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As a researcher of thirty years experience, I am
appalled at the thoughtless use of the scientific method as exemplified in
the Journal of the American Medical Association article “Risks and
Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women.” In
this extremely important study rigorous scientific procedures were
followed, unfortunately this included a completely randomized design. In
the desire to randomly assign women to estrogen plus progestin versus
placebo, and to include as many women as possible, no one thought to
screen out smokers.
Over the last 30 years it has been common medical
practice to caution smokers against using first, birth control pills and
later hormone replacement therapy. This practice was to avoid increasing
the smoker’s risk of high blood pressure, coronary heart disease events,
stroke and pulmonary embolisms. It should have been no surprise that the
group of women who received estrogen plus progestin had increased
incidences of coronary heart disease, stroke and pulmonary embolisms.
The media has reported the study’s increased risks of
coronary heart disease events, stroke, and pulmonary embolisms associated
with Hormone Replacement Therapy as contrary to previous medical thinking
and research. Given that smokers were: (1) allowed into the study and
(2) randomly assigned to the placebo group or the estrogen plus progestin
group, the incidence of increased risks of coronary heart disease events,
stroke, and pulmonary embolisms associated with the estrogen plus
progestin group is more accurately understood as being in tune with
previous medical research, thinking and advice.
The real question raised by the American Medical
Association article “Risks and Benefits of Estrogen Plus Progestin in
Healthy Postmenopausal Women” is which women experienced coronary heart
disease events, stroke, and pulmonary embolisms and how much of this
effect can be correlated with smoking?
To release the information in this article without a
careful investigation of the data only served to sensationalize the
issue. The anxiety this created in the female population is despicable
and unnecessary. It calls into question the purpose of the investigators
as they clearly were not interested in the scientific progress of
information for the medical community and the general population. They
have allowed the fear and misinformation to continue to spread unabated.
Even in the professional community, many physicians were unaware that
smokers were allowed into this study and there has been no concerted
effort to correct this misinformation. |
