Just Because a Drug is FDA Approved Doesn't Mean it Works
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- เผยแพร่เมื่อ 16 พ.ค. 2024
- The drug approval process in the United States is complicated. There are many stakeholders and varying agendas when bringing a drug to market, and profit motives often are as big a factor as helping patients. The loopholes and shortcuts in this complex system can sometimes be used to bring drugs to market that aren't actually proven to do anything to improve patients' lives. Today we'll learn about some recent controversies about some drugs that have taken alternative and sometimes controversial routes to FDA approval.
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Never clicked on a video so fast - such an important thing to know about
Thank you Doctor for keeping us properly informed so that we can understand how the rules are created and how those rules apply to our own lives. And I thank the team behind the cameras as well. Go Team, as with surgeon admiral Sam, you people are making a difference in the world.
I don't see this problem going away while medicines are made for profit.
Excellent series please do more of these explainer type videos
Thank you for explaining this!
Will you discuss the role of physicians in drug treatment decisions? They have the privilege of being gatekeepers of prescription drug usage and should be the main influencers of treatment choice, yet I have heard very little discussion of their role in the opioid crisis.
Only the USA and New Zealand allow direct to consumer drug advertising; all other countries allow drugs to be advertised only to prescribing professionals.
Do you have any videos on the various types of topical antiseptics?
If you haven’t already, could you do a video on the link between HIV and AIDS? It’s a bit more controversial than your usual content but I feel it’s something that needs to be brought to attention.
I believe in the fast track approach as long as the patient is well informed about the potential risks and benefits
Can you do an episode on the dangers of fragrance in healthcare, and how it can be a barrier to treatment for those of us with asthma, allergies, mast cell disease, and autism?
Yes. As an autistic with MCAS and asthma, fragrance use in healthcare can be a determining factor on whether I can get safe access to healthcare.
Transcript notes of video:
00:00
With support from the nihcm or the national institute for healthcare management we've created a three-episode series about how drugs get approved in the united states the exceptions to the normal rules of approval and what some
00:11
major issues have been and how things have changed or may change in the future in the first episode we discussed the drug approval process from the discovery phase to what happens after approval in the second episode we talked about what
00:24
happens when the usual rules don't apply and in this third and final episode we'll discuss conflicting opinions about the fda's drug approval standards including some major recent drug controversies that's the topic of this
00:37
week's healthcare triage [Music] drug approval and access in the united states is a contentious topic some people think we aren't lenient enough in this regard and others think we are far
00:52
too lenient let's begin with those who think we aren't lenient enough starting with the question is the fda too risk averse both in general and in accelerated and or emergency situations according to a 2010 article in the
01:06
atlantic the number of clinical trials needed for a new drug application and the number of patients needed in those trials have risen dramatically these increased requirements have more than quadrupled the cost of the clinical
01:18
trial stage some argue that this increased cost leads to decreased innovation particularly when it comes to rare diseases and beyond cost many argue that today's drug development standards are preventing generally useful drugs
01:31
from making it to market to exemplify this many point to aspirin and penicillin as mentioned in that atlantic article it's unlikely that either of these drugs would have been approved by the fda if they were discovered today
01:44
mostly thanks to associated safety issues but they have each made dramatic differences in our medical landscape and of course there are many proponents of right to try which excludes the fda all together and provides another avenue for
01:59
terminally ill patients to gain access to investigational drugs the right to try act was signed into law in may of 2018 and is touted as an effort to bring hope to patients who have tried all government approved options those are
02:12
pretty good arguments right so what are people on the opposite side meaning those who say the fda is already too lenient saying we'll start with agia helm one of the most recent controversies agi-helm was granted
02:24
accelerated approval in june of 2021 based on its ability to reduce plaques in the brain that are associated with alzheimer's disease plaque reduction is a surrogate endpoint so the expectation is the post-approval trials will be
02:37
conducted to demonstrate that the drug reduces actual alzheimer's symptoms which is the clinical endpoint we are still awaiting those trials but it was a major controversy for the drug to be approved in the first place one of
02:51
its two major clinical trials reported no significant difference from a placebo normally a drug wouldn't obtain approval with such mixed evidence but this one did even in the face of almost unanimous disapproval from the advisory committee
03:06
this was so controversial that several major medical institutions refused to offer the drug to patients and speaking of accelerated approvals a 2021 article published in the bmj points out that since the accelerated approval option
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We definitely got it wrong about the COVID vaccines lol. This didn’t age well
So like vaccines?
Growing up, my doctor parent covered Thalidomide and the resulting wave of reforms lead to much increased public safety and also consumer confidence in medicine prescribed by doctors. Would be neat to do an appendix on this history, since we actually have data (albeit historical and dated) on what it would be like if we had fewer trials.
This article appears to cover that reasonably well.
www.medicalnewstoday.com/articles/how-the-thalidomide-scandal-led-to-safer-drugs