Appropriate Caution About Elagolix/Orilissa For Endometriosis

aguilaroja

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The FDA reportedly approved Elagolix/Orilissa for endometriosis on July 24. The history of modern pharma includes hype, cashing the checks, and, as in ecology, later understanding of long term effects.

Millions of people taking €722/$844 per month of pills adds up quickly to real money. Elagolix will reportedly be at pharmacies in August.
https://www.businessinsider.com/fda-approves-abbvie-endometriosis-drug-elagolix-orilissa-2018-7
“A new treatment for a condition that can feel like tiny people skating on razor blades in your stomach and affects an estimated 200 million women just got approved”

Dr. Peat has clearly expressed for decades the influence of the pituitary over effects impaired metabolism. It is easy to predict that commerce plus limited knowledge is going to lead to more unwarranted ideas about estrogen, progesterone, and metabolism. Or to paraphrase @haidut, FUD-plus.

Aging, estrogen, and progesterone
When W. Donner Denckla demonstrated that the removal of an animal's pituitary (or, in the case of an octopus, its equivalent optic gland) radically extended the animal's life span, he proposed the existence of a death hormone in the pituitary gland. But the case of the octopus makes it clear that the catabolic, death-inducing hormone is produced by the ovary, under the influence of the optic gland's gonadotropins.

Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. - PubMed - NCBI
Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings.

https://medicalresearch.com/author-...etriosis-associated-pain-with-elagolix/34695/
“Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.”
 

haidut

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The FDA reportedly approved Elagolix/Orilissa for endometriosis on July 24. The history of modern pharma includes hype, cashing the checks, and, as in ecology, later understanding of long term effects.

Millions of people taking €722/$844 per month of pills adds up quickly to real money. Elagolix will reportedly be at pharmacies in August.
https://www.businessinsider.com/fda-approves-abbvie-endometriosis-drug-elagolix-orilissa-2018-7
“A new treatment for a condition that can feel like tiny people skating on razor blades in your stomach and affects an estimated 200 million women just got approved”

Dr. Peat has clearly expressed for decades the influence of the pituitary over effects impaired metabolism. It is easy to predict that commerce plus limited knowledge is going to lead to more unwarranted ideas about estrogen, progesterone, and metabolism. Or to paraphrase @haidut, FUD-plus.

Aging, estrogen, and progesterone
When W. Donner Denckla demonstrated that the removal of an animal's pituitary (or, in the case of an octopus, its equivalent optic gland) radically extended the animal's life span, he proposed the existence of a death hormone in the pituitary gland. But the case of the octopus makes it clear that the catabolic, death-inducing hormone is produced by the ovary, under the influence of the optic gland's gonadotropins.

Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. - PubMed - NCBI
Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings.

https://medicalresearch.com/author-...etriosis-associated-pain-with-elagolix/34695/
“Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.”

Thanks for the heads up. I think something more sinister is involved here. Big Pharma is simply trying to avoid pointing the finger squarely at estrogen. So, instead of approving things like AI drugs of estrogen antagonists like fulvestrant for endometriosis, they are inhibiting the pituitary and this way the doubt remains about what it is exactly that is causing endometriosis. So, if anybody tries to blame estrogen, Big Pharma can counter that we do know if it is estrogen since ovaries also produce progesterone, T, pregnenolone, and even a little DHEA. All we know, they'd say, is that the ovaries are the source of the problem and they are going after what "we" know so far, hence the ovarian inhibition.
The same issue was recently highlighted with the small trials with T injections directly into the prostate that quickly regressed late stage metastatic prostate cancer. The doctors, probably under the advice of their pharma rep, also administered an LH/FSH antagonist together with the T, since the use of such antagonist is approved for "treating" prostate cancer. Almost all experimental therapies are done as an adjuvant, together with an approved drug, because it would be "unethical" (they say) to only administer the experimental drug. The convenient result of such design due to "ethical" reasons is that it prevents the study authors (or other medical practitioners) to officially claim T therapy cured prostate cancer since there was another drug co-administered with the T and as such the benefit cannot be individually assigned. At least legally speaking, which is all that PR arms of Big Pharm care about.
The great care taken to avoid blaming the estrogen is most likely tied to the recent push to start administering estrogen again to older women for all sorts of conditions, but especially Alzheimer Disease (AD).
Hormone Levels Likely Influence A Woman's Risk Of Alzheimer's, But How?
This coincides with a number of recent high profile opinions published in medical journals claiming that the WHI studies were flawed and estrogen was unfairly blamed. Yet some of those (female) opinion authors steadfastly refuse to take estrogen for their menopausal symptoms. The reasoning goes that since we are all unique you see, just because estrogen is going to give ME cancer does not mean it will give YOU cancer as well and that you should be avoiding it. Of course, the fact that ME (the opinion authors) is getting paid to promote estrogen's use has nothing to do with what I am publishing.
 
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