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AS THE US enters a third surge of coronavirus cases, the two agencies charged with shepherding it through the public health crisis have lost their biggest asset: trust. The impact could be catastrophic, with one expert warning that the country may be heading for a national security crisis.

鈥淏oth the FDA and the CDC rely on one common element, which is public trust and confidence,鈥� says J. Stephen Morrison at the Center for Strategic and International Studies in Washington DC. 鈥淭hat is their essential asset that they have to treat as precious, and they have to guard it and sustain it through all sorts of twists and turns. As we鈥檝e seen, that鈥檚 not very easy.鈥�

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are two arms of the US government focused on public health, both part of the Department of 91色情片 and Human Services (see 鈥�Vital roles鈥�). Over the course of the coronavirus pandemic, a series of missteps by both agencies has resulted in a fractured approach to tackling the crisis. These missteps have come from within and have also been a result of political pressure and interference from the Trump administration.

A by the Kaiser Family Foundation, a non-profit organisation, found that since April, trust in the CDC among adults in the US has fallen by 16 percentage points, and about 40 per cent feel that the CDC and FDA are paying too much attention to politics when issuing guidelines and recommendations for coronavirus policy.

The problems started in the chaotic early weeks of the pandemic. 鈥淭he CDC has alternated between being invisible and actually not doing what they are charged with doing,鈥� says Peter Hotez, co-director of the Texas Children鈥檚 Hospital Center for Vaccine Development in Houston. 鈥淭hey missed the entry of the virus from Europe into New York, so transmission went on undetected there for weeks.鈥�

Both agencies then made crucial mistakes with coronavirus test kits, which delayed mass testing. Rather than manufacture tests according to guidelines set by the World 91色情片 Organization (WHO) that other countries used, the CDC opted to devise its own test.

In January, the CDC sent its test kits to 26 labs for initial evaluation. Nearly all of them found problems with false positives in the control portion of the test. This was later found to be due to .

By early February, the CDC had sent , which can each analyse 700 to 800 samples, to about 100 labs around the country, distributing them evenly even though some areas had seen no cases and others, such as New York City, were already seeing spikes in hospitalisations.

Testing capabilities were also hampered by early FDA rules that prevented labs from producing test kits, so they had to rely on those from the CDC. The FDA eventually reversed this. Still, testing couldn鈥檛 keep up with the spread of covid-19. The disease had taken hold, and the FDA and CDC had lost valuable weeks.

As hospitals filled up, the search for treatments that could lessen the severity of the disease was on. This is the area where the FDA should work to limit the use of drugs and treatments that haven鈥檛 been proven as safe, effective or appropriate. But politics got in the way. 鈥淭he FDA bent to political pressure, and it created false hope and false understanding in the public of potential treatments,鈥� says Morrison.

In a briefing on 19 March, President Donald Trump made the first of many mentions of the antimalarial drug hydroxychloroquine, suggesting that it should be tested as a treatment for covid-19. Days later, he that a combination of hydroxychloroquine and an antibiotic could be 鈥渙ne of the biggest game changers in the history of medicine. The FDA has moved mountains 鈥� Thank You!鈥� He also said the pair of drugs should be put into use immediately.

鈥淭he FDA created false hope and understanding in the public of potential treatments for covid-19鈥�

Alarm bells rang among the scientific community, as there was no robust clinical evidence that this drug cocktail would limit the severity of covid-19 or help with symptoms. On 23 March, 鈥� a parasite treatment for fish 鈥� that he and his wife took thinking it could protect them from the coronavirus.

But on 28 March, the FDA authorised hydroxychloroquine for emergency use to treat covid-19. 鈥淭hat emergency use authorisation was the FDA鈥檚 biggest mistake,鈥� says Hotez. The agency revoked the authorisation in June after trials showed it had no benefit for treating covid-19.

Political pressure on the FDA has mounted further as the presidential election draws closer. On 15 September, Trump said in an interview with Fox and Friends that a vaccine could be ready in which would coincide with the election.

However, the FDA has been holding its ground on this front. 鈥淭hey have learned from some rookie mistakes and are now doing a really good job at holding the line and preventing the White House from exploiting the FDA for political expediency,鈥� says Hotez.

In a webinar on 8 October, FDA commissioner Stephen Hahn spoke about the timeline and criteria for approving a vaccine. 鈥淪cience will guide our decision, and I will not, and the FDA will not, allow pressure from anybody to change that,鈥� he said.

鈥�54% of people polled in the US would not get a coronavirus vaccine鈥�

Hahn has been backed up by the drug industry. Nine pharmaceutical companies that are developing potential vaccines recently signed a safety pledge that said they wouldn鈥檛 submit a vaccine for FDA approval until it has been shown to be safe and effective in large clinical trials.

The FDA has also brought in new rules for forthcoming vaccines, which require two months of data to ensure a vaccine is safe and effective. Trump has criticised the agency, tweeting on 6 October: 鈥淣ew FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day.鈥�

An FDA spokesperson said in a written statement: 鈥淭he agency will not authorise or approve any COVID-19 vaccine before it has met the Agency鈥檚 rigorous expectations for safety and effectiveness. Decisions to authorize or approve any COVID-19 vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes, and science will guide any and all decisions.鈥�

The CDC hasn鈥檛 held as firm. In May, the for reopening schools, churches, public transport, restaurants and bars that included social distancing measures such as encouraging face coverings in churches, closing rows of seats on buses and trains, and separating schoolchildren into groups that don鈥檛 mix. The White House , and subsequently nor did the CDC, leading instead to a patchwork of public health policies cobbled together by state governors.

Elsewhere, political pressure has led to a flip-flopping of CDC policies on whether asymptomatic people should be tested.

Before this year, the CDC was widely recognised as the gold standard of a high-quality public health agency. It was a repository of up-to-date information and statistics relied upon by doctors, researchers and public health officials, but that has changed.

鈥淲e couldn鈥檛 rely on CDC for our modelling,鈥� says Hotez. 鈥淚 basically gave up on CDC data about five or six weeks into the epidemic.鈥� The CDC and White House didn鈥檛 respond to requests for comment.

Where does this leave things? Most urgently, the FDA and CDC will need to rebuild trust in order to effectively distribute a future vaccine. The pandemic has crashed headlong into a US anti-vaccine movement that has been gaining strength for years.

The Kaiser Family Foundation poll found that if a vaccine were approved before the US election and given for free, 54 per cent of people wouldn鈥檛 get vaccinated.

鈥淭he question I get is, 鈥榃hich vaccine are you going to wait for?鈥�,鈥� says Hotez. 鈥淣o one should wait. There should be a scientist from the CDC or FDA out there weekly explaining this to people.鈥�

Efforts to rebuild trust cannot start soon enough, says Morrison. 鈥淭he loss of trust is not just dangerous, it鈥檚 catastrophic.鈥� He has participated in pandemic preparedness exercises in the past and says even experts who play out various scenarios don鈥檛 know how to account for the CDC and FDA losing public trust. 鈥淧andemic war games don鈥檛 take that into account,鈥� says Morrison. 鈥淲e鈥檙e facing an uncontrolled pandemic, social instability, economic consequences and uncertainty around whether a large segment of the public will reject a vaccine. This is a national security matter.鈥�

Digging out of this could simply mean increasing the transparency of these agencies鈥� work. The over the approval process for coronavirus vaccines. For example, it opened up a meeting of the Vaccines and Related Biological Products Advisory Committee on 22 October to the public, instead of the usual closed-door policy.

Or it could require a full rewrite of these health agencies鈥� missions. That may depend, in part, on the outcome of the presidential election in November. If Trump isn鈥檛 re-elected, the heads of both the CDC and FDA may change, as they are appointed by the president. But if Trump stays in the White House, things could go on as they have. Such an outcome could have a devastating impact on a country that has already seen more than a quarter of a million deaths from covid-19.

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