Coffee enemas are also included as part of the detoxification process. The enemas are administered twice daily. The use of coffee enemas is based on a belief that coffee introduced into the lower intestinal tract will improve liver function and stimulate emptying of the gallbladder, thereby enhancing the elimination of toxins and waste products from the body.[2,3]
The Gonzalez regimen is available only to private patients of its New York-based practitioner.
Pancreatic enzymes are sold in the United States as either prescription drugs indicated for pancreatic insufficiency  or over-the-counter (OTC) dietary supplements. As of 2004, those sold as prescription drugs must have a New Drug Approval from the US Food and Drug Administration (FDA) to be marketed legally in the United States. Pancreatic enzymes sold as OTC dietary supplements are regulated as foods, not drugs. Dietary supplements in the United States are therefore sold without a requirement of a market approval by the FDA, as long as they do not claim to treat or prevent a specific disease or condition. According to the developer of the Gonzalez regimen, most OTC preparations or other commercially available pancreatic enzymes are not effective against cancer.
For the FDA, PPE falls under the category of a new prescription drug that is under investigation. To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA. To date, only one group of investigators is known to have IND approval to study this pancreatic enzyme preparation as a treatment for cancer. The IND process is confidential, and the existence of an IND can be disclosed only by the applicant(s).
- Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.
- Gonzalez N: Dr. Nicholas Gonzalez on nutritional cancer therapy: a Moneychanger interview. The Moneychanger July 1995. Also available online. Last accessed May 24, 2012.
- Gonzalez NJ: Pancreatic cancer, proteolytic enzyme therapy and detoxification [excerpts]. Clinical Pearls News November 1999. Also available online. Last accessed May 24, 2012.
- Physician's Desk Reference 2005. 59th ed. Montvale, NJ: Thomson PDR, 2005.