VACCINE SAFETY

Is Government Ordering Experiments on Humans?
November 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 approval.

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 touch).

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?