Discrimination in the KEEPS trial Part 1 of 5

It is discrimination, plain and simple. At the Kronos Longevity Research Institute (KLRI) there are two hormone trials going on; one for women and one for men.

One clinical trial uses pure, bio-identical hormones and levels are checked to make sure they are raised to normal and in the other clinical trial the source of the hormones is horse excrement and no hormone levels are checked or adjusted to normal levels.

Guess which trial is for men and which is for women?  You guessed it. The clinical trial for men used pure, bio-identical hormone gel which was rubbed onto the skin. Included in the men's clinical trial were scheduled blood tests to make sure the hormone levels were in the normal adult range and the dose was adjusted as needed.

And the clinical trial for women? Some of the 720 recruited women got pills condensed down from horse excrement (urine) and the rest of the women got pure, bio-identical hormones in a skin patch. Unfortunately, this patch contained so little hormone that it was impossible to ever reach normal adult levels. None of the 720 recruited women received any hormone testing to make sure adult levels were reached so there was no dose adjustment like in the men's trial. All of the women in the KEEPS study started with abnormal levels of hormones and continued to have abnormal levels of hormones with both hormone regimens, from the patch and from the pills condensed from horse excrement. This fact is covered up by not doing any hormone testing before or after the trial started.

The results from the KEEPS trial are predictable. There will be no harm from the pure, bio-identical hormone group because the body knows what to do with bio-identical estradiol and will put it to good use. Imagine how much better the health of the recruited women would be if actual adult levels were achieved.

There will be harm in the group given the horse excrement because the body knows what is foreign and will always try and protect itself from it. This group of women will have side-effects, like increased triglycerides, increased risk of blood clots, and reduced thyroid hormone availability. The significant reduction in availability of all androgens, including testosterone, is a side-effect of the body trying to cope with the stronger estrogens from a 2000 pound animal now circulating in a 150 pound woman.

There is no excuse for this kind of discrimination and deception. The principle investigator, S. Mitch Hartman, MD, has a strong background in the study of hormones in both women and men. He should have known that if he was going to recruit women with the promise of menopausal hormone therapy then he should have followed through on that promise. Every woman in the clinical trial was recruited with a promise to use menopausal hormone therapy which created an expectation that all of the ovarian hormones would be brought up to normal levels. Clearly, this promise wasn't kept and it was not the intent of this trial to bring hormone levels up to normal because no testing was done on any of the recruited women to verify adult levels were achieved and no provisions were made to adjust any dosages. Further, using a non bio-identical product ensures side effects because the body has to protect itself from foreign (pregnant horse) hormones.

Dr. Hartman is the director of the Kronos Longevity Research Institute and advertises on his website that KLRI is a not-for-profit 501 (c) (3) organization that conducts state-of-the-art clinical translational research on the prevention of age-related diseases and the extension of healthier human life.

State of the art? Collecting urine from horses with a bag strapped between their legs all day long? Denying these pregnant horses water so their urine is more concentrated to make it easier to condense the urine into pills? Chaining these pregnant horses into very small stalls for 6 months straight during their pregnancy so they can't move very much to lessen the chance of dropping urine from the collection bags? This is how hormones were produced nearly 100 years ago. Dr. Hartman, is this state of the art clinical translational research and state of the art in medical technology?

Not for women, it isn't. This is just the tip of the iceberg for the KEEPS study. More to come in part 2.

4/5/2013 7:39:03 PM
Beth Rosenshein
Written by Beth Rosenshein
Beth Rosenshein is an electrical/bio-medical engineer and is very familiar with medical research. She holds two United States patents, one for a unique design of a vaginal speculum, and one for a clever urinary collection device specifically designed for women. Beth discovered and documented an important drug interaction...
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