FDA Commissioner on Covid Vaccine Safety and Men's Health

Bloomberg

Watch FDA Commissioner on Covid Vaccine Safety and Men's Health - Bloomberg on Dailymotion

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00:00A spokesperson sent a statement to Bloomberg last Tuesday that the FDA is doing a thorough

00:05investigation across multiple age groups here of deaths potentially related to COVID vaccines.

00:12What is the end goal for this inquiry? So first of all, it's been known that there have been rare

00:18cases of death following the COVID shot that's been published in the New England Journal of

00:22Medicine. It came out in a Senate subcommittee report and we have patient testimonials from

00:28families out there. So this is nothing new. But the moral dilemma when we came into office is that

00:33under the Biden administration, there were cases reported to the FDA. And the question is,

00:39should they be public information or not? So we believe they should. But we wanted to make sure,

00:45in fact, there was truly a link between the COVID shot and the death before we make it public.

00:50And so CNN also reported in the past week or so that the FDA is considering a black box warning

00:57on COVID vaccines. And just for the audience, a black box warning is one of the strongest pieces

01:02of caution out there. So this is a bit of a two part question. First of all, whether or not the FDA

01:08is looking at that. And when you think about the risks of the disease itself, whether putting such

01:15a warning on sort of matches that risk reward balance? Well, first of all, it's up to doctors

01:20whether or not to recommend it. And we are generally in the United States moving towards the same model

01:26they use in Europe. That is a risk stratified approach as opposed to an absolute recommendation

01:31for every single person, including young, healthy children. Does a six-year-old girl need another

01:3770 COVID shots, one each year for the rest of her life? That's a theory. It's a scientific unknown.

01:42In France, you have to be 80 years old to have the shot recommended or high risk. In the UK,

01:47I think it's 75. So we're just moving more towards that risk stratified approach internationally.

01:52Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine.

01:58The Safety and Epidemiology Center within the FDA did recommend that. It was a recommendation

02:05formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said

02:10it may be different today than it was in the first year of COVID when the shot came out. Because

02:16when you have those two doses three months apart, that's when you see the side effects go way up,

02:21like myocarditis in young people. Now that it's annual, you may not see that same prevalence.

02:26So we don't want to extrapolate findings to today if it's not transferable.

02:30I am curious, and this broadens it out beyond just COVID, but overall, the reviews that the FDA takes

02:36on existing drugs and applications out there relative to new ones coming in, how do you balance

02:42out the need to sort of speed up the initial application process with this idea that, of course,

02:47drug makers don't necessarily like you coming back to them after something's been approved and

02:51saying, okay, we need that now to vet this all over again?

02:54Well, I mean, we have a simple process. Companies present data to us, and we decide whether or not

03:00the claims that companies want to make about their products match the data they've submitted.

03:05So it's a pretty simple process. If a drug works and it's safe, it's going to get approved by the FDA.

03:09We took a big step this year in the spirit of transparency to make all FDA rejection letters

03:15public information, because if we don't accept a drug, the public deserves to know why.

03:19It also reduces corporate spin to investors of a company when they're told that, hey, the FDA wanted

03:26one little tweak. Well, that may not be the case.

03:29Well, on the issue of transparency, I mean, you guys had an announcement this morning about a move

03:33to sort of using more real-world evidence in the approval of applications. But I am curious,

03:38was the issue that you didn't have access to that information, or was the issue that you didn't

03:42necessarily, it wasn't transparent enough? You didn't actually know who these people were and

03:46what the circumstances of that evidence were? The issue is the bureaucracy of the FDA created

03:51such rigorous requirements for real-world evidence to be submitted with applications that a lot of

03:58real-world evidence just didn't qualify. I mean, the FDA had said you basically need to have patient

04:04level specific information or the ability to drill down to that. Well, that requires informed consent

04:09from an individual. So most of the large databases, the Medicare database, for example,

04:14the SEER database, the Swedish database, these large databases, you can actually see pretty granular

04:21things happening in those big databases, but companies haven't been able to submit it. So we're

04:25saying you can submit whatever you want. We're going to still hold high scientific standards,

04:31but at least give companies the ability to submit data. Is the informed consent still in place,

04:36or is that being removed? So we're still requiring a pivotal phase three randomized control trial.

04:41That's the gold standard. Now, earlier this year, just a couple weeks ago, actually, we said we're

04:46going to go from a baseline two randomized control trials required for a drug to a baseline one with

04:51exceptions. And if we allow real-world evidence to be looked at, for example, with rare diseases,

04:57that's really important. We are going down to reduce the investment required. You can actually achieve

05:04better statistical significance with one well-powered, well-designed, well-controlled,

05:10single randomized trial than you can with two mathematically. So we just need to modernize

05:15the agency and incorporate new Bayesian statistics.

05:19Well, I want to switch gears briefly from the announcement that you made this morning to

05:22something that was said by the FDA at a panel last week. This is about testosterone products,

05:27and we were talking about black box warnings earlier. You said, or the FDA said at a panel

05:33last week that it's open to making changes on black box warnings for testosterone products. Just

05:39walk us through the thinking there. Why now?

05:42Well, about four weeks ago, we announced we're removing the black box warnings on hormone replacement

05:47therapy for post-menopausal women. We got a tremendous positive response. We're setting the record

05:53straight after 22 years of dogma that has scared women away from that powerful treatment that has

05:59profound long-term health benefits. And so we turned our attention this week to men's health. And so

06:05we had experts come in and talk about the fact that over a third of men over age 45 have low

06:12testosterone. Many have symptoms, including mood decrease, depression sometimes, vitality being lower,

06:21libido being lower. Many men have symptoms, but we never talk about the topic. It's like it's taboo.

06:27This is a part of public health. It is a part of why doctors come in to see why patients come in to

06:33see their doctors. And so we want to remove the stigma, consider removing it as a schedule three

06:39controlled substance because it was made a schedule three controlled substance in the 1980s and 90s

06:44during the Olympic doping scandals. We're now, well, now the scientific community has matured to

06:49understand the benefits of testosterone therapy. So we're considering, um, um, we removed the black

06:56box warning earlier this year at the FDA, and we're getting all that information out for individuals

07:02and men across country. 10 million men take testosterone and more people need to know about

07:07it. When do you think there'll be more of a formal decision on this? Uh, you know, I would say in the

07:11next couple of months, perhaps, I mean, we already took the action to clear up the dogma that it

07:16increases, that testosterone therapy increases cardiovascular disease. We removed that black

07:21box warning earlier this year. Uh, it does not cause prostate cancer. So we're, we're trying to

07:25tell people the truth and cut through the dogma so that men who have low vitality depression or

07:31whatever the symptom is from low testosterone can consider this option objectively without the stigma

07:37that they're a drug addict or that they really shouldn't be on it. This is medical science.

07:42And so we have to apply basic scientific rigor to this issue of low testosterone in men.

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