Electronic Informed Consent Joins Target Health’s Software Suite

 

Target Health Inc., the innovator of the paperless clinical trial, has incorporated the electronic informed consent (Target e*Informed Consent™) into Target e*Studio®. Interestingly, at the same time we were finishing up the software, our colleagues at FDA released a draft guidance on electronic informed consent. We are doing some minor modifications to the software based on the draft guidance and plan to meet with FDA shortly and show them what we have.

 

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First Day of Spring in NYC – View From 88th Street

 

The Big Apple had a snowy Winter in 2014-2015 and the first day of Spring offered no let up. Look carefully as there are trees, cars, tables, benches and air conditioners covered with snow.

 

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Late Snow in NYC©target Health Inc. 2015

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

QUIZ

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The Limbic System

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Emotion involves the entire nervous system, of course. But there are two parts of the nervous system that are especially significant: The limbic system and the 1) ___nervous system. The limbic system is the collective name for structures in the human brain involved in emotion, motivation, and emotional association with memory. The limbic system plays its role in the formation of memory by integrating emotional states with stored memories of physical sensations. The limbic system is a complex set of structures that lies on both sides of the thalamus, just under the cerebrum. It includes the hypothalamus, the hippocampus, the amygdala, and several other nearby areas. In this drawing, you are looking at the brain cut in half, but with the brain stem intact. The part of the limbic system shown is that which is along the left side of the thalamus (hippocampus and amygdala) and just under the front of the thalamus (hypothalamus):

 

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Hypothalamus

The hypothalamus is a small part of the brain located just below the thalamus on both sides of the third ventricle. (The ventricles are areas within the cerebrum that are filled with cerebrospinal fluid, and connect to the fluid in the spine.) It sits just inside the two tracts of the optic nerve, and just above (and intimately connected with) the pituitary gland. The hypothalamus is one of the busiest parts of the brain, and is mainly concerned with homeostasis. Homeostasis is the process of returning something to some “set point.“ It works like a 2) ___. The hypothalamus is responsible for regulating hunger, thirst, pain responses, pleasure levels, sexual satisfaction, anger, aggressive behavior, and more. It also regulates the functioning of the autonomic nervous system, which in turn, regulates pulse, blood pressure, breathing, and arousal in response to emotional circumstances.

 

The hypothalamus receives inputs from a number of sources. From the vagus nerve, it gets information about blood pressure and the distension of the gut (stomach satisfaction, fullness). From the reticular formation in the brainstem, it gets information about skin temperature. From the optic nerve, it gets information about light and darkness. From unusual neurons lining the ventricles, it gets information about the contents of the cerebrospinal 3) ___, including toxins that lead to vomiting. And from the other parts of the limbic system and the olfactory nerves, it gets information that helps regulate eating and sexuality. The hypothalamus also has some receptors of its own, that provide information about ion balance and temperature of the blood. In one of the more recent discoveries, there is a protein called leptin which is released by fat cells when overeating The hypothalamus apparently senses the levels of leptin in the bloodstream and responds by decreasing appetite. Some people have a gene mutation which produces 4) ___, and their bodies can’t tell the hypothalamus that they have had enough to eat. However, many overweight people do not have this mutation, so there is still a lot of research to do!

 

The hypothalamus sends instructions to the rest of the body in two ways. The first is to the autonomic nervous system. This allows the hypothalamus to have ultimate control of things like blood pressure, heartrate, breathing, digestion, sweating, and all the sympathetic and parasympathetic functions. The other way the hypothalamus controls things is via the pituitary gland. It is neurally and chemically connected to the pituitary, which in turn pumps hormones called releasing factors into the bloodstream. As you know, the pituitary is the so-called “master gland,“ and these hormones are vitally important in regulating growth and metabolism.

 

Hippocampus

The hippocampus consists of two “horns“ that curve back from the amygdala. It appears to be very important in converting things that are “in your mind“ at the moment (in short-5) ___ memory) into things that you will remember for the long run (long-term memory). If the hippocampus is damaged, a person cannot build new memories, and lives instead in a strange world where everything they experience just fades away, even while older 6) ___ from the time before the damage are untouched! This very unfortunate situation is fairly accurately portrayed in the wonderful movie Memento, as well as in a more light-hearted movie, 50 First Dates. But there is nothing light-hearted about it: Most people who suffer from this kind of brain damage end up institutionalized.

 

Amygdala

The amygdalas are two almond-shaped masses of neurons on either side of the thalamus at the lower end of the hippocampus. When it is stimulated electrically, animals respond with aggression. And if the amygdala is removed, animals get very tame and no longer respond to things that would have caused rage before. But there is more to it than just anger: When removed, animals also become indifferent to stimuli that would have otherwise have caused fear and even sexual responses.

 

Besides the hypothalamus, hippocampus, and 7) ___, there are other areas in the structures near to the limbic system that are intimately connected to it: The cingulate gyrus is the part of the cerebrum that lies closest to the limbic system, just above the corpus collosum. It provides a pathway from the thalamus to the hippocampus, seems to be responsible for focusing attention on emotionally significant events, and for associating memories to smells and to pain. The ventral tegmental area of the brain stem (just below the thalamus) consists of dopamine pathways that seem to be responsible for pleasure. People with damage here tend to have difficulty getting 8) ___ in life, and often turn to alcohol, drugs, sweets, and gambling.

 

The basal ganglia (including the caudate nucleus, the putamen, the globus pallidus, and the substantia nigra) lie over and to the sides of the 9) ___ system, and are tightly connected with the cortex above them. They are responsible for repetitive behaviors, reward experiences, and focusing attention. The prefrontal cortex, which is the part of the frontal lobe which lies in front of the motor area, is also closely linked to the limbic system. Besides apparently being involved in thinking about the future, making plans, and taking action, it also appears to be involved in the same dopamine pathways as the ventral tegmental area, and plays a part in pleasure and addiction. When we look more closely at the areas of the brain involved with laughter, the limbic system seems to be central. The limbic system is a network of structures located beneath the cerebral cortex. This system is important because it controls some behaviors that are essential to the life of all 10) ___ (finding food, self-preservation).

 

ANSWERS: 1) autonomic; 2) thermostat; 3) fluid; 4) leptin; 5) -term; 6) memories; 7) amygdala; 8) pleasure; 9) limbic; 10) mammals

 

Pierre Paul Broca MD (1824-1880)

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Pierre Paul Broca was a French physician, surgeon, anatomist, and anthropologist. He is best known for his research on Broca’s area, a region of the frontal lobe that has been named after him. Broca’s Area is involved with articulated language. His work revealed that the brains of patients suffering from aphasia contained lesions in a particular part of the cortex, in the left frontal region. This was the first anatomical proof of the localization of brain function. Broca’s work also contributed to the development of physical anthropology, advancing the science of anthropometry.

 

Paul Broca was born on June 28, 1824, in Sainte-Foy-la-Grande, Bordeaux, France, the son of Benjamin Broca, a medical practitioner and former surgeon in Napoleon’s service. Broca’s mother was the daughter of a Protestant preacher. Broca received basic education in his hometown school, earning a bachelor’s degree at the age of 16. He entered medical school in Paris when he was 17, and graduated at 20, when most of his contemporaries were just beginning as medical students. After graduating, Broca undertook an extensive internship, first with the urologist and dermatologist Philippe Ricord (1800-1889) at the Hopital du Midi, then in 1843 with the psychiatrist Fran?ois Leuret (1797-1851) at the Bicetre. In 1844, he became an intern with Pierre Nicolas Gerdy (1797-1856), a great anatomist and surgeon. After two years with Gerdy, Broca became his assistant.

 

In 1848, Broca founded a society of free-thinkers, sympathetic to Charles Darwin’s theories. Broca was fascinated by the concept of evolution and once remarked, “I would rather be a transformed ape than a degenerate son of Adam“. This brought him into conflict with the church, which regarded him as a subversive, materialist, and a corrupter of the youth. The church’s animosity toward him continued throughout his lifetime, resulting in numerous confrontations between Broca and the ecclesiastical authorities.

 

In 1848, Broca became Prosector of anatomy at the University of Paris Medical School. He was also appointed secretary to the Societe Anatomique. In 1849, he was awarded a medical doctorate. In 1859, in association with Etienne Eugene Azam, Charles-Pierre Denonvilliers, Francois Anthime Eugene Follin, and Alfred Armand Louis Marie Velpeau, Broca performed the first experiments in Europe using hypnotism as surgical anesthesia. In 1853, Broca became professor agrege, and was appointed surgeon of the hospital. He was elected to the chair of external pathology at the Faculty of Medicine in 1867, and one year later professor of clinical surgery. In 1868, he was elected a member of the Academie de medicine, and appointed the Chair of clinical surgery. He served in this capacity until his death. He worked for the Hopital St. Antoine, the Pitie, the Hotel des Clinques, and the Hopital Necker. In parallel with his medical career, Broca pursued his interest in anthropology. In 1859, he founded the Society of Anthropology of Paris. He served as the secretary of the society from 1862. In 1872, he founded the journal Revue d’anthropologie, and in 1876, the Institute of Anthropology. The Church opposed the development of anthropology in France, and in 1876 organized a campaign to stop the teaching of the subject at the Anthropological Institute. Near the end of his life, Paul Broca was elected a lifetime member of the French Senate. He was also a member of the Academie francaise and held honorary degrees from many learned institutions, both in France and abroad.

 

Broca died on July 9, 1880, at the age of 56 due to a brain hemorrhage.  His two sons both became distinguished professors of medical science.

 

Broca’s early scientific works dealt with the histology of cartilage and bone, but he also studied cancer pathology, the treatment of aneurysms, and infant mortality. One of his major concerns was the comparative anatomy of the brain. As a neuroanatomist he made important contributions to the understanding of the limbic system and rhinencephalon. Olfaction was for him a sign of animality. He wrote extensively on biological evolution, then known as transformism in France (the term was also adopted in English at the time but is today used little in either language). In his later career, Broca wrote on public health and public education. He engaged in the discussion on the health care for the poor, becoming an important figure in the Assistance Publique. He also advocated secular education for women and famously opposed Felix-Antoine-Philibert Dupanloup (1802-1878), Roman Catholic bishop of Orleans, who wanted to keep control of women’s education. One of Broca’s major areas of expertise was the comparative anatomy of the brain. His research on the localization of speech led to entirely new research into the lateralization of brain function. Broca is celebrated for his discovery of the speech production center of the brain located in the ventroposterior region of the frontal lobes (now known as Broca’s area). He arrived at this discovery by studying the brains of aphasic patients (persons with speech and language disorders resulting from brain injuries). This area of study began for Broca with the dispute between the proponents of cerebral localization – whose views derived from the phrenology of Franz Joseph Gall (1758-1828) – and their opponents led by Pierre Flourens (1794-1867) – who claimed that, by careful ablation of various brain regions, he had disproved Gall’s hypotheses. However, Gall’s former student, Jean-Baptiste Bouillaud (1796-1881), kept the localization of function hypothesis alive (especially with regards to a “language center“), although he rejected much of the rest of phrenological thinking. Bouillaud challenged professionals of the time to disprove him by finding a case of frontal lobe damage unaccompanied by a disorder of speech. His son-in-law, Ernest Aubertin (1825-1893), began seeking out cases to either support or disprove the theory, and he found several in support of it.

 

Broca’s Society of Anthropology of Paris became the new platform for the localization of function controversy when several experts of head and brain anatomy joined, including Aubertin. Most of these experts still supported Flourens argument, but Aubertin was persistent in presenting new patients to counter their views. However, it was Broca, not Aubertin, who finally put the localization of function existence issue to rest. In 1861, Broca heard of a patient, named Leborgne, in the Bicetre Hospital who had a 21-year progressive loss of speech and paralysis but not a loss of comprehension nor mental function. He was nicknamed “Tan“ due to his inability to clearly speak any words other than “tan“. When Leborgne died just a few days later, Broca performed an autopsy. He determined that, as predicted, Leborgne did in fact have a lesion in the frontal lobe of the left cerebral hemisphere. From a comparative progression of Leborgne’s loss of speech and motor movement, the area of the brain important for speech production was determined to lie within the third convolution of the left frontal lobe, next to the lateral sulcus. For the next two years, Broca went on to find autopsy evidence from 12 more cases in support of the localization of articulated language. Although history credits this discovery to Broca, another French neurologist, Marc Dax, made similar observations a generation earlier, but he died before he had the time to do the research to further his evidence. Today the brains of many of Broca’s aphasic patients are still preserved in the Musee Dupuytren, and his collection of casts in the Musee d’Anatomie Delmas-Orfila-Rouviere. Broca presented his study on Leborgne in 1861 in the Bulletin of the Societe Anatomique.

 

Patients with damage to Broca’s area and/or to neighboring regions of the left inferiorfrontal lobe are often categorized clinically as having Expressive aphasia (also known as Broca’s aphasia). This type of aphasia, which often involves impairments in speech output, can be contrasted with Receptive aphasia, (also known as Wernicke’s aphasia), named for Karl Wernicke, which is characterized by damage to more posterior regions of the left temporal lobe, and is often characterized by impairments in language comprehension. Broca first became acquainted with anthropology through the works of Isidore Geoffroy-Saint Hilaire (1805-1861), Antoine Etienne Reynaud Augustin Serres (1786-1868) and Jean Louis Armand de Quatrefages de Breau (1810-1892), and anthropology soon became his lifetime interest. He spent much time at his Anthropological Institute, studying skulls and bones. In that sense, Broca was a pioneer in the study of physical anthropology. He advanced the science of cranial anthropometry by developing many new types of measuring instruments (craniometers) and numerical indices. Broca also contributed significantly to the field of comparative anatomy of primates. He was interested in the relationship between anatomical features of the brain and mental capabilities, such as intelligence. He believed, as did many in his time, that man’s intellectual qualities could be measured by the size of his brain.

 

New research has found that dysfunction in the Broca area may lead to other speech disorders such as stuttering and apraxia of speech. Recent anatomical neuroimaging studies have shown that the pars opercularis of Broca’s area is anatomically smaller in individuals who stutter whereas the pars triangularis appears to be normal.

 

Paul Broca’s name is one of the 72 names inscribed on the Eiffel Tower.

 

Biogen Idec Presents Positive Interim Results from Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab (BIIB037)

 

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral disturbances that eventually result in a person’s inability to perform daily activities. In 2010, it was estimated that 25 million individuals were living with AD worldwide. Evidence suggests that pathophysiological changes typically begin years prior to the symptoms that lead to a clinical diagnosis. As the disease progresses, cognitive impairments, behavioral changes and functional disability commonly associated with AD begin to manifest.

 

Aducanumab (BIIB037) is an investigational compound being developed for the treatment of AD. Aducanumab is a human recombinant monoclonal antibody (mAb) selected from a population of elderly, healthy donors and cognitively stable patients using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen Idec licensed aducanumab from Neurimmune under a collaborative development and license agreement. Aducanumab targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque levels.

 

Biogen Idec announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab, in which aducanumab demonstrated an acceptable safety profile and positive results on radiologic and clinical measurements in patients with prodromal or mild AD. Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain. Amyloid plaque is believed to play a key role in the development of the symptoms of AD. In exploratory analyses, a dose-dependent, statistically significant effect of slowing clinical decline was observed on the Mini Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scales.

 

PRIME is an ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of aducanumab in patients with prodromal or mild AD. This interim analysis of PRIME reflects data for 166 patients, up to week 54 in the placebo (n=40), 1 mg/kg (n=31), 3 mg/kg (n=33) and 10 mg/kg (n=32) dose arms, and up to week 30 data for the 6 mg/kg (n=30) dose arm.

 

Radiology Results: In patients receiving aducanumab, a dose- and time-dependent reduction of amyloid plaque was observed over 54 weeks of treatment. PET imaging using the radiotracer florbetapir, which binds to amyloid plaque, was used to measure plaque levels in the brain. A composite standardized uptake value ratio (SUVR) of six regions of the brain -frontal, parietal, lateral temporal, sensorimotor, anterior and posterior cingulate – was calculated at baseline, at 26 weeks and at 54 weeks using whole cerebellum as a reference. In the placebo arm, the SUVR was virtually unchanged at 26 and 54 weeks. Aducanumab treatment resulted in a statistically significant reduction of amyloid plaque in the 3 mg/kg [average change of -0.087, p<0.01)], 6 mg/kg [-0.143 (p<0.001)] and 10 mg/kg [-0.205 (p<0.001)] dose arms compared to placebo at 26 weeks. Amyloid plaque levels were reduced by -0.030 in the 1 mg/kg arm, which was not significant. At week 54, a statistically significant reduction of amyloid plaque was observed in the 3 mg/kg [-0.139 (p<0.001)] and 10 mg/kg [-0.266 (p<0.001)] dose arms. The reduction of amyloid plaque in the 1 mg/kg (-0.056) arm was not significant. The 6 mg/kg arm is ongoing and the week 54 data will become available at a later date.

 

Clinical Results: The effect of aducanumab on AD-related impairment was measured using the MMSE and Clinical Dementia Rating sum of boxes (CDR-SB). The MMSE is used to assess a patient’s cognitive status and the CDR-SB characterizes a patient’s cognitive and functional performance. On the MMSE, patients in the placebo group worsened by an average of 3.14 at one year, whereas the decline was 2.21 in the 1 mg/kg arm, 0.75 in the 3 mg/kg arm and 0.58 in the 10 mg/kg arm. Relative to placebo, the 3 mg/kg and 10 mg/kg doses demonstrated a statistically significant slowing of cognitive decline on the MMSE, both with p-values <0.05. On the CDR-SB, patients in the placebo group worsened by an average of 2.04 at one year. In comparison, the worsening was 1.70 in the 1 mg/kg arm, 1.33 in the 3 mg/kg arm and 0.59 in the 10 mg/kg arm. Relative to placebo, the 10 mg/kg showed a statistically significant slowing of clinical decline on the CDR-SB with p-value <0.05.

 

Safety Results: Based on the sponsor, Aducanumab demonstrated an acceptable safety and tolerability profile in this analysis. The most frequently reported treatment-related serious adverse event (SAE) and adverse event (AE) was ARIA (amyloid-related imaging abnormalities). Based on MRI scans, the incidence of ARIA-E (edema) was dose- and apolipoprotein E4-(ApoE4) status-dependent. In general, the onset of ARIA-E was observed early in the course of treatment and was asymptomatic or with mild, transient symptoms. The majority of patients with ARIA-E continued treatment and did so at a lower dose. In ApoE4 carriers, the incidence of ARIA-E was 5% in the 1 mg/kg and 3 mg/kg arms, 43% in the 6 mg/kg arm and 55% in the 10 mg/kg arm. In ApoE4 non-carriers, the incidence of ARIA-E was 9%, 11% and 17% in the 3 mg/kg, 6 mg/kg and 10 mg/kg aducanumab arms, respectively; no cases were reported in the 1 mg/kg arm. In ApoE4 carriers, the incidence of patients who developed ARIA-E and discontinued treatment was 5% in the 1 mg/kg arm, 10% in the 6 mg/kg arm, and 35% in the 10 mg/kg arm. There were no discontinuations in the 3 mg/kg arm. In ApoE4 non-carriers, the incidence of patients who developed ARIA-E and discontinued treatment was 11% in the 6 mg/kg arm and 8% in the 10 mg/kg arm. There were no discontinuations in the 1 mg/kg and 3 mg/kg arms. Headache occurred in 22% of patients receiving aducanumab compared to 5% in the placebo groups and appeared to be dose-dependent. Three deaths were reported in the time period of this analysis, two in the placebo group and one in the 10 mg/kg study arm; none were considered to be treatment related. Other AEs and SAEs were consistent with what is typically observed in the study population.

 

ONCOLOGY

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Association of Aspirin and NSAID Use with Risk of Colorectal Cancer According to Genetic Variants

 

As we wrote last week, the new pharmaceutical industry will focus on mechanisms of actions and potential therapies and “old drugs“ may be part of the “new therapies.“

 

Use of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) has been shown to be associated with lower risk of colorectal cancer. As a result, a study published in the Journal of the American Medical Association (2015;313:1133-1142) was performed to identify common genetic markers that may confer differential benefit from aspirin or NSAID chemoprevention. For the study, gene/environment interactions were tested between regular use of aspirin and/or NSAIDs and single-nucleotide polymorphisms (SNPs) in relation to risk of colorectal cancer.

 

The investigation was a case-control study using data from 5 case-control and 5 cohort studies initiated between 1976 and 2003 across the United States, Canada, Australia, and Germany, and included colorectal cancer cases (n=8634) and matched controls (n=8553) ascertained between 1976 and 2011. Participants were all of European descent. Data included Genome-wide SNP data and information on regular use of aspirin and/or NSAIDs and other risk factors.

 

Results showed that regular use of aspirin and/or NSAIDs was associated with lower risk of colorectal cancer (prevalence, 28% vs 38%; 6.2×10-28) compared with nonregular use. In the conventional logistic regression analysis, the SNP rs2965667 at chromosome 12p12.3 near the MGST1 gene showed a genome-wide significant interaction with aspirin and/or NSAID use (P = 4.6×10-9 for interaction). Aspirin and/or NSAID use was associated with a lower risk of colorectal cancer among individuals with rs2965667-TT genotype (prevalence, 28% vs 38%; OR, 0.66; P = 7.7×10-33) but with a higher risk among those with rare (4%) TA or AA genotypes (prevalence, 35% vs 29%; P = 0.002). In case-only interaction analysis, the SNP rs16973225 at chromosome 15q25.2 near the IL16 gene showed a genome-wide significant interaction with use of aspirin and/or NSAIDs (P = 8.2×10-9 for interaction). Regular use was associated with a lower risk of colorectal cancer among individuals with rs16973225-AA genotype (prevalence, 28% vs 38%; P = 1.9×10-30) but was not associated with risk of colorectal cancer among those with less common (9%) AC or CC genotypes (prevalence, 36% vs 39%; P = 0.76).

 

In this genome-wide investigation of gene/environment interactions, use of aspirin and/or NSAIDs was associated with lower risk of colorectal cancer, and this association differed according to genetic variation at 2 SNPs at chromosomes 12 and 15. Validation of these findings in additional populations may facilitate targeted colorectal cancer prevention strategies.

 

Genetically Engineered Arctic Apples and Innate Potatoes are Safe for Consumption

 

Foods derived from genetically engineered plants must meet the same legal standards, including safety standards, as foods derived from traditional plant breeding methods. To help developers of foods derived from genetically engineered plants comply with their obligations under the Federal Food, Drug, and Cosmetic Act and FDA regulations, the FDA encourages them to participate in a voluntary consultation process with the agency prior to commercial distribution.

 

The FDA has completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are as safe and nutritious as their conventional counterparts. Okanagan’s Granny Smith and Golden Delicious varieties of apples, known collectively by the trade name “Arctic Apples,“ are genetically engineered to resist browning associated with cuts and bruises by reducing levels of enzymes that can cause browning. Simplot’s varieties of Ranger Russet, Russet Burbank and Atlantic potatoes are collectively known by the trade name “Innate“ and are genetically engineered to reduce the formation of black spot bruises by lowering the levels of certain enzymes in the potatoes. In addition, they are engineered to produce less acrylamide by lowering the levels of an amino acid called asparagine and by lowering the levels of reducing-sugars. Acrylamide is a chemical that can form in some foods during high-temperature cooking, such as frying, and has been found to be carcinogenic in rodents.

 

As part of its consultation process, both Okanagan, of British Columbia, Canada, and Simplot, of Boise, Idaho, submitted to the FDA a summary of their safety and nutritional assessments. The consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties. At present, FDA has no additional food safety questions at this time concerning food from these plant varieties. It is a company’s continuing responsibility to ensure that food it markets is safe and otherwise in compliance with all applicable legal and regulatory requirements. In certain circumstances, characteristics of these varieties of apples and potatoes that differ from their conventional counterparts may require disclosure to the consumer. Both companies are encouraged to consult with the FDA about potential labeling requirements.

 

Blueberry Muffins and/or Pudding

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These warm, just out of the oven blueberry muffins are easy to make, healthy and good with coffee ©Joyce Hays, Target Health Inc.

 

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Blueberry puddings in various size individual dishes ©Joyce Hays, Target Health Inc.

 

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The moist Blueberry Pudding went fast ©Joyce Hays, Target Health Inc.

 

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You can add whipped cream or cool whip (or ice cream) to the warm pudding ©Joyce Hays, Target Health Inc.

 

Ingredients

 

2 cups almond flour

1.5 teaspoons baking powder

1/4 teaspoon baking soda

Pinch salt

1/3 cup brown sugar (or Splenda)

1/2 cup Agave

2 eggs

1 stick butter

1/4 cup canola oil

1 teaspoon vanilla extract

1 cup almond milk

Zest of 2 lemons

6 ounces fresh blueberries, washed well

Garnishes optional: whipped cream, cool whip, vanilla ice cream (you decide)

 

Directions

 

1. Preheat oven to 300 degrees

2. In a small pan, melt the butter over a low flame, then remove and let cool. Add the canola oil to the melted butter and stir.

3. Dip a pastry brush into the butter/oil and lightly brush any baking dishes of muffin tins you’re using with the butter mixture. I used one muffin tin with six holes and 8 little individual ramekins. The ramekins are for pudding. If you want only muffins then use another muffin tin or 2 and forget about the ramekins.

4. Combine the first 4 dry ingredients together and set aside.

5. In a large mixing bowl beat the eggs, add the milk and beat. Gradually add the brown sugar (or brown Splenda) to the eggs and hand whisk (or use electric beaters). Next add the cooled down butter mixture. Then add the agave, vanilla, zest and beat or whisk.

6. Finally, add the blueberries. Fold them into the mixture; do not beat them.

7. Now fill up your muffin tin cups half full. Fill the ramekins half full and put them into the oven for 20 minutes.

8. Remove after 20 minutes and if serving the ramekins pudding serve right away with garnish (optional).  For muffins: after you take them out of the oven, run a knife around the outside of each muffin, just to loosen them a bit.  Set aside to cool, then dig in.

 

 

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Whisk the wet ingredients together first. Notice the modern whisk from a dear friend. ©Joyce Hays, Target Health Inc.

 

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Add the blueberries to the mixture, last ©Joyce Hays, Target Health Inc.

 

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We still love that Sexy Beast cabernet from Australia by Two Hands Vineyards ©Joyce Hays, Target Health Inc.

 

Luckily, I made these delicious blueberry treats during the week, since by Friday afternoon, I was feeling, not so good; dunno what it was. Spring arrived this week and I had a slight fever. Would like to call it Spring fever, but nausea was also a part of it. No doubt a slight case of the flu which is going around here in the Big Apple. Our usual wonderful weekend was disrupted. We gave away our opera tickets to Manon at the MetOpera and stayed home eating light and playing Scrabble. (we each won a game). We’ll watch a movie tonight. C’est la vie.

 

Hope your weekend was better than ours. However, I must say, here, the company is always the best!

 

From Our Table to Yours!

 

Bon Appetit!