Admin Admin

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 []. A Phase III clinical trial, NCT04470427 in the U.S. seeks to recruit 30,000 participants for which you may qualify []. 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.

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…

“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 []. 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 []. 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 []. 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?

I’m back… Living with low vision

April 30, 2016


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.” []

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.

Lyme’s disease is not just part of living in the woods

August 16, 2013

trilliumI was flipping through channels and saw Martha Stewart on David Letterman the other night. Dave was revealing that he had a ‘bull’s eye rash’–the stand-out characteristic of Lyme’s disease associated with exposure to ticks. Martha Stewart was completely dismissive, telling him she’d had it numerous times and it’s no big deal, just part of living in the woods. Basically, she told him she didn’t want to see his rash and to take some antibiotics and get over himself.

It is fortunate that Martha Stewart has not had any severe long-term and chronic conditions associated with having had Lyme’s disease. But many others are not as fortunate. For one, they do not display the ‘bull’s eye rash’ and the test for the condition is not very effective, so many people will not be correctly diagnosed. Many others may assume that it is no big deal after hearing Martha Stewart proclaim as much and fail to get care. She does say that antibiotics are needed, meaning that she does get care when she has the condition. So let’s not lose sight of that message. If you think you have been exposed, and if you have a bull’s eye rash most especially, see your doctor immediately and get on those antibiotics. Hopefully, you will have the same outcome as Martha and be fine after doing so.

In the meantime, become better informed than Martha appeared to be. Skim some of the highlights at this site:

Uncertainty, mammograms, and iodine–what do these things have in common?

August 10, 2013

IMG_3213As I looked at my grandson splashing about in the lake, I thought about the upcoming annual mammogram appointment. Last year, I had to go back for follow-up. That turned out to be an ultrasound and the ‘all clear’. More than ten years ago, I had a follow-up that required a needle biopsy but also worked its way to the ‘all clear’ signal. Because it had been so long ago, I wouldn’t say that I took my screening outcome for granted, but I didn’t feel uncertain about it the way that I did this year because of last year’s ‘call-back’.

I did a little research to settle my uncertainty while the days passed and I waited for my appointment. I searched for published science about what causes breast cysts. In one word, I came upon research linking iodine deficiency to breast cysts and a whole lot of other issues summarized by a physician in this Psychology Today article:

Here is an example of one of the published research studies related to iodine deficiency and breast cysts: 

I will be asking my primary care physician this week if I have iodine deficiency. In the meantime, while the technician took an additional x-ray picture at the screening, I did not get a call-back, and I did get a letter from the mammography site giving me the ‘all clear’ based on the screening.

It is interesting to ponder if this is a case of unintended consequences associated with communicating about the danger of consuming salt, which has been iodized to compensate for iodine deficiences noted in the 20th century.

21st century work-related health outcomes–bone spurs in the neck

June 15, 2013

me and john at raystown 2013 sojourn If you’ve read my book, ‘Talking about health,’ you may remember the narrative about physical therapy as an alternative to drugs and surgery. The story relates to having bone spurs in my neck. And one of the strategies I learned in physical therapy to deal with it and the pain they cause–support the neck. Always. So elbows on the table–not rude, pain-saving. Elbows on arm rests in the car, on the plane, any and everywhere–pain-saving. Even here, as we wait to launch our kayaks. There you see it. Elbows on my hips. And where did these bone spurs come from, you might ask. Too much time leaning into the computer without a break. Yes, the 21st century technology has its own ‘factory-worker’ like syndrome. Try to avoid it with frequent breaks and moving your neck around. If it’s too late, support your neck, lift it off the painful spot and give yourself support to relieve the pain…

What is a patent and what did the US Supreme Court decide about human genes and patents?

117_1749June 13, 2014

The US Supreme Court ruled that human genes cannot be patented. A patent is the authority to make, use, or sell something. Myriad Genetics Inc. sought patents regarding genes for which some versions have been linked to breast and ovarian cancer–the BRCA gene mutations. The Court decided that identifying and isolating these genes is not worthy of a patent. On the other hand, Myriad also has created a synthetic form of DNA known as cDNA and that was determined to be worthy of a patent.

For patients, testing for BRCA gene mutations may become more accessible. Until now, Myriad has had the only genetic test for BRCA gene mutations. Perhaps others will now develop testing and contribute to cost reductions, since Myriad does not hold exclusive rights to make, use, or sell products associated with these genes.   


Why are bugs sometimes a good thing when it comes to our rivers, streams, and health?

June 12, 2013

lewistown bridges 2013 sojourn Just returning from the annual Juniata Clean Water Partnership river sojourn. This picture  was taken in Lewistown, Pennsylvania after lunch yesterday as we started to get back on the water to continue our journey. We are near Memorial Bridge with a railroad bridge beyond that. As always, the sojourn was recreational and educational. For example, in listening to the Partnership’s director talk after one of the educational sessions, I realized once more how important visual communication can be. We had been learning about the importance of having insects as a source of food for fish in the water and the sign of a water’s health being in danger when there are no insects and then no fish. Mike told me, “It is much easier to get folks enthused about water quality when you hold up a mason jar of river water that is thick and orange. It is much harder to make your case when the water appears to be relatively ‘clean’.”

Among the chemicals in river water that cannot be seen are arsenic, mercury, and benzene. Exposure to these chemicals is linked to cancer, developmental disorders and reproductive disorders. Arsenic is tasteless and odorless, and you can’t see it. Arsenic comes from natural rock formations into the river water but also comes from mining, smelting, and other human activities.  Mercury is found in many electronic devices and is part of many industrial activities. Mercury is often released into the air and falls to the rivers in rain. For a comprehensive but nontechnical summary about benzene, this paper from the CDC is useful:


Related Posts Plugin for WordPress, Blogger...