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May 17, 2012

Senate Finance Committee Reacts to Reports of Opioid Abuse and Conflict of Interests: Letters to Manufactures and Organizations

FSMB Pain Brochure

Deaths from painkiller overdoses have tripled over the last decade and led to the deaths of 14,800 Americans in 2008, exceeding those caused by heroin and cocaine combined.  More recently, a 2011 GAO report linked prescription pain killers to a 142% spike in emergency room visits between 2004 and 2009.  The increase in deaths from opioids has pushed drug poisoning ahead of automobile accidents to be the leading cause of accidental death in the United States.  Painkiller sales have increased fourfold since 1999.  Opioids, derived from the poppy plant, reduce the perception of pain by attaching to opioid receptors in the brain, spinal cord and elsewhere in the body.  

Pain doctors and patient groups say that while drug overdoses are a legitimate concern, only a small percentage of deaths involves patients who receive them from their doctors. Most deaths involve illicitly obtained drugs, statistics show.  The groups also say that patients' risk is low if they do not have addictive personalities, and that any restrictions should not punish patients who suffer from serious pain. 

The Centers for Disease Control (CDC) reports that improper “use of prescription painkillers costs health insurers up to $72.5 billion annually in direct health care costs and opioid pain medications now kill more people than heroin and cocaine combined, and accounted for almost 74% of fatal presciption drug overdoses in 2008. In response to these alarming numbers, the Food and Drug Administration (FDA) last fall released a Blueprint on opioids.  Despite these and other efforts, the difficulties and dangers associated with opioids have remained.  

According to the New York Times, “the number of prescriptions for the strongest opioids has increased nearly fourfold [over the last decade], with only limited evidence of their long-term effectiveness or risks” while “[d]ata suggest that hundreds of thousands of patients nationwide may be on potentially dangerous doses.”  In addition, allegations have arisen over the past few years that pharmaceutical companies that manufacture and market opioids may be responsible, at least in part, for opioid abuse by promoting misleading information about the drugs’ safety and effectiveness. 

Recent investigative reporting from the Milwaukee Journal Sentinel/MedPage Today and ProPublica “revealed extensive ties between companies that manufacture and market opioids and non-profit organizations” noted above.  According to the Milwaukee Journal Sentinel/MedPage Today, a “network of national organizations and researchers with financial connections to the makers of narcotic painkillers…helped create a body of dubious information” favoring opioids “that can be found in prescribing guidelines, patient literature, position statements, books and doctor education courses.”  

Due to the increased problems opioids have caused, Senators Max Baucus (D-MT) and Charles Grassley (R-IA), recently sent letters to three pharmaceutical companies, Purdue Pharma,  Endo Pharmaceuticals and Johnson & Johnson, as well as five groups that support pain patients, physicians or research: the American Pain Foundation (APF), American Academy of Pain Medicine, American Pain Society, Wisconsin Pain & Policy Studies Group, and the Center for Practical Bioethics

The Federation of State Medical Boards (FSMB), the trade group for agencies that license doctors, also received a letter, as did The Joint Commission, an independent nonprofit that accredits hospitals nationwide and made pain management a national priority in 2001.  The letters inquired into the nature of funding from these companies and educational materials that the patient support groups produced and gave to patients and doctors.  

The senators requested payment information from companies since 1997 (15 years) to 10 groups and eight people, including two doctors featured in ProPublica's December report. They asked about any influence the companies had on a 2004 pain guide for physicians that was distributed by the Federation of State Medical Boards; on the American Pain Society's guidelines; and on the American Pain Foundation's Military/Veterans Pain Initiative. 

Consequently, the APF closed last week, “due to irreparable economic circumstances.”  APF said it “hopes to be able to transfer content from various information, education, and support programs to other organizations so that you may continue to benefit from the value these programs have provided to thousands of individuals and families across the country.”  It is unclear whether the group's announcement was related to the Senators’ letters. 

The American Pain Foundation (APF) 

According to ProPublica, APF received “nearly 90 percent of its $5 million funding from the drug and medical device industry.”  The group had “also lobbied against federal and state proposals to limit opioid use.”  ProPublica wrote that its review of the American Pain Foundation’s “guides for patients, journalists, and policymakers play down the risks associated with opioids and exaggerate their benefits. Some of the foundation’s materials on the drugs include statements that are misleading or based on scant or disputed research.” 

APF’s patient guide discusses several treatments for pain.  It says such pain relievers as aspirin, ibuprofen and naproxen commonly cause gastrointestinal bleeding or ulcers, delay blood clotting, decrease kidney function and could increase the risk of stroke or heart attack.  And it warns patients to use these pain pills at the lowest dose and stop them unless clearly needed. 

The side effects of opioids, on the other hand, are minor, and most go away “after a few days,” the foundation’s guide says. Patients, it says, shouldn’t worry if they need more of a drug. They are not developing an addiction.  “Many times when a person needs a larger dose of a drug,” the guide says, “it’s because their pain is worse or the problem causing their pain has changed.” 

Another guide, written for journalists and supported by Alpharma Pharmaceuticals, likewise is reassuring. It notes in at least five places that the risk of opioid addiction is low, and it references a 1996 article in Scientific American, saying fewer than 1 percent of children treated with opioids become addicted.  According to the investigations, however, “the cited article does not include this statistic or deal with addiction in children.”  “I would much prefer that they would put in there something that could be substantiated by a real reference,” said Leonard Paulozzi, a CDC medical epidemiologist specializing in drug overdoses. 

APF asserts that industry money has had no effect on its advocacy.  “I’m convinced with every shred of my body that our interest is improving the lives of people affected by pain,” said Will Rowe, the foundation’s chief executive, “and we want to do that the best way we can.”  The problem isn’t opioids, Rowe and other group leaders say. It’s poorly trained doctors who prescribe them too easily or in excess.  Rowe, acknowledged that some of its publications need updating and he pointed to additional materials on the group’s new PainSAFE Web site, which includes a broader description of the risks. 

Critics, however, believe that any industry money automatically taints a patient organization—guilt by association.  Its funding makes the group “one and the same” with the pain industry said Gary Franklin, a Washington state official who tussled with the foundation over new restrictions on high-dose painkillers.  This kind of attribution, however, is unwarranted.  In America, individuals and parties are presumed innocent until proven guilty.  In the case of patient organizations who receive funding from industry, the opposite holds true.  In retrospect APF should have sought additional resources and funding outside of industry, but those resource might not have been there.  The automatic assumption that the materials they produced were biased because of industry funding is contrary to the principles of fairness America stands for. 

Media also took issue with the fact that some of APF’s board members connections to the pharma companies.  One member was paid to speak and consult, one researcher’s clinic relied on funding for survival and a public-relations executive represents them.  In ProPublica said “board members have extensive financial ties to drugmakers.”  Last year, one board member was the lead author of a study about a Cephalon drug. Cephalon sponsored the study, and its employees were co-authors. The study found that the drug, Fentora, was “generally safe and well-tolerated” in non-cancer patients even though it is only approved for severe cancer pain. 

The investigation also noted that the APF literature does not mention that the drugs “don’t work for many chronic pain sufferers” and “recent editorials in medical journals and scientific reviews cite little evidence of long-term benefit.”  Most of the clinical trials for opioids to treat chronic pain “were small, lasted less than 16 weeks and excluded patients with a history of substance abuse, psychiatric illness and depression, who are at increased risk for opioid misuse and abuse,” three physicians wrote in an editorial this year in the Archives of Internal Medicine.   

Rowe said he knows plenty of patients for whom the drugs work, “and their lives are together because they use them.”  Scott Fishman, the APF’s chairman and president and chief of pain medicine at the University of California at Davis said, he “always believed that patients in pain in the United States need strong patient advocacy, which APF has offered.”

Federation of State Medical Boards (FSMB) 

In addition, the Sentinel reported, that the FSMB, with financial support from opioid manufacturers, distributed more than 160,000 copies of a model policy book that drew criticism from doctors because “it failed to point out the lack of science supporting the use of opioids for chronic, non cancer pain.”  According to MedPage Today, the FSMB “asked Purdue Pharmaceuticals for $100,000 to help pay for printing and distribution that policy to 700,000 practicing doctors.”  That $100,000 was just a small down payment on the $3.1 million that the Federation's foundation estimated it would cost for its campaign to get out the word about "safe" use of opioid analgesics in treatment of chronic pain. 

An FSMB spokesperson said there were many reasons for it to codify a position on the prescribing of opioids, and among those reasons was a project supported by the Robert Wood Johnson Foundation (RWJ) to seek some common ground in the treatment of chronic pain.  A Journal Sentinel/MedPage Today investigation suggested that it was the $693,000 grant from the RWJ Foundation to University of Wisconsin that started the ball rolling down this slippery slope. That grant went to the UW Pain & Policy Studies Group. 

Last year, the Journal Sentinel/MedPage Today reported that the UW Pain group had received $2.5 million from Purdue and several other opioid makers between 1999 and 2010.  After the story ran last April, the UW Pain group said it had decided to stop taking money from the drug industry.  The investigation, however, still revealed several findings: 

  • The Robert Woods Johnson Foundation funded project started with an advisory committee that recruited several pain experts who were experts in their field and also had done worked with makers of opioids -- a core group that included J. David Haddox, DDS, MD, then a member of the Purdue Pharma speakers' bureau, who went on to become a Purdue employee. Purdue is the maker of OxyContin.
  • FSMB's involvement started with a guideline written in 1998, and then with its model policy, which was adopted in 2004. With that policy in hand, the FSMB decided to spread the word to the nation's physicians by translating the policy into a book and it delegated that task to Scott Fishman, MD, a University of California Davis physician who also works with pharmaceutical companies that market opioids.
  • FSMB reached out to a total of six opioid makers requesting financial support to produce and distribute "Responsible Opioid Prescribing: A Physician's Guide," but it won't disclose how much each company contributed.
  • In 2009 the University of Wisconsin School of Medicine and Public Health decided to offer an online CME course based on the FSMB book, and to fund the activity it sought and received a $119,000 grant from Endo Pharmaceuticals (one the six companies that chipped in to pay for the book's printing and distribution). As course reviewer, UW chose Aaron Gilson, PhD, a UW employee, who had been paid to help another opioid maker, Cephalon, with a new drug application to the FDA. 

Deborah Grady, MD, a professor of medicine at the University of California, San Francisco, said she believes the federation's policy as well as continuing medical education (CME) courses such as the one offered by UW contributed to the marked increase in opioid use.  That policy also helped establish the idea that denying high doses of opioids to patients is a bad medical practice, she said. 

"The sad fact is that for many patients, the pain is never controlled, despite very high, dangerous doses of opioids that may actually result in more side effects than benefit," Grady said.  The model policy, which describes how opioids should be used to treat pain, has been adopted in full or in part by nearly 30 state medical boards. 

Instead of protecting patients from over-prescribing doctors, many of those medical boards have been "duped" by the federation's "pharma-funded campaign" into encouraging aggressive prescribing, said Andrew Kolodny, MD, a New York psychiatrist, addiction specialist and critic of the opioid industry. 

In a statement, Lisa Robin, the federation's chief advocacy officer, said its efforts are not intended to advocate for opioid therapy.  "Far from encouraging opioid use, the policy and book have provided a much-needed warning to physicians that opioids are potentially dangerous, that the use of opioids for other than legitimate medical purposes poses a threat to the individual and society ... Such medications must be used with great caution." 

She said the policy urges physicians to seek balance, "recognizing the fact that millions of legitimate patients rely on these medications for pain relief, while incorporating safeguards into their practices to minimize the potential for the abuse and diversion of controlled substances. 

In a statement, UW said the book and the CME course are not clinical practice guidelines. They are a response to the issue of opioid abuse and how to reduce it, said UW spokeswoman, Lisa Brunette.  The book's content was reviewed for accuracy and balance by 20 experts, including 14 who had no financial relationships with drug companies, she said.  She said Gilson, who reviewed UW's CME course, is a widely published expert on pain policy issues.  He had no financial relationship to the Endo Pharmaceuticals, which funded the course, she said. 

In a statement, Fishman, the book's author, said he was not paid for his work on the book and does not receive royalties.  He acknowledged that when the first edition of the book was written in 2006, the science on the effectiveness of opioids "was not robust" and data on the severe risks "had yet to emerge.”  Since then, new data on risks, including unintended overdose deaths, have emerged, he said. The new risk information will be included in an expanded version of the book that will be published by the spring, he said. 

Janssen Pharmaceuticals, a Johnson & Johnson subsidiary that makes the painkiller Nucynta, said in a statement that it "is committed to the responsible prescribing and appropriate use of opioid pain medications" and has supported educational websites about safe use.  The company is reviewing the senators' letter and "will work with them to fulfill their request for information," spokesman Mark Wolfe said via email.  Purdue Pharma acknowledged in a statement that it had received the letter, was reviewing it and looked forward to "cooperating with the committee on this matter." 


While companies producing opioids have made mistakes in the past, the difference with pain is that there are realistically no other options.  Therapy, surgery, and everything in between do not work for a vast majority of people and these treatments do not last very long.  Nevertheless, the risk of addiction and abuse for opioids is significant.  In addition, FDA and companies have not been successful discovering and approving new treatments for pain.  

Adding to the problems of opioids is the fact that symptoms are hard to detect and patients can easily lie and deceive physicians.  In addition, physicians need more training and CME to understand the risks and challenges of prescribing opioids.  New laws currently being proposed in several states may address some of these issues by restricting the prescription of opioids and creating new regulatory requirement for the dispensing of such drugs.   With the FDA REMS Blue print on long acting Opioids the need for companies to support pain continuing medical education has never been greater. 

With scant options to treat chronic pain, opioids have made the difference between days and nights of agony and a return to productive life for millions of patients. Critics have a hard time understanding that these patients are willing to risk serious side effects to gain relief.  “Policymakers can go to bed at night and say, ‘Well, I protected society’ ” by restricting access to a risky painkiller, Rowe said. “The person with pain or the person with cancer could say: ‘You know, I’m sorry. I’m living with this, and I want to take this chance.’ ” 

With APF gone, patients have lost a valuable resource.  Moving forward, patient groups must ensure the proper balance of industry support in their programs to prevent any appearance of conflict or impropriety.  The problems our country faces with opioids will only continue to grow and become more costly.  As a result, Congress, industry, academia, and federal agencies must begin to work together to implement real and practical solutions that alleviate the physical pain of patients without creating a burden on the way patients receive their treatment.  

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