Transcript Naming of drugs

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.
• 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.
• 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
• 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.
• 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.
• 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
• 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.
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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.
• 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.
• 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.
The Sulfanilamide Disaster
• In 1937, S. E. Massengil Company created an
elixir (liquid form) of the antibiotic
sulfanilamide using diethylene glycol as
solvent.
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.
• 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.
• 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.
• 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.
• 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.
•
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.
• 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.
• 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.
• 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.
• 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 stockmarket value of £110 billion (US$180 billion).
• 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.
• The new antidepressants, the SSRIs,
notably Fluoxetine (Prozac), rapidly
became bestsellers and marketed for
additional disorders.
• Drug development progressed from a hit-andmiss approach to rational drug discovery in both
laboratory design and natural-product surveys.
• Demand for nutritional supplements and socalled alternative medicines created new
opportunities and increased competition in the
industry.
• 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.
• 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.
Industry revenues
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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.
Top Pharmaceutical Companies (sales)
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
How many drug
targets are there?
What classes are important?
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/Pro
ductRegulation/SulfanilamideDisaster/default.htm
• Hopkins Andrew L; Groom Colin R The druggable
genome. Nature reviews. Drug discovery (2002),
1(9), 727-30.