Pharmaceutical industry

Early history and breakthroughs in pharmaceutical industry

  • The modern era of pharmaceutical industry began in the mid-1800s with the expansion of local apothecaries.
  • Intentional drug discovery from plants started with the isolation of morphine in the early 1800s.
  • German dye manufacturers perfected the purification of organic compounds in the late 1880s.
  • Synthetic chemical methods allowed scientists to systematically vary the structure of chemical substances.
  • The emerging science of pharmacology expanded the ability to evaluate the biological effects of structural changes.
  • German apothecary assistant Friedrich Sertürner isolated morphine from opium between 1803 and 1805.
  • German dye manufacturers developed methods for purifying organic compounds from tar and other sources.
  • Scientists could systematically vary the structure of chemical substances due to the development of synthetic chemical methods.
  • The discovery of epinephrine in 1897 led to the development of products for hemostatic and shock treatment.
  • Japanese chemists identified ephedrine in the Ma Huang plant, which was marketed as an oral treatment for asthma.
  • Adrenal extracts containing epinephrine were used as hemostatic agents and for shock treatment.
  • John Abel identified epinephrine as the active principle in adrenal extracts in 1897.
  • Epinephrine was formulated into an inhaler for nasal congestion treatment in 1929.
  • Ephedrine, a structurally similar compound to epinephrine, was marketed as an oral treatment for asthma.
  • Amphetamine was synthesized in 1929 and used for asthma, narcolepsy, and depression treatment.
  • Diethylbarbituric acid, marketed as Veronal, was the first marketed barbiturate.
  • Phenobarbital, discovered in 1911, became widely used for epilepsy treatment.
  • Barbiturates and amphetamines faced increasing restrictions due to their addictive properties and abuse potential.
  • Chlordiazepoxide (Librium), the first benzodiazepine, was discovered in 1958.
  • Benzodiazepines largely replaced barbiturates in medicine due to their superior safety and therapeutic properties.
  • Diabetes was found to be caused by the absence of a substance produced by the pancreas.
  • In 1921, injections of pancreatic extract were shown to reverse diabetes symptoms.
  • Insulin therapy was delayed by difficulties in producing sufficient quantity and purity of the material.
  • Chemist George B. Walden of Eli Lilly and Company developed a method for producing relatively pure insulin.
  • Prior to insulin therapy, the life expectancy of diabetics was only a few months.
  • Arsphenamine (Salvarsan) was the first synthetic anti-infective drug developed in 1911.
  • Arsphenamine was part of a campaign to synthesize compounds with selective absorption properties.
  • Pneumonia, tuberculosis, and diarrhea were the leading causes of death in the early 1900s.
  • The development of drugs for infectious diseases became a major focus of research.
  • The discovery of antibiotics like penicillin revolutionized the treatment of bacterial infections.
  • Post-World War II saw an explosion in the discovery of new classes of antibacterial drugs.
  • Cephalosporins, streptomycin, tetracyclines, and erythromycin were developed during this period.
  • Streptomycin became the first effective treatment for tuberculosis.
  • Antibiotic development contributed to a decline in the incidence of diseases they were effective against.
  • Mortality rates for diseases like tuberculosis declined significantly.
  • Vaccine development continued to accelerate after World War II.
  • Jonas Salk developed the polio vaccine in 1954.
  • The polio vaccine was given to pharmaceutical companies to manufacture as a low-cost generic.
  • Maurice Hilleman identified the SV40 virus, later found to cause tumors.
  • Vaccines played a significant role in the decline of the U.S. death rate in the post-war years.
  • SV40 contamination in vaccines.
  • Measles vaccine developed by John Franklin Enders and Maurice Hilleman.
  • Rubella vaccine developed by Maurice Hilleman.
  • Mumps vaccine developed by Maurice Hilleman.
  • Significant decrease in incidences of rubella, congenital rubella syndrome, measles, and mumps after widespread vaccination.
  • Hypertension as a risk factor for various diseases.
  • Early development of hypertension treatment with quaternary ammonium ion sympathetic nervous system blocking agents.
  • Discovery of orally available vasodilator hydralazine.
  • Development of chlorothiazide as widely used antihypertensive drug.
  • Cochrane review showing thiazide antihypertensive drugs reducing risk of death, stroke, coronary heart disease, and cardiovascular events.
  • Birth control prohibition prior to Second World War.
  • Development of oral contraceptives tied to birth control movement and activists.
  • Development of Enovid, the first oral contraceptive, by G.D. Searle & Co.
  • Initial formulation of Enovid causing severe side effects.
  • Dramatic changes in social mores due to availability of oral contraceptives.
  • Congressional hearings led by Senator Estes Kefauver in 1959.
  • Submission of new drug application for thalidomide by William S. Merrell Company.
  • FDA medical officer Frances Kelsey's concerns about thalidomide's safety.
  • Thalidomide tragedy leading to the passage of Kefauver-Harris Amendment.
  • FDA receiving authority to regulate drug advertising and establish good manufacturing practices.
  • Discovery of mevastatin as an inhibitor of HMG-CoA reductase.
  • Toxic effects of mevastatin in animal studies.
  • Isolation of lovastatin from Aspergillus terreus by Merck & Co.
  • Merck-sponsored study on simvastatin showing positive results.
  • Introduction of simvastatin as a cholesterol-lowering medication by Merck & Co.

Regulation and industry control

  • Prior to the 20th century, there was little regulatory control over drug manufacturing.

Pharmaceutical industry Data Sources

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