December 3, 2012
At a recent lunch in the European Parliament I met a hero of mine, Dr Ben Goldacre, author of Bad Pharma, a great book on science and medicine in the pharmaceutical industry. It is a worthy follow-up to his earlier best seller Bad Science, also a favorite of mine.
“Bad Pharma” is not anti-industry but rather an argument that the industry must do better. It is a carefully argued and evidence based analysis of how science is conducted and used by the pharmaceutical industry. It sets out the problems that inhibit good science, including publication bias, lack of transparency, methods of marketing, and undue influence. It does describe some instances of outright deceit but even without those examples the case for urgent reform is compelling.
It should be compulsory reading for everybody working on the proposal to update the Clinical Trials Directive.
Responding quickly to the publication of extracts from the book, the Association of the British Pharmaceutical Industry stated that “it contests some of the assertions made in the article” and “that the examples he refers to are long documented and historical, and the companies concerned have long addressed these issues”. This last claim was flatly and effectively rejected by Ben Goldacre in his Guardian column here.
(Now, people who have done something bad in the past will naturally claim that they won’t do it again, but are assurances enough in these cases?)
The rest of the APBI response was mostly a set of standard statements of the importance of the industry, a point that had never been denied, but one sentence was absurd:
“The pharmaceutical industry seeks full transparency and discloses all data in-line with international standards such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice”
In other words, they will disclose what they want according to standards and rules they make up for themselves.
EFPIA, the EU level equivalent of the ABPI tends to make similar positive and soothing statements in favour of this or that good thing. In response to my question at a seminar sometime ago about access to clinical data the EFPIA Director General Richard Bergstrom said simply that EFPIA was in favour of transparency and access to data. Well, yes they are, but only on their own terms.
Voluntary or pro-active transparency is rare. Most clinical data that is released has come about by law or by recommendations of the European Ombudsman, and against the will of their industry.