A new study led by researchers at the Johns Hopkins Bloomberg School of Public Health found that manufacturers and marketers of prescription opioid painkillers misused scientific evidence to make five common and false claims about the safety and effectiveness of prescription opioids — including that they are not addictive .

The researchers found that 15 key scientific articles—letters to the editor, case reports, commentaries, original research, and reviews—were cited to support these unsubstantiated claims in more than 3,600 documents in the UCSF-JHU Opioid Industry Documents Archive (OIDA), an archive of millions documents obtained from settlements arising from litigation with opioid manufacturers. A joint project between the University of California, San Francisco and Johns Hopkins University, OIDA builds on a tobacco industry archive developed by UCSF. The OIDA documents are publicly available to help understand industry’s role in the opioid epidemic and prevent future public health crises.

The study was published online Oct. 24 in the journal Teacher in health mattersbelieved to be the first to use OIDA documents to catch industry misrepresentations of scientific claims about opioid safety.

The authors note that the scientific articles used in their analysis are not intended to be an exhaustive representation of all the scientific literature that the opioid industry used to influence audiences and markets.

Our findings highlight the opioid industry’s use of scientific publications to increase opioid sales and prescriptions and to disarm critics. Hopefully this will inform efforts to better regulate products that may harm public health in the future.”

Ravi Gupta, MD, study the corresponding author, assistant professor at the Bloomberg School’s Department of Health Policy and Management and the Johns Hopkins University School of Medicine’s Division of General Internal Medicine

For their qualitative study, the researchers first identified five of the most commonly used unsubstantiated claims about prescription opioids from a review of published literature. These claims were:

• Opioids are effective for the treatment of chronic non-cancer pain.
• Opioids are “rarely” addictive as long as they are prescribed by a doctor to a patient in pain.
• Patients who appear to develop dependence on prescription opioids may have “pseudo-dependence.”
• No opioid dose is too high, and if a patient develops tolerance to opioids, the solution may be to further increase the dose to treat the pain.
• Screening tools can identify high-risk patients who will develop addiction in advance.

The researchers then identified 15 key scientific articles that the industry used to support these five claims. Next, the research team ran keyword searches and the titles of the scientific articles through the OIDA database and found that they were cited in 3,666 documents, including teaching or training materials, knowledge transfer materials, articles or textbooks, statutory registrations and e-mails.

Overuse of prescription opioid painkillers, which began in the late 1990s, helped spark the ongoing opioid epidemic, which has claimed hundreds of thousands of lives in the United States since 1999. Across the country, settlements with current and former opioid manufacturers, distributors and pharmacies have totaled more than 50 billion dollars. These settlement funds are distributed to states, localities, and tribal nations for treatment and prevention programs. The settlement funds also support OIDA.

The prescription opioid industry not only used various marketing strategies to boost sales, but also marshaled seemingly valid scientific evidence to “manufacture doubt” about the dangers of opiates—much like the cigarette industry once did for its products.

The analysis highlighted several key strategies in this misuse of scientific literature. One was to misleadingly suggest the relevance of a medical publication by listing it in the reference section of documents for regulatory approval, but without specifically citing its findings. Another was exaggerating a publication’s findings or applying them to unrelated settings, such as using findings from an acute pain study to support the use of opioids for chronic pain. Another strategy was not to fully disclose the authors’ conflicts of interest.

“The authors of some of these publications were consultants to the opioid industry, but the use of these publications often obscured these conflicts,” says Gupta.

The industry cited these publications to support its claims in a variety of settings, including industry-sponsored continuing medical education courses, briefings to sales representatives, and presentations to patient groups. Unsubstantiated claims based on these scientific publications often ended up being repeated in documents from non-industry organizations, including medical societies.

The findings, Gupta says, add to the evidence that better regulatory safeguards are needed for potentially addictive drugs as well as for any commercial product that could endanger public health.

“As the OIDA documents show, the opioid industry essentially worked from a ‘playbook’ that the tobacco industry once used and that the ultra-processed food, gambling and other industries continue to use,” Gupta said. “So this is really a broad problem, and with limited industry supervision it is not easy to solve.”

The authors note that the study has limitations. The OIDA collection does not include Purdue Pharma documents. That settlement was overturned by the US Supreme Court last year, and the fate of settlement payments and litigation remains unclear.