Despite his family connection to the Hib vaccine, there is neither evidence nor suggestion of undisclosed financial conflict on Thomas Insel’s part; all the Praxis Biologics transactions and development activity associated with HibTITER® occurred at least twenty years ago and involved his brother, Richard Insel.  Nor has Richard Insel been involved in autism research in any way. But HibTITER® contained the ethyl mercury-based preservative thimerosal, a vaccine component that has been at the center of an ongoing controversy in autism. Many organizations concerned over vaccine safety, including many autism groups, have been asking for increased NIH funding for vaccine safety research, including research into the effects of thimerosal. In that context, Age of Autism’s investigation of Thomas Insel’s familial link to a thimerosal-containing vaccine developed by his brother raises important questions, and advocates for more research on a possible link reacted strongly to the connection.

Put simply, Thomas Insel presides over the NIH research into the causes of autism. In his dual capacity as autism planner and brother (see HERE), responding to these concerns would require him to address a personally difficult question: Did his brother help develop a product that increased the risk of autism in children?

“With a topic as sensitive and combustible as vaccines and autism, Insel needs to move on and hand the reigns over to someone with no conflicts, real or perceived," said J.B. Handley of Generation Rescue. Age of Autism outlined this article and the reaction of some autism advocates to a spokeswoman for the National Institute of Mental Health, of which Insel is director. She said Insel is on vacation "this week and next week at least" and could not be reached for comment. In a brief conversation, she said that in general "he falls back on the science, not some personal view of anything" in making policy decisions.

Richard Insel, Praxis Biologics and the Hib Vaccine

Richard Insel was named in 2003 as the Executive Vice President for Research of the Juvenile Diabetes Research Foundation (JDRF). Before that, he spent 26 years in and around the University of Rochester Medical Center, working in pediatrics, immunology and infectious diseases. Early in his career at Rochester, he began researching the Hib bacterium, a major cause of bacterial meningitis in young children.  He subsequently published numerous articles on Hib together with Porter Anderson and David Smith, both of the University of Rochester. Their team at Rochester is widely credited with creating the first licensed infant vaccine for Hib.

Although all of these men were active scientific participants in the development of HibTITER®, there was an apparent division of responsibilities. Anderson took on the leading scientific role while Smith led the business side.  Richard Insel played a subordinate role on both the scientific and commercial sides. Anderson was the top named scientist, according to the standard textbook Vaccines, which reported that “Haemophilus B oligosaccharide conjugate B (HbOC) vaccine was developed by Porter Anderson at the University of Rochester.” David Smith, by comparison, moved on from his role as Chairman of Pediatrics at the University of Rochester (he worked closely there with Anderson) in 1983 when he founded Praxis Biologics and served as chairman and Chief Executive Officer until its sale in 1989. Textbook summaries aside, both leaders received a degree of shared scientific acclamation for their work, as Anderson and Smith shared (along with two NIH researchers who worked on a different Hib vaccine formulation) the Albert Lasker Clinical Medical Research Award in 1996 for their work on the HibTITER® vaccine.

The Praxis Biologics HibTITER® vaccine marked a major shift in childhood vaccine development and ushered in a new age of vaccine administration for infants under six months of age. In a tribute Richard Insel wrote for Smith upon his death in 1999, he noted that “licensing in 1990 of the conjugate vaccine represented the first FDA license for any vaccine for young infants since the trivalent oral poliovirus vaccine was introduced in 1962.”

If Richard Insel was not first in line for the major awards that went to the HibTITER®/HbOC developers (there were three other major variants of Hib vaccine developed around the same time, but HbOC was the first licensed for infants), he was certainly a member of the inner circle. He describes himself in his JDRF biography as “scientific co-founder” of Praxis Biologics and he served there as a member of the Board of Directors, appointed in 1988 when Smith regained his CEO position after a brief boardroom struggle. Both Anderson and Smith valued his contribution highly. In their 1996 essay marking their acceptance of the Lasker award, they wrote, “All our many colleagues in laboratories and in the academic and medical communities who contributed to this work cannot, unfortunately, be acknowledged in the references, [but]... David H. Smith and Porter Anderson thank… their colleagues at…the University of Rochester (NY) for help and collaboration, especially Drs Fred S. Rosen, Richard A. Insel, and Michael E. Pichichero, and they acknowledge the expertise and industry of the staff of Praxis Biologics.”

Insel was well recognized and rewarded for his work at Rochester and Praxis Biologics. In terms of scientific recognition, he was a co-author on over 30 papers on Hib and the related immunology issues. He was also a co-inventor on a vaccine patent for Hib conjugate vaccines. In terms of commercial reward, by 1989, he had received nearly 280,000 common shares of Praxis Biologics. When American Cyanamid purchased the company that year for an estimated $14 per share, Insel’s holdings were worth nearly $4 million. [Note: there is also a possibility that Insel received additional income through royalties paid to the University of Rochester on the patented conjugate technology used in both HibTITER® and Prevnar® vaccines. Age of Autism estimates that Rochester received over $200 million in royalties on Porter Anderson’s patents; 50% of these royalties were distributed to the inventors. But we cannot confirm that anyone other than the named inventors on Anderson’s “Immunogenic conjugates” patents received payments. Richard Insel, although often acknowledged as part of the inventor team, was not a named inventor on the licensed patents.]

By most accounts, the Hib vaccine has been highly successful in reducing cases of childhood bacterial meningitis. But the first versions of the commercial infant Hib vaccines--including products developed by Praxis (then Lederle-Praxis, now Wyeth), Merck and Connaught/Merieux (now Sanofi Pasteur)—were all preserved with thimerosal.

Mercury in all its forms is uniquely toxic to infants, but ethyl mercury stands apart among the most toxic manmade forms of mercury. And starting in 1991, two new mercury containing childhood vaccines—the Hib and the hepatitis B vaccines—were introduced to the childhood immunization schedule. Combined with the DPT vaccine already in use, the licensure of the Praxis Biologics’ Hib vaccine contributed to a sharp increase in infant mercury exposure. As part of the core team that developed and commercialized this new product, Richard Insel was therefore intimately connected to the growing concerns over possible causes of exploding autism rates. And this was an issue his brother Thomas would later face in his role as the head NIH strategic planner for autism.

Thomas Insel, the Autism Strategic Plan and Vaccine Safety Research
 
In his role as chair of the Interagency Autism Coordinating Committee (IACC), Thomas Insel was instructed by the Combating Autism Act (CAA) of 2006 to develop a strategic plan for autism research. According to the CAA, the IACC must “develop and annually update a strategic plan for the conduct of, and support for, autism spectrum disorder research, including proposed budgetary requirements.”

This was no idle provision. The idea of requiring NIH to develop a strategic plan for autism research came out of months of intense discussion and negotiation among autism advocates as different versions of the CAA were making their way through Congress. In their normal course of business, NIH approves grant applications as they are submitted by scientists on a one-by-one basis. Although this approach ostensibly rewards high-quality applications, it also has well-recognized drawbacks. The collective bias of the review panels and the natural inertia of consensus-based science can make it difficult to attack new problems aggressively and sponsor controversial research. When a new disease problem requires more urgent action with funding directed strategically to priority areas for the disease rather than popular problems for science, the passive review approach can break down completely. Scientists are a cautious lot and typically apply for grants in areas that have broad scientific appeal, such as genomics, rather than those that may be most valuable in the case of a specific disease condition.

Because of this problem, autism community advocates, long dissatisfied with the slow response of the broader scientific community to the autism crisis, inserted the strategic plan provision into CAA. In order to make sure the new money was well-spent, these advocates proposed the strategic planning mechanism to hold NIH leaders accountable for their decision making. The autism strategic plan would set priorities and allocate resources for the entire body of autism research and force NIH to truly “combat autism” rather than simply process grants.

So in order to comply with these clear instructions from Congress, and starting in 2007,
Thomas Insel orchestrated a lengthy, complex and increasingly contentious planning process for autism research. After many hours of meetings, much debate and a controversial round of votes on the vaccine issue, the IACC released its first plan on January 26, 2009.

By all accounts, Insel ‘s initial approach to the planning process was made with energy and broad outreach. Nevertheless, many autism advocates were concerned with his managerial decisions from the beginning. At the outset of the process, he appointed another psychiatrist and autism parent, Joyce Chung, as project manager. But Chung’s objectivity was immediately called into question when advocates learned she was married to the anthropologist Roy Grinker. Grinker released a book on autism in 2007 called Unstrange Minds, in which he took the controversial view that rising autism rates are an illusion and the rising recognition of autism is merely a social phenomenon. The idea that his wife, Joyce Chung, would be project manager for the autism strategic plan mandated by an act of Congress inspired by the rising rate of autism sparked suspicion from the start.
 
Initial concerns among autism groups over the objectivity of the process first raised by Chung’s appointment increased over time. Given the instruction from Congress to develop a strategic plan but with no clear blueprint for how to do so, Insel chose to make up the process as he went along. And despite his active outreach, Insel chose to keep decision-making power close to the vest. Authority for writing the plan was first delegated to a hand-picked working group, one selected with no input from the IACC. Confronted with community concerns over the obvious potential for bias under such an approach, Insel disbanded this initial group and set up a second working group, one selected based on nominations by IACC members [full disclosure: one of us (MB) served on this second working group]. This group met once in person and once on the phone, was subsequently disbanded and replaced with a third hand-picked group.

The concerns over Insel’s management of the planning process escalated after that. During the IACC strategic plan reviews, there were numerous areas of debate. These included, but were not limited to, questions of vaccine safety. On December 12, 2008, the IACC debated the vaccine safety issue and voted (narrowly) to recommend research into the study of the link between autism and vaccines. Specifically, the draft plan recommended that NIH undertake to study of “vaccines, vaccine components and multiple vaccine administration in autism causation and severity through a variety of approaches including cell and animal studies and understanding whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines. 
Estimated budget $6,000,000."

In the context of the $900 million budget for autism research authorized under CAA, this was not a large amount, but for the autism community, it was a substantial step forward. IACC member Lyn Redwood of SafeMinds remarked at the time, “Although I would have rather had a colonoscopy than attend another IACC meeting, we surprisingly made some headway!”

But Insel moved swiftly to reverse this vote. In a surprise move during the next IACC meeting on January 14, 2009, Insel singled out this vaccine safety research provision and put it back up for a revote. According to the meeting transcript, Insel made a remarkable admission, “Let me introduce another issue, and I'm sensitive to Lyn's concern about reopening things we voted on…[but] this is perhaps the only issue that we've dealt with that is now part of litigation that involves the department; that  it's a HRSA issue, and I'm concerned about the optics.”

In layman’s terms, the “optics” Insel was referring to was the simple issue of conflict of interest. He was asking how NIH, as part of the Department of Human Health and Services (HHS), could investigate issues relating to the programs of one its agencies (CDC) as it was adjudicating vaccine injury claims under another one of its agencies (HRSA). (The proceedings of the so-called “vaccine court”, including the Omnibus Autism Proceedings into the link between autism and some vaccine injuries, are managed by HRSA under the Vaccine Injury Compensation Act).

Insel claimed not to like how this looked. “So the optics of having HRSA vote on issues related to autism and vaccines, when they have a large court case, the optics of having people who could be perceived to have or to represent those who have a financial investment in this issue. It takes it out of the realm of a scientific question, a research question, and it raises the possibility that some could see whatever comments we make as being biased by non-scientific issues.”

So just two weeks before releasing the final strategic plan, Insel singled out the prior vote on vaccine research, and asked for a new vote. With full support from the HHS members on the panel (HHS holds a solid majority of the votes), the vaccine research was voted out of the plan.

NIH has not been so reticent to fund vaccine safety investigations when the charter and investigator team has been friendlier to vaccine manufacturers. In addition to Richard Insel, one of the three Rochester researchers credited by Porter Anderson and David Smith was Michael Pichichero. Pichichero describes himself on his web-site as “a member of the discovery team at the University of Rochester that invented, tested and licensed a Haemophilus influenza b (Hib) conjugate vaccine (HibTITER®) now universally given to children in the U.S.” But unlike Richard Insel, Michael Pichichero has conducted research into the toxicity of thimerosal. In two NIH funded publications, Pichichero gave thimerosal a clean bill of health. Nowhere in either publication did he mention his personal connection to HibTITER®.

Autism Community Concerns over Thomas Insel’s Leadership

In his remarkable admission, Insel worried aloud about the “optics” of NIH investigating the vaccine programs managed by its sister agency, the CDC, while claims of vaccine injury were being adjudicated by another sister agency, HRSA. His concern appears well-founded. Within the HHS family, there are no clear checks and balances on the power of the department to suppress one public interest (vaccine safety) in favor of another (vaccine promotion) when the department leadership chooses to retain potentially conflicting activities within the family.

But what about his brother’s vaccine? Interestingly, Thomas Insel has never matched his expressed concern over the “optics” of investigations within the HHS family with similar sensitivity to the optics problem within his own family.  It’s a fair question. Could Thomas Insel be using his position as IACC chair to prevent funding of research that risks tarnishing his brother’s accomplishments?

Although Insel’s public posture on the connection on autism and vaccines has shifted over time, he has appeared consistently eager to reject any connection to the Hib vaccine. Himself a vaccine developer (he conducted an HIV vaccine research earlier in his career), he told one of us (DO) in an 2007 interview that while vaccines might be involved, the thimerosal theory had been “disproven.” When asked by a parent at the 2007 NAA conference for his views on the vaccine-autism link, he gave a noncommittal response. But then he went on to make an unsolicited remark. Out of either a desire to be provocative or insensitivity (or both), he told the audience that perhaps scientists would invent “a vaccine for autism” some day.

More recently, Insel’s position has hardened. In testimony in front of a Senate committee this month, he told Senator Tom Harkin that funding more research into the effects of the dramatic increase in childhood vaccines would be “a waste of money.”

When asked whether this information affected their trust in Insel’s capacity to direct autism research resources, autism advocates had more to say. IACC member Lyn Redwood of SafeMinds commented, “That certainly explains his bias with regard to vaccine research, it’s an obvious conflict of interest”, but preferred not to elaborate further.
Redwood’s organization, SafeMinds, issued an official statement, however, calling for institutional changes in the oversight of autism research. “"These revelations on conflicts of interest held by Insel are disturbing and help explain why he has abandoned scientific inquiry in favor of blocking any research relating to vaccines as a cause of autism.  His claim during the Harkin hearing earlier this month that the vaccine-autism science is ‘done’ is in direct conflict with the recommendations of the National Vaccine Advisory Committee (NVAC) and others calling for baseline data on the health of unvaccinated children.  A policy of deliberate ignorance is not an acceptable substitute for sound science.  Our community would be better served by the leadership of an agency such as The National Institute of Child Health and Human Development (NICHD) whose mission is clearly aligned with biomedical research for children who are sick or the National Institute for Environmental Health Sciences (NIEHS) whose mission focuses on finding individual susceptibilities and environmental triggers to disease."

Others were more focused on Insel’s personal leadership and argued that he should resign from his post as head of IACC. "How can any autism organization or parent believe Insel will give vaccines a thorough look with his brother, at the very least, whispering in his ear?”  asked JB Handley of Generation Rescue. “With a topic as sensitive and combustible as vaccines and autism, Insel needs to move on and hand the reigns over to someone with no conflicts, real or perceived."

Wendy Fournier from the National Autism Association was also critical of Insel’s IACC performance. “Tom Insel has lost the confidence of the autism community in his role as chairman of the IACC.  He has wasted precious years for our children with his poor leadership and blatant bias.  Our country is facing the biggest health crisis of our time.  We need answers now, and that means following the science wherever it leads – even if it implicates the vaccine program.” Ms. Fournier also called for Insel to resign as IACC chair, saying, “This community desperately needs and deserves leadership that puts our children first.  Tom Insel is clearly not the man for the job.  How many more children will we allow to be lost under his watch?” 

Although he now researches another chronic childhood onset illness at JDRF, Richard Insel has stayed away from autism research, but between his Rochester colleague Michael Pichichero’s research exonerating thimerosal and his brother Thomas’ efforts blocking research into vaccines in the autism strategic plan, his Hib vaccine has had ample defense. This is scant comfort for parents of autistic children, many of whom believe their children are vaccine injured and are losing faith in the integrity of the vaccine safety system as currently managed within the HHS family of agencies. Revelations like this go further than concerns over “optics”, and only serve to reinforce their perception that the system is rigged against them.

This is true for both weak and powerful autism parents. Katie Wright is the daughter of the founders of Autism Speaks, the world’s largest autism research organization. Her son Christian was the inspiration for her parents to start Autism Speaks and she has been a harsh critic of Insel’s leadership over the few years.

We asked Ms. Wright what she thought about Insel’s family conflict. She made the following statement. “The reason why parents do not trust the medical establishment regarding vaccine safety is because they see the pervasive conflicts of interest throughout the CDC and the NIH. The very same people who have long standing biases or financial interests in our vaccination program are the ones who work so hard to block any vaccine safety research. We need transparent and objective leadership at IACC, and Insel will never be able to provide that. It is time for Insel to go.”

Rebecca Estepp, of Talk About Curing Autism (TACA) concurred, arguing that Insel’s family conflict is only part of this greater concern over a rigged system of vaccine safety and wonders how HHS can defend its oversight of that system. "There’s an ancient dilemma about the problem of checks and balances on the powerful,” Estepp points out. “It goes in the form of a question. ‘Who is guarding the guards?’” She suggests that Insel’s personal connection to the vaccine business is part of this larger problem. “How can we expect impartiality from a regulator who himself has developed vaccines? How can we expect objectivity from a man whose own brother developed one of the vaccines in question?"
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Dan Olmsted is Editor and Mark Blaxill Editor at Large of Age of Autism. Blaxill is also a director of Safe Minds.