Diabetes, Vaccines, and the Patent Troll

Childhood vaccines became a hotly-contested topic of debate when a small, but vocal, group of parents sounded the alarm that vaccine exposure could cause higher rates of autism. It’s an assertion that was championed by a lone U.K. researcher, Andrew Wakefield, whose licence to practice medicine has since been revoked and whose research has been found to be fraudulent by a leading British medical organization.

Largely obscured by this emotional debate is a second assertion that standard childhood vaccines are largely responsible for many cases of childhood diabetes. The argument over this debate takes much the same form as the autism-vaccine argument, with a single researcher sounding the alarm, a small group of parents stridently backing that researcher, and a large body of scientific evidence that seems to disprove any connection between childhood vaccines and diabetes.

This second debate has taken an unusual twist, however, in that it has been stymied by a legal battle waged over whether the very idea of a link between childhood vaccines and diabetes can be patented. In a bizarre twist of fate, the very researcher championing a connection between childhood vaccines and diabetes is suing biotechnology companies who are doing research to explore that connection.

The researcher in question is Dr. John B. Classen, an American immunologist who for years has self-funded research that he says provides evidence that childhood vaccines are fueling diabetes rates throughout the world. Dr. Classen has argued that vaccines, given on a certain schedule, can provoke an immune system response which can trigger diabetes in children. As evidence, he says he has found a correlation between vaccine rates and diabetes rates in world health records. He also says he has found evidence that lab animals which were given immunizations after 8 weeks from birth had a higher rate of diabetes. While those who believe in a connection between autism and diabetes tend to recommend delaying vaccines, Dr. Classen believes that the immune response issue could be minimized if vaccines were started right at birth, rather than at 8 weeks or later.

Dr. Classen is the CEO and owner of a company, Classen Immunotherapies, which is in the business of “finding safer ways of using commercially available products including chemicals, drugs and devices,” according to its website. The site has not been updated since 2011.

The mainstream scientific community, to date, has not found credible evidence to back Dr. Classen’s assertions. Critics in the medical community have accused Dr. Classen of cherry-picking statistics to suit his hypotheses, comparing apples to oranges with health data from different countries, and misrepresenting studies to back his claim. Officials at the U.S. Centers for Disease Control and Prevention have long asserted there is no link between diabetes and vaccinations. The National Centre for Immunisation Research and Surveillance in Australia sums up the prevailing stance on this issue in a fact-sheet:

Two large population-based American studies failed to support an association between any of the childhood vaccines and an increased risk of diabetes in the 10 years after vaccination. The highly respected international Cochrane Collaboration reviewed all the available studies and did not find an increased risk of diabetes associated with vaccination. Expert groups such as the National Institutes of Health in the USA have met and reviewed the evidence and conclude that there is no link between vaccines and diabetes.

As with the autism-vaccine debate, such declarations have not quelled a vocal minority who still believe vaccines pose a danger when it comes to diabetes. Those who still believe in the connection hold up Dr. Classen as a medical champion who is shining a light on a threat they believe the scientific community won’t acknowledge.

But in a curious plot-twist, Dr. Classen may be blocking further research on the matter. His company, Classen Immunotherapies, sued two biotechnology companies, Biogen and GlaxoSmithKline, which are doing research on exploring links between immunization schedules and future medical conditions, including diabetes. The suit isn’t alleging that Dr. Classen has found a “safer’ vaccine schedule or a method for preventing diabetes, but that he has patented the concept that there could be a connection between vaccines and diabetes, according to James Bessen, a patent and intellectual property expert at the Boston University School of Law.

“Classen obtained this very broad, very general patent,” Bessen says in an interview with Insulin Nation.

iStock_000013314045Illustra_Troll_Laptop_300pxThe suit has been decried in the legal community as an another example of a fight against “patent trolls”, or inactive companies which file lawsuits that stymie research and development efforts of other companies. Until recently, patent trolls had largely left the biotechnology world alone, but this case was a signal to some experts that they were moving into the field, according to a report in Nature.

According to the patent blog Patentlyo, one of the patents states that Dr. Classen has discovered that “the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders…and that immunization should be conducted on the schedule that presents the lowest risk with respect to such disorders.” Dr. Classen has argued in court that others infringe on this patent just by reading the scientific literature surrounding this subject.

It’s one thing to assert this claim in court, but it’s another for a court to uphold it. That’s why some legal experts were dismayed in 2011 when a U.S. Federal Court of Appeals upheld Dr. Classen’s claim by a 2-to-1 vote, overturning a lower court’s decision. The case is still working its way through the court system after the Supreme Court declined to review it in 2013. The dissenting judge in the controversial 2011 ruling was scathing in her criticism.

“While I confess the precise line to be drawn between patentable subject matter and abstract idea is quite elusive, at least for me, this case is not even close,” declared Judge Kimberly Moore in her written dissent. She added, “Having discovered a principle – that changing the timing of immunization may change the incidence of chronic immune mediated disorders – Classen now seeks to keep it for himself.”

Reached for comment by Insulin Nation, Dr. Classen was asked why, if he believed that wrongly-timed immunizations can cause diabetes, was he trying to block research that might back up his belief. Speaking frankly, Dr. Classen said that he had self-funded his research for years and that it was only fair that he should now profit.

“The only other option is to collect welfare and do research with your welfare checks,” Dr. Classen says.

But this ongoing court case may have a chilling effect on any kind of research related to diabetes and vaccines or other research efforts related to diabetes and the immune system. Such a move would thwart the purpose of patents if it ultimately prevails, Bessen says.

“Patents are supposed to provide incentives, not to rope off broad areas of research,” Bessen says. “You’re turning the patent system on its head.”

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Craig Idlebrook is a past editor for Insulin Nation, Type 2 Nation, and Información Sobre Diabetes. He is now the community engagement and content manager for T1D Exchange.

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