Renovations Needed: The Fda's Floor/ceiling Framework, Preemption, and the Opioid Epidemic

By Abrams, Michael R. | Michigan Law Review, October 2018 | Go to article overview

Renovations Needed: The Fda's Floor/ceiling Framework, Preemption, and the Opioid Epidemic


Abrams, Michael R., Michigan Law Review


Introduction

In January of 1980, the New England Journal of Medicine published a letter to the editor penned by Boston University medical researcher Dr. Hershel Jick and his assistant Jane Porter.1 The five-sentence letter was titled "Addiction Rare in Patients Treated with Narcotics."2 It reported that of 11,882 hospitalized patients who received at least one dose of narcotic pain killers in the researchers' files, "there were only four cases of reasonably well documented addiction in patients who had no history of addiction."3 Thus, the researchers concluded, "despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction."4

The letter, referred to simply as "Porter and Jick," rose to notoriety.5 Previously, "doctors had long been taught to avoid prescribing highly addictive opioids to patients."6 But by the 1990s, the letter's conclusory observation about opioid addictiveness "was invoked by doctors, academics, pharmaceutical companies and others as evidence that few users would develop addictions" to prescription narcotic pain killers.7 An article in Scientific American cited Porter and Jick's one-paragraph letter as an "extensive study."8 Time magazine referred to their "landmark" research as showing the "exaggerated fear that patients would become addicted" to prescription opioids was "basically unwarranted."9 Almost forty years later, the Journal published a retrospective "bibliometric analysis" of the letter; this analysis found that the letter was cited at least 608 times and that some of these citations "grossly misrepresented the conclusions of the letter."10

Those citations fueled a shift in the healthcare industry's perspective on the treatment of pain.11 Pharmaceutical and healthcare industry figures "aggressively pushed the concept of pain as the fifth vital sign."12 With the introduction of subjective measures like the "pain scale" and the linking of pain treatment to patient satisfaction, new incentives pushed doctors to prescribe narcotic pain killers.13 Concurrently, the pharmaceutical industry ramped up promotion of pain medications.14 Purdue Pharma introduced OxyContin to the market as a long-term solution to chronic pain.15 A 1998 OxyContin promotional video featured a doctor referencing the letter's data: "There's no question that our best, strongest pain medicines are the opioids ... in fact, the rate of addiction amongst pain patients who are treated by doctors is much less than one percent."16 In 2017, Dr. Jick lamented, "I'm essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did."17

Exactly what these drug companies did is now the subject of litigation.18 And unlike previous public health courtroom battles, such as the tobacco litigation of the 1990s, the prescription drugs at the heart of this deadly outbreak are heavily regulated for safety by the federal government.19 As a result, a diverse array of federal agencies have prioritized responding to the emergency.20 To understand why, consider the extent of the damage: the Substance Abuse and Mental Health Services Administration's annual survey found that "over 11 million Americans misused prescription opioids" and "2.1 million had an opioid use disorder due to prescription opioids or heroin" in 2016.21 Drug overdose deaths in 2016 totaled 63,000, which (after adjusting for age) represents a 21 percent increase over the prior year.22 This is "the largest annual jump ever recorded in the United States," reaching a total greater than any peak number of annual deaths caused by car crashes, HIV, or guns throughout history.23 Opioids are responsible for 66 percent of those overdose deaths, killing more Americans annually than breast cancer.24 And 2017 estimates show those numbers rising across all races and nearly all age groups.25 In 2017, Stanford Professor of Psychiatry Keith Humphreys compared "the amount of standard daily doses of opioids consumed in Japan"-a nation with an "older population than us, you would think more aches and pains"-to that of the United States by saying, "double it. …

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Renovations Needed: The Fda's Floor/ceiling Framework, Preemption, and the Opioid Epidemic
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