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Francis Collins

Trial By Error: National Institutes of Health Director Francis Collins on Plans for Long COVID Research

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By David Tuller, DrPH

The US government seems to be taking Long COVID seriously. In December, Congress allocated $1.15 billion over four years for research into the issue. This week, Francis Collins, director of the National Institutes of Health, announced the agency’s plans for that funding. (I’ve posted his announcement in full below.) In a post last month he highlighted the plight of the long-haulers and praised the most extensive report yet on their situation. That well-received research report was spearheaded and produced by a patient-led team from the Body Politic COVID-19 Support Group, an online community.

The relationship between what is generally being called ME/CFS and what is generally being called Long COVID is unclear. A number of high-profile news articles–including ones published by The New York Times, The Guardian, and Kaiser Health News–have noted the apparent overlaps in symptoms and in possible or hypothesized causes. These articles have taken at face value the notion that ME/CFS patients are suffering from a serious disease and have not presumed that psychotherapy and exercise are the optimal approaches to treatment.

Both ME/CFS and long COVID are complex phenomena–as is evident from confusion and disagreement over the appropriate nomenclature. ME/CFS is an unsatisfactory hybrid term used to refer to a range of described clinical entities. Long COVID is a convenient and easy-to-understand term but it conveys nothing about the condition’s expansive range of presentations. That variety is better expressed through the scientific name it has been given: Post-Acute Sequelae of SARS-CoV-2 infection (PASC). In other words, there are lots of different sequelae–not just one entity called Long COVID.

Ramped up funding for research into Long COVID could be beneficial for ME/CFS patients. My sense is that many of the latter are hopeful that these investigations could reveal biological mechanisms and pharmaceutical treatments that could be relevent for them as well–especially given apparent similarities in symptoms like post-exertional malaise and cognitive impairment. (I never expected to see the phrase “brain fog” in news headlines all around the world.)

At the same time, there is cause to be wary. This pandemic is now early in its second year, so so-called Long COVID is still a relatively short phenomenon–especially when compared to the decades of illness experienced by many with ME/CFS. Reports of persistent symptoms are known to be common after many viral infections. It is also known that these cases self-resolve most of the time–even if it can take a year or more in some cases.

If it is asserted prematurely or simplistically that Long COVID and ME/CFS are somehow the same, what happens if most of these legions of Long COVID patients get better in the next few months or over the next year? It could easily be presumed that the “multi-disciplinary rehabilitation”–or any number of helpful or non-helpful interventions–led to improvements, even if the recoveries would have happened in any event. In such a scenario, that advice could be presumed to be applicable to ME/CFS patients. Before declarative statements can be made, we need to see a lot more data.

In the meantime, it’s great that NIH has found more than $1 billion to investigate Long COVID. It certainly suggests that more money could have been found ten or twenty years ago to study ME/CFS than the pittance that has historically been allocated. While the amount has increased significantly in recent years, two or three times a pittance is still a relative pittance. (Jennie Spotila provides regular analyses of NIH funding at Occupy M.E., her blog)

Below is the announcement from NIH Director Francis Collins:

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NIH launches new initiative to study “Long COVID”

I write to announce a major new NIH initiative to identify the causes and ultimately the means of prevention and treatment of individuals who have been sickened by COVID-19, but don’t recover fully over a period of a few weeks. Large numbers of patients who have been infected with SARS-CoV-2 continue to experience a constellation of symptoms long past the time that they’ve recovered from the initial stages of COVID-19 illness. Often referred to as “Long COVID”, these symptoms, which can include fatigue, shortness of breath, “brain fog”, sleep disorders, fevers, gastrointestinal symptoms, anxiety, and depression, can persist for months and can range from mild to incapacitating. In some cases, new symptoms arise well after the time of infection or evolve over time. In December, NIH held a workshop to summarize what is known about these patients who do not fully recover and identify key gaps in our knowledge about the effects of COVID-19 after the initial stages of infection. In January, I shared the results from the largest global study of these emerging symptoms. While still being defined, these effects can be collectively referred to as Post-Acute Sequelae of SARS-CoV-2 infection (PASC). We do not know yet the magnitude of the problem, but given the number of individuals of all ages who have been or will be infected with SARS-CoV-2, the coronavirus that causes COVID-19, the public health impact could be profound.

In December, Congress provided $1.15 billion in funding over four years for NIH to support research into the prolonged health consequences of SARS-CoV-2 infection. A diverse team of experts from across the agency has worked diligently over the past few weeks to identify the most pressing research questions and the areas of greatest opportunity to address this emerging public health priority. Today we issued the first in a series of Research Opportunity Announcements (ROAs) for the newly formed NIH PASC Initiative. Through this initiative, we aim to learn more about how SARS-CoV-2 may lead to such widespread and lasting symptoms, and to develop ways to treat or prevent these conditions. We believe that the insight we gain from this research will also enhance our knowledge of the basic biology of how humans recover from infection, and improve our understanding of other chronic post-viral syndromes and autoimmune diseases, as well as other diseases with similar symptoms.

Some of the initial underlying questions that this initiative hopes to answer are:

  • What does the spectrum of recovery from SARS-CoV-2 infection look like across the population?
  • How many people continue to have symptoms of COVID-19, or even develop new symptoms, after acute SARS-CoV-2 infection?
  • What is the underlying biological cause of these prolonged symptoms?
  • What makes some people vulnerable to this but not others?
  • Does SARS-CoV-2 infection trigger changes in the body that increase the risk of other conditions, such as chronic heart or brain disorders?

These initial research opportunities will support a combination of ongoing and new research studies and the creation of core resources. We anticipate subsequent calls for other kinds of research, in particular opportunities focused on clinical trials to test strategies for treating long-term symptoms and promoting recovery from infection.

Research Studies: A SARS-CoV-2 Recovery Cohort—the central program of this initiative—will leverage ongoing COVID-19 studies, long-term cohort studies established well before the pandemic began, and new studies of people with Long COVID. These studies aim to characterize the long-term effects of infection in a diverse set of people and the trajectory of symptoms over time. The initiative will support a multidisciplinary consortium of investigators who collaborate and coordinate across studies. The initiative also will support two complementary studies: 1) large data studies from resources such as electronic health records and health systems databases that will be critical to understand how many people are affected and what factors contribute to recovery; 2) studies of biological specimens to understand injury to the brain and other organs.

Core Resources: A clinical science core, data resource core, and biorepository core will provide overall consortium coordination, clinical expertise in post-acute COVID symptoms, and facilitate the use of standardized data and biological specimens collected from the consortium studies by consented volunteers.

Our hearts go out to individuals and families who have not only gone through the difficult experience of acute COVID-19, but now find themselves still struggling with lingering and debilitating symptoms. Throughout this pandemic, we have witnessed the resilience of our patient, medical, and scientific communities as they have come together in extraordinary ways. NIH deeply appreciates the contributions of patients who have not fully recovered from SARS-CoV-2 infection and who have offered their experiences and insights to lead us to this point, including those with other post-viral infections. Through the PASC Initiative, we now ask the patient, medical, and scientific communities to come together to help us understand the long-term effects of SARS-CoV-2 infection, and how we may be able to prevent and treat these effects moving forward.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

Would we have an Ebola virus vaccine if not for NIH cuts?

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Dr. Francis Collins, the head of the National Institutes of Health, believes that we would have an Ebola virus vaccine if not for the past ten years of flat budgets for life science research:

NIH has been working on Ebola vaccines since 2001. It’s not like we suddenly woke up and thought, ‘Oh my gosh, we should have something ready here.’ Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would’ve gone through clinical trials and would have been ready. (Source: Huffington Post)

I do understand that Collins needs to be a champion of life sciences research, but to promise that a vaccine would be ready by now is overly optimistic. Vaccines are not easy to design, as the efforts to make an HIV-1 vaccine illustrate. There is no guarantee that even unlimited resources would have produced an approved vaccine. However, more money might have allowed clinical trials of the Ebola virus vaccine candidates currently beginning phase I testing.

I believe that Collins should take the Ebola virus outbreak as an opportunity to emphasize the need for continuous, strong support of basic life sciences research. Michael Eisen, who is particularly annoyed with Collins’ statement, is right about what Collins should have said:

But what really bothers me the most about this is that, rather than trying to exploit the current hysteria about Ebola by offering a quid-pro-quo “Give me more money and I’ll deliver and Ebola vaccine”, Collins should be out there pointing out that the reason we’re even in a position to develop an Ebola vaccine is because of our long-standing investment in basic research, and that the real threat we face is not Ebola, but the fact that, by having slashed the NIH budget and made it increasingly difficult to have a stable career in science, we’re making it less and less likely that we’ll be equipped to handle all of the future challenges to public health that we’re going to be face in the future.

Don’t get me wrong. I get what Collins is trying to do. I just think it’s a huge mistake. Every time I see testimony from NIH officials to Congress, they are engaged in this kind of pandering – talking about how concerned they are about [insert pet disease of person asking question] or that and how, if only they could get more money, we’d be able to take make amazing progress. But guess what? It hasn’t worked. The NIH budget is still being slashed. It’s time for the people who run the biomedical research enterprise in this country to make basic research the center of their pitch for funding. Collins had a huge opportunity to do that here, but he blew it.

NIH head defends new center for translational science

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Head of the US National Institutes of Health Francis Collins was asked some tough questions by a House of Representatives subcommittee examining the new National Center for Advancing Translational Sciences, NCATS.

The goal of the new center, opened in 2012, is to reduce the amount of time needed to develop new drugs, diagnostic tests, and medical devices. One concern, voiced by Representative Michael Simpson (R, Idaho)  is that the center will divert funds from basic research:

Can you ensure that the development of NCATS will not take resources away from basic sciences?

Colllins replied that the amount of money for NCATS is small. Which lead to an attack by Roy Vagelos, former CEO of Merck, who noted that the pharmaceutical industry spends far more money without solving the problems targeted by NCATS:

Does anyone in the audience believe that there is something that NCATS is going to do that the industry thinks is critical and that they are not doing? That is incredible to think that. If you believe that you believe in fairies.

Translational science takes the findings of basic research and applies them to practical problems. Without basic research there would be no translational science. Therefore it makes no sense to take funds from the former to support the latter. Especially when the funds are being used to support a translational center of questionable value.

No basic science for NIH?

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bacteriophageThe new director of the National Institutes of Health, Francis Collins, has been scrutinized for his Evangelical Christian beliefs, which some think might influence his science policy. But there may be an even more serious problem with his leadership of the biggest supporter of scientific research in the United States.

A recent New York Times article focused on Collins’ religious beliefs. The following statement, which was buried in the article, worries me much more:

While acknowledging the importance of basic sciences like biochemistry and genetics, he said he wanted scientists to consider clinical or therapeutic implications in their work. “We’re not the National Institutes of Basic Sciences,” he said. “We’re the National Institutes of Health.”

Since its inception, the NIH has supported both clinical research, the kind that can make us healthier, and basic research, which might not ever have a ‘payoff’. But basic research – letting scientists pursue what interests them – often leads to practical advances. One example is the work on bacteriophages, plasmids, and restriction enzymes, seemingly only of academic interest, that lead to the field of recombinant DNA technology.

It’s very easy to identify medically important problems – cancer, diabetes, heart disease – but who is smart enough to know which obscure area of research will lead to improvement of human health? Often the most important advances come from unexpected beginnings.

If the NIH reduces its support of basic science, who will step in to fill the void? Or will there be no more research on insect viruses (which lead to novel ways to synthesize proteins in cells), viruses that protect aphids from fatal wasp stings, and the diverse and abundant viruses of the seas?