Understanding the Opioid Crisis
The Opioid Epidemic began in the 1990s, when physicians were attempting to treat pain patients more efficiently. Meanwhile, pharmaceutical companies were falsely marketing opioids as safe and effective to increase their revenues. On the other hand, patients suffering from chronic pain did not necessarily have the resources to seek appropriate opioid-free treatment. As a result, the misuse and addiction to painkillers blew up. The situation aggravated as users built up a tolerance to painkillers while their access was limited, compelling them to seek out unsafe alternatives such as heroin and fentanyl. As the supply of heroin in the US increased to match the demand, the drug became much more accessible to the general public. This resulted in increased drug overdose deaths and more generally, a full-on addiction epidemic in the country.
Stats and Numbers
Based on stats published by the National Institute on Drug Abuse (NIH) on March 2018:
Over 115 people in the United States die after overdosing on opioids every day.
Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
Between 8 and 12 percent develop an opioid use disorder.
An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.
About 80 percent of people who use heroin first misused prescription opioids.
Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.
Additionally, the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that about 2.1 million people in America have an opioid use disorder.
The Financial Side of the Opioid Epidemic
A report from the CEA estimated the opioid epidemic to have cost the US economy $504 billion in 2015, or 2.8 percent of gross domestic product. This estimate is much higher than that of other studies since it incorporates the value of lost lives. Among the most recent (and largest) estimates was that produced by Florence, who estimated that prescription opioid overdose, abuse, and dependence in the United States in 2013 cost $78.5 billion. The authors found that 73 percent of this cost was attributed to nonfatal consequences, including healthcare spending, criminal justice costs, and lost productivity due to addiction and incarceration. The remaining 27 percent was attributed to fatality costs consisting almost entirely of lost potential earnings.
Understanding Addiction and the Effect of Opioids on the Brain
Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, morphine, and many others.
Based on the National Institute on Drug Abuse (NIH), addiction is a chronic disease characterized by drug seeking and use that is compulsive, or difficult to control, despite harmful consequences. Frequent use of a drug can permanently alter the brain chemical systems and circuits, and ultimately, affect functions such as learning and decision-making. The brain produces a neurotransmitter called dopamine, when in anticipation of rewarding activities. It enables people not only to see rewards but to take action and move towards them. Meanwhile, inhibitory neurons in the brain work hard to slow down the release of dopamine until something good comes along.
When opioids are first ingested, they block dopamine inhibitors, flooding the brain with dopamine. This leaves the consumer with a feeling of euphoria and calmness. Therefore, the brain learns to directly associate positive things with the use of these drugs. Additionally, the frequent use of opioids makes the brain’s reward circuit less sensitive to those drugs. This leads to an effect known as tolerance, incentivizing the consumer to increase their dosage to achieve the same high. These brain adaptations and the depletion of dopamine in the brain leave the consumer incapable of driving pleasure from routine activities they once enjoyed. Consequently, they fall into the vicious cycle of addiction which is only driven by the brain trying to regain its balance.
Key Players in the Opioid Crisis
Doctor David Kessler, former head of the FDA, believes that the opioid crisis has been one of the greatest mistakes of modern medicine. “The FDA has responsibility, the pharmaceutical companies have responsibility, physicians have responsibility. We didn’t see these drugs for what they truly are,” Dr. Kessler said. The first step to eradicating a problem is finding its roots. In the case of the opioid epidemic, identifying the source of the issue is very difficult, as many factors have contributed to it over the years. Understanding the perspective of the different key players can help unravel the complexity of this matter.
The overprescription of opioids started in the 1990s with the intent to cure pain more efficiently. At that time, the risk of addiction and the dosage ceiling for opioids were still unknown. However, This phenomenon still continues to date. For example, in 2015, 240 million opioid prescriptions were dispensed in the US alone, nearly one for every adult in the general population. While doctors are not to solely blame for the opioid crisis, they have certainly played a critical part in its progression. That being said, there are many reasons that contribute to physicians’ behaviors regarding opioids.
Based on an article in Harvard Health Publishing, in medical school, doctors receive very little training on safely managing chronic pain, recognizing patients at high risk for overdose, intervening when patients need to be taken off opioids, and adequately treating addiction. The current medical culture emphasizes the need for pills to treat almost every medical condition as drugs are proven to be very effective in the short run. As a result, patients believe that drugs are the only solution for eliminating pain and expect to receive drugs after visiting their doctor. They put a lot of pressure on their doctors, motivating them for unnecessary or excessive opioid prescription. On the other hand, because of this cultural shift in medicine and the lack of training in pain management, doctors have become overly dependent on opioids for treating pain.
Additionally, prescribing physicians might not always have access to the patients prior medical or mental health records because of the communication gap in the American healthcare system. Based on a study by a group of Boston Medical Center researchers, almost 90 percent of patients are prescribed opioids again after a nonfatal overdose. 7 percent of those patients overdosed for a second time during the next 300 days. In most cases, the same doctor wrote the opioid prescription before and after the initial overdose. Surprisingly, it is very likely that the prescribing doctor was never made aware of the overdose unless the patient was sent to a hospital affiliated with the doctor. Therefore, the fragmented healthcare system can mislead doctors to prescribe opioids to ineligible patients.
In 1995, Purdue Pharma, a privately held company, based in Stamford, Connecticut, developed the prescription painkiller OxyContin. This drug is a long-lasting narcotic that can relieve patients of moderate to severe pain. Its active ingredient, oxycodone, is a chemical cousin of heroin. It has reportedly generated $35 Billion in revenue for Perdue. Purdue launched OxyContin with one of the biggest pharmaceutical marketing campaigns in history. Despite Oxycontin’s known and unknown risks, the company promoted it as a product “to start with and to stay with.” Many believe that the success of the drug was solely due to unethical marketing techniques and ultimately, misinformed physicians. For instance, sales reps were trained to tell doctors things like “the drug is ‘virtually’ non-addicting.” Andrew Kolodny, the co-director of the Opioid Policy Research Collaborative, at Brandeis University, believes that the opioid crisis was brought about after a shift in the culture of prescribing when Purdue launched OxyContin. “It’s not a coincidence. That was the year  Purdue launched a multifaceted campaign that misinformed the medical community about the risk.”
More generally, the aggressive marketing tactics used by pharmaceutical companies were a huge contributing factor to the opioid epidemic. These companies targeted physicians, sponsoring educational courses on the benefits of opioids and posting advertisements in reputable medical journals. Additionally, pharmaceutical companies used lobbyist groups to push their products in the market. For example, a group known as Pain & Policy received $2.5 million from pharmaceutical companies to promote opioid use and discourage the passing of regulations against opioid use in medical practice. As a result, many lawsuits have been filed against these companies, accusing them of spending millions on marketing campaigns that “trivialize the risks of opioids while overstating the benefits of using them for chronic pain.”
Government policy played a big role in the forming of the opioid epidemic. Although the intention was never bad, some policies led to a surge in opioid prescriptions. In the early 1990s, the American Pain Society suggested that pain should be categorized as the “fifth vital sign” due to a high rate of untreated pain. Considering the fact that pain is a subjective feeling and cannot be accurately measured, This practice led to the overprescription of opioid-based painkillers. In 1998, the Federation of State Medical Boards issued a policy, reassuring physicians that even large doses of narcotics are acceptable as long as it is “in the course of treatment.” In 2001, the Joint Commission mandated that all hospitals in the country assess pain on each patient that they treat. As a result, the overprescription of opioid painkillers became prevalent. "The current requirements for hospitals and other healthcare organizations to assess patients' pain encourage unnecessary, unhelpful and unsafe pain treatments that interfere with primary disease management," said Dr. Michael Carome, director of Public Citizen's Health Research Group.
Additionally, the Drug Enforcement Administration’s (DEA) role has been critical in the production of opioids. The DEA is in charge of setting annual quotas to determine the amount of schedule I and II controlled substances that are manufactured each year. Despite the casualties of the opioid crisis, the DEA continues to approve significant increases in opioid quotas. This is because the quotas are solely based on factors such as past sales and estimated demand instead of abuse rates and overdose deaths. The opioid crisis came about due to multiple intertwined factors that fed into each other, one of them being bad government policy.
Fighting the Opioid Epidemic: Addiction Treatment Market
SAMHSA has estimated that the general market for addiction treatment is about $35 billion per year. Addiction treatment was a $21 billion business in 2003 and is expected to double to $42 billion by 2020 – a growth rate some three times faster than inflation, according to federal health and census data. Investors are attracted to addiction treatment businesses since it is very fragmented and has a lot of room for improvement. Nevertheless, the huge financial opportunity in this industry can be very risky. A Market Alert brief for investors, by The Braff Group, which provides financial analysis of the treatment industry, described financial risk in the recovery businesses this way: “It’s not all kittens and rainbows. As we have seen countless times in other frenzied healthcare sectors, when the money flows in, so do the ne’er-do-wells, which can bring the sector the kind of attention it doesn’t want. Markets in hyper-drive are extremely fragile.”
Eradicating the Crisis with Blockchain
One of the main causes of the opioid epidemic is the lack of transparency in the current medical system. For example, doctors might not always be aware of patients’ addictive behaviors or even past overdoses. Blockchain’s extremely secure and distributed ledger can help address this issue.
Intel Corp. has collaborated with health companies to use blockchain technology in an effort to fight the opioid epidemic. The objective is to identify where drugs leak out of the supply chain with a technology that ensures patients’ privacy. The technology can track drugs from the manufacturer to the patient’s home, and eventually to the point when it’s ingested by the patient. It can also flag “double doctoring,” where a patient receives more than one prescription from multiple doctors. Additionally, it allows the FDA to monitor prescribing behaviors, to identify “pill mills,” and to ultimately exchange medical records. By interconnecting entities that do not readily interact, blockchain technology can be used to repair the fragmented healthcare system.
“Once you start tagging drugs with an immutable audit trail, you can do what was impossible before,” said Josh Greenbaum, Principal of Enterprise Applications Consulting (EAC). “It’s fairly easy to game a national database of prescriptions, providers, and patients. But making the drugs traceable provides a much more comprehensive view of what each party is doing with the opioids. Blockchain adds the full distribution picture, and could be tremendously valuable in exposing leaks.”
Startups fighting the opioid epidemic
The advancement of the opioid crisis has inspired many startups to develop new technology or techniques for addiction and pain management. These private companies can be categorized into two main groups: startups that target addiction treatment and startups that target pain treatment to prevent addiction. The most prominent examples of these new breed companies include:
Triggr ($4.2M total funding- Series A) makes an app that monitors phone use to determine when someone recovering from addiction is most at risk. It also uses cognitive behavioral therapy techniques to help identify the best therapy for those fighting addiction, assists them in finding doctors to prescribe anti-opioid medication, and checks in with them between appointments with addiction counselors.
Chrono Therapeutics ($82.5M total funding- Series B) was founded in 2004 with a vision of transforming disease and addiction management in wearable, patient optimized drug delivery. With real-time wireless connectivity and tailored behavioral support, Chrono's science of specifically tailoring the timing and dose sizes of drugs, preempts predictable peak disease and addiction symptoms with an easy-to-use device. In partnership with the University of Basel, Switzerland and three affiliate Universities, CHRONO has built a pipeline of pharmaceutical applications. The fruition of these efforts will see a widespread impact to better manage common conditions and diseases with next generation "Smart" drug products.
Groups ($4M total funding- Series A) is very simple: for $65 a week, it offers group therapy in areas plagued by opioid addiction--targeting towns with fewer than 10,000 residents and little access to recovery programs--so people at different stages of recovery can learn from one another. It also prescribes Suboxone, a combination of buprenorphine and naloxone, which is used to treat addiction. Its first location opened in New Hampshire; the company has since expanded to California, Indiana, Maine, and Ohio. The company says that after working with Groups for six months, 95 percent of patients attend counseling each week and 85 percent abstain from opiates.
Braeburn Pharmaceuticals ($110 total funding- Mezzanine) manufactures Probuphine, a long-acting prescription implant that provides those who are addicted with a steady low dose of buprenorphine. In clinical trials, patients who used a Probuphine implant were significantly more likely to refrain from opioid use than patients who took buprenorphine orally.
Appriss Health markets NarxCare and Awarxe. NarxCare analyzes data about the medicines doctors give to patients, so health professionals can see health histories and prescription drug usage patterns and help identify those predisposed to addiction. Awarxe is a prescription-monitoring program that helps state governments identify, anticipate, and address the improper prescribing of controlled substances.
Biobot Analytics ($2.5M total funding- Seed) builds robots that collect sample from city sewage. Those samples are then analyzed to measure the concentration of prescription and illicit opioids, to better identify communities experiencing addiction issues.
etectRX™ is a pre-market medical device company that is developing an ingestible event marker (the ID-Cap™ System) that potentially gives clinicians the ability to accurately monitor patients' medication adherence on a per-dose basis. The App communicates with cloud-based software which stores the ingestion confirmation messages and allows the pharmacist or clinician to better manage the patients' medication adherence.
SPR Therapeutics ($43.3M total funding- Series C) is a medical device company that is commercializing pain treatments utilizing its peripheral nerve stimulation (PNS) products. The company is developing a pipeline of neurostimulation pain therapies that will exploit the same physiologic mechanism of action, proprietary technology, and clinical approach. The first product to be commercialized is the SMARTPATCH PNS System, which is a short-term, minimally invasive system that is simple to deliver and can be used for up to 30 days to stimulate electrically a peripheral nerve to relieve pain.
MyoScience ($124.6M total funding- Venture) is a privately-held medical device company committed to making its platform technology, the iovera° system, the standard of care for the treatment of peripheral nerves. The iovera° treatment is powered by the Focused Cold Therapy® delivery system, a patented miniaturization of traditional cryotherapy. The ioveraº system is 510k cleared in the U.S. for the blocking of pain, for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days, and for general surgical use.
Prospira PainCare ($85.7M total funding- M&I) provides interdisciplinary pain management services to patients using its network of partnered physicians. By leveraging its network, the company provides individualized care for those with acute or chronic pain.
Centrexion Therapeutics ($152.6M total funding- Series D) develops non-opioid drug therapies to treat those with moderate to severe chronic pain. By using its STRATI technology, Centrexion makes pain alleviating drugs from synthetic forms of capsaicin, a natural analgesic’ compound found in chili peppers.
Kineta ($68.5M total funding- venture) develops therapeutics derived from neutral ingredients to function as analgesics as an alternative to opioids. Its lead product is a venom that comes from a small cone snail native to Caribbean Sea.
Axial Healthcare ($26.3M total funding- Series B) is a pain management solutions company with platforms that link physicians, health insurers, pain clinics, and patients together. The company’s 4 software products facilitate this and give a higher degree of insight to each party.
Vapogenix ($23.7M total funding- Series C) is developing non-opioid analgesics for localized pain management associated with procedures, wounds, and inflammation. Its lead product is rapidly acting topical analgesic for pain relief in situations such as minor dermatological procedures.
Concentric Analgesics ($13.7M total funding) is a drug discovery and development company focused on localized therapeutics for pain associated with surgery recovery, chronic osteoarthritis, and cancer. The company develops water-soluble inactive compounds that convert into active drugs once metabolized in the body, which then desensitize pain.
Hinge Health ($11.3M total funding- Series A) is pioneering digital care programs for people with chronic musculoskeletal conditions such as back or joint pain. its market-leading technology creates a delightful participant experience by combining sensor-guided exercise therapy with health coaching and education.
Alternative Programs for Pain Management and Addiction Control
UMMC physicians creating opioid use alternatives model
UMMC’s pain management physicians have partnered with the Department of Psychiatry and Human Behavior to develop a first-time clinical treatment model around the issue of opioid abuse. Their goal is to effectively manage and treat patients’ pain without opioids. Dr. Ken Oswalt, leader of the Medical center’s acute pain service, believes that the mindset change of using opioids only as a rescue drug is already in place and has already limited the use of opioids in the hospital.
3 fronts in Cleveland Clinic's flight against the opioid crisis
Cleveland Clinic’s Neurological Institute is dealing with the opioid epidemic in a multidisciplinary fashion, focusing on strategies for prevention, treatment, or a combination of the two. These approaches include Back on TREK, Behavioral interventions, and a chronic pain rehab program.
Aetna's programs against the opioid epidemic
Aetna is building on current initiatives to impact every phase of awareness, delivery, and use of opioids. They sponsor programs to educate prescribing physicians and their members. They actively analyze their claims database and intervene if there is any evidence of abuse. For instance, they monitor a member receiving multiple prescriptions from different physicians. Additionally, Aetna prompts members to think of alternatives for pain relief.
USF Healthcare and pain relief without opioids
Among the things OSF HealthCare is doing for hospitalized patients is to implement an automatic reassessment by doctors of any opioid pain medication a patient is taking within 48 hours of starting them to see if they can be switched to non-opioids or other pain alternatives. For outpatients or people being discharged from the hospital, the amount of opioid pain medication – pills – that a person is prescribed automatically through the electronic medical record system has been cut in half. The prescription is able to be refilled if necessary. Another important part of the effort, according to Jerry Storm, Senior VP of Pharmacy for OSF HealthCare, is educating providers to change the way they prescribe opioids for pain control.