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How are health care technologies managed?
Examples:
MRI
Laparoscopic cholecystectomy
Vitamin C treatment for scurvy
ResearchFunding
RegulatoryApproval
Reimbursement Diffusion
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
Recently Approved Devices
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1
NIRflex Stent System http://www.fda.gov/cdrh/mda/docs/p020
040.html
http://www.medinol.com/nirflex.html http://www.fda.gov/cdrh/PDF2/P020040a
http://www.fda.gov/cdrh/PDF2/P020040.html
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
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
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
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.
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
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
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
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
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
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
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
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
Assignments Due Next Time April 29th:
Exam III Practice exam available Saturday
May 4th: Projects Due http://www.utexas.edu/research/rsc/humanresearch/forms/top
ics.doc
Group 3 Presentations May 6th:
Review for final May 18th:
Final Exam 9 am - Noon