DATE: 3/27/01 Judy Converse

LOCATION: Room 234, Massachusetts State House, Beacon Hill, Boston, MA 02133

RE: House Bill No. 1936 (An act relative to the hepatitis B vaccine stating that in the absence of an emergency or epidemic of disease declared by the Department of Public Healh, no child whose parent or guardian objects in writing shall be required to be immunized against hepatitis B virus in order to attend school.)

My name is Judy Converse. I am a registered dietitian with a master of public health degree and undergraduate degree in nutrition. I am testifying in favor of House Bill 1936. I have testified previously on the issue of universal hepatitis B vaccination before the US House of Representatives Committee on Government Reform. I would like to put hepatitis B virus in its correct context for you, as is pertinent to your concerns regarding school entrance requirements. My comments do not describe the clinical course of the disease, but simply the statistical reality of incidence in the US and Massachusetts, as reported by the CDC.

Hepatitis B virus is not a childhood disease. No agency, the CDC included, lists children or infants among individuals at risk. It is an adult lifestyle disease spread in the US primarily by sexual contact and sharing of needles. Because of this, adults age 20-40 are typically affected. Over 90% recover with no permanent effects. Even for adults, hepatitis B virus incidence is almost a non-issue in the US. Incidence is so low, in fact, that the CDC published the following comments: “State level incidence rates of hepatitis B are deemed unreliable. This item is not amenable to survey data collection due to low incidence. National estimates of hepatitis B incidence are corrected for underreporting by using an algorithm that adjusts reported incidence upward by approximately 6-fold”. That is from Healthy People 2000 Statistical Notes, Issue No. 15, December 1997, which is published by the CDC.

Indeed, here in Massachusetts, only 19 cases (NOT DEATHS) were reported for all age groups for the year 2000. This means that there are fewer than 2 cases of hepatitis B per million MA residents. Nationwide, some 6000 cases (not deaths) were reported last year, which means that there are currently about 2 cases of hepatitis B virus per 100,000 persons in the US. Hepatitis B infection in MA follows the national trend, which has shown a steady decline in cases on average of 10% per year since 1986. This is not due to vaccination: Vaccine compliance in the 1980s was poor for high risk groups (injection drug users, sexually promiscuous homosexual and heterosexual men) and the vaccine was not given to children until 1991. According to the CDC, incidence dropped in these groups due to safe sex and needle use practices promoted through AIDS prevention awareness.

Incidence in the US for hepatitis B is so low, there is no reliable way to report it, according to the CDC. Childhood is not a risk factor for hepatitis B virus. In the US, this truly is a vaccine without a market. Once the manufacturer realized this in the late 1980s, it requested permission to sell this vaccine to the perfect market: Infants and children. Once a department of health or department of education requires a vaccine for school entrance, the money flows without hindrance into the manufacturers¹ coffers. The FDA, the CDC, the Advisory committee on Immunization Practices knew full well that children did not need this vaccine. This is admitted in their own documents. But they viewed childhood as a convenient time to give shots. The FDA licensed this vaccine for use in children in a record breaking 5-months¹ time. Inadequate safety testing prevailed ­ no independent testing was done, just a 5-day trial by the manufacturer on a small sample of children, with no control subjects.

This is the first recombinant vaccine marketed, and as such, it was assumed to be safer than a live virus vaccine. It was the first of any type ever given to newborn babies. It was the first time a vaccine was given in childhood to prevent an adult lifestyle disease. Even though this is like taking an aspirin on Monday to prevent a hangover on Friday, all of these firsts were overlooked in pursuit of a phenomenal sales opportunity and potentially phenomenal health outcome. It was an experiment: Could hepatitis B be wiped out, if we vaccinate everyone from birth? Could this work for any disease? Not foreseen were the grievous safety issues that have emerged with using a vaccine containing genetically recombined viral material during the delicate, critical neonatal period and developmental years. Many safety issues have indeed emerged. Without imminent risk for contracting this virus, any school system which requires this vaccine for entrance is, in my opinion, acting criminally, and putting its students at hazard for outcomes like autism, degenerative neuromuscular diseases, chronic fatigue syndrome, deafness, and more. All of these have been linked to hepatitis B vaccine injury, as you can see in the list of references provided today.

I have illustrated that this vaccine is, from public health and safety perspectives, utterly inappropriate for universal use in US children. Now I would like to tell you more about myself. In addition to my public health credential, I am a registered dietitian in private practice. Though I have some typical nutrition diagnoses in my case-load, like FTT, chronic diarrhea, or food allergies, I specialize in dietary intervention for autism. This was not an area of practice included in my training; it is simply too new and many providers who normally see autistic children do not embrace it. I have come into this by way of my own son, who nearly died from one dose of hepatitis B vaccine given at birth. Though he was the healthy product of a normal full term pregnancy and spontaneous delivery without complications, he quickly succumbed to the adverse effects of this vaccine, given without our knowledge or consent because it was recommended by the CDC, when he was less than 2 days old. As I told a Congressional Subcommittee investigating hepatitis B vaccine in 1999, his symptoms matched federal criteria for hepatitis B vaccine injury to the letter with one exception: Symptoms did not all occur within 4 hours of receiving the shot. Because of this arbitrary and scientifically invalid criterion, placed in the vaccine injury tables, some say, to protect vaccine manufacturers, no physician diagnosed his reaction for nearly three years.

My son¹s infancy was fraught with complex feeding problems, growth failure, allergies, seizure and breathholding events, peculiar sensitivities, motor delays, social phobias, and extreme hyperaccusis. He qualified for Department of Health Early Intervention services at age 10 months, and MassHealth coverage soon after, which paid for his occupational therapy and sensory integration treatment at $200/hour, twice weekly, for over a year. By age 2.9 he was diagnosed on the autism spectrum as PDD-NOS at Boston Children¹s Hospital. He now attends school on an IEP, which includes a shared aid, occupational therapy services, and physical therapy services. His IEP paid over $1000 for auditory integration training, so that he could tolerate the sounds of school, and function there without seizing or persevering (hearing changes are a documented feature of hepatitis B vaccine injury). Massachusetts health and education programs have been paying for my son¹s vaccine injury nearly all of his life. He is only one of thousands of children in this state similarly affected, by a vaccine that they don¹t even need.

This sounds bad, but my son is lucky. He is 4 years old and doing very well, thanks to relentless, aggressive, and costly interventions that we have pursued since the day his health was shattered by this vaccine. In Falmouth, my son receives the least services of all children on the autism spectrum whom I know. In other words, he comes cheap as a spectrum kid for DOE. It is much worse for other kids who have not had the benefit of aggressive early intervention and thus need constant, costly supports at school.

It is plain to me that the children who come to my office for nutrition care are suffering from injuries similar to my son’s. The diagnostics, nutrition status, immune panel, growth and gain, gastrointestinal dysfunction, development, and clinical history fit the same pattern, over and over. When infants react adversely to this shot, they face a life of compromised functioning. They will not develop typically. They will need elaborate special education services, early intervention, and constant care. Their parents will be pulled from productive lives and into full time case management. The losses are staggering, and they statistically outpace cases of hepatitis B infection nationwide. I repeat: A child in Massachusetts has a greater chance of reacting adversely to this vaccine and suffering lifelong injury or impairment, than they have of contracting the disease itself. This is public health practice at its worst, the tail wagging the dog. I urge this committee to act responsibly and omit this vaccine from school entrance requirements, for the health and safety of all Massachusetts children. Even one case of childhood hepatitis B is not worth the hundreds or thousands of injuries you will incur if you require this shot for school entrance.

Bibliography

Berkman, N. A case of segmentary unilateral occlusion of the central retinal vein following hepatitis B vaccination. Presse Med 1997; 26:670

Biacabe, Erminy, and Bonfils. A case report of fluctuant sensorineural hearing loss after hepatitis B vaccination. Auris Nasus Larynx 1997; 24:357-60l

Biasi et al. A new case of reactive arthritis after hepatitis B vaccination. Clin Exp Rheumatol 1993; 11:215

Bonfils et al. Fluctuant perception hearing loss after hepatitis B vaccine. Ann Otolaryngol Chir Cervicofac 1996; 113:359-61

Deisenhammer et al. Acute cerebellar ataxia after immunization with recombinant hepatitis B vaccine. Acta Neurolog Scand 1994; 89:462-463

Devin et al. Occlusion of central retinal vein after hepatitis B vaccination. Lancet 1996; 347:1626

F-D-C Reports Inc. Merck¹s Recombivax DNA Derived Hepatitis Vaccine

Approved After 5 Month Review. The Pink Sheet 48(30):3-4, July 28, 1986

F-D-C Reports Inc. Combo Vaccine Antibody Assessments Should Be Encouraged, Not Required.” The Pink Sheet 57(46):T&G-7, T&G-8, T7G-9. November 13, 1995.

Gout et al. Central nervous system demyelination after recombinant hepatitis B vaccination: Report of 25 cases. American Academy of Neurology 49th Annual Meeting, April 12-19, 1997, Boston, MA; Neurology 48:p.A424.

Hepatitis B vaccination for injection drug users ­ Pierce County, Washington, DC. MMWR 2001; 50(19):388-390,399.

Hepatitis Surveillance: Trends Based On Reporting to the National Notifiable Diseases Surveillance System, 1993. CDC Report No. 56, April 1996.

Nadler, JP. Multiple sclerosis and hepatitis B vaccination. Clin Infect Dis 1993; 17:928-9.

National Vaccine Information Center (NVIC). “Hepatitis B Vaccine Reaction Reports Outnumber Reported Disease Cases In Children, According to Safety Group. National Poll Reveals Majority of Americans Want Informed Consent Rights.” Press Release, Washington, DC: January 27, 1999

Notifiable Diseases/Deaths in Selected Cities Weekly Information. Morbidity & Mortality Weekly Report January 5, 2001; 49(51):1167-1174

Priority Data Needs: Sources of National, State, and Local Level Data and Data Collection Systems. Healthy People 2000 Statistical Notes No 15, December 1997. CDC & National Center for Health Statistics.

Orlando et al. Sudden hearing loss in childhood subsequent to hepatitis B vaccine: A case report. Ann NY Acad Sci 1997; 830:319-21

Senejoux et al. Acute myelitis after immunization against hepatitis B with recombinant vaccine. Gastroenterol Clin Biol 1996;20:401-2

Tourbah et al. Encephalitis after hepatitis B vaccination. Neurology 1999;53(2):396-401

US House of Representatives Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy, and Human Resources. “Hepatitis B Vaccine:

Helping or Hurting Public Health?” Testimonies of Bonnie Dunbar, PhD;

Burton Weisbran, MD; Judy Converse, MPH, RD; Barbara Loe Fisher, President, NVIC. Washington, DC: May 18, 1999.

Vaccine Adverse Event Reporting System (VAERS), Food and Drug Administration, Rockville, MD. Searchable at: http://www.fedbuzz.com/vaccine/vac.html

Judy Converse, MPH, RD
Nutrition Care for Children
Office: 205-4B Worcester Court, Falmouth, MA 02540
Mailing: P.O. Box 992, West Falmouth, MA 02574
Telephone: (508) 548-6728

April 11, 2001

The Honorable Robert Antonioni
The Honorable Peter Larkin
Joint Committee on Education, Arts, and Humanities
State House, Room 234
Boston, MA 02133

Dear Senator Antonioni and Representative Larkin:

I recently had the opportunity to review information from Massachusetts Department of Health Commissioner Howard Koh, regarding hepatitis B vaccination as it pertains to H. 1936.

I am eager to enlighten the Committee regarding the Commissioner’s assertions. They are not consistent with data published by the Centers for Disease Control (CDC); indeed, they contradict information his own agency reported to the CDC last year. For 2000, Massachusetts Department of Public Health reported a total of 19 (nineteen) cases of hepatitis B for all age groups. This number follows fifteen years of steady decline in the number of cases in our state and nationwide.

The CDC is the research and policy-making body of the US Public Health Service to which all state health departments must report. Penalties may apply for health departments in non-compliance with respect to reporting notifiable diseases. Hepatitis B is a notifiable disease. A case is reported when a lab confirms the diagnosis of hepatitis B. It is unclear why Commissioner Koh would report different case numbers to you than he did to the CDC, but in his communication to you (letter dated 3/27/01), he appears to have done so.

Total cases for all age groups nationwide last year equaled 6,646. MDPH Commissioner Koh claims that nearly 10% of this figure (600) represents cases in Massachusetts children every year. If true, this would be an alarming scenario since annually, the CDC reports some 300 cases nationwide in children up to age 14. Commissioner Koh also claims that prior to hepatitis B vaccination in children, there were 30,000 pediatric cases of hepatitis B every year. In fact, retrospective reporting by the CDC’s Hepatitis Surveillance Program shows no change in childhood case rates since 1966. Since 1966 (when hepatitis B was first notifiable), total reported cases for all age groups have never exceeded 27,000.

All hepatitis B surveillance data refute the Commissioner¹s claims. A bibliography is attached for your convenience, along with a list of corrections for other misinformed statements he forwarded to the Committee.

Parents and health care providers alike hope the Committee becomes astutely informed on universal childhood hepatitis B vaccination. A decision to universally vaccinate Massachusetts children must be based on need for the vaccine in 0-14 year olds, which does not exist, and safety of the vaccine, which is hotly debated. Please contact me if I can be of further assistance or provide more information. Thank you kindly for your consideration of this matter.

Sincerely,

Judy Converse, MPH, RD