Envita and the FDA

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).