A few days ago, the Los Angeles Times published an extensive investigative report on the dangers of one of the most highly abused drugs in recent history.
The focus of this story is not a street drug like meth, heroin, or cocaine.
It is oxycodone, a legal drug that is commonly prescribed, mainly for people suffering from serious, chronic pain.
The fact that opioid painkillers have addictive properties is not a secret. But the LA Times investigation revealed something that wasn’t widely known, and is perhaps more disturbing: the maker of one of the most popular opioid painkillers pushed doctors to adhere to a dosing schedule that, as it turns out, makes it more likely for patients to become addicts.
This dosing schedule was also approved by federal regulators.
From the LA Times:
The drug in question is OxyContin, a version of the generic opioid painkiller oxycodone that Purdue Pharma introduced 20 years ago as a 12-hour alternative to cheaper, shorter-lived oxycodone products.
The federal Food and Drug Administration approved OxyContin based on evidence that the two-pills-per-day regimen worked for half or more of the patients in a test group. But sealed court records and internal company documents reviewed by The Times showed that the company knew that the relief wore off for many patients well before 12 hours.
The promise of sustained pain control led OxyContin to become America’s bestselling painkiller, and Purdue Pharma’s billion dollar baby – the drug has brought in over $31 billion in revenue for the company.
It is also the likely reason that so many people are addicted to the drug:
The drug wears off hours early in many people, a Los Angeles Times investigation found. OxyContin is a chemical cousin of heroin, and when it doesn’t last, patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug.
Doctors told Purdue that their patients weren’t getting a full 12 hours of relief. Instead of recommending that such patients take OxyContin more than twice per day — which might make it less appealing than cheaper generic opioids with short durations — Purdue’s representatives told doctors to stick to the 12-hour dosing schedule and prescribe higher-strength pills.
Medical experts told the Times that this recommendation accentuates the addictive properties of oxycodone:
When the effects of OxyContin wear off well before 12 hours, a patient’s pain returns along with symptoms of opioid withdrawal, increasing the craving for another pill. Switching to stronger doses offers more profound pain relief, but won’t necessarily solve the problem of needing another pill in less than 12 hours.
Repeated episodes of craving increase the likelihood of addiction, the experts said.
The Times investigation was based on thousands of pages of confidential Purdue documents and other records. The following is a summary of what was revealed.
Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.
The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.
When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to “refocus” physicians on 12-hour dosing. Anything shorter “needs to be nipped in the bud. NOW!!” one manager wrote to her staff.
Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.
More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.
When the effects of OxyContin wear off between doses, patients can suffer body aches, nausea, anxiety, and other symptoms of withdrawal. When the symptoms are relieved by the next dose, it creates a cycle of pain and euphoria that can lead to addiction.
Patients in whom the drug doesn’t last 12 hours can suffer both a return of their underlying pain and “the beginning stages of acute withdrawal,” Cicero said. “That becomes a very powerful motivator for people to take more drugs.”
Oxycodone is categorized on the United States Drug Enforcement Agency (DEA) list of Schedule II drugs, which are substances or chemicals that are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous.
Yet, marijuana is currently listed under the Controlled Substances Act as a Schedule 1 drug, meaning that for the purposes of federal law, the drug has “no medical use and a high potential for abuse” and is one of “the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.”
The plant – which to date, has not caused a single death by overdose – shares Schedule 1 status with heroin, LSD, and methaqualone (Quaalude) and it is more strictly regulated than oxycodone.
According to the LA Times, more than 7 million Americans have abused OxyContin over the last 20 years. Since 1999, prescription opioids have killed over 190,000 people.
Prior to the development of OxyContin, doctors viewed narcotic painkillers as dangerously addictive and saved their long-term use for people with cancer and the terminally ill. That changed when Purdue spent $207 million on a massive launch for the drug. Sales representatives marketed OxyContin to family doctors and general practitioners as a treatment for common problems like back and knee pain.
Purdue’s marketing campaign was wildly successful. OxyContin brought in billions for the company, and other drug manufacturers began marketing their own narcotic painkillers for common aches and pains.
By 2010, one out of every five doctor’s visits in the U.S. for pain resulted in a prescription for narcotic painkillers, according to a Johns Hopkins University study.
With the increasing popularity of OxyContin came increasing rates of addiction and overdose. This led the U.S. Justice Department to launch a criminal investigation of Purdue, and in 2007, the company and three top executives pleaded guilty to fraud for downplaying OxyContin’s risk of addiction. Purdue and the executives were ordered to pay $635 million. The case centered on elements of Purdue’s marketing campaign that suggested to doctors that OxyContin was less addictive than other painkillers.
But nothing changed. Purdue continued to push sales reps to convince doctors to increase the strength of the doses rather than the frequency, despite the fact that people who take higher dosages of the drug are more likely to overdose and die.
The number of prescriptions for opioids doubled over a 15 year period from 105 million in 1998 to 207 million in 2013. As a result, the number of fatal overdoses from the drugs soared almost five-fold, from 4,000 deaths a year in 1999 to nearly 19,000 in 2014. That includes people who illicitly used prescription opioids and those who overdosed on pills prescribed for them, reports PBS News Hour.
The American Society for Addiction Medicine’s Opioid Addiction 2016 Facts & Figures report reveals some tragic statistics:
- Four in five new heroin users started out misusing prescription painkillers. As a consequence, the rate of heroin overdose deaths nearly quadrupled from 2000 to 2013.
- 94% of respondents in a 2014 survey of people in treatment for opioid addiction said they chose to use heroin because prescription opioids were “far more expensive and harder to obtain.”
- In 2014, there were 10,574 overdose deaths related to heroin.
- Of the 21.5 million Americans 12 or older that had a substance use disorder in 2014, 1.9 million had a substance use disorder involving prescription pain relievers and 586,000 had a substance use disorder involving heroin.
- In 2012, 259 million prescriptions were written for opioids, which is more than enough to give every American adult their own bottle of pills.
Recent research suggests that marijuana allows people to treat their pain with lower doses of opioids and that providing access to marijuana reduces the prevalence of opioid use.
Perhaps decriminalizing or legalizing marijuana would help resolve the opioid epidemic that is plaguing the nation.
Dr. David Kessler, former head of the FDA, shared his thoughts on the explosion in opioid use with CBS:
This has been one of the great mistakes of modern medicine.
FDA has responsibility, the pharmaceutical companies have responsibility, physicians have responsibility. We didn’t see these drugs for what they truly are.
The inappropriate promotion of drugs contributed significantly to this epidemic. Because drug companies took a small piece, a sliver of science and widely promoted it as not being addictive. That was false.
Everybody has to do better. The CDC guidelines need to be implemented. Pharmaceutical companies need not over-promote. Doctors need to prescribe more wisely in a more limited way.