By: Annette McElhiney
Nearly everyone has heard the term Precision Medicine. However most of us have only a shallow understanding of what precision medicine means. To fully understand, go to the government web site and read the President’s initiative in its entirety by clicking here.
As a second alternative, I will try, as a cancer survivor myself, to point out the relevant points for survivors by using quotes from that text.
President Obama explains, “Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type — that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?”
This initiative is of special importance to cancer patients, especially those with rare cancers like ovarian cancer, pancreatic cancer and brain cancers because of their low survival rate. Up until the last few years, all cancer patients were given cytoxic chemotherapies, which were not designed to kill specific cells, but behaved like a shotgun in damaging many good cells in addition to the bad.
Traditional chemotherapeutic agents act by killing cells that divide rapidly. This means that chemotherapy also harms cells that divide rapidly under normal circumstances: cells in the bone marrow, digestive tract, and hair follicles. Some of us may still suffer from the side effects of having taken those cytoxic drugs (side effects like neuropathy and lasting fatigue even years later).
Precision medicine, on the other hand, builds on the understanding of genomics. It takes into consideration our genes, our heritage, our environments and our individual life styles.
President Obama’s Precision Medicine’s Initiative mission statement is as follows: “To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.” In addition, it will “incorporate many different types of data, from metabolomics (the chemicals in the body at a certain point in time), the micro biome (the collection of microorganisms in or on the body), and data about the patient collected by health care providers and the patients themselves. Success will require that health data is portable that it can be easily shared between providers, researchers, and most importantly, patients and research participants.”
At the same time, privacy and security will be carefully protected. If you are interested specifically in how this will be accomplished, go to the website and read the appropriate sections, please click here.
The section of the initiative I find most pertinent to me as an ovarian cancer survivor is the section is, “Initiative: Data-Driven Treatments as Unique as Your Own Body.” This section includes two wonderful short videos that explain the bonuses of precision medicine. Because sometimes seeing information is simpler than reading it, I have included one video below.
In order to support this initiative, the President has designated $215 million to design and implement it. How is this money distributed? Again I quote directly from the government website precisely how it is allotted, “$130 million to NIH for development of a voluntary national research cohort of a million or more volunteers to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing. $70 million to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment. $10 million to FDA to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health. $5 million to ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.”
The Fact Sheet on the site explains the objectives of the initiative. It goes as follows:
“The potential for precision medicine to improve care and speed the development of new treatments has only just begun to be tapped. Translating initial successes to a larger scale will require a coordinated and sustained national effort. Through collaborative public and private efforts, the Precision Medicine Initiative will leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries. The Initiative will also engage a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based and more precise medical treatment.”
The Objectives of the Precision Medicine Initiative include:
- “More and better treatments for cancer: NCI will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions.”
- “Creation of a voluntary national research cohort: NIH, in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the Initiative and will have the opportunity to contribute diverse sources of data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.”
- “Privacy will be rigorously protected. This ambitious project will leverage existing research and clinical networks and build on innovative research models that enable patients to be active participants and partners. The cohort will be broadly accessible to qualified researchers and will have the potential to inspire scientists from multiple disciplines to join the effort and apply their creative thinking to generate new insights.”
- “Commitment to protecting privacy: To ensure from the start that this Initiative adheres to rigorous privacy protections, the White House will launch a multi-stakeholder process with HHS and other Federal agencies to solicit input from patient groups, bioethicists, privacy, and civil liberties advocates, technologists, and other experts in order to identify and address any legal and technical issues related to the privacy and security of data in the context of precision medicine.”
- “Regulatory modernization: The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework. As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.”
- “Public-private partnerships: The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort. The Administration will call on academic medical centers, researchers, foundations, privacy experts, medical ethicists, and medical product innovators to lay the foundation for this effort, including developing new approaches to patient participation.”
Yet, with this ambitious agenda, one of the problems will be handling the enormous amount of data this initiative will generate. But that is an issue to be explored in another post!