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
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:
“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.”