|
|
Given ever increasing awareness and education campaigns regarding colorectal cancer screenings, along with the estimated 95 million people in the United States that suffer from gastrointestinal disorders and the current trend for alternative therapies, we anticipate success. There is reported an estimated number of new cases in 2007 for both colon and rectal cancer at 153,760 with deaths estimated at 52,180 to occur in the United States. Reducing the number of deaths from colorectal cancer depends on early stage detection yet, according to the Center for Disease Control (CDC) colorectal cancer screening remains underused, despite the availability of effective screening tests. In 2002, a reported 2.8 million sigmoidoscopies and 14.2 million colonoscopies were performed. The group of physicians reporting this number indicated that they could increase the number of procedures by 6.7 million and 8.2 million, respectively. The intended use for the increased procedures could be used for the unscreened population, thereby providing colorectal cancer screening to all eligible people in the United States. Patient acceptance is listed as a primary contributing factor in underused colorectal screening tests. The American College of Gastroenterology estimates that approximately 95 million people in the U.S. suffer from gastrointestinal disorders. These disordersresult in 30 million office visits annually and a total cost of care estimated at more than $107 billion. Additionally, gastrointestinal disorders are responsible for more hospitalizations than any other disorder. Gastrointestinal disorders include irritable bowel syndrome, constipation, diarrhea, diverticulitis, chrohns, ulcers, and diseases of the colon. In a survey conducted by the Centers for Disease Control and Prevention, all physicians combined (Gastroenterologists and Primary Care Physicians) reported that in 2002, 2.8 million sigmoidoscopies and 14.2 million colonoscopies were performed. The same group of physicians indicated that they could increase the number of procedures by 6.7 million and 8.2 million, respectively. The intended use for the increased procedures could be used for the unscreened population thereby provided colorectal cancer screening to all eligible people in the United States. (Gastroenterology, 2004 Dec: 127(6): 1841-4) New Application, Competition The medical application of colon hydrotherapy for lower endoscopic procedures will be a new market. Following the results of the recently completed clinical study with Danbury Hospital, in which the efficacy and acceptance of colon hydrotherapy versus current laxative methods was clearly demonstrated, some hospitals and gastrointestinal centers have indicated their readiness to adopt and incorporate colon hydrotherapy into their practices and procedures but there are conditions to satisfy. Efforts are currently underway to secure Medicare and Medicaid approval for the use of colon hydrotherapy as a preparatory treatment for loser endoscopic procedures. An informal search for competing manufactures and distributors of colon hydrotherapy equipment in the United States revealed few manufactures, in addition to Dotolo Research Corporation, of colon hydrotherapy equipment. Of the three, only two manufacture equipment suitable for use in medical practices. However, it is important to note that the Dotolo TOXYGEN™ Model BSC-UV is the only machine that has been used in a clinical study and is the only machine part of a study presented to the American College of Gastroenterology. |
|
  December 12, 2008
FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.
FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional. Read the MedWatch 2008 safety summary, including a link to the FDA Drug Information Page, at:
  |
