Dino Prato founded the Fullness of Life Foundation (EIN 20-2571096) in July 2005.

For the tax year 2005, Dino Prato is listed as the president, and Sandy Yozipovic, a senior national sales director partner of Primerica Financial Services, is listed as the co-chair.

The purpose of the foundation is listed on their Form 990 as:

Provide Educational Services Involving Homeopathic, Naturopathic, and Integrative Health Remedies.

On their website, the Fullness Foundation states their mission as:

The purpose of our foundation is to raise millions of dollars through our annual fundraising events. Our “Give Them Wings” program will provide scholarships to help relieve the financial burden that every family faces when they have a child diagnosed with cancer. The scholarship program is currently being built.

The Fullness of Life Foundation funded Poly MVA treatments for Riley, a 14-year girl with a brain tumor who had failed traditional treatments. No funding was offered to the families that brought their children to the Envita clinic in the summer of 2008.

On October 14, 2005, Envita hosted their first major fundraising event, One Night Stand Against Cancer.

Envita’s second annual fundraiser, "Celebrate Life" was held October 20, 2006 and included a charity golf tournament, health talk, silent auction, and live entertainment.

This year’s fundraiser, Believe, a Concert for Life will be held on October 25. Tickets are $85-$135.

Envita’s form 990 for 2006 covers the period July 1, 2006 to June 30, 2007.

The Schedule of Special Events and Activities attached to the form shows that the Foundation spent nearly $70,000 to put on the Celebrate Life event which netted them less than $1,500.

The exact figures:

Envita charges the DIPG kids they treat $1,800 for each Poly MVA infusion. Four infusions a week totals $7,200 per week.

Envita’s recommended protocol for the Poly MVA kids is now 60 infusions total, 4 infusions per week, total treatment taking 15 weeks. At $1,800 a pop, that’s $108,000.

Not including bloodwork and other Envita-recommended supplements, some of which cost well over $1,000 per month.

Despite the almost $70,000 spent to put on the benefit, The Fullness Foundation didn’t raise enough money to pay for one single Poly MVA treatment for one child.

The entire revenue of the Foundation for fiscal year 2006 was $41,433, not quite enough to cover the cost of 23 Poly MVA infusions at the prices they charged those kids.

Other clinics in Arizona, some run by other Envita doctors offer intravenous Poly MVA at half the cost that Envita charges their patients.

An 8-oz. bottle of Poly MVA purchased at full retail price can be ordered for $230. One bottle is used for multiple treatments. Volume buyers get an additional discount.

Most of the desperate families who brought their children to Envita are not wealthy. The amount of their children’s treatment exceeds what most of them make in a year, excluding loss of income, travel, and lodging costs. These families and their friends were able to put together fundraisers that raised well over 10 times what the Fullness of Life Foundation has raised in three years.

The Fullness Foundation knows how to put on a fancy party for rich people at partial taxpayer expense, but the most recent financials don’t show that they know how to raise money.

Caveat emptor.

Maybe they should hire the families and friends of those kids, they know how to raise money.

Envita treats their brain tumor patients with intravenous Poly MVA.

Poly MVA, also known as Polydox, is Lipoic Acid Palladium (LAPd), along with vitamins and minerals. The formulation being used today was developed in 1991.

Currently Envita’s brain tumor protocol calls for 60 intravenous infusions, administered 3 times weekly, so the recommended length of treatment would be 20 weeks.

Envita’s treatment has gotten some attention recently from the parents of children with a particularly nasty sort of brain tumor, diffuse intrinsic pontine glioma, or DIPG.

To date, there is no scientific evidence that Poly MVA works for DIPG. On the Poly MVA survivors site, there are several accounts mentioning brain stem glioma, but not a single case of DIPG.

On Envita’s site is a paper, provided by the makers of Poly MVA. Excerpted from that paper, this is the information that applies to brain tumors:

Basic Scientific Evidence

• This formulation was studied independently at Calvert Laboratories, Inc. to determine its’ effectiveness in halting the growth of glioblastoma cells in vivo. Four groups were given daily intravenous (IV) doses of this formulation or placebo; four groups were given intraperitoneal doses of 0.5, 1.0 or 2.0 mg per mouse for a total of four weeks. Tumor volume was measured throughout the study. Compared to the controls that received no formulation, mice receiving the test material orally or intravenously at 0.5, 1.0 or 2.0 mg had a significantly reduced growth of the glioblastoma (50% or greater reduction in tumor size).

• Studies at Stony Brook University examined the non-toxic chemotherapeutic effects of POLY-MVA on brain and breast tumors. We were investigating the relationship between the degree of anaplasia of malignant cells and effectiveness o f the PdLA complex. Metabolic dysfunction, related to hypoxia and subsequent adaptive gene responses, renders some cells resistant to traditional chemotherapeutics but sensitive to the metabolic modulation of PdLA.

Representatives from Poly MVA have stated that the same effects obtained by giving Poly MVA intravenously can be achieved by taking the higher dosages they recommend on their site, for a child, 1 tsp per 20 lbs body weight per day.

At the maximum 8 tsp per day dose, a monthly supply of Poly MVA would cost between $2550 and $3450 depending on the number of bottles ordered.

Envita’s cost to provide Poly MVA is somewhere between $7,000 – $8,000 per week, $28,000 – $30,000 per month.

Following Envita’s recommended protocol for a child with a brain tumor, the cost of treatment would be around $150,000.

For families who don’t live in the Scottsdale area, it is necessary for them to arrange for living arrangements near to the Envita facility, driving the cost of getting treatment in Scottsdale even higher.

Poly MVA has been available in its current form for over 17 years. To date there are no published articles showing Poly MVA’s effectiveness for brain tumors.

There is one article in PubMed about Poly MVA, where it was shown to have possibility utility as a neuroprotective agent following a heart attach or stroke, based on an experiment using gerbils.

So far, Poly MVA is an unproven treatment for DIPG. On the Poly MVA Survivors site, there are several testimonials from children with brain tumors who have had significant survival, but all of them have had surgery and other conventional treatment and have used Poly MVA as a complement.

Families considering Poly MVA for their children with brain tumors have many less expensive options available to them than Envita’s unproven and expensive treatments.

More information:

• Poly MVA information from AMARC
• Poly MVA information by Merrill Garnett, from Envita site
• Regulation of ischemic cell death by the lipoic acid-palladium complex, Poly MVA, in gerbils.
• Ralph Moss – A Friendly Skeptic Looks at Poly MVA part I
• Ralph Moss – A Friendly Skeptic Looks at Poly MVA part II
• Poly-MVA (American Cancer Society)
• Polydox (Memorial Sloan Kettering)

Physicians and politicians resemble one another in this respect, that some defend the constitution and others destroy it.
~Abbot Gasquet

In September 2005, Envita announced a new immunotherapy treatment for cancer, described by Envita as:

Envita’s therapy, 4NKT, grows a patient’s own antitumor immune cells into the billions. These cells are then analyzed for activation markers and tested for their ability to kill cancer cells in the laboratory, then reinfused into the patient.

In three separate press releases, Envita announced 4NKT as a treatment for breast cancer, prostate cancer, and leukemia.

On March 1, 2006, Dr. Sandra Shire of the FDA conducted an inspection of the labs at Envita. Based on that inspection on June 14, 2006 the FDA issued a warning letter to Dino Prato of Envita.

The FDA charged that:

• Envita’s treated 4NKT cultures constituted both a biological product and a drug, and therefore required a valid Biologics License (BLA) or a New Drug Application (NDA), or an Investigational New Drug (IND) application.

• Envita did not properly conduct its clinical studies because they did not meet the requirements for nor submit an IND.

• Envita’s product was misbranded because the labeling did not contain adequate instructions for the purposes the drug was being used for.
• Envita failed to protect the public health because there was no evidence that Envita’s cell cultures were being tested for sterility, mycoplasma, or endotoxin.
• By failing to comply with FDA regulations, Envita denied its patients the protections of an IND.

Envita disputed the claims of the FDA, saying that:

• Their treatment falls under the practice of medicine and is therefore not subject to an IND.
• The components of 4NKT had already been demonstrated in clinical practice as safe for use.
• 4NKT treatments do not enter interstate commerce
• Envita protected the public health by excluding patients with hepatitis B or C, HIV, leukopenia, anemia, and patients under the age of 18 (this is not mentioned in their 9-24-05 press release touting natural killer cells at Envita as offering new hope to adults and children).
• Envita is a treatment facility and conducts no research.

The FDA concluded that Envita’s response was not sufficient to address their concerns and on December 8. 2006, Envita agreed to cease 4NKT treatments and to submit an IND.

Envita submitted a investigational new drug (IND) application to the FDA for a Phase I clinical drug trial for the use of natural killer cells for the treatment of cancer on April 15, 2008.

More information:

• Natural Killer Cells Destroy Cancer Cells in Breast Cancer Patients – 9-21-05 press release
• Natural Killer Cells Destroy Cancer Cells in Prostate Cancer Patients – 9-21-05 press release
• Natural Killer Cells Brings New Hope to Children and Adults with Leukemia – 9-24-05 press release
• Biologics License Application Process
• IND Application Process
• FDA Warning Letter
• Envita’s Response to the FDA
• FDA Reply to Envita’s Response
• Envita Reply to FDA Response
• FDA Office of Regulatory Affairs Enforcement Story 2006 (see pp. 4-5)
• Envita and The Food and Drug Administration (FDA)
• Biologics Firm Disputes Need for License, Drug Applications
• Biologics Firm Receives FDA Warning Letter
• Envita Natural Medical Centers of America, Scottsdale, AZ, June 14 (CBER).