Subject: Doctor Jenni Levy MD Defends Hep B Vaccination

> Hepatitis B is the most common form of infectious hepatitis in the
> world.  It is far more easily transmitted than HIV through the same
> routes - mother-to-child during birth, injection drug use, blood
> transfusion and occupational injury in health care.  Occupationally
> acquired Hepatitis B kills more health care workers in the US every
> year than HIV has ever killed.
> Hepatitis B has a 5% immediate mortality rate, and a 30% incidence
> of conversion to chronic disease.  Of those who develop chronic
> infection, 40% will go on to cirrhosis and liver failure and death, and
> about 15% will develop liver cancer.
>  Since 1986, the only Hep B vaccine used in the US has been the
>  recombinant vaccine.  The way recombinant vaccines work is that they
> make a piece of the viral genetic material that codes for a protein
> on the surface of the virus; it is that protein which your immune
> system thinks is the virus and which causes antibodies to be produced.
> There is no actual viral material in the vaccine.  Yes, your immune
> system is activated, but not in any way that could be harmful to you.
> The vaccine had been studied for five years prior to FDA approval, and
> has been used in millions of people over the past eleven years.
> The precautions listed on the package inserts are dictated by
> lawyers working for the drug companies who are trying to predict and
> prevent lawsuits.  Adverse event reports are not reliable indicators of
> adverse events (I know it seems as if they should be but they're not.
>  Individual physicians are under no compulsion to report, and there's
> no verification done to ensure that events are really linked to
> medications or procedures.)
> You will find those adverse event categories listed for every
> vaccine licensed by the FDA, and you will notice they are also the common
> symptoms of most viral illnesses, including colds and influenza.
> >From the Centres for Disease Control and Prevention:
> Pain at the injection site (3%-29%) and a temperature greater than
>  37.7 C (1%-6%) have been among the most frequently reported side
> effects among adults and children receiving vaccine. In placebo-controlled
>  studies, these side effects were reported no more frequently among
>  vaccines than among persons receiving a placebo Among children
> receiving both hepatitis B vaccine and DTP, these mild side effects have
> been observed no more frequently than among children receiving only DTP.
> The recommendation to begin hepatitis B vaccination soon after birth has
>  raised the concern that a substantial number of infants will require
> an extensive medical evaluation for elevated temperatures secondary to
>  hepatitis B vaccination. Several population-based studies to
> evaluate this possibility are in progress.
> Adverse Events In the United States: surveillance of adverse
> reactions indicated a possible association between GBS and receipt of the
> first dose of plasma-derived hepatitis B vaccine (CDC,unpublished data).
>  estimated 2.5 million adults received one or more doses of
> recombinant hepatitis B vaccine during 1986-1990, and available data
> concerning these vaccines do not indicate an association between
> receipt of recombinant vaccine and GBS (CDC, unpublished data).
> Based on reports to the Vaccine Adverse Events Reporting System
> (VAERS), the estimated incidence rate of anaphylaxis among vaccine
> recipients is low (i.e., approximately one event per 600,000 vaccine
> doses distributed). Two of these adverse events occurred in children
> (CDC, unpublished data). In addition, only one case of anaphylaxis
> occurred among 100,763 children ages 10-11 years who had been vaccinated
> with recombinant vaccine in British Columbia (D. Scheifele, unpublished
> data), and no adverse events were reported among 166,757 children who had
> been vaccinated with plasma-derived vaccine in New Zealand. Although none
> of the persons who developed anaphylaxis died, this adverse event can
> be fatal; in addition, hepatitis B vaccine can-in rare instances-cause
> a life-threatening hypersensitivity reaction in some persons .
> Therefore, subsequent vaccination with hepatitis B vaccine is
> contraindicated for persons who have previously had an anaphylactic
> response to a dose
> of this vaccine.
> There is no legal or customary requirement for informed consent
> prior to vaccination in the US, although most practitioners provide an
>  information sheet and all should be willing to answer questions.
> Hepatitis B is a devastating, fatal disease with an increasing
> incidence worldwide, and it is completely preventable.
> ***********************************************************
> >From Hilary Butler To Doctor Jenni Levy MD  (72320,
> who quoted from CDC Disease control and Prevention.
>  You have obviously been into the FDA inter net site.  You have
> quoted that no adverse events were reported among 166.757 children who
> were vaccinated with Hepatitis B Vaccine in New Zealand.
>  The CDC quotes from a book called ADVERSE EVENTS ASSOCIATED WITH
> CHILDHOOD VACCINES, (editor Katherine Stratton) pg 229.  I will
> specify this quote:
>  "Anaphylaxis was not observed in the 166,757 children vaccinated
> with a plasma-derived vaccine in New Zealand (Morris and Butler, 1992)"
>  My name is Hilary Butler, and I am co-author of that report.  The
>  original submission sent to NIH included the complete Health
> Department Report in which were detailed 2 cases of anaphylaxis.  We also
> included several Health Department memorandum detailing many cases of
> anaphylactoid reactions.
>  On 30 September 1996, after viewing the FDA web site I sent
> Katherine Stratton the following E-mail:
> "Dear Dr Stratton, As you may (or may not) remember, I wrote you a
> detailed six page letter of 7 January 1994 regarding a major error on pg
> 229 in your book on Adverse Events associated with childhood vaccines...
> you refused, or chose not to reply to it again.
> Now I see that the FDA has put your error onto the Inter net.
> As I said to you at the time:  "This misrepresentation does a
> serious disservice to those who might believe that your book reports
> accurate data submitted to the Vaccine Safety Committee.  If you disagree
> with this assessment, I will welcome your reasons for disagreement.
> However, if you agree that there is misrepresentation, I will welcome
> information on your planned corrective action."
> You did neither, and as a result of your inaction, a lie has been
> perpetrated.
>  For the third time:  "What do you intend to do to correct an error
> brought to your notice two and a half years ago??? It would be nice to
> think that this time you might have the courtesy to reply, since the
> fault is yours, not mine."
> Dr Katherine Stratton's reply was as follows:
> "I have just now reread material you and Dr Morris sent in 1992.
> I assume that the cases were not counted as positive indications of
> vaccine-caused anaphylaxis because the material presented was not
> specific enough to meet the criteria for anaphylaxis as laid out in the
> report.  The report is final, and there is no action that can be taken to
> address your  recent fax."
>  The health Department report was very specific.  Those two cases of
> anaphylaxis were accepted as vaccine related, and were listed as
> such in the table.
> So, as the author of a very specific report sent to the NIH, with
> clear documentation of two clear-cut cases of anaphylaxis, which were
> dismissed because they did not fit the NIH criteria, I would like to ask
> some questions:
>  1)     What right have the NIH to dismiss two cases of reported
>  anaphylaxis, accepted by the NZ health Department medical assessor?
>  2)     What right have the NIH to specifically change clear-cut
>  information presented by myself to say something I did not say?
> I have no confidence in the NIH so-called "gold-standard" book on
> vaccine safety, because my report was deliberately grossly
> misrepresented.
> I consider therefore, that the scientific accuracy of everything else
>  published by the NIH to be similarly tainted.  I do not have the
> luxury of studying everyone else's factual reports to know whether similar
> statistical sculpturing has been achieved.  But I do have the
> "luxury" of being able to put my submission and the book together, and
> knowing that NIH totally stuffed it up.
> Knowing that the FDA continues this myth, and that on the 16
> September, so did you, gives me even less confidence in the truthfulness
> of the rest of your information.
>  You also quote nice little statistics about the mortality rate (5%)
> and incidence of conversion to chronic disease (30%).  I have had
> Hepatitis B twice, lived to tell the tale, and am not a chronic carrier.
> I would suggest that anyone reading this site obtain a book called
> AND FALLACIES IN MEDICINE,  by Petra Skrabanek and James McCormick, both
>  reputed medical people, and on pg 40, they talk about the difference
> between absolute and relative risks.  If you still believe in such
> statistics at the end of the book, there is not hope for you.
> And remember this: On pg 41 these doctors quote:
>  "Since life itself is a universally fatal sexually transmitted
> disease, living it to the full demands a balance between reasonable and
>  unreasonable risk.  Since balance is a matter of judgment, dogmatism
> has little place."
> ***********************************************************
> Doctor Jenni Levy MD  (72320,
> I know of no reasonable pathophysiologic explanation for anaphylaxis
> to a recombinant vaccine.
> The information I posted came from the CDC site, not the FDA site,
> and is relevant to adverse events from the vaccine currently in use in
> the US, which is recombinant.  Older vaccines, no longer used here, were
> made from pooled plasma and had a very different side effect profile.
>  Flippant statements about life being 100% fatal do little justice to
> a serious problem.  Hep B kills more health care workers in the US
> every year than have ever contracted HIV from occupational exposure.  It
> is one of the primary causes of liver cancer and, worldwide, the most
> common cause of cirrhosis and liver failure, and it is completely
> preventable.
> All vaccines carry some risks, but this one is the least risky of
> all the ones we use and may well be the most beneficial to adults.
> I stand by my statements and my recommendation that all sexually
> active adults and certainly all health care workers should be
> vaccinated.  [Doctor Jenni Levy-Smith]
> ***********************************************************
> 1)     You have missed the point.  In quoting something from
> whatever source (CDC info used to be on FDA site), you quoted a lie.  Why
> use that information in the first place if you are now maintaining that
> it
> has no relationship with recombinant vaccines?  Your use of the
> information and response are fallacious.
> 2)     Your conclusions are also incorrect.  the recombinant
> Hepatitis B vaccine has even more side effects than the blood based
> vaccine.  What's more, I have a letter from Dr Katherine Stratton,
> stating that the
> IOM committee has found "the strongest level of causality" between
> Hepatitis B vaccine, and anaphylaxis and that "no stronger level of
> association can be assigned."  Further, the book deals with both blood
> based AND recombinant vaccines and states:
>       "The possibility of a causal relation between hepatitis B
>  vaccination and anaphylaxis is supported by biologic plausibility,
> by the temporal sequence of observed events following vaccination, and by
> the observation of a spectrum of host responses to the Hepatitis B
> vaccine that follow a logical biologic gradient from true anaphylaxis to
> milder hypersensitivity reactions... a possible explanation for the
> occurrence of anaphylaxis after the first vaccine injection is that the
> patients were sensitised to thiomersal or yeast protein, both of which are
> components of recombinant vaccines."
> Regardless of how I feel about the accuracy of scientific
> information, I know this:  that to ADMIT something such as this, is takes
> huge numbers of reports, and research to drag people like IOM kicking and
> screaming into the real world.  For them to actually ADMIT the highest
> possible linkage, shows that the problems are more than real.  In the few
> instances where IOM admits something. I'd rather take the word of
> six specially chosen, supposedly highly qualified vaccine/immunology
> experts, than one MD who purports to know the A - Z's of the issue.
> Life is 100% fatal - that is not a flippant statement.  My point was
> that it is not for you, or any other doctor (who does not realise that
> they are not omnipotent), to put forward their own dogmatism - which has
> little place in the light of an individual deciding what is, or is
> not a reasonable risk for them to take.
> The recombinant Hep B vaccine is causing high numbers of
> demyelinating conditions, as well as other permanently crippling
> conditions, and is presently the subject of huge discontent world-wide,
> especially
> France, Australia and Great Britain, but you will find little information
> in the so-called "good" medical journals, who are primarily funded by
> companies who make vaccines.  Because of the large numbers of medical
> people becoming permanently maimed (and winning cases in court) as a
> result
> of this vaccine, it would be wise for your comments to be a little more
>  circumspect.
> I recommend to any readers of this site, that for your own safety
> and protection, research the issue for yourself.  Dr Horton, Editor of
> the Lancet in his book review of FOLLIES AND FALLACIES IN MEDICINE
> finished his review stating:
> "And that's Skrabanek and McCormick's message:  always be
> skeptical, especially about what your television, newspaper, or doctor
> tells you."
>  And this is not a flippant statement either - for me, and others it
> is deadly serious.
> The first case of GBS from Recombinant Hep B vaccine in New Zealand
> was well known to me.  Three weeks after the jab, the child was first
> diagnosed as having the flu, then Epstein Barr.  The mother was
> quite distraught, and I persuaded her that her child had Guillaine Barre,
> (I can just hear someone say - "and what would she know?" - some of us
> do have brains...)  and to take her child to the hospital.  I also
> talked to the grandmother, and asked her to go with her, because I knew
> there would be a fight.  She did, and there was.  Well away from the
> child, the family and staff argued for over two hours, then the mother,
> unfortunately, got hysterical because the hospital staff wanted her
> to take her daughter home, and it got to the point where the staff were
> on the verge of attempting to get her committed.
> Fortunately for the child and mother, right at that end moment in a
> separate room, the daughter dramatically deteriorated, and was on
> life support within five minutes.  the next problem was to get the staff
> to say what it was, and it was only when the grandmother confronted the
> head paediatrician with medical literature on GBS that he  admitted that
> that was what the granddaughter had.  The relationship was established,
>  admitted, and eventually, through family pressure, the case was
> reported in the New Zealand Medical Journal.
> But my point here is that had the family not taken the stand they
> did, that girl would have died, and this is what it takes to get
> something reported.
> I know of many cases of hospitalised serious reactions to vaccines,
> some THIS YEAR, where similar scenarios were played out.
>  All the staff concerned sincerely believe (note that word - belief
> does not equate to fact) that vaccines cause no damage.  They all say
> "ALL vaccines have some risk", but "never in my back yard".
> An item in Lancet, nearly 60 years ago, bears repeating:
>   "Those who have had to take detailed notice of the immunisation
> accidents of the past few years know that to get the truth of what
> really went wrong generally calls for the resources of something like a
> secret service."
>       Lancet, January 1, 1938, pg 48.
> Now, with so many different vaccines on offer, I believe I'd have
> more chance looking inside the head of a nuclear bomb, than finding out
> the real truth.
> While it's time for the medical profession to wake up, and get real,
> few are prepared to be honest enough.

 [Vaccination]  [Hilary Butler]