For more than a decade, members of a little-known group called the
In 2012, drugmakers and their affiliates in the forum sent a letter to
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
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
The same organizations reinforced their influence with more than
That combined spending on lobbying and campaigns amounts to more than 200 times the
"You can go a long, long way in getting what you want when you have a lot of money," said Professor
Obama gave his first speech on the opioid epidemic last fall. In July,
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
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,
Despite having no physical address or online presence, the
"In practice and governance, the
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 reevaluating 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.
'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.
That line populated her speeches and interviews for months.
Concerns about the use of the statistic in connection with opioids and ties between some of the report authors and the pharmaceutical industry were covered by the
Nearly half the experts assembled by the
Hamburg said in an email that the report was "another piece of scientific literature that helped inform the broader field," which her agency had no role in producing.
Attendees were asked to support a bill from then-Congressman
Rogers, a Republican from
Rogers rejected the idea that he was influenced by the contributions, and said he began working on pain issues as a state senator after helping his brother through a series of back surgeries.
"I think they said, 'This guy is a champion, he's doing something we believe in and we want to support guys like that,'" he said.
Staffers for Hatch did not respond to repeated requests for comment. Dodd, who left office in 2011, said in a statement: "
The academy and the
Experts who could personally profit from reports are prohibited from serving on its committees, she added. But the academies, which advise the federal government on scientific and medical topics, declined to release financial disclosure forms completed by panelists.
Those on opposite sides of the opioids debate agree that the report raised important points about pain treatment, including warnings about the risks of painkillers.
Still, some report passages called for expanding their use: "Regulatory, legal, educational and cultural barriers inhibit the medically appropriate use of opioid analgesics."
At the time, one in five
After the report's release in
The foundation closed the next year.
Meanwhile, a handful of lawmakers tried to draw attention to rising rates of painkiller abuse.
In 2010, then-Rep.
"They were just letting it be known that if I didn't play nicer with them, they could cause some things to happen that I wouldn't like," she said.
'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 plans that the FDA laid out lacked the major reforms suggested by the agency itself in 2009, when it announced the initiative. Instead of mandatory certification training for doctors and electronic registries to track opioid prescriptions to patients, the FDA official outlined much milder steps: Drugmakers would fund optional classes for prescribers and supply pharmacy brochures to patients about opioid risks.
Over several years, the FDA seemed to have backed away from any significant restrictions.
"It was my observation that the staff at FDA had really bought into the idea that pain was greatly undertreated in
As early as
When the FDA sought public comment on how to proceed, the forum helped generate more than 2,000 comments opposing new barriers to opioids, according to a 2010 foundation memo. Additionally, the forum produced a 4,000-signature petition opposing electronic registries for opioid prescriptions, which advocacy groups said would stigmatize patients.
During a comment period, several members of the public warned it was a mistake. Dr.
"The days of prescribers not being trained how to safely prescribe the number one medication in
Ultimately, the panel voted 25-10 against the measures developed by the FDA, saying they would have little effect on opioid abuse. But the FDA put them in place anyway, one month after the agency briefed the
Agency officials said they decided that requiring certification for opioid prescribers would have been overly burdensome and disrupted care for patients.
"You can't imagine the bitter screeds we hear from the prescribing community about the paperwork involved," said Dr.
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. But prescriber training remains optional, even after a second FDA advisory panel again recommended the step earlier this year. Woodcock says the agency is still weighing that recommendation.
Currently, states such as
"The FDA failed to make a decision that could have averted many of the thousands of deaths we're seeing per year," Katz said. "So when people continue to die and communities continue to be devastated, then others will arise to do the policing."
CHARTING A 'SAFER COURSE'
It was a federal agency hundreds of miles from
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,
Opioid proponents said the guidelines were not based on solid evidence and criticized the
One pharma-aligned group, the
Some of the most vigorous pushback came from
At the group's December meeting, panelists with connections to the
Payne himself had received more than
Christopher holds a chair at the nonprofit
Christopher and Payne said they were thoroughly vetted before serving on the panel and disclosed their past work and activities. Federal officials who oversee the panel responded that all members met federal requirements to serve, including completing financial disclosure forms, though the
One week after the
In March, the final guidelines appeared.
The first recommendation for
"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."
Part of a joint investigation by The Associated Press and