7

Question 1

Ethical Issues

Answer 1

● Lack of consent for genetic testing
● Privacy and confidentiality
○ HIPAA is designed to protect us
● Genetic discrimination
● Stigmatization

Question 2

Genetic discrimination

Answer 2

when patients with a known genetic disorder/polymorphism is
treated differently by employers or insurance

Genetic Information Nondiscrimination Act (GINA) protects Americans

Question 3

Stigmatization

Answer 3

this can be when someone is treated differently for a known genetic disorder, predisposition to a genetic disorder, or polymorphism

distinguishing and labelling some feature of a person (religion, disease, skin color)

Question 4

Legal Issues

Answer 4

● Intellectual property
● Ownership of Data/Samples
● Disclosure of Ancillary Information (also ethical)

Question 5

Intellectual Property

Answer 5

Who owns genes?
■ The testing companies did not make the genes, they already existed
■ But they did invent the process of identifying genes
■ Diamond v. Chakrabarty - genetically engineered bacteria was created - SC ruled in favor of patenting the bacteria
■ Courts later ruled against the patent of BRCA genes, including SC - it was decided that HUMAN genes aren’t patentable
● Implication was that FDA later approved indication for a drug specific to a BRCA genotype - would this still have worked if the gene was patented?

Question 6

Disclosure of Ancillary Information (also ethical)

Answer 6

○ If genetic testing is performed and it’s found a patient is at higher risk of a disease they weren’t originally being tested for, should it be communicated to the patient?
■ Decided that it would be a breach of duty to not inform patient of AE risks specific to genotype if patient’s genotype is known
■ Cassidy v SmithKline Beecham (SKB)
● Received lyme disease shot, was paralyzed temporarily due to failure of warning regarding HLA-DR4+ genotype
○ Cross-reaction with immune response lead to autoimmune
responses and paralysis

Question 7

Social Issues

Answer 7

● Certain genotypes have been linked to certain races/ethnicities
● But how do you even define race and ethnicity
● Opens possibility to bias in treatment, discrimination, stigmatization
● Can introduce racial bias in drug development criteria
● Pharmacist education in matters of pharmacogenetics

Question 8

National Revitalization Act of 1993

Answer 8

include different race/ethnicities in research trials