Fred Schulte, Kaiser Health News
As Purdue Pharma confronted mounting criticism over deaths linked to OxyContin, rival drugmakers noticed an opportunity to spice up gross sales by stepping up advertising and marketing of equally harmful painkillers, reminiscent of fentanyl, morphine and methadone, Purdue inner paperwork reveal.
Purdue’s 1996-2002 advertising and marketing plans for OxyContin, which Kaiser Health News made public this 12 months for the primary time, provide an unprecedented take a look at how that firm spent tens of millions of to push opioids for rising legions of ache victims. A wave of lawsuits demanding reimbursement and accountability for the opioid disaster now ravaging communities has heightened consciousness about how and when drug makers realized the potential risks of their merchandise.
The Purdue paperwork lay out how the corporate and its greatest opponents had been jockeying for market share. Some of these drugmakers’ gross sales promotions downplayed or ignored the dangers of taking opioids, or made false claims about their security, federal regulators have asserted in warning letters to the businesses.
Purdue first supplied OxyContin as a treatment for reasonable to extreme most cancers ache in 1996. Within three years, the corporate considered the most cancers market as too restricted, with $261 million in potential annual gross sales versus $1.three billion for a broader vary of persistent ache care, the corporate’s advertising and marketing experiences mentioned.
“That was a pretty good recipe for a blockbuster,” mentioned Andrew Kolodny, who directs Physicians for Responsible Opioid Prescribing, an advocacy group vital of drug business advertising and marketing.
Purdue has grow to be essentially the most high-profile drugmaker linked to the surging opioid disaster. But different opioid producers didn’t sit by idly as gross sales of OxyContin skyrocketed, topping $1 billion in 2000, regardless of experiences of overdose deaths and habit.
Purdue’s advertising and marketing experiences point out the corporate was anxious about shedding enterprise to fentanyl-laced patches known as Duragesic, in addition to morphine capsules and, to a lesser diploma, methadone — which some managed-care teams and Medicaid well being plans most well-liked as a result of it value a lot lower than OxyContin. Methadone and morphine are made by quite a lot of drug corporations.
In its 1999 advertising and marketing report, Purdue famous that Janssen Pharmaceuticals, an arm of drug large Johnson & Johnson, was making “slow but steady” progress in selling its Duragesic patches. The patches, which customers connect to their pores and skin, ship a dose of fentanyl, an opioid drug about 50 to 100 instances extra highly effective than morphine, in response to the Drug Enforcement Administration.
Purdue estimated that Janssen would spend about $four million in 1999 on medical journal promoting to steer docs to prescribe the patches for “early treatment of non-cancer pain and pain in the more frail elderly.” That is greater than triple what Janssen spent the 12 months earlier than, in response to the 2000 Purdue advertising and marketing report. In a press release to KHN, a Janssen spokesman mentioned the corporate give up “actively marketing” Duragesic in 2008.
Purdue additionally spent tens of millions on medical journal advertisements — and like Janssen, it drew criticism from the Food and Drug Administration for minimizing the risks of opioids, authorities data present.
In 2000, the Food and Drug Administration criticized Purdue for exaggerating the advantages of utilizing OxyContin to deal with arthritis, whereas in 2003 the company discovered that another advertisements had “grossly overstated” OxyContin’s security.
Janssen additionally drew the ire of the FDA. In March 2000, the company known as some claims made for Duragesic “false or misleading,” together with the suggestion that the drug “has less potential for abuse than other currently available opioids.”
In September 2004, the FDA told Janssen to “immediately cease” making “false or misleading” claims, together with saying that Duragesic was “less abused than other opioid drugs.” In its assertion to KHN, Janssen mentioned its advertising and marketing actions had been “appropriate and responsible,” including that it “acted quickly to investigate and successfully resolve FDA’s inquiries.”
The Purdue advertising and marketing experiences are a part of a cache of paperwork the corporate offered to the Florida legal professional basic’s workplace in 2002. The Florida legal professional basic released them to 2 Florida newspapers in 2003 after Purdue misplaced a courtroom battle to maintain them underneath wraps.
More than 1,500 teams, principally cities, counties and states, are suing Purdue Pharma, Janssen and a number of other opponents and drug distributers in federal courtroom in Cleveland demanding reimbursement for remedy prices and different compensation. In a press release to KHN, Purdue mentioned: “We vigorously deny these allegations and look forward to the opportunity to present our defense.”
The rising cluster of lawsuits argue that drugmakers got down to deceive docs and the general public by claiming their merchandise introduced little threat.
For its half, Purdue accused Janssen of making an attempt to take advantage of public alarm over OxyContin-linked deaths to spark new gross sales of Duragesic.
“It has been reported that Janssen sales representatives are using improper techniques to capitalize on the negative press surrounding OxyContin Tablets and the issue of abuse and diversion,” reads the 2002 Purdue advertising and marketing plan.
In truth, opioids made by Purdue’s rivals additionally contributed to overdose deaths in these years and have continued to take action. In 2016, greater than 42,000 individuals died nationwide from opioid-related causes, in response to the Department of Health and Human Services.
Florida was one of many early states to see an increase in overdose deaths tied to prescribed drugs. Florida medical examiner’s toxicology reports in 2002 detected oxycodone, the lively ingredient in OxyContin, in tons of of overdose fatalities. Abusers realized they may crush the capsules and inject or snort the powder to get excessive. Many others died after mixing the capsules with sedatives additionally prescribed by their docs.
Florida medical examiner files additionally confirmed that abuse of fentanyl ache patches, methadone and morphine took many lives. Some abusers had discovered drain the Duragesic patch of its liquid fentanyl and inject it like heroin, or in any other case ingest it.
In July 2005, the FDA warned well being care professionals about abuse of fentanyl patches. In December 2007, FDA cited experiences of deaths and “life-threatening adverse events” when the fentanyl patch “was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently and exposed the patch to a heat source.”
Purdue additionally stored a watch on methadone, noting in a 1999 advertising and marketing plan that “market research as well as reports from the sales force indicates that methadone use is increasing in both the management of cancer pain and non-malignant pain due to its low cost.” But as methadone gained acceptance for treating ache, it additionally started to kill with alarming frequency.
The FDA in November 2006 warned of deaths and harmful uncomfortable side effects amongst sufferers “newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers.”
KHN’s protection of prescription drug improvement, prices and pricing is supported partially by the Laura and John Arnold Foundation.
Kaiser Health News (KHN) is a nationwide well being coverage information service. It is an editorially unbiased program of the Henry J. Kaiser Family Foundation which isn’t affiliated with Kaiser Permanente.