Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system.
That’s because investigators have ferreted out “abhorrent” conduct by Practice Fusion, a San Francisco firm that specialized in electronic health care records software, according to the U.S. Attorney’s Office in Vermont.
“During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,” Christina E. Nolan, U.S. Attorney for the District of Vermont, said in a statement. Practice Fusion, she added, “illegally conspired to allow [a] drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”
Although authorities have not identified the drug maker, calling the enterprise Pharma Co. X, Reuters news service has identified Purdue Pharma as the company that prosecutors assert made improper payments to Practice Fusion. Purdue is under federal investigation and is the target of myriad lawsuits, asserting grave harms from its aggressive sales and marketing of various versions of Oxycontin, its powerful and highly addictive opioid painkiller.
Practice Fusion, authorities say, offered “free” software that purported to enhance electronic health records systems, combing through databases to provide doctors with “clinical decision support alerts,” notices that were supposed to give physicians targeted information for their individual patients about the best and latest practices in medicine, including information about medication prescribing.
What the company failed to make clear, however, was that it also ran a “promotion” program with Big Pharma. Federal prosecutors found this to be tantamount to a kick-back scheme, with the software firm getting payments and drug makers benefiting from an authoritative promotion (the so-called CDS alerts) for use of their products:
“Practice Fusion allowed the companies to influence the development and implementation of CDS alerts in ways aimed at increasing sales of the companies’ products. Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself. The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards.”
Although doctors, medical groups, and regulators grew wary of damages caused by potent painkiller prescribing — opioids and overdose deaths spiked to fearsome highs and have retreated only a little since — both Practice Fusion and Purdue knew and failed to alter prescribing alerts of oxycontin. This meant thousands of patients likely were prescribed the drug, even as crackdowns on its use were medically advised.
Jamie Weisman, a dermatologist in the Atlanta area, reacted to the revelations about the software she has used for five years, telling Bloomberg news service she was shocked. She added this about Practice Fusion’s conduct:
“It’s evil. There’s really no other word for it.’ 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.’”
The company has agreed to deferred prosecution and a civil settlement. It will pay a $25 million-plus fine and forfeit the $1 million it was paid by Pharma Co. X, prosecutors reported. The firm also will pay almost $119 million to the federal government and states to settle the kick-back charges and for causing its users to submit false claims for drugs due to misrepresentations tied to Practice Fusion’s software.
Reuters emphasized its report on Purdue that the drug maker was not criminally charged in the Practice Fusion case or accused of wrongdoing. The company told the news service in a statement: “As Purdue Pharma has previously stated, the company is cooperating with investigative demands by various components of the U.S. Department of Justice in connection with criminal and civil investigations of the company.” The Sacklers, who founded and long controlled Purdue, separately issued a statement, saying family members believed their firm had followed all federal laws and regulations and did not know of any wrongdoing involving Practice Fusion.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the havoc that can be wreaked on them and their families by dangerous drugs, especially of the prescription variety. The opioid and overdose crisis took a long time to develop, and doctors, nurses, hospitals, clinics, insurers, Big Pharma — and now software developers — each must take a share of the blame for what has become a leading killer of Americans younger than age 55.
A disturbing and central cause of this lethal nightmare, of course, has been mis- or disinformation about Big Pharma and its wares. The Practice Fusion case spotlights this vulnerability, with news reports finding the firm’s free software popular among solo and small medical practices. That makes some sense with costs a concern for many small- and medium-sized enterprises. And, sure, as experts are discovering with proposed applications of artificial intelligence in health care, software and computing systems can be far from transparent and easy to deal with. But where is the professional or regulatory oversight of products, including those of the high-tech kind, that so affect patient care? An aspect of this transgression that’s nothing less than galling is how it flipped upside down what was supposed to be an important part of electronic health records — giving good doctors and hospitals greater insight and checks on aberrant treatment and prescribing by outlier and problematic colleagues.
The Practice Fusion deferred prosecution, of course, also emphasizes the unacceptable, unchecked, and relentless spending by Big Pharma to hawk already costly medications. Research newly published in the Journal of the American Medical Association has found that in small medical practices with primary caregivers, especially those distant or disconnected from big hospitals or academic medical centers, drug reps visit typically visit doctors weekly and they often shower practitioners with “free” samples.
As an accompanying editorial makes clear, however, these promotional products — along with casual lunches and branded tchotchkes and gewgaws — are far from free. Big Pharma laid out $20.3 billion on its marketing to health care professionals in 2016, including $13.5 billion to cover those sales rep chats and $5.6 billion to pay for “free” samples. As the JAMA editorial observes, “pharmaceutical detailing [sales rep visits] and the use of medication samples will continue to create unnecessary costs for patients and health care organizations.” Patients, in other words, end up paying to hype prescription drugs whose sky-rocketing prices they can’t afford.
We’ve got a lot of work to do to quash the opioid and overdose crisis and to rein in Big Pharma’s wasteful advertising and marketing spending to promote products that cost too much and deliver too little — or too much in the way of harms.