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Who’s Participating in COVID-19 Vaccine Trials

August 14, 2020

Post Hurricane Hanna surge at Matagorda Bay beach

Storm surge goes with hurricanes, but the storm surging in the wake of the COVID-19 pandemic far outlives and outdistances the length of time that the post hurricane ocean churns. One of my most consistent topics when talking about health focuses on inclusion rather than exclusion in clinical trials. In my book co-edited with Celeste Condit, EVALUATING WOMEN’S HEALTH MESSAGES, we highlighted the exclusion of women in scientific research related to our health. Women’s lives present challenges to studies where investigators want to control as many variables as possible in order to reach their conclusions. Happily, the National Institutes of Health began to require the inclusion of women. Of course, many studies receive funding from pharmaceutical companies that do not have to comply with NIH guidelines. Still, progress has been made in the realm of inclusion rather than exclusion.

Enter the vaccine trials for COVID-19. Vaccine development takes time and involve multiple phases [https://www.nccn.org/patients/resources/clinical_trials/phases.aspx]. A Phase III clinical trial, NCT04470427 in the U.S. seeks to recruit 30,000 participants for which you may qualify [https://clinicaltrials.gov/ct2/show/record/NCT04470427]. Inclusion criteria list restrictions for both men and women regarding reproductive health:

“Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through 3 months after the second dose.”

“Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:

  • Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
  • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
  • Has agreed to continue adequate contraception through 3 months following the second dose on Day 29.
  • Is not currently breastfeeding.”

These criteria represent the truth that both sexes contribute to fetal outcomes–that’s progress. As the study protocol notes, any adult over age 18 able to follow study protocol and whose underlying health conditions, if any, are stable as defined by the investigators may volunteer.

Remember that the final reported characteristics of the vaccine study participants provide the best guess of who will benefit. If only young healthy white males volunteer, it won’t mean others won’t benefit from the vaccine. However, inclusion of males and females of different races across the lifespan in sufficient numbers to conduct valid statistical analyses will be the best way to suggest the efficacy of the vaccine for different groups.

Face mask or food deserts–one in the same?

August 13, 2020

Post Hurricane Hanna, Matagorda, TX

Remember when public health folks realized that it doesn’t do much good to promote eating fruits and vegetables if fruits and vegetables are not available or affordable?

Lots of effort was spent mapping out “food deserts” to demonstrate the problem. In 2015, the state where I now reside had the highest number of low income, low access residents–five million [ https://www.ers.usda.gov/data-products/food-access-research-atlas/state-level-estimates-of-low-income-and-low-access-populations/].

Food Desert

That got me to wondering. I haven’t heard any media telling folks where they could get a free mask to wear to protect against COVID-19. Mask wearing is being heavily promoted and even required in many places. But is this another case of telling people to do something that they simply cannot do, then blaming them for their illness when they get exposed, and even fining them for failing to wear a mask?

I checked into this. Of course, it varies by state. Here in Texas, beginning on June 24, 2020, “Governor Greg Abbott today announced that the Texas Division of Emergency Management (TDEM), in partnership with the Texas Military Department, will begin distributing 3-ply surgical masks to every Texan who undergoes COVID-19 testing at state-run mobile test collection sites.” Is this close to a case for closing the barn door after the cattle are out? In general, one is not getting tested without having symptoms and even in many cases a physician recommendation. Wouldn’t it be best if we provided free masks before someone experiences symptoms and maybe then they might never need to be tested?

My First Low Vision Device–An eye patch: “Ahoy, Matie” [and why pirates wore eye patches]

May 7, 2016

I woke up on a lovely Pennsylvania fall Saturday morning and something was not quite right. It took a bit for me to realize that my left eye wasn’t seeing… Well, it was seeing a little. Across the top, even to this day, there is a line of light that comes in. If I move my head about, I can see a narrow–very narrow–squished image. Under that is a line of ‘lavendar’ darkness. A tiny bit of light. Then darkness. I didn’t mention to my spouse for awhile. I was waiting to see–literally.

I don’t think my vision loss is quite like Kubler Ross’s stages of grief [denial, anger, bargaining, depression, acceptance]. I was more confused than in denial. I had been diagnosed with drusen in my optic nerve in both eyes some years earlier and had slowly been losing peripheral vision. If you search on drusen, you will find that there are two types. The other type that I have not been diagnosed with is related to macular degeneration. There is a family history of macular degeneration on my mothers’ side, but I had been told that drusen in the optic nerve is rare and only related to peripheral vision loss.

I emphasize the latter because it is a rather unfortunate thing that loss of peripheral vision had been treated in conversations between me and a long list of eye doctors as ‘only.’ First, I lost the central peripheral vision. I have not seen my own nose except in a mirror [or photos] in years. And, yes, that has posed few problems. Then I lost the lower peripheral vision. Still not limiting in costing me driving privileges. But try stepping out to go down stairs with no lower peripheral vision…scary. I always edge my way to the handrail and in settings where I am often needing to use stairs, I count them. I memorize how many there are so that I don’t have to go too slow in terms of holding onto the hand rail.

I had begun to lose some side peripheral vision by the time this central vision loss occurred. Interesting fact: each state determines the vision requirements for having a driver’s license. My regular ophthalmologist had warned my husband and I prior to this latest event that I was approaching the zone where I would not be able to hold a valid driver’s license due to peripheral vision loss. But I digress.

So, the odd event wasn’t changing. I told my husband. We live in a rural area where a visit to the ER for vision would be something done if your eyes were bleeding, I guess, but not for what I was experiencing. I was, however, at the specialist’s office at 9 a.m. on Monday morning. Many things followed. I remained confused. My brain was also confused. That little line of light coming in above my central vision field was making my brain fight to try to see ‘normally.’ The solution–a beige eye patch like the one in the picture here.

No pictures of me wearing one. No one ever saw me wear it except my spouse and one colleague. A knock at my office door and I could have that thing off in a flash….

http://www.sightconnection.com/ProductImages/778_m_635719018154899028.jpgSo, what does it remind you of–a pirate’s eye patch? Me, too. Do you know why pirates wore eye patches? So that one eye could be used to see in the darkness of the bowels of their ships…that’s right. Remember my story about orange lenses and contrast? Yep. They had it figured out. Interesting story about it here: http://mentalfloss.com/article/52493/why-did-pirates-wear-eye-patches

Why now?: The point of talking about low vision

May 4, 2016

IMG_3776 (1024x768)I retired this past year. It is early, but I could, and so I did. Doing so allows me time to pursue projects I could not otherwise have done. It lets me quit worrying about whether I can meet expectations at work. It lets me quit worrying about whether a human resources person will come knocking on my office door to help me see the wisdom of ‘going on disability.’ It removes the anger, frustration, and hostility I felt toward having to repeatedly ask for a classroom in my own building where my office is located and still not getting assigned to such a classroom. It allows me to be an advocate for people living with low vision, to share our experiences, to promote awareness and understanding, to encourage everyone to recognize this largely invisible group of more than 135 million people, and to apply my communication expertise to these goals… In case you were wondering or had already asked me….and even if you weren’t and didn’t…

What I saw on the last day I could see

May 3, 2016

Well, you may have heard people talk about–at least in the movies or on TV–what they were doing on a particular day before something significant happened to them or something important happened in the world, such as the day that JFK was shot. Well, I know what I was doing on the last day I could see…normally in terms of what was normal for me [I have worn corrective vision glasses since I was elementary school age]. I have beautiful pictures of that day. It was a lovely fall day–Friday, October 12, 2007– and together with my husband, we took a trip to see Frank Lloyd Wright’s ‘Falling Water’ estate. 111_1174c

It had been under construction with a large renovation undertaken for the ‘sagging’ decks overlooking the water. We set out in my Firebird, a treat to myself when I was promoted to Full Professor at the University of Georgia. 111_1124 (1024x768) 111_1115 (1024x768)

 

 

 

 

 

 

 

We purchased tickets allowing us full access to the home and grounds–before normal park hours. So we captured its wonder both inside and out. 111_1136 (768x1024) 111_1144 (1024x768) 111_1150 (768x1024)

 

 

 

 

 

 

 

 

Walking the grounds and imagining both the genius of the architect who designed the home and the serenity it would bring to live within its walls was a calming experience. 111_1151 (768x1024) 111_1154 (768x1024) 111_1156 (1024x768)

 

 

 

 

 

111_1159 (1024x768) 111_1161 (1024x768) 111_1169 (1024x768)

 

What is it that they say? –the calm before the storm….

“Mother Earth living” and turmeric: I tried it and wished FDA regulated the labeling, including interactions with blood thinners

May 2, 2016

People living with low vision trip a lot, stumble, and invariably too often fall, leaving them to seek solutions for the effects, which for me included trying turmeric for joint inflammation. For many, falling leads to broken bones [remember my shattered wrist last year], sprains–which I am constantly dealing with because of the activities I enjoy, and may trigger other conditions. 0211150939a Options of what to do about this situation include sit rather than risk these events. No. Use the white cane I was trained to use during my sessions with the counselor from PA Office for Blindness and Visual Services [https://www.portal.state.pa.us/portal/server.pt/community/blindness_and_visual_services/10367/bbvs_office_directory/718649]. Not so much [more about this another time]. I do use marvelous hiking sticks when hiking, but as discovered last month, they don’t really alert me to tree roots in my path until I trip over them. Ahem…

So, last month, I was on a hike through our woods with my husband and another dreaded fall happened. I am getting so much better at knowing how to do these things. Hence, my reference a couple of days ago to what I have been up to in spending my time learning to adapt. I tried to avoid falling but when it became clear it was inevitable, I fell backwards, landing on my butt, and not repeating any injury to my wrists. In the process, however, I did wrench my knee in a very awkward position because my foot was caught under a massive tree root hidden under the fall leaves that remained. And the knee promptly began to swell.

Because I have had a couple of prior hits to my knee[s] due to my failure to see something in my path [like a coffee table I sent flying], I have learned that I have a condition called calcium pyrophosphate deposition disease or CPPD [http://www.mayoclinic.org/diseases-conditions/pseudogout/basics/definition/con-20028152]. When I hit the coffee table with my knee, it triggered the condition, a reminder that so much of our health is an equation and when we communicate about it, we have to keep all the parts of the equation in mind. rox and rose oct 2013.jpgphotoHad I not hit the coffee table, I might never have known of this underlying condition [which would have been fine with me]. Since I did, I learned about it. I learned that 19-21 inches for a swelled knee [when the normal other knee is 15 inches] does not feel so good. I learned that a soft brace allowed me to go to work, though I put the leg up on a chair as often as possible. And I learned that after weeks of that, and still too much swelling and pain, a needle was used to aspirate the fluid…which hurt…but then the knee was closer to normal in size, though I was instructed to keep it wrapped in an ace bandage or the swelling would reappear. That lasted for awhile. And from it, I learned all about compression wear and ace bandages… So, fast forward, with this fall and swelling of the knee, I iced it and I wrapped it. And that kept the swelling to more like 17 inches as I watched it.

Some weeks passed and I was catching up on some reading, including my subscription to “Mother Earth living”the Nov/Dec 2015 issue with the headline: ‘all about amazing turmeric.’ The article is quite lengthy; I recommend reading it. In the pages of positive summaries related to its effects, I went back recently to find if anything indicated anything negative. “Most of the laboratory-based evidence for curcumin does appear favorable, but we do have to be aware that there are limited reports of potential for adverse effects” [p. 70]. Curcumin is the commercial product designed to deliver turmeric in a time-released, more easily absorbed fashion. Under a section labeled “Safety” in the article, it is noted “Doses up to 8 grams a day of curcumin cause only mild side effects, primarily stomach upset, nausea and diarrhea” [p. 71].

IMGP3160To be honest, I did not remember those cautionary phrases embedded in thousands of words. I just remembered the general gist when I began to have knee swelling that required bandaging…persistently. So I had looked up the research published regarding Curcumin. I liked what I saw. I bought the product. I took it. Day 2…I was sickkkkk. But I did not link it to Curcumin. I knew a friend had told me she takes turmeric when her arthritis acts up…keeps a bottle on the counter. I had literally felt relief in my knee 12 hours after taking a dose. I had told my sister. She then told me her husband uses the same product… It took until day 3 and being to the point of not keeping food down that I went back to the bottle and read it. Nothing about the stomach upset etc. Just a warning to pregnant or nursing women not to use it.

So I went to trusty WebMD [http://www.webmd.com/vitamins-supplements/ingredientmono-662-turmeric.aspx?activeingredientid=662]. I found the warning about stomach upset, which led me back to the Mother Earth article and the above. But, in addition to that content, WebMD noted under that side effects tab: ” Bleeding problems: Taking turmeric might slow blood clotting. This might increase the risk of bruising and bleeding in people with bleeding disorders. ”

That led me to read about interactions, where I found: “Medications that slow blood clotting (Anticoagulant / Antiplatelet drugs) interacts with TURMERIC. Turmeric might slow blood clotting. Taking turmeric along with medications that also slow clotting might increase the chances of bruising and bleeding. Some medications that slow blood clotting include aspirin, clopidogrel (Plavix), diclofenac (Voltaren, Cataflam, others), ibuprofen (Advil, Motrin, others), naproxen (Anaprox, Naprosyn, others), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, warfarin (Coumadin), and others.”

UHHHHH, that is a pretty big oversight missing from the product label and discussion of Curcumin, wouldn’t you agree?

Bono and me…my orange lenses are not a fashion statement

May 1, 2016

117_1726A new identity. One with which I share something in common with Bono, tho it would take years before I would realize that. After more medical tests than I could keep track of, and literally pictures of my eyes that looked like perhaps all that testing was making them bleed, the ophthalmologists finally did the medical equivalent–figuratively speaking–of throwing up their hands and diagnosed the cause of my sudden loss of sight and my dead optic nerve as “idiopathic.” Then the head of the team that had been leading the poking and prodding said, “I am scheduling an appointment for you with our low vision specialist.” “What?” “Well, yes, there is kind of a whole industry–she can explain it to you.” And he was off with a trail of others in his wake. And I was left to wonder what more tests were coming my way. And to think, ‘like my experience over these past weeks hasn’t been part of…a whole industry…to use his phrase?’

117_1731My first appointment with the low vision specialist took hours. There truly are many devices and many many many questions and some, yes, eye exams that go along with figuring out what ‘aids’ might be offered to assist those of us with low vision. On that particular first day, the real life-changing event came when I was handed a large ‘key chain’ like collection of lenses of many colors. The specialist asked me to look through the one that I jokingly said, “Oh, you want me to look through rose-colored glasses?” Get it? At any rate, when I did and looked again at the laminated card she handed me, there was nothing. “Anything?” she asked. “Not really.” Silence. “Well, how about if you take the pile and go ahead and look through them.” So I did. And…what to my wondering eyes did appear but a sharper image when I held up the brightly colored hunter orange lens… Yeah. Auburn hair and bright orange…there is a color combination you want to recommend. Sigh.

All I can say when people ask me to describe it is to compare it to putting on the glasses you wear–if you do–to deal with bright sun glaring off the snow to go sledding or skiing. Those of you who use such glasses know what I mean. And that is really the closest thing I can think of to share what happens when I put on glasses that have been tinted that delightful orange color corrected to my prescription. No, It does nothing for the dead optic nerve. But somehow, for that central vision in the right eye, it makes the contrast sharper…

And so, when I read that Bono finally revealed–after 20 years [see, I am not taking that long to share…] that he wears orange specs due to his glaucoma [http://www.theguardian.com/music/2014/oct/17/bono-glaucoma-20-years-u2-dark-glasses], I felt some real kinship. And when he says, ” “You’re not going to get this out of your head now and you will be saying, ‘Ah, poor old blind Bono’”–I felt particularly connected to him and his experiences…

I’m back… Living with low vision

April 30, 2016

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It has been awhile…. I gave posting a low priority as I learned to deal more and more with a diagnosis of low vision. Never heard of it? Me either. Until I was diagnosed with it. Over the coming months, I will share how asking questions, ranging from my human resources’ representative at work to all kinds of eye doctors and finally a low vision specialist, attending low vision training with a representative from the Pennsylvania Office for the Blind, and coping with endless internal debates regarding my identity and life goals unfolded. For today, I will recall the first conversation with human resources. It came about because I asked for some accommodations at work. What I really wanted was to have my teaching assignments be in the same building that my office was in. Because winters are mostly quite snowy and icy in Pennsylvania, walking across campus under the best of circumstances can be challenging. When you can only see out of the central part of one eye…no vision in the other eye and no peripheral vision in the eye you are now depending on–it is downright scary. If I could not have classrooms to teach in located in my own building–which would be a challenge since the semester was underway–I wanted to pay a graduate student escort to assist me. That meaning having approval for resources. At any rate, I found myself making an appointment to see my human resources representative. I asked my husband to go with me. We appeared at the office and explained our reason for being there. We were told, “I have never dealt with this before… I have had some faculty–mostly elderly men–have trouble hearing in the classroom. More often than not, however, students rather than faculty made me aware of the situation…” Uh, how does this relate to me? I thought. I looked at John and he looked at me. “Do you have long term disability insurance?” the representative asked. I nodded. “Well, you might want to think about” and this is where things are a bit fuzzy–I don’t know if she said resigning, retiring, quitting–but some word that meant ‘ending my career’–“and go on disability insurance.”121_0526

Yeah. Not so much. First, I did not feel ‘disabled.’ I felt that so many things about my health were above par and surely there would be ways to assist me with what had become a challenge. I guess I was shaking my head ‘no’ or something because the representative was saying, “OK, well let me look into this….”

So many questions flooded into my frame of being that day. How many people are drawing disability because someone could not think outside the box in working with them? I would be interested in hearing from you

 

A Book Review: “Deadly Outbreaks” by A.M. Levitt, PhD

December 1, 2013

sam racoon hat dec 2013Phewww. It’s cold outside! This precious pic is my five-year-old grandson snuggled with a furry raccoon stuffed animal and wearing a soft and cuddly raccoon hat. For his nap. He knows how to stay warm!

I recently finished reading Levitt’s book, “Deadly Outbreaks: How Medical Detectives Save Lives Threatened by Killer Pandemics, Exotic Viruses, and Drug-Resistant Parasites.” [http://www.amazon.com/Deadly-Outbreaks-Detectives-Threatened-Drug-Resistant/product-reviews/1626360359/ref=dp_top_cm_cr_acr_txt?ie=UTF8&showViewpoints=1]

Published by Skyhorse Publishing in 2013, this book could provide the basis of a TV drama series and contribute to the audience’s understanding of how public health is organized and delivered in the US and why so many large nations want to model our approach.

The author hopes to introduce readers to field epidemiology, even getting them excited about it as a possible career choice. Because the book is carefully researched and provides a thorough narrative regarding the seven cases highlighted, she may achieve that aim. For these reasons, I will recommend it in future health communication seminars I teach and recommend it to you as well. Here’s more about why.

The CDC’s Epidemic Intelligence Service trains medical detectives, doctors who want to track down the source of population and health risks and guide the public health response. Dead birds, mosquitoes, New York City parks, and West Nile virus–collaboration with animal health officials brought a focus to disparate views about what was happening and what needed to be done in the book’s opening case.

Levitt then moves to a case giving us a historical context for modern policy related to refugees medical screening and movement into the US. This is a chapter that makes clear the need to be assertive in the public health sphere when faced with competing political agendas, to exercise skills that don’t traditionally come to mind when identifying the meaning of epidemiology. These skills include the ability to talk to [not ‘at’] members of local communities and to engage in participant observation, taking thorough notes to document both.

The third case takes us behind the scenes of a hospital in order to uncover the origin of unexplained deaths of children. A wide range of possible explanations were considered and found to be insufficient, including toxic fumes from repair work on the roof entering through air ducts. The point-by-point discourse guides us to both a conclusion and to new policy as accepted practice in most US hospitals today.

The fourth chapter guides the reader through the 1970s case of Legionnaires’ disease. Perhaps because I remember this one well, I was fascinated to read what was going on behind the scenes.

The last three cases introduce other contexts where the public’s health can either be supported or quickly go awry. I will never be on the interstate again passing a tanker-trailer truck labeled as carrying anything related to food without wondering about the conditions for keeping the food safe and bacteria free. Right now, most of the media images of the snowfall and road accidents involve those large semis. How many of them are carrying food-related products and what happens as they have to wait out the storm? What protocols kick-in? I feel comforted, but likely falsely so, that it is cold rather than blistering heat leading to breakdowns. I am thinking that keeping the chill on reduces bacteria’s chance to grow, thought it does not die, as discuss in the fifth case in the book. The case introduces us to FoodNet, a national surveillance system supported by the CDC to track foodborne pathogens.

The sixth chapter explicitly introduces the reader to the important principle of medical detectives sleuthing by asking ‘what if’. Asking that question and revealing the conversations that ensue really does remind me of one of the TV drama show that has been number one for years now and Abby’s character at work in the lab. Different context further broadened with the case in the last chapter. Not one we often have the privilege of looking behind the curtain at. But fascinating and filled with content to engage and inform. I highly recommend this book. Not one for light reading, but one that you will be glad you invested your time in.



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