BME 301

Lecture Twenty-Two

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

$400-$500 million to develop one drug

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

.pdf

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