The Pharmaceutical Year That Was, 2018
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EDITORIAL
The Pharmaceutical Year That Was, 2018 Anthony W. Fox1 Published online: 12 November 2018 © Springer Nature Switzerland AG 2018
As usual, 2018 has been eventful. Some unfinished business has been dealt with, while other unfinished business has become even more unfinished! Readers may remember the case of Dr. Martin Shrekli who featured in this review 2 years ago [1]. After founding Turing Pharmaceuticals, Shrekli acquired the US marketing rights for pyrimethamine, which is used to treat toxoplasmosis, especially in immunocompromised patients. Although well-past its patent expiration, Turing was the sole supplier of this small-volume product, and Shrekli abruptly increased its price from US$13.50 to US$750 per dose. Previously, Shrekli had led two failing hedge funds, and had founded another pharmaceutical company. Shrekli evidently siphoned funds out of his pharmaceutical companies so as to pay investors who had lost money with his hedge funds. Meanwhile, the Trump Presidential campaign was claiming that pharmaceutical company ‘price gouging’ was a widespread problem, with Turing as its greatest example (the extent of the problem was largely contradicted by a White House report in February [2]). In March, the Brooklyn court handed down its sentence for fraud: fines and restitution of US$7.43 million, plus a jail term. Pending US Food and Drug Administration (FDA) blacklisting, it will be at least 7 years before Martin Shrekli can again visit the FDA in Rockville, Maryland [3]. Meanwhile, readers may remember the £90 million fine meted out last year by the UK Competition and Markets Authority (CMA): Pfizer had price-gouged with a humble centenarian, namely phenytoin [4]. Remarkably, on appeal, this fine was overturned in June. The Judicial Review ruled that the CMA did not “appropriately consider the right economic value of the capsules” and “did not make suitable comparisons with other drugs.” On 8 June, the CMA was “actively considering” whether to appeal further [5]. While, * Anthony W. Fox [email protected] 1
Pharmaceutical Medicine Group, Faculty of Life Sciences and Medicine, King’s College London, Room 3.35 Franklin‑Wilkins Building, 150 Stamford Street, London SW1 9NH, UK
a priori, the overnight, more than tenfold increase in the price of an ancient drug seems outrageous, the silver lining to the cloud is that there is at least one small part of the establishment that is willing to contemplate the fact that pharmaceutical products actually do have some true value. The ClinicalTrials.gov database was put to good use this year in what must be the largest audit of registered clinical trials to date [6, 7]. Some 45,620 clinical trials were audited for funding (industry/National Institutes of Health/other), medical specialty, and design type (randomised/non-randomised, placebo-controlled/-uncontrolled, crossover/parallel-group, etc.). The dissemination (i.e. publication) rates for the three different classes of funding were also investigated. Both small molecules and biological products were inclu
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