6 November 2019

Just when GPs thought it was safe to go back into HRT waters

Clinical Endocrinology Research Women

Concerned about recent HRT breast cancer studies and how it might impact your thinking on HRT? CLICK HERE to register for an expert panel webinar on the findings tonight at 7pm AEST

In shades of the notorious 2002 JAMA Women’s Health Initiative (WHI) HRT paper [1] that saw a generation of women abandoning HRT, it appears that a recent Lancet HRT meta-analysis paper looking at breast cancer risk is causing some alarm among Australian GPs on how to now approach menopause with their patients.

In a survey run recently by education provider HealthEd, answered by more than 200 GPs, more than 50% reported that they were a lot more concerned about the risk of breast cancer associated with the use of hormones for menopausal symptoms than prior to the recent Lancet publication [2].

In the 2002 event, as well as the results of the paper being grossly misinterpreted by the global media, it was apparent that medico politics was at play in how quickly the paper was published without consultation of key contributors.

After the fact many senior doctors in the actual WHI program complained they had not been consulted, and others later admitted the medical establishment was wanting to make a point to the pharmaceutical industry. Most of the high level interpretations made of the 2002 JAMA paper were soon found to be overblown or incorrect. The actual relative increase was 26% from 30 to 38 in 10,000 women. One following US study in 2011 estimated that one outcome of the JAMA paper might have been that 50,000 hysterectomised women may have died early as a result of stopping their oestrogen-only therapy.

The Lancet paper has some hint of medico-politics potentially being at play, but this time between different cohorts of specialists in the field.

The paper was a meta-analysis of data from 58 observational studies involving more than 600,000 postmenopausal women, of whom 108,000 had developed breast cancer between 1992 and 2018. Observational means that none of the studies involved randomised blind trials.

Critics immediately pointed out the significant floors in pooling observational studies, that the study had a median diagnosis year of 1999, so did not take into account significant new therapy changes practised today, that again, in the context of overall rates of breast cancer, the risk increase is very small,  and that the paper selectively reports data in parts.

Some experts are concerned there will be behavioural change in both how GPs treat the condition and how patients respond to this latest breast cancer finding.

Most of the critics of the paper are HRT practising doctors – GPs, endocrinologists and sexual health specialists – who see patients, where most of the study authors are epidemiologists.

Tonight, at 7pm AEST, HealthEd will be holding a webcast with a group of specialists aiming to address this high level of new concern among Australia’s GPs.

And it doesn’t feel likely that HealthEd’s expert panel is going to hold back on their views as coal-face HRT practising clinicians.

HealthEd’s panel includes Dr Terri Foran,S exual Health Physician at the Royal Hospital for Women in Sydney; Dr Sonia Davidson, an endocrinologist and the president of the Australian Menopause Society; Dr Bronwyn Stuckey, a clinical endocrinologist at Sir Charles Gardiner Hospital; and Dr Elizabeth Farrell, a gynaecologist and Head of the Menopause Unit at Monash Medical Centre.

A theme likely to emerge between this group, which is sure to be controversial, is that the Lancet paper study has lots of potential flaws given the author conclusions, and, that the authors are mostly epidemiologists, who aren’t seeing HRT patients.

Some of the experts in tonight’s panel have already argued that because epidemiologists never sit in front of women who are suffering terribly, how they interpret what they are observing in their numbers can be affected; that quite apart from the Lancet paper mashing up various non-randomised controlled studies, which is a poorer data set to be making specific findings for one condition, the absence of face-to-face clinical experience in making broad conclusions around such data, can be problematic.

In defence of endocrinologists,  Dr Steven Birrell, a surgical oncologist and researcher, responded to comments in TMR by Dr Sue Davis [3] by saying “sometimes when one has been fighting for a long time you do not realise a friend from an enemy. Epidemiologists are not the enemy. They point clinicians to a problem so they can find a solution, and to that end, randomised controlled trials are only a part, not the whole, solution”. He then goes on to list the important points in history where epidemiology have contributed significantly to how treatment is looked at.

There are no epidemiologists on tonight’s webcast. It should make for some intriguing watching. CLICK HERE to register if want to see tonight’s webcast

References

  1. JAMA. 2002 Dec 11;288(22):2819
  2. Lancet 394 (10294) 1159-1168, Sept 28, 2019
  3. Birrell, S, The Medical Republic, Oct 14, 2019