You may not know or recognize his name, but Austrian Friedrich Serturner was a pharmacist’s assistant who, through 14 years of research and testing, isolated the purest form of the alkaloid base compound morphine from opium poppies.1 He found the opium with the alkaloid removed was not effective on animals, but the alkaloid was 10 times more powerful than the processed opium.2
After spending years testing on himself, he died chronically depressed and addicted to morphine.3 By the mid-1820s morphine was used across Western Europe, provided by several sources, including a new chemical company started by Heinrich Merck.4 Although first thought to be a cure for opium addiction, by the 1870s it became clear morphine was also addictive.
A chemist in a London hospital searching for a nonaddictive drug option to treat pain discovered a more powerful drug called diacetylmorphine. Bayer Laboratories developed and tested the drug and found it was a powerful painkiller.5 They produced and marketed it as a “sedative for coughs” in 1898. They called it heroin.
Although physicians quickly welcomed the new drug, they soon recognized the potential for addiction and in 1913 Bayer stopped production, and instead focused their efforts on marketing their second discovery, aspirin.
Unwilling to be associated with heroin production and distribution, Bayer Laboratories had edited that period from their official company account.6 While the pharmaceutical industry may have initially operated in the best interests of the public and their patients, this quickly changed over the next 100 years.
Database reveals horrific extent of opioid distribution
Before the mid-1980s opioids were prescribed few and far between because of fear their patients would become dependent on these highly addictive drugs.7 In 2017, the National Institute on Drug Abuse8 records there were 1.7 million people who suffered from a substance abuse problem related to prescription opioid pain relievers and 652,000 from addiction to heroin.
During the same year there were 47,600 deaths from an opioid overdose and at least 130 who died every day in 2016 and 2017 from an opioid-related overdose.9 In total, the Centers for Disease Control and Prevention records nearly 218,000 people have died due to opioid-related prescription overdoses.10
The epidemic has devastated communities and families, while physicians, pharmaceutical manufacturers and distributors have enjoyed exceptional profits. This is the crux of a lawsuit brought by 2,000 communities in federal court against 2311 of the biggest drug companies they allege conspired to flood the country with drugs and their pockets with profits.12
The lawsuit covers 2006 to 2012, when the plaintiffs allege 76 billion opioid pain pills were distributed throughout the U.S. as the drug epidemic spiraled out of control.13 That’s enough for every American in 201014 to take one pill every 1.5 days for one year. However, the shipment of the drugs was not evenly distributed throughout the U.S.
According to data from the DEA,15 one small town of 2,831 people received a shipment each month of 3,271 bottles,16 each containing 100 pills.17 The Washington Post reported on emails sent by Kristine Atwell, who managed Walgreens’ distribution of controlled substances for their warehouse in Jupiter, Florida. She urged headquarters to require justification for large orders.18
“I ran a query to see how many bottles we have sent to store #3836 and we have shipped them 3271 bottles between 12/1/10 and 1/10/11. I don’t know how they can even house this many bottle[s] to be honest. How do we go about checking the validity of these orders?”
Further emails in the plaintiff’s lawsuit quoted Victor Borelli, an account manager for Mallinckrodt to Steve Cochrane, vice president of sales for KeySource Medical. In one exchange quoted in The Washington Post:
“Borelli told Cochrane in another email that 1,200 bottles of oxycodone 30 mg tablets had been shipped.
“Keep ’em comin’!” Cochrane responded. “Flyin’ out of there. It’s like people are addicted to these things or something. Oh, wait, people are …” Borelli responded: “Just like Doritos keep eating. We’ll make more.””
DEA and drug companies fought to keep numbers secret
The DEA maintains a database of every controlled substance prescribed, sold and distributed throughout the U.S. — Automation of Reports and Consolidated Order System (ARCOS).19 In an age of digital reporting and computer aided analysis, it’s difficult to imagine the DEA was unable to pinpoint those involved in fraud that was feeding an epidemic killing hundreds of thousands of Americans.
For the first time, data from ARCOS have been released to the public after The Washington Post and HD Media pushed for over one year to access the information. Until July 15, 2019, the litigation proceedings had been held in secrecy. On that date the federal judge lifted a protective order for part of ARCOS.20
Attorneys for the drug companies and the DEA challenged the public release of the information. The drug companies argued the data may give their competitors an unfair advantage in the marketplace.
While protecting market information for business is important to the Federal Trade Commission, it’s also important to remember the drug companies wanted to protect their sales of opioid painkillers, the data which were being released.
The justice department argued the release may potentially compromise ongoing investigations. But the lawyers for the communities suing the drug companies we’re happy to see the data released to the public. Paul Farrell Jr., co-lead counsel for the plaintiff said to The Washington Post:21
“The data provides statistical insights that help pinpoint the origins and spread of the opioid epidemic — an epidemic that thousands of communities across the country argue was both sparked and inflamed by opioid manufacturers, distributors, and pharmacies.”
Each of the drug companies and pharmacies have made statements to the effect they hold no responsibility for the distribution of opioids across the U.S. — except one. Ohio-based pharmaceutical company Miami-Luken Inc. chairman Joseph Mastandrea stood before the House Energy and Commerce subcommittee along with four other executives from the nation’s largest drug distribution companies.22
Each were sworn in and each denied they contributed to the opioid crisis. Only Miami-Luken accepted responsibility.23 Subsequently the company and four employees were indicted, charged with shipping millions of pills to rural Appalachia and 3.7 million pills from 2008 to 2011 to a town of 400 people.24
Midwest and southern states hit hardest by 76 billion pills
The crisis does not respect boundaries. While accidental drug overdose is the leading cause of death in those under 50,25 a study by the Office of Inspector General in 201726 found 1 in every 3 persons on the Medicare prescription plan (Part D)27 filled a prescription for opioids in 2016, and 500,000 received high amounts.
ARCOS is a road map of the distribution of opioid pills. While much of the past attention has focused on the drug manufacturers, the data from ARCOS will help clarify the part distributors and pharmacies have played in this tragic human drama. Farrell, a native of West Virginia, commented to NPR:28
“You’ll be able to see the flow, the steady flow of pills — it’s not a trickle, it’s a tsunami. In my hometown of Huntington, W.Va., there are 24 CVS pharmacies within 40 miles of my house. From those 24 pharmacies, you’ll be able to see that 80 million [opioid] pills were distributed [over a six-year period].”
The Washington Post analyzed the information and found just six companies distributed 75% of the opioid prescriptions in the six years in question.29 According to The Washington Post, “states receiving the highest number of pills per person were: West Virginia at 66.5, Kentucky at 63.3, South Carolina at 58, Tennessee at 57.7 and Nevada at 54.7.”30
The following graphic from The Washington Post showed that data from ARCOS revealed the 10 biggest distributors of opioid prescriptions from 2006 to 2012 were:31
|Company||Number of pills distributed|
Smith Drug Co.
However, while there are always a few who try to break the rules, in this case there appeared to be multiple individuals and companies working independently of each other who have been trying to skirt the system. The DEA mandates32 pharmacies and distribution companies identify suspicious orders and report them.
One example the plaintiffs cite in their allegations is from Walgreens. The company’s formula to screen for suspicious orders identified thousands but these orders were shipped anyway. They were later reported to the DEA as a collection of completed transactions, including 836 pharmacies in more than 12 states. The DEA wrote:33
“Notwithstanding the ample guidance available, Walgreens has failed to maintain an adequate suspicious order reporting system and as a result, has ignored readily identifiable orders and ordering patterns that, based on the information available throughout the Walgreens Corporation, should have been obvious signs of diversion.”
Drug companies place a dollar value on your life
The New York Times34 reported Mallinckrodt, makers of 12 categories of controlled substances,35 agreed to settle for $35 million against charges they had failed to detect and report suspicious orders of opioids.
The Washington Post36 reports the top 10 distributors listed above “paid over $1 billion to the Justice Department and FDA, and hundreds of millions more to states to settle” fines and lawsuits. However, nondisclosure agreements were attached to these settlements, so the information was never made public.
The scope of the hundreds of lawsuits, now in the U.S. District Court in Cleveland, Ohio, are greater than the $245 billion settled over 25 years from the tobacco litigation in the 1980s.37 In May 2019, Purdue Pharma settled with Oklahoma for $270 million.38
The Washington Post reported39 Walgreens has paid an $80 million fine, McKesson has paid a total of $163 million in two settlements and Cardinal $68 million in two settlements. CVS paid a $22 million fine for the distribution of oxycodone in Sanford, Florida, from 2008 to 2011, during which time 2.2 million pills were sold.40
Despite the large fines, settlements and disputes with the government, the pharmaceutical industry found it was lucrative to continue to sell opioid pills to whomever would buy them. With full knowledge of the number of people dying and lives destroyed, the industry placed a numerical value on human life as long as they kept making money.
Blame for the opioid crisis rests with: no one
In documents and testimonies, one after another, physicians, pharmacies and manufacturers are laying the blame for the epidemic — nowhere. According to each group, they were only doing what was asked, ordered or part of their normal business duties.
At no point did any of these medical professionals, sworn to uphold ethical standards, or thousands of employees at Big Pharma decide enough was enough.
In an interview with NPR,41 Scott Higham, Pulitzer Prize-winning investigative reporter from The Washington Post42 who broke the story, was asked if the data from the DEA challenged the assertion by drug companies the epidemic should be blamed on overprescribing doctors and pharmacists who looked the other way. He replied:43
“Well, in some ways, it does. Look; there are corrupt doctors, and this epidemic wouldn’t have started without them. But up and down the chain, everybody has a responsibility. The doctors have a responsibility. The pharmacists have a responsibility. The distributors have a responsibility. And the manufacturers have a responsibility. It’s a tightly regulated supply chain.
And if any of those links in that chain break, the whole thing collapses. And that’s what happened. Up and down the supply chain, there were breaks, and nobody seemed to stop it. And the pills just kept pouring onto the streets of America.”
A position piece44 written by Dr. Arthur Gale, Journal of the Missouri State Medical Association contributing editor, he explains the development of the opioid crisis that is as simple as “follow the money and the ‘experts’ it buys.” In his historical accounting, he discusses the impact neurologist and pain specialist, Dr. Russell Portenoy, had on the field.
Portenoy used his considerable influence to convince medical professionals the risk of addiction was minimal and, conversely, not treating pain was cruel and may even be considered medical negligence.45 During the early 1990s Portenoy’s reputation was impeccable and he won many awards for his work in pain management, becoming known as the “king of pain.”
He consistently used a study published in The New England Journal of Medicine46 that stated a mere 1% of those treated with narcotics would later become addicted. However, as has become known, this “landmark” study was a simple one paragraph letter to the editor, which one author has repeatedly claimed was misinterpreted.
Rules of the marketplace guiding medicine
More recently, Portenoy has backtracked his statements on opioid addiction and admitted he was wrong. In an article in The Wall Street Journal in 2012 Portnoy is quoted from a 2010 videotaped interview saying,47 “I gave innumerable lectures in the late 1980s and ’90s about addiction that weren’t true.”
Despite being discredited, and making false statements about addiction, Portenoy48 is the chief medical officer and executive director of the Metropolitan Jewish Health System hospice and palliative care, after having recently left the department of pain medicine and palliative care at Mount Sinai Beth Israel Medical Center. The Journal writes the Joint Commission published a guide funded by Purdue Pharmaceuticals:49
“The Joint Commission published a guide sponsored by Purdue Pharma. “Some clinicians have inaccurate and exaggerated concerns” about addiction, tolerance and risk of death, the guide said. “This attitude prevails despite the fact there is no evidence that addiction is a significant issue when persons are given opioids for pain control.”
Purdue said the booklet emerged from a process that “represented the consensus of a broad range of interested stakeholders.” Drug makers regularly pay for educational materials for physicians as an element of their marketing.”
While at Beth Israel at the time of the Wall Street Journal article, Portenoy and Beth Israel did not provide details of funding by drug companies for Portenoy’s programs. However, in a 2007 fundraising prospectus, it was revealed his program benefited from millions of dollars in funding from opioid makers. The Wall Street Journal quotes Portenoy saying:50
“My viewpoint is that I can have those relationships, they would benefit my educational mission, they benefit in my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation.”
Ultimately, Gale’s point is twofold:51
• Simple disclosure of conflict of interest is not sufficient, as this “industry-financed and physician-led, physician-driven opioid disaster proves.” He believes it’s likely nothing will come of this as there is too much money to be lost by drug companies, research medical centers, researchers, medical education programs and some physicians.
• While multimillion-dollar fines are paid, the industry keeps churning out drugs. Gale writes:52 “And what has happened to Portenoy and the other “experts” and “thought leaders” who falsely promoted the safety of opioids?
What has happened to the Joint Commission and the Federation of State Medical Boards and hospital lawyers all of whom played ‘follow the leader’ and climbed on the opioid bandwagon and advised doctors they had better treat pain with opioids or possibly face sanctions or malpractice claims? The answer is a resounding nothing.”
Foster care numbers double due to opioid addiction
Death and family destruction come at a significant cost to communities, the criminal justice system and innocent and vulnerable children. A recent research letter published in the Journal of the American Medical Association53 finds an increasing trend in children placed in foster care, removed from their parents and homes due to parent drug use.
After almost 10 years of declining numbers of children being placed into foster care, the cases have begun to rise steadily since 2012.54 Over the past two decades, the number of children going into foster care related to their parent’s drug use has more than doubled, rising from 39,000 in 2000 to 96,700 in 2017.
The researchers found the increase in foster care placement for drug use beginning in 2000 had started even as the overall caseload had been declining. By 2012, the overall number of children placed in foster care showed an increase.55
Caseload information show children going into foster care following parental drug use were more likely to be 5 years old or younger, white and from the southern area of the U.S.
And still nothing has changed
Despite documentation the DEA and manufacturers were aware of the distribution of voluminous numbers of opioids across the U.S. until 2012, and in the seven years since then, nothing has really changed.
In January 2019, well after up-to-date statistics demonstrating the human tragedy being played out before everyone’s eyes were published, the NIH and Health and Human Services updated their priorities to:56
- Improve access to treatment and recovery
- Promote the use of drugs to reverse overdose
- Support more research on pain and addiction
- Advance better pain management practices
- Strengthen their understanding of the epidemic using better public health surveillance
In other words, the agency charged with addressing the drug abuse challenges in the U.S. is seeking more research and hopes to promote the use of drugs used to reverse overdoses without including goals to reduce prescription by physicians, monitoring at pharmacies or coordination with the DEA.
Before accepting a prescription for an opioid painkiller, once reserved only for end-of-life care, think about if you’d use heroin to treat the type of pain you’re experiencing. In essence, opioid painkillers are prescription-strength, legal heroin-type drugs, with the same addictive properties and potential to destroy your life.
Pain is your body’s communication system, letting you know something is wrong. There are other options to help alleviate your pain that do not include addictive medication but are effective when used properly. I always recommend working with your health care provider to identify the source of your pain, since if you’re able to relieve the issue, it often relieves the pain.
For instance, poor posture may be the root of upper or lower back, hip or knee pain. Correcting your posture and strengthening your core may eliminate the problem. There are a number of pain relieving strategies I discuss in my past article, “Treating pain without drugs.”