Belkin's Analysis of VAERS reports on Hepatitis B Vaccine

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MICHAEL BELKIN TESTIMONY TO CONGRESS

Tuesday May 18, 1999

VAERS ANALYSIS (Vaccine Adverse Event Reporting System) studied statistics

at the University Of California at Berkeley and went on to develop

sophisticated proprietary risk/reward statistical models at Salomon

Brothers from 1986-91 -- and in my subsequent, ongoing business provide

statistical economic and financial forecasts to mutual funds, investment

banks, pension funds and hedge funds.

I studied VAERS hepatitis B vaccine data obtained by the National Vaccine

Information Center (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, kline, the CDC, the FDA or the AAP 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.

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, hospitalization, 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.

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. 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 showed 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.

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. 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, hospitalized, disabled). I grouped

convulsive reactions together from the hep-B-vaccine-cocktail data and

found a deeply disturbing pattern. These were anything labeled convulsions,

seizures or tremors in the VAERS hep-B-cocktail data. Of the 1189 such

reports, fully 80% (950) were serious (died, ER, hospitalized, disabled)

median age 0.5 years, median onset after vaccination 0 days (less than one

day). Someone should do follow-up and 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.

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 pediatricians -- 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.?

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). Almost one half

of those are serious, involving an ER visit, hospitalization, 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.

Anyone who doubts if hepatitis B vaccine adverse reactions exist should sit

down and read the

symptoms and text comments of a random selection of VAERS reports. When one

does so, they will find a similar but wide-ranging list of CNS and liver

reactions that occur within days of vaccination. The Merck package insert

claims " Injection site reactions and systemic complaints were reported

following 17% and 15% on the injections, respectively. " The standard rule

of thumb is only about 10% of reactions are reported to VAERS. So the

actual number and full horror of the hepatitis B vaccine reaction story is

potentially much larger than even VAERS suggests.

REACTION ONSET AFTER VACCINATION

(DAYS) HEPATITIS B VACCINE ONLY

72 % OF ADVERSE REACTIONS (HEPATITIS B VACCINE ONLY) HAPPEN WITHIN 4 DAYS

Days After Vaccination

12% happen beyond 40 days

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Sheri Nakken, R.N., MA wwithin@...

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