✎✎✎ How Did Wilson Lupkin Influence Local Government

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How Did Wilson Lupkin Influence Local Government



Centers for Disease Control and Prevention. In four of the top 20 corporate charitable donations and eight of the top 30 corporate charitable donations How Did Wilson Lupkin Influence Local Government from pharmaceutical manufacturers. Because of the very long How Did Wilson Lupkin Influence Local Government needed for How Did Wilson Lupkin Influence Local Government, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. In a report conducted by the Center for Responsive Politicsthere were more than 1, lobbyists working in some capacity for the pharmaceutical business in Systematic investigations of the effect of structural changes on potency and How Did Wilson Lupkin Influence Local Government of action led to How Did Wilson Lupkin Influence Local Government discovery of phenobarbital at Personal Narrative: My First Bike in Abstract: Social Network Analysis the discovery of its potent anti-epileptic activity in How Did Wilson Lupkin Influence Local Government 19 May David Brooks Chapter Summaries Since the How Did Wilson Lupkin Influence Local Government new methods of marketing for prescription drugs How Did Wilson Lupkin Influence Local Government consumers have become important.

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Sprague, John E. Baer, and Frederick C. Novello of Merck and Co. A Cochrane review concluded that thiazide antihypertensive drugs reduce the risk of death RR 0. ACE inhibitors reduce the risk of new onset kidney disease [RR 0. 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 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.

Searle and Co. The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by , 1. In the U. 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 the need for more comprehensive regulation and provided the driving force for the passage of new laws.

On 12 September , 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 The FDA medical officer in charge of reviewing the compound, Frances Kelsey , believed that the data supporting the safety of thalidomide was incomplete. The firm continued to pressure Kelsey and the FDA to approve the application until November , 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, the firm distributed Kevadon to over 1, physicians there under the guise of investigational use. Over 20, Americans received thalidomide in this "study," including 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 Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on 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 and 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 , Akira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin MLB , 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 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.

By , Merck had isolated lovastatin mevinolin, MK from the fungus Aspergillus terreus , first marketed in as Mevacor. Researchers tested simvastatin , later sold by Merck as Zocor, on 4, patients with high cholesterol and heart disease. For his "pioneering research into a new class of molecules" for "lowering cholesterol," [ sentence fragment ] [73] [74]. Drug discovery 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 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 the larger pharmaceutical companies. 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 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 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. On the other hand, there were only 18 approvals in total in and 22 back in Since , the Center for Drug Evaluation and Research has averaged Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. Professors Light and Lexchin reported in , however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades.

Some of these estimates also take into account 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 the industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. 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 is a very large study of efficacy in the intended patient population. 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 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 British National Formulary 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.

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 , patients in the United States, or larger populations in certain circumstances are subject to the Orphan Drug Act. The second and third best selling were Enbrel and Remicade, respectively. IMS Health publishes an analysis of trends expected in the pharmaceutical industry in , including increasing profits in most sectors despite loss of some patents, and new 'blockbuster' drugs on the horizon.

Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the process of producing the drug, granting exclusivity rights typically for about 20 years. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will introduce a generic version before the patent expires in order to get a head start in the generic market. Advertising is common in healthcare journals as well as through more mainstream media routes. In some countries, notably the US, they are allowed to advertise directly to the general public. Pharmaceutical companies generally employ salespeople often called 'drug reps' or, an older term, 'detail men' to market directly and personally to physicians and other healthcare providers.

In some countries, notably the US, pharmaceutical companies also employ lobbyists to influence politicians. The pharmaceutical marketing plan incorporates the spending plans, channels, and thoughts which will take the drug association, and its items and administrations, forward in the current scene. The book Bad Pharma also discusses the influence of drug representatives, how ghostwriters are employed by the drug companies to write papers for academics to publish, how independent the academic journals really are, how the drug companies finance doctors' continuing education, and how patients' groups are often funded by industry.

Since the s, new methods of marketing for prescription drugs to consumers have become important. There has been increasing controversy surrounding pharmaceutical marketing and influence. There have been accusations and findings of influence on doctors and other health professionals through drug reps including the constant provision of marketing 'gifts' and biased information to health professionals; [] highly prevalent advertising in journals and conferences; funding independent healthcare organizations and health promotion campaigns; lobbying physicians and politicians more than any other industry in the US [] ; sponsorship of medical schools or nurse training; sponsorship of continuing educational events, with influence on the curriculum; [] and hiring physicians as paid consultants on medical advisory boards.

Some advocacy groups, such as No Free Lunch and AllTrials , have criticized the effect of drug marketing to physicians because they say it biases physicians to prescribe the marketed drugs even when others might be cheaper or better for the patient. There have been related accusations of disease mongering [] over-medicalising to expand the market for medications. An inaugural conference on that subject took place in Australia in Meta-analyses have shown that psychiatric studies sponsored by pharmaceutical companies are several times more likely to report positive results, and if a drug company employee is involved the effect is even larger.

It has been argued that the design of the Diagnostic and Statistical Manual of Mental Disorders and the expansion of the criteria represents an increasing medicalization of human nature, or " disease mongering ", driven by drug company influence on psychiatry. The expectation is that relationship between doctors and Pharmaceutical industry will become fully transparent. In a report conducted by the Center for Responsive Politics , there were more than 1, lobbyists working in some capacity for the pharmaceutical business in It has been argued that the pricing of pharmaceuticals is becoming a major challenge for health systems. Ben Goldacre has argued that regulators — such as the Medicines and Healthcare products Regulatory Agency MHRA in the UK, or the Food and Drug Administration FDA in the United States — advance the interests of the drug companies rather than the interests of the public due to revolving door exchange of employees between the regulator and the companies and friendships develop between regulator and company employees.

Others have argued that excessive regulation suppresses therapeutic innovation and that the current cost of regulator-required clinical trials prevents the full exploitation of new genetic and biological knowledge for the treatment of human disease. A report by the President's Council of Advisors on Science and Technology made several key recommendations to reduce regulatory burdens to new drug development, including 1 expanding the FDA's use of accelerated approval processes, 2 creating an expedited approval pathway for drugs intended for use in narrowly defined populations, and 3 undertaking pilot projects designed to evaluate the feasibility of a new, adaptive drug approval process.

Pharmaceutical fraud involves deceptions which bring financial gain to a pharmaceutical company. It affects individuals and public and private insurers. There are several different schemes [] used to defraud the health care system which are particular to the pharmaceutical industry. Damages from fraud can be recovered by use of the False Claims Act , most commonly under the qui tam provisions which rewards an individual for being a " whistleblower ", or relator law. Following charges of illegal marketing, two of the settlements set records last year for the largest criminal fines ever imposed on corporations.

One involved Eli Lilly's antipsychotic Zyprexa , and the other involved Bextra. The drugs involved were Paxil , Wellbutrin , Advair , Lamictal , and Zofran for off-label, non-covered uses. Those and the drugs Imitrex , Lotronex , Flovent , and Valtrex were involved in the kickback scheme. The following is a list of the four largest settlements reached with pharmaceutical companies from to , rank ordered by the size of the total settlement. Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud , off-label promotion, and inadequate manufacturing practices.

Due to repeated accusations and findings that some clinical trials conducted or funded by pharmaceutical companies may report only positive results for the preferred medication, the industry has been looked at much more closely by independent groups and government agencies. In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research was not published, the Pharmaceutical Research and Manufacturers of America have published new guidelines urging companies to report all findings and limit the financial involvement in drug companies of researchers. Drug researchers not directly employed by pharmaceutical companies often look to companies for grants, and companies often look to researchers for studies that will make their products look favorable.

Lecture scripts and even journal articles presented by academic researchers may actually be "ghost-written" by pharmaceutical companies. Some prominent medical schools have since tightened rules on faculty acceptance of such payments by drug companies. In contrast to this viewpoint, an article and associated editorial in the New England Journal of Medicine in May emphasized the importance of pharmaceutical industry-physician interactions for the development of novel treatments, and argued that moral outrage over industry malfeasance had unjustifiably led many to overemphasize the problems created by financial conflicts of interest.

The article noted that major healthcare organizations such as National Center for Advancing Translational Sciences of the National Institutes of Health, the President's Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration had encouraged greater interactions between physicians and industry in order to bring greater benefits to patients. Doctors Without Borders warned that high prices and monopolies on medicines, tests, and vaccines would prolong the pandemic and cost lives. They urged governments to prevent profiteering, using compulsory licenses as needed, as had already been done by Canada, Chile, Ecuador, Germany, and Israel.

On 20 February, 46 US lawmakers called for the US government not to grant monopoly rights when giving out taxpayer development money for any coronavirus vaccines and treatments, to avoid giving exclusive control of prices and availability to private manufacturers. Typically, the agreement involved the government taking ownership of a certain number of doses of the product without further payment. This provision is intended to encourage the development of drugs affecting fewer than , Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees.

Patents have been criticized in the developing world, as they are thought [ who? In , the WTO adopted the Doha Declaration , which indicates that the TRIPS agreement should be read with the goals of public health in mind, and allows some methods for circumventing pharmaceutical monopolies: via compulsory licensing or parallel imports , even before patent expiration. In March , 40 multi-national pharmaceutical companies brought litigation against South Africa for its Medicines Act , which allowed the generic production of antiretroviral drugs ARVs for treating HIV, despite the fact that these drugs were on-patent.

This was unaffordable for most South African citizens, and so the South African government committed to providing ARVs at prices closer to what people could afford. To do so, they would need to ignore the patents on drugs and produce generics within the country using a compulsory license , or import them from abroad. In , GlaxoSmithKline the world's sixth largest pharmaceutical company announced that it would be dropping its patents in poor countries so as to allow independent companies to make and sell versions of its drugs in those areas, thereby widening the public access to them.

In four of the top 20 corporate charitable donations and eight of the top 30 corporate charitable donations came from pharmaceutical manufacturers. Copyright The image is from Wikipedia Commons. Wikipedia Page. Main article: History of pharmacy. Main article: Discovery and development of statins. Main articles: Drug discovery and Drug development. Main article: Orphan drug. Main article: Direct-to-consumer advertising. Main articles: Pharmaceutical marketing and Pharmaceutical lobby. See also: List of largest pharmaceutical settlements in the United States. Ullmann's Encyclopedia of Industrial Chemistry.

ISBN Pharmaceutical Online Guest column. Retrieved 30 October The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. Drug Discovery: A History. J Hist Med Allied Sci. PMID S2CID American Journal of Public Health. PMC Neuropsychiatr Dis Treat. Officers of the Food and Drug Administration, aware of the seriousness of the problem, estimate that approximately half the 9,,, barbiturate and amphetamine capsules and tablets manufactured annually in this country are diverted to illegal use.

THE barbiturates, introduced into medicine by E. Fischer and J. Approximately tons of these agents are manufactured each year; this is enough to put approximately 9,, people to sleep each night for that period if each were given a 0. Journal of the Royal Society of Medicine. ISSN Front Microbiol. The demon under the microscope : from battlefield hospitals to Nazi labs, one doctor's heroic search for the world's first miracle drug 1st ed. New York: Harmony Books. Retrieved 19 May A Population History of the United States.

Cambridge University Press. The History of antibiotics: a symposium. American Institute of the History of Pharmacy No. Maugh 13 April Los Angeles Times. Archived from the original on 7 November Food and Drug Law History". From salvarsan to cephalosporins". J Invest Surg. Waksman, and the balance of credit for discovery". Br Med J. November Antibacterial agents chemistry, mode of action, mechanisms of resistance, and clinical applications.

Oxford: WiBlackwell. Archived from the original on 28 October The American Journal of Medicine. 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.

Chemist George B. Walden of Eli Lilly and Company found that careful adjustment of 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 was only a few months. In arsphenamine , the first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of the Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Arsphenamine was prepared as part of a campaign to synthesize a series of such compounds and found to exhibit partially selective toxicity.

Arsphenamine proved to be the first effective treatment for syphilis , a disease which prior to that time was 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 was pursued broadly by industrial scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, and Gerhard Domagk. This work, also based in 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 , Alexander Fleming discovered 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. Early progress toward the development of vaccines occurred throughout this period, primarily in the form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases.

The first diphtheria vaccines were produced in from a mixture of diphtheria toxin and antitoxin produced from the serum of an inoculated animal , but the safety of the inoculation was marginal and it was not widely used. The United States recorded , cases of diphtheria in resulting in 15, deaths. In 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. 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 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. This was followed in 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 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 over people died after ingesting " Elixir Sulfanilamide " manufactured by S. Massengill Company of Tennessee. The product was formulated in diethylene glycol , a highly toxic solvent that is now widely used as antifreeze. In response to this episode, the U. Congress passed the Federal Food, Drug, and Cosmetic Act of , which for the first time required pre-market demonstration of safety before 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 [29] including the cephalosporins developed by Eli Lilly based on the seminal work of Giuseppe Brotzu and Edward Abraham , [30] [31] streptomycin discovered during a Merck-funded research program in Selman Waksman's laboratory [32] , the tetracyclines [33] discovered at Lederle Laboratories, now a part of Pfizer , erythromycin discovered at Eli Lilly and Co.

Streptomycin, discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers in , became the first effective treatment for tuberculosis. A Federal Trade Commission report issued in attempted to quantify the effect of antibiotic development on American public health. 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".

During the years —, the rate of decline in the U. 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. The vaccine process was never patented but was instead given to pharmaceutical companies to manufacture as a low-cost generic. In the United States Cancer Institute announced that it had concluded that SV40 is not associated with cancer in people. Hypertension is a risk factor for atherosclerosis, [44] heart failure , [45] coronary artery disease , [46] [47] stroke , [48] renal disease , [49] [50] and peripheral arterial disease , [51] [52] and is the most important risk factor for cardiovascular morbidity and mortality , in industrialized countries.

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 the long-term health consequences of high blood pressure had not yet been established, and because they had to be administered by injection. In researchers at Ciba discovered the first orally available vasodilator, hydralazine. In the mids Karl H.

Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello of Merck and Co. A Cochrane review concluded that thiazide antihypertensive drugs reduce the risk of death RR 0. ACE inhibitors reduce the risk of new onset kidney disease [RR 0. 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 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.

Searle and Co. The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by , 1. In the U. 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 the need for more comprehensive regulation and provided the driving force for the passage of new laws.

On 12 September , 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 The FDA medical officer in charge of reviewing the compound, Frances Kelsey , believed that the data supporting the safety of thalidomide was incomplete. The firm continued to pressure Kelsey and the FDA to approve the application until November , 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, the firm distributed Kevadon to over 1, physicians there under the guise of investigational use.

Over 20, Americans received thalidomide in this "study," including 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 Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on 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 and 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 , Akira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin MLB , 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 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. By , Merck had isolated lovastatin mevinolin, MK from the fungus Aspergillus terreus , first marketed in as Mevacor. Researchers tested simvastatin , later sold by Merck as Zocor, on 4, patients with high cholesterol and heart disease.

For his "pioneering research into a new class of molecules" for "lowering cholesterol," [ sentence fragment ] [73] [74]. Drug discovery 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 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 the larger pharmaceutical companies. 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 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 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.

On the other hand, there were only 18 approvals in total in and 22 back in Since , the Center for Drug Evaluation and Research has averaged Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. Professors Light and Lexchin reported in , however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades. Some of these estimates also take into account 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 the industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. 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 is a very large study of efficacy in the intended patient population. 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 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 British National Formulary 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. 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 , patients in the United States, or larger populations in certain circumstances are subject to the Orphan Drug Act.

The second and third best selling were Enbrel and Remicade, respectively. IMS Health publishes an analysis of trends expected in the pharmaceutical industry in , including increasing profits in most sectors despite loss of some patents, and new 'blockbuster' drugs on the horizon. Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the process of producing the drug, granting exclusivity rights typically for about 20 years. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will introduce a generic version before the patent expires in order to get a head start in the generic market.

Advertising is common in healthcare journals as well as through more mainstream media routes. In some countries, notably the US, they are allowed to advertise directly to the general public. Pharmaceutical companies generally employ salespeople often called 'drug reps' or, an older term, 'detail men' to market directly and personally to physicians and other healthcare providers. In some countries, notably the US, pharmaceutical companies also employ lobbyists to influence politicians.

The pharmaceutical marketing plan incorporates the spending plans, channels, and thoughts which will take the drug association, and its items and administrations, forward in the current scene. The book Bad Pharma also discusses the influence of drug representatives, how ghostwriters are employed by the drug companies to write papers for academics to publish, how independent the academic journals really are, how the drug companies finance doctors' continuing education, and how patients' groups are often funded by industry. Since the s, new methods of marketing for prescription drugs to consumers have become important. There has been increasing controversy surrounding pharmaceutical marketing and influence.

There have been accusations and findings of influence on doctors and other health professionals through drug reps including the constant provision of marketing 'gifts' and biased information to health professionals; [] highly prevalent advertising in journals and conferences; funding independent healthcare organizations and health promotion campaigns; lobbying physicians and politicians more than any other industry in the US [] ; sponsorship of medical schools or nurse training; sponsorship of continuing educational events, with influence on the curriculum; [] and hiring physicians as paid consultants on medical advisory boards.

Some advocacy groups, such as No Free Lunch and AllTrials , have criticized the effect of drug marketing to physicians because they say it biases physicians to prescribe the marketed drugs even when others might be cheaper or better for the patient. There have been related accusations of disease mongering [] over-medicalising to expand the market for medications. An inaugural conference on that subject took place in Australia in Meta-analyses have shown that psychiatric studies sponsored by pharmaceutical companies are several times more likely to report positive results, and if a drug company employee is involved the effect is even larger.

It has been argued that the design of the Diagnostic and Statistical Manual of Mental Disorders and the expansion of the criteria represents an increasing medicalization of human nature, or " disease mongering ", driven by drug company influence on psychiatry. The expectation is that relationship between doctors and Pharmaceutical industry will become fully transparent. In a report conducted by the Center for Responsive Politics , there were more than 1, lobbyists working in some capacity for the pharmaceutical business in It has been argued that the pricing of pharmaceuticals is becoming a major challenge for health systems. Ben Goldacre has argued that regulators — such as the Medicines and Healthcare products Regulatory Agency MHRA in the UK, or the Food and Drug Administration FDA in the United States — advance the interests of the drug companies rather than the interests of the public due to revolving door exchange of employees between the regulator and the companies and friendships develop between regulator and company employees.

Others have argued that excessive regulation suppresses therapeutic innovation and that the current cost of regulator-required clinical trials prevents the full exploitation of new genetic and biological knowledge for the treatment of human disease. A report by the President's Council of Advisors on Science and Technology made several key recommendations to reduce regulatory burdens to new drug development, including 1 expanding the FDA's use of accelerated approval processes, 2 creating an expedited approval pathway for drugs intended for use in narrowly defined populations, and 3 undertaking pilot projects designed to evaluate the feasibility of a new, adaptive drug approval process.

Pharmaceutical fraud involves deceptions which bring financial gain to a pharmaceutical company. It affects individuals and public and private insurers. There are several different schemes [] used to defraud the health care system which are particular to the pharmaceutical industry. Damages from fraud can be recovered by use of the False Claims Act , most commonly under the qui tam provisions which rewards an individual for being a " whistleblower ", or relator law. Following charges of illegal marketing, two of the settlements set records last year for the largest criminal fines ever imposed on corporations.

One involved Eli Lilly's antipsychotic Zyprexa , and the other involved Bextra. The drugs involved were Paxil , Wellbutrin , Advair , Lamictal , and Zofran for off-label, non-covered uses. Those and the drugs Imitrex , Lotronex , Flovent , and Valtrex were involved in the kickback scheme. The following is a list of the four largest settlements reached with pharmaceutical companies from to , rank ordered by the size of the total settlement. Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud , off-label promotion, and inadequate manufacturing practices. Due to repeated accusations and findings that some clinical trials conducted or funded by pharmaceutical companies may report only positive results for the preferred medication, the industry has been looked at much more closely by independent groups and government agencies.

In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research was not published, the Pharmaceutical Research and Manufacturers of America have published new guidelines urging companies to report all findings and limit the financial involvement in drug companies of researchers. Drug researchers not directly employed by pharmaceutical companies often look to companies for grants, and companies often look to researchers for studies that will make their products look favorable.

Lecture scripts and even journal articles presented by academic researchers may actually be "ghost-written" by pharmaceutical companies. Some prominent medical schools have since tightened rules on faculty acceptance of such payments by drug companies. In contrast to this viewpoint, an article and associated editorial in the New England Journal of Medicine in May emphasized the importance of pharmaceutical industry-physician interactions for the development of novel treatments, and argued that moral outrage over industry malfeasance had unjustifiably led many to overemphasize the problems created by financial conflicts of interest. The article noted that major healthcare organizations such as National Center for Advancing Translational Sciences of the National Institutes of Health, the President's Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration had encouraged greater interactions between physicians and industry in order to bring greater benefits to patients.

Doctors Without Borders warned that high prices and monopolies on medicines, tests, and vaccines would prolong the pandemic and cost lives. They urged governments to prevent profiteering, using compulsory licenses as needed, as had already been done by Canada, Chile, Ecuador, Germany, and Israel. On 20 February, 46 US lawmakers called for the US government not to grant monopoly rights when giving out taxpayer development money for any coronavirus vaccines and treatments, to avoid giving exclusive control of prices and availability to private manufacturers.

Typically, the agreement involved the government taking ownership of a certain number of doses of the product without further payment. This provision is intended to encourage the development of drugs affecting fewer than , Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees. Patents have been criticized in the developing world, as they are thought [ who? In , the WTO adopted the Doha Declaration , which indicates that the TRIPS agreement should be read with the goals of public health in mind, and allows some methods for circumventing pharmaceutical monopolies: via compulsory licensing or parallel imports , even before patent expiration.

In March , 40 multi-national pharmaceutical companies brought litigation against South Africa for its Medicines Act , which allowed the generic production of antiretroviral drugs ARVs for treating HIV, despite the fact that these drugs were on-patent. This was unaffordable for most South African citizens, and so the South African government committed to providing ARVs at prices closer to what people could afford. To do so, they would need to ignore the patents on drugs and produce generics within the country using a compulsory license , or import them from abroad.

In , GlaxoSmithKline the world's sixth largest pharmaceutical company announced that it would be dropping its patents in poor countries so as to allow independent companies to make and sell versions of its drugs in those areas, thereby widening the public access to them. In four of the top 20 corporate charitable donations and eight of the top 30 corporate charitable donations came from pharmaceutical manufacturers. From Wikipedia, the free encyclopedia. Redirected from Pharmaceutical companies. Develops, produces, and markets drugs. Main article: History of pharmacy. Main article: Discovery and development of statins.

Main articles: Drug discovery and Drug development. Main article: Orphan drug. Main article: Direct-to-consumer advertising. Main articles: Pharmaceutical marketing and Pharmaceutical lobby. See also: List of largest pharmaceutical settlements in the United States. The examples and perspective in this section deal primarily with the United States and do not represent a worldwide view of the subject. You may improve this section , discuss the issue on the talk page , or create a new section, as appropriate.

August Learn how and when to remove this template message. Chemistry portal Biology portal Medicine portal Companies portal. Ullmann's Encyclopedia of Industrial Chemistry. ISBN Pharmaceutical Online Guest column. Retrieved 30 October The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. Drug Discovery: A History.

How Did Wilson Lupkin Influence Local Government costsalso known as drug costs are a common health care cost for many people and health care systems. Retrieved 20 June All How Did Wilson Lupkin Influence Local Government people on board died, The Indian Great Awakening Summary county fire spokesman said.