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Monsanto's Rat Tumor Scare: A Wake-Up Call for the Pharma Industry?


Pharmaceutical Executive

The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns.

The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns of European pharmaceutical executives - but the significance of the debate it has generated should not be lost on anyone with an eye on the relationship between industry, health and the public at large.

To summarize the elements of the now widely known debate: A French study, revealed at a press conference in the European Parliament, claimed serious health problems in rats fed with Monsanto’s GM Roundup-ready maize NK603, and led to wide media coverage and expressions of alarm across Europe. But within hours, the methodology of the study, published in Food and Chemical Toxicology, came under criticism from a series of heavyweight academics, who questioned the validity of its findings.

This is not the place to take sides in the long-running debate over the safety of genetically modified organisms. It is, however, a fitting place to reflect on how well-prepared the pharmaceutical industry in Europe is to cope with analogous controversies.

One of the striking aspects of this particular bout of public jousting over the safety of industrial products is the speed with which the industry as a whole reacted to the damaging allegations. The study was officially released at midday on a Wednesday last week. By Wednesday afternoon, an extensive damage-limitation exercise was already underway, delivering a volley of expressions of doubt over the findings - doubts picked up and reported the same day by influential media ranging from the BCC to Reuters to New Scientist, and only hours later by The Telegraph in the UK, Le Figaro in France, and Forbes magazine in the US.

Not only were these defensive reactions rapid. Their nature, volume, precision and tone suggested that a new degree of professionalism had been brought to the exercise.

Under the low-profile heading of “expert reaction to GM maize causing tumours in rats”, media around Europe were provided with a sequence of carefully-worded statements from scientists in the field offering a range of reservations about the findings of the study.

Professor Maurice Moloney, Institute Director and Chief Executive at Rothamsted Research, said that although the study had been published in a peer–reviewed journal, “there are anomalies throughout the paper that normally should have been corrected or resolved through the peer-review process”. Professor David Spiegelhalter, Winton Professor of the Public Understanding of Risk at the University of Cambridge, characterized the methods, statistics and reporting of results as “well below the standard I would expect in a rigorous study”. Dr Wendy Harwood, senior scientist at the John Innes Centre said there was nothing in the study report that contradicted “previous findings that genetic modification itself is a neutral technology, with no inherent health or environmental risks”, and while recognizing that the findings “indicate possible concerns over long-term exposure”, and that these “require further study.”

Irrespective of anyone’s views on GM-crops, or the credibility of the industry that manufactures them, this was an intelligent manner of responding to a highly alarming study. The remarks came not from a company public relations department, but from eminent and widely respected academics. Nor were the remarks extravagant or evidently biased: they were delivered in measured terms, focusing on the science as presented.

At the same time, the principal European biotechnology industry association, EuropaBio, issued a press release raising further questions, not just about the study, but also about the researchers behind it. “Media reporting this story should be aware that some of the researchers behind the study are closely associated with anti-GM campaigning groups”, it said, cautioning that “the funding of the research should be carefully considered, as should the commercial motivations of parties involved and the motivations of political figures associated with the study”. It also highlighted earlier criticisms from EU authorities of methodological failings in GM-critical papers presented in the past by the lead researcher.

There are conclusions that could be tentatively drawn for the pharmaceutical industry from this episode. The obvious common factors are that medicines and GM-crops are both high-profile and high-technology manufactured goods intimately connected to health. But in Europe both the biotech and the pharmaceutical industries are constantly at the centre of highly divisive and divided debate, in which industry advocates are pitched in battle against inveterate critics with deep-rooted hostility to the corporate world. Those battles are played out in a very public space, and the view formed by the public is in turn highly influential on the nature of regulation.

Given that untoward events are likely to occur in every high-profile high-technology sector - in this regard, the health or food sectors are no different from aeronautics or nuclear power - it is prudent for people running companies or industries to be in possession of plans for a multitude of contingencies. Some of those untoward events may amount to real threats to safety. Other events may simply be alarmist, presenting threats not so much to safety as to scope of operation that industry depends on for innovation, by inflaming public opinion to the extent that governments feel obliged to tighten regulation.

The speed and range of the defensive reactions in this case was not sufficient to deflect all concerns. The debate is still unfolding, and unsurprisingly, further accusations are emerging from industry-hostile organizations of a biased attempt to cover up uncomfortable findings. But for anyone with a professional interest in defending their industry’s record, the European biotech industry’s handling of this challenge offers an interesting example of how rapid intervention can at least mitigate negative impacts. And where the negative impact derives from criticisms of questionable scientific merit, that can only be considered good science - and common sense.

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