The Role of Doctors in Fueling the Opioid Use Disorder Crisis

By Ajay K. Singh, MBBS, FRCP, MBA
February 22, 2017

What type of doctor holds the moral high ground on opioid prescribing? Some claim it is held by doctors who believe that pain is the “fifth vital sign.” They prescribe opioids for both acute and chronic pain. They point out that withholding effective pain relief is unconscionable. Others believe that the moral high ground is held by those who rarely prescribe opiate analgesics: yes, for acute pain and, worried about the possibility of abuse, rarely for chronic use, and then only in limited quantities.

Still, at its heart, the debate centers on the importance of a doctor’s prescribing practice in driving opioid addiction. Continue reading “The Role of Doctors in Fueling the Opioid Use Disorder Crisis”

Oliceridine and The Opioid Epidemic: Getting Long-Term Users off Opioids


By Ajay K. Singh, MBBS, FRCP, MBA
Tuesday, January 17, 2017

The 2014 National Survey on Drug Use and Health estimates that approximately two million Americans are addicted to prescription opioids. Over the past 20 years, prescription opioids have led to over 165,000 deaths in the US. In 2015 alone, more than 15,000 people died from overdoses involving prescription drugs.

The recently published Washington Post/Kaiser Family Foundation Survey, explored the factors that led individuals to become long-term users of prescription opioids. The report is important because it provides explanations for why long-term addiction to opoiod painkillers is so difficult to manage.

Some details about the survey…

Telephone interviews of 809 randomly selected adults age 18 years and older, or a household member, were conducted in the fall of 2016. Long-term users were defined as individuals who had taken prescription painkillers for two months or more at some time during the prior two years. They excluded individuals who had taken painkillers for either cancer or terminal illness.  About one-third were telephone surveys of landlines and two-thirds of cell phones.

The report revealed that:

  • Most chronic users were started on opioids via a prescription from a doctor.
  • Indications for opioid drugs included, chronic pain (44%), pain post-surgery (25%) or pain following an accident or injury (25%). Only 3% stated that they started opioids for recreational reasons, but subsequently about 1 in 5 said they were also using painkillers “for fun or to get high.”
  • Most chronic users had debilitating disability or chronic disease (70%).
  • About 57% of chronic users stated that opioids made their quality of life better. 92% indicated that the major reason for taking the painkillers was to reduce physical pain.
  • Doctors discussed the possibility of addiction or dependence only 65% of the time when users began painkillers.
  • Doctors discussed “other ways to manage pain besides these painkillers” only 62% of the time.
  • Most of those surveyed blamed themselves and the doctors who prescribed the drugs, but also stated that the drug manufacturers and the government should take blame.
  • The majority of users (≈80%) recommended greater education directed at doctors and medical students about treating pain. They also recommended more research and greater access to addiction treatment programs.

[HMS CME Online will launch a free CME opioid course in the spring.]

So what’s the bottom-line?

First, it will be hard to get individuals off opioid painkillers if they perceive that they need them. As  Emily Guskin writes in the Washington Post,  “At the center of the nation’s opioid crisis is a simple fact: Large numbers of Americans experience serious pain, and the vast majority of those who have used strong painkillers for a long period say they work.”

Second, doctors need to do a better job of discussing with patients the risks of addiction and alternatives to opioids. As a December 16 editorial in the Washington Post states, “a key condition…is for doctors to become much more careful in the way they distribute these powerful pills, which are still widely prescribed for noncancer pain, notwithstanding what is now a mountain of evidence, accumulating for years, that the drugs are far more addictive than manufacturers once led physicians and patients to believe.”

The Post editorial concludes: “If progress is to be made … American medicine must redouble its commitment to sound prescribing practices.” Clearly, there is a view at least among the media that education for doctors and other clinicians is still needed about whom to treat for pain and for how long.

And, third, better and more effective painkillers are necessary. In a December 22, 2016 article in ScienceNews, Bethany Brookshire reviews the hunt for a safer opioid painkiller, and in a  January 13, 2017 Smithsonian magazine article, John Kelvey discusses the clinical development of the only alternative to morphine, Oliceridine. A powerful rapidly acting and nonaddictive painkiller is desperately needed, and it seems like a candidate is on the horizon.


The Opioid Use Disorder Education Program

The Opioid Use Disorder Education Program (OUDEP) is now available from HMS Global Academy. OUDEP is comprised of 3 free online CE/CME courses produced by Harvard Medical School (HMS) with scientific contributions from The National Institute on Drug Abuse (NIDA). These courses are intended for nurses, nurse practitioners, physician assistants, physicians, and other health care providers collaborating to treat patients with substance use disorders.


Ajay Singh, MBBS, FRCPDr. Ajay K. Singh is the Senior Associate Dean for Global and Continuing Education and Director, Master in Medical Sciences in Clinical Investigation (MMSCI) Program at Harvard Medical School. He is also Director, Continuing Medical Education, Department of Medicine and Renal Division at Brigham and Women’s Hospital in Boston.

*OPINIONS EXPRESSED BY OUR AUTHORS ARE VALUABLE TO US AT LEAN FORWARD, BUT DO NOT REPRESENT OFFICIAL POSITIONS OR STATEMENTS FROM HARVARD MEDICAL SCHOOL.

Marketing Drugs in the US: Is It Free Speech?

One step forward, two steps back.

By Ajay K. Singh, MBBS, FRCP, MBA
January 3, 2017

The 1962 Drug Amendments Act put the last nail in coffin—or so it seemed—for drug manufacturers/pharma companies in making outlandish claims on the effectiveness of their drug in promoting and marketing it. The process generated confidence that drugs were being marketed only after being shown to be effective. This put an end to the “tonic” industry that marketed liver tonics and kidney tonics and the like without much, or any, evidence.

A Perspectives article in the New England Journal of Medicine by Christopher Robinson and Aaron Kesselheim, centers around the controversy about whether a drug can be promoted and marketed based on an “individual’s right to free speech.” It discusses the impact of recent court decisions on whether pharma companies and their representatives can promote or market their drug without an express indication approved by the FDA.

A 2012 decision by the U.S. Court of Appeals for the Second Circuit (which includes New York, Connecticut and Vermont) overturned an earlier decision. Tamara Frazier, writing in Pharmaceutical Compliance Monitor, nicely summarizes the details of the court case:

Alfred Caronia was a pharmaceuticals sales representative for Orphan Medical who, together with a physician in Orphan’s speaker program, promoted the drug Xyrem for off-label uses.  Xyrem, known as the date rape drug, is approved for treatment of narcolepsy.  Caronia and the physician were caught on tape promoting its use for treatment of insomnia, fibromyalgia, restless legs, Parkinson’s disease, and multiple sclerosis, and in unauthorized patient populations. Orphan and the physician pled guilty.  After a trial on the merits, Caronia was acquitted of misbranding, but convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a) (2) of the Federal Drug and Cosmetic Act (“FDCA”). On December 3, 2012, the Second Circuit Court of Appeals overturned Caronia’s conviction, citing his first amendment rights.  It declared, unequivocally, that the government “cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”

The fundamental issue is this: under the umbrella of free speech can someone—the company sales representative or the company itself—claim benefits for a drug that are not proven and not approved by the FDA?

Since the Caronia decision, the US Government has tended to succeed in litigation regarding off-label use drugs with one notable exception. In a 2015 case, Amarin Pharmaceuticals was able to ultimately prevail on off-label promotion of it’s fish oil-derived cardio drug Vascepa, despite not having obtained an approved indication from the FDA.

As discussed earlier, The Drug Amendments of 1962, passed unanimously by the Congress, “recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established prior to marketing—a milestone advance in medical history.” This built on the 1938 Federal Food, Drug, and Cosmetic Act, a law enacted in the aftermath of 100 deaths following treatment with sulfanilamide.

The courts re-interpreting the role of the FDA is unfortunate. Robinson and Kesselheim write, ” Rather than acceding to the views of two judges in one federal circuit, we hope that the FDA continues to stand on principle. The U.S. Constitution should not be misconstrued in such a way as to undermine the primary functions of federal regulation in this area: to protect patients and to create a high-quality market for drugs and devices that is driven by science rather than hype.”


Understanding Addiction, the first in a three-part, accredited opioid use disorder program, is open for enrollment. Each of these self-paced, online CME courses is produced by Harvard Medical School’s Global Academy, and is free of charge with funding from the National Institute of Drug Abuse. These courses are intended for nurses, nurse practitioners, physician assistants, physicians, and other health care providers collaborating to treat patients with substance use disorders.


Ajay Singh, MBBS, FRCPDr. Ajay K. Singh is the Senior Associate Dean for Global and Continuing Education and Director, Master in Medical Sciences in Clinical Investigation (MMSCI) Program at Harvard Medical School. He is also Director, Continuing Medical Education, Department of Medicine and Renal Division at Brigham and Women’s Hospital in Boston.

*OPINIONS EXPRESSED BY OUR AUTHORS ARE VALUABLE TO US AT LEAN FORWARD, BUT DO NOT REPRESENT OFFICIAL POSITIONS OR STATEMENTS FROM HARVARD MEDICAL SCHOOL.