Upcoming International Conference: The National Vaccine Information Center (NVIC) is Presenting the THE SECOND INTERNATIONAL PUBLIC CONFERENCE ON VACCINATION. The title and them of this years conference is "SCIENCE FOR HOPE AND HEALING: Challenging the Status Quo" and will take place September 8-10, 2000 in Arlington, VA.

The long list of prominent and interesting speakers include: Michael Belkin, Bonnie Dunbar, Ph.D., Michael Horwin, Andrew Wakefield, M.D., Ronald Kennedy, Ph.D., Mary Megson, M.D., Scott Montgomery, M.D., Meryl Nass, M.D., Dawn Richardson, Vijendra Singh, Ph.D., Howard Urnovitz, Ph.D., Philip Incao, M.D., Edward Yazbak, M.D., Paul Shattock, Ph.D, Barthelow Classen, M.D., Walter Spitzer, M.D., Robert Johnston, Ph.D., John Menkes, M.D., Marcel Kinsbourne, M.D., Stephanie Cave, M.D., and many more!

CLICK HERE FOR MORE DETAILS ON THE CONFERENCE.

Congressional Committee Examining Conflicts of Interest with Vaccines

The US Government Reform Committee, chaired by Representative Dan Burton (R-IN), held a hearing to examine possible conflicts of interest in two key federal advisory committees involved in vaccine approval.

In the course of their investigation, the committee has discovered that many individuals serving on two key advisory committees have financial ties to the pharmaceutical companies that manufacture vaccines. Often, these individuals were granted waivers to fully participate in the discussions that led to recommendations on vaccine licensing and adding vaccines to the Childhood Immunization Schedule. Under federal law, members of advisory committees are required to disclose any financial conflicts of interest and recuse themselves from participating in decisions in which they have an interest. The Committee's investigation has determined 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 proceedings.

The Committee will examine several specific problems including:

• The CDC routinely grants waivers from conflict of interest rules to every member of its advisory committee.
• CDC advisory committee members who are not allowed to vote on certain recommendations due to financial conflicts of interest are allowed to actively participate in committee deliberations and advocate specific positions.
• The Chairman of the CDC's advisory committee until recently owned 600 shares of stock in Merck, a pharmaceutical company with an active vaccine division.
• Members of the CDC's advisory committee often leave key details out of their financial disclosure statements, and are not required to provide the missing information by CDC ethics officials.

Thursday's hearing focused on FDA and CDC approval of the controversial rotavirus vaccine in 1998 and 1999:

• 3 out of the 5 FDA advisory committee members who voted to approve the rotavirus vaccine in December 1997 had financial ties to the pharmaceutical companies that were developing different versions of the vaccine.
• 4 out of the 8 CDC advisory committee members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.

The vaccine was pulled from the market one year after approval after it was found to cause severe bowel obstructions.

Congressman Burton raised the point that there are 700,000 doctors in this country and why couldn't we find 15 to serve on a CDC committee that did not have conflicts of interest.

The CDC and FDA argued that it is all right because all the conflicts are disclosed and then there are waivers that are given on a case by case basis. When certain members are not allowed to vote they are still allowed to be part of all discussions and use whatever powers of persuasion they may have to influence other voting members.

Congressman Burton brought up the fact that there were only 5 voting members on the FDA committee the day they voted on rotavirus, which is not a quorum. The FDA's charter says they should not vote without a quorum. The FDA responded that, although their charter says that "generally" they should not vote without a quorum, it is not a requirement.

Congressman Burton also brought up the fact that CDC's committee voted before the FDA had licensed the vaccine.

Lyme Vaccine Problems: SmithKline Beecham, the makers of Lymerix, the only licenced Lyme disease vaccine on the market, currently finds themselves the subject of numerous lawsuits by people who claim they suffered disabling, arthritis-related side-effects from the shot. Interestingly, during the clinical trial of the vaccine, participating patients had to sign a paper indicating that they were aware of a "theorical possibility" that it could cause arthritis in certain susceptible people. However, this warning does not currently appear anywhere in the manufacturer's insert or are patients made aware of this possibility.