Genetic Engineering—Secrets of the Rainforest What are the benefits and drawbacks of genetic Engineering? Teacher Guide Complied by Noel Mellon, Mt. Carmel High School, Poway Unified School District Created by Mt. Carmel Biology Teachers Summary of Unit: Using green fluorescent protein, students assume the role of genetic engineers to find, isolate, and purify a possible cancer-curing drug. Students debate the implications of this technology as either cancer patients, FDA, PETA, or a pharmaceutical company. Grade Level: 9-14 Key Terms: • DNA, RNA, Protein (Central Dogma of Molecular Biology) • Genetic Engineering Time Frame: Up to one week

transcription of information from DNA into mRNA. c. Students know how genetic engineering (biotechnology) is used to produce novel biomedical and agricultural products. d. * Students know how basic DNA technology (restriction digestion by endonucleases, gel electrophoresis, ligation, and transformation) is used to construct recombinant DNA molecules. e. * Students know how exogenous DNA can be inserted into bacterial cells to alter their genetic makeup and support expression of new protein products.

Content Standards Addressed: California Science Standards:

Investigation and Experimentation

Cell Biology 1. d. Students know the central dogma of molecular biology outlines the flow of information from transcription of ribonucleic acid (RNA) in the nucleus to translation of proteins on ribosomes in the cytoplasm.

1. Scientific progress is made by asking meaningful questions and conducting careful investigations. As a basis for understanding this concept and addressing the content in the other four strands, students should develop their own questions and perform investigations. Students will:

Genetics

a. Select and use appropriate tools and technology (such as computer-linked probes, spreadsheets, and graphing calculators) to perform tests, collect data, analyze relationships, and display data.

5. The genetic composition of cells can be altered by incorporation of exogenous DNA into the cells. As a basis for understanding this concept: a. Students know the general structures and functions of DNA, RNA, and protein. b. Students know how to apply base-pairing rules to explain precise copying of DNA during semiconservative replication and

b. Identify and communicate sources of unavoidable experimental error. c. Identify possible reasons for inconsistent results, such as sources of error or uncontrolled conditions.

Genetic Engineering—Secrets of the Rainforest What are the benefits and drawbacks of genetic Engineering? Performance Task: Students assume a role as Genetic Engineers to find, =isolate, and purify a possible cancer-curing drug. Learning Plan: Day 1-4: Bio-Rad Explorer Secrets of the Rainforest Kit www.bio-rad.com Life Science Education, Secrets of the Rainforest Schedule for Secrets of the Rainforest Day 1 (suggested Monday): Lesson 1 (reading & answering questions; approx 15 min.) Lesson 2 (streaking plates and answering questions; 30 min) Homework: Assign students their role in Drug Development Assignment and give websites (see handouts). Students will print out articles and highlight important ideas – due Day 3 Day 2: Lesson 3 (picking colonies and answering questions; approx 25 min) Day 3: Collect homework Lesson 4 (centrifuge, lyse bacteria, answer questions; approx 30 min) Day 4: Lesson 5 (release the protein from the bacteria in HIC column—9th graders found this difficult to understand) After purifying the protein, ask students these questions: Should you proceed with continuing to develop and market this drug? Do you think this drug could be profitable? Explain using your research. List the PROs and CONs for continuing the drug research. Summarize why we should proceed or not to proceed. Support your position. Day 5: Complete Drug Development Assignment (approx 40 min)

Genetic Engineering—Secrets of the Rainforest What are the benefits and drawbacks of genetic Engineering? Teacher Instructions: Drug Development Assignment--Getting Product to Market Single Day Lesson Objective: The objective of this lesson is to give the students a brief overview of many of the other factors that might be involved before a product goes to market. Lesson Set Up: 1 Prepare placards for several groupings of students that read: Strongly Agree Somewhat Agree Somewhat Disagree Strongly Disagree (It might be helpful if the cards are printed on different colors) 2 Write sentences on the board as follows: 1. This product should be tested _________(how)____________ . 2. This product should be put to market ___(time frame)_____. 3. This product should cost ___________________________. Or prepare an overhead using the statements on next page—you fill in “?”s. 3.

4.

Assign roles to students. Give students questions and websites for homework, or alternatively, prepare information packets with data for the students to use in class. (Include FDA approval process and testing requirements, include patient advocate group info, biotech company figures and information about PETA concerns). A brief synopsis of group viewpoints is found in Secrets of the Rainforest Lab Manual) After students review information, each group must come up with acceptable numbers/values/means based on their needs. They will be asked to Agree or Disagree as they consider each statement, and tell how strongly by holding up the placards. Each person in each group must be ready to defend their answers and reasons behind it.

5 min: Students decide on reasonable answers with justification using data. 10-15 min

Teacher fills in the blank(or ask one group to) in the first statement starting with the boldest most extreme statement and ask groups to hold up their cards. Ask one or two groups to state their reason as appropriate before changing the answer to continue. When there seems to be a great deal of disagreement stop for a debate on the subject yielding 30 seconds at a time to each group with rebuttals. Try to end each sentence by determining which answer is realistic and brings the most consensus.

35+ min

Repeat process for second and then third statements.

Genetic Engineering—Secrets of the Rainforest What are the benefits and drawbacks of genetic Engineering? Statements: This product should be tested not at all. This product should be tested without giving placebos to stomach cancer patients. This product should be tested using rats with stomach cancer. This product should be tested on larger animals like monkeys. This product should be tested on humans. This product should be tested for treating a very rare disorder. This product should be tested ? This product should be put to market immediately. This product should be put to market in # years? (increase) This product should be put to market never. This product should be put to market if it has large numbers of side effects? This product should be put to market without long term studies on reproduction. This product should be put to market even if results of studies are not strong? This product should be put to market ? This product should cost $ (# values). (change until consensus) This product should cost less in Peru. This product should cost less for Lung Cancer Patients. This product should cost whatever Medicare will cover. This product should cost whatever yields the largest profit to Biotech company. This product should cost ?

Genetic Engineering—Secrets of the Rainforest What are the benefits and drawbacks of genetic Engineering?

CANCER PATIENT http://www.cancer.gov/cancertopics/wyntk/stomach/page1

1. How many people are diagnosed with stomach cancer per year in the U.S.? 2. What is the average age group of those diagnosed? 3. What is the survival rate? (22%) 4. Those diagnosed with stomach cancer can expect to live how long after being diagnosed? During this period of time what will be the quality of life? 5. What are the 3 different treatments & what are some side effects of each? 6. How is stomach cancer detected? 7. What are some of the causes of stomach cancer?

Biotech/Pharmaceutical Company http://www.schoolscience.co.uk/content/4/biology/glaxo/pm1dev1.html

1. What is the approximate cost to develop new drugs? 2. What steps are involved in creating new drugs starting with “target and discovery” and ending with “clinical studies & extensions”? 3. How long does each of the above steps take? How long does the entire process take? 4. Describe the 3 phases of human clinical trials. 5. What information is needed for a company to decide if the drug will be profitable?

Genetic Engineering—Secrets of the Rainforest What are the benefits and drawbacks of genetic Engineering?

FDA http://www.fda.gov/oc/opacom/brochure/fdahealthbro.html http://www.fda.gov/cder/handbook/develop.htm

1. What is the FDA & what do they do? 2. What are the 7 things that the FDA is responsible for regulating? 3. What steps does a biotech company need to pass in order for the FDA to allow the drug to be sold? 4. Explain what’s happening during the Pre-clinical Research, the Clinical Studies, and FDA review. 5. How long (approximately) would it take for each of the steps to be completed? 6. What are FDA “orphan drugs”?

PETA http://www.peta.org/mc/factsheet_display.asp?ID=85

1. What does the acronym “P-E-T-A” stand for? 2. What does PETA believe in? 3. What are 3 alternatives to animal testing? 4. What are the advantages to these alternatives? 5. What does Dr. Bross say about animal testing on cancer vs. human testing on cancer?