Chapter 13–Molecular Biotechnology & Society Development of guidelines for recombinant DNA research Deliberate release of genetically modified microorganisms Regulation of genetically modified foods Societal concerns about genetically modified foods Regulation and safety of medical products of biotechnology Patenting biotechnology Ethical principles Let’s discuss some case studies

Regulations-note that the product, not the process, is evaluated for safety IBC (Institutional Biosafety Committee)-regulates all recombinant DNA experiments NIH (National Institutes of Health)-regulates human gene therapy research EPA (Environmental Protection Agency)-regulates all microbial pesticides (including genetically engineered ones), genetically engineered organisms for pest and pollution control USDA (United States Department of Agriculture)-regulates genetically engineered organisms released into the environment for agricultural purposes FDA (Food and Drug Administration)-regulates all foods and drugs produced using recombinant DNA technology

Some GMO controversies Ice-minus bacteria GM plants (Bt, Roundup Ready, virus resistance) Bt plants and the monarch butterfly (see http://cls.casa.colostate.edu/TransgenicCrops/hotmonarch.html) Bt gene from StarLink corn found in taco shells Roundup Ready turf grass for golf courses Flavr savr tomato “Golden rice” Transgenic fish overexpressing growth hormone genes Use of rBST to increase milk production Labeling of GM foods (US vs. Europe) A Quick Recipe for "Frankenfood" Frenzy Combine lots of emotionally-charged doomsday rhetoric with a good amount of anti-capitalist sentiment.  Add just a pinch of scientific uncertainty about safety and you've created enough "Frankenfood" Frenzy to serve the world.  Caution: This dish can be ruined if contaminated  by facts about the health or environmental benefits of genetically modified foods.

Deliberate release of GMOs Ice-minus Pseudomonas syringae-a naturally occurring mutant form of this bacteria lowers the freezing temperature of plants since it lacks the ice nucleation (crystallization) protein Open field tests of other GMOs including GE plants (>6,000), fish, and animals Frostban being sprayed onto strawberry plants in a 1987 field trial in California.

Table 13.1 Regulation of genetically modified foods

Table 13.2 It costs ~$35 million to bring a transgenic plant to market.

Table 13.3 Societal concerns about genetically modified foods

Table 13.4

Table 13.5

Table 13.6

Table 13.7

Figure 13.1 Labeling of genetically modified food is a contentious issue. On July 29, 2016, President Barack Obama signed a bill into law requiring the labeling of food containing genetically modified ingredients, following a drawn-out battle between the food industry and pro-labeling groups on the issue. See: https://modernfarmer.com/2016/08/gmo-labeling-law/

Table 13.8 Regulation and safety of medical products of biotechnology

Table 13.9

Table 13.10 It costs ~$4-11 billion to bring a drug to market.

Summary of clinical trial phases Primary goal Dose Patient monitor Typical number of participants Success rate[2] Notes Preclinical Testing of drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information unrestricted scientific researcher not applicable (in vitro and in vivo only) Phase 0 Pharmacokinetics; particularly, oral bioavailability and half-life of the drug very small, subtherapeutic clinical researcher 10 people often skipped for phase I Phase I Testing of drug on healthy volunteers for dose-ranging often subtherapeutic, but with ascending doses 20–100 normal healthy volunteers (or for cancer drugs, cancer patients) approximately 70% determines whether drug is safe to check for efficacy Phase II Testing of drug on patients to assess efficacy and side effects therapeutic dose 100–300 patients with specific diseases approximately 33% determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever Phase III Testing of drug on patients to assess efficacy, effectiveness and safety clinical researcher and personal physician 300–3,000 patients with specific diseases 25–30% determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect Phase IV Postmarketing surveillance – watching drug use in public personal physician anyone seeking treatment from their physician N/A watch drug's long-term effects

Table 13.11

Patents Patents are legal documents which give the owner exclusive rights to market a product or invention and thereby earn substantial profits Patents encourage companies to take greater risks and invest more funds into research and development Three criteria for patentability: the invention, which can be a product or a process, must be 1) new, 2) useful, and 3) nonobvious to one skilled in the field In the US, patents end 20 years after the patent application is filed The US Supreme Court ruled that “anything under the sun that is made by man” is patentable; this includes GMOs

Table 13.12 Patenting biotechnology

Ethics Major Ethical Principles 1. Do no harm (nonmaleficence) 2. Do good (beneficence) 3. Do not violate individual freedom (autonomy) 4. Be fair (justice)

Ethics Secondary Ethical Principles 1. Tell the truth (truthtelling) 2. Keep your promise (fidelity and promise keeping) 3. Respect confidences (confidentiality) 4. Use the principle of proportionality; risk-benefit ratio (how much harm can be justifiably risked to effect good) 5. Attempt to avoid undesirable exceptions, also known as the wedge principle, the slippery slope or the camel’s nose

Ethics Although these rules are simple, they represent fundamental values associated with respect for human dignity that most people agree to. These are the principles to which one should refer when making and justifying ethical decisions. Let’s look at and discuss some case studies, as you will see it is not usually simple and straightforward.

Links to Additional Bioethics Case Studies http://www.biotech.iastate.edu/bioethics-case-studies/ http://sciencecases.lib.buffalo.edu/cs/collection/results.asp?subject_headings=Biotechnology http://cls.casa.colostate.edu/transgeniccrops/index.html https://www.beep.ac.uk/content/1.0.html