Government Regulation, Lawyers and the Opioid Crisis

A short letter to a medical journal nearly 40 years ago may have been the nudge that set the opioid crisis in motion. A letter to the New England Journal of Medicine asserted addiction to prescription opioids was rare, claiming only four addictions were documented out of thousands patients who were prescribed powerful opioid pain pills in a hospital setting. The article has been cited hundreds of times in the years since. Doctors and drug makers may have relied on the letter as evidence that it was safe to prescribed opioids to more patients with chronic pain in settings far removed from carefully supervised hospitals.

Nearly 40 years later it has become clear that opioids can be dangerous in the wrong hands. There is also significant risk of diversion to the illicit market. After states began closing down so-called “pill mills,” prescription opioids became less available. To fill the void, heroin and fentanyl began flooding the U.S. to take the place of the once plentiful prescription opioids. Whole regions of the country have been hard hit by prescription drug abuse. Worse yet: other diseases tend to accompany IV drug abuse, including hepatitis C and HIV.

I’m reminded of a sequence of events that occurred about a dozen years ago. In late 2004 there was another pain reliever crisis. Pain relievers from a class of selective cyclooxygenase-2 inhibitors known as COX-2 Inhibitors, were suspected of harming patients by boosting the risk of premature death.

Vioxx and Bextra were both anti-inflammatory drugs once used to treat arthritis and acute pain. Vioxx was withdrawn from the market in 2004 due to safety concerns when prescribed for long-term use or in high doses. Bextra — another COX-2 inhibitor — was withdrawn from the market in 2005 due to some claimed side-effects that included an elevated risk of heart attack and stroke.

Over the course of a multi-year study that followed nearly 2,600 people, 45 of the patients taking Vioxx experienced heart attacks or strokes, compared to 25 people taking a placebo. The number of people in each group who actually died was five. Even though the death rate was equal, Merck removed Vioxx from the market — probably to reduce its liability. The makers of both Vioxx and Bextra paid out huge sums to settle lawsuits for people who died while taking the drugs.

These two drugs were popular because they did not irritate the stomach like other non-steroidal anti-inflammatory drugs (NSAIDs). Another reason people paid more for Vioxx (10 to 15 times more) than less-expensive pain relievers was because they caused less post-operative bleeding and protected the stomach against ulcers cheaper medications often cause. An estimated 16,500 patients who die annually of bleeding ulcers.

The millions of people worldwide who benefitted from access to Vioxx and Bextra are the real losers in withdrawal of the once popular prescription pain relievers. Of course, it’s easier to count those few people whom statistics suggest may have died in greater numbers than expected, even if only from natural causes, than to count those whose lives might have been extended by access to drugs taken off the market. The latter have no right to sue. The family members of thousands of deaths likely caused by older pain relievers can hardly be expected to attribute the deaths of their loved ones to a drug they couldn’t take. Yet under current law, those who die of a heart attack while taking a drug have every right to sue — even if the drug did them far more good than harm. They also have a right to sue even if the death of a family member cannot be proven to have been caused by the drug itself. The less effective, less expensive generic and over-the-counter pain relievers are poor targets for lawsuits.

More than 100 million people took these drugs before they were removed from the market. The use of COX-2 pain relievers also precludes taking aspirin daily to prevent heart attacks. Maybe that explains the slightly elevated risk of heart attacks and strokes from these drugs.

How many of the people in chronic pain who became addicted to opioids could have safely taken Vioxx or Bextra? We will never know. The ones who suffer the consequences are the patients, and they should be allowed to decide whether drugs are worth the risk, rather than having the decision made for them by a risk-averse FDA and other people’s lawyers. There is little reason to deny patients access to drugs like Bextra and Vioxx if they know the risks and are willing to accept them.

Devon Herrick, PhD is a health economist and senior fellow with the National Center for Policy Analysis.

Government Regulation, Lawyers and the Opioid Crisis published first on


Author: wmcerda

I am the founder and medical director of Drug Test Exit since 2003. A former physician in drug test, I am known as the "Pioneer of Drug Test Care" with expertise in travel medicine, sports medicine, and diving medicine. I have provided drug test services in many sports events, competitions, and championships and have handled large corporate events throughout the United States, United Kingdom, South Africa and around the world. Served as an Olympic drug text specialist for 8 years, I am also the medical doctor for many leading sports channel and takes care of many high profile athletes. getpocket

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