After Gayle Manchin took over the National Association of State Boards of Education in 2012, she spearheaded an unprecedented effort that encouraged states to require schools to purchase medical devices that fight life-threatening allergic reactions.
The association’s move helped pave the way for Mylan Specialty, maker of EpiPens, to develop a near monopoly in school nurses’ offices. Eleven states drafted laws requiring epinephrine auto-injectors. Nearly every other state recommended schools stock them after what the White House called the "EpiPen Law" in 2013 gave funding preference to those that did.
The CEO of Mylan then, and now, was Heather Bresch. Gayle Manchin is Heather Bresch’s mother.
Mylan is the subject of congressional investigations related to huge price hikes the company announced last month. It also faces an antitrust probe by the New York attorney general stemming from its EpiPen sales contracts with schools.
Bresch is testifying before the House Oversight and Government Reform Committee on Wednesday at a hearing called by Republican and Democratic members of the panel.
In October 2012, Mylan sponsored a morning of health presentations at the association’s annual conference. The presentations included a panel described as being on three of the biggest school health concerns, including food allergies.
The presenter at the panel, Chicago-based allergy doctor Ruchi Gupta, received more than $400,000 last year from Mylan for research on which she was the principal investigator, according to Centers for Medicare and Medicaid Services records. The center began releasing drug and device makers’ payments to doctors in 2013, when Gupta got more than $17,000 from Mylan for speaking, education, food and travel.
About this time, Mylan launched its "EpiPen4Schools” program, which has provided more than 700,000 free EpiPens to 65,000 schools, about half the nation's schools. The New York attorney general's investigation centers on this program, which required schools to buy EpiPens rather than its competitors if they got discounted versions, but Mylan has since changed the policy.
In December 2012, the association announced an "epinephrine policy initiative" designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use," according to a press release that month. The resulting policy “discussion guide” listed key components that school policies and state legislation should have, including protection from legal liability for the school.
It was the first time the group had addressed food allergies as policy despite its own admission that it had been a growing issue since about 2000.
Previously, the association carefully avoided corporate influence, especially when its policy guidance was involved, says Brenda Welburn, the former longtime executive director. Companies would sponsor conference meals at the most, she said.
Manchin became president-elect of the education association in late 2010 and Welburn retired at the end of 2011. Welburn recalls Manchin stopping by her office saying her "daughter's company" could donate to the group. The following year, it did. "It just looked so bad to me," Welburn said. "She (Manchin) becomes president and all of a sudden NASBE is saying EpiPens are a good thing for schools."
In a statement, Mylan said its sponsorships "focused on initiatives to raise awareness and understanding of anaphylaxis and encouraged policies that supported greater access." (Anaphylaxis is a severe allergic that can be life-threatening and may include trouble breathing, vomiting and a rash.)
"There is no truth to the suggestion that the company's efforts were anything but straightforward or that we are aware of anyone advocating inappropriately for the right of schoolchildren to have access to potential life-saving medicine," the statement said.
Manchin did not respond to requests for comment.
A family affair
Manchin was appointed in 2007 to serve a nine-year term on the West Virginia board of education by her husband, then-Gov. and now Sen. Joe Manchin, D-W.Va. Gayle Manchin became the association president in January 2012, the same month her daughter became Mylan’s CEO.
Minutes of a NASBE board of directors meeting in March 2012 show Mylan funding was discussed. It continued this year with what executive director Kristen Amundson said was a $15,000 contribution from Mylan in April.
Considering the association's $2.5 million annual budget, Amundson said the $25,000 in 2012 to pay for the epinephrine discussion guide wasn't enough for the group to "engage in behavior to cause our members to question why" the money was accepted.
Part of the "boilerplate" language in the association’s Mylan agreement says the group "will not directly or indirectly promote Mylan Specialty’s products," Amundson said.
It didn't have to.
Then, as now, EpiPen was about the only auto-injector for the drug epinephrine, which has been around since about 1900. The Mylan-sponsored materials rarely mentioned EpiPens. Instead, references to treatment for anaphylaxis mentioned only epinephrine and auto-injectors.
In the epinephrine discussion guide,” the association acknowledged Mylan's support, but noted "NASBE alone is responsible for the editorial content contained herein."
David Kysilko, who was the group's director of publications until his retirement in 2014, says that for the discussion guide, "we were provided one person who was our contact within Mylan." That person "provided us with both the background and research (but) not all of it,” as well as contacts for other research, he said. The association also "gave them a look at an early draft," which he said is "fairly common whether it's a company or a foundation."
Still, "we were always very careful in terms of who made final editorial decision," he said.
Rhode Island attorney Patrick Guida, who succeeded Manchin as NASBE president in 2013, says he doesn't "cynically see any of the sinister motives of these companies" that others do.
Who knew what
When asked about the Mylan sponsorship of two panels she moderated at the association's 2012 annual conference, Brenda Gullett, a former Arkansas state senator and school board member, said she wasn't aware of Mylan's funding for either panel or the numerous policy publications.
"Had I been aware, I would have been concerned,” she said, “and, given my proclivity to speak up, I would have addressed it."
Gullett wasn't the only one unaware of the Mylan-Manchin connection. "It's probably true that (NASBE) didn’t highlight that outside of the board of directors meetings," Kysilko said.
NASBE board member Alan Taylor of Connecticut says he doesn't recall knowing there was a family connection between Mylan and Manchin, who succeeded him as president. Guida said he was unaware of the relationship, and "I know Gayle pretty well."
Since there were highly publicized allergy-related deaths, which included a seven-year-old Virginia girl in 2012, state legislatures including Taylor's own were worried about liability if schools handled medication wrong, he said.
"It seemed like a useful thing for NASBE to do for state boards," Taylor said of some state-specific, Mylan-sponsored policy guidance. There were concerns the "funding would control the policy but of course everyone gets skeptical about that."
But Gullett said she can't imagine the group allowing a drug company to sponsor official guidance on concussions — a top school health concern at the same time food allergies were. And Welburn recalls when HIV/AIDS became a concern in the 1990s and NASBE suggested gloves should be worn around blood, she never would have entertained the idea of a latex glove maker sponsoring the education efforts.
"Companies like that don’t know schools," Welburn said. "They want to use you to get into schools."