The Pharmaceutical Year That Was, 2014

Abstract

Last year ended with Europe still wallowing in its Eurocrisis, the promise of a Pharmacovigilance Risk Assessment Committee (PRAC) getting into its stride, and the great ‘EMA will be giving away your data’ controversy [1]. One useful thing that PRAC has started doing is announcing the safety signals that it is interested in. This is particularly valuable because such signals may transcend pharmacological class of drug, and rare hazards may only be identifiable with data drawn from multiple products and manufacturers. At about 17 pages each month, the PRAC agenda is an intimidating document. One wonders whether a more efficient system of sub-committees could be devised. As for the EMA transparency initiative, the publication of data process has come to resemble a Freedom of Information request process. The requester applies to EMA, who then notifies the clinical trial sponsor or Marketing Authorization applicant which documents are involved. The permitted redactions are very narrow: mostly restricted to information that could lead to the identification of a patient, and some junior company employees. However, the names of those who are responsible for each aspect of the study in the sponsor’s organisation cannot be redacted, and neither can the identities of principal and associate clinical investigators. However, the EMA has a selective view of transparency [2]. While happy enough to distribute other peoples’ data, the EMA does not share the identity of the requester with the study or application sponsor. The volume of requests has also not been published (one or two pharmacovigilance specialists in different companies describe receiving requests at up to weekly frequency; personal communication). Since risk management plans are also now required in a template that is publication-ready, it is a reasonable presumption that these are popular publications. The EMA have not made any attempt to assess the impact of publishing all these data; since the destination and quantity of publication is unknown (except to the EMA), there cannot be any independent assessment of whether any harm or benefit, is happening. That’s doubtless the way the EMA wants it. Pfizer’s failed flirt with AstraZeneca must be the large pharma event of the year. Three or four priced offers became public knowledge, although the deal structures (e.g., cash/stock components, etc.) were often unclear. Amusingly, the proffered rationale for the transaction evolved within a period of several weeks. Initially, it was to support the Pfizer drug development pipeline. The R&D going on at AstraZeneca was a great compliment. Then people noticed Pfizer’s large cash stockpile, and an acquisition favoured paying less corporation tax in the USA. It then turned out that cash stockpile was not in the USA at all, but in various low-tax paradise islands. With the newspapers’ opinions declining, Pfizer then stated that post-merger it would move its headquarters to the UK, and become a British company. That remarkable offer was promptly termed a ‘tax inversion’. So, then the politicians got involved. If they had been angling in the back rooms before, the politicians on both sides of the Atlantic now came out against Pfizer in public. On May 14, 2014, the A.W. Fox is the Consulting Editor for Pharmaceutical Medicine.