To doctors opening patients’ electronic records across the U.S., the alert would have looked innocuous enough.
A pop-up would appear, asking about a patient’s level of pain. Then, a drop-down menu would list treatments ranging from a referral to a pain specialist to a prescription for an opioid painkiller.
Click a button, and the program would create a treatment plan. From 2016 to spring 2019, the alert went off about 230 million times.
The tool existed thanks to a secret deal. Its maker, a software company called Practice Fusion, was paid by a major opioid manufacturer to design it in an effort to boost prescriptions for addictive pain pills — even though overdose deaths had almost tripled during the previous 15 years, creating a public-health disaster. The software was used by tens of thousands of doctors’ offices.
Its existence was revealed this week thanks to a government investigation. Practice Fusion agreed to pay $145 million to resolve civil and criminal cases, according to documents filed in a federal court in Vermont. Practice Fusion admitted to the scheme. The opioid maker was not named, though the details of the government case closely match a public research partnership between Practice Fusion and Purdue Pharma Inc., which makes OxyContin.
Representatives for Purdue Pharma and the Vermont U.S. attorney declined to comment. Health-software company Allscripts Healthcare Solutions Inc., which bought Practice Fusion for $100 million in 2018, said in a statement that the conduct predated the deal and that Allscripts has “further strengthened” compliance at Practice Fusion. The company didn’t answer specific questions about the settlement.
As deaths from opioid overdoses mounted, states and individuals filed lawsuits accusing manufacturers of pushing drugs while downplaying risks. Many millions of pills were dispensed at pain clinics in rural areas, fueling a vigorous street trade.
The Practice Fusion case shows a more subtle method of reaching drug consumers. Employees estimated internally that the drug company could add almost 3,000 patients and bolster opioid sales by as much as $11.3 million through the partnership. Under the contract, the drugmaker paid Practice Fusion almost $1 million.
“The pharmaceutical industry was egregious in advancing and propelling the access of opioids to a wider and wider population,” said Bertha Madras, a professor at Harvard Medical School who served on the President’s Commission on Combating Drug Addiction and the Opioid Crisis. She described the Practice Fusion arrangement as “nefarious and subtle.”
Big tech companies have large-scale plans to reinvent healthcare, promising to revolutionize areas such as electronic records, which are a crucial source of data about consumer health. But the Practice Fusion case shows how such plans can be exploited and even provide a new avenue for financial interests to influence treatment.
The San Francisco company was founded in 2005 and became known for its unique model of providing free, ad-supported health-records software to independent doctors. The company says its cloud-based platform has grown to be used in roughly 30,000 practices.
Groundwork for the deal between the companies began in 2013, according to the statement of facts agreed to by Practice Fusion under a deferred prosecution agreement. The idea was to get the opioid maker’s pain drugs to certain kinds of patients: ones who weren’t taking opioids or those being prescribed the company’s less profitable products. It also aimed to secure longer prescriptions, according to the court papers.
The companies also agreed to do a research study. But according to an internal Practice Fusion email cited in the court papers, the drug company considered it “all about marketing.”
Although the settlement doesn’t name the drugmaker, Reuters reported this week — citing unnamed sources — that it was Purdue. Purdue’s opioid offerings also matched the profile of drugs cited in court papers.
Practice Fusion and Purdue researchers publicly announced in a 2017 research report that they had begun to study an online tool with features identical to those described in the court papers. The research tested pain alerts for roughly 13 million patients over a year.
Steven Labkoff, the Purdue researcher who presented that study at a 2017 conference, didn’t return calls seeking comment.
In 2016, the U.S. Centers for Disease Control and Prevention put out new guidelines on opioids and treating patients with chronic pain. The guidelines emphasized non-drug and non-opioid alternatives. When opioids were prescribed, quicker-acting versions were preferable to the long-acting type, the agency said.
The opioid company and Practice Fusion shared those guidelines internally but “did not incorporate the recommendations contained in those guidelines,” according to the court papers.
Practice Fusion reported to the drug company in 2016 that the project was working as intended, shifting prescriptions to the company’s extended-release opioids. The arrangement between Practice Fusion and the opioid company continued even after a lawyer for the drugmaker raised concerns about the substance of the program and started a legal review, according to the papers.
Jamie Weisman, a dermatologist in the Atlanta area, learned this week of Practice Fusion’s partnership with the opioid maker. She has used its platform for five years but doesn’t recall seeing that kind of pain alert.
“It’s evil. There’s really no other word for it,” she said. But “if you want to model electronic health records as a for-profit system and not regulate them as such and force doctors to be on them, it’s almost inevitable that they’re going to be manipulated.”
Makers of electronic medical records have come under increased scrutiny for their business practices, including by the U.S. Justice Department, as they’ve grown since the implementation of the Affordable Care Act.
Practice Fusion had similar agreements with makers of other drugs. The government claimed in its civil case that Practice Fusion struck 14 such deals with pharmaceutical companies from 2013 to 2017.
Practice Fusion admitted only to the opioid agreement, and “there has been no determination of liability” on civil claims, the Justice Department said in a statement.