1. BME 301 Lecture Twenty-Two

3. How are health care technologies managed? Examples: MRI Laparoscopic cholecystectomy Vitamin C treatment for scurvy Research Funding Regulatory Approval ReimbursementDiffusion

4. Review of Last Time Drug and Device Regulation Reaction to Disaster, Tragedy and Misfortune 1906 First federal regulation of drugs Burden on FDA to PROVE it is UNSAFE 1938 Food, Drug and Cosmetic Act Pre-market NOTIFICATION 1962 Drug amendments to FD&C Act Pre-market APPROVAL 1976 Medical Device Amendments to FD&C Act

5. $400-$500 million to develop one drug

6. Recently Approved Devices http://www.accessdata.fda.gov/scripts/cdr h/cfdocs/cfTopic/MDA/mda-list.cfm?list=1 http://www.accessdata.fda.gov/scripts/cdr h/cfdocs/cfTopic/MDA/mda-list.cfm?list=1 NIRflex Stent System http://www.fda.gov/cdrh/mda/docs/p020040. html http://www.fda.gov/cdrh/mda/docs/p020040. html http://www.medinol.com/nirflex.html http://www.fda.gov/cdrh/PDF2/P020040a.pdf http://www.fda.gov/cdrh/PDF2/P020040.html

7. Pancreatic Cancer Pancreas Functions as two separate glands Some cells in gland make pancreatic juice that contains enzymes to break down fats and proteins in food Smaller number of cells in the pancreas are endocrine cells arranged in clusters called islets. Islets make hormones (such as insulin) that help control the amount of sugar in the blood http://www.diabetic.com/children/pancreas.jpg

8. Pancreatic Cancer Incidence: 31,860 people in the US will be found to have pancreatic cancer in 2004 Mortality: 31,270 will die of the disease in 2004 Fourth leading cause of cancer death in men and women Survival: One year survival: 15-20% Five year survival: few percent

9. Detection of Pancreatic Cancer Early detection is difficult: Pancreas is deep inside the body, cannot see or feel tumors during a routine physical exam No blood tests or other tests that can find this cancer early in people without symptoms By the time a person has symptoms, the tumor has often reached a large size and cancer may have spread to other organs Late symptoms: Jaundice Pain Weight Loss Digestive Problems

10. Treating Pancreatic Cancer 3 main types of treatment for cancer of the pancreas: Surgery Radiation therapy Chemotherapy Depending on the stage of the cancer, 2 or even 3 of these types of treatment could be given -- either at the same time or one after the other.

11. New Chemotherapy - Vinblastine Phase I clinical trials: 10 patients One year survival: 5 lived one year with new drug 20% for historical controls Immediate treatment related mortality: 2 patients had short-term fatal drug reaction with Vinblastine

12. New Chemotherapy - Vinblastine Phase II clinical trials: 100 patients One year survival: 45% with new drug Age-matched controls, standard treatment 17% Immediate treatment related mortality: 13% of patients had near-term fatal drug reaction to new drug 2% of patients had near-terms fatal drug reaction to standard treatment

13. New Chemotherapy - Vinblastine Randomized Phase III clinical trials: 300 patients One year survival: 42% with new drug 18% with standard treatment Immediate treatment related mortality: 10% of patients had immediate fatal drug reaction to new drug 1% of patient had immediate fatal reaction to standard treatment

14. FDA Panel Meeting - Vinblastine Cast of Characters: Panel MDs Panel Pharmacologists Pancreatic Cancer Patient Family member of patient who suffered fatal drug reaction in phase III clinical trial Drug company representative FDA Officer

15. Nanoparticle-Laser Robotic Surgery Phase I clinical trials: 10 patients One year survival: 5 lived one year with new surgery 20% for historical controls Immediate treatment related mortality: 1 patient died due to surgical complications with new system

16. Nanoparticle-Laser Robotic Surgery Phase II clinical trials: 100 patients One year survival: 46% with new surgical system Age-matched controls, standard treatment 17% Immediate treatment related mortality: 13% of patients died on the table due to surgical complications with new system 2% of patients had near term fatal drug reaction to standard treatment

17. Nanoparticle-Laser Robotic Surgery Randomized Phase III clinical trials: 300 patients One year survival: 48% with new surgical system 18% with standard treatment Immediate treatment related mortality: 12% of patients died on the table due to surgical complications with new system 2% of patient had immediate fatal reaction to standard treatment

18. FDA Panel Meeting – Nanoparticle Robotic Surgery Cast of Characters: Panel MDs Panel Biomedical Engineers Pancreatic Cancer Patient Family member of patient who suffered fatal complication in phase III clinical trial Medical device company representative FDA Officer

19. Assignments Due Next Time April 29 th : Exam III Practice exam available Saturday May 4 th : Projects Due http://www.utexas.edu/research/rsc/humanresearch/forms/topics.doc Group 3 Presentations May 6 th : Review for final May 18 th : Final Exam 9 am - Noon