By now most people have heard that AstraZeneca, a UK pharmaceutical, working with Oxford University, are one of the major companies developing a vaccine for SARS-CoV-2, and also that they have had to pause their Phase 3 clinical trial because a subject came down with an inflammatory disorder. Let’s put this into some important context.

The basic facts are that the AstraZeneca vaccine did very well in Phase 1 and 2 preliminary trials. These are smaller trials mostly about safety, with the Phase 2 trial including some preliminary (usually open label) efficacy data. These trials are basically used to determine if it is safe and worth it to proceed to a huge Phase 3 trial. The Phase 3 trial includes 30,000 subjects. When you increase the number of subjects by orders of magnitude then you are likely to pick up increasingly rare side effects. That is one of the main points of this staged approach to research. Then, of course, a drug or vaccine might be marketed to millions of people, and still more rare side effects will crop up. There is simply no way to avoid this – it’s math. That is why so-called Phase 4 trials follow reported side effects after market.

But also, when you are studying 30,000 subjects all the things that normally happen to people will happen at the background frequency. Some of them will get sick during the trial by chance alone, having nothing to do with the study drug or vaccine. So every potential adverse effect is tracked, determined if it is biologically likely that it is related to the experimental treatment, and then statistically analyzed to see if it is above the background rate.

In this case one subject developed transverse myelitis, which is inflammation in one segment of the spinal cord. This will cause weakness and numbness at that level and below, therefore usually affecting the legs. The background incidence of transverse myelitis is about 1.3-4.6 cases per million people per year (this does not include people known to have an autoimmune disease like MS that causes transverse myelitis). If we take 4 cases per million per year, that translates to 0.033 cases per 33,000 subjects over three months. That is the probability that one of the subjects in that trial would have randomly developed transverse myelitis. That may seem really unlikely, but actually you have to consider the probability of a subject developing any disease, not just transverse myelitis. When you add it all up it’s actually pretty likely that one or several people in the trial would randomly develop a disease not related to the vaccine. In fact, this is the second person in this particular trial to develop a serious potential adverse event resulting in a pause of the trial.

Continue Reading »

This is the big question facing many countries, but especially the US – how do we reopen schools while still in the middle of a pandemic? This is a serious dilemma. The American Academy of Pediatrics urges that, especially younger children, have the opportunity for in-person learning.  This is important not only for their education but their socialization and development.

The other important variable here, however, is how susceptible are children to SARS-CoV-2 and the COVID-19 infection it causes? Early experience showed that children are less susceptible to getting the illness and when they are infected are less likely to have serious disease. This partly informed the AAP’s recommendation. However – more recent data is casting doubt on the notion that children can safely return to school.

The most comprehensive review of the data so far, just published, shows that children are asymptomatic carriers of the virus, and have high viral loads, which means they can be very contagious. Further, when they do get symptoms they are likely to be more like cold symptoms, with a fever and runny nose, which in adults makes it less likely they have COVID-19. These two factors mean that children have been widely underdiagnosed. Most testing programs are focusing on symptomatic individuals, and children get missed by such efforts.

The review also concludes that a small percentage of children can get a late-stage complication of COVID-19, even if the illness is mild or asymptomatic – their immune reaction several weeks after infection can cause serious illness, including heart disease. This is one of the serious features of this illness, the immune system’s response can sometimes be severe, causing much more damage than the infection itself.

Continue Reading »

One of the challenges of dealing with the COVID-19 pandemic, both on an individual patient level and public health level, is that this is a novel virus. We don’t yet have a lot of experience with it or clinical data about how it behaves, what it is capable of doing, and how the immune system deals with it. We are learning fast, but there is still much we don’t know, especially, of course, about long term effects.

One burning question is – what are the prospects for developing natural herd immunity as the infection spreads throughout communities? Herd immunity (or community immunity) occurs when enough people in a population are resistant to infection due to having effective antibodies that the infection cannot easily spread. This is how epidemics or pandemics burn themselves out – eventually enough people have already been infected and are resistant that the virus cannot find receptive hosts and stops spreading. The percent of the population with resistance needed to achieve herd immunity varies with each type of infection, and can be as high as 90+%. Here are some of the unknowns with COVID-19.

Do people who get infected develop neutralizing antibodies with sufficient activity to resist reinfection?

How severe an illness is required to develop these antibodies? Is a mild or asymptomatic infection enough?

Do these antibodies prevent reinfection alone or do they also prevent passing the virus on to others, even if the host does not get sick themselves?

How long do these antibodies last?

Continue Reading »

As the pandemic goes into its 5th month in the US it’s important that we do not suffer from pandemic fatigue. As I wrote previously, this is a marathon, not a sprint. In the US all indications are that we are failing, miserably. As of right now the world has suffered 13.7 million cases of COVID-19 and 587,000 deaths. The US has had almost 3.5 million of those cases, and 137,000 deaths. These numbers are certainly underestimates. While most other industrialized nations are winding down their cases and safely returning to life as normal, cases continue to rise in the US and are spiking in some states.

The bright side of this story is the massive scientific effort to study this virus and understand how to prevent and treat it. The science has been steadily progressing, and it is now clear what we need to do to stop the pandemic. All that is required is political will. Here are some very recent studies that reinforce what we now know.

First – masks work. They really do.  They protect the wearer a little bit, and they protect other people a lot. This is because the virus is spread mostly in small droplets of fluid that are directly spread from one person to another. When you talk to someone, you are spraying them with these tiny droplets. When you wear a mask, this is mostly blocked. To add to the data that masks work, a recent study looked at infection rates among health care workers at MGB hospital. They found a dramatic decrease in infection rate once universal mask wearing was mandated.

The pushback against maskwearing seems particularly irrational. We are in the middle of a deadly pandemic. Wearing a mask is a small sacrifice that is a courtesy to those around you, mostly to minimize the chance that you infect them. Not wearing a mask is essentially a choice that your personal liberty is so important, you won’t bring yourself to take a small measure that will reduce the chance that you kill other people with your germs and perpetuate the broader pandemic.

Continue Reading »

A promotional video on YouTube for a new documentary, Plandemic, is making the rounds and promoting quite a response. The video features Dr. Judy Mikovits, and is basically an interview with her. Unfortunately this is a slick piece of utter nonsense and conspiracy mongering. Mikovits has zero credibility in any of her claims, but they are combined with music and clips of videos to create the impression that there is some reality behind her outrageous claims. Let me focus on a few claims to show how low her and the filmmaker’s credibility are.

In her introduction the narrator states that she authors a study in Science that “sent shockwaves through the scientific community” because it showed that fetal and animal tissue in vaccines was causing an epidemic of chronic illness. This is straight up lie, but that is the narrative of this video – that she is a courageous fighter going against the establishment, which is killing people for profit and trying to destroy her for calling them out.

Here is the original Science paper. It alleges to have found the XMRV virus in patients with chronic fatigue syndrome. This did make a splash when it was published because it purported to find a possible cause of an otherwise mysterious illness. It has nothing to do with vaccines at all (although you could argue, falsely that the virus came from vaccines, but that is not what the research was on). But then, here is a retraction of the paper by Science. Was it retracted as part of some global conspiracy against Mikovits? No – it was retracted because:

“Multiple laboratories, including those of the original authors, have failed to reliably detect xenotropic murine leukemia virus-related virus (XMRV) or other murine leukemia virus (MLV)-related viruses in chronic fatigue syndrome (CFS) patients,” says the retraction notice. “In addition, there is evidence of poor quality control in a number of specific experiments in the Report.”

Continue Reading »

Perhaps the most persistent and annoying question promoters of science-based medicine get is, “What’s the harm?” The implication is we should just let people use their Reiki or magic potions if it makes them feel like they are doing something, as long as the treatment is not directly physically harmful. As you can see, I have been addressing it for years, including the fact that I will have to address it for years. There is also well documented real physical harm from many unscientific treatments, but even without that the harm is substantial.

As a physician I have seen first hand much of the harm that can result – such as wasted time and effort, expenditure of limited resources, the psychological harm of false hope, and delaying effective treatment. But I have also warned about the harm to our scientific, medical, and societal infrastructures. This is difficult to quantify, but what is happening is that we are allowing to thrive a multi-billion dollar industry funneling money to charlatans, quacks, con-artists, pseudoscientists, those who discount science, and conspiracy theorists. Do you think they are just taking their money and staying quiet? No. They are using some of those billions to lobby for laws to water down public protections, weaken regulations, and funnel taxpayer money into promoting their snake oil.

This multi-billion dollar industry is also engaged in a massive advertising campaign, which amounts to a disinformation campaign, for their “brand”, which is alternative, complementary, integrative, functional, whatever medicine. They have spent decades misinforming the public about the relative significance of various health risks and benefits, the nature of disease, and the trustworthiness of scientists and experts. They have been a major component in the war on expertise, and to a large extent they are winning.

Continue Reading »

The short answer to the question – how do you boost your immune system – is that you can’t. The very concept of “boosting” the immune system is not scientific and does not exist within mainstream medicine. That’s because it is based on a fundamental misunderstanding of immunity, and of biological systems. Having said that there are legitimate things you can do to optimize immune function, which all are simply ways of avoiding things that inhibit immune function. But first let’s cover some basic principles.

Basic Principles

Biological organisms are complex, dynamic, homeostatic systems. This may seem obvious when you think about it, but many dubious health claims violate this basic understanding of biology. The immune system itself is a highly complex system – so complex that even though we have a vast amount of knowledge about the immune system, we have a hard time predicting the net effect of specific changes to the system. We have studied drugs in auto immune diseases, for example, that have had the opposite of the predicted net effect. This means we need to be very wary of any study that purports to show a change in some measure of immune function, and then concludes that this is a good thing, a “boosting” of immunity.

But perhaps even more important is the homeostatic bit. Immunity is a delicate balance, and evolution has tinkered with this system for hundreds of millions of year. If there were a simple way to make this system function better, we would have evolved it already. Put another way, there is no simple way to hack this system with a supplement or other measure. Immunity is also a double-edged sword – it fights off invaders and damaged cells, while trying to minimize harm to our own tissue. Think of inflammation – this is a good thing when it is killing bacteria, but also causes a lot of harm. When this delicate balance is disturbed, the result can be an auto-immune disease.

Therefore, we should think twice or thrice before doing something meant to disturb this delicate balance. Chances are greater we will make things worse than better. We need carefully conducted clinical trials to determine the net effect of doing anything to immunity in specific clinical contexts. Also, there is nothing better than a healthy immune system – there is no “super” immunity you can get from your diet or taking a supplement.

Continue Reading »

“There is a cult of ignorance in the United States, and there has always been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that ‘my ignorance is just as good as your knowledge.”
― Issac Asimov

As science-communicators and skeptics we are trying to understand the phenomenon of rejection of evidence, logic, and the consensus of expert scientific opinion. There is, of course, no one explanation – complex psychological phenomena are likely to be multifactorial. Decades ago the blame was placed mostly on scientific illiteracy, a knowledge deficit problem, and the prescription was science education. Many studies over the last 20 years or so have found a host of factors – including moral purity, religious identity, ideology, political identity, intuitive (as opposed to analytical) thinking style, and a tendency toward conspiratorial thinking. And yes, knowledge deficit also plays a role. These many factors contribute to varying degrees on different issues and with different groups. They are also not independent variables, as they interact with each other.  Religious and political identity, for example, may be partially linked, and may contribute to a desire for moral purity.

Also, all this is just one layer, mostly focused on explaining the motivation for rejecting science. The process of rejection involves motivated reasoning, the Dunning-Kruger effect, and a host of self-reinforcing cognitive biases, such as confirmation bias. Shameless plug – for a full discussion of cognitive biases and related topics, see my book.

So let’s add one more concept into the mix: anti-intellectualism – the generalized mistrust of intellectuals and experts. This leads people to a contrarian position. They may consider themselves skeptics, but they do not primarily hold positions on scientific issues because of the evidence, but mainly because it is contrary to the mainstream or consensus opinion. If those elite experts claim it, then it must be wrong, so I will believe the opposite. This is distinct from conspiracy thinking, although there is a relationship. As an aside, what the evidence here shows is that some people believe in most or all conspiracies because they are conspiracy theorists. Others believe only in some conspiracies opportunistically, because it’s necessary to maintain a position they hold for other reasons. There is therefore bound to be a lot of overlap between anti-intellectualism and holding one or more conspiracies, but they are not the same thing.

Continue Reading »

Homeopathy is pure pseudoscience. No reasonable review of the evidence can come to another conclusion. Most people who use homeopathic products don’t even know what it is – they generally think that the term refers to herbal or natural remedies. Nothing could be further from the truth. In fact, for most people, when I tell them what homeopathy actually is, their first reaction is disbelief. As silly as homeopathy is, it is good to give occasional reminders of how nonsensical the homeopathic industry is and how absurd their claims. This reminder is about homeopathic X-rays, which I will get to below.

The two core claims of homeopathy include the notion that like cures like – that a substance that causes symptoms will reduce those same symptoms in teeny tiny doses. There is no science to this claim, and no, it does not operate like allergy shots or vaccines. The substances and doses used generally do not provoke any immune response. They don’t provoke any response at all, because the doses are so tiny, they are usually non-existence. That is the second core foundation of homeopathy, extreme dilutions.

How extreme? A typical 30C dilution involves dissolving the starting ingredients 1:100 thirty times. That is a 10^60 dilution. There are about 10^50 atoms in the Earth, so you would need 10 billion Earths worth of homeopathic potion to have an even chance of getting a single molecule of “active” ingredient. But to the homeopath this is a feature not a bug, because they believe that the magical “essence” of the starting ingredient remains behind.

Homeopathy, in other words, is not medicine but magical potions, based on prescientific superstitions. That doesn’t stop corporations from pretending it is real medicine and selling it as such.

Continue Reading »

This is going to be a long struggle, perhaps endless. Antivaxxers have been around since there have been vaccines, for over two hundred years, so there is no reason to expect they are going anywhere. Rather, we need an equally permanent anti-antivaxxer movement (otherwise known as the skeptical movement).

After the Disneyland measles outbreak, there has been political pressure to push back against antivaxxers and strengthen our vaccine requirements. This resulted, for example, in SB277 in California, a law to remove personal beliefs as a reason for vaccine exemption. The return of measles in the last few years (1,282 cases in 2019 in the US, more than 140,000 worldwide) has fueled similar push back. But the antivaxxers have not taken this lying down. They are now fired up to defend their debunked conspiracy theories and pseudoscience at the expense of public health.

A recent clash in New Jersey shows the intensity on both sides. Bill S2173 narrowly failed in the senate amid vocal protests by the antivaxxers. The bill would have removed religious exemptions for vaccine requirements for schools and daycare. In order to save the bill, proponents amended it to apply only to public schools, but this only cost more support as some senators correctly pointed out this will only concentrate the unvaccinated in private schools and result in more outbreaks. Proponents of the bill vow to revise it and try again.

It’s clear that there is now intensity on both sides. One side, however, is completely wrong, something I rarely say but there are issues where this is clearly true. Antivaxxers claim, falsely, that vaccines don’t work, they cause more harm than good, they are linked to autism and other serious complications, and even that there is a corporate-government conspiracy to hide these facts. Debunking these claims will take many many articles, but fortunately I and my colleagues have already written them. You can look through here and also here for articles addressing pretty much every antivaxxer claim. But it is an unfortunate reality that there is always an asymmetry in these cases, because it takes much more time and effort to debunk a false claim than to make it in the first place.

Continue Reading »