Response to New York City Economic Development Corporation (NYCEDC) Blog That Featured Target Health

 

Last week the NYCEDC featured Target Health in its Blog. The headline was “Made in NYC: Target Health (http://www.nycedc.com/blog-entry/made-nyc-target-health). One highlight in the piece was that Target Health supports the arts in NYC, including the Metropolitan Opera.  Here are some of the many responses we had on this.

 

1. From Europe: Did you go for Werther with Jonas Kaufman at the MET?

 

2. From Australia: Main reason for writing – was in NYC last week and friends secured a fabulous box at the Met for a brilliant production of Madama Butterfly. Noted in the program that Target Health is a sponsor and just want to thank you guys for supporting a great cause.

 

Here’s Jonas Kaufman singing “Pourquoi Me Reveiller?” (“Why Awaken Me, Oh Breath of Spring) from Werther: https://www.youtube.com/watch?v=3FiWzeBNIWU

 

Here’s Rene Fleming singing from Madama Butterfly,“Un Bel di Vedremo“, (“One Fine Day“):https://www.youtube.com/watch?v=66iKh4KKfME

 

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Springtime in Central Park © Target Health Inc.

 

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

 

Daylight Saving Impacts Timing of Heart Attacks

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Credit: © Les Cunliffe

 

Still feeling the residual effects of springing ahead for daylight saving time? The hour of sleep lost — or gained — may play a bigger, perhaps more dangerous role in our body’s natural rhythm than we think. It seems moving the 1) ___ forward or backward may alter the timing of when heart attacks occur in the week following these time changes, according to research presented at the American College of Cardiology’s 63rd Annual Scientific Session.

 

Data from the largest study of its kind in the U.S. reveal a 25% jump in the number of heart attacks occurring the Monday after we “spring forward“ compared to other Mondays during the year — a trend that remained even after accounting for seasonal variations in these events. But the study showed the opposite effect is also true. Researchers found a 21% drop in the number of heart attacks on the Tuesday after returning to standard time in the fall when we gain an 2) ___ back.

 

“What’s interesting is that the total number of heart attacks didn’t change the week after daylight saving time,“ said Amneet Sandhu, M.D., cardiology fellow, University of Colorado in Denver, and lead investigator of the study. “But these events were much more frequent the Monday after the spring time change and then tapered off over the other days of the week. It may mean that people who are already vulnerable to 3) ___ disease may be at greater risk right after sudden time changes.“

 

Heart attacks historically occur most often on Monday mornings. Sandhu explains that in looking at other “normal“ Mondays, there is some variation in events, but it is not significant. However, when he and his team compared admissions from a database of non-federal Michigan hospitals the Monday before the start of daylight saving time and the Monday immediately after for four consecutive years, they found a consistent 34% increase in heart 4) ___ from one week to the next e.g. 93 heart attacks the Monday before compared to 125 the week after the start of daylight saving time for the duration of the study.

 

Although researchers cannot say what might be driving the shift in heart attack timing after the start of daylight saving time, they have a theory. “Perhaps the reason we see more heart attacks on 5) ___ mornings is a combination of factors, including the stress of starting a new work week and inherent changes in our sleep-wake cycle,“ Sandhu said. “With daylight saving time, all of this is compounded by one less hour of sleep. Whatever the reason, he said, the findings may indicate a need to better staff hospitals the Monday after setting our clocks forward.

 

“If we can identify days when there may be surges in heart attacks, we can be ready to better care for our 6) ___,“ said Sandhu. Gaining an hour in the fall may have the opposite effect, though authors don’t know why there were fewer heart attacks on Tuesday rather than Monday. Researchers used Michigan’s BMC2 database, which collects data from all non-federal hospitals across the state, to identify admissions for heart attacks requiring percutaneous coronary intervention from Jan. 1, 2010 through Sept. 15, 2013. A total of 42,060 hospital admissions occurring over 1,354 days were included in the analysis. Total daily admissions were adjusted for seasonal and weekday variation, as the rate of heart attacks peaks in the winter and is lowest in the 7) ___ and is also greater on Mondays and lower over the weekend.

 

The hospitals included in this study admit an average of 32 patients having a heart attack on any givenMonday. But on the Monday immediately after springing ahead there were on average an additional eight heart attacks. There was no difference in the total weekly number of percutaneous coronary interventions performed for either the fall or spring time changes compared to the weeks before and after the 8) ___change.

 

This study comes amid ongoing debate about whether daylight saving time is actually needed anymore. Widely implemented during World War I, it was primarily adopted to save 9) ___. But some experts question whether it really saves energy and if it has negative health effects beyond just leaving us feeling groggy and out of sorts. “We go through 10) ___ saving time periods twice yearly,“ Sandhu said. “We may want to look more closely at whether the shift in the timing of heart attacks seen after daylight saving time leads to any negative health outcomes.“

 

There are limitations to the study. For example, it was restricted to one state and heart attacks necessitating percutaneous coronary intervention, therefore excluding patients who died prior to hospital admission or intervention. Sandhu said it would be interesting to compare these findings against heart attack trends in Hawaii and 11) ___, which do not have daylight saving time. Future research is also needed to better understand the role of our circadian rhythms on heart health.

 

“We know from previous studies that a lack of sleep can trigger heart attacks, but we don’t have a good understanding of why people are so sensitive to changes in sleep-wake cycles. Our study suggests that sudden, even small changes in 12) ___ could have detrimental effects,“ he said. This study was simultaneously published online in Open Heart at the time of presentation.

Story: American College of Cardiology. “Daylight saving impacts timing of heart attacks.“ ScienceDaily.com; ScienceDaily.com

 

ANSWERS: 1)clock; 2) hour; 3) heart; 4) attacks; 5) Monday; 6) patients; 7) summer; 8) time; 9) energy; 10) daylight; 11) Arizona; 12) sleep

Hardened Arteries Found in Ancient Mummies. Did Diet Do It?

 

Studies of mummies show that the ancients got heart disease too.

 

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There’s a team of cardiologists called The Horus Project who, largely as a hobby, have been taking CAT scans of the hearts of the mummified remains of ancient people, using borrowed machines from hospitals and, in one case, a mobile imaging unit run on gasoline. They started with Egyptian mummies published the first results four years ago. They’ve since expanded their effort to include mummies from other ancient cultures. Unlike the ancient Egyptian mummies, which went through a complicated preservation process to dry out their flesh, most of these corpses were preserved simply by putting them somewhere where moisture was scant.

 

The team found probable or definite atherosclerosis, the artery disease that leads to heart attacks and strokes, in 47 of 137 (34%) mummies. Of the 47 mummies, 38% were from ancient Egypt, 25% from ancient Peru, and 40% were ancient Puebloans.

 

Perhaps most important, though were five mummified Unangan hunter-gatherers from the Aleutian Islands in the North Pacific ocean. Sixty percent of them – that’s three mummies – had atherosclerosis. One woman had calcified deposits in her coronary arteries that looked strikingly like someone with serious heart disease showing up in the hospital today. That means data from 4,000 years of preserved corpses shows that serious cardiovascular disease, the leading killer of people in the Western world, has been with us since before we started planting crops.

 

“It tells us that we don’t know as much as we thought we knew,“ says Samuel Wann, one of the lead investigators and a cardiologist at Columbia St. Mary’s Community Physicians in Milwaukee. “We thought we understood the risk factors for heart disease. I’m still surprised that our predecessors 4,000 years ago still had atherosclerosis.“

 

The research was published about a year ago, in The Lancet, a medical journal, and was presented at the annual meeting of the American College of Cardiology last year, in San Francisco.

 

The Paleolithic diet, the researchers say, was probably better than what we eat today, but it was still not 100% protective. Probably nothing is. “We’re not destined to die of heart disease. But we’re all at risk – vegetarians, vegans, hunter-gatherers,“ says Gregory S. Thomas MD, the lead author of the study. “It behooves us to do what’s known to be helpful: exercise, reducing blood pressure. But we’re all at risk. We shouldn’t think we’re protected by any one of these approaches. When someone has a heart attack they’ll often blame themselves. But I can reassure them that it’s a disease that the American Indians had living on the Colorado plains before the invention of the bow and arrow.“

 

There’s only so much that mummies can tell us, and modern hunter gatherers certainly have relatively low rates of heart attack and stroke. But it’s probably a mistake to construct our thinking about how we should eat and exercise through arguments about what people did before the agricultural revolution. Better to use hard data – like the recent study that showed a Mediterranean diet did better at preventing heart disease than what would otherwise be considered a relatively healthy one. And no matter what we eat, having arteries that clog up as we age is part of being human. We just need to slow the process as much as possible.

 

Gene Linked To Excess Male Hormones in Female Infertility Disorder

 

Polycystic ovary syndrome (PCOS) is a major cause of female infertility and is associated with other serious health problems. In addition to high levels of androgens, symptoms of PCOS include irregular menstrual cycles, infertility, and insulin resistance (difficulty using insulin.) The condition affects approximately 5-7% of women of reproductive age and increases the risk for heart disease, high blood pressure and type 2 diabetes. In PCOS, higher levels of androgens may also cause excess facial and body hair, as well as severe acne. PCOS appears to run in families, but no genes have been definitively linked to the disorder. It is hypothesized that PCOS probably results from the interaction of several genes, and perhaps to interactions between certain genes and the environment.

 

According to a study published online in the Proceedings of the National Academy of Sciences (15 April 2014), a variant in a gene active in cells of the ovary may lead to the overproduction of androgens — male hormones similar to testosterone — occurring in women with PCOS. The discovery may provide information to develop a test to diagnose women at risk for PCOS and also for the development of a treatment for the condition.

 

The authors narrowed their search to the gene called DENND1A, which contains the information needed to make a protein. This protein is made in theca cells, which line the inner surface of ovarian follicles, the temporary, sphere-like structures which ultimately break open and give rise to the egg each month. In women with PCOS, the follicles fail to mature normally. Instead of rupturing during the monthly cycle to release the egg, the follicles accumulate and form numerous cyst-like structures. Previous studies have shown that in PCOS, theca cells are the source of the high levels of androgens found in women with the condition.

 

Previously, researchers conducting genome-wide scans (searches of all of a person’s genes) of women in China identified several candidate genes in locations on chromosomes that were associated with the disease. One of these locations harbored the gene for DENND1A. Genome-wide scans of people of Asian and European descent also confirmed the gene’s association with PCOS.

 

For the current study, theca cells were grown in vitro from women with PCOS. Compared to theca cells from women without PCOS, theca cells taken from women with PCOS produced high levels of a variant form of DENND1A, DENNDA1A.V2. V2 indicates variant 2, to distinguish it from the more commonly seen form of the protein, known as DENND1A.V1. The authors next conducted a battery of experiments on the cells to determine what role DENND1A.V2 might play in PCOS. They began by manipulating the theca cells from women who did not have PCOS to produce high levels of DENND1A.V2. The theca cells, which previously functioned normally, began producing elevated levels of androgens. Similarly, when the function of DENND1A.V2 was blocked in theca cells from women with PCOS, androgen levels in those cells dropped sharply, as did to the activity of other genes that make androgen and the levels of messenger RNA needed to produce androgens. The study authors noted that DENND1A.V2 is also found in other cells that make androgens, including cells in the testes, as well as in a type of cancer cell occurring in the adrenal glands. Click on the link for an illustration of a normal and a polycystic ovary.

 

The cells from women with PCOS also contained higher levels of the messenger RNA for DENND1A.V2. Messenger RNA converts the information contained within DNA into a protein. In addition, it was found that the messenger RNA for DENND1A.V2 protein was higher in urine samples from PCOS patients than in urine samples of women in the control group.

 

Eavesdropping on Brain Cell Chatter

 

Everything we do — all of our movements, thoughts and feelings – are the result of neurons talking with one another, and recent studies have suggested that some of the conversations might not be all that private. Brain cells known as astrocytes may be listening in on, or even participating in, some of those discussions. But a new mouse study suggests that astrocytes might only be tuning in part of the time — specifically, when the neurons get really excited about something. This research, published online in Neuron (16 April 2014), was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

 

For a long time, researchers thought that the star-shaped astrocytes (the name comes from the Greek word for star) were simply support cells for the neurons. It turns out that these cells have a number of important jobs, including providing nutrients and signaling molecules to neurons, regulating blood flow, and removing brain chemicals called neurotransmitters from the synapse. The synapse is the point of information transfer between two neurons. At this connection point, neurotransmitters are released from one neuron to affect the electrical properties of the other. Long arms of astrocytes are located next to synapses, where they can keep tabs on the conversations going on between neurons.

 

In recent years, it has been shown that astrocytes may also play a role in neuronal communication. When neurons release neurotransmitters, levels of calcium change within astrocytes. Calcium is critical for many processes, including release of molecules from the cell, and activation of a host of proteins within the cell. The role of this astrocytic calcium signaling for brain function remains a mystery.

 

In the present study, the researchers wanted to know when astrocytes responded to neuron activity with changes in their internal calcium levels. Using calcium indicator dyes, the researchers were able to image, for the first time, changes in calcium levels in the entire astrocyte. Previously, it was only possible to look at certain areas of the cell at one time, which provided an incomplete picture of what was happening. One of the most important outcomes of this work was in the methods that were used. The ability to use calcium indicators shows is that it is possible to image calcium throughout the entire astrocyte.

 

For the study, the authors focused on the mossy fiber pathway, which connects two areas of the hippocampus, the structure involved in learning and memory. This pathway has a unique architecture and although it has been very well studied, the role of astrocytes in this circuit has not been previously explored. As a result, this study provides one of the first really detailed understandings of astrocytes within this particular circuit.

 

The team activated neurons (getting them to release neurotransmitter by a variety of techniques) and then looked for a response in the neighboring astrocyte. As calcium levels rose, the astrocyte would light up quickly. It was discovered that two neurotransmitters, glutamate and GABA, triggered the astrocytes to release calcium from their internal stores. Importantly, the authors discovered that calcium levels increased through the entire astrocyte only if there was a large burst of neurotransmitter being released. It was found that astrocytes in the mossy fiber pathway do not listen to the constant, millisecond by millisecond synaptic chatter that neurons engage in. Instead, they listen when neurons get excessively excited during bursts of activation.

 

These findings suggest that astrocytes in the mossy fiber system may act as a switch that reacts to large amounts of neuronal activity by raising their levels of calcium. These calcium increases occur over multiple seconds, a relatively long time period compared to that seen in neurons. The spatial extent of the astrocyte calcium increases was also relatively large in comparison to the size of the synapse.

 

The current results in the mossy fiber system differ from those that others have described in other brain regions. This raises the intriguing possibility that astrocytes are not all the same and may serve various roles throughout the brain. According to the NIH, it would be really interesting and important to find that astrocytes function differently in different areas of the brain, in a circuit-specific manner and this study gives a hint that this might be true.

 

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

 

FDA Approves Ragwitek for Short Ragweed Pollen Allergies

 

Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by: avoiding the allergen; medications to relieve symptoms; or with allergy shots.

 

The FDA has approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves.

 

Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home. According to FDA, the approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease.

 

The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26% reduction in symptoms and the need for medications compared to those who received a placebo.

 

The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient. Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom.

 

Broccoli Soup

 

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Broccoli soup with fresh lemon and sprinkled with parmesan cheese
©Joyce Hays, Target Health Inc.

 

Ingredients

1.  1 pound broccoli (about 6 cups, chopped)
2.  1 (1 quart) chicken broth
3.  1 fresh garlic clove, juiced right into pot
4.  3/4 teaspoon salt
5.  Pinch black or white pepper
6.  1 lemon (optional)
7.  2 Tablespoons grated Parmesan cheese

 

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Use beautiful fresh broccoli and not frozen ©Joyce Hays, Target Health Inc.

 

Directions

1.  Wash and trim the broccoli, then coarsely chop.

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If you don’t have chicken stock, use this broth. It’s the lowest calorie broth around (5 calories per serving), plus it’s low sodium and fat free. I get this at Fresh Direct.

 

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One quart of low sodium, fat-free chicken stock or broth

 

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2.  Heat the chicken broth in a large saucepan over medium heat to simmering. Add the chopped broccoli and one garlic clove juiced right into the pot and simmer, covered, until tender, about 15 to 17 minutes.

 

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An immersion blender is about 17“ long and comes apart in two pieces (for easy storage). I’m going to put this right into the pot of chicken broth and broccoli and blend, until the mixture is the consistency I want. Kitchen tools like this, and a food processer, enable you to make any kind of soup quickly and easily. This came from Wm-Sonoma. Also available on Amazon. (can you see one of our cats, Dodi, on the left, supervising this cooking initiative)?

3.  Puree the mixture with an immersion blender right in the saucepan, or in a food processor in one or two batches
4.  Transferring each batch to a clean saucepan or warm tureen.
5.  Stir in the salt and pepper (optional, to your taste)
6.  Ladle into serving bowls and finish with a squeeze of lemon juice and a sprinkle of Parmesan, if desired.

 

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Broccoli soup without cheese; however, we like it better with fresh lemon and parmesan.

©Joyce Hays, Target Health Inc.

 

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Something about a little fresh lemon juice, sharpens

up the flavor of the broccoli soup.

 

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So here we are, another Sunday evening of a beautiful spring weekend here in Manhattan. We’ve been semi-fasting two days a week, and this is having a psychological affect on us. On the five days to eat what we want, we don’t. We find that we’re content to cut calories on other days, as well. Anyway, we began with icy glasses of Orvieto and warm flat bread with hummus. Mmmmm

 

There’s still a chill in the air here, so hot soup was called for. That’s where the homemade broccoli soup comes in. Steaming bowls of this soup was the perfect meal for today. We tried it first plain and then we squeezed fresh lemon into it, sprinkling freshly grated parmesan on top. Plain was a little too bland, but with the added ingredients, this soup became a hit. The recipe is quick and easy. We recommend it highly. We were full after hummus and the soup, so had fresh fruit for dessert.

 

Happy Spring to all of our friends and colleagues around the world!

 

Bon Appetit !