|
Abstracted from lecture by Dr. Erdem Cantekin,
Ph.D. Professor of Otolaryngology at the University of
Pittsburgh at the Second International Vaccine Information
Center Conference September 9, 2000; Washington D.C.
Prevnar is a new
vaccine against pneumococcus. The alleged benefits
are greatly exaggerated and the risks
are significant.
The least of the
risks is the cost. This is the
most expensive routine vaccine to date. The wholesale
cost is about $58.
There are over
90 different serotypes or (different strains based on cell
wall antigens) of pneumococcus. The vaccine only has 7 serotypes
assumed to be the common ones, but this is an uniformed experiment
at best as there is no way to know if this will be covering
all of the strains.
In the US pneumococcus
causes the following:
- 3,000 cases of
meningitis
- 50,000 cases of
bacteremia
- 500,000 cases
of pneumonia
- 7 million cases
of ear infections
The FDA approval
states the drugs is ONLY approved for invasive cases
of pneumococcal disease such as bacteremia and meningitis.
It is NOT approved for
ear infections.
This is most peculiar
as it is commonly recognized that bacterial meningitis is
primarily seen in adults not in infants for which this vaccine
is recommended.
The HMO trial in
which Prevnar was approved had no placebo group. The
control group received another experimental vaccine for mennigococcus.
This was the ONLY trial
that was done to establish the safety and efficacy to recommend
this vaccine for every newborn in the US.
There is an important
concept known as serotype drift, which describes the ability
of the virus to actually shift and mutate. This phenomenon
is well documented in many HIV trials.
Well just how well
did the vaccine work in the HMO trial? In the first 17 cases
of bacteremia it worked perfectly.
However it was
NOT effective for any
cases of ear infections.
Ear infections
are a BIG business in the US. It is estimated that 5
billion dollars a year are spent in treating ear
infections.
If Prevnar could
have stopped this or even reduced this problem it would have
been great. But that is not the case.
The FDA data from
the HMO trial and that in Finland showed that the prevention
benefit is less than 4%.
The efficacy claims
of Prevnar in ear infections and pneumonia remain unproven.
What about adverse
side effects of Prevnar?
The children who
received Prevnar in the trial were
- 4
times more likely to have seizures
- 4
times more likely to have stomach problems
Also, significantly
more children developed asthma that had been given Prevnar
and there was also one death in the Prevnar group and
none in the other.
Prevnar also alters
the developing immune system. Additionally it will put selective
pressure on the pneumococcal serotypes and has the potential
to change the natural pattern of strep infections.
Over one trillion
dollars of health care system are under the watchful eyes
of the FDA, CDC and the NIH. These three pillars of our public
health care system have become to be more and more controlled
by "expert panels" advisory committees.
Such experts dictate
policy and control the complex biomedical system. They directly
influenced taxpayers health and wealth.
However there is
a huge conflict of interest as most of these experts served
the special interest groups who profit in their decision.
Many are in financial
relationships with various manufacturers and are registered
as their paid speakers or as some people might say paid lobbyists.
| 