Prevnar Vaccine Nearly Approved for Ear
Infections
A U.S. advisory panel on May
21, 2002 recommended approval of Wyeth's Prevnar pneumonia vaccine for
preventing some ear infections in children.
Prevnar hit the U.S. market in 2000 for combating seven strains of bacteria
that cause pneumonia.
Already given routinely to U.S.
infants, winning Food and Drug Administration (news - web sites) approval
for ear infections would allow Wyeth to promote Prevnar for the common
childhood malady.
The FDA usually follows the
advice of its advisory panels.
Ear infections are common in
U.S. children, occurring in more than 60 percent in their first year of life
and about 90 percent by age 5. Pneumococcus is the bacteria most often
reported as responsible for ear infections, but they also can be caused by
other bacteria or viruses.
The advisors voted 13-3 to
recommend Prevnar for ear infections, despite concern by some panel members
that the drug has limited effectiveness.
Wyeth estimates Prevnar could
eliminate 1 million to 1.5 million doctor visits a year and cut ear-tube
placements, a treatment for recurrent ear infections, by 60,000 a year.
Reuters May 21, 2002
This is the same vaccine
that was
inappropriately dramatized on ER last year.
Very disappointed to see
that the drug company was able to get this vaccine approved for an
indication that is clearly inappropriate.
Dr. Cantekin summarized this
nicely two years ago:
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. A wholesale cost of about $58 make
this the most expensive routine vaccine to date.
There are over 90 different
serotypes (strains based on cell wall antigens) of pneumococcus. The vaccine
has only 7 serotypes assumed to be common, but 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
drug 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
because bacterial meningitis is primarily seen in adults not in infants, and
it is infants for whom 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.
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 the problem, it would have been great. But
that was not the case.
The FDA data from the HMO
trial 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, in the Prevnar group,
significantly more children developed asthma. There was also one death in
the Prevnar group and none in the other.
Prevnar 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.
With over one trillion
dollars are under the watchful eyes of the FDA, CDC and the NIH, these three
pillars of our public health care system have become more and more
controlled by "expert panels" advisory committees.
Such experts dictate policy
and control the complex biomedical system. They directly influence taxpayers
health and wealth.
However, there is a huge
conflict of interest because most of these experts serve the special
interest groups who profit from their decisions. Many are in financial
relationships with various manufacturers and/or are registered as paid
speakers, in other words - lobbyists.
Related Articles:
Prevnar A Critical
Review
Prevnar Vaccine:
Nearly Half a Billion In Sales Last Year
Prevnar,
Pneumococcal (Strep) Vaccine Does NOT Prevent Ear Infections and Has Major
Side Effects
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