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.

    Sunday, November 25, 2012

    John L. Holahan—SimplyThick—Xanthan Gum—Necrotizing Enterocolitis



    Xanthan gum, a biotechnology product, was invented by the research team of Allene Rosalind Jeanes of the United States Department of Agriculture. This polysaccharide was approved as a food additive in 1968.

    Xanthan:
    is produced by X. campestris, a plant-associated bacterium that is generally pathogenic for plants belonging to the family Brassicaceae. Xanthomonas causes a variety of disease symptoms such as necrosis, gummosis and vascular parenchymatous diseases on leaves, stems or fruits; an example is "black rot" of crucifers such as cabbage, cauliflower or broccoli. Xanthomonas does not form spores, but it is very resistant to desiccation during relatively long periods. Survival at room temperature for 25 years has been reported by Leach et al.(1957).
    Xanthan gum has numerous profitable applications but did not enter the marketplace as an infant formula thickening additive (SimplyThick®) until recently. The FDA is investigating whether the SimplyThick product is linked to the multi-hospital and at home necrotizing enterocolitis events. It is curious to note that the xanthomonas bacterium causes necrotic plant disease.

    John L. Holahan, SimplyThick president, advertises his product as an aid for people suffering from dysphagia, (difficulty swallowing) not for infants exhibiting reflux symptoms. Xanthan gum, the preferred base for SimplyThick®, is proposed as a bulking agent in breast milk according to the patent (2009) filed by Mr. Holahan.

    In 2001, Mr. Holahan paid the Burdock Group for its expert opinion regarding SimplyThick/xanthan gum efficacy and safety. George A. Burdock, PhD  and Ioana G. Carabin, MD relying on one, xanthan gum, clinical adult trial advised their client to initiate marketing.

    The Burdock referenced supportive study:  "The dietary effects of xanthan gum in Man" by researchers: Eastwood, Brydon, and Anderson — Food Additives and Contaminates 1987 Vol. 4 No. 1, 17-26. — determined that the test xanthan product, Keltrol T, "does not appear, therefore, to cause any adverse toxicological effects."  This often-cited work was financed by U.S. xanthan gum manufacturer Kelco, Inc.

    The European Food Safety Authority in 2011 classified the Eastwood et al. uncontrolled xanthan gum study findings inconclusive.

    On September 2012 the FDA issued a SimplyThick alert and warned that the use of the xanthan-gum based product could cause life-threatening injuries to pre and post term infants. In this advisory, the agency reported that 7 infants had died and many others had developed necrotizing enterocolitis (NEC) after being prescribed SimplyThick. The previous, May 2011, FDA communication advised that the SimplyThick product posed a health risk to premature infants.

    Texas Children's Hospital— February 2012
    External thickening agents, including Simply Thick, Thick It, and several other similar products should not be used under any circumstances for any infants < 44 week postmenstrual age *(gestational age plus chronological age). At present the cases of NEC and similar illnesses are limited to those born < 37 weeks who developed illness at < 43 weeks PMA. This puts a small boundary around it.
    SimplyThick®/necrotizing enterocolitis incidents have been reported in the following states:

    New York (May, '10)
    North Carolina (April, '11)
    New Mexico (September '09) A New Mexico hospital reported eleven cluster NEC cases in early 2007, etiology unknown.
    Colorado (May, '09)
    Texas (May, '11)
    Indiana (January, '10)
    Florida (April, '11)

    Canadian health authorities have also established a relationship between SimplyThick® and NEC.

    One of the most relevant NEC cases involve Florida twins, Jaden and Genesis Santos, who were under Florida Hospital Neonatal care in 2011. Shortly after discharge and on a medically prescribed SimplyThick® feeding regime, Jaden Santos died of necrotizing enterocolitis on April 8, 2011. For additional information on this issue please link to SimplyThick Neonatal Intensive Care Practices.

    Those researching the SimplyThick® product for a causal link to necrotizing enterocolitis will find the issue complex.

    SimplyThick Manufacturing Deficiencies &Product Contamination

    The FDA determined during its June 2011 inspection that one of three SimplyThick processors was not following safe manufacturing practices. Bacillus cereus contaminated one raw xanthan gum sample and was found in finished SimplyThick packets. As a result of the FDA findings, SimplyThick products manufactured by Thermo-Pac, June 1, 2009-June 3, 2011, were recalled. For additional information please link to Thermo Pac, LLC—SimplyThick— Processing Deficiencies.

    Infant Formula Thickening Agents Medically Questionable

    A number of researchers and practitioners believe that SimplyThick and other thickeners are not suitable for infants. "Infants are not meant to be eating
    solid foods, so these products are not appropriate," states Jesse Reeves-Garcia, MD, director of gastroenterology, Miami General Hospital.

    Material Injury

    At this juncture, the FDA has not determined whether SimplyThick/xanthan gum, thickening agents, or unsafe manufacturing practices are responsible for the infant NEC fatalities and illnesses.

    While the FDA seeks a NEC cause, CP Kelco, the largest domestic producer of xanthan gum, is claiming material injury as a result of anti-dumping practices on the part of China and Austria.

    U.S. International Trade Commission Xanthan Gum Findings July 2012

    Xanthan gum is a polysaccharide produced by the fermentation of a carbohydrate source using the strain of bacteria known as Xanthmonas capestris. Xanthan gum is sold in the form of a milled, granular powder and in a variety of grades. Due to its unique molecular structure, it is a naturally-derived stabilizer of water-based solutions that is used primarily for its thickening, stabilizing, and suspension properties in a wide variety of products and industries.

    Physical Characteristics and End Uses.

    All grades of xanthan gum are derived from fermentation of the bacteria Xanthomonas campestris and, as such, each grade shares the same basic physical characteristics and chemical composition. The different grades of xanthan gum primarily are used for a variety of purposes in three end-use industries: food and beverage, oil and industrial applications, and consumer applications (e.g., cosmetics and pharmaceutical products). The various grades differ somewhat in terms of purity level or grain size according to the specific needs of purchasers or specific regulatory standards for the end-use application. The various grades of xanthan gum used in the three major end-use applications generally serve as thickening or stabilizing agents.

    Channels of Distribution.

    The different grades of xanthan gum are generally sold in the same channels of distribution, with most xanthan gum being sold directly to end-users and the remainder to distributors.

    Manufacturing Facilities, Production Processes, and Employees

    All xanthan gum is made in similar manufacturing facilities, using similar production processes and employees. The production process for xanthan gum may vary slightly depending on the grade being produced, such as one requiring additional enzymes or a different particle size. Additionally, government regulations require that the manufacture of food grade xanthan gum occur in an environment designed to limit microbiological contamination. Nevertheless, all xanthan gum products can produced on the same production lines that are GMP (good manufacturing processes) because these lines satisfy the necessary quality control requirements.

    Producer and Customer Perceptions.

    The limited evidence in this preliminary phase indicates that all grades of xanthan gum are perceived by both producers and customers to be the same product, although certain food and consumer product grades must meet the necessary regulatory requirements.

    Price

    The record indicates that prices vary among the end-use industries. Food grades and consumer grades are required to be free from microbacterial contamination. As such, these grades are generally higher priced than oil grades. Xanthan gum is manufactured in only four countries, the United States, Austria, China, and France, all of which export xanthan gum. Xanthan gum is produced from the fermentation of the bacteria strain Xanthomonas campestris. The production process requires maintaining the bacteria strain used for culture; providing carbohydrate, nitrogen, and micronutrient sources to initiate the fermentation process; extracting and refining the xanthan gum from the culture; milling the product into a powder; and finally packaging it for distribution. The production process begins with fermentation of the bacteria. First, selected strains of Xanthomonas capestris must be properly maintained and stored for continuous production. A small amount of the strain is expanded in a shake flask, and then further reproduced in a seed tank for scalable expansion, to create the inoculum for large bioreactors. Next it is placed in a bioreactor where it interacts with a carbohydrate source (typically a corn derivative, such as corn starch), a nitrogen source (such as casein hydrolysates, soybean meal, or distillers’ solubles), micro-minerals, and water. At the end of this step xanthan gum broth is produced, which contains xanthan, bacterial cells, and other chemicals. Recovery of the xanthan gum begins by removing the cell debris using either filtration or centrifugation. Next alcohol (such as isopropanol, ethanol, or acetone) is added to broth to separate the xanthan gum from water, creating a xanthan gum fiber. The resulting residual mixture of alcohol, water, cellular debris, and nutrients is distilled to recover the alcohol; while the other residual material is sent to a water waste treatment facility. The xanthan gum fiber is then dried, milled to a particular granule size, and packaged into specified quantities. The product may also be coated with non-water soluble material, such as cottonseed oil or lecithin, to aid in the dispersal of the xanthan gum particles when placed in a solution. At this point, the xanthan gum is marketable. Xanthan gum production requires that facilities meet standards set by the Environmental Protection Agency for wastewater. For industrial grade xanthan gum, this is the main regulatory concern with the production process. In order for xanthan gum to qualify as “food grade,” the FDA requires certain processes and tests be done, as does the USDA for certain meat and dairy products. First, the FDA requires that the strain of Xanthomonas capestris be nonpathogenic and nontoxic to humans and animals. Second, it requires that the recovery process renders no viable cells of the strain. There are also specifications that the residual isopropyl used in the recovery process must not exceed 750 parts per million; the final product must meet certain viscosity properties; the product must also pass two specified laboratory tests; and finally, the product must have proper labeling and use information. Several importers provided additional comments on the comparisons. *** stated that xanthan gum is a complex product, and even if two suppliers offer the same specification, it might happen that one xanthan gum works in a specific application, and the other does not. *** stated that the quality of the imported product from China has always been inferior to the U.S.-produced product, a problem that is a concern to domestic food manufacturers.

    Tuesday, October 30, 2012

    Thermo Pac, LLC—SimplyThick— Processing Deficiencies



    Thermo Pac LLC

    Thermo Pac LLC, a processor of hot fill, liquid and dry powder products for the US Department of Defense, Phagia-Gel Technologies (SimplyThick) and various unpublished food companies, became a manufacturer of FDA interest following MedWatch reports linking the SimplyThick product to infant necrotizing enterocolitis.

    The FDA—May 20, 2011— SimplyThick Advisory:
    Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth. FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.
    September 18, 2012 FDA SimplyThick Infant Health Risk Warning
    Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died. Infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.
    FDA Thermo Pac May 23-June 3, 2011 Inspection (Form 483) Findings

    Companies receiving Forms 483 are considered to be in significant violation of federal regulations because aberrant manufacturing practices are threats to public health.

    The FDA found that Thermo Pac, an acidified food processor, neglected to notify the agency of new products entering the marketplace, had failed to engage a recognized Processing Authority to approve product pH safety parameters and did not employ certified "acidified food" supervisory staff. During the course of investigation the FDA inspector found evidence of bacillus cereus in eleven SimplyThick finished products and one xanthan gum raw sample.

    Contracting parties: John L. Holahan SimplyThick president, and Dennis Straub Thermal Pac Chief Operation Officer agreed that ST products manufactured from June 1, 2009-June 3, 2011 would be recalled. Another, Thermo Pac customer's product (redaction) was also recalled.

    John Holahan notified the FDA on June 29, 201l, that he intended to resume SimplyThick shipments for products manufactured after June 4, 2011.

    Thermo Pac Deficiency Acknowledgments:
    Specifically, this firm has not filed any scheduled processes for any acidified food products manufactured. Furthermore, there is no documentation or evidence to show that the operating processes used in manufacturing these acidified foods were established by a competent Processing Authority. This would include the processing parameters used for the Simply Thick thickening gel.

    Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance capable of growing in the food. Specifically, it was found the Simply Thick gel is being cold-filled as an acidified food. The target pH for this product is (redaction) pH.

    There is no scientific documentation available excluding this product from receiving a thermal process. TPL had been following process parameters that were established and in place for the SimplyThick product prior to its acquisition of the business in July 2008. (AmeriQual purchased Thermo Pac from H. J. Heinz in 2008)

    Failure to perform chemical testing where necessary to identify sanitation failures and possible food contamination.

    Failure to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing.

    Process deviations are not evaluated by a competent processing authority in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health.

    Specifically, due to no scheduled processes being filed for any acidified foods, every batch of every acidified food manufactured by this firm would be considered a deviation. However, the firm continued to manufacture and ship finished product without an evaluation.

    US Department of Defense Thermo Pac LLC Contracts

    The Defense Logistics Agency awarded Thermo Pac LLC a firm fixed $23,473,590 price contract for various food items on February 20, 2009.

    The Defense Logistics Agency awarded Thermo Pac LLC a maximum $22,735,230 firm-fixed-price contract for various food items on February 16, 2010.

    The Defense Logistics Agency awarded Thermo Pac LLC a fixed-price with economic price adjustment, indefinite-quantity contract with a maximum $20,164,784 for food items on January 27, 2012.

    Saturday, October 27, 2012

    FDA "SimplyThick" Infant Health Risk Warnings are Complicated



    SimplyThick®— SimplyThick The Thickening Gel You Can't Taste®

    SimplyThick®, a food and beverage additive, is under FDA investigation as a possible causative, necrotizing enterocolitis, factor in the death of seven pre/post term infants. Product recall is difficult because SimplyThick, a nationwide non-prescription product, is marketed as an aid for those who suffer swallowing disorders (dysphagia).

    Health Canada strengthened SimplyThick infant risk warnings on October 18, 2012.

    There are no preclinical/clinical trial studies to suggest that SimplyThick, a xanthan gum-based, likely-imported Chinese manufactured product, was suitable or safe for Neonatal Intensive Care Unit patients. The company Web site states that:
    SimplyThick® is the next-generation food and beverage thickener designed specifically for people who have difficulties swallowing.
    Burdock Group 2001 Risk Assessment Opinion re Phagia-Gel Technologies SimplyThick Product

    In spite of limited adult clinical trial xanthan gum research, George A. Burdock, Ph.D and Ioana G. Carabin, M.D. favorably determined for Phagia-Gel Technologies principals, John Holahan and Matt Knehans 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).
    Neonatal Intensive Care: SimplyThick Commonly Prescribed

    It is a matter of concern that a number of North Carolina and other states' Neonatal Intensive Care facilities prescribed SimplyThick ® because various 1984-2003 studies indicate that "Thickening milk feeds may cause necrotising enterocolitis." —P Clarke, M J Robinson Neonatal Intensive Care Unit, Hope Hospital, Salford, UK, M6

    Clarke & Robinson are of the opinion that formula thickeners do not reduce the incidence of gastro-esophageal reflux. They further state that thickening agents "may not be free from serious adverse effects and should not become widely adopted without a randomised trial."

    The FDA stated that the agency first became aware of the SimplyThick ® link to infant NEC in December 2010. It is yet to be determined, but as noted in the following reports the 2001 Burdock Group approved SimplyThick product may have been responsible for previous NEC occurrences.

    Cluster of necrotizing enterocolitis in a neonatal intensive care unit: New Mexico, 2007American Journal for Infection Control

    In 2007, a New Mexico hospital experienced a necrotizing enterocolitis neonatal intensive care unit event. A six-week study January 1, 2007- February 13, 2007 conducted by the American Journal for Infection Control found eleven NEC cases, etiology undetermined. Researchers concluded that "enhanced infection control and changing batches of HMF (human milk fortifier) might have played a role in controlling this outbreak."

    The case study: "Development of necrotizing enterocolitis in premature infants receiving thickened feeds using SimplyThick" was submitted to the Journal of Perinatology in May 2011. The authors, all associated with the Brenner Children's Hospital in Winston-Salem, NC stated that:
    We recently began using ST(Simply Thick) to treat premature infants with dysphagia and or gastroesophageal reflux. We describe three cases of premature infants who developed necrotizing enterocolitis (NEC) after they were fed ST. Unlike classic NEC, all three cases presented with late-onset colonic NEC.
    The case study: "Late Onset Necrotizing Enterocolitis in Infants following Use of a Xanthan Gum-Containing Thickening Agent" was submitted to the Journal of Pediatrics in January 2012.

    Abstract:
    Adverse event reports submitted to the US Food and Drug Administration suggested a possible association between necrotizing enterocolitis and ingestion of a commercial feed thickener by premature infants. Review in 2011 of 22 cases with exposure revealed a distinct illness pattern.
    "NEC with Thickened Formula" — August 2012
    Journal of Pediatrics —Volume 161 Page A 4
    Alan H. Jobe, MD, PhD
    Neonatologists seem determined to treat the poorly defined reflux that frequently occurs in preterm infants with something—preferably drugs that are off-label and have no proven efficacy. Popular choices are prokinetic agents and proton pump inhibitors. Another unvalidated strategy is to thicken feeds. In this issue of The Journal, Beal et al report a series of 22 cases of necrotizing enterocolitis NEC that were associated with a commercial xanthan gum-containing food thickener. These cases of NEC are quite unique in the time of onset of the disease after birth. Most of the 22 infants were preterm, but the onset of NEC was at a mean of about 40 weeks gestational age, with a number of infants developing NEC at home after discharge—a most unusual timing for the onset of NEC. Although this case series does not prove cause and effect, the disease presentation strongly implicates this food thickener as a risk for NEC. Perhaps clinicians should restrain their enthusiasm for other thickeners for the feeding of preterm infants as well. The proven treatments for reflux in otherwise normal preterm infants are time and patience.

    WebMD September 2012: "FDA to Parents: Don't Give SimplyThick to Infants" extract:
    This warning is specific to SimplyThick and does not include other thickening products, says FDA spokeswoman Tamara N. Ward. "Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider.”

    SimplyThick and other thickeners are not meant for infants, period, says Jesse Reeves-Garcia, MD. He is the director of gastroenterology at Miami Children's Hospital. “Infants are not meant to be eating solid foods, so these products are not appropriate.”
    Beasley Firm, LLC:
    After issuing the original warning, the FDA continued to conduct extensive reviews of reports potentially linked to the use of SimplyThick. It was noted that approximately 24 full term infants developed NEC after being administered SimplyThick in addition to 21 premature babies.
    CourtHouse News report: Jack Mahoney died of NEC following a prescribed SimplyThick feeding regime. Date of incidence — April 2011, location —Wake Medical Hospital, Raleigh, NC

    Devon Addonizio has filed a SimplyThick et al lawsuit on behalf of her NEC-injured daughter. Date of incidence — May 2010, location —New York City.

    Shane and Jennifer Umphress have filed a SimplyThick et al lawsuit on behalf of their NEC-injured daughter. Date of incidence —September 2009, location—University of New Mexico Hospital Las Cruces, New Mexico.
    University of New Mexico Children's Hospital NICU 2011-2012 Orientation Manual page 17 — SimplyThick is classified as a "dietary snack."

    Pamela Konkle notified the press and the FDA in September 2011 that her daughter Hannah was diagnosed with NEC shortly after being prescribed SimplyThick.
    Date of incidence— January 2010, location — Riley Children's Hospital, Muncie, IN.

    Brayden Harris was born on January 27, 2011 and died of SimplyThick induced necrotizing enterocolitis on May 26, 2011 according to a lawsuit filed by his parents. Case will be adjudicated in Dallas.

    Mackenna Cope died of NEC. Her mother, Stacy, was notified in May 2011 that her daughter's death was possibly related to the NICU's use of SimplyThick. Date of incidence — May 2009, Location —Memorial Hospital Colorado Springs, Co. Memorial Hospital reported four other SimplyThick-NEC cases to the FDA.

    One of the most relevant NEC cases involve Florida twins, Jaden and Genesis Santos, who were under Florida Hospital Neonatal care in 2011. Shortly after discharge and on a medically prescribed SimplyThick feeding regime, Jaden Santos died of necrolizing enterocolitis on April 8, 2011.

    Parents of NEC-damaged infants are seeking redress as a result of the FDA SimplyThick ® warning. Primary parties under scrutiny: SimplyThick, LLC, Phagia-Gel Techologies LLC, owner of SimplyThick— Thermo Pac, LLC manufacturing contractor for SimplyThick, — AmeriQual Group, owner of Thermo Pac and H. J. Heinz the former owner of Thermo Pac.

    Thermo Pac, LLC Deficiencies

    Following the FDA 5/23/2011- 6/3/2011 inspection of the Thermo Pac Stone Mountain, Ga facility, SimplyThick and the FDA jointly decided to recall SimplyThick ( June 1, 2009- June 3, 2011 ) products. During the course of investigation the FDA found evidence of bacillus cereus in eleven SimplyThick finished products and one xanthan-gum raw sample. On June 29, 2011, SimplyThick notified the FDA that the company would resume sales, as its product no longer posed a public health risk.

    FDA SimplyThick Infant Health Risk Communications

    May 20, 2011 FDA SimplyThick Premature Infant Health Risk Advisory
    Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth. The thickening product may cause necrotizing enterocolitis (NEC), a life-threatening condition.

    FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.
    September 18, 2012 FDA SimplyThick Infant Health Risk Warning
    Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died. Infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.
     

    Saturday, October 20, 2012

    Health Canada SimplyThick Infant Product Warning 10/18/12


     Infant— SimplyThick—Alert: Health Canada October 18, 2012

    Health Canada is advising parents and health professionals to be aware of the potential NEC risk "before deciding whether to use SimplyThick to aid in feeding infants of any age." Medical authorities report that at least two cases of infant necrotizing enterocolitis have been linked to the SimplyThick product. The FDA has issued similar SimplyThick warnings.

    SimplyThick Infant Health Warnings are Complicated

    SimplyThick®, a food and beverage additive, is under FDA investigation as a possible causative, necrotizing enterocolitis, factor in the death of seven pre/post term infants. Product recall is complicated because SimplyThick, a nation-wide non-prescription product, is marketed as an aid for those who suffer swallowing disorders (dysphagia).

    There are no preclinical/clinical trial studies to suggest that SimplyThick, a xanthan gum-based, likely-imported Chinese manufactured product, was suitable or safe for Neonatal Intensive Care Unit patients. The company Web site states that:
    SimplyThick® is the next-generation food and beverage thickener designed specifically for people who have difficulties swallowing.
    Burdock Group 2001 Risk Assessment Opinion re Phagia-Gel Technologies SimplyThick Product

    In spite of limited adult clinical trial xanthan gum research, George A. Burdock, Ph.D and Ioana G. Carabin, M.D. favorably determined for Phagia-Gel Technologies principals, John Holahan and Matt Knehans 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).

    Neonatal Intensive Care: SimplyThick Commonly Prescribed

    It is a matter of concern that a number of North Carolina and other states' Neonatal Intensive Care facilities prescribed SimplyThick ® because various 1984-2003 studies indicate that "Thickening milk feeds may cause necrotising enterocolitis." —P Clarke, M J Robinson Neonatal Intensive Care Unit, Hope Hospital, Salford, UK, M6

    Clarke & Robinson are of the opinion that formula thickeners do not reduce the incidence of gastro-esophageal reflux. They further state that thickening agents "may not be free from serious adverse effects and should not become widely adopted without a randomised trial."

    The FDA stated that the agency first became aware of the SimplyThick ® link to infant NEC in December 2010. It is yet to be determined, but as noted in the following reports the SimplyThick ® 2001 product may have been responsible for previous NEC occurrences.

    Cluster of necrotizing enterocolitis in a neonatal intensive care unit: New Mexico, 2007— American Journal for Infection Control

    In 2007, a New Mexico hospital experienced a necrotizing enterocolitis neonatal intensive care unit event. A six-week study January 1, 2007- February 13, 2007 conducted by the American Journal for Infection Control found eleven NEC cases, etiology undetermined. Researchers concluded that "enhanced infection control and changing batches of HMF (human milk fortifier) might have played a role in controlling this outbreak."

    The case study: "Development of necrotizing enterocolitis in premature infants receiving thickened feeds using SimplyThick" was submitted to the Journal of Perinatology in May 2011. The authors, all associated with the Brenner Children's Hospital in Winston-Salem, NC stated that:
    We recently began using ST(Simply Thick) to treat premature infants with dysphagia and or gastroesophageal reflux. We describe three cases of premature infants who developed necrotizing enterocolitis (NEC) after they were fed ST. Unlike classic NEC, all three cases presented with late-onset colonic NEC.
    The case study: "Late Onset Necrotizing Enterocolitis in Infants following Use of a Xanthan Gum-Containing Thickening Agent" was submitted to The Journal of
    Pediatrics in January 2012.

    Abstract:
    Adverse event reports submitted to the US Food and Drug Administration suggested a possible association between necrotizing enterocolitis and ingestion of a commercial feed thickener by premature infants. Review in 2011 of 22 cases with exposure revealed a distinct illness pattern.
    Beasley Firm, LLC:
    After issuing the original warning, the FDA continued to conduct extensive reviews of reports potentially linked to the use of SimplyThick. It was noted that approximately 24 full term infants developed NEC after being administered SimplyThick in addition to 21 premature babies.

    CourtHouse News report: Jack Mahoney died of NEC following a prescribed SimplyThick feeding regime. Date of incidence — April 2011, location —Wake Medical Hospital, Raleigh, NC

    Devon Addonizio has filed a SimplyThick et al lawsuit on behalf of her NEC-injured daughter. Date of incidence — May 2010, location —New York City.

    Shane and Jennifer Umphress have filed a SimplyThick et al lawsuit on behalf of their NEC-injured daughter. Date of incidence —September 2009, location—University of New Mexico Hospital Las Cruces, New Mexico.

    Pamela Konkle notified the press and the FDA in September 2011 that her daughter Hannah was diagnosed with NEC shortly after being prescribed SimplyThick.
    Date of incidence— January 2010, location — Riley Children's Hospital, Muncie, IN.

    Brayden Harris was born on January 27, 2011 and died of SimplyThick induced necrotizing enterocolitis on May 26, 2011 according to a lawsuit filed by his parents. Case will be adjudicated in Dallas.

    Parents of NEC-damaged infants are seeking redress as a result of the FDA SimplyThick ® warning.  Primary parties under scrutiny: SimplyThick, LLC,  Phagia-Gel Techologies LLC, owner of SimplyThick— Thermo Pac, LLC manufacturing contractor for SimplyThick, — AmeriQual Group, owner of Thermo Pac and H. J. Heinz the former owner of Thermo Pac.

    Thermo Pac, LLC Deficiencies

    Following the FDA 5/23/2011 thru 6/3/2011 inspection of the Thermo Pac Stone Mountain, Ga facility, SimplyThick and the FDA jointly decided to recall SimplyThick ( June 1, 2009- June 3, 2011 ) products. During the course of investigation the FDA found evidence of bacillus cereus in eleven SimplyThick finished products and one xanthan-gum raw sample. On June 29, 2011, SimplyThick notified the FDA that the company would resume sales, as its product no longer posed a public health risk.

    FDA SimplyThick Infant Health Risk Communications

    May 20, 2011 FDA SimplyThick Premature Infant Health Risk Advisory
    Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth. The thickening product may cause necrotizing enterocolitis (NEC), a life-threatening condition.

    FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.
    September 18, 2012 FDA SimplyThick Infant Health Risk Warning
    Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died. Infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.

    Tuesday, October 16, 2012

    SimplyThick Neonatal Intensive Care Practices



    SimplyThick Infant Health Warnings are Complicated

    SimplyThick®, a food and beverage additive, is under FDA investigation as a possible causative, necrotizing enterocolitis, factor in the death of seven pre/post term infants. Product recall is complicated because SimplyThick, a nation-wide non-prescription product, is marketed as an aid for those who suffer swallowing disorders (dysphagia).

    There are no preclinical/clinical trial studies to suggest that SimplyThick, a xanthan gum-based likely-imported Chinese manufactured product, was suitable or safe for Neonatal Intensive Care Unit patients. The company Web site states that:
    SimplyThick® is the next-generation food and beverage thickener designed specifically for people who have difficulties swallowing.
    Burdock Group 2001 Risk Assessment Opinion re Phagia-Gel Technologies SimplyThick Product

    In spite of limited adult clinical trial xanthan gum research, George A. Burdock, Ph.D and Ioana G. Carabin, M.D. favorably determined for Phagia-Gel Technologies principals, John Holahan and Matt Knehans 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).
    Neonatal Intensive Care: SimplyThick Commonly Prescribed

    It is a matter of concern that a number of North Carolina and other states' Neonatal Intensive Care facilities prescribed SimplyThick ® because various 1984-2003 studies indicate that "Thickening milk feeds may cause necrotising enterocolitis." —P Clarke, M J Robinson Neonatal Intensive Care Unit, Hope Hospital, Salford, UK, M6

    Clarke & Robinson are of the opinion that formula thickeners do not reduce the incidence of gastro-esophageal reflux. They further state that thickening agents "may not be free from serious adverse effects and should not become widely adopted without a randomised trial."

    The FDA stated that the agency first became aware of the SimplyThick ® link to infant NEC in December 2010. It is yet to be determined, but as noted in the following reports the SimplyThick ® 2001 product may have been responsible for previous NEC occurrences.

    Cluster of necrotizing enterocolitis in a neonatal intensive care unit: New Mexico, 2007— American Journal for Infection Control

    In 2007, a New Mexico hospital experienced a necrotizing enterocolitis neonatal intensive care unit event. A six-week study January 1, 2007- February 13, 2007 conducted by the American Journal for Infection Control found eleven NEC cases, etiology undetermined. Researchers concluded that "enhanced infection control and changing batches of HMF (human milk fortifier) might have played a role in controlling this outbreak."

    The case study: "Development of necrotizing enterocolitis in premature infants receiving thickened feeds using SimplyThick" was submitted to the Journal of Perinatology in May 2011. The authors, all associated with the Brenner Children's Hospital in Winston-Salem, NC stated that:
    We recently began using ST(Simply Thick) to treat premature infants with dysphagia and or gastroesophageal reflux. We describe three cases of premature infants who developed necrotizing enterocolitis (NEC) after they were fed ST. Unlike classic NEC, all three cases presented with late-onset colonic NEC.
    The case study: "Late Onset Necrotizing Enterocolitis in Infants following Use of a Xanthan Gum-Containing Thickening Agent" was submitted to The Journal of Pediatrics in January 2012.

    Abstract:
    Adverse event reports submitted to the US Food and Drug Administration suggested a possible association between necrotizing enterocolitis and ingestion of a commercial feed thickener by premature infants. Review in 2011 of 22 cases with exposure revealed a distinct illness pattern.
    Beasley Firm, LLC:
    After issuing the original warning, the FDA continued to conduct extensive reviews of reports potentially linked to the use of SimplyThick. It was noted that approximately 24 full term infants developed NEC after being administered SimplyThick in addition to 21 premature babies.
    CourtHouse News report: Jack Mahoney died of NEC following a prescribed SimplyThick feeding regime. Date of incidence —April 2011, location—Wake Medical Hospital, Raleigh, NC.

    Devon Addonizio has filed a SimplyThick et al lawsuit on behalf of her NEC-injured daughter. Date of incidence—May 2010, location—New York City.

    Shane and Jennifer Umphress have filed a SimplyThick et al lawsuit on behalf of their NEC-injured daughter. Date of incidence—September 2009, location—University of New Mexico Hospital Las Cruces, New Mexico.

    Pamela Konkle notified the press and the FDA in September 2011 that her daughter Hannah was diagnosed with NEC shortly after being prescribed SimplyThick. Date of incidence—January 2010, location—Riley Children's Hospital, Muncie, IN.

    Brayden Harris was born on January 27, 2011 and died of SimplyThick induced necrotizing enterocolitis on May 26, 2011 according to a lawsuit filed by his parents. Case will be adjudicated in Dallas.

    Mackenna Cope died of NEC. Her mother, Stacy, was notified in May 2011 that her daughter's death was possibly related to the NICU's use of SimplyThick. Date of incidence—May 2009, Location— Memorial Hospital Colorado Springs, Co. Memorial Hospital reported four other SimplyThick-NEC cases to the FDA.

    Premature twins, Jaden and Genesis Santos, were under Florida Hospital Neonatal care in 2011. Shortly after discharge and on a medically prescribed SimplyThick feeding regime, Jaden Santos died of necrolizing enterocolitis (NEC) on April 8, 2011.

    Parents of NEC-damaged infants are seeking redress as a result of the FDA SimplyThick® warning. Primary parties under scrutiny: SimplyThick, LLC, Phagia-Gel Techologies LLC, owner of SimplyThick— Thermo Pac, LLC manufacturing contractor for SimplyThick, — AmeriQual Group, owner of Thermo Pac and H. J. Heinz the former owner of Thermo Pac.

    Thermo Pac, LLC Deficiencies

    Following the FDA 5/23/2011 thru 6/3/2011 inspection of the Thermo Pac Stone Mountain, Ga facility, SimplyThick and the FDA jointly decided to recall SimplyThick ( June 1, 2009- June 3, 2011 ) products. During the course of investigation the FDA found evidence of bacillus cereus in eleven SimplyThick finished products and one xanthan-gum raw sample. On June 29, 2011, SimplyThick notified the FDA that the company would resume sales, as its product no longer posed a public health risk.

    FDA SimplyThick Infant Health Risk Communications

    May 20, 2011 FDA SimplyThick Premature Infant Health Risk Advisory
    Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth. The thickening product may cause necrotizing enterocolitis (NEC), a life-threatening condition.

    FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.
    September 18, 2012 FDA SimplyThick Infant Health Risk Warning
    Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died. Infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.

    Monday, October 1, 2012

    Infant Formula Additives: Generally Recognized as Safe

    Infant Formulas: Are They Safe? Infant Formula additives
    may be marketed without FDA approval.
     

    FDA Questions Martek's Infant Formula DHASCO/ARASCO Additives—2001

    Martek Biosciences, Inc. (est. 1985) asked the FDA in 2001 to recognize the company's self-certified Generally Recognized as Safe (GRAS) status for its patented ARA fungal oil (ARASCO) and DHA algal oil (DHASCO) infant formula product ingredients. ARASCO and DHASCO contain long chain polyunsaturated fatty acids. The federal agency agreed to accept the company's safety assertions but presented evidence disputing the addition of long chain polyunsaturated fatty acids (LCPUFAs) in infant formula products:
    ... some studies have reported unexpected deaths among infants who consumed formula supplemented with LCPUFAs. These unexpected deaths were attributed to Sudden Infant Death Syndrome (SIDS), sepsis or necrotizing enterocolitis. Also, some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed LCPUFAs.
    The public is likely not aware that the Generally Recognized as Safe designation is a US-industry created mechanism to avoid premarket approval and independent testing.

    DHASCO and ARASCO Infant Formula Additives: Further Safety Studies "Would not be Productive"

    In September 1937 the S. E. Massengill Company began marketing an antibiotic product called elixir sulfanilamide. The medication contained the dissolving agent diethylene glycol, a known toxic substance.

    Elixir Sulfanilamide was responsible for 100 deaths, many of them children. To avoid trial publicity and scheduled expert testimony, Dr. Samuel E. Massengill pleaded guilty to the federal charges of adulteration/misbranding of the company's product and paid fines.

    Following the "Taste of Raspberries, Taste of Death" poisoning scandal Congress expediently passed the 1938 Food, Drug, and Cosmetic Act.

    Congressional actions twenty years after the fact compromised the intent of the 1938 legislation and the ability of the Federal Drug Administration to protect consumers from injurious products.

    The 1958 Food Additives Amendment, aka "The GRAS Law" permits financially-positioned manufacturers to establish the safety and suitability of their products by way of industry-sponsored trials and selected approval panels.

    The question of whether DHASCO and ARASCO oils are benign/beneficial infant formula additives is unknown because Martek would not support the FDA's position that "any evaluation that a use of a food ingredient is safe is a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient."

    In 2001 Martek advised the FDA that further DHASCO/ARASCO safety trial studies "would not be productive":
    As such it is doubtful that convening a group of experts to answer purely hypothetical concerns would be scientifically productive, but such a step would certainly and unnecessarily further delay the availability of the proven clinical benefits of Arasco/Dhasco-supplementation to preterm and term infants of American families.
    The Agency and the courts have long held that GRAS determination requires neither unanimity nor the absence of a conflict in the scientific community.
    Bloomberg Businessweek reported in 2005 — "A Growing Boost for Baby Formula"—that Martek's first-mover DHASCO/ARASCO status and the company's 15-24 year contracted partnerships with 14 infant formula producers were stock-enhancing factors.

    A federal anti-trust lawsuit was filed against Martek Bioscience, Inc. in 2011. The plaintiff, BNLfoods, claims that Martek has a US-infant formula monopoly.

    Martek's 2010 Petition for DHA Algal Oil Organic Certification

    It is instructive to consider Martek's organic certification revenue strategy:
    If our oils are unable to be used in organic food and beverage products, the opportunity for sales of our oils into the food and beverage market will be limited to non-organic products.
    Upon consideration, the fifteen member National Organic Standards Board determined during their fall 2011 Savannah meeting that Martek's proprietary DHA algal and ARA fungal oils should be included on the National List as organic substances. This recommendation was made in spite of the fact the ARASCO® and DHASCO® additives (Formulaid®) are:
    derived from genetically mutated algae and soil fungus, are processed with petrochemical solvents, grown in genetically engineered corn, and formulated for use in infant formula, dairy and other products with a myriad of other unreviewed synthetic ingredients.
    Reference— Cornucopia Institute white paper report: "The Organic Watergate"
    _________________________________________________________________
    DNA-altered corn seed is not only an organic issue: Does the consumption of genetically-engineered herbicide-resistant corn products pose a health risk? A recently released two-year study indicates that the novel Monsanto NK603 food/feed product can significantly promote tumor growth, impair organ function and shorten life expectancy.

    Other investigative articles such as "GM food nightmare unfolding in the regulatory sham" (2007) and The Very Real Danger of Genetically Modified Foods (2012) stress the urgent need for further study.

    Photos of rats used in the  “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize”  study
     
    The Monsanto Company Genetically Modified Food Safety website ignores the precautionary principle by stating:
    There is no need for, or value in testing the safety of GM foods in humans. So long as the introduced protein is determined safe, food from GM crops determined to be substantially equivalent is not expected to pose any health risks. Further, it is impossible to design a long-term safety test in humans, which would require, for example, intake of large amounts of a particular GM product over a very large portion of the human life span. There is simply no practical way to learn anything via human studies of whole foods. This is why no existing food--conventional or GM--or food ingredient/additive has been subjected to this type of testing.
    South Africa, Russia, France, Egypt and EU regulatory agencies are finding the Seralini documentation cause for investigation.  Gilles-Eric Seralini led the “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize” research trial.
    ___________________________________________________________________

    Martek Bioscience, Inc. notified the National Organic Standards Board in its 2010 petition that the inclusion of negative DHA algal/ANA fungal oil information was unwarranted:
    Martek also is concerned that by quoting the Cornucopia report, the TAP (Technical Advisory Panel) could be creating the unintentional impression that it has reviewed the underlying data and believes that there is some legitimacy to the positions advanced by Cornucopia.
    Organic Business Concerns

    The May 2012 International Formula Council's letter to the National Organic Standards Board warned that unfavorable determinations on the part of the Board re infant formula product substances such as choline, inositol, carrageenan, and arachididontic acid might result in market disruption and force manufacturers to reconsider whether to continue in the organic baby formula business.

    International Formula Council members: Abbott Nutrition, Mead Johnson Nutrition, NestlĂ© Infant Nutrition, PBM Products, LLC, A Perrigo Company, and Pfizer Nutrition are of the opinion that hexane-extracted ingredients are suitable for inclusion on the National Organic List.

    For a historic perspective on harmful industry marketing concepts please read the 1981 NYT report: "The Controversy Over Infant Formula."  Summary: The World Health Organization agreed by a vote of 118 to l that infant-formula advertising should be restricted. The U.S. was the lone opponent.

    Is the U.S.D.A. certified-organic label meaningless? That issue is under debate. Evidence supplied by The New York Times and others indicate that the National Organic Standards Board is and has been unduly influenced by corporate petitioners.

    National Organic Standards Board May 25, 2012 recommendations: add synthetic ingredients, choline and inositol to the National Organic List. Carrageenan, another synthetic product, was allowed to remain on the National Organic List but is considered unsuitable for use in infant, under six months, formula. The World Health Organization advises that carrageenan should not be added to infant formulas. Some studies referenced by WHO suggest that degraded carrageenan may be a "possible human carcinogen." This manufactured product is present in food products, pet food and pharmaceuticals. Carrageenan's primary production site is the Philippines.

    ARASCO® and DHASCO® Synthetic Oils 1999—Generally Recognized as Safe Expert Panel Infant Formula Approval

    Martek marketing strategy 1996:
    Even if [the DHA/ARA blend] has no benefit, we think it would be widely incorporated into formulas, as a marketing tool and to allow companies to promote their formula as ‘closest to human milk.'
    The Martek Biosciences, Inc. Generally Recognized as Safe [GRAS] panel concluded in 1999 that Martek's proprietary products— ARASCO® and DHASCO® —single cell oils were suitable for inclusion in infant formula and children's food.
    Manufacturer's logic: Since widely varying amounts of DHA and ARA triglycerides docosahexaenoic acid (DHA) and arachidonic acid (ARA), are naturally present in human milk, these substances are appropriate infant formula supplements.

    FDA response: There is no independent scientific data to support Martek's assertion that the digestion and absorption of DHA from DHASCO, and ARA from ARASCO, would be the same as that of DHA and ARA from triglycerides present in human milk.

    Martek panel members certifying Arasco/Dhasco limited-term (90 days or less) trials as credible research were: Joseph Borzelleca, Ph.D.; Gary Flamm, Ph.D.; Bruce German, Ph.D.; Walter Glinsman, M.D..; David Kritchevsky, Ph.D.; and David Bechtal, Ph.D. These, under-contract often-invited, expert panel reviewers:
    independently and critically evaluated materials submitted by Martek Biosciences Corporation and other material deemed appropriate and conferred by telephone several times before preparation of this report.
    Much of the affirmative DHASCO/ARASCO test data supplied to the GRAS panel was industry-reliant. Short term preclinical/clinical trial periods, though cost effective, can produce unreliable results.

    Industry players conducting 1990s ARASCO®/DHASCO® trials were: Wyeth Ayerst/Pfizer acquisition as of 2009, Martek Biosciences/ Royal DSM N.V. acquisition as of 2011, Mead Johnson, Numico (Nutricia) and Gist-Brocades/ Royal DSM N.V acquisition as of 1998.

    In their 1999 Generally Recognized as Safe support documents, the Martek panel reported that the novel ARASCO®/ DHASCO® oils had been tested in 12 animal species and 1478 human babies.

    The Martek team noted that cited ARASCO®/ DHASCO® research was modeled after FDA Redbook guidelines and conducted in Good Laboratory Practice facilities.

    Wyeth-Ayerst 1998 Notice of Claim to the FDA For Arasco/Dhasco Oils' Exemption From Premarket Approval

    In its FDA waiver request letter, Wyeth-Ayerst affirmed that the products:
    ...conditions of use are such that ARASCO and DHASCO will comprise less than 3.5% of an infant formula fat blend, their use does not meaningfully affect the overall content of heavy metals, pesticides, trans fatty acids, residual extraction solvent, or non-saponifiables in the infant formulas in which they are used.
    Wythe initiated research trials found that (US/Canada) infant study groups supplied with ARASCO/DHASCO enhanced formula "grew significantly better than the human milk fed group." The Wythe promotional claim is not true.

    As a result of its and other industry-funded animal/infant research projects, Wythe concludes that "the safety and tolerance of the of the Arasco and Dhasco-supplemented formula" is well documented and needs no further inquiry.

    ARASCO®/DHASCO® Oils Alleged Health Benefits

    The Royal DSM N.V. owner of Martek Bioscience, Inc. as of 2011, corporate website references its DHA product as:
    An omega-3 with proven brain, eye and heart health benefits for all stages of life - from pregnant and nursing women to infants, children and adults. Life's DHA is a fish-free and sustainable source of DHA from algae. It is a trusted vegetarian source of DHA found in hundreds of foods, supplements and infant formulas worldwide.
    The Federal Trade Commission cautioned Martek Biosciences, Inc in 2004 re the company's practice of unsubstantiated health benefit advertising.

    Pharmaceutical Business Review September 2012: A Royal DSM N.V. supported study has found that daily use of the company's DHA algal oil dietary supplemental product will improve a child's reading ability and lesson behavioral problems.

    Failure to Communicate Consumer Product Health Risks

    Companies manufacturing consumer goods are expected, but not obliged, to report health complaints and defects to the FDA. This conflict of business interest notification system is illogical.

    Case in point: St. Jude Medical, Inc faulty defibrillator Riata wires. In November 2011 the company reported that less than 1% of the 80,000 U.S. patients using the surgically implanted device were adversely affected by product failure. St. Jude Medical acknowledged in July 2012 that approximately 19% of its defibrillator product patients are likely to experience harmful, potentially life-threatening Riata wire malfunction. Both the FDA and St. Jude Medical were aware of the increased patient risk. It was a Freedom of Information Act request that prompted St. Jude Medical to revise its numbers. For additional information please read The New York Times report, "Unpredictable Danger Looms Close to the Heart."

    Cornucopia Institute Freedom of Information Act Request re DHASCO/ARASCO Infant Formula Additives

    Various studies referenced by the FDA in 2001 indicated that infants fed with Omega 3-fatty acids enhanced formula can and have experienced harmful reactions.

    When the FDA asked the company to defend its Generally Recognized as Safe conclusion, Martek countered:
    ARASCO and DHASCO pose unique testing problems because it can be difficult to distinguish whether an observed effect related to the test material is a normal physiological response to the high dietary load of that particular macronutrient, a dietary deficiency that is related to presence of a large amount of the test material in the diet, or a toxicological effect.

    ...studies conducted in term and preterm infants with balanced addition of ARASCO and DHASCO as sources of both bioactive fatty acids showed no difference in deaths between treatment and control groups.

     ...some studies have reported changes attributed to possible effects on the kidney. Martek presents an analysis of these studies and concludes that there are no consistent treatment related effects of DHASCO and ARASCO, either alone or in combination, with respect to kidney weight, kidney function or kidney histopathology.
     
    The Cornucopia Institute and the National Alliance for Breastfeeding Advocacy petitioned the FDA in 2008 to revise infant formula labeling to include a warning that products containing DHA/ARA oils may cause gastrointestinal distress. There is no consumer product warning regarding this matter on infant formula products.

    In 2009 the FDA reported the following to the Cornucopia Institute's Freedom of Information Act request:
    We have no responsive information in our files. FDA has never received any reports or studies regarding post-market surveillance or scientific studies monitoring or evaluating the safety of DHASCO and ARASCO (DHA and ANA) in infant formula.

    Arsenic in Food and Infant Formula Alert

    The World Health Organization and the EPA designate arsenic a carcinogen.

    Children chronically exposed to unsafe arsenic levels via water, soil, air and food are likely to experience acute and perennial physical harm. Resource TEACH: Toxicity, Exposure, Assessment Children's Health Database.

    In January 2012 Consumer Reports published its findings on arsenic-contaminated fruit juices, products commonly consumed by infants and children. In September 2012, Consumer Reports followed with its arsenic in rice study. Scientific tests confirm that rice and rice-based products, including infant formula, contain arsenic exceeding federal drinking water thresholds.

    The 2001 EPA Arsenic Rule set 10 parts per billion as a acceptable drinking water requirement and does not distinguish whether the referenced chemical element is inorganic or organic:
    The 10 ppb protects public health based on the best available science and ensures that the cost of the standard is achievable.

    This revision will provide additional protection for 13 million Americans against cancer and other health problems, including cardiovascular disease and diabetes, as well as neurological effects.
    New Jersey's arsenic safety benchmark is 5 parts per billion.

    Even though rice has long been identified as an arsenic absorbent grain, government agencies have not established protocols governing production sites, post-harvest testing, acceptable contamination levels or health risk disclosure.

    In view of the Consumer Reports arsenic test results, some pediatricians and medical professionals suggest limiting rice and rice-contained byproducts. This advice is not easily achievable because rice has many breakdown components.
    Steve Peirce, president of RIBUS (Rice Business US), with rice husks, the basis of his business which produces rice-based additives for food products. Finely ground round rice husks, for example, are added to spices to stop them from clumping together. Photo by Robert Cohen, rcohen@post-dispatch.com
     St. Louis Post-Dispatch July 2012 Georgina Gustin

    Mr. Peirce explains the RIBUS business plan:
    Rice is like a peanut. The outer layers are the husk, and that's about 20 percent of the crop. We're able to take that off and put it in the food system. When you take off that husk, you get brown rice, and when you take that off the skin – the bran – you get white rice. The bran is where 90 percent of the nutrients are. Since they throw that away or feed it to livestock, we take it and extract the nutrients from the bran. For 20 years we've worked with the bran, and over the last four years – and we're patent pending – we've worked on utilizing the hull.
    RIBUS notified the FDA in February 2012 that because its certified organic ground rice hull fiber, (nu-FLOW and nu-FLAC) products had been designated Generally Recognized as Safe food additives by Drs. Robert Nicolosi, Joseph Borzelleca, and Michael Pariza, the products were exempt from premarket approval.

    RIBUS product applications include, but are not restricted to, "prepared foods, nutraceuticals, functional foods, general foods (such as snack foods, bakery products, cereals, crackers, pasta products, dough conditioners, beverages, sports beverages), meal replacement, gluten-free foods, and medical foods."

    Thursday, March 29, 2012

    Alpha Academy Charter School Performance Report


    Alpha Academy Charter School
    Fayetteville, NC opened 2000
    215 K-8 students enrolled for 2010-2011

    Corporate entity holding school charter:
    Student Enhancement Services, Inc.
    Federal Tax I.D. 56-2151813

    The North Carolina Constitution Requires "A Sound Basic Education"

    The North Carolina Constitution states the following: "The people have a right to the privilege of education, and it is the duty of the State to guard and maintain that right." 

    In the matter of Leandro v. State of North Carolina, (N.C. 1997) the state Supreme Court found:
    We conclude that Article I, Section 15 and Article IX, Section 2 of the North Carolina Constitution combine to guarantee every child of this state an opportunity to receive a sound basic education in our public schools. For purposes of our Constitution, a "sound basic education" is one that will provide the student with at least: .

    (1) sufficient ability to read, write, and speak the English language and a sufficient knowledge of fundamental mathematics and physical science to enable the student to function in a complex and rapidly changing society;

    (2) sufficient fundamental knowledge of geography, history, and basic economic and political systems to enable the student to make informed choices with regard to issues that affect the student personally or affect the student's community, state, and nation;

    (3) sufficient academic and vocational skills to enable the student to successfully engage in post-secondary education or vocational training; and

    (4) sufficient academic and vocational skills to enable the student to compete on an equal basis with others in further formal education or gainful employment in contemporary society.” Id. at 255.
    President Bush and Congress recognized basic education as a national right in 2001 with the passage of the No Child Left Behind Act.

    Alpha Academy Charter School Student Performance

    Alpha Academy made adequate yearly progress 2010-2011 and 80-90% of its students were proficient in math and reading.

    Alpha Academy's first time federal and state achievement standards do not compensate the hundreds of students who attended the school from 2000-2009 and who received an unsatisfactory education. During this same time frame a number of North Carolina charter schools were successfully providing their students with basic math and reading skills. If the NC Blue Ribbon Commission's recommendations re consistently non-performing schools were the rule, Student Enhancement Services, Inc. would have had its charter revoked in 2007.

    Alpha Academy Charter School Students Left Behind 

    State records show that for the 2006-07 term, fewer than 50% of Alpha Academy students were at grade level.  The 2008-2009 Alpha Academy Charter School ABC Performance Report does not find marked improvement: 57.6% of Alpha Academy students Grade 3-8 were proficient in reading and 68.5 % were proficient in math.

    Alpha Academy Charter School Student Performance on the End-of-Grade Science Tests at the end of 2009:
    Grade 5: 38.5% of Alpha Academy students passed science tests
    Grade 8: 33.3% of Alpha Academy students passed science tests

    Alpha Academy Charter School Classroom Instructors

    The No Child Left Behind Act defines a “Highly Qualified Teacher” as a professional with full certification, a bachelor’s degree and demonstrated competence in subject knowledge and teaching.

    Alpha Academy educators were 100% licensed and highly qualified for 2010-2011 but since the school's founding, the Student Enhancement Services, Inc. board has employed a number of individuals who were not qualified to teach. For further information re the board's 2003-2011 employment practices please link to NC School Report Card web site.

    Alpha Academy Charter Renewal

    In 2004 the State Board of Education deemed Alpha Academy an Effective and Efficient Operation (EEO) and granted Student Enhancement Services, Inc. a 10-year extended charter.

    Alpha Academy/Student Enhancement Services, Inc. Board of Directors 

    Eugene Slocum, the long-term principal, is the founder and CEO of Alpha Academy. Don McQueen, one of the Alpha Academy Board Members, is the executive director of Torchlight Academy, a low-performing charter school. Other Alpha Academy Board Members include Norma J. Campbell, (Chair), Susan Slocum (Alpha Academy secretary), Tommy Evans and Jerome Scott.

    In 2010 Alpha Academy and other charter holders filed a federal complaint: "Charter schools allege inequity in state policy."

    North Carolina Charter School Financing

    Charter schools are tax-payer financed, privately-managed K-12 public educational facilities. Since 1997 North Carolina charter holders have received more than a billion and a half dollars ($1,558,404,984) in state funds for their school operations.

    The state paid charter school management boards over $200 million ($200,058,046) for 2010-2011. This money was allocated to ninety-nine charter schools.

    Charter schools also receive federal and county funds.

    Alpha Academy Charter School Funding FY 2010-2011: $1,714,210

    The North Carolina Department of Public Instruction reports that the Alpha Academy charter school received $1,330,670 in state and federal funds for 2010-2011. The breakdown is as follows: state $1,170,970 and federal $159,700.

    In addition to state and federal support, charter schools are entitled to county appropriations provided to local boards of education: "If a student attends a charter school, the LEA in which the child resides shall transfer to the charter an amount equal to the per pupil local current expense appropriation to the LEA for the fiscal year." (LEA: Local Education Agency)

    Cumberland County, location of Alpha Academy, allocated $78,831,036 to local boards of education for the year ending June 2010. The average daily membership (the state's method of counting students) for Cumberland County 2010-2011 was 52,208.
    Based on Alpha Academy's ADM of 254 students,  Cumberland County paid the charter holder $383,540.

    Alpha Academy Charter School Expenditures

    In contrast to local education agencies, North Carolina charter holders have unrestricted use of their allocated state and local education funds. The only exception to this rule is that these entities may not purchase buildings with public money.

    Alpha Academy Primary Fund Expenditures 2010-2011: Salaries 48%, Vendors 31%