By the time of their September 2015 meeting, they knew they weren’t working on a project to merely study opioid prescribing patterns or educate physicians. Employees for the electronic health records company Practice Fusion and an unnamed pharma manufacturer—reportedly Purdue—had a mutual understanding.
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.