Lectures 14 and 15 and 16 : Epidemiology

NOTE: Part of this lecture was given using the chalkboard only. If you were absent, make sure to get the notes from a classmate.

1. What is a surrogate measure, as defined by Dr. Avorn?

2. Do you agree with the use of surrogate measures as drug testing endpoints? why or why not?


After this lecture, you should be able to answer the following:

1. What is an epidemic? What do we mean by the term "endemic rate?"

2. What did Winslow say about epidemiology?

3. What do we mean by the term "notifiable disease?" Give some examples of these types of diseases.

4. What did Dr. John Snow do in response to the cholera epidemic that struck London in the mid 1800s? What was his hypothesis? What were the results of his study?

5. What is "shoe-leather" epidemiology? What is epidemiological surveillance? Illustrate these concepts by using the example of Hepatitis A.

6. What is Eosinophilia-Myalgia Syndrome? What was it caused by? What is Legionnaire's Disease? What causes Legionnaire's Disease? How were these health threats originially identified? What were the Public Health responses?

7. How can epidemiology be used to study chronic disease? What was the Framingham Heart Study? What did this study discover with respect to heart disease? In other words, what were the risk factors uncovered by the study that contribute to heart disease?

8. How did epidemiology link cigarette smoking to lung cancer? What was the Doll and Hill study? Explain its design and its major conclusions. What was the Hammond and Horn study? How did its design differ from the Doll and Hill study? Compare the conclusions of the two studies. Based on these results would you want someone very close to you to become a habitual smoker? why or why not?

9. What has epidemiology uncovered so far concerning risk factors for Alzheimer's disease?
It's kind of amazing that despite all of the recent technological advances, we really know very little about this disease. Wouldn't it be nice to know more about it so it can possibly be prevented?

10. What is relative risk? What does it tell us in comparison studies?

11. What is radiography? what can it be used for?

12. Make sure you read the assigned readings carefully and answer all the homework questions.

Lecture 13: Powers and Responsibilities of Government- continued

NOTE: Part of this lecture was given using the chalkboard only. If you were absent, make sure to get the notes from a classmate.

After this lecture, you should be able to answer the following:

1. Explain the detrimental aspects of the Dalkon Shield to the Public Health. In terms of the regulation of medical devices by the FDA, what resulted from that disaster? Does the FDA regulate dietary supplements? Why not?

2. What was the role of the FDA in the "Lucky Dragon" incident? What was the "Lucky Dragon" incident?

3. What is the Orphan Drug Act? What is it intended to do?

4. Who was Jere Goyan? What important contribution(s) did he make during his tenure at the FDA?

5. List several major governmental agencies involved in environmental health.

6. What is the relationship of the Department of Labor and OSHA?

7. List and briefly describe some of the important nongovernmental organizations which are involved in public health, particularly those which were discussed in class.

8. Discuss the difference between pre-clinical trials and clinical trials.

9. What is the difference between in vitro and in vivo (animal) experiments?

10. How long do pre-clinical trials generally take?

11. What is a IND application and when is it filed to the FDA? When will the company file for a patent? How long is the patent valid?

12. How are clinical trials arranged? Discuss the four phases of clinical trials in detail. How large is the sample pool in Phase I, in Phase II, and in Phase III? What is the placebo effect? Why are Phase III trials done in a randomized double-blind manner? What changes occur in the Clinical Trials portion when an orphan drug like pegademase was being tested for approval? What is pegademase used for? How many people have that illness?

13. What is Phase IV? Can the FDA pull a drug during Phase IV? Can you name a drug that was recently taken off the market during Phase IV?

14. When is a NDA application filed to the FDA? What happens if the FDA approves the NDA? Why might the FDA reject a NDA? About how much money does it cost the pharmaceutical company to take a drug from pre-clinical trials to market? About how many years will a company have patent protection after the drug goes to market? What usually happens the day the patent expires? When the company has patent rights, are there available generics?


15. Make sure you read the assigned articles carefully and answer the homework questions.

Lectures 11 and 12: Chapter 3- Powers and Responsibilities of Government (cont).

After this lecture, you should be able to answer the following:

1. What is the Public Health Service (PHS)? What is its history? Is it a Commissioned Service? What does that mean? Who is the leader of the PHS? Who does this PHS leader report to? Who is the current Surgeon General? What is his stance on folic acid for pregnant mothers? What kinds of things will folic acid prevent? How can we get folic acid to all pregnant mothers, even those in under-developed countries where resources are scarce? Suggest/develop a policy that might help meet that goal. Is that policy realistic?

2. What are the minimum requirements to be Surgeon General?

3. What is the name of the weekly publication issued by the Centers for Disease Control and Prevention? You can find that publication at: www.cdc.gov/mmwr/index.html

4. What was so significant about the First Surgeon General's Report on Smoking and Health?

5. What do we know about the prevalence of cigarette use in racial/ethnic populations in the United States as measured from 1999-2001. In each age group studied, who smokes the most? the least?

6. What is the National Institutes of Health? What is the National Library of Medicine? What is Pubmed?

7. Tell your study partner about the first Pure Food Law that was enacted in America. When was it enacted? where? what was the point of it?

8. What is a nostrum?

9. Who was Harvey Washington Wiley? What was he famous for? What were the "poison squad" experiments?

10. Who was Upton Sinclair? What was his book about? Was it a book that had a significant impact on Public Health? How so?

11. Who was Samuel Hopkins Adams? Do you think that he enjoyed drinking Peruna?

12. Tell your study partner about the Pure Food and Drug Act passed by Congress in 1906. What was the point of the legislation?

13. What happened in 1937 to trigger a public outcry that resulted in passage of the Food, Drug and Cosmetic Act of 1938? How did that Act differ from the Pure Food and Drug Act of 1906?

14. What is thalidomide? What was it used for? What was it found to cause in newborns of mothers who took it during pregnancy? Was it ever sold for morning-sickness in the United States? On the heels of the thalidomide crisis in Europe, what Amendment to the Food, Drug and Cosmetic Act was passed? What was the purpose of this amendment?

15. What was the "Dalkon-Shield?" Is it a drug? a food? a medical device? what was it about this product that caused problems? Which amendment to the Food, Drug and Cosmetic Act was passed following the Dalkon-Shield Disaster? What was the point of that amendment?

16. What are the long term effects of ramelteon? What do you mean we don't know? Why don't we know? Didn't the clinical trials do long-term studies? Hmm... interesting.. don't you think? You'll be dispensing this drug one day.

17. Make sure you read the assigned articles carefully and answer the homework questions.

Lectures 9 and 10: Chapter 3-Powers and Responsibilities of Government

After this lecture, you should be able to answer the following:

1. What is the "interstate commerce provision" of the U.S. Constitution? How is it connected to Public Health?

2. What is the Medicaid Program? Which level of government administers the program?

3. When the Massacusetts legislature passed a law in 1905 requiring all citizens of the state to be immunized for smallpox, who objected? Using this case as an example, explain how courts play a role in "interpreting" the law.

4. What is the Occupational Safety and Health Act? What government agency was established to set standards regulating an employee's exposures to hazardous substances? How did that governmental agency set standards regarding benzene? What was the response from the petrochemical industry? By the way, what is benzene? What can it do to humans?

5. List some of the activities of "local" health departments. What is the source of funds for these activities?

6. List some of the activities of "State" health departments.

7. What is the difference between a Federal Law and a State Law?

8. What is the Department of Health and Human Services? Is that were the Occupational Safety and Health Administration is housed? No? So, where is OSHA housed within the government? What kinds of agencies and services are housed in the HHS department? Who is the current Secretary of HHS?

9. Who is the Health Commissioner of the State of New York? What position did he hold prior to his present one? http://www.health.state.ny.us/commissioner/bio/. Cool web-site!!

10. Please make sure to do the assigned readings and the homework questions for today’s lecture.

Lectures 7 and 8: Chapter 2- Why is Public Health Controversial?

After these lectures, you should be able to answer the following:

1. Compare Dan Beauchamp’s concepts of “Social Justice” and “Market Justice.” Is Public Health a broad social movement? In what way? What does the "Institute of Medicine" say about this?

2. List some social problems that have started to be considered Public Health problems.

3. What are the three main issues that surface at debates concerning Public Health policies? List examples of each.

4. What is Garret Hardin’s, “The Tragedy of the Commons?” How does it apply to Public Health?

5. What is the Libertarian point-of-view concerning Public Health issues?

6. How far do you believe government should go in advocating and/or enforcing moral behavior?

7. Public Health can lead to controversy on moral grounds. Provide examples that support this statement.

8. Does conscientious objection have a role in Pharmacy? What does the American Pharmacists Association have to say about the issue? How about you? What do you think?

9. Please make sure to do the assigned readings and the homework questions for today’s lecture.

INTERESTING PUBLIC HEALTH STORY ABOUT DRINKING WATER

Dear Students,

Look at what happened yesterday to the drinking water in an Ohio town.

http://www.wtov9.com/news/18621661/detail.html

Public Health in Action!