Risks of HRT Could Were Known Much Earlier

March 3, 2004

Risks of HRT Could Have Been Revealed Much Earlier

Provided by NEWSWISE/Medical News on 2/25/2004

Risks of HRT Could Have Been Revealed Much Earlier

Source: British Medical Journal

NEWSWISE Medical News, 25-Feb-2004 --

BMJ 28 February 2004 edition

Synthesising licensing data to assess drug safety BMJ Vol 328, pp 518-20

The risks of hormone replacement therapy would have been revealed much earlier

if better use had been made of existing evidence. As such, women have been

needlessly exposed to an increased risk of heart disease, argue researchers in

this week's BMJ.

The large US Women's Health Initiative trial was stopped prematurely in 2002

after showing an increased risk of cardiovascular events from combined hormone

replacement therapy.

However, well before the Women's Health Initiative trial was published, the

authors analysed 23 small trials of hormone replacement therapies and found that

they were not as protective as the observational data had shown. Many of these

trials were done by pharmaceutical companies to obtain drug licences and were

not publicly available.

When they published their findings in 1997, they were ridiculed. But extra data

from six further studies confirmed their concerns. High Court dispensation was

required to access these trials.

If trials done by pharmaceutical companies for licensing purposes had to include

adequate data on harms and ineffectiveness, we could learn much more quickly

what we need to know about new drugs, say the authors.

Regulators should require drug manufacturers to record adverse events and make

the results public, they conclude.

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