May 12, 2010
By Mark Blaxill
In the first part of this report (HERE), Age of Autism identified a pattern of conflict of interest at the Department of Health and Human Services (DHHS) involving Merck’s Gardasil vaccine. Researchers at the National Cancer Institute (NCI) invented critical technology for the “virus-like particles” (or VLPs) that were used in the Gardasil vaccine. As the invention reached the commercial marketplace, these researchers’ bosses at the National Institutes for Health (NIH) celebrated their work as “heroic” and “a journey we can learn from.” Meanwhile, officials in the NIH Office for Technology Transfer (OTT) filed for patents on the VLP technology invented at NCI, licensed those patent rights to vaccine manufacturers and eventually received royalties from Merck, Gardasil’s manufacturer, and GlaxoSmithKline (GSK).
In the second part of the series, Age of Autism will follow the Merck-DHHS “public-private partnership” as it moved beyond NIH to its sister agencies. In a subsequent process at the Food and Drug Administration (FDA), officials in the Center for Biologics Evaluation and Research (CBER) supervised the clinical trials and granted Merck the first “Biologics License Application” (BLA) for a human papillomavirus (HPV) vaccine. Three weeks later, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommended universal HPV vaccination for women from nine to twenty-six years of age, guaranteeing in one series of votes that Gardasil would reach blockbuster status for Merck: annual revenues of well over $1 billion. Subsequently, agencies within FDA and CDC have been responsible for monitoring Gardasil’s safety in the field, as officials within the Health Resources Services Administration (HRSA) brace themselves to sit in judgment over a new wave of vaccine injury claims. As we pointed out in the first part of this series, this conflict of interest is both extraordinary in scope and poorly understood by the general public.
At the same time, simply observing the possibility of conflict between the commercial activities of NIH and the regulatory roles of other agencies doesn’t necessarily mean that there will be bias, negligence or lack of diligence on the part of DHHS regulators. Nevertheless, the proclamation of great victory for a vaccine against cervical cancer—one that prompted the NIH Director to single out the invention for praise to both Congress and the President and won its inventors recognition as Federal Employees of the Year—could certainly have created pressure to usher Gardasil through the BLA approval and ACIP recommendation processes with special attention and unusual dispatch. As a result, one might argue that the potential for bias on the part of CBER and ACIP regulators–regulators who would have had a dangerous temptation to relax their required skepticism and hold the favored new product to lower standards of safety—gave them a responsibility for unusual diligence and extra care. But what does the evidence really say about their actual level of diligence? Did CBER and ACIP officials betray their eagerness to enable the celebration of a new “anti-cancer vaccine” or did they hold Gardasil to even more exacting standards of safety? Let’s take a closer look at how FDA and CDC approached their respective responsibilities for Gardasil.