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In the first study buy 40mg atomoxetine otc symptoms whiplash, six volunteers were given a single oral dose of glutamine at three different doses (0 buy discount atomoxetine 40mg 247 medications, 0 buy atomoxetine 10 mg with visa symptoms 4 weeks. A second study in nine volunteers was performed to investigate the effects of intravenous infusion of glutamine at three doses (0, 0. After single oral doses, plasma glutamine concentrations rose in proportion to the dose given, by approximately twofold after 1 hour for the higher dose, and returned to basal within 4 hours. Overall, there were no indications of adverse effects at any dose when glutamine was given by either the oral or intravenous route. There was no significant increase in plasma glutamine concentration, and no other adverse effects were observed, but the authors noted their concern regard- ing elevations in liver enzymes. After 6 days the plasma glutamine was increased by 8 percent in the treated group compared with a decrease of 15 percent in the controls. Plasma glutamine was modestly increased and nitrogen balances were improved compared with the control group. On the basis of plasma ammonia and glutamate levels and the absence of clinical signs of neuro- toxicity, it was concluded that glutamine at this dose is safe in preterm infants. Also, Roig and coworkers (1996) reported no increases in the concentrations of glutamine, glutamate, and ammonia in very low birth- weight infants given enteral supplements of glutamine (0. It is notable that despite the substantial number of published investi- gations in which glutamine has been administered to humans, very few, if any adverse effects have been reported. However, the published studies of toxicity have not fully taken account of a number of important factors, including the chronic consumption of glutamine. Glutamine is an impor- tant fuel utilized by most rapidly growing tumors (Kovacevic and Morris, 1972), which may deplete the body’s ability to provide glutamine (Chen et al. Moreover, tumor cells are dependent on a supply of glutamine for growth (Colquhoun and Newsholme, 1997), and the growth rates correlate with the activity of glutaminase (Knox et al. Therefore, although providing supplemental glutamine might restore the body glutamine pool, it is also important to examine the possibility that glutamine supplements may pro- mote cancer. However, the evidence points to the contrary, and in vivo studies have not confirmed this suspicion (Klimberg and McClellan, 1996; Souba, 1993). Oral administration of glutamine did not enhance tumor growth in rats in vivo (Klimberg et al. It is the only amino acid that does not have an asymmetric carbon atom, and its metabolism is linked to that of L-serine. Men 19 through 30 years of age had the highest intakes at the 99th percentile of 7. Growth depression in rats and chicks has been reported after feeding diets containing as much as l0 percent glycine (Harper et al. In patients with schizophrenia, oral doses of approximately 60 g/d of glycine for several weeks failed to reveal adverse effects (Leiderman et al. There have been no chronic dose–response studies with L-glycine in healthy humans. Further, men fed amino acid-based diets containing 10 g of nitrogen/d devoid of histidine remained in nitrogen balance for up to 2. Conversely, it has been observed that nitrogen balance becomes gradually negative over a longer period of time and nitrogen balance rapidly became positive upon the reintroduction of histidine (Kopple and Swendseid, 1975). Histidine is an important component of hemoglobin (8 percent), with the bulk being in the globin portion. In addition, the dipeptide carnosine, found in skeletal muscle, is a large store of histidine and serve as a source of histidine (Christman, 1971). Because of these large body pools of histidine it takes a prolonged period (more than 60 days) to deplete an adult of histidine. Men 51 through 70 years of age had the highest intakes at the 99th percentile of 5. Histidine given acutely by intraperitoneal injection or intravenously has been shown to result in changes in the concentration of brain amino acids (Oishi et al. Young rats (4 to 5 weeks old) treated with an inhibitor of histidinase exhibited reduced locomotor activity after an intra- peritoneal injection of histidine (250 mg/kg of body weight) (Dutra-Filho et al. Pilc and coworkers (1982) reported “bizarre behavior” in rats dosed intraperitoneally with histidine (400 to 800 mg/kg of body weight). Feeding low-protein diets supplemented with L-histidine for 3 to 4 weeks resulted in significant body weight losses after only several days in rats. However, the effects became less as increasing levels of high-quality protein were added to the diet (Benevenga and Steele, 1984). Short-term feeding studies (7 to 46 days) in rats have shown growth retardation, hepatomegaly, and hypercholesterolemia at L-histidine levels of approximately 2 to 4 g/kg body weight/d (Harvey et al. Harvey and coworkers (1981) reported significantly reduced concentra- tions of copper and zinc in the plasma and reduced liver concentrations of copper after feeding diets containing 8 percent L-histidine (~4 g/kg body weight/d) for 46 days. Hypercholesterolemia was eliminated by the simul- taneous feeding of an L-histidine- and copper-supplemented diet, support- ing the hypothesis that the histidine-induced hypercholesterolemia was a result of changes in copper status. No significant treatment-related increases in any tumors were reported when compared to matched controls. Pinals and coworkers (1977) treated 30 rheu- matoid arthritis patients and 30 controls daily with capsules containing 4. It is not clear which adverse effects were examined; however, the authors concluded that no adverse effects of the histidine therapy were noted. In a similar double-blind treatment design, Blumenkrantz and co- workers (1975) treated 42 patients (16 chronic uremic and 26 undergoing maintenance dialysis) with oral doses of 4 g/d of L-histidine for 17. No adverse effects were reported; however, it was not evident from the report which adverse effects were examined. Studies on the effects of L-histidine on taste and smell acuity in humans have produced conflicting results. Henkin and coworkers (1975) reported decreased taste and smell acuity in six patients given 8 to 65 g of histidine/d for up to 24 days. In view of the increased urinary excretion of zinc and a decreased concentration of serum zinc, the authors postulated that the effects of histidine administration were due to a zinc-deficient state. In a study of eight healthy men given 4 g/d of histidine for 2 weeks, no effects on smell or taste acuity were reported (Schechter and Prakash, 1979). Similarly, Geliebter and coworkers (1981) failed to find any effect of L-histidine on taste and smell after oral dosing of L-histidine between 24 and 64 g/d for 4 weeks. Even at the lower dose (4 g/d), adverse effects such as headaches, weakness, drowsiness, and nausea were reported, while at the highest doses (24 and 64 g/d) anorexia, painful sensations in the eyes, and changes in visual acuity were reported in two females. Although the study examined parental administration, it pro- vides further evidence that excess histidine intake in humans can lead to histidine/zinc interactions that might lead to a zinc-deficient state. Dose–Response Assessment In experimental animals, the only dose–response study on the chronic oral administration of L-histidine was that of Ikezaki and coworkers (1996).

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Personalised medicine is an approach to healthcare that puts the citizen in the centre discount atomoxetine 10 mg otc treatment naive definition. By developing tailor-made diagnostic order 25mg atomoxetine amex medications diabetic neuropathy, treatment and prevention strategies discount 10mg atomoxetine with visa medications 222, patients receive therapies that specifically work for them. It also allows people to participate in the management of their own health by having access to information about the prevention and treatment of disease. There is no universally accepted definition of personalised medicine and the concept is evolving with the advance of technology. A definition which is gaining acceptance in Europe was however presented (see keynote session). Already in 2011, a European Commission conference on the subject highlighted the role of molecular diagnostics in helping healthcare professionals identify which patients were most likely to respond to specific interventions. New diagnostic technology was making it possible to match patients with the most appropriate treatments. Since then diagnostics have become more sophisticated, and a revolution in information technology has made it possible for researchers to collect, store and analyse ever-larger quantities of data that are relevant to patient care. On 1-2 June 2016, the European Commission held a second conference on personalised medicine, this time to discuss a broader policy perspective. Putting the patient at the center of healthcare will require innovation in the way medicines are developed and healthcare systems are structured to deliver care. Under this new paradigm, the patient ceases to be the subject of research or treatment and instead becomes an active partner. This will require a big adjustment amongst all participants in the healthcare system. But the potential rewards can be significant: better healthcare at more affordable prices. They will use their own funding rules and policy processes to contribute to the overall goals of the consortium. As highlighted by the Commissioner, the focus of this consortium will be to make Europe a global leader in personalised medicine, define the research challenges and develop the science and drive innovation. Ruxandra Draghia-Akli, Director of the Health Directorate, Directorate-General for Research and Innovation, gave an overview of the subject. While there are other ways to describe patient-centric healthcare, such as stratified medicine and precision medicine, the Commission has elected to use the term personalised medicine. According to this definition, personalised medicine “…refers to a medical model using characterisation of individuals’ phenotypes and genotypes (eg molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention. The Commission was an early mover in the field, already in 2011 it looked at the role of the ‘omics’ disciplines in helping understand the causes of disease. Robert-Jan Smits, Director-General for Research and Innovation, said that personalised medicine goes beyond the scope of pharmaceuticals to include other industries. It promises to make healthcare smarter and proactive and it is in line with the Commission’s priorities of supporting cutting edge research, driving innovation and creating new markets and jobs. It will rely on the ability of participants to integrate data from multiple sources and use this information to improve health without affecting patient confidentiality. He noted that inequalities still exist within healthcare systems at a national level. Personalised medicine is an opportunity to look at new ways of delivering healthcare, assessing healthcare technologies and monitoring regulatory systems to make sure that they are keeping up with innovation. It is an approach to healthcare that presents an opportunity to bring people together to work on big issues of common interest. There are opportunities for industry to develop new business models based on the widespread use of digital technologies. Personalised medicine also goes hand-in-hand with the development of 2 The Council conclusions on personalised medicine for patients can be consulted on the web page: http://eur- lex. While the regulatory aspects of some of the new technologies are being addressed, there remains the issue of the cost of personalised medicine. Roberto Viola, Director-General for Communications Networks, Content and Technology, addressed the issue of data. For example, computing power needs to be increased, with the possibility of creating a European science cloud. The Directorate-General for Communications Networks, Content and Technology plays various roles in the personalised medicine initiative; considering activities in e-Health, Big data and High Performance Computing. The regulatory aspects are equally important: such as data flows, cybersecurity and data exchanges. Using breast cancer as an example, he said molecular analysis has shown that there is not one, but several types of the disease. Yet will these new treatments help a woman with cancer who also lives in a deprived area and may also be suffering from obesity and diabetes? Personalised medicine may be a way of closing the gap between clinical medicine and the other aspects of real life that affect human health. These differences can be captured in data, but patients must consent to provide this data. Another question is whether it will be possible to produce a better quality of care at a reduced cost. This will require a shift from a system that reacts to disease to one that seeks to prevent disease. Patient-reported outcome statistics will make it possible to establish which interventions are necessary and which are not. Anders Olauson, Honorary President of the European Patients’ Forum, ended the session with a call for patient empowerment. This entails giving patients access to information that will enable them to work with doctors in the management of their own healthcare. Personalised medicine puts the patient at the centre of healthcare decision-making. She illustrated this with an example of a woman whose aunt had a gene mutation which was predictive of cancer. After genetic counselling, the woman asked to be tested and discovered that she too was positive and had a risk of developing cancer. This points to a new model for care where the patient is engaged in researching aspects of his or her own health. Diagnosed with lymphoma in 2005, Peter Kapitein is a founder of the patient advocacy group Inspire2Live. Based in the Netherlands, Inspire2Live has about 34 members who are living with cancer. They meet with clinicians, scientists and business people to identify parts of the cancer healthcare system that could be improved. The group supports a fundraising event each year where cyclists bike up and down Alpe d’Huez in the French Alps six times in one day. They are: engage people with different perspectives; search for the root cause of a problem; think on a big scale, and remain independent.

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This risk em- bodies powerful reasons for hospitals and physicians to collaborate in improving patient safety cheap atomoxetine 40 mg amex premonitory symptoms, as well as to increase efficiency and customer service cheap atomoxetine 18 mg with visa medications knowledge. Increased cost sharing will probably increase bad debts for pro- viders of all types and friction with patients in collecting those debts order atomoxetine 40mg visa natural pet medicine. Hospitals and physicians will become increasingly visible as a source of health cost increases as the veil of third-party insurance is partially stripped away. Interactive claims management between hospitals, doctors, and health plans could lead to instantaneous electronic payment for health services, markedly reducing not only accounts receivable, but also clerical expense on both ends of the transaction. Hospitals and physicians must be prepared to digitize their back offices and connect their claims systems to health insurers via the Internet. As suggested earlier, nurses and hospital personnel presently wrestling the paperwork monster of antiquated healthcare pay- ment schemes could be reassigned to supporting continuity of care and communication with patients. Health plans have been strangled by the sheer magnitude of their back-office problems. Just as with hospitals, health plans must have modern enterprise information systems before they can fix the customer service problems that have plagued them. Health plans certainly have as much incentive to change their business model as any actor in the healthcare system. If physicians face the crippling inability to take collective action and hospitals struggle with an anarchic clash of professional interests and cultures, then health plans will struggle with a legacy of paternalism and insensitivity to the needs of the consumer and family. Humana not only has invested $1 billion in the last four years to renovate and computerize its back office, but it has also invested in a suite of consumer applications to bring “consumer directed” health plan options to its members. Blending web-enabled health plan customization with sharp increases in cost sharing for hospital services, Humana was able to reduce its own employees’ health benefits cost escalation from 19 percent per year to under 5 percent in the first two years of its new plan. Delivering promised improvements in service is the true test of good intentions by health plans. If, as it is said in architecture, God is in the details, in e-commerce, God is in the back end. Adminis- trative systems in health plans need to be completely renovated and digitized for any of the promising Internet tools discussed above to make any difference. Properly executed, Internet applications can help health Health Plans 141 plans rebuild their relationships with hospitals and physicians by reducing or eliminating paperwork and bureaucratic interference with medical practice. Information technology enabled by the Internet can, again if properly executed, bring tangible benefits to consumers that will help them make constructive use of the choice they have demanded. In addition, information systems strategies can help health plans offset a significant percentage of the present cost rise with improved productivity and efficiency and more responsible consumer choices. Connectivity makes all organizations more transparent and ac- countable to customers. Health plans that embrace the need for openness and responsiveness will find their position in the health system strengthened in future years. The health plans that succeed in the digital transformation will not only survive, but also prosper. How government responds to these political pressures and how it structures payment for health services under the Medicare and Medicaid programs will affect both the speed and universality of the changes discussed in this book. Changing healthcare payment methodology Each of these issues will be discussed below. Personal health informa- tion is the most intimate documentary information that exists in the 145 U. Someone with access to this information knows a person’s most carefully guarded secrets—personal medical and psy- chiatric history, sexual orientation and history, lifestyles and their risks, drug history, and a lot of things about relationships with others. Insurers who see the totality of someone’s healthcare use can use that information to estimate how good or bad an insurance risk he or she may be in the future and decide not only if they wish to provide coverage, but also how much to charge for it. That patients disclose this information to physicians is vital to ensuring optimal care. Physicians require it because making intel- ligent treatment decisions is based on understanding medical and personal history and the impact of those decisions on health. If physicians cannot be trusted with intimate personal knowledge, the opportu- nity for injury or death escalates alarmingly. Yet this intimate doctor-patient relationship is really a three-way relationship, in which only two of the parties are physically present. Despite its intimacy, medical information is also among the most widely distributed and poorly protected personal information in our society. Thanks to federal legislation passed in the wake of the highly publicized Congressional hearings of Supreme Court Justice Clarence Thomas, video rental records were actually safer from dis- closure than a patient’s medical records. The main reason is that health costs have grown to the point that they are no longer an affordable personal respon- sibility. As a direct consequence, third parties, typically employers and the health insurers they hire to manage their health costs, de- mand access to this information. With the growth in managed care, health plans use personal health information to establish whether the healthcare they pay for is necessary and appropriate. Because insurers and employers have an economic incentive to minimize their outlays, their interest in obtaining personal medical information has acquired a pungent adversarial odor. Employers with access to employees’ health history may decide they no longer 146 Digital Medicine wish to employ someone or invest in training or promoting that person into a leadership position to avoid being responsible for their medical costs. When someone sees a physician or visits a hospital, he or she is typically required to sign a release that authorizes the provider to release whatever information the health insurer may require to review the medical claim arising from the visit. The result is a legal authorization for the physician to breach medical confidentiality in order to get paid. The information patients authorize physicians to release is not only compared to the health plan’s contract to ensure that the service is covered by the health plan. It is also compared to the informa- tion provided about the employee’s medical history when he or she enrolled in the health plan. The purpose of this review is to determine if the condition for which the patient is being treated predates enrollment in the health plan. If it does, but the employee did not disclose that precondi- tion, the plan can not only refuse to pay the claim, but it may also move to invalidate coverage on the grounds that the employee misrepresented his or her health status. Employees may even be sued for fraud if the health plan can prove that they willfully withheld information and lied when attesting to the completeness of their health history. Because people frequently switch health plans, an individual health plan may not have a complete picture of their medical his- tory and claims experience. As a consequence, health insurers have created medical information clearinghouses, which aggregate med- ical information from diverse sources. Insurers routinely draw on this source of information to obtain additional information about consumers to determine if there is a reason to avoid paying their medical claims. The health information in these bureaus is technically avail- able only to health insurers. In practice, however, it is available on Health Policy Issues Raised by Information Technology 147 demand to law enforcement agencies, which can obtain access to it merely by asking for it. They do not even require a court-issued search warrant; they can just send a letter and obtain health infor- mation without the knowledge or consent of the person involved. Also, like virtually every other computerized database, medical information is accessible to computer hackers who “break and en- ter” the provider, insurer, or clearinghouse database. In 2000,a hacker broke into the clinical information system at the University of Washington’s principal teaching hospital and obtained extensive personal health histories on a number of patients.