The Disrupter

By Richard Laliberte

Janine Jagger ’72 can pinpoint the moment when her career—really her life—completely changed over a single dismissive remark. She was a young research epidemiologist in neurosurgery, long enamored of truths that data can reveal. It was 1985, and she was attending a hospital meeting at the University of Virginia, where she is now a professor of medicine but was then in her first faculty position, when the issue of health care workers injured by needlesticks came up. AIDS was snowballing, and the risk of transmitting bloodborne disease was a serious concern. “I said what any colleague with my training might say,” Jagger recalls: “‘If injuries are product related, look at product design to alter risk from those devices.’ To me it was a simple conclusion, but this was a completely novel idea among infectious-disease people at the time.”

Some colleagues in the room thought that shifting focus from changing behavior to changing product design was a terrific insight. “But the most senior professor took the floor and said, ‘This is pie in the sky and not our business, don’t waste our time,’” Jagger says. “I thought, ‘What does that mean, “It’s not our business”? Whose business is it? If no one makes it their business, nothing will happen.’” She felt convinced that changing designs of medical devices with needles or sharps was feasible. “That reaction caused me to completely reorient my attention and make a 180-degree turn in my career path,” she says. “I walked out of that meeting thinking, ‘I’m going to make it my business.’”

Taking On the Status Quo

Jagger had already established her capacity to be a maverick or what today might be called a disrupter. She was accustomed to dealing with resistance and pushback over designs related to safety, and had experience quietly wielding barrages of epidemiological evidence. It started when she learned early on that you couldn’t do much about brain injuries once they’d happened. That shifted her focus to prevention and a path of inquiry about preventable brain injuries in automobile crashes.

“Airbags at the time were not required in passenger vehicles,” Jagger says. “I contributed to the epidemiology of brain trauma and understanding what fraction could be prevented by requiring airbags as safety equipment in frontal driver and passenger positions.” The fraction turned out to be large—25 percent. But redesigning cars to include airbags would take effort and money. “There was a decades-long struggle between the auto industry and safety advocates,” she says. Evidence eventually won, and cars became markedly safer. “The gains in human health have been huge,” she says.

Jagger expected—and prepared for—a similar confrontation with medical-device manufacturers. Pushback suggested opportunity. “As a researcher, you look for that niche where you can do something unique,” she says. “The novel idea of combining infection control with injury control was undeniably attractive.”

Fruitful Collaboration

To her surprise, the medical-device industry quickly got on board. “They were at the cutting edge,” she says—“an apt pun.” She entered a remarkably fruitful period, coordinating with federal agencies, health care systems, device manufacturers, and other stakeholders to gather data and propose safety standards for device design. “What had the most impact in the long run was establishing a standardized surveillance system for hospitals to record occupational incidents and embed descriptions of events and devices, which manufacturers could use to understand product risks and measure injury reductions when new devices were introduced with different features,” Jagger says.

Improved safety-engineered devices incorporated needle-shielding or needle-retracting features. Vacuum tubes for blood drawing were changed from glass to plastic, and tube stoppers were reconfigured so that blood samples could be extracted in the lab without popping off stoppers. Some needles did not need to be sharp, and for those purposes blunt needles were developed. Along the way, Jagger and her colleagues were awarded five US patents. Eventually, Jagger would stand next to President Bill Clinton as he signed the US Needlestick Safety and Prevention Act of 2000 into law. It mandated that health care employers identify, evaluate, and implement safer medical devices.

Two years later, Jagger got a call out of the blue. It was the MacArthur Foundation: She’d been named a MacArthur Fellow, one of the nation’s most prestigious grants for people showing exceptional creativity in their intellectual, professional, or artistic endeavors. “The award was a tremendous encouragement,” Jagger says. “It gave me courage to be bolder in resisting pushback to things that look unconventional. Now I feel it’s my responsibility to be a maverick.”

A New Direction

Jagger plowed much of the no-strings-attached $500,000 MacArthur award into her medical-device work. But she held a portion back, anticipating some unknown future effort. The wellspring for her next major cause soon came from an unexpected source: her own body.

She began experiencing attacks of severe abdominal pain and fever, and in 2006 was diagnosed with a rare genetic condition, familial Mediterranean fever (FMF), which is mostly found in Middle Eastern populations. “I had never heard of it,” she says. Fortunately, colchicine, an extract from the seed of the autumn crocus, is an effective treatment for the disease. “Colchicine is a ticket out of hell,” she says.

Just as startling as her diagnosis was Jagger’s unexplored heritage. Did she really have Middle Eastern roots? She began researching the only ancestor she knew of with a written historical record—a Long Island steamboat captain whose ship was broadsided by another and sank on a foggy night in 1880, killing 50. Buried in a newspaper account of the resulting inquiry, a reporter noted the captain was unable to appear in court because he “had been attacked with fever and ague to which he is subject.” The word “ague” refers to fever marked by paroxysms of chills and sweating that occur at regular intervals. It was an almost clinical description of Jagger’s chronic disease. “When I found that, I almost fell off my chair,” Jagger says. “It was quite a revelatory moment. But as soon as I found him, I realized there could be others affected.”

Searches on Ancestry.com led her to a distant cousin who was also a descendant of the ship captain. The cousin knew nothing of FMF but was seriously ill with signs of it. “She was much more ill than I ever was,” says Jagger, who informed her relative of their shared genetic disease and its treatment. “My cousin was resurrected.” The two teamed up for aggressive genealogy research that potentially could result in treatment for other relatives. “Where that led was completely unanticipated,” Jagger says. Eventually she identified her specific gene mutation, which was closely related to FMF but not specifically tied to Middle Eastern ethnicity. “Instead, our search led to a community of inbred Puritans on Long Island that went back 10 or 12 generations, which was fascinating in itself,” Jagger says.

Wisdom of the Crowd

Equally fascinating was what she found in online communities, often Facebook groups, organized around FMF or similar diseases. She had shied away from online groups initially, figuring they offered little substantive information. “I was a researcher on the medical side,” she says. “Patients were subjects; researchers were the professionals. That was how I saw things.”

She changed her view with just one exposure to online conversation threads. “People were telling each other things unknown to the medical community that, if true, were very significant for treatment of this disease,” she says. Like the fact that people had different responses to different brands of colchicine. “My epidemiologist brain immediately went into gear,” Jagger says. She did an online survey and confirmed existing research that suggested about 15 percent of patients don’t respond to the medication. “But it’s very brand-specific,” Jagger discovered. Switching to another brand significantly improved the odds of the treatment working.

Jagger was startled. “I thought if this information—groundbreaking for treatment of FMF—could be observed in a patient population in a single day, these groups must be an untapped well of significant clinical insights,” she says. “At that point I saw myself playing a unique role in bringing together the patient population as a research entity in its own right.” She established the Familial Mediterranean Fever Foundation and began developing a research platform to engage the patient community as a primary source of discovery for therapeutic and quality-of-life strategies.

Among the promising strategies that have emerged so far are the identification and elimination of inflammatory triggers, which had never been investigated before. Dietary gluten appears near the top of the identifiable trigger list with many patients showing profound improvements in inflammatory symptoms after the elimination of gluten from the diet. She is also tapping veterinary medicine for overlooked treatments that could be applicable to FMF. One example is uveitis, an inner eye inflammation, for which effective treatment has been elusive and which can cause blindness. She explains, “Dogs are being treated successfully with a low-level, 11/2-minute red spectrum light exposure to the affected eye. Well beyond our little rare disease, there are 30,000 Americans who go blind every year from uveitis while dogs are being cured in 11/2 minutes. What do I do with that information?” She adds that the recent availability of cannabidiol, a nonpsychoactive compound of cannabis, has resulted in many patients trying it for its reputed benefits for inflammation and pain. The initial reports have been impressive, warranting clinical trials on a novel class of drugs. The process of discovery within the patient community has had an abundant and promising yield.

Once again Jagger finds herself on the other side of convention. “It has been a challenge to engage the scientists at the forefront of FMF research, whose vision is focused on genetic discovery and the search for new drug targets. I applaud further genetic discovery. But it does not rule out the potential significance of the vast unexplored territory within the patient community,” Jagger says. Beyond the society of FMF researchers, however, there’s been scientific interest and confirmation. “Immunologists view our observations in a completely different light. There is deeply embedded paradigm-thinking within the different specialties,” she says.

Beyond these new disruptions, Jagger is appreciating life’s roses. She relishes relationships she’s building within the diverse patient community, looks forward to spending time with a new granddaughter, enjoys sewing and collecting textiles, plans to spend more time in France with her native French husband, works on providing FMF resources to Syrian refugee children, and is developing writing projects, including two books. She’s undaunted about the challenges ahead for patient-community research. “If something is not scientifically valid, let it fail,” she says. “We will just keep building the evidence and let the evidence speak for itself.”