Who Qualifies as an “Expert” And How Can We Decide Who Is Trustworthy?
This article is part of the magazine, "The Future of Science In America: The Election Issue," co-published by LeapsMag, the Aspen Institute Science & Society Program, and GOOD.
Expertise is a slippery concept. Who has it, who claims it, and who attributes or yields it to whom is a culturally specific, sociological process. During the COVID-19 pandemic, we have witnessed a remarkable emergence of legitimate and not-so-legitimate scientists publicly claiming or being attributed to have academic expertise in precisely my field: infectious disease epidemiology. From any vantage point, it is clear that charlatans abound out there, garnering TV coverage and hundreds of thousands of Twitter followers based on loud opinions despite flimsy credentials. What is more interesting as an insider is the gradient of expertise beyond these obvious fakers.
A person's expertise is not a fixed attribute; it is a hierarchical trait defined relative to others. Despite my protestations, I am the go-to expert on every aspect of the pandemic to my family. To a reporter, I might do my best to answer a question about the immune response to SARS-CoV-2, noting that I'm not an immunologist. Among other academic scientists, my expertise is more well-defined as a subfield of epidemiology, and within that as a particular area within infectious disease epidemiology. There's a fractal quality to it; as you zoom in on a particular subject, a differentiation of expertise emerges among scientists who, from farther out, appear to be interchangeable.
We all have our scientific domain and are less knowledgeable outside it, of course, and we are often asked to comment on a broad range of topics. But many scientists without a track record in the field have become favorites among university administrators, senior faculty in unrelated fields, policymakers, and science journalists, using institutional prestige or social connections to promote themselves. This phenomenon leads to a distorted representation of science—and of academic scientists—in the public realm.
Trustworthy experts will direct you to others in their field who know more about particular topics, and will tend to be honest about what is and what isn't "in their lane."
Predictably, white male voices have been disproportionately amplified, and men are certainly over-represented in the category of those who use their connections to inappropriately claim expertise. Generally speaking, we are missing women, racial minorities, and global perspectives. This is not only important because it misrepresents who scientists are and reinforces outdated stereotypes that place white men in the Global North at the top of a credibility hierarchy. It also matters because it can promote bad science, and it passes over scientists who can lend nuance to the scientific discourse and give global perspectives on this quintessentially global crisis.
Also at work, in my opinion, are two biases within academia: the conflation of institutional prestige with individual expertise, and the bizarre hierarchy among scientists that attributes greater credibility to those in quantitative fields like physics. Regardless of mathematical expertise or institutional affiliation, lack of experience working with epidemiological data can lead to over-confidence in the deceptively simple mathematical models that we use to understand epidemics, as well as the inappropriate use of uncertain data to inform them. Prominent and vocal scientists from different quantitative fields have misapplied the methods of infectious disease epidemiology during the COVID-19 pandemic so far, creating enormous confusion among policymakers and the public. Early forecasts that predicted the epidemic would be over by now, for example, led to a sense that epidemiological models were all unreliable.
Meanwhile, legitimate scientific uncertainties and differences of opinion, as well as fundamentally different epidemic dynamics arising in diverse global contexts and in different demographic groups, appear in the press as an indistinguishable part of this general chaos. This leads many people to question whether the field has anything worthwhile to contribute, and muddies the facts about COVID-19 policies for reducing transmission that most experts agree on, like wearing masks and avoiding large indoor gatherings.
So how do we distinguish an expert from a charlatan? I believe a willingness to say "I don't know" and to openly describe uncertainties, nuances, and limitations of science are all good signs. Thoughtful engagement with questions and new ideas is also an indication of expertise, as opposed to arrogant bluster or a bullish insistence on a particular policy strategy regardless of context (which is almost always an attempt to hide a lack of depth of understanding). Trustworthy experts will direct you to others in their field who know more about particular topics, and will tend to be honest about what is and what isn't "in their lane." For example, some expertise is quite specific to a given subfield: epidemiologists who study non-infectious conditions or nutrition, for example, use different methods from those of infectious disease experts, because they generally don't need to account for the exponential growth that is inherent to a contagion process.
Academic scientists have a specific, technical contribution to make in containing the COVID-19 pandemic and in communicating research findings as they emerge. But the liminal space between scientists and the public is subject to the same undercurrents of sexism, racism, and opportunism that society and the academy have always suffered from. Although none of the proxies for expertise described above are fool-proof, they are at least indicative of integrity and humility—two traits the world is in dire need of at this moment in history.
[Editor's Note: To read other articles in this special magazine issue, visit the beautifully designed e-reader version.]
How Will the New Strains of COVID-19 Affect Our Vaccination Plans?
When the world's first Covid-19 vaccine received regulatory approval in November, it appeared that the end of the pandemic might be near. As one by one, the Pfizer/BioNTech, Moderna, AstraZeneca, and Sputnik V vaccines reported successful Phase III results, the prospect of life without lockdowns and restrictions seemed a tantalizing possibility.
But for scientists with many years' worth of experience in studying how viruses adapt over time, it remained clear that the fight against the SARS-CoV-2 virus was far from over. "The more virus circulates, the more it is likely that mutations occur," said Professor Beate Kampmann, director of the Vaccine Centre at the London School of Hygiene & Tropical Medicine. "It is inevitable that new variants will emerge."
Since the start of the pandemic, dozens of new variants of SARS-CoV-2 – containing different mutations in the viral genome sequence - have appeared as it copies itself while spreading through the human population. The majority of these mutations are inconsequential, but in recent months, some mutations have emerged in the receptor binding domain of the virus's spike protein, increasing how tightly it binds to human cells. These mutations appear to make some new strains up to 70 percent more transmissible, though estimates vary and more lab experiments are needed. Such new strains include the B.1.1.7 variant - currently the dominant strain in the UK – and the 501Y.V2 variant, which was first found in South Africa.
"I'm quite optimistic that even with these mutations, immunity is not going to suddenly fail on us."
Because so many more people are becoming infected with the SARS-CoV-2 virus as a result, vaccinologists point out that these new strains will prolong the pandemic.
"It may take longer to reach vaccine-induced herd immunity," says Deborah Fuller, professor of microbiology at the University of Washington School of Medicine. "With a more transmissible variant taking over, an even larger percentage of the population will need to get vaccinated before we can shut this pandemic down."
That is, of course, as long as the vaccinations are still highly protective. The South African variant, in particular, contains a mutation called E484K that is raising alarms among scientists. Emerging evidence indicates that this mutation allows the virus to escape from some people's immune responses, and thus could potentially weaken the effectiveness of current vaccines.
What We Know So Far
Over the past few weeks, manufacturers of the approved Covid-19 vaccines have been racing to conduct experiments, assessing whether their jabs still work well against the new variants. This process involves taking blood samples from people who have already been vaccinated and assessing whether the antibodies generated by those people can neutralize the new strains in a test tube.
Pfizer has just released results from the first of these studies, declaring that their vaccine was found to still be effective at neutralizing strains of the virus containing the N501Y mutation of the spike protein, one of the mutations present within both the UK and South African variants.
However, the study did not look at the full set of mutations contained within either of these variants. Earlier this week, academics at the Fred Hutchinson Cancer Research Center in Seattle suggested that the E484K spike protein mutation could be most problematic, publishing a study which showed that the efficacy of neutralizing antibodies against this region dropped by more than ten-fold because of the mutation.
Thankfully, this development is not expected to make vaccines useless. One of the Fred Hutch researchers, Jesse Bloom, told STAT News that he did not expect this mutation to seriously reduce vaccine efficacy, and that more harmful mutations would need to accrue over time to pose a very significant threat to vaccinations.
"I'm quite optimistic that even with these mutations, immunity is not going to suddenly fail on us," Bloom told STAT. "It might be gradually eroded, but it's not going to fail on us, at least in the short term."
While further vaccine efficacy data will emerge in the coming weeks, other vaccinologists are keen to stress this same point: At most, there will be a marginal drop in efficacy against the new variants.
"Each vaccine induces what we call polyclonal antibodies targeting multiple parts of the spike protein," said Fuller. "So if one antibody target mutates, there are other antibody targets on the spike protein that could still neutralize the virus. The vaccine platforms also induce T-cell responses that could provide a second line of defense. If some virus gets past antibodies, T-cell responses can find and eliminate infected cells before the virus does too much damage."
She estimates that if vaccine efficacy decreases, for example from 95% to 85%, against one of the new variants, the main implications will be that some individuals who might otherwise have become severely ill, may still experience mild or moderate symptoms from an infection -- but crucially, they will not end up in intensive care.
"Plug and Play" Vaccine Platforms
One of the advantages of the technologies which have been pioneered to create the Covid-19 vaccines is that they are relatively straightforward to update with a new viral sequence. The mRNA technology used in the Pfizer/BioNTech and Moderna vaccines, and the adenovirus vectors used in the Astra Zeneca and Sputnik V vaccines, are known as 'plug and play' platforms, meaning that a new form of the vaccine can be rapidly generated against any emerging variant.
"With a rapid pipeline for manufacture established, these new vaccine technologies could enable production and distribution within 1-3 months of a new variant emerging."
While the technology for the seasonal influenza vaccines is relatively inefficient, requiring scientists to grow and cultivate the new strain in the lab before vaccines can be produced - a process that takes nine months - mRNA and adenovirus-based vaccines can be updated within a matter of weeks. According to BioNTech CEO Uğur Şahin, a new version of their vaccine could be produced in six weeks.
"With a rapid pipeline for manufacture established, these new vaccine technologies could enable production and distribution within 1-3 months of a new variant emerging," says Fuller.
Fuller predicts that more new variants of the virus are almost certain to emerge within the coming months and years, potentially requiring the public to receive booster shots. This means there is one key advantage the mRNA-based vaccines have over the adenovirus technologies. mRNA vaccines only express the spike protein, while the AstraZeneca and Sputnik V vaccines use adenoviruses - common viruses most of us are exposed to - as a delivery mechanism for genes from the SARS-CoV-2 virus.
"For the adenovirus vaccines, our bodies make immune responses against both SARS-CoV-2 and the adenovirus backbone of the vaccine," says Fuller. "That means if you update the adenovirus-based vaccine with the new variant and then try to boost people, they may respond less well to the new vaccine, because they already have antibodies against the adenovirus that could block the vaccine from working. This makes mRNA vaccines more amenable to repeated use."
Regulatory Unknowns
One of the key questions remains whether regulators would require new versions of the vaccine to go through clinical trials, a hurdle which would slow down the response to emerging strains, or whether the seasonal influenza paradigm will be followed, whereby a new form of the vaccine can be released without further clinical testing.
Regulators are currently remaining tight-lipped on which process they will choose to follow, until there is more information on how vaccines respond against the new variants. "Only when such information becomes available can we start the scientific evaluation of what data would be needed to support such a change and assess what regulatory procedure would be required for that," said Rebecca Harding, communications officer for the European Medicines Agency.
The Food and Drug Administration (FDA) did not respond to requests for comment before press time.
While vaccinologists feel it is unlikely that a new complete Phase III trial would be required, some believe that because these are new technologies, regulators may well demand further safety data before approving an updated version of the vaccine.
"I would hope if we ever have to update the current vaccines, regulatory authorities will treat it like influenza," said Drew Weissman, professor of medicine at the University of Pennsylvania, who was involved in developing the mRNA technology behind the Pfizer/BioNTech and Moderna vaccines. "I would guess, at worst, they may want a new Phase 1 or 1 and 2 clinical trials."
Others suggest that rather than new trials, some bridging experiments may suffice to demonstrate that the levels of neutralizing antibodies induced by the new form of the vaccine are comparable to the previous one. "Vaccines have previously been licensed by this kind of immunogenicity data only, for example meningitis vaccines," said Kampmann.
While further mutations and strains of SARS-CoV-2 are inevitable, some scientists are concerned that the vaccine rollout strategy being employed in some countries -- of distributing a first shot to as many people as possible, and potentially delaying second shots as a result -- could encourage more new variants to emerge. Just today, the Biden administration announced its intention to release nearly all vaccine doses on hand right away, without keeping a reserve for second shots. This plan risks relying on vaccine manufacturing to ramp up quickly to keep pace if people are to receive their second shots at the right intervals.
"I am not very happy about this change as it could lead to a large number of people out there with partial immunity and this could select new mutations, and escalate the potential problem of vaccine escape."
The Biden administration's shift appears to conflict with the FDA's recent position that second doses should be given on a strict schedule, without any departure from the three- and four-week intervals established in clinical trials. Two top FDA officials said in a statement that changing the dosing schedule "is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19."
"I understand the argument of trying to get at least partial protection to as many people as possible, but I am concerned about the increased interval between the doses that is now being proposed," said Kampmann. "I am not very happy about this change as it could lead to a large number of people out there with partial immunity and this could select new mutations, and escalate the potential problem of vaccine escape."
But it's worth emphasizing that the virus is unlikely for now to accumulate enough harmful mutations to render the current vaccines completely ineffective.
"It will be very hard for the virus to evolve to completely evade the antibody responses the vaccines induce," said Fuller. "The parts of the virus that are targeted by vaccine-induced antibodies are essential for the virus to infect our cells. If the virus tries to mutate these parts to evade antibodies, then it could compromise its own fitness or even abort its ability to infect. To be sure, the virus is developing these mutations, but we just don't see these variants emerge because they die out."
COVID Vaccines Put Anti-Science Activists to Shame
It turns out that, despite the destruction and heartbreak caused by the COVID pandemic, there is a silver lining: Scientists from academia, government, and industry worked together and, using the tools of biotechnology, created multiple vaccines that surely will put an end to the worst of the pandemic sometime in 2021. In short, they proved that science works, particularly that which comes from industry. Though politicians and the public love to hate Big Ag and Big Pharma, everybody comes begging for help when the going gets tough.
The change in public attitude is tangible. A headline in the Financial Times declared, "Covid vaccines offer Big Pharma a chance of rehabilitation." In its analysis, the FT says that the pharmaceutical industry is widely reviled because of the high prices it charges for its drugs, among other things, but the speed with which the industry developed COVID vaccines may allow for its reputation to be refurbished.
The Media's Role in Promoting Anti-Biotech Activism
Of course, the media is partly to blame for the pharmaceutical industry's dismal reputation in the first place because of journalists' penchant for oversimplifying complicated stories and pinning blame on an easy scapegoat. While the pharmaceutical industry is far from angelic and places a hefty price tag on its products in the U.S., often gone unmentioned is the fact that high drug prices are the result of multiple factors, including lack of competition (even among generic drugs), foreign price controls that allow citizens of other countries to "free load" off of American consumers, and a deliberately opaque drug supply chain (that involves not only profit-maximizing pharmaceutical manufacturers but "middlemen" like distributors). But why delve into such nuance when it's easier to point to villains like Martin Shkreli?
Big Ag has been subjected to identical mistreatment by the media, with outlets such as the New York Times among the biggest offenders. One article it published compared pesticides to "Nazi-made sarin gas," and another spread misinformation about a high-profile biotech scientist. The website Undark, whose stated mission is "true journalistic coverage of the sciences," once published an opinion piece written by a person who works for an anti-GMO organization and another criticizing Monsanto for its reasonable efforts to defend itself from disinformation. These aren't cherry-picked examples. Overall, the media clearly has taken sides: Science is great, unless it's science from industry.
If the scientific community can use the powerful techniques of biotechnology to cure a previously unknown infectious disease in less than a year, then why shouldn't it be able to cure genetic diseases in humans?
Now, the very same media – which has portrayed the pharmaceutical and biotech industries in the worst possible light, often for political or ideological reasons – is wondering why so many Americans are reluctant to get a COVID vaccine. Perhaps their reportage has something to do with it.
Tech Strikes Back
For years, the agricultural, pharmaceutical, and biotech industries fought back, but to no avail. GMOs are feared, pharma is hated, and biotech is misunderstood. Regulatory red tape abounds. But that may be all about to change, not because of a clever PR campaign, but thanks to the successful coronavirus vaccines produced by the pharma/biotech industry.
All of the major vaccines were created using biotechnology, broadly defined as the use of living systems and organisms to develop products intended to improve human life or the planet. The Pfizer/BioNTech and Moderna vaccines rely on mRNA (messenger RNA), which is essentially a molecular "photocopy" of the more familiar genetic material DNA. The mRNA molecules were tweaked using biotech and then shown to be 95% effective at preventing COVID in human volunteers. The AstraZeneca/Oxford vaccine is based on an older technology that genetically modifies a harmless virus to resemble an immunological target, in this case, SARS-CoV-2. Their vaccine is 62% to 90% effective.
Even better, the pharma/biotech industry showed that it can work hand-in-hand with the government, for instance the FDA, to produce vaccines in record-breaking time. Operation Warp Speed provided some financing to facilitate this process. History will look back at this endeavor and likely conclude that the unprecedented level of cooperation to develop a vaccine in less than 12 months was one of the greatest triumphs in public health history. (The bungled slow rollout is another story.)
Perhaps the most important lesson that society will learn is that the scientific method works.
The pharma/biotech industry has thus gained tremendous momentum. For the first time it seems, those who are opposed to scientific progress and biotechnology are on the defensive. If the scientific community can use the powerful techniques of biotechnology to cure a previously unknown infectious disease in less than a year, then why shouldn't it be able to cure genetic diseases in humans? Or create genetically modified crops that are resistant to insects and drought? Or use genetically modified mosquitoes to help fight against killer diseases like malaria? The arguments against biotechnology have been made exponentially weaker by the success of the coronavirus vaccine.
Perhaps the most important lesson that society will learn is that the scientific method works. We observed (by collecting samples of an unknown virus and sequencing its genome), hypothesized (by predicting which parts of the virus would trigger an immune response), experimented (by recruiting tens of thousands of volunteers into clinical trials), and concluded (that the vaccines worked). It was a thing of pure beauty.
Thanks to all the players involved – from Big Government to Big Pharma – we are beginning the process of being rescued from a modern-day plague. Let us hope that this scientific success also deals a fatal blow to the forces of ignorance that have held back technological progress for decades.
[Editor's Note: LeapsMag is an editorially independent publication that receives program support from Leaps by Bayer. LeapsMag's founding in 2017 predates Bayer's acquisition of Monsanto in 2018. All content published on LeapsMag is strictly free of influence, censorship, and oversight from its corporate sponsor. Read more about LeapsMag's organizational independence here.]