|Vaccination Liberation - Information|
Ingredients of Vaccines
Artificially Sweetened Times
Books Videos Tapes
100+ Anti-Vax links
Burton Calls Committee Hearing on Vaccines[This article taken from http://www.house.gov/reform/press/00.08.23b.htm]
Burton Calls Committee Hearing on Vaccines
Contact: Sean M. Spicer
Burton Critical of Vaccine Approval Process
Staff Report Details FDA and CDC Conflicts in Approval of Controversial Rotavirus Vaccine
A House Government Reform Committee staff report published this week criticized the FDA and the CDC for routinely allowing scientists with conflicts of interest to serve on two influential advisory committees that make recommendations on vaccine policy.
The report concludes that, "conflict-of-interestrules employed by the FDA and the CDC have been weak, enforcement has been lax,and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings."
In an August 10 letter, Chairman Burton called on HHS Secretary Donna Shalala to implement reforms to crack down on conflicts of interest on the two committees. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) makes recommendations on the approval of new vaccines. The CDC's Advisory Committee on Immunizations Practices (ACIP) makes recommendations on guidelines for the administration of vaccines. The Government Reform Committee staff report found that the majority of members of both committees have financial ties to vaccine manufacturers or hold patents on vaccines under development.
The report focuses on the advisory committees'review of the controversial rotavirus vaccine in 1997 and 1998. Despite concerns about potentially serious side effects of the drug, it won unanimous votes ofsupport in both committees. Within one year, the vaccine, made by Wyeth Lederle,had to be pulled from the market because it was causing severe bowel obstructions in infants that required surgery to correct. One baby died.
The Committee found that three out of the five full-time FDA advisory committee members who voted for the vaccine had financialties to Wyeth Lederle or two companies developing rival rotavirus vaccines --Merck and SmithKline Beecham. Four out of eight CDC advisory committee members who supported the vaccine had conflicts with the same companies. The staff report concludes that the committees demonstrated a 'lack of vigilance' in their review of the rotavirus vaccine known as 'Rotashield', with the CDC'scommittee rushing to approve guidelines for the vaccine even before the FDA had licensed it.
Other highlights from the staff report include:
In his letter to Secretary Shalala, ChairmanBurton stated:
'For the public to have confidence in the decisions made by their government, they must be assured that those decisions are not being affected by conflict of interest.'
'It has become clear over the course of this investigation that the VRBPAC and the ACIP are dominated by individuals withclose working relationships with the vaccine producers. This was never the intent of the Federal Advisory Committee Act, which requires that a diversity of views be represented on advisory committees.'
-- 30 --
|Back to 50+ Q & A|