Naming of drugs

1. Naming of drugs A marketed drug has three names: a chemical name, a generic name, and a brand name. • A chemical name is given when a new chemical entity (NCE) is developed.

2. The chemical name is a scientific name based on the compound's chemical structure (e.g., 6-thioguanine) and is almost never used to identify the drug in a clinical or marketing situation. • Often, the name is long and difficult to pronounce, and, since it has numbers, the number in the name might become confused with the numbers in the prescription.

3. The generic name (or non-proprietary name) is granted by the USAN Council and is commonly used to identify a drug during its useful clinical lifetime. • Link

4. The generic name does not belong to the company that discovers the drug (or owns the patent). Once the patent lifetime is expired, any company may market the drug under the generic name.

5. The generic name must be screened to assure that it does not resemble any other generic or brand name. • The generic name must also be appropriate for the class of drug.

6. A listing of appropriate drug stem names can be found in the National Library of Medicine’s Drug Portal • The stems refer to the mechanism of action of the drug (not the disease condition) • Link

8. The company that patents the drug creates the brand name (trademark). This name identifies the drug during the 17 years that the company has exclusive rights to make, sell, and use it under patent law.

9. Link Link

10. History of the Pharmaceutical Industry • Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. • Key discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed (penicillin in WW II). Switzerlnd, Germany and Italy had particularly strong industries, with the UK and US following suit.

11. Legislation was enacted to test and approve drugs and to require appropriate labeling. • Prescription and nonprescription drugs became legally distinguished from one another as the pharmaceutical industry matured.

12. Attempts were made to increase regulation and to limit financial links between pharmaceutical companies and prescribing physicians, including by the relatively new US FDA. • Such calls increased in the 1960s after the thalidomide tragedy came to light, in which the use of a new tranquilizer in pregnant women caused severe birth defects.

14. The Sulfanilamide Disaster • In 1937, S. E. Massengil Company created an elixir (liquid form) of the antibiotic sulfanilamide using diethylene glycol as solvent.

15. Ethylene Glycol Diethylene Glycol • Diethylene glycol is a great solvent, but extremely toxic. • Unfortunately, at the time, there were no legal requirement to test the toxicity of the drug • This resulted in the deaths of more than 100 people in the U.S.

16. The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) was passed by Congress in 1938 • This law gives authority to the FDA to oversee the safety of food, drugs, and cosmetics.

17. Numerous new drugs were developed during the 1950s and mass-produced and marketed through the 1960s. • This included the first oral contraceptive, The Pill, Cortisone, blood-pressure drugs and other heart medications. MAO Inhibitors, chlorpromazine (Thorazine), Haldol (Haloperidol) and the tranquilizers ushered in the age of psychiatric medication.

18. Valium (diazepam), discovered in 1960, was marketed from 1963 and rapidly became the most prescribed drug in history, prior to controversy over dependency and habituation.

19. In 1964, the World Medical Association issued its Declaration of Helsinki, which set standards for clinical research and demanded that subjects be given informed consent before enrolling in an experiment. Pharmaceutical companies became required to prove efficacy in clinical trials before marketing drugs.

20. Cancer drugs were a feature of the 1970s. From 1978, India took over as the primary center of pharmaceutical production without patent protection.The industry remained relatively small scale until the 1970s when it began to expand at a greater rate. Legislation allowing for strong patents, to cover both the process of manufacture and the specific products, came in to force in most countries.

21. By the mid-1980s, small biotechnology firms were struggling for survival, which led to the formation of mutually beneficial partnerships with large pharmaceutical companies and a host of corporate buyouts of the smaller firms. • Pharmaceutical manufacturing became concentrated, with a few large companies holding a dominant position throughout the world and with a few companies producing medicines within each country.

22. The pharmaceutical industry entered the 1980s pressured by economics and a host of new regulations, both safety and environmental, but also transformed by new DNA chemistries and new technologies for analysis and computation. • Drugs for heart disease and for AIDS were a feature of the 1980s, involving challenges to regulatory bodies and a faster approval process.

23. Managed care and Health maintenance organizations (HMOs) spread during the 1980s as part of an effort to contain rising medical costs, and the development of preventative and maintenance medications became more important. • A new business atmosphere became institutionalized in the 1990s, characterized by mergers and takeovers, and by a dramatic increase in the use of contract research organizations for clinical development and even for basic R&D. • 'Big Pharma' confronted a new business climate and new regulations, born in part from dealing with world market forces and protests by activists in developing countries. • Animal Rights activism was also a problem.

24. Glaxo Wellcome + SmithKline Beecham = GlaxoSmithKline Merger of Glaxo Wellcome and SmithKline Beecham creates pharmaceutical giant Alison Abbott, MUNICH, Munich JONNY EGGITT/FT Garnier: to head Glaxo SmithKline. The merger of the British pharmaceutical companies Glaxo Wellcome and SmithKline Beecham, which comes into effect this summer, creates a giant which could rank number one in the world in terms of spending on research and development (R&D). It will boast a portfolio of 30 new drugs and 19 vaccines in clinical trial. Glaxo Wellcome is currently the fifth-largest pharmaceutical company in the world in terms of turnover and SmithKline Beecham is ranked twelfth. The new company will have a stock-market value of £110 billion (US$180 billion).

25. Marketing changed dramatically in the 1990s, partly because of a new consumerism. • The Internet made possible the direct purchase of medicines by drug consumers and of raw materials by drug producers, transforming the nature of business. • In the US, Direct-to-consumer advertising proliferated on radio and TV because of new FDA regulations in 1997 that liberalized requirements for the presentation of risks.

26. The new antidepressants, the SSRIs, notably Fluoxetine (Prozac), rapidly became bestsellers and marketed for additional disorders.

27. Drug development progressed from a hit-and-miss approach to rational drug discovery in both laboratory design and natural-product surveys. • Demand for nutritional supplements and so-called alternative medicines created new opportunities and increased competition in the industry.

28. Controversies emerged around adverse effects, notably regarding Vioxx in the US, and marketing tactics. • Pharmaceutical companies became increasingly accused of disease mongering or over-medicalizing personal or social problems.

29. There are now more than 200 major pharmaceutical companies, jointly said to be more profitable than almost any other industry, and employing more political lobbyists than any other industry. • Advances in biotechnology and the human genome project promise ever more sophisticated, and possibly more individualized, medications.

30. Industry revenues • For the first time ever, in 2006, global spending on prescription drugs topped $600 billion, even as growth slowed somewhat in Europe and North America. • Sales of prescription medicines worldwide rose 7 percent to $602 billion, according to IMS health, a pharmaceutical information and consulting company. • The United States still accounts for most, with $252 billion in annual sales. Sales there grew 5.7 percent.

31. Top Pharmaceutical Companies (sales)

32. Lipinski’s Rules of Five An orally active drug should have the following: • No More than five hydrogen bond donors • No more than ten hydrogen bond acceptors • A molecular weight under 500 daltons • An octanol-water partition coefficient less than 5

33. How many drug targets are there?

38. What classes are important?

39. Assigned Reading • Gundersen L The complex process of naming drugs. Annals of internal medicine (1998), 129(8), 677-8. • http://www.medscape.com/viewarticle/469843 • (you will need to create a free medscape account, and to click on the box at lower right to see all 4 sections) • http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm • Hopkins Andrew L; Groom Colin R The druggable genome. Nature reviews. Drug discovery (2002), 1(9), 727-30.