June 11, 2021
Facebook Live: What Does Aducanumab Mean for Alzheimer’s?
Apollo Health’s Chief Science Officer Dr. Dale Bredesen and Chief Health Liaison Julie Gregory discussed the FDA’s recent approval of Biogen’s drug Aduhelm (aducanumab) and what this means for those seeking treatment for Alzheimer’s.
One of the many topics discussed was how this approval was “fast-tracked” by the FDA against every member of their independent advisory panel. Three members resigned in protest this week after the announcement, citing the previous data integrity issues and the lack of proof for efficacy, asserting that more trials needed to be completed before final approval was granted.
The cost of delivering the drug (including an amyloid PET scan or lumbar puncture, monthly infusions, doctor’s visits, and follow-up MRIs) which may be as high as $100,000K per year was also discussed, including the potential side effects of brain swelling and hemorrhaging. In comparison, the estimate for those on the ReCODE Protocol is around $10k per year, with the side effect of health optimization.
We’ve included a full transcript of the session and a complete recording of it below for your convenience.
Dr. Bredesen: Hi, everybody. I hope everyone is doing well and staying safe. Welcome, Julie. Good to have you again.
Julie G: Happy to be here.
Dr. Bredesen: Great. I mean, lots to talk about. There’s lots happening in the in the world of Alzheimer’s this week, and I thought it would be really a good idea to talk about the approval that happened on Monday, the FDA approved a new drug, aducanumab, which is to be called Aduhelm as its trade name. And there’s been tremendous controversy about this. And why such controversy? Don’t we all want the same thing? I think it’s important to start out by saying, yes, we all want the same thing, which is we want optimal outcomes for people who have cognitive decline, whether you have Alzheimer’s, whether you have mild cognitive impairment, whether you have SCI, subjective cognitive impairment, or whether you’re just interested in prevention. We all want the best outcomes. So why aren’t people buzzing with happiness about this approval? And so let me just put up, I’m going put up a graph here so I can show everyone one of the reasons that there’s a lot of controversy here. And so here is, let me share that. Okay, so what you can see here is what happens to someone who actually has cognitive decline. So if you look at, as you know, when you have Alzheimer’s or pre-Alzheimer’s, typically people over time decline. That’s, of course, the problem. And so here you can see, typically, people lose about 3 1/2 points on their cognitive scoring, whether you use it use MMSE or MoCA or other those sorts of scoring, you’ll lose about 3 1/2 points per year. Now, aducanumab in one trial actually was worse than the placebo. So actually, it would be down here. So I’ve put on here on the graph the best case scenario. So what was shown is that not that you get better, not that you stabilize, but you have about a 22% or slower rate of decline, that was the best outcome. Donanemab, which is not yet approved, just published recently, that they, in their best trials, got a 32% reduction or slowing of the decline. And for comparison, the trial that we just posted about two weeks ago, looking at the ReCODE approach, actually increased the score. So in other words, people actually improved instead of just slowing up the decline. So I think many people have misunderstood and thought, “Oh, aducanumab is something that’s going to make me better.” No, it doesn’t make people better. What it does is in the best case scenario, it slightly, by about 1/5, slows the decline. Now, here’s the strange thing. With the FDA approval, the FDA approved this not based on its impact on cognition, but based on its impact on amyloid. And so this is a drug that removes amyloid, and years ago, it was thought that removing amyloid would be good enough to make people better. However, multiple trials of bapineuzumab, solanezumab, crenezumab, gantenerumab, aducanumab, and on and on, have all shown that reducing the amyloid burden does not improve the cognition, these two are separate. So when the FDA came along and said, “Well, we’re not approving this based on performance and cognitive performance. We’re approving it because it removes amyloid, and we reasonably expect that that will ultimately improve cognition,” which is exactly the opposite of what the trials shown. So actually, two different people who were advisors have both resigned over this. Other people have called it intellectually insulting. And as another of the statisticians pointed out, as Julie had mentioned before, this is like shooting bullets into a barn and then going after the fact and drawing a target around the bullets that you hit it. This, in no way, hit its target. And in fact, the trials were actually stopped early because of failure. So Julie, I know you have a lot of interaction with the APOE4 community with APOE4.info with thousands of people. What has been the response to this approval?
Julie G: Most people are pretty skeptical. We do have one member who is ready to go. His order is placed in two weeks and he plans to micro-dose this drug as a preventative. He’s got his own little theory going, but that’s one of thousands of our members. So I think most people are pretty skeptical, and rightly so given the data.
Dr. Bredesen: Yeah, I would say if there is a silver lining in this fairly dark cloud, it would be that after you remove all the different things that are actually contributing to the decline, then it actually may make some sense to remove the amyloid. Now, interestingly, that was the thing that wasn’t tested in any of these studies, removing the inducers, the insulin resistance and the various pathogens and toxins, and then saying, “Okay, now that we don’t have to have the amyloid to protect ourselves against these things, is it okay to remove the amyloid after the fact?” I think that would actually be an interesting study to do. But instead, this has been used as a monotherapy, and I should add another thing here. This was used, they kept moving earlier and earlier because it didn’t work in people with Alzheimer’s, so this is now used for people who were very early on, people who had MCI and very early Alzheimer’s. This was not used for people who had mid stage or late stage Alzheimer’s, so that’s yet another caveat. And, Julie, maybe we could talk for a minute about the approval process itself because the approval process used by the FDA was highly unusual, and maybe you could comment a little on that.
Julie G: Very unusual, from what I understand the FDA, after both phase two trials were halted early, because it was clear they were not going to meet the endpoints. The FDA reached out and collaborated with Biogen and said, “Hey, guys, come on. Can we find some good news in here?” And they did a post-hoc analysis of the data. Essentially, the people for whom the drug was ineffective, were tossed out and they were able to find this very small subset of people for whom it was effective at one dose in one trial. So essentially, they threw out their data set and created a new one to make the drug appear to be effective.
Dr. Bredesen: Yeah, there were several real red flags here. One of them, of course, the statistician who was employed by Biogen, by the company itself, was the one who then found the positive effect. And then shortly after that, left the company, and claimed that it had nothing to do with this rejiggering of the data, which is a little bit questionable. And then, of course, the other thing is that they think very reasonably had an expert panel with 11 members, and 10 of the members said, “Absolutely, this should not be approved. There’s no data that say that this actually works. There are no data that say that this works.” But one other person said, “I don’t know.” So not a single person on the expert group, on the expert panel, recommended approval of this drug. And it’s not sure that it’s ever happened before, but it’s at least highly, highly unusual for the FDA to rule against every single one of the experts and say, “Oh, we’re going approve it anyway.” So another highly unusual thing, and then, of course, that caused two of the members of the panel to resign in protest of this. So it’s been a very, very strange situation here. Now, interestingly, this was approved with the proviso that in the next nine years, there’ll be a trial to see if it actually works or not. Well, we already know it doesn’t work, and so it’s going be interesting. Nine years of collecting billions and billions and billions of dollars for something that we already know doesn’t work just to see if after the fact that, can we really show that it works? So that’s another thing that’s a bit strange here. And then, of course, the other issue here is that this is now an approval that is based on amyloid, not on cognition. We want people with Alzheimer’s to have better cognition, and so that these two don’t match up. And this is now going raise the question of, what about all the other drugs? There are lots of drugs that target amyloid. they just don’t work for cognition. So here for the first time, you have something that doesn’t work for cognition that works for amyloid and has been approved. So do we now need to go back and approve bapineuzumab and solanezumab and all these other amyloid-targeted drugs that haven’t been approved because they didn’t improve cognition? So that raises a huge other issue. And then, Julie, maybe you could talk a little bit about costs? Because you’ve got to pay not just for the drug, but you’ve got to pay for all sorts of testing because of the major side effects that are associated with this drug.
Julie G: Right, so I think what Biogen is estimating now is that the drug alone is going to be $56,000 a year for a monthly infusion, but what’s not included in that figure is that we first have to determine, is there amyloid? So we need an amyloid PET scan or spinal tap, that’s fairly expensive. We also need a baseline MRI then two follow-up MRIs here, because the incident of ARIA, which is brain swelling, is very high. For a APOE4 carriers, it’s 50%. For non-APOE4 for carriers, it’s 40% of people that use this drug at the dose that supposedly effective, they get this fairly significant brain swelling. Ninety-eight percent of the cases resolved within 16 weeks, but the side effects were pretty severe for those 16 weeks. Forty percent of those with ARIA also go on to get hemorrhaging in the brain, and 17% of all people end up with micro-hemorrhages as a side effect. I also read that there were other common side effects that they didn’t attribute to either of those, including headache, falling down, diarrhea, confusion, delirium, and disorientation. So this is not a drug that is without risk. It’s extraordinarily expensive and it’s very risky.
Dr. Bredesen: Yeah, yeah, I mean, this is one of the big issues. It’s going to, one physician estimated that this will cost, overall, close to $100,000 per year by the time you get done paying for the drug, paying for all the scans, paying for all the follow up, And then of course, hoping that you don’t have to go into the hospital with these common side effects. So it’s really an unusual situation. I understand that. It does make some sense, when we’re desperate, then maybe anything is better than nothing. And unfortunately, this is one of the issues here. It’s not so clear that this is better than nothing. And in fact, with all the side effects, it may turn out to be worse than nothing for many, many people. So I think that’s one of the reasons that there’s been such a huge pushback from so many experts, and there was just low, just before it was approved, so just last Friday, there was a New York Times op-ed, from Dr. Greicius from Stanford, saying, “This is not the drug to be approved.” And this is not the way to go. And we’ve had Dr. Karlawish from Penn as well, who’s come out against this, and then many, many more. It really is kind of backwards reasoning. We really haven’t had, we haven’t had evidence that this thing actually helps people with Alzheimer’s disease. So I look forward to seeing any evidence in the future that it does help. And again, we’ve got other things coming down the road. One of the questions is, does this mean now that there will be a lot more effort on the part of multiple pharmaceutical companies to look at what other drugs might remove amyloid? Let’s not worry about the cognition, let’s just get after removing the amyloid, which again, was a theory that made sense 25 years ago, but it’s really been disproven by the various amyloid targeted drugs. You can remove the amyloid that does not make the cognition better. Unfortunately, Alzheimer’s is a little more complicated than that. And let me give an analogy here. If you let’s say, the brain is a beautiful thing. It’s like the Mona Lisa, if you’ve got a bunch of people throwing eggs at the Mona Lisa, which is basically what’s happening to your brain with Alzheimer’s. You have insults, you have insulin resistance, or pathogens, or toxins, or vascular compromise, or sleep apnea, or microbiome changes on and on and on. So what happens, you now put a barrier in front of the Mona Lisa, so that the eggs don’t damage the Mona Lisa. So what this drug does is remove the barrier. Well, okay, the eggs are just going to keep on coming. And the Mona Lisa is going be destroyed, unfortunately if we don’t stop the, if we don’t identify where these things are coming from, and if we don’t go after these sorts of things. So I think in the long run, it’s going to be critical for us, again, to go back and look at, why are you making that amyloid? Instead of just saying, “Amyloid came for some reason, nobody knows what it is, let’s just remove it.” Well, that doesn’t make people better. We really need to understand why is this amyloid coming? What actually happened to each person? Dig in for each person and determine why this actually happened? So all right, and so Julie, you mentioned that one person, and I guess one of the issues is going be, is there a difference between APOE4 positive, APOE4 negative, in terms of response, in terms of interest in this particular drug. Certainly there’s a difference in terms of side effects.
Julie G: Right, we’re more likely to have negative side effects. But Dale, why don’t we talk about the side effects of your protocol? Because there are significant side effects there and we would be wrong not to mention those.
Dr. Bredesen: Yeah, and as we’ve talked about many times the major side effect is that you get healthier. So people, the side effects are people tend to not need their antihypertensives anymore, so their blood pressure normalizes. They tend to not need their anti-diabetic drugs if they’re on them. So things like Metformin. So their insulin sensitivity improves, as you well know. Of course, they tend to lose some weight and get in better shape, just as we heard from Bruce recently, your husband, all the good things that happen there. And then of course, they tend to be able to go off their statin drugs because their lipid profiles have improved. So again, we’re not trying to fool Mother Nature, but we’re trying to work with Mother Nature. And unfortunately, the drugs are trying to go around Mother Nature, which is what gives you the side effects. So yeah, the side effects are actually all very positive, from getting on the protocol that we use as opposed to aducanumab where you can have brain swelling. And as you indicated, APOE4 positive, you’re talking about 50% of people, so very, very high, and about 17% of people with micro-hemorrhages, so you actually have some bleeding into the brain in about one out of every six people, unfortunately. So these are these are huge, huge issues going forward. And again, this also raises the question about, do we trust the FDA? The FDA has made a decision that goes against all reason and goes against their own expert?
Julie G: It goes against science.
Dr. Bredesen: Goes against the science.
Dr. Bredesen: And as one expert said, the elite editor in one of the major Alzheimer journals said, this is a setback treatment in Alzheimer’s by 15 to 20 years, so it’s very unfortunate. So let’s go, we have some excellent questions here. Let’s see what the questions are here. Okay, so, first, it says, “I heard that it’s more risky for APOE4s to take aducanumab.” Yes, absolutely, possible brain bleeds, yes. Do you know anything about this? Yes, that’s true, as Julie said, and is the risk even bigger if you’re a 4/4 versus a 4/3?
Julie G: I’m not aware of that, but it seems to make sense that it would be in a dose dependent fashion. But I am not aware of that.
Dr. Bredesen: Yeah, yeah. Okay, and then here’s a good question. This is I think, a very fair question. This is from Derrick, says, “Why can’t you just let this go? Criticizing an effort to try to help the masses with a legitimate,” here we go, “legitimate effort to offer some hope to those who could get relief or treatments?” I think it’s a very fair question, and I’m glad you brought it up. It says “the FDA, this is completely self-centered.” Okay, so no, this is, I’m, by no means, the only person. Again, let’s go back to the panel of experts. They have absolutely nothing to do with the drug. They evaluated the data, not a single one of the 11 experts recommended approval. And in fact, 10 of them strongly recommended non-approval for all the reasons that they gave because this actually doesn’t help the masses. This only helps one group, which is, it helps the group of investors in Biogen. So there is no evidence that it helps anybody else. And unfortunately fleeces a lot of people with a tremendous amount of payment. So that’s the key piece. And again, we’re all interested in best outcomes. I started this by saying we’re all interested in the same thing, best outcomes. Let’s look for how we can help everyone to prevent and reverse cognitive decline. I think that’s our common goal to the extent that Biogen is doing that, Hallelujah, and I completely agree with that. This just, again, as the op ed said from last Friday, this just isn’t the thing that does it, unfortunately. Then here’s one from Maria, “Do you know if there’s a certain level of amyloid plaque detected by scanner CSF that will qualify a person to receive the drug?” Well, certainly, in the trials, they had to show that in fact, there was amyloid plaque there, as I understand it, but I don’t know if you have to have a specific level of it to get this. I think you will have to probably have, well, you’ll have to have demonstration that there is some amyloid there. And again, as I said earlier, if there’s a positive here, it may be that after you remove the various causes, then in fact, removing the amyloid itself might turn out to be quite helpful. That just hasn’t been tested yet, but I think it would be very interesting to see. And then Lisa says here, “Read that Biogen moved the target to say it was successful and get it approved.” So yeah, I think that’s pretty clear. And that’s, again, what a number of experts have said. And again, let me go back to the fact, this is not about what we’re saying. This is about what experts all over the world are saying. Let’s see here, and then Let’s Cure Alzheimer’s says, “Could be to provide hope to patients since no new drug has been approved doesn’t seem any better than Aricept?” Oh, I think this is not even close to being as good as Aricept. Aricept actually does improve cognition. The problem with Aricept is that it’s a very modest improvement. It’s a short lived, you go right back to declining afterwards. And in the long run, the people who were on it intended to do slightly worse than those who weren’t on. But absolutely, Aricept, it does have a short-term improvement. It’s just that it doesn’t get at the root causes of the illness. So this drug is nowhere near as good as Aricept unfortunately. Let’s see then. Lynette asks, let’s see here, “When will the FDA recognize functional holistic approaches?” Yeah, that’s a great question. I do understand that this is Food and Drug Administration, so the FDA. So we have to change the narrative to include protocols as opposed to just single approaches. And I think that that is happening, I think people are beginning more and more to understand that these are complex, chronic illnesses that demand a precision medicine type of approach. And I think as more and more laboratories publish positive data from more and more of these trials using these precision medicine or systems biology protocols, I do think that the FDA will ultimately get on board and begin to look at that as well. So I do think that the future looks good in many ways. And then we’ll see, Valerie says, “I’d never heard about ARIA until yesterday.” Yeah, this is a very important thing to know about. And Julie, maybe if you could just reiterate, what is ARIA? And why is that so important with respect to aducanumab?
Julie G: Well, it’s an actual swelling of the brain that is seen on imaging, on MRI imaging, and it can have very significant side effects that accompany it, vision changes, cognitive abnormalities, all sorts of negative side effects. It’s certainly nothing that I would want to subject myself to.
Dr. Bredesen: Right, and then Alicia says, “How do you stay hopeful and sleep at night knowing the intellectual dishonesty at the FDA?” Again, I don’t think the FDA was intellectually dishonest. I think that they simply didn’t look at the data carefully enough. And then I understand they wanted something and said, “Well, there has been nothing approved since 2003. It’s 18 years, we’ve got to have something. This is better than nothing.” I also think there were a lot of major influencers that weighed in and said, “We want this, this is something that’s better than nothing.” Okay, maybe, so I do hope that in the long run, there will be a recognition that there are better ways to go. And by the way, they’re already published better results than from this. So hopefully, the FDA will pick those up over the years. Next one here. Valerie says, “Fascinating to hear about this. Wanted to look at, yeah, preventive, and actually in reversing, I think that’s the key. Letting the body heal itself.” I think that’s a very good point. Thank you, Valerie. And let’s see, Tim. So Tim is saying he’s been able to get off metformin, he’s been able to get off glucophage By doing the sort of protocol that we recommend. So fantastic, we see this again and again and again, turns out that those drugs are typically needed because we’re actually doing the wrong things, and so we’re bringing this on ourselves to some extent. And then Teresa says, “As an APOE 4/4, there is no way I would want to use this drug.” Yeah, I think you bring up a good point and I think many people are coming to the same conclusion. And I should say, as far as losing sleep, I do think there are a lot of experts around the world that are really shaking their heads and saying, “Oh my gosh, what happened? Why do we have these panels of experts if we’re not even going to listen to the panels of experts?” Now the point was made that 22% of the time, the FDA has not done what the panel recommended, but those were always when the panel was like four to six, it was split. This was 10 to zero, everybody was against it. So that’s a little bit different than the usual. And so-
Julie G: They’re not confident, yeah.
Dr. Bredesen: Yeah, this is going against everything the panel recommended. And then Valerie says, “I choose the protocol side effects.” Yeah, I do too, I do as well, very good point. And, these are associated with longer life. I mean, one of the things I’m waiting for someone to do is line up all the things that have been said, well, this really has minimal effect ’cause you can take almost anything. Take saffron, take Aricept, take dandelion. There’s a 100 things that will actually have better impacts on cognition than aducanumab. So it’s strange people have complained about all these other things, saying, “Oh, the effect isn’t that big.” Well, here the effect is virtually nothing. Okay, and then, Tammy says, “There’s a difference between hope and false hope.” Yeah, I think that’s one of the most important points, so I appreciate you bringing that up. And that’s been pointed out a lot that this is unfortunately bringing false hope to many people. And I think many people will say, “Well, I’ve got to have this. If the FDA approved it, it must be good.” And unfortunately, it really has a very minimal impact, and again, doesn’t make cognition better, slows the decline at best by about 1/5. Tim asked, “Is my allergy to NSAIDs related to brain health issues?” I don’t know for that, and it depends. Are you taking NSAIDs? And do you have auto antibodies because of those? Are you a hypersensitive to them? I mean, there are lots of things that we’d need to know to be able to weigh in on that. I would certainly check with your physician. Valerie says, “I’m shocked at how expensive this drug is.” Absolutely, $56,000 a year as we talked about plus another about 30,000 to do all the required tests, et cetera. so unfortunate, really unfortunate. “Are there natural ways to remove plaques?” Suzanne asks. Suzanne, that is a great question. And there are actually a number of things. And this was one of the excitements about curcumin years ago. Curcumin interacts with amyloid. It has both the nice anti-inflammatory effect and it has an anti-amyloid and amyloid removing effect. Another one, cat’s claw has been studied especially by Rudy Tanzi in his nice work at Harvard, looking at the reduction in amyloid with cat’s claw. So there are a number of ways to do this. And then there are other things that have been used as well, even things like bacopa and ashwagandha, that in some cases have effects to reduce the amyloid as well. So again-
Julie G: I just wanted to mention, even deep sleep helps remove amyloid. There’s many things you can do, yeah.
Dr. Bredesen: Absolutely. I think this is a really good point. And then the next question here, let’s see from Professor Woodward lectured, covered the drugs, the trials, why it came back into reasoning? Seems the New England Journal disallowed the second look now with dual-pronged approach benefits of drug given a large dose so a considerable promise.” Yeah, I think that it’s, I don’t think anything here shows considerable promise. I think the issue is it clearly does reduce the amyloid. It’s just that that hasn’t had a positive impact on the cognition. The next one here is from Bozenka, who says, “Please mention that Julie’s been diagnosed nine years ago.” Yeah, that’s a good point. So Julie, you had your initial issues, and I know saw a neurologist, and talk a little bit about you. You went to a real expert on Alzheimer’s disease about nine years ago. And you always talk about what he said to you when you talked about your genetic status and what you were trying to do, and the fact that you were already clearly having issues at that time.
Julie G: Right, I was very desperate, as you know. I turned to the Alzheimer’s Association who told me that Alzheimer’s can’t be prevented, treated, is incurable, progressive, and that most people are dead within 10 years. That’s why I was terrified by the time I saw this expert. And when I asked him what I can do to prevent my symptoms from getting worse, he said, “Good luck with that.”
Dr. Bredesen: Yeah, so he didn’t, he sounds like he had nothing to offer you.
Julie G: Yeah, nothing, nothing to offer me. So I understand the desperation from the FDA, and I appreciate that they’re willing to fast track something, but this was the wrong thing to back for sure.
Dr. Bredesen: Yeah, Nick’s saying, “Aside from Big Pharma issues, any official word yet and follow up clinical trials for the programmatic approach that we just published?” That’s a great point, we are now taking the next step in publication of that to put it into a, we have that as the preprint. Now we have to go the preprint server, which is medRxiv, now we have to go into a peer-reviewed journal and that’s what’s ongoing now. We should be starting the larger randomized controlled trial around the end of this year, so we still have to get IRB approval for that. And I should say, there is a proviso, as I mentioned earlier, that Biogen go ahead and do another trial to determine whether this, in fact, has efficacy, but they’re not required to do that for nine years. So they have nine years to do this next trial. And of course, if the trial fails, they’re not going to give back the money that people have paid for the drugs over the billions of dollars over nine years. Let’s see here. The next one is Melissa, “My 85-year old mother was taken off for cholesterol and blood pressure medicines since she’s been on the protocol.” Fantastic, so always great to hear that when people are doing the right things and not having to have those various drugs. So in fact, you’re going to save some money, certainly on those. Any credible or relied upon organizations advocating and are promoting us new treatment? Oh, absolutely, so the Alzheimer’s Association has been steadfastly behind this new treatment, I think in part because they want to have something to offer. And I think again, we all understand that that makes sense. But having false hope, having something to offer that’s now going to require all the things we’ve talked about is really tough, and unfortunately is going to put some people into the poorhouse for no improvement. Next one is Valerie, “My friend was observably better. APOE4 with the drug, so I can only speak on what I observed.” Okay, “Since I’m on Aricept and will continue as proof of long-term benefit economically.” Okay, good, well, it’s good to hear if someone was better, great. And in all trials, there will be one or two people that randomly might be better, though, this is the reason for statistics. And looking statistically, as I said, one whole trial with many people actually was worse than placebo. Another one, it was 22% less decline, but not improvement. But again, for some people great, we still need to understand why. That’s always fantastic to hear no matter what the reason. Let’s see, Chris asked, “Do the MRIs to investigate the presence of amyloid require gadolinium contrast?” So this will be amyloid plaque, so this is going be PET scans, so it’s going to be different than MRIs. And Maria says, “After following your protocol for five years, I’ve seen huge improvements. I would be interested to see if I also reduce the amount of amyloid.” Yeah, this is a great point, and I would say, if you’ve done everything right, and if you’re now removing, that would be one of the times that it actually may make sense to have an amyloid-reducing drug. I would start by using curcumin and cat’s claw and ashwagandha. Those are things that can slowly remove this, and much, much less likely. I mean, they’re not associated with ARIA. They’re not associated with microhemorrhages in the brain. But I think it’s a great point. It would be very helpful to know whether you have reduced amyloid. You can see that on amyloid PET scan. And Tim is pointing out that in his case, he has microhemorrhages. And these things can occur from a number of reasons. And he says, in his case, they were related to NSAID medications. So yes, that can happen. And of course, bacteria, mold, other inflammatory states. And then Maria says, “Desperation on all sides, especially as a person living with Alzheimer’s, it is something to hope.” Absolutely, I agree. Again, we started out by saying, anything that can help, we are all for it. At the end of the day, we all want the same thing, better outcomes. We look forward to a world in which Alzheimer’s is truly a rare disease, instead of the third leading cause of death in the United States, which it currently is. And then Bozenka says, “Are you concerned that the news will overshadow the clinical trials? Was there coincidence?” No, I think that this was something that was started years ago and our trials were started. It’s just happened, they were both started years ago. They both ended up around the same time, but that’s okay. I think, again, we want the best outcomes for everyone. So, Julie, are there other things that you want to bring up? Our time is at an end here, but I want to bring up any other important points about this particular trial, about this particular drug, and about the implications for the approval of other drugs in the future?
Julie G: Yeah, I did a cost analysis of what it costs to do ReCODE through Apollo Health. They’ve organized the protocol in a streamlined fashion. And I included the minimal subscription fee for their services, the physician visits, the supplements, and two sets of labs. And you can easily do the protocol which optimizes health and improves cognition for less than $10,000 a year. So just compare that, you have no side effects, $10,000 a year, but the costs being reduced in subsequent years because you need fewer supplements, you see your physician less and so on, but compare that to $100,000 a year for very little chance of any stabilization and the severe side effects that you’re subjected to just compare the two. I mean, please, there is hope. So many people have talked about real hope. There is real hope. And I’ve walked the walk for nine years. And I know that what we’re offering makes a difference. So buy the book, do what you can, but please, adopt these strategies, find the root causes of your disease and address them.
Dr. Bredesen: Yeah. Thank you very much, Julie. Just while we’ve been talking here, we’ve had just another couple of last minute questions here. So Valerie mentions probable vascular dementia and some degree of toxic and mentions, thank you for looking over the files with her physician, Dr. Dave Jenkins from Australia, diagnosed in 2015. The MRI now showing improvement. And by the way, we showed in our clinical trial improvements in MRIs as well. So this is another piece showing support. And so good. Yeah, please. She says, “Please start early. I could not agree more. Prevention or early reversal, those are the keys.” Tim mentions lion’s mane. Absolutely, that improves nerve growth factor, so this is absolutely. Sarah mentions, ReCODE actually improves things, reverses. Yeah, that’s the idea of reversal of cognitive decline, which is not shown in any of these other trials. Valerie mentions, she’s the host of the DAI Brain Health Hub, fantastic, still focusing on the protocol. So thank you very much for everyone for the comments. And again, we recognize, this is a controversial area. You’re entitled to your opinion, there are people who feel that this was absolutely a landmark decision, this is going be the right thing to do, and there are people that think it was the worst decision that the FDA ever made, and there’s everything in between. We want to get to the facts. We want to get to what actually happened with the approval and what the important implications are for all of us. So let’s all keep moving toward a day where Alzheimer’s is truly a rare disease. Thanks to everyone for the excellent questions and comments. And Julie, we’ll see you next time.
Julie G: Take care.
Dr. Bredesen: Bye.