November 10, 1999
It isn't often that federal bureaucrats admit to embarrassment,
but the New York Times reported on October 23 that it was "highly
embarrassing to federal health officials" to have to admit the "causal
association" between the RotaShield rotavirus vaccine and the painful
condition called intussusception. The embarrassment was aggravated "in
part because the vaccine was 23 years in development and much of the
work was done at the National Institutes of Health."
It isn't enough, however, that these health officials admit they
are embarrassed. They should be apologizing and expressing deep and
sorrowful regret for the terrible damage they have done to infants.
Intussusception is a bowel obstruction caused by one portion of the
bowel sliding inward, like a telescope, into another part of the bowel,
causing a previously healthy infant to scream in terrible pain, and
often requiring surgery to repair.
The government's formal position until October 22 had been that
all infants in the United States should receive three doses of the
vaccine, at 2, 4 and 6 months of age, although caution was expressed by
the Centers for Disease Control (CDC) on July 15 and the manufacturer
withdrew the vaccine from the market on October 15.
CDC immunization spokesman Dr. John Livengood said that the health
officials' decision to withdraw the vaccine recommendation reflected a
stepped-up review of scientific evidence, which showed that the
rotavirus vaccine appeared to cause intussusception in about 1 in 5,000
recipients, and that vaccinated babies were 25 times as likely to
develop intussusception three to seven days after the first dose as
those who did not receive it.
What is so shocking about this admission is that the high rate of
intussusception was known before Food and Drug Administration (FDA)
approval in August 1998. The raw data were kept secret and the CDC
went ahead with its recommendation.
Another disturbing piece of news is that, of the federal health
advisory panel's 12 members, only 4 voted, all for the recommendation
to withdraw use of the vaccine. We are told that the others were
absent "because of emergencies or abstained because of ties to the
manufacturer or other conflicts of interest."
It is unacceptable that members of the advisory panel are
permitted to have conflicts of interests, and it's no answer to say
they merely don't vote on the decisions where their conflict of
interest is immediate. Panel members should represent the public, not
be beholden to the pharmaceutical companies or the CDC.
All the raw data supporting any vaccine recommendation should be
made public so they can be reviewed by disinterested parties. Many
infants would have been saved from the intussusception tragedy if the
raw data about the rotavirus tests had been available to the public.
We are long overdue for a Congressional investigation to educate
the public about the current process of mandating vaccines, the secrecy
about raw data, the failure to do risk and cost-benefit analysis, and
the role of the pharmaceutical corporations in lobbying for mandates.
The American people have a right to know exactly how and why the CDC
disregarded the danger signals in the test data and recommended the
rotavirus vaccine anyway.
The Association of American Physicians and Surgeons has urged
Congress to investigate the process by which vaccines are approved and
recommended. The public is entitled to know if government approval is
a political rather than a scientific decision, as well as the fact that
government mandates are what make vaccines so commercially profitable.
Parents are beginning to fear that the real clinical tests may be
post-mandate instead of pre-mandate. When the CDC can conceal the raw
data about the pre-tests and reveal only summary statistics, it's easy
to distort the results, recommend a vaccine for all infants, and make
the universal use of the vaccine the real test.
This process amounts to experimentation on humans without telling
the recipients or their parents that the vaccine is experimental.
President Clinton poured gasoline on the fires of this vaccine scandal
on September 30 when he issued Executive Order 13139 requiring military
personnel to receive experimental vaccines that don't even have FDA
It appears that EO 13139 is an attempt to finesse Pentagon
responsibility for administering the controversial anthrax vaccine to
all military personnel. The Defense Department has been inoculating
for inhalational anthrax even though the only FDA approval, issued
nearly 30 years ago, was only for cutaneous anthrax (contact through
Hundreds of servicemen (including dozens of pilots) have resigned
rather than submit to the anthrax vaccine because they have observed or
heard about adverse reactions in many of their peers. Dozens of
military personnel have been prosecuted and punished for refusing to be
inoculated, and more than 1,000 are now awaiting trial.
Infants and military personnel are two groups of Americans subject
to medical decisions made by others. Is our government using those two
groups for human experimentation with inadequately tested drugs?