Medical Technology Business Europe reported yesterday that the Directive — the Physical Agents (Electromagnetic Fields) Directive — issued by the European Union Commission in 2004 and is required to be national law in all EU countries by April 2008, will ban the use of magnetic resonance imaging (MRI), an important medical diagnostic test.
Professor Dag Rune Olsen, a scientist of experimental radiation therapy at the Norwegian Radiation Hospital, Oslo, Norway, and chairman of the physics committee of the European Society for Therapeutic Radiology and Oncology, is speaking out and said that the Directive, which set “safe” limits on radiation exposure for workers, were set so low that they will prevent the use of MRIs and deny millions of patients the benefits of MRIs.
How’d that happen?
For years, the European Commission has been monitoring the potential health effects of electromagnetic fields (EMF), financing research, distributing information, and working to establish legal protections, which were embodied, in part, in the Directive, according to the June 2007 Eurobarometer report. This report was commissioned by the Directorate-General Health and Consumer Protection of the European Union to assess the public’s level of concerns about EMF and other environmental exposures. A sampling of 30,000 Europeans were interviewed in their homes last October and November and the results were startling.
It’s well-known among marketing and media professionals that fear sells and they’ve become quite adept at using fear, and taking advantage of the public’s general lack of understanding of science, to promote agendas or products. Whenever we hear something that makes us feel anxious or worried, our emotions are being played and that’s our baloney alert that what we’re hearing is marketing rather than sound, impartial science. Hitchcock was the master of fear manipulation and could convince entire audiences that there was danger in a mere shadow.
When we feel anxious about something(s) we believe could harm us, it’s natural to feel increasingly vulnerable and want to feel safer. And when the risks are uncertain or the possible dangers unseen, any exposure at all seems too much and no amount of risk feels acceptable. Safety becomes the primary focus.
We’re increasingly being inundated with news of “what ifs” and worst case scenarios about everything. They are also being embraced by governmental agencies, especially across Europe, in what Mike Hume of Spiked-online, calls the politics of organized paranoia. Policy makers “dream up fantasy disasters and then try to plan to deal with these hypothetical crisis.”[sic]
Fears and “the sky is falling” worries have led to the growing popularity of the precautionary principle. While there are numerous definitions, generally, it’s the “better safe than sorry” idea that results from trying to avoid risks. If something could potentially cause harm, even when there is no evidence of harm, then people and politicians are encouraged to err on the side of caution and avoid it.
Of course, everything in life, including most scientific and technological developments, comes with possible risks of harm. But under the precautionary principle, the new development is eliminated or restricted “to protect the public,” without carefully weighing:
· the science to determine how realistic the risk is
· the benefits of the development
· the harm that could come from not having the new development
That last one is often forgotten but it is an important reason why the precautionary principle is rarely actually the safest option or the best solution, because it comes at the cost of false positives, as we’ll see happened with MRIs. When leading scientists were asked to name the advances that have made our lives better and safer but could never have come about if the precautionary principle had been in place in the past, “they came up with a scary list, starting with A for aspirin and going through to X for x-rays,” said Mike Hume.
The precautionary principle was officially adopted by the European Union in the Treaty of Maastricht in 1992. One example of it was the expert panel on mobile phones established by Sir William Stewart in 1999. Its conclusions were published in the renowned Stewart Report. It said that, while the balance of evidence showed no adverse health effects from wifi, the panel still recommended to officials that “a precautionary approach to the use of mobile phone technologies be adopted until much more detailed and scientifically robust information on any health effects becomes available.” Specifically, it stated:
Government has in place national guidelines established by the National Radiological Protection Board on the maximum levels of exposure to RF radiation emitted from mobile phones, base stations and other sources.... [which] were based on a comprehensive review of the scientific literature... In 1998, the International Commission on Non-Ionizing Radiation Protection published its own guidelines .... [however,] the maximum levels of exposure of the public are about five times less than those recommended for workers. The reason for this approach was the possibility that some members of the general public might be particularly sensitive to RF radiation. However, no detailed scientific evidence to justify this additional safety factor was provided....
We conclude therefore that it is not possible at present to say that exposure to RF radiation, even at levels below national guidelines, is totally without potential adverse health effects, and that the gaps in knowledge are sufficient to justify a precautionary approach...
We are concerned at the variability and the limited extent of the information made available to consumers on mobile phone products. We recommend that Government circulates a leaflet to every household in the UK providing clearly understandable information on mobile phone technology and on related health aspects...
Skeptics probably already caught the biggest fallacy of logic there: one can never prove a negative and “prove” without a doubt that something is totally safe and completely free from potential effects. No amount of science can, which is why traditional risk analysis weighs what is known and the scientific plausibility of harm against the benefits.
So, for years, not only the media, but public officials have also been raising concerns in the minds of the public about possible health risks from EMF. While it may be easy to laugh at scare-mongering stories or consumers who take to protecting themselves using beehive hats, the fact is, people actually believe these things.
Sadly, the Eurobarometer results illustrated just how effective the continual drumbeat of doomsday scares about the safety of EMF, our food and environment have been. [Keep in mind that our food and water have never been safer and people have never been healthier or enjoyed such long lifespans...]
It found that 91% of people believe “chemicals” are affecting their health — 64% said to a big extent. Following close behind are concerns that the quality of food, air and water are affecting their health, at 89%, 81% and 86%, respectively, with half believing each of these affect their health to a big extent. Three-fourths are concerned about the health effects from EMF — cell phones and towers and high tension wires. Over the past several years, EMF fears had grown more than any other health risk. Most citizens felt that public health officials weren’t protecting them from the possible risks of EMFs and about 7 out of 10 weren’t happy with the information they received and half felt they weren’t being told the whole story.
Combine fear and excessive caution with poor or no science, and the results are unsound and potentially harmful public policies. As we’ll see, this is exactly what appears to have happened with these Directives. There had been no reports of a single worker being harmed from MR exposure or any new research suggesting dangers from EMF leading to their action. It was led by fear.
What have they done?
As Med Tech Business Europe reported this week:
European Directive on radiation exposure will ban MRI scans
...Currently eight million MRI patient examinations per year are carried out in Europe, said Professor Dag Rune Olsen... “But these are likely to have to stop, since the Directive sets limits to occupational radiation exposure which will mean that anyone working or moving near MRI equipment will breach them... A British study into operator exposure to electromagnetic fields from MRI, published by the Heath and Safety Executive in June 2007, found that anyone standing within about one metre of an MRI scanner in use would breach the exposure limits laid down in the directive. The Commission has accepted this, and said that it will consider the HSE report together with the study it has commissioned itself, and which is due for publication in October 2007, when deciding whether and how to propose amendments to the directive or to extend the implementation period.
“But they may already be too late,” said Professor Olsen. “ Slovakia has already implemented the directive, on the grounds that it was based on the assumption that the limits which it sets would have no effect. This would appear to mean that it is now illegal to carry out MRI scanning in the country.”
The directive in its present form poses particular problems to those healthcare staff who care for patients such as children, the elderly, or those who have been anaesthetised, who need help and comfort during scans. It will also stop the use of MRI for interventional and surgical procedures, and will curtail cutting-edge research.
A bit of background: The Health and Safety Executive is under the UK government’s Health and Safety Commission, and is tasked to “ensure that risks to people's health and safety from work activities are properly controlled.” The June report referenced in the news was the HSE’s RR570 Report. A consultant, Professor Stuart Crozier of the University of Queensland, had conducted a project in which he took measurements from magnetic field dosemeters worn by MRI personnel working an average 9.3 hour shifts and attending to 10 scans per day and, with computer modeling, calculated various types of exposures, distances, intensities and durations. He concluded that there are situations which could possibly lead to exposure guidelines being exceeded.
Other MR experts note threats to patients
This isn’t the first report expressing the concerns of science and medical MR professionals that the Directive could severely limit the use of MRIs for research, diagnosis and treatment. In June, the Wellcome Trust and the Medical Research Council surveyed MR professionals at 54 centers across the UK and found that three quarters of medical professionals needed to be in the exam room working within one metre of the MRI scanner. They concluded:
The current exposure limits for gradient fields would prevent [this, and] would prohibit interventional MRI, limit the provision of patient care, and restrict researchers from reaching into the magnet bore, for example for positioning and checking equipment, or providing technical support. Paediatric and neonatal work would be particularly threatened, because expert nursing care is often required during imaging.
The EU Physical Agents (EMF) Directive could seriously limit the use of MRI for research purposes, prohibiting research that has clinical and public benefit. The use of new, more powerful high-field scanners in research will be particularly restricted and the Directive threatens the development of new MR methodologies and improvements in technology.
A 2 1/2 year investigation of the scientific evidence and development of the Directives was conducted by the Science and Technology Committee appointed by the House of Commons. It found that the EU Commission had never evaluated the potential negative impacts on medicine or research when they wrote the Directives. It had reacted only to the possibility of risk.
In addition to eliminating the ability to monitor patients requiring close supervision during imaging — such as sedated or critically-ill patients, children, anxious and psychiatric patients — the investigators noted that the Directives would also affect testing of the magnets during manufacture and maintenance. “Some MRI studies will become impossible—e.g. studies on deaf-blind subjects, where staff ‘sign’ into the palm of the patient during imaging,” they wrote. Finally, “there is likely to be an increase in X-ray and CT imaging in place of MRI, resulting in increased radiation risk to staff and patients, where the risks are known.”
‘No risk’ can be riskier
The Science and Technology Committee concluded:
It is deeply regrettable that the impact of the Directive on MRI procedures was not established before the Directive was adopted. This case study illustrates the potential consequences of the failure of policy makers to seek comprehensive scientific advice early in the policy formulation process and to commission the necessary research to inform this process where uncertainty or gaps in knowledge exist. While there should be an obligation to reduce risks to a reasonable level, to actually pursue the “lowest achievable limit” would entail health and safety practices which most would consider unnecessary and economically unviable, if not counter-productive in certain circumstances. Risks need to be balanced against gains, rather than necessarily minimised [out of hand].
Not only that, but the science investigators found “significant uncertainties around the scientific basis of the guidelines” and that there wasn’t a strong enough case for “enshrining the exposure limits in a Directive.” They found that the views of the MR professional community were “diametrically opposed” to those of the Commission, but those hadn’t been heard. In fact, other MR scientists were publishing similar concerns, questioning the scientific evidence on which the limits are based.
They found the Commission had used the precautionary principle to set public policy, but that this “approach is at present ill-defined and certainly unsatisfactory as a tool for practical use,” adding:
The exposure limits, presented as thresholds for “known short-term adverse effects,” are based on extremely cautious, in effect precautionary, interpretation of limited scientific data....Against this, around 400 million patients have been imaged using MRI, with no evidence of adverse effects at the EMF exposure levels indicated in the Directive.
At a Science and Technology Committee meeting on May 11, 2006, member Dr. Desmond Turner shared the HSE risk assessment, saying: “I can quote from what they said which was that they were “unable to identify any health and safety benefit from the Directive.” Interestingly, it was also revealed that day that the Commission had used a 10-year old risk assessment and not requested an updated one before passing the Directive.
The Science and Technology Committee said that existing guidelines were sufficiently protecting the public and the Directives were unworkable and would impose considerable burdens on MR professionals:
The Directive prescribes action limits, which when exceeded require monitoring to be carried out to check compliance with exposure limits. This requires detailed calculation in each individual case. It can be difficult to measure what values have been exceeded in MRI as an MRI scanner involves the combination of three different EMF.... The exposure of a worker will depend on many factors including: the design of the MRI equipment; the strength and frequency of all the EMF fields used in the system; the precise location of the worker relation to the EMF fields; the speed of motion of the worker; and the sequences that the scanner is running (scanners have different sequences for different medical applications which switch the time-varying fields on and off at different rates).
At the conclusion of this week’s news story, professor Olsen said:
Policy-making should be based on sound science, and to my knowledge there is no scientific evidence of long-term adverse health effects of exposure to static or fluctuating magnetic fields that are commonly found during MR scanning. Hasty decisions without scientific support will in this case have a severe impact on medical diagnostics and must thus be avoided. I hope that the Commission will allow a delay in implementation to enable it to examine this issue again and that the Directive could be amended...
Official “safety thresholds” are not the same thing as risk measures
Professor Olsen reminded readers that setting arbitrary safety limits are meaningless when there’s no real danger to begin with! Yet, this fact is lost or ignored as we get caught up in fear and the sense that we “need to do something.”
We’ve looked at a number of risks levels said to be “high” that aren’t really high, nor measures of actual risk. Crossing an arbitrary safety limit does not mean we’re in any actual risk. Also, exposure does not equal danger. Anything in toxic levels can hurt us, but that doesn’t mean that there’s any harm in the amounts we’re normally exposed to. If that were true, none of us would dare even drink a sip of water.... water intoxication is dangerous, don’t you know?
Who has more reason to be wary of actual health concerns with MRIs and keep up to date with the science, than the medical professionals who work with MRIs everyday? Why are they not scared? The public never hears what they’ve concluded about the science. To help put all of this hubbub into some perspective, let’s take a look.
According to researchers at the University of Southern California and Institute for Magnetic Resonance Safety, Education and Research who reviewed the safety issues and evidence to date in an article for the professional journal Radiology:
The introduction of MR technology as a clinical imaging modality in the early 1980s is responsible for a substantial increase in human exposure to strong static magnetic fields. Most MR systems in use today operate with magnetic fields ranging from 0.2 to 3.0 T. In the research setting, an exceptionally powerful MR system operating at 8.0 T is located at Ohio State University (Columbus). According to the latest guidelines from the FDA, clinical MR systems that use a static magnetic field up to 8.0 T are considered a “nonsignificant risk" for patients.
Schenck conducted comprehensive reviews of biologic effects associated with exposure to static magnetic fields. With regard to short-term exposures, the available information for effects of static magnetic fields on biologic tissues is extensive... In the majority of these studies, the authors concluded that exposures to static magnetic fields produce no substantial harmful biologic effects. Although there have been some reports of potentially injurious effects of static magnetic fields on isolated cells or organisms, none of these effects have been verified or firmly established as a scientific fact. The relatively few documented injuries that have occurred in association with MR system magnets were attributed to the inadvertent presence or introduction of ferromagnetic objects (eg, oxygen tanks, aneurysm clips) into the MR environment [unrelated to these Directives].
With regard to the effects of long-term exposure to static magnetic fields, there are interactions between tissues and static magnetic fields that could theoretically lead to pathologic changes in human subjects. However, quantitative analysis of these mechanisms indicates that they are below the threshold of importance with respect to long-term adverse biologic effects.
And, as with anything, they reiterated that “it may be virtually impossible to demonstrate absolute safety,” but with 150 million MRIs performed to date in the U.S., there’s no reason to believe that when proper safety guidelines are followed they won’t continue to be safe.
And a recent issue of RadioGraphics, outlined the current safety and quality control issues from the AAPM/RSNA Physics Tutorial for medical residents. Concerning MR safety, it advised doctors:
[T]he FDA has published guidelines for the safe operation of MR imaging systems. Manufacturers are mandated to ensure that their equipment operates in accordance with these guidelines, and proof of compliance is required by the FDA before any MR imaging system is approved.
MR safety issues are related to the... static magnetic field, the time-varied magnetic field from the gradient subsystem, and the RF field from the RF subsystem.... Most epidemiologic studies about the effect of static magnetic fields on the human body have been performed in populations of MR imaging technologists and other workers in a controlled environment. Investigators have focused on the long-term exposure of workers [at low levels] and short-term exposure to [high levels]. None have demonstrated a significant increase in any disease rate....
Despite very low or nonexistent risk from high-strength static magnetic fields, there are sporadic reports of headache, vomiting, hiccupping, numbness, and tinnitus, but they have not been substantiated. It should be noted that these sensory effects also were reported when the electrical current through the magnets was turned off.
However, investigators in other studies have shown significant sensory effects at 4.0 T compared with 1.5 T. There also have been reports of an experience of flashing lights ... which are called magneto-phosphenes, are thought to be caused by retinal stimulation by induced currents. In 1996, the FDA designated all field strengths of less than 4.0 T as posing a nonsignificant risk.
The truth is, living is risky. Working comes with risks. And even having fun carries risks. But we pay a very heavy price when we let fear of risks take over and consume us.
This week’s news was just one more example of reacting to scares of a theoretical risk for which there is no scientific evidence of concern at current exposures, no evidence anyone has ever been harmed, and no evidence that lower safety limits will keep anyone safer or improve health at all. All we have are “what-ifs.” In contrast, there is plenty of evidence that by ignoring science and failing to carefully weigh actual risks and benefits, millions of people risk being harmed. How smart is that?
© 2007 Sandy Szwarc
For some weekend reading on the precautionary principle, Spiked hosted a conference at London's Royal Institution in May 2003 called “Panic Attack: Interrogating our Obsession with Risk.” The papers that have been published are linked here.