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.
Yes, Grace… I was. We were painting the swingset and ‘chit-chatting’ as my granddaughter likes to call it. Being a baby-boomer has its perks as I have this long view of such matters as ‘what girls and boys do’ and some opinions about how it affects our health…all the way from bone density based on early childhood through developmental years of activity versus inactivity to body image and weight. Or so I thought.
Why is it that the same divisions that seemed like we worked through in the past still remain? The boys always played together at recess…something fun like kickball or chase or even just ‘let’s go expore the other side of the playground.’ The girls always played together at recess…something like ‘let’s catch up on who’s wearing what’ [like we couldn’t all see that and who cares…] and ‘let’s play house’…
Much to my surprise, Grace told me as we were painting all about how she is the girl who crosses over to play with the boys. I knew she played sports at recess because shopping for clothes for Grace means buying something pretty and pink but something–like she is wearing to drive the tractor with Granddad–that she can hang upside down in on any number of jungle gym type toys… skorts–those marvelous crossovers between shorts and skirts are the perfect ticket and have only gotten much cuter over the years. She told me that her best friend is a boy. She was the only girl invited to his birthday party. She told me how there is one boy who sometimes plays with the girls…when they need a ‘daddy’ for their household.
Interesting, I told her. I was the one rolling down hills, climbing trees, and well–being a ‘tomboy’ when I was growing up, too. “A tomboy? What’s that,” Grace asked me.
How odd that we have such difficulty talking with our kids about things that are so important. Why is that?
For one thing, it might lead to questions we can’t answer. Once we open the door with a toe halfway wedged, we know we shouldn’t be surprised if we get asked questions. We might not be able to answer questions because we don’t know the answers. They just might be asking about technical stuff that relates to science and biology, and we might not know. So, agree to find the answers. If your child is of an age where it seems appropriate, find the answers together.
Another thing that happens, of course, is that we want to save face–for us and for them. We don’t want to appear to fail to practice what we preach, whether it is having engaged in premarital sex or failing to protect ourselves from sexually transmitted infections. And we just know that if it sounds like we are trying to control our kids’ behavior, they won’t like it anymore than we do when sometimes tries to control us.
So, how do you do it–talk with your kids about sex? Listen. What do they have to say and what are they asking you? That is the part of talking that we so often forget…listening.
I am working on a project designed to understand how college students think about HPV. I have learned that the human papillomavirus — HPV — is confused with HIV by some male college students in this project and that some females confuse it with HBV — the hepatitis B virus…
The media has covered the HPV vaccine and, of course, we have all those direct-to-consumer ads appealing to the ‘I want to be one less’ angle. What isn’t clear in many of these stories and ads is that HPV is transmitted by skin-to-skin contact. That is why genital HPV cannot be guaranteed to be protected by use of a condom during sexual intercourse.
The HPV vaccine is, of course, not designed to prevent HIV. A female who has completed the series of HPV shots likely has about five years of protection from HPV. She is not protected from the human immunodeficiency virus — HIV. Males who mistake the two conditions, HPV and HIV, may wrongly believe that the HPV vaccine protects her and him from HIV and thus feel less inclined to use a condom to prevent HIV. That is a serious mistake.
The incidence of head and neck cancers over the past decade has been found to be related to oral HPV. College males who report engaging in open-mouthed kissing have been found to be more likely to test positive for oral HPV. But this is not the only path for transmitting oral HPV. As with genital HPV, the skin-to-skin contact provides a transmission route.
There is a vaccine for HBV. HBV affects the liver and is transmitted in ways that are similar to HIV, including blood and bodily fluids. It really can be a matter of life and death if we fail to keep straight the differences between these three and our actions to prevent them.
Near the end of 2009, the U.S. FDA approved the use of an HPV prevention vaccine for boys. It will be interesting to see how this will be sold in the marketplace. After taking such care to sell a vaccine as a strategy to reduce the incidence of cervical cancer with the slogan, “I want to be one less,” and assuming that even among a public with moderate to low levels of health and science literacy — most know that males do not have a cervix, what will the pitch be to convince parents to vaccinate their sons? It seems unlikely that any ad will focus on selling a vaccine to parents that implies that their sons could be the vectors of disease for girls, as that would turn attention toward sex which the advertisers so carefully avoided in focusing on cervical cancer.
Whatever the pitch, part of our conversation should focus on the vaccine’s efficacy. Clinical studies vary in estimating how many years of protection a vaccine affords, but it seems to be around three years. Some say it may be five years. In either case, there is no revaccination policy at present. As consumers, parents, patients…we need to advocate for a policy.
We need to ask ourselves if and when it is the right time to be vaccinated. We need to understand what HPV is and how it is transmitted. Since the virus is spread in skin to skin contact, a condom may not be enough protection from getting the virus if we come in contact with it during sex. We should talk about that fact with our daughters who may be trying to decide if the use of a condom is the best way to protect themselves from sexually transmitted infections and diseases. And we need to talk with our sons about the fact as well, and remind them that the HPV prevention vaccine does not protect from HIV.
We need to realize that for women, being vaccinated does not mean we do not need to have cervical cancer screenings. Will the advertisers include that in their future messages?