The Women's Health Initiative and its study drug, Premarin™
The field of hormone replacement is one of the most successful areas of medicine and is based on a simple recipe for success, the hormone replaced is measured, it is monitored, and it is as close in structure as possible to the hormone the body no longer produces.
In sharp contrast to the success enjoyed in the field of hormone replacement medicine, the Women's Health Initiative (WHI) had very poor results. Over ½ billion dollars was spent on the Women's Health Initiative and over 27,000 women were recruited based on their health status as being profoundly hypogonadal. Instead of the expected health improvements that are normally associated with long term use of hormone replacement and occur with every other kind of hormone replacement, i.e. insulin, thyroid, cortisol, etc., the study drug, Premarin, which was widely advertised as Hormone Replacement Therapy (HRT), decreased overall health. The overall health of the recruited women became worse than before they entered the clinical trial. The Women's Health Initiative makes it appear that, for the first time in history, HRT failed to improve health, which begs the question, did the WHI use Hormone Replacement Therapy as advertised?
In an unprecedented move for a clinical trial that was supposed to be using HRT, the WHI never tested a single hormone level in a single woman before, during, or after the WHI. The design documents for the WHI did not cite even one drug study for Premarin which supported calling the study drug HRT. The design documents for the WHI did not include a single hormone test on a single woman, not on the hormones to be replaced, nor on the hormones that were adversely affected by using the study drug, Premarin. The recipe for successful hormone replacement was not used. There was no measuring or monitoring to check if too much or too little hormone was used or on any other hormone adversely affected by the study drug. The hormones used were from another mammal, the horse. Equine hormones, which are not very close in structure to humans, were used when hormones that are structurally identical to human hormones were available. The actions of the NIH sponsored WHI are unprecedented for a clinical trial claiming to be using HRT.
Diamond Research Foundation has been asking the NIH, FDA, Office of WHI, and the NIA since 2004 to show proof that the WHI study drug, Premarin, is HRT in even one drug study and all of those agencies have refused to answer. Diamond Research Foundation has been referred to the Freedom of Information Office and for the last 6 years, despite repeated requests, has not been provided with even one drug study on Premarin.
President Obama's administration is dedicated to transparency in government, which includes the federal agencies that DRF has contacted. The NIH continues to misinform the public that HRT was used in the WHI. This misrepresentation has caused millions of women around the world to unnecessarily endure the harsh reality of untreated profound hypogonadism on their health, their livelihood, and their marriages. With transparency the NIH would inform the public that HRT was not used in the WHI and millions of women around the world would finally have the opportunity to maintain their health, their competiveness in the job market, and the health of their personal relationships.
It easy to prove that Premarin is not HRT as available drug studies clearly show that it replaces no hormones at all.
Every day that the NIH is allowed to continue this misrepresentation is another day added to this tragedy of epic proportions on women here in the US and around the world. Finally acknowledging this will clear the way for the first ever actual HRT trial using the recipe for successful hormone replacement and progress can be made towards the effective treatment of profound hypogonadism.
The first step is for the NIH sponsored WHI to acknowledge that hormone replacement was not used and that in fact, blood studies show the opposite of replacement was done, and that the results of the WHI are not relevant to the effective treatment of profound hypogonadism in women.
DRF will continue to request that the NIH publically acknowledges that no hormones were replaced in the WHI , that the public was misled in to believing HRT was used and that the results of the WHI are irrelevant to the treatment of profound hypogonadism in women.
Here's what you can do to stop and reverse this tragedy.
First, you can call menopause by its real name, profound hypogonadism. By calling it by its real name you can see easily that it is a real medical problem. It is a real medical problem that your doctor can treat. It is a real illness that is making you sick.
Second, call your local Congressperson and Senator and ask for an investigation into why the FDA allowed the NIH sponsored WHI to call Premarin™ HRT when it isn't. Let the Congressperson and Senator know that you don't like be misled.
Third, call your local news station and ask for an investigation into why the FDA allowed the NIH sponsored WHI to call PremarinTM HRT when it isn't. Let the reporter know that you don't like be misled.
Fourth, don't ever give up trying to get treatment. You have a treatable illness.