Saving Access to Bio-Identical Hormones & other Compounded Medications

by | Sep 13, 2015

The patients of Naturopathic Physicians derive tremendous benefit from safely compounded medications that are made available or administered to them in the physician’s office (known as “office use”).  Nutritional, herbal, homeopathic and Bio-Identical Hormone Replacement medications are compounded to meet unique patient needs. These medications are not available from large pharmaceutical manufacturers that do not make small batches of these specialized products.  These medications, as well as nutritional injectables and IV solutions, have been used in doctors offices safely for decades.
 

The FDA is seeking to limit the availability of these safely compounded drugs, including Bio-Identical Hormones, which goes far beyond the legislative intent of the Drug Quality and Security Act of 2013.  On the one hand, the FDA interprets the law as banning office use under Section 503A of the Food, Drug, and Cosmetic Act – despite the long-standing practice of many states to permit office use.  At the same time, the FDA has issued a proposed Memorandum of Understanding (MOU) relating to Section 503A that would unreasonably limit the interstate distribution of safely compounded drugs.  If these FDA actions go unchecked, patients will lose access to products that they need and are used to receiving.

 

This is why I am asking you along with the American Association of Naturopathic Physicians (AANP) to urge your Senators to cosponsor S. 1406, the Saving Access to Compounded Medications for Special Needs Patients Act.  The bill is sponsored by Senator David Vitter of Louisiana (one of the many states that would be severely affected by the FDA’s actions).  S. 1406 clarifies that Congress did not intend state regulation of office use under Section 503A to be overridden.  The bill would also revise the FDA’s proposed MEO so that the interstate distribution of safely compounded medications is not arbitrarily limited.

 

Vitter Bill – S. 1406 will ensure that the manifest needs of patients, and the pragmatic needs of doctors, will be safeguarded from FDA overreach.  We appreciate your emailing your United States Senators today!

 

Take Action Now: Save Access to Compounded Medications – Support S. 1406

Click here to write your Senators now! (It will only take a minute)

 

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.”

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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