Americans spent close to $250 million on prescription medications in 2009, around 12 percent of their total personal health care costs.[1] Pharmaceuticals are a lucrative market in the United States, as 70 percent of all Americans take at least one prescription drug, and more than half of all Americans take at least two.[2] Antidepressants and opioid painkillers top the list as some of the most prescribed prescription medications in the United States, both of which have a high potential for abuse, diversion, dependency and addiction.[3]
Prescriptions are being dispensed like candy, and America is at the forefront of that dispensation. Americans make up a little less than five percent of the world’s population, but consume 80 percent of the world’s opioids, often in the form of opioid pain relievers.[4]
This may be partly due to aggressive marketing by pharmaceutical companies to consumers and prescribing health care professionals alike as they seek to increase their profits, often without regard to the potential consequences. Society’s perception of prescription drugs has also possibly become more tolerant of pharmaceuticals, accepting them as a normal part of everyday life; from 1999 to 2009, rates of dispensed prescriptions in America rose 39 percent.[5] Social media, the Internet, music, movies and television all glorify prescription medications, making many of these drugs household names. Americans regularly take drugs to promote sleep, regulate moods and numb pain.
As the popularity and incidence of prescriptions drugs increase, so does the abuse of these medications, which in turn raises addiction rates. Anytime a prescription drug is used beyond its medical scope, it is considered abuse. In 2013, about 6.5 million people in the United States aged 12 and older abused prescription medications in the month prior to the national survey.[6]
Mind Drugs Become Bestsellers
In the 1960s, drug trials were not as rigorous as they are today, and pharmaceutical companies were able to approve drugs for marketing after small clinical trials. This led to the entrance of several anxiety-reducing and sedative drugs, such as Valium and Klonopin, from drug-maker Hoffman-La Roche. These mood-stabilizing drugs have sedative effects, calming nerve endings responsible for anxiety and stress. The drugs made mental illness seem more mainstream.
The legendary band The Rolling Stones dubbed Valium “mother’s little helper.” It was the first drug to top one billion in sales. Valium quickly became a household name and the answer to anxiety symptoms for millions of Americans.[7] In its heyday, Valium prescriptions topped two billion in the United States, and even today, Valium is still the 13th most prescribed psychiatric medication in the country.[8]
Valium was so successful in part due to an aggressive marketing campaign, and it became super popular with a new drug clientele – middle class women. Experts in the medical field were concerned about its addictive qualities even early on, however, and in 1964, the Justice Department rescheduled Valium to Schedule IV, making it harder to refill and giving stiffer penalties for its illegal distribution. As a result, prescriptions dropped.[9] Valium’s popularity may have opened the door for other psychiatric medications to make their entrance, however.
In 1981, as a follow-up to Valium, the pharmaceutical maker Upjohn Company released Xanax, which was the first drug to be marketed to reduce panic attacks.[10] The once rare panic attack disorder was classified as a diagnosis and brought to the forefront, with Xanax as the immediate answer to the growing popularity with the affliction. Xanax, and its generic form alprazolam, is still the most popular psychiatric drug on the market in America today. With more than 50 million prescriptions dispensed a year, a Xanax prescription is written at least once every second.[11] Upjohn Company has since been incorporated into Pfizer, although Upjohn may be credited with creating a cultural icon in Xanax through clever marketing strategies, targeting the overworked and often stressed-out middle class.
In the 1990s, antidepressant medications began to gather steam as well with the arrival of Prozac, further mainstreaming yet another psychiatric mood disorder – depression. In 2009, antidepressants were prescribed at a rate of two to one over anti-anxiety drugs.[12] Pharmaceutical companies may have marketed these drugs as having more positive effects than negative side effects, highlighting the positive drug trials over the negative ones. In September 2010, Forest Laboratories was criminally charged with illegally marketed its antidepressant Celexa to adolescents, emphasizing a positive study in kids while completely ignoring another study that showed the drug having no effect. They agreed to pay $313 million for this issue, as well as other allegations surrounding Celexa, Lexapro, and another drug.[13]
Regardless of their potential for abuse and dependency, these medications are touted as “wonder drugs,” and many seek them out in order to cure whatever ails them. In 2013, a national survey found that 1.7 million Americans aged 12 and older currently abused tranquilizer medications while another 251,000 were abusing sedatives.[14]
The Rise of Opioid Narcotics
Close to two million Americans aged 12 and older either abused or were considered dependent on prescription
opioid pain relievers in 2013.[15] Opioids are derived from the opium poppy plant and serve to block pain sensations and promote feelings of calm while stimulating the production of dopamine, which is responsible for pleasure. Drugs like OxyContin, Vicodin and Percocet are all prescription opioids designed to relieve chronic and moderate to severe pain.
These drugs are similar to the dangerous street drug heroin and have a high potential for abuse and dependency that may have been initially understated by the big pharmaceutical companies marketing them. Prior to the mid-1990s, prescription painkillers for chronic pain were largely reserved for cancer or terminally ill patients. Purdue Pharmaceuticals sought to change that with its release of the extended-release oxycodone medication OxyContin in 1996.[16]
Gaining FDA Approval
In order for a drug to gain approval for sale and use in the United States, it must first undergo an approval process through the U.S. Food and Drug Administration, or FDA. An purported unbiased team of professionals including chemists, statisticians, pharmacologists, and physicians working for the FDA’s Center for Drug Evaluation and Research (CDER) evaluate data provided by the drug company in order to prove that the drug’s medical use will outweigh its potential risk factors. Laboratory and animal testing is used to evaluate the drug’s effectiveness and safety before moving on to clinical trials in humans, which are often sponsored by the drug companies themselves.[17]
The FDA is somewhat limited in its ability to control how drugs are marketed and promoted, and pharmaceutical companies may aggressively market their products once they have been approved for use. Purdue’s marketing campaign of OxyContin is an example of this. OxyContin’s extended-release format means that it only needs to be taken once every 12 hours in order to manage pain, and initially the drug showed no benefit over other opioid narcotics with immediate-relief formats dispensed once every four hours.[18] OxyContin probably didn’t gain popularity due to its merit, but rather its dramatic rise was likely due to the marketing campaign directed by its manufacturer, Purdue Pharmaceuticals.
Purdue Pharmaceuticals embarked on one of the most historically aggressive and sophisticated marketing campaigns, targeting prescribing physicians through all-expense-paid pain-management conferences and symposiums highlighting the benefits of OxyContin for relieving previously untreated chronic pain patients, beyond just cancer patients. Purdue also offered incentives and bonuses to sales reps of OxyContin as well as funded non-profit pain-management organizations that advocated the use of opioids in treating more patients’ pain symptoms long-term. The campaign worked, and sales of OxyContin grew from $48 million in 1996 to a staggering $1.1 billion by the year 2000.[19]
Addiction Rates Underplayed
OxyContin wasn’t the first oxycodone drug to be prescribed, although its extended-release format allowed more pure oxycodone to be administered in a single dose. Users quickly discovered that by crushing the drug, or stripping away the extended-release format, OxyContin’s full dosage could be administered at once, causing a burst of euphoria, or a high. Abusers began crushing the tablets to snort or inject the residue, bypassing the intended route of ingestion and sending the drug rapidly across the blood-brain barrier. This method increases the potential for a life-threatening overdose as well as quickly induces a tolerance to the drug, and users will require higher doses to continue to feel the drug’s desired effects.
Chronic use, or abuse, of OxyContin may lead to the brain becoming physically dependent on the drug as the chemical reward pathways are altered. Drug cravings and withdrawal symptoms may occur when the drug is removed, and psychological dependence and addiction may soon follow.
Purdue Pharmaceutical sales officials may have falsified scientific data and touted OxyContin as having a low risk for dependency and abuse despite knowing otherwise. Their findings of the drug being low-risk made it into highly regarded medical journals and were accepted and approved by the FDA. The FDA reviewed 16 key drug trials related to opioid dependency in order to refine their opioid policy; however, Purdue Pharma funded five of them, two were funded by other drug companies, and two were co-authored by employees of Purdue.[21] Not surprisingly, none of them showed a high risk of dependency or addiction potential.
Federal officials have since proved that Purdue Pharmaceuticals was aware of the dangers of the drug’s abuse and addiction potential before the drug was marketed and intentionally mislead the public and prescribing doctors with a fraudulent marketing campaign. In 2007, Purdue Pharmaceuticals was found guilty of civil and criminal charges for its deliberate “misbranding” of OxyContin and fined over $600 million dollars.[22] It may have been too little, too late, as addiction to and the abuse of prescription drugs including opioid narcotics has taken hold of millions of Americans. Prescription and over-the-counter drugs are the most commonly abused substances in the country by those aged 14 and older, besides marijuana and alcohol.[23]
Prescription Drug Epidemic
The Centers for Disease Control and Prevention, CDC, has labeled prescription drug abuse an epidemic in America, as prescription drug overdose has become the leading cause of injury death in this country, killing 22,767 people in 2013.[24] The most commonly abused prescription drugs include stimulants, such as ADHD medications like Adderall and Ritalin, central nervous system depressants used as mood stabilizers, anti-anxiety medications and sedatives which are often benzodiazepines like Xanax and Valium, or opioid pain relievers like OxyContin, Vicodin and methadone.
- Prescription drug abuse caused 1.4 million emergency department (ED) visits in 2011.[25]
- Opioid painkillers were involved in 71.3 percent of all prescription drug overdose fatalities in 2013, and benzodiazepine medications were involved 30.6 percent of the time.[26]
- Benzodiazepines and opioids are commonly combined and often both found to be involved in prescription overdose deaths.[27]
- High school seniors abused stimulant ADHD medications like Adderall and Ritalin at rates of 6.8 percent and 1.8 percent respectively, while 4.8 percent abused Vicodin specifically and 6.1 percent abused opioid pain relievers.[28]
- Prescription painkiller medications are obtained free from a friend or relative 53 percent of the time.[29]
- Treatment admission for substance abuse disorders related to prescription drugs tripled from 1998 to 2008, from 2.2 percent to 9.8 percent.[30]
- Prescription opioid abuse, in 2007, cost American society $55.7 billion in lost workplace production, health care, and legal costs.[31]
The Future of Big Pharma
Deceptive marketing, coupled with not enough warnings about the negative side effects of using many prescription medications long-term, has led to several legal battles with large pharmaceutical companies. The City of Chicago, for example, filed a lawsuit in June 2014 against Actavis plc, Purdue Pharma L.P., Endo Health Solutions, Inc., Cephalon, Inc., and Janssen Pharmaceuticals, Inc. for incorrectly encouraging doctors to prescribed addictive opioid pain relievers for the effective management of chronic pain long-term in order to expand the market for these drugs for their financial gain; profits exceeded $8 billion in 2010 for these drugs.[32]California’s Orange and Santa Clara counties also brought a lawsuit to these big five pharmaceutical companies’ doorsteps, citing damage done to patients by the prescription of these drugs under false pretenses in order to make a buck.[33] The lawsuit claims that in Orange County alone, narcotic painkillers are involved in a death every other day.[34] These lawsuits seek to undo some of the damage done by Big Pharma in the previous years through aggressive marketing to prescribing doctors and health care professionals, encouraging the prescription of highly addictive drugs for long-term use.
Similarly, the DEA and FDA are cracking down on potentially dangerous medications as well. In October 2014, the DEA reclassified hydrocodone combination products containing hydrocodone, a narcotic opioid, and aspirin or acetaminophen from Schedule III to Schedule II under recommendations from the FDA.[35] This rescheduling affects drugs such as Vicodin and Lortab, making them more tightly regulated with stiffer criminal penalties for the illegal distribution, possession, and sale of these products.[36]Unfortunately, these stricter laws and tighter control over prescription narcotics may lead to a boon in heroin abuse as prescription narcotics become harder to obtain and more expensive on the street. Four out of five new heroin abusers turn to heroin after using an opioid painkiller for non-medical purposes first.[37] What
may have started with Big Pharma may be spilling over into street drugs. Addiction is a serious disease with high personal and societal costs. Fortunately, with the right treatment, it can be managed and recovery is possible. Mental health disorders such as depression, anxiety, sleep issues, and even chronic pain may be managed with psychotherapeutic tools and therapies instead of, or in tandem with, medications. Instead of reaching for a pill as a “magic bullet” every time they feel the need, users can learn new coping mechanisms and more positive ways of managing stress and anxiety, thus helping to regulate emotions. Medications have their uses and may be an important part of recovery from mental illness and addiction, although they should be coupled with psychotherapies in order to obtain the best results.
Citations
[1]( June 2013). “Study Shows 70 Percent of Americans Take Prescription Drugs.” CBS News. Accessed April 10, 2015.
[2] (June 2013). “Nearly 7 in 10 Americans Take Prescription Drugs, Mayo Clinic, Olmsted Medical Center Find.” Mayo Clinic News Network. Accessed April 10, 2015.
[3] Ibid.
[4] Avila, J., Murray, M. (April 2011). “Prescription Painkiller Use at Record High for Americans.” ABC News. Accessed April 10, 2015.
[5] Tadena, N. (Aug. 2010). “The Most Medicated States.” Forbes. Accessed April 10, 2015.
[6] (2014). “Results from the 2013 National Survey on Drug Use and Health (NSDUH): Summary of National Findings.” Substance Abuse and Mental Health Services Administration (SAMHSA). Accessed April 10, 2015.
[7] Cooper, A. (Nov. 2013). “An Anxious History of Valium.” Wall Street Journal. Accessed April 13, 2015.
[8] Herper, M. (Sept.2010). “America’s Most Popular Mind Medicines.” Forbes. Accessed April 13, 2015.
[9] Cooper, A. (Nov. 2013). “An Anxious History of Valium.” Wall Street Journal. Accessed April 13, 2015.
[10] Herper, M. (Sept.2010). “America’s Most Popular Mind Medicines.” Forbes. Accessed April 13, 2015.
[11] Ibid.
[12] Ibid.
[13] Ibid.
[14] (2014). “Results from the 2013 National Survey on Drug Use and Health (NSDUH): Summary of National Findings.” Substance Abuse and Mental Health Services Administration (SAMHSA). Accessed April 13, 2015.
[15] April 2015. “Prescription Drug Overdose Data.” Centers for Disease Control and Prevention (CDC). Accessed April 10, 2015.
[16] Pokrovnichka, A. MD. (Nov. 2008). “History of OxyContin: Labeling and Risk Management Program.” U.S. Food and Drug Administration (FDA). Accessed April 10, 2015.
[17] (Oct. 2014). “Development and Approval Process (Drugs).” U.S. Food and Drug Administration (FDA). Accessed April 10, 2015.
[18] Van Zee, A. MD. (Feb. 2009). “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy.” American Journal of Public Health. Accessed April 10, 2015.
[19] Ibid.
[20] Pokrovnichka, A. MD. (Nov. 2008). “History of OxyContin: Labeling and Risk Management Program.” U.S. Food and Drug Administration (FDA). Accessed April 10, 2015.
[21] Whorisky, P. (Dec. 2012). “Rising Painkiller Addiction Shows Damage from Drugmakers’ Role in Shaping Medical Opinion.” Washington Post. Accessed April 10, 2015.
[22] Meier, B. (May 2007). “In Guilty Plea, OxyContin Maker to Pay $600 Million.” New York Times. Accessed April 10, 2015.
[23] (Dec. 2014). “Drug Facts: Prescription and Over-the-Counter Medications.” National Institute on Drug Abuse (NIDA). Accessed April 10. 2015.
[24] April 2015. “Prescription Drug Overdose Data.” Centers for Disease Control and Prevention (CDC). Accessed April 10, 2015.
[25] Ibid.
[26] Ibid.
[27] Ibid.
[28] (Dec. 2014). “Monitoring the Future Survey, Overview of Findings 2014.” National Institute on Drug Abuse (NIDA). Accessed April 13, 2015.
[29] (2014). “Results from the 2013 National Survey on Drug Use and Health (NSDUH): Summary of National Findings.” Substance Abuse and Mental Health Services Administration (SAMHSA). Accessed April 13, 2015.
[30] Tadena, N. (Aug. 2010). “The Most Medicated States.” Forbes. Accessed April 13, 2015.
[31] April 2015. “Prescription Drug Overdose Data.” Centers for Disease Control and Prevention (CDC). Accessed April 13, 2015
[32] Gray, A. (June 2014). “Chicago Blames Big Pharma for Epidemic Addictions to Painkillers.” Time. Accessed April 13, 2015.
[33] Girion, L., Glover, S. (May 2014). “Counties Sue Narcotics Makers, Alleging ‘Campaign of Deception.'” L.A. Times. Accessed April 2015.
[34] Ibid.
[35] Meier, B. (Oct. 2014). “Urging a Tighter Rein on Painkillers.” New York Times. Accessed April 13, 2015.
[36] (Aug. 2014). “Rules 2014.” Drug Enforcement Agency (DEA), Office of Diversion Control. Accessed April 13, 2015.
[37] (Aug. 2013). “Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States.” Substance Abuse and Mental Health Services (SAMHSA) Center for Behavioral Health Statistics and Quality (CBHSQ). Accessed April 13, 2015.