In 1958, the UK licensed a drug for treating morning sickness. It worked very well. The studies all showed that pregnant women suffering from morning sickness received much relief with the drug. Three years later it was withdrawn, but not before 2,000 babies were born with birth defects — 20,000 worldwide — three quarters of whom would die in infancy. The drug was, of course, thalidomide. It managed to get licensed because too many of the people studying it were focused on very specific aspects of its activity on the disease states that it was thought to treat, and too few were stepping back and looking at the big picture. It prevented morning sickness, therefore it worked — the logic of the day.
A disaster on the scale of Thalidomide can’t happen these days because the path to drug licensing forces researchers to comprehensively check all effects and outcomes of a new drug. Individual researchers will know in extravagant detail very narrow aspects of how a new drug achieves its desired effect. Some of them will know the exact rate at which it crosses the various barriers into the blood and into organs; others will know the exact chain of activation of molecules and genes within cells, down the individual amino acid residues that are modified and the exact number of seconds after the drug is administered; others will know the exact schedule and mechanism by which the drug is broken down or expelled from the body. They’ll be really excited and enthusiastic about their new drug. But when somebody steps back and points out that the drug causes heart failure, it won’t get anywhere.
But the BMA seems to forget everything it knows about testing interventions when it comes to bicycle helmets. There are some superficial differences between helmets and what we normally think of as “medical intervention”. They are a physical intervention rather than a drug — but medicine deals with and properly tests physical interventions all the time. And it’s supposed to prevent rather than treat injuries — but medicine deals with and properly tests preventative measures, including conventional drugs, all the time. There is no intrinsic reason why bicycle helmets can not be tested properly, in line with the rules that were designed to prevent another thalidomide disaster. We have the methods and the expertise.
And yet the evidence that we have on bicycle helmets is currently in a worse state than the evidence that got thalidomide licensed. There is some (limited) evidence that in people who have had crashes, helmets reduce the rate of specific types of head injury — just as there is undisputed evidence that thalidomide is effective in relieving morning sickness. But there is also (equally limited and disputed) evidence of several different side effects — an increase in other types of injury* and an increased rate of crashes (particularly crashes with vehicles, which are more likely to have negative outcomes). And there is also evidence that helmets discourage many people from cycling* — an activity that adds many quality years to people’s lives by preventing or delaying cardiovascular disease, cancers, diabetes, depression, dementia, and all those other diseases of sedentary lifestyles. Helmets might be an effective intervention for the types of injuries they are claimed to prevent, but that would be irrelevant if, like thalidomide, they cause more problems than they solve.
I’m not saying that they do. The issue is not that there is overwhelming evidence against helmets. The evidence that they are the cause of crashes and other injuries is no stronger than the evidence that they prevent head injuries. The issue is that the evidence either way is nowhere near good enough to make a recommendation. If helmets were a drug, they would be nowhere close to getting licensed right now.
Which is why British doctors should be embarrassed that the British Medical Association currently lobbies for helmets to be compulsory when riding a bicycle. Imagine if a pharmaceutical company developed a drug which, if administered before receiving a specific kind of traumatic injury, makes that injury easier to treat. Imagine doctors and medical scientists lobbying for it to be compulsory for everybody to take this drug daily, without anybody ever having checked for side-effects.
How has this situation arisen? The policy decision has largely been made on the insistence of A&E consultants and trauma surgeons. Consider the anonymous quotations that are scattered through the BMA’s cycling pages:
‘I have seen – in my practice and when working in A/E – quite a number of serious head injuries from children falling off bicycles. I have also seen a number of children who wore helmets who only suffered minor injury. I am convinced that helmets reduce injury.’ — GP
’I would certainly support cycle helmet wearing for cyclists. I have seen far too many young lives ruined by head injuries.’ — Consultant in Emergency Medicine
’I am an Emergency Department Consultant and a keen cyclist. I wholly agree…that we need to move to an environment where cycle helmet wearing is the norm, rather than the exception’ — Emergency Department Consultant
’As a regular commuting cyclist through twelve miles of heavy London traffic and as a Consultant Emergency Physician I whole-heartedly support the BMA’s stance on the introduction of legislation to make the wearing of helmets mandatory.’ — Consultant and Honorary Senior Clinical Lecturer in Emergency Medicine
’Over the [last] 16 years I have worked in A/E. I have dealt with hundreds of head and facial injuries, particularly in children, that could have been avoided had a cycle helmet been worn. I have also had the misfortune to deal with a number of fatalities that I believe would have been avoided by simply wearing a helmet. I firmly believe that legislation making cycle helmet usage mandatory is essential.’ — Emergency Medicine Consultant and Clinical Director
‘I have worked in emergency medicine for the last twelve years. Personally I cycle around two and a half thousand miles each year and my family are rapidly becoming keen cyclists also. Prior to working in emergency medicine, I did not routinely wear a cycle helmet.
I have seen numerous examples of patients sustaining severe head injuries from which they will never recover whilst cycling at low speed without a helmet. I have never seen this pattern of pathology in cyclists wearing helmets under these circumstances.
I am aware of the recent Cochrane review on the subject. I firmly believe that all cyclists should wear helmets. I also believe that the only way to ensure this happens is through legislation. I can see no justification for allowing this entirety predictable pattern of head injuries to persist. I strongly support the BMA position…’ — Consultant in Emergency Medicine
That’s five emergency medics and a GP, all reciting anecdotes from A&E. Nobody who specialises in, say, public health.
Emergency medics and trauma surgeons are obviously very enthusiastic about the potential to put an end to injuries, just as people who were very focused on the problem of morning sickness were excited by thalidomide. But ironically, most doctors and scientists are not very good with complexity. They are good with the intense detail of their own specialism, but when they have a problem to solve they fail to consider that there might be relevant things happening outside of their own field. When emergency medics want to solve the problem of head and brain injury, they look at those injuries in isolation from the rest of medicine. It’s not their job to think about the bigger the picture, or worry about things like side-effects.
Indeed, dare I suggest that for most working emergency medics and GPs, the science of evidence-based medicine is not their job or even a major part of their training: they only need to practice what the scientists amongst them tell them to practice; most working doctors don’t need to understand how we know their interventions work.
Which is fine. But that stuff is somebody‘s job, and somebody isn’t doing it right at the BMA.
This way of thinking about the issue — as an isolated problem of emergency medicine — is reflected all through the BMA’s bizarre “safe cycling” pages, which emphasise these individual anecdotes and opinions of doctors in that field (despite “expert opinion” being frequently out of line with the science and despite everything we know about the ability of anecdotes to lead readers astray), while failing to ever think of the issues around helmets in terms of effects and side-effects or the usual path of research that is demanded for medical interventions.
The authors of the Cochrane review on bicycle helmets say, in dismissing risk compensation, “the fundamental issue is whether or not when bicycle riders crash and hit their heads they are benefited by wearing a helmet.” This is exactly analogous to saying that “the fundamental issue is whether or not when a pregnant woman has morning sickness her symptoms are relieved by thalidomide.” That is not the fundamental issue at all. The fundamental issue with any medical intervention is whether it does more help than harm, whether it improves the length and quality of our lives, whether we are better with it or without. That the authors of a Cochrane review are allowed to get away with saying otherwise is a great failure for evidence-based medicine. That the BMA think there is sufficient grounds not merely to promote this intervention but to enforce it is an epic failure.
* I thought about posting separately on these sets of side-effects too, but those posts would have been much like the rest of this series: there’s a plausible hypothesis, there’s some evidence to support it, but the evidence has limitations. Ultimately the conclusions always are: the evidence base is nowhere near good enough to support helmet promotion, let alone legislation.