By Pat Anson, Editor
Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s "voluntary" recommendations as policies or even law.
As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them. We have tried to keep you informed and aware of these facts.
Now one of the world’s largest drug makers has agreed to not make any statements that conflict with the CDC guideline and to withdraw support for any organizations that challenge it. Pain News Network is among them.
In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”
That voluntary guideline discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.
Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a $10,000 charitable grant awarded to PNN. Pfizer had sponsored PNN’s newsletter for the past year.
"Kindly note Pfizer recently entered into an agreement with Santa Clara County, California that places limits on Pfizer’s ability to provide opioids-related funding to outside organizations. After careful consideration, we regret to inform you that we are unable to support your request and must rescind the previous approval notification," the email said.
“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”
Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and exaggerated their benefits.
“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”
Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release and little known pain medication called Embeda.
As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no studies supporting the use of opioids long-term for pain relief. Pfizer signed a nearly identical agreement with the city of Chicago last year to avoid litigation.
Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.
In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses.
Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.