Over the past two decades, conflicting medical ideas have surfaced about narcotic painkillers, the drugs that Rush Limbaugh blames for his addiction while being treated for chronic back pain. And both of them, not surprisingly, have centered on the bottom-line question: just how great a risk of abuse and addiction do narcotics pose to pain patients?
Throughout much of the last century, doctors believed that large numbers of patients who used these drugs would become addicted to them. That incorrect view meant that cancer sufferers and other patients with serious pain were denied drugs that could have brought them relief.
But over the past decade, a very different viewpoint has emerged, one championed by doctors specializing in pain treatment and drug companies eager to broaden the market for such drugs. It held that these medications posed scant risk to pain patients, and some experts now believe that it also had unfortunate consequences because it caused, among other things, physicians to develop a false sense of security about these drugs.
”The pendulum went in two opposite directions,” said Dr. Bradley S. Galer, group vice president for scientific affairs at Endo Pharmaceuticals, which manufactures two widely used narcotics, Percodan and Percocet. ”Luckily, now the pendulum is focusing where it should be, right in the middle.”
The reassessment of narcotic risk comes at a time of skyrocketing rates of misuse and abuse of such drugs. Medical experts agree that most pain patients can successfully use narcotics without consequences. But the same experts also say that much remains unknown about the number or types of chronic pain sufferers who will become addicted as a result of medical care, or ”iatrogenically” addicted. The biggest risk appears to be to patients who have abused drugs or to those who have an underlying, undiagnosed vulnerability to abuse substances, a condition that may affect an estimated 3 to 14 percent of the population.
Dr. James Zacny, an associate professor at the University of Chicago and a leading narcotics researcher, said there was a dearth of data about the long-term risks that narcotics pose. ”We don’t know a lot about the rate of iatrogenic addiction,” he said.
It is not unusual for views about particular drugs and their hazards to change over time. But a look at the shift in medical thinking about the risk of addiction shows a struggle that was waged both as a guerrilla war among doctors and a high-powered drug industry initiative. It was also an effort that, while seeking a laudable goal, inaccurately portrayed science.
Modern views about the threat posed to patients by narcotics were shaped in the mid-1980′s when pain treatment experts reported that cancer patients treated with such drugs did not exhibit the type of euphoria displayed by people who abused narcotics. That led some physicians to argue that strong, long-acting narcotics could also be used safely to treat patients with serious pain unrelated to cancer, like persistent back pain or nerve disorders.
One leader of this initiative, known as the ”pain management movement,” was Dr. Russell Portenoy, who is now chairman of the pain medicine and palliative care department at Beth Israel Medical Center in New York. And soon Dr. Portenoy and others were pointing to studies that they said backed up their contention that the risk of powerful narcotics to pain patients was scant.
”There is a growing literature showing that these drugs can be used for a long time, with few side effects and that addiction and abuse are not a problem,” Dr. Portenoy said in a 1993 interview with The New York Times.
Drug companies amplified that theme in materials sent to doctors and pharmacists. For example, Janssen Pharmaceutica, the producer of Duragesic, called the risk of addiction ”relatively rare” in a package insert with the drug. Endo termed the risk ”very rare” in presentations to hospital pharmacists. Purdue Pharma, the manufacturer of the powerful narcotic OxyContin, distributed a brochure to chronic pain patients called ”From One Pain Patient to Another,” contending that it and similar drugs posed minimal risks.
”Some patients may be afraid of taking opioids because they are perceived as too strong or addictive,” the brochure stated. ”But that is far from actual fact. Less than 1 percent of patients taking opioids actually become addicted.”
The trouble, however, was that studies that looked at the experience of pain patients who used long-acting narcotics for extended periods of time did not exist. So narcotics advocates like Dr. Portenoy and drug companies like Purdue Pharma had looked elsewhere, at surveys of patients whose use of narcotics was limited. And those reports were not always put into proper context.
A frequently cited survey of narcotics use, taken in 1980, found ”only four cases of addiction among 11,882 hospitalized patients.” A director of that survey, Dr. Hershel Jick, an associate professor of medicine at Boston University, said his study did not follow patients after they left the hospital and did not address the risk of narcotics when they were prescribed in outpatient settings.
In another case, advocates of increased narcotics use also misstated a study’s results. It involved a study of chronic headache sufferers conducted at the Diamond Headache Clinic in Chicago that some pain care specialists repeatedly claimed had found only ”three problem cases” among some 2,000 patients.
While the Diamond Headache Clinic did treat 2,369 patients in the study period, just 62 were studied because they met the criteria of having used painkillers alone or in combination with barbiturates for six months before entering the clinic. And the report’s findings were far different from the way they were characterized by narcotics advocates. It concluded, ”There is a danger of dependency and abuse in patients with chronic headaches.”
Dr. Seymour Diamond, the clinic’s director, said in a recent interview that neither pain experts nor narcotics manufacturers like Purdue Pharma who cited his study contacted him to discuss how they planned to use it. And he added that he believed that it was mischaracterized.
”It distorts the picture and it clearly underplays the risks,” Dr. Diamond said.
In a recent interview, Dr. Portenoy said he now had misgivings about how he and other pain specialist used the research. He said that he had not intended to mischaracterize it or to mislead fellow doctors, but that he had tried to counter claims that overplayed the risk of addiction. Still, he and others acknowledge, the campaign by pain specialists and drug companies has had consequences.
”In our zeal to improve access to opioids and relieve patient suffering, pain specialists have understated the problem, drawing faulty conclusions from very limited data,” Dr. Steven D. Passik, a pain management expert wrote in a 2001 letter published in The Journal of Pain and Symptom Management. ”In effect, we have told primary care doctors and other prescribers that the risk was so low they essentially could ignore the possibility of addiction.”
Today, some narcotics manufacturers like Endo have changed or are changing the way they present abuse and addiction information. For example, Purdue Pharma, while maintaining the accuracy of its past position, now states in patient information that it does ”not know how often patients with continuing (chronic) pain become addicted to narcotics but the risk has been reported to be small.” Ligand Pharmaceuticals, which manufactures a time-released form of morphine under the brand name Avinza, makes a similar statement.
For its part, a spokeswoman for the federal Food and Drug Administration, Kathleen K. Quinn, said the agency believed that ”the risk of addiction to chronic pain patients treated with narcotic analgesics has not been well studied and is not well characterized.”
In a letter to The New York Times, Purdue stated that it had found no cases of iatrogenic addiction in a recently completed long-term study of chronic pain patients suffering from osteoarthritis, diabetes and low pain back. Purdue did not identify where it planned to submit the study for publication although the company said it involved an older group of patients whose average age was 55.
Such results are encouraging. But several pain experts said that the full risks of narcotics will not be fully known until these drugs are tested in a wide range of pain patients of different ages and conditions.
”You may have a study telling how uncommon these problems are in patients over 50,” Dr. Portenoy said. ”But what does that tell you about the risks to younger patients or those patients who walk into a doctor’s office with a history of substance abuse or psychological problems.”
By Barry Meier from The New York Times
