The Pharmaceutical Year That Was, 2020

Pharmaceutical Medicine (2020) 34:365–368 https://doi.org/10.1007/s40290-020-00363-8 EDITORIAL The Pharmaceutical Year That Was, 2020 Anthony W. Fox1 Published online: 8 December 2020 © Springer Nature Switzerland AG 2020 When one penetrates the cloud of COVID-19, this year has seen more than its fair share of charlatans and pharmaceutical jailbirds. NHS England started us off by firing a new salvo at homeopathy, for which the United Kingdom (UK) taxpayer ceased paying in 2017 [1]. This time, NHS England expressed its incredulity that the Professional Standards Authority (the regulator of regulators in the UK) had recently renewed its accreditation of the Society of Homeopaths (SoH), especially when homeopaths were ‘propagating misinformation about vaccines’ [2]. This misinformation included unfounded therapeutic claims for ‘CEASE’ therapy, for which the concomitant use of homeopathic remedies helps ‘clearance’ of antigens and toxins, thus curing autism and replacing vaccination for infectious diseases [3, 4]. In fact, when read closely, the web pages showing the SoH position statement declare ‘CEASE’ therapists acceptable, although they do not actually and directly support the therapeutic claims. NHS England has now emphasised that, in particular, homeopaths should not abet the decline in uptake of pre-school vaccinations. Meanwhile, the SoH is running workshops centred on the ‘three vital steps towards becoming a homeopath—belief, confidence and risk-taking’ [5]! The abuse of ‘anabolic’ steroids is getting much less press than that for opioids. Evidence that athletic performance is enhanced by steroids is meagre (beyond mere increase in muscle mass) [6], while there is robust evidence for endocrinological, hepatic, and psychological toxicities of these drugs [7]. A dubious record was broken this year by one Jacob Sporon-Fiedler, a Danish owner of an Indian generic drug manufacturer. He had been managing to ship approximately four tonnes of anabolic steroids each month (sic) into the illicit European market. In the UK alone, his revenues were about £65 million per year [8]. Importantly, this * Anthony W. Fox 1 Editor Emeritus, Pharmaceutical Medicine, Birkbeck, University of London, Malet Street, Bloomsbury, London WC1E 7HX, UK record-breaking case illustrates an international disparity in drug regulation and a legal loophole. Anabolic steroids are Schedule 3 controlled substances in the USA (i.e. possession without medical prescription is a felony). However, in England and Wales, while also being Class C drugs, possession of anabolic steroids is not necessarily an offence, unlike supplying them.1 The loophole, therefore, is that a Londoner receiving a retail shipment from, say, India, might not commit any offence because the supplier is outside the UK jurisdiction. However, as a matter of logistical efficiency, to fulfil his large markets, Mr Sporon-Fiedler had to resort to shipping wholesale quantities into European countries, and these were then broken down into smaller shipments for local, retail distribution. In the UK, that does count as supplying within the jurisdiction, about which Mr SporonFiedler now has plenty of time to reflect, while serving his 5 years and 4 months sentence imposed at the Old Bailey (in all likelihood, he is likely to serve about half of it before being released on licence). A very questionable effort was started in February by the French Government to incriminate a large pharmaceutical company for failure to warn about a drug adverse event (AE). The AE in question is that sodium valproate has a low incidence of cleft palette after exposure in utero [10]. Rarer, and more controversial, are associations with mental retardation and spina bifida [9]. One wonders about the motivation for the charge. The information on the AE has been well known for decades [10], the hazards are in product labelling, the drug is one of the most effective anti-seizure medications ever discovered, and alternative therapies commonly have similar (if not worse) teratogenic effects [11]. Furthermore, the hazards to the foetus of untreated maternal 1 The Misuse of Drugs Act 1971 s.28 (3) provides the commonly used defence of ignorance that a substance is a controlled drug. A claim of taking possession to prevent a further offence by either destroying the substance or delivering it to an authorised person (e.g. ‘I was going to turn it in at the Police Station on the following day’) can also be used as a defence. The Misuse of Drugs Act 1971 ss.4 (1)-(3) and 5(3) for supplying, in general; The Misuse of Drugs Act (Amendment) Order 2009 (no.3209) s.2 (3)(b)(i)-(xi) for anabolic steroids, in particular. Vol.:(0123456789) 366 epilepsy have been well-known since the 19th century: they are devastating and, nowadays, no placebo-controlled trial of anti-seizure medications in pregnancy would be ethical [12]. That seems to leave financial gain as the French Government’s most likely motive. The legal system is inquisitorial in France, and the company has responded stoically that it will defend itself, and use this false charge as an opportunity to ‘prove it has always complied with its duty to inform, and has been transparent’. The case continues. Dr. John Kapoor was the founder of Insys Therapeutics (Chandler, Arizona). While the company was filing amendments to its Chapter 11 Bankruptcy arrangements in the Spring, Dr. Kapoor was sentenced to five and a half years in prison (four of his colleagues got lesser sentences) [13]. The proximate reason for this, the courts found, was the payment of bribes to encourage greater prescribing of a fentanyl sublingual spray. The scheme involved the sales’ people at Insys Therapeutics, and even a nurse practitioner in a Connecticut pain clinic. At previous companies, Dr. Kapoor had been associated with major manufacturing violations, and failure to train a low-salary salesforce motivated by large bonuses based on territory prescription volumes. In short, Dr. Kapoor is a rogue violator of everything that modern, ethical pharmaceutical marketing is meant to be. It is a pity that the press will doubtless extrapolate this to other pharmaceutical companies, and conflate it with the heightened sensitivities of the epidemic of opioid over-use in the USA. Price-fixing usually requires collusion amongst competitors. In the UK, this is a violation of a variety of commercial laws, and is enforced by the Competition and Markets Authority. In March, four small pharma companies were found to be colluding. The miscreants conspired to carve up the market by creating monopolies for each dose size of generic nortriptyline [14]. Penalties are limited to 10% of global turnover, and therefore the fines ranged from £75,573 to £1,882,238 for what was essentially the same conduct. Three of the four companies admitted the offence, and, perhaps unjustly, the company that did not admit the offence did not get the largest fine. An unexpected newcomer to p (...truncated)