Pharma wrap : Purdue Pharma settlement, US opioid crisis and lessons for India

New Delhi, Sept. 01 : Last week, US-based Purdue Pharma and its owners, the Sackler family, offered to settle over 2,000 lawsuits against the company for $10 billion to $12 billion, reports suggest. This would be one of the largest ever settlements in the history of healthcare and pharmaceutical industry.
The Purdue Pharma, or Sacklers, have not confirmed this yet. However, Purdue said in a statement that it sees little good coming from years of wasteful litigation and appeals.
The amount, if Purdue settles, will be larger than half the size of entire Indian pharmaceutical market.
Reports of this settlement come just days before Johnson & Johnson was asked by Oklahoma court to pay $572 million, citing misleading marketing of painkillers.
The 2,000 cases were all slapped, by government agencies in US at various levels. These cases are all now consolidated and heard by a federal judge in Cleveland, to reach a single landmark legal resolution to the opioid epidemic.
Lawsuits against Purdue Pharma allege that the company’s sales practices were deceptive. The company was blamed for an aggressive marketing effort to persuade doctors to prescribe its OxyContin, more widely and at higher doses.
OxyContin is an extended release version, which is a narcotic analgesic used to treat pain.
In 2007, Purdue had pleaded guilty to federal charges of misleading doctors and the public about the drugs. Purdue paid a $635 million fine.
To be sure, it is not Purdue alone. Opioid makers like Endo, Teva, Johnson & Johnson, Allergan, Reckitt Benckiser, Insys, Mallinckrodt, among others, are facing charges in the lawsuits.
The lawsuits also included distributors Cardinal Health, AmerisourceBergen and McKesson; and four pharmacies Walgreens, Walmart, CVS and Rite Aid Corp.
The stakes are so high that around $150 billion worth of settlements are expected by analysts such as Patrick Trucchio of Berenberg Capital Markets in opioid-related litigation. However, that’s one-third of the cost that US government spent in battling the opioid crisis through de-addiction programmes.
So far, Indivior, the unit of British drug maker Reckitt Benckiser has settled one case with the US Department of Justice (DoJ) for $1.4 billion. Oklahoma reached settlement with Teva for $85 million.
Insys, promoted by Indian origin entrepreneur John Kapoor agreed to pay $225 million, pleading guilty for alleged payment of bribes to doctors to prescribe a highly addictive fentanyl-based painkiller drug Subsys. Insys filed for bankruptcy protection in the wake of opioid litigation.
How serious is the Opioid crisis faced by America?
Opioids are a class of drugs derived from the opium poppy plant. Over the years, many synthetic and more potent versions of opioids have emerged. They range from codeine, to illegal drugs like heroin. Prescription opioids are primarily used for pain relief. Morphine, tramadol, fentanyl, methadone, alfentanil are more frequently used opioid drugs.
The effects of opioid addiction are devastating. What started as prescription for relieving acute and chronic pain, has transformed into a full blown crisis. To be sure there is a clear problem of regulation.
People started abusing or getting addicted to opioids as they make feel good, while diminishing the perception of pain. But, at higher doses, opioids can slow your breathing and heart rate, which can lead to death.
Adding to risky side-effects of opioids, the misleading marketing practices of pharmaceutical companies and gullible doctors, made patients to think the pills were safe and effective through that contributed to the more than 7 lakh drug overdose deaths in the US since 1999.
It is estimated that every day more than 130 people in the United States die after overdosing on opioids.
Lessons for India
Given the huge settlement payments involved, some companies facing charges may find it difficult to survive. This will open-up opportunities for Indian generic drug makers to make some opportunistic acquisitions in US.
But India too is at risk of Opioid addiction problem, as government loosens restrictions to make these drugs available for palliative care, especially for treating serious illnesses such as cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), kidney failure, Alzheimer’s, Parkinson’s, among others. In India, opioids are regulated under Narcotic Drugs and Psychotropic Substances Act, 1985 or NDPS and schedule H1 drug drugs.
Under NDPS Act manufacturers, distributors, sellers, importers, exporters and consumers of specified controlled substances to register, maintain records and file quarterly returns with the Narcotics Control Bureau (NCB). The schedule H1 drugs should be labelled with the symbol ‘Rx’ in red, clearly displayed on the left top corner of the drug label.
NDPS is a stringent regulation with a 10-year mandatory minimum prison term for violations involving narcotic drugs, along with cumbersome licensing procedures of import, export and transport between states. Following the Act, medicinal morphine use in the country dropped by a staggering 97 percent. India has a strange problem, it overregulates on one hand, sometimes making these drugs unavailable for patients who need them badly, at the same time it faces challenge of enforcement, or restricting the people who misuse them, given the complexity, and corruption within the healthcare system.
Despite these, opioid drugs like tramadol and tapendadol have been sold in India as over-the-counter (OTC) drugs for years, before government started tightening noose.
A recent story by The Guardian explained how big pharma companies are targeting India’s booming opioid market.
It is time we tighten our enforcement, as we cannot afford an opioid crisis.