Regulatory Affairs Expertise at Target Health

 

No matter what happens in the discovery phase, innovators of drugs, devices and biologics will always need to amass data and have expertise in regulatory affairs. While Target Health is well-known in the data and software space, and is the champion of the paperless clinical trial, we are also quite known and respected in the regulatory space. Our esteemed head of regulatory affairs is Glen Park, PharmD, and yes, he is the only Park at Target Health who is not of Korean descent. Glen joined us 9 years ago and has been a major asset of our company. Glen had over 20 years of experience at AVENTIS PHARMA (FORMERLY HOECHST MARION ROUSSEL), SANKYO PHARMA DEVELOPMENT and the UNIVERSITY OF IOWA, and now leads the regulatory team at Target Health which represents 36 clients at FDA. The following are major Target Health accomplishments where we made significant contributions to the regulatory approval process:

 

1. NDA  –  Gaucher Disease (orphan disease)

2. NDA  –  Cystic Fibrosis (orphan disease)

3. NDA  –  Head Lice (2)

4. NDA  –  Emergency Contraception

5. BLA  –  Auto-inflammatory diseases (orphan disease)

6. PMA  –  Surgical Adhesions

7. PMA  –  Periodontal Disease

8. PMA  –  Companion Diagnostic

9. 510(k) – Heart Rate Variability (2)

 

In addition to regulatory approvals, we obtained orphan drug designation for the following indications:

 

1.   Gaucher Disease – NDA Approved

2.   Hereditary angioedema – NDA Approved

3.   Debridement in hospitalized patients with 3rd degree burns – EMA approved

4.   Growth Hormone

5.   Scleroderma

6.   Alagille Syndrome

7.   Burn progression in hospitalized patients

8.   Caries prevention, head and neck cancer

9.   Cushing’s syndrome secondary to ectopic ACTH secretion

10. Edema-related effects in hospitalized patients with 3rd degree burns

11. Osteonecrosis of the jaw

 

As a biologist, Dr. Mitchel is fascinated by the fauna and flora of Central Park, the heart and lungs of New York City. How brilliant it was to put a park right in the middle of it all. Every week we will try to share the breath of wildlife in NYC.

 

Springtime in NYC – Central Park ©Target Health Inc.

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Nesting Pair of Canadian Geese                                               Black Crowned Night Heron

 

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

 

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 Chief Editor of On Target

Jules Mitchel, Editor

Battlefield Medicine

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Arterial bleed controlled by a tourniquet

 

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Practicing IV procedures in dark conditions.

 

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This photo shows the back of an armored personnel carrier set up as an ambulance. Given that this vehicle is designed to withstand attack from rockets, much of the equipment is concealed from view.

 

A medical corps is generally a military branch or officer corps responsible for medical care for serving military personnel. Such officers are typically military physicians. Since 90% of combat 1) ___ occur on the battlefield before the casualty ever reaches a medical treatment facility, Tactical Combat Casualty Care (TCCC) focuses on training major hemorrhaging, and airway complications such as a tension-pneumonthorax. This has driven the casualty fatality rate down drastically since the Vietnam conflict to less than 9%. Today, TCCC is quickly becoming the standard of care for the tactical management of combat casualties within the Department of Defense and is the sole standard of care dually endorsed by both the American College of Surgeons and the National Association of EMT’s for casualty management in tactical environments. TCCC is built around three definitive phases of casualty care: 1) Care Under Fire; 2) Tactical Field Care; 3) Tactical Evacuation Care.

 

Combat medics (also known as medics) are military personnel who have been trained to at least an EMT-Basic level (16 week course in the U.S. Army), and who are responsible for providing first 2) ___ and frontline trauma care on the battlefield. They are also responsible for providing continuing medical care in the absence of a readily available physician, including care for disease and battle injury. Combat medics are normally co-located with the combat troops they serve in order to easily move with the troops and monitor ongoing health. An eight-year process to transform the training and skills of Army combat medics culminated recently, as all members of the old 91B Military Occupational Specialty (MOS) became qualified as 68W Healthcare Specialists. A group of past and present leaders of Army Medicine gathered at Fort Sam Houston, Texas, to celebrate this event. This Corp was originally established in 1887.

 

68W medics all qualify as emergency 3) ___ technicians. They are trained in advanced airway skills, hemorrhage control techniques, shock management and evacuation. All Soldiers in the new MOS must re-certify their skills every two years, and must earn 72 hours of continuing education credits during those two years. Retired Lt. Gen. James B. Peake, former Army surgeon general and former Secretary of the Department of Veterans Affairs, spoke recently, “When you see a Soldier without a leg, and with an external fixator on his other leg, and he says, ?I was lucky that day because I was with my medic in my vehicle, that’s why I’m here,’ that’s what it boils down to,“ Peake said. Peake began the process that led to the 68W MOS when he commanded the Army Medical Department Center and School. He discussed the process of improving training, adding simulation technology and re-engineering the second-largest MOS in the Army. “This was an opportunity to take medical care much farther forward than we had been able to before, with a higher level of technical enablement and skill,“ Peake said. Peake added that the process of improving training continues. “It is made better by continually listening to Soldiers, continually shaping the way that training is done,“ he said. “When you talk to those who have earned the Silver Star or the Distinguished Service Cross, and we’ve had those in medics, they say, ?I was just doing my job. I was just doing what I was trained to do,’“ he said

 

Soldiers of the 232nd Medical Battalion stage practice events, which demonstrate the 68W’s advanced ability to save 4) ___ on the battlefield. Soldiers portray a modern squad treating a thigh wound. The 68W quickly applied a Combat Application Tourniquet and prepared the casualty for evacuation by a Stryker armored ambulance. The 68W medic’s patient was well on his way to advanced care at a combat support hospital. On today’s modern battlefield, medical care has made remarkable strides in saving the lives of the wounded. Soldiers and Marines who would have perished in yesterday’s wars are returning home in spite of devastating injuries. Our troops are equipped to stabilize their own injuries and those of their buddies, even in the absence of medical personnel. Medics and corpsmen are armed with advances in technology as they emerge, and our experience helps set new standards of trauma 5) ___.

 

Front-loading definitive medical care at the point of injury makes obvious sense. The patient’s own well-oxygenated blood, circulating in a system of relatively intact blood vessels, is the gold standard of perfusion. Does it make sense to lie still on the battlefield, bleeding and yelling “Medic!“ when the means exist for the injured to stop his own bleeding? Does it make sense for the casualty with a patched-up circulatory system to arrive at the hospital without an airway, suffering from irreversible hypoxic 6) ___ injury? Of the many advances in battlefield medicine, some of the most beneficial are also the simplest. Consider the tourniquet. The military has adopted newer tourniquets, manufactured with a sturdy nylon strap and an attached windlass instead of a stick. Today, every soldier is issued this one-handed 7) ___ to apply to their own injured limbs, stopping the loss of blood before significant hemorrhage occurs. These are much quicker and simpler to apply than yesterday’s homemade strip of cloth and a stick foraged from the woods. When penetrating trauma with significant 8) ___ occurs, the combat medic approach is often defined by the simultaneous efforts of more than one EMT. In this arrangement, one rescuer might well be spared to do nothing but provide direct pressure, elevation and squeeze a pressure point, while others tend to the airway. In the case of the military medic, however, they’re often presented with multiple casualties, many of whom may simultaneously suffer from severe penetrating extremity trauma with uncontrolled hemorrhage and airway compromise. Battlefield triage differs as well: sometimes, it’s necessary to return the most troops to the fight as quickly as possible in order to prevent the loss of additional lives. It is sometimes necessary to treat and return the lesser-injured to the fight first, so that they may defend the medics, while they attend to the more serious casualties. There are even times when the combat 9) ___ may save the most lives by taking up his own weapons and jump into the fight personally. This is a vastly different proposition from the civilian EMT staging at a safe distance while law enforcement makes the scene safe. In this setting, rapid application of the tourniquet makes good sense. The newer tourniquets are quick to apply, and every soldier carries one. Even with a compromised 10) ___, patients can survive a brief hypoxic event. Most can survive for the time it takes to apply the tourniquet. In deciding whether to address airway or bleeding first, the significance of the injury is considered. While penetrating trauma to an artery may require the rapid application of a tourniquet, one is often not needed in the case of a slower venous bleed. If there are numerous critical patients awaiting medical attention, however, the tourniquet may be the quickest way to stabilize the patient with the venous bleed, permitting a medic to move on to the next case and ultimately save the most life.

 

An experienced U.S. medic recounts:

After a 20-year career in EMS, during which I went on to become a registered nurse and worked part-time in an emergency department, I was deployed to Ramadi, Iraq, as a combat medic with the Vermont National Guard. Aside from my weapons, I found my three most useful tools were tourniquets, the new trauma dressings with built-in elastic bandages, and my laryngoscope. The new one-handed tourniquets are designed to be used by the casualty, and every soldier has one. When I was in Iraq, however, we did not have these in sufficient quantity to use them frequently on other people. Instead, we used simple ratchet straps cut down to size. These are inexpensive and available at any neighborhood hardware store. While they require two hands to apply, they are effective at controlling bleeding and cheap enough to be disposable. My next favorite innovation was the “Israeli“ dressing, consisting of a thick gauze pad sewn into an elastic bandage. Developed and manufactured in Israel, it is remarkably effective, simple to apply and inexpensive to manufacture. The thick gauze is held tight to the injury by the attached bandage. The more significant the hemorrhage, the tighter the bandage is applied. There were other tools at our disposal. The simple tampon does a phenomenal job of stopping the bleeding in a bullet hole or stab wound. The Asherman Chest Seal comes with a flutter valve and is used for sucking chest wounds, with or without a 14-gauge IV needle to decompress a pneumothorax. In addition to the traditional IV catheters and tubing, the military medic carries a spring-loaded device called a FAST1 to initiate intraosseous infusions in the upper part of the adult sternum when venous access is impossible.

 

The fluids we carried were also different. Subscribing to the logic of controlled hypotension, we no longer ran large volumes of Ringer’s lactate wide open in every case of trauma. I carried equal quantities of normal saline and Ringer’s lactate, knowing the NS was compatible with blood products to be used later and more useful in managing heat casualties. Farther from the hospitals, medics might use heat-starch, a hypertonic starch-based solution designed to draw interstitial fluid into the circulatory system and keep it there longer, thus providing more effective fluid volume replacement per liter of IV fluid administered. This is especially useful when medics must carry supplies over long distances in rucksacks. Water is heavy. Then there was QuikClot, a powder that undergoes an exothermic reaction in the presence of 11) ___, effectively cauterizing wounds it’s poured into. We also carried HemCon bandages, which are fabricated from chitosan and designed to stop bleeding by adhering to wounds. Both of these tools were expensive, in short supply and we were concerned about potential complications such as burns and foreign-body emboli in the bloodstream.While we carried these tools for hemorrhage that couldn’t be controlled through other means, I never used either of them.

 

While control of major bleeding was an obvious necessity, it was also imperative to provide definitive and reliable airways. In the civilian sector, we might have enough medical personnel to spare a rescuer who does nothing but attend to the airway, but in combat this is not always the case. The combat medic often has to give the patient their best chance of survival and move on to the next casualty. Just as in the civilian sector, there are a variety of tools to accomplish that task.

 

Traditionally, medical personnel did not carry weapons and wore a distinguishing red 12) ___, to denote their protection as non-combatants under the Geneva Convention. This practice continued into World War II. However, the enemies faced by professional armies in more recent conflicts are often insurgents who either do not recognize the Geneva Convention, or do not care, and readily engage all personnel, irrespective of non-combatant status. For this reason, most modern combat medics are armed combatants who do not wear distinguishing markings.Combat Medics in the United States Army and United States Navy Hospital Corpsman are virtually indistinguishable from regular combat troops, except for the extra medical equipment they carry. The colloquial form of address for a Hospital Corpsman is “Doc.“

 

ANSWERS: 1) deaths; 2) aid; 3) medical; 4) lives; 5) care; 6) brain; 7) tourniquet; 8) hemorrhage; 9) medic; 10) airway; 11) blood; 12) cross

Dominique Jean Larrey (1766 1842)

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Dominique Jean Larrey was a French surgeon in Napoleon’s army and an important innovator in battlefield medicine.

 

Larrey was born in the little village of Beaudean, in the Pyrenees. Larrey was orphaned at the age of 13 and then raised by his uncle Alexis, who was chief surgeon in Toulouse. After serving a 6-year apprenticeship, Larrey went to Paris to study under the great Desault, who was chief surgeon at the Hotel-Dieu de Paris. However, his studies were cut short by war.

 

Larrey was surgeon-in-chief of the Napoleonic armies from Italy in 1797 to Waterloo in 1815. During this time, he initiated the modern method of army surgery, field hospitals and the system of army ambulance corps. After seeing the speed with which the carriages of the French flying artillery maneuvered across the battlefields, Larrey adapted them as Flying Ambulances for rapid transport of the wounded and manned them with trained crews of drivers, corpsmen and litter bearers. Larrey also increased the mobility and improved the organization of field hospitals, effectively creating a forerunner of the modern MASH units.

 

Larrey established a rule for the triage of war casualties, treating the wounded according to the seriousness of their injuries and urgency of need for medical care, regardless of their rank or nationality. Soldiers of enemy armies, as well as those of the French and their allies, were treated. Before Larrey’s initiative in the 1790s, wounded soldiers were either left amid the fighting until the combat ended or their comrades would carry them to the rear line. Larrey was made a Commandeur of the Legion d’Honneur on 12 May 1807, and was the a favorite of the Emperor, who commented, “If the army ever erects a monument to express its gratitude, it should do so in honor of Larrey.“ Larrey was ennobled as a Baron on the field of Wagram in 1809.

 

In 1811, Baron Larrey co-led the surgical team that performed a pre-anesthetic mastectomy on Frances Burney in Paris. Her detailed account of this operation gives insight into early 19th century doctor-patient relationships, and early surgical methods in the home of the patient.

 

At Waterloo in 1815, Larrey’s courage under fire was noticed by the Duke of Wellington who ordered his soldiers not to fire in his direction so as to “give the brave man time to gather up the wounded“ and saluted “the courage and devotion of an age that is no longer ours“?. Larrey was taken prisoner by the Prussians and condemned to death. However, he was recognized by one of the German surgeons, who pleaded for his life. Perhaps partly because Larrey had saved the life of General Gebhard Leberecht von Blucher, Furst von Wahlstatt, Prussian General Blucher’s son, when he was wounded and taken prisoner by the French, Larrey was pardoned, invited to Blucher’s dinner table as a guest and taken back to France under escort. Larrey devoted the remainder of his life to writing and to a civilian medical career; he died on July 25, 1842 in Lyon.

 

Often considered the first modern military surgeon, Larrey’s writings are still regarded as valuable sources of surgical and medical knowledge and have been translated into all modern languages.

 

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An illustration showing a variety of wounds from the Feldbuch der Wundarznei (Field manual for the treatment of wounds) by Hans von Gersdorff, (1517). Editor’s note: We’ve come a long way from brutal warfare, or have we? Give me intelligent negotiations that persevere and loyal allies, any day.

 

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Statue of Larrey at Val-de-Grace

 

His statue in bronze, as sculpted by David d’Angers in 1843, is standing in the courtyard outside the Val-de-Grace military hospital.

Single Episode of Binge Drinking Linked to Gut Leakage and Immune System Effects

 

Binge drinking is defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as a pattern of drinking alcohol that brings blood alcohol concentration (BAC) to 0.08g/dL or above. For a typical adult, this pattern corresponds to consuming five or more drinks for men, or four or more drinks for women, in about two hours. Some individuals will reach a 0.08g/dL BAC sooner depending on body weight. Binge drinking is known to pose health and safety risks, including car crashes and injuries. Over the long term, binge drinking can damage the liver and other organs.

 

According to an article publish online in PLOS ONE, a single alcohol binge can cause bacteria to leak from the gut and increase levels of bacterial toxins in the blood. These increased levels of these bacterial toxins, called endotoxins, were shown to affect the immune system, with the body producing more immune cells involved in fever, inflammation, and tissue destruction.

 

For the study, 11 men and 14 women were given enough alcohol to raise their blood alcohol levels to at least .08 g/dL within an hour. Blood samples were taken every 30 minutes for four hours after the binge and again 24 hours later. Results showed that the alcohol binge resulted in a rapid increase in endotoxin levels in the blood and evidence of bacterial DNA, showing that bacteria had permeated the gut. Endotoxins are toxins contained in the cell wall of certain bacteria that are released when the cell is destroyed. Compared to men, women had higher blood alcohol levels and circulating endotoxin levels. According to the authors, it was found that a single alcohol binge can elicit an immune response, potentially impacting the health of an otherwise healthy individual, and that the study results suggest that an alcohol binge is more dangerous than previously thought.

 

Earlier studies have tied chronic alcohol use to increased gut permeability, wherein potentially harmful products can travel through the intestinal wall and be carried to other parts of the body. Greater gut permeability and increased endotoxin levels have been linked to many of the health issues related to chronic drinking, including alcoholic liver disease.

Treatment of Chagas Disease

 

Chagas disease, also known as American trypanosomiasis, is a tropical parasitic disease caused by the protozoan Trypanosoma cruzi and spread mostly by insects known as Triatominae or kissing bugs. Chagas disease is endemic throughout much of Mexico, Central America, and South America where an estimated 8 million people are infected. The triatominae are known by a number of local names, including: vinchuca in Argentina, Bolivia, Chile and Paraguay, barbeiro (the barber) in Brazil, pito in Colombia, chinche in Central America, and chipo in Venezuela. The disease may also be spread through blood transfusion, organ transplantation, eating food contaminated with the parasites, and from a mother to her fetus. The symptoms change over the course of the infection. In the early stage, symptoms are typically either not present or mild and may include: fever, swollen lymph nodes, headaches, or local swelling at the site of the bite. After 8-12 weeks, individuals enter the chronic phase of disease and in 60-70% it never produces further symptoms. However, the other 30-40% of people develop further symptoms 10 to 30 years after the initial infection. This includes enlargement of the ventricles of the heart in 20 to 30% leading to heart failure. An enlarged esophagus or an enlarged colon may also occur in 10% of people.

 

By applying published seroprevalence figures to immigrant populations, CDC estimates that more than 300,000 persons with Trypanosoma cruzi infection live in the United States. Most people with Chagas disease in the United States acquired their infections in endemic countries. Although there are triatomine bugs in the U.S., only rare vectorborne cases of Chagas disease have been documented.

 

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Rhodnius prolixus

 

Current therapeutic options for Chagas’ disease are limited to benznidazole and nifurtimox, which have been associated with low cure rates in the chronic stage of the disease and which have considerable toxicity. Posaconazole has shown trypanocidal activity in murine models.

 

According to an article published in the New England Journal of Medicine (2014; 370:1899-1908), a prospective, randomized clinical trial was performed to assess the efficacy and safety of posaconazole as compared with the efficacy and safety of benznidazole in adults with chronic Trypanosoma cruzi infection. The study randomly assigned patients to receive posaconazole at a dose of 400 mg twice daily (high-dose posaconazole), posaconazole at a dose of 100 mg twice daily (low-dose posaconazole), or benznidazole at a dose of 150 mg twice daily; all the study drugs were administered for 60 days. Antiparasitic activity was assessed by testing for the presence of T. cruzi DNA, using real-time polymerase-chain-reaction (rt-PCR) assays, during the treatment period and 10 months after the end of treatment. Posaconazole absorption was assessed on day 14.

 

The intention-to-treat population included 78 patients. During the treatment period, all the patients tested negative for T. cruzi DNA on rt-PCR assay beyond day 14, except for 2 patients in the low-dose posaconazole group who tested positive on day 60. During the follow-up period, 92% of the patients receiving low-dose posaconazole and 81% receiving high-dose posaconazole, as compared with 38% receiving benznidazole, tested positive for T. cruzi DNA on rt-PCR assay (P<0.01). In the per-protocol analysis, 90% of the patients receiving low-dose posaconazole and 80% of those receiving high-dose posaconazole, as compared with 6% receiving benznidazole, tested positive on rt-PCR assay (P<0.001). In the benznidazole group, treatment was discontinued in 5 patients because of severe cutaneous reactions; in the posaconazole groups, 4 patients had aminotransferase levels that were more than 3 times the upper limit of the normal range, but there were no discontinuations of treatment.

 

According to the authors, posaconazole showed antitrypanosomal activity in patients with chronic Chagas’ disease. However, significantly more patients in the posaconazole groups than in the benznidazole group had treatment failure during follow-up.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.

 

FDA Allows Marketing of First Prosthetic Arm That Translates Signals From Person’s Muscles to Perform Complex Tasks

 

The FDA has allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes. EMG electrodes detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached. The electrodes send the electrical signals to a computer processor in the prosthesis that translates them to a specific movement or movements. The EMG electrodes in the DEKA Arm System convert electrical signals into up to 10 powered movements, and it is the same shape and weight as an adult arm. In addition to the EMG electrodes, the DEKA Arm System contains a combination of mechanisms including switches, movement sensors, and force sensors that cause the prosthesis to move.

 

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From the DEKA Website

 

The FDA reviewed clinical information relating to the device, including a 4-site Department of Veterans Affairs study in which 36 DEKA Arm System study participants provided data on how the arm performed in common household and self-care tasks. The study found that approximately 90% of study participants were able to perform activities with the DEKA Arm System that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair. The DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. It cannot be configured for limb loss at the elbow or wrist joint.

 

Data reviewed by the FDA also included testing of software and electrical and battery systems, mitigations to prevent or stop unintended movements of the arm and hand mechanisms, durability testing (such as ability to withstand exposure to common environmental factors such as dust and light rain), and impact testing.

 

The FDA reviewed the DEKA Arm System through its de novo classification process, a regulatory pathway for some novel low- to moderate-risk medical devices that are first-of-a-kind.

 

The DEKA Arm System is manufactured by DEKA Integrated Solutions in Manchester, N.H.

Chocolate Avocado Delight with Strawberries and Amaretto

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Chocolate Avocado Delight ©Joyce Hays, Target Health Inc.

 

Ingredients

1 ripe avocado

1/4 cup cocoa powder

1/4 cup raw agave nectar

1/4 cup almond milk

1 teaspoon vanilla extract

1 pint fresh sweet strawberries

Amaretto (optional)

 

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All the ingredients ©Joyce Hays, Target Health Inc.

 

Directions

1. Put all ingredients into a food processer and puree until smooth.

2. Pour the mixture into a bowl and chill for 2-3 hours or overnight.

3. Wash the strawberries and dry on paper towel.

4. Cut small strawberries in half and large ones in quarters or slice all of them.

 

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Soaking the strawberries in Amaretto ©Joyce Hays, Target Health Inc.

 

1. Put strawberries in a bowl and pour some of the Amaretto over them and let them soak it up.

2. When you take the mousse out of the fridge, cut the strawberries in half and put some in the bottom of each individual glass dessert dish. Cover strawberries with chocolate plus more. Add a few more strawberries, then cover with more chocolate.

3. Add a dollop of cool whip on each serving and a strawberry on top of that.

4. Enjoy!

 

The avocado is a climacteric fruit (the banana is another), which means it matures on the tree, but ripens off the tree. Persea americana, or the avocado, is believed to have originated in the state of Puebla, Mexico,though fossil evidence suggests that millions of years ago similar species were much more widespread, occurring as far north as California at a time when the climate of that region was more hospitable to them. The native, undomesticated variety is known as a criollo, and is small, with dark black skin, and contains a large seed.It likely coevolved with extinct megafauna.The oldest evidence of avocado use was found in a cave located in Coxcatlan, Puebla, Mexico, that dates to around 10,000 BCE.

 

Avocados are an incredibly versatile fruit, well known as the main ingredient inguacamole and one of my favorite things to put in a salad. Besides having a delicious nutty flavor, they’re loaded with healthy fats and nutrients. But did you know it’s a fruit and not a veggie? In fact, it’s a berry.

 

A fruit is “the matured ovary of a flower,“ according to University of California Agriculture & Natural Resources. Fruits consist of a tough outer layer (the skin or rind), a middle layer we typically think of as the flesh of the fruit and a casing around a seed (or seeds). Avocado is further classified as a fleshy as opposed to a dry fruit, and a berry rather than a drupe, which has tough pits or stones, like peaches. An avocado also has more potassium than a banana. A single avocado has 975 milligrams of potassium, while a banana, well-known for being loaded with potassium, delivers just half that, with 487 milligrams per large fruit.

 

Buy your avocados ahead of time (like, for this week’s recipe) and ripen them at home with a banana or an apple. Bananas and apples release ethylene gas, a naturally-occurring plant hormone. If you store your unripe avocados in a brown bag with an apple or a banana, the gases trapped in the bag will help your avocado ripen faster.

 

Besides containing potassium, it makes sense to use an avocado in desserts because one avocado has four grams of protein, among the highest amount coming from a fruit. Plus this is good quality protein. They don’t contain every single amino acid, required in the body’s protein-building process, but they do have all 18 of the important ones. Plus, all of that protein is available for the body to use, while some of the protein you might get from meat sources is not.

 

As you see from this week’s recipe, you can swap avocados for butter. How healthy is that if you’re watching your cholesterol.

 

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©Joyce Hays, Target Health Inc.

 

I’ve been experimenting with this recipe and it’s delicious with Amaretto strawberries and without. Just a matter of taste.

 

On individual plates or small bowls, you could also spoon out the cut Amaretto strawberries, then serve the chocolate-avocado as a sauce, over the berries, topping with cool whip, whipped cream or vanilla ice cream. As a sauce, this would also be wonderful over the flourless almond cake I came up with, in one issue of the ON TARGET newsletter, sent out around the Easter/Passover holidays.

 

No wine photo. Not drinking wine this weekend, because my lover and best friend is off on the hunt.

 

So, until next week.

 

Bon Appetit !