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Tag: Precision Medicine Initiative

The Mischief and the Good In Precision Medicine

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When The White House announced their Precision Medicine Initiative last year, they referred to precision medicine as “a new era of medicine,” signaling a shift in focus from a “one-size-fits-all-approach” to individualized care based on the specific characteristics that distinguish one patient from another. While there continues to be immense excitement about its game-changing impact in terms of early diagnoses and targeting specific treatment options, the advancements in technology, which underlie this approach, may not always yield the best medical results. In some cases, low cost approaches, based on sound clinical judgment, are still the better option.

For example, tuberculosis (TB) is an infectious disease that continues to pose global burden with 9.6 million new cases and 1.5 million deaths reported in 2014 alone. The large toll is partly due to lack of effective treatments (particularly for drug-resistant cases) but also due to delays in diagnosis. One might think that precision medicine technology leading to improved diagnosis would be effective at minimizing the related death toll but we shouldn’t automatically assume that. It turns out that sometimes the latest technological advancements can be so sensitive that we detect organisms that are not causing disease.

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Cancer and Moonshot Economics

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The Obama Administration’s cancer “moonshot” initiative, announced in January and now being debated in Congress, comes at a time of significant advances in cancer treatment and a spurt of cultural attention to the disease.

A batch of new immunotherapy drugs approved in the last few years, such as Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda, are being widely touted as breakthrough medicines—and aggressively advertised to both doctors and the public.  Jimmy Carter’s unexpected remission from melanoma that had spread to his liver and brain is attributed to Keytruda.

At the same time, a cancer memoir (When Breath Becomes Air by Dr. Paul Kalanithi) tops The New York Times nonfiction best-seller list.  The Death of Cancer by Dr. Vincent DeVita, a former director of the National Cancer Institute, has also garnered positive reviews and wide attention for its critical assessment of today’s cancer research establishment.

Before these two books, John Green’s 2012 novel The Fault in Our Stars—the touching story of two teens with cancer—was widely acclaimed and read, especially after it was made into a blockbuster movie in 2014.

The administration’s initiative comes at a significant time for me personally, too.  My brother, 70, was diagnosed with stage IV lung cancer 10 months ago.  Unlike Jimmy Carter, one of the new immunotherapy drugs (Opdivo) did not defeat his cancer.  He continues to fight for his life.  As with so many families, cancer has stalked ours.  My sister died of colon cancer in 2006, age 54.  My mother died of lung cancer in 1985, at 65.  Like anyone over age 60, I’ve seen friends suffer and succumb, their lives cut short.  And I’ve battled two cancers myself, melanoma (localized) and a salivary gland tumor.

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Precision Medicine’s First Real Patient: The National Health IT System

Niam YaraghiIn his 2015 State of the Union address President Obama announced the launch of his precision medicine initiative, an audacious initiative to address these issues. In a nutshell, precision medicine customizes health care; That is, medical decisions are tailored based on the individual characteristics of the patients, ranging from their genes to their lifestyle. To have a clear understanding of the relationship between individual characteristics of patients and medical outcomes, it is necessary to collect various types of data from a large population of individuals. The precision medicine initiative requires a longitudinal cohort of one million individuals to provide researchers with various data types including DNA, behavioral data, and electronic health records. Assembling such a large sample of many different data types proposes two unique challenges pertaining to healthcare information technology: interoperability and privacy.

The federal government has already spent $28 billion to incent medical providers to adopt electronic health record (EHR) systems. As a result, almost all of the medical providers in the United States currently compile an electronic archive of their patients’ medical records. However, most of the EHR systems are not able to exchange information with each other. This is a strange problem in the age of information technology and Internet connectivity. There are a variety of technical and economic reasons, which make it especially complicated and difficult to solve.

Given the current lack of interoperability between EHR systems, it seems highly unlikely to be able to obtain a complete medical history of one million Americans. To succeed, the precision medicine initiative has to either overcome the lack of interoperability problem in the nation’s health IT system or to find a way around it. Congress members in both the House and Senate are considering new rules that would stop EHR vendors from interfering with medical providers that had already started transferring records. These efforts are fraught with difficulty and will take a very long time to produce tangible results.Continue reading…

Good News: NIH Discovers Data Scientists and The Private Sector

Shaywitz 2.oLate last month, President Obama unveiled a $215 million Precision Medicine initiative, which has won early bipartisan support. The centerpiece of this proposal is an ambitious effort to integrate disparate clinical datasets to advance science and improve health.  The question now is whether the National Institute of Health officials entrusted to carry out this program will seize this opportunity to leverage the thinking and experiences of the entrepreneurs, engineers, and data scientists from the private sector who have been wrestling these sorts of challenges to the ground.  The early indications are encouraging.

(Disclosure/reminder: I work at a cloud-enabled genomic data management company in Mountain View, California.)

Data is the organizing principle of Silicon Valley; the landscape is dotted with companies – from behemoths like FacebookGoogle GOOGL -0.99%, Salesforce, and Palantir to younger entrants like ours – devoted to collecting, analyzing, and collaborating around huge amounts of data, often enabled by cloud computing.

The same engineers who gave us photo sharing, Angry Birds, and smart thermostats are increasingly bringing their talents to healthcare, trying to enable health data sharing, motivate healthy behaviors, and empower elders living at home alone.

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