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Association of American Physicians and Surgeons, Inc.
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FOR RELEASE 4/6/2000

Rotavirus Vaccine Withdrawal Prompts Doctors to Ask for Congressional Investigation of Vaccine Approval Process

CDC and FDA May Have Ignored or Concealed Data About Life Threatening Side Effects to Infants

WASHINGTON - The Association of American Physicians and Surgeons (AAPS) has asked Rep. Dan Burton to initiate a congressional investigation of the process by which all vaccines are tested, approved, and recommended as mandatory by the CDC. This action was prompted by the recent withdrawal of the rotavirus vaccine after it was revealed that between the vaccine's approval in August of 1998 and this July, at least 15 infants suffered life threatening intestinal obstructions (intussusception) after receiving the vaccine.

But what may be even more alarming is the rate of intussusception in the clinical trials that were the basis for the vaccine's approval. A search of the records by AAPS reveals that it was thirty times the expected rate. But neither physicians nor parents were warned for watch for symptoms of intussusception. Eight infants have needed surgery, and one lost 7 inches of bowel.

8/31/99 letter to Rep. Burton, chairman of the Committee on Government Reform and Oversight, Jane M. Orient, MD, Executive Director of AAPS, writes:

The situation with the rotavirus vaccine may be a clue to a far more serious problem with the vaccine approval process. The Surgeon General and CDC claim the vaccine's withdrawal prompted by the VAERS [Vaccine Adverse Effect Reporting System] reports received through July 1999.

But why was the vaccine approved in the first place when the incidence of the serious complication of intussusception was far higher in prelicensure trials than in the VAERS reports?

We must ask, what did they know and when they know it? AAPS has been studying the reports and has concluded that the FDA and CDC may have ignored or concealed data that showed the problems from the outset.

Despite this evidence of potential problems, information from the CDC web site, dated 3/23/99 reads: "In studies that have been done so far, rotavirus has been associated only with mild problems."

"As increasing numbers of vaccines are being mandated, one has to inquire whether the rotavirus story is the tip of the iceberg," said Dr. Orient. "Just how rigorous is the process of safety testing? What are the guarantees of the integrity of the process? We believe the process may be tainted by conflicts of interest."

The letter also calls for public disclosure of the approval process and independent review of data, and supports a provision introduced by Sen. Shelby that would require public access to all federally funded research:

The tragedy of the rotavirus vaccine might never have happened if the public had access to the data used by the FDA and CDC in recommending the vaccine. The Shelby Amendment, if properly implemented, would ensure that federally financed research about vaccines could not be withheld from the public.

...Sunshine is a disinfectant, and public access to such data minimizes the opportunity for corruption, mistakes, and fraud concerning such data. . "Decisions about vaccines given to children should be made by parents in consultation with the child's attending physician, not mandated by a small group of 'experts' with minimal accountability," said Dr. Orient. "While vaccines have been a very effective weapon against certain infectious diseases, this is no reason to relax safety standards or to override informed consent."

CONTACT: Kathryn Serkes (202) 333-3855

Note: Letter to Rep. Burton and data on rotavirus vaccine trials and adverse effect rates are posted here.