By Mark Blaxill
May 13, 2010
In parts 1 (HERE) and 2 (HERE) of this series, Age of Autism identified a disturbing pattern of conflicts within the Department of Health and Human Services (DHHS) regarding Merck’s Gardasil vaccine. In an unprecedented “public-private partnership,” researchers at the National Institutes of Health (NIH) patented the technology for the “virus-like particles” (VLPs) that provoke Gardasil’s immune response to the human papillomavirus (HPV) and licensed their VLP technology to Merck. The terms of the patent license effectively made DHHS Merck’s financial partner on Gardasil, giving DHHS a clear conflict of interest on decisions regarding Gardasil.
This partnership gave Gardasil favorable treatment at key decision points, treatment that was financially rewarding to both parties. While the NIH Director celebrated his researchers’ “heroic” achievement and the researchers received numerous awards, including “Federal Employees of the Year,” officials at NIH’s sister agency, the Center for Biologic Research and Evaluation (CBER) of the Food and Drug Administration (FDA), stood watch over the Gardasil clinical trials. CBER’s review failed to hold Gardasil to a high standard of safety. Instead of comparing Gardasil to an inert placebo, as they should have, CBER based its entire safety assessment on a comparison of Gardasil’s adverse event profile with the adverse events associated with a “placebo” that was actually an immunologically active aluminum-based adjuvant. Despite the fact that an alternative comparison, pitting Gardasil against a relatively inert “carrier solution,” should have warned them of clear evidence of harm to Gardasil recipients, CBER approved Merck’s Gardasil Biologics License Application (BLA) anyway. In the meantime, following CBER’s approval of Merck’s BLA a key committee at the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP), put Gardasil on a fast track and immediately recommended three doses of the Gardasil vaccine to all American women between nine and twenty-six years of age. In a matter of days, Merck was guaranteed a blockbuster launch for Gardasil and within months Gardasil had reached annual revenue levels of well over $1 billion. Soon, Gardasil would become the #1 royalty generator for NIH’s technology licensing group, completing the partnership circle.