Healthy Skepticism Library item: 19485

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
University Researchers & The Spread Of Pain Meds
Pharmalot 2011 Apr 4
http://www.pharmalot.com/2011/04/university-researchers-the-spread-of-pain-meds/

Full text:

Five years ago, a study from the US Centers for Disease Control and Prevention staffers linked deaths from widely abused addictive painkillers to an increase of up to 500 percent in the number of prescriptions written. But in the same journal, two researchers from the University of Wisconsin School of Medicine and Public Health disagreed with the conclusions and warned against increased regulation.
The article, however, did not disclose their UW Pain & Policy Studies Group already been paid most of the $2.5 million in expected fees from the same drugmakers that make the pills. And these drugmakers, including Purdue Pharma, which sells OxyConting, faced declining sales if regulations were tightened, The Milwaukee Journal Sentinel writes. And so PPSG played a quiet, but significant role in liberalizing the way the meds have been prescribed.
Moreover, the paper found records showing “cozy personal financial relationships” between drug makers and two officials with the PPSG, Aaron Gilson and David Joranson. Those include helping Purdue win FDA approval for a new narcotic painkiller and working as speakers or consultants. Gilson and Joranson refer to themselves as scientists, but neither are physicians. As their bios indicate, Gilson has a doctorate in social welfare; Joranson has a master’s in social work.
The industry funding, the paper maintains, is a unique twist on industry use of medical schools to sell more products, sometimes at the expense of patients. For its part, UW tells the paper that PPSG money came with no strings attached, and the goal was to improve pain care and access to opioids. The group, the paper notes, says its mission is to “balance” international, national and state pain policies and to achieve availability of pain meds while minimizing diversion and abuse.
But doctors in the addiction and pain fields say the UW Pain Group pushed an industry agenda not supported by rigorous science. “They advocate for policies that benefit pharmaceutical companies and harm pain patients and the public health,” Andrew Kolodny, chairman of psychiatry at the Maimonides Medical Center in New York, tells the paper. “You have to wonder if they’re doing this because their bread is buttered by big pharma.” Their efforts helped create a climate that vastly expanded unproven medical use of the often abused drugs, he adds.
Meanwhile, the paper identified several instances in which financial relationships between drugmakers and PPSG were not disclosed in medical articles co-authored by PPSG staffers. In any event, most money came from Purdue Pharma which, between 1999 and 2010, paid PPSG about $1.6 million, according to university records obtained by the Journal Sentinel.
For those who may not recall, Purdue and three former and current execs pleaded guilty in federal court in Virginia to criminal charges for misleading regulators, doctors and consumers about the addictive risks of Oxycontin. Purdue and its parent agreed to pay $634 million in fines, the execs were banned from Medicare (back story here and here). At the time, numerous deaths were attributed to the painkiller.
In 1996, Joranson, who is listed as PPSG founder and distinguished scientist, was vice chairman and co-author of a committee that issued a consensus statement from the American Pain Society and the American Academy of Pain Medicine. The statement suggested opioids were safe and effective for chronic, non-cancer pain and that the risk of addiction was low, the paper writes.
The committee chairman and co-author of the paper was J. David Haddox, who was a paid speaker for Purdue and a physician with Emory University School of Medicine who would become a Purdue exec three years later. He is now vp of health policy at Purdue Pharma, and critics tell the paper there is a lack of rigorous evidence supporting usage for long-term pain. “People have gotten a little cavalier about things,” Roger Chou, an associate professor of medicine at Oregon Health & Science University, tells the paper. “A good portion of patients on opioids probably should not have been started on them. There are a lot of people who could be taken off these medications.”
Just months before the consensus statement was published, OxyContin was approved by the FDA and its sales eventually hit $3 billion last year, according to data from IMS Health, a market research firm. UW’s Joranson, who did not respond to the paper, worked with Purdue’s Haddox in 2002 to co-author an article warning state medical boards that fears of regulatory scrutiny could harm the efforts to manage pain in the US. The article, which also was authored by PPSG’s Gilson, did not mention fees from Purdue or other drugmakers selling narcotic painkillers.
Haddox tells the paper it was “very jaundiced” to believe Purdue was giving PPSG money to take positions that would allow drug sales to increase. And while PPSG work may have boosted, that was not the intent of the funding. “They are trying to promote balanced access to pain care, including the use of opioids,” Haddox tells the paper. “We believe in the work they are doing.”
Gilson tells the paper he disclosed conflicts “if there was a requirement by the journals” to submit a disclosure form, and cited Medscape as an example, but could not remember if it was required for other articles that appeared in publications years ago. But if it was, he says he submitted the forms. However, five Medscape articles by Gilson about opioids and pain stated that he “has disclosed no relevant financial relationships.” “Authors do not control how any journal or website chooses to present information in their publication,” Gilson wrote the paper in an email.
EDITOR’S NOTE: This is lengthy article, so please read the rest here…