The traditional path to bring new medical therapies from the laboratory bench to the patients' bedside is relatively straight: Test first in cell culture, then in small laboratory animals, next in larger laboratory animals, and finally in humans. However, this process has resulted in a spectacularly high failure rate. Recent studies indicate that less that 10 percent of drugs entering clinical trials receive FDA approval – and that success rate is even lower for chemotherapeutics. Why do so many drugs, particularly chemotherapies, fail in clinical trials?
One significant weakness in the development pipeline is the preclinical data used to determine whether a specific drug warrants a clinical trial. This crucial evidence usually comes from small animal studies – in other words, the mouse. Laboratory mice live extremely well-controlled lives: Their diets and environments are sterilized and standardized. Their light exposure and temperature are carefully regulated. Mice in a study are the same age and are virtually indistinguishable genetically. All of this is intentional – it reduces the number of variables and confounding factors, simplifying data analysis. But does this decades-old system do more harm than good?
A Tribute to Professor Ferenc A. Jolesz (May 21, 1946 – December 31, 2014)
[This blog was adapted from a presentation made by Morry Blumenfeld on June 14, 2019, at the joint meeting of the International Society for Therapeutic Ultrasound (ISTU) and the European Focused Ultrasound Charitable Society (EUFUS) in Barcelona, Spain.]
In June, I was honored to have been invited by EUFUS to present a tribute to my close friend, Professor Ferenc A. Jolesz, who was instrumental in all the subjects that were considered during the recent ISTU/EUFUS meeting in Barcelona. I am privileged to have taken part in the journey that Ferenc and I experienced together in the development of image-guided therapy and focused ultrasound.
In the foreseeable future, our shared vision is that the lives of millions of people around the world will be improved, and the cost of their care will be reduced, as a result of a revolution in therapy created by focused ultrasound – a noninvasive, game-changing, highly disruptive technology that is an alternative or supplement to traditional surgery, radiation, drug therapy, and immunotherapy.
Scale of Focused Ultrasound Technology The revolution in therapy created by focused ultrasound will be of the same magnitude as the revolution in diagnosis created by magnetic resonance (MR) imaging, in terms of impact on health and wellness. And, like MR scanning, it will result in a multibillion-dollar industry.
My Gleason Score, which is used to determine the aggressiveness of prostate cancer;
Risk factors for incontinence and impotence; and
The various treatment options available, including conventional surgery, robotic surgery, radiation therapy, and high-intensity focused ultrasound (HIFU).
Consider this hypothetical example: if I were diagnosed with low-risk prostate cancer (Gleason 3 + 3), I would be eligible to receive focal treatment – as opposed to hemi-ablation or whole-gland ablation. However, my physician would be unlikely to recommend any treatment, invasive or otherwise.
Lung cancer is the most common cancer worldwide and the leading cause of cancer death in both men and women in the United States. The five-year survival rate is only 18.6 percent, and more than half of people with lung cancer die within one year of diagnosis. These devastating statistics bring to light the gravity of the current lung cancer landscape. Despite continued efforts by physicians and scientists around the world to improve the statistics, lung cancer remains almost impossible to cure and difficult to control with the current treatment modalities of surgical resection, chemotherapy, radiation therapy, and immunotherapy.
Complete surgical resection of the primary tumor is currently the only cure for lung cancer, and only in some cases. However, almost 70 percent of cases are deemed inoperable at the time of diagnosis due to advanced stage of the disease. The addition of focused ultrasound as an alternative or complement to current therapies has the potential to improve lung cancer outcomes, especially for those whose tumors are inoperable.