Target Health Supports Innovation in the Pharmaceutical Industry

 

Besides providing software, know-how and regulatory success to support the “paperless clinical trial and beyond,“ Target Health is also an active participant in 3 of the major industry groups supporting transformation of the clinical trial process.

 

Clinical Trials Transformation Initiative (CTTI)

 

The FDA and Duke co-founded CTTI to identify and promote practices to increase the quality and efficiency of clinical trials. CTTI engages all stakeholders as equal partners to analyze existing research impediments and recommend consensus-driven, actionable solutions that will lead to a more sustainable and effective clinical trial system. In order to accomplish CTTI’s mission. Target Health has been a member of CTTI since 2008 and Dr. Mitchel co-authored the seminal paper on Monitoring the Quality of Conduct of Clinical Trials: A Survey of Current Practices, published in 2011 with colleagues from Alquest, BMS, Duke Translational Medicine Institute, FDA, Pfizer, Roche, Training Extension/Pastor Consulting and the University of Minnesota.It has also been an extreme honor for Dr. Mitchel to represent the Steering Committee on the Executive Committee of CTTI over the past 2 years.

 

eClinical Forum

 

The eClincal Forum was started in 2000, the idea of a group of people who were keen to create something unique – a group run by its members for its members. Pharmaceutical, healthcare, regulatory, academic and support industry members participate in open discussion, networking and exchange that provides the practical information, approach and learning experiences required to maximize the success of eClinical initiatives. Many eClinical Forum deliverables are made freely available within the public domain. The non-commercial environment is important to the eClinical Forum. Target Health has been a member of the eClinical Forum since 2010 and Jules Mitchel and Dean Gittleman coauthored a seminal paper on Risk Based Approaches to clinical trials with colleagues from: Allergan, Array BioPharma. BMS, PPD, Eli Lilly, Novartis, Perceptive Informatics, Pharmapros and Quintiles.

 

Multi-Regional Clinical Trials (MRCT)

 

The MRCT Center engages expert stakeholders from industry, academia, advocacy groups, nonprofits, and regulatory agencies to take on critical issues in the conduct and oversight of clinical trials. MRCT is a neutral convening organization associated with two of the world’s most respected names in healthcare and academia: Brigham and Women’s Hospital and Harvard University. Working in the pre-competitive space, MRCT’s multidisciplinary teams collaborate to identify challenges and deliver ethical, actionable, and practical solutions for the global clinical trial enterprise, with a focus on emerging economies. Target Health has been a member of MRCT since 2013 and is a member of the working group establishing guidelines onReturn of Individual Results.

 

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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Legionnaires’ Disease

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Legionella pneumophila is the leading cause of Legionnaire’s Disease, an often fatal disease. Source: Woods Hole Oceanographic Institution, MA; whoi.edu/oceanus/feature/legions-of-legionella-bacteria

 

 

Legionnaires’ disease is a severe form of 1) ___  usually caused by a bacterium known as legionella. You can’t catch Legionnaires’ disease from person-to-person contact. Instead, most people get Legionnaires’ disease from inhaling the bacteria. Older adults, babies and young children, smokers and people with weakened immune systems are particularly susceptible to Legionnaires’ disease. People are exposed to Legionella when they breathe in a mist or vapor (small droplets of water in the air) containing the bacteria. One example might be from 2) ___ in droplets sprayed from a hot tub that has not been properly cleaned and disinfected. Less commonly, Legionella can be transmitted via aspiration of drinking 3) ___, which is when water “goes down the wrong pipe,“ into the trachea (windpipe) and lungs instead of down the digestive tract. People at increased risk of aspiration include those with swallowing difficulties.

 

Legionella cannot spread from one person to another person. A person diagnosed with Legionnaires’ disease or 4) ___ fever is not a threat to family members, co-workers, or others. However, if you believe that your workplace was the source of the person’s illness, contact your local health department, immediately. Most people exposed to the bacteria do not become ill. If you have reason to believe you were exposed to the bacteria, talk to your doctor or local health department. Be sure to mention if you have spent any nights away from home in the last two weeks.

 

Pontiac fever, caused by the legionella bacterium, is a milder illness resembling the flu.. Separately or together, the two illnesses are sometimes called legionellosis. Pontiac fever usually clears on its own, but untreated Legionnaires’ disease can be fatal. Although prompt treatment with 5) ___ usually cures Legionnaires’ disease, some people continue to experience problems after treatment.

 

As climate change continues to raise the temperature of the world’s oceans, the warmer waters may encourage the growth of new species of pathogens, as well as more virulent forms of pathogens that we may know about; however, we may not know how to control more virulent forms. As climate change wreaks havoc on our planet, disease is one of those agents to watch closely and try to guard against. A public health mandate! Woods Hole Oceanographic Institute does a very broad range of research, watching for 6) ___ in the world’s oceans, rivers, lakes, ponds is one area of important study. Salty ocean water is undrinkable and it corrodes nearly everything it touches. But salt water has always had one benefit: The salt kills microbes, making the ocean a fairly antiseptic environment. Until now. In the late 1990s, oysters in Chesapeake Bay began turning up infested with Cryptosporidium, a freshwater microbe familiar to backpackers who drink unfiltered stream water. It causes diarrhea and is occasionally fatal in young or weakened people. The freshwater microbe had learned/evolved to survive in 7) ___ water. Rebecca Gast, a biologist at Woods Hole Oceanographic Institution, found another common freshwater microbe, this time, in the Great Salt Lake, Utah: Legionella. Several species of this bacterium cause Legionnaires’ 8) ___, an illness that causes pneumonia, confusion, and fatigue. Now, there is the very serious possibility that these and other freshwater microbes traveling by stream, gutters, and sewage systems might be surviving the jump into salt water. Evolution in real time. Gast and colleague, Linda Amaral-Zettler of the Marine Biological Laboratory in Woods Hole have been conducting a sampling project to see what’s actually lurking out there in the oceans.

 

People have not paid responsible attention to this. The extent of the problem needs to be examined whether human pathogens end up in the coastal marine environment, how they are distributed, and how they persist. And even those who do pay attention, as reported in the news recently, regarding the drinking water in Flint, Michigan, those warnings were ignored. Warmer waters may be increasing the threat of microbes and Woods Hole is funding research to find out. Funding from the Woods Hole Center for Oceans and Human Health, supports the important research being done by the Gast team, working in nearby Mount Hope Bay, which receives plenty of runoff, rich in the nutrients and organic matter that microbes thrive on. Mount Hope Bay also has relatively warm waters that make it easier for human pathogens to survive. The summer sun heats the shallow bay, and a power plant empties water approaching human body temperature (980F or 370C) into the bay. Initial findings proved a basic premise in marine microbiology: The more you look, the more you find. Back in 2005, samples taken, turned up 32 strains of Legionella. Subsequent DNA typing indicated that none were the strain responsible for Legionnaires’ disease. However, the saltwater discovery was unexpected and significant.

“We’re seeing a huge diversity of 9) ___ in marine environments that mirrors what people see in fresh water,“ Gast said. After combing through a hefty green textbook titled simply Legionella, Gast still hasn’t found the names of the 32 strains or whether they’ve been formally described at all. New to science or not, it would help to know whether the Legionella in Mount Hope Bay can make beachgoers sick. To find out, Gast found published DNA sequences for disease-causing genes in other Legionella. Now, she is constructing experiments that will look for those harmful genes in the Legionella from Mount Hope Bay.

 

Gast and her team started looking for pathogenic Legionella because of a quirk: This particular bacteria can invade amoebae and in doing so become more virulent. Amoebae fight infections by trying to digest the invaders. That’s the same way human white blood cells operate, so Legionella cells that have survived inside amoebae also tend to foil human immune systems. The two scientists are also testing the Mount Hope Bay samples for two kinds of amoebae that cause problems all on their own: Naegleria and Acanthamoeba. People most often encounter Naegleria by taking a dip in warm, stagnant fresh water. Though cases are rare, it causes a brain infection that is fatal. Acanthamoeba is more widespread, found in fresh to salty water and even contact lens cases. It can cause persistent eye infections and occasionally attacks the 10) ___. Sources: Woods Hole Oceanographic Institute, MA; CDC.gov; NIH.gov; Wikipedia

 

ANSWERS: 1) pneumonia; 2) breathing; 3) water; 4) Pontiac; 5) antibiotics; 6) pathogens; 7) salt; 8) disease; 9) Legionella; 10) brain

 

Legionnaires’ Disease: Another Serious Public Health Issue

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The Legionella pneumophila bacteria are tagged with a monoclonal antibody treated with a fluorescein dye. After binding to the bacteria the slide is viewed under ultraviolet light, and the bacterial cell walls glow green. Source: National Library of Medicine, NIH.gov/medlineplus/legionnairesdisease

 

 

Between June 2015 and January 2016, 87 cases of Legionnaires’ disease were reported by the Michigan Department of Health and Human Services for the city of Flint, Michigan and surrounding areas. 10 of those cases were fatal.

 

The first recognized cases of Legionnaires’ disease occurred in 1976 in Philadelphia, Pennsylvania. Among more than 2,000 attendees of a Legionnaires’ convention held at the Bellevue-Stratford Hotel, 221 attendees contracted the disease and 34 of them died. In April 1985, 175 people in Stafford, England, were admitted to the District or Kingsmead Stafford Hospitals with chest infection or pneumonia. A total of 28 people died. Medical diagnosis showed that Legionnaires’ disease was responsible and the immediate epidemiological investigation traced the source of the infection to the air-conditioning cooling tower on the roof of Stafford District Hospital. In March 1999, a large outbreak in the Netherlands occurred during the Westfriese Flora flower exhibition in Bovenkarspel; 318 people became ill and at least 32 people died. This was the second-deadliest outbreak since the 1976 outbreak and possibly the deadliest as several people were buried before Legionnaires’ disease had been diagnosed.

 

The world’s largest outbreak of Legionnaires’ disease happened in July 2001 with people appearing at the hospital on July 7, in Murcia, Spain. More than 800 suspected cases were recorded by the time the last case was treated on July 22; 636-696 of these cases were estimated and 449 confirmed (so, at least 16,000 people were exposed to the bacterium) and six died, a case-fatality rate around 1%. In late September 2005, 127 residents of a nursing home in Canada became ill with L. pneumophila. Within a week, 21 of the residents had died. Culture results at first were negative, which is not unusual, as L. pneumophila is a fastidious bacterium, meaning it requires specific nutrients and/or living conditions in order to grow. The source of the outbreak was traced to the air-conditioning cooling towers on the nursing home’s roof.

 

As of 12 November 2014, 302 people have been hospitalized following an outbreak of Legionella in Portugal and 7 related deaths have been reported. All cases, so far, have emerged in three civil parishes from the municipality of Vila Franca de Xira in the northern outskirts of Lisbon, Portugal and are being treated in hospitals of the Greater Lisbon area. The source is suspected to be located in the cooling towers of the fertilizer plant Fertiberia. As of 10 August 2015, there have been over 110 confirmed cases and 12 deaths from the 2015 New York Legionnaires’ disease outbreak in the New York City borough of the Bronx. City health inspectors identified Legionella in the cooling systems of five public places: a hotel, Concourse Plaza Mall, a Verizon office, the Streamline Plastic Company, and at a building in the Lincoln Hospital complex. All of these places have since been decontaminated, according to the city. On August 28, 2015, an outbreak of Legionnaire’s disease was detected at San Quentin State Prison in Northern California.

 

Repurposing of Drugs – Actos May Prevent Recurring Strokes

 

Drugs are chemicals that potentially have multiple uses outside of their initial indication for use. For example sildenafil (Viagra for ED ) is also indicated for the treatment of pulmonary arterial hypertension (PAH) under the brand name of Revatio.

 

Ischemic stroke and transient ischemic attacks can occur when a cerebral blood vessel becomes blocked, cutting off the delivery of oxygen and nutrients to brain tissue. Insulin regulates metabolism and keeps blood sugar levels from getting too high, along with many other processes, in the body. Insulin resistance is a condition in which the body produces insulin but does not use it effectively. Insulin resistance is a hallmark of type 2 diabetes but also occurs in more than 50% of people with ischemic stroke who do not have diabetes. People with diabetes are known to have increased risk of stroke and previous research suggested that insulin resistance increases risk for stroke.

 

According to the results of the Insulin Resistance Intervention after Stroke (IRIS) trial presented at the International Stroke Conference 2016 in Los Angeles and published online the New England Journal of Medicine (17 February 2016), Pioglitazone (Actos, Takeda Pharmaceuticals), a drug used for type 2 diabetes, may prevent recurrent stroke and heart attacks in people with insulin resistance but without diabetes. The data suggest a potential new method to prevent stroke and heart attack in high-risk patients who have already had one stroke or transient ischemic attack. The IRIS trial is the first study to provide evidence that a drug targeting cell metabolism may prevent secondary strokes and heart attacks even before diabetes develops.

 

For the study, more than 3,000 patients from seven countries who had experienced an ischemic stroke or transient ischemic attack within the previous six months were randomized to receive pioglitazone or placebo for up to five years in addition to standard care. Results showed that stroke or heart attack occurred in 9% of participants taking pioglitazone and 11.8% of patients on placebo, which was a relative decrease of 24%. The results suggest that 28 strokes or heart attacks may be prevented for every 1000 patients who take pioglitazone for up to five years. Not unexpectedly, pioglitazone also reduced the risk of diabetes by 52% in the study participants.

 

It should be noted that pioglitazone is not FDA-approved for the uses studied in the IRIS trial.

 

The study evidenced an additional known side effect of the drug, which is an increased risk of bone fractures. To help doctors and patients choose the best strategy for preventing recurring strokes, future studies will attempt to identify a person’s risk of bone fractures due to pioglitazone.

 

Tick Genome Reveals Secrets of a Successful Bloodsucker

 

Ixodes ticks have three blood-feeding life stages, and during each one, they feed on a different vertebrate animal. During feeding, ticks ingest blood for hours or days at a time. After mating, adult female ticks rapidly imbibe a large blood meal during which they expand hugely. Ticks spread more different kinds of infectious microbes to people and animals than any other arthropod group, with the spiral-shaped bacterium that causes Lyme disease perhaps the best known microbe transmitted by ticks. However, ticks also transmit infectious agents that cause human babesiosis, anaplasmosis, tick-borne encephalitis and other diseases.

 

According to the NIH, “With tenacity befitting their subject, an international team of nearly 100 researchers toiled for a decade and overcame tough technical challenges to decipher the genome of the blacklegged tick (Ixodes scapularis).“ The following was.

 

Because genes may switch on or off depending on the life stage of the tick, a study, published in Nature Communications (9 February 2016), first needed to culture and collect ticks at each stage for analysis. Not an easy task. Another challenge was the sheer size of the tick genome — some 2.1 billion DNA base pairs — and expansive regions where sequences are repeated. According to the authors, the degree of DNA repetition — approximately 70% of the total — made assembling the full genome in the correct order very difficult. Nevertheless, the study determined the sequence for 20,486 protein-coding genes, of which 20% may be unique to ticks.

 

Although the latest research represents just a first look at the tick genome, the authors have already identified genes and protein families that shed light on why Ixodes ticks succeed so well as parasites and hint at the reasons they excel at spreading pathogens. For example, compared with other blood-feeders, ticks have many more proteins devoted to consuming, concentrating and detoxifying their iron-containing food. Although mosquitoes, which quickly siphon up relatively small amounts of blood through a tube-like mouthpiece and have several proteins dedicated to blood digestion, ticks have many more proteins involved in this process. Other genes code for proteins that help ticks concentrate the blood and rapidly excrete excess water that accompanies large blood meals. Still other genes allow ticks to quickly expand their stiff outer coats to accommodate a 100-fold increase in total body size during blood feeding.

 

Other peculiarities of the tick’s lifestyle reflected in the genome include genes associated with the multifaceted sensory systems that the parasite uses when “questing“ for a host during each of its separate blood-feeding stages. Compared with mosquitoes, ticks appear to have fewer genes used to detect hosts, and, unlike a mosquito’s “smell“ receptors, ticks may use “taste“ receptors to locate their food sources.

 

In an effort to explain variations in Lyme disease prevalence across the United States, the authors also examined genetic diversity within and among I. scapularis populations gathered from five states in the Northeast and Midwest and three in the South. Some have speculated that ticks in the Northeast and Midwest spread the bacteria that cause Lyme disease more easily than those in the South, or that the two populations perhaps comprise separate species. The genetic analysis showed that there is only one species of I. scapularis, but subtle genetic differences were detected, and these may help explain some of the variance in the ability of populations to transmit disease and, therefore, affect disease prevalence.

 

Dr. Hill, the lead author, admitted to a grudging admiration for her eight-legged subjects. “I find them almost endearing in the way they stick so firmly to the business of parasitizing their hosts. They are persistent and resilient. In a way, our team took a page from the tick’s book in working together over so many years until we achieved our goal.“

 

2014 Study Examines Reasons for Delay, Denial of New Drugs by FDA

 

With all the worries about the use of modern technology in the clinical trial ecosystem, the industry should note the real reasons drugs get delayed or turned down by FDA.

 

According to a study published in the January 22/29, 2014 issue of the Journal of the American Medical Association (JAMA), several potentially preventable deficiencies, including failure to select optimal drug doses and suitable outcome measures for a study, accounted for significant delays in the approval of new drugs by the FDA, Clearly, the road from medical product discovery to marketing is typically long and costly with the interval between initial clinical testing and product approval averaging about 8 years, with and only 1 in 6 drugs entering clinical trials ultimately obtaining approval. According to the article, many drugs do not receive approval not because they are unsafe or ineffective, but because the information supplied is unsatisfactory to make that determination. Delays and failures that occur late in development affect the availability of innovative new drugs and increase the costs of drug development. Leonard V. Sacks,M.B.B.Ch., of the FDA and colleagues reviewed marketing applications for all new molecular entities (NMEs; active ingredients never before marketed in the United States in any form) first submitted to the FDA between 2000 and 2012. Using FDA correspondence and reviews, the authors investigated the scientific and regulatory reasons approval of NMEs were delayed or denied. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) eventually achieved marketing approval. Of the 151 first-cycle failures, 71 (47.0%) eventually obtained approval in a median (midpoint) of 435 days following the first unsuccessful submission.

 

Among the reasons for failure to initially receive approval:

 

1. Uncertainty about the optimal dose to maximize efficacy and to minimize safety risks;

2. Populations that were studied did not reflect the populations likely to use the drug;

3. End points used in clinical trials were unsatisfactory;

4. Inconsistent results for multiple predefined end points in clinical studies;

5. Inconsistencies in efficacy for portions of the study population.

 

There were 20 drugs (13.2%) that despite showing superiority to placebo were considered to have inadequate efficacy compared with the standard of care.

 

The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval. However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals. Among the 48 drugs with initial efficacy concerns alone, only 31.3% were eventually approved compared with 61.5% of the 39 drugs with safety concerns alone.

 

For drug developers and clinical investigators, the  findings suggest areas of deficiencies in new drug applications in which strategies for drug development could be improved. Early and frequent dialogue between the FDA and drug sponsors addressing critical aspects of study design (including the selection of study populations, study end points, and drug doses) has the potential to reduce delays in the approval of new drugs.

 

Please also see a terrific article entitled Current Trends in FDA Inspections Assessing Clinical Trial Quality: An Analysis of CDER’s Experience by our colleagues Ann Meeker-O’Connell and Leslie K. Ball Food and Drug Law Institute (March, April 2011).

 

Devil’s Delight Appetizer: Eggs with Mushrooms

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Delish, Quick, Easy – You can do this ©Joyce Hays, Target Health Inc.

 

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This recipe is for two to four people, double or triple it for more. ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

3 large eggs (organic, if you can)

1 Onion, chop very fine

1 fresh large garlic clove, chop well

4 ounces cremini mushrooms, or baby bella, or shitaki, or whatever, cleaned and sliced

2 – 3 Tablespoons Kraft Mayonnaise

2 Tablespoons extra virgin olive oil

Pinch salt plus another few pinches for boiling the eggs

Pinch black pepper

Pinch chili flakes

1/2 teaspoon fresh cilantro leaves for garnish

 

 

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Simple ingredients (I forgot to include the Kraft mayo) for a really delicious appetizer. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

Boil the eggs in a saucepan for 10-15 minutes. Be sure to add a few pinches of salt to the water. Set a timer, and when the eggs are done, plunge them right away into a container with cold water and a few ice cubes. You may find that the salt plus the cold bath, make it easier to peel the eggs. Let the eggs sit in the ice water for 5 to 10 minutes.

 

 

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Not yet reached a boil. I put eggs into the pan when the water is warm-ish, way before the boil. Add a few pinches of salt to the water.  ©Joyce Hays, Target Health Inc.

 

 

Then peel the eggs. Cut them in half the long way and put the hollowed out egg whites on the dish you plan to serve them with.

 

 

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Hard boiled eggs have been cut in half, lengthwise, yolks removed and put into a bowl. You don’t want/need to remove every last bit of yolk, because you could nick the egg in doing this, so why bother when it doesn’t affect the outcome one single bit. ©Joyce Hays, Target Health Inc.

 

 

Carefully, remove the yolks and put them in a medium bowl. Not a big deal if you don’t get every last speck of yolk. With a fork, mash the yolks then set aside.

 

 

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Here, the egg yolks have been removed and mashed in this bowl. ©Joyce Hays, Target Health Inc.

 

 

Clean the mushrooms by wiping with damp cloth or paper towel. Then slice them, including the stems. While the eggs are boiling in salted water, take out a medium frying pan, add the 2 Tablespoons of olive oil (be sure only to use extra virgin olive oil for everything and not a bottle that simply reads: olive oil), to the pan and over a low to medium flame, cook the well chopped onions first for a few minutes, then add the sliced garlic and cook for a few minutes, then add the pinch salt, pinch black pepper, pinch chili flakes and stir in.

 

 

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Here the onions & garlic have cooked a few minutes and sliced mushrooms have been added. ©Joyce Hays, Target Health Inc.

 

 

Finally, add the mushroom slices, stir and cook for another 5 minutes. When the mushrooms release their juice, cook it down, until there’s barely any juice left. At this point, use a spatula to remove the contents of the pan and scrape everything onto a cutting board, where you can chop the mushrooms into very tiny pieces.

 

 

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Here, I’m chopping all the cooked onion, garlic, mushrooms (including stems). The pieces above are an okay size, but I’m going to chop a little longer because smaller pieces will blend better with the egg yolks. ©Joyce Hays, Target Health Inc.

 

 

Once the onions, garlic, mushrooms have been chopped into tiny pieces, carefully scrape everything on the cutting board, into the bowl with the mashed egg yolks.

Now, with a fork, stir the mushroom mixture with the egg yolks, until everything is well combined.

 

Finally, add 2 Tablespoons of Kraft mayonnaise to the bowl and mix it in with the mushroom/eggs. Taste to see if you want to add more of anything. Depending on how you like your deviled eggs, decide on whether you want another Tablespoon of mayo or not. If yes, add it and combine it well into the mushroom/egg mixture.

 

 

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Here is the mushroom/egg filling, just about ready. ©Joyce Hays, Target Health Inc.

 

Now, you’re ready to fill the hollowed out egg whites. Using a teaspoon or small demitasse size spoon, spoon into each egg white half, a generous mound of the egg mixture. Top each stuffed egg with one tiny fresh cilantro leaf and serve immediately.

 

 

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Here, the eggs have been filled with the mushroom/egg stuffing. This is not the serving dish. Next, they need one fresh cilantro leaf on each, and will be ready to bring to table. ©Joyce Hays, Target Health Inc.

 

 

Don’t put the eggs into the fridge, because they won’t taste as good when you take them out. Try to make only what you know you will eat on the day you make these deviled eggs, because they taste the best on the day they’re made. It’s not that they will spoil overnight, they won’t; it’s just that they are so-o much more yummy eaten right after being stuffed, and at room temperature. It’s unusual that a dish this good, is extremely easy to make and takes very little time.

 

 

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Chilled Stag’s Leap Cellars Sauvignon Blanc, an old favorite, goes very well with this appetizer. ©Joyce Hays, Target Health Inc.

 

We started our dinner with the chilled white wine you see above, and the yummy eggs stuffed with mushrooms. We have served these for dinner parties and they’re gobbled up rapidly as popular as shrimps with cocktail sauce. After, feeling a certain relaxation setting in with this first course, we moved on to a new recipe I’m working on, salmon dill cakes with a simple yogurt/mayo/pickle sauce; a veggie/apple casserole; and potatoes stuffed with broccoli, a delicious dinner according to both of us. For dessert we had Tofutti bars (FreshDirect), which are like small ice cream sandwiches except they’re tofu/soy and not ice cream, which cuts the calories way down.

 

BTW, I know I said, in the recipe above, that the deviled mushroom eggs are best eaten the same day. But this time, I purposely saved three of them, just to see how they tasted one day and two days later. I have to take back what I previously remarked. They are just as good the next day and two days later. In fact, the taste of the mushrooms seems to permeate the yolks even more a day or two later.

 

Our weekend was very relaxing: we went to the theater (good enough), had dinner at our favorite neighborhood Italian, slept late and Jules beat me in Scrabble (teeth gnashing).

 

Hope your weekend was relaxing and stimulating and fun!

 

From Our Table to Yours !

 

 

Bon Appetit!