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The Process Behind Medical Innovations Revealed

by Claire Watry, Terra Linda HS

This week Dr. Art Wallace returns to the Marin Science Seminar to present “Making Medicine Safer with Drugs, Devices, Software & More”. Dr. Wallace is a cardiac anesthesiologist at the San Francisco Veterans Affairs Medical Center (SF VAMC) and the Chief of the Anesthesia Service. He is also a professor of Anesthesiology and Perioperative Care at the University of California, San Francisco. Dr. Wallace provides clinical anesthesia care to patients at the SF VAMC and has a laboratory that works on reducing perioperative risk. He has compiled an impressive list of innovative theories for perioperative cardiac patients. Dr. Wallace will explain the process of developing a new drug, device, or software and answer your burning questions: How is a drug or device developed? How is a new product tested? How is it determined whether the therapy is successful or not?  How do new technology and therapies change medical care? For a sneak peek preview of his presentation, check out part of my interview with Dr. Wallace below. 

What is the process of researching, developing, and implementing a new drug, device, or software?

a. The first step is to identify a problem and then identify the likely etiologic factors (what causes the problem). When we looked at patients having heart attacks around the time of surgery we first did an epidemiologic study to find out how often they died. We then put holter monitors (small portable ECG monitors) on the patients. We found that they had myocardial ischemia (not enough blood supply to the heart muscle).

b. The next step is to test likely therapies. We tested 20 different drugs to find ones that would prevent myocardial ischemia. We found four that worked.

c. The next step is to implement the programs. We implemented programs in our hospital to use those medications. Those programs decreased the mortality of patients about 35%.

d. The next step is to disseminate the program to other hospitals. We helped more than  1000 other hospitals implement the programs and they found similar reductions in mortality.

e. For devices the approaches are similar – 1) Identify a problem. 2) Find possible causes. 3) See if you can create a device to eliminate the problem. 4) Test the device to see  if it reduces or eliminates the problem.

How long does the process typically take?
The development of perioperative cardiac risk reduction takes many years and many billions of dollars. It depends when you start the clock. When did you identify the problem? When did you find a likely solution? When did you prove it works? When did you get others to use it? Science takes a long time. Once you find a therapy, it takes the average doctor 17 years to adopt it.

When asked about what serious health issues he believes can be alleviated by the development of new technology, Dr. Wallace answered that even with new technological advances, prevention is key because “many of the health care problems we face are related to behaviors”. Dr. Wallace cited using birth control and HIV prevention, not smoking, taking illegal drugs, becoming obese or drinking excessively, and exercising regularly as prime examples of how proper education and behavior alterations can dramatically reduce health problems. He maintained that “it is vastly easier and more effective to avoid having a problem than to attempt to fix it” and mentioned computerized reminders to eat reasonably, to avoid drugs, cigarettes, and excessive alcohol, and to exercise as an effective way to avoid having a problem.

Dr. Wallace stressed that even with advanced technology “developing some miracle drug or therapy for a disease is really, really hard. Avoiding getting the disease in the first place is vastly easier and cheaper. Literacy, flush toilets and sewers, washing your hands, chlorine and fluoride in drinking water, refrigerators, pasteurization, electricity, seat belts, and social security did vastly more for people than medicine.”

Learn more about the development of new medical therapies at Making Medicine Safer with Drugs, Devices, Software & More” with Dr. Art Wallace M.D. Ph. D. on Wednesday, October 23rd, 2013, 7:30 – 8:30 pm, Terra Linda High School, San Rafael, Room 207

Claire Watry

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