Posts made in April, 2016

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.

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Read the Fine Print Before You Send Your Spit to 23andMe

Posted on Apr 7, 2016

Our genomic sequence constitutes the most sensitive and personal of information: uniquely identifying us, revealing our propensity to develop certain diseases and conditions, and exposing familial connections of close genetic relatives. In recent years, Big Data has taken firm hold in numerous sectors, revolutionizing the volume and velocity at which businesses can collect, curate, and use digital information. Consumers can track what they eat, their fertility, whether they are exercising, and how much they are sleeping. Combining these pieces of data with genomic and health information such as family history, health conditions, disease state, and demographic information constitutes a gold mine for scientific research.

23andMe capitalized on the quantified self movement and consumers’ effusive willingness to collect and share personal data, transforming it into a highly profitable venture. Within the past year, 23andMe rapidly reinvigorated its business model, introducing Food and Drug Administration-compliant Carrier Screening Reports as part of its new Personal Genome Service, introduced on online recruitment platform for disease specific research cohorts, and publicized multimillion dollar partnerships with pharmaceutical giants such as Genentech.

In numerous media interviews, 23andMe CEO and cofounder Anne Wojcicki beams with positivity about how this model will revolutionize health care; empowering consumers with an awareness of the secrets of their genome while accelerating the speed of research and drug discovery. As one article in theSan Francisco Chronicle characterized it, “23andMe wants to do for health what Google has done for the search: make massive quantities of information digital, accessible, and personal.” 23andMe made this vision a reality by digitalizing and compiling genotypic-phenotypic data into a searchable format for interested investigators to run queries in its Research Portal, an online searchable database of over genotyped individuals with more than 225 million phenotypic data points, including demographic, clinical information, and family history.

An exciting prospect for research scientists, but also attractive to many other business as well. The sheer amount of information 23andMe’s database makes it appealing to a number of external parties, including data brokers, the pharmaceutical industry, employers, health insurers, and law enforcement. Entities may want to use the data for predictive modeling and draw inferences to market a product, decide suitability for employment, deny life insurance coverage, or target suspects pursuant to a criminal investigation. These uses of the data pose significant informational risks: shame, embarrassment, discrimination, or being subjected to law enforcement investigations. Perhaps surprisingly, many of these secondary uses of the data are currently permitted by law.

Just how much information does 23andMe collect? Much more than consumers may imagine unless they read the fine print. Purchasing the test and submitting DNA creates a potentially indelible electronic record of your genomic sequence in 23andMe’s database, along with a composite mosaic of additional health, lifestyle, and consumer generated personal details. In addition to the information the consumer actively sends, 23andMe employs numerous techniques to collect and track additional details through social media, web beacons, and consumer IP addresses such as compiling personal photos, place of employment, a record of every website the consumer clicks on, and real time tracking of the consumer’s location.  23andMe uses this data internally for marketing purposes and shares the data for research if the consumer provides consent.

But- the fine print also contains a provision that permits 23andMe to unilaterally modify its privacy policy at any time, effectively changing current promised limitations. Wojcicki’s positive intentions aside, she is not the sole party controlling the data. If 23andMe follows in Google’s footsteps, then the private information may not stay private. Indeed, Google Ventures managing partner Bill Maris (a financial supporter of 23andMe) has dismissively challenged, “What are you worried about? Your genome isn’t really secret.” If 23andMe modifies its policy to widely sell consumer data without consent, the lightning nature of electronic data sharing means Pandora’s Box is open.

How is this possible? In addition to expediting the process for research, 23andMe also challenged the traditional regulatory and ethical requirements that ordinarily correspond to collecting and disseminating private genomic and health information. The massive paradigm shift to collecting genomic and health information in the commercial arena, as opposed to the health care setting, means the transaction may occur outside the scope of regulatory structures designed to ensure informed consent when subjects provide DNA and to protect health data privacy.

The HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule does not apply to consumer curation of health data or any associated protections related to privacy, security, or minimizing access. Similarly, unless a commercial entity conducts research that is supported by a federal department or agency, such as NIH funding, regulations set forth in the Common Rule will not govern that entity’s practice. Even though 23andMe receives NIH funding, 23andMe currently asserts that its data-mining analysis does not constitute research on human subjects under the current version of the Common Rule because it de-identifies the data. This stance is significant because it means 23andMe believes any consent it obtains to retain, use, and share consumer data is not necessary for regulatory compliance, but rather constitutes a transactional courtesy.

The traditional informed consent dialogue intended as a means to convey risks and benefits shifts dramatically when the consent process occurs online via consumer interaction with a website clickwrap interface rather than a physical contact person from the research team. Clicking through to purchase the test constitutes an entangled package consisting of a service, agreeing to receive medical information, and research.Recent litigation over 23andMe’s model of presenting its terms reiterates that just because you don’t read the fine print does not mean you can claim those terms are unfair and erase your decision.

Consumers may be blinded by the genomic technological imperative to know and widely share their genetic profile or assuaged by notions of altruism highlighting their contribution to important scientific research. They may bypass reading the fine print, or alternatively, they may not fully appreciate the implications of the transaction. Read the policies closely, and read them carefully, to assess whether the benefits outweigh such looming informational risks.

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