Healthy Skepticism Library item: 18278

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Sweet M
Lessons from the HRT story
BMJ 2003 Jan 4; 326:(7379):58
http://www.bmj.com/cgi/content/full/326/7379/58

Abstract:

The media must become more critical of unproven interventions

This was not simply because the findings were so significant, in challenging long held assumptions about the merits of hormone replacement therapy (HRT) in disease prevention. Of equal interest has been the diversity of the medical profession’s response to the findings.

The trial, part of which was published last year (JAMA 2002;288:321-33)[Abstract/Free Full Text], showed increased risk of cardiovascular events from continuous combined oestrogen-progestogen hormone replacement, although it showed benefits for hip fractures and bowel cancer. The relative risks for invasive breast cancer, coronary heart disease, and stroke were increased, although the absolute risks were small.

Soon after the study’s publication, Canadian epidemiologist Professor David Sackett wrote of the “arrogance” of preventive medicine in promoting unproven interventions and estimated that hundreds of thousands of healthy women had been harmed as a result of HRT’s widespread use.

But others questioned or sought to downplay the significance of the findings. In Australia, eminent specialists were quoted in the media saying that the fallout from the study was a “beat up” and that women should continue to take HRT, and that it would be a “knee jerk reaction” to stop doing so.

Others said it could not be assumed that the findings would apply to other HRT products, and compared the increased breast cancer risk with that of having a few drinks a day. Another wrote: “No women on HRT should stop therapy simply because of poorly handled publicity which made mild risks seem like major ones.”

Many specialists were critical of the media coverage and of the New South Wales Cancer Council, which issued a release highlighting the increased relative risk for breast cancer, for provoking public alarm.

Several months later, the dust is yet to settle. The Australasian Menopause Society (AMS) recently refused to endorse New Zealand guidelines on HRT, which had been updated to take account of the women’s health initiative findings.

The guidelines, produced by the New Zealand Guidelines Group, say that combined HRT is not recommended for long term use except in limited circumstances, that even short term use is associated with risk, and that HRT should be used only where menopausal symptoms are troublesome and women are fully informed of the risks.

The Australasian Menopause Society argues, however, that sections of the guidelines are “alarmist,” “overly proscriptive,” and likely to “become a useful tool for lawyers looking to cause trouble.”

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists says that it is still reviewing the guidelines.

The varying reactions to the women’s health initiative findings can be viewed in many lights. They reflect the scientific process of critical assessment of new findings; that interpretation of evidence inevitably involves subjective judgment; the difficulty of coming to terms with unexpected new evidence and of relinquishing entrenched beliefs and practices; the varying perspectives of clinicians versus those with a broader, population based focus; and battles over professional turf.

They may also reflect damage control. For industries confronted with negative research, a major aim of crisis management—-as the tobacco industry has so ably shown—-is to create confusion and argument about the significance of the findings.

Many have criticised the media’s coverage of the study for provoking unnecessary alarm by reporting the increase in relative risk of harms, rather than the absolute risk. The irony, of course, is that the presumed benefits of HRT in preventing heart disease were widely promoted, through the media and elsewhere, in terms of relative risk reduction, as are many other medical interventions.

Another criticism of the media might be that for many years we were too ready to promote enthusiasts’ beliefs about the benefits of HRT—-whose very name, some argue, is a marketing rather than a scientific term.

We often failed to ask the experts that we quoted enough tough questions about what evidence was available to support their claims, or about their conflicts of interest.

We also often failed to appreciate that studies providing evidence suggestive of benefit—-laboratory research, studies looking at surrogate measures in humans (such as effect on cholesterol), and observational studies examining the differences between women who elected to take HRT and those who didn’t—-provided less reliable evidence than randomised trials such as that of the women’s health initiative.

It’s not only the medical profession and drug regulators who have had a painful lesson from this study. The media also have a lesson to learn about the pitfalls of premature enthusiasm for unproven interventions and uncritical amplification of experts’ claims.