@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg This is a good conversation, but just some info: Experimental drugs are difficult to access, not because of cost, but because of approval. You have to be either A.) Part of a clinical trial, or B.) Granted "expanded access" by the FDA, which is a long process.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg There's not a good legislative solution to this issue, as most "right-to-try" policies do more harm than good. That's why an initiative into funding federal agencies is the most proactive step because, in theory, it would reduce time for people to be granted expanded access.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Moreover, the turn-around time from the form a doctor must submit to grant a patient "expanded access" to an experimental drug is actually pretty good from the FDA, but the issue is born out of the company sponsoring the drug not approving the doctor's submittal of the form.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg And there's no health insurance policy that's going to fix that. Why? Because it's incredibly risky for the company sponsoring the experimental drug, and it's incredibly risky to the patient, and it's incredibly risky to the clinical trial's success. That means if the patient...
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg ...isn't an ideal candidate for the drug, and has a bad outcome, that could lead to a clinical trial's failure. Resulting in millions of wasted research and production dollars and no new drug; that would be a net-loss for everyone suffering from AWS.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Sorry, ALS*. This diseases are hard to beat, and they're hard to treat. Our medicine just isn't where it needs to be, and more funding for research will help us get to where we need to be faster. Passing legislation that creates haste in clinical trials would lead to waste.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg And ultimately, you probably wouldn't be helping the patient if you granted them expanded access to an experimental drug. The most recent study on this shows that clinical trials are only successful 14% of the time.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Meaning the drug actually treats the illness it's designed to only 14% of the time. A single bad outcome with a non-ideal patient would likely cripple the drug's chances of gaining FDA approval.
centerwatch.com/articles/12702…
centerwatch.com/articles/12702…
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Which also means that people who demonize companies that invest in experimental drugs and turn people down aren't really understanding the whole complicated mess. Could you imagine investing in something that's only got a 14% chance of returning that investment? Yikes.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Anyway, in sum, there's just nothing on the front-end that will improve access to experimental drugs. The only way you can improve access is on the back end, through investment and research funding. For more info expanded access, go here:
fda.gov/media/85675/do…
Take care.
fda.gov/media/85675/do…
Take care.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Actually, after a little more research on this, there is one idea that I think could be policy. Legislation could be passed that removes the IRB (that's the review board for granting extended access) from reviewing individual requests, if a clinician makes that request directly.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg That would shift the liability to the clinician, and not affect the clinical trial. Such legislation would likely directly help the lady in this video.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg Of course, no Presidential candidate would have this idea on his or her radar. It's one of those ideas you come to after discovering a need for it. I'd be interested to see if @PeteButtigieg would revise his pharmaceutical proposal to include it. @PeteForAmerica
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg @PeteForAmerica It's kind of hilarious how much research I did on this topic just now, and a testament to how inspiring Buttigieg can be. This video alone was a force for good in me, just now, because it inspired me to explore the topic. I explored out of a desire to help this woman.
@Rowena_lia @ArgoSachel @drmistercody @PeteButtigieg @PeteForAmerica Which is the whole point of the Buttigieg campaign. The idea of unity and #belonging, coupled with a call to service. As Americans, Buttigieg calls on us to act on our compassion for our fellow countrymen and countrywomen. This video demonstrates that value from his campaign.
