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171-525: At the time, pharmaceutical companies were making considerable money by selling drugs under their trade names , giving out biased information about the branded drugs as against those named generically. Doctors often prescribed branded drugs, which were far more expensive than generic drugs , which have the same efficacy. The United Front Government of 1970 appointed the Wickremasinghe-Bibile commission of inquiry into this issue and it recommended

342-499: A variety of laws and regulations that govern the patenting , efficacy testing, safety evaluation , and marketing of these drugs. The global pharmaceuticals market produced treatments worth a total of $ 1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, including the effects of the COVID-19 pandemic . In historical terms, a pharmaceutical industry as an intellectual concept arose within

513-449: A variety of laws and regulations that govern the patenting , efficacy testing, safety evaluation , and marketing of these drugs. The global pharmaceuticals market produced treatments worth a total of $ 1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, including the effects of the COVID-19 pandemic . In historical terms, a pharmaceutical industry as an intellectual concept arose within

684-492: A 20% drop in those for which antibiotics were not effective. The report concluded that "it appears that the use of antibiotics, early diagnosis, and other factors have limited the epidemic spread and thus the number of these diseases which have occurred". The study further examined mortality rates for eight common diseases for which antibiotics offered effective therapy (syphilis, tuberculosis, dysentery, scarlet fever, whooping cough, meningococcal infections, and pneumonia), and found

855-492: A 20% drop in those for which antibiotics were not effective. The report concluded that "it appears that the use of antibiotics, early diagnosis, and other factors have limited the epidemic spread and thus the number of these diseases which have occurred". The study further examined mortality rates for eight common diseases for which antibiotics offered effective therapy (syphilis, tuberculosis, dysentery, scarlet fever, whooping cough, meningococcal infections, and pneumonia), and found

1026-517: A 56% decline over the same period. Notable among these was a 75% decline in deaths due to tuberculosis. During the years 1940–1955, the rate of decline in the U.S. death rate accelerated from 2% per year to 8% per year, then returned to the historical rate of 2% per year. The dramatic decline in the immediate post-war years has been attributed to the rapid development of new treatments and vaccines for infectious disease that occurred during these years. Vaccine development continued to accelerate, with

1197-517: A 56% decline over the same period. Notable among these was a 75% decline in deaths due to tuberculosis. During the years 1940–1955, the rate of decline in the U.S. death rate accelerated from 2% per year to 8% per year, then returned to the historical rate of 2% per year. The dramatic decline in the immediate post-war years has been attributed to the rapid development of new treatments and vaccines for infectious disease that occurred during these years. Vaccine development continued to accelerate, with

1368-411: A Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin (ML-236B), a molecule produced by the fungus Penicillium citrinum , as an inhibitor of HMG-CoA reductase, a critical enzyme used by the body to produce cholesterol. Animal trials showed very good inhibitory effect as in clinical trials , however a long-term study in dogs found toxic effects at higher doses and as

1539-411: A Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin (ML-236B), a molecule produced by the fungus Penicillium citrinum , as an inhibitor of HMG-CoA reductase, a critical enzyme used by the body to produce cholesterol. Animal trials showed very good inhibitory effect as in clinical trials , however a long-term study in dogs found toxic effects at higher doses and as

1710-414: A compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate formulation and dosing , as well as to establish safety . Research in these areas generally includes a combination of in vitro studies, in vivo studies, and clinical trials . The cost of late stage development has meant it is usually done by

1881-414: A compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate formulation and dosing , as well as to establish safety . Research in these areas generally includes a combination of in vitro studies, in vivo studies, and clinical trials . The cost of late stage development has meant it is usually done by

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2052-465: A drug could be sold, and explicitly prohibited false therapeutic claims. The aftermath of World War II saw an explosion in the discovery of new classes of antibacterial drugs including the cephalosporins (developed by Eli Lilly based on the seminal work of Giuseppe Brotzu and Edward Abraham ), streptomycin (discovered during a Merck-funded research program in Selman Waksman's laboratory ),

2223-408: A drug could be sold, and explicitly prohibited false therapeutic claims. The aftermath of World War II saw an explosion in the discovery of new classes of antibacterial drugs including the cephalosporins (developed by Eli Lilly based on the seminal work of Giuseppe Brotzu and Edward Abraham ), streptomycin (discovered during a Merck-funded research program in Selman Waksman's laboratory ),

2394-540: A heart attack were reduced by 42%. In 1995, Zocor and Mevacor both made Merck over US$ 1 billion. Endo was awarded the 2006 Japan Prize , and the Lasker-DeBakey Clinical Medical Research Award in 2008. For his "pioneering research into a new class of molecules" for "lowering cholesterol," Since several decades, biologics have been rising in importance in comparison with small molecules treatments. The biotech subsector, animal health and

2565-452: A heart attack were reduced by 42%. In 1995, Zocor and Mevacor both made Merck over US$ 1 billion. Endo was awarded the 2006 Japan Prize , and the Lasker-DeBakey Clinical Medical Research Award in 2008. For his "pioneering research into a new class of molecules" for "lowering cholesterol," Since several decades, biologics have been rising in importance in comparison with small molecules treatments. The biotech subsector, animal health and

2736-501: A highly toxic solvent that is now widely used as antifreeze. Under the laws extant at that time, prosecution of the manufacturer was possible only under the technicality that the product had been called an "elixir", which literally implied a solution in ethanol. In response to this episode, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938 , which for the first time required pre-market demonstration of safety before

2907-446: A highly toxic solvent that is now widely used as antifreeze. Under the laws extant at that time, prosecution of the manufacturer was possible only under the technicality that the product had been called an "elixir", which literally implied a solution in ethanol. In response to this episode, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938 , which for the first time required pre-market demonstration of safety before

3078-469: A number of companies developed products based on adrenal extracts containing varying purities of the active substance. In 1897, John Abel of Johns Hopkins University identified the active principle as epinephrine , which he isolated in an impure state as the sulfate salt. Industrial chemist Jōkichi Takamine later developed a method for obtaining epinephrine in a pure state, and licensed the technology to Parke-Davis . Parke-Davis marketed epinephrine under

3249-469: A number of companies developed products based on adrenal extracts containing varying purities of the active substance. In 1897, John Abel of Johns Hopkins University identified the active principle as epinephrine , which he isolated in an impure state as the sulfate salt. Industrial chemist Jōkichi Takamine later developed a method for obtaining epinephrine in a pure state, and licensed the technology to Parke-Davis . Parke-Davis marketed epinephrine under

3420-499: A protocol to discontinue their use. A series of experiments performed from the late 1800s to the early 1900s revealed that diabetes is caused by the absence of a substance normally produced by the pancreas. In 1869, Oskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. In 1921, Canadian professor Frederick Banting and his student Charles Best repeated this study and found that injections of pancreatic extract reversed

3591-499: A protocol to discontinue their use. A series of experiments performed from the late 1800s to the early 1900s revealed that diabetes is caused by the absence of a substance normally produced by the pancreas. In 1869, Oskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. In 1921, Canadian professor Frederick Banting and his student Charles Best repeated this study and found that injections of pancreatic extract reversed

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3762-463: A push for revisions of the FD&;C Act emerged from Congressional hearings led by Senator Estes Kefauver of Tennessee in 1959. The hearings covered a wide range of policy issues, including advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry. While momentum for new legislation temporarily flagged under extended debate, a new tragedy emerged that underscored

3933-414: A push for revisions of the FD&C Act emerged from Congressional hearings led by Senator Estes Kefauver of Tennessee in 1959. The hearings covered a wide range of policy issues, including advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry. While momentum for new legislation temporarily flagged under extended debate, a new tragedy emerged that underscored

4104-504: A reduction in initial public offerings being floated. A 2022 article articulated this notion succinctly by saying "In the business of drug development, deals can be just as important as scientific breakthroughs", typically referred to as pharmaceutical M&A (for mergers and acquisitions). It highlighted that some of the most impactful of the remedies of the early 21st Century were only made possible through M&A activities, specifically noting Keytruda and Humira . Drug discovery

4275-504: A reduction in initial public offerings being floated. A 2022 article articulated this notion succinctly by saying "In the business of drug development, deals can be just as important as scientific breakthroughs", typically referred to as pharmaceutical M&A (for mergers and acquisitions). It highlighted that some of the most impactful of the remedies of the early 21st Century were only made possible through M&A activities, specifically noting Keytruda and Humira . Drug discovery

4446-400: A result mevastatin was believed to be too toxic for human use. Mevastatin was never marketed, because of its adverse effects of tumors, muscle deterioration, and sometimes death in laboratory dogs. P. Roy Vagelos , chief scientist and later CEO of Merck & Co , was interested, and made several trips to Japan starting in 1975. By 1978, Merck had isolated lovastatin (mevinolin, MK803) from

4617-400: A result mevastatin was believed to be too toxic for human use. Mevastatin was never marketed, because of its adverse effects of tumors, muscle deterioration, and sometimes death in laboratory dogs. P. Roy Vagelos , chief scientist and later CEO of Merck & Co , was interested, and made several trips to Japan starting in 1975. By 1978, Merck had isolated lovastatin (mevinolin, MK803) from

4788-431: A series of such compounds, and was found to exhibit partially selective toxicity. Arsphenamine proved to be the first effective treatment for syphilis , a disease untl then had been incurable and led inexorably to severe skin ulceration, neurological damage, and death. Ehrlich's approach of systematically varying the chemical structure of synthetic compounds and measuring the effects of these changes on biological activity

4959-431: A series of such compounds, and was found to exhibit partially selective toxicity. Arsphenamine proved to be the first effective treatment for syphilis , a disease untl then had been incurable and led inexorably to severe skin ulceration, neurological damage, and death. Ehrlich's approach of systematically varying the chemical structure of synthetic compounds and measuring the effects of these changes on biological activity

5130-557: A sleep aid beginning in 1904. Systematic investigations of the effect of structural changes on potency and duration of action led to the discovery of phenobarbital at Bayer in 1911 and the discovery of its potent anti-epileptic activity in 1912. Phenobarbital was among the most widely used drugs for the treatment of epilepsy through the 1970s, and as of 2014, remains on the World Health Organizations list of essential medications. The 1950s and 1960s saw increased awareness of

5301-488: A sleep aid beginning in 1904. Systematic investigations of the effect of structural changes on potency and duration of action led to the discovery of phenobarbital at Bayer in 1911 and the discovery of its potent anti-epileptic activity in 1912. Phenobarbital was among the most widely used drugs for the treatment of epilepsy through the 1970s, and as of 2014, remains on the World Health Organizations list of essential medications. The 1950s and 1960s saw increased awareness of

Sri Lanka National Pharmaceuticals Policy - Misplaced Pages Continue

5472-489: A small fraction are eventually approved in most nations by government-appointed medical institutions or boards, who have to approve new drugs before they can be marketed in those countries. In 2010 18 NMEs (New Molecular Entities) were approved and three biologics by the FDA, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001,

5643-443: A small fraction are eventually approved in most nations by government-appointed medical institutions or boards, who have to approve new drugs before they can be marketed in those countries. In 2010 18 NMEs (New Molecular Entities) were approved and three biologics by the FDA, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001,

5814-558: A third of the global pharmaceutical market, with $ 340 billion in annual sales followed by the EU and Japan. Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent. The top ten best-selling drugs of 2013 totaled $ 75.6 billion in sales, with the anti-inflammatory drug Humira being the best-selling drug worldwide at $ 10.7 billion in sales. The second and third best selling were Enbrel and Remicade, respectively. The top three best-selling drugs in

5985-513: A third of the global pharmaceutical market, with $ 340 billion in annual sales followed by the EU and Japan. Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent. The top ten best-selling drugs of 2013 totaled $ 75.6 billion in sales, with the anti-inflammatory drug Humira being the best-selling drug worldwide at $ 10.7 billion in sales. The second and third best selling were Enbrel and Remicade, respectively. The top three best-selling drugs in

6156-451: Is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA reviews the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted. A fourth phase of post-approval surveillance is also often required due to

6327-406: Is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA reviews the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted. A fourth phase of post-approval surveillance is also often required due to

6498-497: Is no effective monitoring system for prescription practices is in place; there is little quality assessment and no incentive for rational use. In 2005 the United People's Freedom Alliance Government promised to establish a National Medicinal Drugs Policy (NMPD) that would enable Sri Lankans significantly to cut down on drug expenses and get quality drugs at affordable prices while saving billions of rupees in foreign exchange for

6669-450: Is not associated with cancer in people. Other notable new vaccines of the period include those for measles (1962, John Franklin Enders of Children's Medical Center Boston, later refined by Maurice Hilleman at Merck), Rubella (1969, Hilleman, Merck) and mumps (1967, Hilleman, Merck) The United States incidences of rubella, congenital rubella syndrome, measles, and mumps all fell by >95% in

6840-401: Is not associated with cancer in people. Other notable new vaccines of the period include those for measles (1962, John Franklin Enders of Children's Medical Center Boston, later refined by Maurice Hilleman at Merck), Rubella (1969, Hilleman, Merck) and mumps (1967, Hilleman, Merck) The United States incidences of rubella, congenital rubella syndrome, measles, and mumps all fell by >95% in

7011-430: Is the core guide for pharmacists and clinicians. In many non-US western countries, a 'fourth hurdle' of cost effectiveness analysis has developed before new technologies can be provided. This focuses on the 'efficacy price tag' (in terms of, for example, the cost per QALY ) of the technologies in question. In England and Wales NICE decides whether and in what circumstances drugs and technologies will be made available by

Sri Lanka National Pharmaceuticals Policy - Misplaced Pages Continue

7182-430: Is the core guide for pharmacists and clinicians. In many non-US western countries, a 'fourth hurdle' of cost effectiveness analysis has developed before new technologies can be provided. This focuses on the 'efficacy price tag' (in terms of, for example, the cost per QALY ) of the technologies in question. In England and Wales NICE decides whether and in what circumstances drugs and technologies will be made available by

7353-498: Is the most important risk factor for cardiovascular morbidity and mortality , in industrialized countries . Prior to 1940 approximately 23% of all deaths among persons over age 50 were attributed to hypertension. Severe cases of hypertension were treated by surgery. Early developments in the field of treating hypertension included quaternary ammonium ion sympathetic nervous system blocking agents, but these compounds were never widely used due to their severe side effects, because

7524-498: Is the most important risk factor for cardiovascular morbidity and mortality , in industrialized countries . Prior to 1940 approximately 23% of all deaths among persons over age 50 were attributed to hypertension. Severe cases of hypertension were treated by surgery. Early developments in the field of treating hypertension included quaternary ammonium ion sympathetic nervous system blocking agents, but these compounds were never widely used due to their severe side effects, because

7695-595: Is the process by which potential drugs are discovered or designed. In the past, most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen , and manipulating these pathways using molecular biology or biochemistry . A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions. Drug development refers to activities undertaken after

7866-595: Is the process by which potential drugs are discovered or designed. In the past, most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen , and manipulating these pathways using molecular biology or biochemistry . A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions. Drug development refers to activities undertaken after

8037-415: Is the value of the publicly traded companies. Small Molecules modality had 58.2% of the valuation share down from 84.6% in 2003. Biologics was up at 30.5% from 14.5%. The valuation share of Chinese Pharma grew from 2003 to 2021 from 1% to 12% overtaking Switzerland who is now ranked number 3 with 7.7%. The United States had still by far the most valued pharmaceutical industry with 40% of global valuation. 2023

8208-415: Is the value of the publicly traded companies. Small Molecules modality had 58.2% of the valuation share down from 84.6% in 2003. Biologics was up at 30.5% from 14.5%. The valuation share of Chinese Pharma grew from 2003 to 2021 from 1% to 12% overtaking Switzerland who is now ranked number 3 with 7.7%. The United States had still by far the most valued pharmaceutical industry with 40% of global valuation. 2023

8379-508: The Nobel Prize in Medicine for this discovery. Nonetheless, the dramatic decrease in deaths from infectious diseases that occurred prior to World War II was primarily the result of improved public health measures such as clean water and less crowded housing, and the impact of anti-infective drugs and vaccines was significant mainly after World War II. In 1928, Alexander Fleming discovered

8550-404: The Nobel Prize in Medicine for this discovery. Nonetheless, the dramatic decrease in deaths from infectious diseases that occurred prior to World War II was primarily the result of improved public health measures such as clean water and less crowded housing, and the impact of anti-infective drugs and vaccines was significant mainly after World War II. In 1928, Alexander Fleming discovered

8721-636: The State Pharmaceuticals Corporation of Sri Lanka (SPC) was established with Bibile as Chairman. The SPC channeled all imports and production of pharmaceuticals, calling for worldwide bulk tenders which were limited to the approved drugs listed in the CHF. The public and private health sectors had to obtain all their requirements from the SPC. Hence the stranglehold of the Multinational corporations on

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8892-577: The birth control movement and the efforts of activists Margaret Sanger , Mary Dennett , and Emma Goldman . Based on fundamental research performed by Gregory Pincus and synthetic methods for progesterone developed by Carl Djerassi at Syntex and by Frank Colton at G.D. Searle & Co. , the first oral contraceptive, Enovid , was developed by G.D. Searle & Co. and approved by the FDA in 1960. The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by 1962, 1.2 million American women were on

9063-577: The birth control movement and the efforts of activists Margaret Sanger , Mary Dennett , and Emma Goldman . Based on fundamental research performed by Gregory Pincus and synthetic methods for progesterone developed by Carl Djerassi at Syntex and by Frank Colton at G.D. Searle & Co. , the first oral contraceptive, Enovid , was developed by G.D. Searle & Co. and approved by the FDA in 1960. The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by 1962, 1.2 million American women were on

9234-474: The curing or preventing of disease , as well as alleviating symptoms of illness or injury . Pharmaceutical companies may deal in " generic " medications and medical devices without the involvement of intellectual property , in " brand " materials is specifically tied to a given company's history, or in both within different contexts. The industry's various subdivisions include distinct areas, such as manufacturing biologics , which are all subject to

9405-474: The curing or preventing of disease , as well as alleviating symptoms of illness or injury . Pharmaceutical companies may deal in " generic " medications and medical devices without the involvement of intellectual property , in " brand " materials is specifically tied to a given company's history, or in both within different contexts. The industry's various subdivisions include distinct areas, such as manufacturing biologics , which are all subject to

9576-477: The opportunity cost of investing capital many years before revenues are realized (see Time-value of money ). Because of the very long time needed for discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. A direct consequence within the pharmaceutical industry value chain is that major pharmaceutical multinationals tend to increasingly outsource risks related to fundamental research, which somewhat reshapes

9747-477: The opportunity cost of investing capital many years before revenues are realized (see Time-value of money ). Because of the very long time needed for discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. A direct consequence within the pharmaceutical industry value chain is that major pharmaceutical multinationals tend to increasingly outsource risks related to fundamental research, which somewhat reshapes

9918-454: The Center for Drug Evaluation and Research has averaged 22.9 approvals a year. This approval comes only after heavy investment in pre-clinical development and clinical trials , as well as a commitment to ongoing safety monitoring . Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is taken into account,

10089-405: The Center for Drug Evaluation and Research has averaged 22.9 approvals a year. This approval comes only after heavy investment in pre-clinical development and clinical trials , as well as a commitment to ongoing safety monitoring . Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is taken into account,

10260-489: The Chinese pharmaceutical sector have also grown substantially. On the organisational side, big international pharma corporations have experienced a substantial decline of their value share. Also, the core generic sector (substitutions for off-patent brands) has been downvalued due to competition. Torreya estimated the pharmaceutical industry to have a market valuation of US$ 7.03 trillion by February 2021 from which US$ 6.1 trillion

10431-439: The Chinese pharmaceutical sector have also grown substantially. On the organisational side, big international pharma corporations have experienced a substantial decline of their value share. Also, the core generic sector (substitutions for off-patent brands) has been downvalued due to competition. Torreya estimated the pharmaceutical industry to have a market valuation of US$ 7.03 trillion by February 2021 from which US$ 6.1 trillion

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10602-509: The Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Ehrlich, noting both the general toxicity of arsenic and the selective absorption of certain dyes by bacteria, hypothesized that an arsenic-containing dye with similar selective absorption properties could be used to treat bacterial infections. Arsphenamine was prepared as part of a campaign to synthesize

10773-408: The Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Ehrlich, noting both the general toxicity of arsenic and the selective absorption of certain dyes by bacteria, hypothesized that an arsenic-containing dye with similar selective absorption properties could be used to treat bacterial infections. Arsphenamine was prepared as part of a campaign to synthesize

10944-682: The Ministry of Health requested Prof. Seneka Bibile to look into his matter and he prepared the Ceylon Hospital Formulary (CHF) of about 630 drugs under their generic names . Subsequently the Ministry of Health established a National Formulary Committee (NFC), consisting of representatives from the public and private health sectors and the University Medical Schools, led by Bibile. It published Formulary Notes for doctors, keeping them updated on developments. Accordingly, in 1971

11115-806: The NHS, whilst similar arrangements exist with the Scottish Medicines Consortium in Scotland, and the Pharmaceutical Benefits Advisory Committee in Australia. A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' and a net benefit to society. There are special rules for certain rare diseases ("orphan diseases") in several major drug regulatory territories. For example, diseases involving fewer than 200,000 patients in

11286-502: The NHS, whilst similar arrangements exist with the Scottish Medicines Consortium in Scotland, and the Pharmaceutical Benefits Advisory Committee in Australia. A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' and a net benefit to society. There are special rules for certain rare diseases ("orphan diseases") in several major drug regulatory territories. For example, diseases involving fewer than 200,000 patients in

11457-785: The Orange Book site. In the UK, the Medicines and Healthcare products Regulatory Agency approves and evaluates drugs for use. Normally an approval in the UK and other European countries comes later than one in the USA. Then it is the National Institute for Health and Care Excellence (NICE), for England and Wales, who decides if and how the National Health Service (NHS) will allow (in the sense of paying for) their use. The British National Formulary

11628-464: The Orange Book site. In the UK, the Medicines and Healthcare products Regulatory Agency approves and evaluates drugs for use. Normally an approval in the UK and other European countries comes later than one in the USA. Then it is the National Institute for Health and Care Excellence (NICE), for England and Wales, who decides if and how the National Health Service (NHS) will allow (in the sense of paying for) their use. The British National Formulary

11799-586: The Transfer of Technology: Pharmaceutical Policies in Sri Lanka". [1] This document has proved to be a very valuable guideline for developing countries intending to initiate pharmaceutical reforms. Translated into other languages, it may be found with health planners of almost every Third World country. The first response from the multi-national corporations came in May 1973. Executives of the major pharmaceutical companies in

11970-458: The US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices . The law required that all drugs introduced between 1938 and 1962 had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began ten years later. In 1971, Akira Endo ,

12141-458: The US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices . The law required that all drugs introduced between 1938 and 1962 had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began ten years later. In 1971, Akira Endo ,

12312-695: The United States in 2013 were Abilify ($ 6.3 billion,) Nexium ($ 6 billion) and Humira ($ 5.4 billion). The best-selling drug ever, Lipitor , averaged $ 13 billion annually and netted $ 141 billion total over its lifetime before Pfizer's patent expired in November 2011. Pharmaceutical company The pharmaceutical industry is an industry involved in medicine that discovers, develops, produces, and markets pharmaceutical goods for use as drugs which are then administered to (or self-administered by) patients. These medications are created and put to market for

12483-717: The United States met Sri Lanka's ambassador in Washington, D.C. and handed him a letter addressed to the Prime Minister of Sri Lanka from the President of the Pharmaceutical Manufacturer's Association (PMA) of the US. The letter concluded with a statement that the PMA believed that the proposed actions would have most serious effects not only on the pharmaceutical industry and on all private industry in Sri Lanka but potentially for

12654-679: The United States, or larger populations in certain circumstances are subject to the Orphan Drug Act. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents. In 2011, global spending on prescription drugs topped $ 954 billion, even as growth slowed somewhat in Europe and North America. The United States accounts for more than

12825-572: The United States, or larger populations in certain circumstances are subject to the Orphan Drug Act. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents. In 2011, global spending on prescription drugs topped $ 954 billion, even as growth slowed somewhat in Europe and North America. The United States accounts for more than

12996-495: The addictive properties and abuse potential of barbiturates and amphetamines and led to increasing restrictions on their use and growing government oversight of prescribers. Today, amphetamine is largely restricted to use in the treatment of attention deficit disorder and phenobarbital in the treatment of epilepsy . In 1958, Leo Sternbach discovered the first benzodiazepine , chlordiazepoxide (Librium). Dozens of other benzodiazepines have been developed and are in use, some of

13167-495: The addictive properties and abuse potential of barbiturates and amphetamines and led to increasing restrictions on their use and growing government oversight of prescribers. Today, amphetamine is largely restricted to use in the treatment of attention deficit disorder and phenobarbital in the treatment of epilepsy . In 1958, Leo Sternbach discovered the first benzodiazepine , chlordiazepoxide (Librium). Dozens of other benzodiazepines have been developed and are in use, some of

13338-401: The antibacterial effects of penicillin , but its exploitation for the treatment of human disease awaited the development of methods for its large scale production and purification. These were developed by a U.S. and British government-led consortium of pharmaceutical companies during the world war. There was early progress toward the development of vaccines throughout this period, primarily in

13509-401: The antibacterial effects of penicillin , but its exploitation for the treatment of human disease awaited the development of methods for its large scale production and purification. These were developed by a U.S. and British government-led consortium of pharmaceutical companies during the world war. There was early progress toward the development of vaccines throughout this period, primarily in

13680-476: The biological effects of these structural changes. By the 1890s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as treatment for shock, and

13851-476: The biological effects of these structural changes. By the 1890s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as treatment for shock, and

14022-404: The cost of developing a successful new drug ( new chemical entity , or NCE), has been estimated at US$ 1.3 billion (not including marketing expenses ). Professors Light and Lexchin reported in 2012, however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades. Industry-wide research and investment reached a record $ 65.3 billion in 2009. While

14193-404: The cost of developing a successful new drug ( new chemical entity , or NCE), has been estimated at US$ 1.3 billion (not including marketing expenses ). Professors Light and Lexchin reported in 2012, however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades. Industry-wide research and investment reached a record $ 65.3 billion in 2009. While

14364-590: The cost of research in the U.S. was about $ 34.2 billion between 1995 and 2010, revenues rose faster (revenues rose by $ 200.4 billion in that time). A study by the consulting firm Bain & Company reported that the cost for discovering, developing and launching (which factored in marketing and other business expenses) a new drug (along with the prospective drugs that fail) rose over a five-year period to nearly $ 1.7 billion in 2003. According to Forbes, by 2010 development costs were between $ 4 billion to $ 11 billion per drug. Some of these estimates also take into account

14535-590: The cost of research in the U.S. was about $ 34.2 billion between 1995 and 2010, revenues rose faster (revenues rose by $ 200.4 billion in that time). A study by the consulting firm Bain & Company reported that the cost for discovering, developing and launching (which factored in marketing and other business expenses) a new drug (along with the prospective drugs that fail) rose over a five-year period to nearly $ 1.7 billion in 2003. According to Forbes, by 2010 development costs were between $ 4 billion to $ 11 billion per drug. Some of these estimates also take into account

14706-447: The costs of supplying drugs. In Sri Lanka, drug information was provided from official sources. The Prescriber , a quarterly publication edited by the NFC, was published by the SPC and distributed to all medical personnel. The extravagant promotional practices of drugs manufacturers were stopped to remove the dangers and costs inherent in process. The Sri Lanka experience became a model for

14877-553: The country. Implementation of the NMDP could reduce the number of drugs imported, prescribed and sold in Sri Lanka to about 350 varieties. Dr. K Balasubramaniam , 'The neglected solution', Daily News , 30 September 2002. Dr. K. Balasubramanium, 'Drugs: David and Goliath', Daily Mirror , 8 November 2002. Include Medicinal Drugs Policy in Polls Manifesto Dr. Nihal Jayathilaka, Improving access to affordable essential drugs:

15048-451: The data supporting the safety of thalidomide was incomplete. The firm continued to pressure Kelsey and the FDA to approve the application until November 1961, when the drug was pulled off the German market because of its association with grave congenital abnormalities. Several thousand newborns in Europe and elsewhere suffered the teratogenic effects of thalidomide. Without approval from the FDA,

15219-402: The data supporting the safety of thalidomide was incomplete. The firm continued to pressure Kelsey and the FDA to approve the application until November 1961, when the drug was pulled off the German market because of its association with grave congenital abnormalities. Several thousand newborns in Europe and elsewhere suffered the teratogenic effects of thalidomide. Without approval from the FDA,

15390-409: The development of tricyclic antidepressants in the 1960s. In 1903, Hermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and urea, induces sleep in dogs. The discovery was patented and licensed to Bayer pharmaceuticals , which marketed the compound under the trade name Veronal as

15561-409: The development of tricyclic antidepressants in the 1960s. In 1903, Hermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and urea, induces sleep in dogs. The discovery was patented and licensed to Bayer pharmaceuticals , which marketed the compound under the trade name Veronal as

15732-436: The drug trade was successfully broken and they were made to compete with each other and with generic drug producers, enabling the country to obtain drugs much cheaper. Branded drugs were replaced by generic drugs in the prescription and sale of medicines. In 1972 it imported 52 drugs at a third of their previous prices. In 1973, the SPC itself bought the raw material necessary for 14 private processing laboratories established in

15903-413: The establishment a national policy and of a state body to regularize the trade. In the 1970s Sri Lanka demonstrated that a state buying agency linked to a national formulary was a viable and powerful instrument for reducing drug costs without compromising quality, for saving foreign exchange, for rationalizing drug usage and for supplying essential drugs at reasonable prices to the whole community. This

16074-590: The experience of Sri Lanka Prof. Tissa Vitarana, The Sri Lankan who challenged global giants Bibile, S, and Lall, S, 'The Political Economy of Controlling Transnationals: The Pharmaceutical Industry in Sri Lanka (1972-76)', World Development , August 1977. Pharmaceutical companies The pharmaceutical industry is an industry involved in medicine that discovers, develops, produces, and markets pharmaceutical goods for use as drugs which are then administered to (or self-administered by) patients. These medications are created and put to market for

16245-448: The extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin. The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This

16416-448: The extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin. The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This

16587-425: The fact that even the largest clinical trials cannot effectively predict the prevalence of rare side-effects. Postmarketing surveillance ensures that after marketing the safety of a drug is monitored closely. In certain instances, its indication may need to be limited to particular patient groups, and in others the substance is withdrawn from the market completely. The FDA provides information about approved drugs at

16758-425: The fact that even the largest clinical trials cannot effectively predict the prevalence of rare side-effects. Postmarketing surveillance ensures that after marketing the safety of a drug is monitored closely. In certain instances, its indication may need to be limited to particular patient groups, and in others the substance is withdrawn from the market completely. The FDA provides information about approved drugs at

16929-670: The firm distributed Kevadon to over 1,000 physicians there under the guise of investigational use. Over 20,000 Americans received thalidomide in this "study," including 624 pregnant patients, and about 17 known newborns suffered the effects of the drug. The thalidomide tragedy resurrected Kefauver's bill to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October 1962. Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on

17100-552: The firm distributed Kevadon to over 1,000 physicians there under the guise of investigational use. Over 20,000 Americans received thalidomide in this "study," including 624 pregnant patients, and about 17 known newborns suffered the effects of the drug. The thalidomide tragedy resurrected Kefauver's bill to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October 1962. Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on

17271-418: The first vaccine against Japanese Encephalitis . Hilleman later moved to Merck , where he played a key role in the development of vaccines against measles , mumps , chickenpox , rubella , hepatitis A , hepatitis B , and meningitis . Prior to the 20th century, drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy. To

17442-418: The first vaccine against Japanese Encephalitis . Hilleman later moved to Merck , where he played a key role in the development of vaccines against measles , mumps , chickenpox , rubella , hepatitis A , hepatitis B , and meningitis . Prior to the 20th century, drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy. To

17613-407: The form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases. In 1885, Louis Pasteur and Pierre Paul Émile Roux created the first rabies vaccine . The first diphtheria vaccines were produced in 1914 from a mixture of diphtheria toxin and antitoxin (produced from the serum of an inoculated animal), but

17784-407: The form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases. In 1885, Louis Pasteur and Pierre Paul Émile Roux created the first rabies vaccine . The first diphtheria vaccines were produced in 1914 from a mixture of diphtheria toxin and antitoxin (produced from the serum of an inoculated animal), but

17955-520: The fungus Aspergillus terreus , first marketed in 1987 as Mevacor. In April 1994, the results of a Merck-sponsored study, the Scandinavian Simvastatin Survival Study , were announced. Researchers tested simvastatin , later sold by Merck as Zocor, on 4,444 patients with high cholesterol and heart disease. After five years, the study concluded the patients saw a 35% reduction in their cholesterol, and their chances of dying of

18126-439: The fungus Aspergillus terreus , first marketed in 1987 as Mevacor. In April 1994, the results of a Merck-sponsored study, the Scandinavian Simvastatin Survival Study , were announced. Researchers tested simvastatin , later sold by Merck as Zocor, on 4,444 patients with high cholesterol and heart disease. After five years, the study concluded the patients saw a 35% reduction in their cholesterol, and their chances of dying of

18297-518: The health of its citizens. The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) issued a statement to UNCTAD strongly criticizing the UNCTAD report on the Sri Lankan pharmaceutical policies. This policy was watered down by the multi-national-friendly United National Party Government of 1977. There was continued government control of the types of drugs imported, but permission

18468-401: The immediate aftermath of widespread vaccination. The first 20 years of licensed measles vaccination in the U.S. prevented an estimated 52 million cases of the disease, 17,400 cases of mental retardation , and 5,200 deaths. Hypertension is a risk factor for atherosclerosis, heart failure , coronary artery disease , stroke , renal disease , and peripheral arterial disease , and

18639-401: The immediate aftermath of widespread vaccination. The first 20 years of licensed measles vaccination in the U.S. prevented an estimated 52 million cases of the disease, 17,400 cases of mental retardation , and 5,200 deaths. Hypertension is a risk factor for atherosclerosis, heart failure , coronary artery disease , stroke , renal disease , and peripheral arterial disease , and

18810-907: The industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop. In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III

18981-861: The industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop. In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III

19152-452: The island. Some drug prices dropped by half or two-thirds. The SPC bought from an Indian company the raw material necessary for a widely used tranquilizer at a much lower price than that charged by a Swiss multinational. It is essential that correct information on drugs and therapeutics be given to all medical personnel. The promotional material provided by the drugs manufacturers tends to be distorted in favour of their own products and adds to

19323-436: The isolation of tuberculosis-infected people were an ubiquitous feature of cities in developed countries, with 50% dying within 5 years of admission. A Federal Trade Commission report issued in 1958 attempted to quantify the effect of antibiotic development on American public health. The report found that over the period 1946–1955, there was a 42% drop in the incidence of diseases for which antibiotics were effective and only

19494-436: The isolation of tuberculosis-infected people were an ubiquitous feature of cities in developed countries, with 50% dying within 5 years of admission. A Federal Trade Commission report issued in 1958 attempted to quantify the effect of antibiotic development on American public health. The report found that over the period 1946–1955, there was a 42% drop in the incidence of diseases for which antibiotics were effective and only

19665-462: The larger pharmaceutical companies. The pharmaceuticals and biotechnology industry spends more than 15% of its net sales for Research & Development which is in comparison with other industries by far the highest share. Often, large multinational corporations exhibit vertical integration , participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on

19836-462: The larger pharmaceutical companies. The pharmaceuticals and biotechnology industry spends more than 15% of its net sales for Research & Development which is in comparison with other industries by far the highest share. Often, large multinational corporations exhibit vertical integration , participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on

20007-413: The law to prosecute manufacturers for making unsupported claims of efficacy were undercut by a Supreme Court ruling restricting the federal government's enforcement powers to cases of incorrect specification of the drug's ingredients. In 1937 over 100 people died after ingesting " Elixir Sulfanilamide " manufactured by S.E. Massengill Company of Tennessee. The product was formulated in diethylene glycol ,

20178-413: The law to prosecute manufacturers for making unsupported claims of efficacy were undercut by a Supreme Court ruling restricting the federal government's enforcement powers to cases of incorrect specification of the drug's ingredients. In 1937 over 100 people died after ingesting " Elixir Sulfanilamide " manufactured by S.E. Massengill Company of Tennessee. The product was formulated in diethylene glycol ,

20349-513: The long-term health consequences of high blood pressure had not yet been established, and because they had to be administered by injection. In 1952 researchers at Ciba discovered the first orally available vasodilator, hydralazine . A major shortcoming of hydralazine monotherapy was that it lost its effectiveness over time ( tachyphylaxis ). In the mid-1950s Karl H. Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello of Merck and Co. discovered and developed chlorothiazide , which remains

20520-513: The long-term health consequences of high blood pressure had not yet been established, and because they had to be administered by injection. In 1952 researchers at Ciba discovered the first orally available vasodilator, hydralazine . A major shortcoming of hydralazine monotherapy was that it lost its effectiveness over time ( tachyphylaxis ). In the mid-1950s Karl H. Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello of Merck and Co. discovered and developed chlorothiazide , which remains

20691-626: The mid-1800s, and from discoveries resulting from applied research. Intentional drug discovery from plants began with the isolation between 1803 and 1805 of morphine – an analgesic and sleep-inducing agent – from opium by the German apothecary assistant Friedrich Sertürner , who named this compound after the Greek god of dreams, Morpheus . Multinational corporations including Merck , Hoffman-La Roche , Burroughs-Wellcome (now part of Glaxo Smith Kline ), Abbott Laboratories , Eli Lilly and Upjohn (now part of Pfizer ) began as local apothecary shops in

20862-578: The mid-1800s, and from discoveries resulting from applied research. Intentional drug discovery from plants began with the isolation between 1803 and 1805 of morphine – an analgesic and sleep-inducing agent – from opium by the German apothecary assistant Friedrich Sertürner , who named this compound after the Greek god of dreams, Morpheus . Multinational corporations including Merck , Hoffman-La Roche , Burroughs-Wellcome (now part of Glaxo Smith Kline ), Abbott Laboratories , Eli Lilly and Upjohn (now part of Pfizer ) began as local apothecary shops in

21033-453: The mid-1800s. By the late 1880s, German dye manufacturers had perfected the purification of individual organic compounds from tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis . The development of synthetic chemical methods allowed scientists to systematically vary the structure of chemical substances, and growth in the emerging science of pharmacology expanded their ability to evaluate

21204-453: The mid-1800s. By the late 1880s, German dye manufacturers had perfected the purification of individual organic compounds from tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis . The development of synthetic chemical methods allowed scientists to systematically vary the structure of chemical substances, and growth in the emerging science of pharmacology expanded their ability to evaluate

21375-522: The middle to late 1800s inside of certain nation-states with developed economies such as Germany , Switzerland , and the United States given that multiple businesses engaging in synthetic organic chemistry , such as a number of firms generating dyestuffs derived from coal tar on a large scale, sought out new applications of their artificial materials in terms of human health . This trend to increased capital investment occurred in tandem with

21546-467: The middle to late 1800s inside of certain nation-states with developed economies such as Germany , Switzerland , and the United States given that multiple businesses engaging in synthetic organic chemistry , such as a number of firms generating dyestuffs derived from coal tar on a large scale, sought out new applications of their artificial materials in terms of human health . This trend to increased capital investment occurred in tandem with

21717-524: The more popular drugs being diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), and lorazepam (Ativan). Due to their far superior safety and therapeutic properties, benzodiazepines have largely replaced the use of barbiturates in medicine, except in certain special cases. When it was later discovered that benzodiazepines, like barbiturates, significantly lose their effectiveness and can have serious side effects when taken long-term, Heather Ashton researched benzodiazepine dependence and developed

21888-524: The more popular drugs being diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), and lorazepam (Ativan). Due to their far superior safety and therapeutic properties, benzodiazepines have largely replaced the use of barbiturates in medicine, except in certain special cases. When it was later discovered that benzodiazepines, like barbiturates, significantly lose their effectiveness and can have serious side effects when taken long-term, Heather Ashton researched benzodiazepine dependence and developed

22059-448: The most notable achievement of the period being Jonas Salk 's 1954 development of the polio vaccine under the funding of the non-profit National Foundation for Infantile Paralysis . The vaccine process was never patented but was instead given to pharmaceutical companies to manufacture as a low-cost generic . In 1960 Maurice Hilleman of Merck Sharp & Dohme identified the SV40 virus, which

22230-402: The most notable achievement of the period being Jonas Salk 's 1954 development of the polio vaccine under the funding of the non-profit National Foundation for Infantile Paralysis . The vaccine process was never patented but was instead given to pharmaceutical companies to manufacture as a low-cost generic . In 1960 Maurice Hilleman of Merck Sharp & Dohme identified the SV40 virus, which

22401-439: The most widely used antihypertensive drug today. This development was associated with a substantial decline in the mortality rate among people with hypertension. The inventors were recognized by a Public Health Lasker Award in 1975 for "the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension". A 2009 Cochrane review concluded that thiazide antihypertensive drugs reduce

22572-439: The most widely used antihypertensive drug today. This development was associated with a substantial decline in the mortality rate among people with hypertension. The inventors were recognized by a Public Health Lasker Award in 1975 for "the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension". A 2009 Cochrane review concluded that thiazide antihypertensive drugs reduce

22743-457: The need for more comprehensive regulation and provided the driving force for the passage of new laws. On 12 September 1960, an American licensee, the William S. Merrell Company of Cincinnati, submitted a new drug application for Kevadon ( thalidomide ), a sedative that had been marketed in Europe since 1956. The FDA medical officer in charge of reviewing the compound, Frances Kelsey , believed that

22914-407: The need for more comprehensive regulation and provided the driving force for the passage of new laws. On 12 September 1960, an American licensee, the William S. Merrell Company of Cincinnati, submitted a new drug application for Kevadon ( thalidomide ), a sedative that had been marketed in Europe since 1956. The FDA medical officer in charge of reviewing the compound, Frances Kelsey , believed that

23085-500: The other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances. More recently, multi-nationals are increasingly relying on contract research organizations to manage drug development. Drug discovery and development are very expensive; of all compounds investigated for use in humans only

23256-500: The other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances. More recently, multi-nationals are increasingly relying on contract research organizations to manage drug development. Drug discovery and development are very expensive; of all compounds investigated for use in humans only

23427-429: The pH of the extract allowed a relatively pure grade of insulin to be produced. Under pressure from Toronto University and a potential patent challenge by academic scientists who had independently developed a similar purification method, an agreement was reached for non-exclusive production of insulin by multiple companies. Prior to the discovery and widespread availability of insulin therapy the life expectancy of diabetics

23598-429: The pH of the extract allowed a relatively pure grade of insulin to be produced. Under pressure from Toronto University and a potential patent challenge by academic scientists who had independently developed a similar purification method, an agreement was reached for non-exclusive production of insulin by multiple companies. Prior to the discovery and widespread availability of insulin therapy the life expectancy of diabetics

23769-401: The pill, and by 1965 the number had increased to 6.5 million. The availability of a convenient form of temporary contraceptive led to dramatic changes in social mores including expanding the range of lifestyle options available to women, reducing the reliance of women on men for contraceptive practice, encouraging the delay of marriage, and increasing pre-marital co-habitation. In the U.S.,

23940-401: The pill, and by 1965 the number had increased to 6.5 million. The availability of a convenient form of temporary contraceptive led to dramatic changes in social mores including expanding the range of lifestyle options available to women, reducing the reliance of women on men for contraceptive practice, encouraging the delay of marriage, and increasing pre-marital co-habitation. In the U.S.,

24111-594: The rest of the world. The policy was supported by the World Health Organization and other United Nations agencies with enormous benefit to Third World countries. The United Nations Conference on Trade and Development Secretariat examined the Sri Lankan experience, concluding that an analysis of the Sri Lankan model could give other developing countries an insight into ways of formulating, developing and implementing integrated national pharmaceutical policies. With Bibile’s assistance, it published "Case Studies in

24282-486: The risk of death ( RR 0.89), stroke (RR 0.63), coronary heart disease (RR 0.84), and cardiovascular events (RR 0.70) in people with high blood pressure. In the ensuring years other classes of antihypertensive drug were developed and found wide acceptance in combination therapy, including loop diuretics (Lasix/ furosemide , Hoechst Pharmaceuticals , 1963), beta blockers ( ICI Pharmaceuticals , 1964) ACE inhibitors , and angiotensin receptor blockers . ACE inhibitors reduce

24453-486: The risk of death ( RR 0.89), stroke (RR 0.63), coronary heart disease (RR 0.84), and cardiovascular events (RR 0.70) in people with high blood pressure. In the ensuring years other classes of antihypertensive drug were developed and found wide acceptance in combination therapy, including loop diuretics (Lasix/ furosemide , Hoechst Pharmaceuticals , 1963), beta blockers ( ICI Pharmaceuticals , 1964) ACE inhibitors , and angiotensin receptor blockers . ACE inhibitors reduce

24624-473: The risk of new onset kidney disease [RR 0.71] and death [RR 0.84] in diabetic patients, irrespective of whether they have hypertension. Prior to the Second World war, birth control was prohibited in many countries, and in the United States even the discussion of contraceptive methods sometimes led to prosecution under Comstock laws . The history of the development of oral contraceptives is thus closely tied to

24795-418: The risk of new onset kidney disease [RR 0.71] and death [RR 0.84] in diabetic patients, irrespective of whether they have hypertension. Prior to the Second World war, birth control was prohibited in many countries, and in the United States even the discussion of contraceptive methods sometimes led to prosecution under Comstock laws . The history of the development of oral contraceptives is thus closely tied to

24966-634: The safety of the inoculation was marginal and it was not widely used. The United States recorded 206,000 cases of diphtheria in 1921, resulting in 15,520 deaths. In 1923, parallel efforts by Gaston Ramon at the Pasteur Institute and Alexander Glenny at the Wellcome Research Laboratories (later part of GlaxoSmithKline ) led to the discovery that a safer vaccine could be produced by treating diphtheria toxin with formaldehyde . In 1944, Maurice Hilleman of Squibb Pharmaceuticals developed

25137-501: The safety of the inoculation was marginal and it was not widely used. The United States recorded 206,000 cases of diphtheria in 1921, resulting in 15,520 deaths. In 1923, parallel efforts by Gaston Ramon at the Pasteur Institute and Alexander Glenny at the Wellcome Research Laboratories (later part of GlaxoSmithKline ) led to the discovery that a safer vaccine could be produced by treating diphtheria toxin with formaldehyde . In 1944, Maurice Hilleman of Squibb Pharmaceuticals developed

25308-612: The scholarly study of pathology as a field advancing significantly, and a variety of businesses set up cooperative relationships with academic laboratories evaluating human injury and disease. Examples of industrial companies with a pharmaceutical focus that have endured to this day after such distant beginnings include Bayer (based out of Germany) and Pfizer (based out of the U.S.). The modern era of pharmaceutical industry began with local apothecaries that expanded for their traditional role of distributing botanical drug s such as morphine and quinine to wholesale manufacture in

25479-612: The scholarly study of pathology as a field advancing significantly, and a variety of businesses set up cooperative relationships with academic laboratories evaluating human injury and disease. Examples of industrial companies with a pharmaceutical focus that have endured to this day after such distant beginnings include Bayer (based out of Germany) and Pfizer (based out of the U.S.). The modern era of pharmaceutical industry began with local apothecaries that expanded for their traditional role of distributing botanical drug s such as morphine and quinine to wholesale manufacture in

25650-528: The symptoms produced by pancreas removal. Soon, the extract was demonstrated to work in people, but development of insulin therapy as a routine medical procedure was delayed by difficulties in producing the material in sufficient quantity and with reproducible purity. The researchers sought assistance from industrial collaborators at Eli Lilly and Co. based on the company's experience with large scale purification of biological materials. Chemist George B. Walden of Eli Lilly and Company found that careful adjustment of

25821-528: The symptoms produced by pancreas removal. Soon, the extract was demonstrated to work in people, but development of insulin therapy as a routine medical procedure was delayed by difficulties in producing the material in sufficient quantity and with reproducible purity. The researchers sought assistance from industrial collaborators at Eli Lilly and Co. based on the company's experience with large scale purification of biological materials. Chemist George B. Walden of Eli Lilly and Company found that careful adjustment of

25992-418: The tetracyclines (discovered at Lederle Laboratories, now a part of Pfizer ), erythromycin (discovered at Eli Lilly and Co.) and their extension to an increasingly wide range of bacterial pathogens. Streptomycin, discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers in 1943, became the first effective treatment for tuberculosis. At the time of its discovery, sanitoriums for

26163-418: The tetracyclines (discovered at Lederle Laboratories, now a part of Pfizer ), erythromycin (discovered at Eli Lilly and Co.) and their extension to an increasingly wide range of bacterial pathogens. Streptomycin, discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers in 1943, became the first effective treatment for tuberculosis. At the time of its discovery, sanitoriums for

26334-494: The trade name Adrenalin . Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version was sold in the United States until 2011 ( Primatene Mist ). By 1929 epinephrine had been formulated into an inhaler for use in the treatment of nasal congestion. While highly effective, the requirement for injection limited the use of epinephrine and orally active derivatives were sought. A structurally similar compound, ephedrine ,

26505-494: The trade name Adrenalin . Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version was sold in the United States until 2011 ( Primatene Mist ). By 1929 epinephrine had been formulated into an inhaler for use in the treatment of nasal congestion. While highly effective, the requirement for injection limited the use of epinephrine and orally active derivatives were sought. A structurally similar compound, ephedrine ,

26676-439: Was a year of layoffs for at least 10,000 people across 129 public biotech firms globally, albeit most small firms; this was a significant increase in reductions versus 2022 was in part due to worsening global financial conditions and a reduction in investment by "generalist investors". Private firms also saw a significant reduction in venture capital investment in 2023, continuing a downward trend started in 2021, which also led to

26847-439: Was a year of layoffs for at least 10,000 people across 129 public biotech firms globally, albeit most small firms; this was a significant increase in reductions versus 2022 was in part due to worsening global financial conditions and a reduction in investment by "generalist investors". Private firms also saw a significant reduction in venture capital investment in 2023, continuing a downward trend started in 2021, which also led to

27018-519: Was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Inhaler. Amphetamine was eventually developed for the treatment of narcolepsy , post-encephalitic parkinsonism , and mood elevation in depression and other psychiatric indications. It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in 1937, and remained in common use for depression until

27189-449: Was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Inhaler. Amphetamine was eventually developed for the treatment of narcolepsy , post-encephalitic parkinsonism , and mood elevation in depression and other psychiatric indications. It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in 1937, and remained in common use for depression until

27360-454: Was followed in 1906 by the Pure Food and Drugs Act , which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered misbranded if it contained alcohol, morphine, opium, cocaine, or any of several other potentially dangerous or addictive drugs, and if its label failed to indicate the quantity or proportion of such drugs. The government's attempts to use

27531-403: Was followed in 1906 by the Pure Food and Drugs Act , which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered misbranded if it contained alcohol, morphine, opium, cocaine, or any of several other potentially dangerous or addictive drugs, and if its label failed to indicate the quantity or proportion of such drugs. The government's attempts to use

27702-696: Was given to the private sector to import multiple brands. The SPC was never dissolved and continued to supply affordable drugs, continuing to be responsible for centralized procurement for the government health sector. In 1987 the Pharmaceuticals Manufacturing Corporation was established to import raw materials and manufacture generic drugs. This has effectively withstood very strong pressures for privatization. The earlier centrally controlled system enabled effective monitoring. However, at present, because of decentralization of drug supply, while standard treatment guidelines are available, there

27873-476: Was identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma. Following the work of Henry Dale and George Barger at Burroughs-Wellcome , academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in 1929. The drug proved to have only modest anti-asthma effects but produced sensations of exhilaration and palpitations. Amphetamine

28044-426: Was identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma. Following the work of Henry Dale and George Barger at Burroughs-Wellcome , academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in 1929. The drug proved to have only modest anti-asthma effects but produced sensations of exhilaration and palpitations. Amphetamine

28215-485: Was later shown to cause tumors in many mammalian species. It was later determined that SV40 was present as a contaminant in polio vaccine lots that had been administered to 90% of the children in the United States. The contamination appears to have originated both in the original cell stock and in monkey tissue used for production. In 2004 the National Cancer Institute announced that it had concluded that SV40

28386-418: Was later shown to cause tumors in many mammalian species. It was later determined that SV40 was present as a contaminant in polio vaccine lots that had been administered to 90% of the children in the United States. The contamination appears to have originated both in the original cell stock and in monkey tissue used for production. In 2004 the National Cancer Institute announced that it had concluded that SV40

28557-435: Was made possible by the formulation and implementation of an integrated national pharmaceutical policy . A unique phenomenon about Sri Lanka's pharmaceuticals policy was that the entire programme was conceived, formulated, developed and implemented by Sri Lankan nationals without any form of external aid or assistance. A careful selection of drugs is an essential prerequisite of a national pharmaceutical policy. In Sri Lanka,

28728-448: Was only a few months. The development of drugs for the treatment of infectious diseases was a major focus of early research and development efforts; in 1900, pneumonia, tuberculosis, and diarrhea were the three leading causes of death in the United States and mortality in the first year of life exceeded 10%. In 1911 arsphenamine , the first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of

28899-448: Was only a few months. The development of drugs for the treatment of infectious diseases was a major focus of early research and development efforts; in 1900, pneumonia, tuberculosis, and diarrhea were the three leading causes of death in the United States and mortality in the first year of life exceeded 10%. In 1911 arsphenamine , the first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of

29070-535: Was pursued broadly by industrial scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, and Gerhard Domagk . This work, also based on the testing of compounds available from the German dye industry, led to the development of Prontosil , the first representative of the sulfonamide class of antibiotics . Compared to arsphenamine, the sulfonamides had a broader spectrum of activity and were far less toxic, rendering them useful for infections caused by pathogens such as streptococci . In 1939, Domagk received

29241-535: Was pursued broadly by industrial scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, and Gerhard Domagk . This work, also based on the testing of compounds available from the German dye industry, led to the development of Prontosil , the first representative of the sulfonamide class of antibiotics . Compared to arsphenamine, the sulfonamides had a broader spectrum of activity and were far less toxic, rendering them useful for infections caused by pathogens such as streptococci . In 1939, Domagk received

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