Recently unsealed internal corporate documents and emails in a massive lawsuit pending against the drug industry, along with filings by lawyers representing nearly 2,500 cities, counties and Native American tribes, describe an industry-wide marketing campaign to promote the use of opioids for pain.
Below are statements issued by opioid manufacturers that are defendants in the lawsuit, along with pain groups cited in The Post report about marketing.
In the early 1990s, there was a widespread recognition among doctors, medical and scientific experts, and government agencies that pain was not being adequately treated, causing millions of people to suffer needlessly.
Purdue’s OxyContin was a breakthrough in the treatment of chronic severe pain when it was introduced in 1996. OxyContin’s extended release formula meant that it only needed to be taken every 12 hours, compared to other pain medications that had to be taken every 4 or 6 hours. The 12 hour dosing meant that many patients could sleep through the night without having to wake to take more medication or risk waking up in pain.
The FDA’s [Food and Drug Administration] New Drug Application for OxyContin was approved based on 24 total studies – six well-controlled clinical studies, four additional clinical studies, and 14 pharmacokinetic studies, involving more than 700 patients. Its product label has always included prominent statements that the medication is a Schedule II drug, defined as a drug with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. The FDA has reviewed OxyContin more than 30 times since its initial approval and continues to approve it as safe and effective for treating chronic pain.
Between January 1996 and June 2001, certain Purdue employees improperly marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other opioid pain medications. Purdue takes full responsibility for its misconduct.
Johnson & Johnson and its subsidiary Janssen Pharmaceuticals
Janssen did what a responsible pharmaceutical company should do with medicines that play an important role in the lives of patients with severe pain. Janssen’s Schedule II prescription opioid medicines have, since launch, accounted for less than one percent of total opioid prescriptions in the United States and were rarely diverted and rarely abused.
Janssen provided extensive compliance training for its salesforce so they could educate doctors based on the FDA-approved labels for its medications. In the Oklahoma trial, the State did not produce a single doctor who testified that they were misled by a Janssen marketing communication.
In a separate statement, Sabrina Strong, attorney for the company, said:
Counting up the number of sales representative visits, as the State did at trial, says nothing about how doctors made treatment decisions for their patients. Janssen sales representatives compliantly educated doctors to inform their knowledge of the medicine, and Oklahoman doctors testified that they were aware of the risks stated in the black box warning on the prescription labels.
Janssen sales representatives were trained to act according to company standards and in compliance with regulations and, like employees in many industries, were eligible for performance-based incentives.
Janssen from time to time supported and collaborated with pain patient advocacy groups, just as it does with groups focused on other medical conditions, like heart disease and cancer. These interactions occur continually in the health care industry and are essential to knowledge sharing, the advancement of treatment and ultimately improving patient care.
Teva Pharmaceutical Industries
Purchased Cephalon in 2011 and said it was not involved in the company’s marketing strategies.
Declined to comment.
Declined to comment.
American Pain Foundation and the American Pain Society
Dissolved this year, citing financial reasons.
U.S. Pain Foundation
The U.S. Pain Foundation receives funding from individual donors and private companies, including pharmaceutical companies, for its free programs and services for people with chronic pain. These programs range from a network of support groups to free patient education days to a print magazine called the INvisible Project.
U.S. Pain Foundation representatives speak frequently in a variety of forums about multimodal pain management. U.S. Pain Foundation does not promote any specific treatments or medications. Instead, the organization aims to ensure that persons with chronic pain are afforded access to a full complement of appropriate pain management options, which for some individuals with severe pain, may include opioid medication, amongst other therapies. When it comes to pain management and opioids, U.S. Pain Foundation supports a balanced approach, with doctors and patients working closely together to weigh the clinical benefits and safety risks.
American Academy of Pain Medicine
In a statement, the American Academy of Pain Medicine’s president, Tim Lamer, said: AAPM has always advocated that opioids are only one of many pain treatments available and that they should be prescribed in a responsible manner as part of a patient’s individualized treatment plan. AAPM is dedicated to promoting multidisciplinary pain care that incorporates a variety of treatment methods to provide the right treatment for the right patient at the right time.