The 1994 WORLD numbers are:

1. - World population as determined by the World Health Organization (W.H.O.) ⁽¹⁾
1. "5,000,000,000 people


2. - People in the world who have come into contact with the hepatitis B virus ⁽¹⁾
1. "2,000,000,000 people


3. - People in the world who die each year from complications of the hepatitis B virus ⁽²⁾
1. "1-1,500,000 people


4. The 1994 U.S.A. numbers are:



5. - U.S. Population ⁽³⁾
1. "261,000,000 people


6. - Cases of hepatitis B virus in the U.S.A. reported each year to the Centers for Disease Control (CDC) ⁽⁴⁾
1. "25,000 cases/yr


7. If corrected for estimated under-reporting (x4) and for asymptomatic infections (x3), the estimated actual number is closer to ⁽⁴⁾
1. "300,000 cases/yr

For HEALTH CARE WORKERS:

      - Of all reported U.S. cases, only 4-5% were due to occupational exposure of health care workers, and this was before the hepatitis B vaccines and before the protective "work practice controls" were in place. ⁽⁵⁾

      - Studies suggest that hepatitis B-infected health care workers seem to be virtually no threat to their patients. Gitnick reports that in a number of studies, such workers were followed to collect evidence of spread of infection to patients. None was found. ⁽⁶⁾

2. How do adults respond to the hepatitis B virus?

      - Approximately 50% have low viral growth and an early immune system response, and therefore develop no symptoms, resolve (defeat) the virus, and have lifelong immunity to it. ^(7,10)

      - About 30% more experience what they think is the flu, also go undiagnosed, resolve the virus and develop lifelong immunity. ⁽¹⁰⁾

      - Approximately 20% have higher viral growth and a later immune response, so they get sick enough to be diagnosed as having hepatitis B. The vast majority resolve the virus and have lifelong immunity. ^(7,10) They rarely (<5%of them) become chronic carriers of the virus. ⁽⁹⁾

      -About two tenths of 1% get sick, don't defeat the virus, and die of liver complications. ⁽⁷⁾

      - Approximately 1-5% of adults ^{(9, 10)} become so-called "healthy carriers", having no symptoms, but being capable of spreading the virus. Most of these people will reach the end of their lives with little or no damage done to their livers by the virus living there. ^{(11, 12)} However, about a quarter of these carriers are in danger of developing life threatening liver disease decades later in life. ^{(7, 8)} Bader ⁽¹⁰⁾ points out that "It is widely taught that 5-10% of patients...advance to the carrier state." But that this figure "should not be taught at all; instead a notation of the fact should be made that chronicity varies widely depending upon a number of defined and undefined factors." These factors include age at infection, gender, race, general health, and the functioning of your immune system.

IN SUMMARY:

Of the adults who are infected with the virus, almost 95% will recover, most with no symptoms at all and all with lifelong immunity to the virus. Fewer than 5% will live essentially symptom-free with declining but continuous infectiousness. About one fourth of this 5% will face life threatening liver complications decades later. About two tenths of one percent of all infected adults will die soon after becoming infected with the virus. With today's protective workplace procedures required here at Baylor, fewer than 5% of those developing symptoms will have become infected through occupational exposure.

3. WORST CASE SCENARIO: What's it like to have Hepatitis B virus? or to have an autoimmune disorder?

The Illness         Symptoms & Duration        Infectiousness

Hepatitis B
- acute form ^{(6, 11)}

Worst acute form: nausea, vomiting, low grade fever, constant fatigue, may develop jaundice which fades along with symptoms over approx. 4 weeks. Must stay home to recover for few months. Fatigue can last up to a year. Blood chemistry returns to normal within 6 months.
Mothers pass to babies if they become infected during the third trimester. Blood is infectious as long as viral antigen is in bloodstream: generally for 3 mos. Major danger is to sexual partner (20%-70% of non-immune spouses will catch it from their infected mate). Less than 1% of other family members are found to become infected. Fetal infection probably occurs in the birth canal, or possibly through the placenta. Breast milk is an unlikely source.

Hepatitis B
- chronic form ^{(6, 9, 11)}

Most do not have symptoms, but virus has not been cleared from blood after 6 months following exposure. Ten to thirty or more years later, about a quarter of these people will develop life threatening cirrhosis or even more rarely, liver cancer. Blood remains infectious until age 35 or so when it becomes "relatively noninfectious" but still must be careful.

Autoimmune disorders ⁽¹³⁾

Depends upon systems affected.
Inflammation of blood vessels (vasculitis), joints (arthritis) can cause disabling pain. Attack on the tissue of the nerves can cause blindness (optic neuritis), motor function impairment (multiple sclerosis, Guillain-Barre, other neuropathies), problems with thinking and memory. Other symptoms include temperature control problems, disabling fatigue, eventual failure of attacked organs (diabetes). All such disorders are frequently permanent, although there may be periods of remission in some.
Not infectious

4. What about the medical organizations that "recommend" the vaccine?

Individual representatives were contacted by phone in the last month (for this document these names have not been included) and asked whether their organization recommended any vaccines. They all said NO. They recommend vaccination procedures, since they must decide what populations are at risk, and how best to cover those populations. They neither test nor assert the safety or efficacy of any specific vaccine. When asked what authority(ies)they depended upon to determine vaccine safety, they responded as indicated below.

Organization and spokesperson         Their authority on safety

American College of Preventive Medicine (ACPM)

CDC, National Coalition for Adult Immunization

American Medical Association (AMA)

CDC, FDA

American Academy of Family Physicians (AAFP)

Substance is on the market, therefore must have passed FDA inspection

American College of Physicians (ACP)
Substance is on the market

5. Why should we not take the word of the FDA concerning the necessity of the vaccine when it is good enough for the CDC and for all these organizations?

      A. The FDA based its decisions upon clinical trials and upon post marketing surveillance studies in which patients and their doctors were asked to report any adverse effects they noticed within 4-5 days after each injection [4 days for Smith/Kline and 5 days for Merck]. ^{(14, 15, 16)} The problems being reported in increasing numbers as occurring after hepatitis B vaccination appear to be autoimmune in origin. Such problems take weeks to months to produce noticeable symptoms, and cannot be spotted in a 4-5 day observation period.

      B. In 1992, a study was begun by the Institute of Medicine of the National Academy of Sciences to look at all reports of adverse effects that might have been caused by a number of vaccines including the hepatitis B vaccine. They did this because they were so directed by Congress through the Dept. of Health and Human Services . This was because of increasing fears voiced , mainly by parents, about the health of their children after vaccination.

The National Academy of Sciences published their findings concerning the hepatitis B vaccine in 1994 ⁽¹¹⁾ . The results are reproduced here.

(INSERT TABLES)

The Academy notes that:
      - Sensitivity to the recombinant vaccine was rarely seen, and then mostly took the form of a temporarily sore arm. Ten to fifteen percent experienced fatigue, headache, fever, etc. No follow-up to these symptoms or what might follow them was ever done. ⁽¹⁶⁾

      - They report that "the trials are notable for the absence of any serious adverse reactions", but that "the studies were not designed to assess serious, rare adverse events; the total number of recipients is too small and the follow-up generally too short to detect rare or delayed serious adverse reactions." ⁽¹⁶⁾

      - They report that "None of the clinical trials reviewed by the committee contained information regarding hepatitis B vaccine and ....central demyelinating diseases" (ie: Guillian-Barre syndrome, multiple sclerosis, transverse myelitis, optic neuritis, etc.). "Evidence is inadequate to accept or reject a causal relation between the hepatitis B vaccine and (the above demyelinating syndromes). Nevertheless, the number of reports questioning the relation between one or the other of these disorders of similar character suggests the need for systematic research." ⁽¹⁶⁾

They report that "No controlled clinical trials reviewed by this committee contained information regarding hepatitis B vaccine and arthritis." However, "The possibility that the hepatitis B vaccine can cause an exacerbation of rheumatoid arthritis should be carefully evaluated in a population-based study." ⁽¹⁶⁾

They note that "Antigenic stimulation of any type in such people" (genetically susceptible to autoimmune disease) might precipitate either an exacerbation or even the first clinically evident attack of disease exacerbation." ⁽¹⁶⁾

      C. Since the Academy's report,

      - None of the recommended studies have been funded by any of the drug companies, and none have been reported in the literature. ^{(17, 18)}

      - Clinical studies (by laboratories not associated with the drug companies) investigating links between the vaccine and rheumatoid arthritis are underway. ^{(19, 20, 23)}

      - Epidemiological studies specifically aimed at testing the existence of a relationship between the vaccine and the development or exacerbation of autoimmune disorders are being planned. ⁽¹⁹⁾

      - In France, there is increasing concern among both doctors and lay people about recent reports of multiple sclerosis and other neurological disorders appearing in vaccinated patients. Recently, 150 doctors appealed to the French Academy of Sciences to commission a study by investigators with no connections to manufacturers of the vaccine. The Academy endorsed the call for a survey ^{(21, 22)}Meanwhile, doctors in France are under a gag order not to talk to the press.⁽¹⁹⁾

Scientists planning and carrying out such studies (both in the U.S. and abroad) report receiving 2 and 3 communications per day (email, fax, letter, phone) from patients and medical personnel asking to contribute their own or their patients' data to the studies. ^{(19, 23)}

Literature Cited

1. Kane, M.A. [WHO, Geneva, Switzerland] Global programme for control of hepatitis B infection. In: Viral Hepatitis Prevention Board's "Proceedings of the International Congress: Action Towards Control of Hepatitis B as a Community Health Risk", Nov., 1993. In: Vaccine, 13, Suppl #1, 1995, pp. S47-S49.

2. Kane, M.A. [WHO, Geneva, Switzerland] Progress on the control of hepatitis B infection through immunisation. In "Viral Hepatitis Management. Standards for the Future." Proceedings of a symposium held in Cannes, France, May 1992. In Gut, 34, Suppl #2, pp. S10-S12, 1993.

3. Statistical Abstracts of the United States, 1996 Edition.

4. Alter, M.J. , et al (1994) The epidemiology of viral hepatitis in the United States. , Viral Hepatitis, 23 (3), 437-579. [originally from Cohen, B., et al (1987) Dig. Dis. Sci., 32, 1428-1430.]

4. Meheus, A. (1995) Risk of hepatitis B in adolescence and young adulthood. In: Viral Hepatitis Prevention Board's "Proceedings of the International Congress: Action Towards Control of Hepatitis B as a Community Health Risk", Nov., 1993. In: Vaccine, 13, Suppl #1, 1995, pp. S31-34.

5. Alter, M.J. et al (1994) The epidemiology of viral hepatitis in the United States. Viral Hepatitis, 23 (3), 437-579. [Originally from Cohen, B., et al. (1987) Dig. Dis. Sci., 32, 1428-1430.]

6. Gitnick, G. (ed), (1994) "Principles and Practice of Gastroenterology and Hepatology" Second Edition, Appleton & Lange, Norwalk, Ct. , pp784-795.

7. Crawford, James M., M.D., Ph.D., Director, Program in Gastrointestinal Pathology, Yale University School of Medicine (1997) (Personal Communication) and Crawford, James M. (1994) The liver and the biliary tract, In: "Robbins Pathologic Basis of Disease", 5th edition, Cotran, R.S., Kumar, V., Robbins, S.L. and Schoen, F.J. (eds), W.B. Saunders Co., Phila., PA. pp.844-845. [Text used by BCM medical students]

8. Sherlock, S. (1990) Hepatitis B: the disease. : Proceedings of the International Conference on Prospects for Eradication of Hepatitis B Virus. In: Vaccine, 8 (Suppl), S-6 - S-10.

9. Hyams, K.C. (1995) Risks of chronicity following acute hepatitis B virus infection: A review. Clin. Infect. Dis. 20, 992-1000.

10. Bader, T.F. (1995) "Viral Hepatitis: Practical Evaluation and Treatment", Hogrefe & Huber Pub., Seattle, WA., pp. 52-78.

11. Sherlock, S. and Dooley, J. (1997) "Diseases of the Liver and Biliary System", Tenth edition, Blackwell Science, London, U.K., pp. 267-279, 315-334.

12. Dragosics, B., Ferenci, P., Hitchman, E. et al. (1987) Long-term follow-up study of asymptomatic HBsAg-positive voluntary blood donors in Austria: a clinical and histologic evaluation of 242 cases. Hepatol. 7, 302.

13. Abbas, A.K., Lichtman, A.H. and J.S. Pober (1994) "Cellular and Molecular Immunology" (second edition), W.B. Saunders Co., London, U.K. pp.382-392. [Text used by BCM medical students]

14. Physician's Desk Reference, 1997 and flyer enclosed with Merck Recombivax vaccine

15. Physician's Desk Reference, 1997 and flyer enclosed with Smith/Kline Beecham Engerix vaccine

16. Stratton, K.R., Howe, C.R., Johnston, R.B. (eds) for Institute of Medicine, (1994) "Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality", National Academy Press, Washington, D.C.

17. Computer searches of the literature from 1966 to present.

18. Dr. Richard T. Johnson, Dept. Neurology, Johns Hopkins University (personal communication).

19. Dr. Bonnie S. Dunbar, Dept. Cell Biology , Baylor College of Medicine (personal communication).

20. Pope, J. E., Stevens, A. , Howson, W. and Bell, D.A. (1998) The development of rheumatoid arthritis following recombinant hepatitis B vaccination. (in preparation).

21. GPV's Expanded Programme on Immunization (1997) Immunization news. Vaccine and Immu. News, (4), June, p.8.

22. Appeal listing concerns of physicians addressed to presidents of the Academie des Sciences, Academie de Medecine, and Academie de Pharmacie , Sept. 18, 1996; Reply by Institute de France, Academie des Sciences, Dec. 10, 1996; Reply by Academie Nationale de Medecine, Feb. 4, 1997.

23. Dr. C. Shepherd, Medical Director, Myalgic Encephalomyelitis Assoc. , Gloucestershire, U.K. (personnal communication)

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