This article originally appeared in Orthopedics This Month: SPINE and on ryortho.com.
The National Institutes of Health (NIH) is the nation’s primary funder of academic medical research. Our taxpayer dollars fund the agency, and the returns have been nothing short of transformational.
For example, of the more than 350 drugs approved by the FDA for use in humans, each one was discovered or invented by academic centers with NIH funding. Just to provide a reference point for the economic return for this underlying research, one of these drugs, Eliquis, has yearly sales in excess of $16 billion.
Another project, the Human Genome Project, has been thoroughly analyzed and the return on this investment has been calculated to be 21,000 percent.
The NIH is an economic powerhouse, and vital to the future health and financial well-being of our country. And it is medicine for our economy by protecting against medical disability which brings with it both lost productivity and the need for social welfare support.
The money funded to NIH is not a cost. It is, in every sense of the word, an out-performing ultra-high-yield investment. Beyond economics, the value of healthier, happier, more productive, and longer lives is incalculable.
Knowledge, Technology and Innovation as a Strategic Asset
Our country can no longer compete in the global economy on the price of labor. The average wage of U.S. auto workers is $28 per hour, while in other countries, it is as low as $1.00 per hour. For the same reason, we cannot compete on the price of goods that are labor-dependent. But where we can and do compete is with knowledge, technology, and innovation.
NIH, like Silicon Valley, is a great American economic engine. The United States was once the world’s leader in research and development and has been richly rewarded for that investment. But today, as a percent of GDP [gross domestic product], federal funding for research is declining, hitting a near all-time low in 2021.
Now policymakers and the public are asking, is it time “to modernize the agency so it is more transparent, nimble, and forward thinking?”
The agency has attempted to be effective stewards of each dollar entrusted to it. To that end, has it become too rigidly possessed of the belief that incremental research, that is, research that builds in a step-like manner upon prior research, is less risky and is a better investment of the taxpayers’ money than bolder, more daring research?
For example, the federal government funded research based on the erroneous belief that a bodily substance CTLA-4 was an Immune System enhancer. In 2018, Jim Allison was awarded the Nobel Prize in Medicine for his work that disproved that and recognized the detrimental effect of this molecule on the immune system’s ability to combat cancers. As an aside, when he applied to NIH for a grant to carry out his work in 1993, that application was denied.
In addition, the evidence is clear that the grantmaking process has failed to sufficiently fund brilliant young scientists, women, and researchers from underrepresented populations. In fact, the average age at which a scientist first receives NIH funding is now 44, the highest it has ever been.
As the amount of knowledge in the world has continued to increase at an ever-increasing rate, the result has been that our present generation of scientists know more and more about less and less. Their expertise, though perhaps exquisite, has become ever narrower.
Changing Funding Focus From Individual Researchers to Convergent Team Research
Could it be time for the NIH to abandon its long-held practice of funding individual investigators in favor of funding convergently focused team research that would foster intra-institutional and inter-institutional collaboration?
Here are some possible solutions:
- Revise grantmaking guidelines to adopt a new, less risk-averse, and more inclusive philosophy to guide decisions, and shift away from funding individual investigators. Be far more inclusive of funding team research.
- Develop a system to provide publicly transparent metrics and analysis to identify and track what algorithms best predict which researchers and experiments should subsequently be funded, as well as the demographics of the funding applicants and recipients.
- Next, whether by Presidential order under the powers provided for by the Bayh-Dole Act, a new act of Congress, or by an agency policy decision, there should be a “most favored nation” provision in every NIH grant that requires that in the licensing of drugs discovered with taxpayers’ dollars, that the purchaser or licensee of that technology can sell those drugs for no more in this country than the least that it chooses to sell those drugs in any of the G7 countries, a so-called “most favored nation provision.” Why should Americans pay five times as much for the drugs that they paid to develop?
The Critical Need for Information Sharing
Further improvements to NIH policy have to do with information sharing.
The results of all federally funded research should be made publicly available through an organized searchable database, much like the system so successfully in operation at the United States Patent and Trademark Office.
At present, purportedly successful research gets published, and the bulk of the research, having failed to prove out the underlying premise, just disappears.
- We should have a system where the results of every experiment, whether successful or not, are readily available in an organized and coherent form so that people can learn from other people’s failures and not repeat them.
- Further, is it time to require that each report of any experiment be “enabling?” That is a patent law concept that requires that a patent be sufficiently enabling such that one of “ordinary skill in the art” can practice the taught invention from the disclosure.
This, combined with a requirement that the underlying data be made available, could go a long way to addressing the problems of the irreproducibility of purportedly successful experiments and research integrity. Having to clearly present exactly how the experiment was performed, along with the resulting data, would lay bare the quality, or shortcomings, of the experiment’s design and allow others of equal skill in the art to derive their own conclusions as to the results.
In fact, armed with the exact “how to” needed to perform an experiment, NIH could save the millions of dollars on incremental research that was later discovered to be based on defective and misleading work, by inexpensively repeating these seminal experiments.
Lastly, the greatest technical breakthrough in all of science is Big Data and the ability to process it to derive meaning. Billions have already been spent converting from analog to digital medical records.
- We should de-identify, that is, to remove any details that would identify individual patients, collect all the remaining medical information, and make it available to all researchers.
These changes would make an already good thing even better still.
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