In-Depth: Sen. Bernie Sanders (I-VT), a candidate for the 2020 Democratic presidential nomination, reintroduced this bill from the 115th Congress to prohibit illegal marketing and distribution of opioids; create criminal liability for top company executives; penalize drug manufacturers who illegally advertise, market, or distribute an opioid product; and require drug makers to reimburse the United States for their products’ negative economic impact:
“We know that pharmaceutical companies lied about the addictive impacts of opioids they manufactured. They knew how dangerous these products were, but refused to tell doctors and patients. While some of these companies have made billions each year in profits, not one of them has been held fully accountable for its role in an epidemic that is killing tens of thousands of Americans every year. At a time when local, state and federal governments are spending many billions of dollars a year dealing with the impact of the opioid epidemic, we must hold the pharmaceutical companies and executives that created the crisis accountable.”
In an interview when he introduced this bill in the 115th Congress, Sen. Sanders argued that it was needed to hold opioid companies accountable for paying for the opioid crisis:
“At a time when local, state and federal government are spending many billions of dollars a year, those people will be held accountable and asked to contribute to help us address the crisis. It shouldn’t just be the taxpayer that has to pay for the damage that they did.”
Original Senate cosponsor Sen. Michael Bennet (D-CO) adds:
“Communities across the country are being ripped apart by the opioid epidemic. Multi-billion-dollar pharmaceutical companies and their executives reaped large profits for years while their questionable marketing and distribution practices precipitated a devastating public health crisis. It is far past time for Congress to ensure opioid manufacturers, distributors, and executives fund our response to the crisis they created. Our bill will support programs that combat the opioid crisis and ensure we hold companies and their executives accountable for any future misconduct.”
Rep. Tulsi Gabbard (D-HI), also a candidate for the 2020 Democratic nomination, has sponsored the House version of this legislation in both the 115th and 116th Congresses. She says:
“Opioid companies have lied, cheated, and profited from the addiction and death left in the wake of the crisis they helped create. The criminal nature of these companies’ actions have destroyed lives and families, and overwhelmed the criminal justice and public health systems. This bill provides tools to hold those like Purdue Pharma accountable for preying on patients using deceptive marketing tactics, as they proliferated these highly-addictive and destructive drugs on our streets.”
Original House cosponsor Rep. Ro Khanna (D-CA) adds:
“When I visit the communities that have been ravaged by the opioid epidemic, I see the victims of unscrupulous pharmaceutical companies that have put profits over the patients they were intended to serve. This bill holds opioid manufacturers and their executives accountable for decades of dishonest sales practices and malicious drug distribution. Over the past 20 years, more than 400,000 people have died of opioid overdoses, and millions more have been stricken by addiction. Their loved ones deserve justice.”
In 2017, Dr. Ronald Hirsch, vice president of the regulations and education group at R1 Physician Advisory Services, called on Congress to convene hearings on the opioid epidemic to compel top pharmaceutical company executives, the Joint Commission, Press-Ganey, the Centers for Medicare and Medicaid Services (CMS), and hospital executives to testify as to their roles in the crisis. He drew a parallel between the opioid crisis and tobacco in the nineties, arguing that a Master Settlement Agreement is needed for the opioid crisis as well:
“Blame must be placed; it is the American way. In 1998, the Tobacco Master Settlement Agreement was signed between the four largest tobacco companies and the attorneys general of 46 states. This agreement set limits on advertising and provided payments to states to cover the cost of tobacco-related illnesses. Could there be any better parallel? The co-conspirators [in the opioid crisis have created the] current crisis and should be required to enter into an Opioid Master Settlement Agreement to pay for treatment and prevention efforts for all those affected by their nefarious activities.”
Pacific Standard health and drug policy writer Francie Diep notes that states have provided a “natural experiment” showing the effect that painkiller sales have on opioid misuse and death. In a 2011 Centers for Disease Control and Prevention (CDC) study, researchers found that opioid sales quadrupled while, at the same time, overdose deaths involving opioids also almost quadrupled, and the proportion of people in addiction treatment centers saying they had an opioid addiction increased 600%. The CDC also found that states with higher-than-average opioid sales also tended to have higher-than-average death rates.
In a study published in JAMA Network Open in January 2019, a team of researchers found a clear link between aggressive opioid marketing and overdose deaths. In their study, they analyzed a non-research-related marketing of opioid products from August 1, 2013 to December 31, 2015 (a total of $39.7 million in opioid marketing targeted to 67,507 physicians). They found that the more aggressively opioids were marketed to doctors in a given county, the more overdose deaths that county experienced a year later.
At the American College of Physicians annual meeting, Dr. Charles Reznikoff argued that the health care system, not pharmaceutical companies, bears the most responsibility for the opioid crisis. In his remarks, Reznikoff noted that other countries are handling the opioid very differently from the United States: France began allowing any doctor to prescribe buprenorphine for opioid use disorder (OUD) in 1995, leading to a 10-fold increase in buprenorphine prescribing and an 80% reduction in the overdose death rate. Today, half of all people with OUD in France are on addiction medications, compared with 15% in the U.S. In Portugal, Reznikoff added, “They basically stopped incarcerating people with opioid addiction” in favor of treating opioid addiction as a public health, rather than criminal, issue. Thanks to this, Portugal moved from having the highest rate of opioid death in Western Europe to now having the lowest rate — today, Reznikoff noted, Portgual’s opioid death rate is 1/50th of the death rate in the U.S.
This legislation has three Democratic Senate cosponsors in the 116th Congress. Its House companion, sponsored by Rep. Tulsi Gabbard (D-HI), has one House cosponsor, Rep. Ro Khanna (D-CA). Neither bill had received a committee vote as of August 26, 2019. This legislation is endorsed by Public Citizen, CREDO, American Medical Student Association (AMSA), National Collaborative for Health Equity and Prescription Justice.
Last Congress, this legislation had three Democratic Senate cosponsors.Its House companion, sponsored by Rep. Gabbard, had five Democratic House cosponsors. Neither bill received a committee vote last Congress.
Of Note: Opioid pain relievers were marketed by pharmaceutical companies as non-addictive in the 1990s. During that time, health care providers began prescribing them at higher rates. It soon became clear that these medications are highly addictive.
By 2017, both prescription and non-prescription opioid abuse were so rampant, the federal government declared a public health emergency and announced a 5-Point Strategy to Combat the Opioid Crisis with five specific strategies for the Dept. of Health and Human Services (HHS) HHS to execute against:
- Improving access to treatment and recovery services;
- Promoting use of overdose-reversing drugs;
- Strengthening our understanding of the epidemic through better public health surveillance;
- Providing support for cutting edge research on pain and addiction; and
- Advancing better practices for pain management
Nearly 70% of the more than 70,000 drug overdose deaths in 2017 involved an opioid. Today’s rate of opioid overdose is six times higher than it was 20 years ago. Over the period 1999-2016, the number of opioid overdose deaths more than tripled, causing U.S. life expectancy as a whole to fall for three consecutive years from 2015-2017. In total, the opioid epidemic is estimated to have cost the U.S. over $1 trillion from 2001-2017 — and it’s estimated to cost another $500 billion by 2020.
Several states, including Ohio and Kentucky (which is among the hardest hit by drug addiction), have filed lawsuits against opioid manufacturers for fueling the opioid crisis. Observing this, Sen. Sanders says, “The real legal struggles have taken place at the state level. It seems to me that it’s appropriate to take that fight ... here to the federal government.”
In a landmark ruling on August 26, 2019, drugmaker Johnson & Johnson was ordered to pay $572 million for its part in fueling Oklahoma’s opioid addiction crisis. Since 2000, about 6,000 people have died from opioid overdoses in Oklahoma. During the seven-week non-jury trial, lawyers for the state argued that Johnson & Johnson carried out a years-long marketing campaign that minimized opioids’ addictive risks and promoted their benefits. The state’s lawyers called the company an opioid “kingpin” and argued that its marketing efforts created a public nuisance as doctors over-prescribed opioids, leading to a surge in overdose deaths in the state.
Johnson & Johnson denied wrongdoing, arguing that its marketing claims had scientific support. It also claimed that its painkillers, Duragesic and Nucyntha, comprised only a small fraction of opioids prescribed in the state.
The judge in the case, Judge Thad Balman, concluded that prosecutors proved that Johnson & Johnson contributed to a “public nuisance” in its deceptive promotion of opioids. In his ruling, he said, “Those actions compromised the health and safety of thousands of Oklahomans. The opioid crisis is an imminent danger and menace to Oklahomans.”
The amount that Johnson & Johnson has been ordered to pay is much lower than the $17.5 million Oklahoma officials requested. In fact, according to estimates detailed in Judge Balman’s decision, the $572 million payment will only fund Oklahoma’s opioid recovery plan for a single year. Reacting to this, University of Kentucky law professor Ricahard Ausness asked, “If Johnson & Johnson is responsible for the opioid epidemic as a long-term problem, why only provide enough money for one year?"
After the Oklahoma ruling, Johnson & Johnson’s share price rose because investors had been expecting a much larger fine. Jared Holz, healthcare strategies for Jefferies, said, “The expectation was this was going to be a $1.5bn to $2bn fine, and $572m is a much lower number than had been feared."
Summary by Lorelei Yang(Photo Credit: iStockphoto.com / fstop123)