FDA Sends Amazon a Warning Letter
At issue is company’s distribution of products illegally marketed as drugs.
Complaint alleges that painkiller companies schemed to deceive U.S. market.
Weaving together a web of evil conspirators, including doctors and sham organizations, and secret alliances worthy of a John Grisham novel, California has brought a 100-page complaint against five pharmaceutical companies and their affiliates. The complaint alleges that they, together and independently, engaged in a “campaign of deception that: (1) misrepresented the efficacy of opioids, (2) trivialized or obscured their serious risks and adverse outcomes, and (3) overstated their superiority, compared with other treatments.”
The companies, according to the complaint, targeted the elderly and veterans, among others, and worked with front groups and doctors who helped disseminate misleading information about the safety and efficacy of the opioids.
There are five principle defendants in the case and some have been in trouble in the past:
1. Purdue Pharma L.P.: Purdue distributes OxyContin, which accounts for roughly 30% of the entire painkiller market and has annual sales of about $2.5 billion per year. Purdue settled criminal and civil charges against it for $635 million in 2007 for marketing misconduct and misbranding of OxyContin. Specifically, Purdue admitted in its plea that its promotion of OxyContin was misleading and inaccurate, misrepresented the risk of addiction, and was unsupported by science.
2. Cephalon, Inc.: Cephalon makes Actiq and Fentora, which are only approved by the FDA for the care of opioid-tolerant cancer patients. It pled guilty to a criminal violation of the Federal Food, Drug and Cosmetic Act and paid $425 million in 2008 for its misleading promotion of Actiq and two other drugs. Cephalon was found to have launched an illegal marketing campaign to sell Actiq to non-cancer patients suffering from chronic pain.
3. Janssen Pharmaceuticals, Inc.: Janssen sells Duragesic, Nucynta, Ultracet, and Ultram. Sales of Janssen opioids totaled $4.7 billion between 2009 and 2012.
4. Endo Health Solutions, Inc.: Endo makes Opana, Percocet, and Percodan. Sales of these opioids accounted for $403 million in revenues for Endo in 2012, and Opana yielded revenue of $1.16 billion between 2008 and 2012.
5. Actavis plc: It markets and sells Kadian and generic versions of Duragesic and Opana.
California charged that for the past two decades these companies have been engaged in a “common, sophisticated, and deeply deceptive marketing campaign” to convince health-care providers and the general public that compassionate treatment of chronic pain requires opioids. As a result of this alleged fallacy, the complaint said that:
In order to mastermind this opioid epidemic, California asserts that the companies “supported, encouraged, and directed employees, front groups, and doctors they identified as ‘Key Opinion Leaders’ (‘KOL’) to publicize biased and misleading studies and promotional material and conduct thousands of medical education programs that were deceptive and lacked balance.”
The complaint singles out six physicians that it characterizes as paid puppets in the drug companies’ master plan to increase sales of opioids. Specifically, the state contends that these six doctors, among others:
have written, consulted on, edited, and lent their names to books and articles and given speeches and continuing medical education programs supportive of chronic opioid therapy. . . . Defendants cultivated and promoted only those KOLs who could be relied on to help broaden the opioid therapy market. Defendants selected and funded doctors whose public positions were unequivocal and supportive of using opioids to treat chronic pain.
The six principle physicians described in the complaint are:
1. Russell Portenoy: Dubbed the “King of Pain” by Time Magazine. Portenoy received “research support,” consulting fees and/or honoraria from the various companies and was a paid consultant to Cephalon and Purdue while he advocated that chronic opioid therapy was a safe and effective treatment for patients with intractable non-malignant pain.
2. Lynn Webster: Currently under investigation by the U.S. Drug Enforcement Administration as a result of more than 20 deaths of former patients from opioid overdoses, Webster has been an ardent supporter of chronic opioid therapy. He is senior editor of the Pain Medicine Journal, and past-president of the American Academy of Pain Medicine.
3. Scott Fishman: He served on the board of directors of the American Pain Foundations, which is described by California as a prominent front group for the companies’ deceptive marketing campaign.
4. J. David Haddox: A paid speaker and consultant for Purdue who promoted widespread opioid use for common non-cancer chronic pain. He subsequently became a Purdue employee and executive.
5. Perry Fine: Served on the board of directors of the American Pain Foundation with Fishman.
6. Kathleen Foley: Also served on the board of directors of the American Pain Foundation with Fishman and Fine.
In addition to promoting the widespread use of opioids, the companies are alleged to have used their monetary might to influence at least eleven organizations in the promotion of opioid drug use for chronic pain. Said the complaint:
Taking a page from the tobacco industry’s play book, which had created and used front groups to proclaim tobacco was not harmful, Defendants harnessed and warped existing organizations to disseminate their deceptive messages with the expectation that these messages would circulate among and influence the conduct of prescribing physicians and other members of the medical community. These front organizations appeared to be legitimate scientific and patient advocacy organizations (and perhaps started out as such) and publicized seemingly scientific, balanced, and accurate information on opioid use. In fact, the information was false and misleading and paid for and encouraged by Defendants for the purpose of creating a vast market for the use of opioids for chronic pain.
The companies, the complaint said, influenced if not outright controlled the messages disseminated by the front groups, which received millions of dollars in grants and were aided by public relations firms hired by the companies to spread the misrepresentations central to their fraudulent promotion of opioids.
These “front groups” included:
1. American Pain Foundation: Described as the most prominent of the front groups, the APF is alleged to have issued education guides that promoted the benefits of opioids for chronic pain and trivialized their risks, particularly the risk of addiction. It launched a campaign to promote opioids for returning veterans. After receiving an inquiry from two U.S. senators, the APF closed its offices and dissolved the foundation before it was required to respond to the inquiry.
2. American Academy of Pain Medicine: The complaint alleges that with the assistance, prompting, involvement and funding of the companies, the AAPM issued treatment guidelines, and sponsored and hosted medical education programs critical to the companies’ deceptive marketing of chronic opioid therapy.
3. American Geriatric Society: According to the complaint, the AGS in 2009 revised its guidelines, which were thought to have been funded by Purdue and Janssen, for the Pharmacological Management of Persistent Pain in Older Persons. The revised guidelines included pro-opioid use for the elderly that is purportedly not supported by any reliable scientific evidence.
4. Pain Care Forum: This group was established and run by Purdue’s in-house lobbyist Burt Rosen and was substantially funded to promote the use of opioids for chronic non-cancer pain.
The complaint charges that the companies and the above cast of characters engaged in a multitude of deceptive marketing tactics knowing that their statements regarding the risks, benefits and superiority of opioids for chronic pain were untrue and unproven.
“Defendants had access to scientific studies, detailed prescription data, and reports of adverse events, including reports of addiction, hospitalization, and deaths – all of which made clear the significant adverse outcomes from opioids and that patients were suffering from addiction, overdoses, and death in alarming numbers.”
There can be no doubt that the allegations in this complaint tell a story of epic deception and corporate misconduct, which sets the stage for a mighty litigation battle. Chicago filed a similar suit in November 2014 against Purdue and several other pharmaceutical companies. But a federal judge in May 2015 dismissed Endo International, Actavis, Teva Pharmaceuticals and Johnson & Johnson from the suit.
For better or worse, odds are that in the years to come defendants will settle this case. TINA.org’s prediction is that at some point headlines will be written about a billion dollar plus settlement, and then these pharmaceutical companies will retreat quietly back to their offices ever ready to put profits above the health and well-being of their customers.
This story was updated on 5/12/15.
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