As Purdue Pharma faced mounting criticism over deaths linked to OxyContin, rival drugmakers saw a chance to boost sales by stepping up marketing of similarly dangerous painkillers, such as fentanyl, morphine and methadone, Purdue internal documents reveal.
Purdue鈥檚 1996-2002 marketing plans for OxyContin, which Kaiser Health News made public this year for the first time, offer an unprecedented look at how that company spent millions of dollars to push opioids for growing legions of pain sufferers. A wave of lawsuits demanding reimbursement and accountability for the opioid crisis now ravaging communities has heightened awareness about how and when drug makers realized the potential dangers of their products.
The Purdue documents lay out how the company and its biggest competitors were jockeying for market share. Some of those drugmakers鈥 sales promotions downplayed or ignored the risks of taking opioids, or made false claims about their safety, federal regulators have asserted in warning letters to the companies.
Purdue first offered OxyContin as a remedy for moderate to severe cancer pain in 1996. Within three years, the company viewed the cancer market as too limited, with $261 million in potential annual sales versus $1.3 billion for a broader range of chronic pain care, the company鈥檚 marketing reports said.
鈥淭hat was a pretty good recipe for a blockbuster,鈥 said Andrew Kolodny, who directs Physicians for Responsible Opioid Prescribing, an advocacy group critical of drug industry marketing.
Purdue has become the most high-profile drugmaker linked to the surging opioid crisis. But other opioid manufacturers didn鈥檛 sit by idly as sales of OxyContin skyrocketed, topping $1 billion in 2000, despite reports of and addiction.
Purdue鈥檚 marketing reports indicate the company was worried about losing business to fentanyl-laced patches called Duragesic, as well as morphine pills and, to a lesser degree, methadone 鈥 which some managed-care groups and Medicaid health plans preferred because it cost much less than OxyContin. Methadone and morphine are made by a variety of drug companies.
In its 1999 marketing report, Purdue noted that Janssen Pharmaceuticals, an arm of drug giant Johnson & Johnson, was making 鈥渟low but steady鈥 progress in promoting its Duragesic patches. The patches, which users attach to their skin, deliver a dose of fentanyl, an opioid drug about 50 to 100 times more powerful than morphine, according to the Drug Enforcement Administration.
Purdue estimated that Janssen would spend about $4 million in 1999 on medical journal advertising to persuade doctors to prescribe the patches for 鈥渆arly treatment of non-cancer pain and pain in the more frail elderly.鈥 That is more than triple what Janssen spent the year before, according to the 2000 Purdue marketing report. In a statement to KHN, a Janssen spokesman said the company quit 鈥渁ctively marketing鈥 Duragesic in 2008.
Purdue also spent millions on medical journal ads 鈥 and like Janssen, it drew criticism from the Food and Drug Administration for minimizing the dangers of opioids, government records show.
In 2000, the Food and Drug Administration criticized Purdue for exaggerating the benefits of using OxyContin to treat arthritis, while in 2003 the agency found that some other ads had 鈥溾 OxyContin鈥檚 safety.
Janssen also drew the ire of the FDA. , the agency called some claims made for Duragesic 鈥渇alse or misleading,鈥 including the suggestion that the drug 鈥渉as less potential for abuse than other currently available opioids.鈥
In September 2004, to 鈥渋mmediately cease鈥 making 鈥渇alse or misleading鈥 claims, including saying that Duragesic was 鈥渓ess abused than other opioid drugs.鈥 In its statement to KHN, Janssen said its marketing actions were 鈥渁ppropriate and responsible,鈥 adding that it 鈥渁cted quickly to investigate and successfully resolve FDA鈥檚 inquiries.鈥
The Purdue marketing reports are part of a cache of documents the company provided to the Florida attorney general鈥檚 office in 2002. The Florida attorney general them to two Florida newspapers in 2003 after Purdue lost a court battle to keep them under wraps.
More than 1,500 groups, mostly cities, counties and states, are suing Purdue Pharma, Janssen and several competitors and drug distributers in federal court in Cleveland demanding reimbursement for treatment costs and other compensation. In a statement to KHN, Purdue said: 鈥淲e vigorously deny these allegations and look forward to the opportunity to present our defense.鈥
The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.
For its part, Purdue accused Janssen of trying to exploit public alarm over OxyContin-linked deaths to spark new sales of Duragesic.
鈥淚t 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,鈥 reads the 2002 Purdue marketing plan.
In fact, opioids made by Purdue鈥檚 rivals also contributed to overdose deaths in those years and have continued to do so. In 2016, more than 42,000 people died nationwide from opioid-related causes, according to the Department of Health and Human Services.
Florida was one of the early states to see a rise in overdose deaths tied to prescription drugs. in 2002 detected oxycodone, the active ingredient in OxyContin, in hundreds of overdose fatalities. Abusers realized they could crush the pills and inject or snort the powder to get high. Many others died after mixing the pills with sedatives also prescribed by their doctors.
also showed that abuse of fentanyl pain patches, methadone and morphine took many lives. Some abusers had figured out how to drain the Duragesic patch of its liquid fentanyl and inject it like heroin, or otherwise ingest it.
, the FDA warned health care professionals about abuse of fentanyl patches. In December 2007, FDA cited reports of deaths and 鈥渓ife-threatening adverse events鈥 when the fentanyl patch 鈥渨as used to treat pain in opioid-na茂ve 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.鈥
Purdue also kept an eye on methadone, noting in a 1999 marketing plan that 鈥渕arket 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.鈥 But as methadone won acceptance for treating pain, it also began to kill with alarming frequency.
The FDA warned of deaths and dangerous side effects among patients 鈥渘ewly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers.鈥
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