[e-drug] NEJM this week: Clinical trials ethics

[Kirsten Myhr <myhr@online.no>]

E-drug: NEJM this week: Clinical trials ethics
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[Copied and translated from an e-mail list for Norwegian GPs.
Thanks to Hogne Sandvik, see below, instrumental in the
international protest against the WHO hypertension guidelines. KM]

In this week's issue of the New England Journal of Medicine
(http://content.nejm.org/, unfortunately only freely available after 6
months) three randomised, placebo-controlled studies of
All-antagonists for treatment of diabetes-2 nephropathy are
published. All patients were also undergoing treatment for
hypertension. Two studies used irbesartan, they were sponsored by
Sanofi and BMS, one study used losartan, sponsored by Merck.

All studies show that All-antagonists restrain the devlopment of
nephropathy. So far so good? However, the accompanying edito-
rials question the research ethics. Why did they use All-antagonists
and not ACE-inhibitors? Or why did they not at least compare
All-antagonists with ACE-inhibitors?

The editorials are interesting in the debate on drug patents and drug
costs. Here is one quote:

"The costs of the two classes of drugs have already begun to
distinguish them from one another. Patent protection will lapse
sooner for ACE inhibitors, and therefore the prices of
angiotensin-receptor blockers will remain higher for longer. Another
likely reason why ACE inhibitors were not tested in the present
trials was that sales of angiotensin-receptor blockers would be
lower if the two classes of drugs proved equally effective. We must
focus more attention on the regrettable tendency of study sponsors
to drop good drugs from important trials when their patents expire
and the drugs therefore become less profitable. The legitimate need
to develop and profit from new compounds must be explicitly
balanced against the obligation to test established and effective,
but cheaper, agents. An imbalance is too common, and as a result,
trial design blurs into marketing strategy."

Hogne Sandvik, MD PhD, General Practitioner, Bergen, Norway
Hogne.Sandvik@isf.uib.no - http://www.uib.no/isf/people/hogne.htm

Kirsten Myhr
Head of Eastern Region Drug Information Centre

RELIS Ost
Ulleval University Hospital
0407 Oslo, Norway
Tel.: +47 23 01 64 11(o)  Fax: +47 23 01 64 10
+47 22 56 05 85 (h)  mobile: +47 416 38 747
myhr@online.no (h)
kirsten.myhr@relis.ulleval.no (o)
www.relis.no


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