They intended to strike a $1 million marketing deal to increase sales of extended-release opioids, especially among the “opioid-naïve,” people who had never been prescribed such a drug.

The companies aimed to achieve this goal by influencing doctors’ behavior in the exam room through an alert on their electronic health record system—delivered right when they were considering which medications to prescribe to their patients.

Clouded by legal concerns, Practice Fusion sales reps pushed forward by cloaking their intentions. When one employee asked another for a copy of the return-on-investment model, the individual clarified, “Actually … without saying ROI … I mean the ROI spreadsheet ;).”

Sales reps were happy to estimate a gain of 2,777 patients, worth between $8.5 million and $11.3 million in revenue. That kind of calculation was critical to success, as the buyer wasn’t a healthcare or research expert, but a team of pharma marketers.

Sales of extended-release opioids had fallen, and they hoped to reach the tens of thousands of healthcare providers and millions of monthly patient visits served by Practice Fusion’s technology.

The deal closed in early 2016. By the end of the year, Practice Fusion had sent alerts promoting extended-release opioids to 97,000 healthcare providers during 21 million patient visits. Last spring, the total number of issued alerts jumped to 230 million, and the companies found that targeted providers had prescribed extended-release opioids at a higher rate than their peers. The campaign worked.

We know this information thanks to documents (PDF) revealed on January 27 by the US Department of Justice, which accompanied news that Practice Fusion agreed to pay $145 million to settle criminal and civil investigations into violations of the Anti-Kickback Statute and related issues.

The settlements stemmed from the deal that Practice Fusion had inked with the pharma company at, as government officials called it, “the height of the opioid crisis.” The tech company’s solicitation and acceptance of payments in exchange for influencing healthcare providers to write more extended-release opioid prescriptions proved to be a grave mistake.

The simplistic narrative that opioid prescribing caused the overdose crisis is flawed, ignoring vital socio-economic and policy factors, as Filter‘s coverage has reflected. The overwhelming majority of people who use prescription opioids don’t move on to addiction, chaotic use or heroin. There is some connection; for example, one 2013 study found that most people who use heroin started with prescription pain relievers. Yet the much-hyped image of the doctor as drug dealer has driven crackdowns that cut off people with pain from receiving vital meds.

But the fact remains that Practice Fusion and its pharma partner unethically expanded extended-release opioid prescribing to people who were denied unbiased consideration of other options, including immediate-release opioids.

We’re not talking about a banner advertisement for Oxycontin. We’re talking about a clinical alert. One that doctors had a right to believe was not influenced by commercial motives.

The means employed to get opioids in patients’ hands is deeply disturbing. These companies set out to influence healthcare providers’ behavior at the point of care. The prescription pad was in reach when they received the alerts. And those notifications came from a clinical decision support system—a tool designed to fill medical knowledge gaps, drawing on evidence and quality standards.

Take a second to digest that. We’re not talking about a banner advertisement for Oxycontin. We’re talking about a clinical alert. One that doctors had a right to believe was not influenced by commercial motives.

When profit-driven third parties enter the patient-physician encounter in unscrupulous ways, covert bias and greater risk enter medicine. If a doctor can be influenced by marketing material masquerading as a clinical warning, as they were in the Practice Fusion case, then we have a big problem.

Healthcare providers might lose trust in evidence-based alerts, and patients might lose trust in their care teams. That complicates and perhaps destroys the patient-doctor trust required in making important decisions—like the one to begin taking extended-release opioids. And the revulsion prompted by a scheme like this simultaneously threatens to further block pain patients from accessing much-needed opioid medications.

I’ve worked in the health-tech space for several years, both as a journalist and as a marketing and communications strategist. I’ve spent plenty of time discussing, writing and editing pieces on clinical decision support systems, so I appreciate their ability to improve medicine. The tech can warn doctors of risks such as dangerous medication combinations, improve prescribing and even nudge providers toward less expensive medications. Considering medical errors are a leading cause of death in the US, clinical decision support could benefit all of us in powerful ways.

That’s precisely what Practice Fusion was doing before it turned to opioids. According to the DOJ, the company impressed its potential pharma partner by pointing to a clinical-decision support initiative that led to greater vaccination rates. The opioid deal could have focused on gathering real-world evidence to help us better understand opioid prescribing, use and outcomes.

But according to the government, Practice Fusion and its pharma partner had little interest in research except as cover for their money-hungry endeavors. Make no mistake: This deal was all about cash.

As healthcare tech and policy expert Dan O’Neill wrote in a must-read Twitter thread, this unfortunate case spawned from an original sin: exorbitant pharma marketing spend. In 2016, he noted, drug manufacturers dropped roughly $20 billion on advertising for doctors and other clinicians.

Some reasonable voices oppose the demonization of pharma, and I’ve worked for useful companies that rely on pharma dollars. But whether you love, tolerate or hate it, pharma ads are part of the American marketing fabric. In fact, the US FDA doesn’t just approve medications; it also regulates the marketing that supports these drugs, clinical software and medical devices.

Pharma companies and ad agencies employ med legal review teams, whose sole job is to make sure the ads don’t land the organization in hot water. At the same time, much of the anti-pharma sentiment over opioids can be tied to companies’ questionable or downright sleazy marketing.

Over the past decade, electronic health records companies have entered nearly every doctor’s office in the nation. It wasn’t long before these tech firms saw the opportunity to partner with pharma to fill ad space in their systems, O’Neill wrote. Still, he added, this was hardly incomprehensible, considering pharma’s long history of schmoozing doctors and plastering its brand names on medical office products.

But, once you choose that ad-driven path, commercial gravity tugs in the direction of selling more ad inventory, and creating more effective advertising tools (See: Facebook). All the more so, perhaps, if the company is venture-backed and trying to reach breakeven.

— Dan O’Neill (@dp_oneill) January 28, 2020

By late 2016, the year the extended-release opioid deal launched, Practice Fusion had raised more than $157 million in venture capital, according to Crunchbase. In the run-up to that time, Practice Fusion’s then-CEO, Ron Howard, brushed off concerns that clinical decision support ads could cause patient harm, Jacob Reider, a doctor and former clinical decision support regulator, wrote in a popular blog post.

Howard reportedly said the responsibility was still on the doctor. “But he was concerned about revenue,” Reider wrote. “And revenue was not flowing as fast as the investors had been promised it would.” Indeed, government documents confirm Practice Fusion’s urgent need for cash, highlighting internal emails that said as much.

It feels like the game is rigged, as the forces that claim to be fighting for us work against us.

Google’s motto used to be, “Don’t be evil.” Privacy scandals, contracts with authoritarian governments and misinformation have tainted tech’s image. Through my work with tech companies, including at least one Practice Fusion competitor, it’s clear to me that most people in the business want to improve healthcare. But the Practice Fusion debacle has jolted perceptions to a new low—sickening doctors, industry insiders and patients alike. The worst of tech, it turns out, is no better than the worst of pharma. At risk are healthcare autonomy, patient care and public health.

It feels like the game is rigged, as the forces that claim to be fighting for us work against us. Pharma develops a pain reliever that can restore quality of life, and then pharma misleadingly downplays its risks and dishonestly markets it. Tech creates tools that can fill critical gaps in care, and then tech uses them to surreptitiously promote drugs for financial gain. The government busts companies involved in a kickback scheme, and the government continues to criminalize addiction. We lose.

In this cycle of reckless behavior and bias, it’s important to note that many patients can retain some trust in their doctors. The kind of high-rate opioid prescribing that might induce suspicion, for example, is associated with a small percentage of healthcare providers, according to a new study. Many doctors want to provide strong, human-centered care so badly that they experience burnout when structural forces impede this approach to medicine.

But if you’re the one waiting for a prescription, it’s hard to overlook the Practice Fusion case’s implications that commercial interests might be unknowingly influencing your provider’s behavior.

One thing we can do as patients is to become active partners in our medical care and ask doctors about the reasons for their decisions. Covert commercial bias doesn’t guide every healthcare decision, but we have a right to all the scrutiny we can muster.

Photo by Nathan Dumlao on Unsplash.

The post After a $145 Million Opioid Kickback Settlement, Can We Trust Our Doctors? appeared first on Filter.

I break down and wail. Kelsey was 21 years old. She had barely begun to live.

After a few minutes, I shower and head to work, as if this is a normal day. On the drive, I recall times Kelsey (a pseudonym to protect her immediate family’s privacy) and I shared as teenagers in middle-class New Jersey suburbs. When I was in high school, I joined a cheesy pop-punk band that couldn’t play on time. Kelsey and another cousin came to nearly every show, despite the 90 minutes of highway separating our hometowns. She showed up when many others didn’t.

My aunt’s visible, crushing heartbreak is the only thing I remember from the funeral and wake.

So where was I when she needed someone the most? I walk inside the office, sit down, stand up and leave.

The next few days are draining. My aunt’s visible, crushing heartbreak is the only thing I remember from the funeral and wake. Over the next few weeks and months, there’s crying and reminiscing, cursing, questioning and drinking. The sadness eventually sinks to a point where this tragedy no longer controls every conversation. But no one stops thinking of Kelsey.

More than six years later, the country has changed. Since 2013, New Jersey, the United States and the public have altered their view and, in some cases, their response to opioid addiction. Governments have expanded Good Samaritan laws and access to the overdose-reversal drug naloxone. Treatment with buprenorphine or methadone has gained prominence. Safe consumption sites, where people can use drugs under medical supervision, are close to taking root. Perhaps most remarkable, after 200,000 additional drug overdose deaths since Kelsey’s passing and intense lobbying, some people in the US are abandoning the idea of the “addict” as the morally bankrupt, repulsive junkie.

I chose to write this piece to answer some simple questions: What could have saved my cousin’s life? Could recently implemented state and federal policy have prevented this awful outcome? And what work remains to help those who use opioids today?

A Good Samaritan

After Kelsey died, stories from the years she spent on opioids trickled out. Her final overdose, I learned, wasn’t her first. During that initial respiratory shutdown, she got lucky. Someone found her, called 911 and secured medical treatment. Kelsey woke up.

After the nation’s latest “opioid crisis” entered the public consciousness around 2008, overdose response emerged as a prime target for drug policy reform advocates, bereaved parents and some politicians. They began demanding and passing Good Samaritan laws, which typically granted immunity from arrest or prosecution for low-level drug offenses to people who called 911 for medical assistance during a companion’s overdose.

“We want you to save a life first,” New Jersey’s then-governor Chris Christie said at a bill signing ceremony in 2013—though only after changing his mind on the law. “I would rather you didn’t do it in the first place, but I live in the real world.”

New Jersey lawmakers had introduced an early incarnation of the bill in 2012, which Christie vetoed. He said it didn’t promote deterrence and public safety. Next spring, the Democratic legislature and the Republican governor’s office struck a deal and enacted a similar law, the Overdose Prevention Act, which provided for immunity and expanded naloxone access to spouses, parents and guardians.

On the day of the signing, a 23-year-old man overdosed in a Burger King parking lot in South Brunswick Township, not far from Rutgers University. Cops declined to bring drug charges against the person who called for medical assistance, which they said was consistent with existing departmental practice. But police noted that other criminal charges remained on the table.

So despite the Overdose Prevention Act, the fact that drug users could face some form of legal consequence was clear immediately after New Jersey cemented the law.

By July 2018, all but five states had adopted some form of Good Samaritan law. But people who use drugs often don’t understand the legislation.

Sheila Vakharia, deputy director of the Department of Research and Academic Engagement for the Drug Policy Alliance*, a leading advocate of harm reduction policies, said similar problems remain in communities across the US. “Some cops know that they can’t charge you if you call 911 in the case of an overdose, but now they’ll charge you for murder, rape. Drug-induced homicide is a new charge that people are finding,” she told Filter, summing up a report examining homicide charges against people who buy drugs to consume with a friend. “I can be charged with your murder because I woke up and you didn’t, and I supplied you with the drug that led to your death.”

By July 2018, all but five states had adopted some form of Good Samaritan law. But people who use drugs often don’t understand the legislation. In some places, 911 callers receive protection from probation and parole violations, while those in other states don’t. Vermont, meanwhile, goes as far to extend protections to drug dealers.

The degree of immunity and applicability are scattershot, dependent on local politics and deal-making. The murkiness breeds ignorance, misinformation and fear—meaning people who use drugs often remain hesitant to call 911. “Most people don’t actually know what’s protected,” Vakharia said. And when people discover that they are or could be vulnerable under state law, many don’t take the risk.

Good Samaritan rules continue to evolve. (In 2015, for instance, New Jersey updated its law to further naloxone access and liability safeguards.) While the system is flawed, it’s encouraging that states are taking immunity seriously. That’s in part because it works. In 2011, the state of Washington found that 88 percent of people who use opioids were more likely to call for help thanks to these protections. Researchers observed similar effects of immunity on alcohol poisoning calls on college campuses.

But when my cousin Kelsey overdosed on heroin (in her case, unlike most, heroin alone was involved), New Jersey had already enacted the Overdose Prevention Act. Naloxone and immunity from arrest couldn’t save her. She was alone in her room. No one could have noticed.

A Safe Place to Use

Everyone knew Kelsey was making progress on recovering from her addiction. She had gotten off of opioids and relapsed before. But it was never easy.

On that early September morning, her father walked upstairs to check on her, just in case. He found Kelsey unresponsive with a needle in her arm. He called 911, and emergency responders rushed her to the hospital. They couldn’t bring her back.

I often wonder what would be different had she overdosed alongside someone else. Easier to answer is the question of what would have happened had she overdosed at a safe consumption site (SCS).

Also known as overdose prevention or safe injection facilities, these havens, which operate successfully in many parts of the world, allow people to use drugs they bought on the street under medical supervision. Staffers provide access to clean syringes and water, offer resources on getting help, and monitor for signs of overdose, equipped with naloxone. The thinking: If people are going to use opioids, we ought to keep them alive while they do it.

The first such facility opened in the mid-1980s in Switzerland, sparking a wave of SCS across Europe. In 2003, Insite Vancouver and its team of nurses began welcoming drug users in Canada, making it the first SCS on the continent. As of this past July, the renowned organization had hosted more than 3.6 million visits and nearly 50,000 clinical treatments, performing more than 6,000 overdose interventions, according to Vancouver Coastal Health. Not a single person has died on its watch—nor in any authorized SCS around the world.

“They have amazing research outcomes.”

Not a single US city has opened a sanctioned SCS, though numerous unauthorized ones operate. But that could change. In October, a judge ruled in favor of one such facility slated for Philadelphia, making its launch foreseeable. The decision further motivated SCS advocates in Seattle, San Francisco and Portland, Oregon. Legislators from California to Maryland—and yes, New Jersey, Kelsey’s home state—have also tried to legalize them.

“They have amazing research outcomes,” Erin Zerbo, a psychiatrist who works in Newark, New Jersey, and teaches at Rutgers New Jersey Medical School, told Filter. “Of course, this never convinces anyone, but it decreases costs, people don’t go to the [emergency department] for their access anymore, and then even the local police and the neighbors end up liking it because the streets are cleaner. People don’t litter their needles and car thefts go down.”

By and large, she added, SCS serve the most vulnerable populations: LGBTQ youth, homeless people and other marginalized groups. Here, people have a chance to not only use safely but also to rebuild connections and trust with the healthcare system, as well as social services or treatment. (Still, SCS and their guests risk backlash or increased scrutiny from police, Vakharia warned.)

It’s wonderful to hear of a resource geared toward society’s most vulnerable members. The US needs to begin holding ribbon-cutting ceremonies for these sites—now. But had SCS facilities dotted New Jersey in 2013, it’s unlikely that my cousin Kelsey would have visited one. As Zerbo said, SCS often don’t tend to draw people who have housing. They can simply inject at home—safe from the law but at greater risk of overdose.

Follow the Evidence

Kelsey went to inpatient rehab several times, but her health insurer denied continued coverage after she relapsed. Insurance and cost remain substantial barriers for people who use opioids, even in the face of reforms such as the Affordable Care Act. After Kelsey’s death, I considered her insurer a culprit. I overlooked, however, another contributor: the ineffectiveness of many rehab clinics.

More than a century ago, physicians used drugs such as morphine to help people with substance use disorder taper off, Zerbo said. Then, after prohibition took hold, the government vowed to end the practice and arrested thousands of doctors. “So they basically stopped treating addiction,” she said. “And in my medical school, we got very little addiction education, even in my psych residency.”

Twelve-step culture⁠—with a success rate that Lance Dodes, a retired Harvard Medical School psychiatry professor, estimated at between 5 and 8 percent⁠—took over the treatment landscape. Emboldened by glitzy reality TV shows, celebrity endorsements and promises of a luxurious recovery, the market grew receptive to unproven treatments. This came at the expense of medication-assisted treatment, which initially consisted of methadone, whose proven clinical value suffered from stigma and stringent regulations.

Enter buprenorphine. The drug first drew attention in the 1970s when it was marketed as a nonaddictive painkiller, despite its potential to reduce cravings for other opioids and treat depression and anxiety. “I can’t tell you what really went on behind closed doors in executive boardrooms,” Arnold Washton, a psychologist who specializes in substance use disorder treatment and practices in New Jersey and New York, told Filter, “but the sense that those of us in the field got is that they did not want the image of the drug tainted.”

Decades later, buprenorphine, commonly prescribed under the brand name Suboxone, is, like methadone, a critical tool for people with opioid addiction. Both Zerbo and Washton are huge proponents of the clinically validated drug, especially in combination with therapy.

The stigma of medication-assisted treatment remains, causing some patients to reject buprenorphine and methadone entirely.

Still, burdensome regulation and corporate policy cap the medication’s prevalence. To prescribe it, physicians must take a special course, obtain a license and open their clinics up to DEA inspections. They can only prescribe buprenorphine to so many patients—a limitation known as the “X Waiver.”

And while insurance regulations have become friendlier to buprenorphine, Zerbo said that payers use legal workarounds to avoid covering the drug. Prior authorization requirements can slow prescribing times and increase physician burden—and thus their reluctance to prescribe buprenorphine. Finally, the stigma of medication-assisted treatment remains, causing some patients to reject buprenorphine and methadone entirely.

These pathways existed when my cousin Kelsey sought treatment, but they were less accessible than they are now. While government and passionate physicians and advocates have succeeded in expanding reach, they have a ways to go. Still, I wonder if this path or a more committed health insurer might have empowered Kelsey to survive. The evidence says it’s likely.

Criminalizing a Public Health Issue

I grew overwhelmed while writing this piece. I took a walk through the woods on a bitter-cold December day, much like one I spent with Kelsey when we were younger. I recalled telling her about some teenage problem or accomplishment of mine. She was attentive and compassionate, like always. As I searched my mind for a conclusion, I could find only one: I miss her. So much.

What could have saved my cousin? There are clearly things that would have improved her odds, but no one knows for certain.

“You can’t deny the fact that criminal justice involvement is a health risk and an overdose risk.”

Each harm reduction policy or innovation plays an important role in reducing opioid-related deaths. But as my sources pointed out, each potential solution faces challenges posed by common forces: criminalization and stigmatization. While those things persist, people like Kelsey will continue to be forced into secrecy and shame and placed at heightened risk.

“You can’t deny the fact that criminal justice involvement is a health risk and an overdose risk,” Vakharia said. Over the past decade, the US has made great strides in caring for people with opioid addiction. But we’ve yet to take the biggest step. The one that might help people like my cousin—and your friends and loved ones—more than anything else.

* Dr. Vakharia is a member of the board of directors of The Influence Foundation, which operates Filter. The Drug Policy Alliance has provided a restricted grant to The Influence Foundation to support a drug war journalism diversity fellowship.

Photo adapted from Ava Sol on Unsplash

The post Six Years Ago, My Cousin Overdosed. What Could Have Saved Her Life? appeared first on Filter.