December 9, 2013
There have been many serious cases of mis-selling and off-label promotion of medicines in the US. Could the same thing be happening here, or do pharmaceutical companies behave better on this side of the Atlantic?
For my BMJ blog I compiled a table of cases taken by the US Department of Justice since 2004 involving off-label promotion, where the company had to pay over $300 000 in fines, penalties and/or settlements – you can see the table here.
Of the seventeen companies listed, at least seven were among the top ten companies by sales in recent years – see below (1)
Of the medicines involved, at least twelve were among the top ten selling branded medicines for one year or more – the kind of medicines that would be followed closely by the CEO and other senior executives of the companies concerned -see below (2).
It seems clear therefore that off-label promotion was more than a temporary lapse or oversight by just a few companies.
In some cases the company pleaded guilty to one or more charge. In others, a settlement was agreed without any admission on the part of the company.
The forms of mis-selling were many and various – promoting for children medicines approved only for adults, selling on the basis of symptoms when the same symptoms (e.g. dementia) may have many different causes, withholding publication of inconvenient trial results, citing partial results of trials that were never subject to regulatory review, paying doctors to recommend off-label uses etc.
So, is this also happening in Europe? We don’t know. We have 28 member states, with nearly as many languages, with medicines agencies and enforcement authorities of varying size and sophistication. There is also a problem of transparency. Compared to the US, we know little about payments to doctors (or political parties) in Europe. Access to data in national medicines agencies is often very limited.The lack of public access to clinical trial data also facilitates mis-selling. Information on sales, marketing and the uses of medicines can be very patchy, or expensive to obtain.
Against that background it is difficult to believe that pharmaceutical companies behave very much better here than in the US.
Anyone care to comment?
(1) Abbott, Eli Lilly,GSK, J&J, Merck, Novartis, Pfizer
(2) Abilify, Aranesp, Epogen, Lexapro, Lyrica, Neurontin, Oxycontin,Paxil, Risperdal, Seroquel, Vioxx, Zyprexa,