||Drug maker pushed painkiller aggressively
By Doris Bloodsworth
Sentinel Staff Writer
February 21, 2003
FORT LAUDERDALE -- The maker of the highly profitable narcotic painkiller OxyContin has been aggressively marketing the drug far beyond its original purpose to ease the suffering of cancer patients, according to company documents released Thursday.
Purdue Pharma for several years has promoted the powerful drug to treat less-threatening ailments, such as arthritis and back pain, according to company marketing plans. Those materials also discuss future marketing of the drug to obstetricians and specialists in sports medicine.
The company fought to keep the sensitive documents secret, but a circuit judge in Broward County ordered them released as a result of a suit by the Orlando Sentinel and the South Florida Sun-Sentinel.
Marianne Skolek, whose daughter died from an overdose of the drug, said the marketing plans back up her allegations that the product was marketed inappropriately.
"Purdue Pharma should be held criminally responsible for deceptive marketing of a Schedule II narcotic," Skolek, of New Jersey, said Thursday. Her daughter, who had an OxyContin prescription, died last year. "It has nothing to do with pain management -- it is all about profit management, and Purdue should be ashamed of themselves."
Purdue officials say OxyContin is a highly effective product and, when used properly, has a relatively low addiction rate.
Federal officials have admonished the company several times for marketing the narcotic inappropriately. And a number of class-action suits have been filed against Purdue in other states.
OxyContin, which has come under fire because of the number of deaths linked to its abuse, was introduced in 1996 to help cancer patients and others cope with chronic pain.
But Purdue, based in Stamford, Conn., recognized early on that non-cancer patients represented a larger and more lucrative market and sought to expand the use of its time-release painkiller, according to the marketing plans.
In a marketing overview for 2002, the company noted that $2.1 billion in opiate sales were for non-cancer pain compared with $396 million for cancer patients. The 1999 plans state more than 70 percent of OxyContin prescriptions were written for non-cancer pain.
$1.4 billion a year
The marketing plans reflect that by 2000 the company was making eight times the original projection. Court records show the synthetic narcotic produced $1.4 billion annually.
The plans, for 1996-2002, were released by the Florida Attorney General's Office, which had investigated how the company was marketing the drug in the state. The probe was launched in 2001 after state officials reported 140 people died from oxycodone overdoses between July and December 2001. Oxycodone is the active ingredient of OxyContin.
Purdue's most recent marketing plan states: "In 2002 OxyContin Tablets will continue to be promoted for use in the non-malignant pain market." The plan cited as examples back pain, osteoarthritis, injury and trauma.
Broader usage sought
Another goal was an attempt to "broaden OxyContin Tablets usage in the management of pain due to various causes (e.g., back pain, osteoarthritis, neuropathic pain, post-operative pain)."
"In spite of impending competitive threats, the future for OxyContin Tablets is very bright.
"Future growth of OxyContin Tablets will be achieved through targeted efforts to penetrate: primary care, rheumatology, OB/GYN, surgical, oncology and sports/physical medicine/rehabilitation."
Purdue spokesman Jim Heins said the company has since decided not to target obstetrical and gynecology patients.
The federal government has criticized the pillmaker several times for how it promotes its product.
Thomas Abrams, the FDA's director of drug marketing, faxed a "warning letter" last month to Purdue saying recent ads in the Journal of the American Medical Association violated regulations.
"Your journal advertisements omit and minimize the serious safety risks associated with OxyContin and promote it for uses beyond which have been proven safe and effective," Abrams wrote. He also said the ads "grossly" overstated the safety profile of OxyContin by not referring to the "serious, potentially fatal risks" associated with the drug.
Purdue discontinued the ads and called the FDA's letter "the result of an honest misunderstanding, which we regret."
The U.S. Drug Enforcement Agency has asked Purdue to market the drug only to pain specialists and to modify the company's claim that OxyContin may be less prone to abuse than similar narcotics. DEA officials can only make recommendations.
The FDA also has ordered the pillmaker to stiffen its warning, a so-called "black box" labeling because of the box around the insert warning used to draw attention to danger and seriousness.
Purdue's 2002 marketing plans acknowledge that because of such measures "the ability to expand OxyContin Tablets use in non-cancer pain will be more challenging. It is unlikely that an opioid approved by the FDA in the future will have as broad of an indication [usage] as OxyContin now enjoys."
While some pain patients hail the drug as a miracle, others complain that they became addicted or dependent. The drug also became popular among abusers who would crush it and snort it for its heroinlike high.
Butterworth probed drug
Former Attorney General Bob Butterworth launched a highly publicized investigation in 2001 into how the drug was marketed. His office requested thousands of pages of documents from Purdue. But it is unclear whether many people were interviewed.
Assistant Attorney General Jody Collins in Fort Lauderdale said she knew of one former Purdue employee who was interviewed.
The investigation was dropped when Purdue pledged $2 million to help Florida develop computer software to monitor prescriptions.
Purdue says it reached an agreement with the state when the company offered the money, but Collins said it was a settlement the state negotiated.
"Yes, they had very aggressive marketing plans, and, yes, there were things they corrected," Collins said. "You sometimes come to a point where there is an offer on the table that benefits the state of Florida and all over the country. You say, this is something you can't pass up."
When asked about Florida patients who may get the drug inappropriately, she said that was a matter for the FDA to handle.
OxyContin has been the subject of great debate. Abuse of the drug and addiction to it became such a problem in the Appalachian region that it became known as "hillbilly heroin."
A Drug Enforcement Administration official last year testified to Congress that such problems were due, in part, "to aggressive marketing and promotion" of the drug.
Federal officials have said no drug in the past 20 years has been so abused in such a short time.
Besides Florida, several states have investigated Purdue Pharma, but the company has been successful in fighting most of the lawsuits.
That hasn't stopped Skolek, who has teamed up with Chelly Griffith of Davenport, Iowa. They fire off almost daily faxes to officials, including Florida's attorney general.
Griffith started taking OxyContin about four years ago.
For the first few months, she said the drug worked well. But as her body started requiring more doses, Griffith said she became hopelessly addicted. She said her behavior became bizarre, as she started cutting her front lawn with scissors and plucking out body hairs one by one.
Griffith said the marketing plans show Purdue is aware of problems caused by its popular painkiller.
"When Purdue Pharma acknowledged that future FDA opioids will not have as broad of indication as OxyContin, they acknowledged that there was something unsafe or harmful about OxyContin," Griffith said.
Skolek contacted the Florida Attorney General's Office last month asking to become involved in any investigation of Purdue. She is raising her daughter's 7-year-old son.
Investigators and lawyers from around the country were in the process Thursday of getting copies of Purdue's marketing plans for use in a number of investigations and lawsuits.
Paul Hanley, a New York lawyer assisting in more than 600 lawsuits filed against the pillmaker, said the marketing plans and a recent harshly worded admonishment from the U.S. Food and Drug Administration show Purdue pushed OxyContin for purposes broader than those for which it was intended.
Drug experts say one 80-milligram OxyContin equals 16 Percocets.
Collins said that although the state had agreed not to sue for problems incurred before Nov. 1, 2002, the Attorney General's Office could reopen an investigation if subsequent problems warranted it. She said other state agencies will now focus on getting a law passed when the Legislature convenes next month that would allow the $2 million prescription-tracking program funded by Purdue.
Doris Bloodsworth can be reached at [email protected] or 407-420-5446.