Rosiglitazone and the need for a new drug safety agencyBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c5506 (Published 06 October 2010) Cite this as: BMJ 2010;341:c5506
All rapid responses
I am not surprised that the director and the head of a drug
regulatory policies laboratory want to set up a new safety evaluation
agency but I am surprised by their statement "that many patients developed
heart disease while seeing no significant improvement in their diabetes".
I cannot see why any patient would continue taking any drug designed
to reduce blood glucose unless it had a positive effect. Rosiglitasone
caused the obvious unwelcome side effects of weight increase and fluid
retention that patients would only continue taking it if they could see
the benefit of a "significant" improvement in their HbA1c. In my
experience there were many such patients, who are now taking pioglitazone.
Competing interests: No competing interests
On the 17th and 18th June 2010 in Ditchley Park, Oxfordshire we
organised a workshop on how a pharmaceutical transparency initiative
should best look like in Europe. Based on this meeting and the subsequent
discussions that followed we believe that for the European Medicines
Agency, or for any nation state medical/pharma regulatory body, the
following measures must be taken for a European pharmaceutical
transparency initiative to be successful.
a) Acknowledge that there is more than just one form of transparency.
For example, putting everything out in the open, such as data dumping on
the internet, does not lead to better decision making or to informed
patients and publics. Rather, in many cases, the opposite is the case.
What is now needed is a form of rational or reasoned transparency in which
regulators and other bodies explain the decisions they took in an open and
b) Any transparency initiative must be underpinned by the best available
communication science. Too often initiatives put forward in the
pharmaceutical, food, environmental and other sectors are based on input
from stakeholder consultations without paying attention to communication
c) All transparency initiatives, as any risk communication programme,
should be properly evaluated. Evaluation leads to better, more thoughtful
and robust transparency initiatives;
d) Realise that any transparency initiative by itself does not
automatically lead to better informed publics or patients. Any initiative
must be coupled with tools and skills ensuring that the publics and
patients have the ability to understand it.
e) Understand that transparency initiatives may have benefits as well as
negative consequences associated with it. These initiatives, many put in
place for political rather scientific reasons, raises the expectations of
the members of the public, which in many cases simply cannot be met. In
such circumstances, the trust and credibility of the transparency
initiator will decline;
f) Realise that different nations will benefit from better coordinating
their transparency initiatives. Different levels of openness in a wide
array of nations/trade blocks will lead to calls of unfairness, and
attempts by outside stakeholders to pull up the "openness laggards" to the
same level as the "openness leaders" sometimes with disastrous
consequences due to differences in cultural norms and societal
King's College London
University of Maastricht
We are grateful for the comments and advice received from the participants
at this meeting. Materials, assistance and advice were provided by the
Dutch Medicines Evaluation Board (CBG-MEB), Eli Lilly, the European
Medicines Agency (EMA), The US Food and Drug Administration (US FDA), the
Irish Medicines Board (IMB), the UK Medicines and Healthcare products
Regulatory Agency (MHRA) and the Swedish Medical Products Agency (MPA).
The funding of the meeting was provided in part by grants from Eli Lilly
and Roche. Specific travel costs were covered by the CBG-MEB and the MPA.
We are grateful to the following individuals who have provided us with
materials or who have commented on an earlier draft of this paper: Jane
Alquist, Sir Alastair Breckenridge, Baruch Fischhoff, Hans Georg Eichler,
Andrew Jack, Deborah Szafir, as well as officials at CBG-MEB, EMA, US FDA,
MHRA, and MPA. All the remaining errors remain our own.
The Corresponding Author has the right to grant on behalf of all
authors and does grant on behalf of all authors, an exclusive licence (or
non exclusive for government employees) on a worldwide basis to the BMJ
Publishing Group Ltd and its Licensees to permit this article (if
accepted) to be published in BMJ editions and any other BMJPGL products
and sublicences to exploit all subsidiary rights, as set out in our
Competing interests: No competing interests