OPINION:
The American vaccine schedule is the most aggressive in the world, and that has led to a lot of debate and controversy.Â
As physician and vaccine expert Dr. Robert Malone says, the narrative that all vaccines are safe and effective is frankly, propaganda. However, he also argues that factor does not mean vaccines should be avoided entirely, as they also have benefits that need to be weighed with the risks.
Hear more from Dr. Malone as he joins Washington Times Commentary Editor Kelly Sadler on Politically Unstable to discuss rethinking how we approach vaccines, bureaucracy in the FDA, and more.
[SADLER] You wrote a piece for us this week criticizing the FDA, in the fact that it’s belaboring potential life-changing drugs. Can you explain to me, now that RFK Jr. is in charge, the bureaucracy, why it’s so tough to get new drugs to market?
[MALONE] That’s a really great lead. One of the problems that we have — with the secretary, who I consider a good friend — I was speaking to him earlier today about all the recent events in HHS and the turnover. It’s been very challenging for the secretary to implement significant change across the entire HHS enterprise, because we have career staff that really aren’t very responsive to the efforts to create change. And in particular, the efforts to advance a sense of urgency.
And you have career staff — you know, of course, you have the executive leadership appointed staff like Marty [Makary] and Vinay [Prasad] and the temporary director of CDER — that are very motivated to move things through. But then, as soon as products encounter the individual sections responsible for review in the various silos, what happens is it slows down to a crawl, because you’re back with the same established bureaucracy. And, you know, there’s this famous saying that’s bandied about in the industry: the only way that FDA ever changes is when somebody retires or passes away. It’s really quite ossified as an agency and highly resistant to change or any kind of innovation.Â
[SADLER] President Trump and RFK Jr. have their work cut out for them, taking on what President Trump calls the swamp. But it’s these embedded bureaucrats who are used to doing things a certain way and don’t want to learn a new way forward. What would be your recommendations in terms of how the FDA can adapt? Or what rules or regulations need to happen? Does Congress need to act? What’s the remedy for this? Because in your piece you spoke of this drug for autism. We know autism is a key focus of HHS and RFK Jr., and the fact that it’s just exploded amongst our youth. This could be a life-changing drug, but it’s still caught up in the process of being approved.
[MALONE] Yes. This agent — termed LI-79 — is really showing great response. Patients are very enthusiastic about it, as are their caregivers and parents. But what’s happening again is that despite repeated congressional efforts to implement policies and statutes that will encourage the FDA to be flexible and to have a sense of urgency in moving products like this forward, it kind of just doesn’t seem to matter. It doesn’t seem to impact on the day-to-day operations within the review branch.
I don’t think there’s any other solution there other than leadership and really bringing in new blood into many of these groups. And Kelly, that’s been one of the major issues — it’s become very, very difficult to onboard new folks within HHS. It’s not only the line regulatory staff; it’s the bureaucracy associated with recruitment, vetting, conflict of interest review, etc., that all seem to be slow-walking these appointments. It’s one of the reasons why the secretary — and it’s not just in HHS, it’s across all the agencies — is having a real challenge in bringing in new staff. I’m sure you’ve covered that the FDA appears to be increasingly hollowed out, but the leadership is not able to bring in new blood to address these problems. And so things are just slowing down more and more.
Watch the video for the full conversation.
Read more: FDA bureaucracy effectively blocking an autism-treating drug
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