What did Big Pharma know and when did they know it?
Purdue Pharma has long denied that it knew about and tolerated widescale abuse of their opioid products, and that they only learned of the problem in 2000. Officially, the company states that its business practices have little to nothing to do with the current opioid epidemic.
However, a bombshell new article published in late-May by the New York Times reveals that Purdue did in fact know that its supposedly-safe opioid drugs were being diverted and misused as early as 1996, shortly after OxyContin was released.
Irrefutable Proof of Prior Knowledge
The primary source for this damning revelation was the company’s own internal emails, according to a confidential investigation from the US Justice Department. Per the 120-page report, Purdue Pharma learned about “significant” OxyContin and MS Contin abuse within the first few years after the painkiller’s introduction:
- 1997-1999: 117 internal notes from Purdue sales representatives used the words “snort”, “crush”, or “street value”.
- 1999: The company’s general counsel, Attorney Howard Udell, wrote, “We have in fact picked up references to abuse of our opioid products on the Internet.”
- 1999: Company officials were aware that OxyContin was described as, “…the hottest thing on the street – forget Vicodin.”
- High-ranking executives knew of instances where doctors were arrested and charged with selling prescriptions.
- Purdue’s owners were sent reports about the abuse of the company’s products.
Purdue Pharma concealed that damaging information. Of special relevance, investigators wrote that the company continued to market their products as having a lesser potential for abuse and addiction than other prescription painkillers, even “in the face of this knowledge”.
In 2006, after a four-year investigation, Justice Department prosecutors were ready to indict three Purdue Pharma executives on multiple felony charges, including conspiracy to defraud the United States. If convicted, the men could have been sent to prison.
Instead, the case was settled in 2007.
The Jick Letter: The Start of the Opioid Epidemic
“We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”
~Dr. Hershel Jick, in a “Letter to the Editor” of the New England Journal of Medicine
How did it all get this bad, to the point of being called “the greatest drug crisis in American history”?
It all started in 1980, when a medical researcher with the Boston University Medical Center wrote a five-sentence, one-paragraph letter and submitted it to the editor of the New England Journal of Medicine. The gist of the letter was Dr. Jick’s conclusion that opioid painkillers presented an extremely low risk of addiction.
And while the “Jick letter” was not based on an official peer-reviewed study, drug company sales representatives nonetheless cited it thousands of times as supposed “proof” that bolstered the companies’ claims that opioids were not habit-forming. Purdue Pharma, the manufacturer of OxyContin, specifically and extensively trained its sales to regularly quote the letter and report that the risk of dependence and addiction was “less than 1%.”
Big Pharma and got even bigger when other drug manufacturers started copying Purdue’s strategy. Salespeople aggressively pushed opioid painkillers to physicians everywhere – traveling nonstop across the nation extolling the virtues of these “safe” drugs.
Specifically, they touted OxyContin and other opioids as a first-line treatment for neck and back pain.
OxyContin – an Industry-Changing Medication
It all started in 1996, when Purdue was granted FDA-approval for a controlled-release formulation of oxycodone, to be sold under the brand-name OxyContin. Because of an aggressive marketing campaign focusing directly on doctors, OxyContin was a smashing success.
In its first full year alone, Purdue saw $49 million in OxyContin sales. By 2002, however, that number had ballooned to $1.6 billion, and by 2010, $3.1 billion. In fact, in 2010, OxyContin accounted for one-third of all prescription painkiller sales.
As of 2016, OxyContin has generated over $31 billion in sales.
The Economic Impact of the Opioid Epidemic
But if that sounds like a lot, consider the NEGATIVE economic impact that opioid abuse and addiction has had in the United States.
- Opioid misuse and addiction keeps at least 1 million Americans from working.
- This equates to 5 billion lost work hours.
- In the last 15 years, the number of “prime-age” men between the ages of 25 and 54 in the workplace decreased by 20%.
- Fatal overdoses hurt economic productivity. The average age of an opioid overdose victim is 41, and when the loss of productivity and wages is considered, it adds up to $800,000 per person.
- When there aren’t enough people joining the job market, there also isn’t enough room for the economy to grow. One report estimates that the growth of the US economy has been slowed .2% by the opioid crisis. While that doesn’t sound like much, .2% equates to approximately $700 billion in losses.
“$$$$$$$$$$$$ It’s Bonus Time in the Neighborhood!”
~Purdue Sales Manager
In a calculated move, Big Pharma companies began to donate huge sums nonprofit agencies such as the American Pain Society and the American Academy of Pain Management.
Unsurprisingly, the American Pain Society soon released guidelines recommending that healthcare providers significantly expand their use of prescription opioid painkillers. Even the Federation of State Medical Boards received donations from drug manufacturers. Again coming as no surprise, the Federation released prescribing guidelines supporting increased opioid dispensing.
These guidelines were so pro-prescription painkillers that doctors could be punished if they treated pain “inadequately“.
According to the Centers for Disease Control and Prevention, the clinical use of prescription opioid painkillers more than doubled between 2000 and 2014, and because of intentionally-disseminated misleading information and aggressive, unscrupulous marketing practices, America is currently in the midst of what has been called an “opioid epidemic”.
Exaggeration and Omission: How Doctors were Deceived
“(Purdue Pharma) over-sold the benefits of opioid therapy for chronic non-malignant pain, while providing false reassurance about what the real risks are of addiction for patients taking opioids for chronic non-malignant pain.”
~Dr. Art Van Zee
Big Pharma sales reps focused on hospitals and surgical centers across the country – ER doctors, surgeons, anesthesiologists, and pain management teams were all targeted. Reps visited doctors during rounds, bought lunches just to squeeze in a few extra minutes of pitch time, and even delivered snacks in an attempt to foster goodwill.
In internal Purdue Pharma sales memos, reps were called “Royal Crusaders” or “Knights”. It was their duty to sally forth from the “Royal Court of OxyContin” on a noble mission for the “Supreme Sovereign of Pain Management” the “Empress of Analgesia”.
Official memos would read, “As you continue to carry the OxyContin banner onto the field of battle, it’s important to keep highlighting OxyContin benefits to your doctors.”
Of special relevance, the research cited in the Jick letter only included hospitalized patients that were given small, controlled doses of opioids, not patients receiving prescriptions on an outpatient basis. Purdue Pharma sales reps were fully aware of this important limitation, but they were directed to that information out of their sales pitch. Prescribers were told that because of the time-release formulation of OxyContin, it was impossible to get high via misuse.
But OxyContin’s supposed benefits were often without scientific backing (at best), and patently false (at worst). Egregiously, the company:
- Downplayed OxyContin’s potential for abuse and addiction.
- Claimed OxyContin was safe and effective as a remedy for chronic pain.
- Falsely stated that OxyContin provided continuous and steady pain relief.
- Exaggerated OxyContin’s duration of effects, claiming it relieved pain for 12 hours, instead of the actual 8 hours.
This pattern of omission and misrepresentation directly led to the opioid epidemic.
Ignoring Pill Mills
“The first few of these prescriptions…looked legitimate…[but] after those were filled, a steady flow of younger, more ambulatory, customers came in with the same prescriptions.”
~A pharmacist complaining about the Lake Medical Center
In 2009, a District Manager for Purdue Pharma was tracking sales noticed a disproportionate surge in OxyContin orders from a particular small clinic in Huntington Park, California. Significantly, this relatively-small establishment was filling more painkiller prescriptions than some major chain pharmacies.
The quantities were astonishing:
- September 2008: In one week, 1500 OxyContin pills were ordered. This is more than some pharmacies fill in a month.
- Specifically, these prescriptions were written for the 80 mg dosage favored by addicts.
- Between June and September 2009, one physician, Dr. Eleanor Santiago, prescribed nearly 250,000 OxyContin pills.
The District Manager went to investigate, eventually concluding that illegal activities were occurring.
In a 2009 internal Purdue e-mail, the manager wrote “This is clearly diversion. Shouldn’t the DEA be contacted about this? I feel very certain this is an organized drug ring…”
Purdue Pharma did not notify the authorities, as they were required to by federal law.
Instead, Purdue added Santiago’s name to “Region Zero”, a confidential internal roster maintained by the company listing doctors suspected of improperly prescribing to dealers or addicts. In 2013, Region Zero contained the names of over 1800 physicians.
While the roster sounds like an effective control against diversion, Purdue only reports about 8% of the doctors to the proper authorities.
But even more alarming, the drug manufacturer also did not attempt to shut off the supply of OxyContin. In the four months after Dr. Santiago was placed on Region Zero, Purdue received at least 11 reports about her suspicious prescribing practices.
In fact, by the time Lake Medical went out of business because of criminal indictments, it had released over 1 million pills to the local black market. The estimated street value of those drugs was almost $100 million.
Why Do People Abuse Prescription Painkillers?
“It has become increasingly clear that opioids carry substantial risk but only uncertain benefits – especially compared with other treatments for chronic pain. We lose sight of the fact that the prescription opioids are just as addictive as heroin.”
~Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention
No one ever starts taking a drug with the intention of becoming addicted. However, certain prescription medications – opioid painkillers – drug dependency, abuse, and addiction may result even when the medication is taken exactly as prescribed.
The first thing to consider is that prescription opioids don’t exactly make pain go away. Instead, they mask pain by blocking signals from the brain.
In addition to pain relief, opioids also produce pleasurable feelings of euphoria, freedom from stress or worry, and a profound sense of well-being. These effects are similar to those felt when using other intoxicants such as marijuana or alcohol.
These pleasurable euphoria is a sign that the brain is being “hijacked” by the drug.
Whenever any activity necessary to survival is performed – sex or eating, for example – the brain releases a flood of dopamine, the neurotransmitter linked to with pleasure, reward, learning, and motivation.
It works like this – the survival action is performed and the individual is quickly rewarded with pleasurable sensations. In a very short time, they learn to associate the behavior with the resultant reward. This motivates them to repeat the behavior.
To put it simply – in the beginning, people choose to abuse opioids because it makes them feel good.
Why Are Prescription Opioids so Addictive?
“…licit pharmaceuticals may be sold on the street to obtain money to purchase illicit drugs, they may be used as a substitute for illicit drugs when the latter aren’t available, or they may be sought as drugs of choice.”
~Dr. Brian Goldman, M.D., in an editorial
In a similar fashion, opioid use and abuse also triggers a dopamine response, but the surge is far faster, much stronger, and longer-lasting. But with chronic use, however, the brain’s dopamine receptors become burnt out from the constant over-stimulation. This blunts the reward response – not just to opioids, but to ALL pleasurable activities.
This means that the person is almost completely unable to experience pleasure or motivation – or even feel “normal” – unless they are under the influence of opioids.
This limited response—also known as drug tolerance—is why addicts need to constantly up their dosage in order to the same high. But higher doses of opioids also increase the likelihood of overdose or death.
Significantly, when use of the drug is discontinued – or is even nearly delayed –an opioid -dependent person will begin to experience unpleasant or painful withdrawal symptoms– sometimes, within just a few hours:
- Strong drug cravings
- Mood swings
- Inability to concentrate
- Excessive sweating
- Alternating hot flashes and chills
- Muscle cramps
- Joint pain
- Nausea and vomiting
- Tremors, especially in the extremities
This is the addicted body’s way of crying out that it NEEDS the drug. Now, the ability to choose is virtually non-existent. The addict must compulsively abuse opioids to keep from feeling bad.
Switching from Painkillers to Heroin
The American Society of Addiction Medicine reports that 80% of heroin addicts misused prescription opioids such as OxyContin first.
Why might this be the case?
Prescribing guidelines have recently changed, and doctors are now urged to prescribe opioid painkillers only as a last resort, and even then, at the lowest effective dose and for the shortest possible duration. As a consequence, fewer opioids are being dispensed.
While in theory this is an excellent step, in practice, it means an increase in the number of desperate painkiller-dependent people.
When their formerly easily-obtained prescription opioids are no longer an option, a painkiller addict will do almost anything to get their fix – doctor “shopping”, faking injuries, buying or stealing pills from friends and family members, or, increasingly, purchasing drugs on the Internet from not-quite-legitimate sources.
But the price of doing business on the black market quickly becomes problematic. The most popular OxyContin dosage among addicts – 80 mg – can run $80 or more per pill.
A single dose of heroin, on the other hand, can be purchased for about the same price as a pack of cigarettes, according to an article published in the Washington Post.
These obstacles are why 94% of opioid addicts in rehab admit to moving from painkillers to heroin, because prescription opioids were “far more expensive and harder to obtain”.
That makes the opioid addiction even worse, because when heroin is injected or smoked, the “rush” can be felt in a matter of seconds. And because different batches of heroin can vary wildly in terms of purity and potency, there is almost no way to tell the difference between a dose that will grant a high and one that will cause a potentially-fatal overdose.
In fact, 7 out of 10 heroin users will overdose at some point during. Even more alarming, 1 out of 4 heroin users overdose at least once annually.
How Bad Is the American Opioid Crisis?
Calling the problem of opioid abuse, addiction, and overdoses in the US an “epidemic” is not an exaggeration. According to the American Society of Addiction Medicine:
- The US consumes 80% of the world’s prescription painkillers.
- Fatal drug overdoses are the leading cause of accidental death in America, accounting for an estimated 72,000 deaths in 2017.
- Over 70% of those deaths – almost 52,000 – were due to prescription or illicit opioids.
- That works out to an average of 142 opioid-related deaths every single day
Prescription Painkiller Abuse Leads to Counterfeit Drug Deaths
Opioid abusers face another danger—counterfeit drugs.
This is an increasingly-common hazard where the expected painkiller or heroin is cut or substituted with another substance another substance – usually without the user’s knowledge.
Recently, the counterfeit drug most-often seen has been the ultra-powerful synthetic opioid fentanyl. This drug is at least 50 times stronger than pure heroin. Some of the chemical analogues of fentanyl are thousands of times more potent.
And more deadly, because a fatal dose of fentanyl can be as small as six grains of salt. A fentanyl poisoning may require multiple applications of the opioid overdose reversal drug Narcan.
Drug cartels substitute fentanyl for other opioids for two reasons— FIRST, to boost the strength of inferior product, and SECOND, to cut costs. Because it is completely synthetic, fentanyl can be made in a laboratory for a third of the cost of heroin.
But fentanyl-for-heroin is not the only danger.
Fentanyl powder is often pressed into pill or tablet form, intentionally mislabeled as a prescription painkiller, and then sold on the street. In 2017, US Customs and Border Control seized pill presses at the US-Mexico border at an alarming rate – 19 times higher than in 2011.
In 2016, counterfeit drugs caused the death of music superstar Prince. Long addicted to prescription painkillers, he unknowingly took a fatal dose of fentanyl disguised to look like Vicodin.
So Much Time, So Little Change
“Year, how about fewer ads that fuel opioid addiction and more on access to treatment?”
~Denis McDonough, White House Chief of Staff
During 2016’s Super Bowl, commercials normalizing the long-term use of opioid painkillers were aired. This sparked outrage from many addiction recovery professionals. For example, Dr. Aikur Mohammed, M.D., with the University of Southern California’s Keck School of Medicine, weighed in, saying, “Everyone is on board with these new initiatives, except the opioid drug manufacturers and a segment of doctors who overly prescribe their products. Many of them are only looking at ways to make more money, even if it’s at the expense of those who might already be addicted or will be soon…”
Karma for Big Pharma?
In 2007, Purdue Pharma as a corporate entity and three of its top executives as culpable individuals, entered guilty pleas to criminal charges that they had knowingly misled the Food and Drug Administration, prescribers, and patients about the abuse/addiction potential of their top product, OxyContin.
One of the charges was that Purdue’s sales reps had fraudulently and over-aggressively misrepresented OxyContin as a much safer alternative to other short-acting painkillers. The government’s major charge was that Purdue’s sales force had been expressly directed to strongly emphasize that “OxyContin had less euphoric effect and less abuse potential than short-acting opioids“.
Purdue was slapped with a $635 million fine.
Currently, Purdue and other Big Pharma drug manufacturers are facing lawsuits initiated by dozens of individual states, counties, and cities seeking recompense for the financial and societal damage resulting from the companies’ irresponsible business practices.
For his part, Dr. Jick has reconsidered his original position, saying, “The letter wasn’t of value to health and medicine in and of itself. So, if I could take it back — if I knew then what I know now, I would never have published it. It wasn’t worth it.”