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臨床試驗的科學原理 台北醫學大學 醫學科學研究所 許重義. What is the most widely read book on medicine? It is Merck Manual !

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Presentation on theme: "臨床試驗的科學原理 台北醫學大學 醫學科學研究所 許重義. What is the most widely read book on medicine? It is Merck Manual !"— Presentation transcript:

1 臨床試驗的科學原理 台北醫學大學 醫學科學研究所 許重義

2 What is the most widely read book on medicine? It is Merck Manual !

3 Western vs. Eastern

4 In Medicine, which world advances faster and is more successful? Eastern or Western?

5 Amazon.com

6 This is serious stuff. The most widely used medical text in the world. Ref. Amazon. com

7 “more than 10 million copies sold in 18 languages since it was first published in 1899 “

8 the oldest continuously Published general medical text in the English language.

9 The year 1999 marks a milestone in medical publishing —the 100th anniversary of The Merck Manual

10 The Merck Manual: A Century of Medical Publishing and Practice

11 A Century of Trust The Merck Manual: Centennial Edition

12 What a century for advances in medicine!

13 Keryn AG Lane Executive Editor Merck Manuals Robert Berkow Editor-in-Chief Merck Manuals

14 The history of the Manual provides a wonderful overview of how medical practice has changed.

15 The first edition reveals a remarkable reliance on poisons, such as strychnine and arsenic.

16 Arsenic was listed as a medication for more than 100 diseases, including jaundice, hydrophobia, elephantiasis, and impotence.

17 Tobacco was recommended to treat asthma

18 The first edition was an instant success!

19 A book reviewer in the Chicago Medical Recorder commented: “Although this little book is gotten out by a manufacturing firm----, it nonetheless is of such merit -----.”

20 Dr M R Dinkelspiel, the 7 th edition (1940) editor noted that therapy was approached not as a science, but as an art.”

21 The ninth edition (1956) reflected the growing list of corticosteroids for pain.

22 The 12th edition (1972) contained many new chapters, for example, on coronary care units, cardiovascular and malignant diseases, immunology and genetics, and the chemotherapy of psychiatric disorders.

23 As an interesting endnote, all people who purchase the 17th edition of The Merck Manual during its centennial year will receive a facsimile copy of the first edition.

24 Readers can then see for themselves how much medicine has changed during this century.

25 What about oriental medicine? How much has been advanced in herbal medicine in the past 100 years?

26 In the USA, herbal medicine pills are noted frequently to contain western medications such as steroid (cortical), chemotherapeutic agents (method rebate), anticonvulsants (Dilating) and others.

27 Based on the 100 years of experience with Merck Manual, could we, the doctors, be looked back “stupid” in year 2099?

28 In the 18 th Century Doctors are killing patients with arsenic, strychnine and other poisons

29 100 years from now how the contemporary doctors then would see their counterparts 100 years earlier?

30 Traffic death in the US: 50,000 a year

31 Death caused by healthcare professionals in the US: 100,000 a year!

32 Death caused by medications prescribed by doctors in the US 200,000 a year!

33 Health care professionals and the medications they prescribed kill 6 times more people than traffic accident in the US

34 Are you convinced that doctors kill patients?

35 In Israel A nation-wide physician strike in 1972 lowered the mortality in the nation by more than 50%

36 In Los Angeles, California A partial physician strike lowered the mortality in the city by 18%

37 In Bogota, Columbia A partial physician strike lowered the mortality in the city by 36%

38 In Singapore, Hong Kong and Taiwan SARS mortalities were more than 10%

39 In Vietnam SARS mortality was 5 %

40 In Vietnam There were no modern meds such as antiviral agents or steroids to treated patients

41 In Vietnam There were no advanced facilities such as negative pressure wards or respirators to support incubated patients

42 In medical practice Doing nothing could be better than meds or interventions such as surgeries

43 In medical practice The first thing every doctor should know is Do no harm

44 How do we know the meds we give to patients are helpful to patients?

45 How do we prove the meds we prescribe to patients are helpful scientifically?

46 It takes rigorously designed clinical trials to confirm the efficacy of a drug.

47 The gold standards for the criteria to establish drug efficacy was established by Food and Drug Administration (FDA) in the US

48 FDA established its reputation in a well known act to prohibits the use of thalidomide in the US when it was widely used in the Europe for a number of diseases in the 50s.

49 FDA, with its authoritative measures, sets very high standards to approve drugs that are to be approved for prescriptions by doctors in the US.

50 The rest of the world has since adapted FDA protocols in approving prescription medications.

51 FDA specifically asks if a new drug is safe makes patient better keeps patient live longer

52 A new drug to be approved by FDA entails extensive preclinical and clinical tests to fulfill the 3 major criteria on safety, quality of life and longevity.

53 A new drug may take 7-10 years to go from the lab bench to bedside and costs hundreds of millions in US dollars to get FDA approval.

54

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56 Drug Development and Approval Process


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