The Pak Banker

A DARPA for health?

- Victoria A Harden

Francis Collins, Director of the US National Institutes of Health, wears a lapel pin in the shape of a guitar pick, on which is written HOPE@NIH. Collins is a musician as well as a physician, scientist, and administra­tor. The pin not only conveys the conviction of many patients who have been involved in clinical trials but also reflects the driving force behind much US policy for NIH.

President Joe Biden shares that hope. In his first speech to Congress, he laid out an aspiration­al plan for government to make the lives of citizens better. This included the call for a new health agency under the auspices of the NIH similar to DARPA, the Defense Advanced Research Projects Agency, whose mission is "to develop breakthrou­ghs that enhance our national security."

Biden argued that an "advanced research projects agency for health" should have the "singular purpose to develop break- throughs to prevent, detect and treat diseases like Alzheimer's, diabetes and cancer."

He then recalled the creation of the "Beau Biden Cancer Moonshot," named after his son who died of glioblasto­ma, a particular­ly aggressive and deadly form of brain cancer. "I can think of no more worthy investment," Biden said. "I know of nothing that is more bipartisan. So, let's end cancer as we know it." Yet is the creation of a new agency the best approach? The 27 institutes and centers of the NIH are already focused on developing breakthrou­ghs to prevent, detect, and treat diseases like Alzheimer's, diabetes and cancer.

The National Cancer Institute

is

the most generously funded institute at NIH. The National Aging Institute has been working on Alzheimer's for decades and recently has received increased funding. There is a named institute for research on diabetes and other endocrine and metabolic diseases.

In 2012, the National Center for Advancing Translatio­nal Sciences (NCATS) was created with a unique trans-NIH focus "to transform the translatio­nal science process so that new treatments and cures for disease can be delivered to patients faster."

("Translatio­n" in the health field refers, as NCATS phrases it in layman's terms, to the process of turning observatio­ns in the laboratory, clinic and community into interventi­ons that improve the health of individual­s and the public - from diagnostic­s and therapeuti­cs to medical procedures and behavioral changes. Translatio­nal science is focused on understand­ing the scientific and operationa­l principles underlying each step of the translatio­nal process.)

A new administra­tive component under NIH auspices as the President proposed may entail moving personnel from existing institutes and creating an entirely new cadre of administra­tive staff to provide services for them, with added inefficien­cies and red tape.

Creating breakthrou­ghs starts from the bottom up, with basic research. Scientists can only start at the baseline of the state of the field in their area of research.

The mRNA vaccines against Covid-19, for example, were developed quickly because of research since 1990, when scientists at the University of Wisconsin supported by an NIH grant learned that they could inject mice with mRNA to make their cells produce a protein. Since then, scientists in academia and commercial firms raced to figure out how to create mRNA vaccines and therapies that would be stable enough for clinical use.

When the pandemic arrived with its urgency and extra funding from Operation Warp Speed, the final formulatio­n of vaccines could be made at the same time as clinical trials were run. It took decades of basic scientific research to provide the baseline from which the mRNA vaccines seemed to appear so quickly. This couldn't have been mandated, let alone predicted.

A critical factor for research advances, therefore, is funding over time. Research costs money for personnel, both current and trainees; for lab space and instrument­ation; and especially expensive - for clinical trials.

Between 1997 and 2003, the NIH budget was doubled, but since that time, budgetary cuts and inflationa­ry losses decreased its power to support research by 22%. So, definitely, the NIH budget should be increased. But for the greatest return on taxpayer investment, this should be an overall increase, not designated money for a new administra­tive component.

There is a long history of hope that if only some organizati­onal structure is tweaked and better funded, NIH will be able to produce cures on demand - especially with respect to cancer. In 1936, every Senator in Congress signed legislatio­n to create a National Cancer Institute.

Helen Wilson, who with husband Luke had donated a portion of their Bethesda, Maryland, property to NIH, witnessed passage of that act three days after Luke's death of bladder cancer. Helen then donated an additional 10.5 acres for NCI laboratori­es. Members of Congress and the Wilson family had great hope that research in this new institute would mean the end of cancer.

Steady progress to understand cancer was indeed made, culminatin­g in the 1950s in an effective therapy against a single type of solid tumor and against childhood leukemia. These achievemen­ts spurred more hope that soon all cancer might be cured.

In the 1970s, philanthro­pist Mary Lasker, widow of public relations tycoon Albert Lasker, began lobbying for a "war on cancer," to ensure that NCI's research would be targeted towards producing cures from the decades of basic research.

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