Better use of data could have predicted HRT risk earlier
The risks associated with hormone replacement therapy would have been revealed earlier if better use had been made of existing evidence. This is the view of researchers from Oxford and Finland who suggest that many women were needlessly exposed to an increased risk of heart disease while taking HRT (BMJ 2004;328:518).
The US Women’s Health Initiative study was stopped prematurely
in 2002 after showing an increased risk of cardiovascular events from
combined HRT. However, before publication of this study, the above researchers
had analysed 23 small trials of HRT and found that it was not as protective
as observational data had indicated. Many of these trials had been carried
out by pharmaceutical companies to obtain drug licences.
The researchers were criticised when they published their findings in
1997 but extra data from six further studies not in the public domain
confirmed their concerns. These data were obtained in Finland, ultimately
by resorting to the Finnish High Court. The authors say that obtaining
such data in the UK would not have been possible.
They say that regulators should require drug manufacturers to record
adverse effects and make the results public. “Regulators should
require that all efficacy studies record all outcomes, whether or not
they are thought contextually relevant.”
Such studies should be in registers of clinical trials, with data available
to independent scientists and regulators should anxieties arise, they
add. |
The
Pharmaceutical Journal