The new variant has exposed dysfunction in America's public health institutions that has continued under a new president.
One of the first things President Joe Biden did after being elected was to name a new advisory board of doctors and scientists to deal with the Covid-19 pandemic. The message was clear: no longer would the White House take its cues from Fox News hosts and conspiracy theorists, as he believed it had under Donald Trump. Biden would be guided by "science and by experts", he said on November 9 2020.
In the first year of Biden's presidency, much has changed about the US response to Covid-19. Most adults have now been vaccinated and new, more effective treatments have been approved. There's no more talk of miracle cures in the White House briefing room, or self-medication with bleach.
Yet the past few months have also been plagued by some of the missteps and administrative dysfunction which occurred during the Trump era. The Biden administration's policies on boosters, at-home testing, masking and quarantine have been halting and inconsistent, which critics say have made the country's Omicron wave far worse than it should have been.
At the root of these problems, say public health experts and government officials, is a malaise afflicting the US government's major public health institutions. Feted for years as global leaders in scientific research and public health policy, the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health have been slow to respond to the fast-changing nature of the pandemic and unable to co-ordinate effectively among themselves.
"We have had a situation in which these agencies have not responded as they should have — that is pretty undeniable," says Dr Ezekiel Emanuel, professor of healthcare management at the University of Pennsylvania and a former adviser to Biden on Covid-19. "The underlying theme is inflexibility, both with resources and ideology."
Many now believe that unless Biden prioritises reforming these agencies, which collectively employ nearly 50,000 people within the sprawling US Health and Human Services Department, the US will continue to suffer a higher infection and death rate than many other developed countries.
"The Biden administration is probably now quickly figuring out that some of the problems the Trump administration had were structural and institutional," says James Capretta, a senior fellow at the right-leaning American Enterprise Institute and a former White House official. "Fundamentally the CDC in particular doesn't seem to be an operational agency. They are just too slow and not forward leaning and aggressive enough."
One former Trump health official says: "Biden thought he could come in, put the scientists back in charge and turn Covid around by simply not being the lunatic who preceded him.
"Well, the lunatic is gone. But this administration is still making almost exactly the same mistakes he did."
Cultural and structural challenges
Nowhere has the failure of America's public health response to the pandemic been clearer than at the CDC.
For decades, the agency has been viewed as a global leader in public health, having led the government response to every previous outbreak of an infectious disease since its inception in 1946. It is the CDC's job to assess the risks of the virus, track its spread and issue public health guidelines to states.
But the weaknesses became apparent as soon as Covid-19 emerged. The CDC struggled to ensure air travellers entering the US from China's Hubei province, where Wuhan is located, in the very earliest weeks of the pandemic were screened for the virus. Scott Gottlieb, the former head of the FDA during the Trump administration, claimed in his book Uncontrolled Spread that communication failures at the agency allowed "thousands of passengers to stream into the country uncontested" in February 2020.
Beyond poor communication, the CDC often faltered in part because its normal bureaucratic processes were too slow. In early 2020, for example, the agency insisted it should be the only organisation to produce a Covid-19 test for public health labs to use, stymying any efforts by private companies to do so. But when it shipped its test, it used contaminated ingredients by mistake, rendering almost all of them completely unusable.
When Biden took over he installed Rochelle Walensky, the well-respected head of infectious diseases at Massachusetts General Hospital, as director of the organisation. But despite new leadership the same structural weaknesses that dogged the organisation's early pandemic response have returned.
Critics say the CDC was slow to recognise the threat posed by Omicron, not just in terms of infection levels, but also what it would mean to have so many people quarantined at one time. When the new strain first hit, large sectors of the economy struggled to stay open. Thousands of flights were cancelled over the Christmas weekend because crew members tested positive.
"A lot of people at CDC have never been in the situation where we need to move fast," says Tom Frieden, a former CDC director. "They do not understand the need for timeliness."
CDC responded by slashing the recommended quarantine period from 10 days to five. But it did not recommend that infected people record a negative test before leaving quarantine, a decision that was criticised by many public health experts and openly questioned by Anthony Fauci, Biden's chief medical adviser.
Meanwhile, the CDC has often found it hard to collect accurate and timely information from state health departments, making it hard to track exactly how widespread the new variant is.
In December, the CDC shocked the public health community by announcing the strain had jumped from 13 per cent of all cases to 73 per cent in just a week. Just a week later it admitted it had got its estimates completely wrong, and the variant had risen more gradually from 23 per cent to 59 per cent.
"The challenges at CDC are cultural and structural," says Gottlieb. "It is going to require a change in direction and leadership, some reprogramming of the agency. I don't think the administration has even begun that process."
The CDC did not respond to multiple requests to comment on this story.
Sluggish approvals
Slow decision-making and a lack of co-ordination have also plagued the Food and Drug Administration, the organisation responsible for approving new drugs in the US.
The FDA is considered by many to have performed better during the pandemic than the CDC, not least because of its success in approving three safe and effective vaccines.
But the agency has stumbled in other fields, most notably in approving rapid at-home tests. Unlike in the UK, where such tests have been available free from pharmacies for much of the pandemic, US residents have until recently had to pay about US$24 ($36) for a pair of tests, when they could find them. During the Omicron wave, pharmacies began rationing them due to short supplies, before running out completely in many major cities.
The cause of this lack of supply is in part due to the slow pace at which the FDA has approved new tests. For months, only two companies were allowed to sell at-home tests: Quidel and Abbott. Smaller companies say they found it impossible to navigate the regulator's complex and stringent approvals process.
"The rapid test situation is a disaster," says Matt Stoller, director of research at the American Economic Liberties Project, a progressive think-tank. "If you put out an at-home pregnancy test right now the FDA would probably oppose it as not being accurate enough."
Senior officials at the FDA have previously told the FT they wanted to make sure people did not take undue confidence from a false negative test. But many experts argue it would have been better to flood the market with tests and let people test regularly to minimise the disruption caused by a single false result.
The FDA has now granted authorisation to many more at-home tests, while the White House recently promised to buy about 1bn of them to distribute to people's homes.
But the tension between upholding rigorous standards and moving fast enough to pre-empt a public health crisis played out again with booster doses.
Biden announced in August that his administration would offer widespread vaccine booster shots amid growing evidence that antibody levels began to wane months after a second shot. That pledge triggered an extraordinary public row over whether they were needed for anyone beyond the most vulnerable, resulting in the resignations of two of the most senior officials in charge of approving vaccines at the FDA.
At first the FDA only authorised booster shots for those most vulnerable to severe disease, but soon reversed course to do so for all adults. By November, boosters were approved and widely available.
But relatively few people have elected to receive one. According to the FT's Covid-19 vaccine tracker, only 25.4 per cent of Americans have received booster doses. In the UK 55 per cent have been boosted. This is one reason why more Americans are dying. During the Omicron wave, the UK's case count peaked at a higher rate than in the US. But in the US, the death rate has been nearly 50 per cent higher.
Luciana Borio, a former senior official at the FDA, says the agency's problems have come in part because of the absence of a strong commissioner who can liaise between scientists and politicians. Janet Woodcock, the current acting commissioner, is soon to be replaced by Robert Califf, who led the organisation from 2016 to 2017.
"The booster decision should have worked out differently," she says. "If the commissioner's office was more involved there would have been more time to work out a solution that might not have led to the resignation of two senior scientists."
Tunnel vision on treatments
Of all the public health agencies at the heart of the US pandemic response, the least scrutinised has been the National Institutes of Health, despite the high profile of one of its most senior officials, Fauci. The organisation has less to do with the public as it primarily funds biomedical and public health research, including into drugs and vaccines.
The NIH was able to contribute in one major way to the pandemic public health response: it partnered with Moderna in 2020 to help the company bring its successful mRNA vaccine through the regulatory process and to market.
But when it comes to therapeutics, critics say the NIH has proved far less successful.
In England, scientists at Oxford university set up a vast trial at the start of the pandemic, using data from hundreds of NHS hospitals to evaluate which treatments might work best against Covid-19.
The Recovery Trial, as it was known, was the first to spot that dexamethasone, a cheap steroid, was proving effective at preventing deaths among patients on ventilators. The trial also found that hydroxychloroquine, the antimalarial drug touted by Trump, was not effective in treating Covid-19.
The US process by contrast has focused on particular treatments deemed likely successes, limiting its scope. One therapy the NIH has focused on heavily is monoclonal antibodies, which works by injecting patients with Covid antibodies at an early stage of their disease.
This type of treatment proved successful at first. But at least two of them — one produced by Regeneron and another by Eli Lilly — have proved to be largely useless against Omicron, and the NIH is no longer recommending their use for people who have mild to moderate Covid symptoms.
"The NIH was completely focused on monoclonal antibodies, and that was a serious mistake," says Emanuel. "It was entirely predictable that they wouldn't work well if the virus mutated." The NIH also declined to comment on this story.
The need for reform
Last September, the White House released a 27-page plan for fighting future pandemics. It included asking Congress for an extra $65bn over the next 10 years and setting up a pandemic "mission control", which would co-ordinate response efforts across the federal government.
Four months on, however, the money has still not been allocated and there is little sign of Congress getting round to discussing it. Meanwhile, the White House has not mentioned more serious reform of the agencies which have led the US response to this pandemic.
The Biden administration did prioritise one departmental restructuring upon taking office: it dismantled a new unit set up by Trump to steer the process of developing vaccines, known as Operation Warp Speed.
OWS helped speed up the vaccines' development by signing pre-orders worth billions of dollars which enabled vaccine developers to accelerate clinical trials without the normal risks of failure. It also worked with the private sector to find manufacturing facilities even before the vaccines were approved — something beyond the remit of a traditional health agency. Even Trump's worst critics would agree that the rapid development of vaccines has been an unmitigated success story.
But one of Biden's first actions after entering office was to scrap the OWS name and integrate its members more fully into the traditional bureaucratic structures at the health department. Jen Psaki, Biden's press secretary, linked OWS to the "failures of the Trump team approach to vaccine distribution".
Many former Trump officials believe that by jettisoning the entire pandemic response until 2021, Biden failed to learn from their successes, especially when it came to dealing with the US's creaking public health infrastructure. The OWS showed that it's possible to put "critical pandemic response functions above agency turf wars and bureaucratic workflows", says Michael Pratt, the unit's former head of communications.
Even if there is broad consensus that structural reforms are overdue, the timing is challenging, say those who advised Biden as he prepared to take over the White House. "It is really hard to reform these agencies in the middle of a pandemic," says Céline Gounder, an epidemiologist who served on Biden's transition team. "When you have people who are working 100-hour weeks for two years, the last thing you want to be doing is destabilising the environment further."
But many now think reform should be a priority for the second half of Biden's term as president, or whenever Covid-19 does not have the country in its grip. "Maybe we don't want to take apart agencies in the midst of a pandemic," says Emanuel. "But coming out we need to reimagine them completely."
Additional reporting by Jamie Smyth in New York
Written by: Kiran Stacey
© Financial Times
