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Every headline this morning mentioned possible treatments for COVID. Yet when you read the actual story it quickly pivoted into a binary, "he said-he said" morass.
As someone who has lived the fight for treatments, let me drop some knowledge that I wish was included instead
As someone who has lived the fight for treatments, let me drop some knowledge that I wish was included instead
Let me start with a disclaimer: I'm not a doctor. Instead, I'm an ALS patient and advocate who has lived with and fought to update the drug access and discovery system every day since being diagnosed with this 100% terminal disease 2.5 years ago. So I write from that experience.
The drug discovery system in this country is not a binary process where a drug gets approved with a snap of the fingers: instead it is typically a multi-year process with a handful of off-ramps along the way.
So buckle in, this ain't gonna be a short thread.
So buckle in, this ain't gonna be a short thread.
Also spoiler alert: our drug discovery system has some good facets and some tremendous flaws. Good reporting on COVID--and how we are rewriting the system on the fly--could expose these flaws, creating huge benefits for millions whose disease fights don't grab national headlines.
So let's get started, the reductive way in which we are approaching the public discussion around the search for treatments is best distilled by this back and forth between Wolf Blitzer and Dr. Patrice Harris, head of the AMA: https://www.cnn.com/videos/politics/2020/04/06/donald-trump-coronavirus-doctor-drug-hydroxychloroquine-sot-vpx-tsr.cnn/video/playlists/coronavirus/
I don't know Dr. Harris. I'm guessing she is an amazing doctor and human being, but when Blitzer asks her what she would say to someone who wants to try an experimental treatment to fight COVID, the answer isn't, "I would say no."
The answer is: "I would first talk to them about possibly enrolling in a clinical trial or obtaining it through another FDA approved pathway."
Let me step back for a minute because many may not know what a clinical trial is.
Let me step back for a minute because many may not know what a clinical trial is.
To correct that, here is a short but incredibly clear video put out by a cancer group
The video describes the normal clinical trial process in which a drug passes through 3 phases of testing before going to market:
The video describes the normal clinical trial process in which a drug passes through 3 phases of testing before going to market:
Indeed, had Dr. Harris said what I propose above, she and CNN (and others) could have then directed people to this handy CDC website which walks through the experimental COVID treatments and links to real ongoing or planned clinical trials https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html
https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html
Normally, our clinical trial process takes years, even in some cases nearly decade. Recognizing this, FDA and Congress have come up with some off-ramps to allow for faster access.
The first is off-label use (this is what Pres. Tump keeps calling for).
The first is off-label use (this is what Pres. Tump keeps calling for).
As is explained more in this FDA link, off-label use occurs when a doctor prescribes a drug for a patient when FDA has NOT approved the drug to treat that patient's disease or condition, but has approved it to treat some other disease or condition. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
, off-label use occurs when a doctor prescribes a drug for a patient when FDA has NOT approved the drug to treat that patient's disease or condition, but has approved it to treat some other disease or condition. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
The 2nd off-ramp is called Expanded Access or Compassionate Use. According to FDA, this pathway is available for patients with (i) an immediately life-threatening condition or serious disease (ii) when no comparable or satisfactory alternative therapy options are available, and
(iii) there is both no possibility of enrolling in a clinical trial and the potential benefit to the patient outweighs the risks. Again, FDA's own words below
The final off-ramp is the recent Right to Try legislation. https://www.fda.gov/news-events/public-health-focus/expanded-access
The final off-ramp is the recent Right to Try legislation. https://www.fda.gov/news-events/public-health-focus/expanded-access
I'm not going to spend much time on this as it does not apply here as: (i) no potential treatment for COVID has gone through a full phase 1 (outside of China) and (ii) all the leading candidates HAVE been approved by FDA for another use.
But if you want to learn more here is a link to the FDA's explanation of Right to Try
Our discourse delves into none of this, preferring instead to focus on the salacious aspects of each press conference. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
Our discourse delves into none of this, preferring instead to focus on the salacious aspects of each press conference. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
This a travesty as the fight against COVID is--for better or worse--literally rewriting how we can fight disease.
Imagine if we spent every day discussing how to reform our clinical trial system to help not only those fighting COVID but the millions of people like me.
Imagine if we spent every day discussing how to reform our clinical trial system to help not only those fighting COVID but the millions of people like me.
People who will be diagnosed with a terminal illness and spend their remaining years praying that a drug that can slow death churns slowly through Phase I, then Phase II and Phase III in time to save them.
Imagine if we were all learning about this system and thinking
Imagine if we were all learning about this system and thinking
about ways to help empower the incredible doctors and civil servants at FDA and NIH move therapies faster for those fighting COVID and those fighting terminal illness.
Imagine if we seized this moment to be bold, to become informed, to become awake to the realities of a
Imagine if we seized this moment to be bold, to become informed, to become awake to the realities of a
broken system and then used that knowledge to actually change it, to actually build a more humane system and a brighter future for millions.
Imagine.
@BenLaBolt @samstein @Elise_Jordan @WillieGeist @jaketapper @DanaPerino @RepSwalwell @BrianFitzUSA @AdyBarkan @JDVance1
Imagine.
@BenLaBolt @samstein @Elise_Jordan @WillieGeist @jaketapper @DanaPerino @RepSwalwell @BrianFitzUSA @AdyBarkan @JDVance1
