MILWAUKEE — When faced with intense criticism for her agency’s approval of the powerful narcotic painkiller Zohydro, U.S. Food and Drug Administration Commissioner Margaret Hamburg turned to a sobering statistic:100 million Americans are suffering from severe chronic pain, she said.
The 100 million figure has become a central part of the debate over the use of narcotic painkillers.
It is cited in news stories, by medical organizations and by drug companies seeking approval for new opioid therapies. When Hamburg spoke in April at a prescription drug conference, she noted it means debilitating pain affects more people than heart disease, cancer and diabetes combined.
That number – the equivalent of more than 40 percent of the U.S. adult population – is exaggerated and misleading, according to pain experts familiar with how it was derived.
It came out of a report ordered by Congress that was introduced by lawmakers who have received hundreds of thousands of dollars from drug manufacturers. Companies that make pain treatment lobbied for the bill. The measure also was backed by pain organizations that get opioid industry funding and, in turn, had several of their members serve on the panel.
Legislation authorizing the report was rolled into the Patient Protection and Affordable Care Act – better known as the Obamacare reforms. It required the federal government to enter into an agreement with the Institute of Medicine “to increase the recognition of pain as a significant public health problem in the United States.”
A Milwaukee Journal Sentinel/MedPage Today investigation found that nine of the 19 experts on the panel that produced the number had financial connections to companies that manufacture narcotic painkillers within three years of their work on the report.
Some were officers or board members of groups that received opioid company funding, others were drug-company consultants or were paid for educational programs funded by companies that make pain drugs.
The figure is problematic in part because it lumps together everyone who reports chronic pain, which is defined as lasting three to six months – from those with persistent but manageable back pain to those recovering from surgery or battling cancer. It includes those who may not even seek medical help or treat their condition with over-the-counter products, as well as those who turn to prescription opioids.
In February, two experts connected with the pain report said the 100 million figure was exaggerated and misleading and they raised concerns about how it was being used. Their comments came at a meeting of pain experts held at the National Institutes of Health.
In a video of the meeting, Allan Basbaum, one of the reviewers of the Institute of Medicine report, said he was stunned when he saw the 100 million figure.
“If we are concerned about the message we are sending, we shouldn’t exaggerate the message because the eyeballs start to roll,” said Basbaum, a professor of anatomy at the University of California, San Francisco. “The message will be more powerful if people can believe it.”
A moment later in the video, pain expert Michael Von Korff said the 100 million figure was derived from a research paper that he co-authored.
“Nobody asked me about it before they used it,” said Von Korff, senior investigator with Group Health Research Institute in Seattle.
While the 100 million represents more than 40 percent of the adult population, Von Korff said only about 20 percent to 25 percent of adults are substantially impaired by chronic pain and a smaller number – about 10 percent to 15 percent – have substantial work disability because of chronic pain.
“The 100 million number, I don’t like it because I think it is a little misleading,” he said.
In interviews with the Journal Sentinel both experts reiterated their comments, but stressed that pain still is a serious problem in America.
Von Korff said comparing the number of chronic pain sufferers to those with conditions such as cancer, heart disease and diabetes – as the report did – also was misleading.
“There are certainly 100 million people who experience back pain and arthritis,” he said. “These are common problems. Is there 100 million who have chronic pain that is as consequential as cancer? No.
“You don’t want to over-medicalize something.”
When FDA Commissioner Hamburg brought up the figure at a three-day summit on America’s opioid epidemic in April, she went even further than the report did.
She said concerns about opioid abuse must be balanced against “the very real medical needs of the estimated 100 million Americans living with severe chronic pain or coping with pain at the end of life.”
But the pain report does not apply the figure to “severe chronic pain.” Rather, it says 100 million suffer from “common chronic pain.”
In an email, FDA spokesman Jeff Ventura said Hamburg intended to quote the information in the institute’s report, that “chronic pain affects about 100 million American adults – more than the total affected by heart disease, cancer, and diabetes combined.”
The institute’s 364-page “Relieving Pain in America” report devotes only a few pages to opioids, but it warns against efforts to restrict their use. The report also discussed the need for new pain treatments and the challenges pain presents to the health care system. It said chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity.
Past Journal Sentinel/MedPage Today investigations found the nation’s dangerous boom in narcotic painkillers has been fueled in part by aggressive promotion by drug companies that funded nonprofit groups that advocated for greater use of opioids.
Six of the pain report panel members have been officers or board members of advocacy groups that were named in a 2012 U.S. Senate Committee on Finance investigation into those links. A seventh panel member co-founded an organization that is the subject of a separate investigation launched in February by two U.S. senators.
In that case, the group collected as much as $35,000 each from various drug companies and arranged private meetings at expensive hotels that were attended by drug company executives, FDA officials and academics who discussed developing new pain treatments, the Journal Sentinel and MedPage Today found last October.
A year before the report was ordered, the Institute of Medicine had taken a strong stand in favor of disclosure of conflicts of interest in medicine.
“Society traditionally has placed great trust in physicians and researchers, granting them considerable leeway to regulate themselves,” the institute concluded in a 2009 report. “However, there is growing concern among lawmakers, government agencies and the public that extensive conflicts of interest in medicine require stronger measures.”
However, in producing the report, the institute didn’t follow its own advice about disclosing conflicts.
Catherine DeAngelis, an Institute of Medicine member and the former editor of the Journal of the American Medical Association, took it one step further saying the pain organization board members and officers should have excluded themselves from serving on the panel.
“It’s a conflict,” she said.
The Journal Sentinel/MedPage Today investigation found a series of links, starting with the panel’s chairman – Philip Pizzo, the former dean of the medical school at Stanford University.
In January 2010 – 10 months before the pain panel began meeting – Pfizer gave Stanford a $3 million, three-year grant to fund medical education. Stanford said the grant came with no conditions and Pfizer would not be involved in developing the curriculum.
Pfizer makes several pain-treatment drugs, including Celebrex and Lyrica. In addition, other companies that make pain treatments have provided thousand of dollars in research and other funding to Stanford, according to the ProPublica “Dollars for Docs” database.
In an email and an interview, Pizzo defended his work and the committee members.
“At no point in the process or since have I ever felt that any of our committee members operated with anything other than integrity and commitment to an incredibly important national health issue – pain in America,” he wrote.
He said the Pfizer grant to Stanford was given for medical education and “was completely unlinked to any of the company’s products.”
“I did not review the Pfizer portfolio and was never influenced in any way by products that company was engaged with,” he said. “That was irrelevant to the gift for medical education and clearly unrelated to the work of the IOM committee on which I served as chair.”
In an interview, he said the institute took a rigorous approach to reviewing conflicts among members.
“It is up to them to determine what is to be disclosed,” he said.
Jennifer Walsh, a spokeswoman for the Institute of Medicine, said under the policy, created in 2003, the institute can obtain conflict of interest information from its experts that will be in confidence. The institute’s policy said the information will not be released without their permission.
Walsh said members first disclose in writing any potential conflicts to the institute. After they are selected for a panel, there is a group discussion about the conflicts at the first committee meeting.
The decision on whether anyone has conflicts that should bar them from participating is made by the leadership of the institute, according to William Skane, a spokesman for the National Academy of Sciences, which includes the institute.
Daniel Carlat, a psychiatrist and director of the Pew Charitable Trusts’ Prescription Project, which seeks to increase transparency in health care, said doctors and the public need to know if financial incentives could influence the institute’s recommendations.
“It’s hard to rationalize why they would not simply disclose all the potential conflicts on that panel,” Carlat said.
In emails, several panel members said they complied with the institute’s disclosure rules.
Dennis Turk, one of the panel members, is the co-founder of a group known as IMMPACT that organized the meetings that included FDA officials and representatives of drug companies.
Turk, a University of Washington researcher, has worked as a consultant or received grants from several companies that market opioids and other pain drugs.
In an email, Turk said the institute has a formal policy for selecting members and handling conflicts of interest.
“To the best of my understanding I was in compliance with all of the IOM’s procedures regarding disclosures of any potential conflicts of interest,” he said.
Pizzo took exception with criticism that the 100 million figure lacked credibility.
“Let’s not debate whether it’s 60 million or 80 million or 120 million,” Pizzo said in an interview. “It is a significant problem. I totally disagree that we are not using numbers that are credible. This was our best estimate of the data.”
The Institute of Medicine’s report on pain was ordered by Congress. It grew out of 2008 and 2009 Senate and House bills that called on the institute to examine pain issues.
The House bill was introduced by U.S. Reps. Mike Rogers (R-Mich.) and Lois Capps (D-Calif.).
From 2009 through 2014, Rogers received more than $300,000 from individuals and PACs of companies that make and market pain treatments, including more than $55,000 from Abbott Laboratories, the maker of Vicodin at the time the pain report was issued, according to data compiled by the Center for Responsive Politics. Capps received less than $26,000.
In an email, Rogers spokeswoman Kelsey Knight said the congressman, who is a cancer survivor, introduced the bill to address barriers to patient care by improving research, doctor education and public awareness about acute and chronic pain.
The Senate bill was introduced by Sen. Orrin Hatch (R-Utah) and Sen. Chris Dodd (D-Conn).
From 2005 through 2010, Dodd received $167,000 from companies that make or market pain treatments, according to the Center for Responsive Politics. Dodd retired after the 2010 election.
Hatch got more than $250,000 in contributions from companies that make pain treatments from 2009 to 2014.
In an email, Hatch spokesman Matthew Harakal said the senator’s support of the legislation had nothing to do with campaign contributions.
“Throughout his service in the Senate, Senator Hatch has always supported policies that he feels are the best for our country for that reason and that reason alone,” he said.