EDITORIAL

 

More evidence against hormone replacement therapy in menopause

 

 

In 2002, hormone replacement therapy (HRT) for menopausal women gained media visibility based on the results of the Women's Health Initiative study (JAMA 2002; 288:321-33). The estimates indicated an increase in the risk of cardiovascular disease and breast cancer among users of estrogens and progesterone. The final part of the study was concluded in 2004: estrogen use was associated with increased risk of stroke (BMJ News 2004; 328:540). Other studies identified further complications: an increase in cases of dementia, mainly Alzheimer disease, as well as late diagnosis of colorectal cancer among users. Specialists concluded that the harm associated with HRT outweighs the benefits.

However, since the 1990s it had already been suspected that even the purported benefits of HRT resulted from distortions in observational studies, in which it was impossible to completely control for the presence of other protective factors. The observed protection was not related to the medication, but resulted from a selection bias. Despite the evidence, Brazilian government agencies and academic institutions remained silent on the subject, thereby jeopardizing treatment decisions by clinicians. Difficulties exist even for those with a solid background in epidemiology and pharmacology; other health professionals remain at the mercy of biased information furnished by drug manufacturers.

According to Sackett (CMAJ 2002; 167:363-4), given the frequency with which HRT is prescribed, hundreds of thousands of healthy women have been harmed. When asked who the villains of this story are, he answers: "I place the blame directly on the medical 'experts' who, to gain private profit (from their industry affiliations), to satisfy a narcissistic need for public acclaim, or in a misguided attempt to do good, advocate 'preventive' maneuvers that have never been validated in rigorous randomized trials".

However, the huge pressure by manufacturers to protect their gains must be highlighted. In the United States in 2000, estrogen + progesterone combinations were the second most widely prescribed medication in the country; in 2001, revenue from HRT drugs totaled US$ 2 billion. By no coincidence, when Wyeth Ayerst was faced with the requirement to perform randomized trials to test the alleged cardiovascular protection from HRT, the company claimed that such trials were unfeasible. Drug manufacturers' aggressive behavior is explained by the international context, predominated by deregulation, the notion of a minimum state, and liberalism in economic relations. On the other hand, civil society urgently needs to organize to replace the absent public sector, multiplying the number of actors capable of denouncing such irregularities committed in the name of economic interests.

The aspects discussed above transcend ideology, since they are anchored in scientific evidence.

Yet a muffled ideological struggle is waged whenever some study identifies either drug-related risks or absence of benefits.

We Brazilians must take a position in this struggle. The Food and Drug Administration (the U.S. regulatory agency) has already done so. In the United States, hormone replacement therapy is only recommended to relieve vasomotor symptoms, and even then at the lowest possible doses and after weighing the risks and benefits.

  

Suely Rozenfeld
Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil

Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz Rio de Janeiro - RJ - Brazil
E-mail: cadernos@ensp.fiocruz.br