Efficacy, Safety, Quality Control, Marketing and Regulatory Guidelines for Herbal Medicines

Calixto, J. B. (2000). Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (Phytotherapeutic agents). Brazilian Journal of Medical and Biological Research, 33(2),179-189. Retrieved from: http://dx.doi.org/10.1590/S0100-879X2000000200004

This is a review about the safety, efficacy, quality control, marketing and regulation of botanical medicine, published in 2000 by the Brazilian Journal of Medical and Biological Research. The target audience would be regulatory, medical researchers, clinicians, and the public. The review is written by Professor Joao Batista Calixto a pharmacologist working at the Federal University of Santa Catarina, Brazil.  The article mentions the growing market in phyto-medicine which has attracted the interest of major pharmaceutical companies.  The study highlights the lack of access to related data on most plants and states that it is a fallacy to assume that herbal medicines are totally safe. This research is relevant because despite the scientific basis by significant publications of clinical studies for general practitioner’s prescriptions, still there is a lack of data to assess the efficacy and safety of most herbal medicine.  The review indicates that in many countries including the United States herbal medicine is sold as a dietary supplement, while in some other countries like the UK, there are drug regulations on some herbals, which require the safety and efficacy need to be proved in order to be registered. The study includes a compact review of policies in different countries following the suggestion for a global regulatory mechanism for herbal medicine regulation. In order to achieve this, a variety of steps are needed including well-controlled and randomized clinical trials to prove the efficacy and safety of herbal medicine; a process of regulation achieve global harmonization, and the requirement domesticate and genetic studies need.  This research has been done more than one and half decades ago, nevertheless, the issue of herbal medicine remains crucial, therefore, more up-to-date research is needed.

Cultural Variation in Style of Thinking

Extra compact note taking:

Culture effects

1. Different cultures = different ways in which people approach a task
2. Each Culture Þ bring diff purposes Þ way of thinking Þconsequently finishes with different results  
3. Traditions have specific implications Þ not just WHAT to think Þ but also HOW to think.

Different systems of educations in different countries:

Conserving systems of education	Extending systems of education
Questioning is not welcomed	Asking questions is encouraged
Information is exclusively limited to what teachers dictate	Students get supports to search for information by themselves
Students are obliged to imitate exactly what they are taught	Students are encouraged for further exploration
Memorization	Critical thinking
keep a preserving behaviour	Attitude to extend knowledge
Learning approach results in repeating the existing knowledge	Learning approach oriented toward  speculation

Different approach Þ emphasize on particular disciplines Þ distinctive styles of writing.

Robert Kaplan: Five distinct patterns for structuring expository writings.

In Western cultures:

English = linear Þ stick to the idea Þ strict on relevance Þ moving right to the point.  Romance & Russian = similar linear Þ moving a bit around the main idea permitted. Semitic = parallelism Þ repeats variations of the same sentences, either reflect or contradict the main idea. Oriental = circles around the topic, defining ideas in the opposite way.   

Each academic discipline Þ happens in a specific discourse Þ create a subculture

Subcultures Þ presenting their contents in their own applicable approaches.

Sub cultures Þ different criteria for determining relevance.

Common rules: Brevity + clarity + reliability

Same materials used in different ways in different disciplines. i.e. statistics, formula, graphics and illustrations. 

Different disciplines lead to think differently and advise (flexibility)

 Cultural background interferes studying abroad. 

Asian students need to develop analytical and critical ways in order to study successfully. 

A Piece of Speech

Mr President, Ladies and Gentlemen!

History is more than the path left by the past.  It influences the present and can shape the future.  We met today, in Westminster Hall, a building begun nine hundred years ago.  When the Vikings were visiting the shores of what would become the United States. Even it was Columbus who would subsequently demonstrate the politician ought, of arriving late but claiming all the credit.  This whole has witnessed grim trails on the sentencing to death of a king, coronation banquets, ceremonial addresses, and the coffins of those receiving the last respects of our people. Few places reach so far into the hearth of our nation. Yet, until today, no American President has stood on these steps to address our country's parliament. It is my honour Mr. President to welcome you as our friend and as a statesman.  Statesmen-ship is the cement which seals our shared idealism as nations.  It makes meaning-full the unity of and ambition, passion for freedom an abhorrence of injustice, that is the core of our close alliance.  It is fallen to you to tackle economic turbulence at home, to protect the health of those without wealth and to seek that precious balance between security which is too often threatened and human rights which is too often denied. History is not the burton of any one man or woman alone, but some are called to meet a special share of its challenges.  Its a duty that you discharged with a dignity, determination and distinction that are widely admired. Abraham Lincoln once observed that nearly all man can stand adversity but if you want to test the man’s character, give him power. Ladies and gentlemen the President of The United States of America, Barak Obama.