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21 Cards in this Set
- Front
- Back
- 3rd side (hint)
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What are some examples where ethics were called into question?
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Nazi medical war crimes
Radiation experiments (1940s-60s US) Willowbrook Study 1963-1966 Tuskegee Syphilis study 1930s-72 |
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What was the Tuskegee syphilis trials?
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Conducted on african american males
about 400 with syphilis, 200 control men never informed about penicillin as effective treatment no informed consent |
prompted the national research act of 1974
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what did the national research act of 1974 do?
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Create the National Commission for the protection of human subjects of biomedical and behavioral research
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created conduct guidelines
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What was the belmont report?
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In 1974 set up ethical principles:
Respect for persons Beneficence Justice |
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What is the criteria for "ethical" research?
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Social Value, Scientific Validity, Fair subject Selection, Risk/Benefit Balance, Independent Review, Protection of Human Subjects, Set Up IRB
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What is the IRB responsible for?
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Review research to ensure benefits outweigh risks; develop & issue written procedures; review research for proper protection of subjects; issue written notice of approval/disapproval to investigator; review & respond to protocol changes submitted by investigator
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NSABP trials of 1994
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Falsified procedure dates and hormone receptor status by a physician
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Informed Consent
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-View as ongoing process, not one time event
-Respect for patient/subject autonomy, values, preferences, decisions -Patient has right to withdraw and be updated with new information |
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What is intellectual property?
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-Product of the brain which can be owned
-70-80% of any given drug company's value |
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What are the types of intellectual property?
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-Patents(protect ideas)
-Copyrights (provide author the right to reproduce, display, perform) -Trade Secrets(Info kept secret that has economic value) |
-Trademarks(distinctive sign or indicator used to identify products or services to consumers)
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What is a patent?
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-"contract" between inventor & govt
-grant of property right to inventor -prevents invention from others during duration of patent -in return, inventor must fully disclose details of invention to the public -limited monopoly awarded by govt for sharing invention with the public |
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Paten Theory
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-Inventor discloses details FULLY
-govt allows monopoly for LIMITED TIME *20 years from filing date *14 years from issuance |
-Inventor doesn't have guarantee (3rd party's dominating patent may exist)
-Grant owner exclusive rights to make, sell, use, import... -Does not confer the right to use (subject to other national laws) |
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Patentability Tests
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-Useful, novel, not obvious
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So what is NOT patentable?
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-Laws of nature
-physical phenomenon -abstract ideas -algorithms -inventions offensive to public morality |
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How do you get a patent?
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-Patent examination
-Full disclosure -Operability -Distinguish "state of the art" |
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Benefits of a patent to society include:
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-Promote innovation
-Disseminate knowledge earlier & publicly -Provide incentives for risky research & development activities for novel & useful products |
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What happens when a drug goes off patent?
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Generics!!!
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When a patent nears expiration, other drug companies can apply to the FDA to sell a generic version
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Hatch Waxman Act (1984)
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Simplified the approval process for generics, created ANDA (abbreviated new drug application)
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-Started the generic drug industry
-FDA Orange Book -Have to prove Bioequivalence -Can manufacture before patent runs out but not sell |
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What is the Orange Book?
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Don't you wish you knew?
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It has all new patent-protected drugs since Hatch-Waxman listed
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Infringement Lawsuits
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-Legal fees for each side $5-20 million
-Patent holder runs risk of losing the patent -If you win, "reasonable royalty" damages and "lost profits" damages, injuction |
-Triple damages if found willful infringement
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Why are lab notebooks important?
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-Initial record of innovation
-Establish date of invention -determine actual inventorship |
Today, it's all about who files first
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