We all know Big Pharma doesn’t have the greatest public image. It came second to last in a 2016 Gallup Poll that surveyed the public’s perception of 25 business sectors. Even the legal field and the oil and gas industry trumped it; only the federal government fared worse.
Does the same apply for biotech?
While biotech doesn’t share the same disdain as Big Pharma, Jim Kozubek, author of “Modern Prometheus: Editing the Human Genome with Crispr-Cas9,” believes citizens are increasingly backing away from the cutting-edge of genomic science.
In an essay for Undark Magazine exploring reasons behind the public’s growing distrust of biotech, Kozubek suggests that aggressive commercialization of biotech products and the high-profile CRISPR patent dispute have exposed the industry’s focus on profits.
As proof of the public’s dwindling trust, he cites the extremely low consent rates for an ongoing study in Boston, Massachusetts, dubbed the BabySeq Project. Just seven percent of parents have consented to have their baby’s genome sequenced.
The lead scientists report that many parents declined to participate for logistical reasons (there are several questionnaires, a return visit to receive results, and a one-year follow-up period).
For those that did mull over the pros and cons of the study with a genetic counselor, there were three main reasons for declining: Not wanting to learn of unfavorable or uncertain findings (38 percent), concerns about insurance discrimination (26 percent) and concerns about privacy (22 percent).
Kozubek believes parents may have also lost faith that such studies are fueled by good intentions. He writes:
But there’s a contrasting story, taking place in San Diego, California.
On a need-to-know basis
Under the leadership of Stephen Kingsmore at Rady Children’s Institute for Genomic Medicine, a similar program called RadySeq has reported consent rates of 88 percent.
Kingsmore said in an email that he is familiar with BabySeq. Both are NIH-funded studies examining whether newborns today can benefit from genome sequencing. They share notes biweekly. However, he also highlighted some important distinctions.
RadySeq enrolls newborns that have been admitted to the hospital with an unknown illness. Many are in the neonatal intensive care unit (NICU). If clinicians can find the exact cause of the baby’s symptoms through rapid genome sequencing, the resulting diagnosis could be life-saving.
With the BabySeq program, a majority of the newborns are healthy. A smaller proportion may still be found to have a genetic disease that hasn’t yet shown symptoms. But to do so requires a broader analysis of the genome and with that, there’s a chance they will discover incidental findings that are unrelated to the baby’s health status. Some call this the ‘incidentalome.’
Following a 2013 recommendations from The American College of Medical Genetics and Genomics (ACMG), clinicians are obliged to report notable variations in 57 genes, representing the known and likely causes of 55 diseases. It includes mutations that greatly increase the child’s risk of cancer as an adult.
Kingsmore was against the ACMG guidelines from the outset. Several months after their release, he published an article in Science Translational Medicine. In it, he argued that the obligation to report key variants will discourage whole genome sequencing.
That may be happening here. RadySeq parents are requesting information they may need to save their child’s life. BabySeq parents, on the other hand, don’t have an immediate need for the genetic information. What remains are the risks (such as data privacy) and the burden of knowing their child is at high risk of developing certain diseases later in life.
In that sense, the issue is less about mistrust of biotechs and more about the perceived risk-reward ratio of genetic sequencing for infants.
“It’s more likely that while parents are desperate for a diagnosis in their newborn, they are unconvinced of the value of genome sequencing with return of results that might not have impact until adulthood,” Kingsmore wrote.
The real test?
This debate over public trust in biotech and genomics is about to be put to the test at an unprecedented scale. Led by the National Institutes of Health (NIH), the “All of Us” research program is hoping to enroll over one million Americans for a comprehensive longitudinal study. It’s currently in beta testing and in September, the group announced that it now has 2,500 volunteers signed up.
That’s a drop in the ocean compared to the eventual cohort aim, which the website states “…will have the statistical power to detect associations between environmental and/or biological exposures and a wide variety of health outcomes.”
To complicate things further, the NIH has specific goals for its demographic spread. It doesn’t want exclusively educated, well-to-do white adults — the kind that disproportionately fills clinical trials. It wants a representation of the wider United States, with 50 percent of its volunteers coming from communities that are traditionally underrepresented in biomedical research. It also wants to recruit people of all ages.
There’s nothing in it for the participants; it’s an act of goodwill. So how many individuals will enroll or allow their children to enroll to have their genetic data mined and stored for research? Time will tell how people really feel.
Photo: bernie_photo, Getty Images
The OpSus Healthcare Cloud by CloudWave is more than a cloud built for healthcare.
By adopting a precision medicine approach to pregnancy management, we can help empower today’s expectant parents in their individual pregnancy journey and provide physicians with the tools to provide optimum care.
Varda Shalev, MD, MPH
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