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FDA Wants to Take Away Your Bioidentical Hormones

by | May 30, 2015

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FDA initiating new regulations to limit Compounding Pharmacies and Bio-Identical Hormones

 
Big Drug Companies want to limit your access to natural, Bio-Identical Hormones, so that the only options you have left are the drugs that only they make, i.e. the synthetic copies of your hormones that they can patent and sell for billions of dollars annually.
 
These synthetic drugs, like Premarin, Prempro, Estrace, Vivelle-Dot, etc, don’t work as well as Bio-Identical Hormones and cause significant side-effects that are not found in Compounded Bio-Identical Hormones. The only reason Big Drug Companies make the synthetic drugs instead of Bio-Identical Hormones is because they can’t patent something natural that already exists in nature, like Bio-Identical Hormones. God holds the patent to natural Bioidentical hormones. So, in order get a patent and the 20 year exclusivity that comes with it, the drug companies must alter the natural chemical structure of the hormone in order to make it unique enough to claim patent rights.
 
Before the new FDA regulatory changes, I was able to order Bio-Identical Hormones in bulk from Compounding Pharmacies and dispense them to all of my patients directly, in any amount needed for each individual patient. I had approximately 100 different combinations of the natural Bio-Identical Hormones, including combinations of Estriol, Progesterone and Testosterone, which I dispensed based on the individual symptoms and lab test results of each patient.
 
The new FDA regulation requires that a prescription for each Bio-Identical Hormone must be written and shipped to each individual patient. This is extremely time consuming and has made it impossible for the Compounding Pharmacy to make all of the unique individual formulas that I typically prescribe for my patients. There simply is not enough time in the day. So in order to comply with the new FDA regulations our Compounding Pharmacy in Texas had to reduce the number of my formulas from 100’s of single and various combinations down to only twelve.
 
We tried to make this work, but it was too limited, so in order to remedy the situation we moved our Compounding operations from Texas to Florida. We now have a Compounding Pharmacy in Florida who can make 36 of my most frequently prescribed single ingredient and combination Bioidentical Hormone formulas.
 
We realize that we are fighting against the current of the Mainstream Medicine and Big Drug Companies. They are trying to take away your options and your freedom to choose by preventing you from having options to choose. Mainstream Medicine and Big Drug Companies are also trying to squash the competition and put Compounding Pharmacies and Doctors who prescribe natural medicines out of business. Please don’t let that happen. We hope you will continue to fight with us by continuing to choose natural medicines and nutritional supplements because it is your right and because it is a safer option that will make you healthier.
 

Ivermectin + Mebendazole taken together produce remarkably Positive Clinical Cancer Benefits in 84.4% of Patients.

The largest real-world human analysis to date evaluating ivermectin and mebendazole in cancer patients has just been published—and the results represent one of the most compelling clinical signals ever documented for repurposed anti-parasitic therapies in oncology.

This groundbreaking analysis was made possible through a unique collaboration between The Wellness Company, the McCullough Foundation, and the Chairman of the President’s Cancer Panel (Dr. Harvey Risch)—uniting real-world clinical data, frontline medical experience, and high-level epidemiologic expertise to deliver urgently needed insights in oncology.

This was a real-world prospective clinical program evaluation of 197 cancer patients, with 122 completing a follow-up survey at about six months (61.9% response rate).

Cancer patients were prescribed compounded ivermectin–mebendazole, with each capsule containing 25 mg ivermectin and 250 mg mebendazole—most commonly taken at 1–2 capsules per day.

The cohort represented a clinically relevant population, including a wide variety cancer types, with 37.1% of patients reporting actively progressing disease at baseline and many having already undergone chemotherapy, radiation, and surgery.

At six months, 84.4% of cancer patients reported clinical benefit (Clinical Benefit Ratio: 84.4% [95% CI: 77.0–89.8%]):

✅ 32.8% reported NO evidence of cancer (95% CI: 25.1–41.5%)
✅ 15.6% reported tumor regression (95% CI: 10.2–23.0%)
✅ 36.1% reported stable disease (95% CI: 28.1–44.9%)

Treatment adherence was high, with 86.9% completing the full protocol and 66.4% remaining on therapy at six months.

The regimen was well tolerated, with 25.4% reporting side effects, primarily mild and gastrointestinal, and over 93% continuing treatment despite these events.

Patients were treated in real-world conditions alongside concurrent therapies, including chemotherapy (27.9%), radiation (21.3%), surgery (19.7%), supplements (49.2%), and dietary modification (37.7%), supporting use as an adjunctive approach.

Together, these findings represent a large, internally consistent real-world clinical signal that supports URGENT further investigation of ivermectin and mebendazole as low-toxicity, adjunctive cancer therapies.

Given the strength of the signal observed here, advancing this line of investigation is no longer optional—it is necessary.

This is NOT the end. We will continue advancing this work with larger datasets to further define and validate the role of anti-parasitics in cancer outcomes.

The manuscript is now available as a preprint on the Zenodo research repository, operated by the European Organization for Nuclear Research, while undergoing peer review at leading oncology journals: “Real-World Clinical Outcomes of Ivermectin and Mebendazole in Cancer Patients: Results from a Prospective Observational Cohort.”

Click Here to see the full Report of the Research
Bar chart showing distribution of common cancer types with breast cancer most prevalent.
Infographic on disease status and median duration since diagnosis.

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