Bio & Life Sciences Healthcare Opinion

Obama’s Not-So-Daring Precision Medicine Plan


President Barack Obama delivers the State of the Union address in the House Chamber at the U.S. Capitol, Jan. 20, 2015. (Official White House Photo by Pete Souza)

For all the attention that President Obama’s precision medicine initiative has garnered in the weeks since he first mentioned it in his State of the Union address, you’d think the program was the next version of the Human Genome Project. But unlike that effort, which was a wildly audacious push to revolutionize biology and medicine, the modest new initiative—and its $215 million price tag—seems downright underwhelming. For an area of medicine that promises to be critical in delivering better healthcare to patients, the plan should have been bigger and more ambitious.

To be clear: Obama’s plan is better than nothing. As a staunch supporter of precision medicine, I am thrilled to see any kind of national attention and funding for this field. But the plan put forth seems lackluster, particularly coming from NIH Director Francis Collins, who has proven himself more than capable of conceiving, and executing, big challenges.

As proposed, the initiative breaks down this way: $130 million for a U.S. research effort to study the biomedical data of 1 million volunteers; $70 million to pinpoint genetic mechanisms leading to cancer; $10 million to develop new FDA review procedures for personalized medicine; and $5 million to sync important IT systems so they can talk to each other.

Let’s start with the cancer funding. The National Cancer Institute, which would be responsible for distributing this $70 million, had a 2014 budget of $4.9 billion—yes, billion with a B. To put it in context, $70 million is slightly more than the institute spent on liver cancer research in 2013, and less than a third of what it spent on colorectal cancer research that year. I’m sure scientists who get money from NCI will appreciate the extra 1.5 percent of funding, but is it really the level needed to support an entirely new paradigm of medicine?

Next, the million-volunteer study. A decade ago, this concept would have been truly game-changing. Today, a few existing studies are already up and running, well into their recruitment of a targeted million participants: the Resilience Project and Million Veteran Program are two examples. Lower the threshold to studies targeting 100,000 people and there are many such projects around the world.

Given the fairly modest target of $130 million for this part of the program, Obama’s plan wisely takes advantage of those existing projects: the idea is to pull together many large databases into one mega resource, rather than building a completely new one. The $5 million for IT is a key factor here, and it’s where the allocation could have been smarter. Thanks to federal and philanthropic funding in the past decade, we have a population database bonanza right now. DNA information for thousands of autism patients? Check. Genetic studies of thousands of breast cancer patients, hundreds of Alzheimer’s patients, thousands of newborns? Check, check, check. The challenge is that every database is purpose-built for each research study, with each scientist including different information and formatting it his own way.

Any scientist looking for information across these various databases has to query them, one at a time, and hope the resulting data will have enough metrics in common to make for a useful comparison. For someone who wants to connect these databases so a single query could look at all of this data in one shot, the current setup is a nightmare. (Imagine if internet search providers could only access certain sections of the Web; you’d have to enter “funny kitten video” repeatedly into Google, Yahoo!, and Bing in the hopes that one of those engines was connected to the part of the internet where the data was located.)

In the research community, this is a widely acknowledged problem—and it will take a lot more than $5 million to fix. For the important biomedical findings that might be available from data we already have but just can’t search properly, it would have been well worth spending the entire initiative’s budget on making existing databases interoperable, and on requiring data format standards for all federally funded DNA databases in the future.

Finally, a moment to mourn the paltry $10 million for the creation of new regulatory channels dealing with personalized medicine at the FDA. This is mission critical if precision medicine is ever to be more than a dream, and the FDA, like most regulatory agencies, moves at a glacial pace. No matter how many research breakthroughs we have, no matter how many new precision therapeutics are developed, none of it matters if the FDA doesn’t have the resources to figure out a review framework that makes sense for these new drugs.

The precision medicine vision is a beautiful one. For all the health benefits it promises to each and every one of us, implementing it should be a billion-dollar idea. Sadly, this new initiative feels like a dream that was shrunk to an unduly diminutive size. Maybe that was just to make it more likely to get through Congress without much debate.

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