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California and Illinois Sue Pharma for Opioid EpidemicMarianne Skolek Salem-News.com Investigative Reporter
Why are the other 48 states so reluctant to follow their lead?
(MYRTLE BEACH, SC) - For the past 12 years I have been exposing Purdue Pharma for criminally marketing their highly addictive opioid, OxyContin to the medical profession and patients through their physician spokespersons and funded pain foundations.
I have long written for Salem-News.com on the individuals responsible for the epidemic of opioids/heroin in the U.S. and Canada. The State of California was taking note and recently filed a Complaint for The People of the State of California, acting by and through Santa Clara County Counsel Orry P. Korb and Orange County District Attorney Tony Rackauckas, Plaintiff vs. Purdue Pharma, L.P., Purdue, Inc., The Purdue Frederick Company, Inc., Teva Pharmaceutical Industries, Ltd., Cephalon, Inc., Johnson & Johnson, Janssen Pharmaceuticals, Inc., Endo Health Solutions, Inc., Actavis, PLC, Defendants.
The City of Chicago, State of Illinois has also filed a similar lawsuit -- which leaves 48 states to recognize their deaths and addictions to opioids/heroin cries out for accountability not only by the Defendants named above, but also by:
Russell Portenoy, MD
Kathleen Foley, MD
J. David Haddox, MD
Perry Fine, MD
Scott Fishman, MD (and his misleading book referenced below in the complaint)
Lynn R. Webster, MD
The American Pain Foundation
Here are some highlights of the California lawsuit:
Page 2 - Defendants persuaded doctors and patients that what they had long known -- that opioids are addictive drugs and unsafe in most circumstances for long-term use -- was untrue, and quite the opposite, that the compassionate treatment of pain required opioids.
Page 2 - In 2010, 254 million prescriptions for opioids were filled in the U.S. -- enough to medicate every adult in America around the clock for a month.
Page 2 - While American represent only 4.6% of the world's population, they have consumed 80% of the opioids supplied around the world and 99% of the global hydrocodone supply.
Page 3 - Roughly 87% of these prescriptions are for chronic opioid therapy -- a prescribing practice doctors previously considered not just ineffective, but even reckless given the substantial risk of addiction chronic opioid use creates.
Page 3 - Sixty percent of opioid abusers report that their drugs came originally from prescriptions.
Page 4 - Defendants' representations regarding the benefits, risks, and relative superiority of opioids were -- and are -- untrue and unsupported by competent scientific evidence.
Page 11 - Working with "Key Opinion Leaders" (KOL's) like Russell Portenoy, MD, Defendants seized on anecdotal accounts of opioid efficacy in limited populations and methodically, through numerous publications, programs, and spokespeople, overstated the benefits and understated the risks of opioids in order to create and defend a broad market for opioids that never should have and never would have come to exist absent Defendants' concerted, deliberate, and patently misleading efforts.
Page 15 - There simply is no scientific evidence that opioids taken long-term improve function or quality of life for chronic pain patients, and there is significant evidence that opioids impose significant risks and adverse outcomes on long-term users.
Page 21 - Dr. Russell Portenoy -- appeared on "Good Morning America" in 2010 -- and claimed that "Addiction, when treating pain, is distinctly uncommon. If a person does not have a history, a personal history, of substance abuse, and does not have a history in the family of substance abuse, and does not have a very major psychiatric disorder, most doctors can feel very assured that that person is not going to become addicted."
Page 22 - Pro-opioid KOL Lynn Webster, MD developed a basic five question risk screening tool called the Opioid Risk Tool. (I reported on Webster's bogus Opioid Risk Tool - click here for link http://www.salem-news.com/articles/february112014/webster-opioids-ms.php).
Page 28 - In a 1994 article, Defendant-sponsored KOL, Russell Portenoy described common signs of addiction as potential signs of mere therapeutic dependence -- which he likened to a diabetic's response to insulin -- or pseudoaddiction." Portenoy claimed that "Pseudoaddiction describes a specific phenomenon that has also been observed in the population with cancer pain." But his authority for this statement was limited to a single citation to an article by another KOL, and later Purdue executive J. David Haddox. Dr. Haddox's article did not concern a population study at all, but rather, simply reported the possible phenomenon in a single cancer (leukemia) patient with pneumonia and chest wall pain.
Page 30 - KOL Dr. Lynn Webster: advised giving patients more medication when unsure whether a patient is showing signs of addiction or untreated pain. He asserted that pseudoaddiction was the cause "in most cases and should be the clinician's first response." Lynn R. Webster, Beth Dove, Avoiding Opioid Abuse While Managing Pain (2007). (emphasis added). Years later, Dr. Webster reversed himself, acknowledging that "pseudoaddiction" obviously became too much of an excuse to give patients more medication. It led us down a path that caused harm. It is already something we are debunking as a concept."
Page 38 - Dr. Portenoy thus helped to open the door for the use of opioids to treat chronic pain. He served on the American Pain Society/American Academy of Pain Medicine Guidelines Committee, which endorsed the use of opioids to treat chronic pain, and the FDA Anesthetic and Life Support Drugs Advisory Committee, one of a host of FDA advisory committees that serve to provide expertise and technical assistance to assist the FDA decision-making. While he held these positions he also was receiving "research support" consulting fees or honoraria from (Cephalon, Endo, Janssen, and Purdue (among others), and was a paid consultant to Cephalon and Purdue.
Page 39 - Dr. Portenoy also conceded that "data about the effectiveness of opioids does not exist."
Page 42 - On May 8, 2012, Senators Grassley and Baucus wrote the Chairman of American Pain Foundation (APF) seeking information about the source of its funding and asked for a response by June 8, 2012. APF shuttered its offices and dissolved before that deadline.
Page 48 - Path of the Patient, Managing Chronic Pain in Younger Adult at Risk for Abuse, a CME program sponsored, in part, by Purdue and edited by KOL, Dr. Perry Fine, provides one example of Defendants' use of CME's to spread deceptive messages supportive of chronic opioid therapy. Path of the Patient aimed to educate primary care doctors about managing chronic pain with opioids. The presentation is devoted entirely to opioid prescribing and, despite its title, presents no other potential treatments. Far from a therapy of last resort, as conventional medical thought advised, Path of the Patient promotes opioid therapy as the only solution, even for common chronic pain issues such as back pain.
Page 54 - Defendants also promoted the notion - also without adequate scientific foundation that the elderly are particularly unlikely to become addicted to opioids.
Page 55 - Veterans - Between 2001 and 2012, the Veterans Administration hospital in Santa Clara County - the Palo Alto Health Care System - provided 80.3 opioid prescriptions for every 100 patients. That amounts to 681,290 patients who received 546,793 prescriptions - in a single hospital in one county.
Page 55 - Again as with elderly patients, Defendants both purposefully sought to increase opioid prescribing to this vulnerable group and failed to disclose in their promotional materials the known, serious risks opioids posed to them.
Page 56 - Defendants have targeted veterans with fraudulent and unproven representations. As early as 2001, a Purdue promotional plan described spending hundreds of thousands of dollars to target the Veterans Administration and admitted that it was using "education" for what was actually marketing. "Corporate initiatives and partnering efforts were very successful with the Veterans Administration. In addition to building sales for OxyContin Tablets it also positioned Purdue as the leader in pain management education."
Page 58 - Once health practitioners were required to consider a patient's pain along with other vitals, the next step was to convince practitioners that all pain must be treated -- preferably with opioids. In 2004, the Federation of State Medical Boards revised and updated its Model Policy for the Use of Controlled Substances for the Treatment of Pain. In support of those efforts, noted KOL, Dr. Scott Fishman was tapped to author a companion piece, titled "Responsible Opioid Prescribing: A Physician's Guide."
Page 58 - The Guide was sponsored by Defendants Endo and Purdue, and was distributed to state medical boards, healthcare regulatory boards, medical organizations, hospitals and physicians across the country, including in California. The 2007 Physician's Guide contained many of the misrepresentations described above, notably the concept of "pseudoaddiction" and the claim that opioids improve function.
Page 73 - Purdue also used speakers bureaus, which put on programs at resort locations, starter coupons to attract new patients, funded new front group websites, and, even distributed plush toys and hats, which the Drug Enforcement Administration ("DEA") says had never been done before for a controlled substance. The DEA blamed Purdue's "aggressive marketing of OxyContin" for fueling demand for the drug and exacerbating the drug's diversion.
Page 75 - Despite its guilty plea, Purdue continued to deceptively market opioids. And, as a result, its sales continued to grow. OxyContin yielded $3.1 billion in revenue for Purdue in 2010, up four-fold from its 2006 sales of $800 million.
Page 76 - A recent article in the Los Angeles Times revealed that Purdue -- since 2002 -- has kept a data base of 1,800 doctors suspected of inappropriately prescribing its drugs, but did not alert law enforcement or medical authorities to all but a few of these doctors.
Page 76 - Purdue did not use its data base of problem doctors to reduce OxyContin abuse, to rein in dangerous doctors, or to stop the potentially unlawful distribution of a controlled substance.,
I recognize the "highlights" of the California lawsuit shown above is lengthy, but it is critical that families dealing with this epidemic recognize that unless there is accountability by government agencies in the form of lawsuits, this epidemic will continue to run wild -- with profiteers benefiting and recruiting more "snake oil salesmen" to destroy your lives.
Next week -- Why is the F.D.A. slipping through the cracks and not being held accountable?
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