FDA is Pushing eSource Programs

 

This week, FDA conducted a CDER SBIA Webinar based on the Federal Register (FR) Notice: Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data. We want to again congratulate our colleagues at FDA who are the regulatory champions of paperless clinical trial including “eSource, eTMF, EHR/EDC integration, eInformed Consent etc.“ These tools together with Quality by Design (QbD) and Risk-based Monitoring (RBM) methodologies are truly transforming clinical Trials.

 

Target Health, the business champion of the fully integrated paperless clinical trial, is pleased to announce that Applied Clinical Trials has again highlighted our peer-reviewed article entitled “eSource Records in Clinical Research.“ Target Health is also planning a 2nd regulatory submission on behalf of a sponsor for a program with 7 clinical trials all performed with Target e*CRF®, fully integrated with our eSource solution Target e*CTR®(eClinical Trial record), which allowed for direct data entry at the time of the office visit. Benefits were huge.

 

Orchid Grows on Madison Avenue

 

This is the view from our office in mid-town in Manhattan. This orchard has been around for many years and flowers about 2x/year.

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©Target Health Inc. 2015

 

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

 

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

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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Magnesium, a Natural Relaxant, Plus It Helps Insomnia

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Magnesium is an antidote to stress, the most powerful relaxation mineral available, and it can help improve your 1) ___. A deficiency in the critical nutrient, magnesium, makes you twice as likely to die as other people, according to a study published in The Journal of Intensive Care Medicine. It also accounts for a long list of symptoms and diseases – which are easily helped and often cured by adding this nutrient. In fact, this nutrient is a secret weapon against illness. Yet up to half of Americans are deficient in this 2) ___ and don’t know it.

 

It’s strange that more doctors aren’t aware of the benefits of 3) ___, because we use it all the time in conventional medicine. But we never stop to think about why or how important it is to our general health or why it helps our bodies function better. Mark Hyman MD, remembers using magnesium when he worked in the emergency room. It was a critical “medication“ on the crash cart. If someone was dying of a life-threatening arrhythmia (or irregular heart beat), he used intravenous magnesium. If someone was constipated or needed to prepare for colonoscopy, he gave them milk of 4) ___ or a green bottle of liquid magnesium citrate, which emptied their bowels. If pregnant women came in with pre-term labor, or high blood pressure of pregnancy (pre-eclampsia) or seizures, they were given continuous high doses of intravenous magnesium.

 

But you don’t have to be in the hospital to benefit from getting more magnesium. You can start taking regular magnesium supplementation and see results for yourself. Anything that is tight, irritable, crampy, and stiff – whether it’s is a body part or even a mood – is a sign of magnesium 5) ___, according to Dr. Hyman. This critical mineral is actually responsible for over 300 enzyme reactions and is found in all of your tissues – but mainly in your bones, muscles, and brain. You must have it for your cells to make energy, for many different chemical pumps to work, to stabilize membranes, and to help muscles relax. When was the last time you had a good dose of seaweed, nuts, greens, and beans? If you are like most Americans, your nut consumption mostly comes from peanut butter. That is why the list of conditions that are found related to magnesium deficiency is so long. In fact, there are over 3,500 medical references on magnesium deficiency! Even so, this mineral is mostly ignored because it is not a drug, even though it is MORE powerful than drugs in many cases. That’s why it’s used in the hospital for life-threatening and emergency situations like seizures and 6) ___failure.

 

You might be magnesium deficient if you have any of the following symptoms:

 

Muscle cramps or twitches, Insomnia, Irritability, Sensitivity to loud noises, Anxiety, Autism, ADD, Palpitations, Angina, Constipation, Anal spasms, Headaches, Migraines, Fibromyalgia, Chronic fatigue, Asthma, Kidney stones, Diabetes, Obesity, Osteoporosis, High blood pressure, PMS, Menstrual cramps, Irritable bladder, Irritable bowel syndrome, Reflux, Trouble swallowing

 

Magnesium deficiency has even has been linked to inflammation in the body and higher CRP levels. In our society, magnesium deficiency is a huge problem. By conservative standards of measurement (blood, or serum, magnesium levels), 65% of people admitted to the intensive care unit – and about 15% of the general population – have magnesium deficiency. But this seriously underestimates the problem, because a serum magnesium level is the LEAST sensitive way to detect a drop in your total body magnesium level. So rates of magnesium deficiency could be even higher! The reason we are so deficient is simple: Many of us eat a diet that contains practically no magnesium – a highly-processed, refined diet that is based mostly on white flour, meat, and dairy (all of which have no magnesium). When was the last time you had a good dose of sea vegetables (seaweed), nuts, greens, and beans? If you are like most Americans, your nut consumption mostly comes from 7) ___ butter, and mostly in chocolate peanut butter cups. Much of modern life conspires to help us lose what little magnesium we do get in our diet. Magnesium levels are decreased by excess alcohol, salt, coffee, phosphoric acid in colas, profuse sweating, prolonged or intense stress, chronic diarrhea, excessive menstruation, diuretics (water pills), antibiotics and other drugs, and some intestinal parasites. In fact, in one study in Kosovo, people under chronic war stress lost large amounts of magnesium in their 8) ___.

 

This is all further complicated by the fact that magnesium is often poorly absorbed and easily lost from our bodies. To properly absorb magnesium we need a lot of it in our diet, plus enough vitamin B6, vitamin D, and selenium to get the job done. A recent scientific review of magnesium concluded, “It is highly regrettable that the deficiency of such an inexpensive, low-toxicity nutrient results in diseases that cause incalculable suffering and expense throughout the world.“ It is difficult to measure and hard to study, but magnesium deficiency accounts for untold suffering – and is simple to correct. So if you suffer from any of the symptoms mentioned or have any of the diseases, noted, don’t worry – it is an easy fix!! Here’s how.

 

Stop Draining Your Body of Magnesium

 

Limit coffee, colas, salt, sugar, and alcohol

Learn how to practice active relaxation

Check with your doctor if your medication is causing magnesium loss (many high blood pressure drugs or diuretics cause loss of magnesium)

 

Include the following foods in your diet as often as you can:

Kelp, wheat bran, wheat germ, almonds, cashews, buckwheat, brazil nuts, dulse, filberts, millet, pecans, walnuts, rye, tofu, soy beans, brown rice, figs, dates, collard greens, shrimp, avocado, parsley, beans, barley, dandelion greens, and garlic

 

Take Magnesium Supplements

 

The RDA (the minimum amount needed) for magnesium is about 300 mg a day. Most of us get far less than 200 mg.

Some may need much more depending on their condition.

Most people benefit from 400 to 1,000 mg a day.

The most absorbable forms are magnesium citrate, glycinate taurate, or aspartate, although magnesium bound to Kreb cycle chelates (malate, succinate, fumarate) are also good.

Avoid magnesium carbonate, sulfate, gluconate, and oxide. They are poorly absorbed (and the cheapest and most common forms found in supplements).

Side effects from too much magnesium include diarrhea, which can be avoided if you switch to magnesium glycinate.

Most minerals are best taken as a team with other minerals in a multi-mineral formula.

Taking a hot bath with 9) ___ salts (magnesium sulfate) is a good way to absorb and get much needed magnesium.

 

People with kidney disease or severe heart disease should take magnesium only under a doctor’s supervision. Magnesium is truly a miracle mineral. It is essential for lifelong vibrant 10) ___. Source: drhyman.com (Mark Hyman MD); Editor’s note: check with your doctor before you take any vitamin or mineral supplement.

 

ANSWERS: 1) sleep; 2) nutrient; 3) magnesium; 4) magnesia; 5) deficiency; 6) heart; 7) peanut; 8) urine; 9) Epsom; 10) health

 

American Physicians & Religious Professionals in 1872

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The book cover for Dr Ox , written by Jules Verne in 1872*

 

The Medical and Surgical Reporter, a Weekly Journal

Edited by S. W. Butler, M. D., and D. G. Brinton, M. D.

January-July 1872; Vol. XXVI. Philadelphia: S. W. Butler, 115 South Seventh Street.

 

What Shall We Do Eds. Medical and Surgical. Reporter:

 

Physicians are certainly frequently perplexed to know just how to proceed in the matter of charging for professional services rendered ministers of the gospel and their families. As a consideration of the subject recently appeared in your columns, I feel encouraged to offer a few additional thought. Clergymen fill a high and worthy mission, are entitled to an appreciative consideration and general encouragement. The progress of the gospel plough should not be hindered. In a certain sense ministers, as a class, are a hard-working, self-sacrificing, devoted body of men. But, as a rule, ministers do not consider themselves under obligations to devote their time, expend their strength, and appropriate their best talents for the benefit of their fellow-creatures, without some fair pecuniary compensation. They very well understand that something more is required to keep soul and body together than faith and good works; the laborer is worthy of his hire!

 

Furthermore, ministers are human-men of like impulses and general characteristics as other men. They are not insensible to the advantages of ordinary, and even somewhat luxurious comforts; and some of them even seek to acquire an amount of “filthy lucre” sufficient for the emergencies of the future “rainy day.” To this we urge not the slightest objection; it is right in both practice and principle; but all that is right for the minister is also right for the physician. Let us compare the two professions. It is sometimes claimed that ministers perform a great deal of charity work gratuitously; so do physicians. In this respect I believe that the physician is about as magnanimous as the minister. Is there any reason that he should be more so? Ministers seldom take charge of congregations without a preliminary stipulation of the amount of salary they shall receive, and at what periods the installments will be paid in; it is an extraordinary event for physicians to exact such a negotiation before taking charge of patients. It is said ministers are often poorly paid; this is indeed too true, but it is also just as true that often physicians are worse paid. By common consent, ministers are favored by a reduction of prices in all their purchases; I have yet to learn of such considerate advantages being afforded physicians. Again, ministers, like men of other professions, can be spoiled. Gratuities constantly bestowed, in time come to be looked upon as a mere matter of course. Beyond all contradiction, an element of selfishness is native to human nature.

 

A correspondent has suggested that some ministers seem to think the prestige their patronage gives the physician is ample compensation for the professional services of the latter. With equal justness and equal propriety should the physician claim the advantages of church-membership and a church-pew, without money and without price, on the ground of the prestige that his connection with the communion will afford the worthy reverend. There is neither morality nor justice in any such practice. It has been said that some ministers abundantly able to pay would deem themselves insulted were the medical man to present a tyll. All such ministers are sadly in need of being “reconstructed” in the orthodoxy of the golden rule “Do unto others asyou would that they do unto you.“ Your correspondent affirmed that doubtless there are plenty of doctors who would jump at the chance of attending ministers’ families for nothing. Well, let them jump! These men who jump so easy never constitute the class of really valuable men in any profession. Men of brains, studious, thinking, brain-working men, know the value of their toil, and, as a rule (due allowance being made in all proper exceptions), expect a fair compensation for their services.

 

All things considered, what shall we do? What would constitute a fair and just criterion by which we can gauge our charges to ministers? It is the practice of some railroad and steam passenger companies, I believe, to carry ministers at about “half price.” Book, magazine, and other periodical publishers, furnish their ministerial patrons at about “half price.” Booksellers, and merchants of all other classes, frequently make some reductions in price to ministers. Are the professional services of good physicians to ministers’ families not, as a rule, worth “hatf price t” Should we be expected to sacrifice more than anybody else? For one, I cannot see it in such alight. Physicians are human, as well as other people. About four years ago I advocated the “half price” system before a local Medical Society in the interior of this State; it was adopted, and has worked well. Physicians, of course, have discretionary powers, aud can make special deductions in exceptional cases; but, as a rule, let ministers be charged half the usual price for professional services rendered by the physician.

 

Geo. B. H. Swayze, M. D.; 1888 Columbia Avenue, Philad’a.

June 8th, 1872.

On Attending Clergymen’s Families.

Eds. Med. And Surg. Reporter:

 

In the Reporter for May 18, 1872, Dr. E. P. Hurd asks, “Shall we attend the families of clergymen gratuitously?” If the minister is dependent alone upon his salary for support, I answer, Yes, as I believe it to be the duty of every one to contribute to the support of the ministry, and it may often happen that this is the only contribution that the poor physician is able to make. If, however, the minister is engaged in any secular business in connection with his preaching, then I say, “Charge, Chester, charge.” Let me illustrate. Some years ago I was called to attend the family of a minister who was at the same time engaged in teaching and farming. A time after the service was rendered he met my father, and showered ever so many compliments upon me. At the end of the year I called upon him with my account made out at my regular rates, with a “credit by reduction,” $_____ ;”balance due,” $____. He looked at the account, and thought it very high, and remarked that he had never been required to pay physicians’ bills till he came West. I culled his attention to the “credit” on his account, and told him that was for the preacher, but that I should expect the teacher to pay the balance. He not having the money at the time, I took his note bearing the ordinary rate of interest. I was never called to attend this preacher’s family again.

 

Some months afterwards this same preacher volunteered to set the arm of a little boy who had a fracture of the radius and ulna. By accident I passed the house of the boy’s father an hour afterwards, when I was halted by the father and requested to go in and see if the arm was “done up right.” He said that parson S. assured him that it was, as he, the parson, had seen a great deal of surgery in the army, but that he, the father, would be better satisfied if I would go in and look at it. I found the arm with four rough unpadded board splints upon it, one anterior, one posterior, and two lateral, and extending from the wrist-joint to the elbow; the only bandage used was tied around outside the splints. When I took the dressing oft’ I found that the fracture had not been reduced. This little boy would have lost the use of his arm but for my accidental passing of the house. The point I wish to make by the recital of this case is this: Whilst we should do our duty towards preachers, they have a duty to perform towards us, viz., to stop their extensive recommendation and circulation of “patent medicines,” and their promiscuous, gratuitous and dangerous practice of medicine and surgery. W. Jones, M. D., Pine Bluffs, Ark., June 5th, 1872

 

*Dr Ox, the short story by Jules Verne, was adapted by Jacques Offenbach as Le docteur Ox, an opera-bouffe in three acts and six tableaux, premiered on 26 January 1877 with a libretto by Arnold Mortier, Philippe Gille and Verne himself. Annibale Bizzelli composed another version, il Dottor Oss. It was also adapted by Gavin Bryars as Doctor Ox’s Experiment, an opera in two acts with a libretto by Blake Morrison, first performed on 15 June 1998.

 

Bullying Victimization and Risk of Psychotic Phenomena

 

Being bullied is an aversive experience with short-term and long-term consequences, and is incorporated in biopsychosocial models of psychosis. To understand this issue better, a study published online in The Lancet Psychiatry (20 May 2015) used the 2000 and the 2007 British Adult Psychiatric Morbidity Surveys to test the hypothesis that bullying is 1) associated with individual psychotic phenomena and with psychosis, and 2) can predict the later emergence of persecutory ideation and hallucinations.

 

The authors analyzed two nationally representative surveys of individuals aged 16 years or older in Great Britain (2000) and England (2007). Respondents were presented with a card listing stressful events to identify experiences of bullying over the entire lifespan. The statistical analysis assessed associations of the dependent variables of persecutory ideation, auditory and visual hallucinations, with the diagnosis of probable psychosis. All analyses were controlled for sociodemographic confounders, intelligence quotient (IQ), and other traumas.

 

Data were analyzed for 8580 respondents from 2000 and 7403 from 2007. Results showed that bullying was associated with presence of persecutory ideation and hallucinations, even after adjustment for sociodemographic factors, IQ, other traumas, and childhood abuse. Bullying was also associated with a diagnosis of probable psychosis. When reported at baseline, bullying predicted emergence and maintenance of persecutory ideation and hallucinations during 18 months of follow-up. Controlling for other traumas and childhood abuse did not affect the association between bullying and psychotic symptoms, but reduced the significance of the association with diagnosis of probable psychosis. Bullying was most strongly associated with the presence of concurrent persecutory ideation and hallucinations.

 

According to the authors, bullying victimization increases the risk of individual psychotic symptoms and of a diagnosis of probable psychosis, and that early detection of bullying and use of treatments oriented towards its psychological consequences might ameliorate the course of psychosis.

 

Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease

 

COPD, or chronic obstructive pulmonarydisease, is a progressive disease that makes it hard to breathe. COPD can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness, and other symptoms. Cigarette smoking is the leading cause of COPD. Most people who have COPD smoke or used to smoke. Long-term exposure to other lung irritants – such as air pollution, chemical fumes, or dust – also may contribute to COPD. COPD is thought to result from an accelerated decline in forced expiratory volume in 1 second (FEV1) over time. Yet it is possible that a normal decline in FEV1 could also lead to COPD in persons whose maximally attained FEV1 is less than population norms.

 

To evaluate this hypothesis, a study published in the New England Journal of Medicine (2015; 373:111-122) stratified participants in three independent cohorts (the Framingham Offspring Cohort, the Copenhagen City Heart Study, and the Lovelace Smokers Cohort) according to lung function (FEV1>80% or <80% of the predicted value) at cohort inception (mean age of patients, approximately 40 years) and the presence or absence of COPD at the last study visit. The authors then determined the rate of decline in FEV1 over time among the participants according to their FEV1 at cohort inception and COPD status at study end.

 

Results showed that among 657 persons who had an FEV1 of less than 80% of the predicted value before 40 years of age, 174 (26%) had COPD after 22 years of observation, whereas among 2207 persons who had a baseline FEV1 of at least 80% of the predicted value before 40 years of age, 158 (7%) had COPD after 22 years of observation (P<0.001). Approximately half the 332 persons with COPD at the end of the observation period had had a normal FEV1 before 40 years of age and had a rapid decline in FEV1 thereafter, with a mean (+SD) decline of 53+21 ml per year. The remaining half had had a low FEV1 in early adulthood and a subsequent mean decline in FEV1 of 27+18 ml per year (P<0.001), despite similar smoking exposure.

 

According to the authors, the study suggests that low FEV1 in early adulthood is important in the genesis of COPD and that accelerated decline in FEV1 is not an obligate feature of COPD.

 

FDA Approves New Drug to Treat Heart Failure

 

Congratulations to our friends and colleagues at Novartis.

 

Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can’t pump enough blood to meet the body’s needs. Heart failure generally worsens over time as the heart’s pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.

 

The FDA has approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. Entresto was studied in a clinical trial of more than 8,000 adults and was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to another drug, enalapril. Most patients were also receiving currently approved heart failure treatments, including beta-blockers, diuretics, and mineralocorticoid antagonists. The most common side effects in clinical trial participants being treated with Entresto were low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment). Angioedema (an allergic reaction usually appearing as swelling of the lips or face) was also reported with Entresto; black patients and patients with a prior history of angioedema have a higher risk.

 

Patients should be advised to get emergency medical help right away if they have symptoms of angioedema or trouble breathing while on Entresto. Health care professionals should advise patients not to use Entresto with any drug from the angiotensin converting enzyme (ACE) inhibitor class because the risk of angioedema is increased. When switching between Entresto and an ACE inhibitor, use of the two drugs should be separated by 36 hours. Health care professionals should counsel patients about the risk of harm to an unborn baby. If pregnancy is detected, use of Entresto should be discontinued as soon as possible. Entresto is manufactured by Novartis, based in East Hanover, New Jersey.

 

(Soy) Chicken & Mushrooms Cooked in Sherry (Lo-fat) Sour Cream Sauce

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Other sources of protein can be delicious. ©Joyce Hays, Target Health Inc.

 

1 package Gardein soy chicken pieces (10 pcs)

1/2 cup onion, chopped

6 minced garlic cloves

10 fresh cremini mushrooms, sliced

1/4 cup butter

1/4 cup sherry

2 dashes Worcestershire sauce

1 pint low-fat sour cream

Pinch each of salt and pepper

Pinch chili flakes

2 teaspoons fresh basil, chopped

1 teaspoon fresh parsley, chopped

1/2 cup fresh parmesan grated

 

 

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After experimenting several times, I ended up not using the Panko or the egg in this recipe.©Joyce Hays, Target Health Inc.

 

Directions

 

1. Follow package directions to bake the soy chicken. You can bake in a regular oven or toaster oven, or microwave.

2. Make the sauce while the soy chicken is baking.

 

 

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Chop the onions well. ©Joyce Hays, Target Health Inc.

 

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Wipe mushrooms with a damp cloth or damp paper towel; then slice the mushrooms, don’t chop them. ©Joyce Hays, Target Health Inc.

 

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Saute onions, garlic, then add mushrooms. ©Joyce Hays, Target Health Inc.

 

3. To a large skillet, add the butter and let it melt. Saute the onions and garlic, for about 3-4 minutes, until onions start to become translucent, then add the mushrooms and cook for 4-5 minutes.

4. To the same pan, add your sherry and Worcestershire sauce and cook an additional 2 minutes.

 

 

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The sauce is ready for the soy chicken pieces. ©Joyce Hays, Target Health Inc.

 

5. Lower the heat and add the sour cream, salt, pepper, chili flakes, basil, and parsley. Keep the flame low. Add the parmesan and stir all the ingredients well. Set pan aside.

6. When the soy chicken is done, add the chicken pieces to the sauce in the pan

 

 

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In the photo above, the soy chicken has been added to the sauce and we’re just about to serve it with the saffron rice. ©Joyce Hays, Target Health Inc.

 

7. Spoon the sauce over the chicken, cover and simmer on low for 5 minutes just to heat everything up

8. Serve with your favorite rice dish and a salad.

 

 

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This recipe was served with the above saffron (golden raisin, pine nuts) rice dish. ©Joyce Hays, Target Health Inc.

 

Jules and I have slowly moved to a mutual taste for several meat-free meals each week. Luckily, we’re in agreement. We feel better and healthier after a veggie meal, plus, of course, there are fewer calories. Therefore, I am now looking for ways to make our meatless dinners just as tasty as any of the others. I have discovered a company, Gardein, that has the best soy chicken. After sampling dozens of meatless beef, chicken, veal, Gardein does the best job of offering up the best tasting substitutes. Nevertheless, I always wonder how each of my experiments will turn out. We have endured many flops, but this recipe turned out very well; at least, we loved it.

 

We started with a favorite icy cold sauvignon blanc, Te Koko. Then a new recipe for a salad made with edamame beans, tomatoes, garlic, basil, corn kernels; good but not yet ready to share. Then we had the soy chicken with sherry sauce and saffron rice. It was an immediate hit and we finished the whole thing. We both recommend this recipe, highly. If you don’t feel like soy chicken, simply make boneless chicken fillets your own way, and use the sherry sauce in this recipe. For dessert, luscious fresh fruit pieces of

strawberries and sliced mango.

 

This weekend we saw a play by Rajiv Joseph, Guards at the Taj. We’ve seen two other plays by this playwright and this is by far the best of the three. This play had overtones of Waiting For Godot and some of the writings of Franz Kafka. When you couple Beckett and Kafka with shades of Indian culture and whimsy, you get a highly imaginative theater experience. It’s showing now at one of our theater clubs, the Atlantic Theater Company inChelsea.

 

 

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Icy cold, Te Koko, from New Zealand. ©Joyce Hays, Target Health Inc.

 

From Our Table to Yours!

 

Bon Appetit!