Menopause hormone trials are designed to fail

How can a hormone clinical trial predictably fail?

Only on purpose. Scientifically based hormone replacement clinical trials are easy, cheap, and eventually always successful. It is only a matter of adjusting dosages and measuring hormone levels to find success. Done right a hormone replacement clinical trial is guaranteed success because our body never loses it need for its hormones.

How are failed menopause hormone trials different from successful hormone trials?

Successful hormone trials measure hormone levels and make dosage adjustments to make sure normal hormone levels are achieved.
Unsuccessful menopause hormone trials do not measure sex hormone levels and no dosage adjustments are made. A hormone trial can only succeed if the hormones are in the normal range. It is very important to achieve normal hormone levels because by definition higher or lower than the normal levels for hormones will cause ill health.

Therefore, all menopause hormone trials that have failed must have had hormone levels outside of the normal range. An effective way for the public not to find out that hormone levels are outside of the normal range would be to not measure any hormone levels. The FDA has based all of its recommendations for treatment on hormone trials that did not measure any hormone levels.

What could be the goal of the failed Women’s Health Initiative which cost more than 600 billion dollars when other successful clinical hormone trials cost 100 times less?

The stated goal of the Women’s Health Initiative was to use hormone replacement therapy to improve the health of menopausal women. The WHI chose to use hormones from another species which is guaranteed not to work in humans and ensures the failure of the WHI. Following the failure of the WHI, millions of women around the world have been turned away for treatment for advanced hypogonadism.

It would appear that the goal of the Women’s Health Initiative is to persuade women that advanced hypogonadism is untreatable and not to pursue any type of hormonal treatment.

What would the Women’s Health Initiative cost if it were designed to succeed?

If the WHI were designed to succeed it would last 2 years instead of 14 years, it would use 4 bio-identical hormones meant for humans, not 150 hormones meant for horses, recruit 4000-5000 post-menopausal women, and it would identify normal ranges of hormones and adjust dosage based on measured hormone levels throughout the study.

If the Women’s Health Initiative were designed to succeed it would likely cost less than 6 million dollars which is 100 times less than the Women’s Health Initiative.

What happens when an illness like advanced hypogonadism goes untreated?

Predictable bad health. For menopause the cost of taking care of broken bones and breast cancer is in the billions to doctors, hospitals, nursing homes and pharmaceutical companies. Treating an illness is far more profitable than preventing it with inexpensive bio-identical hormone medications.

The Women’s Health Initiative created a win-win for the pharmaceutical industry. Get sick from taking horse hormones or get sick from not getting any treatment at all.

Where did the ‘R’ go? Turning HRT into HT

In 2007 the National Institutes of Health acknowledged that Premarin™, the drug on which all menopause treatment recommendations are based, was in fact not capable of replacing any hormones and dropped the ‘R’, renaming it HT or hormone therapy. Premarin™, the hormone drug that the FDA bases all of its menopausal hormone recommendations on, is made from horse excrement.

Dropping the ‘R’ for replacement verified that Premarin™ is a drug that does not provide replacement. This means the failure of every clinical trial that used Premarin™ was the failure of Premarin™, not healthy HRT. Instead of informing the public, the National Institutes of Health quietly changed all of their stationary and websites and information packets from HRT to HT. No public statement has ever been made about why this change was made.

Calling Premarin™ estrogen makes it sound like it should work for women because women need estrogen to be healthy. Premarin™ is more than just estrogen, it is estrogen made for a horse. A horse goes into heat, a human woman doesn’t, a horse weighs 10 times more than a human woman, a horse has hormones special to its species. That is why a horse has different hormones than a human, because it has a different metabolism to support. It is unethical to intentionally confuse estrogen from a horse with estrogen from a human. Anyone who does this does not understand mammalian physiology.

A woman has a right to say no to non-HRT

Women around the world should be able to say yes to real HRT and no to Premarin™ (made of horse hormones) which is non-HRT. Women have a right to know that the recommendations against the treatment of menopause are based on a non-HRT drug, not a real HRT drug.
Women can’t say no to non-HRT unless they know what real HRT is and what isn’t. Women can only do this if unhealthy estrogen meant for horses is not confused with healthy estrogen for human women.

If no replacement was given then what was in the “HRT” for the Women’s Health Initiative?

The drug chosen, Premarin™, contains over 150 hormones for a horse. Horses are a different species from humans and have their own special hormones. Horse hormones support horse metabolism and have to be much stronger than human hormones to support an animal that weighs about 10 more than a human female. Human hormones support human metabolism. Intentionally giving horse hormones to a human woman when bio-identical human hormones are readily available and cost a fraction of the cost of using horse hormones is scientifically unsound and unethical.

In menopause trials there is no question that extensive scientific misconduct has and continues to occur. For instance, the FDA currently bases its recommendations on a massively expensive failed clinical trial called the Women’s Health Initiative or WHI. Design documents don’t include even one paper that identifies normal hormone levels. Knowing this helps to understand why hormone levels were never measured because healthy hormone replacement was not a goal of the WHI $600,000,000 clinical trial.

Only in menopause clinical trials are trans-species hormones from another mammal used on human women. The public and medical communities are largely unaware of this because the FDA allows drug companies to call any hormone product HRT, or hormone replacement therapy, whether it contains replacement hormones or is therapeutic. So when a non-replacement, non-therapeutic drug fails a clinical trial it sounds like healthy hormone replacement failed because both regimens, healthy and unhealthy are allowed to be called the same thing, HRT.

For a menopause clinical trial to succeed it needs to be designed to succeed

The bottom line is that hormone deficiencies are easy illnesses to treat when using pure, bio-identical hormones meant for human women and men.