Sign this petition to ban the use of the FDA unapproved hormone, equilin, in the drug, Premarin.

As an electrical/bio-medical engineer and a menopausal woman, I want the FDA to ban equilin, a fetal horse estrogenic hormone that is proven to be devasting to the health and well-being of menopausal women, as a major component in the drug, Premarin (PREH-ma-rin).

Premarin is the primary drug that has been used in clinical studies on menopausal women for decades. Premarin contains a large amount of equilin, which means the outcome of these clinical trials were manipulated toward predicable failure.

Equilin has never been approved by the FDA and does not fit the criteria the FDA has to use unapproved drugs. The FDA allows a drug to contain unapproved ingredients only if doctors rely on the unapproved drug to provide therapeutic benefits for serious conditions that no other drug can provide or there is a shortage of an FDA approved drug for the condition. [i]

The only condition unapproved equilin is used for is menopause and it is only used in Premarin, which is manufactured by Pfizer. All menopausal women who use Premarin will be harmed by unapproved equilin.

Premarin is FDA approved as 100% estrogen hormone replacement for estradiol, the main estrogen of the ovary. Estradiol is the specific estrogen hormone that restores a menopausal woman’s health. However, according to Pfizer’s own website on Premarin, the expectation of Premarin is to treat only one symptom of menopause. The FDA approval as 100% hormone replacement for estradiol makes no sense since menopause causes over 100 documented symptoms. With only one symptom treated, Premarin is less than 1% hormone replacement.

Pfizer knows that Premarin could be 100% estradiol hormone replacement because Premarin contains 60% estrone. Estradiol is made from estrone via enzymes, in particular, the HSD1 enzyme.

Pfizer also knows that unapproved equilin blocks the HSD1 enzyme. This means that Pfizer is intentionally sabotaging the formation of estradiol and preventing Premarin from providing estradiol. Pfizer is intentionally reducing the efficacy of Premarin from 100% down to 1%.

Pfizer also knows that estrone can be converted by another enzyme, aromatase, to estradiol. However, estradiol made via the aromatase enzyme is blocked from its own Estrogen Receptors (ER) by unapproved equilin and its metabolites. Unapproved equilin comes from the fetal horse and it is these fetal horse derived hormones that compete with estradiol for Estrogen Receptors.

Unapproved equilin and its metabolites are very effective at blocking the formation of estradiol and blocking estradiol from its own ER’s. According to Pfizer, Premarin provides only 1% estradiol function instead of 100% estradiol function.

Pfizer knows that a drug that blocks the formation of estradiol is called an anti-estrogen. Pfizer also knows that a drug that competes with estradiol for its own receptors is called a Selective Estrogen Receptor Modulator or SERM, which rhymes with the word “term”.

The FDA knows that a SERM drug and an anti-estrogen drug are used to dramatically reduce estradiol’s ability to activate its own Estrogen Receptors. The FDA knows it is unethical to advertise a SERM or an anti-estrogen drug as hormone replacement because the purpose of each of these drugs is to dramatically reduce estradiol’s effectiveness.

The FDA has never approved a SERM like Tamoxifen or an anti-estrogen like Arimidex as estrogen hormone replacement for estradiol. Therefore, the FDA has no reason to continue to approve the use of unapproved equilin, which is a SERM and an anti-estrogen, in Premarin.

The treatment guidelines generated from the clinical trials that used Premarin are based on the expectation that 100% estradiol hormone replacement was used because Premarin was advertised as HRT or Hormone Replacement Therapy for menopause.

But Premarin is adulterated by adding unapproved equilin to dramatically reduce the effectiveness of estradiol.

The FDA knows it. Pfizer knows it. Now you know it.

You can sign this petition to DEMAND the FDA disallow the use of unapproved equilin in Premarin. As long as unapproved equilin is included in Premarin, menopausal women will be denied the health benefits of estradiol, and their menopausal symptoms will continue to go untreated.

Sign this petition to DEMAND the FDA no longer allow unapproved equilin as a component of Premarin as it blocks the formation of estradiol and undermines estradiol’s ability to activate its own Estrogen Receptors, which deprives menopausal women the opportunity to improve their health and quality of life.

[i] Unapproved Drugs | FDA