Pharma, Prescription Opioids, and Heroin Plague—Where We are Now.

Abstract

Opioid drug manufacturers are largely responsible for the tsunami of prescription drug deaths and increase in heroin addiction of the last fifteen years. The sad story of the prescription opioid disaster is now well known. Beginning in the 1990’s manufacturers of these drugs exploited legitimate medical concerns over the under-treatment of pain. Marketing efforts disguised as physician education expanded the prescribed use of long acting forms of opioid pain relievers. Without adequate evidence of their appropriateness[1], opioids were promoted for use against headache, arthritis, and chronic back pain[2]. Widespread addiction followed over-prescription and overuse.

A four-fold rise[3] in deaths due to prescription opioids tracks the tripling of prescriptions for these drugs since the early 1990’s. Prescription opioid availability also drives their illegal trafficking to recreational drug users. Once dependent, they may continue to use the commercial drugs or move onto cheaper heroin. According to the CDC, the strongest risk factor for heroin addiction is “addiction to prescription opioid painkillers.”[4] While prescription opioid deaths are leveling off, heroin use and related deaths are climbing, with fatalities up almost 300% since 2010[5]. In tandem, worrying pockets of increased Hepatitis C [6] and HIV [7] infection reflect needle sharing for both heroin and liquefied opioids. Efforts to prevent infection are hampered by the congressional ban on federal funding [8] of needle exchanges, a proven method for reducing transmission caused by sharing syringes. Especially at risk are rural areas and small towns ill-prepared to quickly institute education and prevention strategies against HIV and Hepatitis C.[9]

Opioid manufacturers’ public relations campaigns portray them as working to prevent illegal access to opioids[10] and engineer abuse-proof drugs. But the disaster of dependent users, their damaged lives, and communities goes largely unacknowledged by these pharmaceutical companies. Lawsuits filed by local governments in California and the city of Chicago in 2014 against manufacturers opened with this sentence: “A pharmaceutical manufacturer should never place its desire for profits above the health and wellbeing of its customers.”[11] It is easy to dismiss this idealistic formulation as irrelevant to a drug industry so regularly content to produce me-too drugs and expensive treatments of limited benefit to patients. But the behavior of drug manufacturers in creating the current opioid disaster has been so outrageous, it is beyond ignoring.

The California and Chicago governments sued to hold manufacturers of opioid drugs responsible for damage caused by the widespread, deceptive marketing of these drugs.[12] Five firms were named in the Chicago action, including Purdue Pharma, best known for OxyContin. (In 2007, Purdue paid a $635 million dollar fine to settle both civil and criminal charges over its marketing of that drug. [13]) This week a Chicago judge dismissed the four other manufacturers from that city’s lawsuit, but the city may re-file guided by the judge’s comments in his ruling.[14]Other actions are already under consideration by additional states and localities. Like the tobacco companies, opioid manufacturers are facing a social accounting they never expected after knowingly using deceptive tactics to push a legal product.

Manufacturers have already been compelled to address some of the disasters they have created. These companies have been forced by the FDA to offer drug reformulations that make them more difficult to abuse—for instance, by altering their composition so that crushing pills for snorting or dissolving for shooting up is difficult.[15] Of course drug reformulations preserve market share. OxyContin has been deemed so dangerous by the FDA that it refused to approve a generic version.[16] As a result, Perdue’s own reworking of the drug is without generic competition that would cut costs for those patients with a real medical need for opioid pain relief. In addition, abuse resistance is important when effective, but does not equal lower risk of dependence for patients.

Opioid drug manufacturers trumpet their contributions to mitigating the hazards of prescription opioid over use. Along with drug reformulations, they have supported state registries and databases to identify and prevent over-prescription. Purdue makes much of its close relationship with law enforcement and joint efforts to combat criminal diversion of prescription opioids to the illegal market.[17] But no manufacturer says anything about repairing the damage it has done to users and communities. The future-oriented perspective of drug companies is convenient for them. It externalizes the ongoing burden of addressing the prescription opioid and related heroin plague to communities, government and individuals.

Opioid manufacturers could act today to mitigate the harms they have caused, but they will not. They will discount responsibility, perhaps privately pointing out the legal and insurance disincentives to acknowledging a leading role in a public health disaster. They could support needle exchange programs and treatment efforts for opioid and heroin users incorporating newer treatment regimens using buprenorphine [18] alone and in combination with other drugs, but they will not. They could apologize both to patients who have become drug dependent and to pain sufferers whose legitimate access to drugs is compromised by restrictions designed to combat illegal use. They could simply align their marketing with the best available medical judgment on the appropriate use of these drugs, but they will not. So we will see continuing human suffering and death, while these opioid manufacturers parry regulations and legal actions that threaten their market and revenues.

References:

[1] https://www.aan.com/PressRoom/Home/PressRelease/1310

[2] http://www.ncbi.nlm.nih.gov/pubmed/23983011

[3] http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

[4] http://www.cdc.gov/vitalsigns/heroin/%202015

[5] http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

[6] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6417a2.htm

[7] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a4.htm

[8] http://www.nytimes.com/2015/05/17/us/surge-in-cases-of-hiv-tests-us-policy-on-needle-exchanges.html?_r=0

[9] http://www.npr.org/sections/health-shots/2015/04/24/401968600/cdc-warns-of-more-hiv-hepatitis-c-outbreaks-in-drug-users

[10] http://www.rxsafetymatters.org/law-enforcement-and-government/education-and-resources/

[11] http://www.nytimes.com/2014/08/25/us/chicago-and-2-california-counties-sue-drug-companies-over-painkiller-marketing.html

[12] http://www.nytimes.com/2014/08/25/us/chicago-and-2-california-counties-sue-drug-companies-over-painkiller-marketing.html

[13] http://money.cnn.com/2007/07/20/news/companies/purdue/index.htm

[14] http://www.bloomberg.com/news/articles/2015-05-08/chicago-loses-bulk-of-claims-in-drug-company-suit-over-opiates

[15] http://www.pharmacytimes.com/contributor/jeffrey-fudin/2015/01/abuse-deterrent-opioid-formulations-purpose-practicality-and-paradigms

[16] http://www.pharmacytimes.com/contributor/jeffrey-fudin/2015/01/abuse-deterrent-opioid-formulations-purpose-practicality-and-paradigms

[17] http://www.rxsafetymatters.org/law-enforcement-and-government/education-and-resources/

[18] http://www.drugabuse.gov/blending-initiative/buprenorphine-suite-blending-products