FDA Requests Removal of Opana ER for Risks Related to Abuse

 

The FDA has requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

 

The FDA’s decision is based on a review of all available post-marketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.

 

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.

 

The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product. The FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.

 

Filed Under News, Regulatory | Leave a Comment 

Practically Perfect Veggie Burger

After much trial and error, I want to share with you, a delicious veggie burger recipe.  By adding one fresh beet, health, flavor and color are well dispensed.  Tempeh is another must; it adds wonderful texture, as well as flavor.  Never have burgers disappeared so fast over one weekend.  These burgers were served over tri-color farfalla with a mushroom gravy.  What looks like mashed potatoes, to the right, is actually an easy recipe that I concocted about two years ago: steamed cauliflower mashed with chopped scallions and truffle oil.  ©Joyce Hays, Target Health Inc.

 

Ingredients

1 medium beet or two small beets: wash, peel, dice or slice

4 ounces extra-firm tofu, drained

1/2 cup Coconut oil or extra virgin olive oil

1/2 pound cremini, button or baby bella mushrooms, trimmed and sliced

Pinch kosher salt (or to your taste)

Pinch black pepper (or to your taste)

2 Pinches chili flakes (or to your taste)

1 (15-ounce) can kidney beans, drained

3/4 cup toasted (unsalted) cashews

1/3 cup panko

2 ounces Queso blanco cheese, crumbled or grated (about 1/2 cup)

2 large eggs

2 Tablespoons Kraft mayonnaise

2 scallions, sliced

4 garlic cloves, finely chopped, plus 1 more squeezed

3/4 teaspoon sweet smoked paprika

4 ounces tempeh, crumbled

1/2 cup cooked brown rice

 

Directions

1. Heat oven to 425 degrees.

2.  In a medium to large bowl, put the oil, salt, pepper, chili flakes, 1 squeezed garlic clove and mix together.  Set aside

3. Slice tofu into 1/4-inch-thick slabs and pat dry with paper towel. Then put into the bowl with oil and seasoning.

4. Line 2 rimmed baking sheets with parchment and with a slotted spoon, remove the tofu and place on one side of the baking sheet.

5. Clean mushrooms, then slice them and put into the bowl with oil.

6.With a slotted spoon, remove mushrooms and put them on the other half of the baking sheet.

 

Going into the oven.  ©Joyce Hays, Target Health Inc.

 

7. Toss the beans in the bowl of oil and seasonings, then with slotted spoon, remove the beans and put on one side of the second rimmed baking sheet.

8. Put the sliced or diced beet into the bowl of seasoned oil, then remove the beets and put on the other half of the rimmed baking sheet.

 

Going into the oven.  ©Joyce Hays, Target Health Inc.

 

9. Put both baking sheets into the oven. Roast the beans and beets until the beans start splitting. By this time, the beets should be tender. This should take about 15 minutes. Roast  the baking sheet with mushrooms and tofu until the tofu is golden.  This should take about 25 minutes. Remove sheets from oven: 1 after 15 minutes, the other after 25 minutes; then let everything cool.

10. Meanwhile, put nuts in food processor.  Pulse until coarsely ground. Next add the beans and beets and pulse.  Next the mushrooms and tofu and pulse.  At any time, when the food processor is filled, and contents have been pulsed, take a spatula and scrape all contents into a large mixing bowl.

11. Next, add to food processor the panko, cheese, eggs, mayonnaise, scallion, 4 garlic cloves, paprika, chili flakes. Pulse until ingredients are just combined. Pulse in the tempeh and rice but do not over-process. You want small chunks, not a smooth mixture. You do NOT want a smooth paste, because you want the burgers to have texture to chew down on.

 

One of many batches in food processor.  ©Joyce Hays, Target Health Inc.

 

Another batch getting pulsed.  ©Joyce Hays, Target Health Inc.

 

This recipe doesn’t work without a food processor.  ©Joyce Hays, Target Health Inc.

 

Nearly done.  ©Joyce Hays, Target Health Inc.

 

12. After everything has been pulsed, scrape it all into that large mixing bowl and chill in fridge, overnight.  The burgers will cook better the next day, if you have chilled them overnight.

 

Be sure to mix everything together very well.  Do not use electric beaters for this step of the recipe.  ©Joyce Hays, Target Health Inc.

 

13. When you are ready to make the burgers, divide mixture into 6 equal portions which yields large burgers.  I’ve made these many times and now prefer a slightly smaller size.  You decide the size you want and form each portion into a patty about 1 inch thick. Return to the fridge until just before grilling. They cook better when they start out cold.  I have never baked the burgers, but am betting they would be very good; also tasty, if grilled.

14. Cook the burgers in a skillet, over a high flame, until they are charred on both sides.  Then lower the flame and cook for about 5 to 7 minutes, over low heat.  You want these burgers to be crispy on the outside.

 

Before chilling overnight in fridge, the mixture should look like this, or close to it.  ©Joyce Hays, Target Health Inc.

 

Cooking the burgers – you want them to be crispy on the outside.  ©Joyce Hays, Target Health Inc.

 

15 That’s it!  Use your imagination and serve these veggie burgers any way you want.  In a bun or without.  With ketchup or with your own sauce.  For one meal, I made a mushroom gravy.  On another day, I made a yogurt garlic sauce, and served the burgers with fresh sliced tomatoes and avocados.  I haven’t tried a mustard sauce, but am thinking about doing that.

 

Out of the pan and onto the table.  ©Joyce Hays, Target Health Inc.

 

You could add a bun, onion rings, ketchup, etc.  Your choice.  ©Joyce Hays, Target Health Inc.

 

A delicious dinner: burgers, farfalle, mushroom gravy. mashed cauliflower with truffle oil and a crunchy garden salad.  Not to mention a delicious Shiraz.  ©Joyce Hays, Target Health Inc.

 

Definitely worth snacking on.  ©Joyce Hays, Target Health Inc.

 

We’re drinking another Henschke (Australia) Shiraz, which went well with the burgers.  ©Joyce Hays, Target Health Inc.

 

 

From Our Table to Yours

Bon Appetit!

 

Filed Under News, Target Healthy Eating (recipes) | Leave a Comment 

Date:
June 8, 2017

Source:
Cell Press

Summary:
It’s well known that young babies are more interested in faces than other objects. Now, researchers have the first evidence that this preference for faces develops in the womb. By projecting light through the uterine wall of pregnant mothers, they found that fetuses at 34 weeks gestation will turn their heads to look at face-like images over other shapes.

 

This is a 4-D ultrasound of a fetus tracking the stimulus.
Credit: Kirsty Dunn & Vincent Reid

 

 

It’s well known that young babies are more interested in faces than other objects. Now, researchers reporting in Current Biology on June 8 have the first evidence that this preference for faces develops in the womb. By projecting light through the uterine wall of pregnant mothers, they found that fetuses at 34 weeks gestation will turn their heads to look at face-like images over other shapes.

The findings are the first to show that it’s possible to explore visual perception and cognition in babies before they are born.

“We have shown the fetus can distinguish between different shapes, preferring to track face-like over non-face-like shapes,” says Vincent Reid of Lancaster University in the United Kingdom. “This preference has been recognized in babies for many decades, but until now exploring fetal vision has not been attempted.”

Reid said that technical barriers had prevented earlier studies of fetal vision and behavior in the womb. But he and his colleagues realized those challenges could be overcome. The new work was made possible thanks to high-quality 4D ultrasound. Scientists had also realized that it’s possible for light to penetrate through human tissue and into the uterus, where a fetus could see it.

The researchers tested the responses of 39 fetuses to face-like patterns of light presented to them in both upright and inverted orientations. The projected light moved across their field of vision while researchers watched the fetuses’ reactions using 4D ultrasound. Those ultrasound movies showed that the developing babies turned their heads to look more often at face-like stimuli that were upright than those that were presented to them upside down.

“There was the possibility that the fetus would find any shape interesting due to the novelty of the stimulus,” Reid says. “If this was the case, we would have seen no difference in how they responded to the upright and upside-down versions of the stimuli. But it turned out that they responded in a way that was very similar to infants.”

The findings suggest that babies’ preference for faces begins in the womb. There is no learning or experience after birth required.

The findings also confirm that fetuses have enough light to see and have visual experiences in the womb. However, Reid says that he discourages pregnant mothers from shining bright lights into their bellies.

The researchers are now working to improve the light source used in the current study in preparation for further exploration of fetal perception and cognition in the womb. For example, they say, newborns can discriminate numbers and quantities. They want to find out whether a fetus in the third trimester also has that capacity.


Story Source:

Materials provided by Cell Press. Note: Content may be edited for style and length.


Journal Reference:

  1. Reid et al. The Human Fetus Preferentially Engages with Face-like Visual Stimuli. Current Biology, 2017 DOI: 10.1016/j.cub.2017.05.044

 

Source: Cell Press. “Developing fetuses react to face-like shapes from the womb.” ScienceDaily. ScienceDaily, 8 June 2017. <www.sciencedaily.com/releases/2017/06/170608123655.htm>.

Filed Under News | Leave a Comment 

Date:
June 7, 2017

Source:
University of Washington

Summary:
For the first time, scientists have discovered magnetism in the 2-D world of monolayers, or materials that are formed by a single atomic layer. The findings demonstrate that magnetic properties can exist even in the 2-D realm — opening a world of potential applications.

 

This is a top-view depiction of a single CrI3 layer. Grey balls represent Cr atoms, and purple balls are I atoms.
Credit: Efren Navarro-Moratalla

 

 

Magnetic materials form the basis of technologies that play increasingly pivotal roles in our lives today, including sensing and hard-disk data storage. But as our innovative dreams conjure wishes for ever-smaller and faster devices, researchers are seeking new magnetic materials that are more compact, more efficient and can be controlled using precise, reliable methods.

 

A team led by the University of Washington and the Massachusetts Institute of Technology has for the first time discovered magnetism in the 2-D world of monolayers, or materials that are formed by a single atomic layer. The findings, published June 8 in the journal Nature, demonstrate that magnetic properties can exist even in the 2-D realm — opening a world of potential applications.

“What we have discovered here is an isolated 2-D material with intrinsic magnetism, and the magnetism in the system is highly robust,” said Xiaodong Xu, a UW professor of physics and of materials science and engineering, and member of the UW’s Clean Energy Institute. “We envision that new information technologies may emerge based on these new 2-D magnets.”

Xu and MIT physics professor Pablo Jarillo-Herrero led the international team of scientists who proved that the material — chromium triiodide, or CrI3 — has magnetic properties in its monolayer form.

Other groups, including co-author Michael McGuire at the Oak Ridge National Laboratory, had previously shown that CrI3 — in its multilayered, 3-D, bulk crystal form — is ferromagnetic. In ferromagnetic materials, the “spins” of constituent electrons, analogous to tiny, subatomic magnets, align in the same direction even without an external magnetic field.

But no 3-D magnetic substance had previously retained its magnetic properties when thinned down to a single atomic sheet. In fact, monolayer materials can demonstrate unique properties not seen in their multilayered, 3-D forms.

“You simply cannot accurately predict what the electric, magnetic, physical or chemical properties of a 2-D monolayer crystal will be based on the behavior of its 3-D bulk counterpart,” said co-lead author and UW doctoral student Bevin Huang.

Atoms within monolayer materials are considered “functionally” two-dimensional because the electrons can only travel within the atomic sheet, like pieces on a chessboard.

To discover the properties of CrI3 in its 2-D form, the team used Scotch tape to shave a monolayer of CrI3 off the larger, 3-D crystal form.

“Using Scotch tape to exfoliate a monolayer from its 3-D bulk crystal is surprisingly effective,” said co-lead author and UW doctoral student Genevieve Clark. “This simple, low-cost technique was first used to obtain graphene, the 2-D form of graphite, and has been used successfully since then with other materials.”

In ferromagnetic materials, the aligned spins of electrons leave a telltale signature when a beam of polarized light is reflected off the material’s surface. The researchers detected this signature in CrI3 using a special type of microscopy. It is the first definitive sign of intrinsic ferromagnetism in an isolated monolayer.

Surprisingly, in CrI3 flakes that are two layers thick, the optical signature disappeared. This indicates that the electron spins are oppositely aligned to one another, a term known as anti-ferromagnetic ordering.

Ferromagnetism returned in three-layer CrI3. The scientists will need to conduct further studies to understand why CrI3 displayed these remarkable layer-dependent magnetic phases. But to Xu, these are just some of the truly unique properties revealed by combining monolayers.

“2-D monolayers alone offer exciting opportunities to study the drastic and precise electrical control of magnetic properties, which has been a challenge to realize using their 3-D bulk crystals,” said Xu. “But an even greater opportunity can arise when you stack monolayers with different physical properties together. There, you can get even more exotic phenomena not seen in the monolayer alone or in the 3-D bulk crystal.”

Much of Xu’s research centers on creating heterostructures, which are stacks of two different ultrathin materials. At the interface between the two materials, his team searches for new physical phenomena or new functions to allow potential applications in computing and information technologies.

In a related advance, Xu’s research group, UW electrical engineering and physics professor Kai-Mei Fu led a team of colleagues published a paper May 31 in Science Advances showing that an ultrathin form of CrI3, when stacked with a monolayer of tungsten diselenide, creates a ultraclean “heterostructure” interface with unique and unexpected photonic and magnetic properties.

“Heterostructures hold the greatest promise of realizing new applications in computing, database storage, communications and other applications we cannot even fathom yet,” said Xu.

Xu and his team would next like to investigate the magnetic properties unique to 2-D magnets and heterostructures that contain a CrI3 monolayer or bilayer.


Story Source:

Materials provided by University of Washington. Note: Content may be edited for style and length.


Journal Reference:

  1. Bevin Huang, Genevieve Clark, Efrén Navarro-Moratalla, Dahlia R. Klein, Ran Cheng, Kyle L. Seyler, Ding Zhong, Emma Schmidgall, Michael A. McGuire, David H. Cobden, Wang Yao, Di Xiao, Pablo Jarillo-Herrero, Xiaodong Xu. Layer-dependent ferromagnetism in a van der Waals crystal down to the monolayer limit. Nature, 2017; 546 (7657): 270 DOI: 10.1038/nature22391

 

Source: University of Washington. “Scientists discover a 2-D magnet.” ScienceDaily. ScienceDaily, 7 June 2017. <www.sciencedaily.com/releases/2017/06/170607133239.htm>.

Filed Under News | Leave a Comment 

Date:
June 6, 2017

Source:
Michigan State University

Summary:
The power of friendship gets stronger with age and may even be more important than family relationships, indicates new research.

 

“Friendships become even more important as we age,” said William Chopik, a Michigan State University assistant professor of psychology whose study suggests friendships may actually be more important than family relationships.
Credit: © pablocalvog / Fotolia

 

 

The power of friendship gets stronger with age and may even be more important than family relationships, indicates new research by a Michigan State University scholar.

In a pair of studies involving nearly 280,000 people, William Chopik found that friendships become increasingly important to one’s happiness and health across the lifespan. Not only that, but in older adults, friendships are actually a stronger predictor of health and happiness than relationships with family members.

“Friendships become even more important as we age,” said Chopik, assistant professor of psychology. “Keeping a few really good friends around can make a world of difference for our health and well-being. So it’s smart to invest in the friendships that make you happiest.”

For the first study, Chopik analyzed survey information about relationships and self-rated health and happiness from 271,053 participants of all ages from nearly 100 countries. The second study looked at data from a separate survey about relationship support/strain and chronic illness from 7,481 older adults in the United States.

According to the first study, both family and friend relationships were linked to better health and happiness overall, but only friendships became a stronger predictor of health and happiness at advanced ages.

The second study also showed that friendships were very influential – when friends were the source of strain, participants reported more chronic illnesses; when friends were the source of support, participants were happier.

Chopik said that may be because of the optional nature of relationships – that over time, we keep the friends we like and make us feel good and discard the rest. Friends also can provide a source of support for people who don’t have spouses or for those who don’t lean on family in times of need. Friends can also help prevent loneliness in older adults who may experience bereavement and often rediscover their social lives after they retire.

Family relationships are often enjoyable too, Chopik said, but sometimes they involve serious, negative and monotonous interactions.

“There are now a few studies starting to show just how important friendships can be for older adults. Summaries of these studies show that friendships predict day-to-day happiness more and ultimately how long we’ll live, more so than spousal and family relationships,” he said.

Friendships often take a “back seat” in relationships research, Chopik added, which is strange, especially considering that they might be more influential for our happiness and health than other relationships.

“Friendships help us stave off loneliness but are often harder to maintain across the lifespan,” he said. “If a friendship has survived the test of time, you know it must be a good one – a person you turn to for help and advice often and a person you wanted in your life.”

The study appears online in the journal Personal Relationships.


Story Source:

Materials provided by Michigan State University. Note: Content may be edited for style and length.


Journal Reference:

  1. WILLIAM J. CHOPIK. Associations among relational values, support, health, and well-being across the adult lifespan. Personal Relationships, 2017; 24 (2): 408 DOI: 10.1111/pere.12187

 

Source: Michigan State University. “Are friends better for us than family?.” ScienceDaily. ScienceDaily, 6 June 2017. <www.sciencedaily.com/releases/2017/06/170606090936.htm>.

Filed Under News | Leave a Comment 

Date:
June 5, 2017

Source:
Polytechnique Montréal

Summary:
Scientists have known for centuries that light is composed of waves. The fact that light can also behave as a liquid, rippling and spiraling around obstacles like the current of a river, is a much more recent finding that is still a subject of active research.

 

The flow of polaritons encounters an obstacle in the supersonic (top) and superfluid (bottom) regime.
Credit: Polytechnique Montreal

 

 

Scientists have known for centuries that light is composed of waves. The fact that light can also behave as a liquid, rippling and spiraling around obstacles like the current of a river, is a much more recent finding that is still a subject of active research. The “liquid” properties of light emerge under special circumstances, when the photons that form the light wave are able to interact with each other.

Researchers from CNR NANOTEC of Lecce in Italy, in collaboration with Polytechnique Montreal in Canada have shown that for light “dressed” with electrons, an even more dramatic effect occurs. Light become superfluid, showing frictionless flow when flowing across an obstacle and reconnecting behind it without any ripples.

Daniele Sanvitto, leading the experimental research group that observed this phenomenon, states that “Superfluidity is an impressive effect, normally observed only at temperatures close to absolute zero (-273 degrees Celsius), such as in liquid Helium and ultracold atomic gasses. The extraordinary observation in our work is that we have demonstrated that superfluidity can also occur at room-temperature, under ambient conditions, using light-matter particles called polaritons.”

“Superfluidity, which allows a fluid in the absence of viscosity to literally leak out of its container,” adds Sanvitto, “is linked to the ability of all the particles to condense in a state called a Bose-Einstein condensate, also known as the fifth state of matter, in which particles behave like a single macroscopic wave, oscillating all at the same frequency.

Something similar happens, for example, in superconductors: electrons, in pairs, condense, giving rise to superfluids or super-currents able to conduct electricity without losses.”

These experiments have shown that it is possible to obtain superfluidity at room-temperature, whereas until now this property was achievable only at temperatures close to absolute zero. This could allow for its use in future photonic devices.

Stéphane Kéna-Cohen, the coordinator of the Montreal team, states: “To achieve superfluidity at room temperature, we sandwiched an ultrathin film of organic molecules between two highly reflective mirrors. Light interacts very strongly with the molecules as it bounces back and forth between the mirrors and this allowed us to form the hybrid light-matter fluid. In this way, we can combine the properties of photons such as their light effective mass and fast velocity, with strong interactions due to the electrons within the molecules. Under normal conditions, a fluid ripples and whirls around anything that interferes with its flow. In a superfluid, this turbulence is suppressed around obstacles, causing the flow to continue on its way unaltered.”

“The fact that such an effect is observed under ambient conditions,” says the research team, “can spark an enormous amount of future work, not only to study fundamental phenomena related to Bose-Einstein condensates with table-top experiments, but also to conceive and design future photonic superfluid-based devices where losses are completely suppressed and new unexpected phenomena can be exploited.”


Story Source:

Materials provided by Polytechnique Montréal. Note: Content may be edited for style and length.


Journal Reference:

  1. Giovanni Lerario, Antonio Fieramosca, Fábio Barachati, Dario Ballarini, Konstantinos S. Daskalakis, Lorenzo Dominici, Milena De Giorgi, Stefan A. Maier, Giuseppe Gigli, Stéphane Kéna-Cohen, Daniele Sanvitto. Room-temperature superfluidity in a polariton condensate. Nature Physics, 2017; DOI: 10.1038/nphys4147

 

Source: Polytechnique Montréal. “A stream of superfluid light.” ScienceDaily. ScienceDaily, 5 June 2017. <www.sciencedaily.com/releases/2017/06/170605121359.htm>.

Filed Under News | Leave a Comment 

DIA Annual Meeting Presentation on the Paperless Clinical Trial and its Impact on the Clinical Trial Enterprise

 

Target Health Inc. is pleased to announce that Dr. Jules T. Mitchel will be chairing a Content Hub presentation/conversation which will take place during DIA Annual Meeting in Chicago. Please join us at 4pm on Tuesday June 20, 2017 at the S400 Concourse. The topic is:

 

How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies

 

Co-presenting will be our colleagues and friends:

 

Jonathan Helfgott, MS, who is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University, and previously the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and;

 

Mitchell D. Efros MD FACS, CEO of Verified Clinical Trials

 

The following is an outline of the presentation and we look forward to seeing you there:

 

In the not too distant future, we as an industry will execute, manage and monitor clinical trials the same way we execute, manage and monitor banking transactions online, quickly and without the need to maintain paper records. However, as we bring new and innovative technology solutions to the market, we must assess and address the concerns of all of the stakeholders within the clinical trial enterprise. We need to assure patients, clinical research sites, pharmaceutical and device companies, as well as regulators, that there will be improved efficiencies, improved data quality and integrity, improved patient safety, reduced fraud and an overall better experience during the clinical trial process. Topics to be addressed include clinical site acceptance, regulatory concerns, software validation, risk assessments, change management within companies, and a comprehensive assessments of the risks and rewards.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Filed Under News, What's New | Leave a Comment 

Fat Cells Step in to Help Liver During Fasting

This UT Southwestern study determined that the metabolite uridine helps the body regulate glucose. This graphic depicts how the body’s fat cell-liver-uridine axis works to maintain energy balance.

Credit: UT Southwestern

 

How do mammals keep two biologically crucial metabolites in balance during times when they are feeding, sleeping, and fasting? In a study published in Science, UT Southwestern Medical Center it was reported that that fat 1) ___ is directly involved in maintaining tight regulation of glucose (2) ___ sugar), as well as uridine, a metabolite the body uses in a range of fundamental processes such as building RNA molecules, properly making proteins, and storing glucose as energy reserves. Their study may have implications for several diseases, including diabetes, cancer, and neurological disorders.

 

Metabolites are substances produced by a metabolic process, such as glucose generated in the metabolism of complex sugars and starches, or amino acids used in the biosynthesis of 3) ___. According to Dr. Philipp Scherer, senior author of the study and Director of UT Southwestern’s Touchstone Center for Diabetes Research “Like glucose, every cell in the body needs uridine to stay alive. Glucose is needed for 4) ___, particularly in the brain’s neurons. Uridine is a basic building block for a lot of things inside the cell.“ The study found that while the liver serves as the primary producer of this metabolite only in the fed state, in the fasted state, the body’s 5) ___ cells take over the production of uridine. Basically, this method of uridine production can be viewed as a division of labor. Researchers found that during fasting, the 6) ___ is busy producing glucose — and so fat cells take over the role of producing uridine for the bloodstream. These findings were replicated in human, mouse, and rat studies. Although uridine has many roles, this study is the first to report that fat cells produce plasma uridine during fasting and that a fat cell-liver-uridine axis regulates the 7) ___ energy balance. Study lead author Dr. Yingfeng Deng, Assistant Professor of Internal Medicine, found that blood uridine levels go up during fasting and down when feeding. During feeding, the liver reduces uridine levels by secreting uridine into bile, which is transferred to the gallbladder and then sent to the 8) ___, where it helps in the absorption of nutrients. According to the authors, the 9) ___ in the blood works through the hypothalamus in the brain to affect another tightly regulated system — body temperature, and that it appears that only uridine made by fat cells reduces body temperature.

 

Among the study’s other key findings:

 

– Blood uridine levels are elevated during fasting and drop rapidly during feeding. Excess uridine is released through the bile.

– The liver is the predominant uridine biosynthesis organ, contributing to blood uridine levels in the fed state.

– The fat cells dominate uridine biosynthesis and blood levels in the fasted state.

– The fasting-induced rise in uridine is linked to a drop in core body temperature driven by a reduction in the metabolic rate.

 

In dietary studies, tit was found that prolonged exposure to a high-fat diet blunted the effects of fasting on lowering body temperature, an effect also associated with obesity. Further testing indicated those findings were due to the reduced elevation in uridine in response to fasting.

 

Future research questions include studying the effects of feeding-induced reductions in uridine levels in organs that rely heavily on uridine from plasma, such as the 10) ___, and whether bariatric surgery affects blood uridine levels.

 

The authors concluded that the studies reveal a direct link between temperature regulation and metabolism, indicating that a uridine-centered model of energy balance may pave the way for future studies on uridine balance and how this process is dysregulated in the diabetic state.

 

Sources: UT Southwestern Medical Center; Yingfeng Deng, Zhao V. Wang, Ruth Gordillo, Yu An, Chen Zhang, Qiren Liang, Jun Yoshino, Kelly M. Cautivo, Jef De Brabander, Joel K. Elmquist, Jay D. Horton, Joseph A. Hill, Samuel Klein, Philipp E. Scherer. An adipo-biliary-uridine axis that regulates energy homeostasisScience, 2017; 355 (6330): eaaf5375 DOI: 10.1126/science.aaf5375; ScienceDaily.com

 

ANSWERS: 1) cells; 2) blood; 3) proteins; 4) energy; 5) fat; 6) liver; 7) body’s; 8) gut; 9) uridine; 10) heart

 

Filed Under News | Leave a Comment 

Short History of Fasting

The Buddha emaciated after undergoing severe ascetic practices, including fasting. Gandhara, 2nd to 3rd Century CE. British Museum. Credit: User:World Imaging – Own work, Public Domain; Wikipedia Commons

 

Once when the Buddha was touring in the region of Kasi together with a large sangha of monks he addressed them saying:

 

I, monks, do not eat a meal in the evening. Not eating a meal in the evening I, monks, am aware of good health and of being without illness and of buoyancy and strength and living in comfort. Come, do you too, monks, not eat a meal in the evening. Not eating a meal in the evening you too, monks, will be aware of good health and….. and living in comfort.

 

Used for thousands of years, fasting is one of the oldest therapies in medicine. Many of the great doctors of ancient times and many of the oldest healing systems have recommended it as an integral method of healing and prevention. Hippocrates, the father of Western medicine, believed fasting enabled the body to heal itself. Paracelsus, another great healer in the Western tradition, wrote 500 years ago that “fasting is the greatest remedy, the physician within.“ Ayurvedic medicine, has long advocated fasting as a major treatment. In ancient Greece, Pythagoras was among many who extolled its virtues. During the 14th century, fasting was practiced by St Catherine of Siena, while the Renaissance doctor Paracelsus called it the “physician within“. Indeed, fasting in one form or another is a distinguished tradition and throughout the centuries, devotees have claimed it brings physical and spiritual renewal.

 

In primitive cultures, a fast was often demanded before going to war, or as part of a coming-of-age ritual. It was used to assuage an angry deity and by native north Americans, as a rite to avoid catastrophes such as famine. Fasting has played a key role in all the world’s major religions (apart from Zoroastrianism which prohibits it), being associated with penitence and other forms of self-control. Judaism has several annual fast days including Yom Kippur, the Day of Atonements; in Islam, Muslims fast during the holy month of Ramadan, while Roman Catholics and Eastern orthodoxy observe a 40 day fast during Lent, the period when Christ fasted 40 days in the desert.

 

Women in particular seem to have had a proclivity for religious fasting, known as “anorexia mirabilis“ (miraculous lack of appetite); surviving for periods without nourishment was regarded as a sign of holiness and chastity. Julian of Norwich, an English anchoress and mystic who lived in the 14th century used it as a means of communicating with Christ. In other belief systems, the gods were thought to reveal their divine teaching in dreams and visions only after a fast by the temple priests. Fasting has also long been used as a gesture of political protest, the classic example being the Suffragettes and Mahatma Gandhi who undertook 17 fasts during the struggle for Indian independence: his longest fast lasted 21 days. Gandhi famously led Indians in challenging the British-imposed salt tax with the 250 mile Dandi Salt March in 1930, and later in calling for the British to Quit India in 1942. He was imprisoned for many years, upon many occasions, in both South Africa and India. Gandhi attempted to practice nonviolence and truth in all situations, and advocated that others do the same. He lived modestly in a self-sufficient residential community and wore the traditional Indian dhoti and shawl, woven with yarn hand-spun on a charkha. He ate simple vegetarian food, and also undertook long fasts as a means of both self-purification and social protest.

 

The practice of fasting, has had its dark side, having been exploited by exhibitionists and fraudsters, and foisted on the gullible. Take “Doctor“ Linda Burfield Hazzard, from Minnesota, thought to have caused the death of over 40 patients whom she put on strict fasts, before being convicted of manslaughter in 1912. She died from her own fasting regime in 1938. Then there were the Victorian “fasting girls“ who claimed to be able to survive indefinitely without food; one of them, Sarah Jacobs, was allowed to starve to death at aged 12, as doctors tested her claims in hospital.

 

Therapeutic fasting – in which fasting is used to either treat or prevent ill health, with medical supervision – became popular in the 19th century as part of the “Natural Hygiene Movement“ in the US. Dr Herbert Shelton 1895-1985) was one revered pioneer, opening “Dr Shelton’s Health school“ in San Antonio, Texas, in 1928. He claimed to have helped 40,000 patients recover their health with a water fast. Shelton wrote “Fasting must be recognized as a fundamental and radical process that is older than any other mode of caring for the sick organism, for it is employed on the plane of instinct.“ Shelton was an advocate, of alternative medicine, an author, pacifist, vegetarian, supporter of rawism and fasting. Shelton was nominated by the American Vegetarian Party to run as its candidate for President of the United States in 1956. He saw himself as the champion of original natural hygiene ideas from the 1830s. His ideas have been described as quackery by critics.

 

In the UK, too, fasting became part of the “Nature Cure“, an approach which also stressed the importance of exercise, diet, sunshine, fresh air and “positive thinking“. “Fasting in Great Britain was at its most popular in the 1920s,“ according to Tom Greenfield, a naturopath who now runs a clinic in Canterbury, England. “The first Nature Cure clinic to offer fasting opened in Edinburgh and I still have one or two patients who fasted there many decades ago.“ Other clinics which offered therapeutic fasting included the legendary Tyringham Hall in Buckinghamshire, now closed, and Champneys in Tring, Hertforshire – in those days a naturopathic center, now a destination spa. “Fasting was used to treat heart disease, high blood pressure, obesity, digestive problems, allergies, headaches – pretty much everything,“ says Greenfield. “Fasts were individually tailored and could be anything from a day or two to three months, for obese patients. The clinics would take a full case history to see if people were suitable and they would be closely monitored.“ Eventually, he says, “scientific“ medicine became dominant as better drugs were developed. Fasting and the “Nature Cure“ fell out of favor in Britain.

 

By contrast, in Germany where fasting was pioneered by Dr Otto Buchinger, therapeutic fasting is still popular and offered at various centers. Many German hospitals now run fasting weeks, funded by health insurance programs, to help manage obesity. Fasting holidays, held at centers and spas throughout Europe, include Hungary, the Czech Republic and Austria, and are growing in popularity. “In Germany fasting is part of the naturheilkunde – natural health practice,“ says Greenfield. “It has remained popular because it became integrated into medical practice so patients could be referred for a fast by their doctors.“ More recently, interest in fasting has revived in the UK and in the United States, with millions trying intermittent fasting such as the 5:2 diet, or on modified fasts where only certain foods or juices are taken for a period of time. According to Greenfield, “If people can do a one day fast for a minimum of twice a year – maybe one in spring and one in the autumn and setting aside a day they can rest, when they just drink water – this will help mitigate the toxic effects of daily living.“

 

Fasting has been used in Europe as a medical treatment for years. Many spas and treatment centers, particularly those in Germany, Sweden, and Russia, use medically supervised fasting. Fasting has gained popularity in American alternative medicine over the past several decades, and many doctors feel it is beneficial. Fasting is a central therapy in detoxification , a healing method founded on the principle that the buildup of toxic substances in the body is responsible for many illnesses and conditions.

 

Filed Under History of Medicine, News | Leave a Comment 

Baby Teeth Link Autism and Heavy Metals

 

Prior studies relating toxic metals and essential nutrients to autism have faced key limitations, such as estimating exposure based on blood levels after autism diagnosis rather than before, or not being able to control for differences that could be due to genetic factors. Now, according to an article published online in the journal Nature Communications (1 June 2017), baby teeth from children with autism have been shown to contain more toxic lead and less of the essential nutrients zinc and manganese, compared to teeth from children without autism. The study evaluated twins in order to control genetic influences and focus on possible environmental contributors to the disease. The findings suggest that differences in early-life exposure to metals, or more importantly how a child’s body processes them, may affect the risk of autism. The differences in metal uptake between children with and without autism were especially notable during the months just before and after the children were born. The authors determined this by using lasers to map the growth rings in baby teeth generated during different developmental periods. Higher levels of lead were observed in children with autism throughout development, with the greatest disparity observed during the period following birth. The authors also observed lower uptake of manganese in children with autism, both before and after birth. The pattern was more complex for zinc. Children with autism had lower zinc levels earlier in the womb, but these levels then increased after birth, compared to children without autism. The authors noted that replication in larger studies is needed to confirm the connection between metal uptake and autism.

 

For the study, patterns of metal uptake were compared using teeth from 32 pairs of twins and 12 individual twins. The study then compared patterns in twins where only one had autism, as well as in twins where both or neither had autism. Results showed that smaller differences in the patterns of metal uptake occurred when both twins had autism, but that larger differences occurred in twins where only one sibling had autism. The findings build on prior research showing that exposure to toxic metals, such as lead, and deficiencies of essential nutrients, like manganese, may harm brain development while in the womb or during early childhood. Although manganese is an essential nutrient, it can also be toxic at high doses. Exposure to both lead and high levels of manganese has been associated with autism traits and severity.

 

Filed Under News | Leave a Comment 

← Previous PageNext Page →