Clinical trials often failing to report results for sex and gender, despite the fact many drugs cause adverse effects in women
Women are being ignored in medical trials and reports, according to a report which calls for more Australian medical research to include gender-specific data.
Failing to account for the different effects a drug may have on men and women compromises quality of care for women, according to the report published in the Medical Journal of Australia on Monday.
“Historically and consistently across a broad range of health domains, data have been collected from men and generalised to women,” the authors of Sex and Gender in Health Research: Updating Policy to Reflect Evidence wrote.
The result is a gender bias in medicine, leading to poorer outcomes for women across illnesses common in both men and women and a lack of knowledge on conditions that mainly affect women.
“Failure to appreciate the differences between and across the sex and gender spectrum risks compromising the quality of care and increasing costs due to inappropriate allocation of resources,” the authors write.
Co-author and neurologist Dr Cheryl Carcel said the federal government needed to ensure sex and gender differences were included in future research.
Clinical trials “quite often” don’t report specific results for males and females, according to Carcel. Drugs which may be effective for both men and women could cause worse side effects in women.
Of the 10 prescription drugs taken off the market by the US Food and Drug Administration between 1997 and 2000 due to severe adverse effects, eight caused greater health risks in women. A 2018 study found this was a result of “serious male biases in basic, preclinical and clinical research”.
A 2010 study by Annaliese Beery and Irving Zucker reviewed sex bias in research on mammals in 10 biological fields during 2009 and their historical precedents. It found male bias was evident in eight disciplines, with neuroscience the worst offender, with single-sex studies of male animals outnumbering those of females 5.5 to 1. “Under-representation of females in animal models of disease is also commonplace, and our understanding of female biology is compromised by these deficiencies,” the authors wrote.
The study also found the justification that researchers gave for excluding female animals – that it introduced too much variability in results – to be “without foundation”.
Monday’s report by Carcel and Dr Zoe Wainer recommended health bodies, researchers and governments develop guidelines and regulations on the issue.
“This is not simply a women’s or men’s health issue, but an issue for all Australians,” it said.
Carcel, a senior fellow at the George Institute for Global Health, said some medical research only tested male genes.
She pointed to a HIV treatment drug in the United States that was approved only for men because researchers never tested it on women.
In Australia, Carcel said they found women were not getting checked as much as men for cardiovascular disease risks. A report published in the Medical Journal of Australia in 2018 found that women who suffered a serious heart attack were half as likely to be treated properly in an Australian hospital as men and twice as likely to die six months after discharge.
The paper also said researchers should get extra funding to ensure sex and gender data was included. In response to increasing knowledge of the gender health gap worldwide, other countries have implemented changes to ensure clinical trials include women, preclinical trials include female rodents and that results are analysed by sex and gender.
The implementation of sex and gender analyses should be managed as an ethical issue by university and higher education ethics committees, Carcel and Wainer said, and medical colleges should include evidence-based sex and gender integration in clinical guidelines and funding for research and training.
“In the absence of implementing these, there is a risk that Australia will fail to keep pace with the rest of the world and, in turn, will become increasingly less competitive when applying for funding from international bodies and will reduce international partnership opportunities with overseas organisations,” the paper said.
Carcel said funding bodies and medical journals should require the medical researchers deliver data on both men and women.
Asked when all of this needs to happen, Carcel simply said “yesterday”.
“I don’t know why it’s taken Australia this long to get on board because it’s certainly been happening in other countries,” she said.
“So we are really lagging behind.”
The Medical Journal of Australia said a growing number of countries had already begun requiring the integration of sex and gender analyses in journal publications and competitive research grants.
All applicants for grants from the Canadian Institutes of Health Research must answer sex and gender questions in their proposals, and the institutes also provide training modules on sex and gender in biomedical research for scientists and peer reviewers.
Australia’s National Health and Medical Research Council and the Diabetes Australia organisation both have policies on collecting, analysing and reporting sex and gender-specific health data, but only the council specifically recommends reporting. Four of the 10 Australian journals interviewed by the researchers did not have such policies.
Australian Associated Press contributed to this report
Source: The Guardian
Author: Guardian staff and agencies