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 Vioxx was withdrawn from the market in 2004 due to safety concerns when prescribed for long-term use or in high doses. Bextra — another COX-2 inhibitor — was withdrawn from the market in 2005 due to some claimed side-effects that included an elevated risk of heart attack and stroke.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

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3 replies »

  1. Liked your post; thanks. Interesting view. You are correct, in my view; patients are the only ones who should make a decision via trade-off of benefit and harm. But, that is not medical care’s way. We have confused notions of choice bathed in a complex stink that does not necessarily aim at patients’ best interests. I wrote years ago that the most perplexing issues medical care will face is how to define evidence, and, hence, value, and who should be the one who defines it (informed patient). We still are miles from nowhere. Until a uniform definition of evidence, value, and choice, medicine and its practitioners will be encouraged to be snake oil salespersons, and regulatory missteps made in haste and in a reactionary manner will prevail.

  2. Let’s not forget the profit motive as part of what lead to the opioid crisis. Some drug companies falsified advertising/studies to gain sales. Some of those execs were prosecuted. Heaven knows the drug reps were pushing the new narcotics as being non-addictive (or having very low risk of such)in the 90s and early 2000s (Oxycontin mostly). I stopped following the Vioxx story a long time ago, but there were certainly accusations that they misrepresented some aspects of the research, or at least tailored the rite ups to minimize the negative effects.

    Would having Vioxx available have made a difference in the use of Oxy over the last 20 years? Dubious at best. There were certainly lots of other NSAIDs, but really the key was that so many people were convinced that because of the way Oxy was made, it had a low addictive risk.


  3. Situations like these are extremely frustrating to physicians who just want to help their patients. When I was training 30 some years ago, we were taught to be very judicious when prescribing narcotic medications, and that was the way I practiced. As many physicians will tell you, we believe the opioid crisis started about 15 years ago with the campaign of “Pain the 5th Vital Sign”. Despite being told that narcotics were actually safe to prescribe more freely, and despite the pressure from the legal profession and advocacy groups to treat pain more aggressively with narcotics, many physicians chose to continue cautious prescribing habits. Unfortunately, many more drank the kool-aid and we are suffering for it now.
    In the meantime, reasonable alternatives like the ones listed above are removed from the market, leaving even fewer alternatives to opioids.