Media Misstates the Message: Investigate CDC Whistleblower’s Claims

Posted on Apr 22, 2016

Media headlines are abuzz around the decision to pull the documentary Vaxxed: from Conspiracy to Cover-Up from the Tribeca Film Festival.  As a disclaimer, I have not viewed the film.  What is deeply troubling, however, is how numerous media outlets (here and here) have misconstrued the film’s message calling for an examination of vaccine safety and efficacy.  Instead, headlines and news content repeat erroneous assertions that are contrary to scientific evidence and focus exclusively on the controversial Dr. Andrew Wakefield as a red herring. (If you are interested in learning the full story about the Wakefield controversy and the role of the media, you can read it in this book).   Both the science and the law relating to vaccination are nuanced and evolving.  When vaccines go through the approval process at the FDA, approval is premised upon data submitted by the vaccine manufacturer showing that the product is safe, effective, and its benefits outweigh the risks.  Glossing over this complex process and improperly labeling any questions pertaining to safety and efficacy as “anti-vaccine” effectively stunts the scientific process as an evolution and pursuit of developing knowledge.

Based on its website, the film intends to address statements made by Dr. William Thomson PhD, senior scientist at the CDC who revealed he was instructed by fellow CDC senior scientists to eliminate highly unfavorable data from studies they conducted examining links between vaccination and neurological injury.  The conclusions of these studies (DeStefano 2004, Thompson 2007,  Price 2010)  have been widely cited and touted by Dr. Paul Offit MD as “definitive” proof demonstrating vaccine safety.  What did that excluded data show?  According to conversations between Thompson and biology Professor Dr. Brian Hooker PhD, the data demonstrated a substantial differential rate of adverse reactions to the MMR vaccine based on sex and race: African American boys who received the vaccine according to the American Academy of Pediatric Schedule had a 3.4 fold increase in risk of autism.  Barry published a book summarizing conversations he had with Thompson including full transcripts of lengthy discussions related to alleged data manipulation and conflicts of interest between industry and the CDC.  You can read a summary written by attorney Robert Kennedy Jr. JD LLM here and the book containing full transcripts here.

Not only is this statistic alarming, but what’s more concerning is lack of mainstream media coverage and public knowledge of this incident and other information that calls into questions vaccine safety from a variety of angles.    CBS Reporter Sharyl Attkisson has referred to the topic of vaccine safety and efficacy as the “most censored and misreported story of the century.” To find that information requires digging through other media channels, such as Attkisson’s website, attorney Robert Kennedy Jr. JD LLM’s work, MIT Senior Research Scientist Stephanie Seneff PhD’s findings, or assessments by physicians Dr. Mark Hyman MD and  Dr. Kelly Brogan MD.

Combing through the research rather than accepting the common meme reveals numerous safety questions about which there has been no open dialogue pertaining to studies demonstrating: long term central nervous system damage including seizures, learning disabilities, and neurological disorders; an increased risk of severe allergies and asthma; the onset of chronic arthritis; and death.  Further, numerous studies (examples here and here) and federal whistleblower claims against Merck point to compelling evidence undermining assumptions of efficacy and the veracity of manufacturer claims of efficacy prior to FDA submission for approval.  Such evidence threatens the massive profits of the global vaccine market, which constituted estimated $24 billion in 2014 (see here and here).

As New York University School of Law Research Scholar Mary Holland JD has noted, the law recognizes vaccines’ risks despite appropriate manufacturing and administration.  Vaccines are classified as “unavoidably unsafe” products; that is, they will necessarily expose some individuals to risk of injury and death.  In 1986 Congress passed the National Childhood Vaccine Injury Act as a means to shield manufacturers from mounting liability claims via private litigation while compensating victims of vaccine injury.  In 2011,  the Supreme Court in Bruesewitz v. Wyeth held that the Act preempts all design-defect claims against vaccine manufacturers, which precludes injured parties from seeking private remedy from the manufacturer.

In a powerful dissent, Justice Sotomayor stated:

“Vaccine manufacturers have long been subject to a legal duty, rooted in basic principles of products liability law, to improve the designs of their vaccines in light of advances in science and technology… the majority’s decision leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements. This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins.”

Excluding information such as Thompson’s allegations from both public and policy discussions has implications for determining the extent and acceptability of risk for adverse events.  Notably, it also disables consideration of the risk of adverse events based on distinct classes and differential responses based on sex, genetic variation, or use during pregnancy.  FDA’s regulatory structure assumes that until a vaccine is given to the general population, all potential adverse events cannot be anticipated.  Many vaccines undergo Phase IV studies and the FDA relies upon the Vaccine Adverse Event Reporting System (VAERS) to identify adverse events after marketing begins.  According to former FDA Commissioner Dr. David Kessler MD, since VAERS’s inception in 1990 about 35.2 million adverse events have been reported, yet Kessler estimated only this accounts for only 1% of all serious adverse events that occurred.

Without an open and frank conversation about the meaning of evidence demonstrating increased risks or decreased efficacy, we face as a society troubling public health implications for which as Justice Sotomayor warned,  no one will be held accountable.