The recent AstraZeneca offers a cautionary tale.
- AstraZeneca's press release about its recent vaccine trials was filled with erroneous data.
- A manufacturing error meant that some participants only received half of the intended dosage.
- In the rush to produce a vaccine, science by press release is of growing concern.
One of the bright spots of 2020 has been the collaborative effort of scientists in their search for a COVID-19 vaccine. Never before have researchers and institutions focused their efforts on a single disease to this degree. Of course, trials are often sponsored by competing companies, increasing the rush for an effective vaccine—a fact coming to the surface in the recent AstraZeneca trials.
After potential successes by Moderna and Pfizer, AstraZeneca announced it reached an average efficacy of 70 percent during its partnership with the University of Oxford. Though not quite the 95 percent efficacy reported by the aforementioned companies, the AstraZeneca vaccine had a few factors in its favor: one dosing scheme achieved 90 percent efficacy; the low cost: $3 per dose compared to $20; this vaccine only needs to be refrigerated, not frozen (causing issues with distribution and storage) as required by other candidates.
Then AstraZeneca admitted a mistake: the dosage data were off. While results ranged from 62 to 90 percent efficacy (averaging out at 70), a manufacturing error meant the pharmaceutical giant only filled half the intended dose for one of the trials. Instead of abandoning the study, researchers redefined the parameters: a number of volunteers received a half-dose during the first round, followed by a full dose a month later. Interestingly, that dosage protocol performed best, leaving researchers flummoxed.
The trials were plagued with issues, including the fact that no one over age 55 was tested. As seniors are the most vulnerable population, this seems to be a grave oversight. We shouldn't be surprised that a half-dose proved efficacious, however. Paracelsus preached the relevance of dosage some 500 years ago. Medical advancements often result thanks to the unexpected.
AstraZeneca Vaccine Trial Likely Needs a Restart: Johns Hopkins
Science has always been and will continue to be complicated. In regards to the pandemic, more surprises await, like the fact that PFAS could negatively impact the efficacy of any COVID-19 vaccine. This is of particular importance to Americans, as this acid is used in many common products in this country.
There's little comfort that an adjunct professor at the Harvard School of Public Health says we "have to cross our fingers and hope for the best" in regards to the possibility that the chemicals in non-stick pans and waterproof clothing might thwart our chance of successful vaccination. Discovering this possibility isn't a conspiracy; it's indicative of science working as intended, even if we don't like the results.
Chemistry matters; so does patience. Weill Cornell Medicine vaccine researcher John Moore phrased it best when calling AstraZeneca's head-scratching announcement "the worst aspect of science by press release." In the rush to deliver good news during a challenging year, we overlook the fact that science is a slow process governed by consensus. Rushing out half-baked data does no one any good.
AstraZeneca's rush to break news is especially perilous given the growing influence of vaccine hesitancy and anti-vaxxers. Misinformation is like a dry forest floor after a hot summer. Vaccine science needs to be evidence-based. Fear-mongering thrives when the focus is a headline instead of clinical efficacy.
Credit: Raquel / Adobe Stock
As Jonathan Berman writes in his recent book, "Anti-vaxxers: How to Challenge a Misinformed Movement,"
"Vaccination occupies a unique space as one of the most effective technologies ever developed to fight disease, as well as the only technology to ever eliminate a disease entirely. Vaccination conveys both individual and collective benefits, and carries very modest individual and collective risks."
Perhaps because this is the first global pandemic in generations we've forgotten how deadly diseases can be. In the 18th century, more humans died from communicable diseases than today's biggest killers, like heart disease and cancer; roughly 300 million people died from smallpox in the 20th century. COVID-19 isn't nearly as deadly, yet that doesn't dampen the real problems we face around vaccine disinformation.
In some ways, even the botched press release isn't new. Conceptually, vaccines are thousands of years old. Louis Pasteur, building on Edward Jenner's work on cowpox, was as much publicist as scientist when his anthrax trial helped usher in the modern age of medicine. He made sure to invite plenty of journalists to observe his trial, which is how word of this medical advancement spread widely.
Expediency often sacrifices integrity. Fortunately, Pasteur's scientific literacy was as dependable as his love of fawning writers. As Victorian-era statistician Francis Galton presciently commented, "In science credit goes to the man who convinces the world, not the man to whom the idea first occurs."
We have to wield the power responsibly. Vaccine development by press release does not serve anyone. There are too many variables in medicine and humans are impatient animals. Good science relies on the input of many researchers and tens of thousands of volunteers.
That great strides have been made in the development of a COVID-19 vaccine should comfort us—a little—but also serve as a reminder that little arrives as quickly as we desire. That's just not how science works.
Stay in touch with Derek on Twitter and Facebook. His new book is "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."
Andrew Wakefield turned away from science and to the tabloids to spread his fabricated data.
- Investigative journalist Brian Deer has published a new book on anti-vaxx ringleader, Andrew Wakefield.
- Discredited in the science community, Wakefield turned to the media to share his anti-vaxx propaganda.
- The disbarred doctor fabricated results and filed for his own vaccine patents, Deer reports.
Michael Gershon is a professor of pathology and cell biology at Columbia University. Dubbed "the father of neurogastroenterology," his classic book, "The Second Brain," introduced the world to the enteric nervous system—a "third'' nervous system that governs the space between our esophagus and anus. His research on GI physiology has transformed the field and prepared the entire planet to better understand the importance of the microbiome.
In short, he's an irreplaceable scholar.
In 2001, Gershon was shown clinical test slides from an intriguing three-year-old study published in the journal, The Lancet. Only something wasn't panning out. The study claimed that the measles virus—specifically, a strain of the measles virus from the measles, mumps, and rubella (MMR) vaccine—made the gut wall leaky. Gershon said if that was the case, it should be leaky in both directions, which was not reported.
That wasn't the only issue. The study also claimed opioid peptides were being released from the gut into the bloodstream, yet similar-sized peptides would also be released if that were the case. Strike two.
Finally, there was a charge that particular foodstuffs penetrated the brain's blood-brain barrier in the 12 children involved in the study. That would imply these substances evaded the liver, which Gershon found unreasonable. The study, he concluded, was trash.
Or, as it turns out, the research was completely fabricated to push an agenda. Investigative journalist Brian Deer is the reason The Lancet eventually retracted that infamous study. Deer's tireless journalism exposed the fraudulent team, led by an incredulous (now former) doctor, that put the notion that vaccines cause autism into widespread circulation.
While Andrew Wakefield's study was engineered for monetary gain, the myth of vaccine dangers, which has morphed from autism to QAnon-level conspiracy, persists. Deer's new book, "The Doctor Who Fooled the World: Science, Deception, and the War on Vaccines," compiles nearly two decades of reporting that details Wakefield's every sinister move.
Brian Deer on the media's role in vaccine scares
Gershon realized the slides were likely contaminated in the laboratory. He wasn't the only one. Science has long suffered from the "replication crisis"—many studies come to a conclusion that cannot be replicated upon further research. Not only did future research fail to confirm Wakefield's research, the doctor balked when his research institution, Royal Free Hospital School of Medicine, offered a large sum of money to conduct a follow-up study. If Wakefield's work was sturdy, it would have held up.
Wakefield never even tried. Instead, he turned to an increasingly popular trick when your data fails: let the media do your work for you. Science is hard and expensive. Clickbait, cheap and addictive.
The actual data is mind-boggling. The 12 children in the original study were handpicked, which is antithetical to clinical research. Wakefield falsified the results from pediatricians. He used microscopic-level stains; a more reliable molecular method found nothing. The parents of study subjects, some with their own agendas (such as litigation), kept changing the timeline of their child's conditions—some children showed symptoms of autism before the MMR vaccine was given while others claimed symptoms started hours after injection when previous reports state that it was months. While Wakefield was raging against the vaccine, he filed for two patents on single measles shots.
After purchasing a six-bedroom house on five acres of prime Austin real estate—Wakefield moved to America to take advantage of growing anti-vaxx fervor—he realized the equation for success: "Autism + vaccines = money."
Every chapter drops your jaw. Consider this example to better understand the myth of vaccine-created autism. On July 20, 2005, Wakefield, with support from anti-vaxx congressman Dan Burton, spoke at the National Mall. The event was a rally against the vaccine ingredient, thimerosal, which itself is a red herring: thimerosal was removed from almost all vaccines in 1999, yet autism cases continued to rise.
Dr Andrew Wakefield (C) walks with his wife Carmel after speaking to reporters at the General Medical Council (GMC) on January 28, 2010 in London, England.
Credit: Peter Macdiarmid/Getty Images
Wakefield read a statement from a UK newspaper apologizing after the former doctor brought a defamation suit. By this point, Deer had published numerous groundbreaking stories in the Sunday Times (circulation: 1.2 million). A tiny local newspaper, the Cambridge Evening News (circulation: 5,000), had reprinted two sentences from Deer's coverage. Instead of bringing Deer to court (which he would do later, unsuccessfully), Wakefield sued the fragile paper in eastern England, which did not have the resources to defend itself.
No one on the Mall that day understood the specifics. They weren't told the backstory. All they heard was that Wakefield was vindicated, for which they cheered.
Every schtick has a shelf life. Deer details the increasingly absurd stakes of Wakefield's career: measles causes Crohn's disease; the MMR vaccine causes autism; all vaccines are suspect. Over the course of two decades, the disbarred doctor chased money wherever it led, taking a willing media along with him. His efforts culminated in the 2016 pseudoscience documentary, "Vaxxed."
Actions have consequences. Andrew Wakefield saw opportunity in vaccine-resistant parents. At first, he filed for his own single-jab measles vaccine—at the time, the demon was supposedly the triple shot MMR—but he wasn't fully aware of what lurked inside of this Pandora's box. Wakefield was paid hundreds of thousands of dollars to fabricate the study, as Deer's reporting shows. A long game hadn't yet been imagined.
Twenty-two years later, during the worst pandemic in a century, 35 percent of Americans claim they will not take an FDA-approved, free COVID-19 vaccine, according to a Gallup poll. The science community called Wakefield's research out for what it was, yet by manipulating the media—more forcefully, social media—the "doctor with no patients" has made a large percentage of people skeptical of one of the best therapeutic interventions ever devised. The cost, if and when a COVID-19 vaccine is developed, will be high.
Never say one man cannot change the world. And never think that change is always for the better.