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A Global Pandemic is No Time to Slow Roll Our Search for Treatment Options

March 31, 2020

March 31, 2020
By Mark Flatten

Time is the enemy in the fight against COVID-19. There are no approved treatments or vaccines. The world’s economy is grinding to a standstill. People in many parts of the United States and other countries are virtually prisoners in their homes. And at this point, no one can say how long this will last.

Yet to many in government and the media, it seems better to simply plod through academic studies and hope for the best, rather than actively hunt for more effective ways of combatting the virus.

An article in Politico is a good example of this by-the-book mentality—representative of the kind of linear thinking that seems to dominate the entrenched bureaucracy and its unwillingness to deviate too much from the norm. At issue is President Trump’s push to advance “unproven” treatments against the virus—specifically the drugs chloroquine, which has been used since World War II to fight malaria and other conditions, and an offshoot, hydroxychloroquine. The upshot of the article is that career federal health officials are miffed that President Trump is pushing them to direct energies into getting fast answers as to whether these drugs are effective in fighting COVID-19, either separately or in combination with another common drug, the antibiotic Zithromax, or Z-Pak. And it cites a variety of anonymous sources carping about the interference by the president.

Of note, this griping among “senior Health and Human Services” officials was published Friday, when the COVID-19 death toll in the United States was 1,695. The next day, March 28, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization for the use of chloroquine and hydroxychloroquine for adolescent and adult patients who are hospitalized and “for whom a clinical trial is not an option.” By then, the death toll had reached 2,220.

In issuing the directive, Denise Hinton, chief scientist at the FDA, concluded “it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective for the treatment of COVID-19,” when used as directed. In the context of the Politico article published the day before, it would be easy to assume the FDA was merely buckling under pressure from the President. The FDA is a division of the Department of Health and Human Services (HHS), where anonymous officials were quoted as dismissive of any hope the malaria drugs would offer a viable treatment since neither has been proven effective against COVID-19. The drugs were no more “proven” effective on Saturday than they were on Friday.

But perhaps some in the federal health bureaucracy are realizing the old way of thinking just doesn’t work in a crisis. Perhaps the old thinking, as reflected in the Politico article, is giving way to a new thinking.

Here are some examples:

Old thinking: The Politico article appears under the headline “Trump’s push for risky malaria drugs disrupts coronavirus response.”

New thinking: Define “risky.” Any medication has risks, even aspirin. But one of the appeals of chloroquine is that it’s been around for decades and its risks are both well-known and minimal when compared to COVID-19. It’s cheap. And until researchers and the President started raising it as a potentially effective treatment, it was readily available.

Old thinking: The article quotes numerous anonymous sources within HHS complaining that interference from the White House is distracting them from other projects.

New thinking: What other projects? What other priorities does the FDA have right now that supersede the need to find an effective treatment of COVID-19? It is not terribly surprising that some within the HHS/FDA bureaucracy are unhappy at getting directives from this or any White House. Bureaucrats, particularly those in specialized and highly technical fields, often feel they know best and do not like interference from the politicians. Whether it’s called the bureaucracy, the administrative state, or the swamp, leaks and anonymous complaints are not unusual in any government agency when the status quo is challenged.

Old thinking: Chloroquine and hydroxychloroquine, whether alone or when combined with Z-Pak, are not “approved” treatments for COVID-19. They have never been proven “effective” at combatting the virus. One unnamed HHS official called giving patients chloroquine a “wild-goose chase,” while another noted it is an unproven therapy when “the data doesn’t support it.”

New thinking: This is all true. We don’t know yet whether it will work. We have little or no data on its effectiveness outside a few small studies. But we certainly need to find out in a hurry, because there is no “approved” medication to combat the disease. The way to find that out is to begin dispensing it and other promising medications to appropriate patients and finding out in real time whether it works. This is not a radical concept. Even before the outbreak, the FDA was under pressure to make better use of real-world evidence in assessing whether a drug or device is effective. This entails administering a treatment after it has been proven safe for use in humans in testing and shows promise of being effective, and then tracking the results in real time in the real world. The FDA has been hesitant to rely more heavily on real-world evidence to assess the safety and effectiveness of new drugs. Or in this case, new treatments for old drugs.

The fact that a treatment is not “approved” or “effective” simply means that the FDA has not branded it as approved or effective, a process that normally takes many years and much statistical study. The normal way the FDA establishes the effectiveness of a drug is to administer it to test patients (half of whom are typically given a placebo) to see if it works. Perhaps the new thinking holds that the old way of collecting data doesn’t work in a life-and-death crisis.

The bottom line of the new thinking is that we need answers now, not a year from now.

Old thinking: Vice President Mike Pence, the President’s point man on the COVID-19 response, has encouraged the off-label use of chloroquine. But according to Politico, “policy experts are increasingly worried that with senior officials like Pence encouraging off-label use rather than trials, more harm will come.” The main concern seems to be that front-line doctors will treat patients without collecting the needed data as to safety and effectiveness that can be used for scientific studies to assess the value of chloroquine and other drugs that show promise.

New thinking: This is not an academic exercise. People are dying in the real world. We don’t have the luxury of leisurely studies to determine whether chloroquine or other potential treatments will meet the statistical thresholds of effectiveness. Safety is not as much of an unknown, since chloroquine and Z-Pak have both been judged safe in humans and have long and extensive track records in treating other ailments. Those griping to Politico seem to imply that gathering data is more important than saving a patient’s life with something that might work. Data collection is important to be sure, and doctors would do well to report their results on this or any other drug. But for the front-line doctor with no other options, saving a patient’s life is rightly more important than collecting data for academic studies.

Old thinking: President Trump’s interest in the treatments seem to coincide with a phone call from a crony offering to build the government a database to track the off-label use of chloroquine treatments, according to Politico.

New thinking: Good. If we don’t have an effective way of tracking whatever data we get from treating patients with chloroquine or other drugs, we certainly need one. It doesn’t have to be some pal of the President. But someone needs to build a mechanism to track this precious data if one doesn’t already exist.

Old thinking: Politico quotes Dr. Arthur Caplan, a bioethicist at New York University, as saying, “It’s not the right thing to do, in the middle of a pandemic, to throw the kitchen sink” at patients.

New thinking: When do we deploy the kitchen sink? We are told that fighting COVID-19 is the moral equivalent to war. And right now, we don’t have any bullets that are FDA-approved. It’s hard to imagine some dog-faced GI in World War II hesitating to crack some Nazi’s skull with a kitchen sink if he had no other alternatives.

Old thinking: Early studies in China, where the outbreak began, and small subsequent studies showed indications that chloroquine could prove to be an effective treatment against the virus. However, a later Chinese study suggests no benefits from the treatment.

New thinking: It’s hard to put too much faith in much of anything coming out of China at this point. The totalitarian Chinese Communist Party early on clamped down on whistleblowers and dissenters who tried to warn the world about the potential deadly effects of COVID-19, apparently more concerned about its international image than stemming the worldwide pandemic. Since then, CCP officials have blamed the virus on some sort of Cold War-esque conspiracy by the United States. Other studies in France and South Korea have shown encouraging signs.

The Politico article couches the White House push for more investigation into the effectiveness of chloroquine as political meddling into the business of public health. This may or may not be true, probably depending more on your views of President Trump than on anything having to do with the effectiveness of the drugs. However, the story correctly notes that controlled clinical trials have been launched by the World Health Organization (WHO) and as of last week in New York State, the epicenter of the outbreak in the U.S. Neither the WHO nor just about any politician of note in New York is a fan of the President. So it is unlikely they buckled to any pressure from the president.

So the bottom line is that no one knows for sure yet whether chloroquine represents a new hope or a dead end in the fight against COVID-19. What is known is that we’d better find out pretty quickly because the death toll from the virus is rising sharply with no end in sight. The old way of thinking, even in normal times, is slow, cumbersome, and not always conclusive. It does not lend itself to a crisis.

The person who best articulated the new approach to determining whether chloroquine is worth a try in the real world is probably Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who has become the face of the response to COVID-19 in the U.S. Fauci was asked last week whether he would try hydroxychloroquine if he was a doctor treating a patient in the real world.

“Yeah, of course, particularly if people have no other option,” Fauci said.

Mark Flatten is the National Investigative Journalist at the Goldwater Institute.



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