Is one of the most common treatments for long-term chronic pain doing more harm than good?
Medications that contain hydrocodone—an extremely addictive opioid found in commonly prescribed painkillers such as Vicodin—are causing more lethal overdoses in the United States than heroin and cocaine combined, according to Bill Morris, a local palliative care doctor for the Palo Alto Medical Foundation (PAMF).
Centers for Disease Control and Prevention (CDC) data indicates that drug overdose death rates, the majority of which are from prescription medications, have more than tripled in the country since 1990, and the CDC has classified prescription drug abuse as an “epidemic.”
Locally, Morris, who also supervises the methadone clinic at the substance abuse treatment center Janus, says most people coming in for treatment are heroin addicts going through withdrawals, but lately an increasing number of clients are struggling with prescription opioid drugs.
In an effort to clamp down on the opioid drug market, the U.S. Food and Drug Administration in October announced that it would recommend tighter restrictions on all products that contain hydrocodone, reclassifying them as a Schedule II class drug. That could help reduce the number of pills being inappropriately consumed or diverted into the wrong hands, but Morris is not so sure the solution to the problem is that simple.
Morris' specialty is helping patients with very severe illnesses, which often entails prescribing strong opioid medications, but he notes a troubling trend in America over the past two decades in which opioid medications are being prescribed more often for long-term, non-terminal chronic pain.
He says that to restrict prescribing and increase monitoring for issues like diversion—stolen or illicitly sold pills—makes the hoop-jumping for patients who legitimately need immediate pain relief more complicated, while ignoring the bigger question: do opioids for chronic, non-terminal pain just not work?
“Opioids are a wonderful medicine,” Morris says. “I would never get rid of morphine—it's one of the best medicines we have in our black bag for acute, chronic pain. But over the long term, they're not very effective.”
The problem with long-term use of opioid medications is that the human pain response system quickly develops tolerance, and the amount of opioids needed to block the same amount of pain increases—a basic trait of addiction.
“So if we try to block our normal system with opioids, our body tries to evade that blockade, and it develops new receptors,” he says. “Different pathways start to build up in our nervous system so that we actually become hypersensitive to pain.”
When a patient starts opioid use, the medication often initially works, but must continually be ramped up. Eventually the patient ends up on a quantity of medication that would kill a person without a tolerance, and yet fails to manage the patient's pain.
At that point, Morris says, the opioid has failed the patient, but the decision to use the medication is not always clear.
“We just don't have a lot of tools to work with long-term chronic pain,” he says.
Betsy Stone, the head of quality assurance and director of risk management for the PAMF Santa Cruz division, says negotiating prescriptions is a tricky science.
“Physicians are often caught between a rock and a hard place,” she says. “We're trying to provide good service, and there are patients who need pain medication, and there are patients who abuse pain medication, and there are patients who abuse pain medication who have true pain that needs to be managed. Identifying which patients go into which group can be very difficult. It's a tightrope walk.”
Stone says she believes the FDA's intent to further regulate opioids is good, but has concerns about how they will implement those regulations.
“Part of it is [that] they're not clinicians,” she says. “How does the FDA decide that the physician is over-prescribing medication for a cancer patient or the chronic pain patient? That's not their role, so they have to look for trends.”
While overdosing, abuse and prescription trends are what the FDA has to follow to gauge regulation, there was a significant turning point decades ago that changed the game.
It was not until the '80s that the United States saw a big surge in opioid pain medications, and a lot of that had to do with re-marketing strategies by pharmaceutical corporations and the realization of an untapped, multi-billion-dollar industry.
Morris says the U.S. population dying from terminal illness every year is approximately 2 million.
“You assume that those people are the market for opioids, so, it's not a large market, and, on top of that, the market continuously goes away,” he says.
For pharmaceutical companies, being restricted to selling drugs to people on hospice [care] is pretty limited, he says. So the industry was very interested in expansion.
“They said, ‘Look, we have all these people with chronic, non-cancer, non-terminal pain. Why not use opioids for them?’” Morris says.
A new wave of big money marketing surged toward this new demographic—roughly 50 to 100 million people in the U.S.—and doctors, on the whole, bought into it, he says.
“Pharmaceutical companies sponsored a lot of the medical board guidelines for chronic pain and a lot of money went into saying it's safe,” adds Morris.
As an example, in the mid ’90s, the painkiller OxyContin came out and was advertised as being less addictive than other opiates, safer, and more effective for chronic pain. “They made a lot of big claims that were not backed up by any data,” Morris says.
Today, OxyContin is one of the most heavily abused prescription drugs on the market, and Morris says many attribute that to the early marketing.
In 2007, Purdue Frederick, the company behind the OxyContin marketing campaign, pleaded guilty to misbranding the drug and had to pay a $630 million fine to the U.S. Justice Department. But with their profits already so high, the fine did little to disable them.
“That kind of looked like the government was clamping down,” Morris says, “but there is still a lot of OxyContin being sold.”
Now, one of Morris' concerns about the opioid industry and the tightening of regulations is what will happen to all of the people who have become physically dependent.
“What some have predicted is going to happen, and to some extent it already has, is that as prescription drug supply starts to dry up—because of education, better monitoring, and better informed physicians and patients—heroin sales and overdoses go up,” he says.
Morris believes that the more people the medical industry exposes to opioids like OxyContin, Vicodin and morphine, the more addicts it will create.
He says early on in the pharmaceutical opioid industry, doctors estimated that less than 5 percent of users would become addicted, or at least suffer a serious problem relating to their use of the pills. Today, he says, that percentage is estimated to be between 30 or 40 percent.
But further regulation, he says, which could make access for patients in need even more difficult, does not so much solve the wider abuse issue as actually drive a shift toward the black market.
The broader scope is improving the understanding of what type of patients benefit from opioids and over how much time the medication is viable.
“My answer is not that no one should get opioids, but I think we need to be very careful how we give them,” he says. “If you're going to go onto opioids, the patient and physician should have a clear understanding that it's a trial. And if after two or three months it's not a stable dose and it's not improving the pain or function, then they need to take you off. It really has to be a risk-benefit balance.”
written by Pain Management Provider, December 13, 2013
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