In an extremely irresponsible move,* the FDA just approved a painkiller 1,000 times stronger than morphine, despite the fact that the U.S. is already experiencing a deadly opioid drug crisis that takes over 100 lives a day.
On Friday, Nov. 2nd, U.S. regulators approved a fast-acting, extremely potent opioid tablet 10 times more powerful than Fentanyl called Dsuvia, developed as an alternative to IV painkillers. This decision comes with a backdrop of reports of tens of thousands of annual deaths caused by overdoses from pharmaceutical opioid-type painkillers throughout the United States. According to a NY Daily News article, “The drug’s manufacturer, AcelRx, said the drug will be marketed with the name Dsuvia and cost between $50 and $60 per dose.”
Lawmakers and consumer advocacy groups have expressed deep concern about this decision. For instance, Sen. Ed Markey, D-Mass., released the following statement on Friday: “There was no public health need to approve this formulation of supercharged fentanyl in the face of these questions, opposition from one FDA advisory committee chair, and without the full participation of another advisory committee devoted to drug safety.”
On the same day Public Citizen released a statement titled, “FDA Makes Wrong Call; Super-Strong Opioid Medication Will Be Abused and Kill People,” which describes how the FDA rigged the committee vote to ensure a positive recommendation.
According to the U.S. Department of Health and Human Services (HHS),
“Opioid overdoses accounted for more than 42,000 deaths in 2016, more than any previous year on record. An estimated 40% of opioid overdose deaths involved a prescription opioid.”
The HHS attributed the crisis to the pharmaceutical industry’s push in the 1990’s to misinform the medical community that patients receiving prescription opioid painkillers would not become addicted. According to the HHS, this lead to both increased prescription of opioid medications and widespread misuse of both prescription and non-prescription opioids before it became clear that these medications could indeed be highly addictive. Below is an infographic provided by the HHS that depicts the extent of the crisis.
What makes this drug approval all the more concerning is the fact that natural, evidence-based alternatives for pain already exist. In fact, we reported on a recent study published in the European Journal of Internal Medicine which found that medical cannabis was superior to opioid drugs for chronic pain. Here is a brief summary of their findings:
The study surveyed 2,736 patients aged 65 years and older, at the inception of medical cannabis treatment, and throughout the 33-month study period. Surveys indicated the most common reasons for using cannabis were pain (66.6%) and cancer (60.8%). Methods of ingestion included cannabis-infused oils and smoking or vaporizing the herb. After six months of cannabis therapy, researchers provided a follow-up questionnaire which sought to determine any changes to pain intensity and quality of life, as well as any adverse events that were experienced. 901 of the original respondents replied.
After 6-months of medical marijuana treatment (all statistics are +/-):
• 94% reported an improved overall condition, and a 50% reduction in pain
• 60% reported improved quality of life, from “bad” or “very bad” to “good” or “very good”
• 70% reported moderate to significant improvement in their condition
• 20% of respondents stopped using opioids or reduced their dose
Notably, the most common side effects reported were mild: dizziness (9.7%) and dry mouth (7.1%), a far cry from the high-percentage of opioid-related deaths that are linked to chronic pain. BGU researchers believe that utilizing cannabis may decrease the use of other prescription medications, including opioids, and encourage further research into this plant-based alternative, especially as it relates to an aging population.
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