It’s frequently asserted that the global pharmaceutical industry is in deep trouble. Owing to the staggering cost of producing a new drug, ‘big pharma’ needs blockbusters (bestsellers that will generate vast amounts of money). These are few and far between these days, and some observers have concluded that they’ve ‘picked all the low hanging fruit’. However, the American medical culture is unique. The USA is one of only two countries (the other is New Zealand) that allow drug companies to advertise on TV. Consequently the USA is swamped with medication, and ‘big pharma’ spends billions on direct advertising to doctors, and on ensuring that regulators and politicians don’t interfere with their activities.
Since 1999, prescription pain medication has killed about 350,000 Americans, and it’s the leading cause of death among the under 50s in the USA. This is ‘the opioid epidemic’, and it’s a monumental human catastrophe. Opium-based treatments for pain were restricted until the early 1980s, when a single paper (later revealed to be based on weak data) and a short 101 word letter to a leading journal established a whopping lie: “Less than 1% of patients treated with opioids become addicted.” Drug companies now produced a range of synthetic versions of opioids, and the marketing aimed at regulators and doctors was explicit. The message was simple and very successful: “It’s irresponsible not to treat pain.”
Several brands were involved in the crisis, but there’s a general consensus that OxyContin is a major culprit. It became available in 1996, and was issued by Purdue Pharma. OxyContin used a proprietary coating designed to offer “continuous release” (hence the “Contin”) and it was disingenuously claimed to be “less addictive”. In fact, the release mechanism made it more addictive, and anyway the coating could easily be removed. However, the Food and Drug Administration (FDA) approved OxyContin for “moderate to severe pain”, and Purdue launched an unprecedented marketing campaign. They employed almost 1,000 reps, and specifically targeted locations where two crucial factors were firmly established; there were high levels of opioid prescription and dependency was already an issue. A typical example is the destitute rural towns of Appalachia, and in one of these (population only 3,000) a single clinic legally prescribed more drugs than the whole of West Virginia’s University Hospital. Unsurprisingly some prescribers were making a fortune, and one enthusiastic doctor crammed some of his $7 million in cash into a safe deposit box.
By 2009 sales of OxyContin hit a staggering $3 billion a year, the same year that drug overdose deaths exceeded road accident fatalities in the USA. This grubby saga of corporate greed relied on blatant misrepresentation (via funded reports) to ensure that the FDA and legislative bodies didn’t interrupt the gravy train or the appalling death toll. Purdue insist that they always follow FDA rules, and they blame doctors for over-prescribing and patients for misuse. Earlier this year (2018) Purdue stopped marketing OxyContin, but 2 million Americans are addicted to opioids and heroin use has accelerated (with opioids identified as the gateway drug to heroin).
Obviously, all prescribed opioids in the US and the UK had to go through the legally required animal testing before they were approved. There are multiple causes of the epidemic, but all the deficiencies and immorality of vivisection are exposed by this tragedy. Negative animal results (in this case, pinpointing the highly addictive nature of opioids) can be ignored and then ‘manipulated’ or simply removed before data is supplied to the FDA (see notes below). The cosy relationship between the FDA and pharma companies – the revolving door syndrome – is another and not unconnected scandal.
In the USA Purdue are facing an avalanche of lawsuits, and they will (almost certainly) have to make huge compensation payments. However, these losses will be fairly insignificant against the billions generated by OxyContin. The final irony is that a new treatment for opioid addiction was recently patented in the USA, and the patent was granted to (wait for it) none other than Purdue Pharma.
Paul Freestone
Notes:
For a full account of the opioid epidemic, see Beth Macy, Dopesick: Dealers, Doctors and the Drug Company That Addicted America, Little, Brown and Co., 2018; also Sam Quinones, Dreamland: The True Tale of America’s Opiate Epidemic, Bloomsbury Press, 2016.
A recent article in the journal Science discusses the “incredibly alarming” practice of cherry-picking data from pre-clinical (i.e. animal) trials of drugs, and the flawed reporting of these trials to the FDA: see ‘Study questions animal efficacy data behind trials’, Science, 13 April 2018 (vol.360, p.142), accessible here: http://science.sciencemag.org/content/360/6385/142 It’s an especially shameful part of a wider problem – the failure of truly dis-interested research – which is the special theme of the journal’s issue for 21 September of this year.
Voice for Ethical Research at Oxford 