In response to the Reboxitine affair, Steinbrook and Kassirer suggest
that "A desirable situation would be for considerably more trials to be
sponsored, funded and conducted by organisations that are independent of
industry" . We agree wholeheartedly. Indeed we are operating close to that
model with one safety study and with another trial planned to start next
year.
Both of these studies were requested by the European Medicines
Agency, the protocols were written by the investigators and owned by a
University. The collaborating centres are all academic. The resulting
study databases are owned by the trial steering committees that have no
voting industry members. The steering committees also controls all
publications and the trial sponsor is a University. Grant funding comes
from industry but they have no role in the conduct of the study or the
collection or interpretation of data.
This sounds close to Steinbrook and Kassirers' desirable model with
the exception that funding still comes from industry. However, for
practical purposes only industry has the considerable funding required to
carry out these large, expensive studies.
So is everything rosy? Unfortunately it is not.
In the UK many primary care practices regard these studies as purely
commercial and are reluctant to participate. As a result recruitment of
practices is difficult. Also, the Danish board of medicines has chosen to
classify these academically-sponsored studies as 'commercial'. As a
result, they now require participating Danish practices to register that
they are doing commercial research. Danish practices are not keen on doing
this and many now wish to withdraw from the research network because of
this. The Danish principal investigator has tried to get this decision
reversed but with no success. This now threatens the viability of doing
further studies in Denmark to the detriment of everyone.
We have specifically sought to do drug safety research at 'arms
length' from the Industry. Were it to be applied widely, we believe that
our model would obviate many of the issues perceived to be problematic
with current industry-sponsored research. We believe that this would be in
the public interest.
Our concern is that academic sponsorship is not regarded or treated
as 'independent' and that our research efforts are still seen as wholly
commercial. The decision by the Danish Medicines Board will result in no
good outcome for anyone; indeed we think their decision retrogressive and
against the public interest.
We hope that more enlightened agencies will view academic ownership
and sponsorship of research more positively. There will be no hiding of
results by us.
Yours sincerely
Competing interests:
The three authors form the executive of a trial that is funded by Pfizer.
11 November 2010
Tom M MacDonald
Professor, University of Dundee
Christopher J Hawkey, University of Nottingham, Ian Ford, University of Glasgow
University of Dundee, Ninewells Hospital & Medical School, Dundee DD1 9SY
Rapid Response:
Academic sponsorship: still commercial?
Dear Editor
In response to the Reboxitine affair, Steinbrook and Kassirer suggest
that "A desirable situation would be for considerably more trials to be
sponsored, funded and conducted by organisations that are independent of
industry" . We agree wholeheartedly. Indeed we are operating close to that
model with one safety study and with another trial planned to start next
year.
Both of these studies were requested by the European Medicines
Agency, the protocols were written by the investigators and owned by a
University. The collaborating centres are all academic. The resulting
study databases are owned by the trial steering committees that have no
voting industry members. The steering committees also controls all
publications and the trial sponsor is a University. Grant funding comes
from industry but they have no role in the conduct of the study or the
collection or interpretation of data.
This sounds close to Steinbrook and Kassirers' desirable model with
the exception that funding still comes from industry. However, for
practical purposes only industry has the considerable funding required to
carry out these large, expensive studies.
So is everything rosy? Unfortunately it is not.
In the UK many primary care practices regard these studies as purely
commercial and are reluctant to participate. As a result recruitment of
practices is difficult. Also, the Danish board of medicines has chosen to
classify these academically-sponsored studies as 'commercial'. As a
result, they now require participating Danish practices to register that
they are doing commercial research. Danish practices are not keen on doing
this and many now wish to withdraw from the research network because of
this. The Danish principal investigator has tried to get this decision
reversed but with no success. This now threatens the viability of doing
further studies in Denmark to the detriment of everyone.
We have specifically sought to do drug safety research at 'arms
length' from the Industry. Were it to be applied widely, we believe that
our model would obviate many of the issues perceived to be problematic
with current industry-sponsored research. We believe that this would be in
the public interest.
Our concern is that academic sponsorship is not regarded or treated
as 'independent' and that our research efforts are still seen as wholly
commercial. The decision by the Danish Medicines Board will result in no
good outcome for anyone; indeed we think their decision retrogressive and
against the public interest.
We hope that more enlightened agencies will view academic ownership
and sponsorship of research more positively. There will be no hiding of
results by us.
Yours sincerely
Competing interests: The three authors form the executive of a trial that is funded by Pfizer.