA Bournes Lane Tamworth, NSW.2340 Australia POSITION STATEMENT: Discussed his findings through his practice. Professor Arthur Zaharsky POSITION STATEMENT: Urged support of SB 185. ACTION NARRATIVE TAPE 96-8, SIDE A SHES - 2/12/96 SB 185 IMMUNIZATION RECORD UPON CHILD'S DEATH  Number 003 CHAIRMAN GREEN called the Senate Health, Education and Social Services (HESS) Committee to order at 9:04 a.m. and introduced SB 185 as the first order of business before the committee. SHERMAN ERNOUF, Staff to Senator Kelly, read the following sponsor statement: SB 185 was introduced in response to a growing concern over the safety of childhood immunizations. For more than a century, childhood immunizations have been one of the foremost public health concerns. Immunization of our children has led to the near elimination of diseases which were once devastatingly fatal. However, some vaccines including the whooping cough vaccine and the German measles vaccine typically contain small quantities of material derived from disease-causing organisms which could possibly be linked to childhood death or injury. SB 185 requires the funeral director or the person acting as the funeral director to include a record of the dates of any immunizations a deceased child under the age of seven has received when filling the death certificate. Further, the death certificate must include the name and type of each vaccine administered, as well as the name of the vaccine's manufacturer and the lot and batch number. If the immunization record cannot be obtained within three days of death the funeral director shall file the death certificate in compliance with existing state law and shall continue to make efforts to obtain the records from the next of kin or other source. If the records are unavailable from these sources, the funeral director is required to request the immunization record from the Immortality Review Committee established by the commissioner of the Department of Health and Social Services. The committee must provide this information within 90 days. There are approximately 125 deaths every year of children under the age of seven. SB 185 might help to establish a link between immunizations and childhood death. Mr. Ernouf emphasized that requiring this information to be included on the death certificate would allow data to be collected in order to determine if there is a link between immunizations and death. He urged the support of the bill. Number 068 SENATOR LEMAN asked if the statistic, 125 total deaths of children under seven, included causes of death that were know such as accidents or does the number represent the total for unknown causes of death. SHERMAN ERNOUF clarified that the statistic referred to the total number of deaths in which the cause is unknown; this is not attributable to accidents. In response to Senator Salo, SHERMAN ERNOUF said that this vaccination record would be required for all deaths of children under the age of seven. Number 090 ELMER LINDSTROM, Special Assistant to Commissioner Perdue in the Department of Health & Social Services, said that the department has concerns with SB 185. There is not a valid scientific purpose for the collection of this data. Widespread compliance would be difficult to obtain; Alaska's population is very transient. Children have 16 to 18 sets of immunizations over seven years which are often administered by various providers in and out of the state and in the case of the military, out of the country. Mr. Lindstrom emphasized that much of the information requested by this bill is not part of an individual's immunization record, especially the manufacturer's information. The funeral director would face difficulties in compiling this information when faced with the various providers that administered the immunizations. Furthermore, this information may not even be available. In conclusion, Mr. Lindstrom stated that requiring the collection of this data is not feasible. He noted that when a child does die from an immunization, that is reported on the certificate. SENATOR SALO asked if other states required that this information be placed on the death certificate or does the National Institute of Health (NIH) have any protocol regarding this issue. ELMER LINDSTROM did not believe that this approach was being utilized in any other states. Mr. Lindstrom did not have information regarding the protocol of NIH, but could look into it. Mr. Lindstrom noted the fiscal note on file. Number 156 SENATOR LEMAN asked Mr. Lindstrom if the statistic of 125 deaths of children under age seven included accidents. ELMER LINDSTROM believed that the statistic represented all deaths from all causes in the state on a yearly basis. SENATOR LEMAN requested that Mr. Lindstrom review that statistic in order to clarify what it signifies. What are the total number of deaths, and of those how many are medically explainable? CHAIRMAN GREEN asked if there were any records kept on those deaths that have a direct correlation to vaccines. ELMER LINDSTROM said that he did not have that information. In a conversation with the division he was informed that when there is a cause and effect established between a vaccine and a death, the death is recorded as such. CHAIRMAN GREEN clarified that she was referring to those children that live. ELMER LINDSTROM did not know. Number 200 MEAD TREADWELL, testifying from Anchorage, said that he was testifying in memory of his son, who died at the age of nine weeks after immunizations and a case of thrush. He pointed out that at the time of his son's death, in 1993, there was no protocol in place to collect information regarding such deaths. Mr. Treadwell gave the following reasons for supporting SB 185: (1) Medicine evolves. Without the information to do the study, medicine cannot evolve very well. (2) Many cases upon review of the history of deaths has improved medicine. He discussed various studies which illustrate this point. (3) Data is becoming cheaper. Mr. Treadwell said that the government is probably best at collecting information. He was interested in data being utilized in order to help preserve and better life. The department may view the collection of this data as without a valid purpose now, but perhaps later it could be utilized to help medicine evolve. In conclusion, Mr. Treadwell commended SB 185. Number 276 SANDY MINTZ, testifying from Anchorage, supported SB 185. She noted that she had sent the committee considerable evidence of the data illustrating that the use of vaccinations is inadequate. In the Congressionally mandated review of the safety of childhood vaccinations, the Institute of Medicine (IOM) reported that they had been handicapped by the lack of good data. SB 185 would show if there is clustering of death at the time of vaccination. There is reason to believe there would be such clustering because the IOM did find, in spite of spotty data, that there is enough data to make a causal connection between antiphylaxic shock and the whooping cough, measles, and hepatitis B vaccine. She stated that children do die from vaccines; the question is how many children die. The Vaccine Adverse Event Reporting System (VAERS) found that in one 19 month period, 2,525 serious adverse vaccine associated reactions were reported including 350 deaths. VAERS is a passive reporting system. Under an active surveillance system such as a post marketing surveillance system, the VAERS data would then report over 120,000 serious reactions including 18,000 deaths would have been identified in that 19 month period using a vaccine manufacturers estimate. Ms. Mintz emphasized that if only 10 percent of those were later assumed to be caused by vaccinations, that would still equal over 10,000 serious adverse vaccination reactions with almost 2,000 deaths. She urged helping Alaska's children by supporting SB 185. She added that anyone interested in a copy of the NBC program which reported that the FDA was not recalling bad lots of the DPT vaccine, even when as many as 10 children had died per lot and over 100 had been seriously damaged per bad vaccine lot, can contact her. In response to Senator Salo, Sandy Mintz clarified that VAERS is a congressionally mandated passive reporting system. SENATOR SALO asked if Alaska participates in VAERS. SANDY MINTZ replied yes and noted that VAERS is voluntary. Ms. Mintz pointed out that the individual must make the connection between the vaccination and the reaction and then choose to report it or the doctor can report it. Ms. Mintz indicated that doctors are often not cooperative when presented with this connection which leads to the notion that the problem is vastly under-reported. Number 330 HARRY GREGSON, testifying from Anchorage, related his experience with his first daughter. In the night after her DPT shot at two months old, she went into respiratory distress and after many efforts she died the next morning in the hospital. Mr. Gregson informed the emergency room physician, the pediatrician, and the hematologist that the DPT shot had been the only variance in the day. All those physicians told Mr. Gregson that there was no connection to her problems and the DPT shot and discouraged the pursuit of this idea. Two months after her death, 60 Minutes aired a program about this issue which prompted Mr. Gregson to interview all attending physicians of his daughter. Mr. Gregson was told that the DPT vaccination was not connected to his daughter's death. Mr. Gregson began his own research and found much material regarding DPT shots and there damage to children. After much research and education on the subject, those who had refuted Mr. Gregson's connection between the DPT vaccine and his daughter's death now agreed with his conclusion. Following that, he and many other families in similar situations received compensation. Mr. Gregson believed that the monetary compensation illustrated the government's interest in correcting this issue, but it has been quite the contrary. SB 185 is a small step. Number 392 DR. ARCHIE KALOKERINOS, testifying from Australia, informed the committee that he had graduated in Medicine & Surgery from the University of Sydney in 1951. He discussed his medical practice which began in 1957 in Collarenebri where he faced an extremely high infant mortality rate. For example, during one 24 hour period three caucasian infants died. Dr. Kalokerinos discussed other children who seemed to be well or experiencing a trivial illness who would then be found dead or suffering unexplained shock from which they could not be resuscitated. Others developed extreme irritability sometimes resembling meningitis or encephalitis followed by unconsciousness and death. All the tests of standard disease administered during autopsies were negative except for the presence of yellow patches in the liver in some cases. Before death, these infants had displayed symptoms of liver pain and tenderness to varying degrees. Dr. Kalokerinos said that all other doctors in Australia denied that these problems and observations existed. He was told that this did not occur anywhere else in Australia. Years later Dr. Kalokerinos learned that the problem was widespread in Australia, particularly in aboriginal communities. Dr Kalokerinos asserted that he was either deliberately misinformed some while others could not recognize the situation. Dr. Kalokerinos noted that such an epidemic had also occurred in Naples, Italy in the late 1970s. One third of those infants and children had recently receive routine childhood vaccines. Eventually Dr. Kalokerinos discovered that if administered early, intramuscular intravenous injections of vitamin C could reverse the shock and unconscious state. The infant mortality rate of infants under Dr. Kalokerinos' care dropped dramatically. Other doctors following this method acheived similar results. Dr. Kalokerinos said that he learned that routine immunization had an awful effect on some infants for weeks after receiving the immunization. Some infants appeared to suffer from immune paralysis and contacted serious bacterial infections. Others, in the up to two week period following a vaccination, would go into sudden unexplained shock or excessive irritability state followed by unconsciousness. Those states could be reversed with the administration of intravenous vitamin C. Bacterial infections are more difficult to control. It became more obvious that the percusses component of the vaccine was the most serious. Therefore, when a vaccinated child was reached during the period of illness, the percusses component was often exploded and all vitamin supplements were increased in doses. All the sick infants received vitamin C. Dr. Kalokerinos informed the committee that in NSW, records are kept of all vaccines administered and a copy is in the possession of the parents. CHAIRMAN GREEN requested that Dr. Kalokerinos fax his written testimony to the committee. Number 460 DR. ARTHUR ZAHARSKY, testifying from Illinois, informed the committee that he was a Professor of Immunology at Southern Illinois University. He posed the following question: why do some children respond adversely to the precusses component of the vaccine and others do not? He pointed out that in the manufacture of the vaccine the whooping cough or precusses component represents an intact bacteria containing biologically active toxin molecules. Those molecules are injected into the bodies of infants. Dr. Zaharsky stated that this vaccine is unpredictably unsafe. The principle toxins are present in unmeasured quantities and available to the biological systems of the infant at the particular state of nutrition, and the particular state of growth and development of the child. Dr. Zaharsky noted that public health officials in Alaska with whom he visited in 1994 did perform appropriate surveys. However, the problem with some of the surveys is the inability to distinguish between children receiving one or more injections of the vaccine and who have then been withdrawn from further injections because of an adverse response to a particular injection of the vaccine. Those children are not entered into the pool of data which reflects what happens to all infants. Dr. Zaharsky explained that these children are placed on an alternative vaccine which does not contain the whooping cough component or they are withdrawn from further vaccinations all together. Therefore, the current data is flawed due to the quality of the data. SB 185 would reveal for those children who come to autopsy, if there are a syndrome of features that would illustrate the biological action of the toxin molecules within the body. This could attribute a child's death to the known multiple effects that the toxin molecules have within some children. He urged the committee to support SB 185 in order to provide evidence for use of a better and safer vaccine known as booster shots. This acellular vaccine has a significantly reduced component of the biologically active toxin molecules. Number 516 CHAIRMAN GREEN added that she too had a similar experience with her eldest son. She explained that had she put her son to bed when she went home after the vaccine, he too would have died. Fortunately, she realized what was happening and rushed her son back and he was resuscitated and lived. Chairman Green inquired as to the committee's preference on whether to wait for the additional information or pass it to the next committee where the information could be presented. SENATOR LEMAN did not know how important having the batch number of the vaccine on the death certificate would actually be, but he did realize the batch number's importance in tracing the batches. CHAIRMAN GREEN believed that information was often included. She indicated that the information is in the records in the doctor's office. She did not believe this would be much of a problem. Moreover, the military surely keeps the information in the individual's record. SENATOR SALO asked if the information the committee wanted was the number of deaths of children under seven. CHAIRMAN GREEN replied yes. SENATOR SALO said that she would like to know that information. She suggested that this information could be required on any death certificate when there is any doubt about the cause of death. CHAIRMAN GREEN held SB 185 until the requested information was obtained. She announced that there would be a Joint HESS meeting on Wednesday in order to hear an overview of the Alaska Native Health Board. SENATOR LEMAN requested that Dr. Zaharsky send his testimony in to the committee as well. There being no further business before the committee, the meeting was adjourned at 9:46 a.m.