PROVIDENCE – When Traci C. Green, Ph.D., testifies this week on July 1 before the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, she will be talking about the lessons learned from Rhode Island’s response to the current epidemic in accidental drug overdose deaths.

In particular, Green will present data summarizing the epidemic – and the state’s responses undertaken with respect to naloxone, or Narcan.

In her testimony, Green said she would be highlighting innovative efforts taken in response to the public health crisis during the last three years. They include: access to pharmacy-based Narcan; the training of law enforcement, physicians, pharmacists and other professionals in overdose prevention and response; community-based training efforts; prison-based Narcan trainings, and hospital emergency department-based recovery coach trainings.

Rhode Island’s exceptional policies – in sharing data, in treatment, in the collaborative approach that brought together law enforcement, the recovery community, and health professionals – were developed in response to the direct threat of a public health emergency, according to Green, who cited the leadership of Dr. Michael Fine, the former director of the R.I. Department of Health, and community advocates.

“We have [had] so many innovations in Rhode Island,” Green said, speaking with ConvergenceRI last week. “We implemented them early enough to actually have lessons to share with the scientific and medication safety communities.”

Green continued: “I will also cover some of the barriers experienced and challenges to further expansion of naloxone access, namely the [rising] cost of naloxone, which places the life-saving medication outside of reach for many of the people and programs that most need them.”

Green’s advice about how best to move forward for Rhode Island is direct: “We need to keep running in the marathon that we’ve been running in.”

Expert advice
Green is one of the region’s leading experts on the epidemic of drug overdose deaths. She is currently the deputy director of the Boston Medical Center Injury Prevention Center at the Boston University School of Medicine, and associate professor of Emergency Medicine and Epidemiology at the Warren Alpert School of Medicine at Brown University.

She chairs the R.I. Drug Overdose Prevention and Rescue Coalition, convened in 2012 by the R.I. Department of Health's Violence and Injury Prevention Program, a structured effort supported by a Centers for Disease Control and Prevention grant. One of the coalition’s collaborative efforts had been the training of first responders in identifying and responding to drug overdoses. Another had been the development of a new digital data collaboration focused on suspected drug overdoses treated by emergency departments in Rhode Island.

In terms of back story, it was Green’s original research, first reported on by ConvergenceRI in July of 2011, documenting the rise in accidental overdose deaths, with evidence taken from actual medical examiner case files, that influenced Fine to change the public health priorities in Rhode Island because of the demonstrated increasing loss of life. [See link to ConvergenceRI story below.]

Quite simply, when Green talks, people have learned to listen. Green was specifically invited to testify before the FDA.

Bow-wow, arf-arf, neigh
Surprisingly, however, no one from the state had reached out to researchers like Green or to anyone in the recovery community to ask them participate in a news conference and roundtable convened by Gov. Gina Raimondo and Sen. Jack Reed on Monday, June 22, at the offices of the R.I. Department of Behavioral Healthcare, Developmental Disabilities and Hospitals in Cranston.

[For the record, ConvergenceRI was the one who reached out to Green; she made it very clear that her priority was working collaboratively with local, state and national officials, and she would not criticize anyone. Any and all critical analysis in this story belongs to ConvergenceRI, not Green.]

The event had been advanced with the news advisory headline: “Reed, Raimondo, Health Officials and Law Enforcement To Address Rhode Island Drug Overdose Crisis.”

It featured Raimondo, Reed, Maria Montanaro, director of BHDDH, Dr. Nicole Alexander-Scott, director of the R.I. Department of Health, and Colonel Steven O’Donnell of the R.I. State Police.

Equally puzzling, no one from the recovery community – health practitioners or peer recovery leaders – was invited to attend or to speak at the roundtable.

The hour-long dog-and-pony show for the news media was held ostensibly to champion the new “Overdose Prevention Act” that was to be submitted the next day by Reed.

Ironically, many of the very things that Reed’s proposed legislation was intended to address – to increase the availability of Narcan and the training of law enforcement in its use, as Reed told ConvergenceRI in a brief interview before the event – were exactly the kinds of efforts that the state's recovery community and public health officials had championed and put into place; topics that Green would be testifying about before the FDA, a week later, based on Rhode Island’s experience.

Can you spell disconnect?

Little substance
The so-called roundtable on June 22 provided little if anything new of substance regarding state policies on substance use and abuse, despite the obvious concern and dedication of state and elected officials in the room.

Beyond Reed’s new legislation, the rationale for calling the news conference was purported to be the release of a report by The Trust for America’s Health, using a three-year average of federal injury data from 2011-2013, that “found that Rhode Island has the 7th-highest rate of drug overdose deaths in the nation,” according to the media advisory.

•   One major problem was that the report’s data was old; it was not news, and it didn’t include the most recent statistics from 2014 and 2015 that Rhode Island has been tracking. 

During the last year and a half, the crisis had peaked in numerous other states such as Massachusetts, where there had been large increases in the number of deaths.

In Rhode Island, the loss of life, while high, was mitigated in large part as a result of the innovative efforts regarding the use of Narcan – the efforts that Green would be testifying about before the FDA. Health agency officials had estimated that as many as 500 lives may have been saved by the expanded use of Narcan.

•   A second major problem was that, on the very same day, Massachusetts released the findings from an 18-member working group, in a comprehensive report detailing 65 actionable steps to curb the deadly epidemic, under the direction of Mass. Gov. Charlie Baker.

The timing of the hastily-called event in Rhode Island struck not just ConvergenceRI but another top Rhode Island news reporter as curious. [Baker had discussed the upcoming report with Raimondo the week before, when they had lunch together at Angelo’s on Federal Hill, according to Raimondo. In response to questions, Rhode Island state officials spoke about the importance of a more regional, strategic approach to the work.] 

“We are not going to arrest or incarcerate our way out of this,” said Mass. Attorney General Maura Healey, who co-chaired the working group, speaking at the Massachusetts’ event announcing the state’s new comprehensive plan, according to a Boston Globe story. “Addiction must be treated like any other chronic illness,” she said, citing the need for a public health approach. Further, Healey said that she would enforce the state law requiring insurers to cover behavioral health in the same way they cover physical health.

[Earlier this year, Healey had sent letters to manufacturers of naloxone, asking them about price increases, and urging them to keep costs low. She has also endorsed a program that would allow the state to buy naloxone in bulk and sell it to municipalities.]

•   Healey’s forceful comments illuminated a potential third major problem looming: the absence of R.I. Attorney General Peter Kilmartin at the table at Monday’s roundtable, and continuing controversy over different versions of the renewal of the Good Samaritan Law then under consideration by the R.I. General Assembly.

The Senate version of the law, favored by the recovery community and many public health professionals, included what advocates saw as important improvements in the law. It would have enabled those who called 911 in order to save the life of someone who is suspected of overdosing to have additional legal protections, so they would not be charged with the potential crime of dispensing drugs or a potential parole or probation violation.

The House version merely extended the previous version of the law with its limited protections, after Kilmartin voiced criticisms of the increased legal protections.

When asked by a reporter about which version the Raimondo administration supported, everyone at the table – Alexander-Scott, Montanaro, O’Donnell and Raimondo – looked at each other, unsure who was going to handle the hot potato.

Then Raimondo stepped up to the plate – but instead of swinging, she ducked the question, avoiding giving an answer that addressed the underlying issues.

The goal, Raimondo said, was to make sure that law did not sunset on July 1, and to get it enacted this session.

[Reed, for his part, also ducked answering the question about the underlying issues. When asked about the controversy before the roundtable, Reed said that it was a matter of state policy, for state lawmakers to decide.]

Raimondo’s strategic choice not to address the underlying issues head-on appears to have backfired.

When the R.I. General Assembly’s current session abruptly recessed on Thursday, June 25, with Senate President M. Teresa Paiva Weed saying that negotiations had reached an impasse, one of the unresolved issues was over the Good Samaritan Law.

As a result, the Good Samaritan Law has been sunset; Raimondo missed a huge opportunity to lead from her bully pulpit – or at least engage the public in a conversation on the substantive issues.

Can you spell disconnect?

In limbo

The Good Samaritan Law will not have significant impact unless you can change people’s behavior, explained Dr. Jody Rich, a professor of Medicine and Epidemiology at Brown University and an attending physician at The Miriam Hospital.

“People at the scene of an overdose need to be encouraged to call 911,” Rich said. “We know there’s a tremendous reluctance to do that.”

The R.I. General Assembly, by not passing the law and allowing it to sunset, Rich continued, have made it more difficult. “That’s going to be a very difficult message to promote,” he said.

The second part of changing behavior, Rich said, applies to law enforcement. “Law enforcement needs clear direction that responding to an overdose is a medical emergency, and should be treated as such – and not treated as a crime scene.”

The goal of the Good Samaritan Law is to save lives, Rich stressed, but it should be seen in the context of a larger public health strategy to recognize and treat addiction as a disease, to reduce its stigma, and to make Narcan more available. “Arguably, it’s the number-one health crisis in the state; it needs the appropriate attention.”

One in eight

Holly Cekala, the executive director of Rhode Island Cares, one of the leaders of the recovery community in the state, had attended the June 22 news conference uninvited. [She had been alerted by ConvergenceRI about the event, who had asked her in advance if she knew anything about the gathering; she hadn’t.]

Afterward, Cekala said she was disappointed. 

“I was unimpressed by what was said at the news conference,” Cekala said, who had supported the Senate version of the Good Samaritan Law as being in the public's best interest, because "it considers all families and makes the public health message clear – call 911."

She rattled off the statistics of what the data show: one in eight people living in a Rhode Island home are at risk of addiction. The risks cut across all social, ethnic, racial and economic boundaries.

It could be the family caretaking for an elder, legally prescribed more and more of an opiate medication for pain, Cekala continued. It could be a family with a young high school athlete being treated for an ankle or knee injury in the ER who is legally prescribed opiates; it could be a family where someone has a serious back injury that results in legally prescribed pain medication; it could be a family with someone just back from a military tour being treated for pain legally at the VA; it could be a family on Medicaid, with little or no access to oral surgery care, being treated legally with prescription painkillers; or it could be a family with a son or daughter in early recovery from a substance use disorder being legally treated with bubenorphine, an anti-opioid drug, by a doctor. It could be family with a member self-medicating not so legally. 

“It doesn't matter what the situation is, because all lives matter. We believe all families have a right to protect their loved ones, without the threat of criminal or civil liability,” Cekala said. But with the sunset of the Good Samaritan Law, she continued, “They no longer have that right. It was a most irresponsible action by our leaders to let that happen.”

[Editor's note: A "live-in" rally and news conference at the State House Rotunda has scheduled for Wednesday, July 1, by Protect Families First, according to Rebecca Nieves McGoldrick, executive director of the community group, to protest the sunset of the Good Samaritan Law.]

History lesson

Back in 2011, when Green was first mining the data from medical examiner case files in Rhode Island and Connecticut, funded by a small, two-year $250,000 grant from the Centers for Disease Control and Prevention, her work exposed a fundamental gap in research and policy: no one – hospital ERs, community mental health agencies, or the R.I. Department of Health – was collecting or tabulating data related to accidental deaths from opioid overdoses in a comprehensive, standardized fashion. 

“The only thing we know is that the number of deaths are extraordinarily high,” Green said at the time.

In response, the R.I. Department of Health, under Fine’s leadership, changed its public health priorities, and began to assemble a coalition across numerous sectors to develop policy responses and interventions, based on what data and evidence revealed.

In early 2014, when 22 people died from drug overdoses within 13 days, with tests showing that 13 of the deaths may have involved fentanyl, a powerful synthetic painkiller, Fine took action, holding a series of dramatic news conferences and community meetings, to address what he saw as a public health crisis. In turn, the Department of Health began to put out the numbers of suspected deaths on a regular basis.

“The speed in which Rhode Island made overdose data available, and the level of detail officials publicized, sets the state apart from Massachusetts, which is trying to get its arms around its own drug problem,” wrote reporter Joseph Markman, in a story published March 16 in The Patriot Ledger. 

Many of the interventions that were developed – particularly around broad access, training, and use of Narcan – came out of the ongoing collaborative conversations of the coalition, and were data-driven. The placement of peer recovery coaches in emergency rooms on the weekends, for instance, was in part driven by data that showed the highest risk of accidental deaths from overdoses occurred on weekends.

In an exit interview in March with ConvergenceRI, Fine had talked about the importance of data and numbers. "The numbers are important, so we actually know what is happening. Deaths are tragic, but they are the tip of the iceberg. It’s important that we all understand how big the iceberg really is," he said. 

Not only did the agency track and frequently report deaths so that people could understand what’s out there, Fine continued, "We track the number of overdoses in emergency departments and report on those on a regular basis. We track the [number of] times Narcan has been used."

Those are critical numbers, Fine explained, "Because when you hear that Narcan had been used something like 2,000 times last year, then you begin to understand that had we not developed the Narcan policy, we might have lost 500 more Rhode Islanders in 2014."

The data also helped the agency understand about the use of fentanyl, Fine continued. "As bad as fentanyl is, and as good as Narcan is, none of this would be necessary if people weren’t using, and that’s the epidemic that we must confront."

Moving forward
As many practitioners in Rhode Island’s innovation ecosystem know, the innovation process is an iterative adventure, requiring nimble and flexible responses when situations change and data point in a different direction.

The success of much of Rhode Island’s interventions around confronting the challenges of overdose deaths and substance abuse in the last few years have been built around collaborative conversation and speedy access to good data.

It’s a point that Green will emphasize in her testimony before the FDA: “Keep really close to the data and be as on point as possible,” she told ConvergenceRI, which she said is the continuing focus of the R.I. Drug Overdose Prevention and Rescue Coalition.