COVID-19 Update 8/26: Metabolic Health, Convalescent Plasma, CDC Recommendations, and More
Dr. Steven Bishop returned with another Facebook Live update on COVID-19. This week, he answered questions on metabolic health, convalescent plasma as a treatment, the CDC's changing recommendations, and more. Watch the video below and read on for a full recap.
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- I really liked those infographics last week from the CDC you shared. Is there any additional data on the decreased/increased risk of COVID complications with metabolic syndrome if the conditions are being managed vs. not being managed?
There's not any specific data to address that question, but in general, if the conditions are being managed and improved upon, then the risk is likely lower than if the conditions are not being controlled. Now it certainly doesn't take your risk down to the levels of someone who doesn't have those things or who's metabolic syndrome is in remission through diet exercise, that sort of thing.
But if it's in the process of being managed, it's certainly going to be a lower risk than if it's someone with type two diabetes whose blood sugar is very uncontrolled all the time. So it's sort of a relative thing there. If you're actively working on managing the problem with your doctor, you're going to be at less risk, but certainly not quite at the risk levels as somebody who doesn't have the condition altogether.
- What is the quality of evidence about the effectiveness of blood plasma as a treatment for COVID? Also, do you perceive political pressure to approve this treatment?
Let me take this one piece at a time. So, the quality of evidence about the effectiveness of convalescent plasma. This was given an emergency use authorization approval by the FDA this week. And so what convalescent plasma means is they are taking the antibodies in the plasma, which is a part of the liquid component of blood, from people who've recovered from COVID and are giving it to people who are still sick with COVID.
There's a lot of good theory and science around this whole idea of using convalescent plasma for many types of infections. And so it makes a lot of scientific sense that it would work for this reason, in general for COVID as well.
That being said, the data that has come out about this so far has not been amazing. The couple of trials that I have seen have shown some benefit, but not major benefits, and they have all been trials in small numbers of people.
Here are the links to a couple of the trials that have come out (Study 1 and Study 2). You guys can read the studies yourselves. The larger trials have been out of China. It's pretty small data. They did show some small benefits in terms of symptom reduction and a quicker onset of symptom improvement, but not big decreases or changes in mortality. Some small improvements in hospital discharge rates and things like that.
But again, we're talking about small studies. We need bigger data sets to really come to a better conclusion about these things. That being said convalescent plasma... it's generally good science. It's a safe treatment, as long as all of the usual precautions are taken whenever you're transfusing blood components from one person to another in terms of infection, risks, and all that sort of thing, for things that are not related to COVID.
In general, it's a pretty safe procedure and in the studies they've done so far, it appears that the patients tolerated the treatments very well. There were no significant side effects.
I think that it's fine to approve these sorts of treatments quickly. And I think that gets to the heart and the crux of this question, which is do I perceive political pressure to approve treatments? Everything seems to be getting politicized these days, no matter what it is.
I think that if the politics were completely out of the equation, any treatment that could work for COVID and is safe, should be pursued quickly, and it should be made available to doctors and patients on a one-on-one basis, especially in people who are very sick or who we don't have a lot of treatment options. And while we don't have a vaccine, it makes sense to give things at least temporary emergency approval while we collect more data and trust the doctors who are on the front lines, dealing with these sick patients, to make the decisions about what should or shouldn't be done. We're trained in these issues for the most part and know how to make these difficult decisions. And if it's out of our depth, there are specialists that we can consult.
We're used to making these decisions in a cloud of uncertainty. That's sort of how medicine is practiced all the time. Nothing is cut and dry. Almost nothing. And so, it makes makes very good sense that if something appears to be safe and doesn't have a high risk of hurting someone, and it may help treat COVID, it makes perfect sense medically, ethically, and otherwise to approve that treatment, at least on an emergency or temporary basis while we continue to collect data.
While there may be political pressure going on behind the scenes to kind of move these things forward at the same time, I think it does make sense to do it. As long as everybody understands what they're getting into, knowing that these treatments are not proven, may not work, and that there's a potential that there are side effects. But knowing all that, if the doctors are aware of that, the patients are informed about what's going on and the risks are reasonably well managed, and there's a potential benefit, I think it makes perfect sense to move forward with these sorts of things.
That's a long answer to that question. But there's probably political pressure, but I don't think that really should matter one way or the other.
I do agree completely. It is imperative that when we get a COVID vaccine, that we get it right on the first try, and that it have as few side effects as possible, so that we don't scare people with the vaccine.
I will comment on something we talked about last week and that's related to this, the whole idea of political pressures, etc. I'm really disturbed by our Virginia health commissioner coming out and saying he's going to make the COVID vaccine mandatory for all citizens in Virginia when we haven't even had the full trial datasets come out yet.
I think that's extremely disturbing. I don't think it's an evidence-based way to approach the issue. I wish that he would not make statements like that until we get the trial data out from the large trials that are going on. We don't know how safe the vaccines are yet. We don't know if they're truly effective. So I think that making those kinds of blanket statements scares people, and I think it's a rush to judgment. And I think that we should wait for this science. Like we all keep saying, let's follow the science. Let's wait for the science before we start making proclamations about what we are or are not going to make 8 million people do in terms of a COVID vaccine that hasn't even been completely through phase three trials yet.
I know last week I said I don't think they're going to try to make this mandatory across the board. And then a couple of days later, Dr. Oliver says that on the news. I was pretty shocked by that. I don't think it's a wise or prudent way to manage the issue. So I hope that cooler heads will prevail in the coming weeks and months as we get this data. And as we figure out what we're going to do with any vaccines that do come out.
- I read that the CDC has dropped the 14 days travel quarantine. Your thoughts?
The answer to your question is not a simple one, and I'm not going to pretend that I have all the answers or have seen all the data behind what drove them to change course on the quarantine recommendations and the testing recommendations. I'm actually seeking information now from our Virginia Department of Health. They have not changed their recommendations on the testing component, talking about people who've been exposed directly on to people who are known to have COVID, they have not changed yet. So as of now, we're still following Virginia Department of Health guidance on that here locally, and company-wide, at PartnerMD...that's what we're following.
So we're seeking some more clarity on that change, but I think what is happening is you're seeing a subtle shift to recognizing that there is no containment possible of the infection at this point, most likely. And I think some of the epidemiologists, and I think a lot of the frontline physicians and, and I suspect that's where we're going with this.
Yes, these small changes is that okay, the virus has become most likely endemic to the population, meaning it's going to continue to circulate on an ongoing basis until we get a effective vaccine or treatment for it, just like a lot of other respiratory viruses that circulate on an ongoing basis. And when you have something that's endemic, what that means is it's sort of native for the population. I suspect that that's what these subtleties shifts are, giving a nod that this is becoming endemic.
We're not likely to ever completely contain or eliminate the virus from circulation. And so it makes sense to start changing some of our strategies around testing, around quarantine, etc., to a little bit more of a practical approach for a virus that's going to continue to circulate in the community for a very long time, versus this sort of seek and destroy. It's a tactic of aggressive contact tracing, of aggressive testing of everyone.I think that's where the strategy is going.
Now you can argue whether that's the right strategy or not. I don't know the right answer to that at this time. I think that it is likely that this is going to continue to become endemic to, the population. I don't think we're going to be able to completely seek out and destroy the virus, even if we got an effective vaccine. I think it will continue to circulate just because we have continued to see small, low-level circulation, even in areas where these large peaks of cases have come and gone.
You're still seeing low-level circulation. It does not burn out completely. I think that a vaccine or an effective treatment will get those numbers lower, but I'm not sure they're ever going to get them to zero. Just like we never really get to zero with the flu. Throughout the year, you're still going to have a case pop up here or there, and I think probably COVID is going to be the same way as time goes on. And I think that's what you're seeing is a subtle, subtle shift in recognizing that practical reality. I think that's where the shift is coming from. It's a recognition of the shift to endemic pattern of infection versus pandemic or episodic infection.
Again, we can talk further about whether that's the right or the wrong approach, but I think that's where these changes are coming from. I know we're seeking more detail on those changes and hopefully we're, we'll get some more answers from, uh, Virginia department of health on that shit soon.
- Thoughts on the ivermectin/doxycycline /zinc treatment regimen?
I have not seen any data on that. I have seen that regimen out there, um, as a potential sort of alternative to the hydroxychloroquine combination. I think a lot of it's along the same theoretical grounds of how the two treatment regimens work. But I have not actually seen any data or trials on that regimen. So I can't say whether that's effective or not.
I would say that since I haven't seen data on it, I would not pursue that treatment option. If I were to get sick with COVID or have someone with COVID, I would not necessarily think that would be a good treatment option at this point, because I have not seen a lot of data on that.
Those drugs are fairly safe drugs in general, all three of those, ivermectin, doxy, and zinc, are safe things to use. That being said I haven't seen a lot of data on how effective they are. I think there's a way less data on that than even the hydroxychloroquine drug combination. So I wouldn't pursue that at this time.
- Please tell us more about the approved treatments.
The approved treatments out there right now are remdesivir, which is the antiviral that's being used in hospitalized patients, and that shows some improvement in time to symptom improvement and discharge and then some weak data on mortality improvement that doesn't really reach statistical significance. That's an approved treatment.
And then the only other approved treatment that I'm aware of in terms of treatment that's been approved for COVID specifically as an indication is the plasma, the convalescent plasma, which received an emergency use authorization. It's not exactly the same as an approval. And I believe from this was maybe approved under a similar EUA and not like a full label approval, because again, the data is really not robust at this point, even for remdesivir or plasma, which are considered the approved therapies.
- Should we get our flu shot early?
No, I would not get your flu shot early necessarily. I would make sure and get one that's right for you. There are several different flu shots actually. If you're in the 65 and older group, I would actually get the higher dose flu shot to increase the chance of developing good antibody protection to the flu virus. But I wouldn't necessarily get it early. I would get it at your usual time, September, early October. You don't want to take it too early, because the antibody response to the vaccine can wane over a period of months.
And so if you take it say, now, in August, the protection may wear out by early March when the flu virus is still circulating. So I wouldn't do it too early. The flu virus hasn't really started circulating just yet. So I would wait a couple of weeks at least before you get it. Get it sometime in mid-September or after that, by mid-October. I think that'll maximize your window in terms of protection and keeping the antibody response through the flu season.
- We discussed last week the difficulty in getting timely testing (i.e. Better Med is booked for days out). Other states (i.e. Maryland) it's easier to get same day testing. What can we do to get more testing available in Virginia?
That's a really good question. I think that the best thing you can do is let our government officials know that we are having trouble getting testing. The Virginia Department of Health lab is very slow. There has been some response from the private sector in terms of increased testing availability, but still remains very limited. As you've pointed out, I think what we continue to need is to reach out to your state senator, your state delegate, let them know that Virginia Department of Health needs drastically more resources to test more people, more efficiently.
Contact your congressional representatives and your U.S. Senator and let them know that they need to put pressure on the FDA to grant more CLIA waivers to tests. CLIA waivers are what make testing in the office for front-line physicians easier. And there are lots of tests out there that are available and that are high quality, but they are not CLIA waived, and they need to be CLIA waived so we can use them more efficiently without having to go through a lot of bureaucratic red tape to get approvals for that.
So please contact your senators, contact your congressional representatives, and ask them to contact the FDA and make these clear waivers happen, because that really is the bottleneck at this point for testing. The faster we can clear up these regulatory issues, the better off we're all going to be. Contact your reps. Let them know that's what we need. \
We need funding for the health department and we need CLIA waivers so that private practices can do more testing, more efficiently, and further. Some of what's causing the bottleneck is that many machine doing rapid testing are actually being completely diverted to nursing homes right now. And we talked about that a little bit last week, and I think that that's fine and the right thing to do. But we need to ramp up the manufacturing of these machines so that we can address these bottlenecks next as well.
- Is the saliva test is not available here?
No, not yet. We've been following that test. I know the NBA has actually been using some of those things as well. They've actually helped test some of those tests and have partnered with some universities to test those, and I'm hoping that they're going to be available as another option, but again, the problem remains CLIA waivers.
Any new test that comes on even after it becomes emergency authorized by the FDA, it's considered by default to be a high complexity test, which means that most physician's offices can actually use it. We need people as soon as these tests comes out and they're proven to be safe and effective, and it can be used easily in the office environment. And we need the FDA to move forward with CLIA, waiving them because, that is the bottleneck.
- Why does a pneumonia shot last for years but a flu shot only for months?
So the issue is not the vaccine. It's the underlying thing that is being vaccinated against in these two scenarios.
Pneumonia, vaccines, both types, the 23 valent and the 13 valent, which are known as the Pneumovax and the Prevnar, are directed at bacteria. Bacteria do not change very rapidly in terms of their gene sequences, their protein expression. They evolve much more slowly than viruses do. So any vaccine that's treated for them is going to last a very long time, because the antibody response and the responses that our body creates to those bacteria as a result of the vaccines that we give is persistent.
And it continues to work because the underlying organism doesn't change very much with the flu. The flu genome is different. It's more like a deck of cards, and it reshuffles every year, and it also mutates rapidly. So every year the flu virus has changed so much. And the underlying genetic sequence that the old flu vaccine is what makes the flu vaccine no longer protective. And the antibodies that develop in response to that vaccine no longer protect you from infection.
- In a way isn’t more people acquiring the virus a good thing? Herd immunity!?
There are two ways to look at that. So the simple answer to your question is, yes, that is a good thing. Assuming that we can do that in a way that minimizes fatalities from the virus. If we can get a lot of people to get the virus quickly, who are not going to do poorly with the virus, and they're gonna just have mild symptoms or no symptoms and get it over with, and then move on with their lives and therefore stop the circulation of the virus.
Yes. That's a good thing. The problem is that in doing that, we have a lot of people who are very high risk. And so relying on a herd immunity strategy in terms of let's just everybody get the infection and move on, that's going to kill a lot of people, as we have seen. So yes, it's a good thing in terms of moving on from the virus more quickly, but that is fraught with a lot of excess death.
The idea would be, let's try to protect the most vulnerable people as much as we can. In a sort of ideal world, what you would, right? You would isolate all the high risk people, the older people, the people with underlying conditions, you would put them in a bubble until we have an effective, safe vaccine.
All the younger people to healthier people would say, go about your life, go about your business. If you get the virus and you get sick, we'll take care of you. A lot of them are going to get the virus. Most of them are going to be completely fine. Only a few of them are going to get actually very sick and they would all get an infection. They would all get it over very quickly. We would protect all the vulnerable. When a vaccine comes out, we'd give them all the vaccine and protect them. And then we could let everybody, you know, out of all the isolation, all the shutdowns could be over. The problem is we have a situation where we don't have a vaccine and we can't always completely separate those two groups of people.
So we're sort of stuck in this limbo right now. And there's a tension between the need for herd immunity to develop and the need to protect the vulnerable, which is why the strategy right now seems a little schizophrenic in terms of the varying levels of lockdown and telling different people, different things in terms of what you need to do to protect yourself. So, and I think that's why you're seeing so much dichotomy from state to state and even locality to locality and school district to school district, and how they're handling this, because everybody's balancing that equation a little differently. I think that's ok to some extent, but it also makes things seem chaotic. It's a long way to answer your question. But herd immunity. Yes. Ultimately that's where we need to get. Ideally, we need to get there in a way that also minimizes the number of people that die.
- If the virus becomes endemic, how should public health interventions change, in addition to the CDC guidance changes we discussed? Also, what would an endemic virus mean for those of us with underlying conditions like asthma or high blood pressure? I assume that would mean we would face continual heightened risk of bad COVID outcomes.
I think what that means is that we have got to have a vaccination that is both safe and effective for high risk people, because if it does become endemic, there's nothing we can do to get it out of the population and from circulating. So our only way out of that conundrum without continually exposing people who are high risk to the virus is with the vaccine or with a prophylactic or other extremely effective treatment that comes out.
So our only way out of that conundrum is basically one of those two options. Without continuing to have the whole country or large population groups in the country in isolation or locked down. So that's the answer. I think you hit the nail on the head with your question from yesterday, getting the vaccine right. That's really the sort of the silver bullet, if you will.