Aid in Dying Trends; Stabilizing Vaccines: It's PodMed Double T!

— This week's topics also include arbovirus trends and the NIH's All of Us study

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PodMed Double T is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

This week's topics include the All of Us study, a method for heat stabilizing vaccines, arboviruses in the U.S., and use of medical assistance in dying.

Program notes:

0:42 Look at trends in medical aid in dying

1:42 95% non-Hispanic white

2:42 Began in 1994

3:44 Allows death with dignity

4:05 West Nile virus

5:08 People present with flu like symptoms

6:07 Seeing more with global warming

7:00 All of Us research program

8:00 Smart phone app

9:00 Particulate matter and health

10:00 Very open study

10:24 Vaccine preservation with sugars

11:25 Stored 3 months and reconstituted and injected

12:45 End

Transcript:

Elizabeth Tracey: How are people using medical aid and dying?

Rick Lange, MD: West Nile virus in the United States.

Elizabeth: What's the status of the All of Us research project?

Rick: And stabilizing vaccines for use in developing countries.

Elizabeth: That's what we're talking about this week on PodMed TT, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I'm Elizabeth Tracey, a medical journalist at Johns Hopkins. This will be posted on August 16th, 2019.

Rick: And I'm Rick Lange, President of the Texas Tech University Health Sciences Center in El Paso, where I'm also Dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, if it's okay with you, I'd like to start with JAMA Network Open, something that's clearly very near and dear to my heart. This was a look at trends in medical aid in dying in the states of Oregon and Washington. This is important to me, of course, in the chaplain role because I really am quite an advocate in full revelation for people having this right if they choose to have it.

They took a look here at 28 years of data combined between Washington and Oregon since 1998 to 2017 in Oregon and 2009 to 2017 in Washington. During that time, 3,368 prescriptions for ingestible medications that would bring dying were written. Of that number, 2,558 patient deaths from lethal ingestion took place. And they looked at the characteristics of all of these folks.

The majority just slightly, the majority of them were male. They were older than 65 and they were mostly, in fact, 95% of them non-Hispanic white. The vast majority of these patients had cancer -- 76.4% -- or neurological illness with other illnesses a little less common. The reasons these folks decided to employ medical aid in dying were the majority saying loss of autonomy, profoundly impaired quality of life, and loss of dignity.

I think also, tellingly, they took a look at what were the complications. There were actually not very many complications at all in the use of this strategy to end life -- 96% did not experience a complication. I've already revealed I'm an advocate for this right for people if they choose to employ it. And I would also note interestingly that in the U.K. there's just been a bill that's been introduced to allow the National Health Service to offer this as a blanket to anyone who's over the age of 90. What are your thoughts?

Rick: This story began in 1994 with the Oregon Death with Dignity Act and it allowed individuals over the age of 18 that were legal residents of Oregon to make a voluntary, informed choice to obtain a physician's prescription for oral drugs to allow them to end their life. Now, it had some parameters or guidelines around it. The procedural guidelines related to this and subsequently in the state of Washington had to have oversight by local and state agencies, and there were precautionary measures. For example, they required the patient to place three separate oral and written requests. There was a built-in waiting time period and there was a required assessment if there were some concerns the person may have some behavioral or mental issues.

Now, the major concern was, were individuals most vulnerable going to be taken advantage of? And that is the undereducated or the poor. But as you highlighted, most of the individuals that took advantage of this were college-educated. It wasn't misused and misapplied. So for individuals with a terminal illness, this allows them to have death with dignity.

Elizabeth: And I absolutely agree. Enough about that one. I think we're going to hear more, of course, of this kind of data analysis as more states are passing laws that allow people to make this choice.

Rick: Obviously, it gives the patient autonomy and a quality of life. And I think all of us value that.

Elizabeth: Indeed. Which of your two would you like to turn to?

Rick: Let's talk about West Nile virus. This is a group of viruses called arboviruses. This was reported in MMWR, that's the Center for Disease Control and Prevention. When people hear about arboviruses, they think maybe it has something to do with a tree. It has nothing at all to do with a tree. These are diseases that are primarily transmitted from humans to other humans via the mosquito vector. And what this is, this is an annual report. It's a surveillance report from 2018 looking at arboviruses, who gets infected, what are the manifestations, and can hopefully give us an idea of how to prevent them, because they're not really treatable.

What they discovered was over the course of 2018, 48 of the 51 states and the District of Columbia actually had reported cases of arboviruses. Most of them were West Nile virus, 94%. The incidence is about 5 cases per million individuals. Because it is mosquito-borne, I thought most of it would have been on the East or West coast, but the incidence was actually highest in the north and in the central region -- North Dakota, South Dakota, Wyoming, Montana. Most importantly, people present oftentimes with flu-type symptoms, but the thing we're most concerned about was neural involvement.

People get meningitis -- infection of the surrounding of their brain, actually -- encephalitis, an infection of the brain, and what's called a flaccid paralysis. That accounts for most of the hospitalizations. In fact, it's estimated there are 70 to 80 times as many non-neuroinvasive cases that don't get reported because people have just kind of flu-type symptoms. If that's the case, that means there's closer to 50,000 to 120,000 cases of West Nile virus across the United States. Most of them occur between July and September, and again, because they're not treatable, we have to take preventative measures -- obviously, to make sure there aren't mosquitoes around you, and to wear repellent and long sleeves, things of that nature.

Elizabeth: I think what's particularly concerning about this is its juxtaposition against global warming or climate change, however you'd like to phrase that. I've been corrected on that a couple of times. And my big concern is, like so many of these other mosquito-borne illnesses like malaria, that we're going to be seeing a whole lot more of this distributed all over the globe.

Rick: The other ones -- dengue and Zika virus -- as well. Your point is very well taken. I guess the message that we need to give to our listeners is if a person has meningitis or encephalitis, then West Nile virus needs to be on the radar screen. We would treat the manifestations, and more importantly begin the surveillance to try to decrease mosquito populations and let other people know that it's in their county.

Elizabeth: Let's talk just a minute about sequelae because we're well aware, of course, that when people have a neurological disease, they frequently have that.

Rick: Right. The vast majority of people recovered, 90% recovered from the neuroinvasive disease, but that means 1 in 10 die.

Elizabeth: So definitely something where we want to get people into supportive care as soon as possible.

Rick: Absolutely.

Elizabeth: OK. Let's turn from here to the New England Journal of Medicine. This is something that fascinates me, the All of Us research program. This is just a little snapshot of hey, where are we today. As a reminder for those who are not aware of this, the All of Us program is huge. Its objective is to enroll a million individuals and to take a look at them over the long haul, gathering a ton of data over these people during that time and also to recruit a very large number of underrepresented individuals, so quite ambitious.

They are including all kinds of things: physical measurements, digital health technology, collection and analysis of biospecimens, and as of July of this year, more than 175,000 participants had contributed biospecimens. Participants have to be 18 years of age or older and there are 340 recruitment sites nationally. Their charge is to get racial and ethnic minorities -- more than 45% -- and underrepresented populations, more than 75%. They asked these people -- of course, it's voluntary.

They can go on to the website when they're recruited or they also have a smartphone app. The material that's on these things is geared to a fifth-grade reading level, and they have several baseline health surveys, each of which is designed to be completed in about 15 minutes. And of course, they also have to have a physical exam for those who are contributing biospecimens.

They have a number of places nationally where people can come and be a part of this, including regional medical centers, federally qualified health centers, and VA centers, but there's also a direct volunteer route where people who are not part of these things can also choose to participate. One of the things that participants can do right now is they can choose to include their own Fitbit data, which I think is really interesting, into this, and they're hoping to expand that to support other devices.

When I took a look at some of the future sources of data they're hoping to employ, one of the things that spoke to me was geospatial and environmental data. I thought that was pretty powerful because we've talked a number of times about things like particulate matter and inhalation, and how that impacts on people's long-term health. So I'm, at least, going to be really interested to see what the outcome of all of that is.

Participants in the study will be able to have access to their own data and most of the results of the research testing while this study is underway. We don't have any results really right now, but I think it's a pretty powerful thing and I think it's going to be fascinating to see it going forward.

Rick: This is one of the few times on the program we don't report the results of a study. We actually report the study itself. Now you say, "Does this prove very helpful because it's not a randomized, control trial?" I'll take people back to the Framingham study.

That was a small community in Massachusetts that informed us that people with high blood pressure or cholesterol or diabetes or cigarette smoking all were at risk for cardiovascular disease because they were followed over the course of decades. Not only them, but their children as well. So I think this data will help us overcome many of the difficulties we have with our current studies in that they're a small sample size.We don't have the genetic information. This is going to be a very open study.

Elizabeth: I, actually, would like to be a part of it, but I think there's a number of reasons why I really wouldn't be able to. Still, we are looking forward to results from it, so stay tuned, folks.

Rick: The results will be coming out over decades, not in the next year or two.

Elizabeth: OK. Let's turn to your final one in Nature Scientific Reports.

Rick: Everybody knows that vaccination is really a critical component of global health. It saves millions of lives. However, most of the vaccines, especially the live vaccines, from the time that they're actually manufactured to the time they're dispensed, have to be kept cold at about 2° to 8° Celsius. In fact, we call this the "cold chain," because at any point from their production to when they're administered, if they're not kept cold, they lose their potency. That makes it very difficult to provide vaccines to developing countries or very rural areas. We'd like to be able to stabilize these vaccines so they can be kept at room temperature.

What these investigators did was they devised a very simple way of making these things heat stable. They added to the vaccine, a vaccine for herpes simplex virus and a vaccine for influenza -- that is a DNA virus vaccine and an RNA virus vaccine -- and they added a disaccharide and a polysaccharide, two sugars, and then they just let it air dry. Then they closed the lid on it and they stored it 3 months. They added water back to it and injected it into mice to see whether the vaccine was still stable. What they discovered when they injected the vaccines into mice, they were, in fact, effective in preventing herpes simplex virus and influenza as well.

It's inexpensive. It's readily available. These things have already been FDA approved, and this would allow us to take vaccines and keep them at room temperature for several months and then be able to use them in individuals in developing and rural areas.

Elizabeth: And I think this is just an incredible thing because that's been such a huge barrier. I would just note this thermostabilization was retained up to 40° centigrade for 8 weeks with the herpes simplex virus vaccine. That's really powerful. This stuff can get super-hot.

Rick: This is El Paso hot, by the way, and to be able to keep it where it's stable for 3 or 4 months. Now, again, that was just tested in animals. I'm not sure it's applicable to every vaccine, but it certainly opens the door to testing. When I initially read it, I thought, "It's very technical." When you get down to see what they did, it was just incredibly simple.

Elizabeth: Good news! We like simple. On that note, that's a look at this week's medical headlines from Texas Tech. I'm Elizabeth Tracey.

Rick: And I'm Rick Lange. Y'all listen up and make healthy choices.