September 10, 2019
Opioid Epidemic: Is Multi-district Litigation Targeting Pharmaceutical Companies a Solution to the Crisis?
The opioid epidemic has resulted from a myriad of causes and will not be solved by any simple solution but rather through a multi-pronged approach that targets each of the contributing factors. The complex opioid epidemic was produced by multiple players in the healthcare industry including: pharmaceutical companies, physicians, hospital administrators and the Centers for Medicare and Medicaid Services. By targeting only pharmaceutical companies, who have the deepest pockets, and not addressing the interplay of the various contributors to the crisis, the multi-district opioid litigation will do no more than the multi-district tobacco litigation of the 90s which produced little impact on quelling the epidemic of tobacco-related illness and death.
In 1973, a manuscript from a highly regarded journal described a failure to treat patients in severe pain with adequate doses of opioid analgesics. Two decades later, another prominent researcher decried the same failure, invoking the conventional wisdom of the day that ‘‘therapeutic use of opiate analgesics rarely results in addiction.’’ Alongside this opioid evolution, the American Pain Society launched their influential ‘‘pain as the fifth vital sign’’ campaign in 1995, with intent to encourage proper, standardized evaluation and treatment of pain symptoms. Solidifying the national response to the aforementioned efforts, the Joint Commission (TJC) published standards for pain management in 2000, emphasizing the need for organizations to conduct quantitative assessments of pain as recommended by the Institute. The Federation of State Medical Boards and the Drug Enforcement Agency also issued statements promising less regulatory scrutiny over opioid prescribers, thereby appeasing physician reluctance to prescribe more liberal amounts of opioid analgesics.
The tobacco litigation of the 90’s and the current opioid litigation have many similarities. Manufacturers of both tobacco and opioids knew that their drugs were addictive and harmful but downplayed the risk in their marketing which led to a public health crisis. Under the tobacco master settlement agreement (MSA), which remains the largest civil settlement in US history, the four largest cigarette manufacturers agreed to pay the settling states $206 billion during 25 years and up to $9 billion annually in perpetuity thereafter, based largely on the volume of cigarettes sold each year. However, the MSA’s effect on reducing smoking rates, its claimed public health purpose, is unclear. Smoking rates declined after the MSA, primarily due to increased cigarette prices, but these declines began before the agreement and were likely influenced by contemporaneous tobacco prevention and control efforts.
Central to the MSA’s shortcomings was its failure to include any requirements or limitations on how states could spend the billions of dollars received from the tobacco industry. Although MSA funding was a welcome benefit to settling states and a handful opted to use those funds to make substantial investments in tobacco control and public health, most states treated them as general revenue to cover budget shortfalls, subsidize tax cuts, and support general government services. In Alaska, $3.5 million in settlement money was spent on shipping docks. In Niagara County, N.Y., $700,000 went for a public golf course’s sprinkler system, and $24 million for a county jail and an office building. And in North Carolina, $42 million of the settlement funds actually went to tobacco farmers for modernization and marketing. The tobacco MSA provided billions of dollars to state and local governments but fell short in fostering future reductions in tobacco-related diseases. Few reasons exist to believe a similarly styled opioid MSA would produce better results.
Targeting only pharmaceutical companies is the wrong approach to ending the opioid crisis. Along with pharmaceutical companies, physicians, the Joint Commission, Press Ganey and the Centers for Medicare and Medicaid Services have all contributed to the opioid crisis. Doctors’ persistent use of opioids for long-term treatment, despite the FDA’s well-publicized warnings against using opioids this way, shows a worrying trend in the way doctors write prescriptions. If the MDL does not address the role doctors and irresponsible prescription-writing played in the opioid epidemic, the court will have failed to adequately address the problem.
In addition, in 2001 the Joint Commission issued standards requiring the use of a pain scale and stressing the safety of opioids even going as far as publishing a guide sponsored by Purdue Pharma on pain management. Furthermore, in 1985, Press Ganey began surveying patients in an attempt to improve the patient experience. Press Ganey monetized this concept, selling not only patient satisfaction surveys but also consulting services to help hospitals improve their patient satisfaction. Unfortunately, the correlation between patient satisfaction and quality has not been established but rather studies actually suggest that striving for high satisfaction is actually bad for a patient, correlating it to higher expenditures, higher rates of hospitalization and a higher risk of death.
The Center for Medicare and Medicaid Services developed the value-based purchasing program where hospitals are scored based on their performance on measures of processes of care, outcomes of care, efficiency and the patient experience. The patient experience is based on scoring on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys that are sent to patients, which includes patient scoring of their satisfaction with their pain control. Because CMS was now attaching significant reimbursement to patient satisfaction, hospital administrators were forced to develop initiatives to improve their scores and avoid a penalty. In 2014, a survey showed that more than 48% of doctors say they have prescribed inappropriate narcotic pain medication because of patient satisfaction questions. Targeting only pharmaceutical companies will do little to end the opioid epidemic as the tobacco settlements of the 90s have taught us that states will not use the settlement money to improve the lives of those suffering from the opioid addiction but rather they will use the money as general revenue to cover budget shortfalls.
October 30, 2019