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Text Box: Let’s start by talking about the ethics of recruiting women to participate in long term observational studies with medically untreated menopause. Ethically, a participant in an observational trial should be informed if effective treatment is available. It is then up to the participant to forgo treatment knowing fully the consequences of forgoing treatment. This is the way research is supposed to work.
Observational studies on
untreated menopause are studies on untreated hypogonadism, which is a serious illness. Effective medical treatment for hypogonadism (menopause) exists. To be properly informed the recruited women need to be told that this treatment exists. They need to be told that it is their choice to forgo treatment and participate in a long term observational study of untreated hypogonadism. This is called informed consent.
Informed consent laws evolved
in part from the public outcry over the immorality of the Tuskegee Syphilis Study from 1932—1972. In this study men with syphilis were recruited for an observational study of untreated syphilis and never offered an opportunity for an effective treatment. The recruited men were never told the true nature of the study. Out of the tragedy of the Tuskegee Syphilis Study informed consent laws were created to protect the public and to prevent this type of research from ever happening again. Unfortunately, these informed consent laws do not help the women who are recruited for observational studies on menopause.

Text Box: There are many disturbing
similarities between how the men were recruited and denied treatment in the observational Tuskegee Syphilis Study and how women are recruited and denied opportunity for treatment in observational menopause studies.
1) The men recruited for the Tuskegee Syphilis Study had to have a confirmed case of an illness called syphilis. The women recruited for observational studies, like the Women’s Health Initiative (WHI), had to have a confirmed case of an illness called hypogonadism.
2) The men recruited for the Tuskegee Syphilis Study were never told the actual title of the trial, “Tuskegee Study of Untreated Syphilis in the Negro Male.” The women recruited for observational studies like the WHI were never told that it was an observational study on medically untreated hypogonadism.
3) The men recruited for the Tuskegee Syphilis Study were not offered effective treatment once it became available and continued to suffer the ill effects of syphilis unnecessarily. The women recruited for observational trials like the WHI were not offered effective treatment and continued to suffer the ill effects of hypogonadism unnecessarily.
The tragedy of misinformation continues today. Women recruited into observational trials are not being told that they have a serious illness called hypogonadism and are not offered the opportunity to turn down effective

Text Box: treatment. Untreated hypogonadism, like untreated syphilis, is an illness that destroys the health and well being of the person who has it. However, unlike syphilis today, women with hypogonadism are not being told that effective treatment is available.
The U.S. Public Health Service deceived the men with treatable syphilis in the Tuskegee study and now the National Institutes of Health (NIH) is continuing that deceit with women with treatable hypogonadism. The information needed to effectively treat hypogonadism in women has been available for decades, but the NIH, a part of the US Health Service, continues to violate recruited women’s right to know about effective treatment.
The lessons learned about
informed consent from the US Health Service sponsored Tuskegee Syphilis Study have not been extended to the women recruited into observational trials of medically untreated hypogonadism. Before you read this newsletter did you know that untreated menopause is untreated hypogonadism or that treatment is available?
Observational studies are
crucial to increasing our understanding of many medical conditions, not just hypogonadism. Sponsoring such trials is part of the NIH’s charter. When done in an appropriate manner the researchers learn more and no one is exposed to any risks that they are not informed of first. In the case of the WHI this is not what happened. I have asked Senator Murray (D-WA) to look into this. If you feel this should be looked into as well please let Senator Murray know.