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.
While 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 [http://www.cbsnews.com/news/us-has-highest-first-day-infant-mortality-out-of-industrialized-world-group-reports/]. 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.
Well, the issue that one of the students in my undergraduate students focused on last semester — in the designing health messages class — was autism and vaccines. She explained how the medical research that led to media stories about vaccines and autism was based on a small sample size of 12 children and that 10 of 13 of the original researchers who authored the study no longer stand behind its conclusion that there is a link between autism and vaccines. Now, we have a new story in a medical journal — telling how the results in the original publication were ‘made up’. See http://kottke.org/11/01/autism-study-fraudulent
As consumers of news and health information, we can question samples sizes. We can question the ways that studies are conducted, including whether there were too few or too many control variables. We can question the lack of representativeness of a study — the failure to include males and females, or the absence of different age groups and various sociodemographic audiences, for example. But we do have to ‘trust’ that the researchers accurately represent what actually happens in the conduct of a study. Just as we trust grocers to put expiration dates on our food labels that reflect actual dates, that bankers take precautions to safeguard our accounts, that pilots and bus drivers and auto mechanics are honest when they say they have been trained to do the work that we trust them to do. And for the most part, in all of these cases, and in medical research as well — we can trust… But it doesn’t mean that we shouldn’t ask questions. And it doesn’t mean that we shouldn’t look for the credentials to support our trust…