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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 []. 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.

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.

Public Health and Health Insurance as a Public Good: Part 3

October 30, 2013

IMGP3157While the media has given a lot of coverage to citizens complaining about having to pay for health insurance for pregnancy when they are men or have wives past child-bearing age/interest, or for pediatric care, or birth control–the story being lost is the one about health insurance as a public good. If all citizens have access to a certain level of care, then all citizens should achieve a certain level of health, and that should be good for all of us, the public good associated with health insurance and the public’s health.

Of course, we hear these arguments in other contexts. There are people who don’t have children who don’t want to pay for public schools. People who don’t use the interstate system not wanting to pay for maintenance of the interstate system. So it seems to be a very old tune, but the words for the new verse haven’t been rehearsed very well. Without telling more about how sharing the cost of paying for a level of health care aims to benefit all of us, complaints get heard and the argument for the ACA gets lost.

Likely, over time, debates will unfold as data collects to support or fail to support ACA’s benefits for society. Will we improve on some of the major health indicators, such as infant mortality rate–with the U.S. ranking 30th on a recent list []. That is the hope. It will likely take some discussion and some effort to work toward achieving such aims. And some revision of the ACA. A foundation of understanding related to its purpose is a good place to start.

What is wrong with this picture of the US Public Health Service and commissioned corps?

October 30, 2013

Where is “public health” in the credentialing? While being a civil engineer to work on safe and quality water issues makes sense, many of the issues discussed go beyond the scope of what a civil engineer learns. The passion described for the work being done best fits education in public health. I recommend that the requirements for jobs and internships throughout the US PHS Commissioned Corps site be updated to include requirements related to public health training. These would reflect the IOM report discussed in the last post.


Health communication and children’s backpacks: Should they carry a warning label?

August 12, 2012

Warning labels. We find them on so many things. And we too often ignore them. But parents are devoted to knowing what dangers face their children. So parents often read warning labels that have to do with products they might purchase for a son or daughter. Such warnings appear on bicycle safety helmets. The CDC notes that,

Three organizations — ANSI, the Snell Memorial Foundation, and the American Society for Testing and Materials (ASTM) — have developed voluntary standards for bicycle helmets Table_1. Helmets are tested for the amount of impact protection they provide by dropping the upper torso and helmeted head of a crash-test dummy (i.e., a “helmeted headform”) onto a metal anvil and measuring the amount of force on the headform (22). Testing for strap-system strength is done by dropping a weight on the fastened strap; the weight causes weaker strap systems (i.e., straps or buckles) to break. Helmets that meet Snell standards provide better protection against bicycle- related head injury than do helmets that meet the less rigorous ANSI standards (18). The Consumer Product Safety Commission is developing federal standards for bicycle helmets. These standards will apply to all helmets sold in the United States and will most likely be similar to the existing standards.

All three existing standards require that manufacturers include warning labels that advise consumers that helmets are for bicycle use only (e.g., “not for motor-vehicle use” {23}) (24, 25). In addition, manufacturers are required to warn consumers (e.g., by including a warning label in the helmet) that a) a helmet that has sustained an impact should be returned to the manufacturer for inspection or be destroyed and replaced, and b) helmets need to be fitted and securely fastened to the bicyclist’s head to provide maximum protection

Some research and experience begins to suggest that perhaps a warning label should appear on children’s backpacks. Some backpacks used for recreational backpacking have warning labels

Some children’s backpacks have warning labels because the material that the pack is made from includes content known to be a cause of cancer. See this review for example:

“This item just arrived, a gift for my 2 year-old son. He was thrilled when he saw it. It was therefore terribly upsetting to discover the following warning (in tiny print) on one of the product labels: “WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.” This warning follows the requirements of California Proposition 65 (ample material about it on the web). This warning is, of course, unacceptably vague. However, no caring parent would risk exposing their child to a toxic substance. This morning, my son woke up asking for his backpack. I am saddened, angered, and frustrated that he and I have been put in this position by inadequate regulation of toy safety (the backpack is made in China) and inadequate disclosure (both on the toy tag and on the Amazon website) identifying the specific potential risk” [].

Consumer reports suggests that the size of the backpack, including how far down on a child’s back it falls and the width of straps, is important for the comfort of the pack for your child. For a full review of things to consider, see the report at:

Happy back to school shopping!

Applause applause for Disney and ban on junk food ads for cartoons

June 11, 2012

Disney has decided to ban ads for junk food when it comes to kids’ cartoons. That’s some good news when it comes to media exposure and kids’ learning product names. The bad news is that it won’t take effect until 2015. Wow. Why? Contracts?

Read more in the AP story here:

Weighing in on…’pink slime’

March 23, 2012

I am sure that you’ve all heard about it. But just to be sure we are on the same page, let me share a brief story about ‘pink slime’ below so you know what I am talking about. I guess one of my favorite comments I’ve heard during this discussion came from a vegetarian who stated, “If I knew where my meat was coming from, I might eat it.” For me, it is the use of the word “lean” that gets me. Count the number of times it appears in the news story here. It really makes me wonder how often I have purchased really ‘lean’ ground beef in the past and got it at a good price–but really wasn’t getting what I thought I was buying.. Hmm. And when did pink slime first get added to our meat supply? Anyone know?

Would you like to have a copy of the book, ‘Moral problems in medicine’, edited by Samuel Gorovitz and colleagues?

October 7, 2011

It happens. My library at home and in the office spills over onto the floor in my office. The floors at home. In the library. And the bedroom. There is the chair beside the TV. Oh and the table in the library. There is the tactic of placing a few books here and a few books there. All in the name of ‘decorating’ with books. But it reaches a critical mass and is just…too much. So I have selected some to part with. Before just dumping them into the local book drive box, I thought I would give you a chance to say that you would like to have this book. I will tell you a bit about it and how to have it [book jacket in tact and all] for your own.

First, let me just say that Penn State has approved a dual title degree program in bioethics, with Communication Arts & Sciences being one of the departments within which a student might elect to pursue this degree I have always been fascinated and engrossed in debates about health, health care, and ethics. Not the least of these is the continuous discussion about whether access to health care paid for by insurance ’causes’ individuals to use more care–the moral hazard linked to insurance. It is because of my interest in this area that I’ve read hundreds [yes, ’tis true] of books dealing with the topic on all kinds of levels in all kinds of nations. And I own a lot of books on this subject–broadly speaking. Which brings me to this book.  

Regarding the book itself, it is listed in this bibliography: regarding “General works in medical and bioethics.”

The book was reviewed positively in the Journal of the American Medical Association shortly after publication.  Notably, the reviewer comments on the fact that the book does not limit the topic to any one field but provides varied views from contributors in a number of fields. At any rate, if the topic interests you and you want this book, tell me so in the comment section. I will select someone to receive the book and go out of the blog to get your mailing information via email. Then the book will soon be traveling your way…

What interesting bit of information did I learn on the Rachael Ray show?

September 8, 2011

Imagine my surprise when I was listening to Rachael Ray’s cooking show and one of the guests was a female doctor who talked about a number of important health issues and took some questions from audience members. I was surprised that this guest was on a cooking show. But then I was surprised by some of the information she discussed.

Along the way, she told the audience that they should refrain from sexual intercourse for 24 hours before having a pap smear to screen for cervical cancer.  The reason for doing so is to increase the accuracy of the test results. I always receive written guidelines about preparing for my annual mammogram, including such things as not to wear deodorant or powder or lotion. But I have never received any guidelines about preparing for a pap smear. Not on an appointment reminder card. Not face-to-face with the person checking me in. Not from my doctor. Not in passing in conversation with other women.

I wonder how many dollars we would save if women knew to avoid sexual intercourse for 24 [the recommendation in the attached summary says 48] hours before an appointment for a pap smear and followed this advice. Apparently, sometimes the test result will show something that seems to be a problem but isn’t because a woman has had sexual intercourse.

I looked online and found some guidelines at I guess I will make it a goal to check whether there are things I should do to prepare for screening tests I have from now on. I suspect if you are like me, getting these things done on the prescribed timetable is hard enough. Too easy to procrastinate. I sure don’t want to have to them again just because I wasn’t prepared properly the first time.

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