Dear Colleagues! This is Asrar Qureshi’s Blog Post #721 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to email@example.com for publishing your contributions here.
This series of blogposts is based on multiple sources, links of some of which appear at the end.
The Opioid Crisis emerged out of the opioid epidemic which started getting noticed in the US in the early 2010s. The magnitude of problem was so big that the US Department and of Health and Human Sciences – DHSS soon declared it to be a Public Health Emergency, and the entire machinery got active. Since then, there have been numerous lawsuits against the main companies; most have been decided while others are in progress.
We shall look in some detail at what opioids are, how is pharma implicated, the magnitude of the problem, and what is happening now.
Opioids are the class of narcotic drugs which are mainly used for pain relief (analgesia). Opioids are used for moderate to severe pain which may be due to arthritis, trauma, injuries, or cancer. The patients suffer greatly, and ordinary analgesics do not provide relief, therefore, the patients are prescribed (in the developed world) opioid analgesics or buy off the shelf (developing world like ours). Morphine and Pethidine are in this class and fortunately these are largely controlled by the governments, including ours. Oxycodone (Oxycontin internationally) is the best-known opioid analgesic which started the era of oral opioids. Fentanyl was developed later which also comes as patches. Fentanyl is a semi-synthetic opioid. Other drugs are codeine, hydromorphone, hydrocodone, methadone, tramadol, buprenorphine, pentazocine, and dextropropoxyphene, and more recently tapentadol. Heroin is also an opioid, not a drug, but sells on the streets all over the world.
75% people who became addicted to opioids stated that they started off with the prescription drugs and later resorted to illegal drugs on the market.
Opioids carry a high risk of addiction. Mayo Clinic says, “anyone who takes opioids is at risk of developing addiction. Your personal history and the length of time you use opioids play a role, but it is impossible to predict who is vulnerable to eventual dependence on and abuse of these drugs”.
Opioid dependence occurs due to misuse of drugs. Some figures can illustrate the magnitude of the problem.
- 10.1 million people misused prescription in the US in 2019
- 1.6 million people misused prescription pain relievers for the first time
- 7.45 million people had an opioid use disorder
- 70,630 people died from drug overdose
- 48,006 deaths attributed to overdosing on synthetic opioids other than methadone
- 130 people die of drug overdose every day
In Pakistan, we do not have exact statistics about the problems associated with pharmaceutical products based on opiates. Tens of companies are manufacturing such drugs; tramadol is manufactured by over 30 companies, for example. Tramadol + paracetamol combination is now manufactured by even more companies. Tramapar from Efroze was the first to come on to market, but Tonoflex-P from Sami now reigns supreme. Hundreds of thousands of prescriptions are issued for this combination which is manufactured by around 50 other companies also. What no one is considering is that almost all patients who start using this combination get hooked on it and keep using it without going back to doctor. Unfortunately, they do not get relief with any other drug after that. And after a while, they may have to increase the dose.
Tramadol + paracetamol combination started off with 12.5mg/325mg respectively, but now it is 37.5mg/325mg, which means that the quantity of opioid has increased three times. What kind of havoc it plays with the patients is no one’s concern. The Pharma companies are maximizing profits, and the regulators are looking the other way.
Story of Opioid Misuse
The opioid crisis in the US is usually presented as a cascading story of three interconnected waves.
First, drug companies, led by Purdue Pharma, maker of the notorious drug OxyContin, convinced doctors to prescribe their drug, which largely might have been unneeded. The patients felt immediately better due to strong pain-relieving effect, and it led to a steady stream of prescriptions causing hundreds of thousands of new addictions in the 1990s and 2000s. Overdose and overdose-related deaths arrived on the heels of increased use.
Second wave is said to begin around 2011, when states started cracking down on the so-called ‘pain clinics’ who were easy sources of drugs offering doses for dollars. The crackdown made prescriptions and availability become scarce, prices rose, and people who were addicted began to turn to heroin, which was cheaper. Drug cartels found a new opportunity and started serving a new pool of customers happily. Again, overdose deaths increased.
The third wave was initiated by illicit drug dealers. They saw a bigger chance of making even more money more securely. They cut supplies of heroin and substituted it with fentanyl and other synthetic opioid tablets/capsules which were illegally manufactured in pharmaceutical companies in various parts of the world and smuggled into the US. These were cheaper to make and were more potent. The problem of addiction worsened, and nearly 100,000 people allegedly died from overdose in 2020.
This is the story which has been told repeatedly in the cases against Purdue Pharma and other manufactures and distributors of opioid drugs. It is also contested as being too simplistic.
Purdue Pharma, Mallinckrodt pharma, and Johnson & Johnson are three big names among manufacturers along with three major distributors, AmerisourceBergen, Cardinal Health, and McKesson.
Purdue Pharma, maker of OxyContin (oxycodone), is an American company based in Stamford, Connecticut. It was founded in 1892 by John Purdue Gray and George Frederick Bingham. It was largely owned and run by Sackler family.
OxyContin came on the market in 1996. Up until that time, strong painkillers were not prescribed to long term patients. The drugs for arthritis like phenylbutazone and later diclofenac sodium were available, but these were not as strong. Idarac (floctafenine) and Dolobid (diflunisal) came on the market with claims of strong analgesia but did not stand up to it. Dolobid was withdrawn internationally, Idarac still survives as a small drug. It was a time when doctors did not have a choice and asked the patients to simply tolerate the pain.
Purdue’s sales team aggressively launched and promoted OxyContin as a wonder drug for pain relief, a claim which was endorsed by the patients later. Emboldened, the doctors started prescribing it for acute and chronic pain. In about four years, the sales grew to $1.1 billion.
Later, reports started surfacing that OxyContin tablets were stolen from pharmacies, crushed, and snorted, an act more in line with addictive substances abuse. In 2007, Purdue Pharma and its three executives pleaded guilty to federal criminal charges for downplaying the risk of addiction to doctors, regulators, and patients. They paid a combined sum of $634.5 million in damages. The Sackler family withdrew $10.4 billion between 2008 and 2017, about half of which was paid to taxes.
The tide of epidemic kept spiraling causing deaths due to overdose. By 2014, local government began filing lawsuits against Purdue. Sackler family became the biggest villain in the substance epidemic, though others were no less culprits. More lawsuits were filed against Purdue and others in the supply chain were also tied in.
By September 2019, Purdue was facing 2,900 lawsuits, 628 of which named the Sacklers directly. Purdue applied for bankruptcy under chapter 11 to pause further claims. Dr. Richard Sackler, a former President and co-chairman of Purdue’s Board of Directors said that neither the family nor its products bore responsibility for the opioid epidemic.
As part of the settlement with a number of lawsuits, the company agreed to pay $6 billion. Sackler family also claim they were unaware of the wrongdoings by company executives. Purdue Pharma was subsequently dissolved in September 2021.
To be Continued……
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