Pillars of medical establishment wobbling under pandemic’s big stresses

asclepliusrodof-70x300As the Covid-19 pandemic has put huge stresses on medical systems around the globe, the strains have taken their toll:  The credibility and authority — of federal agencies like the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and elite professional journals like the Lancet and the New England Journal of Medicine — have taken big hits in recent weeks.

In times of huge uncertainty and high anxiety, the public should be able to turn to these respected pillars of the health care establishment for steady, trustworthy, and independent information and execution of crucial policies that benefit the public.

The agencies are not just a pile of letters. Their work, based in rigorous medical science and the best available evidence, is supposed to reject damaging and dangerous rumor, hunch, myth, mis- and dis-information. They help to set standards for care, especially in crises, and they are charged with safeguarding us from disease, dangerous drugs and vaccines, and in protecting the old, sick, and injured in institutional care.

Instead, the CDC has been sidelined by its own blunders, the FDA has played policy catch-up and struggles to avoid becoming (even more) politicized, CMS has all but withered as the novel coronavirus has savaged elder care facilities, one of the major areas it is supposed to oversee, and the Lancet and NEJM both have been forced into embarrassing retractions of flawed studies,  published in haste, about the effectiveness of certain drugs in treating Covid-19.

To be sure, political partisans — notably President Trump and his minions — have made it not a bug but a feature of their time in office to accelerate the debasement of science and the erosion of fact-based policy. Republicans have espoused the view, in theological fashion, that government has no place in individuals’ health, waging a decades-long war on any federal role in affordable health insurance that would increase poor and middle-class Americans’ access to life changing and saving medical services.

Trump has picked weak leaders for his health-related agencies, including the giant Health and Human Services department, as well as the CDC and FDA. He has made churn at the top a crucial component of his governance (such as it is), leaving agencies with interim chiefs with limited authority. He has proposed to slash department budgets, though congressional forces have kept him from doing so. The message apparently still got through.

Here’s just the headlines of a deep New York Times dig into the CDC’s problems made large during the Covid-19 pandemic:

“The CDC waited ‘its entire existence for this moment.’ What went wrong? The technology was old, the bureaucracy slow, the guidance confusing, the administration not in agreement. The coronavirus shook the world’s premier health agency, creating a loss of confidence and hampering the U.S. response to the crisis.”

The reading that follows is sad and painful. And, over at the Politico news site, there’s grim reporting about the FDA, again just take it from the headlines:

FDA struggles to remain independent amid race for virus cure. [Vaccine experts] Peter Marks’s abrupt switch was the latest sign of the FDA’s struggle to fend off outside political pressure, particularly from the White House.”

CMS’ sluggish and ineffectual role in safeguarding nursing homes and other long-term care facilities during the pandemic, as the agency is supposed to do, is the subject of a whole separate post on this blog this week.

As for the prestige medical journals, here is part of what the New York Times reported on their yanking two separate studies on the effectiveness in treating the coronavirus, including with combinations of antimalarials and antibiotics and blood pressure drugs, due to big doubts about the data used in the research:

“The retractions may breathe new life into the antimalarial drugs hydroxychloroquine and chloroquine, relentlessly promoted by Mr. Trump as a remedy for Covid-19 despite a lack of evidence … after the journals noted concerns about the studies, the World Health Organization announced that it would resume trials of the medications. But the retractions also raise troubling questions about the state of scientific research as the pandemic spreads. Thousands of papers are being rushed to online sites and journals with little or no peer review, and critics fear long-held standards of even the most discerning journals are eroding as they face pressure to rapidly vet and disseminate new scientific reports.”

The flawed data in the separate Lancet and NEJM studies, both led by a Harvard professor and relying on an outfit called Surgisphere, has drawn big scrutiny of the tiny U.S. health care company, including this reporting from the British news organization the Guardian:

“A Guardian investigation can reveal the US-based company Surgisphere, whose handful of employees appear to include a science fiction writer and an adult-content model, has provided data for multiple studies on Covid-19 co-authored by its chief executive, but has so far failed to adequately explain its data or methodology. Data it claims to have legitimately obtained from more than a thousand hospitals worldwide formed the basis of scientific articles that have led to changes in Covid-19 treatment policies in Latin American countries. It was also behind a decision by the WHO and research institutes around the world to halt trials of the controversial drug hydroxychloroquine.”

In the relentless, 24/7 news cycle, and in a world where skepticism if not outright cynicism about authority is burgeoning, the medical journal retractions likely distracted attention from a third important study and another development about the anti-malarial drugs. In this British work, the data has not been published but it was independently reviewed throughout the research, as reported by the medical news site Stat:

“A major clinical trial showed the malaria drug hydroxychloroquine had no benefit for patients hospitalized with Covid-19, likely closing the door to the use of the highly publicized medicine in the sickest patients — a use for which it was widely prescribed as the pandemic hit the U.S. The results come from a study called RECOVERY, funded by the U.K. government, that sought to randomly assign large numbers of patients to multiple potential treatments in the country’s National Health Service. The goal was to rapidly get answers as to what worked and what didn’t. ‘Today’s preliminary results from the RECOVERY trial are quite clear – hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease,’ University of Oxford epidemiologist Martin Landray, one of the study’s leaders, said in a statement. ‘This result should change medical practice worldwide and demonstrates the importance of large, randomized trials to inform decisions about both the efficacy and the safety of treatments.’”

Got it? Is this good science or pandemic pandemonium?

In my practice, I see not only the harms that patients suffer while seeking medical care, but also their struggles to access and afford safe, efficient, and excellent medical care. This has become an ordeal due to the skyrocketing cost, uncertainty, and complexity of therapies and prescription drugs, too many of which turn out to be dangerous drugs.

The Covid-19 pandemic has driven home how, under duress, the public and patients need clear, accurate, timely, and reliable guidance about their health care from nonpartisan, independent, and trustworthy sources. Taxpayers have invested untold sums in federal agencies for this very quality. Decades of outstanding work and toil to build the governmental and institutional credibility and authority have started to vanish in weeks, however.

The coronavirus, in the meantime, is not going away. It will not disappear by magic. While Americans are rushing out to beaches, bars, restaurants, shopping malls, and other public conveniences, Covid-19 infections are rising. They were headed up in many places that still chose to ease public health restrictions. The hot spots keep flaring. Hospitals in some areas are reporting rises in coronavirus cases, including in their intensive care units.

We can’t just tut-tut about what a shame it is about the CDC, FDA, CMS, and other parts of the medical establishment. We need to hold them accountable and to help them perform in their highest and best ways — not at their fumbling worse. The president, now that he no longer can hog the media spotlight with information-light daily news conferences, has let the White House coronavirus task force vanish. The administration has declined to develop a national strategy and action plan to respond to the pandemic, kicking the hard work and responsibility back to the states and local governments.

The death toll, exceeding 100,000, keeps growing, albeit somewhat more slowly. The United States, with almost 2 million cases, persists as the world’s Covid-19 infection leader. We need to do better. We must. The virus has inflicted huge damage on the world and the nation already. It may do much more, as history warns.

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