A randomized controlled trial of parachutes had a surprising outcome. Anti-vaxxers, take note.

One of my themes in this column over the years has been that you need to be skeptical of many of the claims out there about science and medicine. A healthy dose of skepticism can be a good thing, especially when someone is telling you something that seems surprising.

On the other hand, anti-science forces often pretend that they too are just being skeptical, or “just asking questions,” when what they’re doing is actually science denialism. Denialism is what someone is doing when the science is basically settled, but they refuse to accept it.

Let’s consider perhaps the clearest example of denialism, and the one that causes the most harm to public health: vaccine denialism. The anti-vaccine movement, which has grown alarmingly fast during the Covid-19 pandemic, insists that vaccines don’t save lives, and even more they insist that vaccines cause neurological damage. The latter claim is a favorite of Robert F. Kennedy Jr., as he’s proclaimed in multiple books and articles, and of his VP running mate Nicole Shanahan as well.

The claim that vaccines cause autism was first promoted in a bogus 1998 article in The Lancet by Andrew Wakefield. That article was later shown to be fraudulent, and the journal retracted it, but not before it spawned the modern anti-vaccine movement and made Wakefield one of their heroes. I’ve written many columns on this topic, and others have written far more, but the movement persists.

Scientists and doctors have pointed out, over and over again, that vaccines have saved millions of lives, and are one of the greatest medical advances in the history of civilization. The rapid development of the Covid-19 vaccine was a triumph, and it undoubtedly saved tens of millions more lives.

In defending their denialism, anti-vaxxers frequently ask this question: “where are the randomized controlled trials for vaccines?” They imply that scientists haven’t run such trials because they (the scientists) know that vaccines don’t really work.

That’s nonsense, of course. Scientists have conducted hundreds of studies, involving millions of people, showing how vaccines prevent disease and death.

But we don’t have any randomized controlled trials for childhood vaccines, and we never will, for an obvious reason: it would be deeply unethical. Let me explain.

A randomized control trial (an RCT) works like this: first, you identify a large group of people whom you want to treat, say by giving them vaccines. Then you divide them at random into two groups: the treatment group, who get the vaccine, and the control group, who get nothing. To prevent bias, you might also “blind” the subjects and experimenters so that no one knows who’s getting treated. For example, you could use shots filled with saline solution for the control group, so they think they’re getting a vaccine.

Once you’ve administered the treatment, you follow everyone for some period of time and see who does better. If the treatment group does better, then we say that the treatment worked.

Obviously, we cannot run an RCT for childhood vaccines, because withholding vaccines from children could grievously harm or even kill them. Instead, we can use data collected over time from millions of children, some of them vaccinated and some not, and measure vaccines’ effects from that. It’s not perfect, but these observational data show overwhelming evidence that vaccines for diseases including measles, mumps, rubella, polio, and smallpox are incredibly effective.

Yet anti-vaccine activists continue to call for RCTs, and they pretend that scientists who point out what I just wrote are not to be trusted.

Now to those parachutes in the title of this piece. We know that parachutes work, right? And yet where are the randomized controlled trials? Maybe we shouldn’t use parachutes until some scientists conduct that study? Hmm.

Well, if you’re thinking of skydiving and wondering about this question, you’re in luck! Because a few years ago, a group of scientists at Harvard, UCLA, and the University of Michigan ran an RCT on parachutes! And they published it, too, in the highly regarded British Medical Journal, now called BMJ.

I’m sure you’re curious about how they did this study, and how it turned out. Well, I’m going to tell you.

It was a small study: they approached 92 aircraft passengers and enrolled just 23 people. They randomized them into two groups, with 12 people wearing parachutes and 11 jumping with just an empty backpack.

What happened? Amazingly, there was no difference! Also amazingly, no one died! How could that be?

Well, reading the details of this (ahem) well-executed study, one learns that “randomized participants ... could have been at lower risk of death or major trauma because they jumped from an average altitude of 0.6 m on aircraft moving at an average of 0 km/h.”

In other words, participants did jump from a plane, but they were jumping from less than a meter off the ground and the plane wasn’t moving. A figure from the study illustrates the experiment:

Representative study participant jumping from aircraft with an empty backpack. This individual did ... [+]

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So as you see, this particular RCT of parachute use didn’t prove anything. Even so, the authors note, tongue in cheek, that “Beliefs grounded in biological plausibility and expert opinion have been proven wrong by subsequent rigorous randomized evaluations. The PARACHUTE trial represents one more such historic moment.”

In case you’re wondering how on earth the BMJ would publish a study like this, I can explain that the date of publication was Christmas 2018. The BMJ has a long tradition of publishing satirical but seemingly serious articles on Christmas, and this was a particularly good one.

On the other hand, though, my larger (and serious) point is that the public shouldn’t lose trust in science. Even when science gets things wrong–and it does–it’s still the best toolkit we have for figuring out whether or not something works, or is true. The recently popular cultural trope that truth is malleable, and that each person can choose their own “facts,” is dangerous. When it comes to scientific facts, that’s just wrong.

Parachutes work, and not using them would be exceedingly risky. Vaccines aren’t quite as guaranteed as parachutes, but they come pretty close.

Russian homeopathy, hiding in plain sight

It turns out that Russia has its very own brand of bogus medicine:"release-active drugs," or RADs. Dozens of scientific articles have been published claiming that these substances can be used to treat or cure a remarkably broad range of illnesses, including:

"... influenza, hemorrhagic fever, meningococcal meningitis, herpes, HIV, diabetes, erectile dysfunction, sleep disorders, obesity, chronic inflammatory joint diseases, attention deficit hyperactivity disorder, ..., alcoholism, allergies, and many other health problems." 

If this sounds too good to be true, that's because it is.

Thanks to a new report published in the journal BMJ Evidence-Based Medicine (provocatively titled "Drug discovery today: no molecules required") we now know that RADs aren't drugs at all, because they don't actually contain anything. As the new study reveals,

"The problem [with RADs] is that typical dilutions of the active ingredient are so high (from 1:10²⁴ to 1:10¹⁹⁹¹) that no molecules of the initial antibodies should be present in the ‘drug’ itself."

In other words, RADs are simply homeopathy by another name. As I've written many times before, homeopathy is one of the most patently absurd forms of pseudoscience, and although it's been debunked countless times, it remains popular due in part to commercial interests that profit handsomely from selling ineffective but expensive sugar pills.

RADs are produced by a single Russian company, with the odd name "OOO NPF Materia Medica Holding." The papers promoting the benefits of RADs are authored by a variety of Russian authors, but they are nearly all co-authored by or associated with one person, Oleg Epstein, who is also the company's founder.

Epstein and his Russian compatriots have been very clever about disguising the fact that their "release-active drugs" aren't drugs at all. Their papers are full of scientific jargon, which has no doubt helped them get their work past reviewers who (as every scientist who has published papers knows) can sometimes be a bit lazy.

They've also taken advantage of–one might say abused–the U.S. clinical trials system, ClinicalTrials.gov, by registering 22 studies of RADs there, such as this one.

The authors of the BMJ report (Alexander Panchin, Nikita Khromov-Borisov, and Evgenia Dueva, all Russian, though Dueva is based in Canada) are unsparingly blunt in revealing how Epstein has manipulated the scientific system in Russia to gain approval (and lucrative sales) of his so-called drugs. For example, Epstein has published 90 papers on RADs in a single journal, including 48 in a special issue that he edited himself.

Panchin and colleagues also took a closer look at 6 papers about RADs that were published in English-language journals, all co-authored by Epstein. They report that

"the articles contained misleading descriptions of active substance concentrations, severe flaws in study design and methodology, as well as concealed conflict of interests.... the authors did not mention that MMH manufactures and sells RADs and holds the corresponding patents. Epstein was not mentioned as the founder and CEO of MMH."

They contacted all of these journals, and only one journal, PLoS ONE, went so far as to retract the bogus science on RADs. Kudos to PLoS ONE for doing so. The other journals, some of them published by reputable scientific publishers including Elsevier, Wiley, and Springer, either didn't respond or refused to take action.

Fortunately for consumers, RADs haven't yet spread into U.S. and European markets, although their manufacturers are trying. In a recent letter published in a the Journal of Medical Virology, Epstein and his co-authors write that

"Currently we are in the process of approving evaluation requirements for our products, taking into account their peculiarities and allowing their potential authorization in the USA and Europe."

Buyer beware. The Russian quacks are coming.

Do high voltage power lines cause cancer?

This could be a very short article. I could just write “no, power lines don’t cause cancer"—but that wouldn't explain why so many people believe otherwise. And it won’t help people who are thinking about buying a home that has power lines nearby. So let’s look at this question a bit more closely.

For the past century or more, humans have been surrounding ourselves with an ever-growing array of electrical devices. All of these devices create electrical or magnetic fields, often called EMFs. There’s no doubt that our exposure to EMFs has increased dramatically in modern times. Not surprisingly, many people have worried that this is a bad thing. The belief is so pervasive that NIH has at least two websites devoted to this topic, one by NIEHS and one by NCI, as does the Medical College of Wisconsin. Realtors have created webpages to inform home buyers about how power lines might affect the value of their home. Not surprisingly, you can easily find companies on the Internet that will sell you devices (such as SafeSpace and EMFshield) to protect your body from the supposed perils of EMF.

People worry especially about high-voltage power lines, probably because they are carried by very large, highly visible structures that look vaguely threatening. This fear seems to have started with a 1979 study in which Nancy Wertheimer and Ed Leeper reported a correlation between high-voltage power lines and childhood leukemia in the area around Denver, Colorado. Wertheimer's results spurred numerous studies in the years since. A review of the evidence in 1995 pointed out that

“There is no known mechanism by which magnetic fields of the type generated by high voltage power lines can play a role in cancer development. Nevertheless, epidemiologic research has rather consistently found associations between residential magnetic field exposure and cancer.”

Scientifically, the question at the time was, were these associations real or coincidental?  If they were real, what’s the mechanism? Clearly, further studies were needed. Well, twenty years later, the data are in: power lines do not cause cancer.

In 2002, the WHO commissioned a huge (339 pages) and very thorough report on all the types of electrical and magnetic fields on the planet and how these EMFs might effect our health. Among its findings were:

“There is little experimental or theoretical evidence that mutations could be directly caused by ELF [extremely low frequency] magnetic fields…. There is little evidence that ELF electric or magnetic fields can cause malignant transformation of cells in culture.”

The final conclusion of the WHO commission was that

“Static electric and magnetic fields and extremely low-frequency electric fields are not classifiable as to their carcinogenicity to humans (Group 3).”

Group 3 means we don’t have any positive evidence that EMFs cause cancer. The only lower category, Group 4, would mean we have evidence that electromagnetic fields do NOT cause cancer, but such evidence is very difficult to produce. In other words, they concluded that the evidence didn't support a link, but more studies might yet find something.

After the 2002 report by the WHO, a study in 2005 raised the alarm again. In that study, Gerald Draper and colleagues claimed to find an association between the distance to the nearest high voltage power line and childhood leukemia. Draper found that living less than 200 meters from these power lines (in England and Wales) raised the risk of leukemia significantly compared to living at least 600 meters away.

The scientific reaction to the Draper study immediate and highly critical. Hepworth and colleagues pointed out that the results did not support a causal role for electromagnetic fields (which were not measured), but at best a geographic correlation. Kheifets and colleagues demonstrated out that the effect disappeared when the control groups were analyzed differently. Other critiques quickly emerged as well: a sign that science was working to self-correct, as it often does. But Draper’s study was widely reported, while the criticisms were not. The critiques, though, paint a compelling picture that Draper’s work was seriously flawed.

One of the most recent studies is from 2013 by Elliott et al. who looked at over 50,000 cases of cancer, including leukemia, brain cancer, breast cancer, skin cancer, and others. They found no increased risk for any of these cancer types and concluded

“Our results do not support an epidemiologic association of adult cancers with residential magnetic fields in proximity to high-voltage overhead power lines.”

This debate sounds very familiar. Many false hypotheses, such as the notion that vaccines cause autism, or that acupuncture can reduce pain, show the same pattern: a few small studies produce weak positive evidence, but then larger, better studies fail to back them up. Proponents always call for more studies, but if the effect is real, it doesn't disappear when you do a bigger study. If anything, the effect should appear stronger.

A major problem that the EMF alarmists have, which none of the proponents have ever answered, is one of mechanism: how is the very weak EMF from a power line supposed to cause cancer? Multiple theories have been suggested: maybe EMFs affect the movement of magnetic particles within cells, or alter the voltages across cell membranes—but as the editor of BMJ, Geoff Watts, put it in his response to the 2005 Draper study:

“Evidence to support these and other ideas is at best thin and at worst non-existent.”

So no, electrical power lines do not cause cancer. But they're still ugly. We should bury them all underground.

Everything in this journal is wrong

Moxibustion at work.

In real science, we agonize over every detail.  When we publish a paper, we strive to get everything just right.  We qualify our findings, always allowing for the possibility that we might have missed something.

Oh, to be freed of the constraints of reality.  But fiction, alas, doesn't work in the real world.  Fantasy medicine is, well, a fantasy.  Or is it?  Let's enter the world of Complementary and Alternative Medicine.

Imagine a scientific journal in which every single article was wrong.  Not just an occasional mistake, as happens with many journals.  No, I'm talking about a publication where every single article has at least one fundamental flaw.

No, it's a real journal, published by BMJ, the publishers of the well-known journal by the same name (the British Medical Journal).  "Helping doctors make better decisions since 1840", they proclaim.  Then why, among their 40+ journals, do they publish Acupuncture in Medicine?

It appears - I can't prove this, but it seems to be so - that every single article in this journal is wrong.  Not just a little bit wrong, either.  Let's look at the "Editor's choice" article from the latest issue, which must be one of their best.  It's called "Using moxibustion in primary healthcare to correct non-vertex presentation: a multicentre randomised controlled trial".

In this study, a group of Spanish doctors looked at the use of moxibustion to correct a common problem in pregnancy known as a breech position - that's a baby that is turned the wrong way round in the mother, head up instead of down.  What, you may ask, is moxibustion?  Well, let me use the authors' explanation:

"The application of heat from the combustion of Artemisia vulgaris (moxibustion) for therapeutic purposes has long been used in China. Among other effects, it is believed to contribute to correcting the non-vertex presentation of the fetus when applied at a specific acupuncture point (BL67 Zhiyin) located at the outer corner of the little toenail."

That's right: you burn an herb (Artemisia) next to the little toenail of the pregnant mother, right next to an acupuncture point, and that's supposed to make baby flip right around so its head comes out first.

You can't make this stuff up.

These guys are serious.  They ran a study where they divided pregnant women into 3 groups, with about 135 women in each.  One group got moxibustion, another got "fake" moxibustion, where they burned the herb next to a different toe (really!), and the last group got standard care.

Amazingly, the doctors found that it works!  More of the women with moxibustion had babies born the right way round, head down, than in either of the other two groups.  To be precise, 79 babies in the moxibustion group came out the right way, versus 60 and 59 in the other two.  By the authors' own analysis, this difference was statistically significant.

Wow.  Maybe this stuff really does work.  And moxibustion is cheap and easy to administer.  Maybe this is the solution to our rising health care costs.

How to explain this result?  I see several possibilities:

1. The small effect was just a random variation, not due to the treatment.  Previous studies of exactly the same treatment (such as this one) showed that moxibustion did not work.  So either those studies are wrong, or this one is.
2. There was bias in how the women were assigned to treatment, and the effect can be explained by that.
3. The authors manipulated the data to make the numbers come out better.  (Quelle surprise! Not in a BMJ journal!)  Of course we can't prove this without much more investigation.
4. Burning an herb next to the little toe at just the right place - and nowhere else - stimulates a mystical "qi" pathway, and zaps that little baby back around the way he's supposed to be.

Hmmm, which seems the most likely?

OK, I admit it: I haven't read every single article in BMJ's acupuncture journal.  So I don't really know that they are all wrong.  But who has time to read all this bad science?  The latest issue has a disturbing number of articles about acupuncture for cancer, which I find particularly upsetting because that practice takes advantage of highly vulnerable patients.  It also includes an article on ear acupuncture, a practice invented out of whole cloth by an Army doctor in the U.S., who has been inflicting it on injured service members, as I've written about before.

Actually there is one article that seems plausible.  It reports a case of arterial hemorrhage caused by an acupuncture needle.  But we don't need to dwell on that.

Acupuncture in Medicine has all the trappings of a real journal, including an editorial board whose members work at respectable medical schools.  I know that BMJ wants us to believe it; after all, they make money on this stuff.  As for the journal itself: I can't bear to read any more.  It is just too painful.  Perhaps acupuncture would help.