News Release From
For Immediate Release
23 August 2000
Contact: Sean M. Spicer
(202) 225-5074
sean.spicer@mail.house.gov
Burton Critical of Vaccine Approval Process
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-interest rules 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 hearings.”
In an August 10th 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 of support 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 financial ties to Wyeth Lederle or tow 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’s committee rushing to approve guidelines for the vaccine even before the FDA had licensed it.
One physician who voted to recommend the rotavirus vaccine on the FDA’s advisory committee received $255,000.00 per year in research funds from the maker of the vaccine, Wyeth Lederle. She received a waiver from the FDA to vote on the issue because her research for Wyeth focused on other vaccines.
One member of the CDC’s advisory committee who was not allowed to vote on the rotavirus vaccine because of a conflict was allowed to participate in closed-door working group meetings that drafted the committee’s recommendations for the vaccine. He was also allowed to make an impassioned plea for approval of the vaccine at the full committee hearing.
Another member of the CDC’s advisory committee held a lucrative patent on a rival rotavirus vaccine under development by Merck. Despite this conflict, the doctor voted three times on recommendations regarding Wyeth’s vaccine. It was not until the committee voted to rescind its recommendation of the rotashield that he recused himself because of a “perception of conflict”.
The staff report takes issue with the FDA’s tax guidelines for conflicts of interest. For instance, under the FDA’s rules, ownership of up to $100,000.00 in stock is considered a “medium involvement” conflict that is also eligible for waiver. Until some time in 1999, the Chairman of the CDC’s advisory committee owned 600 shares of stock in Merck, one of the world’s largest vaccine manufacturers. The chairwoman of the FDA’s advisory committee also owned stock in Merck.
The staff report finds that the CDC’s practice of automatically granting annual waivers to all members of its committee for one-year periods “does not lend itself to a healthy respect for the conflict-of-interest rules.” (Members who have direct conflicts with the sponsor of a vaccine are generally not allowed to vote on that company’s products, but they are free to participate in working groups that draft the recommendations and in committee deliberations leading up to the vote.)
In his letter Secretary Shalala, Chairman Burton 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 with close 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.”
Committee on Government Reform
2157 Rayburn House Office Building
Washington, DC 20515 – (202) 225-5074
Article taken from http://www.house.gov/reform/press/00.08.23b.htm
An update for the 2024 - 2025 flu season will be coming soon.
Any update for the 2024 flu?
Based on your articles and the experience of Cardinal Burke I received the Covid vaccinations tp protect myself and those…
James, Entyvio (Natalizumab) was pre-clinically tested in animal models (Guinea Pig) and is produced in Chinese Hamster Ovary (CHO) cell…
Jose, Any info on monoclonal treatments for other diseases? How about Entyvio? Used for ulcerative colitis?
Debbi, you are most welcome! And thank you for your kind words.
Thank you for the information in your article and the responses you made in the comments. God bless you.
Elisha, I have yet to research a psychotropic drug that was developed using fetal cell lines or fetal tissue of…
Dorothy, Actonel/risedronate sodium was not developed or tested, nor is it manufactured using aborted fetal cell lines or tissues of…
Hi, I appreciate your research and response. In your research do all psychotropic medications have fetal cells or MRC-5 fetal…
Vorrei sapere se gli anticorpi monoclonali per curare l'emicrania sono etici. Grazie.
Is risedronate sodium or actonel tested or derived from aborted fetal cells.
Andrew, the Tdap shots are ethically developed, tested and produced. There's a note at the bottom of the chart informing…
Anyone know about ethics and safety of Tdap for older kids and adults? I did not see it on the…
Thank you very much. I greatly appreciate your help and all the great work you do. God bless you all,…