“Weak patenting standards and ineffectual policing” have helped turn the pharmaceutical industry into a key driver of the opioid epidemic, according to a study published in the Harvard Law & Policy Review.
The study, entitled “The Opioid Epidemic: Fixing a Broken Pharmaceutical Market,” argues that the failure to effectively regulate fraudulent marketing and anti-competitive practices by Big Pharma have contributed to the “over-utilization of costly and often harmful” branded prescription drugs.
At the same time, it has hindered access to low-cost generics, say the three authors of the study, Ameet Sarpatwari, Dr. Michael S. Sinha and Dr. Aaron S. Kesselheim—all professors at Harvard Medical School with appointments to the Brigham and Women’s Hospital.
“To boost profits, pharmaceutical companies have often engaged in false or misleading marketing,” the authors charge. “Over the past twenty-five years, the industry has paid $35.7 billion to settle claims of illegal marketing, including making false or misleading claims or failing to disclose known risks.”
The authors cite an estimate from the American Society of Addiction of Medicine that over 2.5 million Americans now have an opioid use disorder. In 2015, 33,092 Americans died from an opioid-related overdose—a fourfold increase from 1999.
Over four million Americans misuse opioids each month. Between 2005 and 2014, the annual number of opioid-related emergency department visits doubled. Almost as many people now die from an opioid-related overdose each day as die in automobile accidents.
A fundamental cause of the epidemic was—and continues to be—an over-prescription of opioids, the study says. From 2000 to 2010, the number of prescriptions for oral opioid analgesics rose 104%.
The authors call on the federal government to take a more “proactive” role in challenging pharmaceutical patents, and recommend that Congress authorize the Food and Drug Administration to “impose user fees that would fund comparative cost-effectiveness research and dissemination.”
The full study and recommendations are available here.