YES: Government should not be a roadblock to patient treatment
By Christina Sandefur
For decades, the Food and Drug Administration's overly bureaucratic drug approval process has stopped patients from accessing potentially lifesaving vaccines and treatments. And thanks to the current COVID-19 pandemic, we're learning that just how severely this red tape has hampered our ability to prepare for this crisis and any public health crises ahead.
Fortunately, "Right to Try" — a federal law passed in 2018 that protects the right of terminally ill patients to try safe, experimental treatments that could prolong or save their lives — has given the FDA a new mandate to meet the needs of patients facing life-threatening illnesses. As treatments to fight COVID-19 are discovered and developed, Right to Try will guarantee that patients have more options than ever before. Right to Try has changed the way we think about what role the government should — and should not — play in determining whether patients should be free to use potential treatments.
This principle that was vindicated in Right to Try should be reinforced today: Government should get out of the way and let doctors — not bureaucrats — make medical decisions. It's not government's role to determine what kinds of hope are permitted.
Unfortunately, it can sometimes be difficult to cut through the politics. President Donald Trump has recently been criticized for touting the use of chloroquine as a possible "game changer" treatment for COVID-19. At the other extreme, some state governors have issued orders banning or limiting the use of this "unproven" treatment.
It's true that chloroquine is not FDA-approved to treat COVID-19 — no drug is. But chloroquine is "FDA-approved." In fact, it's been around for more than 80 years and was approved by the FDA years ago for use against malaria, lupus and rheumatoid arthritis. While its effectiveness against COVID-19 isn't known, its risks are. And thanks to a long-standing legal principle called "off-label use," doctors are perfectly free to prescribe an FDA-approved drug even for other diseases than the ones the FDA had in mind when that drug was approved.
Such "off-label" prescriptions are quite common — about one in every five prescriptions is made "off-label." That's why, absent other approved or proven treatments, doctors nationwide are already prescribing chloroquine as both a prophylactic and a treatment for COVID-19. Indeed, as physicians bound to save lives as best they can, they're ethically obligated to do so.
Politicians, on the other hand, aren't physicians, and they shouldn't be making medical decisions. Instead, government should be doing everything in its power to ensure that such delicate and personal choices are left where they belong: with patients and their doctors.
Yet those who have opposed Right to Try and other measures that enable patients and doctors to make their own medical choices are now speaking out against off-label use, arguing that such prescriptions will give patients "false hope."
This charge has never made sense. What exactly is "false" hope? If it means doctors might prescribe medicines that prove ineffective, that's always a possibility — even with medicines that are FDA-approved for particular ailments. A government stamp of approval doesn't mean a treatment will always be effective for everyone, and the lack of such approval doesn't mean it won't be effective for anyone. The charge of "false hope" is a rhetorical device that obscures the real hope that exists while we fight this virus.
As we fight the COVID-19 outbreak, it's clear that nobody has perfect information — not scientists, not medical professionals and definitely not the government. But one thing that is certain is that bureaucrats who aren't medical professionals should neither encourage nor discourage specific treatments. In the midst of a global pandemic — and in ordinary times, too — we should demand a drug approval system that empowers doctors to treat patients, rather than dictate the terms on which patients can live.
Christina Sandefur is the executive vice president at the Goldwater Institute. She wrote this for InsideSources.com.
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NO: Dr. Trump's snake oil might cost lives
By Michael Carome
Like a carnival barker selling snake oil, President Donald Trump repeatedly touted the use of chloroquine, an antimalarial drug, and hydroxychloroquine, another antimalarial drug that also is used to treat lupus and rheumatoid arthritis, as a "game changing" treatment for COVID-19. No scientific evidence exists to back up Trump's claims; the data on which he bases his statements are derived from poorly designed studies and anecdotes.
Should the federal government — particularly the president — encourage the use of a drug for a purpose other than that for which it was approved by the U.S. Food and Drug Administration? Absolutely not.
First, doing so can be dangerous. Both chloroquine and hydroxychloroquine have serious — and sometimes fatal — side effects. Trump casually says, "Try it, what do you have to lose?" The answer: Your life.
Both can damage the heart muscle and lead to heart failure. They also can cause a change in the electrical activity in the heart that can lead to a life-threatening and often fatal abnormal heart rhythm.
To make matters worse, some reports indicate that COVID-19 can cause inflammation of the heart muscle. That could make these patients more susceptible to chloroquine and hydroxychloroquine's adverse cardiac events. Moreover, critically ill patients, including those with respiratory failure due to the coronavirus, often develop severe blood electrolyte abnormalities that further increase the risk of dangerous abnormal heart rhythms. If these drugs are used widely to treat COVID-19 and are subsequently shown not to work, no benefit will have been provided, but some patients undoubtedly will have been harmed.
It wouldn't be the first time. History is filled with examples of long-term use of major treatments that were believed to be effective based on inadequately designed studies but later were shown to be ineffective and, in some cases, result in worse outcomes once well-designed clinical trials were conducted.
Second, promoting an FDA-approved drug for unapproved uses may trigger hoarding and subsequent drug shortages, so that patients with diseases for which the drug is FDA-approved and has been shown to be safe and effective may not be able to get critically important treatment. This is happening thanks to Trump's reckless promotion of hydroxychloroquine; patients with lupus and rheumatoid arthritis who have been treated successfully with hydroxychloroquine have not been able to refill their prescriptions.
Third, promoting an FDA-approved drug for unapproved uses could interfere with and delay the conduct of the well-designed, randomized clinical trials necessary to find out whether a drug is safe and effective for the unapproved use. Rather than consenting to enroll in a randomized trial, many patients who have heard Trump advocate the use of chloroquine and hydroxychloroquine may be unwilling to enroll in a trial and take the chance of getting a placebo.
The longer it takes to find out whether these drugs are safe and effective for treating COVID-19, the longer the period of potential exposure of a large group of patients to an ineffective but harmful treatment.
In touting chloroquine and hydroxychloroquine, Trump has invoked the "Right to Try Act," which was passed in 2018. Again, the carnival barker is misleading his audience. The Right to Try Act doesn't even apply to this situation; it applies only to experimental drugs that have not yet been approved by the FDA for any use and therefore are not on the market. Chloroquine and hydroxychloroquine were approved by the FDA for marketing in the United States in 1949 and 1955, respectively.
A doctor doesn't need the Right to Try Act to prescribe chloroquine or hydroxychloroquine to COVID-19 patients. The law already allows a doctor to prescribe an approved drug for any use.
Further, the FDA for decades has had a program for seriously ill patients with limited or no treatment options to access experimental medications. It's called the Expanded Access program, and it provides for FDA review of experimental therapies used outside the context of a clinical trial, thereby helping to ensure that proposed uses of the treatments do not pose unacceptable risk. Roughly 99% of these "compassionate use" requests are approved by the agency.
Trump should step away from his carnival booth and let qualified public health experts take the lead in truthfully informing the public about treatment options for COVID-19.
Dr. Michael Carome is director of Public Citizen's Health Research Group. He wrote this for InsideSources.com.
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