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The Prescription Opioid and Heroin Epidemic and the FDA
Epidemic: OriginsEpidemic: First PhaseEpidemic: Second PhasePrevious Opioid Epidemics
Epidemic: Origins
Previously Physicians Prescribed Opioids Only for Acute Pain
     Through most of the mid-20th century, physicians were taught that prescription opioids were of great value for treatment of acute pain, but that long-term treatment of chronic pain was highly likely to lead to addiction
. Laws were passed in many states restricting prescription of prescription opioids for chronic non-cancer pain.

Acceptance of Prescription Opioids for Cancer Pain
     Attitudes toward prescription opioid use began to change with the development of the hospice movement, which promoted the practice of treating terminal cancer patients in pain with opioids irrespective of concerns about addiction.  This view has come to be accepted as standard practice. 

Acceptance of Prescription Opioids as Treatment for Chronic Non-Cancer Pain
     Beginning in the 1980s and 1990s, the view of the treatment of chronic non-cancer pain with opioids began to change. 
In 1980, Dr. Hershel Jick's influential letter, "Addiction Rare in Patients Treated with Narcotics," was published.  By 1985, the pharmacologist John Morgan coined the term "opiophobia" to describe irrational under-utilization of prescription opioids for seriously ill patients.
     Still, physicians as a group were concerned about the addictive potential of prescription opioids. 

Purdue Pharmaceuticals and OxyContin  
     What was needed to overcome physician resistance was a new drug and a story.  
     Purdue Pharmaceuticals with its blockbuster painkiller OxyContin played a unique role in spreading the belief that prescription opioids could be safely used for chronic non-cancer pain.  OxyContin was approved by the FDA on Dec. 12, 1995.  Purdue launched an "aggressive" marketing campaign, misinforming physicians that the rate of addiction from OxyContin was under 1%.  In addition to its direct campaign with physicians, between 1996 and 2002, Purdue Pharma provided ļ¬nancial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. 

A
gencies Step in to Promote Treatment of Pain with Opioids
     As the belief that chronic non-cancer pain could be managed safely and effectively by use of prescription opioids, important organizations began to press for changes to deal with the "undertreatment" of chronic pain. 
     In 1997-1998, the Federation of State Medical Boards developed new regulatory guidelines meant to eliminate "physician fear of investigation and/or disciplinary action by state and federal regulatory agencies for prescribing opioids to manage long-term pain...," including chronic non-cancer pain.  
     In 1999, the Veterans Health Administration introduced its new pain management strategy, referring to pain as the 5th vital sign.  
     In 2000, the Joint Commission on the Accreditation of Health Care Organizations introduced new pain management standards including the expectation that all patients would have an initial assessment and regular reassessment of pain. 

Prescription Opioids Take Off
     
     Under these circumstances, OxyContin sales increased 1000% between 1997 and 2002, and prescription of opioids for chronic non-cancer pain had became accepted practice. 
     Not only did OxyContin prescriptions increase, but between 1995 and 2011, the number of all opioid prescriptions increased by 250%, from 87 million to 219 million.  Even more striking, between 1997 and 2010, the amount of opioid prescribed per adult rose from 740% from 96 mg to 710 mg of morphine equivalents.  And by 2011, the quantity of opioid prescribed in hydrocodone equivalents was such that each adult American could have received the equivalent of a standard dose of Vicodin 5 mg four times a day for 45 days annually.

Purdue pleads guilty of criminal charges of misbranding 
     In 2007 Purdue and three top executives pleaded guilty in federal court to criminal charges of misbranding, and were fined $634.5 million. 
     But by then it was too late to reverse the exponential increase
in opioid prescriptions and the damage it caused.   



    




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