I am sure many of you have heard recently that a task force was formed to evaluate the results of the 'HRT' trials that have been done over the years. Well, the task force has released their draft results and they say that HRT is bad for you. The task force was partly right. The drugs reviewed are bad for you. The task force was also wrong as the authors widened the intellectual abyss between what is and what isn't HRT by calling the drugs that they reviewed HRT when none of the regimens contained replacement levels of any ovarian hormones. Real HRT is very specific, it is measured and it is monitored. In the studies reviewed by these authors no hormone testing was done and drug studies show the hormones used provide no replacement.
These two reasons are why the National Institutes of Health (NIH) stopped calling the drugs in hormone clinical trials HRT since 2007. The NIH dropped the 'R' because there is no replacement in the hormone drugs used in their clinical trials. That's the first change, from HRT -> HT. At the very least the authors of the task force should have called the drugs reviewed HT to follow the convention of the NIH.
Since the task force has declared this HT to be unhealthy it is time to drop the 'T' because these drugs are not therapeutic. If the NIH follows the recommendations of the task force then it has no choice but to drop the 'T' and call the drugs used in these menopausal hormone trials H.
Drop the 'R' because there is no replacement and drop the 'T' because there is no therapy.
Now the NIH can refer to the drugs used in their clinical trials as H or hormones because they are not replacement and they are not therapeutic. At what point is the NIH going to apologize to the thousands of women lured into these clinical trials that were promised HRT but never got it? Has there been an apology to the public for denying millions of women around the world proper healthcare because clinical trials said they were testing HRT and didn't? When is the NIH going to do the right thing? When are women going to be offered real HRT to protect their health?
Before releasing their final recommendations the task force offered the public a chance to comment on their draft findings. Read below for the questions they asked and the comments I submitted in response.
When the final report is published we'll know if the intellectual abyss continues to widen or not.
How could the USPSTF (US Preventative Services Task Force) make this draft Recommendation Statement clearer?
The final recommendation is very clear. The drug regimens that were reviewed were found to be unhealthy. However, that is not a complete representation of all of the facts.
To make the recommendations complete the authors should have:
- Pointed out that none of the studies reviewed used HRT.
- Made it clear that they were reviewing drug regimens that did not contain any replacement levels of ovarian hormones.
- Made it clear that drug studies show either lower than normal or higher than normal levels of ovarian hormones were created in the reviewed drug regimens.
- Pointed out that none of the clinical trials ever measured any ovarian hormone levels making it a guessing game as to what hormone level was achieved.
- Pointed out the unethical treatment of the women who were told that they would receive HRT and never did.
I expected the U.S. Preventive Services Task Force to:
- Notice that there was no proof of replacement in any study reviewed by either blood tests or pharmacokinetic studies.
- Notice that since 2007 the NIH no longer refers to the drug regimens used in the reviewed studies as HRT instead they are now referred to as HT or hormone therapy.
- Notice that the change in description of these regimens by the NIH is because it is recognized that no replacement of any hormone was given in any of the reviewed studies.
- Require proof that demonstrates replacement of all ovarian hormones before a regimen can be called Hormone Replacement.
I believe that the draft recommendation, which recognizes the drug regimens reviewed are unhealthy, came to the right conclusion for that regimen. However, calling that regimen HRT is the wrong conclusion.
The NIH recognizes that replacement of any ovarian hormone is not done with the studies reviewed. Therefore, before the review the drug regimen should be called HT or hormone therapy. Now that the USPSTF has finished its review of the ineffectiveness of the drugs reviewed it is clear that none of the regimens are therapeutic.
Now that it is clear the drugs regimens reviewed are not replacement per NIH mandate (HRT-> HT) and are not therapeutic, per USPSTF recommendations, the 'T' should be dropped (HT->H). These drug regimens should be simply be referred to as H or hormones.
Finally, based on the evidence, the recommendation that HRT is unhealthy is unjustified because the studies reviewed did not use HRT. Since HRT was not investigated, it should be made clear that non-HRT is not recommended.
What resources or tools could the USPSTF provide that would make this Recommendation Statement more useful to you in its final form?
Comparing what was used in the studies with real Hormone Replacement Therapy and describing the failings of the studies would be more useful. Clearly explaining that the recommendations given only apply to inappropriate treatment would show primary care givers and other interested parties the information they need to make informed decisions about real HRT, actual replacement of ovarian hormones that are measured and monitored.
The USPSTF is committed to understanding the needs and perspectives of the public it serves. Please share any experiences that you think could further inform the USPSTF on this draft Recommendation Statement.
The USPSTF should recognize profound hypogonadism for what it is, a treatable illness. Real HRT is successful in every area of endocrine medicine because it is measured and monitored. Statements from the USPSTF saying HRT is unhealthy create an opportunity for doctors to deny appropriate treatment to women with a treatable illness.
Women who request treatment for profound hypogonadism should be able to receive treatment just as easily as it is to receive treatment for every other hormone deficiency illness.
Do you have other comments on this draft Recommendation Statement?
I am disappointed in the lack of intellectual curiosity on the part of the writers of this recommendation. Each author should have the background to see that in the field of endocrinology hormone replacement, when done methodically with the intention of replacement, is therapeutic 100% of the time. Why wasn't this point brought up? If it were it would help bring to light that the failure of the reviewed studies was caused by using non-HRT regimens.
The authors have not included in this draft any indication that no replacement had been given in any of the reviewed regimens and yet the term HRT continues to be used. By not acknowledging that none of the studies used HRT shows this panel to be ill chosen to the task requested of them. While they correctly identified the ill health associated with non-HRT regimens reviewed in this draft document, they failed to recognize that true HRT would have a very different result. Failing to contrast the predicable ill health of non-HRT regimens with potentially lifesaving real HRT is a failure to come to a complete conclusion.
This task force should have pointed out that real HRT works in every area of medicine in which it is employed to improve both short and long term health. Real HRT, which is measured and monitored, works for all age groups from infancy to the oldest old, because metabolic pathways that utilize hormones never change during a person's lifetime. The authors did not point out that no hormone testing was done at all in any trial. The authors did not point out that not one drug study exists that demonstrates replacement of any hormones. The authors did not point out that women were given doses of hormones without regard to levels and observed for years for ill effects. The authors did not show the scientific rigor necessary to reach a complete and accurate result.
The studies reviewed do not contain replacement and are not therapeutic. Another task force that can understand basic chemistry, basic pharmacodynamics, and basic human physiology should be assembled to revisit the topic with the scientific rigor that is applied to actual HRT regimens.