Anna Törner: Kalashnikovs in a new guise

Thanks to resisting European regulatory authorities, Europe has been spared the opioid epidemic. In the 1960s, the situation was the opposite as the American pharmaceutical authority, the Food and Drug Administration (FDA), refused to approve thalidomide (Neurosedyn), writes Anna Törner in a column.

My only actual knowledge of the Satanic Verses is that they gave rise to the expression roundabout dogs. I also admit willingly and without shame that I am not sure if I have read any contemporary French literature. Probably not. Quite often, I’m sprawled out on the couch, and this week, with a cold and streaming “Dopesick” – a docu-drama chronicling America’s opioid crisis.

Surprisingly often, reality surpasses fiction. Besides the Netflix series “Narcos”, which describes Escobar’s cartel activities in Colombia, I have probably never seen anything scarier with the angle of profit hunger connected to drugs without regard for human life, and if you think that Regulatory Affairs, pharmacokinetics and statistics cannot play the leading parts in a rip-roaring thriller; think again.

Most of us know the outer framework of the story; sleazy marketing of Oxycontin (an opioid derivative related to morphine) for the treatment of primarily severe pain conditions has led to an opioid epidemic in the United States, which is still estimated to claim nearly 100,000 lives annually, even long after most of the facts were revealed and we know what went wrong. Why was this slick marketing only possible in the US and not in, say, nearby Canada or Europe?

Silence and drum rolls…

Well, the most important reason is the less strict product description (label) that was somehow approved by the American pharmaceutical agency FDA, describing how and when the medicine can and should be used. The risks of drug addiction were downplayed and paved the way for more aggressive marketing and use in even moderate pain conditions.

However, as a rule, the FDA is no more lax than European authorities. The story is more complicated than that. Instead of focusing unilaterally on the profit-hungry pharmaceutical industry, the film adaptation shows the complex interaction between industry, authorities, patient organisations and the medical profession.

When Escobar pulled out his Kalashnikovs, the pharmaceutical company in question worked with far more sophisticated weapons and in many ways, even more treacherous ones, masquerading as science. The lack of the 12-hour effect and the development of tolerance, a well-known phenomenon for opiates, was explained as “breakthrough pain”, and the standing recommendation was to increase the dose. A whole new expression was born: “pseudo-addiction”. The term was used to explain withdrawal symptoms as lacking effect, and the symptoms should be treated with, yes, you guessed correctly, further dose increases. Add log-linear scales and pharmacokinetic discussions to create perfect smokescreens.

Thanks to resisting European regulatory authorities, Europe has been spared the opioid epidemic. In the 1960s, the situation was the opposite. Doctor Frances Kelsey at the FDA refused to approve thalidomide (Neurosedyn®), and the United States thus avoided thousands of babies being born with congenital disorders in the form of missing arms and legs and other deformities. In 1962, she received a medal from President Kennedy for her civilian courage.

Life science is a fascinating industry that really makes a difference to people. However, magic is made in collaboration with regulatory agencies and the medical profession.

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