In our oncology focus month, Nathan Nagel and Dr Scott Kahn discuss how the new era of personalized medicine is going to change the lives of cancer patients in years to come.
We are in the early stages of a paradigm change that dictates how cancer patients are treated. Until recently, patient care relied on evidence based observations on how patients with certain clinical presentations responded to cancer therapies. With the maturation of molecular technologies brought upon recently by the genomics and other –omics revolutions, we are now in the earliest stages of the era of personalized medicine.
Personalized medicine promises clinically optimized therapies for each and every cancer patient based on the molecular profiles of their tumors, coupled with individualized pharmacogenetics. In theory, we should have at our disposal, clinical regimens in the form of targeted therapies and more conventional treatments that will provide individual patients with the best chance of defeating their cancers. This 'smart approach' is a long time coming, as it was known decades ago that cancer is a genetic disease, where specific mutated genes drive abnormal growth. When mutations in cellular ras genes were discovered by a number of independent groups, Robert Weinberg and others prematurely declared that we had won the war on cancer. We appreciate the complexity of the cancer cell, and its ability to take advantage of Darwinian changes that enable it to constantly evolve and circumvent therapeutic intervention. Has the cancer cell met its match in the personalized medicine approach?
"Has the cancer cell met its match in the personalized medicine approach?"
We have made enormous progress in the treatment of specific leukemias (e.g. Gleevec for CML), but our track record against solid tumors is disappointing, to say the least (though certain patients do experience remarkable responses). Obviously, we look forward to the next years bringing a deeper understanding of how to improve the targeted killing of cancer cells, as well as the development of novel approaches. But along with scientific hurdles, we need to eliminate artificial hurdles that stand in the way of getting therapies to the bedsides of patients who need them at this moment. While you are reading this article, note that one person dies from cancer every minute in the United States, every eight seconds worldwide. Every day that we remain bogged down in debates that delay our progress getting targeted therapies and diagnostic testing to patients, we lose hundreds of lives. So, what are these artificial boundaries? Not a comprehensive list by any means, but by addressing the following hurdles, we can bring the promise of personalized medicine more quickly to desperate cancer patients.
EDUCATION. We need to educate all stakeholders, patients, clinicians, decision makers in regulatory agencies, reimbursement officials, and politicians to the importance of personalized medicine and targeted therapies, and how to utilize these approaches at the bedsides of patients. We need to educate decision makers on the benefits of personalized medicine in so many areas, cost savings included.
POLITICS. We need to keep progress above politics. The Sequester in the United States is an eyesore on so many levels. The recent decision this year by the CMS, to temporarily interrupt reimbursements for diagnostic testing while parties agree upon fees, has undoubtedly cost lives. We also need to incorporate incentives into Obama-care that will reward molecular profiling approaches that promise to lower expenses over the long term.
PRIVACY ISSUES. We cannot allow privacy issues to interfere with the immediate care required for a late stage cancer patient. We must have in place mechanisms whereby a late stage cancer patient can obtain molecular profiling, and direct that the use of such information be kept private and used only for clinical treatment. Privacy is an important debate, but should not stand in the way of those patients who desperately need and want life-saving treatment.
"Every day that we remain bogged down in debates that delay our progress getting targeted therapies and diagnostic testing to patients, we lose hundreds of lives."
STANDARDIZATION OF PROCEDURES. Regulatory agencies must, proactively, designate standardized procedures for ordering molecular profiling tests, and procedures for how tests are performed. We cannot allow uncertainty to stand in the way of individual cancer patients having such tests performed. And, we need to consider ways for patients to have input on ordering tests, instead of being at the mercy of clinicians who may not want tests performed for reasons other than clinically relevant ones.
FUNDING. We need to keep pressure on federal agencies to maintain funding for personalized medicine. Especially the development of Whole Genome Sequencing / RNA-seq as clinical diagnostic tests.
ADVOCACY. We need to fund patient advocacy groups that are at the forefront of the personalized medicine approach. The groundbreaking experience that they obtain can be used in cancer centers and other patient treatment facilities to improve the hands on implementation of personalized medicine.
By keeping our eye on the prize, and our vision on where personalized medicine can take us, we can retain focus on ensuring that this paradigm change is smartly adapted in a global setting. At the same time, we must also keep true to the science behind the personalized approach to cancer care, constantly adapting so that one day we are able to out-Darwinize cancer cells.
About the authors:
Nathan Nagel Managing Director Oncology Pharma Ltd and LifeScience Ventures Ltd
Dr Scott M. Kahn, Ph.D. Adjunct Associate Research Scientist at Columbia University Member, Herbert Irving Comprehensive Cancer Center Chairman, Biomarkers Council, International Cancer Advocacy Network (ICAN)
Has the cancer cell met its match in the personalized medicine approach?