Coronavirus crisis calls for competence, clarity and courage at the top

Commentary: FDA's missteps on COVID-19 made a bad situation worse. Strong leadership is urgently needed.

In times of crisis, societies need competence, clarity and courage from their leaders -- qualities that have been in short supply during the COVID-19 outbreak.

Now more than ever, agencies like CDC and FDA need to be insulated from politics, and to be led by seasoned experts.

The agencies’ failures to act fast on COVID-19 testing damages their standing among a public that knows it has been put at risk.

Americans will be asking if political considerations, under-investment in science, and the White House’s deprioritization of pandemic response contributed to flaws in government-made tests and to delays in unleashing academic and commercial labs.

There can be no doubt that mass testing could have started in the U.S. a month ago and that it might have reduced community spread in the U.S.

The perception that these mistakes are at least partly the result of leaders putting politics ahead of public health could cause lasting damage far beyond the boundaries of the pandemic response, undermining confidence in agencies that have been held in high esteem.

The sense that politics is getting in the way is exacerbated by the silence of FDA and CDC leadership in the face of a stream of misleading and inaccurate statements about the COVID-19 outbreak from President Donald Trump and HHS Secretary Alex Azar.

These range from downplaying evidence that the virus was spreading, to presenting overly optimistic timelines for countermeasures development and falsely blaming the Obama administration for delays in deploying diagnostics.

There can be no doubt that mass testing could have started in the U.S. a month ago.

FDA sets a standard globally viewed as the gold standard by drug developers.

The ability of FDA to effectively regulate medical products, and of companies to develop them, requires that patients trust it to act independently. That trust is imperiled when confidence in the independence and competence of its leaders is in doubt.

FDA staff also deserve to know that their decisions will not be compromised by political considerations.

There is some good news. Diagnostics capacity in the U.S. is finally starting to ramp up.

Life sciences companies working around the world and around the clock have stepped up to the plate.

With unprecedented speed, a three-pronged countermeasures strategy has evolved: the first wave will be repurposed antivirals that could save lives and reduce morbidity; the second will probably be antibody-based products that will protect healthcare professionals and front-line caregivers from infection and treat hospitalized patients; and the third will be vaccines.

FDA has extraordinarily talented and dedicated employees who will make the difficult decisions that will be needed to bring COVID-19 countermeasures to patients and the public. It is essential that they receive support from the top.

The diagnostics debacle

The U.S. has lagged on the fourth prong, diagnostics, which FDA is only now bringing into the arena.

Medical testing giants Laboratory Corp. of America Holdings (NYSE:LH) (LabCorp) and Quest Diagnostics Inc. (NYSE:DGX), along with public health labs around the country, have started to provide testing.

The situation is still chaotic and test capacity is inadequate, but it is likely that over the coming two weeks U.S. testing capacity will get to where it should have been a month ago.

In China, massive COVID-19 testing started weeks after the government realized the scope of the threat. Within a week of the first case of community transmission in South Korea, over 60,000 of its residents were tested for COVID-19.

South Korea did not have access to technology that is unavailable in the U.S.; that country has succeeded where the U.S. has failed because its government immediately treated the outbreak as a public health crisis, not a public relations problem.

Singapore has contained the outbreak because it implemented an efficient testing program and coupled it with clear, honest communications from government leaders.

The delay in the U.S. was caused by incompetence at CDC and poor decisions at FDA.

Investigations have already started to flesh out the mistakes that caused CDC to roll out a flawed test that throttled U.S. capacity.

FDA’s decision for a month to rely on CDC, rather than immediately mobilizing academic and commercial labs, also needs to come under scrutiny.

The delay in the U.S. was caused by incompetence at CDC and poor decisions at FDA.

For a month after it was clear that China was battling an epidemic, Trump and Azar told the public there was no reason for concern.

Rather than insist on a massive, urgent response, U.S. government leaders were telling the American people as recently as Feb. 26 that COVID-19 was under control and would not be a problem.

Many public health experts, including officials who served in the Trump administration, predicted that banning travel from China would slow but not prevent spread of the virus to the U.S.

FDA Commissioner Stephen Hahn’s highest priority starting in January should have been creating massive testing capacity.

Instead of relying on the CDC to develop diagnostic tests, FDA should have immediately embarked on an aggressive “all of the above” approach by engaging academic labs and private test developers, clearing the regulatory hurdles that slowed by weeks the development of tests that are crucial for an effective public health strategy.

Taking the right steps early on would have required both a deep knowledge of the scientific and regulatory issues, and the courage to act aggressively at a time when Trump and Azar were downplaying the seriousness of the outbreak.

Because commercial and academic labs were on the sidelines, weeks were lost that could have been used to track and respond to the outbreak.

Even with the commercial labs ramping up testing capacity, Hahn’s repeated assurances about test capacity have been misleading.

For example, at a White House briefing on March 2 the FDA Commissioner said that “by the end of this week, close to a million tests will be able to be performed.”

The implication was that by March 8 the U.S. will have the ability to test hundreds of thousands of individuals to determine if they have been infected by the virus that causes COVID-19. This is wrong by more than an order of magnitude.

Political attacks

All FDA commissioners have had to cope with political pressure. To take two recent examples, Scott Gottlieb battled the White House and Congress over tobacco policy, and Margaret Hamburg’s decisions about female reproductive health were overruled by HHS Secretary Kathleen Sebelius and criticized by President Barack Obama.

The difference today is that there is no evidence that the FDA Commissioner is fighting to insulate the agency from White House demands that are intended to bolster Trump's political fortunes.

Hahn knows that there is no truth to Trump’s claims that decisions FDA made during the Obama administration “turned out to be very detrimental” to efforts to get COVID-19 diagnostic tests approved and deployed.

While Trump hasn’t explained this assertion, Azar told Lou Dobbs on Fox News television that the testing snafus were caused by “an Obama-era FDA requirement that required that any lab-developed test be approved by FDA.”

This seems to be a reference to Emergency Use Authorization (EUA) procedures created in legislation signed by President George W. Bush and reauthorized in bipartisan legislation signed by President Obama. In fact, there is no reason why the EUA process should slow the development of tests.

Falsely blaming today’s policy failures on decisions made under Obama injects politics into a situation that is already fraught.

Hahn should set the record straight.

Of course, Hahn isn’t responsible for all or even most of the mess. But he has not yet risen to the occasion and seized the opportunity to communicate clearly and accurately, or to act boldly.

The FDA Commissioner has a platform to communicate to the world, and to provide unbiased expert advice to the HHS Secretary and the President.

Of course, Hahn isn’t responsible for all or even most of the mess.

Previous commissioners, including Gottlieb and Hamburg, haven’t hesitated to stand up for science and facts when the facts were controversial or inconvenient for powerful political interests, including those of the President. That’s the commissioner’s job.

Instead, Hahn has stayed silent. For example, at a televised White House meeting with President Donald Trump, senior administration officials and biopharmaceutical executives, he said almost nothing, leaving it to others to explain basic facts about medical product development to Trump and the viewers.

It would have sent a powerful message if Hahn had spoken up to explain the difference between an antibody therapy and a vaccine, and to explain how essential the regulatory process is to ensuring the safety and efficacy of medicines.

Instead, Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, played designated adult and tried to set the record straight.

Hahn missed a chance to inform the American people that no matter how dedicated companies are to public health, and regardless of how much the President wants to deliver positive news, there are limits to how quickly therapies and vaccines can be created and made available.

Public perceptions that Hahn’s statements are misleading, and that they are calibrated to supporting political goals, could create lasting damage. When FDA approves therapies and vaccines for COVID-19, it is critical that the public believe that decisions were made based on science.

If the public loses trust in FDA’s COVID-19 policies, or in the integrity of its commissioner, there will be less confidence in its regulatory decisions in other domains.

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