Here’s a look at the opioid crisis.
Experts say the United States is in the throes of an opioid epidemic. An estimated 10.1 million Americans aged 12 and older misused opioids in 2019, including 9.7 million prescription pain reliever abusers and 745,000 heroin users.
Opioids are drugs formulated to replicate the pain-reducing properties of opium. Prescription painkillers like morphine, oxycodone and hydrocodone are opioids. Illegal drugs like heroin and illicitly made fentanyl are also opioids. The word “opioid” is derived from the word “opium.”
In 2019, there were 70,630 overdose deaths in the United States and 49,860 of those overdose deaths involved opioids.
More than 130 people died every day from opioid-related drug overdoses in 2016 and 2017, according to the US Department of Health & Human Services.
Prescription opioid volumes peaked in 2011, with the equivalent of 240 billion milligrams of morphine prescribed, according to the market research firm, IQVIA Institute for Human Data Science. In 2018, prescription opioid volume fell by 29.2 billion morphine milligram equivalents, a dramatic decline.
Opioids such as morphine and codeine are naturally derived from opium poppy plants more commonly grown in Asia, Central America and South America. Heroin is an illegal drug synthesized from morphine.
Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients.
Fentanyl is a fully synthetic opioid, originally developed as a powerful anesthetic for surgery. It is also administered to alleviate severe pain associated with terminal illnesses like cancer. The drug is up to 100 times more powerful than morphine. Just a small dose can be deadly. Illicitly produced fentanyl has been a driving factor in the number of overdose deaths in recent years.
Methadone is another fully synthetic opioid. It is commonly dispensed to recovering heroin addicts to relieve the symptoms of withdrawal.
Opioids bind to receptors in the brain and spinal cord, disrupting pain signals. They also activate the reward areas of the brain by releasing the hormone dopamine, creating a feeling of euphoria or a “high.”
People who become dependent on opioids may experience withdrawal symptoms when they stop using the medication. Dependence is often coupled with tolerance, meaning that users need to take increasingly larger doses for the same effect.
People who become dependent on pain pills may switch to heroin because it is less expensive than prescription drugs. Individuals who are addicted to prescription opioids are 40 times more likely to become addicted to heroin.
In 2018, almost 15,000 people in the United States died from a heroin overdose, down 4.1% from 2017.
A drug called naloxone, available as an injection or a nasal spray, is used as a treatment for overdoses. It blocks or reverses the effects of opioids and is often carried by first responders.
Regulation and Funding
The 21st Century Cures Act, passed in 2016, allocated $1 billion over two years in opioid crisis grants to states, providing funding for expanded treatment and prevention programs. In April 2017, Health and Human Services Secretary Tom Price announced the distribution of the first round of $485 million in grants to all 50 states and US territories.
In August 2017, Attorney General Jeff Sessions announced the launch of an Opioid Fraud and Abuse Detection Unit within the Department of Justice. The unit’s mission is to prosecute individuals who commit opioid-related health care fraud. The DOJ is also appointing US attorneys who will specialize in opioid health care fraud cases as part of a three-year pilot program in 12 jurisdictions nationwide.
On October 24, 2018, President Donald Trump signed opioid legislation into law. The SUPPORT for Patients and Communities Act includes provisions aimed at promoting research to find new drugs for pain management that will not be addictive. It also expands access to treatment for substance use disorders for Medicaid patients.
State legislatures are also introducing measures to regulate pain clinics and limit the quantity of opioids that doctors can dispense.
Oklahoma v Purdue Pharma et al
District Court in and for Cleveland County, Oklahoma
Defendants include Purdue Pharma, Johnson & Johnson and Teva Pharmaceuticals
June 30, 2017 – Oklahoma’s attorney general files a lawsuit against 13 pharmaceutical companies involved in the opioid crisis.
March 26, 2019 – Purdue agrees to pay a $270 million settlement.
May 26, 2019 – Teva Pharmaceuticals reaches an $85 million settlement.
August 26, 2019 – Oklahoma wins its case against Johnson & Johnson in the first major opioid lawsuit trial to be held in the United States. Cleveland County District Judge Thad Balkman orders Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis. The penalty is later reduced to $465 million, due to a mathematical error made when calculating the judgment.
September 25, 2019 – Johnson & Johnson files an appeal.
National Prescription Opiate Litigation
US District Court Northern District of Ohio
Defendants include such drugmakers as Purdue Pharma, Teva Pharmaceuticals and Endo International and retail pharmacies including CVS, Walgreens and Walmart
October 27, 2017 – Cuyahoga County in Ohio files a lawsuit against opioid drugmakers in the Cuyahoga County Court of Common Pleas.
December 20, 2017 – Summit County in Ohio files a lawsuit against opioid drugmakers in the Summit County Court of Common Pleas. The Summit and Cuyahoga cases are later moved to federal court and incorporated into national litigation involving hundreds of plaintiffs.
October 1, 2019 – Johnson & Johnson announces that it has reached a $20.4 million settlement with Summit and Cuyahoga counties.
October 21, 2019 – Four pharmaceutical companies – McKesson Corp., Cardinal Health Inc., AmerisourceBergen Corp. and Teva Pharmaceuticals – reach a $260 million settlement with Summit and Cuyahoga counties in lieu of a trial.
February 25, 2020 – Mallinckrodt, a large opioid manufacturer, reaches a settlement agreement in principle worth $1.6 billion. Mallinckrodt says the proposed deal will resolve all opioid-related claims against the company and its subsidiaries if it moves forward. Plaintiffs would receive payments over an eight-year period to cover the costs of opioid-addition treatments and other needs.
1861-1865 – During the Civil War, medics use morphine as a battlefield anesthetic. Many soldiers become dependent on the drug.
1898 – Heroin is first produced commercially by the Bayer Company. At the time, heroin is believed to be less habit-forming than morphine, so it is dispensed to individuals who are addicted to morphine.
1914 – Congress passes the Harrison Narcotics Act, which requires that doctors write prescriptions for narcotic drugs like opioids and cocaine. Importers, manufacturers and distributors of narcotics must register with the Treasury Department and pay taxes on products
1924 – The Anti-Heroin Act bans the production and sale of heroin in the United States.
1970 – The Controlled Substances Act becomes law. It creates groupings (or schedules) of drugs based on the potential for abuse. Heroin is a Schedule I drug while morphine, fentanyl, oxycodone (Percocet) and methadone are Schedule II. Hydrocodone (Vicodin) is originally a Schedule III medication. It is later recategorized as a Schedule II drug.
January 10, 1980 – A letter titled “Addiction Rare in Patients Treated with Narcotics” is published in the New England Journal of Medicine. It looks at incidences of painkiller addiction in a very specific population of hospitalized patients who were closely monitored. It becomes widely cited as proof that narcotics are a safe treatment for chronic pain.
1995 – OxyContin, a long-acting version of oxycodone that slowly releases the drug over 12 hours, is introduced and aggressively marketed as a safer pain pill by manufacturer, Purdue Pharma.
May 10, 2007 – Purdue Pharma pleads guilty for misleadingly advertising OxyContin as safer and less addictive than other opioids. The company and three executives are charged with “misleading and defrauding physicians and consumers.” Purdue and the executives agree to pay $634.5 million in criminal and civil fines.
2010 – FDA approves an “abuse-deterrent” formulation of OxyContin, to help curb abuse. However, people still find ways to abuse it.
May 20, 2015 – The DEA announces that it has arrested 280 people, including 22 doctors and pharmacists, after a 15-month sting operation centered on health care providers who dispense large amounts of opioids. The sting, dubbed Operation Pilluted, is the largest prescription drug bust in the history of the DEA.
March 18, 2016 – The CDC publishes guidelines for prescribing opioids for patients with chronic pain. Recommendations include prescribing over-the-counter pain relievers like acetaminophen and ibuprofen in lieu of opioids. Doctors are encouraged to promote exercise and behavioral treatments to help patients cope with pain.
March 29, 2017 – Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. New Jersey Governor Chris Christie is selected as the chairman of the group, with Trump’s son-in-law, Jared Kushner, as an adviser.
July 31, 2017 – After a delay, the White House panel examining the nation’s opioid epidemic releases its interim report, asking Trump to declare a national public health emergency to combat the ongoing crisis
September 22, 2017 – The pharmacy chain CVS announces that it will implement new restrictions on filling prescriptions for opioids, dispensing a limited seven-day supply to patients who are new to pain therapy.
November 1, 2017 – The opioid commission releases its final report. Its 56 recommendations include a proposal to establish nationwide drug courts that would place opioid addicts in treatment facilities rather than prison.
February 27, 2018 – Sessions announces a new opioid initiative: The Prescription Interdiction & Litigation (PIL) Task Force. The mission of the task force is to support local jurisdictions that have filed lawsuits against prescription drugmakers and distributors.
March 19, 2018 – The Trump administration outlines an initiative to stop opioid abuse. The three areas of concentration are law enforcement and interdiction; prevention and education via an ad campaign; and job-seeking assistance for individuals fighting addiction.
April 9, 2018 – The US surgeon general issues an advisory recommending that Americans carry the opioid overdose-reversing drug, naloxone. A surgeon general advisory is a rarely used tool to convey an urgent message. The last advisory issued by the surgeon general, more than a decade ago, focused on drinking during pregnancy.
May 1, 2018 – The Journal of the American Medical Association publishes a study that finds synthetic opioids like fentanyl caused about 46% of opioid deaths in 2016. That’s a three-fold increase compared with 2010, when synthetic opioids were involved in about 14% of opioid overdose deaths. It’s the first time that synthetic opioids surpassed prescription opioids and heroin as the primary cause of overdose fatalities.
May 30, 2018 – The journal Medical Care publishes a study that estimates the cost of medical care and substance abuse treatment for opioid addiction was $78.5 billion in 2013.
June 7, 2018 – The White House announces a new multimillion dollar public awareness advertising campaign to combat opioid addiction. The first four ads of the campaign are all based on true stories illustrating the extreme lengths young adults have gone to obtain the powerful drugs.
December 12, 2018 – According to the National Center for Health Statistics, fentanyl is now the most commonly used drug involved in drug overdoses. The rate of drug overdoses involving the synthetic opioid skyrocketed by about 113% each year from 2013 through 2016.
January 14, 2019 – The National Safety Council finds that, for the first time on record, the odds of dying from an opioid overdose in the United States are now greater than those of dying in a vehicle crash.
July 17, 2019 – The CDC releases preliminary data showing a 5.1% decline in drug overdoses during 2018. If the preliminary number is accurate, it would mark the first annual drop in overdose deaths in more than two decades.
September 15, 2019 – Purdue files for bankruptcy as part of a $10 billion agreement to settle opioid lawsuits. According to a statement from the chair of Purdue’s board of directors, the money will be allocated to communities nationwide struggling to address the crisis.
September 30, 2019 – The FDA and DEA announce that they sent warnings to four online networks, operating a total of 10 websites, which the agencies said are illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol.
October 21, 2020 – The Justice Department announces that Purdue Pharma, the maker of OxyContin, agree to plead guilty to three federal criminal charges for its role in creating the nation’s opioid crisis. They agree to pay more than $8 billion and close down the company. The money will go to opioid treatment and abatement programs. The Justice Department also reached a separate $225 million civil settlement with the former owners of Purdue Pharma, the Sackler family. In November 2020, Purdue Pharma board chairman Steve Miller formally pleaded guilty on behalf of the company.
March 15, 2021 – According to court documents, Purdue files a restructuring plan to dissolve itself and establish a new company dedicated to programs designed to combat the opioid crisis. As part of the proposed plan, the Sackler family agrees to pay an additional $4.2 billion over the next nine years to resolve various civil claims.