Target e*Studio® (EDC Builder) Now Includes Target e*ICD™ (Informed Consent)


Target e*CRF® has been used in multiple clinical trials and multiple FDA, EMA, HC and global regulatory approvals, for drugs, biologics, devices and diagnostics (including companion diagnostics). Our patented direct data entry eSource solution has also revolutionized clinical trial operations where in most cases, 80-90% of data are entered in real time, and onsite monitoring has dropped by over 60%. You can do the math.


The whole clinical trial can now be managed at one website, including direct data entry capture (eSource), risk-based monitoring, randomization, drug supply management, SAE management, monitoring reports etc. We give you what is needed, no more, no less.


Based our approval record and regulatory inspection success, our software delivers virtually everything needed to run the daily requirements of a clinical trial. Already this year, our software was used in an approved NDA, as well as for an expansion of an indication of a de novo 510(k) device, to include all patients receiving chemotherapy who are at risk for hair loss.


Of course, there is always the need to grow and this past year we added Target e*ICD™ (Informed Consent Document) and successfully completed the study with 65% of subjects, in a dermatology indication, signing electronically.


Version Control


To make clinical trials even more efficient, we are building the next version of Target e*Studio in order to accommodate and facilitate the needs of academic studies, research fellows, smaller CROs, biotech startups, as well as big pharma and global CROs. What makes us different is our deep knowledge of the clinical trial space, as well as tangible successes over the last 18 years that Target e*CRF has been used for clinical trials.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. 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



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Sigmund Freud’s Couch: Photo credit: Robert Huffstutter –, CC BY 2.0; Wikipedia Commons


International Psychoanalytic Congress. Photograph, 1911. Freud and Jung in the center

Photo credit: Anonymous – Prints & Photographs Division. Library of Congress, Public Domain; Wikipedia Commons


Psychoanalysis began, of course, with the genius of the great Sigmund 1) ___. Psychoanalysis refers both to a theory of how the mind works and a treatment modality. Today, psychoanalysis continues to be (despite hurdles along the way, like all great ideas) a thriving field, with more and more people opting for this type of therapy. Belief in the primacy of the interpretation of 2) ___, the unconscious fantasy life that we all have, desires, as well as (everyone’s) murderous rage, repressed or otherwise and the concept of sublimation, has not wavered. Freud also identified such basic mental maneuvers as transference, projection, and defensiveness, and demonstrated how they distort our functioning. As a treatment based on extended self-exploration with a highly qualified psychoanalyst, psychoanalysis has evolved beyond the silent-shrink stereotype. In our experience, highly qualified means a PhD, MD, and/or a MS counseling or social work degree; plus certified post graduate work at a psychoanalytic institute, plus most important of all, a full (self) analysis with a certified psychoanalyst. You don’t want just “anyone“ tinkering with your delicate 3) ___.


Neuropsychoanalysis is an up-and-coming subfield that aims to wed the insights of Freudian psychology and its emphasis on subjective experience with neuroscientific findings about brain processes. Psychiatrist, neurologist, Columbia University professor and Nobel Prize winner, Eric Kandel MD, provides a breakthrough perspective on how biology has influenced modern psychiatric thought, in his book: Psychiatry, Psychoanalysis, and the New Biology of Mind. Dr. Kandel never fails to acknowledge and praise the ideas of Sigmund Freud, that made us aware of the mysteries of the human mind, and the existence of an 4) ___ part of the mind. Dr. Kandel’s unique perspective on both psychoanalysis and biological research has led to breakthroughs in our thinking about neurobiology, psychiatry, and psychoanalysis. Another supporter of Freud’s theories was the internationally respected neurologist, Oliver Sachs and finally the influential pediatrician Benjamin Spock MD, all of whose childrearing books are based on Freudian theory, as well as common sense. Today, predominant psychoanalytic theories all emphasize the influence of unconscious elements on the 5) ___ part of the mind. Freud called dream interpretation, the “royal road to the unconscious.“ Topographic theory was named and first described by Sigmund Freud in The Interpretation of Dreams (1900). The theory hypothesizes that the mental apparatus can be divided into the systems Conscious, Preconscious, and Unconscious. These systems are not anatomical structures of the 6) ___ but, rather, mental processes. Although Freud retained this theory throughout his life he largely replaced it with the Structural theory. The Topographic theory remains as one of the meta-psychological points of view for describing how the mind functions in classical psychoanalytic theory. Structural theory divides the psyche into the id, the ego, and the super-ego. The id is present at birth as the repository of basic instincts, which Freud called “Triebe“ (“drives“): unorganized and unconscious, it operates merely on the ‘pleasure principle’, without realism or foresight. The ego develops slowly and gradually, being concerned with mediating between the urging of the id and the realities of the external world; it thus operates on the ?reality principle’. The super-7) ___ is held to be the part of the ego in which self-observation, self-criticism and other reflective and judgmental faculties develop. The ego and the super-ego are both partly conscious and partly unconscious.


Psychoanalytic object relations theory is concerned with early infantile human relationships, with all of the pitfalls, studying how internal representations of the self and others are organized. The clinical symptoms that suggest object relations problems are typically developmental delays throughout life, often referred to as “arrested 8) ___.“ They include disturbances in an individual’s capacity to feel warmth, empathy, trust, sense of security, identity stability, consistent emotional closeness, and stability in relationships with significant others. (however, It is not suggested that one should trust everyone, for example.) Concepts regarding internal representations (also sometimes termed, “introspects“, “self and object representations“, or “internalization of self and other“) although often attributed to Melanie Klein, were actually first mentioned by Sigmund Freud in his early concepts of drive theory. Freud’s 1917 paper “Mourning and Melancholia“, for example, hypothesized that unresolved grief was caused by the survivor’s internalized image of the deceased becoming fused with that of the survivor, and then the survivor shifting unacceptable anger toward the deceased onto the now complex self-image.


Freudian theories believe that adult problems can be traced to unresolved conflicts from certain phases of 9) ___and adolescence, caused by fantasy, stemming from their own drives. Freud, based on the data gathered from his patients early in his career, suspected that neurotic disturbances occurred when children were abused in childhood. Later, Freud came to believe that, although child abuse occurs, neurotic symptoms were not necessarily associated with this. He believed that neurotic people often had unconscious conflicts that involved incestuous fantasies deriving from different stages of their development. Freud found the stage from about three to six years of age (preschool years) to be filled with fantasies of having romantic relationships with both parents. Arguments were quickly generated in early 20th-century Vienna about whether adult seduction of children, i.e. child abuse, was the basis of neurotic illness. There still is no complete agreement, although nowadays professionals recognize the negative effects of child abuse on mental health. Many psychoanalysts who work with children have studied the actual effects of child abuse, which include ego and object relations deficits and severe neurotic conflicts. Much research has been done on these types of trauma in childhood, and the adult sequelae of those. In studying the childhood factors that start neurotic symptom development, Freud found a constellation of factors that, for literary reasons, he termed the Oedipus complex (based on the play by Sophocles, Oedipus Rex, where the protagonist unwittingly kills his father Laius and marries his mother Jocasta). The shorthand term, “oedipal“ refers to the powerful attachments that children make to their 10) ___ in the preschool years. These attachments involve fantasies of intimate relationships with either (or both) parent, and, therefore, competitive fantasies toward either (or both) parents.  The most common problems treatable with psychoanalysis include: phobias, conversions, compulsions, obsessions, anxiety attacks, depressions, a wide variety of relationship problems (such as dating and marital strife), and a wide variety of character problems (for example, painful shyness, meanness, obnoxiousness, workaholism, hyper-seductiveness, hyperemotionality, hyper-fastidiousness).


Sigmund Freud Biography – worth watching


Interesting explanation of Freud’s theories of human nature


ANSWERS: 1) Freud; 2) dreams; 3) psyche; 4) unconscious; 5) conscious; 6) brain; 7) ego; 8) development; 9) childhood; 10) parents


Freudian Psychoanalysis – Two Other Branches, Out of Many

Graphic image: by historicair 16:56, 16 December 2006 (UTC) – en:Image:Structural-Iceberg.png by en:User:Jordangordanier, Public Domain; Wikipedia Commons



Freudian psychoanalytic theory spawned other creative approaches to the practice of psychoanalysis, which built upon Freud’s theories of psychic development.


Object Relations and The Basic Fault


Michael Balint (1896-1970) was a Hungarian psychoanalyst who spent most of his adult life in England. He was a proponent of the Object Relations school.


Balint was born Mihaly Maurice Bergsmann, the son of a practicing physician in Budapest. It was against his father’s will that he changed his name to Balint Mihaly. He also changed religion, from Judaism to Unitarian Christianity. During World War I Balint served at the front, first in Russia, then in the Dolomites. He completed his medical studies in Budapest in 1918. On the recommendation of his future wife, Alice Szekely-Kovacs, Balint read Sigmund Freud’s “Drei Abhandlungen zur Sexualtheorie“ (1905) and “Totem und Tabu“. He also began attending the lectures of Sandor Ferenczi, who in 1919 became the world’s first university professor of psychoanalysis. In 1920, Balint married and then moved to Berlin, where he worked in the biochemical laboratory of Otto Heinrich Warburg (1883-1970), who won the Nobel Prize in 1931. Balint worked on his doctorate in biochemistry, while also working half time at the Berlin Institute of psychoanalysis. In 1924 the Balints returned to Budapest, where he assumed a leading role in Hungarian psychoanalysis. During the 1930s the political conditions in Hungary made the teaching of psychotherapy practically impossible, and they emigrated to London in 1938, settling in Manchester, England. In early 1939, Balint became Clinical Director of the Child Guidance Clinic. In 1944, his parents, about to be arrested by the Nazis in Hungary, committed suicide. That year Balint moved from Manchester to London, where he was attached to the Tavistock Clinic and began learning about group work from W.R. Bion; he also obtained the Master of Science degree in psychology. In 1949, Balint became the leader of the Tavistock Institute of Human Relations and developed what is now known as the “Balint group“: The Balint Group consisted of a group of physicians sharing the problems of general practice, in particular, focusing on the responses of the doctors to their patients. This first group of practicing physicians was established in 1950. In 1968 Balint became president of the British Psychoanalytical Society.In Hamburg, Germany, The Michael-Balint-Institut fur Psychoanalyse, Psychotherapie und analytische Kinder- und Jugendlichen- Psychotherapie is named for him.


Balint took an early interest in the mother-infant relationship, a key paper on “Primary Object-Love“ was received with approval by other Freudian psychoanalysts. One respected psychoanalyst wrote that “Michael Balint has analyzed in a thoroughly penetrating way the intricate interaction of theory and technique in the genesis of a new conception of analysis, of a “two-body psychology“. On that basis, Balint explored the idea of what he called “the basic fault“: this was that there was often the experience in the early two-person relationship that something was wrong or missing, and this carried over into the Oedipal period (age 2-5). By 1968, then, Balint had distinguished three levels of experience, each with its particular ways of relating, its own ways of thinking, and its own appropriate therapeutic procedures. Balint’s “three person or level 3,“ was the level at which a person is capable of a three-sided experience, primarily the Oedipal problems between self, mother, and father’. By contrast, ‘the area of the Basic Fault is characterized by a very peculiar exclusively two-person relationship’; while a ‘third area is characterized by the fact that there are no external objects in it – level number 1.


Therapeutic failure is attributed by Balint to the analyst’s inability to “click in“ to the mute needs of the patient who has descended to the level of the basic fault; and he maintained that the basic fault can only be overcome if the patient is allowed to regress to a state of oral dependence on the analyst and experience a new beginning. Balint developed a process of brief psychotherapy he termed “focal psychotherapy,“ in which one specific problem presented by the patient is chosen as the focus of interpretation. The therapy was carefully targeted around that key area to avoid (in part) the risk that the focal therapy would have degenerated into long-term psychotherapy or psychoanalysis. Here as a rule interpretation remained ‘entirely on the whole-person adult level, it was the intention to reduce the intensity of the feelings in the therapeutic relationship. In accordance with the thinking of other members of what is known as the British independent perspective, such as W. R. D. Fairbairn and D. W. Winnicott, great stress was laid upon the creative role of the patient in focal therapy: To our minds, an “independent discovery“ by the patient has the greatest dynamic power. It has been suggested that it was in fact this work of Michael Balint and his colleagues which led to time-limited therapies being rediscovered.


Michael Balint as part of the independent tradition in British psychoanalysis, was influential in setting up groups (now known as “Balint groups“) for medical doctors to discuss psychodynamic factors in relation to patients. Instead of repeating futile investigations of increasing complexity and cost, Balint taught active search for causes of anxiety and unhappiness, and treatment by remedial education aiming at insight by the patient. Such seminars provided opportunities for GPs to discuss with each other and with him aspects of their work with patients for which they had previously felt ill equipped. Since his death the continuance of this work has been assured by the formation of the Balint Society.


Psychoanalysis and Low Dose LSD


The term anaclitic (from the Greek anaklinein – to lean upon) refers to various early infantile needs and tendencies directed toward a pregenital love object. This method was developed in the 1950s by two London Freudian psychoanalysts, Joyce Martin MD and Pauline McCririck MD. It is based on clinical observations of deep age regression occurring in LSD sessions of psychiatric patients. During these periods many of them relive episodes of early infantile frustration and emotional deprivation. This is typically associated with agonizing cravings for love, physical contact, and other instinctual needs experienced on a very primitive level. The technique of LSD therapy practiced by Martin and McCririck was based on psychoanalytic understanding and interpretation of all the situations and experiences occurring in drug sessions and in this sense is very close to psycholytic approaches. The critical difference distinguishing this therapy from any other was the element of direct satisfaction of anaclitic needs of the patients. In contrast to the traditional detached attitude characteristic of psychoanalysis and psycholytic treatment, Martin and McCririck assumed an active mothering role and entered into close physical contact with their patients to help them to satisfy primitive infantile needs reactivated by the drug.


More superficial aspects of this approach involve holding the patients and feeding them warm milk from a bottle, caressing and offering reassuring touches, holding their heads in one’s lap, or hugging and rocking. The extreme of psycho-dramatic involvement of the therapist is the so-called “fusion technique,“ which consists of full body contact with the client. The patient lies on the couch covered with a blanket and the therapist lies beside his or her body, in close embrace, usually simulating the gentle comforting movements of a mother caressing her baby. The subjective reports of patients about these periods of “fusion“ with the therapist are quite remarkable. They describe authentic feelings of symbiotic union with the nourishing mother image, experienced simultaneously on the level of the “good breast“ and “good womb.“ In this state, patients can experience themselves as infants receiving love and nourishment at the breast of the nursing mother and at the same time feel totally identified with a fetus in the oceanic paradise of the womb. This state can simultaneously involve archetypal dimensions and elements of mystical rapture, and the above situations be experienced as contact with the Great Mother or Mother Nature. It is not uncommon that the deepest form of this experience involves feelings of oneness with the entire cosmos and the ultimate creative principle, or God. The fusion technique seems to provide an important channel between the psychodynamic, biographical level of the LSD experience and the transcendental states of consciousness. Patients in anaclitic therapy relate that during their nourishing exchange with the mother image, the milk seemed to be “coming directly from the Milky Way.“ In the imaginary re-enactment of the placentary circulation the life-giving blood can be experienced as sacramental communion, not only with the material organism, but with the divine source. Repeatedly, the situations of “fusion“ have been described in all their psychological and spiritual ramifications as fulfillment of the deepest needs of human nature, and as extremely healing experiences. Some patients described this technique as offering the possibility of a retroactive intervention in their deprived childhood. When the original traumatic situations from childhood become reenacted in all their relevance and complexity with the help of the “psychedelic time-machine,“ the therapist’s affection and loving care can fill the vacuum caused by deprivation and frustration.


The dosages used in this treatment technique ranged between 100 and 200 micrograms of LSD, sometimes with the addition of Ritalin in later hours of the sessions. Martin and McCririck described good and relatively rapidly achieved results in patients with deep neuroses or borderline psychotic disorders who had experienced severe emotional deprivation in childhood. Their papers, presentations at scientific meetings, and a film documenting the anaclitic technique stirred up an enormous amount of interest among LSD therapists and generated a great deal of fierce controversy. The reactions of colleagues to this treatment modality ranged from admiration and enthusiasm to total condemnation. Since most of the criticism from the psychoanalytically oriented therapists revolved around the violation of the psychoanalytic taboo against touching and the possible detrimental consequences of the fusion technique for transference-countertransference problems, it is interesting to describe the authors’ response to this serious objection. Both Martin and McCririck seemed to concur that they had experienced much more difficulty with transference relationships before they started using the fusion technique. According to them, it is the lack of fulfillment in the conventional therapeutic relationship that foments and perpetuates transference. The original traumatic situations are continuously reenacted in the therapeutic relationship and the patient essentially experiences repetitions of the old painful rejections. When the anaclitic needs are satisfied in the state of deep regression induced by the drug, the patients are capable of detaching themselves emotionally from the therapist and look for more appropriate objects in their real life. This situation has a parallel in the early developmental history of the individual. Those children whose infantile emotional needs were adequately met and satisfied by their parents find it relatively easy to give up the affective ties to their family and develop independent existence. By comparison, those individuals who experienced emotional deprivation and frustration in childhood tend to get trapped during their adult life in symbiotic patterns of interaction, destructive and self-destructive clinging behavior, and life-long problems with dependence-independence. According to Martin and McCririck, the critical issue in anaclitic therapy is to use the fusion technique only during periods of deep regression, and keep the experience strictly on the pregenital level. It should not be used in the termination periods of the sessions when the anaclitic elements could get easily confused with adult sexual patterns.


The anaclitic technique never achieved wide acceptance; its use seemed to be closely related to unique personality characteristics in its authors. Most other therapists, particularly males, found it emotionally difficult and uncomfortable to enter into the intimate situation of fusion with their clients. However, the importance of physical contact in LSD psychotherapy is unquestionable and many therapists have routinely used various less-intense forms of body contact.


Sources: History of LSD Therapy by Stanislav Grof, M.D.; Wikipedia

New Clues to Niemann-Pick type C1


Niemann-Pick type C1 (NPC1) a rare, lysosomal storage disease, occurs when a faulty gene fails to remove cholesterol and other lipids from cells. The disease is characterized by too much accumulation of cholesterol and other lipids in the cell’s lysosomes, which are sacs of enzymes that break apart proteins, fats and other materials for recycling. In NPC1, a gene mutation blocks the transport of fats like cholesterol out of the lysosome, causing them to pile up. Elevated cholesterol and other fats thus accumulate in the spleen, liver and brain, which are hallmarks associated with severe neurological problems The lipids accumulation results in impaired movement, slurred speech, seizures and dementia. Patients with NPC1 typically die in their teens, though a late-onset form of the disease affects young adults.


According to an article published in the journal Autophagy (17 July 2017), it has been demonstrated how an investigational drug works against NPC1. The study found that a closely related compound can activate an enzyme, AMPK, thus triggering a cellular “recycling“ system that helps reduce elevated cholesterol and other accumulated fats in the brains and livers of NPC1 patients. Autophagy is what cells use to recycle their trash. This process malfunctions in NPC1 and a number of neurodegenerative diseases, thus making the AMPK enzyme a potential target for future drugs. The research was led by scientists at the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, and their colleagues. The work could lead to a new generation of potential therapies for NPC1 and other similar disorders, as well as neurodegenerative diseases such as Parkinson’s and Alzheimer’s diseases.


An investigational drug, called 2-hydroxypropyl-beta-cyclodextrin, is being tested in a Phase 3 clinical trial in patients with NPC1. Pre-clinical studies, including those at NCATS, and previous testing in patients showed the potential drug reduced cholesterol and other lipids in patient cells, delaying disease onset and lessening some disease symptoms. However, investigators were unsure of how the drug worked. To find out, the authors turned to a similar, more potent compound named methyl-?-cyclodextrin. In several pre-clinical experiments using cells from NPC1 patients, the authors determined that the compound could bind to AMPK, turning on its activity and the autophagy process, resulting in a drop in accumulated cholesterol in NPC1 cells. When they blocked AMPK activity, preventing methyl-beta-cyclodextrin from turning on the enzyme, there was no reduction in cholesterol in NPC1 cells. In addition, the authors found that other compounds that also turned on AMPK had similar effects in reducing cholesterol in NPC1 cells, suggesting that AMPK is a potential target for the design of new drugs to treat NPC1 patients.


Visual Engagement is Heritable and Altered in Autism


Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social interaction, verbal and non-verbal communication, and restricted and repetitive behavior. Parents usually notice signs in the first two years of their child’s life. These signs often develop gradually, though some children with autism reach their developmental milestones at a normal pace and then regress. How children visually engage with others in social situations is a heritable behavior that is altered in children with autism. Reduced attention to other people’s eyes and faces is a behavior associated with autism, and it is often used to screen for and help diagnose the disorder. The diagnostic criteria require that symptoms become apparent in early childhood, typically before age three.


According to an article published in Nature (20 July 2017), eye-tracking experiments were conducted in a group of 250 typically developing toddlers ages 18 to 24 months, including 82 identical twins (41 pairs), 84 non-identical twins (42 pairs) and 84 non-sibling children (42 randomized pairs). The study also evaluated 88 non-twin children diagnosed with autism.


For the study, each child watched videos that showed either an actress speaking directly to the viewer or scenes of children interacting in daycare. In all video frames, children could look at the onscreen characters’ eyes, mouth, body or surrounding objects. Special software captured how often the children looked at different regions, as well as the timing and direction of eye movements. Results showed that identical twins had synchronized visual patterns, compared to non-identical twins and non-sibling pairs. There was high monozygotic twin-twin concordance and relatively low dizygotic concordance. Identical twins also tended to shift their eyes at the same times and in the same direction. They also were more likely to look at the subject’s eyes or mouth at the same moments. Using a statistical measurement called the intraclass correlation coefficient (ICC), which measures how well individuals within a group resemble each other (with a value of 1 marking perfect agreement), the authors found that identical twins had an ICC of 0.91 for eye-looking and 0.86 for mouth-looking. On the other hand, non-identical twins had scores of 0.35 and 0.44, respectively, while non-sibling pairs had scores of 0.16 and 0.13. According to the authors, by comparing identical twins who share the same genes to non-identical twins, and randomly paired children who do not share the same genes, the study is one of the first to show that social visual behaviors are under genetic control.


To explore this concept further, the authors evaluated children with autism and discovered that they looked at eye and mouth regions – the most heritable visual traits – much less compared to the other groups of children. These characteristics, that are the most highly heritable, were also found to be differentially decreased in children with autism (P?<0.0001).


According to the authors, the study results implicate social visual engagement as a neurodevelopmental endophenotype not only for autism, but also for population-wide variation in social-information seeking. The authors added that with these findings, it should be possible to 1) explore which genes are involved in social visual engagement, 2) how these genes interact with a child’s environment to shape his/her social engagement, and 3) how these genetic pathways are disrupted in neurodevelopmental disorders such as autism.


FDA Approves New Treatment For Sickle Cell Disease


Sickle cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent, or sickle, shape). This restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage. According to the National Institutes of Health, approximately 100,000 people in the United States have sickle cell disease. The disease occurs most often in African-Americans, Latinos and other minority groups. The average life expectancy for patients with sickle cell disease in the United States is approximately 40 to 60 years.


The FDA has approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with this blood disorder. The safety and efficacy of Endari were studied in a randomized trial of patients ages 5-58 years old with sickle cell disease who had two or more painful crises within the 12 months prior to enrollment in the trial. Patients were assigned randomly to treatment with Endari or placebo, and the effect of treatment was evaluated over 48 weeks. Patients who were treated with Endari experienced fewer hospital visits for pain treated with a parenterally administered narcotic or ketorolac (sickle cell crises), on average, compared to patients who received a placebo (median 3 vs. median 4), fewer hospitalizations for sickle cell pain (median 2 vs. median 3), and fewer days in the hospital (median 6.5 days vs. median 11 days). Patients who received Endari also had fewer occurrences of acute chest syndrome (a life-threatening complication of sickle cell disease) compared with patients who received a placebo (8.6 percent vs. 23.1 percent). Common side effects of Endari include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.


Endari received Orphan Drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare diseases. In addition, development of this drug was in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and/or effectiveness of products for use in rare diseases or conditions.


The FDA granted the approval of Endari to Emmaus Medical Inc.


Lemon Mousse Delicieux

This is a delicious, cooling dessert, that’s quick and easy to make. No cooking, no hot oven; just your trusty food processor. ©Joyce Hays, Target Health Inc.


Yummy with fresh strawberries, or fresh mangoes, or fresh blue berries. Experiment with your favorite fresh fruit. ©Joyce Hays, Target Health Inc.


Wonderful (do ahead of time) dessert for a group of people. ©Joyce Hays, Target Health Inc.


Ingredients for two desserts – two people

1 small can sweetened condensed milk,

1 container of Tofutti (soy cream cheese)

3-4 fresh lemons

2-3 drops of vanilla essential oil

2 or 3 ripe mangos for bottom of dessert dish and for garnish

Tiny fresh mint leaves, for garnish


Shopping list doesn’t get much shorter than this. ©Joyce Hays, Target Health Inc.




1. Fill a medium or large saucepan with water and boil it. Add the lemons and blanch them. This means let them boil for 30 to 60 seconds. Doing this softens the skins and makes it easier to squeeze them.


Blanching the lemons, 30 to 60 seconds in boiling water. I should have used a larger pot, but, hey, I’m not perfect. :) ©Joyce Hays, Target Health Inc.


2. When lemons are blanched, either let them cool down so you can handle them, or put them in a bowl of cold water so they cool more quickly.

3. Cut the mangos in half, scoop all the flesh out and cut as many strips as you need to garnish the top of each dessert. Chop the remaining mango in tiny pieces and set aside.

4. Get two or four (or more) dessert dishes out and in the bottom of each, add some of the chopped mango.


Cut mango in half. With a teaspoon, dig the pit out. Scoop out all the rest of the flesh from the inside of the mango. Also, scrape off the pit, as much of the mango as you can. Put everything on a cutting board and chop. Before you chop, take out as much mango as you’ll need to garnish the mousse later; set aside. ©Joyce Hays, Target Health Inc.


5. Get a large mixing bowl out.

6. Grate 1 whole lemon for the zest and put into the bowl.


Put a flat grater over the mixing bowl, and great 1 whole lemon, for the zest. Some of the zest will fall into the bowl, so you’ll have to scrape all of the zest, off the grater and into the bowl. ©Joyce Hays, Target Health Inc.



7. Cut the lemons in half. If they’re large, you might want to cut in thirds. Put each section of lemon in a lemon squeezer or old fashioned juicer and squeeze out all the juice. Place a strainer over the large bowl. You’re going to use the strainer to remove lemon pits and pieces of the flesh.


My lemon squeezer catches the pits, etc. ©Joyce Hays, Target Health Inc.


8. Pour the fresh lemon juice through the strainer and into the bowl.

9. To the bowl, add the Tofutti, the drops of vanilla extract, the condensed milk


All ingredients are now in the mixing bowl. ©Joyce Hays, Target Health Inc.


10. The secret to the light fluffiness of the mousse comes next. With electric beaters at high speed, beat the contents of the bowl for 3 to 5 minutes, until you can see that it is light and fluffy. Then take the beaters out, tap them on the bowl to get every last delicious bit and let this mixture stand about 5 minutes, before you do anything else.


Five minutes of beating at highest speed and the lemon mousse is done. Beaters will be tapped to get everything off, then it’s time to lick them. Be sure to let the mousse sit in the bowl for another 5 minutes, before you spoon it into your dessert dishes. ©Joyce Hays, Target Health Inc.


11. Lick the beaters.  :)

12. While the mixture is standing, if you haven’t spooned chopped fresh mango in bottom of dessert dishes, do that now.

13. Finally, after letting the bowl of mousse sit for 5 minutes, spoon the lemon mousse into the dessert dishes. Decorate the top with the strips of mango. If you can’t find ripe mangos in your neighborhood, use any ripe fresh fruit, like strawberries, peaches, blueberries, bananas, etc. I suppose you could use a topping of whipped cream or cool whip, but in my opinion, that would be gilding the lily, so to speak.   :)

14. Put the dessert dishes in the fridge for about 3 hours.

15. Just before serving, add one tiny mint leaf to the top.


Enjoy !



For variety, you can add some of the lemon mousse to your favorite pound or coffee cake. ©Joyce Hays, Target Health Inc.


I got quite sick this week with a horrible chest cough, requiring antibiotics. We didn’t have any wine all week. I lost my appetite for everything. However, we did want to share with you our recent find, of bottled Bellinis. The flavor is fine. I was wondering how Bellinis would taste with the lemon mousse dessert, but we never got around to trying it as an after dinner drink.


Even if you don’t make the lemon mousse recipe, you might like to try bottled Bellinis before (during?) and after dinner. ©Joyce Hays, Target Health Inc.


From Our Table to Yours

Bon Appetit!