In 1998, Purdue Pharma sponsored clinical trials of OxyContin in several states on arthritis patients. The test of the drug, a timed-release synthetic morphine, included patients in Broward County and Gainesville in an apparent effort to expand the narcotic painkiller’s use to millions more people.
After only a one-month study, according to documents supplied by the company to Attorney General Bob Butterworth, the researchers suggested that arthritis patients, especially women and the elderly, could benefit from starting on OxyContin at earlier stages of the disease.
Dr. Martin Hale, of Park Place Orthopedics and Rehabilitation in Plantation, was one of the researchers and authors of the article with the findings that appeared in The Journal of Rheumatology in 1999.
“The company was looking to see if it was appropriate for arthritis,” Hale said. “The FDA demands studies, and I gather this was so they could determine whether it would work. The patients did very well with the medication. They were getting relief.”
Hale said he does not routinely prescribe OxyContin for arthritis without trying other medications or physical therapy first.
Purdue bought an ad in the prestigious New England Journal of Medicine to promote the drug to physicians caring for the nation’s 21 million arthritis sufferers, but drew the ire of the Food and Drug Administration.
In May 2000, the FDA told the company the ad was false and misleading, and Purdue agreed to stop using it, according to FDA documents.
Dr. John K. Jenkins, director of the FDA’s Center for Drug Evaluation and Research, said the ad implied OxyContin had been studied in all types of arthritis and could be used as first-line therapy for osteoarthritis, meaning the first drug a doctor prescribed for arthritis pain.
Jenkins also said the ad failed to include important limitations to claims it made based on one osteoarthritis study and promoted OxyContin to a selected class of patients without presenting the risks to those patients.
Butterworth said the arthritis campaign illustrates how far out of bounds Purdue’s marketing strategies have spun.
“This drug should be used for people in severe pain — terminal cancer patients, managing pain in hospice,” Butterworth said. “People with arthritis? Someone whose knee hurts? This is not the drug to prescribe.”
The American Pain Society guidelines for the treatment of arthritis say mild to moderate arthritis pain can be treated with over-the-counter medications such as acetaminophen, and moderate to severe pain with drugs such as Celebrex and Vioxx.
Narcotics such as oxycodone, the generic name for OxyContin, and morphine “are recommended for treating severe arthritis pain” only if other drugs are not effective, the society guidelines say.
Butterworth put Purdue on notice in November that he is conducting a civil investigation of its marketing practices. He said problems with OxyContin have reached crisis levels in Florida.
“I got involved primarily because I was reading the reports of the deaths from the medical examiners,” Butterworth said. “In Palm Beach alone there were 33 deaths in the first half of last year. That sort of gets your attention.”
Butterworth’s office is still waiting for Purdue Pharma to submit more documents. No suit has been filed.
OxyContin, meantime, has become the most frequently prescribed narcotic in the country, with almost 6 million people using it, according to the federal Drug Enforcement Administration.
Asa Hutchinson, who heads the DEA, told a congressional committee hearing in December that Purdue encouraged physicians to prescribe OxyContin as a substitute for a variety of less-addictive existing medications.
Purdue, a privately held company based in Stamford, Conn., and its marketing partner, Abbott Laboratories, saw sales hurtle upward from $47.3 million in 1996 to $1.2 billion last year.
OxyContin has been blamed by attorneys general and families for hundreds of deaths and a new wave of drug addictions in people of all ages from Maine to West Virginia to Florida.
West Virginia’s attorney general filed suit against the company last June over its marketing practices, alleging “highly coercive and inappropriate tactics” to get physicians to prescribe the drug.
As investigations and lawsuits have spread across several states, the company hired at least three high-profile former law enforcement investigators, including former assistant U.S. attorneys in Maine and Kentucky, who previously had been highly critical of the company’s tactics, to serve as consultants.
When Jay McCloskey was U.S. attorney in Maine, he sent letters to 4,800 doctors and other health professionals in the state warning them of “serious problems across the state regarding the misuse of OxyContin.”
Joseph Famularo, former U.S. attorney in Kentucky, called OxyContin abuse “a locust plague” and in February 2001 participated in a joint federal-state drug sweep that netted 207 arrests, which he said in news reports at the time mostly involved OxyContin.
Both went into private practice in their respective states in mid-2001, and both later became consultants for Purdue Pharma, according to documents filed in a lawsuit against the company.
Purdue says it has done nothing wrong and has not pushed the boundaries in its marketing of the drug.
“One of the phrases that keeps coming up is ‘aggressive’ marketing. We need to put it in context,” said Tim Bannon, senior director of public affairs for the company.
“Purdue Pharma does no direct-to-consumer marketing of OxyContin. It is permitted by law, but we’ve decided voluntarily not to do that,” Bannon said. “It seems to me that fact alone defeats the theory that Purdue’s marketing is aggressive.”
He declined, “for competitive reasons,” to say how much the company has spent on marketing OxyContin.
The drug was first approved by the FDA in 1995 for moderate to severe pain, and brought respite and relief to people with cancer or chronic, intractable pain.
But after Purdue invited doctors around the country to seminars on pain management, sometimes flying them to Florida, Arizona and California for the meetings, the use of OxyContin spread rapidly.
“When this drug first came out, it was 80 percent prescribed by oncologists,” Butterworth said. “Now it’s 80 percent by family physicians.”
According to the documents received by Butterworth’s office, top executives said that their product, in the right hands, is neither addictive nor dangerous.
They said most patients could stop taking the drug abruptly with no ill effects, while others might need to be weaned off by decreasing the doses over a period of time, the documents show.
The company changed the product’s package insert in 1998 to remove the words: “Warning: May be habit forming,” according to company documents.
Bannon said that warning was removed because the FDA said a similar warning appeared elsewhere in the package insert.
But after the FDA intervened last year, Purdue was forced to change the label. Since July the drug has carried a “black-box warning” — the strongest warning on any FDA-approved product — to alert doctors and patients to the dangers.
Inside a black-border and in bold letters, the label now says:
“WARNING: OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.”
The warning goes on to say misuse, abuse and diversion of the drug might occur.
Purdue also agreed to send letters to the nation’s doctors saying it is not recommended for short-term pain, such as the pain following surgery.
“Unfortunately it appears this drug was presented as a panacea for far too many things,” said Jim McDonough, director of the Florida Office of Drug Control, who has been tracking the numbers of deaths statewide.
“The ability of OxyContin to addict is unnerving,” he said. “We’ve had anecdotal reports of people who used it three times and became addicted. They say they were going into withdrawal and they had to have it.”
McDonough said Purdue Pharma has backed off some of its earlier claims.
“Time has brought experience,” he said, “and experience has brought caution.”
