RCGM Witness Brief Michael Godfrey

Publications & Resources

Witness Brief Royal Commission on Genetic Modification

1. Name of Witness Michael Godfrey

My name is Michael Godfrey. I hold a medical degree from London University (M.B.B.S.1963). I am a Fellow of American College of Advancement in Medicine (FACAM) and the Australasian College of Nutrition and Environmental Medicine (FACNEM). I am the Medical Director of the Bay of Plenty Environmental Health Clinic. I have published 2 papers in the NZ Science Review and 4 in peer-reviewed U.S.biomedical journals on subjects related to environmental toxicology. I have been invited to present related papers at international medical conferences in the USA, Australia and India.

2. Name of “Interested Person” (on behalf of whom the witness will appear): Physicians and Scientists for Responsible Genetics New Zealand (PSRG)

3. Witness Brief Executive Summary

My brief of evidence concerns a number of medical issues regarding the approval and use of recombinant vaccines, in particular the hepatitis B (Hep B) vaccine as addressed in my submission. I enclose correspondence from the Association of American Physicians and Surgeons (AAPS) to the FDA and CDC as further evidence of my brief.

Our recommendations are:

PSRG appeal to the Commission to recommend to Government that we have in place an indefinite moratorium on the release of genetically engineered organisms (GEOs). And that the precautionary principle should dictate that we declare an immediate moratorium on

(i) the release of any genetically engineered organisms into the environment, and

(ii) the incorporation of GEOs, their parts, processes and products, into the food chain.

Section B (b)

B (b) the evidence (including the scientific evidence) and the level of uncertainly, about the present and possible future use, in New Zealand, of GM, GMO’s, and products.

Section B(b) Summary

1. RECOMBINANT GE. HEPATITIS B VACCINE

Certain facts regarding this vaccine need to be considered concerning purported benefits vs adverse effects.

2. RECOMBINANT INSULIN (Humalog) (See Witness Brief Dr Bernard Conlon and Robert

Anderson.)

1. People at high risk for getting hepatitis B disease (which is transmitted by coming into direct contact with an infected person's body fluids) are I/V drug users, prostitutes, prisoners, sexually promiscuous persons and babies born to infected mothers. (1)

2. 90-95% of all hepatitis B cases recover completely after 3 to 4 weeks of nausea, fatigue, headache, arthritis, jaundice and tender liver. (2)

3. Up to 17 percent of all hepatitis B vaccinations are followed by reports of fatigue and weakness, headache, arthritis and fever of more than 100 F. (3) The vaccine can cause death, according to a 1994 Institute of Medicine report. (4)

4. According to Merck and Company: "The duration of the protective effect of [the vaccine] in healthy vaccinees is unknown at present and the need for booster doses is not yet defined."

5. In 1996, there were 10,637 cases of hepatitis B reported in the U.S. and the Centre for Disease Control (CDC) stated that "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexual and heterosexuals of both sexes." (5)

6. In 1996, only 279 cases of hepatitis B disease were reported to have occurred in the U.S. in children under 14 years old. (5)

7. An historic report in 1994 published by the Institute of Medicine, National Academy of Sciences, reviewed the medical literature for evidence that vaccines, including hepatitis B vaccine, can cause a variety of immune and neurological health problems. An independent committee of physician experts concluded that there were no case controlled observational studies or controlled clinical trials conducted on hepatitis B vaccine either before or after licensure to scientifically evaluate persistent reports that hepatitis B vaccine can cause sudden infant death syndrome, Guillain-Barre syndrome (GBS) and other central demyelinating diseases including transverse myelitis, optic neuritis, and multiple sclerosis; and immune system dysfunction including chronic arthritis.

8. The IOM report concluded: "The lack of adequate data regarding many of the adverse events under study was of major concern to the committee ... the committee encountered many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunisation, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies...." (5)

9. A recent PMID Medline search contains 75 papers on the various significant immunomodulatory adverse effects of the recombinant hepatitis B vaccine, as mentioned above, since the FDA approval of this first genetically engineered vaccine in 1991. Another extensive search by B. S. Bunbar, Professor of Molecular and Cellular Biology at Baylor College of Medicine, Houston, and honoured by the U.S, National Institute of Health for her pioneering research into vaccines, has identified 121papers in medical journals listing severe neurological and immunological adverse effects.

10. In his testimony to the US Congress May 18th 1999, Belkin stated, “I studied VAERS hepatitis B vaccine data obtained by the National Vaccine Information Centre (NVIC) under the Freedom of information Act.

The data has some flaws (incomplete fields, some multiple reports) but any qualified, impartial quantitative analyst or statistician not affiliated with Merck, Smithkline, the CDC, the Food and Drug Administration (FDA) or the AAPS who examines these reports will find a clear and undeniable pattern of central nervous system (CNS) and liver disease striking thousands of people within 0-4 days after vaccination with hepatitis B vaccine. These reports have been ignored, explained away, or considered "acceptable" by the FDA, CDC and drug companies. This Committee should launch an investigation of the VAERS hepatitis B data by a team of independent scientists not beholden to vaccine manufacturers or the FDA/CDC bureaucracy. The following is intended to be a starting point for such an investigation. This does not profess to be a complete, exhaustive analysis - simply an overview, highlighting aspects of the data that may not previously have been brought to your attention.

12. The total 24,775 VAERS hepatitis B reports from July 1990 to October 31, 1998 show 439 deaths and 9673 serious reactions involving emergency room visits, hospitalisation, disablement or death. Therefore, more than one third of total reports were serious events. 17,497 of those total reports were for hepatitis B vaccine only, the remainder were vaccine cocktails where hepatitis B was administered along with DPT, HIB, IPV, OPV, etc.

13. The hepatitis-B-vaccine-only reports show a shocking cluster of reactions in females starting in their teenage years (the male/female reporting ratio is balanced before age 16). For ages 16-55, 77% of VAERS reports are women - more than three times as many women as men are reporting adverse reactions to hepatitis B vaccine. The median onset of adverse event after vaccination is one day, 70% of reactions happen within four days of vaccination. Independent scientists should investigate why females are more disposed to have adverse reactions to hepatitis B vaccine and/or report them to VAERS. One possible explanation is that nurses have to take this vaccine for their jobs and are thus more exposed than most adults to hepatitis B vaccine adverse reactions.

14. Rather than dismiss that factor as an "over-reporting bias" as Dr Chen of the CDC did at the February ACIP meeting, perhaps investigators might consider that nurses are alert health care workers and ought to be listened to with regard to the dangers of adverse events with any vaccine (rather than ignored). Personal case studies reported to the author have shown many teenage girls getting severe, debilitating adverse reactions to hepatitis B vaccine, having nothing to do with nursing. Do women have a greater vulnerability to auto-immune reactions to hepatitis B vaccine? Is the government discriminating against women by administering this vaccine without regard for genetic risk of CNS and liver disease? Those are questions that independent scientists should investigate.

15. A second area of concern is the VAERS reports involving hepatitis B vaccine administered with other vaccines (vaccine cocktails). Health officials are fond of dismissing those reports as being attributable to hepatitis B vaccine, because of the multiple other antigens present (almost as if they wanted to cloak hepatitis B vaccine reactions from scrutiny). Let's avoid that controversy and focus on the extremely disturbing VAERS data of hepatitis B vaccine with other vaccines.

16. These reports amount to only one third of total reports (7,275), but account for two thirds of total deaths (291). The median onset of those deaths was 2 days after vaccination - displaying a clear temporal association. The median age of death was 0.5 years in this group. 50% of all hepatitis-B-vaccine-cocktail reports were serious (died, emergency room, hospitalised, disabled).

17. I grouped convulsive reactions together from the Hep-B-vaccine-cocktail data and found a deeply disturbing pattern. These were anything labelled convulsions, seizures or tremors in the VAERS Hep-B-cocktail data. Of the 1189 such reports, fully 80% (950) were serious (died, ER, hospitalised, disabled) median age 0.5 years, median onset after vaccination 0 days (less than one day).

18. We recommend that this should be followed up to find out what happened to those poor infants who suffered severe convulsions after a hepatitis B-multi-vaccine cocktail. In the personal reports I've taken of similar adverse reactions, the children were left brain damaged and developmentally disabled.

19. Looking beyond the debate over whether VAERS reports of vaccine cocktails can be attributed to hepatitis B, the data strongly suggests combining multiple vaccines may be convenient and profitable for paediatricians - but fatal or debilitating for infants. Where are the scientific studies showing hepatitis B vaccine is safe to administer with DPT, HIB, IPV, OPV, etc.? Letter to Dr Shalala FDA and Dr Koplan PHS. Attached.

20. Did anyone doing cost/benefit analysis for those studies include data showing the higher mortality and serious reactions present in the VAERS data? Why not? Is there an identifiable genetic marker in those who suffered convulsive reactions to screen out those vulnerable in the future? These are all matters for independent scientists to audit. Another area that leaps out of the VAERS database is something I dubbed arthritic reactions. These are joint pains, tingling, numbness, aching, fatigue, etc. I found 2,400 of those reports in just a quick survey of the first reporting column of VAERS (hepatitis B vaccine only).

21. Almost one half of those are serious, involving an ER visit, hospitalisation, death or disablement. These are the type of adverse reactions reported by many adults who are forced to take the hepatitis B vaccine for their jobs. In the reports of such adverse reactions I've taken, the symptoms do not go away, most patients complain it gets worse over time. Scientists not corrupted by drug company or CDC/FDA institutional bias should examine the thousands of VAERS hepatitis B arthritic reaction reports and develop a diagnosis of their hepatitis B vaccine-related illness.

22. This vaccine has had minimal pre-marketing research with much relating to the earlier normally manufactured vaccine and not the GE version. Notably, neither were there any studies on new-born infants and those performed on merely 2000 older children, were limited to a few days’ observation. It is not yet known which of the ingredients in the GE Hep B vaccine could be the underlying cause of the adverse effects, but it is apparent that these severe adverse effects are occurring in an unacceptable rate. Other GE vaccines are being developed and if permitted to be used with equally inadequate research, even more costly results will inevitably occur. The current U.S. large-scale class action against the manufacturer of the GE humalog insulin where known adverse effects were apparently concealed, is yet another example of the risks of commercial expediency overruling the precautionary principle in research. [See Dr Bernard Conlon Witness Brief]

REFERENCES

(1) CDC Prevention Guidelines: A Guide to Action (1997)

(2) Harrison's Principles of Internal Medicine (1994)

(3) Merck & Co. Hepatitis B Vaccine product insert (1993)

(4) Adverse Events Associated with Childhood Vaccines (1994)

(5) Adverse Events Associated with Childhood Vaccines (1994)

SUPPORTING DOCUMENTATION:

1. AAPS Press release, 4/6/2000, “CDC and FDA Ignored or Concealed Data About Life Threatening Side Effects to Infants.”

2. Letter 3 August 1999 to Dr Margolis, National Centre for Infectious Disease.

3. Letter 20 September 1999 to Senator Dan Burton, US Senate.

4. Letter 3 August 1999 to Dr D Shalala, Department of Health and Human Services (FDA)