The Opiate Epidemic: The FDA’s Struggle to Control Opiate Abuse

Opioid epidemic and the issues that can come from this dangerous drug. | Courtesy of Google Images

Heath Ledger was born in Perth Australia to his parents Kim and Sally Ledger on April 4, 1979. Kim Ledger pursued a career in racecar driving while his wife Sally worked as a French teacher. Sally and Kim both raised Ledger to become a very charismatic child, and they soon discovered their child’s love for performing. Early in life, Ledger found a passion for playing chess. At the age of ten, he won Western Australia’s Junior Chess Championship. It was around this time that he found an interest in becoming a stage performer, as he performed the lead role in Guildford Grammar School’s production of Peter Pan. At age sixteen, Ledger completed his early graduation exams, and he traveled cross-country to Sydney to pursue an acting career with his longtime friend Trevor DiCarlo. Heath began his acting career in Australia with several television and film productions in the 1990s as a seventeen year old boy. Ledger found greater acting opportunities in the United States, and moved to New York in 1998. Ledger is famous for his American acting in the films The Dark Knight (2008), 10 Things I Hate About You (1999), Brokeback Mountain (2005), and The Patriot (2000). Ledger is known for his great acting skills in countless famous American films, but unfortunately, Ledger is also known for an overdose on the use of opiate prescription drugs.1

Opiates are produced from the sap of the poppy plant, and have been used for medicinal purposes for centuries. Opium poppies do not grow in the continental United States but was brought to the U.S. from four geographic areas: Southwest Asia, Southeast Asia, Mexico, and South America.2 During the Industrial Revolution, opium was brought into the U.S., specifically to the city of San Francisco. San Francisco was the first city to ban the use of opium; immigrant flow into San Francisco created the large prevalence of opium during the Industrial Revolution. The mix of cultures brought into America at this time made many Americans begin to consider the prohibition of unpopular drugs. Many of these drugs were associated with certain immigrant groups. In San Francisco, the Chinese were working to build the railroads but quickly became the target of exclusion laws and prejudice. Many of the male Chinese immigrants working on the railroad were lonely, and smoked opium in their free time. The opium would relax them, and ease their sore muscles from the physical labor of the railroad. Many viewed the drug as a drug that stimulated uncontrollable sexual desires in women in its early days due to lack of knowledge regarding the drug.3 So, Americans believed that Chinese men were luring white women to have sex in opium dens. This idea scared many white Americans, and ultimately brought about the decision to prohibit opium in 1876 in San Francisco.4

In the late nineteenth century women gravitated to opium unknowingly, using opium and morphine as “soothing syrups” for female problems or to sleep when they had cranky babies. The women used patent medicines due to the fact that doctors were rare in many areas. Patent medicines were over the counter drugs that did not need to be prescribed by a physician. Patent medicines were marketed under specific patent or protected trademark. Purchasing these patents or cure-all medicines solved many illnesses and cured the pain of most women. Many women would give themselves and their babies a dose of the patent medicine before they went to sleep so they could both get a good night’s rest. Patent medicines did not have labels describing the ingredients or drugs used in the “cure-all” medicine. At this time, the Food and Drug Administration (FDA) did not exist, so the government did not mandate a regulation of what could and could not be sold to the public. Later the community found out the “cure-all” medicines main ingredient was opium, which was highly addictive for the women and babies using these syrups in everyday life. The Harrison Tax Act (1914) was the first step in making opiate drugs illegal nationwide; under the new law, to use opiates, you must be a patient, and to sell and prescribe it, you must get a license and pay a tax. The phrase illegal possession is a term unknown before the Harrison Act became a part of the new language of drug law, and a new precedent for drug enforcement agents to send people to jail. This Act criminalized the conduct of up to 200,000 people who were using opiates, and a year after the Act passed, drug enforcement agents shut down all of the drug clinics (basically anyone who used the drug was a criminal). Heroin was thought to create criminals through the use of the drug, but now there was a greater chance of criminal activity for the means to attain heroin through theft. Doctors were most likely to be arrested and convicted for violations of the Harrison Tax Act because opiates can only be prescribed in the due course of medical treatment. Over 10,000 medical doctors were arrested within the first five years of the Harrison Act. These physicians were most commonly arrested for prescribing opiates to their patients when that was not the proper diagnosis, and some physicians prescribed opiates to people who were not their patients in exchange for money. Heroin became involved in this opium crisis because prescribed opiate pills led users looking for an illegal form of opium due to the end of prescribed opiates through the Harrison Tax Act; this opium crisis made heroin the drug of choice.5

This is a photo of the well-known actor Heath Ledger, who died of opiate addiction. | Courtesy of Google Images

Ledger, known to many as an inspired and dedicated actor, gave it his all to capture the role of certain characters. Ledger began using anti-depression drugs during the making of The Patriot in 2000. This movie led to his involvement with prescription drug activity due to his depression, loneliness, and lack of confidence while on set. Ledger is most famous for his role as the Joker in the film The Dark Knight. Ledger went to extensive lengths to perfect the role of the Joker, but unfortunately, this negatively impacted his state of mind. Ledger would stay alone in his hotel room where he would mimic the behavior of the Joker’s everyday actions. He practiced talking and walking like the Joker. Ledger also kept a “dark diary” where he would store dark thoughts that occurred to him while playing the role of the Joker. Many believe that the practice for the role of the Joker is what led to Ledger’s demise. Holding himself in dark rooms alone just to find the character of the Joker led him to a stronger reliance on prescription opiate drugs.6 There are many medical uses for opiate drugs, but most importantly, the drug treats pain.

Opiate drugs like morphine and codeine continued to be prescribed after the Harrison Act, but because of the awareness of their addictive properties, these drugs were used sparingly. Morphine was discovered in the nineteenth century in an effort to produce a stronger form of opium, and soon it became the most powerful and addictive painkiller in the world. Frederick Turner discovered morphine and noticed the drug appeared to cure alcoholism.7  Morphine has ten times the strength of pure opium and reduces pain and induces euphoria. Many doctors prescribed morphine to cure their patient’s alcoholism, knowing that they would become addicted to it. At the time, alcohol was viewed as the world’s most dangerous drug, so doctors viewed addiction to morphine as being better than addiction to alcohol. Morphine was considered as God’s own medicine because of the change it brought to American medicine during the Civil War. Morphine’s role in the Civil War was vital in most cases due to the lack of advanced tools in the medical kits. The only remedy to most wound victims was to amputate the limb that was affected. But with morphine, medics were able to sedate the patients and kill the pain. Morphine also allowed the medics to do real surgeries rather than amputations because morphine gave them the time to operate strategically while the patient was sedated. Morphine was given to the patients during the Civil War through a hypodermic needle due to the quickness of the drug passing through the bloodstream as opposed to drinking the drug where the effect could be felt as late as twenty minutes after consumption. Injecting the drug into the bloodstream renders the drug in seconds, but it also creates an era of drug addiction. The route of administration was more direct, which led to stronger and quicker effects of the drug. The injection of the drug led to an intense high that also brought an intense low or withdrawal from the drug. Due to the new route of administration of hypodermic needles used during the Civil War, surviving war veterans became morphine junkies and this addiction was known as the Army’s disease.8

In the 1970s, synthetic opiates became more prevalent in medicinal drugs to treat pain. More recently, synthetic pain killers are called opioids to contrast them with naturally occurring opiates.9 The term opioid constitutes both natural and synthetic drugs that contain a form of opium, morphine, or heroin. The opiate epidemic began in 1999 when physicians prescribed four times the usual amount of pain killers. There are several reasons for this dramatic change in opiate use. First, the philosophy of pain treatment changed, such that physicians began to treat pain, even chronic pain, with opiate drugs. The philosophical change was driven by the belief that pain patients were unlikely to become addicted to opiates. This change of view was brought through a single study of a few patients that turned out to be highly misleading. The promotion of newly developed opiates by the pharmaceutical industry fueled the increase in opiate prescriptions, specifically of OxyContin. Treatment of chronic pain with opiates were seen as inappropriate due to the addiction it could cause through one use. Regular use of opiates results in tolerance and an abstinence syndrome characterized by flu-like symptoms and intense drug craving. Opioid addiction has become a global epidemic and a national health crisis in recent years, with the number of opioid overdose fatalities steadily increasing since the 1990s. In contrast to the dynamics of a typical illicit drug or disease epidemic, opioid addiction has its roots in legal, prescription medication, a fact that greatly increases the exposed population and provides additional drug accessibility for addicts.10

Graphic image implying the issues of the opiate epidemic. | Courtesy of Government Technology

Ledger fell in love with his co-star actress in Brokeback Mountain, Michelle Williams. The two began to spend a lot of time together, and it was noticed by many of their fellow cast-members that the two had a strong connection. Michelle became pregnant in 2005 with their daughter. Ledger continued to take prescription antidepressants, and also began to use sleeping medication due to his inability to sleep. Ledger had just become a father to his daughter Matilda, and the schedule of acting and maintaining the support and care of a parent led to his sleep deprivation. The sleeping medication was also prescribed by Ledger’s physician, and ultimately led him to regain control of his schedule.11

Despite a growing awareness of the problem, the opiate epidemic continues to be deadly. The rapid rise in overdose deaths associated with prescription opiates is readily seen in the U.S. In 2010, the FDA presented the strategy of taking steps to make it more difficult to use prescription opiates. The FDA wanted to steer away from the injection of prescription opiates due to the danger and strength of the drug once it is in the bloodstream, so they looked for other routes of administration and ingredients that could weaken the drug. A common ingredient in opiate prescription drugs, OxyContin produced by Purdue Pharma, was reformulated to prevent the injection of the drug. This was a success for the FDA, but opiate users found other opiate prescription drugs, such as Opana to satisfy their addiction. Opana was designed to fill a familiar need to OxyContin, which is the treatment of severe pain using a timed release of relatively high doses of the pain killer. The same issue reoccurred where the FDA had to request reformulation of Opana in 2011. The abuse of prescription opiates increased, and in June of 2017 the FDA took the unprecedented step of requesting Endo Pharmaceutical to remove Opana from the market.12 Currently, with considerable public concern that opiate drugs are being overprescribed, there is much scrutiny and criticism of the medical community’s approach to pain treatment. This scrutiny has led to new medical guidelines for the treatment of pain and prescription of opiates.13 The newest growing issue of the opiate epidemic occurs when addicted opiate prescription users are trying to find something stronger, for example, heroin. In 2016, 63,632 persons died of a drug overdose in the United States; 66.4% (42,249) were due to opioid deaths, including prescription opioid analgesics (morphine, oxycodone), illicit opioids (heroin, illicitly manufactured fentanyl), or both.14

Heroin was first developed in 1898 by a German chemist who derived a new alkaloid from opium like morphine. Heroin suppresses pain, coughing, and appetites; heroin also depresses respiration, slows the heart, and induces euphoria. It was first used in the U.S. in the Bayer company as a cough medicine in 1898. Heroin was created with good intentions, but was too powerful and addictive for regular use. Heroin quickly became the drug of choice for opiate addicts looking for something stronger than opiate prescription drugs to relieve their withdrawal. Opiate drugs remain the most valuable medication for the relief of severe pain, but the FDA has noted the many problems associated with their use and misuse. New strategies are being developed to help reduce some of these problems that involve the combination of prescription opiate pain killers with other drugs. One strategy suggests the use of drugs called partial opiate agonists. Full opiate agonists bind to endorphin and opiate receptors and produce strong physiological activity; partial agonists bind to these same receptors, but produce lower levels of activity. Partial agonists are often still able to produce levels of analgesia, but generally have lower abuse liabilities than agonists. Data provided by Substance Abuse and Mental Health Services Administration (SAMHSA) Drug Abuse Warning Network indicates that visits to hospital emergency departments related to narcotic prescription pain relievers increased significantly from 1994 to 2001. The highest increases were seen with oxycodone, methadone, morphine, and hydrocodone. Narcotic pain relievers, also known as opiates, are the most commonly abused prescription drugs. The FDA is working with manufacturers of controlled-release opiates to implement risk-management plans aimed at minimizing abuse while still keeping the products available for people with a legitimate medical need. In many cases, prescription opiate pain relievers are the most effective treatments available to help patients control their pain and lead productive lives. But they also have potentially fatal side effects, the most serious of which is the risk of respiratory failure. While addiction occurs after repeated use, death can occur after a single dose, so the first time that someone decides to abuse or misuse a prescription opiate pain reliever may be their last decision. The Controlled Substances Act (CSA), part of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal cornerstone of the government’s war against drug abuse. The U.S. Drug Enforcement Administration (DEA) has divided these substances into five categories, called “schedules,” based on each drug’s (1) potential for abuse, (2) safety, (3) addictive potential and (4) whether or not it has any legitimate medical applications. Schedule 2 (II) drugs, substances, or chemicals are defined as drugs with a high potential for abuse, less abuse potential than Schedule 1 (I) drugs, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. This is a part of that strategy. In December 2013, the FDA recommended that hydrocodone, an opiate that comes in long-acting doses, be reclassified as a Schedule II drug, which restricts who can prescribe it and how use of the medication is monitored.15 For drugs in this class, doctors cannot phone in prescriptions and can only call for a three-month supply; doses cannot be refilled without a new prescription in order to avoid potential dependence.16

This is a graphic image representing the symbol of the Food and Drug Administration | Courtesy of MarlerBlog

Ledger managed to get his sleep schedule and lifestyle in order and was offered a role in the movie The Imaginarium of Doctor Parnassus. The character Ledger played hung from a bridge in the pouring rain; this caused Ledger to hang from the bridge in cold rainy weather for hours to capture the scene. After shooting this scene, Ledger fell ill with a severe case of pneumonia. His physician prescribed pain-killers and a cough suppressant, which both contained forms of opium.17 The combination of anti-depressant, sleep aid, and opioid cough suppressant medications led to a synergy overdose. A synergy overdose is the interaction of two or more drugs that causes the total effects of the drug to be greater than the sum of the individual effects of each drug.18 Ledger died on January 22, 2008 due to the combination of prescription opioids mixed with other medications. His death was a shock to friends, family, and especially to the world. His family explained that the news was so shocking and sudden that the media displayed the information of Ledger’s death before they had heard from his own agent. There have been many other actors in recent years after the death of Ledger who have experienced the opiate epidemic in the same measures such as: Phillip Seymour Hoffman (The Hunger Games) , Cory Monteith (Glee), and Lisa Robin Kelly (That 70’s Show).19

The FDA is scrambling to find a way to limit the opiate epidemic from affecting more and more people. One strategy the FDA is now implementing to safely promote prescription opiates is by creating new labeling for prescriptions. From April to June of 2018, the FDA relabeled topics to include: exposure of patients to the risks of opioid addiction, abuse, and misuse of the drug. FDA is working with manufacturers of long-acting and extended-release opiate drugs to craft a risk evaluation and mitigation strategy (REMS) to ensure the safe and appropriate use of these medications. The agency met in March of 2019 with manufacturers of opiates to discuss options for the REMS and scheduled a public meeting on the topic for May 27 and 28. Possible components of the REMS include a registry for patients, prescribers, and pharmacies, which is a prospect that conference attendees feared would prevent seriously ill patients from obtaining timely relief from their pain. The staggering number in that is that three out of four new heroin users start with prescription opiates. From a medical standpoint, we must reduce the degree to which we prescribe opiates. There’s now a call for physicians to prescribe medications that are not opiates, recognizing and relying more on other options. We need better alternatives for pain than we have available. Physicians need to be better educated about how to make that balance between pain and whether and how much opiate prescriptions they need and other alternatives. Many have been lost to this epidemic, such as Ledger, and educating ourselves could limit the amount of deaths the U.S. experiences each year. Exposing all people to the harsh truths of opiates would lead to a drop in addiction and misuse. Although Ledger did not survive, he has taught many more about opiates and their danger through his own experience with the drug.20

  1. Current Biography, 2016, s.v. “Health Ledger,” by K.J.E.
  2. James F. MacKenzie, R. R. Pinger, and Denise Seabert, An Introduction to Community & Public Health (Burlington, MA: Jones & Bartlett Learning, 2018), 331.
  3. Stephen A. Maisto, Mark Galizio, and Gerard J. Connors, Drug Use and Abuse (Australia: Cengage 2019), 253.
  4. Stephen A. Maisto, Mark Galizio, and Gerard J. Connors, Drug Use and Abuse (Australia: Cengage 2019), 253.
  5. Stephen A. Maisto, Mark Galizio, and Gerard J. Connors, Drug Use and Abuse (Australia: Cengage 2019), 256.
  6. Current Biography, 2016, s.v. “Health Ledger,” by K.J.E.
  7. James F. MacKenzie, R. R. Pinger, and Denise Seabert, An Introduction to Community & Public Health (Burlington, MA: Jones & Bartlett Learning, 2018), 331.
  8. Stephen A. Maisto, Mark Galizio, and Gerard J. Connors, Drug Use and Abuse (Australia: Cengage 2019), 258, 259, 260.
  9. James F. MacKenzie, R. R. Pinger, and Denise Seabert, An Introduction to Community & Public Health (Burlington, MA: Jones & Bartlett Learning, 2018), 331.
  10. Kate Traynor, “For Opiate Management, FDA Pledges to Balance Enforcement, Palliative Care Needs,” American Journal of Health-System Pharmacy 66 (2009): 969.
  11. Current Biography, 2016, s.v. “Health Ledger,” by K.J.E.
  12. “Summaries of Safety Labeling Changes Approved by FDA–Boxed Warnings Highlights, July–September 2018,” 2018, American Journal of Health-System Pharmacy 75 (23): e892–93. doi:10.2146/news180070e.
  13. James F. MacKenzie, R. R. Pinger, and Denise Seabert, An Introduction to Community & Public Health (Burlington, MA: Jones & Bartlett Learning, 2018), 331.
  14. “Summaries of Safety Labeling Changes Approved by FDA–Boxed Warnings Highlights, July–September 2018,” 2018, American Journal of Health-System Pharmacy 75 (23): e892–93. doi:10.2146/news180070e.
  15. Stephen A., Maisto, Mark Galizio, and Gerard J. Connors. Drug Use and Abuse (Australia: Cengage 2019), 260, 261, 263.
  16. “Summaries of Safety Labeling Changes Approved by FDA–Boxed Warnings Highlights, July–September 2018,”  American Journal of Health-System Pharmacy 75 no. 23 (2018): e892–93. doi:10.2146/news180070e.
  17. Alex Tresniowski, et al., “A Life Cut Short,”People 69, 2008.
  18. Stephen A., Maisto, Mark Galizio, and Gerard J. Connors, Drug Use and Abuse (Australia: Cengage 2019), 259.
  19. Alex Tresniowski, et al., “A Life Cut Short,”People 69, 2008.
  20. Alice Park, “FDA Expands Access to Overdose Antidote to Stem Opiate Addiction Epidemic,” Time (website), April 5, 2014, 1. http://search.ebscohost.com.blume.stmarytx.edu:2048/login.aspx?direct=true&db=a9h&AN=95522905&site=ehost-live&scope=site.

Share this post

Share on facebook
Share on google
Share on twitter
Share on linkedin
Share on pinterest
Share on print
Share on email

23 Responses

  1. I know the more recent history of opiate abuse but the fact that people thought that Chinese men were luring white women into opium dens to have sex with them was new information for me. It shows that anything from drugs to jobs can be related to racist practices.

  2. Great article! Very informing! I remember it being a very big deal when Heath Ledge dies, but I guess I was to young to realize that it was because of his addiction to opioids. I know am very aware that this is a huge crisis, and it is especially evident because everyone is being affected by it, not just criminals. Wrong diagnosis is a huge reason of why this became a problem, but I am glad that people are aware of the issue now, and with the right, education, treatments, and help, we can overcome this as a nation.

  3. I thought Heath Ledger was still alive up until this moment, I was shocked. We keep losing more of our favorite actors/singers because of OD to opiates. From this article what I have gained is how opiates came to be. I thought they were made in the lab but are derived from plants, that the initial plan for its inception was for a pain reliever, and the reason it got banned.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.