Wierd Science At NIH

  • by: |
  • 06/09/2015
The late and great management genius Peter Drucker once observed: "Every organization needs one core competence: innovation."

Now, innovation is NOT invention.  Here's Sir Harold Evans, another very smart person on this issue:  innovation is bringing an invention to use (i.e. commercialising it)...a scientist will have understanding, an inventor will have a solution but an innovator will have a universal solution.
An invention without innovation is a past-time. Essentially, many inventors are hobbyists, since an MIT study has shown that fewer than 10% of patents granted have had any commercial application.

Evans says that few scientists are able to turn ideas into a commercial impact.

Which leads me to the NIH' foolish foray into drug development.  

Innovation is about commercialization.  Commercialization especially today requires something that is in large supply in the private sector and short supply at the NIH:

Experience in commercialization, which includes constantly learning from failure in the development of a product that one hope's will have mass appeal and consumption. 

Further, as a Fast Company article notes:  ln a world of rapid disruption, having a core competency—that is, an intrinsic set of skills required to thrive in certain markets—is an outmoded principle of business. Just as Google needed Android to attack mobile and Apple needed Siri to pursue search, thriving businesses need to constantly evolve, either through partnerships, new talent, acquisitions—or all three. Nike, No. 1 on Fast Company's 2013 list of Most Innovative Companies, proves this idea more than most. Last year, it launched FuelBand, a high-end electronic wristband that tracks your energy output and signaled Nike's growing strength in the digital realm. "Think about it: Nike is now included in conversations around technology—it's shifted into an adjacent industry, breaking out of apparel and into tech, data, and services," says Forrester Research analyst Sarah Rotman Epps. "That strategic shift is incredibly important to Nike's future."

NIH has been throwing little bits of money to keep up with the furious pace of evolution and the rapid shift of life science firms into related industries.  It looks a little desperate but there's no choice because most of what NIH does and spends money on are discoveries and technologies developed outside it's walls.  

Thus, while it was great to see that the NIH and FDA is looking for an entrepreneur in residence (for database analysis), I had to laugh since the idea of an entreprenuer locked inside government regulations and surrounded by people who's job longevity depends on avoidng risk and stifling others has the makings of a great comedy sketch. 

Add to that the fact that entrepreneurs commercialize.. How can you do that when you have little experience scaling up clincal trials with safe and consistent and ample supplies of the materials you need to make something. 

Ask people at the FDA what they think about the ability of NIH bureaucrats and researchers to engage in drug development.  It's a good way to get them to laugh for a change.  

I won't go into the demise of government run vaccine development facilties.  I will mention that even before NIH contaminates samples that it is not very good at deciding what to develop or not.  

Further,  the NIH is horrible at clinical trial recruitment and management.  Just ask cancer patients who on average wait 800 days for NIH sponsored trials to get up and running.  Here's what Vince DiVita, the former head of the NCI said in 2008.  Sadly, it is still relevant today. 

"The requisite talent to know the right way to design and modify an ongoing study does not reside on remote review committees at the NCI or the FDA, yet those are the places where the delays are greatest. Too many cooks are spoiling the broth."

As John LaMattina points out When NIH was asking for funding for the National Center For Advancing Translational Science (NCATS) Dr. Roy Vagelos, the legendary former Merck CEO and now Chairman of the Board of Regeneron Pharmaceuticals.  Testifying before the subcommittee as an adviser to the American Society for Biochemistry and Molecular Biology, he made the following point:

“Does anyone in the audience believe that there is something that NCATS is going to do that the industry thinks is critical and that they are not doing?  That is incredible to think that.  If you believe that you believe in fairies.”

In fact, what NIH has done has pull funding from the Molecular Libraries Program which supported has made a contribution to the  development of drug discovery tools.  These tools have, in the hands of Hugh Rosen, who runs a lab at Scripps, revolutionized drug discovery.  Rosen's work only led to the development of biotech startup  Receptos which has  several drugs under development and as well as the development of a drug to control the cytokine storms that cause sudden death in people with the flu.  So what did NIH do?  It not only rejected future grant requests from MLP participants it pulled the money that would have supported improvements and next generation tools and it put it into the NCATS, the government's drug company.   That's not what entrepreneurs do unless they want to waste money.  As one advisor to the Molecular Library Program noted the kind of spinoff for which Receptos is the poster child is “something that has come from this and is probably going to disappear.”

Think of NIH as a $30 billion business that has strayed from it's core competency: funding outside the box research and ideas and supporting small groups of researchers who contribute to and interact with anyone that seems to be solving key research questions and wants to turn them into products.  The way back is to democratize and de-routinize grant giving and break up the cartel of research centers that rely upon NIH money for overhead.   Craig Venter's suggestion should be taken seriously:

"The academics might not like it, but peer review is like the prisoners running the prison. They're not going to vote for change. Universities like this system because it helps support the universities. We have to change it so that 25%, 30%, 40% of the money is set aside for true risk research with independent parties to do that. That's going to disrupt a lot of things. I argue that the American public should be outraged that there's not 10 times to 100 times more breakthroughs in medicine every year over what we're getting, particularly for the money that's being spent."

Congress is likely to increase NIH funding.  Unfortunately,  the influx of cash will go to waste without the kind of mission change Venter has suggested.  

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog