The barrier to the particle motion was discovered in the Van Allen radiation belts, two doughnut-shaped rings above Earth that are filled with high-energy electrons and protons, said Distinguished Professor Daniel Baker, director of CU-Boulder’s Laboratory for Atmospheric and Space Physics (LASP). Held in place by Earth’s magnetic field, the Van Allen radiation belts periodically swell and shrink in response to incoming energy disturbances from the sun.
As the first significant discovery of the space age, the Van Allen radiation belts were detected in 1958 by Professor James Van Allen and his team at the University of Iowa and were found to be composed of an inner and outer belt extending up to 25,000 miles above Earth’s surface. In 2013, Baker — who received his doctorate under Van Allen — led a team that used the twin Van Allen Probes launched by NASA in 2012 to discover a third, transient “storage ring” between the inner and outer Van Allen radiation belts that seems to come and go with the intensity of space weather.
The latest mystery revolves around an “extremely sharp” boundary at the inner edge of the outer belt at roughly 7,200 miles in altitude that appears to block the ultrafast electrons from breeching the shield and moving deeper towards Earth’s atmosphere.
“It’s almost like theses electrons are running into a glass wall in space,” said Baker, the study’s lead author. “Somewhat like the shields created by force fields on Star Trek that were used to repel alien weapons, we are seeing an invisible shield blocking these electrons. It’s an extremely puzzling phenomenon.”
A paper on the subject was published in the Nov. 27 issue of Nature.
The team originally thought the highly charged electrons, which are looping around Earth at more than 100,000 miles per second, would slowly drift downward into the upper atmosphere and gradually be wiped out by interactions with air molecules. But the impenetrable barrier seen by the twin Van Allen belt spacecraft stops the electrons before they get that far, said Baker.
The group looked at a number of scenarios that could create and maintain such a barrier. The team wondered if it might have to do with Earth’s magnetic field lines, which trap and control protons and electrons, bouncing them between Earth’s poles like beads on a string. The also looked at whether radio signals from human transmitters on Earth could be scattering the charged electrons at the barrier, preventing their downward motion. Neither explanation held scientific water, Baker said.
“Nature abhors strong gradients and generally finds ways to smooth them out, so we would expect some of the relativistic electrons to move inward and some outward,” said Baker. “It’s not obvious how the slow, gradual processes that should be involved in motion of these particles can conspire to create such a sharp, persistent boundary at this location in space.”
Another scenario is that the giant cloud of cold, electrically charged gas called the plasmasphere, which begins about 600 miles above Earth and stretches thousands of miles into the outer Van Allen belt, is scattering the electrons at the boundary with low frequency, electromagnetic waves that create a plasmapheric “hiss,” said Baker. The hiss sounds like white noise when played over a speaker, he said.
While Baker said plasmaspheric hiss may play a role in the puzzling space barrier, he believes there is more to the story. “I think the key here is to keep observing the region in exquisite detail, which we can do because of the powerful instruments on the Van Allen probes. If the sun really blasts Earth’s magnetosphere with a coronal mass ejection (CME), I suspect it will breach the shield for a period of time,” said Baker, also a faculty member in the astrophysical and planetary sciences department.
“It’s like looking at the phenomenon with new eyes, with a new set of instrumentation, which give us the detail to say, ‘Yes, there is this hard, fast boundary,'” said John Foster, associate director of MIT’s Haystack Observatory and a study co-author.
- D. N. Baker, A. N. Jaynes, V. C. Hoxie, R. M. Thorne, J. C. Foster, X. Li, J. F. Fennell, J. R. Wygant, S. G. Kanekal, P. J. Erickson, W. Kurth, W. Li, Q. Ma, Q. Schiller, L. Blum, D. M. Malaspina, A. Gerrard, L. J. Lanzerotti. An impenetrable barrier to ultrarelativistic electrons in the Van Allen radiation belts. Nature, 2014; 515 (7528): 531 DOI: 10.1038/nature13956
University of Colorado at Boulder. “Invisible shield found thousands of miles above Earth blocks ‘killer electrons’.” ScienceDaily. ScienceDaily, 26 November 2014. <www.sciencedaily.com/releases/2014/11/141126133829.htm>.
“I was extremely surprised when my colleagues, Jing Liu-Zeng and Dirk Scherler, showed me the evidence for this canyon in southern Tibet,” says Jean-Philippe Avouac, the Earle C. Anthony Professor of Geology at Caltech. “When I first saw the data, I said, ‘Wow!’ It was amazing to see that the river once cut quite deeply into the Tibetan Plateau because it does not today. That was a big discovery, in my opinion.”
Geologists like Avouac and his colleagues, who are interested in tectonics–the study of the earth’s surface and the way it changes–can use tools such as GPS and seismology to study crustal deformation that is taking place today. But if they are interested in studying changes that occurred millions of years ago, such tools are not useful because the activity has already happened. In those cases, rivers become a main source of information because they leave behind geomorphic signatures that geologists can interrogate to learn about the way those rivers once interacted with the land–helping them to pin down when the land changed and by how much, for example.
“In tectonics, we are always trying to use rivers to say something about uplift,” Avouac says. “In this case, we used a paleocanyon that was carved by a river. It’s a nice example where by recovering the geometry of the bottom of the canyon, we were able to say how much the range has moved up and when it started moving.”
The team reports its findings in the current issue of Science.
Last year, civil engineers from the China Earthquake Administration collected cores by drilling into the valley floor at five locations along the Yarlung Tsangpo River. Shortly after, former Caltech graduate student Jing Liu-Zeng, who now works for that administration, returned to Caltech as a visiting associate and shared the core data with Avouac and Dirk Scherler, then a postdoc in Avouac’s group. Scherler had previously worked in the far western Himalayas, where the Indus River has cut deeply into the Tibetan Plateau, and immediately recognized that the new data suggested the presence of a paleocanyon.
Liu-Zeng and Scherler analyzed the core data and found that at several locations there were sedimentary conglomerates, rounded gravel and larger rocks cemented together, that are associated with flowing rivers, until a depth of 800 meters or so, at which point the record clearly indicated bedrock. This suggested that the river once carved deeply into the plateau.
To establish when the river switched from incising bedrock to depositing sediments, they measured two isotopes, beryllium-10 and aluminum-26, in the lowest sediment layer. The isotopes are produced when rocks and sediment are exposed to cosmic rays at the surface and decay at different rates once buried, and so allowed the geologists to determine that the paleocanyon started to fill with sediment about 2.5 million years ago.
The researchers’ reconstruction of the former valley floor showed that the slope of the river once increased gradually from the Gangetic Plain to the Tibetan Plateau, with no sudden changes, or knickpoints. Today, the river, like most others in the area, has a steep knickpoint where it meets the Himalayas, at a place known as the Namche Barwa massif. There, the uplift of the mountains is extremely rapid (on the order of 1 centimeter per year, whereas in other areas 5 millimeters per year is more typical) and the river drops by 2 kilometers in elevation as it flows through the famous Tsangpo Gorge, known by some as the Yarlung Tsangpo Grand Canyon because it is so deep and long.
Combining the depth and age of the paleocanyon with the geometry of the valley, the geologists surmised that the river existed in this location prior to about 3 million years ago, but at that time, it was not affected by the Himalayas. However, as the Indian and Eurasian plates continued to collide and the mountain range pushed northward, it began impinging on the river. Suddenly, about 2.5 million years ago, a rapidly uplifting section of the mountain range got in the river’s way, damming it, and the canyon subsequently filled with sediment.
“This is the time when the Namche Barwa massif started to rise, and the gorge developed,” says Scherler, one of two lead authors on the paper and now at the GFZ German Research Center for Geosciences in Potsdam, Germany.
That picture of the river and the Tibetan Plateau, which involves the river incising deeply into the plateau millions of years ago, differs quite a bit from the typically accepted geologic vision. Typically, geologists believe that when rivers start to incise into a plateau, they eat at the edges, slowly making their way into the plateau over time. However, the rivers flowing across the Himalayas all have strong knickpoints and have not incised much at all into the Tibetan Plateau. Therefore, the thought has been that the rapid uplift of the Himalayas has pushed the rivers back, effectively pinning them, so that they have not been able to make their way into the plateau. But that explanation does not work with the newly discovered paleocanyon.
The team’s new hypothesis also rules out a model that has been around for about 15 years, called tectonic aneurysm, which suggests that the rapid uplift seen at the Namche Barwa massif was triggered by intense river incision. In tectonic aneurysm, a river cuts down through the earth’s crust so fast that it causes the crust to heat up, making a nearby mountain range weaker and facilitating uplift.
The model is popular among geologists, and indeed Avouac himself published a modeling paper in 1996 that showed the viability of the mechanism. “But now we have discovered that the river was able to cut into the plateau way before the uplift happened,” Avouac says, “and this shows that the tectonic aneurysm model was actually not at work here. The rapid uplift is not a response to river incision.”
- P. Wang, D. Scherler, J. Liu-Zeng, J. Mey, J.-P. Avouac, Y. Zhang, D. Shi.Tectonic control of Yarlung Tsangpo Gorge revealed by a buried canyon in Southern Tibet. Science, 2014; 346 (6212): 978 DOI: 10.1126/science.1259041
California Institute of Technology. “Geologists discover ancient buried canyon in South Tibet.” ScienceDaily. ScienceDaily, 20 November 2014. <www.sciencedaily.com/releases/2014/11/141120141752.htm>.
We are putting our money where our mouth is. We are doing it, not just talking about it. Next month, we are submitting a PMA that used Target e*CTR®, our eSource solution fully integrated with Target e*CRF®, and a NDA is planned for 2015. And yes, both programs used risk-based monitoring (RBM).
As we are now starting our 20th study using our eSource solution full integrated with Target e*CRF, we would like to share some additional metrics from one of our ongoing studies. Please look at publications on our website (www.targethealth.com) for even more support to our approach to the paperless clinical trial and how Target e*CTR® (eClinical Trial Record) fully integrated with Target e*CRF® is revolutionizing clinical research.
- Approximately 94% of the data have been entered into Target e*CRF on the day of the subject’s visit.
- Of the 26,000 forms entered to date, source document verification (SDV) and/or source document review (SDR) was performed for 7,700 forms (30%).
- Of the 7,700 forms, 133 (1.7%) of the queried forms were modified.
- Interestingly, of those 133 forms, 102 occurred at just one site, and within that site, 99 involved changes to time points that have absolutely no impact either on subject safety or efficacy
Moon Over Manhattan – ©Target Health Inc.
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
Meditation: A Simple Way to Reduce Anxiety and More
Highlighted region shows the anterior cingulate cortex, a region of the brain shown to be activated during meditation.
Meditation and its effect on brain activity and the central nervous system became a focus of collaborative research in neuroscience, psychology and neurobiology during the latter 20th century. Research on meditation sought to define and characterize various practices. Meditation’s effect on the 1) ___can be broken up into two categories: state changes and trait changes, respectively, alterations in brain activities during the act of meditating and changes that are the outcome of long-term practice. Mindfulness meditation, which is frequently studied, is a Buddhist meditation approach found in Zen and Vipassana. Mindfulness meditation can be defined, in simple terms, as a complete, unbiased attention to the current moment.
Electroencephalography (EEG) has been used in many studies as a primary method for evaluating the meditating brain. Electroencephalography uses electrical leads placed all over the 2) ___ to measure the collective electrical activity of the cerebral cortex. Specifically, EEG measures the electric fields of large groups of neurons. EEG has the benefit of excellent temporal resolution and is able to measure aggregate activity of portions or the entire cortex down to the millisecond scale. Unlike other imaging based methods, EEG does not have good spatial resolution and is more appropriately used to evaluate the running spontaneous activity of the cortex. This spontaneous activity is classified into four main classifications based on the frequency of the activity, ranging from low frequency delta waves (<4 Hz) commonly found during sleep to beta waves (13-30 Hz) associated with an awake and alert brain. In between these two extremes are theta waves (4-8 Hz) and alpha waves (8-12 Hz).
Many studies on mindfulness meditation, have linked lower frequency alpha and theta waves to meditation. Other studies report more specific findings, such as decreased alpha blocking and increased frontal lobe specific theta activity. Alpha blocking is a phenomenon where the active brain, normally presenting beta wave activity, cannot as easily switch to alpha wave activity often involved in memory recall. These findings would suggest that in a meditative state a person is more relaxed but maintains a sharp awareness. Two large, recent comprehensive review works, however, point to poor control and statistical analyses in these early studies and comment that it can only be said with confidence that increased alpha and theta 3) ___ activity exists. Functional magnetic resonance imaging (fMRI) is another highly utilized methodology for studying state changes in meditating brains. fMRI detects subtle increases in 4) ___ flow to areas of the brain with higher metabolic activity. Thus these areas of increased metabolic activity indicate which regions of the brain are currently being used to process whatever stimuli is presented. Counter to EEG, the advantage of fMRI is its spatial resolution, with the ability to produce detailed spatial maps of brain activity. It suffers, however, in temporal resolution and cannot measure progressive activity, like the EEG, with much detail. fMRI has only recently been used to assess brain state changes during meditation. Recent studies have shown heightened activity in the anterior cingulate cortex, frontal cortex, and prefrontal cortex, specifically in the dorsal medial prefrontal area during Vipassana meditation. Similarly, the cingulate cortex and frontal cortex areas were shown to have increased activity during Zen meditation. Both studies comment on the possibility that these findings could indicate some state of heightened voluntary control over attention during mindfulness meditation. These results indicate consistency in meditation’s effect on these regions of the brain. A multitude of other studies spanning other meditative disciplines, come to the same conclusions, but mention the need for further investigation with better controls.
Studies also describe a heightened emotional state of meditators. A more complex study, conducted in 2008 by Lutz et al., focused on emotional response during meditation. This investigation involved the creation of a compassion meditation state by novice and experienced meditators and testing the meditators response to emotionally charged sounds. fMRI results indicated heightened activity in the cingulate cortex but also in the amygdala, temporo-parietal junction, and right posterior superior temporal sulcus in response to the emotional sounds. The authors of this study believe this indicates greater sensitivity to emotional expression and positive emotion due to the neural circuitry activated. Some studies make more specific claims about trait changes in meditators versus non-meditators. Changes to the alpha wave were indicated to be a trait, as well as state, phenomena. Studies have reported an increase in the specific frequencies expressed in the alpha range, increased alpha band power, and an overall slowing (reduction in frequency) in EEG activity in experienced meditators versus less experienced meditators while meditating. The alpha blocking phenomena, observed as a state change in brain function, was investigated as a possible trait change as well. One study that examined a variety of meditation techniques tried to show that alpha blocking was affected by the long term practice of meditation by testing response to auditory stimuli. Review works, however, comment on inconsistent findings as well as a lack of repeated results in this, and other studies. They further remark that, similar to observations in brain state changes, only general assertions can be made about brain trait changes: some change in the electroencephalographic profile exists but with some inconsistency. It is also important to note that these trait changes were observed during meditation, and although it does indicate that a practitioner’s electroencephalographic profile is modified by the practice of meditation, these EEG studies have not yet shown changes in non-meditating brains, even of experienced 5) ___.
Red region of the brain shows the hippocampus which had been shown to have heightened activity during meditation by experienced meditators.
Brain trait changes have also been observed in neuroimaging studies, most often employing fMRI. In a meta-analysis of 21 neuroimaging studies, eight brain regions were found to be consistently altered, including areas key to meta-awareness (frontopolar cortex/Brodmann area), exteroceptive and interoceptive body awareness (sensory cortex and insular cortex), memory consolidation and reconsolidation (hippocampus), self and emotion regulation (anterior cingulate cortex and orbitofrontal cortex), and intra- and interhemispheric communication (superior longitudinal fasciculus; corpus callosum. These changes were distinguished by density increases in grey matter regions and white matter pathways in the brains of individuals who meditate in comparison to individuals who do not. Of all areas with reported findings, a greater number of structural changes were found in the left hemisphere.
There is also evidence to suggest meditation plays a protective role against the natural reduction in grey matter volume associated with 6) ___. One study found evidence that Zen meditators experienced a slower age related decline rate for cerebral gray matter volume in the putamen which plays a role in learning, cognitive flexibility and attentional processing. This could suggest a better attentiveness in aging meditators versus non-meditators. Long-term meditation practitioners have also shown to have a higher tolerance for pain. This effect has been correlated to altered function and structure in somatosensory cortices and an increased ability to decouple regions in the brain associated with the cognitive appraisal of pain (anterior cingulate cortex and dorsolateral prefrontal cortex). The brain state changes found in meditators are almost exclusively found in higher-order executive and association cortices. This supports the notion that meditation increases self-regulation and attentiveness. Recent studies have also investigated how these changes may alter the functionality and connectivity of the default mode network, which is a hypothesized network of brain regions that are active when an individual is engaged in internal tasks such as daydreaming.
Validity of Findings
In the meta-analysis performed by Fox et al., several sources of bias were indicated which bring into question the validity of meditation studies which use neuroimaging. Fox suggests a publication bias may be leading to the over-reporting of significant results. Fox also acknowledged that the significant brain differences found in many meditation studies could be explained by preexisting brain differences in those who meditate. More research will be needed before any firm conclusions can be made. Besides scientific literature, some authors have written of the promising research on meditation in books targeted for general audiences. Once such book, Buddha’s Brain by Rick Hanson, PhD shares the current scientific research and investigations into meditation. Hanson, a neuroscientist and researcher, explains to readers the scientific studies in plain language and discuss the impact of the results. Hanson’s main argument is that positive emotions, like love can be strengthened through meditation in a neuroplastic manner, citing dozens of scientific studies to support this claim. Hanson’s viewpoint is representative of a larger popular movement to study and embrace Eastern phenomena including meditation in the Western world.
Critics, like Owen Flanagan, PhD, believe that Hanson, and those like him, are overextending the results of current scientific studies. In his book, Bodhisattva’s Brain: Buddhism Naturalized, Flanagan presents a more conservative viewpoint of current scientific research and cautions readers against the seemingly exciting results of recent studies. Flanagan does not believe current science supports the idea that positive emotion can be strengthened in the same way that stroke victims can recover use of limbs with use. Flanagan does acknowledge that meditation may be beneficial in some way, but the mechanism of how meditation affects the brain is still clouded. Flanagan and Hanson use many of the same scientific studies to attempt to support their differing viewpoint, but both authors identify the need and importance of future studies investigating meditation.
Each person should be the judge, of what works for them. For some, meditation can wipe away the day’s stress, bringing with it inner peace. You can easily learn to practice meditation. Spending even a few minutes a day, in meditation can restore your calm and inner peace. Anyone can practice meditation. It’s simple and inexpensive, and it doesn’t require any special equipment. Meditation has been practiced for thousands of years. Meditation originally was meant to help deepen understanding of the sacred and mystical forces of life. These days, meditation is commonly used for relaxation and 7) ___ reduction. Meditation is considered a type of mind-body complementary medicine. Meditation can produce a deep state of relaxation and a tranquil mind. During meditation, you focus your attention and eliminate the stream of jumbled thoughts that may be crowding your mind and causing stress. This process may result in enhanced physical and emotional well-being.
The emotional benefits of meditation can include:
- Gaining a new perspective on stressful situations
- Building skills to manage your stress
- Increasing self-awareness
- Focusing on the present
- Reducing negative emotions
Meditation might also be useful if you have a medical condition, especially one that may be worsened by stress. With that in mind, some research suggests that meditation may help people manage symptoms of conditions such as:
- Anxiety disorders
- Heart disease
- High blood 8) ___
- Sleep problems
Be sure to talk to your health care provider about the pros and cons of using meditation if you have any of these conditions or other health problems. Meditation isn’t a replacement for traditional medical treatment. But it may be a useful addition to your other treatment.
Ways to meditate can include:
Guided meditation. Sometimes called guided imagery or visualization, with this method of meditation you form mental images of places or situations you find relaxing.
You try to use as many senses as possible, such as smells, sights, sounds and textures. You may be led through this process by a guide or teacher.
Mantra meditation. In this type of meditation, you silently repeat a calming word, thought or phrase to prevent distracting thoughts. For example, if I can’t fall asleep I repeat mentally (silently): relaxation leads to harmony.
Mindfulness meditation. This type of meditation is based on being mindful, or having an increased awareness and acceptance of living in the present moment.
In mindfulness meditation, you broaden your conscious awareness. You focus on what you experience during meditation, such as the flow of your breath. You can observe your thoughts and emotions, but let them pass without judgment.
Qi gong. This practice generally combines meditation, relaxation, physical movement and breathing exercises to restore and maintain balance. Qi gong (CHEE-gung) is part of traditional Chinese medicine.
Tai chi. This is a form of gentle Chinese martial arts. In tai chi (TIE-CHEE), you perform a self-paced series of postures or movements in a slow, graceful manner while practicing deep breathing.
Transcendental meditation. Transcendental meditation is a simple, natural technique. In transcendental meditation, you silently repeat a personally assigned mantra, such as a word, sound or phrase, in a specific way. This form of meditation allows your body to settle into a state of profound rest and relaxation and your mind to achieve a state of inner peace, without needing to use concentration or effort.
Yoga. You perform a series of postures and controlled breathing exercises to promote a more flexible body and a calm mind. As you move through poses that require balance and concentration, you’re encouraged to focus less on your busy day and more on the moment.
Elements of meditation
Different types of meditation may include different features to help you meditate. These may vary depending on whose guidance you follow or who’s teaching a class. Some of the most common features in meditation include:
Focused attention. Focusing your attention is generally one of the most important elements of meditation.
Focusing your attention is what helps free your mind from the many distractions that cause stress and worry. You can focus your attention on such things as a specific object, an image, a mantra, or even your breathing.
Relaxed breathing. This technique involves deep, even-paced breathing using the diaphragm muscle to expand your lungs. The purpose is to slow your breathing, take in more oxygen, and reduce the use of shoulder, neck and upper chest muscles while breathing so that you breathe more efficiently.
A quiet setting. If you’re a beginner, practicing meditation may be easier if you’re in a quiet spot with few distractions, including no television, radios or cellphones.
As you get more skilled at meditation, you may be able to do it anywhere, especially in high-stress situations where you benefit the most from meditation, such as a traffic jam, a stressful work meeting or a long line at the grocery store.
A comfortable position. You can practice meditation whether you’re sitting, lying down, walking, or in other positions or activities. Just try to be comfortable so that you can get the most out of your meditation.
Don’t let the thought of meditating the right way add to your stress. If you choose to, you can attend special meditation centers or group classes led by trained instructors. But you can also practice meditation easily on your own.
Here are some ways you can practice meditation on your own, whenever you choose:
Breathe deeply. This technique is good for beginners because breathing is a natural function.
Focus all attention on your breathing. Concentrate on feeling and listening as you inhale and exhale through your nostrils. Breathe deeply and slowly. When your attention wanders, gently return your focus to your breathing.
Scan your body. When using this technique, focus attention on different parts of your body. Become aware of your body’s various sensations, whether that’s pain, tension, warmth or relaxation.
Combine body scanning with breathing exercises and imagine breathing heat or relaxation into and out of different parts of your body.
Repeat a mantra. You can create your own mantra, whether it’s religious or secular. Examples of religious mantras include the Jesus Prayer in the Christian tradition, the holy name of God in Judaism, or the Om mantra of Hinduism, Buddhism and other Eastern religions.
Engage in prayer. Prayer is the best known and most widely practiced example of meditation. Spoken and written prayers are found in most faith traditions.
You can pray using your own words or read prayers written by others. Check the self-help section of your local bookstore for examples. Talk with your rabbi, priest, pastor or other spiritual leader about possible resources.
Read and reflect. Many people report that they benefit from reading poems or sacred texts, and taking a few moments to quietly reflect on their meaning.
You can also listen to sacred music, spoken words or any music you find relaxing or inspiring. You may want to write your reflections in a journal or discuss them with a friend or spiritual leader.
Focus your love and gratitude. In this type of meditation, you focus your attention on a sacred object or being, weaving feelings of love, compassion and gratitude into your thoughts. You can also close your eyes and use your imagination or gaze at representations of the object.
Building Your Meditation Skills
Don’t judge your meditation skills, which may only increase your stress. Meditation takes practice. Keep in mind, for instance, that it’s common for your mind to 9) ___ during meditation, no matter how long you’ve been practicing meditation. If you’re meditating to calm your mind and your attention wanders, slowly return to the object, sensation or movement you’re focusing on.
Experiment, and you’ll likely find out what types of meditation work best for you and what you enjoy doing. Adapt meditation to your needs at the moment. Remember, there’s no right way or 10) ___ way to meditate. What matters is that meditation helps you reduce your stress and feel better overall.
Meditation is a mind-body practice in complementary and alternative medicine (CAM). People practice meditation for a number of health-related purposes. A national Government survey that asked about CAM use in a sample of 23,393 U.S. adults Meditation was found to aid physical or emotional symptoms that may be associated with chronic illnesses (such as heart disease, HIV/AIDS, and cancer) and their treatment. Meditation was also found to be used for overall wellness.
ANSWERS: 1) brain; 2) scalp; 3) wave; 4) blood; 5) meditators; 6) aging; 7) stress; 8) pressure; 9) wander; 10) wrong
Albert Schweitzer (1875 – 1965)
Dr. Albert Schweitzer in 1955
Albert Schweitzer was an amazingly accomplished Renaissance Man of the 20th Century, with the talent, energy and drive of twenty. His search for the truth was focused and relentless; a life worth living. He was a theologian, organist, philosopher, physician, and medical missionary in Africa. Schweitzer was born in the province of Alsace-Lorraine, at that time part of the German Empire, but considered himself French and wrote mostly in French. Schweitzer, a Lutheran, challenged both the secular view of Jesus as depicted by historical-critical methodology current at his time in certain academic circles, as well as the traditional Christian view.
Albert Schweitzer received the 1952 Nobel Peace Prize for his philosophy of Reverence for Life, expressed in many ways, but most famously in founding and sustaining the Albert Schweitzer Hospital in Lambarene, now in Gabon, west central Africa (then French Equatorial Africa). As a music scholar and organist, he studied the music of German composer Johann Sebastian Bach and influenced the Organ reform movement.
Born in Kaysersberg, Schweitzer spent his childhood in the village of Gunsbach, Alsace , where his father, the local Lutheran-Evangelical pastor, taught him how to play music. Long disputed, the predominantly German-speaking region of Alsace or Elsass was annexed by Germany in 1871; after World War I, it was reintegrated into France. The tiny village is home to the Association Internationale Albert Schweitzer (AIAS). The medieval parish church of Gunsbach was shared by the Protestant and Catholic congregations, which held their prayers in different areas at different times on Sundays. This compromise arose after the Protestant Reformation and the Thirty Years War.
Schweitzer grew up in this exceptional environment of religious tolerance, and developed the belief that true Christianity should always work towards a unity of faith and purpose. His home language was an Alsatian dialect of German. At Mulhouse high school he got his Abitur (the certificate at the end of secondary education), in 1893. He studied organ there from 1885 to 1893 with Eugene Munch, organist of the Protestant Temple. In 1893 he played for the French organist Charles-Marie Widor (at Saint-Sulpice, Paris), for whom Johann Sebastian Bach’s organ-music contained a mystic sense of the eternal. Widor, deeply impressed, agreed to teach Schweitzer without fee, and a great and influential friendship was begun. From 1893 he studied Protestant theology at the Kaiser Wilhelm University of Strasburg. There he also received instruction in piano and counterpoint from professor Gustav Jacobsthal, and associated closely with Ernest Munch (the brother of his former teacher), organist of St William church, who was also a passionate admirer of J.S. Bach’s music.
Schweitzer served his one year compulsory military service in 1894. In 1898 he went back to Paris to write a PhD dissertation on The Religious Philosophy of Kant at the Sorbonne. He also studied piano at that time. He completed his theology degree in 1899 and published his PhD thesis at the University of T?bingen in 1899. In 1899 Schweitzer became a deacon at the church of Saint Nicholas in Strasburg, and in 1900, with the completion of his licentiate in theology, he was ordained as curate. In the following year he became provisional Principal of the Theological College of Saint Thomas (from which he had just graduated), and in 1903 his appointment was made permanent. Beginning in the mid-1890s, Schweitzer formed the inner resolve that it was needful for him as a Christian to repay to the world something for the happiness which it had given to him. As a result, he decided that he would pursue his younger interests until the age of thirty and then give himself to serving humanity, with Jesus serving as his example. In The Quest, Schweitzer reviewed all former work on the historical Jesus back to the late 18th century. He showed that the image of Jesus had changed with the times and outlooks of the various authors, and gave his own synopsis and interpretation of the previous century’s findings. He maintained that the life of Jesus must be interpreted in the light of Jesus’ own convictions, which reflected late Jewish eschatology. Schweitzer believed that Christianity began as a Jewish apocalyptic movement as evidenced by the teachings of the Historical Jesus. Not only did he preach he would rise from the grave, but that he would also ascend to the Heaven and one day return to judge and rule over the world.
Schweitzer rapidly gained prominence as a musical scholar and organist, dedicated also to the rescue, restoration and study of historic pipe organs. With theological insight, he interpreted the use of pictorial and symbolical representation in J. S. Bach’s religious music. He wrote a pamphlet The Art of Organ Building and Organ Playing in Germany and France, which in 1906, was republished with an appendix on the state of the organ-building industry, which effectively launched the 20th-century Orgelbewegung. The Organ Reform Movement or Orgelbewegung (also called the Organ Revival Movement) was an early 20th-century trend in pipe organ building, originating in Germany. In 1909 he addressed the Third Congress of the International Society of Music at Vienna on the subject. In 1905, Widor and Schweitzer were among the six musicians who founded the Paris Bach Society, a choir dedicated to performing J.S. Bach’s music, for whose concerts Schweitzer took the organ part regularly until 1913. He was also appointed organist for the Bach Concerts of the Orfeo Catala at Barcelona and often travelled there for that purpose. Bach Preludes with Schweitzer’s analyses, were to be worked on in Africa: but these were never completed, perhaps because for him they were inseparable from his evolving theological thought. On departure for Lambarene, Africa, in 1913 Schweitzer was presented with a pedal piano, a piano with pedal attachments (to operate like an organ pedal-keyboard). Built especially for the tropics, it was delivered by river in a huge dug-out canoe to Lambarene, packed in a zinc-lined case. At first he regarded his new life as a renunciation of his art, and fell out of practice: but after some time he resolved to study and learn by heart the works of Bach, Mendelssohn, Widor, Cesar Franck, and Max Reger systematically. It became his custom to play during the lunch hour and on Sunday afternoons. Schweitzer’s pedal piano was still in use at Lambarene in 1946. And according to a visitor, the old, dilapidated piano-organ was still being played by Dr. Schweitzer in 1962 and stories told of his fingers were still lively on the old instrument at 88 years of age. Schweitzer developed a technique for recording the performances of Bach’s music. Known as The Schweitzer Technique, it is a slight improvement on what is commonly known as mid-side. The technique has since been used to record many modern instruments.
At the age of 30, in 1905, Schweitzer answered the call of The Society of the Evangelist Missions of Paris which was looking for a medical doctor. However, the committee of this French Missionary Society was not ready to accept his offer, considering his Lutheran theology to be incorrect. He could easily have obtained a place in a German Evangelical mission, but wished to follow the original call despite the doctrinal difficulties. Amid a hail of protests from his friends, family and colleagues, he resigned his post and re-entered the University as a student in a three-year course towards the degree of a Doctorate in Medicine, a subject in which he had little knowledge or previous aptitude. He planned to spread the Gospel by the example of his Christian labor of healing, rather than through the verbal process of preaching, and believed that this service should be acceptable within any branch of Christian teaching. Even in his study of medicine, and through his clinical course, Schweitzer pursued the ideal of the philosopher-scientist. By extreme application and hard work, he completed his studies successfully at the end of 1911. His medical degree dissertation was another work on the historical Jesus, The Psychiatric Study of Jesus.
In June 1912, Schweitzer married Helene Bresslau, daughter of the Jewish pan-Germanist historian Harry Bresslau. In that same year, now armed with a medical degree, Schweitzer made a definite proposal to go as a medical doctor to work at his own expense in the Paris Missionary Society’s mission at Lambarene on the Ogooue river, in what is now Gabon, in Africa (then a French colony). He refused to attend a committee to inquire into his doctrine, but met each committee member personally and was at last accepted. Through concerts and other fund-raising, he was ready to equip a small hospital. In Spring 1913, he and his wife and son Peter, set off to establish a hospital (Albert Schweitzer Hospital) near an already existing mission post. The site was nearly 200 miles (14 days by raft) upstream from the mouth of the Ogooue at Port Gentil (Cape Lopez. In the first nine months, he and his wife had about 2,000 patients to examine, some travelling many days and hundreds of kilometers to reach him. In addition to injuries, he was often treating severe sand flea and crawcraw sores, framboesia (yaws), tropical eating sores, heart disease, tropical dysentery, tropical malaria, sleeping sickness, leprosy, fevers, strangulated hernias, necrosis, abdominal tumors and chronic constipation and nicotine poisoning, while also attempting to deal with deliberate poisonings, fetishism and fear of cannibalism among the Mbahouin.
Schweitzer’s wife, Helene Schweitzer, was an anesthetist for surgical operations. After briefly occupying a shed formerly used as a chicken hut, in autumn 1913 they built their first hospital of corrugated iron, with two 13-foot rooms (consulting room and operating theatre) and with a dispensary and sterilizing room in spaces below the broad eaves. The waiting room and dormitory (42 by 20 feet) were built, like native huts, of unhewn logs along a 30-yard path leading from the hospital to the landing-place. The Schweitzers had their own bungalow and employed as their assistant Joseph, a French-speaking Galoa (Mpongwe) who first came as a patient. When World War I broke out in summer of 1914, Schweitzer and his wife, Germans in a French colony, were put under supervision at Lambarene by the French military, where Schweitzer continued his work. In 1917, exhausted by over four years’ work and by tropical anaemia, they were taken to Bordeaux and interned first in Garaison and then from March 1918 in Saint-Remy-de-Provence. In July 1918, after being transferred to his home in Alsace, he was a free man again. At this time Schweitzer, born a German citizen, had his parents’ former (pre-1871) French citizenship reinstated and became a French citizen. Then, working as medical assistant and assistant-pastor in Strasbourg, he advanced his project on The Philosophy of Civilization, which had occupied his mind since 1900. By 1920, his health recovering, he was giving organ recitals and doing other fund-raising work to repay borrowings and raise funds for returning to Gabon. In 1922, he delivered the Dale Memorial Lectures in Oxford University, and from these in the following year appeared Volumes I and II of his great work, The Decay and Restoration of Civilization and Civilization and Ethics. The two remaining volumes, on The World-View of Reverence for Life and a fourth on the Civilized State, were never completed.
In 1924, he returned without his wife but with an Oxford undergraduate, Noel Gillespie, as assistant. Everything was heavily decayed, and building and doctoring progressed together for months. He now had salvarsan for treating syphilitic ulcers and framboesia. Additional medical staff, nurse (Miss) Kottmann and Dr. Victor Nessmann, joined him in 1924, and Dr. Mark Lauterberg in 1925; the growing hospital was manned by native orderlies. Later Dr. Trensz replaced Nessmann, and Martha Lauterberg and Hans Muggenstorm joined them. The original assistant, Joseph also returned. In 1925-6, new hospital buildings were constructed, so that the site became like a village. The onset of famine and a dysentery epidemic created fresh problems. Much of the building work was carried out with the help of local people and patients. Drug advances for sleeping sickness included Germaninand tryparsamide. Dr. Trensz conducted experiments showing that the non-amoebic strain of dysentery was caused by a paracholera vibrion (facultative anaerobic bacteria). With the new hospital built and the medical team established, Schweitzer returned to Europe in 1927, this time leaving a functioning hospital at work.
He was there again from 1929 to 1932. Gradually his opinions and concepts became acknowledged, not only in Europe, but worldwide. There was a further period of work in 1935. In January 1937, he returned again to Lambarene and continued working there throughout World War II. Schweitzer considered his work as a medical missionary in Africa to be his response to Jesus’ call to become fishers of men but also as a small recompense for the historic guilt of European colonizers. He wrote:
Who can describe the injustice and cruelties that in the course of centuries they [the colored peoples] have suffered at the hands of Europeans? If a record could be compiled of all that has happened between the white and the colored races, it would make a book containing numbers of pages which the reader would have to turn over unread because their contents would be too horrible.
Schweitzer was one of colonialism’s harshest critics. In a sermon that he preached on 6 January 1905, before he had told anyone of his plans to dedicate the rest of his life to work as a doctor in Africa, he said:
Our culture divides people into two classes: civilized men, a title bestowed on the persons who do the classifying; and others, who have only the human form, who may perish or go to the dogs for all the ‘civilized men’ care. Oh, this ‘noble’ culture of ours! It speaks so piously of human dignity and human rights and then disregards this dignity and these rights of countless millions and treads them underfoot, only because they live overseas or because their skins are of different color or because they cannot help themselves. This culture does not know how hollow and miserable and full of glib talk it is, how common it looks to those who follow it across the seas and see what it has done there, and this culture has no right to speak of personal dignity and human rights I will not enumerate all the crimes that have been committed under the pretext of justice. People robbed native inhabitants of their land, made slaves of them, let loose the scum of mankind upon them. Think of the atrocities that were perpetrated upon people made subservient to us, how systematically we have ruined them with our alcoholic ‘gifts’, and everything else we have done. We decimate them, and then, by the stroke of a pen, we take their land so they have nothing left at all. If all this oppression and all this sin and shame are perpetrated under the eye of the German God, or the American God, or the British God, and if our states do not feel obliged first to lay aside their claim to be ‘Christian’ – then the name of Jesus is blasphemed and made a mockery.
Schweitzer was nonetheless, sometimes accused of being paternalistic, colonialist and racist in his attitude towards Africans when he wrote things like: No society can go from the primeval directly to an industrial state without losing the leavening that time and an agricultural period allow. However, in 2014, we know that the hope for democracy during the so-called Arab Spring, didn’t work because of an absence of a political infrastructure in country after country. Schweitzer’s use of the word brother at all was, for a European of the early 20th century, an unusual expression of human solidarity between whites and blacks. Later in life he became more convinced that modern civilization was actually inferior to or the same as previous cultures in terms of morality. The keynote of Schweitzer’s personal philosophy, which he considered to be his greatest contribution, was the idea of Reverence for Life. He thought that Western civilization was decaying because it had abandoned affirmation of life as its ethical foundation.
In the Preface to Civilization and Ethics(1923) he argued that Western philosophy from Descartes to Kant had set out to explain the objective world expecting that humanity would be found to have a special meaning within it. But no such meaning was found, and the rational, life-affirming optimism of the Age of Enlightenment began to evaporate. A rift opened between this world-view, as material knowledge, and the life-view, understood as Will, expressed in the pessimist philosophies from Schopenhauer onward. Scientific materialism (advanced by Herbert Spencer and Charles Darwin) portrayed an objective world process devoid of ethics, entirely an expression of the will-to-live. Schweitzer wrote, True philosophy must start from the most immediate and comprehensive fact of consciousness, and this may be formulated as follows: ‘I am life which wills to live, and I exist in the midst of life which wills to live.’ In nature one form of life must always prey upon another. However, human consciousness holds an awareness of, and sympathy for, the will of other beings to live. An ethical human strives to escape from this contradiction so far as possible. For Schweitzer, mankind had to accept that objective reality is ethically neutral. It could then affirm a new Enlightenment through spiritual rationalism, by giving priority to volition or ethical will as the primary meaning of life. Mankind had to choose to create the moral structures of civilization: the world-view must derive from the life-view, not vice-versa. Respect for life, overcoming coarser impulses and hollow doctrines, leads the individual to live in the service of other people and of every living creature. In contemplation of the will-to-life, respect for the life of others becomes the highest principle and the defining purpose of humanity. The laying down of the commandment to not kill and to not damage is one of the greatest events in the spiritual history of mankind.
The Schweitzer house and Museum at Konigsfeld in the Black Forest.
After the birth of their daughter (Rhena Schweitzer Miller), Albert’s wife, Helene Schweitzer was no longer able to live in Lambarene owing to her health. In 1923 the family moved to Konigsfeld im Schwarzwald, Baden-Wurttemberg, where Schweitzer was building a house for the family. This house is now maintained as a Schweitzer museum. From 1939-48 he stayed in Lambarene, unable to go back to Europe because of the war. Three years after the end of World War II, in 1948, he returned for the first time to Europe and kept traveling back and forth (and once to the USA) as long as he was able. During his return visits to his home village of Gunsbach, Schweitzer continued to make use of the family house, which after his death became an Archive and Museum to his life and work. His life was portrayed in the 1952 movie Il est minuit, Docteur Schweitzer.
The Nobel Peace Prize of 1952 was awarded to Dr. Albert Schweitzer. His The Problem of Peace lecture is considered one of the best speeches ever given. From 1952 until his death he worked against nuclear tests and nuclear weapons with Albert Einstein, Otto Hahn and Bertrand Russell. In 1957 and 1958 he broadcast four speeches over Radio Oslo which were published in Peace or Atomic War. In 1957, Schweitzer was one of the founders of The Committee for a Sane Nuclear Policy. On 23 April 1957, Schweitzer made his Declaration of Conscience speech; it was broadcast to the world over Radio Oslo, pleading for the abolition of nuclear weapons. He ended his speech, saying: The end of further experiments with atom bombs would be like the early sunrays of hope which suffering humanity is longing for.
Weeks prior to his death, an American film crew was allowed to visit Schweitzer and Drs. Muntz and Friedman, both Holocaust survivors, to record his work and daily life at the hospital. The film The Legacy of Albert Schweitzer, narrated by Henry Fonda, was produced by Warner Brothers. In 1955 he was made an honorary member of the Order of Merit by Queen Elizabeth II. He was also a chevalier of the Military and Hospitaller Order of Saint Lazarus of Jerusalem. Schweitzer died on 4 September 1965 at his beloved hospital in Lambarene, Gabon. His grave, on the banks of the Ogooue River, is marked by a cross he made himself.
Schweizer’s cousin Anne-Marie Schweitzer Sartre, was the mother of Jean-Paul Sartre. Her father, Charles Schweitzer, was the older brother of Albert Schweitzer’s father, Louis Th?ophile. The Albert Schweitzer Fellowship was founded in 1940 by Schweitzer to unite U.S. supporters in filling the gap in support for his Hospital when his European supply lines was cut off by war, and continues to support the Lambarene Hospital today. Schweitzer, however, considered his ethic of Reverence for Life, not his Hospital, his most important legacy, saying that his Lambarene Hospital was just my own improvisation on the theme of Reverence for Life. Everyone can have their own Lambarene.
Today ASF helps large numbers of young Americans in health-related professional fields find or create their own Lambarene in the U.S. or internationally. ASF selects and supports nearly 250 new U.S. and Africa Schweitzer Fellows each year from over 100 of the leading U.S. schools of medicine, nursing, public health, and every other health-related field (including music, law, and divinity), helping launch them on lives of Schweitzer-spirited service. The peer-supporting lifelong network of Schweitzer Fellows for Life numbered over 2,000 members in 2008, and is growing by nearly 1,000 every four years. Nearly 150 of these Schweitzer Fellows have served at the Hospital in Lambarene, for three-month periods during their last year of medical school. The International Albert Schweitzer Prize was first awarded on 29 May 2011 to Eugen Drewermann and the physician couple Rolf and Raphaela Maibach in Konigsfeld im Schwarzwald, where Schweitzer’s former residence now houses the Albert-Schweitzer Museum.
Previous brain studies have shown that when a person witnesses someone else in an emotional state – such as disgust or pain – similar activity is seen in both people’s brains. This shows a physiological base for empathy, defined as the ability to understand and share another person’s experience. Now research at the University of Wisconsin has used advanced brain images (fMRI, functional magnetic resonance imaging) to show that compassion meditation – a specific form of Buddhist meditation – may increase the human capacity for empathy. In the study, researchers compared brain activity in meditation experts with that of subjects just learning the technique (16 in each group). They measured brain activity, during meditation and at rest, in response to sounds – a woman in distress, a baby laughing, and a busy restaurant – designed to evoke a negative, positive, or neutral emotional response.
Results showed that both the novice and the expert meditators showed an increased empathy reaction when in a meditative state. However, the expert meditators showed a much greater reaction, especially to the negative sound, which may indicate a greater capacity for empathy as a result of their extensive meditation training. According to the authors, an increased capacity for empathy may have clinical and social importance. The next step, they added, is to investigate whether compassion meditation results in more altruistic behavior or other changes in social interaction.
The article was published in Annals of the NT academy of Sciences (2009; 1172: 34-53).
Understanding the malleable determinants of cellular aging is critical to understanding human longevity. Telomeres may provide a pathway for exploring this question. Telomeres are the protective caps at the ends of chromosomes. The length of telomeres offers insight into mitotic cell and possibly organismal longevity. Telomere length has now been linked to chronic stress exposure and depression. This raises the question of how might cellular aging be modulated by psychological functioning.
The article considers two psychological processes or states that are in opposition to one another–threat cognition and mindfulness–and their effects on cellular aging. Psychological stress cognitions, particularly appraisals of threat and ruminative thoughts, can lead to prolonged states of reactivity. In contrast, mindfulness meditation techniques appear to shift cognitive appraisals from threat to challenge, decrease ruminative thought, and reduce stress arousal. Mindfulness may also directly increase positive arousal states.
The article reviewed data linking telomere length to cognitive stress and stress arousal and present new data linking cognitive appraisal to telomere length. Given the pattern of associations revealed so far, the authors propose that some forms of meditation may have salutary effects on telomere length by reducing cognitive stress and stress arousal, and increasing positive states of mind and hormonal factors that may promote telomere maintenance. Aspects of this model are currently being tested in ongoing trials of mindfulness meditation.
Meditation is a mind and body practice. There are many types of meditation, most of which originated in ancient religious and spiritual traditions. Some forms of meditation instruct the practitioner to become mindful of thoughts, feelings, and sensations and to observe them in a nonjudgmental way.
The publisher’s final edited version of this article is available at Substance Abuse (2009;30:263).
This thematic issue of Substance Abuse was devoted to an emerging, promising area of research, mindfulness meditation as a therapy for addictive disorders. Conceptual framework and findings from a pilot-level research combined with an anecdotal evidence from clinical practice support the use of this innovative therapy for a broad spectrum of substance use disorders and mental health problems in general. If effective, mindfulness meditation based interventions could help improve treatment outcomes in addictive disorders.
The link between stress and addiction is well-known. Stress increases the likelihood of alcohol and drug use, and can precipitate relapses following treatment. Clinicians and researchers recognize the critical need to incorporate stress management techniques into inpatient and outpatient treatment. The goal is to assist clients to replace substance use with healthy coping skills when confronted with the inevitable stressors that threaten sobriety. Improved treatment retention and relapse prevention are desired outcomes of the challenging search for evidenced-based programs for recovering addicts.
Mindfulness meditation, originally derived from Buddhist Vipassana meditation, is the cornerstone of the Mindfulness-Based Stress Reduction (MBSR) program developed by Kabat-Zinn in 1979 to teach patients with chronic physical and mental health problems how to improve their lives. MBSR is now used as an adjunctive treatment for a wide range of disorders and is increasingly finding its way into the treatment of addiction. Kabat-Zinn defines mindfulness as paying attention in a particular way: on purpose, in the present moment, and nonjudgmentally. Mindfulness encourages awareness and acceptance of thoughts, feelings and bodily sensations as they arise, and recognition of their impermanence. Mindfulness practitioners are taught to acknowledge and accept their experiences rather than to modify or suppress them. This change in one’s relationship to present-moment experience has been described as reperceiving or attentional control, and may facilitate more mindful behavioral choices. The set of skills associated with mindfulness can be taught independent of religious or cultural background, and in a variety of forms of interventions. In addition to MBSR, mindfulness-based interventions, used in a context of addictive disorders, include Mindfulness-Based Cognitive Therapy (MBCT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT). Recent modifications of these approaches, developed specifically for substance abusing populations, include Mindfulness-Based Relapse Prevention (MBRP) and Mindfulness-Based Therapeutic Community (MBTC) treatment.
Guidance for Outsourcing Facilities That Compound Sterile Human Drugs
The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013. The DQSA added section 503B to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 503B, a compounder can elect to register with the FDA as an outsourcing facility. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the FD&C Act, including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and increased federal oversight. Some health care providers purchase compounded sterile drugs to treat patients whose medical needs cannot be met by FDA-approved drugs. In such cases, the FDA encourages health care providers to purchase from compounders that register as outsourcing facilities.
The new guidance documents are:
- Final guidance on registration of human drug compounding outsourcing facilities under section 503B of the FD&C Act. This final guidance assists compounding facilities that decide to register as outsourcing facilities with the logistics of registering with the FDA, and the process for registering, re-registering, and de-registering.
- Final guidance on fees for human drug compounding outsourcing facilities under sections 503B and 744K of the FD&C Act. This final guidance provides information about the fees that a facility must pay to register as an outsourcing facility; how facilities can submit payment to the FDA; the consequences of failure to pay fees; and how a facility can qualify as a small business to obtain a reduction in registration fees. The guidance also provides information on fees that may be assessed for reinspection of outsourcing facilities.
- Revised draft guidance on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the FD&C Act. This revised draft guidance provides information about the electronic submission of drug product reports to the FDA for registered outsourcing facilities. Upon initial registration as an outsourcing facility and twice each year, registrants must electronically submit a drug product report to the FDA. This report must identify all drugs compounded by the outsourcing facility during the previous six-month period and provide certain information for each compounded drug.
The draft guidance on electronic drug product reporting is available in the Federal Register for public comment for 60 days.
Baked Halibut with Sour Cream, Dill, Scallions, Parmesan
Out of the oven and onto the table – ©Joyce Hays, Target Health Inc.
2 pieces fresh halibut fillet or other mild white fish, cleaned, dry with paper towels
salt and fresh ground black pepper to taste
1 pint sour cream
2 garlic cloves minced
1 onion, chopped fine
2 teaspoons Dill, fresh chopped (extra for garnish)
1/2 cup Parmesan, finely grated
3 Tablespoons, thinly sliced scallions
First step: Gather the ingredients together in one place – ©Joyce Hays, Target Health Inc.
- Preheat oven to 375 degrees
- With canola or olive oil, spray the baking dish once and spread the oil around
- Put halibut in baking dish
Stir the topping ingredients in a small bowl – ©Joyce Hays, Target Health Inc.
- In a small bowl, stir together the sour cream, garlic, and dill weed. Stir in the finely grated Parmesan cheese and scallions and onion.
Topping is spread over the two Halibut fillets, now ready to go into oven ©Joyce Hays, Target Health Inc.
- Use a spatula to spread an even coating of this topping over each piece of the fish, using all the topping mixture.
- Wrap foil around your baking dish, (or use a cover) so essentially the fish gets steamed and stays moist. My own oven took 32 minutes to get the fish, which was thick, just right. Also, although I preheated my oven to 375, I lowered the heat once the fish was in oven, to 350.
- Bake between 20 and 35 minutes, depending on the thickness of the fish, and the way your oven heats. Just be sure that the fish is firm but not dry or too hard. Serve hot, sprinkled with remaining chopped fresh dill.
Lots to be thankful for this Thanksgiving – ©Joyce Hays, Target Health Inc.
This recipe turned out to be better than I ever dreamed. I think it’s because, at the very last minute, I decided to wrap the whole casserole dish in foil, instead of baking it uncovered. The thick halibut fillets were beautifully moist and velvet-y. If you don’t like garlic and onion as much as we do, simply use 1 garlic clove instead of 2, and use ? an onion instead of one.
This fish was amazingly good. We had it with a lovely fresh salad, creamed spinach and some leftover pasta. Jules said this rated 5 stars. He had chilled Santa Margherita, Pinot Grigio and I had Paul Hobbs Pinot Noir. I should have saved this delicious Pinot Noir for filet mignon, veal or pasta with marinara.
The Pinot Grigio was the better choice. There was a chemical reaction within my mouth, after swallowing fish and then taking a sip of the red, definitely not in sync. The only red that has worked with fish or seafood, is Hall Vineyards, Cabernet Sauvignon, and we’re getting low on that. This was not fair to the Paul Hobbs. At least five years ago, I began to hear about this CA master wine maker. When I tried to buy some at Sherry-Lehmann, I learned about state wine shipping rules. At that time, Paul Hobbs wines could not be sent to NY State but now they can. The Paul Hobbs Pinot Noir got at least a 93 point rating and is delicious.
We tried out the halibut recipe earlier in the week than usual, because we’re off to a great adventure in Austin, Texas this weekend, overlooking lovely Lady BirdLake.
Ladybird Lake and downtown Austin
Hope everyone has a pleasant Thanksgiving, with lots to be thankful for.
From Our Table to Yours!
HIV-1 harms people by invading immune system cells known as T lymphocytes, hijacking their molecular machinery to make more of themselves, then destroying the host cells — leaving the infected person more susceptible to other deadly diseases. T lymphocytes are not complete sitting ducks, however. Among their anti-virus defense mechanisms is a class of proteins known as APOBEC3s that have the ability to block the HIV-1’s ability to replicate. Not surprisingly, however, HIV-1 has a counter-defense mechanism — a protein called Vif that cons the T lymphocytes into destroying their own APOBEC3.
Suspecting differential susceptibility to HIV-1 might be related to genetic variations in this system, a research team led by doctoral student Eric Refsland and Reuben Harris of the University’s College of Biological Sciences and Medical School took a closer look. First, the researchers found that HIV-1 infection boosts the production of one kind of APOBEC3, APOBEC3H — suggesting it’s a key player in fighting back. Then, using an experimental technique known as separation of function mutagenesis, they discovered that different people have different strengths/potencies of APOBEC3H, with some proteins expressed stably and others inherently unstable. The stable variations, the researchers found, were able to successfully limit HIV-1’s ability to replicate if the infecting virus had a weak version of Vif — but not for HIV-1 viruses that had strong Vif.
“This work shows that the competition between the virus and the host is still ongoing,” Refsland says. “The virus hasn’t completely perfected its ability to replicate in humans.”
Armed with this clearer picture of the multifaceted interactions between Vif and APOBEC3, Harris says, the next step is to figure out how to stop Vif from disabling the APOBEC3 enzymes. “One could imagine drugs that stop Vif from binding with APOBEC,” he said. “This is a bonafide HIV killing pathway, and we just have to devise clever ways to activate it in infected persons. Such an approach could indefinitely suppress virus replication, and even result in curing it.”
- Eric W. Refsland, Judd F. Hultquist, Elizabeth M. Luengas, Terumasa Ikeda, Nadine M. Shaban, Emily K. Law, William L. Brown, Cavan Reilly, Michael Emerman, Reuben S. Harris. Natural Polymorphisms in Human APOBEC3H and HIV-1 Vif Combine in Primary T Lymphocytes to Affect Viral G-to-A Mutation Levels and Infectivity. PLoS Genetics, 2014; 10 (11): e1004761 DOI:10.1371/journal.pgen.1004761
University of Minnesota. “Why some people may be immune to HIV-1: Clues.” ScienceDaily. ScienceDaily, 20 November 2014. <www.sciencedaily.com/releases/2014/11/141120141750.htm>.