Target Health and LifeOnKey Have Been Awarded a BIRD Foundation Grant to Develop Integration of the Electronic Health Record and EDC

 

 

The Israel-United States Binational Industrial Research and Development Foundation (BIRD Foundation) has announced that the organization will be providing $9 million in funding for 10 new joint projects in infrastructural sectors. BIRD established in 1977, receives joint funding from the American and Israeli governments to back collaborative research and development projects involving one American company and one Israeli company.

 

For one of the 10 new projects in the biomedical sector, LifeOnKey of Israel and Target Health Inc. of New York City will be integrating clinical trial electronic databases with electronic health record systems.

 

The integration of the LifeOnKey EMR with the Target e*CRF EDC system, and the new applications and solutions to be developed, assures that 1) the clinical research investigator maintains the original source document or a certified copy (Requirement 5, ICH GCP 2.11, 5.15.1); 2) source data can only be modified with the knowledge or approval of the clinical research investigator (Requirement 6, ICH GCP 4.9.3, 4.9.4 and chapter 8), and 3) the pharmaceutical company sponsoring a clinical trial will not have exclusive control of a source document (Requirement 10, ICH GCP 8.3.13); 4) Physicians will be able to use the data entered in the patient clinic, to be automatically driven to the EDC system; and 5) clinical trial data and registries used as a tool for post marketing surveillance, will be maintained in one platform.

 

Financing up to 35 “full-scale“ and 20 “mini“ projects each year, the foundation provides up to 50% of each company’s research and development expenses, according to the organization. These 10 new projects will be joining an already existing database of 835 BIRD projects involving $295 million worth of investments, which have help generate direct and indirect sales amounting to more than $8 billion, the organization added.

 

“The benefits for both the US and Israeli economies show that it is a worthwhile effort,“ said Avi Hasson, chief scientist of the Industry, Trade and Labor Ministry and co-chairman of the BIRD board. “The diversified projects that were approved address the market need for innovation in every area of our daily life such as water technologies, environmental recycling, cyber security and firefighting,“ said BIRD executive director Dr. Eitan Yudilevich.

 

Other projects include a system for advanced water leakage control, which will be developed by Steam Control Ltd. in Israel and American Water Works Company in New Jersey. A second project, to be generated by Polysack Flexible Packaging of Israel and Applied Extrusion Technologies of Delaware, will focus on building sustainable materials that enable the recycling of shrink-packaged food containers. In the telecommunications sector, Ubiqam of Israel and Global Wireless Technologies of New Jersey will be developing a mobile relay station for 4G long-term-evolution (LTE) with mesh networking capabilities – in which the connection is dispersed among a variety of nodes rather than relying on one single source. Also in telecommunications, Vayyar Imaging Ltd. of Israel and Agilent Technologies of California will be creating a low-cost, high-performance network analyzer. Foresight of Israel and Net Optics Inc. of California will be developing business continuity solutions for websites, while GONET Systems of Israel and Juniper Networks of California will be generating an analog WiFi beamformer – a type of processing system for signal transmission. In the transportation industry, Silentium of Israel and Johnson Controls of Wisconsin will be creating an ambient active noise reduction solution for the automative industry, according to BIRD. Elbit Systems Ltd. of Israel and Trace Worldwide Cooperation of California will be developing advanced aerial firefighting tools for American helicopters. In the biomedical arena, B.R.F Engineering Ltd. of Israel and InfraScan, Inc. of Pennsylvania will be working on a device for early detection of abdominal hematoma.

 

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 at www.targethealth.com

Aging in Brain Found to Hurt Sleep Needed for Memory

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Scientists have known for decades that the ability to remember newly learned information declines with 1) ___, but it was not clear why. A new study may provide part of the answer. The report, posted online last Sunday by the journal Nature Neuroscience, suggests that structural 2) ___ changes occurring naturally over time interfere with sleep quality, which in turn blunts the ability to store memories for the long term. Previous research had found that the prefrontal 3) ___, the brain region behind the forehead, tends to lose volume with age, and that part of this region helps sustain quality sleep, which is critical to consolidating new memories. But the new experiment, led by researchers at the University of California, Berkeley, is the first to directly link structural changes with sleep-related memory problems. The findings suggest that one way to slow memory decline in aging 4) ___ is to improve sleep, specifically the so-called slow-wave phase, which constitutes about a quarter of a normal night’s slumber.

 

Doctors cannot reverse structural changes that occur with age any more than they can turn back time. But at least two groups are experimenting with electrical stimulation as a way to improve deep sleep in older people. By placing electrodes on the 5) ___, scientists can run a low current across the prefrontal area, essentially mimicking the shape of clean, high-quality slow waves. The result: improved memory, at least in some studies. “There are also a number of other ways you can improve sleep, including 6) ___,“ said Ken Paller, a professor of psychology and the director of the cognitive neuroscience program at Northwestern University, who was not involved in the research. Dr. Paller said that a whole array of changes occurred across the brain during aging and that sleep was only one factor affecting memory function. But he said the study told “a convincing story, I think: that atrophy is related to slow-wave sleep, which we know is related to 7) ___ performance. So it’s a contributing factor.“

 

In the study, the research team took brain images from 19 people of retirement age and from 18 people in their early 20s. It found that a brain area called the medial prefrontal cortex, roughly behind the middle of the 8) ___, was about one-third smaller on average in the older group than in the younger one – a difference due to natural atrophy over time, previous research suggests. Before bedtime, the team had the two groups study a long list of words paired with nonsense syllables, like “action-siblis“ and “arm-reconver.“ The team used the nonwords because one type of memory that declines with age is for new, previously unseen information. After training on the pairs for half an hour or so, the participants took a 9) ___ on some of them. The young group outscored the older group by about 25%. Then everyone went to bed and bigger differences emerged. For one, the older group got only about a quarter of the amount of high-quality slow-wave sleep that the younger group did, as measured by the shape and consistency of electrical waves on an electroencephalogram machine, or 10) ___. It is thought that the brain moves memories from temporary to longer-term storage during this deep sleep. On a second test, given in the morning, the younger group outscored the older group by about 55%. The estimated amount of atrophy in each person roughly predicted the difference between his or her evening and morning scores, the study found. Even seniors who were very sharp at 11) ___ showed declines after sleeping.

 

“The analysis showed that the differences were due not to changes in capacity for memories, but to differences in sleep 12) ___,“ said Bryce A. Mander, a postdoctoral fellow at Berkeley and the lead author of the study. His co-authors included researchers from the California Pacific Medical Center in San Francisco; the University of California, San Diego; and the Lawrence Berkeley National Laboratory. The findings do not imply that medial prefrontal atrophy is the only age-related change causing memory problems, said Matthew P. Walker, a professor of psychology and neuroscience at Berkeley and a co-author of the study. “Essentially, with age, you lose tissue in this 13) ___ area,“ Dr. Walker said. “You get less quality deep sleep, and have less opportunity to consolidate new memories.“ Source: The New York Times, January 29, 2013, by Benedict Carey

 

ANSWERS: 1) age; 2) brain; 3) cortex; 4) adults; 5) scalp; 6) exercise; 7) memory; 8) forehead; 9) test; 10) EEG; 11) night; 12) quality; 13) prefrontal

Mental Afflictions

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Medieval Painting of Trepanation

 

 

Editor’s note: On an NIH website, there is an honest appraisal of what is known today, 2013, about mental illness: “At this time, scientists do not have a complete understanding of what causes mental illnesses. If you think about the structural and organizational complexity of the brain together with the complexity of effects that mental illnesses have on thoughts, feelings, and behaviors, it is hardly surprising that figuring out the causes of mental illnesses is a daunting task. The fields of neuroscience, psychiatry, and psychology address different aspects of the relationship between the biology of the brain and individuals’ behaviors, thoughts, and feelings, and how their actions sometimes get out of control. Through this multidisciplinary research, scientists are trying to find the causes of mental illnesses. Once scientists can determine the causes of a mental illness, they can use that knowledge to develop new treatments or to find a cure.“

 

Perhaps, it will be discovered that we all have a neurosis and that it’s just a matter of degree. This approach might be more helpful than creating a separate category, with a disparaging label, in which others are cast, always the other, but never ourselves. There is something more humane about the approach of the ancient Greeks and Romans, as well as Traditional Chinese Medicine (TCM), where all illness is part of a malfunction of the physical system, considered holistically and treated as such, and, of course, the Freudian concepts of, unconscious mind, dream analysis, talking it out and working it through, (with transference and counter transference), changed the whole landscape and pivoted our thinking toward rational discourse on the profound subject of the mind and what exactly is meant by normal?

 

 

Stone Age

During the Stone Age, approximately 2 million years ago in Europe and 30,000 years ago in the Americas, it was believed that evil spirits caused mental illnesses or abnormal behaviors. The most common treatment during this time period was trepanning. The process of trepanation was done by drilling holes into the skull of the possessed person, therefore allowing the evil spirits to leave.

 

Ancient Egypt

In Ancient Egypt, approximately 6000-5000 BCE, mental and physical illness were seen as the same thing. The causes of illness, whether physical or mental, was seen as originating from evil spirits/demons or as the wrath of the gods. Healing, for these illnesses, was seen as a religious practice and the majority of therapy involved the use of temples and advice from religious deities. Physicians, magicians, and priests all had the same role therefore the treatment of the mentally ill was no different from other illness treatment. The majority of illnesses began with a bodily etiology and were treated physically or with psychotherapy. Incubation or temple sleep was a therapeutic treatment which took place inside a temple and strongly focused on the interactions between the patients dreams and powers of the supernatural gods. The content of these dreams was highly affected by the psycho-religious climate of the temple, the confidence in the supernatural powers of the deity and the suggestive procedures carried out by the divine healers.

 

Hysterical Disorder Treatment

Because hysterical disorders were seen to be caused by either “starvation“ of the uterus or the movement of the uterus into the upper part of the body, two techniques were used in order to attempt to move the uterus back to where it was supposed to be. First, fumigation of the genitals may have been used, by covering the genitals with sweet smelling substances in order to attract the uterus back down. Another method was through inhalation or injection of foul smelling/tasting substances in order to drive the uterus back down through the body.

 

Greeks and Romans, But Especially the Greeks

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Pythagoras

 

 

Pythagoras was the first to claim the brain as the organ of human thought, in addition to being the source of mental disturbances. He adopted the notion of biological humors, and believed mental illnesses were the result of a disequilibrium of the basic harmonies (good-bad, love-hate, single-plural, and limited-unlimited). Thales moved attention away from mystical causes of mental illness, viewing them as natural events (with the source being inside the sufferers themselves) that should be approached from more of a scientific perspective. It is important to note that Hippocrates was the first to establish the brain as the seat of consciousness, and attributed mental illness to some sort of pathology in the brain, in addition to the fact that he differentiated between mania, melancholia, and dementia. According to Hippocrates, the mind made humans mad or delirious, and he believed mental illness was the result of some sort disparity between the content of dreams and reality. He also showed a relationship between diagnosis and treatment, and believed these illnesses had a natural, rather than a spiritual cause.

 

Aside from Hippocrates, however, a more scientific view of possible causes of mental illness was mostly absent during this time period. For example, most Greek medicine men continued to support some type of a magico-religious demonology as a cause of mental illness and illness in general. Hippocrates was opposed to exorcism and punishment as a treatment of mental illness, and advocated exercise and tranquility instead, and in some cases bloodletting to reestablish humoral balance.

 

Ascledpiades (4th century BCE) was the first to distinguish between hallucinations, delusions and illusions, and he stressed the environmental influences of mental illness. He opposed harsh treatments such as bloodletting and mechanical restraints to treat mental illness instead recommended measures that would relax patients. Opposed to keeping patients in darkness as well as bloodletting and fasting, Soranus (1st/2nd century CE) suggested treatments that would exercise the mind, such as having patients participants in discussions with philosophers to aid them in banishing their fears and sorrows.

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Galen

 

 

In dealing with mental illness, Galen stressed the importance of observation as well as systematic evaluation, and his concept of “psychic pathology“ was based on the physiology of the central nervous system, and also spoke of many types of depression. In addition, he saw clinical symptoms as a sign of malfunctioning neurological structures. Aurelianus believed that psychic symptoms were based on problematic mechanical structuring as opposed to an imbalance of fluid humors or vaporus animal spirits.

 

Medieval and Renaissance

With the fall of the Roman Empire, the Middle Ages saw the return of a belief in the supernatural as a cause for mental illness and the use of torture to gain confessions of demonic possession. However, some physicians began to support the use of psychotherapy. Paracelsus (1493-1541) advocated psychotherapy for treatment of the insane. When looking at the Middle Ages with regard to mental illness, it is also important to look at what was happening in religion, and more specifically Christianity. As Christianity was on the rise, many scientific findings from the Greek era were all but forgotten; the metaphysics of Plato and Aristotle were incorporated into the religious dogma of the Christian Church, and melancholia was believed to be a potential cause of behaviors originating with demons. People were burned and drowned as witches who put spells on others, with odd behavior.

 

18th and 19th Century Industrialized Europe

In the countryside, those with mental afflictions, who were wealthy, were able to stay at home because the family was able to pay for people to watch over them and for doctors to make house calls. The poor were forced into madhouses, prisons, hospitals, and work-houses because they had nowhere else to turn.

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A Madhouse in Bedlam, London

 

Throughout the 18th century, the mentally ill were referred to as lunatics and idiots. Establishments for the mentally ill were called madhouses but later became private asylums. Eventually, asylums worked in conjunction with general hospitals. By the end of the 18th century, the number of madhouses increased significantly. They made money for the entrepreneurs.

 

America – 17th, 18th, 19th Centuries

Rural living provided easy care for the mentally ill because they were spread throughout a large area. Insanity was not a substantial problem in America in the 17th and 18th centuries because rural and agricultural societies kept people at farther distances from each other than in Industrialized England. A few mentally ill people scattered over hundreds of miles in agricultural societies is much different in terms of care than when colonization begins and there is more than one mentally ill person within the same few miles. Legally, if there was a mentally ill case that was too much for one family to support financially, the community was required to intercede and assist. Because mental illness was few and far between in rural America, having a family member confined in an institution was a rare occurrence. Only when the person threatened harm to the family or to the community at large, or the family did not have the financial resources to care for their mentally ill family member, were they placed into almshouses or were given room and board with another family.

 

However, as soon as colonization began and land demographics changed, mental illness became a problem because there was no place to care for the mentally ill. This simultaneously transformed mental illness from an insignificant rural problem into a larger social problem. An increase in immigration, religiosity, awareness of medical problems, and news of Philippe Pinel?s treatise on insanity had a large impact on changes in how the mentally ill were treated. Treatment and the cost of treatment of the mentally ill changed hands from families and local communities to the state. Within a forty year time span, free public institutions increased exponentially: from only one to at least one in every state by the beginning of the Civil War.

 

Europe in the 19th and 20th Centuries

Below are some documentary videos which tell the fascinating and poignant story of the closure of Britain’s mental asylums. In the post-war period, 150,000 people were hidden away in 120 of these vast Victorian institutions all across the country. Today, most mental patients, or service users as they are now called, live out in the community and asylums have all but disappeared. Through powerful testimonies from patients, nurses and doctors, the film explores this seismic revolution and what it tells us about society’s changing attitudes to mental illness over the last sixty years.

 

 

TCM (Traditional Chinese Medicine

 

Psychiatry never really took root in China; likely because Asian cultures never emphasized cultivation of the “individual“. Self-sacrifice and self-effacement is more the norm throughout Asia. Spending money on personal development is a foreign idea. Despite the deluge of Western ideas and money, you’ll still find only a handful of psychiatrists or therapists in Beijing.

 

In China, before the twentieth century, mental illness was treated almost exclusively with acupuncture and herbal medicine. These treatments, well documented in the annals of TCM, were often successful. Perhaps the best evidence of this is the famous Fog Tea of Tianmu Mountain, which, helped free millions of Chinese from opium addiction after the opium war. Libraries full of documented case histories suggest that these 19th century herbal methods worked, or at least worked as well as anything pre-Freudian doctors were prescribing in the West. Psycho-pharmacy, the Asian approach remains valid and useful and can complement any modern day prescription or therapy. They are not a substitute for modern drugs or counseling, but can be a valuable tool in the hands of a practitioner, counselor, or patient.

 

Qi’ means the flow of our bodily energies. Practitioners of Chinese medicine believe that health is linked to these invisible flows, and that when our qi flows improperly we get sick. Health is also about harmony or balance, or the lack of it. The terms yin and yang help to describe this. When life is out of balance, we say that yin and yang become unbalanced in our body, causing physical or mental distress and disease. To practitioners of TCM, most any mental disease is, first of all, a sign of poor flow or bad balance. Phobia, paranoia, schizophrenia, depression, insomnia, etc. are symptoms of disharmony or congestion, not separate diseases in themselves. Healing these symptoms requires normalizing flow or restoring balance in the life of those afflicted. Herbal medicine can help immensely.

 

TCM reserves a special place for spirit, known as Shen. Shen resides in the heart, not in the brain. Mental disharmonies often indicate that the Shen, residing in the heart, is unsettled or troubled. We call this condition Disturbed Shen. Anxiety, insomnia, and psychosis all originate with Disturbed Shen. Though sufferers may exhibit deviant brain chemistry, these are not brain diseases. They are diseases of the chest rather than the brain, because the Shen resides in the heart, not in the head. For most people, disturbed Shen will not lead to heart disease or any physical heart problem. Nevertheless, disturbed Shen is a physical condition and will respond to therapies such as exercise, massage, acupuncture, and herbal medicines. Disturbed Shen can have many causes. Shen can be disturbed by events in our life or in our memory, by stagnation, heat, drugs, diet, loss of sleep, loss of blood, by constraint of emotion, or by excess emotions. Besides disturbing the Shen, strong emotions can also affect our organs. Excessive joy or being startled can stress the heart, worry eats at the gut, grief endangers the lungs, fear taxes the kidneys, and anger assaults the liver.

 

Shen is disturbed by tension in the chest. Thoughts about loss, inhibited expression, and guilt among other things, cause the chest to tighten. In this protective state there are fewer feelings and less emotion. Modern clinicians call this condition ?depression’. The Chinese call it stagnation of the chest qi, or Liver Qi Stagnation (LQS), and consider it to be the origin of many mental health problems. To the Chinese, clinical depression is not a definable disease, but a sign that the qi of the chest is stuck, constrained, or oppressed. In time, chest constraint can affect the underlying organs, generating anger by inflaming the liver, or anxiety by heating up the heart.

 

And Then There Was Freud – 19th and 20th Century – and Medicine Turned Around

 

Sigmund Freud developed psychoanalysis around the turn of the century, and made profound contributions to the field with his descriptions of the unconscious, infantile sexuality, the use of dreams, and his model of the human mind. He turned the sadistic treatment of mental misery, into an intelligent force for compassion and understanding. Freud’s work with neurotic patients led him to believe that mental illness was the result of keeping thoughts or memories in the unconscious, bottled up. Treatment, primarily listening to the patient and providing interpretations, would bring these memories to the forefront and thus decrease symptoms. For the next fifty years, and to the present, Freud’s methods of psychoanalysis and various versions of it were the main psychotherapy used in clinical practice. Around the 1950s, the growth of American psychology led to new, more active therapies that involved the psychotherapeutic process. However, all modern psychotherapy and psychoanalysis can be traced back to the genius of Sigmund Freud. The next major style of psychotherapy was developed not as the result of new ideas, but due to economic issues. Traditionally, psychotherapy was a long progress, often involving years of treatment. As psychotherapy became more widely available, emphasis was placed on a more brief form of treatment. This trend was further driven by the arrival of managed care insurance plans and limitations to coverage for mental health issues. Today, virtually all therapeutic modalities offer some sort of brief therapy designed to help the person deal with specific problems. Sources: Jim Haggerty MD, Wikipedia, MedPage.com, WebMD.com

Bedside Detection of Awareness in the Vegetative State

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This week it was reported that brain tests conducted on Ariel Sharon, who has been in a vegetative state since 2006, show significant brain activity.“ One bioethicist, however, says that the strange readings from functional MRI scanning conducted by UCLA and Israeli scientists do not suggest, as some in Israel hope, that the beloved one-time prime minister will come back to consciousness. So is he conscious but unable to express himself — trapped in his own body?

 

Back in 2011, a study published online in Neurology (10 November 2011) indicated that patients diagnosed as vegetative have periods of wakefulness, but seem to be unaware of themselves or their environment. Although functional MRI (fMRI) studies have shown that some of these patients are consciously aware, issues of expense and accessibility preclude the use of fMRI assessment in most of these individuals. As a result, a study was performed to assess bedside detection of awareness with an electroencephalography (EEG) technique in patients in the vegetative state.

 

This study was undertaken at two European centers which recruited patients with traumatic brain injury and non-traumatic brain injury who met the Coma Recovery Scale-Revised definition of vegetative state. A novel EEG task was developed involving motor imagery to detect command-following – a universally accepted clinical indicator of awareness – in the absence of overt behavior. Patients completed the task in which they were required to imagine movements of their right-hand and toes to command. The study analyzed the command-specific EEG responses of each patient for robust evidence of appropriate, consistent, and statistically reliable markers of motor imagery, similar to those noted in healthy, conscious controls.

 

A total of 16 patients were assessed who were diagnosed in the vegetative state, and 12 healthy controls. Three (19%) of 16 patients could repeatedly and reliably generate appropriate EEG responses to two distinct commands, despite being behaviorally entirely unresponsive (classification accuracy 61-78%). No significant relation was noted between patients’ clinical histories (age, time since injury, cause, and behavioral score) and their ability to follow commands. When separated according to cause, two (20%) of the five traumatic and one (9%) of the 11 non-traumatic patients were able to successfully complete this task.

 

According to the authors, despite rigorous clinical assessment, many patients in the vegetative state are misdiagnosed. The EEG method that the authors developed is cheap, portable, widely available, and objective and it could allow the widespread use of this bedside technique for the rediagnosis of patients who behaviorally seem to be entirely vegetative, but who might have residual cognitive function and conscious awareness.

Successful and Schizophrenic: When Existing Medical Knowledge is Not Enough and the Individual Takes Charge of Her/His Affliction

20130204-4

The New York Times, by Elyn R. Saks

 

 

The following was excerpted from an article (NYT) by Elyn R. Saks, a law professor at the University of Southern California and the author of the memoir “The Center Cannot Hold: My Journey Through Madness.“

 

THIRTY years ago, I was given a diagnosis of schizophrenia. My prognosis was “grave“: I would never live independently, hold a job, find a loving partner, get married. My home would be a board-and-care facility, my days spent watching TV in a day room with other people debilitated by mental illness. I would work at menial jobs when my symptoms were quiet. Following my last psychiatric hospitalization at the age of 28, I was encouraged by a doctor to work as a cashier making change. If I could handle that, I was told, we would reassess my ability to hold a more demanding position, perhaps even something full-time. Then I made a decision. I would write the narrative of my life. Today I am a chaired professor at the University of Southern California Gould School of Law. I have an adjunct appointment in the department of psychiatry at the medical school of the University of California, San Diego, and am on the faculty of the New Center for Psychoanalysis. The MacArthur Foundation gave me a genius grant.

 

Although I fought my diagnosis for many years, I came to accept that I have schizophrenia and will be in treatment the rest of my life. Indeed, excellent psychoanalytic treatment and medication have been critical to my success. What I refused to accept was my prognosis. Conventional psychiatric thinking and its diagnostic categories say that people like me don’t exist. Either I don’t have schizophrenia (please tell that to the delusions crowding my mind), or I couldn’t have accomplished what I have (please tell that to U.S.C.’s committee on faculty affairs). But I do, and I have. And I have undertaken research with colleagues at U.S.C. and U.C.L.A. to show that I am not alone. There are others with schizophrenia and such active symptoms as delusions and hallucinations who have significant academic and professional achievements.

 

Over the last few years, my colleagues, including Stephen Marder, Alison Hamilton and Amy Cohen, and I have gathered 20 research subjects with high-functioning schizophrenia in Los Angeles. They suffered from symptoms like mild delusions or hallucinatory behavior. Their average age was 40. Half were male, half female, and more than half were minorities. All had high school diplomas, and a majority either had or were working toward college or graduate degrees. They were graduate students, managers, technicians and professionals, including a doctor, lawyer, psychologist and chief executive of a nonprofit group. At the same time, most were unmarried and childless, which is consistent with their diagnoses. (My colleagues and I intend to do another study on people with schizophrenia who are high-functioning in terms of their relationships. Marrying in my mid-40s – the best thing that ever happened to me – was against all odds, following almost 18 years of not dating.) More than three-quarters had been hospitalized between two and five times because of their illness, while three had never been admitted.

 

How had these people with schizophrenia managed to succeed in their studies and at such high-level jobs? We learned that, in addition to medication and therapy, all the participants had developed techniques to keep their schizophrenia at bay. For some, these techniques were cognitive. An educator with a master’s degree said he had learned to face his hallucinations and ask, “What’s the evidence for that? Or is it just a perception problem?“ Another participant said, “I hear derogatory voices all the time. You just gotta blow them off.“ Part of vigilance about symptoms was “identifying triggers“ to “prevent a fuller blown experience of symptoms,“ said a participant who works as a coordinator at a nonprofit group. For instance, if being with people in close quarters for too long can set off symptoms, build in some alone time when you travel with friends. Other techniques that our participants cited included controlling sensory inputs. For some, this meant keeping their living space simple (bare walls, no TV, only quiet music), while for others, it meant distracting music. “I’ll listen to loud music if I don’t want to hear things,“ said a participant who is a certified nurse’s assistant. Still others mentioned exercise, a healthy diet, avoiding alcohol and getting enough sleep. A belief in God and prayer also played a role for some.

 

One of the most frequently mentioned techniques that helped our research participants manage their symptoms was work. “Work has been an important part of who I am,“ said an educator in our group. “When you become useful to an organization and feel respected in that organization, there’s a certain value in belonging there.“ This person works on the weekends too because of “the distraction factor.“ In other words, by engaging in work, the crazy stuff often recedes to the sidelines. Personally, I reach out to my doctors, friends and family whenever I start slipping, and I get great support from them. I eat comfort food (for me, cereal) and listen to quiet music. I minimize all stimulation. Usually these techniques, combined with more medication and therapy, will make the symptoms pass. But the work piece – using my mind – is my best defense. It keeps me focused, it keeps the demons at bay. My mind, I have come to say, is both my worst enemy and my best friend.

 

THAT is why it is so distressing when doctors tell their patients not to expect or pursue fulfilling careers. Far too often, the conventional psychiatric approach to mental illness is to see clusters of symptoms that characterize people. Accordingly, many psychiatrists hold the view that treating symptoms with medication is treating mental illness. But this fails to take into account individuals’ strengths and capabilities, leading mental health professionals to underestimate what their patients can hope to achieve in the world. It’s not just schizophrenia: earlier this month, The Journal of Child Psychology and Psychiatry posted a study showing that a small group of people who were given diagnoses of autism, a developmental disorder, later stopped exhibiting symptoms. They seemed to have recovered – though after years of behavioral therapy and treatment. A recent New York Times Magazine article described a new company that hires high-functioning adults with autism, taking advantage of their unusual memory skills and attention to detail.

 

I don’t want to sound like a Pollyanna about schizophrenia; mental illness imposes real limitations, and it’s important not to romanticize it. We can’t all be Nobel laureates like John Nash of the movie “A Beautiful Mind.“ But the seeds of creative thinking may sometimes be found in mental illness, and people underestimate the power of the human brain to adapt and to create. An approach that looks for individual strengths, in addition to considering symptoms, could help dispel the pessimism surrounding mental illness. Finding “the wellness within the illness,“ as one person with schizophrenia said, should be a therapeutic goal. Doctors should urge their patients to develop relationships and engage in meaningful work. They should encourage patients to find their own repertory of techniques to manage their symptoms and aim for a quality of life as they define it. And they should provide patients with the resources – therapy, medication and support – to make these things happen. “Every person has a unique gift or unique self to bring to the world,“ said one of our study’s participants. She expressed the reality that those of us who have schizophrenia and other mental illnesses want what everyone wants: in the words of Sigmund Freud, to work and to love.

Mindfulness-Based Meditation May Help Reduce Inflammation

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Psychological stress is a major provocative factor of symptoms in chronic inflammatory conditions. In recent years, interest in addressing stress responsivity through meditation training in health-related domains has increased astoundingly, despite a paucity of evidence that reported benefits are specific to meditation practice. Mindfulness-based stress reduction, originally designed for patients with chronic pain, consists of continuously focusing attention on the breath, bodily sensations, and mental content while seated, walking, or practicing yoga. The goal is to focus on the present experience to help change one’s relationship to it in a beneficial way.

 

In an article published in Brain, Behavior, and Immunity (2013;27:174-184), the authors present a comparison between an 8-week mindfulness-based stress reduction program (MBSR) and an 8-week active control health enhancement program (HEP) that included walking, balance, agility, core strength, nutritional education, and music therapy in 49 community volunteers randomly assigned to 1 of the 2 groups.

 

The intervention and active-control groups had similar levels of stress-evoked cortisol response and similar reductions in psychological distress, but the group trained in mindfulness-based stress reduction had significantly smaller post-stress inflammatory responses.

 

The study used the Trier Social Stress Test (TSST) to induce psychological stress and a topical application of capsaicin cream to induce inflammation. The TSST induces psychological stress by requiring participants to give a 5-minute impromptu speech on a given topic, followed by 5 minutes of mental arithmetic. The authors measured local inflammation by applying vacuum pressure to the skin of the volar forearm just below the cubital fossa to raise suction blisters. The forearm area, including the acrylic blister template with eight 6-mm holes, was wrapped in a heating pad to facilitate the formation of the blisters, which took an average of 53.6 minutes. The vacuum pressure was removed and fluid was collected from 4 blisters using a tuberculin syringe and immediately frozen for analysis by enzyme-linked immunosorbent assay. The authors applied capsaicin cream around the perimeter of, but not touching, the remaining 4 blisters for 45 minutes and then extracted and froze fluid from those blisters.

 

Blister fluid was assayed by enzyme-linked immunosorbent assay for levels of tumor necrosis factor alpha and of interleukin 8 because these cytokines are sensitive to modulation by psychological stress and because neuropeptides released from capsaicin-sensitive nerve endings trigger their release.

 

Despite the group difference in change in cortisol slope after training, the authors found no change in cortisol reactivity to the TSST. It was, however, observed that more time spent in MBSR practice was associated with lower blister fluid cytokine levels, whereas more time spent in HEP practice was associated with higher blister fluid cytokine levels. According to the authors, it seems that the postintervention potentiation of the flare response in the HEP group was related to increased skin irritability associated with colder, drier winter weather in Wisconsin. The preintervention data collection occurred during warmer months, and the daily temperature on the day of data collection was correlated with the size of the flare response.

 

According to the authors, the results suggest behavioral interventions designed to reduce emotional reactivity may be of therapeutic benefit in chronic inflammatory conditions and that mindfulness practice, in particular, may be more efficacious in symptom relief than the well-being promoting activities cultivated in the HEP program.

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

 

Federal Judge Approves Consent Decree with Ben Venue Laboratories

 

The FDA has announced today that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law.

 

The action restrains Ben Venue Laboratories, from manufacturing and distributing drugs from its Bedford, Ohio, facility until FDA determines that its operations are compliant with the Federal Food, Drug, and Cosmetic Act. Recent FDA inspections found several product quality problems, including particles in some sterile products and basic facility cleaning and maintenance issues. Poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs.

 

Ben Venue’s chief executive officer, vice president of operations, and vice president of quality operations were named defendants in the consent decree, which was signed by Judge Lesley Wells of the U.S. District Court for the Northern District of Ohio on Jan. 31, 2013.

 

Ben Venue manufactures numerous products, including drugs that are sold under its own label, Bedford Laboratories. These products include sterile injectable drugs. The company also manufactures drugs for other companies. FDA is working with Ben Venue during the company’s remediation to prioritize and ensure the availability of the company’s medically necessary drugs to respond to and prevent potential drug shortages.

 

Ben Venue has agreed to adhere to a strict timetable to bring the facility under compliance with regulatory requirements, or face substantial fines and other consequences as described in the decree. Under the decree, the FDA may order Ben Venue to stop manufacturing, recall products, and take other corrective action as necessary to ensure that patients receive safe and effective drugs.

Mindful Mouthful Bourbon Salmon

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Ingredients

 

  • 3 Tablespoons brown sugar, substitute
  • 3 Tablespoons bourbon
  • 2 Tablespoons low-sodium soy sauce
  • 1 Tablespoon grated peeled fresh ginger
  • 1 Tablespoon fresh lime juice
  • 3 garlic cloves, juiced
  • 1 onion, minced
  • 1/3 cup cilantro, chopped (save a little for garnish)
  • 1/4 teaspoon freshly ground black pepper
  • 4 (6-ounce) skinless salmon fillets
  • Cooking spray
  • 1 Tablespoon sesame seeds, toasted (for garnish)

 

Directions

 

1) Combine first 9 ingredients in a large zip-top plastic bag. Add fish to bag; seal. Marinate in refrigerator 1 1/2 hours, turning occasionally.

2) Heat a large nonstick skillet over medium-high heat. Coat pan with cooking spray.

3) Add the salmon fillets and the marinade to the pan and cook fish 4 minutes on each side or until it’s done to your taste.

 

Serve the salmon with jasmine rice and drizzle each fillet with the sauce. Sprinkle each fillet with chopped fresh cilantro and the toasted sesame seeds. Make your favorite green bean/toasted almond salad, some warm 7-grain bread or rolls. Prepare a platter of cheeses and fruit and a full bodied Merlot or a Plum wine, or a chilled Sauvignon Blanc

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Plum wine – Cheers!

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