What do Doctors, Opioid Abuse, and Pain Have in Common? Gabapentin.
Initially approved 25 years ago as a medication to treat seizure disorders, gabapentin is now one of the most widely prescribed drugs in the country. It’s also now commonly prescribed off-label for children to treat all kinds of acute and chronic pain, along with chronic coughing; in addition, it’s commonly given to women to treat hot flashes.
Millions take gabapentin, despite little or no evidence that it actually relieves pain.
You’re probably wondering why the FDA initially approved the drug.
FDA Approval Logistics
The FDA will approve a pharmaceutical for specific uses and doses if the manufacturer demonstrates that it is effective and safe for those uses. The drug must also offer benefits that outweigh any potential risks it may cause. When a drug is used “off label”, it means that a healthcare provider can prescribe the drug that has been approved by the FDA legally for any condition – not only the ones for which it was initially approved.
This leaves patients at the receiving end of whatever doctors think is a good idea.
The burden of proof is then passed to those patients, who at that point need to decide for themselves if the medication actually is safe and effective for their ailments. As you can imagine, this is no easy task for patients, since it isn’t simple for even the most well-educated doctors.
A Tale of Two Doctors
Two physicians recently reviewed evidence of the risks and benefits of the off-label use of gabapentin for pain management. Dr. Christopher Goodman and Dr. Allan Brett, of the University of South Carolina School of Medicine, found that the drugs, known as gabapentinoids, were mostly ineffective in most of the cases for which they were being prescribed.
Dr. Goodman explained, “There is very little data to justify how these drugs are being used and why they should be in the top 10 in sales. Patients and physicians should understand that the drugs have limited evidence to support their use for many conditions, and there can be some harmful side effects, like somnolence, dizziness and difficulty walking.” He also stated that the gabapentinoids are potentially addictive, especially for patients who are prone to substance use disorders.
A Trifecta of Trouble
Gabapentinoids seem to represent three critical issues in the practice of medicine today:
- The limited pain management training many doctors receive
- The deadly national crisis of opioid addiction that prompts doctors to find alternative drugs for pain
- The influence of aggressive (and not always legal) promotion of prescription drugs, which often happens through direct-to-consumer advertising.
These issues are blatant in the case of Gabapentin and Lyrica, which are both sold by Pfizer. The two medications have been approved by the FDA to treat only four debilitating issues: diabetic neuropathy, spinal cord injuries, fibromyalgia, and postherpetic neuralgia. However, Drs. Goodman and Brett found that even for these four approved uses, the drugs hardly offered pain relief to patients.
Several controlled studies were performed, displaying results that showed less than a one-point difference on a ten-point scale between patients taking a placebo and those who took the drugs.
Clinically, this less-than-one-point difference is meaningless.
To illustrate, for a Lyrica study, 209 patients with sciatica were involved – and Lyrica did not significantly reduce leg pain when compared to the placebo for any of them. What’s worse is that dizziness was reported more often in those who took the medication as opposed to the placebo. However, and this is where part of that trifecta comes into play, providers still often prescribe Lyrica or gabapentin for pain relating to osteoarthritis, migraines, sciatica, and more.
What’s the Solution, Then?
In order to find a solution, the problem has to be dissected, since there are many parts to it (the trifecta). It’s not that alternatives to opioids for chronic pain management don’t exist – they do – but doctors may not be aware of the options and if they are, they must put in more effort than writing a prescription for them. These alternatives include cognitive behavioral therapy, hypnosis, and physical therapy. In addition, many patients find that it’s just easier to swallow a pill than go through the alternatives.
A family doctor in Columbus, Dr. Michael Johansen explained the all-too-common predicament that many physicians and other prescribers find themselves in: “I use gabapentin clinically and try to stay close to the approved indications, but occasionally we run out of options when faced with patients who hurt. It’s rare that these drugs eliminate pain, and I don’t tell patients their pain will go away. If there’s any benefit, it’s probably marginal.”
And therein lies another problem within the bigger problem: Sometimes, doctors just aren’t sure what else to try; they run out of pain management options for their patients.
While the search for a solution to these issues continues, the number of people taking gabapentinoids more than tripled in 13 years from 2002-2015, as revealed in a study published in JAMA in February of 2019 by Dr. Johansen. The Trifecta of Trouble grows as patients find little relief and doctors run out of options.
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