Class Two/Discuss

From Cyberlaw

1. How do biotech companies, driven by profit, pursue cures or treatments for orphan diseases (diseases or conditions that are found in an unprofitably small number of patients)? (6)

one mustn't make the assumption the orphan drug market is either an end in itself or necessarily unprofitable. A drug may first be entered into (tested for approval in) an orphan market to have a rapid route to market. The next step would be additional phase IIb or phase III testing for the purposes of extending the market and modifying the package insert by improving the summary basis for approval.

--T Forcht Dagi 24.41.1.58 00:14, 15 February 2006 (EST)

2. How do private biotechnology companies manage ethical issues of targeting drug development for controversial patient groups (e.g., a drug aimed at, and tested on, a discrete racial group)? (4)

The ethical problem is not focused on the patient groups, but on the testing. The "management" of the problem (and I am using the term in the most unsophisticated sense, i.e., not as a fundamental issue to be "resolved" but rather one to be "managed") is often relegated to the IRB (institutional review board) charged with approving the study. So long as the study is scientifically valid and statistically sound, IRB approval allows testing on a discrete racial group Italic textso long as the intent is to improve the outcome of using the drug and not to exclude one group or favor or spare another.Italic textThus, choriocarcinoma is far more common in Arab women; G6PD deficiency in Italians; stomach cancer in Hong Kong; sickle cell disease in certain African populations; and Von Hippel Lindau disease in young Scandinavian women. The identification and focus on specific demographic groups would not be considered inherently, or Italic textprima facieItalic text unethical under these circumstances.

--T Forcht Dagi 24.41.1.58 00:23, 15 February 2006 (EST)

3. Cancer and cardiovascular disease are huge segments of disease; what blockbusters has non-pharm biotech actually produced (4)

4. You say that the ethics question is still up for debate -- how would you envision industry playing into setting guidelines or rules, or would you have them stay out? (3)

5. Are BIO and PHARMA as public-minded as they make themselves seem in their overview materials? (3)

6. Are some classes of biotechnological problems on average just more profitable to solve than others (e.g. screening for inhibitors of ligand/receptor interactions), and what if anything is shut out? (3)

7. is the industrial distinction bw pharma and biotech meaningful today -- ignoring FDA's definitions, but thinking, rather about the development of new technoligies? (2)

8. The presentation focused on drugs. How about GM foods? Is it dominated by several major companies like Monsanto, or are there many small burgeoning biotech companies in that field? (2)

9. how does a company like Merck (either pharmaceutical or, foreseeably, biotech) recover from a large-scale incident like Vioxx? (2)

10. This question calls for an opinion...About how much wealth have you amassed through biotech investment? (1)

11. How can Biotech help with the dwindling number of manufacturers producing vaccines. (1)

12. Is there a strategy to protect patents from outside countries, especially developing ones such as Brazil and India?? It seems int'l frameworks, such as WTO TRIPS agreement are not functioning well. (1)

13. SSRI =selective serotonin reuptake inhibitor (for depression) (0)

14. At what point do we allow patients to assume risks – and to focus on informed consent (and the presence of risk and of unknowns) rather than trying to eliminate all safety risks? (0)