Discrimination in the KEEPS trial, Part 4 of 5

The discrimination in the KEEPS trial is very real and very damaging to the clinician's and patient's ability to receive appropriate care of advanced/profound hypogonadism (untreated menopause). The KEEPS clinical trial uses archaic and uncomfortable methods, ignores modern technology and misrepresents the drugs used as hormone therapy as neither regimen are predictably therapeutic. You can read more about the discrimination in the KEEPS trial in parts 1, 2, 3 of my series.

The KEEPS clinical trial is not only discriminatory towards women but it is also an unethical clinical trial. Informed consent laws are clear in that all participants in a clinical trial must be properly informed of the intent of the trial and about the regimens used. Not one of the recruited women were properly informed about the regimens they were to receive.

In violation of the informed consent laws none of the women were informed of the following:

1. They would not receive treatment for the illness that qualified them for the KEEPS trial, profoundly low ovarian hormone levels.
2. There was never any intent to bring ovarian hormone levels to normal.
3. The intent of the trial was to create abnormal hormone levels.

FDA drug studies of the two regimens documents the abnormal hormone levels with the two KEEPS drug regimens prior to the start of the KEEPS trial.

Studies have been available for 2 decades that show that the dose of bio-identical hormones in the estradiol patch used does not bring estradiol levels above the lowest pre-menopausal level. In a paper by Limor Raz et al., Mayo clinic 2014, the following was said of the KEEPS study;

"With the transdermal product used in this study, premenopausal levels of 17beta-estradiol were not achieved"

No horse hormone levels were measured. If they were it would be clear to see just how abnormally high the estrogen levels would be – about the equivalent of 2-3 birth control pills. Drug studies provided by the manufacturer of the horse excrement, Pfizer, to the FDA confirm the abnormally high levels of estrogen.

Combine high doses of progesterone to the respective KEEPS regimens and you get the following:

1. Horse excrement and progesterone resemble an estrogen secreting tumor with a progesterone secreting tumor that turned on and off every two weeks.
2. Bio-identical patch and progesterone resemble continued menopausal hormone levels with a progesterone secreting tumor that turned on and off every two weeks.

The KEEPS trial like all clinical trials has to be reviewed by an institutional Review Board (IRB). A review of the informed consent document shows that the recruited women were not properly informed about what the KEEPS trial called 'hormone therapy'. So where are the bio-ethicists when the fundamental rights of the recruited women are being trampled?  Is no one watching? Each university that the KEEPS trial is involved in has a bio-ethical department. Why the silence?

The design of the KEEPS trial is nothing short of scientific misconduct. Implicit in the misconduct is the FDA and National Institutes of Health for not stopping it.

The whole point of clinical trials is to improve the health and welfare of people. The bio-ethical community is supposed to make sure that happens. Treatment of hypogonadism can be safe and effective and clinical trials like the KEEPS trial make it look like an untreatable illness.

Every day that women are denied treatment for chronically low ovarian hormone levels is another day of lost opportunity to have healthy levels of ovarian hormones and their health and sexual function restored.

Even without the bio-ethical community women can still get effective treatment. When women ask for treatment they should make it clear that they have an illness and to treat that illness by bringing all of their ovarian hormone levels to normal. Drug studies show that only bio-identical hormones, given in appropriate dosages, work to do that.

Without the bio-ethical community it is unlikely a real hormone replacement clinical trial using bio-identical hormones will take place in the foreseeable future. If and when a real hormone replacement trial takes place then greater numbers of women around the world will be able to maintain their health and sexual function. Until then the situation remains the same, continue interviewing doctors until you get one that understands how and is willing to treat profound hypogonadism in women.

Beth