Prescriptions for this painkiller abound. Evidence of its effectiveness doesn’t.

lyrica-300x248Patients’ struggles with medical pain are a major problem. So, too, is the proclivity of Big Pharma, doctors, hospitals, insurers, and many others to respond to pain not only by pushing more prescription pills but also by overstating their benefits and downplaying their costs and potential harms.

As the nation grapples with an opioid painkiller crisis, New York Times columnist Jane E. Brody deserves credit for drilling down on gabapentin, “taken by millions of patients despite little or no evidence that it can relieve their pain.”

The drug won approval from the federal Food and Drug Administration a quarter century ago for treatment of seizure disorders. But it since has become a go-to medication for doctors who write “off-label” prescriptions for it to care for “all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems,” Brody wrote.

Lyrica — or pregabalin, a “brand-name cousin” of gabapentin — has become a top-seller for its maker Pfizer, generating more than $4 billion annually in revenue. Gabapentin and Lyrica, both sold by Pfizer, have “been FDA approved to treat only four debilitating pain problems: postherpetic neuralgia, diabetic neuropathy, fibromyalgia and spinal cord injury,” Brody reported. But “even for these approved uses, the evidence for relief offered by the drugs is hardly dramatic.”

She cited the analysis by two South Carolina researchers who published their findings in JAMA Internal Medicine online. Here’s what they discovered:

In many well-controlled studies, they found there was less than a one-point difference on the 10-point pain scale between patients taking the drug versus a placebo, a difference often clinically meaningless. For example, among 209 patients with sciatica, Lyrica did not significantly reduce the intensity of leg pain when compared with a placebo, and dizziness was more commonly reported by the 108 patients who took the drug.

Still, as Brody reported, “when patients complain of pain related to conditions ranging from sciatica and osteoarthritis to foot pain and migraine, clinicians often reach for the prescription pad and order either gabapentin or the more costly Lyrica.”

Dr. Christopher W. Goodman, one of the two study authors, told Brody: “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 added “that for patients prone to substance use disorders, like an opioid addiction, the gabapentinoids, although they are not opioids, are potentially addictive.”

Brody, reporting that there are other published studies, too, doubting gabapentinoids use, effectiveness, and addictiveness, says the drug’s persistent popularity underscores at least four big problems in medicine:

  • a deadly national epidemic of opioid addiction prompting doctors to seek alternative drugs for pain;
  • the limited training in pain management received by most doctors;
  • and the influence of aggressive and sometimes illegal promotion of prescription drugs, including through direct-to-consumer advertising.

I’d agree. In my practice, I see not only the harms that patients suffer while seeking medical care, but also the damage that can be wreaked on them by dangerous drugs, especially these days powerful painkillers.

It took us, as a nation, a while to plunge into our current opioid crisis, with Big Pharma aggressively and falsely promoting the benefits of powerful and addictive painkillers — and doctors, hospitals, and insurers all too willing to play roles, from gullible to criminal, in inundating patients with risky drugs. The Washington Post has rolled out a deep dig into the political and regulator morass that has fueled the opioid crisis and its latest, most lethal phase involving the super-potent drug fentanyl. It is unacceptable to read the political ins-and-outs of a so far insufficient response to a public health menace that has become a leading killer of Americans younger than 55. The opioid crisis is metastasizing before our eyes, merging with abuses of other prescription and illicit drugs and contributing to the rise of infectious diseases, as well as devastating communities rich and poor, white and black and brown.

While the battle to determine legal responsibility for these painkillers’ harms is taking center stage in courts — notably in Oklahoma with a big opioid trial set to begin and involving Johnson & Johnson, as well as an $85 million settlement with drug maker Teva — who is looking out for patients with persistent agony from chronic disease or serious medical treatment? As Brody reported:

It’s not that there are no other alternatives to opioids to treat chronic pain, among them physical therapy, cognitive behavioral therapy, hypnosis and mindfulness training. But practicing clinicians may be unaware of the options, most of which require more effort for the doctor than writing a drug prescription and are not as easy or accessible for patients as swallowing a pill.

She also quoted Dr. Michael E. Johansen, a family doctor in Columbus, Ohio, who told her “there is no recipe book” for treating pain with gabapentinoids. “Doctors need to work with one patient at a time and figure out what works and what doesn’t work,” he said. He noted that many times pain resolves with “the tincture of time” but patients and doctors may attribute improvement to the prescribed drug.

Patients shouldn’t go “cold turkey” of the medications. For those taking a gabapentinoid, Johansen suggested that patients’ doctors readdress its use after two or three months.

We’ve got a lot of work to do in dealing with pain, while slashing the harms of opioids.

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