For more than a decade, members of a little-known group called the Pain Care Forum have blanketed Washington with messages touting prescription painkillers’ vital role in the lives of millions of Americans, creating an echo chamber that has quietly derailed efforts to curb U.S. consumption of the drugs, which accounts for two-thirds of the world’s usage.
In 2012, drugmakers and their affiliates in the forum sent a letter to U.S. senators promoting a hearing about an influential report on a “crisis of epidemic proportions”: pain in America. Few knew the report stemmed from legislation drafted and pushed by forum members and that their experts had helped author it. The report estimated that more than 100 million Americans—roughly 40 percent of adults—suffered from chronic pain, an eye-popping statistic that some researchers call deeply problematic.
The letter made no reference to another health issue that had been declared an epidemic by federal authorities: drug overdoses tied to prescription painkillers. Deaths linked to addictive drugs like OxyContin, Vicodin, and Percocet had increased more than fourfold since 1999, accounting for more fatal overdoses in 2012 than heroin and cocaine combined.
An investigation by The Associated Press and The Center for Public Integrity reveals that similar feedback loops of information and influence play out regularly in the nation’s capital, fueled by money and talking points from the Pain Care Forum, a loose coalition of drugmakers, trade groups, and dozens of nonprofits supported by industry funding that has flown under the radar until now.
Hundreds of internal documents shed new light on how drugmakers and their allies shaped the national response to the ongoing wave of prescription opioid abuse, which has claimed the lives of roughly 165,000 Americans since 2000, according to federal estimates.
Painkillers are among the most widely prescribed medications in the United States, but pharmaceutical companies and allied groups have a multitude of legislative interests beyond those drugs. From 2006 through 2015, participants in the Pain Care Forum spent over $740 million lobbying in the nation’s capital and in all 50 statehouses on an array of issues, including opioid-related measures, according to an analysis of lobbying filings by The Center for Public Integrity and AP.
The same organizations reinforced their influence with more than $140 million doled out to political campaigns, including more than $75 million alone to federal candidates, political action committees, and parties.
That combined spending on lobbying and campaigns amounts to more than 200 times the $4 million spent during the same period by the handful of groups that work for restrictions on painkillers. Meanwhile, opioid sales reached $9.6 billion last year, according to IMS Health, a health information company.
“You can go a long, long way in getting what you want when you have a lot of money,” said professor Keith Humphreys of Stanford University, a former adviser on drug policy under President Barack Obama. “And it’s only when things get so disastrous that finally there’s enough popular will aroused to push back.”
Obama gave his first speech on the opioid epidemic last fall. In July, Congress passed its first legislation targeting the crisis, an election-year package intended to expand access to addiction treatment. But the law includes little new funding and no restrictions on painkillers, such as mandatory training for prescribers, a step favored by federal advisory panels.
Obama administration officials say they have tried to strike a balance between controlling the harms of opioids and keeping them available for patients.
“We did not want to deny people access to appropriate pain care,” said Michael Botticelli, Obama’s drug czar. “We were all trying to figure out what the balance was, and that’s still the case going forward.”
Painkillers are modern versions of ancient medicines derived from the opium poppy, also the source of heroin. Prescription opioids were long reserved for the most severe forms of pain associated with surgery, injury, or terminal diseases like cancer.
That changed in the 1990s with a surge in prescribing for more common ailments like back pain, arthritis, and headaches. A combination of factors fueled the trend, including new medical guidelines, insurance policies, and pharmaceutical marketing for long-acting drugs like OxyContin.
The drug’s manufacturer, Purdue Pharma, pleaded guilty and agreed to pay more than $600 million in fines in 2007 for misleading the public about the risks of OxyContin. But the drug continued to rack up blockbuster sales, generating more than $22 billion over the last decade.
Despite having no physical address or online presence, the Pain Care Forum hosts high-ranking officials from the White House, Food and Drug Administration, and other agencies at its monthly gatherings.
Purdue’s Washington lobbyist, Burt Rosen, co-founded the forum more than a decade ago and coordinates the group’s meetings, which include dozens of lobbyists and executives.
Purdue declined to make Rosen available for interviews and did not answer specific questions about its lobbying activities or financial support for forum participants. Purdue said it supports a range of advocacy groups, including some with differing views on opioids.
“In practice and governance, the Pain Care Forum is like any of the hundreds of policy coalitions in Washington and throughout the nation,” the company said in a statement, adding: “Purdue complies with all applicable lobbying disclosure laws and requirements.”
While Purdue, Endo Pharmaceuticals, and other members have maintained that the forum does not take policy positions, the AP and Center for Public Integrity’s reporting shows the group’s participants have worked together to push and draft federal legislation, blunt regulations, and influence decisions around opioids.
Opioid drugmakers say they are striving to improve the safety of their products and how they are used. They point to new harder-to-crush pills and initiatives that, among other things, allow states to share databases designed to spot “doctor shopping” by patients.
Elsewhere, experts are re-evaluating the effectiveness of opioids for most forms of chronic pain, noting little long-term research.
“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” said Dr. Caleb Alexander, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “It’s an artificial conflict, but there are lots of vested interests behind it.”
‘The Epidemic of Pain’
By spring 2014, the figure that 100 million Americans suffered from chronic pain was getting new attention: as a talking point for the nation’s top drug regulator.
The head of the FDA used the statistic to illustrate the importance of keeping painkillers accessible, despite the escalating toll of opioid addiction and abuse in American communities.
In an online essay, then-Commissioner Dr. Margaret Hamburg said reducing the toll was a “highest priority,” but that her agency had to “balance it with another major public health priority: managing the pain that affects an estimated 100 million Americans.”
That line populated her speeches and interviews for months.
But Michael Von Korff of the Group Health Research Institute, whose research contributed to the statistic, said the number has no connection to opioids. Instead, he said, it mostly represents “people with run-of-the-mill pain problems who are already managing them pretty well.”
Von Korff’s work is funded by federal, foundation, and health insurance sources. He also is an officer with Physicians for Responsible Opioid Prescribing, a group that’s pushing for restrictions on the drugs.
Pain Care Forum participants spent nearly $19 million on lobbying efforts that included the legislation requiring federal research on pain and the Institute of Medicine report that first highlighted the figure.
Nearly half the experts assembled by the Institute of Medicine to write the 364-page report had served as leaders in Pain Care Forum-affiliated groups, such as the American Pain Foundation, the American Pain Society, and the American Academy of Pain Medicine—all supported by industry funding.
In June 2006, the forum organized a Capitol Hill briefing headlined “The Epidemic of Pain in America.” Briefing materials included statements like: “Appropriate use of opioid medications like oxycodone is safe and effective and unlikely to cause addiction in people who are under the care of a doctor and who have no history of substance abuse.”
Attendees were asked to support a bill from then-Congressman Mike Rogers, which would later be rewritten by the forum and reintroduced in 2007 and 2009, according to the memos.
Rogers, a Republican from Michigan, received at least $310,000 in contributions from forum groups from 2006 to 2015, which went to his campaign and to a leadership account that he could use to donate to his peers. Sen. Orrin Hatch (R-Utah) and former Sen. Chris Dodd (D-Conn.), who together introduced the Senate version of the bill, received more than $360,000 and $190,000 respectively from forum participants.
After the report’s release in June 2011, the American Pain Foundation received $150,000 from Purdue to promote its findings through the Pain Care Forum. The foundation planned “congressional briefings and hearings” and “meetings with the leadership of various federal agencies,” according to a November 2011 letter.
The foundation closed the next year. Senate investigators had asked about the nonprofit receiving nearly 90 percent of its funding from industry.
Meanwhile, a handful of lawmakers tried to draw attention to rising rates of painkiller abuse.
In 2010, then-Rep. Mary Bono (R-Calif.), co-founded the Congressional Caucus on Prescription Drug Abuse, which focused on educating lawmakers about drug abuse. She clipped newspaper stories from her colleagues’ home states, but recalled, “They’d just say ‘Yeah, yeah, yeah,’ and move on to more pressing matters.”
Bono, whose family had dealt with opioid addiction, drafted legislation in 2010 designed to curb opioid prescribing by requiring the FDA to limit the labeling for OxyContin and related drugs to “severe pain.” OxyContin had long been marketed for a broader indication listed on the label as “moderate-to-severe pain.”
According to Bono, a Purdue lobbyist visited her and threatened to pull back on its state-level funding for drug abuse initiatives.
Purdue spent nearly $800,000 on lobbying efforts that included Bono’s bill and subsequent versions of it. Pain Care Forum participants gave her campaigns more than $60,000 from 2006 through 2012.
Bono’s bill, the Stop Oxy Abuse Act, never received a congressional vote or hearing, even after Republicans regained control of the House in the November 2010 elections. She lost her congressional seat in 2012.
‘What’s a Regulator to Do?’
In June 2012, a senior FDA official gave a presentation to the Pain Care Forum titled “FDA and Opioids: What’s a regulator to do?”
For several years, the FDA had been developing risk-management plans to reduce misuse of long-acting opioids like OxyContin. With oversight of drugmakers and their marketing efforts, the agency seemed perfectly positioned to tackle the problem. But the agency ended up backing away from creating any significant restrictions.
“It was my observation that the staff at FDA had really bought into the idea that pain was greatly undertreated in the United States,” said Dr. Elinore McCance-Katz, former chief medical officer with the Substance Abuse and Mental Health Service Administration, a federal health agency.
As early as December 2008, the Pain Care Forum was developing a strategy to “inform the process” at the FDA, according to meeting minutes from the American Pain Foundation. Feedback poured in about how burdensome and disruptive it would be for the FDA to require certification for opioid prescribers.
“You can’t imagine the bitter screeds we hear from the prescribing community about the paperwork involved,” said Dr. Janet Woodcock, head of the FDA’s drug center. She added that the opioid crisis fundamentally stems from individual prescribing decisions, saying, “We don’t regulate medical practice.”
In the last two years, the FDA has placed several limitations on opioids, including adding new bolded warnings to immediate-release opioids such as Vicodin and Percocet. Prescriber training remains optional.
Currently, states such as Massachusetts are imposing their own physician-training requirements, a development that Katz attributes to a lack of federal action.
Charting a ‘Safer Course’
It was a federal agency hundreds of miles from Washington that finally sidestepped the influence of the pain care lobbyists.
The Centers for Disease Control and Prevention, located in Atlanta, overcame threats of congressional investigation and legal action to publish the first federal guidelines intended to reduce opioid prescribing earlier this year.
Essentially, the agency said the risks of painkillers greatly outweigh the benefits for the vast majority of patients with routine chronic pain. Instead, the guidelines said, doctors should consider alternatives like non-opioid pain relievers and physical therapy.
For more than 15 years, CDC officials have tracked the precipitous rise in painkiller overdoses, which has been followed by a similar surge in heroin deaths. The CDC called the painkiller trend an epidemic in 2011, pushing Washington officials to do the same. The agency’s director, Dr. Tom Frieden, labeled opioids “dangerous medications” that “should be reserved for situations like severe cancer pain.”
When the CDC drafted its opioid guidelines, it moved quickly and quietly, initially giving outside groups just 48 hours to comment on draft guidelines distributed last September.
Opioid proponents said the guidelines were not based on solid evidence and criticized the CDC for not disclosing outside experts who had advised the effort, alleging that they included physicians who were biased against painkillers, but House committee staffers said a probe did not uncover any violations. Some of the most vigorous pushback came from Pain Care Forum affiliates embedded in the federal system, who had received payments or positions paid by Purdue.
One week after the NIH panel’s critique, the CDC said it would delay finalizing its guidelines to allow more public comment and released a list of advisers.
In March, the final guidelines appeared.
The first recommendation for U.S. doctors: “Opioids are not first-line therapy” for chronic pain. It was a statement considered common practice by many doctors as recently as the early 1990s, a decade before the Pain Care Forum formed in Washington.
“We’re trying to chart a safer and more effective course for dealing with chronic pain,” Frieden said. “We don’t expect any magic. We don’t expect things to be better in 15 months when it’s taken 15 years to get this much worse.”