“Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug.”
–OxyContin Package Insert, 1996
This sentence, not backed by science, but approved by one examiner at the US Food and Drug Administration (FDA), would help spur the opioid crisis that has led to hundreds of thousands of drug overdose deaths across the nation. Netflix’s new six-episode series, Painkiller, highlights how science was sidelined by the FDA in its drug approval process for the highly addictive opioid painkiller, OxyContin. The story illustrates the critical importance of the role science plays in government decisions and the harsh reality of what can happen without it.
Purdue Pharma and the Disinformation Playbook
Some corporations manipulate science and scientists to distort the truth about the dangers of their products, using a set of tactics made famous decades ago by the tobacco industry. We describe these tactics in UCS’s Disinformation Playbook and Purdue Pharma is no stranger to using them.
Painkiller introduces us to the Sackler family, owners of Purdue Pharma, as their patent on an opioid drug known as “MS Contin” is expiring. The family, facing a substantial loss of company profits, decides to develop a new prescription opioid that can be marketed for use outside of the confines of a hospital. They release OxyContin in 1996 with an aggressive marketing campaign based on fraudulent claims and deceit.
Sales representatives for OxyContin told doctors that “less than one percent of patients become addicted to OxyContin.” According to Purdue Pharma and their sales reps, this statistic came from a scientific study published in one of the world’s most revered scientific journals, The New England Journal of Medicine. Investigations later found, however, that the study, authored by Jane Porter and Dr. Hershel Jick, wasn’t a scientific study at all. It was a four-sentence letter about data Dr. Jick had collected on addiction to opioids—not OxyContin—when patients were confined in a hospital setting. Dr. Jick had no idea the letter he coauthored was being used to market OxyContin. Regardless, our government should be weighing multiple studies, not just one, when making decisions that can impact thousands across the country.
Using the disinformation tactic known as “The Screen,” Purdue and the Sacklers hid behind medical schools and hospitals to boost their credibility. The company used their millions of dollars to develop the “Massachusetts General Hospital Purdue Pain Program” and gave money to Tufts University which began a “Tufts Master of Science program in Pain Research.” In both programs, Purdue had a heavy hand in the research and education disseminated. Purdue’s doctors and medical scientists gave seminars to other doctors and medical experts in which they propagated disinformation about OxyContin.
Purdue manipulated an FDA medical officer
Purdue Pharma also used a tactic explained in the Disinformation Playbook as “The Fix” to manipulate government officials or processes to inappropriately influence policy. Investigations into how FDA approved a new drug application for OxyContin with the flimsy claim that it was “believed” to reduce “abuse liability” eventually pointed to an FDA medical officer who oversaw the drug’s approval named Dr. Curtis Wright.
In a 2018 deposition conducted as part of a class-action lawsuit in US District Court, Dr. Wright said that, at first, he had concerns about the scientific basis for the claims that Purdue Pharma made in OxyContin’s application. An internal Department of Justice memorandum also confirms that Dr. Wright initially showed concerns about approving the application for OxyContin.
Nonetheless, he oversaw the approval of two statements for OxyContin’s “package insert” that were not supported by scientific consensus: first, that “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug,” and secondly, that “When the patient no longer requires therapy with OxyContin tablets, patients receiving doses of 20-60 mg/day can usually have the therapy stopped abruptly without incident.”
In a 2003 deposition, Dr. Curtis Wright stated that he never met individually with representatives of pharmaceutical firms, noting that “one of the requirements is that a consumer safety officer be present, and the consumer safety officer was tasked with maintaining records of such things.” This conflicted with records from Purdue Pharma that show Dr. Wright told Purdue that their new drug application could be accelerated if the company traveled nearby to an FDA office in Rockville, Maryland.
Between January 31 and February 2 of 1995, Dr. Wright met with Purdue personnel at a hotel near Rockville, Maryland, without a consumer safety officer present. The company officials helped him write his reviews of clinical study reports and integrated summaries of efficacy and safety for OxyContin’s application. OxyContin was approved in 1996. On October 9, 1998, a year after Dr. Wright left his post with the FDA, he was offered and accepted a job at Purdue Pharma.
Government processes informed by science save lives
The Center for Science and Democracy has long advocated for scientific integrity and for stronger processes informed by science throughout the federal government. The case of Purdue Pharma clearly underscores why such policies and processes are so vitally important.
The facts tell the story: according to the National Institutes of Health, annual drug overdose deaths increased more than sevenfold—from 1,960 in 1999 to 15,248 in 2017 . More than one million people in the United States have died from drug overdoses since 1999 and opioids are the main driver of those drug overdose deaths. And these horrific numbers don’t even account for the grief and destruction that drug abuse can bring to families and loved ones. When science is sidelined in government decisions, it truly can impact the lives of people in serious and often harsh ways.
Federal agencies are working now to develop strong scientific integrity policies in line with the White House’s scientific integrity framework to protect federal scientists and their work from political interference. This is especially true when it comes to conflicts of interest – employees should conduct, manage, evaluate, and report scientific research and other scientific activities honestly and thoroughly, and disclose any conflicts of interest to their supervisor or other appropriate agency official(s).
We are also about to enter another presidential election cycle where anti-science candidates will be on the ticket. Your voice can help shape how our government uses science in its decisionmaking processes—processes that can have huge impacts on public health. I encourage you to speak up and advocate on behalf of the need for scientific integrity and science-based processes. Given the challenges we face today, we need science front and center as our government makes critical decisions that affect all our lives.