The discovery of cures for cancer are rare, but in the last 20 years, we have seen remarkable progress, highlighted by the discovery and development of immune checkpoint blockade therapies. Then, in 2022, the unimaginable happened. Dr. Andrea Cercek, a medical oncologist from Memorial Sloan Kettering Cancer Center, and colleagues reported that the use of immune checkpoint blockade cured 12 patients with a specific type of rectal cancer. Incredible advances like these, from the basic science discoveries that identify potential therapy targets through the clinical studies that apply these findings to patients, are supported by taxpayers via funding from the National Institutes of Health (NIH).
Now, with public opinion of the NIH reeling and the incoming Trump administration promising to reform the sprawling federal government bureaucracy, one of the (many) pressing questions is: How will a Trump presidency impact the NIH? Although the reputations of many have been challenged by attempting to predict what Donald Trump will do, we might garner some insight by looking at his nominee for NIH director, Dr. Jayanta “Jay” Bhattacharya.
Who is Jay Bhattacharya?
Bhattacharya, who was born in Kolkata, India, and emigrated to the U.S. as a child, has a long list of degrees and qualifications that make him a solid choice for NIH director. He earned a medical degree and doctoral degree in economics from Stanford University and holds or has held an assortment of other positions and fellowships at premier institutions. Beyond his credentials, he has an established history of obtaining research funding from the NIH. Prior to gaining national attention for his concerns about the global pandemic response, he and his colleagues sought to broadly understand how factors such as socioeconomic status affect the welfare of different populations, including a highly cited study looking at how nutritional status, poverty, and food security relate to one another. He is a serious scientist with a track record of success. (Disclosure: I advocated for his nomination to Trump’s transition team.)
Like Trump’s choice for commissioner of the Food and Drug Administration, Dr. Marty Makary, Bhattacharya has a tendency to go against the grain but is not, contrary to some characterizations, a fringe pick. He has advocated positions that challenge the dominant bureaucracy and declared his willingness to make changes that improve transparency and restore trust in public health policy. This is best represented by his advocacy for an alternative public policy approach to COVID as detailed in the Great Barrington Declaration. Despite being based on sound scientific evidence that COVID mortality was dramatically different between old and young and that nonlethal infection produces strong immunity, Bhattacharya’s advocacy for a “compassionate approach that balances COVID risks and collateral damage to public health” (aka the successful Swedish model) drew public and private criticism from several major governmental public health bureaucracies in the U.S.—including top NIH officials—and abroad. Indeed, Bhattacharya’s position on the public health approach to COVID remains a topic of intense debate, particularly as increasing data supports Bhattacharya’s position, including evidence of the negative effects lockdowns have had on the health, psychological well-being, and learning in children. Ultimately, he was willing to advocate for policies that many scientists, physicians, and public health experts agreed with, or at least thought should be up for scientific debate, at a time when those speaking up risked public censure.
Further, Bhattacharya says he seeks to improve transparency and restore public trust in the NIH. During the peak of the pandemic, several difficult decisions had to be made in regard to what information to share with the public, including the known versus predicted efficacy of various interventions. In many instances, the U.S. public health bureaucracy, including the directors of the NIH, chose a “noble lie” approach such as the changing policy on surgical mask use that has had a negative impact on public trust. As discussed below, there are several reforms that Bhattacharya could, and should, implement that would begin to mend some of the trust lost.
What Bhattacharya could prioritize.
Improve NIH transparency and congressional oversight: Regardless of which political party is in power, Congress determines the amount of money allocated to a federal agency and how it can be spent. This oversight is especially important for the NIH, as approximately 80 percent of the $41 billion NIH budget is spent for activities performed by nongovernmental (extramural) entities such as public universities and nonprofit medical centers.
Bhattacharya could support Congress in its oversight duties by improving the responsiveness of both his office and the offices of individual NIH institutes and centers to Senate and House subcommittee requests for information and testimony. As reported previously, the NIH has for years stonewalled legitimate congressional investigations into serious issues, such as the NIH funding of dangerous or illegitimate research, some of which occurred well before the first Trump administration and the COVID pandemic.
Under Bhattacharya, it’s likely that the inner workings of the NIH will become more transparent to the general public and the leaders within the NIH will be more responsive to congressional oversight. Perhaps such changes will begin to make the NIH worthy of the public’s trust again, in accordance with one of Bhattacharya’s stated goals.
Oversee and implement NIH reforms directed by Congress and the White House: The possibilities discussed above likely do not require legislative action. However, there have been calls in Congress to reform the NIH, something that has not happened in nearly 20 years. The nature of these proposed structural and policy reforms, as well as their pros and cons, has been discussed in detail previously. However, if Congress were to pass a much-needed reform bill, Bhattacharya would serve an important role in implementing those reforms. Because such a process would be complex and Congress likely would not specify exact details, it would fall to Bhattacharya to define and implement more specific reforms.
The White House, through the Office of Science Technology & Policy (OSTP), recently released its policy on public funding for research on pathogens with enhanced pandemic potential, also known as gain-of-function research of concern, which leaves open the possibility of future research that could lead to a public health crisis or compromise our national security. Given the skepticism of the past Trump administration and other allies on such risky research, it is possible that the Trump OSTP will enforce a policy that aims to restrict risky research, and it would fall in part to Bhattacharya and the NIH to define and establish standards for lab security and oversight of the funding given to such research. Interestingly, there appears to be bipartisan support in Congress for federal oversight of risky research, such as a new bill from Sen. Rand Paul of Kentucky that would create an independent agency to evaluate, and potentially restrict, high-risk biomedical science research.
Changes to internal NIH processes and priorities: There are numerous changes, some more controversial than others, that Bhattacharya could make within the NIH itself that would not require congressional approval. For instance, Bhattacharya has discussed wanting to restructure the leadership hierarchy and power dynamics within the various institutes and centers. He could eliminate the NIH’s Office of Equity, Diversity, and Inclusion and other DEI initiatives (such as the NIH FIRST program), responsible for hundreds of millions of dollars of spending on controversial grants and programs. Bhattacharya would not have the authority to lay off most of the employees who work in these positions, but the money that would be freed up for other innovative research priorities by eliminating these extramural funding programs would be substantial.
An additional, and potentially controversial, change would be to decrease the level of research funding that investigators currently working at the NIH receive. The NIH currently spends 21 percent of its annual budget, approximately $10 billion, at the NIH itself with half of that money funding intramural research. On one hand, this research spending comes under much less scrutiny than the funding subject to the rigorous and competitive review process for outside research. On the other hand, much of this funding allows the NIH to perform some of the most important and difficult clinical trials in the world. The NIH often performs trials with and treats patients who have otherwise exhausted all other treatment options. Along with better transparency and oversight of this spending, Bhattacharya might seek to reduce spending waste or introduce a competitive evaluation process for internal research funding while maintaining the funds needed to support the important work the NIH Clinical Center performs.
Expand funding for innovative research: One of the funding entities created by the 2006 NIH reforms provided funds to the NIH director for so-called “high-risk, high-reward” research. Given Bhattacharya’s reported desire to increase NIH funding of biomedical innovation, expanded congressional funding for this purpose seems likely. But are there changes that Bhattacharya can make to increase funding and support of innovative and creative research that do not require congressional approval? More than likely, yes. Bhattacharya could require the NIH’s institute and center directors to allocate more of their annual budgets to “investigator” grants, drawing from conventional project-based grants.
The major criticism of existing project-based mechanisms is that they are overly conservative and reward incremental research, often relying on the investigator to demonstrate feasibility through extensive “preliminary data,” which in practice means much of the proposed work is completed before a grant is awarded. Investigator grants, exemplified by the NIH director’s New Innovator Award (disclosure: I am a recipient), focus more on the novelty and potential impact of the proposed project. Investigator grants can free up the researcher to explore exciting and often unexpected lines of investigation and provide funding for scientists who focus on developing novel technologies, such as approaches for imaging metabolism in humans or methods of altering genetic interactions to better understand tissue regeneration, instead of conducting conventional hypothesis-based research that is better served by project-based grants.
Traditional project-based grants can still contribute to important discoveries and innovation despite the bias in funding towards less-risky proposals. Given their long track record of successes, such grants should remain a dominant component of the NIH portfolio alongside any new programs established by Bhattacharya.
A good choice to lead the NIH.
For the U.S.’s biomedical research enterprise to continue to make groundbreaking discoveries and life-saving treatments such as the rectal cancer cure mentioned above, the NIH needs to have the support of the public. To ensure sustained support, the public’s trust in the NIH must also be restored. On top of Bhattacharya’s excellent academic credentials, his training in economics could be a benefit in helping the NIH stretch limited taxpayer dollars to stimulate and support creativity and innovation. He also has the character and potential to make the necessary changes that would help renew trust in the NIH. However, in his drive to reform the NIH and re-establish public trust, he must be careful not to overreach in a way that causes further disillusion in an already disillusioned biomedical science community.
As recently noted by Dr. Marcia McNutt, the president of the U.S. National Academy of Sciences, the U.S. is starting to cede ground as the global scientific leader to other countries, especially China. Bhattacharya has the opportunity to contribute to the creation of what McNutt calls a national research strategy and ensure U.S. supremacy. Although the default position of many biomedical scientists and physicians is to resist and criticize Trump’s nominees, Bhattacharya’s selection to lead NIH should be welcomed.
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