Drug overdoses accounted for more than
109,000 deaths in 2021 in the United States
, an astounding 43% surge from 76,000 deaths just the year before. A
recent study
predicted another 1.2 million opioid overdose deaths by the end of this decade.
And absent from these numbers is the toll on the hundreds of thousands of people who suffer from nonfatal overdoses and the countless family members affected. These mind-boggling figures bring me back to an exchange I once had with the playwright and AIDS activist Larry Kramer, founder of ACT-UP, in New York in 1994. I recall his perspective on the increasing annual AIDS death counts: “If a bus crashes and 20 people die,” he submitted, “it’s a ‘tragedy;’ when 100,000 people die, it’s a ‘statistic.’”
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Much of this epidemic today is a result of the illicit use of synthetic opioid fentanyl, which spiked because of the social isolation from the COVID-19 pandemic. But that’s only half the story. Illegal opioid use didn’t just come out of nowhere — according to
the NIH
, 80% of heroin users reported using prescription opioids before heroin. And sadly, prescription opioids only gained so much clinical traction because better, safer alternatives simply did not exist. Unfortunately, they still do not exist.
I say this as I sit on the front line of the epidemic, day in and day out. As a surgeon, I make use of these medications routinely. There are only so many tools in our war chest for treating acute pain. The alternatives to addictive opioids are either acetaminophen/Tylenol, which has a risk of damaging the liver, or nonsteroidal anti-inflammatory drugs or NSAIDs, which collectively have a risk of kidney injury and substantial gastrointestinal toxicity. Compared to other fields of medicine, such as cancer and diabetes, there is
disproportionally less innovation in next-generation pain medications
. I find this ironic, given that pain affects more adults than diabetes and cancer combined, with an estimated cost to the healthcare system of $635 billion/year in the U.S. alone.
Yet, as it relates to pain therapeutics, there are fewer discoveries by academics, less R&D forged by biotech, less investment seeded by financiers, and fewer strategic partnerships inked by pharmaceutical companies. As a result, we continue running in place and using the same inferior pain medicines that came to market decades ago — the 1950s in the case of acetaminophen, and the 1970s in the case of ibuprofen and other NSAIDs.
Acetaminophen has a narrow window in which it can work to relieve pain. But when a dose exceeds this threshold repeatedly, injury to the liver is a significant risk. This occurs with deliberate acetaminophen overuse (e.g., suicide attempt) and unintentional overuse (e.g., consuming it without realizing it is present in various prescription and over-the-counter formulations, such as cold medicines).
Thirty thousand patients are hospitalized due to acetaminophen hepatotoxicity
every year in the U.S. Risks from NSAIDs overuse include kidney injury and gastrointestinal damage.
If all this alone wasn’t enough, five notable events in November and December 2022 underscore the need to make improvements toward safer pain treatments. First,
CVS, Walgreens
, and
Walmart
agreed to pay a total of $13.8 billion to settle thousands of lawsuits for their roles in mishandling opioid pain drugs, including filling prescriptions they should have flagged as inappropriate. This followed the agreements by Johnson & Johnson and distributors AmerisourceBergen, Cardinal Health, and McKesson to a
$26 billion deal
for their roles in prompting doctors to prescribe opioids for conditions that did not require a narcotic, a significant cause of the opioid crisis.
Second, in the updated
Clinical Practice Guidelines for Prescribing Opioids
, the Centers for Disease Control and Prevention encourages physicians to prescribe opioids in individualized cases for moderate-to-severe acute and chronic pain, responding to a crisis of untreated pain left over from its prior 2016 guidelines.
Third,
Regeneron announced that it stopped developing its investigational nerve growth factor inhibitor
for knee and hip osteoarthritis pain in a Phase 3 trial due to safety concerns. Fourth,
Australian regulators are considering
restricting the over-the-counter sale of acetaminophen this month after an independent expert report raised concern about overdoses in teenagers, with teenage girls at the highest risk. The proposals include limiting the amount bought over the counter so that it is not “stockpiled” at home and even requiring a prescription for those under 18. Fifth, responding to the need for more real-time opioid overdose data, the White House has developed a
national system to track opioid overdoses
at local levels.
On the bright side, recognizing the need for novel nonopioid therapies, the National Institutes of Health established the
Helping to End Addiction Long-Term Initiative in
2018, from which my research benefits. As a funded NIH-HEAL investigator, I’m grateful for the program’s financial, scientific, and commercialization support — it is an essential start toward pain relief innovation. However, the government alone cannot bear the costs of developing and commercializing new innovative pain medicines. The NIH simply needs the collaboration of the entire ecosystem responsible for bringing a new drug to market: Research scientists, biotechnology, the investment community, and pharmaceutical companies themselves. Future progress toward safer pain treatment will only come from an all-hands-on-deck approach.
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Dr. Hernan Bazan is the John Ochsner endowed professor of surgery and cardiovascular innovation at Ochsner Health in New Orleans, Louisiana, and co-founder of South Rampart Pharma.
