Expert View: A knee-jerk reaction is no way to deliver a safer world

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The Independent Online

The media is inundated with risk stories. Headlines such as "Toxin in plastics harming baby boys" and "Ibuprofen increases heart attack risk, warn doctors" are common.

These headlines themselves practically demand regulation. Why is it that a toxin found in everyday products that may affect an individual's ability to reproduce is not immediately banned? Should we not aim to reduce heart attacks by taking ibuprofen off the market? These cases are as clear as they can be, are they not?

Unfortunately, increasingly, this is not true. Extensive regulation over the past 30 years has reduced many of the most obvious and easily preventable risks to our health. Future regulation of ever smaller and more uncertain risks is likely to encounter diminishing returns. Here, the regulator comes face to face with the so called "risk-risk trade-off". This occurs when efforts to combat a so-called "target risk" unintentionally lead to "countervailing risks" or side effects. There are many examples of so-called risk-risk trade-offs that urgently need to be addressed.

There is at present a huge debate in Europe about controls on the use of chemicals through the proposed Reach directive. The environmental NGOs want a tougher Reach, arguing that there will be benefits for both the planet and for public health. Meanwhile, the chemicals industry has commissioned a multitude of regulatory impact analyses to show that virtually any form of Reach will lead to thousands of job losses in Germany alone.

However, the question that needs to be asked is what happens when one set of chemicals is replaced by another set of chemicals. In April 2000, for example, Danish authorities reported a substantial increase in skin allergies among hospital workers handling blood bags. What had happened was that, some three years previously, a decision had been taken to replace the use of chemicals called phthalates in the manufacturing of the bags, since there were fears they could prove carcinogenic to patients. What the authorities did not foresee was that the substitute chemicals would cause averse skin reactions. A possible tiny risk for patients in the long term had been replaced with a real short-term hazard for hospital workers, a classic risk-risk trade-off. Even more ironically, the World Health Organisation shortly afterwards confirmed that phthalates were non-carcinogenic to humans.

There are similar cases of questionable judgement in the medical field. Among them are Merck's decision to withdraw its arthritis drug Vioxx in October last year, and the US Food and Drug Administration's decision in April to ban another arthritis drug, Bextra (manufactured by Pfizer). This led a large number of doctors to encourage their patients to take non-steroidal anti-inflammatory drugs such as ibuprofen instead. However, ibuprofen at that time had not been tested for cardiovascular side effects in the same way as the banned drugs. New scientific findings now show that ibuprofen-type drugs carry roughly the same increased risk of heart problems as Vioxx and Bextra, but without their beneficial effect of protecting the stomach lining from ulcers. To sum up, it could be argued that Bextra and Vioxx should never have been taken off the market.

Clearly, regulators need to work with scientists to ensure that the evidence for proposed controls is firmly grounded before a directive is put forward. Regulators should not respond to emotive headlines with knee-jerk reactions. These may vindicate them in the short-term in the eyes of the public and some stakeholders, but in the long term it will have a detrimental impact on their reputations.

Ragnar Lofstedt is professor and director of the King's Centre for Risk Management

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