Does the landmark judgement of a US Court against Johnson & Johnson for promoting excessive opioids lay bare the complicity of large pharmaceutical corporations in placing profits before social responsibilities?
Opioids are drugs that are derived from the opium poppy plant which is also the source of morphine, heroin, and cocaine. They are used as medicine because they contain chemicals that relax the body and relieve pain. It is usually safe when prescribed by a doctor and for a short time but because they produce euphoria in addition to the relief, they can be misappropriated for drug abuse.
Up until 1996, opioids were used to manage severe pain during surgery. The invention of OxyContin by Purdue Pharma laid the basis for opioid endemic. Purdue, along with other pharma companies, launched campaigns to change the culture of pain management and rebrand opioids deceptively. OxyContin represented 80% of Purdue profits within two years of its introduction. Since then, 76 billion opioid pills flooded the country, and its overdose has allegedly led to deaths.
Fentanyl, a J&J product, which is one of the most widely used pain medications, is a synthetic opioid. It is claimed that this drug has caused 32,000 deaths in 2018 itself. It’s inexpensive, easy to manufacture, and can be combined with other drugs to increase profits. Government agencies have investigated the involvement of global criminal organizations in trafficking illicitly mass-produced Fentanyl.
The verdict issued by Cleveland County District Judge Thad Balkman marks the end of the first state trial attempting to hold a pharmaceutical company accountable for one of the worst drug-related health epidemics in history. It is the first court case where a drug maker, that too a powerful global corporation, was held accountable for the spread of highly addictive painkillers.
District Judge Thad Balkman said, “the state met its burden that the defendants Janssen and Johnson & Johnson’s misleading marketing and promotion of opioids created a nuisance as defined by [the law],”. “Specifically, defendants caused an opioid crisis that’s evidenced by increased rates of addiction, overdose deaths and neonatal abstinence syndrome,” he added. About 18 million opioid prescriptions were written in Oklahoma, a state of less than 4 million people, in the three years to 2018.
According to the court, J&J also ignored warnings from the Food and Drug Administration and its advisory board over the marketing of Duragesic, a high strength fentanyl drug.
The ruling stated that the company and its subsidiary, Janssen, had trained sales representatives to say that the risk was 2.6% or less and those physicians who prescribed high amounts of opioids were classified as ‘key customers’.
In its defence, J&J said it is not responsible for the crisis because it produced less than 1% of the opioids in the state and said that it would appeal the decision. J&J had already paid millions of dollars in settlements for using talc in baby powder when they knew of its carcinogenic effects. Thousands of women have died from ovarian cancers caused by talc powder.
Johnson & Johnson has been ordered to pay up $572 million for its role in fuelling Oklahoma’s opioid case. The state of Oklahoma had demanded $17 billion, but according to the ruling, the state prosecutor did not provide sufficient evidence to justify the length of time and costs necessary, beyond one year. Hence, the judge ruled only one year of costs. The state is required to use the settlement money to fund de-addiction treatment programs.
The decision of the court is likely to open a can of worms with 2000 similar lawsuits against opioid makers and pharmaceutical companies including J&J waiting on the wings for filing. The state of Oklahoma has also sued Purdue Pharma which started the opioid endemic in the 1990s with OxyContin.
In another case, Reckitt Benckiser, a British pharmaceutical company, paid a civil settlement of about $1.4bn over the opioid epidemic to settle a federal indictment. Suboxone, a Reckitt Benckiser subsidiary,
had been pressing doctors to prescribe it to help those addicted to prescription pills or heroin to cope with withdrawal symptoms by falsely claiming it was safer and more effective than similar medicines in the market.
- It is likely that the success of counter drug campaigns, such as the building of border wall and trade restrictions on China due to its supply of Fentanyl products, has created new dynamics in demand- consumption of prescription medicines, to supplement banned narcotics to satisfy the burgeoning demand for drugs in the US.
- Crackdown on pharma companies who market legal medicinal opioids is aimed at choking this supply route and is part of the larger war on drugs.
- The scant regard that pharma companies have for ethical and socially responsible business practises stands exposed. With shrinking profit margins and faced by competition of cheaper drugs from multiple sources, large corporations are resorting to ruthless practices to pitch their sales, unmindful of the negative impact on the human body which they profess to cure.
- Pharmaceutical corporations often employ doctors and researchers known as “key opinion leaders” (KOLs) because they recognise that there is a credibility gap when they directly present evidence about their products to doctors. This medical practice with deceptive claims is intended to break down caution among doctors.
- In order to be able to perform higher-risk trials and encourage more innovation within the field, drug companies argue that they need to have higher profit margins. Capitalism has led to a profit over people system.
- This landmark court judgement will inhibit large corporations from resorting to unethical practices.
Opioids are regulated under the Narcotic Drugs and Psychotropic Substances Act, 1985 or NDPS, and schedule H1 drugs in India. Although India is the world’s top producers of opium for legal medical market, the availability of essential opioid analgesics is among the lowest in the world. India has not placed Fentanyl, or most other opioids, on its controlled substances list yet because of lack of domestic concern about addiction.
Image Courtesy: flickr.com