By Jeff Sturgeon and Laurence Hammack
Some doctors and pharmacists are put off by what they say is an overly aggressive pitch by the maker of OxyContin to sell a wonder drug for a long list of painful conditions.
Others say OxyContin is a good product and that its marketing is no different from that of other prescription drugs.
Connecticut drug manufacturer Purdue Pharma recently pulled back on its blockbuster 1996 prescription painkiller, trimming shipments to Mexico and pulling its highest-dose pill off the market.
But Purdue, which sold $1 billion worth of OxyContin last year, still supplies most forms of OxyContin in this country, advertises in medical journals and sends some 900 sales representatives to call on physicians and pharmacists. It is the private company’s best-selling product.
Sales representatives are key information sources for physicians about painkillers, as medical schools historically have skimped on pain-management training.
Most recently, Purdue and other drug companies have underwritten meetings of physicians to discuss pain management, including strategies to continue the safe use of OxyContin.
Robin Hogen, director of public relations for Purdue Pharma, said the company does not market the drug irresponsibly.
“We would contest that up, down and sideways. The company is a conservative marketeer by any measure and responsible by all measures,” Hogen said.
That’s not how Dr. Art Van Zee sees it. Van Zee is a St. Charles physician who is leading a national petition drive to have OxyContin recalled. He lives and works in Lee County, a part of Southwest Virginia where crime has soared as OxyContin addicts rob pharmacies, steal from homes and businesses, and forge prescriptions to support their habits. Since 1998, there have been at least 37 fatal overdoses west of Roanoke attributed to oxycodone, the active ingredient in OxyContin.
Van Zee said Purdue marketed the drug too strongly.
As an example, he said Purdue sent printed promotional material containing studies about OxyContin with an offer of a compact disc with 1950s dance tunes and a smiling, elderly couple under the words “swing in the right direction with OxyContin.” The offer also included a pedometer with the drug’s name and the words “a step in the right direction” and a beige beach hat with a large OxyContin logo. He told Purdue he wanted the items. When he received the promotional package, he said he found it “beyond the limit of what I would consider reasonable.”
“I thought it was inappropriate, considering by the summer of 2000 how evident it was that there was epidemic proportions of abuse,” Van Zee said.
“I told them at the time that not only was this a disservice to the situation, but that it was counterproductive.”
With OxyContin being a valuable street drug, “you could put the hat on and ride through St. Charles and have 300 people in a mob that would follow you around.”
The promotion ran for its scheduled length of time and now is over, said Purdue Pharma spokesman James Heins.
Andrew Kramer, a general surgeon who operates at Russell County Medical Center in Lebanon, said many drugs are aggressively marketed. OxyContin was no different. “It certainly was pushed hard as all money-making drugs are. My only concern with the company is I think they responded slowly to reports of abuse,” he said.
In November 2000, well after the drug’s deadly potential was clear to law enforcement officials, he approached a Purdue booth at a national surgeon’s conference. “I went up and said we in Southwest Virginia, we’re having epidemic levels of abuse of the drug. The response I got was, the drug’s fine. It’s the people in your area,” Kramer said. “They sort of pooh-poohed it.”
The conversation was with a sales representative, he noted, not a company executive.
Kramer said he believed the company eventually took the abuse seriously. “It took ’em a long time, but they finally realized this is a potentially dangerous drug,” said Kramer, who prescribes it more cautiously than he used to.
Sam Okoronkwo, a pharmacist at retailer CVS in Blacksburg, told of an encounter with a Purdue sales representative while he worked at the Tazewell CVS.
According to Okoronkwo, the Tazewell CVS stopped carrying OxyContin because of problems in that community, provoking a Purdue Pharma sales representative to warn that the store could be sued for failing to fill a doctor’s prescription. “I think he was trying to intimidate us to think that if we refused to fill a prescription, if sued, we could be liable for a substantial amount of money,” Okoronkwo said. “I think they’re being overly aggressive.”
A Purdue representative was taken to task last month by Alabama Gov. Don Siegelman for promotional remarks the governor found inappropriate.
At a news conference, Siegelman announced a task force to fight prescription drug abuse. At the governor’s invitation, Dr. Sheryl Siegel, Purdue’s associate medical director for health policy, spoke next but Siegelman interrupted her in the middle of her remarks.
Siegelman, according to the local newspaper, said: “I find this very offensive. … When people are agonizing over the loss of their children, we don’t need to turn this into a press conference for your company or this drug.
We’ve had enough public relations and enough sugarcoating of this issue and, quite frankly, as governor, I am fed up.”
He told Siegel to sit down.
The U.S. Drug Enforcement Administration and Food and Drug Administration have deemed the marketing of OxyContin as excessive.
In May 2000, an FDA regulatory review officer told Purdue it should “immediately discontinue” an ad that appeared in the New England Journal of Medicine that said OxyContin was “Proven Effective in Arthritis Pain.”
The FDA said it found the ad unsubstantiated and misleading because OxyContin had been tested on some but not all types of arthritis. In addition, the ad neglected to say only the 20-milligram dose level had been proven effective, that higher doses had not been studied, and that a 10-milligram dose was no better than a placebo. Finally, the ad pictured an elderly person but neglected to explain that elderly people who take OxyContin may experience respiratory depression or uncontrollable shallow breathing.
Purdue’s Heins said the company stopped running the ad in magazines, made changes requested by the FDA and printed revised materials for sales representatives to hand out.
More recently, the DEA announced an official request to Purdue that the company scale back marketing and distribution of OxyContin. DEA official Terry Woodworth said Purdue’s promotion and distribution of the drug to general practitioners might have led to its wide misuse. He said the DEA asked Purdue to limit distribution to pain specialists.
When it introduced the drug in 1996, Purdue had reason to be upbeat. It was hailed as a breakthrough. The promise lay in Purdue’s ability to develop a long-acting form of oxycodone without the side effects such as organ damage that are typically associated with oxycodone use. Oxycodone is a powerful painkiller based on a compound in the opium poppy.
No oxycodone-containing drug to that point provided relief that lasted more than six hours. OxyContin lasts 12 hours and two pills a day provide 24-hour relief. Suddenly, with OxyContin, legions of people hobbled by pain could sleep a full night or work a full shift at a job. Purdue met its first-year sales projection in eight months. Last year, OxyContin was the 18th best-selling brand-name drug in the United States by retail sales, with 5.6 million prescriptions written.
Lipitor, which lowers cholesterol levels, led with 44.7 million prescriptions last year.
Many doctors are enthusiastic about OxyContin.
John Dreyzehner, a physician employed by Russell County Medical Center, saw a clear divide among about 20 medical staff physicians who recently discussed OxyContin.
“Some felt that it was a medication that – because of its high abuse potential – perhaps shouldn’t be prescribed at all. There were other doctors who felt very strongly that it was not appropriate or desirable to penalize the many patients who use it legitimately and derive a substantial benefit from its use to take it off the market,” Dreyzehner said.
He said Purdue spelled out the risks clearly enough for physicians once they were known.
What some people fail to see, he said, is that all drugs and many other substances can be abused or employed outside medically or socially approved uses, such as to create euphoria.
“We’ve had kids abusing Robitussin. That’s an over-the-counter [item]. We’ve had people abusing various solvents,” he said. Despite this, they’re available today.
“People haven’t suggested we take model airplanes off the market just because model airplane glue can be abused.”
Dreyzehner said it would be an overreaction to take OxyContin off the market. He supports using it for its FDA-sanctioned purpose: to alleviate or reduce “moderate to severe pain where use of an opioid analgesic [opium-derived painkiller] is appropriate for more than a few days.”
Purdue Pharma agrees. While a strong supporter of new efforts to curb prescription drug abuse, it has helped stage organizational meetings for two pain-management societies where OxyContin was hailed and seldom ridiculed. One in the New River Valley and one in the Roanoke Valley, the groups are open primarily to physicians, especially pain specialists, pharmacists, nurses and mental health professionals.
Although Purdue did not control the agenda, at each group’s first meeting the company helped pay for dinner with what Heins called an unrestricted educational grant and sent a sales representative or two who greeted participants.
For the Roanoke meeting, Purdue sales representative Steve May suggested whom to invite, said Dr. Conrad Daum, a Roanoke psychiatrist who organized and led the meeting. For the New River meeting, May reserved the meeting room.
The company denied any marketing motives and said doctors concerned about proper pain treatment are the driving force behind both groups.
Unless a physician is genuinely interested in a group of this type, “a piece of chicken… that isn’t going to motivate someone who gets $200,000 [income a year] to sit and talk about pain management, ” said Purdue spokeswoman Terri Jones.