Hydroxy hysteria: When saving lives collides with politics and bureaucracy

Field reports from physicians around the world suggest that hydroxychloroquine, a relatively inexpensive drug used to treat malaria for more than 60 years, may be useful in fighting COVID-19. Based on this emerging data, President Trump has suggested that doctors consider the “off-label” use of hydroxychloroquine in this global emergency.

So why is President Trump being ridiculed or condemned for at least spreading a ray of hope against a disease so new it would be impossible for the Food and Drug Administration (FDA) to have its own officially approved treatment yet? Is the president promoting quackery, or worse?

Nothing of the sort.

To start, hydroxychloroquine is not being used without any safeguards. The standard clinical trials proving its value against this disease have not been conducted — but hydroxychloroquine was tested and approved six decades ago, and it has an established record of efficacy and side effects that physicians can review. More importantly, no doctor is (or should be) prescribing it without following standard protocols observed for any drug or any patient.

While hydroxychloroquine may not be the best or ultimate cure against COVID-19, and while its use may be more experimental than proven at this stage, the fact is that this is not a normal situation. We face a new, dangerously infectious virus, and abnormal times can require abnormal measures. Hydroxychloroquine has shown promise in treating symptomatic cases of COVID-19, which is why many doctors are using it. And a recent survey of some 1,200 U.S. doctors found that 65 percent said they would prescribe it to treat or prevent COVID-19 in a family member.

Indeed, medical authorities have explained for years that off-label drug use — prescribing a medication for a health condition other than its normal, approved purpose — can be an innovative way to broaden therapeutic tools in challenging medical situations. Here is what the FDA itself tells us:

Once the FDA approves a drug, health care providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. You may be asking yourself why your health care provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your health care provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.

And here is what the National Library of Medicine said — well before COVID-19 appeared on the scene — about using hydroxychloraquine against diseases for which the drug had never been officially approved: “It is also used to treat discoid or systemic lupus erythematosus and rheumatoid arthritis in patients whose symptoms have not improved with other treatments. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.”

What, then, is really going on with this debate? Sad to say, it appears that at least some of the president’s critics are being influenced by what might otherwise be rational disagreements with him on other issues, a legitimate rivalry between political parties, or even a purely personal dislike for Trump. This, despite the potential for needless deaths of thousands of Americans who contract COVID-19, long before the FDA can finish the typical multi-year process of approving a drug for any one disease.

If any example shows us that partisan politics generally has gotten out of hand, it would be this. But it is more than this, too. In truth, President Trump has a different view of “expertise” than most liberals, progressives, academics or Washington insiders. He has shown a willingness to listen to the results of scientific research, but he does not automatically “defer to the experts” on the policy implications of that research. As his record of regulatory reform has demonstrated, he is willing to cut bureaucratic red tape in order to get results.

There is not an FDA-approved treatment for COVID-19 yet — it is simply too early. But that does not mean it is an “insult against science” to conclude that governmental action should be taken in the midst of an emergency based on the best facts available. Indeed, even outside of an emergency, it is no disrespect to science to say some medical treatments that some physicians deem prudent for their patients should be allowed — and, yes, promoted — even if those have not been the subject of someone’s peer-reviewed Ph.D. thesis or years of regulatory process. Even when the experts have the time to spend years studying a problem, they often can be wrong. Doctors in the field who are treating patients have valuable information to contribute in this crisis, too.

Even when the experts are correct, there often are many assumptions and policy biases hidden in the way they articulate their conclusions and recommendations. And organizations like the FDA have their own inherent institutional biases. The more involved and sophisticated the FDA can make the process of investigating drug “efficacy,” the more the process tends to help the biggest drug companies and deter smaller competitors. If you are part of that process — a lobbyist, a drug company executive, or even an FDA scientist committed to applying the most rigorous possible standards — you may see an emergency order moving an experimental drug or process to the top of the list as a challenge to the established way of doing business.

In this crisis, the president rightly has become deeply involved in the details of public policy and is working closely with members of his White House coronavirus task force. You may disagree with his views or his style, but the establishment needs to be shaken up: The normal order of business will not be enough to defeat COVID-19. And even if you think we were unprepared for COVID-19, it was not simply the fault of one man. It is part of the problem with our national approach to solving challenges: too much regulation, too much cronyism, too much corruption.

This crisis is a wake-up call. We need to set aside the old ways of doing things in Washington, innovate together, put on our masks, and get our country back to work. 

Ramin Oskoui, MD, is CEO of Foxhall Cardiology in Washington and has met with President Trump and White House advisers on the coronavirus pandemic.

Tags Coronavirus COVID-19 Donald Trump Food and Drug Administration Hydroxychloroquine

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