Discrimination in the KEEPS trial - Part 3 of 5

<p>To recap from parts 1 and 2: The KEEPS trial is one of two hormone trials out of the Kronos Longevity Research Institute. One trial is for men and one is for women, both for the same condition, low hormones. The difference is that discrimination is designed into the women's clinical trial.</p>
<p>The difference is that the men's trial:</p>
<li>included modern hormone products</li>
<li>tested and adjusted hormone levels</li>
<li>used pure drugs with no impurities</li>
<li>restored youthful levels and used a comfortable, state of the art, gel application onto the skin.</li>
<p>In sharp contrast, the women's trial:</p>
<li>used technology nearly 100 years old</li>
<li>did not test or adjust hormone levels</li>
<li>used drugs with many, many impurities</li>
<li>did not restore youthful levels and used an uncomfortable skin patch or a pill derived directly from horse excrement.</li>
<p>Both of these trials are advertised as state of the art in their design and implementation. Clearly, only the men's trial is state of the art. This shows bias against women as well as false advertising about the KEEPS clinical trial.</p>
<p>The discrimination against women at the Kronos Longevity Center in the KEEPS trial is clear and evident. But what is so important about one clinical trial? The answer is how it translates into continuing the discrimination from the clinical trial to the doctor's office.</p>
<p>Think of the KEEPS trial as a 'dry run' for your doctor.</p>
<p>Let's say a husband and wife show up in the office of their doctor. Being that both the husband and wife are in their mid-50's they are both suffering from the same illness, low hormones. Based on the Kronos Longevity clinical trials for men and women, the doctor will follow the pattern in the men's trial for the husband and the pattern for the wife in the women's trial. This is called evidence based medicine. Basically, do what the clinical trial does to get the results of the trial. This is also called translational medicine as it translates what was done in a clinical trial into what is done in the doctor's office.</p>
<p>So how are the husband and wife likely to feel after they receive their treatment based on these two hormone trials?</p>
<p>The husband is likely going to feel very good. He is going to be taking a pure, bio-identical hormone with no impurities delivered in a comfortable daily gel. He is going to get his hormone levels checked and adjusted to the normal adult range to feel his very best. His sexual function will likely improve significantly.</p>
<p>The wife is likely not going to feel so good. She is going to get either an uncomfortable bio-identical hormone patch or a pill made directly from horse excrement containing many, many impurities. She is not going to get any hormone testing. Without hormone testing or adjustments her hormones levels will remain below normal because the patch contains too little hormone and the pill made from horse excrement creates very abnormal hormone levels. No attempt will be made to bring hormone levels to the normal, adult range because it was never done in the KEEPS trial. After treatment, the wife will continue to suffer from abnormally low hormone levels and may feel it is better to abandon treatment because low hormone levels is less uncomfortable than abnormal hormone levels. It is unlikely her sexual function will improve as neither of these treatments create normal hormone levels.</p>
<p>With such blatant discrimination weaved into the KEEPS trial why are such prestigious universities participating in the KEEPS trial? Why sully the reputations of these universities with outright discrimination against women?</p>
<p>First you have to ask yourself, are the universities even aware of the discrimination designed into the KEEPS trial? Universities rely on staff who solicit or are solicited to be involved with clinical trials. These staff are called Principal Investigators or PIs. A PI is supposed to conduct high quality research, protect the rights and welfare of those enrolled, and maintain integrity of the clinical trial and ethical standards.</p>
<p>Are the universities below aware of the nature of the KEEPS trial? Is it possible that each PI for each university could not see the discrimination woven into the KEEPS trial? If not, is the academic bar not high enough at these universities?</p>
<p>Here is a list from the Kronos Longevity website of the universities and their PIs involved in the KEEPS trial</p>
<li>In New York City, New York,  Albert Einstein College of Medicine/Montefiore Medical Center  and  Columbia University College of Physicians and Surgeons, Principal Investigators, Drs. Nanette Santoro, Genevieve Neal-Perry</li>
<li>In Boston, Massachusetts, Harvard Medical School/Brigham and Women's Hospital, Principal Investigators, Principal Investigator, Dr. JoAnn Manson</li>
<li>In Rochester, Minnesota. Mayo Clinic College of Medicine, Principal Investigator, Dr. Virginia Miller</li>
<li>In San Francisco, California, University of California, San Francisco/Center for Reproductive Health, Principal Investigator, Dr. Marcelle Cedars</li>
<li>In Salt Lake City, Utah, University of Utah School of Medicine, Principal Investigators, Drs. Eliot Brinton and Paul Hopkins</li>
<li>In Seattle, Washington, University of Washington School of Medicine, Principal Investigator Dr. George Merriam</li>
<li>In New Haven, Connecticut, Yale University School of Medicine, Principal Investigator, Dr. Hugh Taylor</li>
<p>All of us rely on prestigious universities to further and improve medical care via clinical trials. We also rely on the Principal Investigators to conduct only ethical clinical trials that protect the rights and welfare of those enrolled. What do you think the women that were enrolled would say if they knew about this discrimination? Do you think they would have enrolled? Unlikely.</p>
<p>When a prestigious university is associated with a clinical trial we tend to listen more to its results. The dose of bio-identical hormone for the women's trial is so low that it will not be much help. The dose of horse excrement will cause harm and it will show more over time. The bottom line here is that women who take the bio-identical hormones will still have low hormone levels and will continue to have illnesses associated with low hormone levels. The remaining women who take horse excrement pills will have abnormal hormone levels meaning they will continue to suffer long term from a new, completely manufactured and unnecessary illness.</p>
<p>On the Kronos Longevity website the KEEPS trial is described as a state of the art translational clinical trial. That means that the way this trial was designed is what is expected to be carried out after the trial. This means it is expected that doctors will do to women what this trial did to their recruited women. This perpetuates the discrimination and the myth that it used state of the art medicine.</p>
<p>Assuming these prestigious universities know of this discrimination, are they participating in the KEEPS trial because they are turning a blind eye to the discrimination, they are indifferent to the well being of women, or something else? Shouldn't we expect Principal Investigators from such prestigious institutions to represent the best that medicine has to offer?</p>
<p>More to come in part 4.

3/5/2014 4:09:40 AM
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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