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Friday, April 18, 2008
Tuesday, April 8, 2008
Biomedical Engineering
Biomedical Engineering Study Demonstrates the Healing Value of Magnets
Magnets have been touted for their healing properties since ancient Greece. Magnetic therapy is still widely used today as an alternative method for treating a number of conditions, from arthritis to depression, but there hasn't been scientific proof that magnets can heal.
Lack of regulation and widespread public acceptance have turned magnetic therapy into a $5 billion world market. Hopeful consumers buy bracelets, knee braces, shoe inserts, mattresses, and other products that are embedded with magnets based on anecdotal evidence, hoping for a non-invasive and drug-free cure to what ails them.
"The FDA regulates specific claims of medical efficacy, but in general static magnetic fields are viewed as safe," notes Thomas Skalak, professor and chair of biomedical engineering at U.Va.
Skalak has been carefully studying magnets for a number of years in order to develop real scientific evidence about the effectiveness of magnetic therapy.
Skalak's lab leads the field in the area of microcirculation research-the study of blood flow through the body's tiniest blood vessels. With a five-year, $875,000 grant from the National Institutes of Health's National Center for Complementary and Alternative Medicine, Skalak and Cassandra Morris, former Ph.D. student in biomedical engineering, set out to investigate the effect of magnetic therapy on microcirculation. Initially, they sought to examine a major claim made by companies that sell magnets: that magnets increase blood flow.
The researchers first found evidence to support this claim through research with laboratory rats. In their initial study, magnets of 70 milliTesla (mT) field strength-about 10 times the strength of the common refrigerator variety-were placed near the rat's blood vessels. Quantitative measurements of blood vessel diameter were taken both before and after exposure to the static magnetic fields-the force created by the magnets. Morris and Skalak found that the force had a significant effect: the vessels that had been dilated constricted, and the constricted vessels dilated, implying that the magnetic field could induce vessel relaxation in tissues with constrained blood supply, ultimately increasing blood flow.
Dilation of blood vessels is often a major cause of swelling at sites of trauma to soft tissues such as muscles or ligaments. The prior results on vessel constriction led Morris and Skalak to look closer at whether magnets, by limiting blood flow in such cases, would also reduce swelling. Their most recent research, published in the November 2007 issue of the American Journal of Physiology, yielded affirmative results.
In this study, the hind paws of anesthetized rats were treated with inflammatory agents in order to simulate tissue injury. Magnetic therapy was then applied to the paws. The research results indicate that magnets can significantly reduce swelling if applied immediately after tissue trauma.
Since muscle bruising and joint sprains are the most common injuries worldwide, this discovery has significant implications. "If an injury doesn't swell, it will heal faster-and the person will experience less pain and better mobility," says Skalak. This means that magnets could be used much the way ice packs and compression are now used for everyday sprains, bumps, and bruises, but with more beneficial results. The ready availability and low cost of this treatment could produce huge gains in worker productivity and quality of life.
Skalak envisions the magnets being particularly useful to high school, college, and professional sports teams, as well as school nurses and retirement communities. He has plans to continue testing the effectiveness of magnets through clinical trials and testing in elite athletes. A key to the success of magnetic therapy for tissue swelling is careful engineering of the proper field strength at the tissue location, a challenge in which most currently available commercial magnet systems fall short. The new research should allow Skalak's biomedical engineering group to design field strengths that provide real benefit for specific injuries and parts of the body.
"We now hope to implement a series of steps, including private investment partners and eventually a major corporate partner, to realize these very widespread applications that will make a positive difference for human health," says Skalak.
University of Virginia
Related Magnetic Therapy News ArticlesMedia invitation: Groundbreaking spinal injury therapy to be showcased in new exhibition
In response to a recent study published by a team of doctors from Imperial College London and Charing Cross hospital, the Science Museum in London has created a mini exhibition exploring magnetic therapy. The recent study found early evidence that administration of magnetic stimulation to the brains of people with incomplete lesions of the spinal cord improved muscle and limb movement and increased ability to feel sensations. The Spinal Injuries Association (SIA), the national charity for people with spinal cord injury, are welcoming this development and marking their annual 'Spinal Cord Injuries Awareness Day' by being present at the opening of the new mini exhibition on Friday 21 May 200
Magnetic treatment may help people with spinal cord injuries
A preliminary study has shown for the first time that it may be possible to help people who have suffered partial damage to their spinal cord by applying a magnetic therapy to their brain.More Magnetic Therapy News Articles
Magnetic Current
by Edward Leedskalnin
The How-To Book Of Hypnotism
by Tom Silver, Ormond McGill
Transcranial Magnetic Stimulation in Clinical Psychiatry
Healing Magnets: A Guide for Pain Relief, Speeding Recovery, and Restoring B
The Invisible Force: Traditional Magnetic Therapy
by Fred Rinker
Biomagnetica/ Biomagnetics: Campos Magneticos: Fuente de la Vida/ Magnetic Field: The Fountain Of Life (Biblioteca Cientifico Espiritual)
by Graciela Perez Martinez
Brain Stimulation in Psychiatric Treatment (Review of Psychiatry)
Imaging of Orthopedic Sports Injuries (Medical Radiology / Diagnostic Imaging)
Brain Imaging in Substance Abuse: Research, Clinical, and Forensic Applications (Forensic Science and Medicine) (Forensic Science and Medicine)
Magnetic Miracles
Magnets have been touted for their healing properties since ancient Greece. Magnetic therapy is still widely used today as an alternative method for treating a number of conditions, from arthritis to depression, but there hasn't been scientific proof that magnets can heal.
Lack of regulation and widespread public acceptance have turned magnetic therapy into a $5 billion world market. Hopeful consumers buy bracelets, knee braces, shoe inserts, mattresses, and other products that are embedded with magnets based on anecdotal evidence, hoping for a non-invasive and drug-free cure to what ails them.
"The FDA regulates specific claims of medical efficacy, but in general static magnetic fields are viewed as safe," notes Thomas Skalak, professor and chair of biomedical engineering at U.Va.
Skalak has been carefully studying magnets for a number of years in order to develop real scientific evidence about the effectiveness of magnetic therapy.
Skalak's lab leads the field in the area of microcirculation research-the study of blood flow through the body's tiniest blood vessels. With a five-year, $875,000 grant from the National Institutes of Health's National Center for Complementary and Alternative Medicine, Skalak and Cassandra Morris, former Ph.D. student in biomedical engineering, set out to investigate the effect of magnetic therapy on microcirculation. Initially, they sought to examine a major claim made by companies that sell magnets: that magnets increase blood flow.
The researchers first found evidence to support this claim through research with laboratory rats. In their initial study, magnets of 70 milliTesla (mT) field strength-about 10 times the strength of the common refrigerator variety-were placed near the rat's blood vessels. Quantitative measurements of blood vessel diameter were taken both before and after exposure to the static magnetic fields-the force created by the magnets. Morris and Skalak found that the force had a significant effect: the vessels that had been dilated constricted, and the constricted vessels dilated, implying that the magnetic field could induce vessel relaxation in tissues with constrained blood supply, ultimately increasing blood flow.
Dilation of blood vessels is often a major cause of swelling at sites of trauma to soft tissues such as muscles or ligaments. The prior results on vessel constriction led Morris and Skalak to look closer at whether magnets, by limiting blood flow in such cases, would also reduce swelling. Their most recent research, published in the November 2007 issue of the American Journal of Physiology, yielded affirmative results.
In this study, the hind paws of anesthetized rats were treated with inflammatory agents in order to simulate tissue injury. Magnetic therapy was then applied to the paws. The research results indicate that magnets can significantly reduce swelling if applied immediately after tissue trauma.
Since muscle bruising and joint sprains are the most common injuries worldwide, this discovery has significant implications. "If an injury doesn't swell, it will heal faster-and the person will experience less pain and better mobility," says Skalak. This means that magnets could be used much the way ice packs and compression are now used for everyday sprains, bumps, and bruises, but with more beneficial results. The ready availability and low cost of this treatment could produce huge gains in worker productivity and quality of life.
Skalak envisions the magnets being particularly useful to high school, college, and professional sports teams, as well as school nurses and retirement communities. He has plans to continue testing the effectiveness of magnets through clinical trials and testing in elite athletes. A key to the success of magnetic therapy for tissue swelling is careful engineering of the proper field strength at the tissue location, a challenge in which most currently available commercial magnet systems fall short. The new research should allow Skalak's biomedical engineering group to design field strengths that provide real benefit for specific injuries and parts of the body.
"We now hope to implement a series of steps, including private investment partners and eventually a major corporate partner, to realize these very widespread applications that will make a positive difference for human health," says Skalak.
University of Virginia
Related Magnetic Therapy News ArticlesMedia invitation: Groundbreaking spinal injury therapy to be showcased in new exhibition
In response to a recent study published by a team of doctors from Imperial College London and Charing Cross hospital, the Science Museum in London has created a mini exhibition exploring magnetic therapy. The recent study found early evidence that administration of magnetic stimulation to the brains of people with incomplete lesions of the spinal cord improved muscle and limb movement and increased ability to feel sensations. The Spinal Injuries Association (SIA), the national charity for people with spinal cord injury, are welcoming this development and marking their annual 'Spinal Cord Injuries Awareness Day' by being present at the opening of the new mini exhibition on Friday 21 May 200
Magnetic treatment may help people with spinal cord injuries
A preliminary study has shown for the first time that it may be possible to help people who have suffered partial damage to their spinal cord by applying a magnetic therapy to their brain.More Magnetic Therapy News Articles
Magnetic Current
by Edward Leedskalnin
The How-To Book Of Hypnotism
by Tom Silver, Ormond McGill
Transcranial Magnetic Stimulation in Clinical Psychiatry
Healing Magnets: A Guide for Pain Relief, Speeding Recovery, and Restoring B
The Invisible Force: Traditional Magnetic Therapy
by Fred Rinker
Biomagnetica/ Biomagnetics: Campos Magneticos: Fuente de la Vida/ Magnetic Field: The Fountain Of Life (Biblioteca Cientifico Espiritual)
by Graciela Perez Martinez
Brain Stimulation in Psychiatric Treatment (Review of Psychiatry)
Imaging of Orthopedic Sports Injuries (Medical Radiology / Diagnostic Imaging)
Brain Imaging in Substance Abuse: Research, Clinical, and Forensic Applications (Forensic Science and Medicine) (Forensic Science and Medicine)
Magnetic Miracles
Rectal artemisinins
Rectal artemisinins rapidly eliminate malarial parasites
Artemisinin-based suppositories can help 'buy time' for malaria patients who face a delay in accessing effective, injectable antimalarials, according to research published in the online open access journal BMC Infectious Diseases.
Plasmodium falciparum malaria can progress to severe disease and death in a number of hours, so prompt treatment is crucial. As such, rectal artemisinins can be used as emergency treatment, particularly in rural areas with limited access to injectable antimalarial therapy and suitably trained staff.
Derived from sweet wormwood, artemisinin has been used in traditional Chinese medicine for thousands of years. In the 1990s, researchers recognised its antimalarial activity and since then a number of safe and effective artemisinin derivatives have been developed. These drugs, given by mouth, as a rectal suppository or injected into a vein or muscle have been shown to rapidly reduce heavy parasite infection. Oral artemisinin-based combination treatments now form the basis of antimalarial treatment policies in most malaria endemic countries.
Suppositories are easy to administer and the World Health Organization Malaria Treatment Guidelines currently recommends rectal artemisinins as a pre-referral treatment for severe malaria. However, more information is needed about the comparative efficacy of the different artemisinin derivatives. Researchers pooled the individual patient data of over 1000 patients from 15 clinical trials of rectal artemisinins - artemisinin, artesunate and artemether - to compare the efficacy of these drugs with each other and conventional injectable antimalarials such as quinine.
In the 24 hours after treatment, rectal artemisinins - artemisinin, artesunate, and artemether - cleared malarial parasites in the blood more rapidly than quinine injection. A higher single dose of rectal artesunate to initiate treatment was five times more likely to reduce the number of parasites by over 90% than multiple lower doses of artesunate - suggesting that immediate rapid achievement of high drug concentration in severe malaria might be key to effectively killing parasites. This analysis did not look at whether the early use of rectal artemisinins saves lives, but it is hoped that their ability to rapidly kill large numbers of parasites might make a real difference to survival.
The authors write: "Early effective treatment with artemisinin-based suppositories has potential as a lifesaving intervention, particularly at the periphery of the health-care system, where suppositories might be administered early in lieu of parenteral treatment in remote communities by relatively untrained personnel. Combined with accurate diagnosis and artemisinin-based combination therapy, rectal artemisinins have been effectively used to reduce malaria incidence and mortality in Asia, an approach which holds great promise for malaria control elsewhere."
Artemisinin-based suppositories can help 'buy time' for malaria patients who face a delay in accessing effective, injectable antimalarials, according to research published in the online open access journal BMC Infectious Diseases.
Plasmodium falciparum malaria can progress to severe disease and death in a number of hours, so prompt treatment is crucial. As such, rectal artemisinins can be used as emergency treatment, particularly in rural areas with limited access to injectable antimalarial therapy and suitably trained staff.
Derived from sweet wormwood, artemisinin has been used in traditional Chinese medicine for thousands of years. In the 1990s, researchers recognised its antimalarial activity and since then a number of safe and effective artemisinin derivatives have been developed. These drugs, given by mouth, as a rectal suppository or injected into a vein or muscle have been shown to rapidly reduce heavy parasite infection. Oral artemisinin-based combination treatments now form the basis of antimalarial treatment policies in most malaria endemic countries.
Suppositories are easy to administer and the World Health Organization Malaria Treatment Guidelines currently recommends rectal artemisinins as a pre-referral treatment for severe malaria. However, more information is needed about the comparative efficacy of the different artemisinin derivatives. Researchers pooled the individual patient data of over 1000 patients from 15 clinical trials of rectal artemisinins - artemisinin, artesunate and artemether - to compare the efficacy of these drugs with each other and conventional injectable antimalarials such as quinine.
In the 24 hours after treatment, rectal artemisinins - artemisinin, artesunate, and artemether - cleared malarial parasites in the blood more rapidly than quinine injection. A higher single dose of rectal artesunate to initiate treatment was five times more likely to reduce the number of parasites by over 90% than multiple lower doses of artesunate - suggesting that immediate rapid achievement of high drug concentration in severe malaria might be key to effectively killing parasites. This analysis did not look at whether the early use of rectal artemisinins saves lives, but it is hoped that their ability to rapidly kill large numbers of parasites might make a real difference to survival.
The authors write: "Early effective treatment with artemisinin-based suppositories has potential as a lifesaving intervention, particularly at the periphery of the health-care system, where suppositories might be administered early in lieu of parenteral treatment in remote communities by relatively untrained personnel. Combined with accurate diagnosis and artemisinin-based combination therapy, rectal artemisinins have been effectively used to reduce malaria incidence and mortality in Asia, an approach which holds great promise for malaria control elsewhere."
A coffee
A coffee with your doughnut could protect against Alzheimer's disease
A daily dose of caffeine blocks the disruptive effects of high cholesterol that scientists have linked to Alzheimer's disease. A study in the open access publication, Journal of Neuroinflammation revealed that caffeine equivalent to just one cup of coffee a day could protect the blood-brain barrier (BBB) from damage that occurred with a high-fat diet.
The BBB protects the central nervous system from the rest of the body's circulation, providing the brain with its own regulated microenvironment. Previous studies have shown that high levels of cholesterol break down the BBB which can then no longer protect the central nervous system from the damage caused by blood borne contamination. BBB leakage occurs in a variety of neurological disorders such as Alzheimer's disease.
In this study, researchers from the University of North Dakota School of Medicine and Health Sciences gave rabbits 3 mg caffeine each day - the equivalent of a daily cup of coffee for an average-sized person. The rabbits were fed a cholesterol-enriched diet during this time.
After 12 weeks a number of laboratory tests showed that the BBB was significantly more intact in rabbits receiving a daily dose of caffeine.
"Caffeine appears to block several of the disruptive effects of cholesterol that make the blood-brain barrier leaky," says Jonathan Geiger, University of North Dakota School of Medicine and Health Sciences. "High levels of cholesterol are a risk factor for Alzheimer's disease, perhaps by compromising the protective nature of the blood-brain barrier. For the first time we have shown that chronic ingestion of caffeine protects the BBB from cholesterol-induced leakage."
Caffeine appears to protect BBB breakdown by maintaining the expression levels of tight junction proteins. These proteins bind the cells of the BBB tightly to each other to stop unwanted molecules crossing into the central nervous system.
The findings confirm and extend results from other studies showing that caffeine intake protects against memory loss in aging and in Alzheimer's disease.
"Caffeine is a safe and readily available drug and its ability to stabilise the blood-brain barrier means it could have an important part to play in therapies against neurological disorders," says Geiger.
A daily dose of caffeine blocks the disruptive effects of high cholesterol that scientists have linked to Alzheimer's disease. A study in the open access publication, Journal of Neuroinflammation revealed that caffeine equivalent to just one cup of coffee a day could protect the blood-brain barrier (BBB) from damage that occurred with a high-fat diet.
The BBB protects the central nervous system from the rest of the body's circulation, providing the brain with its own regulated microenvironment. Previous studies have shown that high levels of cholesterol break down the BBB which can then no longer protect the central nervous system from the damage caused by blood borne contamination. BBB leakage occurs in a variety of neurological disorders such as Alzheimer's disease.
In this study, researchers from the University of North Dakota School of Medicine and Health Sciences gave rabbits 3 mg caffeine each day - the equivalent of a daily cup of coffee for an average-sized person. The rabbits were fed a cholesterol-enriched diet during this time.
After 12 weeks a number of laboratory tests showed that the BBB was significantly more intact in rabbits receiving a daily dose of caffeine.
"Caffeine appears to block several of the disruptive effects of cholesterol that make the blood-brain barrier leaky," says Jonathan Geiger, University of North Dakota School of Medicine and Health Sciences. "High levels of cholesterol are a risk factor for Alzheimer's disease, perhaps by compromising the protective nature of the blood-brain barrier. For the first time we have shown that chronic ingestion of caffeine protects the BBB from cholesterol-induced leakage."
Caffeine appears to protect BBB breakdown by maintaining the expression levels of tight junction proteins. These proteins bind the cells of the BBB tightly to each other to stop unwanted molecules crossing into the central nervous system.
The findings confirm and extend results from other studies showing that caffeine intake protects against memory loss in aging and in Alzheimer's disease.
"Caffeine is a safe and readily available drug and its ability to stabilise the blood-brain barrier means it could have an important part to play in therapies against neurological disorders," says Geiger.
Medical Students
Medical Students To Learn How To Prescribe Safely And Effectively
Tomorrow's doctors will be better prepared for the complexities of prescribing modern medicines following new training recommendations produced by the British Pharmacological Society. 'Teaching safe and effective prescribing in UK medical schools' is published in the June issue of the British Journal of Clinical Pharmacology.
The society has initiated new guidelines on the core curriculum for undergraduate courses because, as author Dr Simon Maxwell from the University of Edinburgh says, "Prescribing medicines is almost the definition of what doctors do. For the vast majority, drugs represent the major treatment they can offer to their patients." Newly qualified doctors are expected to prescribe powerful medicines from day one of their clinical work. Although these have the potential to bring great benefits to patients, if used incorrectly, they can also cause great harm.
The rapid pace of new drug developments, increasing specialisation and the vulnerability of elderly patients to side effects are among the many pressures doctors have to cope with. Yet, says the society, training in the basic principles of prescribing and therapeutics, drug action and basic knowledge about commonly used drugs is failing.
Professor Rod Flower, president of the BPS said, "We could see a scene unfold in which the patients would not receive optimal treatment simply because doctors do not know how to prescribe properly. The astonishing advances in medicines would be undermined by inadequate knowledge."
The problem was highlighted in a report by the Audit Commission, 'A Spoonful of Sugar' (December 2001), which demonstrated that the rising number of errors in medication and adverse effects of medicine are a major cause of preventable death in UK hospitals. The medical school curriculum, recently updated by the General Medical Council, recognised the importance of training in the principles of therapy but did not offer guidance how this might be achieved. Over the last few years, several medical schools have lost their pharmacology departments where medical students learn about how drugs work in the body and how to prescribe medicine safely and effectively.
The disappearance of specific courses in scientific disciplines such as pharmacology from some medical school curricula means that students are now expected to absorb the knowledge in other parts of the course. "In reality, this is difficult because of competition with other learning priorities," said Dr Maxwell. "Even if they hear about the drugs that would be used for certain conditions, they do not get the practical information they require to prescribe them safely and effectively when they qualify."
The BPS will distribute the document to medical schools as a tool to integrate essential training into the core curriculum, ideally overseen by an individual teacher in each school. It defines the knowledge and skills required by students, covering aspects such as writing prescriptions, monitoring the impact of drug therapy, avoiding adverse effects and interaction between drugs, legal and ethical issues of prescribing and, importantly, advising patients and obtaining informed consent. Among the core attitudes a young doctor is expected to acquire are risk-benefit analysis and recognising personal limits in his or her knowledge.
Robust assessment of the learning objectives will help to overcome the dangers of poor prescribing. 'It should not be possible to compensate for a poor performance in this area by a good performance in other areas,' it states.
Dr Ross Taylor from the department of general practice and primary care at the University of Aberdeen and a member of the Committee on Safety of Medicines (CSM), said, "For the GP, prescribing is the most important part of the patient care. Nurses and pharmacists, however, are now authorised to prescribe medicines, while responsibility for the more complex forms of treatment remain with the medical practitioner." Welcoming the BPS's initiative, he added that the new recommendations will enable doctors to cope more efficiently with the pressures they face when making decisions about treatment.
"There is a crystal clear need for students to have a good grasp on how to prescribe," said Dr Maxwell. "Our recommendations offer a blue-print on how this can be achieved."
Tomorrow's doctors will be better prepared for the complexities of prescribing modern medicines following new training recommendations produced by the British Pharmacological Society. 'Teaching safe and effective prescribing in UK medical schools' is published in the June issue of the British Journal of Clinical Pharmacology.
The society has initiated new guidelines on the core curriculum for undergraduate courses because, as author Dr Simon Maxwell from the University of Edinburgh says, "Prescribing medicines is almost the definition of what doctors do. For the vast majority, drugs represent the major treatment they can offer to their patients." Newly qualified doctors are expected to prescribe powerful medicines from day one of their clinical work. Although these have the potential to bring great benefits to patients, if used incorrectly, they can also cause great harm.
The rapid pace of new drug developments, increasing specialisation and the vulnerability of elderly patients to side effects are among the many pressures doctors have to cope with. Yet, says the society, training in the basic principles of prescribing and therapeutics, drug action and basic knowledge about commonly used drugs is failing.
Professor Rod Flower, president of the BPS said, "We could see a scene unfold in which the patients would not receive optimal treatment simply because doctors do not know how to prescribe properly. The astonishing advances in medicines would be undermined by inadequate knowledge."
The problem was highlighted in a report by the Audit Commission, 'A Spoonful of Sugar' (December 2001), which demonstrated that the rising number of errors in medication and adverse effects of medicine are a major cause of preventable death in UK hospitals. The medical school curriculum, recently updated by the General Medical Council, recognised the importance of training in the principles of therapy but did not offer guidance how this might be achieved. Over the last few years, several medical schools have lost their pharmacology departments where medical students learn about how drugs work in the body and how to prescribe medicine safely and effectively.
The disappearance of specific courses in scientific disciplines such as pharmacology from some medical school curricula means that students are now expected to absorb the knowledge in other parts of the course. "In reality, this is difficult because of competition with other learning priorities," said Dr Maxwell. "Even if they hear about the drugs that would be used for certain conditions, they do not get the practical information they require to prescribe them safely and effectively when they qualify."
The BPS will distribute the document to medical schools as a tool to integrate essential training into the core curriculum, ideally overseen by an individual teacher in each school. It defines the knowledge and skills required by students, covering aspects such as writing prescriptions, monitoring the impact of drug therapy, avoiding adverse effects and interaction between drugs, legal and ethical issues of prescribing and, importantly, advising patients and obtaining informed consent. Among the core attitudes a young doctor is expected to acquire are risk-benefit analysis and recognising personal limits in his or her knowledge.
Robust assessment of the learning objectives will help to overcome the dangers of poor prescribing. 'It should not be possible to compensate for a poor performance in this area by a good performance in other areas,' it states.
Dr Ross Taylor from the department of general practice and primary care at the University of Aberdeen and a member of the Committee on Safety of Medicines (CSM), said, "For the GP, prescribing is the most important part of the patient care. Nurses and pharmacists, however, are now authorised to prescribe medicines, while responsibility for the more complex forms of treatment remain with the medical practitioner." Welcoming the BPS's initiative, he added that the new recommendations will enable doctors to cope more efficiently with the pressures they face when making decisions about treatment.
"There is a crystal clear need for students to have a good grasp on how to prescribe," said Dr Maxwell. "Our recommendations offer a blue-print on how this can be achieved."
Pharmaceutical Clinical Trials
ntroduction to Statistics in Pharmaceutical Clinical Trials
First edition
Todd A Durham - Senior Director, Biostatistics and Data Management and J Rick Turner - Associate Professor of Clinical Research
All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics.
Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.
This textbook conveys:
* why, and how data are collected in clinical studies
* how these data are summarized and analyzed
* what the results mean in the context of the clinical research question
* how the results are communicated to regulatory agencies and to the scientific and medical communities.
Designed primarily for students of pharmacy, clinical research, and allied health professions, Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology, and contract research organization industries who wish to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials.
Contents:
1. The Discipline of Statistics: Introduction and Terminology: 2. The Role of Clinical Trials in New Drug Development: 3. Research Questions and Research Hypotheses: 4. Study Design and Experimental Methodology: 5. Data, Central Tendency and Variation: 6. Probability, Hypothesis Testing and Estimation: 7. Early-phase Clinical Trials: 8. Confirmatory Clinical Trials: Safety Data I: 9. Confirmatory Clinical Trials: Safety Data II: 10. Confirmatory Trials: Analysis of Categorical Efficacy Data: 11. Confirmatory Clinical Trials of Analysis of Continuous Efficacy Data: 12. Additional Statistical Considerations in Clinical Trials: 13. Concluding Comments: Appendix: References: : : : : : : : :
First edition
Todd A Durham - Senior Director, Biostatistics and Data Management and J Rick Turner - Associate Professor of Clinical Research
All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics.
Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.
This textbook conveys:
* why, and how data are collected in clinical studies
* how these data are summarized and analyzed
* what the results mean in the context of the clinical research question
* how the results are communicated to regulatory agencies and to the scientific and medical communities.
Designed primarily for students of pharmacy, clinical research, and allied health professions, Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology, and contract research organization industries who wish to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials.
Contents:
1. The Discipline of Statistics: Introduction and Terminology: 2. The Role of Clinical Trials in New Drug Development: 3. Research Questions and Research Hypotheses: 4. Study Design and Experimental Methodology: 5. Data, Central Tendency and Variation: 6. Probability, Hypothesis Testing and Estimation: 7. Early-phase Clinical Trials: 8. Confirmatory Clinical Trials: Safety Data I: 9. Confirmatory Clinical Trials: Safety Data II: 10. Confirmatory Trials: Analysis of Categorical Efficacy Data: 11. Confirmatory Clinical Trials of Analysis of Continuous Efficacy Data: 12. Additional Statistical Considerations in Clinical Trials: 13. Concluding Comments: Appendix: References: : : : : : : : :
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Publishers participating in the AdSense program are required to adhere to the following policies. We ask that you read these policies carefully and refer to this document often. If you fail to comply with these policies, we may disable ad serving to your site and/or disable your AdSense account. While in many cases we prefer to work with publishers to achieve policy compliance, we reserve the right to disable any account at any time. If your account is disabled, you will not be eligible for further participation in the AdSense program.
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Sites displaying Google ads may not include:
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* Excessive profanity
* Gambling or casino-related content
* Content regarding programs which compensate users for clicking on ads or offers, performing searches, surfing websites, or reading emails
* Excessive, repetitive, or irrelevant keywords in the content or code of web pages
* Deceptive or manipulative content or construction to improve your site's search engine ranking, e.g., your site's PageRank
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* Sites showing Google ads may not contain pop-ups or pop-unders that interfere with site navigation, change user preferences, or initiate downloads.
* Any AdSense code must be pasted directly into webpages without modification. AdSense participants are not allowed to alter any portion of the code or change the behavior, targeting, or delivery of ads. For instance, clicks on Google ads may not result in a new browser window being launched.
* A site or third party cannot display our ads, search box, search results, or referral buttons as a result of the actions of any software application such as a toolbar.
* No AdSense code may be integrated into a software application.
* Webpages containing AdSense code may not be loaded by any software that can trigger pop-ups, redirect users to unwanted websites, modify browser settings, or otherwise interfere with site navigation. It is your responsibility to ensure that no ad network or affiliate uses such methods to direct traffic to pages that contain your AdSense code.
* Referral offerings must be made without any obligation or requirement to end users. Publishers may not solicit email addresses from users in conjunction with AdSense referral units.
* Publishers using online advertising to drive traffic to pages showing Google ads must comply with the spirit of Google's Landing Page Quality Guidelines. For instance, if you advertise for sites participating in the AdSense program, the advertising should not be deceptive to users.
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* A maximum of two Google AdSense for search boxes may be placed on a page.
* Up to three link units may also be placed on each page.
* Up to three referral units may be displayed on a page, in addition to the ad units, search boxes, and link units specified above.
* AdSense for search results pages may show only a single ad link unit in addition to the ads Google serves with the search results. No other ads may be displayed on your search results page.
* No Google ad or Google search box may be displayed in a pop-up, pop-under, or in an email.
* Elements on a page must not obscure any portion of the ads.
* No Google ad may be placed on any non-content-based pages.
* No Google ad may be placed on pages published specifically for the purpose of showing ads, whether or not the page content is relevant.
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Pharmacologist
giyanto-05
KNOWLEDGE AND SKILLS OF CLINICAL PHARMACOLOGISTS CURRENTLY UNDERUSED, SAYS REPORT
The NHS
The report notes the increasing need for cost-effective prescribing and co-ordinated drug prescribing policies. It suggests that clinical pharmacologists could be at the forefront in evaluating cost-effective prescribing and the development of drug formularies. With the advent of the NICE, the need for co-ordination between national, regional and local policies on the prescription of new and existing drugs will be paramount, and the report recommends that the expertise of clinical pharmacologists should be accessed more at all these levels. (p.11)
In the university setting
This chapter covers undergraduate education, postgraduate education and research. In relation to undergraduate education, the report suggests that a national core curriculum in pharmacology, clinical pharmacology and therapeutics needs to be agreed to reduce variations or lack of structure in training and teaching methods (p.14). Appendix 2 sets out a proposed core curriculum. The report also identifies the merger of university departments of clinical pharmacology with larger departments of medicine as having an impact on the career progression of staff and recommends that this issue must be addressed (p.14).
The report recommends that postgraduate education needs to be more targeted and integrated between primary and secondary care, and must also serve the needs of physicians working in the pharmaceutical industry. In addition, CME for all doctors and the construction of guidelines and protocols are seen as areas which are particularly suitable for the further involvement of clinical pharmacologists.
The recommendations relating to research recognise the close relationships clinical pharmacology has with other disciplines, and the need to maintain a stream of young researchers in the specialty. The research base must be made secure, and the new epidemiological aspects of research in clinical pharmacology must be integrated into the existing research programmes.
The pharmaceutical industry
The major changes occurring in the pharmaceutical industry have implications for the training, work patterns, and staffing levels of industrial clinical pharmacologists. They will have to keep up-to-date with the new regulatory requirements for safety testing biologically produced materials and the ethical and practical issues arising from the subsequent changes to Phase I studies (p.21).
The increasing use of genetic and molecular techniques are likely to mean more early testing of agents on people rather than animals. This will need to be reflected in the curricula of both higher medical training in pharmaceutical medicine and the examination for the Diploma of the Faculty of Pharmaceutical Medicine, particularly in relation to the knowledge and skills needed to run Phase I trials. The industry will need more clinical pharmacologists, and arrangements need to be made to increase the interchange of specialists between the NHS, academia and industry, including where appropriate, joint appointments (pp21, 25).
Training
Training programmes need to maintain flexibility, and there should be opportunities for trainee clinical pharmacologists to develop a special interest in specialties other than, or in addition to, General (Internal) Medicine eg. Cardiology, Geriatrics. Training programmes leading to triple specialist certification will be essential to this objective (p.29). Joint programmes for training between industry, the NHS and academia should be established to maximise experience, potential and flexibility in the career market (p.30).
Advisory role to Government and its agencies
Clinical pharmacologists often find themselves at the cutting edge of policy-making, advising Government departments such as the DoH, MAFF, and Government agencies such as the Medicines Control Agency and the National Institute for Clinical Effectiveness. The report suggests that this role will increase as new technologies and developments place increasing demands on healthcare delivery systems. The report also advocates the exploration and encouragement of more formal links between academic departments, NHS physicians and agencies such as the Medicines Control Agency (p.34).
Relationships with other health care professionals
The report recognises the existing links which clinical pharmacology has with other medical specialties, and other healthcare disciplines such as pharmacy and nursing and recommends continuing collaboration in both training and service provision with these specialties, and further development of professional relationships (pp37,38).
Appendices
1 Useful information on doctors working in the pharmaceutical industry
2 Core content of an undergraduate course in clinical pharmacology
3 Clinical pharmacology and pharmacoeconomics
4 Curriculum for higher specialist training in clinical pharmacology and therapeutics
5 Four job descriptions for physicians in clinical pharmacology
6 Job plan for a consultant physician in clinical pharmacology and therapeutics
Dr Nick Bateman, Secretary of the Working Party which produced the report, said:
"This report gives a new impetus to clinical pharmacologists, who will be able to use the recommendations to build a stronger research base for the development of new drugs and treatments and will enable them to contribute to more cost-effective prescribing in the NHS."
Dr Bateman can be contacted at the Scottish Poisons Unit on 0131 536 2303, or via the Edinburgh Royal Infirmary switchboard on 0131 536 1000.
"Clinical Pharmacology and Therapeutics" costs £17.50 including UK p&p and can be ordered from the Royal College of Physicians on 0171 935 1174 ext.358.
For further information or for a copy of the report please contact Linda Cuthbertson, RCP Press and PR Manager on 0171 935 1174 ext.254 or e-mail Linda.Cuthbertson@rcplondon.ac.uk.
Royal College of Physicians
KNOWLEDGE AND SKILLS OF CLINICAL PHARMACOLOGISTS CURRENTLY UNDERUSED, SAYS REPORT
The NHS
The report notes the increasing need for cost-effective prescribing and co-ordinated drug prescribing policies. It suggests that clinical pharmacologists could be at the forefront in evaluating cost-effective prescribing and the development of drug formularies. With the advent of the NICE, the need for co-ordination between national, regional and local policies on the prescription of new and existing drugs will be paramount, and the report recommends that the expertise of clinical pharmacologists should be accessed more at all these levels. (p.11)
In the university setting
This chapter covers undergraduate education, postgraduate education and research. In relation to undergraduate education, the report suggests that a national core curriculum in pharmacology, clinical pharmacology and therapeutics needs to be agreed to reduce variations or lack of structure in training and teaching methods (p.14). Appendix 2 sets out a proposed core curriculum. The report also identifies the merger of university departments of clinical pharmacology with larger departments of medicine as having an impact on the career progression of staff and recommends that this issue must be addressed (p.14).
The report recommends that postgraduate education needs to be more targeted and integrated between primary and secondary care, and must also serve the needs of physicians working in the pharmaceutical industry. In addition, CME for all doctors and the construction of guidelines and protocols are seen as areas which are particularly suitable for the further involvement of clinical pharmacologists.
The recommendations relating to research recognise the close relationships clinical pharmacology has with other disciplines, and the need to maintain a stream of young researchers in the specialty. The research base must be made secure, and the new epidemiological aspects of research in clinical pharmacology must be integrated into the existing research programmes.
The pharmaceutical industry
The major changes occurring in the pharmaceutical industry have implications for the training, work patterns, and staffing levels of industrial clinical pharmacologists. They will have to keep up-to-date with the new regulatory requirements for safety testing biologically produced materials and the ethical and practical issues arising from the subsequent changes to Phase I studies (p.21).
The increasing use of genetic and molecular techniques are likely to mean more early testing of agents on people rather than animals. This will need to be reflected in the curricula of both higher medical training in pharmaceutical medicine and the examination for the Diploma of the Faculty of Pharmaceutical Medicine, particularly in relation to the knowledge and skills needed to run Phase I trials. The industry will need more clinical pharmacologists, and arrangements need to be made to increase the interchange of specialists between the NHS, academia and industry, including where appropriate, joint appointments (pp21, 25).
Training
Training programmes need to maintain flexibility, and there should be opportunities for trainee clinical pharmacologists to develop a special interest in specialties other than, or in addition to, General (Internal) Medicine eg. Cardiology, Geriatrics. Training programmes leading to triple specialist certification will be essential to this objective (p.29). Joint programmes for training between industry, the NHS and academia should be established to maximise experience, potential and flexibility in the career market (p.30).
Advisory role to Government and its agencies
Clinical pharmacologists often find themselves at the cutting edge of policy-making, advising Government departments such as the DoH, MAFF, and Government agencies such as the Medicines Control Agency and the National Institute for Clinical Effectiveness. The report suggests that this role will increase as new technologies and developments place increasing demands on healthcare delivery systems. The report also advocates the exploration and encouragement of more formal links between academic departments, NHS physicians and agencies such as the Medicines Control Agency (p.34).
Relationships with other health care professionals
The report recognises the existing links which clinical pharmacology has with other medical specialties, and other healthcare disciplines such as pharmacy and nursing and recommends continuing collaboration in both training and service provision with these specialties, and further development of professional relationships (pp37,38).
Appendices
1 Useful information on doctors working in the pharmaceutical industry
2 Core content of an undergraduate course in clinical pharmacology
3 Clinical pharmacology and pharmacoeconomics
4 Curriculum for higher specialist training in clinical pharmacology and therapeutics
5 Four job descriptions for physicians in clinical pharmacology
6 Job plan for a consultant physician in clinical pharmacology and therapeutics
Dr Nick Bateman, Secretary of the Working Party which produced the report, said:
"This report gives a new impetus to clinical pharmacologists, who will be able to use the recommendations to build a stronger research base for the development of new drugs and treatments and will enable them to contribute to more cost-effective prescribing in the NHS."
Dr Bateman can be contacted at the Scottish Poisons Unit on 0131 536 2303, or via the Edinburgh Royal Infirmary switchboard on 0131 536 1000.
"Clinical Pharmacology and Therapeutics" costs £17.50 including UK p&p and can be ordered from the Royal College of Physicians on 0171 935 1174 ext.358.
For further information or for a copy of the report please contact Linda Cuthbertson, RCP Press and PR Manager on 0171 935 1174 ext.254 or e-mail Linda.Cuthbertson@rcplondon.ac.uk.
Royal College of Physicians
Healthy Dinners
giyanto-05
5 Healthy Dinners That Will Satisfy Your 'Meat and Potatoes' Man
I have several friends who look at the quick and healthy recipes on my website, and say, O' Gosh, they all look so good, but my husband is so picky, he wouldn't eat them. This does make meal planning a little more difficult, but with a little creativity, you can still enjoy many delicious, healthy meals - even with the pickiest husband or family!
Here are five delicious ideas you can try:
Meal #1: Believe it or not, pork tenderloin is quite lean actually comparable with chicken breast. Marinate a pork tenderloin with some delicious flavorings, grill or bake and serve with brown rice and steamed green beans. Keep it healthy by minimizing butter.
Meal #2: Meatloaf is an old-standby that can be modified to make it lighter, yet still tasty. Make a meatloaf with ground turkey or extra lean ground beef. Again, eaten in moderation with mashed potatoes and peas, you'll be sticking to a balanced diet and still satisfying your meat and potatoes eaters.
Meal #3: While deep-fried chicken strips can be delicious, you might be surprised at how good they can be baked in the oven. This meal consists of baked chicken fingers, reduced fat packaged biscuits and a tossed green salad. For a tasty baked chicken recipe, dip in buttermilk and roll in crushed low-fat chips, crackers or breadcrumbs.
Meal #4: The basic burger! As with the meatloaf, use extra lean ground beef or ground turkey. Serve on whole wheat buns, with light mayo, lettuce, and tomato (add some sauteed onions if desired). For side dishes, bake some frozen steak fries (lower fat than others) and vegetarian baked beans (they'll never know the difference!).
Meal #5: Tonight you'll be enjoying steak, baked potatoes and steamed broccoli. Just serve a lean cut of beef, keep your own portion small (around 4 ounces) and this meal easily can fit into a healthy diet. Try topping your potato with a fat-free butter spray or sprinkles, fat-free sour cream, low-fat cheese, or salsa.
Once you find some meals your family enjoys, add them to your regular menu rotation (don't forget about them) and also try variations on ingredients and flavorings. A little creativity goes a long way!
Related Information: Holisticonline.com Healthy Recipes Infocenter for recipes on healthy foods from around the world.
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5 Healthy Dinners That Will Satisfy Your 'Meat and Potatoes' Man
I have several friends who look at the quick and healthy recipes on my website, and say, O' Gosh, they all look so good, but my husband is so picky, he wouldn't eat them. This does make meal planning a little more difficult, but with a little creativity, you can still enjoy many delicious, healthy meals - even with the pickiest husband or family!
Here are five delicious ideas you can try:
Meal #1: Believe it or not, pork tenderloin is quite lean actually comparable with chicken breast. Marinate a pork tenderloin with some delicious flavorings, grill or bake and serve with brown rice and steamed green beans. Keep it healthy by minimizing butter.
Meal #2: Meatloaf is an old-standby that can be modified to make it lighter, yet still tasty. Make a meatloaf with ground turkey or extra lean ground beef. Again, eaten in moderation with mashed potatoes and peas, you'll be sticking to a balanced diet and still satisfying your meat and potatoes eaters.
Meal #3: While deep-fried chicken strips can be delicious, you might be surprised at how good they can be baked in the oven. This meal consists of baked chicken fingers, reduced fat packaged biscuits and a tossed green salad. For a tasty baked chicken recipe, dip in buttermilk and roll in crushed low-fat chips, crackers or breadcrumbs.
Meal #4: The basic burger! As with the meatloaf, use extra lean ground beef or ground turkey. Serve on whole wheat buns, with light mayo, lettuce, and tomato (add some sauteed onions if desired). For side dishes, bake some frozen steak fries (lower fat than others) and vegetarian baked beans (they'll never know the difference!).
Meal #5: Tonight you'll be enjoying steak, baked potatoes and steamed broccoli. Just serve a lean cut of beef, keep your own portion small (around 4 ounces) and this meal easily can fit into a healthy diet. Try topping your potato with a fat-free butter spray or sprinkles, fat-free sour cream, low-fat cheese, or salsa.
Once you find some meals your family enjoys, add them to your regular menu rotation (don't forget about them) and also try variations on ingredients and flavorings. A little creativity goes a long way!
Related Information: Holisticonline.com Healthy Recipes Infocenter for recipes on healthy foods from around the world.
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