Purdue Pharma left almost nothing to chance in its whirlwind marketing of its new painkiller OxyContin.
From 1996 to 2002, Purdue pursued almost every avenue in the drug supply and drug sales chain, a strategy now considered reckless and illegal in more than 1,500 federal civil lawsuits from communities in Florida to Wisconsin to California that allege that the drug has fueled a national epidemic of addiction.
Kaiser Health News is publishing years of Purdue internal budget documents and other records to give readers the opportunity to assess how the private company in Connecticut spent hundreds of millions of dollars to launch and promote the drug, a large number of Information made available to the public here for the first time.
All of these internal Purdue records were obtained from the Florida Attorney General's Office investigating the Purdue sales efforts that were completed in late 2002.
I have had copies of those records in my basement for one year rs. I was a journalist in the South Florida Sun-Sentinel, which, along with the Orlando Sentinel, won a court battle to force the attorney general to release the company's files in 2003. At that time, the Sun-Sentinel was writing extensively on a growing tide of deaths from prescription medications such as OxyContin.
We resorted to marketing files to write two articles, including one that exposed a possible misleading marketing of the drug. Now, given the disastrous arc of prescription drug abuse in the last decade and the sequence of lawsuits filed – more than a dozen in a few days – I thought it appropriate to share these fundamental documents that reveal the breadth and detail of Purdue's efforts. .
When asked by Kaiser Health News about OxyContin's marketing files and lawsuits against the company, Purdue Pharma spokesman Robert Josephson issued a statement that says in part:
"Suggesting activities that occurred by The last time more than 16 years ago, for which the company accepted responsibility, helped contribute to the complex and multifaceted opiate crisis of today, it has many flaws.Most of the opiate prescriptions are not, and never they have been, for OxyContin, which represents less than 2% of current opioid prescriptions. "
Marketing files show that approximately 75 percent of more than $ 400 million in promotional expenses occurred after 2000 and beyond. , the year in which Purdue officials informed Congress that they had learned of OxyContin's growing abuse and drug-related deaths by peer inform you of the media and regulators. These internal Purdue marketing records show that the pharmacist financed activities in almost all areas of medicine, from granting subsidies to health care groups that set standards for the use of opiates to reminding reluctant pharmacists how they could benefit from storing pills. OxyContin on its shelves.
Purdue bought more than $ 18 million in advertising in leading medical journals that cheerfully promoted OxyContin. Some of the warnings, federal officials said in 2003, "greatly exaggerated" the drug's safety.
Purdue records show that the company invested more than $ 8 million in a website called "Partners Against Pain," which helped connect patients to doctors willing to treat their pain, presumably with OxyContin or other opioids.
Made and distributed 14,000 copies of a video claiming that opiates caused addiction in less than 1 percent of patients, a claim that Food and Drug Administration officials later said "has not been corroborated."
Purdue hoped to become one of the top 10 pharmaceutical companies in the country, both in sales and in "image or professional position," according to the documents; OxyContin was the means to that end.
Purdue marketed cancer pain medicine for the first time, but planned to expand that use to meet its multimillion dollar sales targets. In 1998, the market for treating opioid cancer amounted to $ 261 million, compared to $ 1,300 million to treat other types of pain, reports Purdue.
Purdue's OxyContin sales targets were clearly established in the first marketing plan in the records, for 1996. It sought $ 25 million in sales and to generate 205,000 prescriptions. For the next year, his goals had tripled: $ 77.9 million in sales and generate 600,000 prescriptions.
Purdue bombarded doctors and other health workers with publications and sales calls. Records show that in 1997 the company budgeted $ 300,000 to send mail to physicians prescribing opioids freely, based on sales data purchased by pharmaceutical companies. The senders recommended OxyContin for "pain syndromes," including osteoarthritis and back pain. He added $ 75,000 for mailings "to keep in touch with our best OxyContin clients to ensure they continue to prescribe it."
Sales agents made thousands of visits to GPs and others who had little training or experience in the use of potent opioids, according to an audit by the Office of Government Accountability 2003. The motto of OxyContin in 1999 was : "The one who starts and the one who stays". OxyContin has earned Purdue about $ 2.8 billion in revenue since the beginning of 1996 through June 2001, according to the Department of Justice.
In May 2000 Purdue's hope of conquering the arthritis market became entangled when the FDA criticized an announcement by OxyContin in the New England Journal of Medicine. The FDA said the announcement, which Purdue Pharma agreed to stop using, overstated the benefits of the drug to treat all types of arthritis without pointing out the risks.
News about abuse and deaths from overdose also began to appear. Purdue's 2001 marketing document noted that OxyContin had "experienced significant challenges" the previous year due to abuse and illegal diversion in Maine, Ohio, Virginia, Louisiana and Florida.
OxyContin pills contain oxycodone, an opioid as potent as morphine and maybe more so. The abusers quickly discovered that they could crush the pills and inhale or inject the powder
. In response, Purdue's 2001 marketing budget included funds to help physicians recognize patients who needed "substance abuse counseling" and more to "prevent abuse and fun." He added $ 1.2 million in expenses for what he called "anti-diversion" efforts in 2002, according to internal records.
POWERFUL SALES FORCE
In 2002, the Florida Attorney General's office was one of the first law enforcement agencies to investigate Purdue. The state finalized its investigation after Purdue agreed to pay Florida $ 2 million to help fund a data system to monitor narcotic prescriptions. He did not admit any irregularity in the agreement.
However, handwritten notes from a state investigator interview with a former Purdue sales manager for West Virginia and western Pennsylvania named Bill Gergely, then 58, suggested the opposite. The notes were part of the documents published by the state.
Gergely, who worked for the company from 1972 to 2000, said Purdue executives told sales staff at a launch meeting that OxyContin "did not create a habit," according to the undated researcher's notes. Gergely said Purdue gave its sales force material – some of which was not approved by the FDA – for "education," the notes show. He told the researcher that Purdue had a bonus system and paid well; the last year he worked for Purdue, Gergely earned $ 238,000.
While Purdue loaded with OxyContin, prescription pills outperformed illegal drugs such as heroin and cocaine as killers in Florida, according to the coroner's records. In May 2002, the South Florida Sun-Sentinel documented nearly 400 pill deaths in three South Florida counties in the previous two years, based on an autopsy and police search examination.
Half of the deaths involved drugs containing oxycodone, according to medical records of the examiner. But it was not always clear in these records that it was OxyContin because oxycodone was an ingredient in many other narcotic pills. However, in 70 of the deaths, the records of the police or the forensic doctor specifically identified OxyContin as one of the drugs. Although some people who died bought pills in a thriving black market, many were under the care of doctors for what seemed, at least at some point, to be legitimate injuries, according to the coroner's records.
Purdue did not question the accuracy of the newspaper reports. He fought that the articles "harmed" the company and the patients who take their medications "according to the instructions of their doctors." While the company said its executives "deeply regret the tragic consequences that have resulted from the misuse and abuse of medications." our pain medicine … advances in pain management should not be limited or reversed because some people illegally divert, misuse or abuse these drugs. "
For your sales force, according to Purdue's internal records, Purdue blamed the bad press for cutting sales. "Media attention to abuse and diversion of OxyContin tablets has provided state Medicaid plans and some HMOs, concerned about the effect the product is having on their budget, an excuse to look for ways to limit the prescription of OxyContin tablets, "the 2002 marketing document said.
But five years after his legal battle with Florida officials, Purdue made a surprising admission in a federal court in Virginia. pleaded guilty in 2007 to felony counts of "fraudulent labeling" of OxyContin "with intent to defraud or cheat." The company paid $ 600 million in fines and other penalties. Among the deceptions he confessed that he was directing his salesmen to tell doctors that the drug was less addictive than other opiates.
Three Purdue Pharma executives pleaded guilty to minor charges of criminal charges for their role in the marketing scheme. The three men paid a total of $ 34 million in fines and penalties, according to court records. Accepting Purdue's guilty plea, US District Judge James P. Jones noted that federal prosecutors believed that the 2007 Purdue case would send a "strong message of deterrence to the pharmaceutical industry."
A COSTLY RECOGNITION?
Ten Years Later, More than 1,500 lawsuits, filed mostly on behalf of cities, counties and states, could be costly for the opiate industry. The lawsuits are demanding the return of Purdue and other drug manufacturers for the high costs of treating addiction and other compensation, as well as the litigation against Big Tobacco in the late 1990s.
Other manufacturers of drugs named as The defendants in most of the suits include those that Purdue considered its main competitors in the pain sector: Janssen Pharmaceuticals, Teva Pharmaceutical Industries, Endo International PLC and Mallinckrodt PLC.
Federal officials estimate that the economic cost of opioid abuse exceeded $ 500 billion in 2015 alone. Since 1999, at least 200,000 people have died in the United States from these overdoses, according to the Centers for Disease Control and Prevention. Disease Prevention. More than 52,000 of them died in 2015 alone, more than those who died in car crashes and armed homicides combined, the lawsuits contend.
A case filed in April by Baltimore County in Maryland presents a common argument for many of the lawsuits:  "From the mid-1990s to the present, the manufacturing defendants aggressively promoted and falsely promoted the liberal prescription of opioids for presenting little or no risk of addiction, even when used long-term for chronic pain. They infiltrated academic medicine and regulatory agencies to convince physicians that treating chronic pain with long-term opioids was a based on the evidence when, in fact, it was not.
"These efforts generated huge benefits, as did the current addiction and overdose crisis. "
Purdue has not yet filed an answer to the claims in the lawsuit.
Other drug manufacturers" emulated Purdue's fake marketing strategy "and sold billions of prescription opioids" as safe and effective over the long term. " "Use, knowing full well that they were not," Wisconsin's Oneida County alleges in its November 2017 lawsuit. Purdue has not yet filed a response to the allegations in this lawsuit.
But Purdue spokesman Josephson told KHN: "We share the concern of public officials about the opiate crisis and we are committed to working collaboratively to find meaningful solutions." We vigorously denounce these allegations and look forward to the opportunity. to present our defense. "
A California doctor who was sentenced to 25 years in prison for overprescribing OxyContin is also suing Purdue. Masoud Bamdad alleges that the representatives of the company made sales calls and gave him "misleading, deceptive and hypermeditated information", in which he confided to prescribe the drug, in some cases with deadly consequences for his patients, according to the lawsuit, which is pending. Purdue has requested that the case be suspended, while the judges decide whether to consolidate with others filed against the company. In February, Purdue announced that he would no longer promote opiates to doctors.
Because the trials of the US UU They contain similar allegations, many of them have been consolidated in Ohio, as a multi-site litigation. Some days, federal court records record a dozen or more new cases. Many of the suits have a hundred pages or more and claim that the deceptive schemes of opioid marketing continue to this day.
Manufacturers, in a joint court motion late last year, contend that opiates "play a critical public health role by providing relief to patients who suffer pain that is often debilitating" and that they were wrongly blamed .
They also point out that the FDA approved all its products as "safe and effective".
This month, the manufacturers presented the moves to rule out several of the cases, arguing that the county governments lack a legal basis for their claims. In trying to blame drug manufacturers, these lawsuits ignore "the criminal acts of third parties, the crucial role of health care providers and the thorny issues of public policy surrounding the problem of opiate abuse," says a motion to dismiss a case filed by Monroe County, Michigan, against Purdue Pharma and other pharmaceutical companies.
Dan Polster, the federal judge handling the cases, told a crowd in his court that the opioid epidemic has become so severe that it is reducing the average life expectancy of Americans.
"I'm quite ashamed that this happened while I was around," he said in January, adding that "I think we should all be."
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KHN's coverage of the development of prescription drugs, costs, and prices is funded in part by Laura and John Arnold Foundation.