http://bmj.bmjjournals.com/cgi/eletters?lookup=by_date&days=21#121832
IN RESPONSE TO:  Why can't the Daily Mail eat humble pie over MMR?


Why we are in this position in the first place. 20 November 2005
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Hilary Butler,
freelance journalist.
home 1892 N.Z.

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Re: Why we are in this position in the first place.



Dear Sir,

If vaccine trials were done properly in the first place, we wouldn't be in
this position today. When you study the Cochrane Review you can see very
clearly part of the shortcomings that lead to this situation. But there is
something else as well.

Not one vaccine that has been used today, has been trialled correctly. Not
the DPT, not the meningitis ones... not the MMR ... not the influenza vaccine.

A vaccine to be tested, needs to take two large groups representative of
society, diseases, immunodeficiencies, cancers, the lot, and without
reference to their medical histories, split them into two groups. One group
get the vaccine, the other gets absolutely nothing. No placebo, and
certainly not the recently mockery of a placebo, which is a comparable
vaccine with an assumed safe profile.

Both groups are then compared.

And the scientists are set to repeat their mistakes yet again.

Here are the protocols for a new smallpox vaccine:

http://www.clinicaltrials.gov/ct/gui/show/NCT00079820

They asked for participants and here was the criteria.

>>>adult males or females who provided informed consent for the study.

>>>adults 18 and 31 years (inclusive).

>>>good general health,

>>>female subjects must not be pregnant or lactating and be on appropriate
contraception or be a female unable to bear children.

>>>subjects be available for participation during the entire study.

~~~~~~~~~~~~~~~~~~~~~

OKAY?

BUT>>>>

They didn't want you in the study if -----

~~~~~~~~~~~~~~~~~~~~~

>>>>>military service prior to 1989 or after December 13th, 2002.

>>>>>history of previous smallpox vaccination

>>>>>known/suspected history of immunodeficiency, or with current radiation
treatment or use of immunosuppressive or anti- neoplastic drugs.

>>>>>subjects with a household member or intimate contact with the same
conditions listed above.

>>>>>known or suspected impairment of other immunologic function.

>>>>>malignancy, including squamous cell or basal cell skin cancer at
vaccination site

>>>>>active autoimmune disease.

>>>>>subjects with known eye diseases or other conditions that require the
use of corticosteroid eye drops.

>>>>>known/history of cardiac disease.

>>>>>subjects who have been diagnosed with 3 or more of the following risk
factors for ischemic coronary disease:

a) high blood pressure

b) elevated blood cholesterol levels

c) diabetes or high blood sugar

d) first degree relative (for example, mother, father, brother, or sister)
who had a heart condition before the age of 50

e) smoke cigarettes

>>>>>subjects with a history of palpitations or abnormalities of cardiac
rhythm.

>>>>>subjects with odd ECG patterns

>>>>>subjects with a ten percent or greater risk of developing a myocardial
infarction or coronary death within the next 10 years.

>>>>>positive or elevated creatinine kinase, CK-MB, or Troponin I
laboratory test levels.

>>>>>abnormalities of clinical laboratory assessments. past history or
current diagnosis of chronic renal disease, adverse reactions to drugs
characterized by renal impairment, a serum creatinine > 1.5 mg/dL, or
presence of 1+ protein in urinalysis at screening and a calculated
creatinine clearance of not less than 80 mL/min.

>>>>>current diagnosis or past history of eczema.

>>>>>subjects with a household member or intimate contact with the same
conditions listed above.

>>>>>presence of acute, chronic, or exfoliative skin conditions, open
wounds, or burns.

>>>>>history of keloid formation.

>>>>>known allergies to MVA or to any known components (Neomycin,
Gentamycin) of the vaccine.

>>>>>known allergy to eggs or egg products.

>>>>>known allergies to any component of the Dryvax® vaccine.

>>>>>Antibiotics in Dryvax® include neomycin, streptomycin,
chlortetracycline, and polymixin B.

>>>>>known allergies to any known component of the Dryvax® diluent (i.e.,
glycerin and phenol).

>>>>>known allergies to any known component of VIG, (i.e., thimerosal or
previous allergic reaction to immunoglobulins).

>>>>>known allergies to cidofovir or sulphur containing drugs, including
probenecid, trimethoprim, and sulfonamide antibiotics.

>>>>>transfusion of blood or treatment with any blood product, including
intramuscular or intravenous serum globulin within 6 months of the
screening visit.

>>>>>positive serology result for HIV, hepatitis B surface antigen, or
hepatitis C.

>>>>>current diagnosis or history within six months of the screening visit
of drug or alcohol abuse disorders.

>>>>>significant acute or chronic psychiatric illness.

>>>>>female subjects with a positive serum pregnancy test result

>>>>>subjects with a household member or direct contact with someone who is
pregnant or lactating.

>>>>>temperature or acute illness within 3 days prior to vaccination

>>>>>inoculation with an inactivated vaccine with 14 days of Day 0 or with
a live attenuated vaccine within 30 days of Day 0.

>>>>>subjects who have participated in another investigational drug or
vaccine trial within 30 days of Day 0.

>>>>>subjects who are planning on donating blood or organs within 30 days
of vaccination.

~~~~~~~~~~~~~~~~~~~~~~~~~~~

If the vaccine proves satisfactory in this trial, it will not show that it
is suitable for the whole population at large. It will only show that in
that very restricted population it did not appear to cause too many problems.

If the FDA, or anyone else, then releases it to the general public, then as
Thomas Pynchon says in "Gravity's Rainbow" .... "If they can get you asking
the wrong questions, the answers don't matter."

That is the problem with the MMR issue, which must be seen in the context
of all the vaccines that went before as well.

Vaccine trials have always asked the wrong questions.

Therefore, the protestations of those who say any vaccine is "safe" have to
be analysed, because if the questions the safety studes asked were wrong in
the first place, all other "answers" and jury-rig explanations are largely
irrelevant.

Hilary Butler.

Competing interests: None declared

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