• Alison Kartevold / GistSayn.com

Opioids and Big Pharma, is 2019 a Year of Reckoning?

So here’s the Gist:

2019 is setting up to be a year of reckoning for Big Pharma.

Drug Companies have been heavily marketing prescription opioids for decades providing relief for those with acute pain and making billions. But now that America is in the midst of a full-blown opioid epidemic, State and local governments are lining up to carve off pieces of Big Pharma’s profits to help stem the tide of addiction and offset the cost of dealing with the crisis.

A jury in a Boston federal court is currently hearing accusations of racketeering and conspiracy against employees of Insys Therapeutics Inc., the company that makes fentanyl. The case involves alleged bribes ranging from speaker’s fees to a lap dance. The federal prosecutor in the case says the founder ran his company as a criminal enterprise and "put profits over people.”

This case is considered bell weather. If the claims resonate with the jury, and guilty verdicts come down, “profits over people” is sure to become the new battle cry for thousands of lawsuits already lined up against drug companies.

On January 29th the district court judge in Cleveland who has been appointed to hear some 1500 combined claims against multiple Big Pharma companies, set a trial date of October 21st.

And on January 31, the complaint initially brought back in July of 2018, by the Massachusetts Attorney General against Purdue Pharma and members of the Sackler family who own it was released unredacted to the public.

The Current Crisis

In the past two decades, more than 700-thousand people in this country died from a drug overdose.

According to the Center for Disease Control, the number of deaths by overdose involving both prescription and illegal opioids is more than six times higher than it was in 1999. Meaning 70,237 people died due to drug overdoses in 2017. Of those deaths, 47,600 were the result of an opioid overdose. That is an average of 130 Americans a day.

Things are so bad that in October of 2017, President Donald Trump declared a public health emergency. Here are a couple of comparisons to put things in perspective. The FBI estimates that in 2017 the number of murders in the nation was 17,284. That same year, the National Safety Council reported that 40,100 people died in motor vehicle crashes.

This means 7500 more people are dying from opioid drug overdoses each year than from riding in or driving a vehicle, an activity in which virtually everyone in the country participates.

We've Been Here Before

The evolution of opioids spans millennia. Opium, the natural source of opiates is a derivative of the opium poppy plant. The plant's cultivation as a painkiller is nothing new. It was first recorded back in 3400 BC in lower Mesopotamia where the Sumerians called it the "Joy Plant."

Jump forward to 460 B.C. and Hippocrates, known as the "father of medicine," wrote of the usefulness of opium as a narcotic. He prescribed drinking the juice of the white poppy mixed with the seed of nettle. For you Game of Throne fans out there, think "milk of the poppy." Its use traveled throughout the ancient empires of Alexander the Great and Rome.

The Holy Inquisition cast opium in such an unfavorable light that it disappears from Europe's historical record for about two hundred years.

Then in 1500 Portuguese sailors, are credited with initiating the smoking of opium while trading in the East China Sea. It was a practice considered barbaric and subversive by Chinese culture. Twenty-seven years later the drug was reintroduced into European medical literature, described as black pills or "Stones of Immortality," and prescribed as painkillers.

In the 1600s residents of India and Persia began eating and drinking opium mixtures for recreational use.

In the 17 and 1800s, the Dutch and then Great Britain ran a lucrative opium export trade from India to China. By the early 19th century, China faced an epidemic that saw millions addicted to smoking the narcotic. When the Chinese emperor tried to block imports, Britain went to war, twice, to keep and expand its profitable drug trafficking routes.

It was in the 1800s when men of science ramped up the quest to develop stronger, less addictive opium that things became even more complicated. The first result of this endeavor was morphine. Though stronger, and partly responsible for enabling advancements in surgical medicine, morphine is also more addictive and deadly than the opium from which chemists created it.

Soon doctors in the U.S. were using it as a mainstay to treat everything from the pain of wounds suffered by soldiers on Civil War battlefields, to the illnesses of anxiety, consumption, and respiratory problems associated with life in the 1800s. Its use was also heavily recommended to women of middle class means to relieve troubles feminine in nature.

The invention of both the hypodermic needle in 1853 and the synthesized derivative of morphine, called heroin, in 1895 lead to the next significant evolution in opioid use.

A philanthropic group introduced heroin in the United States as a "non-addictive" substitute for morphine and the chemical company, Bayer, first offered heroin as a cough suppressant. Keep in mind; there was no government regulation of opioids at this point.

However, the post-war addiction rate of civil war veterans and homemakers alike was so high that as the 19th century came to a close, the United States moved to end the use of non-medicinal opium.

The early 20th century saw Congress pass laws that; banned recreational opium and its importation, required pharmaceutical companies to list the ingredients of patent medicines on labels; and forced physicians and pharmacists to pay a tax and register to be a distributor.

In the 1920s all non-prescription sales of narcotics were banned in the United States, and addicts turned to underground black markets to get their fix.

By this time oxycodone had already been developed with the hope that it could offer the analgesic effects of morphine and heroin, with less physical dependence. Unless your name is Rip Van Winkle, you've heard how that played out. The point is we have been here before.

In the 1980s, medical professionals, abiding by the national crusade to "Just say no to drugs," were reluctant to prescribe any opioid derivatives. However, a growing need for pain management caused the pendulum to reverse course, just in time for time-released prescription opioids to come to market in the 90s.

Waves of Death

The CDC outlines the current epidemic in opioid overdose deaths in three distinct waves.

"The first wave began with the increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids (natural and semi-synthetic opioids and methadone) increasing since at least 1999.

The second wave began in 2010, with rapid increases in overdose deaths involving heroin.

The third wave began in 2013, with significant increases in overdose deaths involving synthetic opioids – particularly those involving illicitly-manufactured fentanyl (IMF). The IMF market continues to change, and IMF can be found in combination with heroin, counterfeit pills, and cocaine."

Purdue Pharma

The pending criminal case in Massachusetts is not the first time Purdue Pharma has been taken to court concerning the marketing of its drug OxyContin.

When appropriately used, the powerful narcotic OxyContin can relieve severe pain for up to 12 hours due to its time-release formula. Upon its introduction back in 1996, the company claimed that the time release formula made OxyContin less addictive than other opioids like Percocet or Vicodin.

Based on this premise, Purdue Pharma launched a massive marketing campaign aimed largely at general practitioners, who often had little experience with treating acute pain or prescription narcotics. Sales quickly reached then surpassed the billion dollar mark.

Just as quickly, experienced drug abusers and novices alike, including teenagers, discovered that chewing an OxyContin tablet or crushing one and then snorting the powder or injecting it with a needle produced a high as powerful as heroin.

By 2000, parts of the United States, mainly rural areas, began to see skyrocketing rates of addiction and crime related to the use of the drug.

In 2007 Purdue Pharma plead guilty in federal court to criminal charges that it and three current and former executives had misled regulators, doctors, and patients about the drug's potential of abuse and risk of addiction over the six years previous.

As part of the plea agreement, the Company agreed to pay $600 million in criminal and civil penalties. Purdue Pharma's president, top lawyer and medical director pleaded guilty as individuals to the criminal violation of misbranding and agreed to pay a $34.5 million in combined fines.

In a statement released back in 2007, Purdue said:

“Mr. Friedman, Dr. Goldenheim (while at Purdue) and Mr. Udell neither engaged in nor tolerated the misconduct at issue in this investigation. To the contrary, they took steps to prevent any misstatements in the marketing or promotion of OxyContin and to correct any such misstatements of which they became aware.”

The Attorney General of Massachusetts, Maura Healey, doesn't believe much has changed since 2007. The current lawsuit filed against Purdue Pharma, members of the Sackler family, and other company employees lay out charges of wrongful actions from that point forward that claim they are responsible for the deaths of more than 670 Massachusetts residents who were prescribed Purdue opioids since 2009.

The unredacted complaint contains troubling examples of how the company allegedly targeted the elderly, veterans, and patients it deemed “trustworthy” because of their commercial and government-funded insurance plans. It claims Purdue Pharma even funded a book and held special events to encourage doctors to prescribe opioids to veterans. The complaint claims that the company also targeted so-called “opioid naive” patients without proper warnings of the risks of addiction and death.

In a statement following the ruling to un-redact the complaint, the Massachusetts Attorney General welcomed Judge Janet Sanders decision saying, 'For many years, Purdue, its executives, and members of the Sackler family have tried to shift the blame and hide their role in creating the opioid epidemic. We are grateful to the court for lifting the impoundment on our complaint so that the public and families so deeply impacted by this crisis can see the allegations of the misconduct that has harmed so many.'

People who have lost ones protest outside courthouse in Boston. (STAT)

In the complaint, the AG alleges to have documents that show the Sacklers approved public marketing plans that would blame people hurt by opioids while the family continued to pocket millions in profits.

“We have to hammer on the abusers in every way possible,” Dr. Richard Sackler allegedly wrote in an email in February 2001. “They are the culprits and the problem. They are reckless criminals.”

More than a decade later, Kathe Sackler, a board member, allegedly proposed a secret plan to grow Purdue by providing not just the painkillers, but the drug, Suboxone, that is used to treat those that have become addicted to painkillers.

"It is an attractive market." she allegedly wrote in September 2014. "Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction."

When the unredacted copy of the complaint was made public on January 31st, Purdue Pharma's Attorneys responded with a statement of their own that reads in part:

“Today’s release of the remaining portions of the Massachusetts Attorney General’s amended complaint is part of a continuing effort to single out Purdue, blame it for the entire opioid crisis, and try the case in the court of public opinion rather than the justice system.

Such a serious allegation demands clear evidence linking the conduct alleged to the harm described, but Massachusetts fails to show such causation and offers little evidence to support its sweeping legal claims.

Instead, Massachusetts seeks to publicly vilify Purdue, its executives, employees and directors while unfairly undermining the important work we have taken to address the opioid addiction crisis by taking out of context snippets from tens of millions of documents and grossly distorting their meaning. The complaint is riddled with demonstrably inaccurate allegations.”

“Absent from the complaint is any acknowledgment of the fact that most opioid overdoses now result from heroin and illicit fentanyl. In fact, rates of overdoses from illegal fentanyl have skyrocketed in Massachusetts between 2012-2016, according to the National Institute on Drug Abuse (NIDA stats).

Instead, Massachusetts deliberately conflates illegal street drugs with legitimate prescription opioids in an attempt to assign to Purdue liability for all misuse of all opioids.

Purdue’s opioid pain medicines represent less than 2% of total opioid prescriptions. They are approved by FDA, prescribed by doctors, and dispensed by pharmacists. The material released today once again shows Massachusetts conveniently disregarding basic facts about Purdue’s prescription opioid medications."

Where Things Stand Now

The CDC has attributed the ongoing third wave of opioid overdose deaths, that began in 2013, to synthetic opioids, particularly illicitly-manufactured forms of fentanyl also know as IMFs, which brings us back to the criminal trial currently underway in Boston.

Even if most overdoses are now from IMFs in combination with heroin, counterfeit pills, and cocaine, governments want the American companies that have profited for decades from sales of legal painkillers to pay for stoking the fires of addiction and help them recoup the costs of fighting it.

On the first day of the trial against Insys Therapeutics, the prosecutor told the jury that a sales manager performed a lap dance for a doctor to woo him into writing more prescriptions for fentanyl. It was a salacious introduction to the racketeering and conspiracy charges that will be laid out over the next several months against the company CEO, John Kapoor, and four other former Insys sales managers.

Fentanyl is meant to be prescribed solely to cancer patients. The once billionaire, Kapoor, is accused of developing marketing schemes that include dinners, speakers' fees and cash to entice doctors into writing more prescriptions for it. If convicted, he and the other defendants could face up to 25 years in prison.

The verdict, in this case, is likely to reverberate through the thousands that are set to follow.

U.S. District Judge Dan Polster recently ruled that crucial claims made in the combined jurisdictional lawsuits brought against Big Pharma companies should proceed to trial and has set that trial to begin in late October.

Manufacturers and distributors will now have to defend against the charges of racketeering and fraud or settle with the various municipal, county, and state governments that have brought those charges.

“Plaintiffs allege that Defendants have contributed to the addiction of millions of Americans to these prescription opioids and to the foreseeable result that many of those addicted would turn to street drugs,” wrote judge Polster of the Northern District of Ohio. “While these allegations do not fit neatly into the legal theories chosen by Plaintiffs, they fit nevertheless.

"Whether Plaintiffs can prove any of these allegations remains to be seen, but this Court holds that they will have that opportunity.”

Co-lead counsel for the Plaintiffs' Executive Committee in this National Prescription Opiate Litigation had this to say in a statement about the Judge's ruling:

“This ruling is a major step forward for the more than 1,500 communities across the country who have been battling the opioid crisis and demanding accountability from the opioid manufacturers, distributors and pharmacies that are responsible for creating the epidemic. This is among the largest and most complex civil litigation in U.S. history, and it’s moving at an historic rate. In 2019, we expect opioid manufacturers, distributors and pharmacies will finally be held accountable for the public crisis they wrought when they fraudulently marketed and over-distributed addictive and dangerous opioids. As we enter the trial year, we’re glad that Judge Polster has sent a strong message about the future of the litigation, and we’re particularly encouraged that the Judge has allowed a common law principle—the ‘law of public nuisance’— to move forward. For all the communities involved, the goal is the same—it’s past time that the counties, towns, cities and municipalities receive support and resources for the decades-long recovery that lies ahead.”

So there you have it, you can agree or disagree on how this should all play out, but this is where we are at, I'm Gist Say'n.

As these cases move through the court system this year, Gist Say'n will keep tabs and follow up on the developments. To make sure you stay informed, please follow the podcast through the website, your favorite app, and on social media.

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