The rural North Carolina county renowned for its success in combating prescription drug abuse has a dirty little secret: Things are just as bad as they were before. When activist and hospice chaplain Fred Brason appeared to dramatically slash Wilkes County's drug abuse rates with his well-known "Project Lazarus," he became a virtual celebrity among health advocates.
The White House drug office praised his work. News organizations wrote about him. Other counties tried to copy his approach, which focuses on getting the community involved and increasing access to naloxone, a life-saving drug that reverses the effects of an overdose. The situation did temporarily improve in Wilkes, a county of about 70,000 in the state's northwestern corner where nearly one in four people lives below the poverty line. But the county's rate of deaths and hospitalizations from prescription drug overdoses have since climbed, returning to peak levels and underscoring the difficulty activists and policymakers face in tamping down abuse once and for all.
Overdose deaths in Wilkes had soared for half a decade before Brason built a coalition of law enforcement, doctors and activists to combat the problem, peaking at 28 fatalities in 2009. Then, within a few years of Project Lazarus, deaths began steadily declining, dropping to 14 in 2010 and then down to nine the following year. But then the progress stopped — and reversed. According to the most recent data available, 28 people in Wilkes County died from prescription drug abuse in 2014 and 40 were hospitalized in 2013, the highest rates ever recorded.
"I think the problem in itself is very concerning," said Theo Pikoulas, an associate director at Community Care of North Carolina. "It's not surprising to me we continue to battle this problem." Also concerning, at least to critics, is that Brason and his associates were paid by drug companies for consulting work. Brason, who disclosed payments from Indivior in a presentation to the Food and Drug Administration last year, says he provided consulting specifically related to opioid safety.
In the larger sense, Wilkes County's story illustrates the difficulties health officials face in combating prescription drug abuse, a nationwide epidemic in which overdose deaths have more than tripled in the past 20 years. The problem has become so severe that President Obama recently asked Congress to fund new prevention efforts and has announced new initiatives to crack down on overprescribing and improve access to overdose treatments. The Senate recently passed an opioid bill that would authorize funding for programs to combat prescription drug and heroin abuse.
Much of the problem stems from doctors over-prescribing pain medications, either giving patients too many pills at one time or giving them when they're not needed. But pain management advocates and makers of such drugs have recently pushed back against opioid-prescribing guidelines being written by the CDC, causing them to be delayed indefinitely.
Sticking up for Project Lazarus
But while Wilkes officials, activists and researchers, and even Brason himself, admit the uptick is troubling, most are careful not to criticize Project Lazarus or discredit its perceived ability to cut down on prescription drug abuse. "It's disappointing in a way," Brason told the Washington Examiner. "The numbers have bounced around a little bit," admitted Nabarun Dasgupta, an epidemiologist at the University of North Carolina at Chapel Hill who helped with Project Lazarus and recently completed a study on a major effort to replicate the approach statewide, funded by the Centers for Disease Control and Prevention.
Both men say the uptick is because people are now obtaining drugs outside Wilkes County, instead of in it.
But those assertions are anecdotal, as neither the county's health department nor the Wilkes County Sheriff consistently tracks the numbers. Rosie Summers, who handles records for the sheriff's department, said their data confirm that deaths from prescription drugs are rising again, but it's not clear where the drugs are being obtained. While Brason and law enforcement were focusing on drug overdoses half a decade ago, one officer devoted exclusively to the problem worked with pharmacies to gather information on who was obtaining a lot of drugs. But that's no longer the case, said Wilkes County Chief Deputy David Carson. Carson said he hasn't looked at the most recent data, but wouldn't be surprised if overdose rates had returned to near the 2009 peak levels. "I would imagine we are close, without looking at the data," he said.
Carson recalls Brason's efforts in Wilkes County during the height of the Project Lazarus rollout. He said he sent officers to a few training sessions, but says the agency didn't partner with Brason much beyond that. "I wouldn't call it a partnership," Carson said. "I think as far as education goes, he was helpful in that aspect, and then much beyond that I couldn't speak to it." When asked for comment on the current situation, the Wilkes County Health Department referred the Washington Examiner to Philip Nofal, medical director of Daymark Recovery Services, a local provider of mental health and substance abuse treatment.
Nofal said he wasn't aware of recent data showing overdose deaths are back to record highs. "Even if it does plateau, the effort has definitely shown benefits," he said. Nofal praised Brason's work, saying Project Lazarus deserves "lots of accolades" for introducing an approach that can be imitated in other counties. "All I can tell you is you rarely see scientific data that is so easily reproducible," he said.
Prompted by the project's initial success, leaders at Community Care of North Carolina decided to team up with Brason to try it out in other counties. Armed with a $2.6 million grant from the private Kate Reynolds Charitable Trust and the state's Office of Rural Health, they embarked on a three-year effort to train health providers on overprescribing and build community coalitions. "We had this idea that we would partner with Project Lazarus and we would try and take his model and try to implement that model statewide," said Theo Pikoulas, an associate director at Community Care of North Carolina. But Dasgupta found in his recently completed evaluation that the key was getting local health departments involved, and not necessarily precisely following Project Lazarus' hub-and-spoke model, which emphasizes coalition-building, public awareness, data and evaluation.
In the counties where the coalition was led by an entity other than the local health department, there was virtually no change in the rate of opioid-related emergency department visits relative to how many prescriptions were given out, even if the coalition got funding. But in counties where local health departments themselves led the coalitions, the rate of opioid-related emergency department visits relative to prescriptions was 27 percent lower compared to counties without local leadership.
Rather than casting any doubt on Project Lazarus' long-term effectiveness, Dasgupta largely blames Wilkes' recent rise in overdose deaths on a shift to heroin. Many drug abusers start with prescription drugs, but then move on to heroin, which can be cheaper and easier to obtain. "You'll see deaths have shifted toward more heroin and less toward the pills," Dasgupta said. But in the last five years, only one person in Wilkes County has died due to heroin use, according to data from the state's health department.
Heroin poisoning in Wilkes rose by about 6 percent from 1999-2014, a rate of growth much slower than in North Carolina overall, where poisoning rates increased 25 percent over the same period. Things "are a mess" in Wilkes right now, said one employee at a drug use coalition in North Carolina who asked not to be named for fear of retribution by colleagues. Project Lazarus initially seemed to do some good, she said, but that didn't last. "My theory on Wilkes County would be when a lot of attention was paid to that one county, it was effective, but now that it's gone statewide and no one is focusing on Wilkes County, it's just gone back up," the employee said. Brason is "definitely someone who talks a lot of game but doesn't do that much," she added. To achieve his initial success with Project Lazarus, Brason relied almost exclusively on volunteers. The group's only paid employees were himself and his wife, Karen Brason.
Brason reported an income of $106,456 plus $30,000 in additional compensation through Project Lazarus, which he ran through a nonprofit called "Coastlands Ministries," according to a 990 tax form for 2014. Karen Brason was paid $8,995 that year, according to the form.
Brason Paid by Drugmakers
Project Lazarus signed onto a letter last fall from the American Academy of Pain Management and other pain-management groups chiding the CDC for draft guidelines they said could make it too hard for patients to get pain meds. "Not only are the CDC draft guidelines inconsistent with established best practices, they will potentially make it difficult for patients who rely on them for pain control to access them from clinicians who are clear on how best to use them," the letter said.
Brason, who has accepted payments from makers of opioid painkillers for his consulting work on opioid safety and has been criticized by some for it, says he doesn't think it's right to go after just doctors and opioids themselves. His approach emphasizes educating patients on proper disposal and not giving their prescriptions to others as well as improving access to naloxone. "I think some of the incorrect approaches are to get doctors to prescribe less without any other activities going on," Brason told the Examiner. "Even a prescriber could do all the right things, but once that person walks out with that prescription, it's in the community."
At a July 2015 presentation to the Food and Drug Administration, Brason disclosed that his Project Lazarus received a charitable contribution that year from drugmakers Zogenix and Kaleo. The year prior, he got a contribution from Ameritox and an unrestricted educational grant from Perdue Pharma. Last year, he worked as a consultant for Indivior. Dasgupta has also received payments from drugmakers, including King Pharmaceuticals and Covidien. Brason says no one has paid him to advocate any specific approach to drug abuse prevention to the FDA or any other group. But some charge that his connections to drugmakers have caused him to shift responsibility from doctors who overprescribe pain medications. "Project Lazarus delivers a message that serves the interests of the pharmaceutical companies that give it money," said Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing. "That message is that we don't need more regulation for the drug companies. We don't need reduced prescribing because communities can solve this problem," Kolodny said.
Brason countered: "We completely stayed away from the blame game ... I don't take the approach that you're doing something wrong." Meanwhile, Brason has continued to receive widespread praise for his Project Lazarus.
In a November editorial, the Boston Globe called the effort "genius," writing that it offers lessons for other communities. But while the editorial noted that Wilkes County's overdose fatalities dropped by 69 percent over three years, the newspaper only later added a "clarification" that they're increasing again. The Robert Wood Johnson Foundation awarded Brason its Community Health Leaders Award in 2012. That same year, the White House jumped to praise Brason's work, with drug czar Gil Kerlikowski visiting Wilkes in August to applaud Project Lazarus. "I think Project Lazarus is really an exceptional organization," Kerlikowski said at the time. "Your approach is a bit unique, so we have this wonderful opportunity to talk about what you're doing and show the collaborations the reverend talked about are really important."
When Brason travels the country touting the results of his Project Lazarus to local health officials and medical associations, he doesn't mention the most recent data, which call into question its long-term effectiveness. About a year ago, in a meeting with health officials from Westmoreland County, Pa., Brason pointed to Project Lazarus-collected data he says show that in 2011, no overdose deaths resulted from opioids from a prescriber in the county, down from 82 percent in 2008. But nine people still died in Wilkes from overdosing that year. And Brason didn't appear to share that overdose deaths are back on the rise.
In November 2014, Brason told a state legislative meeting convened by the American Academy of Family Physicians that Wilkes County experienced an 89 percent drop in the number of overdose cases. But the decrease doesn't appear to have been that sizeable. Fatalities fell by 69 percent from 2009 to 2011 and hospitalizations dropped by 45 percent from 2009 to 2010, but began rising again the following year. Dasgupta insists Project Lazarus left an important legacy in Wilkes County, even if overdose deaths are increasing again. "Year-on-year the people dying in Wilkes are not getting the pills from anyone in the county," he said. "The public record numbers don't tell that story, but you need to go into understanding each case."
Another person who helped kick off Project Lazarus was Kay Sanford, an epidemiologist for North Carolina before her retirement in 2007. Around that time, Sanford met Brason and helped him design Project Lazarus and get it going in Wilkes. Sanford admitted she's aware of a "small increase" or at least a "plateau" in the number of overdose fatalities in Wilkes, but insisted there hasn't been a "continued dramatic increase."
"To me, that is a reflection of the real difficulty in dealing with people who are misusing or addicted to pain medication," Sanford told the Examiner. "There is no quick fix, and even though we can see some major shifts, it's something we'll never be able to clap our hands and say we're done."
By Page Winfield Cunningham - The Washington Examiner/April 3, 2016
Graphic: The Lazarus Project