Drugmakers shaped policy amid the drug crisis

Thursday, Sept. 22, 2016 10:33 PM
Purdue Pharma agreed to pay more than $600 million in fines in 2007 for misleading the public about the risks of OxyContin.
Brands and dosages of fentanyl, a narcotic that is typically administered to people with chronic pain, including end-stage cancer patients.
Purdue Pharma offices in Stamford, Conn. In 2007, the company pleaded agreed to pay more than $600 million in fines for misleading the public about the risks of OxyContin.
Keith Humphreys, a professor of psychiatry and behavioral sciences at Stanford University on Aug. 29, 2016. “You can go a long, long way in getting what you want when you have a lot of money,” he says.
Food and Drug Administration Commissioner Dr. Margaret Hamburg speaks during an event in the East Room of the White House in Washington in 2014 argued that the number of Americans living in pain justified keeping painkillers accessible.
Keith Humphreys, a professor of psychiatry and behavioral sciences at Stanford University on Aug. 29, 2016. “You can go a long, long way in getting what you want when you have a lot of money,” he says.
Dr. Nathaniel Katz, a former adviser to the Food and Drug Administration, and currently CEO of Analgesic Solutions, implored an FDA panel to support tougher requirements to manage opioid risks in 2010.

For more than a decade, members of a little-known group called the Pain Care Forum have blanketed Washington with messages about 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 drugs like OxyContin, Vicodin and Percocet.

In 2012, drugmakers and their affiliates in the forum sent a letter to U.S. senators promoting a recent report that called pain a “crisis of epidemic proportions” in America. The report estimated more than 100 million Americans — 40 percent of adults — suffered from chronic pain. Few knew that forum members and that their experts had helped write it.

The letter made no reference, however, to the drug overdoses tied to prescription painkillers. Deaths linked to addictive opioid drugs had increased more than fourfold since 1999, accounting for more deaths in 2012 than heroin and cocaine combined.

An investigation reveals that similar feedback loops of information and influence play out regularly in Washington, D.C., fueled by money and talking points from the Pain Care Forum, a coalition of drugmakers, trade groups and nonprofits supported by industry money.

Hundreds of internal documents shed 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 165,000 Americans since 2000, according to federal figures.

Painkillers are among the most widely prescribed medications in the U.S., 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 keeping opioids accessible, according to an analysis of lobbying filings.

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.

“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.”

The surge in opioid prescriptionsOpioids were long reserved for severe pain due to surgery, injury or terminal diseases like cancer. That changed in the 1990s, with a surge in prescribing for more common ailments like back pain and arthritis. Marketing for new long-acting painkillers like OxyContin helped fuel the trend, along with other factors.

OxyContin-maker Purdue Pharma pleaded guilty and agreed to pay more than $600 million in fines in 2007 for misleading the public about the risks of its drug. But the painkiller continued to rack up blockbuster sales, generating more than $22 billion over the last decade.

Purdue’s Washington lobbyist, Burt Rosen, co-founded the Pain Care Forum more than a decade ago and coordinates the group’s monthly meetings in Washington. Purdue declined to make Rosen available for interviews and did not answer questions about its lobbying activities.

The company 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.”

By spring 2014, even the head of the Food and Drug Administration was citing the statistic that 100 million Americans suffered from chronic pain.

Then-commissioner Margaret Hamburg used the figure to illustrate the importance of keeping painkillers accessible — despite the escalating toll of opioid addiction and abuse. Yet a researcher whose work contributed to the number said it was being misquoted, since most people included in the figure had common pain ailments and managed them without opioids.

When the FDA began developing plans to reduce misuse of long-acting opioids, the Pain Care Forum intervened with a “strategy to inform the process,” according to an internal memo from the American Pain Foundation, a now-defunct forum member.

The FDA’s initial proposals included requiring doctors to undergo certification training to prescribe opioids and tracking opioid prescriptions via databases. But when the FDA sought public comment on how to proceed, the forum helped generate more than 2,000 comments against new barriers to opioids and a 4,000-signature petition opposing electronic registries, according to another memo.

Ultimately, the agency announced far milder steps than its initial ideas: Drugmakers would fund optional classes for doctors and supply brochures to patients about opioid risks. FDA leaders said certification for prescribers would have been burdensome, disrupting care for patients and doctors.

But experts said regulators had missed a pivotal chance to curb deadly misuse and abuse with the drugs.

“The FDA failed to make a decision that could have averted many of the thousands of deaths we’re seeing per year,” said Dr. Nathaniel Katz, a former FDA adviser who urged the agency to make training mandatory for prescribers.

A new chance to reduce opioid useToday, the FDA is taking another look at requiring training for opioid prescribers, following a recommendation by a panel of expert advisers in May.

Earlier this year, the Centers for Disease Control and Prevention in Atlanta overcame threats of congressional investigation and legal action to publish the first federal guidelines intended to reduce opioid prescribing.

Essentially, the agency painkillers are too risky to treat routine chronic pain and that doctors instead should consider alternatives like physical therapy.

When draft guidelines emerged in September, forum members criticized the CDC for not disclosing outside experts who had advised its effort. One pharma-aligned group, the Washington Legal Foundation, said the lack of disclosure violated federal law. A longtime forum participant — now known as the Academy of Integrative Pain Management — called for investigations, though Congress found no violations.

After months of scrutiny, the CDC in December released a list of its advisers. One of 17 “core experts” had served as a paid consultant to a law firm suing opioid drugmakers.

The final guidelines appeared in March. The first recommendation for U.S. doctors was unequivocal: “Opioids are not first-line therapy” for routine 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.