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Emergency Medicine News:
doi: 10.1097/01.EEM.0000453158.43106.29
Toxicology Rounds

Toxicology Rounds: California Counties Sue Opioid Manufacturers for Deceptive Marketing

Gussow, Leon MD

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Dr. Gussowis a voluntary attending physician at the John H. Stroger Hospital of Cook County in Chicago, an assistant professor of emergency medicine at Rush Medical College, a consultant to the Illinois Poison Center, and a lecturer in emergency medicine at the University of Illinois Medical Center in Chicago. Read his blog atwww.thepoisonreview.com, follow him @poisonreview, and read his past columns athttp://bit.ly/Gussow-ToxRounds.

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Two California counties this past May sued five pharmaceutical companies that manufacture opioid analgesics, accusing them of working to “create a sea-change in medical and public perception” about these drugs by carrying out a “deeply deceptive marketing campaign.”

The complaint filed by attorneys for Santa Clara and Orange counties alleged that the campaign was waged over 20 years, using a multipronged initiative aimed at medical professionals and the public. The complaint charged that the goal was to destigmatize opioids by consistently overstating their effectiveness and by dismissing or minimizing their risks in treating chronic non-cancer pain.

“The United States is now awash in opioids,” the suit claimed, pointing to the statistic that someone dies of opioid-related causes every other day in Orange County alone, and that 16,651 deaths were attributed to opioid overdose in the United States in 2010.

The entire 100-page claim lays out allegations of conspiracy and misleading advertising. (Read the lawsuit at http://bit.ly/1lHxf8q.) It should be read by any medical professional who prescribes opioids or sees patients who are taking them. The suit charges that the defendants co-opted some leading physicians in pain management, channeling money to them as speaker fees, research support, and consulting agreements. Often these arrangements were not adequately disclosed, and the key opinion leaders were able to promote dubious medical information that appeared to be unbiased and reliable, according to the lawsuit. It does not, however, allege that those key opinion leaders deliberately disseminated misleading information.

One of those was Lynn Webster, MD, a former president of the American Academy of Pain Medicine and a former senior editor of Pain Medicine, a journal that published articles supporting more liberal use of opioid analgesics for chronic non-cancer pain, according to the complaint. Dr. Webster introduced an opioid risk tool for predicting which pain patients might go on to misuse or abuse opioid analgesics in a 2005 article in that journal. (Pain Med 2005;6[6]:432.) Ironically, the U.S. Drug Enforcement Administration raided Dr. Webster's Salt Lake City pain clinic in 2010 after reports that more than 20 of his patients had died of opioid overdoses. (http://cnn.it/1swNaKn.)

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The complaint also cites articles by the Milwaukee Journal Sentinel, the online site MedPage Today, and the investigative organization ProPublica that many purportedly independent and unbiased organizations with a history of encouraging aggressive use of opioid analgesics received significant funding from opioid manufacturers. These groups include the American Pain Foundation (APF), the American Academy of Pain Medicine (AAPM), the Federation of State Medical Boards, and the Joint Commission.

The APF, which billed itself as a patient advocacy group, received as much as 90 percent of its $5 million funding from the pharmaceutical and medical device industries, according to ProPublica and the Dec. 23, 2011, Washington Post. It joined forces with the AAPM in 2009 to issue a consensus statement and revised guidelines that emphasized use of opioid analgesics for treating chronic pain, the lawsuit notes, adding that 14 of the 21 panelists who helped prepare the guidelines received funding from opioid manufacturers. The APF dissolved itself in 2012 shortly after a U.S. Senate Committee began looking into its ties to drug companies.

This process extended beyond organizations like the APF and the AAPM. The complaint alleges that Purdue and Janssen funded the effort when the American Geriatric Society (AGS) revised its chronic pain treatment guidelines in 2009. Resulting guidelines recommended that “[a]ll patients with moderate to severe pain ... should be considered for opioid therapy,” the suit claims. It also suggested that risks of addiction in older chronic pain patients treated with opioids was exceedingly low if the patient had no history of substance abuse. The complaint says the AGS received considerable funding from opioid manufacturers. Five of the 10 members on the expert panel that developed these guidelines disclosed financial ties to one or more of the defendants, according to the complaint.

The lawsuit gives numerous examples of CME programs, seemingly evidence-based and unbiased, that were funded by the defendants to endorse their message. Often these programs featured key opinion leaders and relied on guidelines like those put out by the AGS to support their position, the suit says.

Some papers funded by the defendants referenced a study by Porter and Jick (N Engl J Med 1980;302[2]:123) to support the claim that the risk of addiction is low in chronic pain patients treated with opioids, according to the complaint. That study, however, was a one-paragraph letter to the editor that concerned hospitalized patients only and had virtually no methods, the suit says. Porter and Jick, however, have been cited 819 times in the medical literature.

The pharmaceutical companies have not yet filed answers to the complaint, but Emergency Medicine News contacted each for comment. Purdue Pharma declined to comment, and an Actavis spokesman said company policy prohibits comment on pending litigation. Teva, Cephalon, Johnson & Johnson, and Endo Health Solutions did not respond.

Janssen spokeswoman Robyn Reed Frenze, however, emailed EMN a statement, saying: “More than 100 million American adults suffer from chronic pain, a significant public health problem that places a tremendous emotional and financial burden on patients and their families and costs society hundreds of billions of dollars annually in hospitalization, rehabilitation and lost productivity. Janssen's opioid pain medications give doctors and patients important choices to help manage the debilitating effects of chronic pain. We are committed to supplying healthcare providers with complete, accurate information on prescribing these medications responsibly, according to U.S. Food and Drug Administration (FDA) rules and regulations. Furthermore, we help prevent misuse by supporting educational programs about the safe and responsible use of pain medicines. Janssen is prepared to vigorously defend against the claims in these lawsuits.”

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Wolters Kluwer Health | Lippincott Williams & Wilkins

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