ethics, legalities in decisions about vaccines

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Hepatitis B Vaccine? Part 2 2002-08-07 20:16:34

 

The five-year-old non-profit Immunization Action

Coalition operates the Hepatitis B Coalition, which

nationally promotes hepatitis B vaccination for all

children. Funding comes from private donations,

including a grant from SmithKline Beecham,

manufacturer of the hepatitis B vaccine, and a new

$750,000 grant from the Centers for Disease Control. A

newsletter produced by this group contains the

assurance that " Everything herein is reviewed by the

Centers for Disease Control and Prevention for

technical accuracy (unless it is an opinion piece

written by a non-CDC author). "

 

Pharmacists Now Vaccinate - SmithKline Beecham,

through the American Pharmaceutical Association, has

also funded a nationwide campaign called

" Pharmacy-Based Immunization Advocacy " which allows

pharmacists to vaccinate children and adults. As of

1998, the Hepatitis B Coalition reports that 23 states

have passed laws giving pharmacists the right to sell

and administer hepatitis B and other vaccines.

 

Families Penalized For Refusing Hep B Vaccine - As

state health departments accumulate power and money to

force vaccination with all federally recommended

vaccines, including hepatitis B vaccine, child and

adult citizens are punished by both federal and state

health officials with economic sanctions for refusing

to comply. Refusal to be injected with hepatitis B

vaccine can result in citizens being denied an

education, including enrollment in daycare, elementary

school, high school, college and graduate school;

denial of health insurance; denial of employment;

denial of federal entitlement benefits for poor

children including food under the Women, Infants and

Children (WIC) program and medical care under

Medicaid. In some states, like Texas, a needy family

loses $25 per month per child in state health benefits

if all children have not received all federally

recommended vaccines, including hepatitis B vaccine.

 

Hep B Vaccine Licensed By FDA Without Adequate Proof

of Long Term Safety - In 1986, the FDA gave Merck &

Co. a license to market the first recombinant DNA

hepatitis B vaccine, which replaced the old hepatitis

B vaccines made from blood taken from human chronic

hepatitis B virus carriers. In awarding Merck & Co.

and, later, SmithKline Beecham Pharmaceuticals,

licenses to market their genetically engineered

hepatitis B vaccines in the U.S., the FDA allowed both

drug companies to use " safety " studies which only

included a few thousand children monitored for only

four or five days after vaccination to check for

reactions. As " proof " their hepatitis B vaccine is

safe to be used in children, Merck & Co. stated in

their 1993 product insert that " In a group of studies,

1636 doses of RECOMBIVAX HB were administered to 653

healthy infants and children (up to 10 years of age)

who were monitored for 5 days after each dose. "

 

Merck & Co. found that injection site and systemic

complaints, such as fatigue and weakness, fever,

headache and arthralgia (joint pain), were reported

following up to 17 percent of all hepatitis B

injections. Because the FDA did not require drug

companies to provide scientific evidence that

hepatitis B vaccine does not compromise the immune and

neurological systems of children and adults over

weeks, months or years post-vaccination, Merck & Co.

warns in the 1996 product insert that " As with any

vaccine, there is the possibility that broad use of

the vaccine could reveal adverse reactions not

observed in clinical trials " and SmithKline Beecham

(1993) has a similar warning that " it is possible that

expanded commercial use of the vaccine could reveal

rare adverse reactions.

 

Another warning in the Merck 1996 product insert is

" it is also not known whether the vaccine can cause

fetal harm when administered to a pregnant woman or

can affect reproduction capacity " and " it is not known

whether the vaccine is excreted in human milk. Because

many drugs are secreted in human milk, caution should

be exercised when the vaccine is administered to a

nursing woman. "

 

And, although doctors routinely inject hepatitis B

vaccine into children along with many other vaccines

such as DPT, HIB, MMR and chicken pox vaccine, Merck &

Co. state in the 1996 product insert: " Specific data

are not yet available for the simultaneous

administration of RECOMBIVAX HB with other vaccines. "

 

Hep B Vaccine Efficacy Also Questioned - All vaccines

stimulate only an artificial, temporary immunity, and

the length of immunity conferred by the hepatitis B

vaccine and the future need for more " booster " doses

later in life is still not clear. Merck & Co state in

their 1996 hepatitis B vaccine product insert that

" the duration of the protective effect of RECOMBIVAX

HB in healthy vaccines is unknown at present and the

need for booster doses is not yet defined. "

 

In the CDC Prevention Guidelines: A Guide to Action

(1997), the CDC states " The duration of protection [of

hepatitis B vaccine] and need for booster doses are

not yet fully defined. Between 30% and 50% of persons

who develop adequate antibody after three doses of

vaccine will lose detectable antibody within 7 years

but protection against viremic infection and clinical

disease appears to persist. " If immunity only lasts 7

years, babies vaccinated with hepatitis B vaccine may

be candidates for more shots at age seven.

 

IOM Report Reveals Lack Of Adequate Scientific Studies

- In Adverse Events Associated with Childhood Vaccines

published in 1994 by the Institute of Medicine,

National Academy of Sciences, observations about the

limitations of hepatitis B vaccine studies included

the statements that " it is important to note that

individual trials usually involved a few hundred

subjects for study...when larger vaccination programs

were monitored, observations of adverse events were

necessarily less detailed and less accurately

reported " and " 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. "

 

The IOM report also noted that no controlled

observational studies or controlled clinical trials

have ever been held to evaluate repeated reports that

hepatitis B vaccine can cause Guillain-Barré syndrome;

arthritis; transverse myelitis, optic neuritis,

multiple sclerosis and other central demyelinating

diseases of the nervous system (degeneration of the

myelin sheath of the brain that helps transmit nerve

impulses); or sudden infant death syndrome (SIDS).

 

A major conclusion of the Institute of Medicine report

was that almost no basic science research has been

undertaken to define at the cellular and molecular

level the biological mechanism of vaccine-induced

injury and death. The report concluded that " 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 immunization, insufficient or inconsistent

information from case reports and case series...and

inadequate size or length of follow-up of many

population-based epidemiologic studies…. "

 

Medical Literature Cites Immune System/Brain Damage -

During the past decade, there have been many reports

in the medical literature (primarily in international

medical journals rather than U.S. medical journals)

that hepatitis B vaccination is causing chronic immune

and neurological disease in children and adults,

including lupus: Tudela & Bonal (1992); Mamoux &

Dumont (1994); Guiserix (1996); arthritis, including

polyarthritis and rheumatoid arthritis: Christan &

Helin (1987); Hachulla et al (1990); Rogerson & Nye

(1990); Biasi et al (1993),(1994); Vautier & Carty

(1994); Hassan & Oldham (1994); Rheumatic Review

(1994); Gross et al (1995); Pope et al (1995);

Cathebras et al (1996); Soubrier et al (1997);

Guillain Barre Syndrome GBS): Shaw et al (1988), Tuohy

(1989); demyelinating disorders such as optic

neuritis, Bell's Palsy, demyelinating neuropathy,

transverse myelitis and multiple sclerosis: Shaw et al

(1988); WHO (1990); Reutens et al (1990); Herroelen et

al (1991); Nadler (1993); Brezin et al (1993);

Mahassin et al (1993); Kaplanski et al (1995); Baglivo

et al (1996); Marsaudon & Barrault (1996); Berkman et

al (1996); Waisbren (1997); diabetes mellitus: Poutasi

(1996); Classen (1996); chronic fatigue: Salit (1993);

Delage et al (1993); vascular disorders: Fried et al

(1987); Goolsby (1989); Cockwell et al (1990); Poullin

& Gabriel (1994); Mathieu et al (1996); Graniel et al

(1997); and others.

 

In 1996, Burton A. Waisbren, M.D., a cell biologist

and infectious disease specialist, who is a founding

member of the Infectious Disease Society of America

and past President of the Infectious Disease Society

of Milwaukee, pointed out in the Wisconsin Medical

Journal that " there is an increasing number of reports

in the refereed medical literature about demyelinizing

diseases occurring after an individual has received

the hepatitis B vaccination...since the hepatitis B

virus itself has been reported to cause autoimmune

problems, should we not be wary of giving antigens

that seem to have triggered these problems? " Waisbren,

in a presentation before a 1996 Institute of Medicine

Vaccine Safety Forum, warned that genetically

engineered hepatitis B vaccines contain polypeptide

sequences that are present in human neurologic tissues

such as myelin and that, by a mechanism called

molecular mimicry, these polypeptides can act as

autoantigens which can induce autoimmune demyelinating

diseases of the brain such as multiple sclerosis.

 

In that same year, Montinari et al published a study

in Italy evaluating 30 children and adults, the

majority aged 3 to 9 months, who suffered central

nervous system disorders, such as seizures and autism,

following hepatitis B vaccination. The purpose of the

study was to investigate whether there is an

immunogenetic basis (autoimmune type) responsible for

the demyelination process in the brain that can occur

following recombinant hepatitis B vaccination. The

authors concluded " autoimmune diseases are more

frequent in nations where vaccines are widely used,

the so called " clear " communities " and they identified

several potential genetic markers that " may visualize

risk patients for autoimmune diseases following

hepatitis B vaccination.

 

Montinari's work to identify genetic factors for

predisposition to hepatitis B vaccine reactions is

important in light of the study in 1989 by Alper et al

to identify genetic factors for those who do not

respond to hepatitis B vaccination. In that study, the

authors concluded that there was genetic

predisposition to failure to respond to the vaccine.

They stated: " These results support our hypothesis

that the production of anti-HBsAg [vaccine-induced

antibodies] is a dominant trait and that the inability

to produce high titers of anti-HBsAG after adequate

immunization is a recessive trait... " The authors

concluded that the genetic markers they identified are

most prevalent in caucasians of European descent " and

is associated with a wide variety of diseases with

autoimmune features in this population, including Type

1 diabetes mellitus... "

 

In 1996, Barthelow Classen, M.D., CEO of Classen

Immunotherapies Inc., published an epidemiologic study

in the New Zealand Medical Journal and reported that

there was a 60 percent increase in Type 1 diabetes

(juvenile diabetes) following a massive campaign in

New Zealand from 1988 to 1991 to vaccinate babies six

weeks of age or older with hepatitis B vaccine. His

analysis of a group of 100,000 New Zealand children

prospectively followed since 1982 showed that the

incidence of diabetes before the hepatitis B

vaccination program began in 1988 was 11.2 cases per

100,000 children per year while the incidence of

diabetes following the hepatitis B vaccination

campaign was 18.2 cases per 100,000 children per year.

 

 

Vaccine Injuries Reported At NVIC Conference on

Vaccination - At the First International Public

Conference on Vaccination sponsored by the NVIC on

September 13-15, 1997 in Alexandria, Virginia,

physicians and scientists from around the world

gathered to speak about vaccine-induced chronic

illness. Canadian physician Byron Hyde, M.D., Chairman

of the Nightingale Research Foundation, and an

internationally recognized authority on myalgic

encephalomyelitis (also known as chronic fatigue

syndrome), spoke about the data he has accumulated on

more than 200 cases of serious immune and neurological

dysfunction following hepatitis B vaccination. Dr.

Hyde said:

 

" There was a nurse in Wisconsin who had had two

immunizations against hepatitis B. After the second,

she started to complain. They insisted that she have

three more [shots], full dosage. They gave her the

first, she complained of headaches, pain, and they

told her this was anxiety neurosis. They gave her the

fourth and fifth and she lost I.Q., measurable loss of

intelligence, measurable loss in stamina, all of the

things you see in the worst cases of ME or chronic

fatigue syndrome.....A lot of these cases that we've

looked at suggest demyelinating disease, disseminated

myelitis, localized injuries, three unexplained

deaths...the problem with all of this is that nobody

has ever seriously studied it.... "

 

Dr. Hyde was particularly critical of the poor science

and medicine that hurts patients. He concluded " Almost

all of these people who had adverse reactions after

the first immunization, after the second immunization

were individuals who had immunological side effects

and who told their physicians and the physicians did

nothing about it but continued to proceed with

immunization... I think part of the problem is the

pharmaceutical companies and the governments

themselves have attempted to say 'Here, take this

sugar pill, it is danger-free, it is a wonderful

thing, it has no risk, no problems' and doctors have

become lazy and actually believed this dangerous

philosophy put out by the pharmaceutical companies and

the governments. "

 

 

 

 

 

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