Originally published in SF Chronicle.
By Victoria Colliver
June 4, 2013
(06-06) 17:16 PDT SAN FRANCISCO —
Jenelle Prins doesn’t envision ever being able to live without taking at least some medication to help her cope with chronic pain due to the skeletal and shoulder injuries she suffered from a car accident in 1988 and a plane crash in 1999.
But after a nurse practitioner blanched at her quantity of painkillers, Prins realized she had to change her drug regimen – opiates including morphine, fentanyl patches and methadone along with benzodiazepines like Xanax and Valium – if she wanted any relief from the cycle of constant pain and fatigue, and the haze of medication.
“I’d just like to be able to live something close to a normal life,” said Prins, 55, who has been on disability from her job as an attorney for seven years. “It would be nice to take a walk and not be afraid I’m doing too much or that I’d get to the end of the walk and not be able to get home.”
Prins, who lives in Emeryville, was referred to the Alameda County Medical Center’s Pain Management and Functional Restoration Clinic, a part-time clinic at Oakland’s Highland Hospital. The clinic works with a small group of motivated clients to help them lower their dependency on highly addictive and potentially dangerous opiate painkillers while improving their quality of life.
She’s also part of a relatively new and not widely used protocol to treat pain that relies on an old drug called buprenorphine. While the semi-synthetic opioid was developed in Great Britain more than 35 years ago for people in chronic pain, it is approved in the United States in pill form as an addiction drug, similar to methadone.
So giving the drug to patients, like Prins, to help ease them away from narcotic painkillers makes sense, say its advocates. It is effective for pain but causes far fewer side effects than more powerful pharmaceutical opiates common on today’s market, like oxycodone, codeine or morphine.
“We know this drug has no toxicity to the kidneys and much less toxicity to the liver than any other opiates. It works better for chronic nerve pain, and it doesn’t cause overdoses,” said Dr. Howard Kornfeld, the medical director of Highland’s pain clinic who is among a cadre of physicians who have been championing the use of buprenorphine for pain. “In most addicts or pain patients, it decreases cravings but doesn’t cause this kind of euphoric state people get drawn into.”
Buprenorphine has the added safety benefit of a weaker ability to suppress the respiratory system, which leads to overdose deaths.
Overdosing on prescription drugs is a huge problem in the United States, eclipsing car crashes as a leading cause of accidental death nationwide. More than 16,650 people in the United States died from prescription painkiller overdoses in 2010, according to the latest figures from the U.S. Centers for Disease Control and Prevention.
Kornfeld doesn’t believe the majority of patients with chronic pain need opiates at all – including buprenorphine. But, he said, for those who do need such drugs, as well as those trying to wean themselves off addictive painkillers, buprenorphine is a safer option that should be more widely considered.
Then why isn’t the drug used more to curb pain?
More research needed
Kornfeld, who also has a private practice in Mill Valley that specializes in pain and addiction medicine, said more research and clinical trials are needed to show the effectiveness of buprenorphine. Observational studies have shown the drug to work well for pain, but additional research is needed.
The U.S. Food and Drug Administration first approved oral buprenorphine in 2002 for opiate addiction, but not pain. Since 2009, the FDA has approved a generic version of the addiction-weaning drug in the form of a tablet that dissolves under the tongue and other brand-name forms such as a low-dose transdermal patch. Other proprietary forms of the drug are in the works.
Doctors can order the tablet for pain even though it isn’t approved for that use – an acceptable practice known as “off label” prescribing. That makes insurers less likely to cover it, in turn making physicians less willing to offer it to their patients. To complicate matters, doctors need a special license from the Drug Enforcement Administration to prescribe it and often have to go through insurance and Medi-Cal authorization hoops to get reimbursement for buprenorphine.
“Not many people know about it, and it’s not something the pain treatment industry has embraced,” said Dr. Paul Abramson, a San Francisco primary-care physician and addiction specialist who has been treating patients with buprenorphine for about five years.
In fact, Abramson won’t treat his pain patients with any other opiate because he finds it works well, and patients don’t develop a tolerance or become addicted to it.
“If you do need opiates for your pain, and many people identify they do, buprenorphine is a very nice option that will often produce a better, functional outcome,” he said.
Drug companies have shown interest in buprenorphine, but the industry is more focused on creating and marketing newer, more expensive ways to deliver the drug than promoting the use of the lower cost, generic version.
But the generic version can be used for pain management at considerably less cost than the patch or brand-name versions, making it an option for low-income patients. Poorer communities are hard hit by health problems relating to addiction and chronic pain.
A 2-milligram, daily generic buprenorphine costs about $50 a month without insurance, compared with up to $400 a month for the equivalent dose of the patch, which is approved for chronic pain and is sold under the brand name Butrans.
More than half the patients at Highland’s pain clinic have been shifted from their more potent drug regimen to buprenorphine. Prins, the Emeryville woman, is only two months into the program, but has already been able to drop the fentanyl and is tapering down on methadone.
Kornfeld acknowledges the shift can be rough, especially if the patient is addicted to the euphoric effects of the drugs, and this drug doesn’t work for everyone.
120 patients served
The Oakland clinic, which opened in 2011 and has served about 120 patients, requires patients to commit to an intensive 12-week program that includes individual and group sessions, psychological counseling and physical therapy. Most patients are monitored in the program for nine months to a year.
“It’s not just a physical process. You can’t separate the mind and the body,” said Amy Smith, a physician’s assistant at the clinic. “So many of our patients come in on just truckloads of opiates and feel they need even more because it just isn’t working anymore.”
An exception to that is Marlene Verdile, who never took opiates or other pain medications despite a more than 30-year history of pelvic pain that doctors have not been able to diagnose.
“My pain, I can only describe as having a knife in my right side, and with every step, it’s twisting and burning, twisting and burning,” said Verdile, 49, of Newark. “I’ve had doctors say it’s all in my head. I’ve been through the gambit.”
She is now on the clinic’s buprenorphine program. Verdile said she was apprehensive about even trying the drug, but she was so limited by pain she was willing to give it a shot.
Finally pain free
Verdile said it wasn’t easy. Initial side effects of nausea and dizziness made her want to quit numerous times, but she stuck with the program and eventually had one pain-free afternoon. That turned into a full day.
Now, eight months after starting the program, she has been relatively pain free for the past three months. “I’ve been living with this for 30 years, and it took such a low dosage to bring me to normalcy,” she said.
What is buprenorphine? It’s a semi-synthetic opioid developed in England to treat pain, but used in the United States primarily as a way to wean people off narcotics such as heroin, morphine and other opiate painkillers.
What forms is it available in? Buprenorphine may be sold as Subutex, which is available in generic form, and Suboxone, which contains an opiate blocker. Both are tablets that have been approved in the U.S. for addiction. Butrans, marketed by Purdue Pharma, is a patch available for chronic pain. The drug as an injection is called Buprenex.
What are the advantages of the drug? Doctors who support the use of buprenorphine for pain say it’s effective, and patients are less likely to become tolerant or overdose on the drug. It also doesn’t provide the euphoric high that other opiates may cause.
What are the concerns? Like any opiate, buprenorphine carries some risk of abuse and overdose. It also has side effects and tapering is recommended to reduce symptoms of withdrawal.
Source: Chronicle research
Edited on June 11, 2018.