By Ed Coghlan
On a chilly November 21, 2012, Dr. Terri Lewis was standing in the Vanderbilt Spine Imaging Center watching television, waiting for her son Ian to complete a series of body scans necessary to plan and execute a third spinal fusion. On the television monitor overhead the newscaster conducted the daily news roundup. On that particular day, the news roundup included a story about the recall of corticosteroids compounded by a firm in Framingham Massachusetts and distributed as epidural steroid injections. At the same time the news was breaking, her son joined her and together they listened to the newscaster who concluded his remarks with something on the order of, “while this is not expected to be a large problem, Tennesseans may be affected and should check with their pain management physicians to determine whether they may have been exposed.’ As the newscast concluded, Terri and Ian looked at each other and at the same time said, “oh hell no!”
On the drive home, she called Nashville News Channel 4 and spoke to the newsroom crew, one of whom she knew. She advised the news crew that this was a potentially deadly event of some magnitude and that whatever they did, they were not to dismiss it since potentially hundreds of persons could be affected. Upon arrival, she emailed the newsroom with copies of scientific articles necessary to understand the story they had just broken to the public.
Tennessee was ground zero, followed closely by Michigan, Indiana, and Virginia. Over the days and weeks that followed, the news filtered from newsrooms across the nation that across 21 states, 17,000 doses of potentially contaminated corticosteroids and other compounded medications were injected into spines, muscles and joints and distributed to 13,500 +/- persons aged 16 – 102 years of age. Injection locations included hospitals, clinics, and physician practices. CDC issued guidance to states to recall both product and locate potentially injured persons. Pain clinics in the 21 states were advised to check their stock and distributions to patients and to notify them of potential exposure and consequences. Unfolding injuries included meningitis, paraspinal infections, epidural abscesses, joint infections, and strokes – alone and in combination. The ‘cure’ was a crapshoot that involved deadly medications, surgeries, and a lot of watching and waiting. Like all medical catastrophes, the follow through by state public health agencies was uneven and inconsistent – not only was there no medical precedent, there was no legal or enforcement precedent to force cooperation.
In the days following, the Tennessean Newspaper lifted a Facebook group onto its web tools to track the story of the largest compounding disaster in US medical history. Family members and injured people began to amass in cyberspace as the Facebook link was distributed through media resources. As a clinical practitioner, Terri stepped into the void and enlisted the help of her colleagues, some of whom are themselves chronic pain advocates and persons recovering from injection injuries, to mount a follow along effort through social media, scouring media reports and collaborating together to track and trace, find and follow, potentially impacted victims for the purpose of providing support, information, education and resources to families navigating uncharted waters. For four years, this voluntary effort has provided the most comprehensive natural history of a medical catastrophe outside of the federal public health system. The public’s memories are as short as the news cycles that keeps them informed. Over time, the noise in the news quieted, even as illnesses continued to ramp up and the magnitude of the catastrophe visited upon families became clear. Beyond the stages of grief and loss have emerged educated powerful advocates who schooled within this environment.
Dr. Lewis has extensive experience in the development and administration of community programs and systems of care for persons with disabilities and chronic health impairments. Her work life represents broad community rehabilitation industry experience, having served in the roles of educator; the Director of an overseas embassy based mental health program in the People’s Republic of China; Executive Director of a large rehabilitation organization, and collaborator with local, state, and federal agencies to create community mental health and rehabilitation services for unserved and underserved persons with a wide variety of needs. Her experience has been supplemented by working as an advocate with consumers who have direct personal experience with injuries accrued as the result of medical harms, and retired medical practitioners who were very knowledgeable about the environment in which this event had occurred. Together, they sought out the science, brokered information between patients and government agencies, and rounded up resources to identify, diagnose and move patients into treatment who were abandoned by the physicians who injured them.
They say that in an emergency, look for the helpers. “I really stand on the shoulders of consumers who have been harmed and the helpers – the giants who stepped forward to catch families and fold their arms around them in hours of great need,” reflects Terri. Without the opportunity to educate myself through their experiences, it is unlikely that anyone would have been prepared to respond to the visceral trauma imposed on hundreds of individuals and their families. Nobody recognizes the needs of the injured like those who have gone through a similar experience and survived. Nothing prepares one for the unexpected and needless deaths of our loved ones. To know that these deaths were preventable and avoidable increases the trauma and delays recovery.
More than 800 persons were sickened and detected, and 77 deaths occurred in the months that CDC tracked the outbreak. More deaths have occurred as affected individuals linger between illness and death. Importantly, roughly 12,000 persons remain potential victims of this outbreak, sickened without understanding or the help they need. The information gained from families through this support network served as a reliable resource for addressing impact issues raised during the public hearings that followed. Terri and her volunteer team have contributed literally thousands of hours of patient education to families, legal teams, physicians, and the Congressional and Senate Committee staff. She served on the Patient Safety work group that contributed to the Drug Quality and Safety Act. Because federal charges were filed against the manufacturers of the contaminated materials, trials will be conducted in 2017. Together with information provided by the Department of Justice, the documentation that Terri and her colleagues gathered throughout the many months of this event allowed Congressman Mike Bishop’s (MI) office to successfully advocate for the award of USDOJ Crime Victims funding for injured individuals and families.
The cases have moved to Boston bankruptcy and criminal courtrooms. A lot of work remains to fully understand the longer term magnitude of this event. She and her colleagues continue to closely examine the factors that led to the outbreak, the public health response failures, and monitor the implications for patient safety. Stepping into the healthcare void and asking for help from those who could address gaps in the public health response saved lives. Dr. Lewis doesn’t know who nominated her in the category of Patient Safety Activist for a 2016 WEGO Health Activities award.
But she wants to use this nomination to call attention to the role of medical harm in creating unrecoverable injuries from which chronic and intractable pain develops. The individuals affected by this event, like the majority of those who seek pain management and relief, were working hard to stay functional. They were not diverting medications, addicted to illicit drugs, or misusing multiple forms of compounds. They were like the majority of us, working to conform to healthcare they thought would help them continue to stay as active as possible. And that is why it is so important to keep this event in the public eye.
If you or someone you know may be a victim of the fungal meningitis outbreak, please join at this link: https://www.facebook.com/groups/meningitisoutbreak/?ref=bookmarks
The complex legal history of this event has been closely documented by Walter Roche and can be viewed on his blog at: https://meningitis-etc.blogspot.com/2016/09/extension-sought-in-st-thomas.html