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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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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The University of Washington (UW) has high hopes: to develop a vaccine that could be used to counteract the effects of addictive and illegal drugs, prevent overdoses, and save lives.

The work will occur at UW’s Center for Medication Development for Substance Use Disorders, which opened on January 3.

It will be spearheaded by Marco Pravetoni, a professor of pharmacology. Though The Seattle Times reported on January 5 that, at that time, Pravetoni was the only faculty member at UW’s new center, he will likely soon be joined by more allies and experts focused on the same goal. Pravetoni is optimistic about the progress to be made.

Said Pravetoni, “Every year, we’re going to start a new clinical trial.” The professor is eager to buckle down and get to the hard work of developing an inoculation against addiction that will save lives; the bill associated with such a venture will be large, however.

Pravetoni estimates it could cost as much as $300 million.

The center is off to a good start, however, and Pravetoni may have secured up to $50 million in funding so far. According to The Times, Pravetoni’s goal “is to get enough funding to get through at least Phase 1 and 2 — prove his vaccines are safe and likely work — and then get a pharmaceutical company to fund the rest.”

Addiction Vaccines Have A Long History

The thought of a vaccine for addiction could seem somewhat counterintuitive. Many vaccines function, ultimately, by increasing the amount of antibodies that might be used to fight off a particular virus. But how would a vaccine against addiction work?

As it turns out, much the same way.

According to The New York Times, which reported on the subject of so-called addiction vaccines in 2011, “Like shots against disease, these vaccines would work by spurring the immune system to produce antibodies that would shut down the narcotic before it could take root in the body, or in the brain.”

Unlike the COVID-19 vaccine, best practice for an addiction vaccine would not be to receive the immunization in advance of coming into contact with the thing being immunized against (in this case, illegal drugs). Rather, subjects would be given the vaccine after they’ve already used the drug and developed a dependency.

Animal trials have shown that the idea has legs: rats who were given an inoculation against Heroin no longer experienced the effects of the drug and stopped taking it after they were given a vaccine.

There has been great difficulty in making the jump from non-human animals to humans, however. In one trial of a Nicotine inoculation, the shot didn’t work to help people quit smoking any better than a placebo did.

Researchers have been trying to crack the code for a long time: the first study in a peer-reviewed journal on the subject was published in Nature in 1974. The test subject was a rhesus monkey; according to the study, “Results indicate that antibodies against morphine can block those effects of heroin on the central nervous system (CNS) that maintain self-administration behaviour.”

In other words, an anti-Heroin shot can make a subject stop shooting up. Now it’s up to scientists like Pravetoni, who stand on the shoulders of pioneers like Dr. Kim Janda (whose work involved both the rat experiment detailed above and the Nicotine vaccine trial, and who made advances in the addiction vaccine space for decades) to make those subjects human.

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An “Urgent Need For New Treatment Options”

Operation Warp Speed was the endeavor that brought the COVID vaccine, and it was a race against the clock unlike any other seen in the modern age. Now there is a different race against time occurring, perhaps just as important if not more so — the sprint to take an addiction vaccine to market before drugs like Fentanyl claim untold more lives.

According to a piece published in the Drugs academic journal, “Drug addiction is a chronically relapsing brain disorder. There is an urgent need for new treatment options for this disease.”

That was from 2003.

Since then, overdose deaths have skyrocketed.

Per the Centers for Disease Control and Prevention (CDC), drug overdose deaths annually went from roughly 27,000 in 2003 to over 40,000 in 2011; by 2019, they had climbed to exceed 70,000.

Annual numbers from 2021 were over 100,000.

The White House has backed an approach to the problem based around harm reduction as opposed to punishment; per the Office Of National Drug Control Policy, primary drugs of concern include “illicitly manufactured fentanyl and synthetic opioids other than methadone (SOOTM),” though other targets include “cocaine and other psychostimulants, like methamphetamine.”

Some of the best minds in the world are working tirelessly on solutions to problems that plague the nation. While their work won’t be easy, some solace can be taken in the words of professor Pravetoni; researchers like him, he says, “are trained to overcome adversity.”

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Lyrica, a drug manufactured by Pfizer, was initially developed to treat epilepsy. Since that time, it’s been prescribed off-label to treat pain and anxiety — often with disastrous results.

High-profile cases of the drug’s devastating effects have emerged in Australia, where use of the drug has skyrocketed of late; the number of Lyrica prescriptions filled in the country went from 36,000 in 2012 to 4,000,000 in 2018, an increase of over 10,000%.

A correspondingly high human toll is being paid as the drug predominates; Christalla Andreadis, a 52-year-old prescribed Lyrica after a car accident, declared the drug “gets its claws into your soul” while describing the devastating and addictive nature of Lyrica (the generic name for which is Pregabalin).

In addition to suicidal thoughts, use of Lyrica has been associated with respiratory depression; slowed breathing can be dangerous on its own, and the chance of fatality only increases when the user is elderly, has a pre-existing lung condition, or uses Opioids in combination with Lyrica.

Other side effects have been reported; one mother described her daughter’s descent into Lyrica addiction, characterizing her as a once effervescent young woman who began to lose both her spark and control of her behavior — often falling asleep while standing up and acting in other erratic ways — before tragically dying of an overdose in 2020.

And Lyrica isn’t just creating problems in Australia. Gabapentinoids (a class of drugs of which Lyrica is a member) are incredibly common in the US; Lyrica itself cost Medicare $2.1 billion in 2016, as more than 850,000 Medicare beneficiaries were prescribed the drug in that year alone.

When asked by reporters about the dangers of Lyrica, manufacturer Pfizer punted; the pharmaceutical giant denied ownership of the drug — despite their branding being plainly visible on Lyrica’s packaging — and passed the buck to Viatris, a company Pfizer created in 2020.

There’s now a growing curiosity about what exactly Pfizer knew about the destructive and addictive potential of Lyrica while they were spending millions to market the drug to doctors and to an unsuspecting public; perhaps unsurprisingly, it’s not the first time Pfizer has found themselves in hot water because of Lyrica.

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Pfizer’s Lied About Lyrica Before

The US Department of Justice fined Pfizer $2.3 billion for breaking the law in how it promoted 4 of its drugs, including Lyrica, in 2009. At the time, the settlement was the largest health care fraud payout in history. To date, it’s the second largest.

Pfizer faced allegations of paying kickbacks to doctors for prescribing their drugs, making false claims about Pfizer drugs, and promoting off-label use of drugs like Lyrica; it’s illegal for drug companies like Pfizer to promote use of their drugs for reasons not approved by the FDA.

A similarly aggressive and unscrupulous marketing strategy was used in Australia; Pfizer pumped millions into “educational” events for doctors (where drug companies often get to bend the laws around courting medical professionals to their breaking point, shamelessly “wining and dining” care providers in an attempt to get their proprietary medications into as many prescription pads as possible).

Some elected officials have tried to force Pfizer to answer for their behavior when it comes to Lyrica; Senator Ron Wyden, the current chair and then-ranking member of the Senate Finance Committee, wrote then-Pfizer CEO Ian Read in 2018 to ask Read why Pfizer had hiked the price of Lyrica multiple times, sometimes by as much as 145%, to the detriment of taxpayers who are prescribed the medication.

Read, for his part, had previously insisted that companies like Pfizer don’t make too much money. Pfizer had well over $41 billion in revenue last year and is expecting $26 billion just from COVID-19 vaccine sales alone in 2021.

They Don’t Take It Like Medicine

If the above reports aren’t bad enough, Buzzfeed News reported in 2017 that Lyrica was “the drug of choice to treat rampant depression, anxiety, and PTSD” in a Greek refugee camp. That Lyrica was (and possibly still is) distributed so widely to refugees may help explain the enormously high rate of suicidal ideation among the demographic; The Washington Post reported the results of a survey that found 41% of a certain subset of refugees have contemplated suicide, and suicidal thoughts are a possible side effect of Lyrica. Other factors most certainly contribute to this troubling statistic — it’s a near certainty that Lyrica use isn’t helping, however.

One observer of Lyrica use within the refugee camp told a reporter that “Life here is hard. Some people take the pill,” going on to say that refugees “do not take [Lyrica] as medicine … they take it like drugs.”

Many people across the world, both Americans and Australians, are doing the same. Only time will tell if public outcry over the actions of companies like Pfizer and the harmful overprescription of drugs like Lyrica will be enough to motivate the elected officials who have failed to rein in drug companies, or the drug companies themselves, who often flood Congress and candidates with donations, to change their ways.

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Lindsay Ridgell, an Arizona mother who gave birth in 2019, has been charged with child neglect and placed on Arizona’s child abuse central registry after using Marijuana while pregnant. This case is likely to set a significant precedent regarding legal consequences for the use of Marijuana during pregnancy.

Ridgell’s newborn, Silas, tested positive for Marijuana. The drug screen was ordered after the infant exhibited troubling symptoms. A medical professional observed that Silas was jittery, and the infant was also having trouble breathing in addition to suffering from both strep throat and bleeding in the brain.

Arizona’s Department of Child Safety (DCS), where Ridgell worked at the time of her baby’s birth, was alerted to the positive drug screen by hospital staff. Ridgell has since lost her job.

Since she had been taking Marijuana medically, which has been legal in the state of Arizona for over a decade, Ridgell chose to appeal the DCS’s decision. After raising enough money to afford filing fees on GoFundMe, that’s exactly what Ridgell did; an administrative law judge then agreed with Ridgell, deeming the DCS’s evidence “double hearsay” and ordering Ridgell’s removal from the child abuse registry.

However, despite the fact that Ridgell’s use of Marijuana during pregnancy was, as the judge said, “under her doctor’s care and according to their instructions,” the DCS refused to reverse its earlier decision and kept Ridgell on the registry.

Now Ridgell, who suffered from a rare condition called hyperemesis gravidarum (HG) that caused nausea and vomiting during her pregnancy, is appealing once again. She and her attorney, Julie Gunnigle, attended oral arguments at the Arizona Court of Appeals on September 15.

Gunnigle has said of her client, “[she] was the only one who presented any science,” and that “[Cannabis] is a choice to treat HG during pregnancy, and the risks to the fetus are not extreme … it’s a decision that she was completely entitled to make.”

If the Arizona Court of Appeals rules against Ridgell, she will remain on Arizona’s child abuse registry for the next 25 years.

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How Does Marijuana Affect The Fetus?

Baby Silas presented with respiratory difficulty, brain bleeding, strep throat, and jitteriness after his birth. But was Marijuana use during pregnancy responsible for these symptoms, and what exactly is the impact of maternal use of Marijuana on a developing fetus?

One analysis of data on the subject, published in the Obstetrics & Gynecology medical journal, found that “[Marijuana] use during pregnancy is not an independent risk factor for adverse neonatal outcomes,” clarifying that adverse outcomes such as Silas’s that do correlate with maternal Marijuana use are likely due to either co-occurring use of tobacco or unspecified “confounding factors.”

Another study, published in the West Indian Medical Journal, sought to uncover whether there were more long-term effects on children whose mothers used Marijuana while pregnant. This study, which analyzed almost 5 dozen children from birth up until the age of 5, found that there were “no significant differences in developmental testing outcomes between children of Marijuana-using and non-using mothers.”

In Silas’s case specifically, it’s not necessarily clear how maternal Marijuana use during pregnancy could have caused strep throat. Strep throat is caused by the Streptococcus Pyogenes bacterium, not Marijuana, and the condition is not uncommon in newborns. According to the Mayo Clinic, “Strep throat can occur at any age, even during infancy.”

Meanwhile, brain bleeding — while it sounds serious and certainly can be — is an incredibly common condition in newborns. One study, conducted by the University of North Carolina at Chapel Hill, found that over a quarter of babies born vaginally are affected by the condition. Respiratory distress is also prevalent among newborns; a study published in the Vaccine journal called it “one of the most common problems [infants] encounter,” and the American Academy of Pediatrics reports that roughly 1 in 10 newborns require help breathing at birth.

Finally, jitteriness during crying is normal in children per the Seattle Children’s Hospital; it typically stops on its own after the baby is a few months old. None of Silas’s symptoms, therefore, may have had anything to do with his mother’s Marijuana use.

None of this is to say that Marijuana use during pregnancy is risk-free; according to the Centers for Disease Control and Prevention (CDC), use of Marijuana while pregnant may lead to a baby with a low birth weight. Additionally, breathing in any kind of smoke can be harmful to a mother and a developing fetus. Mothers should also be cautious about using Marijuana during breastfeeding, as more research needs to be done on its effects.

Could Drug Testing Be Discriminatory?

That apparent health issues with newborns may be attributable to many causes other than Marijuana use isn’t the only concern of those who criticize the drug testing of new and soon-to-be mothers. Dr. Jamila Perritt, OB/GYN and president and CEO of Physicians for Reproductive Health, is worried that Americans of color and low-income Americans are likely to be disproportionately punished by drug testing during pregnancy and shortly thereafter.

The case of one Shakira Kennedy, a Black woman who used Marijuana to treat nausea during her pregnancy, may be an example of this. Kennedy testified to the New York State Assembly that “When my twins were born, the hospital drug-tested me without telling me.” Kennedy went on to say that “They found [Marijuana] in my system but not in my children,” but that the hospital notified New York City’s Administration for Children’s Services anyway; apparently just the fact that Kennedy had used Marijuana was enough.

The Supreme Court ruled in 2001 that hospitals cannot drug test pregnant women without their consent or a valid warrant. Testing mothers for drugs shortly after they give birth is another story, however; Ridgell’s case could set a precedent that affects mothers everywhere.

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“The government and the industry are obscuring the true rate of [Antipsychotic] drug use on vulnerable residents,” declared The New York Times in a recent report that found nursing home doctors too often falsely diagnose senior citizen patients with schizophrenia. In doing so, doctors justify prescribing powerful and even debilitating Antipsychotic drugs as a way of sedating patients and making them easier to manage.

The Times used the anecdotal example of one David Blakeney, a 63-year-old man who was diagnosed with schizophrenia and prescribed Haldol — a potent Antipsychotic drug that can have serious side effects — despite the fact that there was no evidence Blakeney suffered from the condition.

What’s more, as the Times reports, “risks to patients treated with [Antipsychotics] are so high that nursing homes must report to the government how many of their residents are on these potent medications.” However, the prescription of Antipsychotics to patients with certain conditions, namely schizophrenia, Tourette’s syndrome, and Huntington’s disease does not have to be reported to the public. Therefore, doctors in nursing homes can use a phony diagnosis of any of the above conditions to prescribe Antipsychotics as a way to reduce overhead costs and keep staffing demands relatively low.

The Times was able to uncover information on how many patients are prescribed Antipsychotic drugs. No less than 21% of nursing home residents are prescribed the drugs despite the fact that the conditions they treat are not all that common; schizophrenia, for example, occurs in barely 1% of the population.

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Why Elderly Fall Risk Has Skyrocketed

Antipsychotic drugs like Haldol aren’t the only kind being heavily prescribed to senior citizens. The Washington Post has reported that, “experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons.”

This phenomenon is having a marked effect on health risks to senior citizens, and it’s not good. Roughly 94% of elderly Americans were prescribed drugs that could raise the risk of a fall in 2017; this is a significant increase from the 57% of elderly Americans that were prescribed such drugs in 1999.

Some demographics are disproportionately prescribed drugs that could induce falls. The Post has shared that, “women were more likely than men to be prescribed drugs that raised the risk of falls, especially African American women … followed by White females, African American men and then White men.”

Seniors Can’t Afford The Drugs They Do Need

While there’s no question that senior citizens have been the victims of overprescription, there are many medications that are medically necessary for this vulnerable population. However, far too many of the elderly are having trouble affording the medications that they do need.

The results of one study on the subject were summarized by Reuters; the outlet reported that, “14% of the urban patients and 26% of the rural patients [studied] said they didn’t always comply with doctors’ instructions for taking medicine because of the cost.” This held true despite the fact that almost all of the senior citizens studied had a form of health insurance.

There is an effort to lower prescription drug prices brewing in Congress; members of both parties have called for reform, and some legislators are pushing to allow Medicare to negotiate lower drug prices with pharmaceutical companies. Many powerful drug executives have opposed the plan, however, with some claiming that their industry would be devastated as a result.

“It’s going to wipe [some pharmaceutical companies] off the face of the earth,” said David Ricks to reporters; Ricks is the CEO of Eli Lilly and Company, a pharmaceutical company that had a global revenue of almost $25 billion last year.

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On Thursday, August 12, US President Joe Biden called on Congress to address the mounting costs of what he deemed “outrageously expensive” prescription drugs in America.

Some of the possible solutions to the crisis offered by Biden in his remarks include enabling Medicare to negotiate drug prices, penalizing drug companies for hiking their prices, and setting an annual cap on out-of-pocket drug expenses for Medicare beneficiaries.

Far from a partisan objective, the vast majority of Americans have said in polls that they’d like the federal government empowered to negotiate lower prescription drug prices. Both the Democratic and the Republican presidential candidates made promises of lower drug prices key focuses of their 2020 campaigns, and prominent members of both political parties have rolled out plans this summer designed to address sky-high prescription drug pricing.

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Price Of Prescription Drugs On The Rise

Almost 25% of Americans have said they struggle to pay for prescription drugs. It’s not uncommon for prescription drugs to see price hikes at double the rate of inflation and, as the President said in his remarks, Americans pay double to triple what residents of other countries pay for their prescription drugs.

This has had a devastating impact, particularly for Americans aged 65 and older. Almost 90% of this demographic take prescription medication, the cost of which can easily outpace earnings. According to the AARP, a June report from its Public Policy Institute found that “the total retail prescription drug costs for the typical older American who takes 4 to 5 prescription drugs per month would be $31,000 per year — [$1,350] more than the $29,650 average annual income for Medicare beneficiaries.”

As senior citizen Marilyn Rose told Kaiser Health News, “It’s just strange you have to make a decision about your treatment based on your finances rather than what’s the right drug for you. I always thought that when I get to Medicare age I’ll be able to breathe a sigh of relief. This is a little nuts.”

Rose is not alone in her assessment; over three-quarters of her cohorts have agreed that prescription drug prices are unreasonable. Far from merely being frustrated by the expenses, many seniors are being forced to restrict their own care in order to avoid breaking the bank. One study found that “Medication restriction is common in seniors who lack prescription coverage, particularly among certain vulnerable groups.”

An Entire Industry Under Fire

Scrutiny against pharmaceutical companies for their pricing practices has ramped up in recent years, with infamous then-CEO of Turing Pharmaceuticals Martin Shkreli taking a scolding from the House Oversight Committee in 2016 after he increased the price of a lifesaving medication by 5,000%.

Pharmaceutical companies and their leaders have been criticized not only for their expensive medication, but also for their role in the ongoing Opioid epidemic. Drug companies have knowingly marketed addictive substances to the public for over a century, with Bayer bringing Heroin to the American market in 1900 — even claiming the drug was safe for children.

Manufacturers of prescription drugs then strongly advocated for Opioids beginning in the late 20^th century, embarking on a campaign to convince doctors, lawmakers, and everyday Americans that Opioids were safe and effective. This has not been born out by the facts. According to the National Institute On Drug Abuse, “Roughly 21 to 29% of patients prescribed [O]pioids for chronic pain misuse them.” Additionally, the vast majority of Heroin users began by using Opioids prescribed by a doctor.

At least one major Opioid manufacturer has plead guilty to charges of fraud and violations of the anti-kickback statute, admitting they knew Opioids were ending up in the hands of abusers and even confessing to lying to the DEA.

Meanwhile, last year set a record for drug overdoses in America, which increased by almost 30% from the year before. Some states have already reported trends that indicate another record-setting year in 2021.

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Since the late 1990s, the Opioid epidemic has been going on in the United States, claiming the lives of 130 people every day. Since 1999, over 760,000 people have died from a drug overdose, and two thirds of those deaths involved Opioids, according to the U.S. Department of Health and Human Services. In the center of the Opioid epidemic are pharmaceutical companies like Purdue Pharma that pushed the sales of Opioid drugs, even after knowing the risks of addiction and death, as well as companies like McKinsey & Company.

The pharmaceutical companies were not alone in their endeavors to promote Opioid drugs. Consulting firms were hired to work on marketing tactics to encourage these sales, such as McKinsey & Company, an American management consulting firm that has gone global since its founding in 1926. As companies are starting to be held responsible for the involvement in perpetrating the Opioid crisis, it has started to raise even more questions.

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McKinsey & Company Settlement To Go To Treatment And Rehab

In December of 2020, the corporate consulting firm McKinsey & Company issued an apology after documents were made public that displayed the firm’s involvement in fueling the Opioid epidemic. McKinsey worked with pharmaceutical company Purdue Pharma, a company that has plead guilty to federal charges linked to the promotion of Opioids, mainly OxyContin. The fact that Opioids are addictive drugs that can lead to dependence and overdose is now common knowledge, with thousands of Americans dying from an Opioid overdose each year. Due to this public knowledge, McKinsey developed a series of proposals designed to “turbocharge” profits of Opioids once again, according to the documents that were released, “by attorneys representing states suing Purdue Pharma,” according to NPR.

NPR stated that one of the proposals involved making $14,000 payments to insurance companies whenever someone became addicted or overdosed on Opioids that were linked to Purdue Pharma. McKinsey & Company released an apology stating, “We recognize that we did not adequately acknowledge the epidemic unfolding in our communities or the terrible impact of Opioid misuse,” after they came under fire for their involvement.

In February 2021, McKinsey & Company reached a $573 million settlement for its role in boosting sales of dangerous Opioids like OxyContin. The settlement will be paid out to 49 states across the United States, primarily for treatment and rehabilitation programs. As part of the settlement McKinsey does not have to admit to any wrongdoing, but they are also required to release thousands of documents that detail their involvement with Purdue Pharma. While this settlement may be seen as a win for many, some sources are raising concern that this settlement may be benefitting a McKinsey hedge fund affiliate that has ties to addiction treatment centers.

Suspected Link To Addiction Treatment Centers

According to an NBC News investigation, MIO Partners is McKinsey’s wholly owned hedge fund affiliate and 8 of its 14 board directors are current or former McKinsey executives. MIO Partners holds indirect stakes in addiction treatment centers, as well as a drug maker that manufactures Opioid overdose treatment products. During the time that McKinsey & Company was working with Purdue Pharma to boost Opioid sales, MIO Partners, “held stakes in companies that profited from increased usage,” according to NBC. This has led some to speculate that this could generate investment gains from the settlement, as the settlement is going to treatment and rehabilitation programs in communities impacted by the Opioid epidemic.

MIO’s investment managers choose where to make investments and are compensated by McKinsey, but a spokesman from McKinsey stated that the hedge fund and the firm’s consulting business are “operationally separate,” according to NBC. The spokesman also stated that, “McKinsey has no visibility into or control of how settlement money will be used by the states,” denying the claims that the firm will benefit from the settlement.

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It has only been a week since President Joe Biden was sworn into office. Yet, already he has signed 40 executive orders. Next on his agenda is the opioid epidemic. According to anonymous sources, some clinical guidelines will be repealed. Specifically, the President will not support the last-minute opioid treatment plan created by the Trump administration. The previous administration enforced less restrictive opioid-related policies. They allowed practitioners to prescribe Buprenorphine (an opioid treatment drug) without an “X-waiver.” The “X-waiver” is a federal license that permits clinicians to prescribe buprenorphine for opioid addiction treatment. The Biden administration is concerned that these laxer rules were leading to rising addiction rates.  

On January 14, 2021, there was a White House press release announcing the new guidelines. The change was in response to a 21% increase in opioid-related deaths over 12 months. From June 2019 to June 2020, over 83,000 people died from a drug overdose. By eliminating the federal rule, practitioners now had easier access to Buprenorphine. Doctors with a DEA narcotics prescribing license were exempt from the mandatory training. Before President Trump, doctors had to attend an eight-hour course to get a federal permit. The constraints had been in place for 20 years to ensure Buprenorphine was not overused. Under Trump’s clinical guidelines, more physicians gained access to Buprenorphine for medical treatment. So, when the news broke out, many clinicians rejoiced. 

Advocates For Buprenorphine

For years, people have been petitioning against the mandate. Advocates claim it slows down recovery for people struggling with opioid addiction. The drug restricted, Buprenorphine, is considered a transformative opioid treatment. Studies have shown it is an excellent tool for reducing deaths from opioid overdose. The medication satiates opioid cravings and decreases drug use. The FDA approved Buprenorphine in 2002 for opioid addiction treatment. Yet, only a few doctors have the proper certification to prescribe it. About 5% of America’s physicians possess the federal waiver, and fewer use it. Advocates hope that by eliminating unnecessary qualifications, more doctors will use Buprenorphine. With fewer restrictions around the drug, more patients could gain access to the medication. 

Promise For Opioid Treatment Reform

During his campaign, President Biden recognized the problem surrounding Opioid treatment. He declared the restrictions on Buprenorphine as unnecessary and outdated. He even promised to lift and review Methadone treatment regulations. But experts in both the legal and healthcare sectors advised against it. Many believe the Department of Health and Human Services did not have the authority to remove a Congress regulation. According to the Washington Post, the new guidelines had “legal and clinical concerns.” They were an attempt by the Trump administration to bypass Congress’s mandated requirements. Even Elinore McCance-Katz attempted to block the plan. Katz was once Trump’s assistant HHS secretary for mental health and substance use. According to Katz, for months she tried to stall the announcement. She believed the policy was not ready for release and needed more restrictions. Without proper limits, a catastrophe like the opioid epidemic could occur, starring Buprenorphine.  

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Back To The Drawing Board

Due to numerous concerns, the Biden administration is planning on withdrawing the hasty order. Change and rapid action are needed to battle the Opioid epidemic. But the Trump administration’s clinical guidelines may be more problematic than helpful. So, a repeal may be necessary to avoid the creation of a new crisis. By delaying the policy change, Biden’s administration can smooth out legal concerns. They may even design a new drug policy based on science, health, and compassion. Soon we could see effective recovery plans in response to the Opioid epidemic. 

The post Biden Canceling Trump’s Plan on Opioid Treatment Prescriptions appeared first on Addiction Center.