Tag: NIH

A Health Economist to lead the NIH

Dec 12, 2024

By SAURABH JHA

Early on in the COVID-19 pandemic a seroprevalence study from Santa Clara indicated that the viral spread was far greater than was believed. The study suggested that the infection fatality rate (IFR) was much lower than the case fatality rate and perhaps even lower than the suspected IFR. The researchers estimated that 2.8% of the county had been infected by April 2020. The virus was contagious and, most importantly, caused many asymptomatic infections.

The study, released as a preprint within a month of the lockdown, should have been published by the NEJM or Lancet. The specificity of the immunoassay was a whopping 99.5% and could not have been lower than 98.5%. Instead, it was roundly criticized by born-again methodological purists. Noted statistician, Andrew Gelman, known expert at dealing with (very) imperfect statistical methods, wanted an apology from the researchers for wasting everyone’s time by making “avoidable screw ups.”

Around the same time, a similar study published in JAMA came to similar conclusions. Researchers found that the seroprevalence COVID-19 antibodies in LA county was 4.65%, 367 000 adults had SARS-CoV-2 antibodies, substantially greater than the 8430 confirmed infections. They concluded that “contact tracing methods to limit the spread of infection will face considerable challenges.” No one asked the researchers for an apology, presumably because the study had passed anonymous peer review and had escaped the wrath of the medical commentariat.

A few months later, a German study suggested that many infected with COVID-19 had myocarditis. This meant that the asymptomatic were not just reservoirs of viral transmission, but walking tombs of cardiac doom. By many, the researchers, who used cardiac MRI to look for myocarditis, put a figure at nearly 80%. That’s a lot. No virus had ever done that. That number itself should have invited scrutiny. The animated, born-again empiricists, who has been energized by the Santa Clara study into becoming methodological sleuths, went into hibernation after the German myocarditis study. The study was swallowed uncritically by many and was covered by the NY Times.

If the rigor demanded of the Santa Clara study was that of a Pythagorean proof, the German myocarditis study received the scrutiny of a cult prophet. The burden of proof in them days was like shifting sand, which shifted depending on the implications of the research. The Santa Clara study suggested the test – isolate strategy was forlorn, as controlling the viral spread was akin to chasing one’s tail. The German myocarditis study was cautionary, emphasizing that that the virus should not be under estimated, as even asymptomatic infections could be deadly. The Santa Clara study challenged lockdowns, the German study supported lockdowns.

The senior author of the Santa Clara study, Jay Bhattacharya, has been nominated by President Trump to be the next NIH director. His nomination has surprised a few, upset a few, irritated a few, shocked a few and, as befits a polarized country, pleased many. Bhattacharya may well have won the popular vote, though I’m uncertain he will win the institutional vote.

Bhattacharya’s anti-lockdown views rapidly made him a persona non grata in academic circles.

The Healthcare Industry Needs a Course Correction

Nov 20, 2024

By STEVEN ZECOLA

The United States healthcare system has failed by any measure.

First, costs are out of control. For example, 17% of the country’s GDP is spent on healthcare. This percentage was less than half that amount in 1980. It is expected to continue growing to 20% by 2032. Seventy-five percent of these costs are attributable to chronic diseases.

Second, notwithstanding the highest percentage of GDP spent on healthcare of the top ten high-income countries, the US has the worst performance outcomes whether measured on life expectancy, preventable mortality through disease management, and even access to care through insurance coverage or other means.

Third, the agency overseeing the healthcare industry is the Department of Health and Human Services. HHS is organized by functions such as Clinical Health Services and Behavioral Health Services rather than organized by disease management. The five strategic imperatives of its 4-year strategic plan do not contain benchmarks for improving the health status of the population, nor concrete steps to achieve the benchmarks. There is no mention of costs.

Fourth, the industry is huge and has many different components from healthcare providers to equipment manufacturers, to researchers, to pharmaceutical companies, to genetic companies, to insurance companies and so on. Over 16 million people are employed in the industry, with 60,000 in HHS alone. At this level of aggregation, leadership and management prowess becomes watered down and there can be no driving force for across-the-board improvements in disease management.

Fifth, the industry spends about $100 billion per year on R&D in pursuit of FDA approvals. The cost of this development translates into more than $2 billion per approved drug. Once approved, the drug effectively gains a barrier against unfettered competition. Independent analysts have estimated the costs of this regulatory scheme vastly exceed the benefits. Yet the FDA holds firm in its approach, given that its primary objective is safety.

Long COVID cardiac studies: More questions than answers.

Aug 15, 2022

BY ANISH KOKA

The NIH recently announced $1.2 billion dollars in funding for research on Long COVID. This is in part because of a faction of scientists that have mined electronic health record databases to find evidence that the long term impacts of COVID on a variety of different organ systems is significant.

I have some concerns when it comes to the cardiac complications discussed related to Long COVID.

ARPHA-H Needs to Think Bigger

Mar 22, 2022

BY KIM BELLARD

Everyone loves DARPA, the Defense Advanced Research Projects Agency that is credited with such hits as the internet and GPS, but is also responsible for things like the Boston Dynamics back-flipping robots and even Siri. DARPA’s mission is to make “pivotal investments in breakthrough technologies for national security,” but, as the previous examples illustrate, we can’t always tell how those breakthrough technologies are going to get used.

Healthcare is, at long last, getting its own DARPA, with ARPA-H (Advanced Research Project Agency for Health). It’s been discussed for years, but just last week was finally funded; a billion dollars over three years. But I fear it is already off on the wrong foot, even ignoring the fact that President Biden had requested $6.5b.

Crowd-Funding for Research Dollars: A Cure for Science’s Ills?

Nov 1, 2018

By Jai Ranganathan

Science in crisis

Scientists – and science generally – are in a moment of crisis on multiple fronts. The gap between science and society has grown to a chasm, with disastrous consequences for issue after issue. For example, just last month, Tennessee passed legislation permitting creation “science” into classrooms. On another front, the concern of Americans about global warming has dramatically declined over the past decade, despite the scientific consensus on the clear and present danger caused by climate change.

But science illiteracy in the general public isn’t the only crisis in science. Funding for research is becoming increasingly unattainable, with funding rates at their lowest levels in a decade at the National Science Foundation (NSF) and the National Institutes of Health (NIH), the two most important American science agencies (see here and here for details). The situation in many other nations is no better. In Spain, for example, science spending by the central government has fallen by 20% since 2009. Even worse, research funding from traditional sources will likely be even harder to come by in the years to come due to ongoing economic instability around the world.

Creative Minds: Building a Better Electronic Health Record

May 28, 2015• 4

By Dr. FRANCIS COLLINS

Is 5 too few and 40 too many? That’s one of many questions that researcher David Chan is asking about the clinical reminders embedded into those electronic health record (EHR) systems increasingly used at your doctor’s office or local hospital. Electronic reminders, which are similar to the popups that appear when installing software on your computer, flag items for healthcare professionals to consider when they are seeing patients. Depending on the type of reminder used in the EHR—and there are many types—these timely messages may range from a simple prompt to write a prescription to complex recommendations for follow-up testing and specialist referrals.

Chan became interested in this topic when he was a resident at Brigham and Women’s Hospital in Boston, where he experienced the challenges of seeing many patients and keeping up with a deluge of health information in a primary-care setting. He had to write prescriptions, schedule lab tests, manage chronic conditions, and follow up on suggested lifestyle changes, such as weight loss and smoking cessation. In many instances, he says electronic reminders eased his burden and facilitated his efforts to provide high quality care to patients.

Still, Chan was troubled by the lack of quantitative evidence Continue reading…

Good News: NIH Discovers Data Scientists and The Private Sector

Feb 17, 2015• 1

By DAVID SHAYWITZ, MD

Late last month, President Obama unveiled a $215 million Precision Medicine initiative, which has won early bipartisan support. The centerpiece of this proposal is an ambitious effort to integrate disparate clinical datasets to advance science and improve health. The question now is whether the National Institute of Health officials entrusted to carry out this program will seize this opportunity to leverage the thinking and experiences of the entrepreneurs, engineers, and data scientists from the private sector who have been wrestling these sorts of challenges to the ground. The early indications are encouraging.

(Disclosure/reminder: I work at a cloud-enabled genomic data management company in Mountain View, California.)

Data is the organizing principle of Silicon Valley; the landscape is dotted with companies – from behemoths like Facebook, Google GOOGL -0.99%, Salesforce, and Palantir to younger entrants like ours – devoted to collecting, analyzing, and collaborating around huge amounts of data, often enabled by cloud computing.

The same engineers who gave us photo sharing, Angry Birds, and smart thermostats are increasingly bringing their talents to healthcare, trying to enable health data sharing, motivate healthy behaviors, and empower elders living at home alone.

Hyping Cancer Genotyping

Jul 28, 2014• 13

By NORTIN HADLER, MD

It was 1970. I was in my laboratory at the NIH sequencing a murine myeloma protein in order to define the structure of its antibody combining region. Studies of protein conformation were at the cutting edge of science then; enthusiasm abounded. But it was clear to me that this work, in all its scientific elegance, had little to do with treating myeloma or anything else in mice or man. The reason for all the painstaking effort was the joy of pushing back the frontier of ignorance, even if only a bit. No one could foresee clinical utility then, nor would any become apparent for decades. Today such monoclonal antibodies are widely used to treat many diseases, sometimes with efficacy that justifies the costliness.

Genomics is in a bigger hurry.

Thanks to 40 years of breakthroughs, many earning Nobel Prizes, the chromosome carrying the defective gene underlying a genetic disease, Huntington’s disease, was identified in 1983 and the gene sequenced a decade later. In short order, defective genes underlying a number of single-gene diseases were defined: cystic fibrosis, hemophilia, and others. We all wait with baited breath for these elegant insights to transform into primary treatments for single allele genetic diseases. Attempts to transfect patients with normal genes are encouraging but barely so; it has proved difficult to get the right gene to stay in the right cells. Likewise, directly modifying the abnormal genetic apparatus is still largely just promising. The fallback remains working downstream from the genetic apparatus, replacing or modifying the defective products of many of these pathogenetic genes. Nonetheless, optimism regarding modifying the genetic apparatus itself is rational as is ever more boldness on the part of molecular biologists.

The Sequestration Cuts That Are Harming Health Care

Oct 24, 2013• 2

By John E. McDonough

Between October 1 and 17, the federal government ceased all nonessential operations because of a partisan stalemate over Obamacare. Although it is premature to declare this the greatest example of misgovernance in modern U.S. Congressional history, this impasse ranks highly.

One casualty of the showdown was any consideration of changes to lessen the impact of the across-the-board sequestration cuts that began on March 1. The cuts have caused economic and other distress across the nation, including serious impacts within the health care sector. Nearly eight months into sequestration, we can move beyond predictions and begin to quantify these effects.

Consider the following impacts of sequestration on Federal health agencies and activities:

NATIONAL INSTITUTES OF HEALTH

Cuts to the FY13 budget: $1.71 billion or 5.5%

This includes:

A 5.8% cut to the National Cancer Institute, including 6% to ongoing grants, 6.5% to cancer centers, and 8.5% to existing contracts

A 5.0% cut to National Institute of General Medical Sciences, and a 21.6% drop in new grant awards

Among the effects:

703 fewer new and competing research projects
1,357 fewer research grants in total
750 or 7% fewer patients admitted to NIH Clinical Center
$3 billion in lost economic activity and 20,500 lost jobs
Estimated lost medical and scientific funding in California, Massachusetts, and New York alone of $180, $128, and $104 million respectively.

Dr. Randy Schekman, whose first major grant was from the National Institutes of Health in 1978, said winning this year’s Nobel Prize for Medicine made him reflect on how his original proposal might have fared in today’s depressed funding climate. “It would have been much, much more difficult to get support,” he said. Congresswoman Zoe Lofgren (D-Calif.) noted the irony that because of sequester cuts, NIH funding was reduced for the research that resulted in Yale’s James Rothman sharing in the 2013 Nobel Prize for Medicine.

The Government Shutdown: Why the Pipeline Matters

Oct 9, 2013• 5

By Suzanne M. Rivera

Much attention has been paid to the government shutdown that started last week. Many of us heard heart-tugging stories on public radio about the NIH closing down new subject enrollment at its “House of Hope,” the clinical trial hospital on the NIH main campus. These stories gave many people the impression that clinical research halted around the country when the federal government failed to approve a Continuing Resolution.

The reality is both less dramatic in the short term and more concerning for the long term. For the most part, federally-funded projects at university campuses and hospitals are continuing as usual (or, the new “usual,” as reduced by sequestration), because the grants already awarded are like I.O.U.s from the government. By and large, university researchers will keep spending on their funded grants, with the knowledge that reimbursement will come once the government re-opens for business. The universities and hospitals are, in a sense, acting like banks that loan the government money while waiting for these expenses to be reimbursed.

Also, many clinical trials are funded by the pharmaceutical industry. So it is not the case that hospitals are closing their doors to research en masse. But the long-term effects of a shutdown will have lasting and compounding effects on our science pipeline. The U.S. federal government is the single largest funder of scientific research at American universities. Each month, thousands of grant proposals are sent to the various federal funding agencies for consideration.

These in turn are filtered and assigned to peer review committees. The whole process of review, scoring, and funding approval typically takes months, sometimes more than a year.