Clinical Research Notes

Walter P. Drake Clinical Research Notes
North Carolina Naturopath Privilege License No. 003829024

Transdermal Bioidentical Hormone Replacement Therapy: A follower of the John R. Lee MD  and Dr. Henry Lidner MD schools of thought on hormone replacement therapy, I developed the Drake protocol for estrogen and progesterone replacement therapy using transdermal hormone preparations monitored via Saliva Tests.  The protocol mirrors the normal cycles for estrogen and progesterone and is a compendium of the consensus of the medical literature. The starting protocol (subject to adjustment for each patient) is: 0.15 mg Estradiol Day 1-7; increase to 0.3 mg Days 8-14; back to 0.15 mg through Day 28 and Stop. Progesterone 15-20 mg Days 1-13 (Estradiol should never be given without compensating progesterone); 75 mg Days 14-26 and Stop. Monitor with saliva testing and adjust as needed; also adjustments due to menstrual status, although if a patient desires it, menstruation can be kept active indefinitely. Dosing calculations based on weight are required. Here is my essay “Why The Transdermal Delivery of Alternative Medicines is Best”

Expert in Stem Cell Therapy shown by this paper: “Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction”. Co-written with leading US stem cell pioneer Kristin Comella, this blockbuster paper was the first of its kind published in the US concerning the safety of autologous stem cell therapy using the stromal vascular fraction obtained from mini-liposuction. Cited over 50 times in other studies, the positive results have been confirmed worldwide in various labs and the procedure is widely used internationally to cure and control most diseases and conditions. Download HERE: Stem Cell Research Report

Mega-dose Vitamin A as a Cure for Acne Vulgaris- Single Patient Clinical Study. I believe that any single-patient clinical study in which data is recorded prior to treatment, and then compared to data recorded after treatment is just as  convincing and appropriate as all these massive clinical trials with controls that include patients not receiving any benefit. The Pharmaceutical companies have skillfully charted a course making their patented medicine, Accutane (and the generic isotretinoin) the sole final solution to curing acne in most individuals, while at the same time seeming to be spinning a story of Vitamin A toxicity. And of course, Accutane, due to its expense, allowed dermatoligists, perhaps unknowningly, to put patients through years of ineffective and worthless facial foams, creams, and lotions, before reaching for the “cure”. It occurred to me, when comparing the molecular structures of both the natural vitamin and the synthetic pharmaceutical, that the similarity was quite surprising, and I could see no reason why Vitamin A, at a comparable dosing to Accutane, would not achieve the same curative result. So when a patient came along with a severe case of acne vulgaris of many years, I knew what to try. The use of high-dose Vitamin A, which amounts are always expressed in International Units (IU), had to be converted to a milligram dose, used for Accutane and isotretinoin; and then the treatment dose calculated based on the weight of the patient. The study demonstrated that high dose Vitamin A at a level of 150,000-200,000 IU per day for 4 months totally eliminated acne in the patient, and in long term follow-up beyond what was published, it never returned. The paper is important for also showing that any toxicity of high dose Vitamin A is non-existent. The very minor “toxicity” of dry and redness of the upper cheeks was helpful in showing the treatment was working. I have had patients from several countries either ask me for further details, or thank me for a report that helped them as well. The paper is: Drake, WP, “High Dose Vitamin A Cures Severe Acne Vulgaris”, International Journal of Science and Research (IJSR), 10(2): 687-691, 2021. Read the report HERE: Report that Vitamin A Cures Acne

Why the Popular and Widely Sold Icariin Supplement Has No Clinical Efficacy for Erectile Dysfunction. Along with colleague Laurence V. Hicks Sr., I co-authored a paper destroying the myth that this widely popular herbal extract, Icariin, has any effect at all on the treatment of Erectile Dysfunction.  For the first time ever, we showed that Icariin (in any powdered form up to 98% purity) is not soluble in water, not soluble in any alcohol, not even soluble in the main stomach acid, hydrochloric acid. Once we found a formulation that would dissolve it, we then mixed it with a penetrating cream at a high concentration for transdermal application in an informal clinical study. Icariin 98%, administered transdermally at a dosage of 500 mg, had no effect whatsoever on erectile problems in our study. Not even one of 12 volunteer subjects noted any erectogenic effect, although all had tried sildenafil in the past with positive results. We found these results disappointing, as it was postulated that the transdermal route of administration, by delivering the compound directly to the blood, would bypass the solubility and low bioavailability issues, causing a beneficial erectogenic effect. This was not the case. Our results were confirmed by another lab that studied the pharmacokinetics of orally administered Icariin. They did serial blood draws over  24 hours following a single oral dose of the drug at 100, 200, 400, 840, 1680 mg icariin. Plasma testing resulted in no finding of any icariin after oral ingestion. So, in reality, with a very poor solubility compounded by almost no uptake in the gut, it is unlikely that the oral ingestion of icariin supplements has any effect whatsoever on improving erections in men, despite the ongoing fanfare and publicity surrounding its proposed use for this purpose. And in fact, that is what our paper showed—no effect whatsoever. Drake, WP and Hicks, LV Sr., “A Transdermal Formulation of Icariin for Use as a Substitute for Sildenafil and a Showing of No Clinical Efficacy”, International Journal of Science and Research (IJSR), 8(9): 939 – 943, 2019. Read about this HERE: Icariin Has No Clinical Efficacy

Why Exosomes Will Never Prove Effective. “From a Tube of Blood To Exosomes… The Stem Cell Therapy Story 2022”. An essay describing the history of stem cell therapy and why the current popular studies concerning the use of exosomes in therapy will not prove useful. Read my essay HERE: Exosomes Will Not Prove to be Useful for Therapy

Stem Cell Therapy for Scleroderma (systemic)- Literature search for a patient summarizing positive results following therapy with the Stromal Vascular Fraction, namely stem cells, cytokines, growth factors, and other molecules collected from a mini-liposuction. The report detailed how and why the procedure worked, and suggested health care providers that offered the procedure. See  my consultation report here: 2019 Consultation Report on Stem Cell Therapy for Scleroderma

IV Iron supplementation for patient with chronic anemia after bariatric surgery. 50 year old patient presented with low iron several years after bariatric surgery. Oral iron supplementation had been prescribed, however, over time, the treating physician apparently believed that a bone marrow abnormality or possible pre-cancer was causing abnormalities exhibited in blood work and iron levels. The bone marrow pathology came in as a “myeloproliferative neoplasm”, however somewhat couched in terms of “pre-fibrotic myelofibrosis or essential thrombocythemia”. The patient’s additional complaint was that of high platelet count. An inquiry into family history uncovered that his mother, still living, had exhibited long term high platelet count (2X over patient) with no apparent effect on her active life at age 80; so the patient’s high platelet count was most likely a genetic anomoly and not a factor in the current low iron presentation or boine marrow issues. Ferritin level was 10.8 (normal 23-336) flagged as low. One IV iron injection caused no increase in iron level, leading the health care provider to consider possible cancer causation. My review and recommendation was that abnormalities in bone marrow pathology were not pre-cancer or any cancer, but rather the effect of long term systemic low iron. Papers were gathered from the medical literature concerning proper dosing and timing of weekly IV iron supplementation, and also some papers demonstrating that Vitamin C increases iron uptake. The recommendation to the patient was to confer with his health care provider about long term weekly IV iron supplementation, with long term being a minimum of 3 months. After one month of weekly IV iron, the patient reported that the ferritin level increased 50%, and will continue on with weekly iron supplementation until normal range achieved, with likely future weekly or bi-weekly IV supplementation required long term. I would expect that the bone marrow to return slowly to normal as the ferritin is re-balanced. [with a bariatric surgery patient, oral Vitamin C supplementation of 5000-10,000 mg/day would be most likely difficult, IVC would be the recommended approach, but in this case, it was felt to just stick with IV iron].

Consultant to physicians on proper laboratory set-up in connection with contemplated new offering of stem cell therapies using Platelet Rich Plasma (PRP), and Stromal Vascular Fraction (SVF). Including recommended equipment such as laminar flow hood sizing (need for two people), centrifuge type and rotor speeds, lite box sourcing, consideration of disposable processing kits, ultrasound vs enzymatic dissociation of cells, refrigeration, design recommendations for size of lab and proximity to patient treatment area.

Consultant to physician on the possible use of Photobiomodulation and other physical techniques such as Pulsed Electromagnetic Fields (PEMF), Low Intensity Pulsed Ultrasound (LIPUS) for possible stimulation and activation of stem cells in vivo and for facial rejuvenation (which would indirectly demonstrate stem cell activation).
Report attached Here: Photobiomodulation for Stem Cell Activation

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Stem Cell Scientist for Over 20 Years
Director, Panama College of Cell Science.

By chance, in 2001, while living in Thailand, I came across reports of the curing of blindness in a Thai patient through the use of stem cell injections. There came further reports of Thailand establishing a “National Stem Cell Mega Project” to fund and coordinate stem cell therapies. Like those others of us that were overseas, it became clear to me that a lot of avant-garde research and treatment was going on around the world that was not happening in the USA. These advances were not even being reported in the US. This was very exciting and led me into the new field of “Stem Cell Medicine”. Over time, I developed the Panama College of Cell Science, the first and still only 3 year online PhD program in Stem Cell Biology. I remain the Director of the College.

Owner and Developer of Bengal Bioscience, a company in the alternative medicine space, engaged in research and development of stem cell biologicals and transdermal herbal formulations.

Walter P. Drake Curriculum Vitae. See HERE: 2023 CV Walter Drake