Saturday, December 22, 2012

John L. Holahan: Burdock Group SimplyThick Safe for Infant Formula Approval 2001

SimplyThick®—John L. Holahan

SimplyThick® entered the health care market in 200l as a dysphagia-treatment therapy. John L. Holahan was granted a patent for the SimplyThick® beverage additive in 2009.

SimplyThick® products contain xanthan gum as the viscous property. Wikipedia informs:
Xanthan gum derives its name from the strain of bacteria used during the fermentation process, Xanthomonas campestris. X. campestris is the same bacterium responsible for causing black rot to form on broccoli, cauliflower and other leafy vegetables. The bacteria forms a slimy substance which acts as a natural stabilizer or thickener.
Mr. Holahan has a proprietary interest in xanthan-gum technology and has several patents pending, including one for thickening breast milk.

Long-term care facilities, home health agencies and various state Medicaid agencies responded favorably to the Holahan-designed product in spite of the fact the FDA had not evaluated or approved SimplyThick® as a medical adjuvant. Some state review boards have declined to cover SimplyThick® citing cost and availability of similar thickeners.

John L. Holahan—SimplyThick® Disclaimer:
Although information provided is believed to be true and accurate, SimplyThick® cannot anticipate all actual situations and/or conditions of use. We cannot assure the suitability of SimplyThick® for any particular situation or that SimplyThick® will work in every situation. The Food and Drug Administration has not evaluated nor approved any food thickener as a swallowing aid.
Wrongful death and personal injury lawsuits evidence that Mr. Holahan was also selling SimplyThick® to neonatal intensive care unit facilities under the premise that the xanthan gum product would reduce infant reflux symptoms. For further information please link to:

SimplyThick Neonatal Intensive Care Practices 
Thermo Pac, LLC—SimplyThick— Processing Deficiencies
John L. Holahan— SimplyThick® — Xanthan Gum— Necrotizing Enterocolitis

The FDA is presently of the opinion that SimplyThick® is the probable cause of infant necrotizing enterocoltis deaths and injuries. In May 2011 PubMed Health listed the following as necrotizing enterocolitis risk factors:
  • Premature infants
  • Infants who are fed concentrated formulas
  • Infants in a nursery where an outbreak has occurred
  • Infants who have received blood exchange transfusions

  • The infant necrotizing enterocolitis death rate is approximately 25%. Infants who survive this disease are subject to recurring health issues.

    Burdock Group SimplyThick® for Infant Endorsement

    Xanthan gum, as a food additive, was FDA approved in 1968. Studies as to whether this processed biogum is suitable for infants have not been conducted.

    Prior to marketing SimplyThick, Mr. Holahan (Phagia-Gel Technologies) contracted with the Burdock Group for its judgment on the safety of his xanthan gum product.

    Burdock Group experts, George A. Burdock, PhD and Ioana G. Carabin, MD, determined that:
    Therefore, allowing the addition xanthan gum to foods for infants and children (200g/(7oz.) day for a 10-kg/(22-pound child) indicates safety for consumption and lack of concern for induction or worsening of dehydration, even at very high levels of xanthan gum. A warning on the Phagia Gel Technologies SimplyThick (TM) product is not necessary, as the warning only applies to over-the-counter drug products (FR, August 26, 1993).
    The Burdock Group— SimplyThick— Opinion Letter lists supportive xanthan gum preclinical studies and includes a copy of the Eastwood et al. 1987 study "The dietary effects of xanthan gum in Man." This clinical trial for Keltro T was financed by U.S. xanthan gum manufacturer Kelco, Inc.—now C.P. Kelco, a Huber, Inc.  acquisition as of '04.

    In 2011 the European Safety Authority classified the Eastwood et al., "The dietary effects of xanthan gum in Man," findings inconclusive.