Thank you so much for your inputs. My father finally had his MRI Fusion TRUS biopsy and below are the results. I am doing all the background work on what the course of treatment would be (leaning towards radiation). Your input would be highly valuable when meeting with the RO.
Quick History : My Father is 74 years old and has been having urinary issues in the night and he was on Tamsulusin and Dutasteride, the PSA increased from 4.6 to 10 over the course of 5 years. This year he got his MpMRI and it showed a Pirads 4 leasion (the biopsy showed nothing in the MpMRI pointed location) Below are the biopsy results. The urologist has been very open to options and suggested men in the 70s prefer radiation to surgery but my dad can undergo surgery if he chooses to do so since he is physically very fit. He asked us to talk to the RO. Additionally he said he wanted to do a cystoscopy before to check for blockage and help with it before radiation. So he won't have urinary issues during / post radiation.
Below are the results
Left
A Base : Adenocarcinoma (Gleason 6 (3+3)) Tumor length percent 40%
As far as I can tell, your father does not have advanced prostate cancer. Advanced prostate cancer is one that has metastasized. You may get more relevant responses by posting on the following site instead:
FYI, many with advanced PC will have good experiences.
Really ? So if a stage 4 man has skeletal metastasis from skull to ankles and lymph node involvement from pelvis to collar bone all he needs is to contact Nutrition 2000 and he will cause his cancer to become stable ?
He won't need chemo, hormone therapy as initial treatment ?
Department of Health and Human Services' logo Department of Health and Human Services
Public Health Service
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
June 3, 2008
FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED
Nutrition 2000
4108 Rucker Boulevard
Enterprise, Alabama 36330
WARNING LETTER
NO. 2008-NOL-14
Dear Sir or Madam:
This is to advise you the U. S. Food and Drug Administration (FDA) has reviewed your website at the Internet address nutrition2000.com and has determined the products “Cesium and Potassium Combo,” “Curcumin,” “Men’s Prosta-Life,” “PC Hope,” “Platinum,” “Protocel Formula 23,” “Protocel Formula 50,” and “Surcan” are promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code, Section 321(g)(1)(B)] (21 USC 321). The therapeutic claims on your website establish the products are drugs, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your web site include:
Cesium and Potassium Combo with DMSO
“Cesium is toxic to cancer cells”
“Cesium both halts and neutralizes lactic acid”
“Lactic acid causes pain and is a source of energy/fuel for cancer”
“Cesium disrupts the ionic balance of cancer cells[sic] membrane”
“… treatment of cancer with cesium, to quickly arrest growth and then gradually kill the cells, is an almost perfect approach. It would be consistent with some of the amazing reports of late stage cancer being arrested in a matter of days.”
“As the cell continues to ingest both cesium and potassium, the effects to the cancer cell are toxic.”
“… the physical results [of taking cesium] are a rapid shrinkage of the tumor masses.”
“In addition to the cancer therapy, … Cesium is very effective in regulating heart arrhythmia. … Based on experimental data available Cesium may also be useful in the treatment of manic-depressives.”
Curcumin
“Scientists showed that curcumin … restores key immune cells that fight off cancer.”
“… curcumin boosts the immune system of tumor-bearing mice by restoring key immune cells called CD4 and CD8 T cells.”
PC Hope
Helps alleviate symptoms associated with prostatitis, BPH, elevated PSA and all stages of prostate cancer.
Shown to reduce PSAs and inhibit tumor growth in men who are refractory and have metastatic cancer.
Shown to extend survival of people with pancreatic cancer.
Your website also contains disease claims in the form of personal testimonials, including:
“Diagnosed with prostrate [sic] cancer in 1999. … Two months ago my PSA was 5.2; Now I am using PC Hope and it has reduced to 1.7.”
“I started taking PC HOPE June 26. At that time my PSA was 17.3, it was rechecked July 3 and was down to 7.39. … You can quote me as saying ‘PC HOPE works!”‘
Platinum
“Platinum is used in the treatment of cancer and as a base in some of the chemotheraputic [sic] treatments in conventional hospitals …”
“Platinum may be effective in killing disease- causing bacteria, fungus, viruses ….”
Protocel Formula 23 and Protocel Formula 50
“Protocel comes in two slightly different formulas. Analysis of the formulas indicate that the following lists represent the better of the two formulas to start your protocol.
Formula 23
Formula 50
Auto-immune diseases
Cervical cancer
Bladder cancer
Colon cancer
Brain tumors (primary)
Esophageal cancer
Breast-cancer
Leukemia
Kidney cancer
Liver cancer (primary)
Multiple melanoma
Lung cancer
Prostrate [sic] cancer
Melanoma
Wilmes tumor
Non-Hodgkin’s lymphoma
Autoimmune disorders
Ovarian cancer
Crohn’s disease
Pancreatic cancer
Diverticulitis
Rhabdoid brain tumors
Endometriosis
Sarcomas
Multiple sclerosis
Stomach cancer
Parkinson’s…
Squamous cell cancer
Viral infections
Throat cancer
(herpes, shingles)…
Uterine cancer
Mononucleosis
Lupus”
“… taking Protocel while taking chemo reduces the side effects of chemo ….”
Surcan
Your webpage titled “Lung Cancer” lists Surcan as a “Recommended” product, and provides a link to purchase the product on the same webpage. The listing of your Surcan product as “Recommended” on your lung cancer webpage is clearly meant to indicate the product’s intended use as a cancer treatment.
Your website also contains a disease claim in the form of a personal testimonial:
“I had some prostate cancer diagnosed by a biopsy in November 1999…. I had another PSA test in January 2006, and the result was 5.65…. [I took] a regimen of Surcan and PC Hope, which I started taking together on February 5, 2006. I had another PSA test on April 14[th]. I found out on April 19[th] that my PSA reading was 2.2 and my free PSA was 50%! I am now taking Surcan and PC Hope on a maintenance basis.”
The claims quoted above are supplemented by the meta tags used to bring consumers to your website through Internet searches. The meta tags include “Bladder Cancer,” “Bone Cancer,” “Brain Cancer,” “Breast Cancer,” “Colon Cancer,” “Liver Cancer,” “Lung Cancer,” “Lymphatic Cancer,” “Metastatic Cancer,” “Oral Cancer,” “Pancreatic Cancer,” “Prostate Cancer,” “Skin Cancer,” “Testicular Cancer,” “Thyroid Cancer,” “Cancer Protocols,” “Leukemia,” and “Cancer Diet.”
Your products are not generally recognized as safe and effective for the above referenced uses, and therefore, the products are “new drugs” under Section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in Section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective. Your products “Cesium and Potassium Combo DSMO,” “Curcumin,” “Men’s Prosta-Life,” “PC Hope,” “Platinum,” “Protocel Formula 23,” “Protocel Formula 50” and “Surcan” are also misbranded within the meaning of Section 502(f)(1) of the Act, because labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure products marketed by your firm comply with the Act and its implementing regulations. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products (21 USC 332 and 334).
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time which the corrections will be completed.
Your response should be sent to Nicole F. Hardin, Compliance Officer, U.S. Food and Drug Administration at the address above. If you have any questions about the content of this letter, please contact Ms. Hardin at (504) 219-8818 extension 102.
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Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
On behalf of my dad, no chemo yet - doc says not yet, please help
Reviewing my final Path report, post RP
