By X. Uruk. Keck Graduate Institute.

Explaining the patient’s probable experience during the procedure in understandable terms buy sildenafil in united states online. Helping to position the patient and make them as comfortable as possible during the procedure buy cheap sildenafil 25mg on-line. Assisting (under supervision purchase 75 mg sildenafil, when appropriate) in the performance of the procedure discount 25 mg sildenafil overnight delivery. Appropriately documenting, when required, how the procedure was done as well as any complications and results. Ordering and interpreting appropriate diagnostic tests on fluids removed from the patient (e. Demonstrate commitment to using risk-benefit, cost-benefit, and evidence- based considerations in the selection of procedures to be performed. Seek feedback regularly regarding procedural skills and respond appropriately and productively. Especially important are those interventions that relate to prevention of cardiovascular disease, the early detection and treatment of potentially curable cancers, and to optimizing care for chronic diseases. The epidemiology and definitions of hypertension, its contribution to cardiovascular risk, the impact of treatment on risk, and current. The epidemiology of hyperlipidemia, its contribution to cardiovascular risk, the reliability of testing modalities, the impact of treatment on cardiovascular risk, and current recommendations for screening. The epidemiology of common cancers, including: • Breast cancer, including the efficacy of available screening modalities, impact of early treatment on survival, and current recommendations for screening. The risks, benefits, methods, and recommendations for immunizing adults against hepatitis B, influenza, pneumococcal infection, tetanus/diphtheria, and mumps/measles/rubella. Safe sexual practices and risks, benefits, and efficacy of common methods of contraception. Efficacy of exercise and weight loss in prevention of cardiovascular disease and recommended exercise programs. The clinical presentations of substance abuse and basic approaches to prevention and treatment. The impact of smoking on cardiovascular and cancer risk and basic approaches to smoking cessation. Daily caloric, fat, carbohydrate, protein, mineral, and vitamin requirements; adequacy of diets in providing such requirements; evidence of need for supplements (e. The functional status assessment in the geriatric patient and its impact on assuring the best possible functional state. Controversies and differences that exist in the recommendations for preventive measures and screening. History-taking skills: Students should be able to obtain, document, and present an age-appropriate medical history, including: • Dietary intake of fats and cholesterol. Laboratory interpretation: Students should be able to recommend and interpret laboratory tests for screening purposes, including consideration of test cost and performance characteristics as well as patient preferences. Communication skills: Students should be able to: • Communicate results of the evaluation and counsel for disease prevention. Basic and advanced procedural skills: Students should be able to: • Perform a urinalysis (dipstick and microscopic). Management skills: Students should be able to develop an appropriate evaluation and treatment plan for healthy patients, including: • Designing an appropriate work-up for any abnormalities noted on the screening exam. Recognize the importance of regularly screening all patients followed and of teaching all patients about preventive measures. Appreciate the necessity of keeping detailed records of screening and health maintenance measures. Understand that physicians and health care delivery organizations are frequently judged by their ability to deliver the highest quality screening and preventive measures. Demonstrate commitment to using risk-benefit, cost-benefit, and evidence- based considerations in the selection of screening tests. Demonstrate ongoing commitment to self-directed learning regarding prevention and screening. Recognize the importance and demonstrate a commitment to the utilization of other healthcare professions in preventative medicine. Mastery of the approach to patients with abdominal pain is important to third year medical students. Relative likelihood of the common causes of abdominal pain based on the pain pattern and the quadrant in which the pain is located. Diagnostic discrimination between common causes of abdominal pain based on history, physical exam, laboratory testing, and imaging procedures. The influence of age, gender, menopausal status, and immunocompetency on the prevalence of different disease processes that may result in abdominal pain. History-taking skills: Students should be able to obtain, document, and present an appropriately complete medical history that differentiates among etiologies of disease, including: • Chronology. Physical exam skills: Students should be able to perform a focused physical exam in patients who present with abdominal pain in order to: • Establish a preliminary diagnosis of the cause. Laboratory interpretation: Students should be able to interpret specific diagnostic tests and procedures that are commonly ordered to evaluate patients who present with abdominal pain. Test interpretation should take into account: • Important differential diagnostic considerations including potential diagnostic emergencies. Communication skills: Students should be able to: • Communicate the diagnosis, treatment plan, and subsequent follow-up to the patient and his or her family. Basic and advanced procedural skills: Students should be able to: • Insert a nasogastric tube. Management skills: Students should be able to develop an appropriate evaluation and treatment plan for patients that includes: • Recognizing the role of narcotic analgesics and empiric antibiotics in treating selected patients who present with acute abdominal pain. Demonstrate commitment to using risk-benefit, cost-benefit, and evidence- based considerations in the selection of diagnostic and therapeutic interventions for abdominal pain. Recognize the importance of patient needs and preferences when selecting among diagnostic and therapeutic options for abdominal pain. Recognize the importance and demonstrate a commitment to the utilization of other healthcare professions in the treatment of abdominal pain. Internists must master an approach to the problem as they are often the first physicians to see such patients. The pathophysiology, symptoms, and signs of the most common and most serious causes of altered mental status, including: • Metabolic causes (e. The importance of thoroughly reviewing prescription medications over-the- counter drugs, and supplements and inquiring about substance abuse. The risk and benefits of using low-dose high potency antipsychotics for delirium associated agitation and aggression. History-taking skills: Students should be able to obtain, document, and present an age-appropriate medical history that differentiates among etiologies of altered mental status including eliciting appropriate information from patients and their families regarding the onset, progression, associated symptoms, and level of physical and mental disability. Physical exam skills: Students should be able to perform a physical exam to establish the diagnosis and severity of disease, including: • Complete neurologic examination. Differential diagnosis: Students should be able to generate a prioritized differential diagnosis recognizing specific history and physical exam findings that suggest a specific etiology for altered mental status. Laboratory interpretation: Students should be able to recommend when to order diagnostic and laboratory tests and be able to interpret them, both prior to and after initiating treatment based on the differential diagnosis, including consideration of test cost and performance characteristics as well as patient preferences. Communication skills: Students should be able to: • Communicate the diagnosis, treatment plan, and subsequent follow-up to the patient and his or her family. Management skills: Students should able to develop an appropriate evaluation and treatment plan for patients that includes: • Recognizing that altered mental status in a older inpatient is a medical emergency and requires that the patient be evaluated immediately. Appreciate the family’s concern and at times despair arising from a loved one’s development of altered mental status. Appreciate the patient’s distress and emotional response to that may accompany circumstances of altered mental status. Demonstrate commitment to using risk-benefit, cost-benefit, and evidence- based considerations in the selection diagnostic and therapeutic interventions for altered mental status. Recognize the importance of patient preferences when selecting among diagnostic and therapeutic options for altered mental status. Demonstrate ongoing commitment to self-directed learning regarding altered mental status.

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Obtaining reasonable and timely consultation with a special- ist is another way of double checking examination findings cheap 75 mg sildenafil visa. Physicians need to make sure that physical examination tools are working properly and that they know how to use them well order sildenafil without prescription. The physician should look at the results of diagnostic tests objectively purchase sildenafil toronto, applying the principles of med- ical decision making contained in the next several chapters generic sildenafil 100mg with visa. The physician should not be overly optimistic or pessimistic about the value of a single lab test, and should apply rigorous methods of decision making in determining the meaning of the test results. The physi- cian should remember that the patient is functioning within a social con- text. Emotional, cultural, and spiritual components of health are important Sources of error in the clinical encounter 243 in getting an accurate picture of the patient. If this is a serious problem, individual physicians could consider dictating charts or using a computer for medical charting. George Bernard Shaw (1856–1950): The Doctor’s Dilemma, 1911 Learning objectives In this chapter you will learn: r the uses and abuses of diagnostic tests r the hierarchical format to determine the usefulness of a diagnostic test The Institute of Medicine has determined that error in medicine is due to overuse, underuse, and misuse of medical resources – resources such as diagnos- tic tests. In order to understand the best way to use diagnostic tests, it is helpful to have a hierarchical format within which to view them. The use of medical tests in making a diagnosis Before deciding on ordering a diagnostic test, physicians should have a good rea- son for doing the test. Examples of this are a throat culture in a patient with a sore throat to look for hemolytic group A streptococcus bacteria or a mammogram in a woman with a palpa- ble breast mass to look for a cancer. Examples of this are the phenylketonuria test in a healthy newborn to detect a rare genetic disorder, a mammogram in a woman without signs or symptoms of a breast mass, or the prostate specific antigen test in a healthy asymptomatic man to look for prostate cancer. Screening tests will not directly benefit the majority of peo- ple who get them, since they don’t have the disease, but the result can be 244 The use of diagnostic tests 245 reassuring if it is negative. In general there are five criteria that must be met for a successful screening test – burden of suffering, early detectability, test validity, acceptability, and improved outcome – and unless all these are met, the test should not be recommended. One example of this is monitoring the prothrombin time in patients on warfarin therapy. This checks the patient’s level of anticoagulation and prevents levels from being either too low, thus leading to new clotting, or too high, and leading to excess bleeding. Another example is therapeutic gen- tamycin level in patients on this antibiotic to reduce the likelihood of toxic levels causing renal failure. Important features to determine the usefulness of a diagnostic test There are several ways of looking at the usefulness of diagnostic tests. This hier- archical evaluation uses six possible endpoints to determine a test’s utility. The more criteria in the schema that are fulfilled, the more potentially useful the test will be. This is usually a function of the instrumentation or operator reliability of the test. While precision used to be assumed to be present for all diagnostic tests, many studies have demonstrated that with most non-automated tests, there is some degree of subjectivity in test inter- pretation. It is also present in tests commonly considered to be the “gold standard” such as the interpretation of tissue samples from autopsies, biopsies, or surgery. The determina- tion of accuracy depends upon the ability of the instrument’s result to be the same as the result determined using a standardized specimen and 1 W. A person with more experience, better train- ing, or more talent will get more precise and accurate results on many tests. If a test is very expensive and not covered by health insurance, the patient may not be able to pay for it, making it a useless test for them. The substances may also prevent the test from picking up true positives and thereby make them false negatives. An example of this if a person eats poppy- seed bagels, they will give a false positive urine test for opiates. Criterion-basedvalidity describes how well the measurement agrees with other approaches for measuring the same characteristic, and is a very important measurement in studies of diagnostic tests. The result of a gold-standard test defines the presence or absence of the dis- ease (i. There are very few true gold standards in medicine and some are better or scientifically more pure than others. These are traditionally consid- ered to be the ultimate gold standard, but their interpretations can vary with different pathologists. Theoretically, all bacteria that are present in the blood should grow on a suitable culture medium. Sometimes, for technical reasons, the culture does not grow bacteria even though they were present in the blood. This can occur because the technician doesn’t plate the culture properly, it is stored at an incorrect temperature, or there just happened to be no bacteria in the particular 10-cc vial of blood that was sampled. This is a set of fairly objective cri- teria for making a diagnosis of rheumatic fever. Factors that could decrease the accuracy of these criteria are that a component of the criteria, such as temperature, may be measured incorrectly in some patients, or another criterion like arthritis may be interpreted incor- rectly by the observer. These criteria are objective, yet depend on the clinician’s interpretation of the patient’s descrip- tion of their symptoms. As mentioned previously, x-rays are open to variation in the reading, even by experienced radiologists. If we are ultimately interested in finding out how well a test works to separate the diseased patients from the healthy patients, we can follow everyone who received the test for a specified period of time and see which outcomes they all have. This technique works as long as the time period is long enough to see all the possible dis- ease outcomes, yet short enough to study realistically. Does the result of the test cause a change in diagno- sis after testing is complete? If we are almost certain that a patient has a dis- ease based upon one test result or the history and physical exam, we don’t need a second test to confirm that result. Diagnostic thinking only considers how the test performs in making the diagnosis in a given clinical setting, and is therefore closely related to diagnostic accuracy. The setting within which this thinking operates is dependent on the prevalence of the disease in the patient population being tested. For example, the venogram is the gold-standard test in the diagnosis of deep venous thrombosis. It is an expensive and invasive test that can cause some side effects, although these side effects are rarely lethal. Part of the art of medicine is determining which patients with one negative ultrasound can safely wait for a confirmatory ultrasound 3 days later, and which patients 248 Essential Evidence-Based Medicine need to have an immediate venogram or initiation of anticoagulant medica- tion therapy. This considers biophysiological parameters, symptom severity, functional outcome, patient utility, expected values, morbidity avoided, mor- tality change, and cost-effectiveness of outcomes. We will discuss some of these issues in the chapter on decision trees and patient values (Chapter 31). Even a cheap test, if done excessively, may result in prohibitive costs to society. Out- comes include the additional cost of evaluation or treatment of patients with false positive test results and the psychosocial cost of these results on the patient and community. Other outcomes are the risk of missing the correct diagnosis in patients who are falsely negative and may suffer negative out- comes as a result of the diagnosis being missed. Again, physicians may need to also consider a cost analysis for evaluating the test. Interestingly, the per- spective of the analysis can be the patient, the payor, or society as a whole. Overall, patient or societal outcomes ultimately determine the usefulness of a test as a screening tool. Bertrand Russell (1872–1970): The Philosophy of Logical Atomism, 1924 Learning objectives In this chapter you will learn: r the characteristics and definitions of normal and abnormal diagnostic test results r how to define, calculate, and interpret likelihood ratios r the process by which diagnostic decisions are modified in medicine and the use of likelihood ratios to choose the most appropriate test for a given purpose r how to define, calculate, and use sensitivity and specificity r how sensitivity and specificity relate to positive and negative likelihood ratios r the process by which sensitivity and specificity can be used to make diag- nostic decisions in medicine and how to choose the most appropriate test for a given purpose In this chapter, we will be talking about the utility of a diagnostic test. This is a mathematical expression of the ability of a test to find persons with disease or exclude persons without disease.

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When s/he spoke of ‘‘some widows who  Introduction are not permitted to take a second vow order generic sildenafil from india,’’150 the author of Treatments forWomen may have been referring to the fact that sildenafil 25 mg amex, in Salerno in this period generic 75 mg sildenafil fast delivery, widows living under traditional Lombard law would have been under special pressure buy generic sildenafil 100mg, more so than women living under Roman law, to keep their late husband’s bed ‘‘chaste. Given that remarriage would have threatened a woman with loss of her property and perhaps guardianship of her children as well, maintenance of chastity may well have been a pressing concern. Five recipes are given as a group (¶¶– and –),153 with a sixth comment on the subject later (¶). The main group of remedies opens with a straightforward and non- apologetic statement: ‘‘A constrictive for the vagina, so that women may be found to be as though they were virgins, is made in this manner. The third recipe (¶) shows that not every kind of deception was ap- proved: ‘‘There are some filthy and corrupt prostitutes who desire to be found more than virgins. They make a certain constrictive for this, but they are ill advised for they render themselves bloody and they wound the male member. They take glass and natron and reduce them to a powder and place them in the vagina. The desire of women, ‘‘honest’’ or ‘‘dishonest,’’ to ‘‘restore’’ their virginity suggests acknowledgment by at least some medical practitioners that women’s honor in this Mediterra- nean culture, to a degree that would never have been true for men, was bound up intimately with their sexual purity. If successful, these recipes may well have made the difference for some women between marriage and financial security, on the one hand, and social ostracization and poverty, on the other. From recognition of difficulties of bladder control (a common affliction of older women, exacerbated by frequent childbearing, ¶) to cracked lips caused by too much kissing (¶) to breast pain during lactation (¶) to instructions for cutting the umbilical cord (¶), we sense the mundane but nonetheless pressing concerns of women. Care of obstetrical problems, especially those consequent to birth, is a particularly frequent concern (¶¶, –, , and –). Here, the only recommendations are to bathe, fumigate, and offer sternutatives (substances that induce sneezing) to women giving birth (¶) and to give a potion and fumigate with vinegar to aid birth and help expel the afterbirth (¶). This absence is perhaps to be explained by the au- thor’s belief that childbirth in and of itself is not pathological. It does not, in other words, demand the attention of a medical practitioner; what needs to be known about aiding labor is already part of the common knowledge of the women (relatives and neighbors) who would normally attend the birth. In ¶, for instance, we find ‘‘a very useful unguent for sunburn and any kind of lesions, but espe- cially those caused by the wind, and for the blemishes on the face which Saler- nitan women make [while mourning] for the dead. Having realized that her husband had reached the end of his life, she delivered an impassioned speech of grief, all the while ‘‘ripping her cheeks with her nails and tearing at her disheveled hair. To the extent that these are mostly uro- genital and otherconditions of the pelvic region that men sharewith women— infertility caused by obesity or emaciation (¶¶–), hemorrhoids (¶),167 kidney and bladder stones (¶¶–), and intestinal pain (¶)—their pres- ence is understandable. Yet the author not merely mentions that men have these same disorders but (with the exception of two cases, where the ther- apy is not differentiated) s/he provides full details of the differing treatments needed for men. Moreover, there are two remedies exclusively for men: ¶ on swelling of the penis and lesions of the prepuce and ¶ on swollen tes- ticles. The inclusion of this material probably reflects more than the mere cate- gorical affinity of gynecological and andrological diseases. In his mid-twelfth- century compendium of medical practices, the Salernitan physician Johannes Platearius credited ‘‘Salernitan women’’ with a remedy for pustules of the penis very similar to that described in ¶. I will have more to say about the Salerni- tan women momentarily; here it should simply be noted that Platearius’s cita- tion suggests that it was not considered problematic for female practitioners to treat both men’s and women’s reproductive complaints. Copho is credited with the statement that sneezing can aid obstructed birth by rupturing the ‘‘cotyledons’’ (¶). He is also mentioned as the ‘‘author’’ of a special powder used for treatment of impetigo (a skin condition). Both place greatest stress on maintaining (or attempting to maintain) regular menstruation;171 both are concerned to remedy displacements and lesions of the uterus; both offer sug- gestions for aiding difficult childbirth. In this respect, it is quite understand- able that the two texts should have been brought together at the end of the twelfth century and ultimately ascribed to a single author (see below). While Conditions of Women is thor- oughly bookish, having little material beyond what the author has found in other tracts (which he readily admits in his prologue), Treatments for Women ranges more broadly, covering well over twice as many gynecological disease entities as its counterpart, not to mention its considerable material on cos- Introduction  metics and other topics. Despite their differences, both texts are equally rep- resentative of twelfth-century Salernitan medicine, though of two clearly dif- ferent varieties. While Conditions of Women embraces the new Arabic medicine and reflects the more learned, literate direction that Salernitan medical writing began to take in the early and middle decades of the twelfth century, Treat- ments of Women reflects an alternate, practical and probably largely oral tra- dition. It advocates a medicine that depends upon access to the international trade routes that brought into the Mediterranean basin spices and other ex- pensive substances like cloves and frankincense,172 and in its references to the treatments or theories of certain Salernitan masters it shows itself aware of a larger realm of medical discourse and practice. Yet on many other levels it is sui generis, independent of the growing theoretical and pharmaceutical sophisti- cation embraced by contemporary authors. There were, these texts suggest, at least two distinct subcultures of medicine in twelfth-century Salerno. The third of the three Trotula texts, On Women’s Cosmetics, reflects a point of intersection between them. Women’s Cosmetics Women’s Cosmetics does not participate in any theoretical system of explana- tion. Though often very detailed in its therapeutic prescriptions, listing down to the finest detail how to prepare this or that mixture, how to test when it is ready, and how to apply it, the text’s sole organizing principle is to arrange the recommended cosmetics in head-to-toe order. Then there are recipes forcare of the hair: for making it long and dark, thick and lovely, or soft and fine. For care of the face there are recipes for removing unwanted hair, whitening the skin, removing blemishes and abscesses, and exfoliating the skin, plus general facial creams. For the lips, there is a special unguent of honey to soften them, plus colorants to dye the lips and gums. For care of the teeth and prevention of bad breath, there are five different recipes. The final chapter is on hygiene of the genitalia: ‘‘There are some women who because of the magnitude of their instrument [i. The author gives detailed instructions on how to apply the water just  Introduction prior to intercourse, together with a powder that the woman is to rub on her chest, breasts, and genitalia. She is also to wash her partner’s genitals with a cloth sprinkled with the same sweet-smelling powder. It also employs a variety of mineral substances: orpiment (a compound of arsenic), quicklime, quicksilver, sulfur, natron, and white lead. White or rosy skin (or both together),177 black or blonde hair seem equally prized. As the figure of the bathing woman in a late-twelfth-century copy of a Salernitan pharmaceutical text shows (fig. One therapy the author even claims to have witnessed himself: ‘‘I saw a certain Saracen woman in Sicily curing infinite numbers of people [of mouth odor] with this medicine alone. What we have here in Women’s Cosmetics, it seems, is confirmation of Ibn Jubayr’s observation of Christian women’s adoption of Muslim cosmetic practices in Sicily. It was, in fact, precisely the Women’s Cosmetics author’s recognition of this demand for knowledge of cosmetics that (by his own account) induced him, a male physi- cian, to strengthen his account ‘‘with the rules of women whom I found to be practical in practicing the art of cosmetics. The portable cauldron is reminiscent of equip- ment in the bathhouse of the Salernitan monastery of Santa Sofia, while the covered box and bag no doubt hold unguents orcosmetics. Two Anglo- Norman writers of the twelfth century, Orderic Vitalis and Marie de France, each tell different stories of a Norman (or, in Marie’s case, possibly English) traveler journeying to Salerno and finding there a woman very learned in medi- cine. The necrology of the cathedral of Salerno lists a woman healer (medica) named Berdefolia,who died in . The motherof Pla- tearius (one of several members of a veritable medical dynasty of that name) is said to have cured a certain noblewoman of uterine suffocation. Moreover, sev- eral male medical writers of the twelfth century who either taught or studied at Salerno refer frequently to the medical practices of the mulieres Salernitane,the ‘‘Salernitan women. In all, more than five dozen such references to the Salernitan women can be found in medical texts of the twelfth and early thirteenth centuries. What these references also show, however, is a limited picture of the Salernitan women’s practices. While their therapies are not confined to any specific area of medicine (they are cred- ited with therapies for gastrointestinal disorders, skin problems, etc. The Salernitan women, to judge from all these references, are em- pirical practitioners: they know the properties of plants and are even credited on occasion with finding new uses for them, but they seem to participate not at all in the world of medical theory or medical books. Set against this background, the phenomenon of Trota is all the more re- markable. Trota is the only Salernitan woman healer whose name is attached to any extant medical writings. First, there is the Practical Medicine According to Trota (Practica secun- dum Trotam).

Radio show host Rush Limbaugh buy sildenafil 75mg line, Restless Legs Syndrome disease mongering cheap sildenafil 50mg on-line, as outlined in the for example buy 50mg sildenafil with visa, has mocked it as a To identify media coverage related first column of Table 1: exaggerating pseudoillness” [10]) sildenafil 100 mg overnight delivery. This is the most common disorder your doctor has never heard of” [17]) and underrecognized by patients (“…many people can suffer in silence for years before it is recognized” [18]). One-quarter of articles encouraged patient self-diagnosis and suggested people ask their doctor whether restless legs might explain various problems (including insomnia, daytime fatigue, attention deficit disorder in children, and depression). One-fifth of articles referred readers to the “nonprofit” Restless Legs Foundation for further information; none reported that the foundation is heavily subsidized by GlaxoSmithKline. No article acknowledged the possibility of overdiagnosis (the idea that some people will be diagnosed unnecessarily and take medication they do not really need). Suggest That All Disease Should Be Treated About half the news stories mentioned the drug ropinirole by name. Frequency of Key Elements of Disease Mongering in Newspaper Articles By contrast, about half the stories Top bar graph analyzes all articles about restless legs syndrome. Bottom bar graph analyzes the mentioning ropinirole included subset that mentions ropinirole. One-third article questioned the validity of the digit dial survey (typical response rates of articles used “miracle language” prevalence estimates. Most likely, the to describe patient response to are reasons to believe the estimates authors meant that 98% of individuals medication (e. Driven to despair by years of sleepless points) compared with 57% taking In a recent large study, only 7% nights, patients have become suicidal” placebo. While over 40% of the articles The drug label [20] also notes that diagnostic criteria, and only 2. The articles also reinforced the placebo group (12% versus 6%; 8% The authors claimed an implausible need for more diagnosis. GlaxoSmithKline (2003 April 1) Restless legs syndrome can significantly impair the most common side effect, reported The news coverage of restless legs quality of life. Research Triangle would use the drug for years or even a been co-opted into the disease- Park (North Carolina): GlaxoSmithKline. GlaxoSmithKline (2003 June 10) New survey Could Do Better think it is likely that our findings would reveals common yet under recognized disorder—Restless legs syndrome—is keeping Unfortunately, there is no obvious apply to others. Research Triangle way to distinguish information from why the media would be attracted to Park (North Carolina): GlaxoSmithKline. In Table 1, we highlight disease promotion stories and why press2003/ clues that should alert journalists to they would be covered uncritically. Lerner M (2005) Respect, relief for restless First, journalists should be very legs; pill helps relieve pain and exhaustion for wary when confronted with a new miracle cures. Star Tribune, or expanded disease affecting large The problem lies in presenting Metro ed; Sect B: 1. The New common and very bothersome, it is may be no public health crisis, the York Times. Journalists uncontrollable urge to move limbs affects need to ask exactly how the disease is vague symptoms that may have a more 1 in 10, runs in families. Allen R, Walters A, Montplaisir J, Hening W, cannot be taken to represent the Myers A, et al. Arch Intern Med 165: 1286– Journalists should also reflexively After all, their job is to inform readers, 1292. Lantin B (2004 December 1) No sleep for We would like to thank Elliott Fisher and those with restless legs. Cresswell A (2005) Relief at hand for restless treatment may end up causing more http:⁄⁄observer. Finally, instead of extreme, How the world’s biggest pharmaceutical The Columbus Dispatch. Home Final Edition unrepresentative anecdotes about companies are turning us all into patients. Reuters (2005 May 6) Glaxo drug for restless Johnson A (1978) Increased absenteeism from what problems it might cause (e. The New York work after detection and labeling of hypertensive whether I might be trading less restless Times; Sect C: 3. Marina Maggini*, Nicola Vanacore, Roberto Raschetti in patients with Alzheimer disease but successes” by 245% in patients with also in patients with vascular dementia, mild to moderate Alzheimer disease dementia with Lewy bodies, dementia [3]. Even in many countries for the treatment when the evidence on the efficacy of of Alzheimer disease, even though it these drugs is lacking, or inconclusive, was clear that the efficacy, in the short the results are often presented in such term, was modest, symptomatic, and a way as to create a false perception evident only in a subgroup of patients andomized controlled trials of efficacy. Unfortunately, many importance of the usually small effect Disease Assessment Scale–cognitive drug treatments are widely used in size observed. The authors looking critically at the clinical trial that it had produced “highly significant themselves have no role in decisions concerning such improvements in cognitive and clinical reimbursement. If the results of these trials are global assessments” in randomized Citation: Maggini M, Vanacore N, Raschetti R (2006) not carefully evaluated, together trials lasting 30 weeks and had Cholinesterase inhibitors: Drugs looking for a disease? A similar conclusion was during consultation on this first draft As in the earlier draft, the committee reported in the preliminary draft suggested that the drugs may be more “noted, however, that the evidence of recommendations on the use of effective for certain groups of people. As with trials of cholinesterase mixed, and that “the assessment and that those with vascular risk factors inhibitors for Alzheimer disease, a six- group suspected selection bias, “experience greater clinical benefit month trial period is unjustified for a measurement bias and attrition bias. The committee recently Alzheimer disease with cerebrovascular global function was observed in a updated its guidance, as shown in the disease, or an intermediate diagnosis greater proportion of patients treated Sidebar. Unfortunately, the study was with donepezil than those treated with not powered to detect treatment placebo in the 5-mg group but not in Patients with Alzheimer Disease differences in the three subgroups; the 10-mg group [16]. Among first 12 months of treatment, and a Dementia Associated with adverse events, Parkinsonian symptoms benefit of donepezil among carriers Parkinson Disease and Dementia were reported more frequently in of one or more apolipoprotein E ε4 with Lewy Bodies throughout the three-year follow-up. Harms-related data were inadequate: reviewers concluded that the trial “showed no statistically significant the flow of participants through the difference between the two groups at the rivastigmine group than in the study phases was not described; the 20 weeks. The authors concluded reasons and timing for discontinuation on neuropsychiatric features was found that rivastigmine was associated with per treatment arm were not reported; only in analysis of observed cases, and moderate but significant improvements only adverse events observed in at least may therefore be due to bias. It would be to investigate whether donepezil donepezil group [three from cardiac difficult to find such a population in a delays the onset of dementia in arrest], six in the vitamin E group, clinical setting for a number of reasons. Erkinjutti T, Kurz A, Gauthier S, Bullock mortality associated with cholinesterase new published trial on the effect of R, Lilienfeld S, et al. Positive results of a 24-week, multicenter, international, randomized, increased mortality. Wilkinson D, Doody R, Helme R, Taubman K, none of the reviewed studies met their biologically plausible intervention has Mintzer J, et al. A randomized, placebo-controlled trials showed a benefit of cholinesterase in patients’ well-being. Wild R, Pettit T, Burns A (2003) Cholinesterase Alzheimer’s disease: Lessons for healthcare inhibitors for dementia with Lewy bodies. Neurology randomised, double blind, placebo controlled, others stayed the same, while others will 50: 136–145. Later-developing dementia and further research is needed to and loss of the levodopa response. Jelic V, Kivipelto M, Winblad B (2005) Clinical (2005) Alert for healthcare professionals inhibitors in Alzheimer’s disease. Eur J Clin trials in mild cognitive impairment: Lessons on galantamine hydrochloride (marketed Pharmacol 61: 361–368. Barbara Mintzes 28 product-specific marketing and steer them towards appropriate plans for prescription drugs, from care. For the individual patient, drug ten companies, obtained through treatment is worth pursuing if potential subpoenas from 1999 to 2002; 3. New diseases may health problems and seeks effective it recommends responsible public be “created” or existing conditions care at an earlier stage, leading to health messages. For this to happen, Medicines Health-Care Products are covered by national laws governing the campaigns must address important Regulatory Agency has issued guidelines drug promotion that forbid misleading health concerns, focus on patients likely stating that the primary purpose of or deceptive advertising. However, to benefit from diagnosis and treatment, disease-awareness advertising must be enforcement is piecemeal and largely health education on a disease and its ineffective. In 2004, fewer than one-sixth of countries Mongering Used to Expand Funding: The author received no specific funding for Drug Sales this article. Although health in healthy individuals 89 countries (46%) reported active Citation: Mintzes B (2006) Disease mongering in • Inflated disease prevalence rates regulation of drug promotion, drug promotion: Do governments have a regulatory • Promotion of aggressive drug role? However, in many other reproduction in any medium, provided the original countries, unbranded disease-oriented distinguish from normal life author and source are credited. However, the Medicines Health- is a key example of disease mongering Care Products Regulatory Agency linked to drug sales.

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