Questionable Motives: $132 million NIH organ-on-a-chip push
In... and out. In... and out. Air flows through the narrow channel carved into the small silicon chip, blood pumping, the miniature lung embedded inside breaths: In... and out. In... and out. It is alive.
Tuesday the 24th marked the official start of the first interagency collaboration by the National Center for Advancing Translational Sciences (NCATS), a recently-created division of the National Institutes of Health (NIH). Working in cooperation with DARPA and the FDA, the NCATS announced 17 grant recipients and began dividing up a total of $132 million in funding for research to create “organ-on-a-chip” systems. First announced by President Obama in September of 2011, the program hopes to accelerate the over-decade-long attempt to create biological systems and tissues on silicon chips.
Ignoring for a moment how exciting the research may be, one should take a step back and ask, “Why is the government investing at all, let alone now?”
In... and out. In... and out. A rush of soft chemicals splater the lung. The breathing slows, pushing, determined, deliberate. The climb begins. Start the trial.
The Official Answer:
If you were to ask the NACTS why the push in funding, the ambitious and rather ambiguous answer you receive will look something like this snippet from their website, “to help streamline the therapeutic development pipeline.” As overly simplistic as that response may seem, it makes good sense with the proper context.
Pharmaceutical Companies spend roughly 14 years developing a successful new drug according to NCATS estimates, with the average cost falling between $800 million to $1.3 billion according to studies from 2003 and 2006. If pharmaceutical companies could cut back on that time and money everyone would benefit from lower costs. In the words of NIH director Francis S. Collins, “we know the development pipeline has bottlenecks in it... What we need are entirely novel approaches to translational science, to take full advantage of the deluge of new biomedical discoveries that have been made in recent years."
While scientists have struggled since the late 1990’s to recreate sufficiently complex and functioning human tissues/systems on small silicon chips, recently researchers at Harvard University’s have begun to make that vision reality, successfully recreating bone marrow, a relatively simple kidney, a peristalsing gut, and a lung on chips.
Because much of the 14 years used in drug development is spent proving a drug is safe for use in both preclinical and clinical trial stages, the NCATS hopes that this funding will result in the development of sufficiently complex and cheap organs-on-chips so that pharmaceutical companies can cut back on human testing and replace animal testing altogether by testing for drug side effects on the chips. Long term this would not only lower the cost of medication, but also increase the number of effective drugs on the market.
It is an ingenious plan -- if bit ambitious -- and a good explanation for the funding. But there are two “small” problems with it that should raise more than a few eyebrows:
First, there is no clear reason as to why now -- beyond recent scientific breakthroughs -- but the point of funding is to cause breakthroughs, so that necessarily really add up.
Second, and more importantly, even though the Pharmaceutical Industry stands to gain the most from this research, there does not appear to be a single dime of funding for it, or research like it, coming from the Pharmaceutical Industry. Curious, as roughly 58% of all biotechnology/medical research funding comes from the Pharmaceutical Industry -- as compared to the 33% from government.
In... and out. In... and out. Wheezing gasps. It struggles, weary with use but continues on, higher and higher. It will make it. This one has to work.
The “Unofficial” Answer:
To fill the those questionable gaps in logic, one doesn’t have to look too hard to find a more complete explanation for the NCATS and NIH’s motivation for the funding push. As NIH director Francis Collins rather openly admits in this CQ article, the underlying reason for this research funding is a NIH rebranding effort.
With Congress cutting the budget of many government agencies, the NIH is in campaign mode and trying to rally all the support it can. “It almost seems like it’s not enough to say what we’re about is to improve human health,” Collins told medical research organizations in May. “We also have to justify expenditures coming from the taxpayers in terms of how those will boost our sagging economy.”
Justifying expenditures is exactly what Collins did during his March 28, 2012 presentation to the Senate Labor-HHS-Education Appropriations Subcommittee, claiming that, “[The] NIH serves as the foundation for the entire U.S. medical innovation sector that employs 1 million U.S. citizens, generates $84 billion in wages and salaries, and exports $90 billion in goods and services.” A bold claim, and Collins didn’t stop there. He also went on to try to connect the NIH with the success of Steve Jobs and Apple, quoting the company’s late founder on innovation and biotechnology.
Not to imply that the work that the NIH and NCATS is doing isn’t innovative and important both to improving the public health and the economy, but how well can one really trust them. The NIH only created the NCATS division in 2012, and the NCATS website could not be more loaded with language like “develop innovations” and “catalyze... innovative methods and technologies” peppered throughout their mission statement and background. Add to it the newsletter header, “NCATS Catalyzing Innovation” and it becomes very hard to take any promised research coming from the NIH and NCATS as anything more than a publicity coup. Any organization so concerned with stressing their own innovation seems questionable at best, especially when results remain to be seen.
Organ-on-a-chip technology is very exciting, and to see a $132 million push along with the recent breakthroughs make the tech’s future promising. While the official explanation for the funding is more than reasonable, it is disconcerting to see a lack of private interest from an industry dominated by private funding, and giving leadership to an agency whose founding seems rooted in a PR blitz only makes things worse. The NCATS expects to see returns from the $132 million investment within five years, but I’m not yet sold.
In... and out. In... and out. Breaths are shallow now. Sporadic and flippant the lung gasps, crying out. A silently whisper is exhaled. It breathes no more. It has climbed the mountain. Its job is done. Another failure. On to the next drug.