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US officials are starting to treat opioid companies like Big Tobacco — and suing them


Ohio’s central claim against opioid manufacturers is that these companies knew — or at least should have known — that their products weren’t safe or effective, yet they advertised their products as safe and effective anyway. The state’s lawsuit goes after five opioid manufacturers and their subsidiaries: Purdue Pharma, Endo, Teva Pharmaceutical Industries (and subsidiary Cephalon), Johnson & Johnson (and subsidiary Janssen Pharmaceuticals), and Allergan.

The lawsuit cites several examples of misleading marketing: An Endo-sponsored website, PainKnowledge.com, in 2009 claimed that “[p]eople who take opioids as prescribed usually do not become addicted.” Janssen approved and distributed a patient education guide in 2009 that attempted to counter the “myth” that opioids are addictive, claiming that “[m]any studies show that opioids are rarely addictive when used properly for the management of chronic pain.” Purdue sponsored a publication from the American Pain Foundation, which was heavily funded by opioid companies, claiming that the risk of addiction is less than 1 percent among children prescribed opioids — suggesting pain is undertreated and opioids are necessary.

This is only a small sampling. In total, DeWine claims opioid companies spent “millions of dollars on promotional activities and materials that falsely deny or trivialize the risks of opioids while overstating the benefits of using them for chronic pain.”

Contrary to opioid companies’ claims, there has been evidence for literally centuries that opioids are highly addictive. Some of their marketing, in fact, explicitly tried to debunk this well-known fact: They characterized the understanding that opioids are addictive and potentially deadly as “opiophobia.” They latched onto a five-sentence letter to a medical journal that, with nearly no proof, claimed addiction among opioid patients is rare. (One author of the letter later said he was “mortified” at what drugmakers had done.) And they directly communicated with doctors — through videos, pamphlets, and other marketing — to foster the idea that new opioids on the market were safe and effective.

The current epidemic is proof of what we already knew: As opioid companies saw their profits increase, so too did drug overdose deaths and treatment admissions.

It’s not just the addiction claims, though. Opioid companies also misled doctors and the public about the effectiveness of their drugs.

As an extensive Los Angeles Times investigation found, Purdue’s opioid OxyContin was marketed for its supposed ability to provide 12 hours of pain relief. But as Harriet Ryan, Lisa Girion, and Scott Glover reported, “Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.”

This was critical to Purdue’s competitive advantage: If it really didn’t provide 12-hour relief, then it wasn’t more effective than other similar painkillers on the market. In the face of the evidence, though, Purdue stood by its claim for years. And it told doctors that if patients weren’t seeing the promised results, then the problem was that doses were too low.

These efforts, it seems, were in the name of profit. One sales memo uncovered by the Times was literally titled “$$$$$$$$$$$$$ It’s Bonus Time in the Neighborhood!”

This is alarming for public health: As the Centers for Disease Control and Prevention warned, higher doses significantly increase the risk of overdose and addiction.

The Los Angeles Times investigation found, “More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.”

Opioid makers’ claims that their drugs are an effective treatment for chronic pain are similarly faulty. There’s simply no good scientific evidence that opioid painkillers can effectively treat long-term chronic pain as patients grow tolerant of opioids’ effects — but there’s plenty of evidence that prolonged use can result in very bad complications, including a higher risk of addiction, overdose, and death. In short, the risks outweigh the benefits for most chronic pain patients.

Yet opioid makers were highly influential in perpetuating the claim that their drugs can treat chronic pain. Several public health experts explained the recent history of opioid marketing in the Annual Review of Public Health, detailing Purdue Pharma’s involvement after it put OxyContin on the market in the mid-1990s:

Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of [opioid painkillers] for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of [opioid painkillers].

By encouraging long-term prescriptions for chronic pain, opioid companies fueled the epidemic. As a CDC study found, the risk of dependency, which can lead to addiction, dramatically increases the longer one uses opioids.

This is the kind of marketing that led Ohio to file a lawsuit. Similar challenges from Mississippi, Oklahoma, Missouri, and New Hampshire are going through the courts right now. Local jurisdictions in several states have also filed similar challenges. Kentucky previously settled with Purdue (for $24 million) and Janssen (for nearly $16 million) in cases alleging misleading marketing.

In 2007, Purdue Pharma and three of its top executives paid more than $630 million in federal fines for their misleading marketing. The three executives were also criminally convicted, each sentenced to three years of probation and 400 hours of community service.

As the opioid epidemic has continued, however, more and more lawsuits are expected to come.

I reached out to the companies named in Ohio’s lawsuit. Only Purdue gave a comment on the record: “We share the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions. OxyContin accounts for less than 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to Naloxone — all important components for combating the opioid crisis.”



Source : CNBC

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