When Congress meddles in how federal agencies set research priorities and disburse grants, the scientific community is, understandably, distraught. But Congress is responsible for rooting out waste, fraud, and abuse at federal agencies, which sets up a fundamental conflict.
The administration's spending should come under special scrutiny when bureaucrats claim they don't have enough money to protect public health; while complaining of lack of funds, bureaucrats are squandering already allocated funds on research that is the subject of inter-agency squabbles.
In a concerted campaign, administration officials have bashed Congress for failing to provide funds needed to respond to the Zika-virus outbreak. At the National Press Club in May, the director of the Centers for Disease Control, Tom Frieden, issued dire warnings and pleaded for additional money from Congress for Zika-related research. He used words such as "unprecedented" and "extremely urgent." In June, Dr. Anthony Fauci, the usually (and appropriately) apolitical director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, said, "If we don't get the money, it's not [a] question of speed or not, it's a question of whether the [Zika] vaccine effort will be blunted or completely aborted." Also in June, U.S. Surgeon General Vivek Murthy said that federal health agencies are nearing the end of their reserves and need new funds from Congress immediately.
In Orlando in last month, Sylvia Mathews Burwell, the secretary of Health and Human Services, joined in, warning that Congress's failure to give the administration the money it requested could slow down development of a Zika vaccine.
And finally, in early August, President Obama, the complainer-in-chief, told reporters at the Pentagon: "The situation is getting critical. For instance, without sufficient funding, NIH critical trials â€” clinical trials could â€” and the possibilities of a vaccine which is well within reach â€” could be delayed."
These dire warnings are suspect, in part because much of the available funds haven't yet been spent. As an August 3 Wall Street Journal editorial pointed out:
The Administration currently has $385 million in reprogrammed Ebola funds at its disposal. Only about half of that has been obligated, which Department of Health and Human Services spokesman Bill Hall attributes to bureaucratic federal procurement regulations. Yet the Administration continues to insist it needs more money even though it can't spend the money it has fast enough.
With NIH and several of its HHS siblings crying poverty, Congress should exercise its oversight function and ask how NIH is spending the rest of its budget and what guides those priorities.
To be sure, politicians should not make decisions about individual grant proposals, but they are responsible for oversight of federal agencies: setting overall priorities; combating waste, fraud and abuse; and putting a stop to inappropriate intransigence,
Especially when research appears to be flawed and to have a policy agenda, the Congress should certainly be involved. But some federal bureaucrats seem to disagree. A worrisome recent example is the response to the request from Representative Jason Chaffetz (R., Utah), chairman of the House Committee on Oversight and Government Reform, for materials to shed light on a particularly egregious waste of taxpayer dollars at the NIH. In a March 3, 2016, letter to Linda Birnbaum, the director of the NIH's National Institute of Environmental Health Sciences (NIEHS) and National Toxicology Program, Chairman Chaffetz requested documents and communications related to NIEHS funding of research on bisphenol A, also known as BPA, a plasticizer used in hard plastics and in the linings of food cans to prevent bacterial contamination.
The Food and Drug Administration, a sibling of NIH in the Department of Health and Human Services, has direct regulatory authority over BPA because it comes into contact with food. The agency's website explains that it "has performed extensive research and reviewed hundreds of studies about BPA's safety." The research has led to the conclusion that "current approved uses of BPA in food containers and packaging are safe."
Yet despite nearly 50 years of studies showing that the chemical is safe, the FDA and the companies that use BPA continue to come under fire from environmental groups, food activists, and other critics. Ironically, much of the ammunition for those complaints comes from academic studies on BPA that appear to be intended to undermine the FDA, and that are funded by the NIEHS (the FDA's sibling agency in the Department of Health and Human Services).
Between 2000 and 2014, NIEHS gave $172.7 million in research grants to scientists trying to demonstrate BPA's adverse effects on humans, in particular as a so-called endocrine disruptor. More than 70 percent of the total funding, or $121.5 million, was provided between 2010 and 2014, much of it going to scientists known to have a strong bias against BPA. In a show of astounding hubris, many of these same scientists who make a living feeding at NIEHS's publicly funded, junk-science trough, wrote to thenâ€“FDA commissioner Margaret Hamburg to complain that the FDA's review of BPA was "flawed scientifically."
The NIEHS-funded studies help perpetuate what New York Times reporter Andrew Revkin dubs the "single-study syndrome," in which advocates on hot-button issues (such as fracking, genetic engineering, and exposure to chemicals, to name just a few) "latch onto and push studies supporting an agenda, no matter how tenuous â€” or dubious â€” the research might be."
Consider an NIH-funded study by a Stanford University post-doctoral student that found that "canned food was associated with higher urinary BPA concentrations, and the more canned food consumed, the higher the BPA." That result supposedly "confirms canned food's outsized influence on exposure to BPA." Different kinds of canned food were associated with different BPA concentrations in subjects' urine, and the "worst offenders (in descending order)" were canned soup, canned pasta, and canned vegetables and fruit.
Okay, but what does that mean? We've long known that BPA is rapidly metabolized (especially when introduced by the oral route) and excreted in the urine and feces, so it makes sense that the more you ingest, the more will show up in your urine. But what we really need to know is whether the blood levels are toxic. After all, the first principle of toxicology is that "the dose makes the poison" â€” in other words, a substance that is toxic at high doses may be completely inconsequential at low doses. Licorice and nutmeg and even water are examples of that.
So, what do we know about the toxicity of BPA at ordinary exposure levels? In addition to the FDA's findings that BPA is safe as currently used, the European Food Safety Authority has found â€” repeatedly, but most recently last year â€“ that "the level of BPA that consumers of all ages are exposed to is well below the estimated level of safe exposure."
That puts the Stanford study in perspective. It makes one wonder what the point of it was â€” except, of course, to indict BPA by innuendo. Never very discriminating and as usual, confusing hazard and risk, the media reported it as though it meant something.
Chairman Chaffetz is right to be concerned about NIEHS's more than $120 million in research grants for questionable studies intended to undermine the regulatory functions and conclusive scientific findings of its sibling, the FDA. But Birnbaum and the NIEHS have ignored his March 17 deadline to produce information for the committee's consideration.
Tougher oversight of NIH, and NIEHS in particular, is long overdue. Birnbaum is no beginner when it comes to wasting federal funds. One of us (Mr. Stier) recently criticized her National Toxicology Program for wasting $25 million on research that found that male rats exposed to cell phones for nine hours a day had a slight increase in two types of rare brain cancers. And the other (Dr. Miller) has taken to task the trivial and wasteful studies funded by another NIH component, the National Center for Complementary and Integrative Health.
Yet when asked whether Chairman Chaffetz's inquiries and concerns over BPA spending will be addressed at the upcoming National Advisory Environmental Health Science Council led by Ms. Birnbaum, an NIEHS spokeswoman told us that those issues were not on the agenda. Without a hint of irony, she pointed out that discussions about the merits of grant proposals will take place in a closed meeting to promote an "open and frank" discussion.
At its best, NIH-funded research advances much of the basic science on which medical progress depends. Although the agency's budget is large, its resources are finite, and given that less than 20 percent of investigator-initiated grants are funded, the support of trivial or wrong-headed projects diverts money from important research. In other words, research funding is essentially a zero-sum game.
Perhaps Birnbaum is more conversant with environmental science than with the federal government's checks and balances. Her fiefdom competes for funds against a broad spectrum of research, so Congress, on behalf of the public, is justified in scrutinizing the agency's procedures and priorities â€” and in holding bureaucrats like Birnbaum accountable.
â€” Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University's Hoover Institution. He was the founding director of the FDA's Office of Biotechnology. Jeff Stier is a senior fellow at the National Center for Public Policy Research in Washington, D.C., and heads its Risk Analysis Division.