On Tuesday, Walmart joined the growing list of companies settling with state, local, and tribal governments over its pharmacies’ involvement in the Opioid epidemic, which has claimed the lives of thousands of Americans since 1999. The second-largest retailer in the world agreed to pay $3.1 billion to resolve thousands of lawsuits accusing Walmart of failing to adequately oversee the dispensing of prescription Opioid medications at its pharmacies.

This tentative settlement follows an announcement made earlier this month that CVS Health and Walgreens Co., the two largest pharmacy chains, will pay a combined $10 billion settlement. While Walmart is not paying the most in its settlement, it will be providing the funds faster than the other pharmacy giants, with most of the funds going out within the first year. Walmart will pay the remainder in payments through 2028. 

Where Will The Opioid Settlement Go?

Walmart’s proposed settlement will be divided across several states, including Indiana and Iowa, and all federally recognized tribes. Indiana, which the Opioid epidemic has considerably impacted, is expected to receive $53 million, according to the Indiana Attorney General’s Office. Iowa is expected to receive $19.9 million, and Native American tribes will receive $78 million. Before Walmart’s plan can take effect, it needs to be approved by 43 states by December 15, and local governments can sign onto the plan until March 31, 2023. 

While the root cause of Opioid-related overdose deaths and addiction is diverse, there are common public health or socioeconomic themes that exacerbate the issue, like financial and housing instability and untreated mental health issues. To address a wide array of issues contributing to the Opioid crisis, the funds from these settlements will go toward wide-reaching harm-reduction programs, treatment programs, and drug policies. However, it is up to the state and local governments and Native American tribes to allocate the funds.

Studies suggest that one of the most effective ways to reduce Opioid-related harms is to provide individuals with access to treatment. Treatment for Opioid abuse can include a variety of treatment facilities, like inpatient or outpatient treatment, and medications for Opioid abuse. Local governments, states, and Native American tribes can allocate the settlement money to create or renovate substance abuse treatment facilities and educational programs. The funds can also help rebuild the communities directly impacted by prescription Opioids by ensuring equitable resource distribution, as the Opioid epidemic has hit many underserved communities. To avoid the previous pitfalls of governments using Tobacco settlement funds for unrelated uses in the 90s, today’s Opioid settlements have been designed to be used to fight the crisis and rebuild communities. 

Why Is The Opioid Crisis So Pervasive In The US?

As we understand it today, the Opioid epidemic has occurred in 3 waves in the US. According to the Centers For Disease Control And Prevention (CDC), the first wave occurred in the 1990s when doctors began overprescribing prescription Opioids because pharmaceutical companies told them that the pills were less addictive than Painkiller alternatives. We now know that Opioids are incredibly addictive, and overdose deaths involving prescription Opioids (i.e., Natural and Semisynthetic Opioids and Methadone) have increased since 1999. 

The second wave of rapid overdose deaths involved Heroin in 2010. The third wave, which is where the US is currently, began in 2013. The CDC has reported a significant increase in overdose deaths involving Synthetic Opioids (particularly those involving illicitly manufactured Fentanyl). In fact, the Synthetic Opioid-related overdose death rate was 18 times higher in 2020 than in 2013. Fentanyl is 50 times more potent than Heroin, but drug dealers still combine the substance with Heroin, counterfeit pills, and Cocaine to increase potency, cut costs, and boost profits. If an individual unknowingly takes a substance cut with Fentanyl, they could potentially overdose, which could be fatal. 

The community harm that came from the over-prescription of Opioids and the exposure to illicit Opioids in the US is what the funds from the Walmart, CVS Health, and Walgreen Co. settlements aim to reduce and heal. The Walmart agreement also included court-ordered requirements to monitor prescriptions closely to reduce “pill-mill doctors” and prevent patients from seeking multiple prescriptions for Opioids. New requirements would also include flagging suspicious prescriptions. 

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Rebuilding Communities And Pursuing Treatment

As the Opioid epidemic continues, time will tell how the settlement funds provided by some of the world’s largest retailers, drugmakers, and distribution companies will be utilized by the state, local, and Native American tribal governments. The Opioid crisis has caused over 500,000 deaths over 20 decades, and the hope is that settlement funds (totaling over $50 billion now) can begin to change the course of this deadly epidemic.     

Prescription Opioid abuse makes up a relatively small portion of the issue nationally, but it still impacts thousands of individuals daily. Individuals can fight the Opioid crisis in their personal lives as well by pursuing treatment for Opioid abuse. Attending treatment can feel daunting, but receiving treatment is the most significant act of kindness you can provide for yourself.  If you or a loved one is experiencing substance abuse, contact a treatment provider today.

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CVS Health Corporation, the healthcare company that owns CVS Pharmacy, has announced it has settled lawsuits over how its role in prescribing powerful and addictive Opioids fueled the Opioid epidemic in the United States. The settlement, which would pay nearly $5 billion to state, local, and Native American Tribal governments over the next 10 years, makes CVS Health the first pharmacy chain to reach a nationwide settlement regarding the Opioid crisis.

The Rhode Island-based company made the announcement Wednesday while also sharing their better-than-expected quarterly earnings, which show the pharmacy giant brought in well over $81.16 billion in yearly profits. CVS Health did not admit liability or wrongdoing and said that non-financial terms remain to be resolved.

“We are pleased to resolve these longstanding claims and putting them behind us is in the best interest of all parties, as well as our customers, colleagues, and shareholders,” Thomas Moriarty, the CVS chief policy officer, and general counsel said in a statement. “We are committed to working with states, municipalities, and tribes, and will continue our own important initiatives to help reduce the illegitimate use of prescription opioids.”

In addition to the settlements, the company says it has also launched educational programs and installed safe disposal boxes for drugs in both their stores and police departments across the country, as well as other harm reduction measures to help mitigate the misuse of Opioids.

Why The CVS Opioid Settlement Is Important

The CVS Health suit brings the nationwide total of finalized settlements to $45 billion. Due to the nature of the settlements, the majority of the money agreed upon must be used to directly address the Opioid crisis.

The Opioid epidemic is one of the nation’s largest public health crises, responsible for over 500,000 overdose deaths since 1999. This nationwide dependence on Opioids did not start on the streets or by way of back-alley drug deals, but rather by major pharmaceutical industries, drug wholesalers, and physicians who pushed Opioids upon the public by way of prescription painkillers.

“We saw this trend back in the 90’s; with an increased amount of Opioid prescribing that occurred amongst medical professionals,” says Dr. Ashish Bhatt, MD addiction medicine specialist and Medical Content Director for Addiction Center. “And this was probably due to a lot of misleading marketing and studies that were embellished or magnified that did not show the true consequence of what could happen with long-term opioid abuse.”

As steps to mitigate the growing dependence on Opioids were taken, making these drugs harder to obtain, many people turned to illicit drugs like Heroin to satiate their addiction. Since 1999, the number of US adults with a substance use disorder to illicit drugs like Heroin has skyrocketed from around 104,000 to nearly 263,000 in 2019.

With so many people turning to illicit drugs, the rate of overdoses has also increased alarmingly in recent years. In 2021 alone, Opioid-related deaths exceeded 80,000, with nearly 89% of those involving Fentanyl; an incredibly dangerous drug that has become widespread in the nation’s drug supply.

While the $5 billion price tag may seem staggering, the CVS Health settlement represents only a fraction of the settlements that have been made in recent years.

Other Notable Opioid Settlements

To date, there have been more than a dozen major Opioid settlements in the United States alone. The largest settlement, which involved four of the nation’s largest Opioid manufacturers and wholesalers; those being Johnson & Johnson, AmerisourceBergen, Cardinal Health, and McKesson, was settled at $26 billion.

In that lawsuit, Johnson & Johnson, the consumer products and health giant that manufactures generic Opioid medications, was ordered to contribute $5 billion to the settlement. The other three massive drug wholesalers were ordered to pay the remaining $21 billion. In total, 46 states and roughly 90% of eligible local governments signed on to the deal, which was said to “directly support state and local efforts to make meaningful progress in addressing the opioid crisis.”

Another major gain in the ongoing battle against those responsible for the Opioid epidemic was the settlement involving Purdue Pharma, the manufacturer of OxyContin, and their owners: the Sackler family. The deal, which was agreed upon in March of 2022, was worth more than $10 billion and called for the members of the Sackler family to pay an additional $6 billion as well as remove themselves from the ownership of the company. While the settlement was widely recognized as a “win,” many were quick to criticize it (including some of those involved in bringing the suit) as they felt the Sackler family got off too easy.

Earlier this year Purdue Pharma agreed to pay $270 million in a settlement with Oklahoma, and in 2007 the company, along with some of its top executives, were ordered to pay $635 million following a lawsuit over “misleading marketing.”

Along with CVS, Walgreens, another of the nation’s largest retail pharmacies, and Walmart have both reached similar settlements this year and will pay $4.79 and $3 billion respectively.

Don’t Battle Opioid Addiction Alone

If you or someone you know is struggling with an addiction to Opioids or other illicit substances, don’t wait any longer to get help. Settlements like the CVS Health suit help highlight the severity of the Opioid crisis and the importance of addiction treatment. If you’re ready to take the first step toward recovery, contact a treatment provider.

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Over the past week, several states have settled lawsuits with Opioid drugmakers, distributors, and pharmacies, tallying up over $390 million in total. The states in question (Alabama, New York, West Virginia, and California), have been deeply impacted by the ramifications of the Opioid epidemic, which has led to over 500,000 overdose deaths nationally in the past 2 decades. Among others across the nation, these settlements are the first steps to providing the financial backbone that many states need to rebuild their communities affected by Opioids. 

The companies involved in these recent settlements, all of which have denied any wrongdoing, include Johnson & Johnson, McKesson Corp, Endo International Plc, and Janssen Pharmaceuticals Inc. (a subsidiary of Johnson & Johnson). The next section of this article will break down who each state settled with and for how much. 

State-By-State Breakdown Of Recent Opioid Lawsuits

Alabama

On Tuesday, Alabama reached $276 million in settlements with Johnson & Johnson, McKesson Corp, and Endo International Plc. According to the state attorney general, this settlement resolves the claim that these companies fueled an Opioid crisis in the state. Alabama had previously accused McKesson of failing to prevent the diversion of Opioids for illicit use and for downplaying the addictive risks of the prescription Painkillers. Johnson & Johnson stated that its past marketing efforts were “appropriate and responsible,” and the company no longer sells prescription Opioids in the US. 

Alabama was one of 4 states that declined to join a nationwide $26 billion settlement of Opioid litigation by McKesson, two other top US distributors, and Johnson & Johnson. If it had agreed to the national settlement, the state would have received $115 million from McKesson over 18 years and $70.3 million from Johnson & Johnson over 9 years. Under this new deal, McKesson will pay $141 million within 9 years, Johnson & Johnson will make full payment within a year, and Endo will pay $25 million. 

New York

On Tuesday, New York State Attorney General Letitia James announced that Central New York would receive over $6.3 million from several settlements negotiated in 2019. The settlements involved 6 Opioid manufacturers and 4 distributors, and the funds will be distributed to Onondaga County and the City of Syracuse, $3.7 million and $263,000, respectively. The money received from this settlement is only a part of the original $1.5 billion settlement finalized by the attorney general, who says more money will be coming.

Central New York City was impacted significantly by the Opioid crisis, specifically during the 2020 lockdown. Onondaga County paused most in-person activities related to Opioid use disorder (OUD) treatment, and a 7th of the economy was forced to shut down, which placed working individuals on the sidelines, said Onondaga County Executive McMahon. 

West Virginia

West Virginia is to receive $99 million in a settlement with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. In this Opioid lawsuit, Janssen was accused of overstating the benefits of their prescription drugs while downplaying, or failing to mention entirely, the potential risks of addiction. The drugmaker has faced multiple Opioid lawsuits throughout dozens of communities in the country, but State Attorney General Patrick Morrisey said during a news briefing that he believes West Virginia’s settlement is the largest in the country per capita. 

West Virginia has long held alarming rates of drug overdose deaths. The Centers for Disease Control and Prevention (CDC) states that the state’s number of fatal overdoses has nearly tripled over the past decade. Additionally, the state has one of the highest rates of non-medical use of prescription Painkillers in 19 to 25-year-olds, with experts testifying in the Janssen case that the rush of prescription Opioids into communities was the driving force behind West Virginia’s drug crisis.

California

On Wednesday, the city of San Francisco reached a $10 million settlement with Endo, who makes the Opioid Painkiller Percocet. According to City Attorney David Chiu, Endo settled with the city days before an upcoming trial, which claims the drugmaker fueled an Opioid epidemic. While Endo hasn’t marketed Percocet since 2016, a 2018 lawsuit filed by San Francisco claims that the company “flooded” the community with prescription Opioids without corrective measures to prevent the drugs from being diverted to illegal use.  

Along with the Endo company, the lawsuit filed by San Francisco also targeted Purdue Pharma LP, Johnson & Johnson, McKesson Corp, Cardinal Health Inc, and AmerisourceBergen Corp. To date, Endo has agreed to pay over $300 million in Opioid settlements to local and state governments, including San Francisco. 

Settlement Money To Be Used For Recovery And Prevention

The funds from these settlements provide financial support for states and cities to rebuild the communities that the Opioid epidemic has deeply impacted. The use of the millions will go well beyond sopping up the damage caused by over-prescription, questionable marketing practices, and illicit use of Opioids; communities hope to stop addiction before it starts. Beyond funding treatment programs for those with an OUD, many communities are planning to use the funds for Opioid prevention and education to reduce the risk of addiction for the youth and individuals throughout the community. 

For example, in Central New York, Onondaga County and the City of Syracuse will use the settlement money to treat individuals with an OUD, to reduce the number of people dying of overdoses, and to give young people additional resources to teach them about the dangers of drugs, specifically Opioids. The settlement money supplied to the states and communities across the US is a necessary step in healing and treating individuals who have suffered at the hands of the Opioid epidemic that has in part been fueled by Opioid drugmakers, distributors, and pharmacies.  

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The US Food and Drug Administration (FDA) can now regulate the sale of synthetic Nicotine, a decision that could potentially wipe thousands of electronic cigarette, or e-cigarette, products off the market. In March, President Joe Biden signed a $1.5 trillion omnibus, or multi-topic, bill that expands the definition of a “tobacco product” to include lab-made synthetic Nicotine and traditional tobacco-derived Nicotine. The Federal Food, Drug, and Cosmetic Act (FDCA) now defines tobacco products as “any product made or derived from tobacco, or containing Nicotine from any source, that is intended for human consumption.”

This redistricting of what constitutes a tobacco product targets the regulatory loophole that some producers of e-cigarettes exploited to keep their products on the market. Over time, the FDA has refused or denied to review the applications of over 5 million vaping products. Instead of taking their products off the shelves, e-cigarette companies switched to synthetic Nicotine, thus avoiding the previous definition of tobacco products. Since their products were no longer under the umbrella of tobacco products, they could continue to sell their products without FDA regulation.

Another driving force that pushed some e-cigarette companies to turn to synthetic Nicotine products involved a requirement by the FDA in 2016 for companies to prove that their tobacco products caused more good than harm. This notion of good versus harm was often measured in the benefit to individuals trying to stop smoking versus the potential dangers of youth vaping. Again, to avoid this regulation, synthetic Nicotine products were manufactured instead of products containing traditionally derived Nicotine from tobacco.

What Are E-Cigarettes And Synthetic Nicotine?

E-cigarettes are battery-operated devices that heat a liquid into an aerosol, or vapor, that is then inhaled by the user. Commonly referred to as vape pens, e-cigs, tank systems, or mods, individuals can also use these devices to administer Cannabinoids like Marijuana and other substances. Inside a vape pen, a cartridge stores the e-liquid or “e-juice.” Besides Nicotine, e-juice can contain artificial flavorings, volatile organic compounds (acrylamide, benzene, and propylene oxide), micro-fine particles that get inhaled into the lungs, and trace amounts of heavy metals like lead, nickel, and tin. The flavorings of e-liquid pods, including bubblegum, strawberry, and many others, have long been criticized for potentially luring adolescents to try vaping and to continue use. Additionally, some flavorings contain diacetyl, a chemical linked to a severe lung disease known as “popcorn lung.” Some companies, including e-cigarette giant Juul, stopped selling fruit-flavored vaping pods altogether after pressure from the FDA to curb youth vaping.

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Synthetic Nicotine, or lab-made Nicotine, is created in a laboratory and is not derived from tobacco like traditional Nicotine. This form of Nicotine is often marketed as “tobacco-free” as it does not contain any tobacco leaf, but under new regulations, synthetic Nicotine can no longer be marketed as such.

How Does This New Law Change E-Cigarette Production?

This change in regulatory law ensures that synthetic Nicotine and tobacco-derived Nicotine products are all regulated under the FDA’s Center for Tobacco Products using the same benchmarks. This law will not ban vaping products and the production of vape pens, but it will have definite consequences for producers and consumers as popular products are potentially withdrawn from sale. For instance, back in 2020, the popular disposable e-cigarette company Puff Bar switched to a synthetic Nicotine formula after the FDA ordered the company to stop selling vapes as it had not followed the agency’s application process. This application process is often lengthy, as multiple big-name brands, including Juul, are still waiting to hear from the agency. The fate of companies like Puff Bar is unclear. To date, the FDA has only approved one vaping product, R.J. Reynolds’ Vuse Solo, and its corresponding tobacco-flavored e-liquid cartridges.

If Puff Bar, and similar companies, want to keep their synthetic Nicotine products on the shelf, they have until May 14 to make a premarket tobacco product application (PMTA) to the FDA. Once the PMTA is submitted, said products may remain on the market until July 13. Any synthetic Nicotine product that has not received FDA authorization by July 13 will be withdrawn from sale.

Criticisms Of The Bill

The response to the FDA’s new classification of tobacco products was split among 2 groups: those opposed to the shrinking number of cigarette alternatives and those in favor of further regulation of synthetic Nicotine products. Amanda Wheeler, president of the American Vapor Manufacturers Association, told Filter, “This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from Nicotine vaping and back into combustible smoking.” For adults trying to quit smoking cigarettes, e-cigarettes are often used to manage Nicotine cravings, but vaping is not without its dangers.

In contrast, some e-cigarette companies, including Juul, support the new regulatory law that will impact some of their largest synthetic Nicotine e-cigarette competitors. A Juul spokesperson previously stated that “illegally marketed and illicit products and products designed to evade federal and state oversight undermine harm reduction and a responsible e-vapor category.” By this sentiment, vaping companies and public health groups are in a tentative agreement.

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Over the past 20 years, nearly 500,000 American lives have been lost to the Opioid Epidemic due to prescription painkillers such as Oxycontin and other illicit substances sold on the street. As recently as Monday, April 11, 2022, the popular pharmacy chain Walgreens is being prosecuted by the state of Florida for the “fraud and addiction that the company should have noticed and acted upon.”

Florida’s prosecutor Jim Webster says the company of roughly 9,000 storefronts, 820 of which located in Florida, was knowingly dispensing medications that were actively killing people. Records show that from May of 2006 to June of 2021 in Florida alone, Walgreens distributed approximately 4.3 billion Opioid pills. Between the years 1999-2020, more than 39,000 Florida residents died from Opioid use. According to Webster, 1 in 4 of these cases was traced to Walgreens’ sale and suspicious circumstances: fake prescriptions, questionable physicians, and unnecessary amounts of pills for any singular patient.

Walgreens’ attorney, Steve Derringer, claims that the real issue lies with the pharmaceutical companies not being entirely forthright and truthful about the addictiveness of Opioids, not that of the individual pharmacy chains like Walgreens.

Walgreens Is The Last To Budge

This is hardly the first lawsuit regarding Opioids and the pharmacies responsible for distributing them in Florida. So far, the state has reached nearly $878 million dollars in settlements: CVS Health Corp agreed to pay the highest so far at $484 million, with Teva Pharmaceuticals Industries Ltd next at $195 million, and Allergan PLC paying upwards of $134 million. This case follows that of the nationwide deal where Purdue Pharma’s owners, the Sackler family, agreed to pay $6 billion in settlements. Considering the estimated total cost of both civil and criminal penalties tied to OxyContin’s parent company since 2007 is roughly $45 billion, the contributions from the family responsible hardly makes a dent in the national deficit. Florida alone has spent nearly $14 billion over the last two decades in various Opioid-related costs, from criminal justice and drug rehabilitation reform to saving infants born with an Opioid addiction.

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Taking place in New Port Richey, Florida, just north of Tampa, the trial is slated to last anywhere from 3-8 weeks. Walgreens, the largest pharmacy chain in the country, is the last stake in this multi-pronged Opioid prosecution campaign. In the opening statement on Monday, Florida’s Attorney General, Ashley Moody said her department wants the store chain to be held responsible “for its role in helping create and fuel the deadly Opioid crisis devastating Florida families and draining taxpayer-funded resources.”

Following the relative success of the settlements with other big pharmacy brands, Webster, in his opening remarks claims:

Walgreens was the last line of defense in improperly distributing Opioids. The evidence will show that millions of times, Walgreens ignored its duty to investigate suspicious prescriptions. Instead, it filled them as quickly as possible.

Who Is Really Responsible?

Due to the number of players and stakeholders and general scope of the Opioid Epidemic, it is tough to determine who and what deserves the largest number of pointed fingers. Many families who have lost loved ones to the addictive power of prescription painkillers blame the Sackler family and their intentional negligence to inform physicians and pharmacies of the inherent danger in medications such as OxyContin. Others point to the drug counters across the country and wonder why no one questioned the increasing amount of Opioid prescriptions running through their systems while still others don’t understand how doctors could be so obtrusively unaware of the devastating side effects.

Regardless of the outcome, the issue proceeds. The scariest part of the Opioid crisis is the fact that an addiction can start from a prescribed medication if the individual is not cautious and aware. If you or someone you love is struggling with an addiction to painkillers, or any other substance, remember you are not alone and there are resources to help you.

As for the judicial trials, only time will tell.

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Johnson & Johnson, alongside 3 major pharmaceutical distributors, have agreed to pay nearly $26 billion to settle thousands of Opioid-related lawsuits on Friday. These lawsuits claimed that their business practices helped fuel and maintain the deadly Opioid epidemic that has claimed over 500,000 American lives since 1999. Of the $26 billion in payouts, Johnson & Johnson agreed to pay $5 billion, and AmerisourceBergen, Cardinal Health, and McKesson will pay $6.1 billion, $6 billion, and $7.4 billion, respectively.

Forty-six states and nearly 90% of eligible local governments signed onto the deal, which the drug wholesalers agreed was enough to move forward with a “comprehensive agreement to settle the vast majority of the Opioid lawsuits,” according to their joint statement. By signing the deal, these localities and states have agreed to drop any present Opioid lawsuits against the companies and not pursue any future action against them. During the settlement, none of the companies acknowledged any wrongdoing for manufacturing and distributing large quantities of prescription medication and continue to deny attributing to the Opioid crisis with their aggressive drug marketing throughout the years.

What The Settlement Will Fund

Of the $26 billion, 85% of the payments will go to addiction prevention, treatment, and health care services. These payments will provide thousands of communities across the US with nearly $20 billion over the next 18 years. Examples of what communities can use this money for include creating public education programs, increasing the number of drug counselors and social workers in municipal courts, and paying for addiction treatment medicine used in correctional facilities.

There will be people alive next year because of the programs and services we will be able to fund because of these settlement proceeds.

Currently, there are no separate funds from the settlement dedicated to compensating the individual victims of the Opioid crisis. The hope is that these payments will help rebuild communities devastated by the Opioid crisis and prevent them from being flooded with high-risk medication in the future through newly-funded monitoring systems. The money is issued to start reaching communities in early April and will continue flowing for the next two decades.

Opioids In America

This settlement comes at a troubling point of the Opioid crisis as many who have developed an Opioid use disorder have switched to using Fentanyl, a synthetic Opioid 50 times stronger than Heroin. According to the Centers for Disease Control and Prevention (CDC), nearly 100,000 lives are lost a year to drug overdoses. The Opioid epidemic is not a new phenomenon by any means, and over the past 2 years, the number of annual overdose deaths have spiked by 50%. The introduction of Fentanyl into the illegal drug market, individuals turning to drugs during the pandemic, and a number of treatment facilities shutting their doors contributed to this spike in overdose deaths.

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Many have accused pharmaceutical companies of creating and maintaining America’s Opioid crisis. Looking to expand the use of prescription Painkillers beyond malignant pain, many pharmaceutical companies marketed Opioids as less addictive or non-addictive in comparison to Morphine and with no dangerous side effects. Doctors, convinced of these claims, began prescribing these drugs and saw no repercussions to patients taking them. This growth in the prescribing of Opioids directly pushed the distribution of Opioids to elevated levels today.

Johnson & Johnson’s History With Opioids

The CDC describes 3 waves of the Opioid epidemic, with the first wave beginning in the 1990s as the rate of prescribing Opioids increased exponentially. In 1994, the Johnson & Johnson company created a strain of poppy to be used to manufacture and distribute large amounts of Opioids. The company made this specific strain in anticipation of future demand for Oxycodone which led to its future partnership with Purdue Pharma as their supplier. Johnson & Johnson additionally supplied 60% of all active ingredients for Opioids manufactured and sold in the US for years to come.

For over a decade, Johnson & Johnson ran marketing campaigns that assured all Opioids as safe for everyday pain. Since the company was the largest supplier of Opioid active ingredients, boosting the Opioid market positively impacted business. In 2001, the company continued to market the drugs as having a low risk of abuse and misuse, even after its medical advisory team and the FDA warned against it.

Johnson & Johnson has since stopped selling Opioids and has agreed not to resume. In contrast, the other 3 distribution companies have agreed to provide data to a clearinghouse, or middleman, to track when prescription drugs enter the black market.

What Lawsuits Brought To The Surface

While the 4 companies claim no wrongdoing in their settlement, surrounding lawsuits brought some troubling practices and actions to the public’s attention. One case revealed that drug wholesalers continued to distribute vast amounts of prescription pills to small, rural communities despite the heavy indication that the drugs, like OxyContin, were dispersed and sold across the black market. The amount of prescription medicine flooding these communities was often disproportionate to the local population.

In a separate lawsuit, an email shared between AmerisourceBergen executives revealed the use of language like “pillbillies” and “hillbilly Heroin” to describe those addicted to Opioids and to refer to OxyContin. These lawsuits, and subsequent lawsuits, highlight the questionable actions of these companies at the height of the crisis.

While the $26 billion settlement serves as a much-needed financial boost for communities to fund addiction prevention and treatment services, the damage done by Opioids throughout the nation will take years to mitigate. Opioid-related lawsuits focused on pharmacy chains that sold egregious amounts of prescription pills directly to consumers continue in other state and federal courts.

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This week, the Centers for Disease Control and Prevention (CDC) presented a set of recommendations for Opioid prescriptions. These new guidelines are the first revisions made to the organization’s 2016 suggestions which stopped many with chronic pain from getting the relief they needed. 

The Opioid Epidemic And The CDC

For over 3 decades, the US has been experiencing a serious public health crisis known as the Opioid epidemic. In the 1990s, pharmaceutical companies, insurers, and pain specialists endorsed Opioid pain relievers as being less addictive and safe to use for common ailments. The marketing of drugs like OxyContin led to an increase in prescriptions being written for issues like backaches and arthritis. 

As a result, US overdose deaths rose drastically. From 1999 to 2017, Opioid-related overdose deaths increased almost sixfold. While local and federal governments attempted to restrict prescriptions, the crisis continued. Those who had already become addicted to Opioids turned to Heroin or Fentanyl when they couldn’t get a prescription. In fact, studies have shown that 80% of people who have used Heroin first used prescription Opioids. 

The CDC released a set of guidelines in 2016 aimed at decreasing the number of Opioids being prescribed. The organization urged physicians to explore other treatment options before turning to Opioids. Other medications and non-drug therapies were recommended as alternatives. If doctors chose to prescribe painkillers for acute pain, the CDC proposed a 3-day limit for prescriptions and that doctors prescribe the lowest possible effective dose. These guidelines also applied to treating chronic pain. Despite being voluntary, doctors and local governments implemented these recommendations. 

An Unintended Consequence

Although these guidelines ultimately contributed to a decrease in Opioid prescriptions being written, they were largely opposed due to their effect on a specific group. Many doctors across the US feared there would be criminal or civil consequences if they did not follow them. Doctors became very hesitant to prescribe Opioids and quickly tapered patients off of their prescriptions. This greatly affected many chronic pain patients who rely on doses higher than the 90 milligram ceiling of Morphine listed in the 2016 guidelines. 

Studies have shown that rapid tapering patients off of Opioids can lead to harmful outcomes. One particular study of 100,00 chronic pain patients found there was 68% increase in overdose deaths for patients experiencing tapering compared to those who were not. For the tapered group, there was also a spike in mental health conditions. Chronic pain patients were also more likely to turn to substances like Heroin and Fentanyl to self-medicate their pain after being tapered off their medications. Suicide can also be an outcome of tapering. It has been reported that up to 30% of Opioid overdoses could be suicides. 

The rigid interpretation of the CDC’s 2016 guidelines also affected those who were struggling with a substance use disorder (SUD). Many doctors developed a one strike policy. This meant that if a patient tested positive for an illicit substance, they were not given further treatment. 

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CDC Proposes New Guidelines

Several organizations spoke out against the original 2016 guidelines. In 2019, the US Food and Drug Administration issued a warning about the dangers that can come from suddenly tapering patients off of Opioids. The American Medical Association recommended that doctors immediately suspend the CDC’s guidelines in 2020. In response, the CDC acknowledged that their suggestions had been misinterpreted and misused. Concerned about the reports of people with chronic pain being denied relief, the CDC began to work on revisions to their 2016 guidelines. This time, their recommendations were drafted with no input from drugmakers. 

The new guidelines, released on Thursday, are aimed at balancing the necessary use of Opioids for severe pain and protecting other patients against harmful risks. The 12 recommendations proposed in the 229 page document changes the “one-size fits all approach” to Opioid prescriptions. Doctors are being urged to look at each patient’s situation and assess the risk and benefits prescribing Opioids. Overall, the CDC still believes that non-Opioid therapies should be attempted before prescribing Opioids for pain. At the same time, they removed the 90 milligram ceiling of morphine for chronic pain patients and the 3 day limit for acute pain. 

While the document warns of addiction, depressed breathing, and effects to mental status, they have noted that they serve a very important medical purpose. Relieving pain from traumatic injuries, such as burns and crushed bones, were listed. In these cases, it is recommended that immediate release pills be used rather than long-acting. The CDC also stated that these guidelines do not apply to those with cancer, sickle cell, and end of life or palliative care. 

The CDC also noted that patients who come in and test positive for illicit substances could have untreated pain or a substance use disorder. The new guidelines recommend that doctors offer treatment, counseling, and careful tapering when necessary. In doing so, they can assist patients in improving their quality of life. 

These recommendations are currently available on the Federal register. For 60 days, the public can make comments on the proposed guidelines. The CDC will then review these comments and will likely release a final issue by the end of the year. 

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New York City officials have proposed a new initiative that will feature the installation of “public health vending machines.” These vending machines will dispense free toiletries, safe sex kits, and harm reduction supplies, such as overdose reversal medications and sterile syringes.

What Is Harm Reduction?

Harm reduction programs are aimed at reducing overdose deaths and other adverse outcomes that can come from drug use. While most policies are focused on abstinence, harm reduction works to give agency to those who are struggling with a substance use disorder (SUD). This is done through a spectrum of approaches such as managed and safer use.

Because each program differs based on the community’s needs, there is no set definition for harm reduction. States in the US who take this approach typically provide medications to reverse overdose, resources on treatment, and needle exchange. The National Harm Reduction Coalition lists 8 principles that are essential for harm reduction programs. These principles include:

1. Accepts that licit and illicit drug use is part of our world and chooses to not ignore or condemn harmful effects. 
2. Recognizes that substance use is a complex situation and that some methods are safer than others. 
3. Uses the quality of individual and community life as the program’s criteria. 
4. Services and resources are provided without judgement or coercion. 
5. Program is created by routinely giving a voice to those who use substances or have a history of substance uses. 
6. Those who use substances are the primary agents in reducing harm. 
7. Acknowledges that social inequalities, like poverty, class, racism, past trauma, and discrimination can affect an individual’s vulnerability for substance use. 
8. Does not minimize or ignore the harms and dangers that are associated with substance use. 

New York City’s Vending Machine Plan

It has been reported that every 4 hours, a person in New York City dies of a drug overdose. Like the rest of the US, New York City has seen an increase in overdose related deaths over the past few years. In 2020, 2,062 overdose deaths were recorded for the city which is 500 more than the prior year.

This $730,000 pilot program is geared towards curbing overdoses by making harm reduction supplies easily accessible. In order to reach the areas that have been especially affected by overdose deaths, 10 public health vending machines will be placed in all 5 boroughs of the city. Central Harlem, Union Square, Far Rockaway, Stapleton, and East New York have been identified as top priority neighborhoods. 

While residents of New York state currently have access to clean syringes at pharmacies throughout the state, these vending machines may be a more appealing option. By eliminating face-to-face interactions and being available 24/7, harm reduction vending machines can get supplies to the people who need them most, where they need them, and on their schedule.

Needle Exchange Programs And Naloxone

Exchanging needles and providing Naloxone will be the main focus of New York’s harm reduction vending machines. 

The Centers for Disease Control and Prevention (CDC) defines syringe services programs (SSP) as community based programs that provide access to sterile needles and syringes, facilitate safe disposal of used syringes, and link people to treatment programs. Studies have shown that those who participate in SSPs are 5 times more likely to enter treatment than those who do not. It has also been proven that these programs can be successful in preventing the spread of HIV, Hepatitis C, and other skin and other high risk infections.

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Naloxone is a medication that can reverse Opioid overdose by attaching to Opioid receptors to block the substance’s effects. This can be achieved through a nasal spray form of Naloxone or by injecting it into muscle. Being able to recognize an Opioid overdose is important when it comes to using Naloxone. Signs of of Opioid overdose include:

• Unconsciousness 
• Small pupils 
• Shallow breathing 
• Vomiting 
• Inability to speak 
• Faint heartbeat 
• Pale skin 
• Purple fingernails or lips 

Once Naloxone has been administered, it will only reverse effects for 30 to 90 minutes. For this reason, it is essential that emergency services be contacted immediately along with the use of Naloxone. 

Las Vegas’s Harm Reduction Vending Machines

Nevada was the first state to install vending machines similar to the ones included in New York’s plan. The state, which began using these vending machines in 2017, saw significant success within the first year, especially in the Las Vegas area. From 2017 to 2018, approximately 23,540 clean syringes were distributed. 1/4th of the transactions were for HIV and Hepatitis C tests and 5% of clients asked for referrals for treatment programs. Additionally, nearly half of those who used the vending machines requested Naloxone.

The 3 vending machines placed in southern Nevada have been deemed a success. Their harm reduction services have been able to keep people safe by providing supplies to otherwise hard to reach groups of people. These populations can receive the supplies they need in a discreet manner which has helped to lower the stigma that is associated with getting help for a SUD. 

Biden’s Push Towards Harm Reduction

The Biden Administration is the first to openly support harm reduction policies. While not everyone is in support of this approach, the need for reducing the harms caused by drug use is more important than ever. In 2021, the US reported its highest number of overdose deaths in a 12 month period at over 100,000. 

On December 8th, 2021, the Biden Administration announced that they will be making efforts to work towards implementing more harm reduction programs. To do so, they will be supplying over $30 million in grants. These grants will be used for harm reduction services such as syringe exchanges and Naloxone. 

Critics of harm reduction believe that these programs do not address the most critical issues of addiction. Additionally, it is often thought that needle exchange programs will create more litter in the area. Studies have found that this claim is not true. 

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On October 5 2021, a young woman named Brittany Poolaw, a member of Wichita and Affiliated Tribes in Oklahoma, was charged with first degree manslaughter and a sentence of 4 years in prison. She had suffered a second-trimester miscarriage. In a fetal autopsy, examiners found a congenital abnormality and a complication with the placenta in addition to traces of Methamphetamine. Whether or not the Meth ultimately caused Poolaw’s miscarriage is decidedly undeterminable and yet, after a year and a half in an overcrowded jail, amidst the ongoing pandemic, she faces more time behind bars for a heartbreaking loss. And she’s not the only one. As Oklahoma Methamphetamine rates rise somewhat steadily, so too do the number of infants born (or lost) to drug exposure. Between 2015 and 2021, the numbers nearly quadrupled and with them, more and more pregnant women are facing incarceration for drug abuse, even in cases where a woman had a medical Marijuana card and/or her baby was born perfectly healthy.

Healthcare Professionals Weigh In

Poolaw’s case has sparked national outcry. Numerous leaders in women’s health such as the March of Dimes organization, the American College of Obstetricians and Gynecologists (ACOG), and the National Advocates for Pregnant Women (NAPW) as well as 37 Oklahoma-based doctors have released numerous letters and statements of outrage all saying the same thing: incarceration for drug abuse in pregnant women, especially in the unfortunate loss of a pregnancy, is not the answer to the variety of underlying issues at stake. Dr. Kate Arnold, an Oklahoma City OBGYN and vice-chair of the Oklahoma chapter of ACOG believes the state is charging these women “supposedly with the hopes that if we can prosecute it [then] it will deter drug use during pregnancy. The problem that we as physicians see is this has actually already been tried in many other states and it does not improve outcomes. In fact, it leads to worse outcomes.”

In a guest column article Arnold wrote for the online publication, The Oklahoman, she expresses the erroneous nature of incarceration for drug abuse with regard to pregnant women’s health, writing:

These misguided policies disproportionately target low-income women and women of Color, and women who represent communities with limited access to medical care, among other factors contributing to worse health outcomes of them and their children. Studies of drug use in pregnancy suggests that other issues—such as poverty, poor diet, and tobacco use—are at least as harmful as drug use itself.

Considering Assistant District Attorney Christine Gailbraith said Poolaw’s case was, “a situation where the defendant put her wants ahead of the baby. She chose Meth over his life,” Dr. Arnold’s claim provides important context; this increasingly common issue is deeper than “wants.”

Outcomes Of Incarcerating Pregnant Women For Drug Abuse

Both state officials and health professionals ultimately wish the same for pregnant women who suffer from varying substance abuse problems: a healthy mom and a healthy baby. The problem, and what doctors are tirelessly working to inform policymakers of, is that by convicting someone who is likely already under immense duress and trauma (especially in the case of a miscarriage) is both detrimental and ineffective. One local news source investigated Poolaw’s case in conjunction with 45 other pregnant women across the state charged with felony child abuse, neglect, or manslaughter in relation with substance use since 2017. While the findings varied dependent upon county, across the board, only 18 received any kind of rehab/treatment for drug abuse as part of their sentence. The statistic appears counterintuitive to some prosecutor’s claim that criminal justice involvement protects children while simultaneously encourages women to seek treatment. For pregnant women, incarceration for drug abuse is not working.

“I wish we could get more education out to assistant district attorneys and judges to better understand substance use and not criminalize individuals that are pregnant for their substance use,” director for the Oklahoma State Department of Mental Health and Substance Abuse Services, Teresa Stephenson said. Because of these decisions being made across the state, when a woman who suffers from addiction or abuse gets pregnant, she now must weigh her options as to whether or not to seek medical help and consultation, afraid she might be prosecuted for her addiction. Thus, a vicious cycle ensues in which this woman either gets help and risks incarceration or her baby being taken, or she says nothing, doesn’t receive treatment, and still risks losing her baby and/or her freedom, as well as the ability to find and pursue the help and treatment she needs.

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Reducing The Stigma

Another issue, is that even if women like Poolaw, who suffer from substance use or addiction while pregnant, had the ability or opportunity to receive prenatal care, they might have a hard time finding doctors willing to treat them. Medical director of Substance Use Treatment And Recovery Prenatal Clinic (STARS), Dr. Stephanie Pierce believes there is a much greater need for services that cater to women struggling with drug abuse, but there are not enough providers. “There [are] so many people that have these issues and there’s just traditionally not a lot of OB providers that are really interested or excited about taking care of these patients and I think a lot of that is due to stigma,” she said. Despite the relative lack in OBGYNs, The STARS clinic is doing quite well; between October of 2019 and July of 2021, 91% of infants were discharged to their parents’ care.

“Most of these women really want their babies and want to be able to take care of their babies. I think early intervention is probably the most key thing,” said Paula Griffith, director of Women and Children’s Services at Conmache County Memorial Hospital where Poolaw received care during her miscarriage. In October of last year, Poolaw obtained a new attorney, John Coyle III, after her story made headlines and national news, who said that hers is “a sad case and an assault on women’s rights.” A local news source reached out to prosecuting district attorney for Poolaw’s case, Kyle Cabelka, for comment; he declined.

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