What “The Science” Really Says about the Coronavirus Pandemic

The answer is not much – at least, not yet.

While advocates of lockdowns and masking mandates claim to be invoking “the science,” science by its very nature can’t provide short-term answers to the efficacy of such measures. The scientific method demands extensive data gathering and testing, which generally take longer than the duration of a pandemic. An abundance of scientific evidence does exist for the effectiveness of vaccination, but whether vaccines can completely eradicate the coronavirus is an open question. Social distancing as a preventive measure is also on firm scientific ground.

Lockdowns have been used for centuries as a way to slow the spread of disease, including the Black Death plague in the 14th century and the Spanish Flu in 1918-1919. But all they do is initially reduce transmission of the virus, and to claim otherwise is scientifically disingenuous.

The primary purpose of slowing down the spread of a contagious and deadly disease is to prevent the healthcare system from becoming overwhelmed. If more people get sick enough to require hospitalization than the number of hospital beds available, some won’t get adequate treatment and deaths will increase. However, lockdowns also have a devastating effect on a society’s economic and mental health. Studies have shown that negative socioeconomic impacts greatly limit the effectiveness of lockdowns over time.

In some countries such as Taiwan and Australia, death rates from COVID-19 are very low so far after repeated lockdowns, causing lockdown supporters to link the two. But other nations with small populations such as Israel have much higher mortality rates despite continued shutdowns. So there’s no correlation and, in fact, many other factors influence the death rate.  

The science behind masking, shown below in use during the Spanish Flu pandemic, is muddier yet and has been badly contaminated by politics. Unfortunately, the gold standard in medical testing – the RCT (randomized controlled trial) – isn’t the basis for evaluating the benefit of mask-wearing by institutions like the U.S. CDC (Centers for Disease Control and Prevention) or the WHO (World Health Organization).

In an RCT or clinical trial, participants are divided randomly into two identical groups, with intervention in only one group and the other group used as a control. Neither the researchers nor the participants are told which group the participants are part of until the very end. Such double-blind trials are therefore able to establish causation.

For masks, just 14 RCTs have been carried out across the world to study how well masks guard against respiratory diseases, primarily influenza. Nearly all the trials tested so-called surgical, three-ply paper masks, rather than the N95 respirator style. Of the 14 trials, just two investigated the claim that wearing a mask benefits others who come in close contact with the mask wearer, while the other 12 tested the combination of benefit to others and protection for the wearer.

A recent analysis by a prominent statistician of all 14 RCTs, which include the only trial to test mask-wearing’s specific effectiveness against COVID-19, reveals that masks have no significant effect on either the wearer or those in close proximity, although some trials were ambiguous. There was no strong evidence that N95 masks performed any better than surgical or cloth masks. Exactly the same conclusions were reached in two independent analyses of 13 (see here) and 11 (here) of the same RCTs.

The CDC, however, relies on observational studies conducted since the start of the coronavirus pandemic, not RCTs, in issuing its masking guidance. An observational study is less scientific in being unable to assign a cause to an effect; it can only establish association.

Vaccination against infectious diseases, on the other hand, has a solid scientific basis. Pioneered by Edward Jenner at the end of the 18th century, vaccination has eradicated killer diseases such as smallpox and polio in many countries, and drastically curtailed others such as measles, mumps and pertussis (whooping cough).

Nevertheless, the science underlying vaccination against COVID-19 is incomplete. In the past it’s taken several years to develop a new vaccine, but the COVID-19 vaccines currently available were brought to market at lightning speed. Although such haste was seen as necessary to combat a rapidly proliferating virus, it meant shortening the RCTs designed to test vaccine efficacy, leaving questions such as long-term side effects and duration of effectiveness unresolved.

And barely understood yet is the greater protection against infection acquired though natural immunity – the result of having recovered from a previous COVID-19 infection – than from vaccination. This complicates calls for vaccine mandates, as those with natural immunity arguably don’t need to be vaccinated.

Moreover, the coronavirus is an RNA virus like influenza and so frequently mutates. This means that mandatory vaccination for the coronavirus is unlikely to be any more effective community-wide than a mandated flu vaccine would be. Regular COVID-19 booster shots will probably be needed, just like the flu.

That’s where science stands on the coronavirus. But rather than following the science, most decisions on lockdowns, masking and vaccination are ruled by politics.

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Science on the Attack: The Vaccine Revolution Spurred by Messenger RNA

The lightning speed with which biotech companies Pfizer-BioNTech and Moderna developed a safe and effective COVID-19 vaccine is testament not only to scientific perseverance, but to the previously unrealized potential of messenger RNA (mRNA) to revolutionize medicine. Today’s blog post in my series showcasing science on the attack rather than under attack highlights the genetic breakthrough behind this transformational discovery.

Genetic vaccines are a relative newcomer to the immunization scene. Unlike traditional vaccines that use killed or weakened versions of the virus to stimulate the body’s immune system into action, genetic vaccines deliver a single virus gene or part of its genetic code into human cells. The genetic instructions induce the cells to make viral proteins that constitute only a small piece of the virus, but have the same effect on the immune system as the whole virus molecule.

But, until 2020, the only approved genetic vaccines – based on DNA, not RNA – were for animal diseases. It was the urgent need to come up with a vaccine to protect against COVID-19 in humans that triggered the worldwide quest to bring an mRNA vaccine to market.

The job of mRNA in the body is to transcribe the DNA code for one or more genes contained in a cell nucleus, and then deliver the encoded information to the protein factory in the cell’s outer reaches. There, the message is decoded and the requisite protein manufactured. DNA contains the blueprint for making nearly all the proteins in the body, while mRNA acts as a delivery service.

The concept of harnessing mRNA to fight disease goes back to the early 1990s, but hopes raised by promising early experiments on mice were dashed when multiple roadblocks arose to working with synthetic mRNA injected into the human body. The primary obstacle was the immune system’s overreaction to mRNA engineered to manufacture virus proteins. The immune system often destroyed the foreign mRNA altogether, as well as causing excessive inflammation in some people. Other problems were that the mRNA degraded quickly in the body and didn’t produce enough of the crucial virus protein for a vaccine to be effective.

So scientific attention switched instead to development of DNA vaccines, which cause fewer problems though are clunky compared to their mRNA cousins. Then, in a series of papers starting in 2005, two scientists at the University of Pennsylvania, Katalin Karikó and Drew Weissman, reported groundbreaking research that brought mRNA back into the limelight.

Karikó and Weissman found that tweaking the structure of the mRNA molecule could overcome most of the earlier obstacles. By exchanging one of mRNA’s four building blocks called nucleosides, they were able to create a hybrid mRNA that drastically suppressed the immune system’s reaction to the intruder and boosted production of the viral protein. In their own words, their monumental achievement was “the biological equivalent of swapping out a tire.”      

Their discovery, however, was initially received with a big yawn by many of their peers, who were still preoccupied with DNA. Karikó found herself snubbed by the research funding community and demoted from her university position. Eventually, in 2013 she was hired by the German company BioNTech to help oversee its mRNA research.

In the meantime, work proceeded on the final impediment to exploiting synthetic mRNA for vaccines: preventing its degradation in the human body. To reach the so-called cytoplasm of a cell where proteins are manufactured, the artificial mRNA needs to penetrate the lipid membrane barrier protecting the cell. Karikó, Weissman and others solved this problem by encasing the mRNA in small bubbles of fat known as lipid nanoparticles.

Armed with these leaps forward, researchers have now developed mRNA vaccines for at least four infectious diseases: rabies, influenza, cytomegalovirus and Zika. But testing in humans has been disappointing so far. The immune response has been weaker than expected from animal studies – just as with DNA vaccines – and serious side effects have occurred.

Nevertheless, COVID-19 mRNA vaccines have been a stunning success story. The major advantage of mRNA vaccines over their traditional counterparts is the relative ease and speed with which they can be produced. But until now, no mRNA vaccine or drug has ever won approval.

Maybe COVID-19 is the exception and synthetic coronavirus mRNA generates a stronger immune response with fewer adverse effects than the other viral mRNA vaccines investigated to date. Mass production of a beneficial and safely tolerated COVID-19 vaccine in less than 12 months is certainly an amazing accomplishment, considering that it’s taken several years to develop a new vaccine in the past. But whether the potential of mRNA vaccines to ward off other diseases or even cancer remains to be seen.

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Science on the Attack: The Hunt for a Coronavirus Vaccine (2)

In the previous post, we saw how three different types of coronavirus vaccine, all based on established technologies, are under development: virus (killed or attenuated live), viral vector, and protein-based vaccines. Here I review experimental genetic vaccines for SARS-CoV-2, which rely on protective antibody production – like the other three do; and T-cell-inducing vaccines, a newcomer approach which arouses a massive army of those immune system warriors, T cells.

Genetic vaccines, sometimes called nucleic acid vaccines, utilize part of the coronavirus’s genetic code to deliver the genetic instructions for a coronavirus protein such as the spike protein, right into human cells. In this seemingly risky move, the cells read the instructions and crank out copies of the viral protein, but not of the whole virus as infected cells do – and thus don’t cause disease. The protein copies stimulate antibody generation, just like the viral protein fragments or shells in protein-based vaccines.

The genetic instructions can be in the form of either DNA or RNA. For DNA vaccines, an engineered loop of coronavirus protein DNA is inserted into cells, which then employ their own messenger RNA to assemble the viral proteins. RNA vaccines deliver synthetic viral messenger RNA directly into cells. An advantage of genetic vaccines is that they can be produced more rapidly than their traditional counterparts.

Other DNA vaccines have been approved for animal diseases such as West Nile virus in horses, and a DNA coronavirus vaccine based on the spike protein has been found to protect monkeys. But no DNA coronavirus vaccines so far have approval for human use. The same is true for RNA coronavirus vaccines, although biotech company Moderna recently obtained promising results in a small trial of coronavirus vaccine safety. 

T-cell vaccines have gained attention because of emerging evidence that many people may already have immune cells capable of recognizing the SARS-CoV-2 virus and warding it off. This extraordinary degree of protection is thought to come from T cells, not antibodies. Although studies have found that antibodies against the deadly coronavirus dissipate fairly quickly, T cells are able to remember past infections and kill pathogens if they reappear, even after long periods of time. A recent research paper reported that up to 50% of people who had never been exposed to the virus had high levels of SARS-CoV-2-specific T cells, a finding replicated in other studies.

Like many advances in science, this particular discovery was accidental. The paper’s authors were conducting an experiment with COVID-19 convalescent blood and needed a control blood sample for comparison. After choosing blood samples collected from healthy residents of San Diego between 2015 and 2018, several years before the current pandemic began, they found to their surprise that about half the samples showed strong T-cell reactivity against the virus.

The authors speculated that this T-cell recognition of the SARS-CoV-2 virus may come partly from previous exposure to one of the four known coronaviruses that cause the common cold and circulate widely among humans. If so, the discovery paves the way to a new type of vaccine, similar to those being used against certain cancers such as melanoma. However, the authors emphasized that the data hadn’t yet demonstrated the source of the T cells or whether they are actually memory T cells.

Memory T cells are the third type of T cell, in addition to helper T cells known as CD4+ cells that identify antigens, or viral protein fragments, and killer T cells that devour virus-infected cells. T-cell memory of past diseases is long lasting, up to decades. People who recovered from SARS, the disease most closely related to COVID-19, still show cellular immunity to that coronavirus after 17 years.

CREDIT: WIKIPEDIA COMMONS

An even more recent study appears to confirm the hypothesis that the observed T-cell response results from previous exposure to common cold coronaviruses. Should this turn out to be the case, it could explain the puzzle of why COVID-19 is much more severe in some people than in others: those who have recently wrestled with the common cold may have an easier time battling a more vicious member of the coronavirus family, and may get less sick. On the other hand, much is still unknown and pre-existing T cells could even interfere with other immune system responses.

As for a coronavirus vaccine, recent Phase III clinical trials have shown the efficacy of potential T-cell-inducing vaccines for diseases such as malaria and HIV. But nothing is yet licensed, so development of a coronavirus T-cell vaccine is unlikely in the short term.

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Science on the Attack: The Hunt for a Coronavirus Vaccine (1)

In my series of occasional posts showcasing science on the attack rather than under attack, this and the next blog post will review the current search for a vaccine against that unwelcome marauder, the coronavirus. This post examines vaccine approaches based on conventional, well-established techniques. The subsequent one will look at experimental technologies not yet approved for medical use.

The coronavirus (SARS-CoV-2) is a very large, bristly molecule – with a genome twice as large as that of influenza – studded with spiky flower-like proteins as seen in red in the figure below. It tricks cells in the body into letting it in through a cellular door: a cup-like protein called an ACE2 receptor, which forms part of the nervous system and regulates bodily processes such as blood pressure and inflammation. Latching on to the receptor enables the virus to penetrate the host cell membrane and hijack the cell’s replication machinery, making copies of itself that then wreak havoc throughout the body.

The main function of the body’s immune system is to detect and annihilate invaders such as foreign bacteria and viruses like SARS-CoV-2. First, immune system scouts known as phagocytes – a type of white blood cell – recognize and digest intruder cells. The phagocyte surface then displays a flag or protein fragment of the bacteria or virus, called an antigen, that signals the foreigner’s identity. Other white blood cells called T cells identify the antigen, prompting the immune system arsenal to unleash one of two types of weapon against the assailant.

The two weapons are a different kind of T cell that homes in on infected cells and kills them, and yet another type of white blood cell called a B cell that produces disease fighting antibodies. Antibodies are specialized Y-shaped proteins with a search-and-destroy mission, either inactivating invasive cells directly or tagging them for elimination by phagocytes or other immune system killer cells. Coronavirus vaccines under development include both those that stimulate antibody production, and those that generate copious quantities of T cells.

Most of today’s vaccines utilize the virus itself. This can be in the form of a killed-virus vaccine,  which is produced by growing live virus and then inactivating it chemically, or an attenuated live-virus vaccine, in which live virus is weakened below the level where it can normally cause disease. Both types of vaccine induce the immune system to churn out antibodies.

The measles-mumps-rubella (MMR) vaccine is an example of a weakened virus vaccine; most flu shots are the inactivated type. An inactivated coronavirus vaccine is now in Phase III efficacy testing by Chinese company Sinovac.

Attracting more attention for SARS-CoV-2 are so-called viral vector vaccines. As indicated in the next figure, these are vaccines in which a “guest” virus such as measles (left) or adenovirus (right), which causes upper respiratory infections and related illnesses, is genetically engineered with the gene for the coronavirus spike protein. Key genes in the guest virus are usually disabled so it can’t replicate, but the piggybacking coronavirus gene is unloaded inside the body’s cells, generating antibodies that combat the coronavirus invasion.

CREDIT: SPRINGER NATURE

The only vaccine currently approved for Ebola is a viral vector vaccine manufactured by Johnson & Johnson, who also have a coronavirus vaccine in the works. But the most advanced coronavirus effort is that of the University of Oxford together with AstraZeneca, who have Phase III trials of a viral vector vaccine well underway.           

A third class of defense against the virus using established technologies is protein-based vaccines. Some protein-based vaccines contain fragments of the coronavirus spike protein, or of an important part of it known as the receptor binding domain. The fragments can’t cause disease because they’re not the actual virus, but the immune system is still able to recognize them as coronavirus proteins – triggering production of antibodies. Other protein-based vaccines contain a protein shell that mimics just the outer coat of the coronavirus, so again isn’t infectious but induces antibody production.

Current vaccines for shingles and human papillomavirus (HPV) are in this category. Several companies have Phase I or Phase II trials of a protein-based coronavirus vaccine in progress.

In the next post I’ll review experimental genetic vaccines for the coronavirus, which are based on antibodies, and newer candidates based on a strong T-cell response.

Next: Science on the Attack: The Hunt for a Coronavirus Vaccine (2)

When Science Is Literally under Attack: Ad Hominem Attacks

Science by its nature is contentious. Before a scientific hypothesis can be elevated to a theory, a solid body of empirical evidence must be accumulated and differing interpretations debated, often vigorously. But while spirited debate and skepticism of new ideas are intrinsic to the scientific method, stooping to personal hostility and ad hominem (against the person) attacks are an abuse of the discipline.

If the animosity were restricted to words alone, it could be excused as inevitable human tribalism. Loyalty to the tribe and conformity are much more highly valued than dissent or original thinking; ad hominem attacks are merely a defensive measure against proposals that threaten tribal unity. 

However, when the acrimony in scientific debate goes beyond verbal to physical abuse, either threatened or actual, then science itself is truly under assault. Unfortunately, such vicious behavior is becoming all too common.  

A recent example was a physical attack on pediatrician and California state senator Richard Pan, who had authored a bill to tighten a previous law allowing medical exemptions from vaccination for the state’s schoolchildren. After enduring vitriolic ad hominem attacks and multiple death threats calling for him to be “eradicated” or hung by a noose, Pan had to get a court restraining order against an anti-vaccinationist who forcefully shoved the lawmaker on a Sacramento city street in August, 2019, during debate on the exemptions bill. Although the attacker was arrested on suspicion of battery, Pan told the court he was fearful for his safety.

Pan has long drawn the anger of anti-vaccine advocates in California for his support of mandatory vaccination laws for children. But science is unquestionably on his side. Again and again, it’s been demonstrated that those U.S. states with lower exemption rates for vaccination enjoy lower levels of infectious disease. It’s this scientific evidence of the efficacy of immunization that has prompted many states to take a tougher stand on exemptions, and even to abolish nonmedical exemptions – for religious or philosophical reasons – altogether.

Medical exemptions are necessary for those children who can’t be vaccinated at all owing to conditions such as chemotherapy for cancer, immunosuppressive therapy for a transplant, or steroid therapy for asthma. Successful protection of a community from an infectious disease requires more than a certain percentage of the populace to be vaccinated against the disease – 94% in the case of measles, for example. Once this herd immunity condition has been met, viruses and bacteria can no longer spread, just as sheer numbers protect a herd of animals from predators.

But the earlier California law was being abused by some doctors, who were issuing exemptions that were not medically necessary at the request of anti-vaccine parents. The practice had caused the immunization rate for kindergarten-aged children to fall below 95% state-wide, and below 90% in several counties. As a result, measles was on the rise again in California.

Shortly after Pan’s bill was passed in September, 2019, another disturbing incident occurred in the legislature itself. An anti-vaccine activist hurled her menstrual cup containing human blood from a balcony onto the desks of state senators, dowsing several of the lawmakers. The woman, who yelled “That’s for the dead babies,” was subsequently arrested and faces multiple charges.

In the lead-up to such violence, the ad hominem attacks on Pan were no more virulent than those directed a century ago at Alfred Wegener, the German meteorologist who proposed the revolutionary theory of continental drift. Wegener was vehemently criticized by his peers because his theory threatened the geology establishment, which clung to the old consensus of rigidly fixed continents. One critic harshly dismissed his hypothesis as “footloose,” and geologists scorned what they called Wegener’s “delirious ravings” and other symptoms of “moving crust disease.” It wasn’t until the 1960s that continental drift theory was vindicated.

What’s worrying is the escalation of such defamatory rhetoric into violence. The intimidation of California legislators in the blood-throwing incident, together with the earlier street attack on Pan and death threats made to other senators, are a prime example. The anti-vaccinationists responsible are attacking both democracy and science.

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Measles Rampant Again, Thanks to Anti-Vaccinationists

Measles is on the march once more, even though vaccination against the disease has cut the number of worldwide deaths from an estimated 2.6 million per year in the mid-20th century to 110,000 in 2017. But thanks to the anti-scientific, anti-vaccination movement and the ever expanding reach of social media, measles cases are now at a 20-year high in Europe and as many U.S. cases were reported in the first two months of 2019 as in the first six months of 2018.

Highly contagious, measles is not a malady to be taken lightly. One in 1,000 people who catch it die of the disease; most of the victims are children under five. Even those who survive are at high risk of falling prey to encephalitis, an often debilitating infection of the brain that can lead to seizures and mental retardation. Other serious complications of measles include blindness and pneumonia.

It’s not the first time that measles has reared its ugly head since the widespread introduction of the MMR (measles-mumps-rubella) vaccine in 1963. Although laws mandating vaccination for schoolchildren were in place in all 50 U.S. states by 1980, sporadic outbreaks of the disease have continued to occur. Before the surge in 2018-19, a record number of 667 cases of measles from 23 outbreaks were reported in the U.S. in 2014. And major epidemics are currently raging in countries such as Ukraine and the Philippines.

The primary reason for all these outbreaks is that more and more parents are choosing not to vaccinate their children. The WHO (World Health Organization), for the first time, has listed vaccine hesitancy as one of the top 10 global threats of 2019.

While some parents oppose immunization on religious or philosophical grounds, by far the most objections come from those who insist that all vaccines cause disabling side effects or other diseases – even though the available scientific data doesn’t support such claims. As discussed in a previous post, there’s absolutely no scientific evidence for the once widely held belief that MMR vaccination results in autism, for example.

Anti-vaccinationists, when accused of exposing their children to unnecessary risk by refusing immunization because of unjustified fears about vaccine safety, rationalize their stance by appealing to herd immunity. Herd immunity is the mass protection from an infectious disease that results when enough members of the community become immune to the disease through vaccination, just as sheer numbers protect a herd of animals from predators. Once a sufficiently large number of people have been vaccinated, viruses and bacteria can no longer spread in that community.

For measles, herd immunity requires up to 94% of the populace to be immunized. That the threshold is lower than 100%, however, enables anti-vaccinationists to hide their children in the herd. By not vaccinating their offspring but choosing to live among the vaccinated, anti-vaxxers avoid the one in one million risk of their children experiencing serious side effects from the vaccine, while simultaneously not exposing them to infection – at least not in their own community.  

But hiding in the herd takes advantage of others and is morally indefensible. Certain vulnerable groups can’t be vaccinated at all, including those with weakened immune systems such as children undergoing chemotherapy for cancer or the elderly on immunosuppressive therapy for rheumatic diseases. If too many people choose not to vaccinate, the percentage vaccinated will fall below the threshold, herd immunity will break down and those whose protection depends on those around them being vaccinated will suffer.

Another contentious issue is exemptions from mandatory vaccination for religious or philosophical reasons. While some American parents regard the denial of schooling to unvaccinated children as an infringement of their constitutional rights, supreme courts in several U.S. states have ruled that the right to practice religion freely doesn’t include liberty to expose the community or a child to communicable disease. And ever since it was found in 2006 that the highest incidence of diseases such as whooping cough occurred in the states most generous in granting exemptions, more and more states have abolished nonmedical exemptions altogether.

But other countries are not so vigilant. In Madagascar, for instance, less than an estimated 60% of the population has been immunized against measles – because of which an epidemic there has caused more than 900 deaths in six months, according to the WHO. Although the WHO says that the reasons for the global rise in measles cases are complex, there’s no doubt that resistance to vaccination is a major factor. It’s not helped by the extensive dissemination of anti-vaccination misinformation by Russian propagandists.

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Corruption of Science: Scientific Fraud

One of the most troubling signs of the attack on science is the rising incidence of outright fraud, in the form of falsification and even fabrication of scientific data. A 2012 study published by the U.S. National Academy of Sciences noted an increase of almost 10 times since 1975 in the percentage of biomedical research articles retracted because of fraud. Although the current percentage retracted due to fraud was still very small at approximately 0.01%, the study authors remarked that this underestimated the actual percentage of fraudulent articles, since only a fraction of such articles are retracted.

One of the more egregious episodes of fraud was British gastroenterologist Andrew Wakefield’s claim in a 1998 study that 8 out of 12 children in the study had developed symptoms of autism after injection of the combination MMR (measles-mumps-rubella) vaccine. As a result of the well publicized study, hundreds of thousands of parents who had conscientiously followed immunization schedules in the past panicked and began declining MMR vaccine. And, unsurprisingly, outbreaks of measles subsequently occurred all over the world.

But Wakefield’s paper was slowly discredited over the next 12 years, until the prestigious medical journal The Lancet formally retracted it. The journal’s editors then went one step further in 2011 by declaring the paper fraudulent, citing unmistakable evidence that Wakefield had fabricated his data on autism and the MMR vaccine. Shortly after, the disgraced gastroenterologist’s medical license was revoked.

In 2015, Iowa State University researcher Dong Pyou Han received a prison sentence of four and a half years and was ordered to repay $7.2 million in grant funds, after being convicted of fabricating and falsifying data in trials of a potential HIV vaccine.  On multiple occasions, Han had mixed blood samples from vaccinated rabbits into human HIV antibodies to create the illusion that the vaccine boosted immunity against HIV. Although Han was contrite in court, one of the prosecuting attorneys doubted his remorse, pointing out that Han’s job depended on research funding that was only renewed as a result of his bogus presentations showing the experiments were succeeding.

In 2018, officials at Harvard Medical School and Brigham and Women’s Hospital in Boston called for the retraction of a staggering 31 papers from the laboratory of once prominent Italian heart researcher Piero Anversa, because the papers "included falsified and/or fabricated data." Dr. Anversa’s research was based on the notion that the heart contains stem cells, a type of cell capable of transforming into other cells, that could regenerate cardiac muscle. But other laboratories couldn’t verify Anversa’s idea and were unable to reproduce his experimental findings – a major red flag, since replication of scientific data is a crucial part of the scientific method.

Despite this warning sign, the work spawned new companies claiming that their stem-cell injections could heal hearts damaged by a heart attack, and led to a clinical trial funded by the U.S. National Heart, Lung and Blood Institute. The Boston hospital’s parent company, however, agreed in 2017 to a $10 million settlement with the U.S. government over allegations that the published research of Anversa and two colleagues had been used to fraudulently obtain federal funding. Apart from data that the lab fabricated, the government alleged that it utilized invalid and improperly characterized cardiac stem cells, and maintained deliberately misleading records. Anversa has since left the medical school and hospital.

Scientific fraud today extends even to the publishing world. A recent sting operation involved so-called predatory journals – those charging a fee without offering any publication services (such as peer review), other than publication itself. The investigation found that an amazing 33% of the journals contacted offered a phony scientific editor a position on their editorial boards, four of them immediately appointing the fake scientist as editor-in-chief.   

It’s no wonder then that scientific fraud is escalating. In-depth discussion of recent cases can be found on several websites, such as For Better Science and Retraction Watch.

Next week: Consensus in Science: Is It Necessary?

Use and Misuse of the Law in Science

Aside from patent law, science and the law are hardly bosom pals. But there are many parallels between them: above all, they’re both crucially dependent on evidence and logic. However, while the legal system has been used to defend science and to settle several scientific issues, it has also been misused for advocacy by groups such as anti-evolutionists and anti-vaccinationists.

In the U.S., the law played a major role in keeping the teaching of creationism out of schools during the latter part of the 20th century. Creationism, discussed in previous posts on this blog, is a purely religious belief that rejects the theory of evolution. Because of the influence of the wider Protestant fundamentalist movement earlier in the century, which culminated in the infamous Scopes Monkey Trial of 1925, little evolution was taught in American public schools and universities for decades.

All that changed in 1963, when the U.S., as part of an effort to catch up to the rival Soviet Union in science, issued a new biology text, making high-school students aware for the first time of their apelike ancestors. And five years later, the U.S. Supreme Court struck down the last of the old state laws banning the teaching of evolution in schools.

In 1987 the Supreme Court went further, in upholding a ruling by a Louisiana judge that a state law, mandating that equal time be given to the teaching of creation science and evolution in public schools, was unconstitutional. Creationism suffered another blow in 2005 when a judge in Dover, Pennsylvania ruled that the school board’s sanctioning of the teaching of intelligent design in its high schools was also unconstitutional. The board had angered teachers and parents by requiring biology teachers to make use of an intelligent design reference book in their classes.

All these events show how the legal system was misused repeatedly by anti-evolutionists to argue that creationism should be taught in place of or alongside evolution in public schools, but how at the same time the law was used successfully to quash the creationist efforts and to bolster science.

Much the same pattern can be seen with anti-vaccine advocates, who have misused lawsuits and the courtroom to maintain that their objections to vaccination are scientific and that vaccines are harmful. But judges in many different courts have found the evidence presented for all such contentions to be unscientific.

The most notable example was a slew of cases – 5,600 in all – that came before the U.S. Vaccine Court in 2007. Alleged in these cases was that autism, the often devastating neurological disorder in children, is caused by vaccination with the measles-mumps-rubella (MMR) vaccine, or by a combination of the vaccine with a mercury-based preservative. To handle the enormous caseload, the court chose three special masters to hear just three test cases on each of the two charges.

In 2009 and 2010, the Vaccine Court unanimously rejected both contentions. The special masters called the evidence weak and unpersuasive, and chastised doctors and researchers who “peddled hope, not opinions grounded in science and medicine.”

Likewise, the judge in a UK court case alleging a link between autism and the combination diphtheria-tetanus-pertussis (DTP) vaccine found that the “plaintiff had failed to establish … that the vaccine could cause permanent brain damage in young children.” The judge excoriated a pediatric neurologist whose testimony at the trial completely contradicted assertions the doctor had made in a previous research paper that had triggered the litigation, along with other lawsuits, in the first place.

But, while it took a court of law to establish how unscientific the evidence for the claims about vaccines was, and it was the courts that kept the teaching of unscientific creationism out of school science classes, the court of public opinion has not been greatly swayed in either case. As many as 40% of the general public worldwide believe that all life forms, including ourselves, were created directly by God out of nothing, and that the earth is only between 6,000 and 10,000 years old. And more and more parents are choosing not to vaccinate their children, insisting that vaccines always cause disabling side effects or even other diseases.

Although the law has done its best to uphold the court of science, the attack on science continues.

Next week: Subversion of Science: The Low-Fat Diet

No Evidence That Aluminum in Vaccines Is Harmful

Part of the anti-vaccinationist stance against immunization is the belief that vaccines contain harmful chemicals such as aluminum, formaldehyde and thimerosal. Although mercury-based thimerosal is no longer used in any U.S. vaccines except certain flu shots, and the amount of formaldehyde is a tiny fraction of that found in many foods – including those fed to babies such as pureed bananas or pears – aluminum remains a villain among the anti-vax crowd. But, as with the discredited link between the measles vaccine and autism discussed in a previous post, no medical evidence exists to support the aluminum hypothesis.

Aluminum salts are employed as powerful adjuvants to enhance the immune system response to a vaccine, thus reducing the number of repeat injections needed. What anti-vaccinationists fail to understand, however, is that less than 1% of aluminum in vaccines is actually absorbed by the body. The same is true of the aluminum found in our food supply, in drinking water and even in the air we breathe, as well as the breast milk or infant formula ingested by babies. For vaccination, the daily quantity of aluminum absorbed by a vaccinated newborn infant is 10 times smaller than the FDA (U.S. Food and Drug Administration)’s threshold for neurotoxicity.

Because it has been suggested that aluminum could be linked to certain neurological disorders such as Alzheimer’s Disease, anti-vaccinationists maintain that injected aluminum rapidly enters the bloodstream and thereby accumulates in the brain, causing neurological damage – reminiscent of Wakefield’s fraudulent claim about autism. There are several scientific fallacies underlying this assertion, however.

The first fallacy is that injected aluminum finds its way into the body more rapidly than ingested aluminum. In fact, most of the aluminum adjuvant in a vaccine remains near the injection site for a long period and is only absorbed slowly into the bloodstream, at approximately the same daily rate as ingested aluminum. Even though the amount of ingested aluminum is much larger, most of that is absorbed in the intestines and only released slowly into the blood.

Another fallacy involves the neurotoxicity of aluminum in the brain. Although aluminum and other chemicals can enter the brain from the bloodstream, they first have to penetrate a protective semipermeable membrane that separates flowing blood from brain tissue, known as the blood brain barrier. The blood brain barrier normally keeps circulating pathogens and toxins from getting into the brain, while allowing the passage of water, nutrients and hormones.

The flawed claim is that injected aluminum sneaks its way into the brain by hiding in macrophages – a type of first-responder white blood cell that devours germs, cellular debris and foreign particles, and plays an important role in the body’s immune system. Unable to digest metals, say anti-vaccinationists, the aluminum-loaded macrophages travel to the brain via the blood or lymphatic system. If the brain is already inflamed, the macrophages can cross the blood brain barrier and unload aluminum inside the brain. The aluminum supposedly causes further inflammation, leading to autism and other neurological disorders.

But none of this makes sense to many doctors and scientists who work in immunology or neuroscience. A neurovascular biologist who’s an expert on the blood brain barrier faults the science in several of the papers behind the Trojan-horse macrophage hypothesis. And he calls out the claim in one paper that macrophages digest injected aluminum as “not only exaggerated … but also provocative and fraudulent,” though this criticism was later accepted as justified on a major anti-vaccinationist website.

The website, whose authors prefer to remain anonymous, claims to be science-based and guided only by scientific evidence – the same as the emphasis of the present blog. The site also attempts to defend itself against charges of cherry-picking research papers supporting its position that aluminum adjuvants cause autism. But it merely lists just the abstracts of a handful of the many papers backing the emerging consensus that autism is caused by maternal exposure to infections or toxins during pregnancy.   

In any case, even if the aluminum hypothesis were correct, the fact that the amount of aluminum absorbed from vaccines is comparable to the amount absorbed from aluminum ingested by the body means that macrophages could sweep up swallowed aluminum just as easily as injected aluminum. There’s no good evidence that either occurs, although the mechanisms by which adjuvants act are still not fully understood. 

Hat tip: Mike @realiwasframed

Next week: Politics Clashes with Science over Glyphosate and Cancer

Measles or Autism? False Choice, Says Science

Perhaps nowhere is the attack on science more visible than in the opposition to vaccination against infectious diseases such as hepatitis, polio and measles. To anti-vaxxers, immunizing a child with the measles vaccine is a choice between sentencing him or her to the lifelong misery of autism, or exposing the child to possible aftereffects of a disease that the youngster may never contract. This view, passionately held by a substantial minority of the population, is completely at odds with the logic and evidence of science.

Despite the insistence of anti-vaccinationists to the contrary, there’s absolutely no scientific evidence of any linkage between vaccines and autism. The myth connecting them was first suggested by U.S. activist Barbara Loe Fisher in the 1980s. It gained steam when British gastroenterologist Andrew Wakefield claimed in a 1998 study that 8 out of 12 children in the study had developed autism symptoms following injection of the combination measles-mumps-rubella (MMR) vaccine.

But Wakefield’s paper in the prestigious medical journal The Lancet was slowly discredited until, in 2011, the journal’s editors took the unprecedented step of declaring the paper fraudulent, saying that Wakefield had falsified his data. Die-hard anti-vaccinationists refused to accept this conclusion, despite Wakefield’s medical license being subsequently revoked by the UK General Medical Council, who found that his fraud was compounded by ethical lapses and medical misconduct in the same study.

The autism episode generated worldwide publicity and led to thousands of court cases in a special U.S. Vaccine Court set up as part of the National Vaccine Injury Compensation Program. To cope with the enormous caseload, the court assigned three special masters to hear just three test cases on each of two theories: that autism was caused by the MMR vaccine together with a mercury-based preservative known as thimerosal, or that it was caused by thimerosal-containing vaccines alone.

In 2009 and 2010, the special masters unanimously rejected both contentions. But they emphasized that their decisions had been guided only by scientific evidence, not by the poignant stories of autistic children. One of the masters declared in her analysis:

“Sadly, the petitioners in this litigation have been the victims of bad science, conducted to support litigation rather than to advance medical and scientific understanding of autism spectrum disorder. The evidence in support of petitioners’ causal theory is weak, contradictory, and unpersuasive.”

Yet, despite the Vaccine Court’s findings in the U.S. and The Lancet’s accusation of fraud against Wakefield in the UK, anti-vaccinationists continue to connect the MMR vaccine to autism.  In 2016, Wakefield directed a documentary, “Vaxxed,” alleging that the U.S. CDC (Centers for Disease Control and Prevention) covered up contrary data in a 2004 study that drew the same conclusions as the Vaccine Court and numerous epidemiological studies.  His allegations were baseless, however, as the 2014 research paper behind his outrageous claim was subsequently retracted.

According to CDC statistics, autism spectrum disorder afflicted 1 in 59 U.S. children in 2014. Diagnosis of the condition can be devastating and highly stressful for the desperate parents of an autistic child, who naturally tend to grasp for explanations and are often quite willing to believe the hype about vaccination.  Currently, the causes of autism remain unknown, although several risk factors have been identified: certain genetic conditions have been implicated, and it’s thought that exposure during pregnancy to toxic chemicals such as pesticides, or to bacterial or viral infections, plays a role.

While there’s no medical evidence tying autism to vaccines, it’s also true that serious adverse reactions to a vaccine shot do occur occasionally – typically about once in every one million vaccinations. Negative and occasionally fatal reactions to various vaccines have been documented in approximately 400 research papers. But these 400 cases need to be weighed against the hundreds of millions of vaccine doses administered every year in the U.S. without any reported side effects, cases that aren’t even worth studying.

And the odds of suffering an adverse reaction have to be compared with the risk of contracting the disease itself. One of 1,000 children who get the measles, for instance, will end up with encephalitis, which can have devastating aftereffects such as seizures and mental retardation; some children still die from measles, often after getting pneumonia. It’s a lot less dangerous to subject a child to an MMR shot than risk exposing the child to a disease as contagious and potentially deadly as measles.