Tag Archives: sex-specific analysis

Report research results separately to ensure new medicines are safe and effective for both sexes

19 Mar

“Women are not small men,” said Jeanine Roeters van Lennep. of the Erasmus Medical Centre in Rotterdam (right):

“There are biological differences in hormones and body composition. Women have smaller kidneys so it’s more difficult to clear medication. They have a different fat and water composition.”

A study published in February showed that trials were more likely to report results for women separately if they had a female lead author, with only one in three papers reporting results separately. The Lancet, which published that research, is one of the few major journals that tell researchers to analyse separately.

Research on drugs withdrawn from the market published by the United States General Accounting Office found that eight out of ten drugs withdrawn from the market between 1997 and 2001, after approval in the US, turned out to have higher health risks for women.

One example was Posicor, which was approved for the treatment of hypertension and angina and slowed or stopped the heart rate in otherwise healthy people, especially elderly women, and interacted with 26 different drugs.

Cholesterol-lowering statins are Britain’s most commonly prescribed medicine but in 45 trials Dr van Lennep analysed, 82% of those studied were men and only five trials made data available on men and women separately. This meant that there was not enough data to show statins prevented heart attacks, strokes and deaths in women with an acceptable number of side-effects, unlike for men.

She said it was probable that statins did work for women, with previous studies suggesting a similar benefit for both sexes, and is not advising women prescribed them to stop. However, she argues, doctors cannot be certain because of sexism which is largely unconscious:

“It’s shocking. Men forget to do sex-specific analysis, to be really polite about it. If 50% of the population is female you can’t just say it’s an optional extra. It’s a blind spot because right now the triallists are generally men. I don’t think it’s malice that they don’t want to perform this analysis; they just really don’t think about it . . . We think journals should make it compulsory to report results for men and women separately.”

A Times article summarises the problem: doctors argue that an absence of women in clinical trials and failure to report results by sex have resulted in an evidence gap that is likely to be hampering treatment. They insist that medical journals should force researchers to report results for men and women separately to be sure that new medicines are safe and effective for both sexes.

 

 

 

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