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Inverse Benefit Law
The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the inverse benefit law, inspired by Tudor Hart's inverse care law. A drug effective for a serious disorder is less and less effective as it is promoted for milder cases and for other conditions for which the drug was not approved. Although effectiveness becomes more diluted, the risks of harmful side effects persist, and thus the benefit-harm ratio worsens as a drug is marketed more widely. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing. State of affairs The law is manifested through 6 basic marketing strategies: * reducing thresholds for diagnosing disease, * relying on surrogate endpoints, * exaggerating safety claims, * exaggerating efficacy Efficacy is the ab ...
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Drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insufflation (medicine), inhalation, drug injection, injection, smoking, ingestion, absorption (skin), absorption via a dermal patch, patch on the skin, suppository, or sublingual administration, dissolution under the tongue. In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect. A pharmaceutical drug, also called a medication or medicine, is a chemical substance used to pharmacotherapy, treat, cure, preventive healthcare, prevent, or medical diagnosis, diagnose a disease or to promote well-being. Traditionally drugs were obtained through extraction from medicinal plants, but more recently also by organic synthesis. Pharmaceutical drugs may be used ...
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Comparative Effectiveness Research
Comparative effectiveness research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances. Engaging various stakeholders in this process, while difficult, makes research more applicable through providing information that improves patient decision making. The Institute of Medicine committee has defined CER as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels." Comparative effectiveness research adopts many of the same ap ...
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Health Economics
Health economics is a branch of economics concerned with issues related to efficiency, effectiveness, value and behavior in the production and consumption of health and healthcare. Health economics is important in determining how to improve health outcomes and lifestyle patterns through interactions between individuals, healthcare providers and clinical settings. In broad terms, health economists study the functioning of healthcare systems and health-affecting behaviors such as smoking, diabetes, and obesity. One of the biggest difficulties regarding healthcare economics is that it does not follow normal rules for economics. Price and Quality are often hidden by the third-party payer system of insurance companies and employers. Additionally, QALY (Quality Adjusted Life Years), one of the most commonly used measurements for treatments, is very difficult to measure and relies upon assumptions that are often unreasonable. A seminal 1963 article by Kenneth Arrow is often cre ...
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Pharmaceutics
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. There are many chemicals with pharmacological properties, but need special measures to help them achieve therapeutically relevant amounts at their sites of action. Pharmaceutics helps relate the formulation of drugs to their delivery and disposition in the body. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Branches of pharmaceutics include: *Pharmaceutical formulation *Pharmaceutical manufacturing *Dispensing pharmacy *Pharmaceutical technology *Physical pharmacy *Pharmaceutical jurisprudence Pure drug substances are usually white crystalline or amorphous powders. Before the advent of medicine as a science, it was common for pharmacists to dispense drugs ''as is''. Most drugs today are administered as p ...
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Disease Mongering
Disease mongering is a pejorative term for the practice of widening the diagnostic boundaries of illnesses and aggressively promoting their public awareness in order to expand the markets for treatment. Among the entities benefiting from selling and delivering treatments are pharmaceutical companies, physicians, alternative practitioners and other professional or consumer organizations. It is distinct from the promulgation of bogus or unrecognised diagnoses. Term The term "monger" has ancient roots, providing the basis for many common compound forms such as cheesemonger, fishmonger, and fleshmonger, for those who peddle such wares respectively. "Disease mongering" as a label for the "invention" or promotion of diseases in order to capitalize on their treatment was first used in 1992 by health writer Lynn Payer, who applied it to the Listerine mouthwash campaign against halitosis (bad breath). Payer defined disease mongering as a set of practices which include the following: * ...
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Efficacy
Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versus effectiveness, distinction is now often made between efficacy and effectiveness. The word ''efficacy'' is used in pharmacology and medicine to refer both to the maximum response achievable from a pharmaceutical drug in research settings, and to the capacity for sufficient therapeutic effect or beneficial change in clinical settings. Pharmacology In pharmacology, efficacy () is the maximum response achievable from an applied or dosed agent, for instance, a small molecule drug. Intrinsic activity is a relative term for a drug's efficacy relative to a drug with the highest observed efficacy. It is a purely descriptive term that has little or no mechanistic interpretation. In order for a drug to have an effect, it needs to bind to its t ...
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Safety
Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to risk management, the control of recognized hazards in order to achieve an acceptable level of risk. Meanings There are two slightly different meanings of ''safety''. For example, ''home safety'' may indicate a building's ability to protect against external harm events (such as weather, home invasion, etc.), or may indicate that its internal installations (such as appliances, stairs, etc.) are safe (not dangerous or harmful) for its inhabitants. Discussions of safety often include mention of related terms. Security is such a term. With time the definitions between these two have often become interchanged, equated, and frequently appear juxtaposed in the same sentence. Readers unfortunately are left to conclude whether they comprise a redundancy. This confuses the uniqueness that should be reserved for each by itself. When seen as unique, as we intend here, ...
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Evidence-based Medicine
Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients. Background, history and definition Medicine has a long history of scientific inquiry about the prevention, diagnosis, and treatment of human disease. The concept of a controlled clinical trial was first described in 1662 by Jan Baptist van Helmont in reference to the practice of bloodletting. Wrote Van Helmont: The first published report describing the conduct and results of a controlled clinical trial was by James Lind, a Scottish naval surgeon who conducted rese ...
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Marketing
Marketing is the process of exploring, creating, and delivering value to meet the needs of a target market in terms of goods and services; potentially including selection of a target audience; selection of certain attributes or themes to emphasize in advertising; operation of advertising campaigns; attendance at trade shows and public events; design of products and packaging attractive to buyers; defining the terms of sale, such as price, discounts, warranty, and return policy; product placement in media or with people believed to influence the buying habits of others; agreements with retailers, wholesale distributors, or resellers; and attempts to create awareness of, loyalty to, and positive feelings about a brand. Marketing is typically done by the seller, typically a retailer or manufacturer. Sometimes tasks are contracted to a dedicated marketing firm or advertising agency. More rarely, a trade association or government agency (such as the Agricultural Marketing Servic ...
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Marketed
Marketing is the process of exploring, creating, and delivering value to meet the needs of a target market in terms of goods and services; potentially including selection of a target audience; selection of certain attributes or themes to emphasize in advertising; operation of advertising campaigns; attendance at trade shows and public events; design of products and packaging attractive to buyers; defining the terms of sale, such as price, discounts, warranty, and return policy; product placement in media or with people believed to influence the buying habits of others; agreements with retailers, wholesale distributors, or resellers; and attempts to create awareness of, loyalty to, and positive feelings about a brand. Marketing is typically done by the seller, typically a retailer or manufacturer. Sometimes tasks are contracted to a dedicated marketing firm or advertising agency. More rarely, a trade association or government agency (such as the Agricultural Marketing Service) ...
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Side Effects
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequences of the use of a drug. Developing drugs is a complicated process, because no two people are exactly the same, so even drugs that have virtually no side effects, might be difficult for some people. Also, it is difficult to make a drug that targets one part of the body but that does not affect other parts, the fact that increases the risk of side effects in the untargeted parts. Occasionally, drugs are prescribed or procedures performed specifically for their side effects; in that case, said side effect ceases to be a side effect and is now an intended effect. For instance, X-rays were historically (and are currently) used as an imaging technique; the discovery of their oncolytic capability led to their employ in radiotherapy (ablation of ...
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Effectiveness
Effectiveness is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression. Etymology The origin of the word "effective" stems from the Latin word effectīvus, which means creative, productive or effective. It surfaced in Middle English between 1300 and 1400 A.D. Usage In mathematics and logic, ''effective'' is used to describe metalogical methods that fit the criteria of an effective procedure. In group theory, a group element acts ''effectively'' (or ''faithfully'') on a point, if that point is not fixed by the action. In physics, an effective theory is, similar to a phenomenological theory, a framework intended to explain certain (observed) effects without the claim that the theory correctly models the underlying (unobserved) processes. In heat transfer, ''effectiveness'' is a measure of the performance of a heat exchange ...
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