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Furthermore cheap acivir pills 200mg with visa, some say the chelation of iron reflexologists order acivir pills 200 mg fast delivery, and other alternative health care increases the body’s production of free radicals, providers. Somewhat less metals such as lead, iron, copper, zinc, aluminum, effective than intravenous administration, oral and manganese. The blood circulation and therefore counteract gan- enzyme cysteine, for example, may be prescribed grene, leg cramps, and other vascular disorders; for nickel poisoning and presence of excessive free treat Alzheimer’s disease, multiple sclerosis, muscu- radicals. As a to lead from vehicle exhaust, to which exposure treatment for occluded arteries, chelation may be was attributed high rates of cancer mortality and chiropractic 27 symptoms including headaches, drug and alcohol imen of theophylline and other bronchodilators; abuse, digestive problems, depression, fatigue, and rather than extend the intake to steroids when the anxiety. A Chinese herbalism A segment of ancient Chinese person with an ulcer who takes traditional antacids medicine that focuses on plants and natural sub- may be further relieved by Chinese herbs that fight stances as sources of relief for medical and psycho- heat and dampness in the stomach, help the liver logical problems. In gen- the active ingredients, and because various herbs eral, Chinese herbalism recognizes remedies for ill- and other substances may be blended, side effects ness but interprets illness as an imbalance of body are minimized or eliminated and results are often constituents that may show up as patterns consist- enhanced. An mineral, and animal substances—are also meant to important aspect of Chinese herbalism is correct treat the root of one’s condition rather than just diagnosis of a patient’s problem; customized herbal target symptoms or potentially create additional treatment of the problem can conquer an entire problems by using one specific drug. Common Chinese herbs mythic sage Shen Nung experimented with and are astragulus, lotus seed, nutmeg, walnut, ginger, codified medicinal herbs 300 years ago, herbalism cinnamon, radish seed, angelica root, schizandra, has become a highly sophisticated, intricate, and poria cocos, licorice, peony, chrysanthemum, ligus- systematized practice that involves more than 6000 ticum, honeysuckle, mulberry, raspberry, mustard substances prescribed by practitioners. Each sub- seed, dianthus, plantain, motherwort, turmeric, stance has certain qualities and properties that myrrh resin, hawthorn, red and black dates, address the body constituents (qi [ch’i], moisture, ephedra root, artemisia leaf, agrimony, magnolia, and blood), organ networks, and what are known corn silk, corydalis root, peach seed, salvia root, as “adverse climates”: wind, heat, cold, dryness, fennel seed, coptis root, dandelion, sargassum, mil- and dampness. Herbs are categorized according to lettia stem, cordyceps, peppermint leaf, sileris root, their nature (warm, cool, or neutral), taste (sour, gardenia, clove, cardamom seed, and unicaria bitter, sweet, salty, spicy, or bland), configuration stem. Chinese herbal substances also have Chinese (shape, texture, moisture), color, and properties, and botanical names. For example, since ginseng is a “broad-spec- alternative discipline, dating back to ancient Egypt trum” tonic for any deficiency of qi, codonopsis and other early civilizations, which is based on augments the qi very specifically in the spleen and hands-on manipulations, or “adjustments,” of the lungs to treat ailments such as anemia, dehydra- spinal cord. Another herb, scutellaria, which theory expressed in 1895 by Daniel David Palmer, of purges heat from the lungs and liver, is used for the Davenport, Iowa, who advocated the teachings of treatment of jaundice and infections. Hippocrates and believed that all illnesses had their Chinese herbalism, which now has entered sources in the spine and the nervous system. Indi- hand,” when vertebrae are subluxated, or dislocated viduals with asthma, for example, may be on a reg- or misaligned, the person experiences any number 28 chiropractic of ailments, including allergy, headaches, skin con- Duncan’s system or joints and recommended 300 ditions, back pain, sciatica, vision and hearing prob- milligrams of aspirin four times daily for sympto- lems, muscle spasms, asthma and other respiratory matic relief. But the pain progressed until the child disorders, peripheral joint injuries, osteoarthritis, cried, was unable to dress himself, and was stooped herniated disk, and various other musculoskeletal over as if he was an elderly man. The boy’s desperate parents finally took him disorders, scoliosis, depression, addiction, and other to a chiropractor. Three hours later, however, Duncan was Chiropractors also work with the concept of the walking “without my knees flapping together,” he body’s innate intelligence and ability to heal. Palmer suggested that innate intelligence flowed After each adjustment, Duncan made considerable throughout the nervous system—which corre- progress until he was totally back to normal. He sponds and communicates with every other part of described as a “numb” feeling the absence of the the body—and could be blocked by a subluxation. When the subluxation is relieved, the body has the Since chiropractors are trained to advise patients opportunity to heal itself. This form of chiropractic, when to seek conventional medical care and now referred to as “straight,” adheres to Palmer’s because there is overwhelming anecdotal evidence original idea of performing only spinal manipula- of success of chiropractic as an alternative or com- tion. A commonsense and holistic Apparently the man had a subluxated vertebra that approach with an emphasis on prevention and corresponded to an injury he had suffered to his wellness, chiropractic is considered the second- upper spine just before he lost his hearing. Patients may be lying supine or prone or sit- who were convinced of Palmer’s philosophy, and ting up, depending upon which type of adjustment case after case seemed to support chiropractic’s suc- is appropriate. One’s first visit to a chiropractor often cess despite the fact that there has long been a requires acute care (the first level of chiropractic), dearth of scientific study to prove its fundamental that is, relief of aggravating symptoms or pain. Coles has also worked with parents, undergraduates, teachers, community chologogue A substance that increases the flow leaders, and medical students and as a volunteer at of bile into the intestinal tract. Chopra, Deepak A New England endocrinologist colonic irrigation The process of injecting originally from India, former chief of staff of Boston enough water (to which herbs or enzymes may be Regional Medical Center, and founding president added) through a tube into the colon to fill and of the American Association of Ayurvedic Medi- cleanse it, also known as an enema, rectal, or cine. In certain alternative and complementary Healing: Exploring the Frontiers of Mind/Body Medicine medicine practices, colonics are used to detoxify (New York: Bantam Books, 1989); Creating Health; the intestinal tract and treat a wide variety of dis- Return of the Rishi; Perfect Health; Ageless Body, Timeless orders, including hypertension, heart disease, Mind; Creating Affluence; The Seven Spiritual Laws of arthritis, depression, and infections. The method Success; Unconditional Life, How to Know God: The evolved from the days before antibiotics had been Soul’s Journey into the Mystery of Mysteries; Overcoming developed to fight infection, when emptying the Addictions; Spiritual Laws for Parenting; Grow Younger, bowels was considered therapeutic for a number Live Longer: 10 Steps to Reverse Aging; The Return of of ailments. A fellow of the Ameri- as in Ayurvedic medicine originating in India, can College of Physicians and a member of the colonics were regarded as rejuvenating. During American Association of Clinical Endocrinologists, the 1920s and 1930s, inducing bowel movements Chopra is considered one of the foremost U. Kel- founder of the Chopra Center for Well-Being, logg later founded the Kellogg cereal company in established in 1995 in La Jolla, California, and now Battle Creek. Colonic enthusiasts believe a buildup scar tissue to form during the healing process. In addi- ical humanities at Harvard Medical School, tion, colonics may deplete the body of enzymes and research psychiatrist for the Harvard University normal colonic flora that keep the intestines func- Health Services, and the author of more than 50 tioning normally, particularly in their ability to books, including The Spiritual Life of Children fight microbial invasion. Contaminated irrigation (Boston: Houghton Mifflin, 1990); The Moral Intelli- equipment may also cause potentially life-threat- gence of Children (New York: Random House, 1997); ening infections such as amebic dysentery. Colonic and The Mind’s Fate: Ways of Seeing Psychiatry and Psy- irrigation is not recommended for individuals who choanalysis.

Fatty acid production Treatment: Antimicrobials + Surgery Clindamycin Metronidazole Cefotetan 262 Cefoxitin Piperacillin Penicillin 2 purchase acivir pills 200 mg on-line. Source of infection: Tuberculous patients Route of infection: Respiratory- Inhalation of droplet nuclei Ingestion of infected milk Disease: Pulmonary and extrapulmonary tuberculosis The disease generally manifests with low-grade persistent fever order acivir pills 200mg mastercard, night sweating, significant weight loss, fatigue and generalized weakness. Used for observing colony morphology, susceptibility testing, and as selective media 2. Lowenstein-Jensen medium It is the ordinary selective media for tubercle bacilli Raised, dry, cream colored colonies of tubercle bacilli after 3-6 wks of incubation 264 3. Pasteurization of milk and milk products Mycobacterium leprae Characteristics: • Typical acid-fast bacilli, arranged in singly, parallel bundles or in globular masses. Foot pads of mice Armadillos Clinical features: Incubation period is months to years. Clinical triads: Anaesthetic skin patches 266 Peripheral neuritis Presence of acid-fast bacilli from skin lesion Two major types of leprosy 1. Comparison of the two types of leprosy Characteristics Lepromatous leprosy Tuberculoid leprosy 1. Usually positive Laboratory diagnosis: Specimen: Skin scrapings from the ear lobe. Non-viable bacilli stain poorly and unevenly as fragmented, beaded and granular red bacilli. When dry, hold fold of skin tightly between the thumb and forefinger until it becomes pale. Using the sterile blade, make a small cut through the skin surface, 5mm long and 2-3mm deep, where the bacteria is be found. Make a small circular smear of the tissue juice (Cover the cut with a small dressing). Wipe the back of the slide clean, and place in a draining rack for the smears to air-dry (protect from direct sun light). Most are soil saprophytes, but some are human pathogens responsible to cause actinomycosis nocardiosis and actinomycetoma. Large group of gram positive bacilli with a tendency to form chains and filaments. Endogenous members of the bacterial flora in the mouth and lower gastrointestinal tract Actinomycosis Chronic suppurative and granulomatous infection with interconnecting sinus tracts that contain sulfur granules Etiology: Actinomyces israeli Actinomyces naeslundii Characteristics:. Gram positive, facultative anaerobe substrate filaments that grow in co2 enriched condition Pathogenesis and clinical features:. Infection is initiated by trauma that introduces these endogenous bacteria into the mucosa 1. Cervico facial actinomycosis 270 Fluctuant mass with draining fistula in jaw area, and may extend to involve bone and lymphnodes in the head and neck 2. Thoracic actinomycosis Resemle subacute pulmonary infection with extension to chest wall and ribs 3. Abdominal actinomycosis May be secondary to ruptured appendix or ulcer with extensive involvement of abdominal organs Lab. Diagnosis: Specimen: Tissue, pus, sputum Smear: Gram-positive filaments with lobulated sulfur granules Culture: Thioglycolate broth or blood agar incubated anaerobically or co2 enriched condition Biochemical reacrion: Catalase positive/negative Treatment: Penicillin Clindamycin + Surgery Erythromycin Nocardiosis Etiology: Nocardia asteroides complex N. Aerobic gram positive, partially aci fast bacilli Pathogenesis and cloinical features: Route of transmission: Inhalation Usual presentation is subacute or chronic pulmonary infection with dissemination to the brain and skin Lab. Spirochete consist of protoplasmic cylinder bounded by a cell wall and outer membrane. There is an axial filament or endoflagella between the cell wall and outer membrane. Not cultured in artificial media, in fertilized eggs and tissue culture, but the saprophytic Reiter strain grows in anaerobic culture. Remain viable in the blood or plasma store at 4 c at least for 24 hrs (transmitted via blood transfusion) Antigenic structure:. Primary stage: Hard chancre: Clean-based, non-tender, indurated genital ulcer with inguinal lymphadenopathy. Secondary stage: Manifests with generalized maculopapular rash condylomata lata and white patches 274 in the mouth. There may be syphilitic meningitis, nephritis, periostitis, hepatitis and retinitis. Primary and secondary syphilis are rich in spirochete from the site of the lesion and patients are highly infectious. Early latent stage: Relapse of symptoms and signs occur, and patients are infectious. Tertiary stage: Manifesting with gumma(granulomatous lesion) in bone, skin and liver; meningovascular syphilis, syphilitic paresis, tabes dorsalis, syphilitic aortitis and aortic aneurysm. One third of cases seems spontaneously cured during primary and secondary syphilis but no clear evidence 2. Out come: Abortion Fetal death Still birth Early neonatal death Organ damage: Congenital syphilis triad. Positive result revert to negative with in 6- 18 months of effective therapy of syphilitic infection Principle: Antigen and antibody (Reagin) reaction results in clumping after aggitation.

This suggests that experimentally created pain does not elicit the association with the treatment environment discount 200mg acivir pills free shipping, whereas the real pain has the effect of eliciting memories of previous experiences of treatment cheap 200 mg acivir pills mastercard, making it more responsive to placebo intervention. Anxiety reduction Placebos have also been explained in terms of anxiety reduction. Downing and Rickles (1983) argued that placebos decrease anxiety, thus helping the patient to recover. In particular, such a decrease in anxiety is effective in causing pain reduction (Sternbach 1978). For example, according to the gate control theory, anxiety reduction may close the gate and reduce pain, whereas increased anxiety may open the gate and increase pain (see Chapter 12). Placebos may decrease anxiety by empowering the individual and encouraging them to feel that they are in control of their pain. This improved sense of control, may lead to decreased anxiety, which itself reduces the pain experience. Placebos may be particularly effective in chronic pain by breaking the anxiety–pain cycle (see Chapter 12). The role of anxiety reduction is supported by reports that placebos are more effective in reducing real pain than reducing experimental pain, perhaps because real pain elicits a greater degree of anxiety, which can be alleviated by the placebo, whereas experimentally induced pain does not make the individual anxious. In addition, Butler and Steptoe (1986) reported that although placebos increased lung function in asthmatics, this increase was not related to anxiety. Placebos have been shown to create dependence, withdrawal and tolerance, all factors which are similar to those found in abstinent heroine addicts, suggesting that placebos may well increase opiate release. In addition, results suggest that placebo effects can be blocked by giving naloxone, which is an opiate antagonist. This indicates that placebos may increase the opiate release, but that this opiate release is blocked by naloxone, supporting the physiological theory of placebos. However, the physiological theories are limited as pain reduction is not the only consequence of placebos. In accordance with this, all theories of placebo effects described so far involve the patient expecting to get better. Experimenter bias theory describes the expectation of the doctor, which is communicated to the patient, changing the patient’s expectation. Expectancy effects theory describes directly the patients’ expectations derived from previous experience of successful treatment. Reporting error theory suggests that patients expect to show recovery and therefore inaccurately report recovery, and theories of misattribution argue that patients’ expec- tations of improvement are translated into understanding spontaneous changes in terms of the expected changes. In addition, conditioning theory requires the individual to expect the conditioned stimuli to be associated with successful intervention and anxiety reduction theory describes the individual as feeling less anxious after a placebo treatment because of the belief that the treatment will be effective. Finally, even the physiological theory assumes that the individual will expect to get better. Ross and Olson (1981) summarize the placebo effects as follows: s the direction of placebo effects parallels the effects of the drug under study; s the strength of the placebo effect is proportional to that of the active drug; s the reported side effects of the placebo drug and the active drug are often similar; s the time needed for both the placebo and the active drug to become active are often similar. As a result, they conclude that ‘most studies find that an administered placebo will alter the recipient’s condition (or in some instances self-report of the condition) in accordance with the placebo’s expected effects’ (Ross and Olson 1981: 419). Therefore, according to the above theories, placebos work because the patient and the health professionals expect them to work. This emphasizes the role of expectations and regards placebo effects as an interaction between individuals and between individuals and their environment. For a long time, medicine has regarded adherence (compliance) with medical recom- mendations to be important for recovery: ‘take these drugs and you will get better’. However, this study suggests that simply adhering to medical recommendations to take pills may be beneficial to recovery following a heart attack, regardless of whether the pills taken are active pills or placebo pills. This has implications for understanding the relationship between the mind and body (‘I believe that I have taken my medication’ is related to actually getting better) and for understanding the central role of beliefs and expectations in health and illness. For these trials, subjects are randomly allocated to either the experimental condition (and receive the real drug) or the control condition (and receive the placebo drug). Placebo drugs are used as a comparison point in order to distinguish the ‘real’ effects of the chemically active drug from both the ‘placebo effects’ and changes that may spontaneously happen over time. However, in 1982, data from the Coronary Drug Project was published which suggested that the best predictor of mortality in men who had survived a heart attack was not taking the lipid-lowering drug compared with taking the placebo drug, but adherence to taking any drug at all (whether an active drug or a placebo drug). The results indicated that adherers had lower mortality at five years than the non-adherers in both the experimental and the placebo groups. Subjects The original study included 3837 men and women aged 30–69 years who were reassessed every three months for an average of 25 months. The data from 1082 men in the experimental condition (who had received the beta-blocker) and 1094 men in the placebo condition were analysed (all women and those men who had not completed the psychosocial measures were excluded from the analysis). Design The study was prospective with subjects completing initial measures six weeks after hospital discharge and completing subsequent follow-up measures every three months.

Tilson 25 Statistical Principles and Application in Biopharmaceutical Research 313 Dan Anbar 26 Data Management 345 T order acivir pills 200mg free shipping. Fox 33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 415 John P purchase 200 mg acivir pills with visa. Fox 43 Organizing and Planning Local, Regional, National and International Meetings and Conferences 575 Zofia Dziewanowska and Linda Packard 44 Drug Withdrawals from the Market – Causes and Consequences 579 Ronald D. Fletcher 46 Pharmaceutical Medicine and the Law 595 Sarah Croft and Timothy Pratt 47 Pharmaceutical Product Liability 605 Han W. Graham Hughes 51 Advertising and Marketing 653 Jonathan Belsey 52 Middle East, India, China and the Far East: Pharmaceutical Medicine in the East 665 Gamal Hammad 53 Financial Aspects of Clinical Trials 689 R. Wells Appendix: Useful Internet Links 745 Index 749 Preface to the First Edition Pharmaceutical medicine is a relatively new, but rapidly growing, academic discipline. As editors, we would like to thank our contributors for their expertise, their dedication, and their vision. We would also like to thank and acknowledge the enormous help, encouragement, and patience of the team at John Wiley & Sons, Inc. Lastly, we would like to thank our families, and friends, who have withstood the frequent telephone calls, e-mails, and meetings, often late into the night. Indeed, to all who made this project possible, both authors and non-authors, we thank you. We are certain that this specialty, and our patients, even though we may help them vicariously, will benefit because of your contributions. Andrew Fletcher Lionel Edwards Tony Fox Peter Stonier Preface to the Second Edition Since the first edition of this book, pharmaceutical medicine has only become more diverse and has also become widely accepted as a recognized medical specialty, for example, with its first graduates of specialist training in the United Kingdom, to add to those of Switzerland, and Mexico. This has been accompanied by pharmaceutical medicine’s rapid progress toward specialty recognition within the European Community, and many changes in the pharmaceutical environment. There are new chapters on European regulations, risk management, the Middle East, Asia and other topical subjects in pharmaceutical medicine. Those chapters that did appear in the first edition have all been brought up to date. But this book is for all those working in pharmaceutical medicine, regardless of their degrees, titles or affiliations. Although it comprehensively covers the internationally harmonized syllabus for the Diplomas in Pharmaceutical Medicine that are awarded in Belgium, Switzerland and the United Kingdom, this book will also usefully serve those teaching other types of certificates and (usually Master’s) degrees in this field, as well as being a vade mecum for those who are not undertaking academic courses. Hannah Bradley got this second edition started, but then went off on a tour around theworld; the editors strenuously deny that they are the reason why. Lucy Sayer and Juliet Booker have since piloted the ship to the dock-side, successfully cajoling us into getting this edition done before its second decade. Not least, we would like to thank you, the reader, for your continued support and suggestions. Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug and devices in 10 therapeutic areas. Previously, he was Vice President of Clinical Research at Bio- Technology Pharmaceutical Corporation, a small biotechnology firm operating both in the United States and internationally. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He teaches pharmaceutical medicine, bioethics and medical and scientific writing at Temple University’s School of Pharmacy. He is a founder member and former trustee of the Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharma- ceutical Physicians). He has also been a clinical and regulatory Vice President within a small pharmaceutical company. His publications span several areas of pharmaceutical medicine, for example, regulation, pharmacology, clinical trials, pharmacovigilance, analgesics, migraine, genotoxicology, and metabolism, and he is named as inventor on several patents. He is on the editorial boards of several journals, and serves in a more senior capacity for two of them. Tony is proud to be an Essex man, researches the history of that County, and has been elected as a fellow of the Royal Geographical and the Royal Numismatic Societies. He is Medical Director of Amdipharm Plc, and of Medical Resource Provider Axess Ltd. His publications include edited works in human psychopharmacology, pharmaceutical medicine, clinical research, medical marketing, and careers in the pharmaceutical industry. Professor Stonier has been elected a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce. Fox Pharmaceutical medicine is unquestionably a strate efficacy, tolerability and purity in drug young medical specialty. The first university chair products (and their equivalents in diagnostics and in pharmaceutical medicine is less than 10 years old, devices), pharmaceutical medicine has become and there are no great buildings or institutions evidence based; it is interesting to note that the dedicated to it, unlike venerable medical specialties more venerable medical specialties are now imitat- such as chest medicine, neurology, physiology, ing the supposed ‘new kids on the block’ with the pharmacology and so on. Possibly because of its recent emphasis on evidence-based approaches to youth, this is a specialty that can be misunderstood the patient.