August 31, 1999
The Honorable Dan Burton
Dear Rep. Burton:
We thank you for holding hearings on vaccine safety on August 3, 1999. You raised many highly pertinent questions, including your inquiry to Dr. Satcher about when the complications of rotavirus vaccine became known.
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 was prompted by the VAERS 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 (see enclosed fact sheet for data)? 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.
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. Ultimately this rule should be extended to all data on which the government makes vaccine policy decisions, including privately funded research data as well. This would greatly improve the integrity of vaccine policymaking.
We believe that in the past vaccines have been a very effective weapon against certain infectious diseases. This is no reason to relax safety standards, or to override the requirement of fully informed consent for medical procedures.
It is imperative that data concerning vaccine safety be made available to the public for independent review. Sunshine is a disinfectant, and public access to such data minimizes the opportunity for corruption, mistakes, and fraud concerning such data.
Therefore, we respectfully request that you undertake a thorough congressional investigation of the process by which all vaccines are tested, approved, and "recommended" - and then become universally mandated without fully informed consent. Please feel free to call on AAPS to assist you and your staff in any way.
Jane M. Orient, M.D.