News headline this week: “TEVA leaps after announcing opioid painkiller settlement in U.S.” Investors felt they could relax after it was made public that the Israeli pharmaceutical giant had reached a $4.35 billion settlement with the majority of the States, Counties and Cities in the U.S. that were suing TEVA for its role in the opioid crisis. Of course, the estimated half a million people who overdosed on OxyContin (the opiod drug that resulted in all the lawsuits), over the past twenty years will not benefit from the settlement, not will the majority of their families.
OxyContin was developed by Purdue Pharma, who brought it to the market in 1995, where it was received as a revolution in pain control. While it became clear quickly that in addition to reducing pain (initially for cancer patients, but upon pushing by Purdue for all pain sufferers) it was addictive (as may be expected from an opioid). While this was known by Purdue from the beginning, together with a range of other side-effects, Purdue continued its aggressive marketing of the pharmaceutical, recognizing it as a “bonanza”. When the drug became generic, other companies, including TEVA jumped on the bandwagon and sales of OxyContin soared even more.
But together with the increasing sales, and the increasing number of deaths by overdose, more and more information about the drug, its path to approval and the sales activities by Purdue and its competitors became known and health services all over the world started to realize that a major addiction crisis was developing, supported and encouraged by the manufacturers of this (legal) drug.
The Opioid lawsuits are being pursued for several years already, and TEVA is not the only pharmaceutical company that was sued and will pay significant sums, with Johnson and Johnson and Cardinal Health two significantly larger players. But the main culprit, Purdue Pharma and its owners, the Sackler families who have become multibillionaires selling the drug, have remained outside these settlements. They made their own deal with the authorities and declared bankruptcy afterwards, with most of the money staying in the hands of the Sackler families.
Where were the national health authorities? And in particular, where was the FDA? The standard development route for a new drug includes a wide range of testing. Testing for safety, efficacy, side-effects, optimal dose etc. After approval, and start of sales, a control mechanism monitors the distribution of the drug, its marketing as well as long-term effects. It is hard to believe that Purdue managed to hide from the FDA all results obtained during the development of the drug s well as after approval, so how did it ever obtain approval?
In the case of OxyContin the almost immediate side-effect of the drug is addiction, and if that fact slipped through the maze at the FDA (and the other national health agencies as well), what to think about the dozens of drugs being developed and approved every year? Are they really as effective as is promised? And their side-effects? If it doesn’t kill you it will be allowed? (And in the case of OxyContin even when it does kill you). Who decides on the dose? The duration of the treatment?
Of course, there is no doubt that OxyContin also helped many people deal with temporary and maybe even chronic pain with not many alternative drugs available. But the aggressive marketing by the pharmaceutical companies, with incentives for family doctors to prescribe the drug and ignoring illogical orders from pharmacist indicating illegal sales with as only goal increasing sales and making more money should be curtailed and the Health agencies that are tasked to do so and in particular with dangerous drugs like OxyContin, a review of procedures is long overdue and must lead to measures to curtail the abuse of such drugs. It may be too late for the addicts that died using (or misusing) OxyContin, but it may save others in the future.
I hope you found this article interesting and I welcome any comments you may have.
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