Automatgenererad bild.

20 November 2015

MistraPharma proposes new centre for drugs and environment

At the final conference for MistraPharma, knowledge and results from this initiative involving research on the environmental impact of medicinal drugs were presented. Besides intensive debates and much praise, the day offered the programme’s recommendations on how its findings should influence decision-makers. One wish is to see a new centre for drugs and the environment at the Swedish Medical Products Agency.

For eight years, MistraPharma has investigated a question that used to be relatively unknown: how pharmaceutical substances in low doses affect sea, lake and watercourse ecosystems. This research programme has also focused on the risks of antibiotic resistance due to drugs in the environment.

‘Being in charge of leading-edge research has been an exciting task. Sweden is in the front line when it comes to research on pharmaceutical substances and aquatic organisms,’ says MistraPharma’s programme director Christina Rudén.

The results from the programme were presented at ‘A Sustainable Recipe for a Healthy Future’, the conference held at the Swedish Society of Medicine in Stockholm on 14 October. MistraPharma has focused closely on disseminating its research findings and influencing political processes with the knowledge it generates.

In her opening address, Rudén mentioned how much has happened, both in Sweden and at EU level, since MistraPharma started.

Nowadays, the Swedish Environmental Management Council’s environmental regulations govern drug procurement and drugs are also included in the National Environmental Protection Agency’s environmental monitoring. Drugs and the environment are now a distinct area in the National Pharmaceutical Strategy, and the EU requires measurement of certain drugs in lakes, watercourses and coastal areas. Moreover, extensive work is under way in Sweden to develop an EU strategy on drugs in the environment.

‘I want to emphasise that MistraPharma has had a great deal to do with this development,’ Rudén says.

New risk substances found

Christina Rudén thinks the programme has been a success.

‘When we started, we said that if we found another substance affecting fish the programme would be a success story. And now we’ve found two substances.’

She is referring to two findings by Ingvar Brandt of Uppsala University in his project about new environmental effects of pharmaceuticals. First, he has found that levonorgestrel, an active substance in contraceptive pills, results in severe hormonal changes and damage in amphibians. Second, he has found that low concentrations of the hormone progesterone in marine environments have an impact on fish health and reproduction.

Another success for MistraPharma has been the research carried out by Jerker Fick at Umeå University. He has been studying how extremely small quantities of anxiolytic agents (medicines against anxiety) affect fish behaviour, in this case perch. This research has meant, first, that new analytical methods have been developed to identify low concentrations of pharmaceutical substances both in perch and in water. Second, it has been noted in various experiments how these particular substances affect how boldly perch behave.

‘Perch must be both careful not to be eaten and bold so that they can find food for themselves,’ Fick explained.

With films, he showed how perch that had ingested drugs cast caution aside and ventured into more dangerous waters. The pattern, moreover, emerged clearly from large-scale experiments in a lake with perch bearing transmitters. The perch affected by the drugs swam over larger areas and were less social with other perch.

This change in behaviour may have a major impact on life in a lake.

‘For the whole playing field to look different, it’s enough for one player to change its behaviour,’ Fick said.

Impact still elusive

John Sumpter of Brunel University related that MistraPharma was the best research project he had taken part in, both for its scientific depth and for its orchestration by Christina Rudén.

‘Sweden’s in the absolute vanguard in this area. You have much better research here than in my home country, Britain,’ he said.

But will this high-class research, published in high-ranking journals, influence agencies’ assessments — such as the Swedish Medical Products Agency’s, in which environmental risk assessments must now be enclosed with licence applications for new drugs?

No, the research will probably not be considered, according to Marlene Ågerstrand, a chemist at Stockholm University and researcher in MistraPharma.

‘In principle, it’s only industrial testing that is approved. The knowledge produced in academia is usually not taken into account. This is wrong for several reasons. One is that academic research is paid for from public funds and should therefore be used. Another is that experimental animals have often been used, and their deaths are utterly futile if the research isn’t used. A third reason is that research produced by people who have financial interests in the risks being low often concludes that the risks are low.’

Role of research discussed

During the conference, a lively panel discussion arose between Marlene Ågerstrand, Inger Andersson (Director General of the Medical Products Agency) and Bengt Mattson (an expert at the Association of the Swedish Pharmaceutical Industry).

Andersson explained that the research approved by the Medical Products Agency must be standardised, according to OECD and EU requirements. Mattson asserted that academic research should, of course, be considered but must then tackle the standards used. Ågerstrand emphasised the problems of standardised research, such as its rigidity and the fact that it sometimes misses effects of drugs. She found it strange that, to the Agency, peer-reviewed published research has a lower status than unpublished research that has not undergone this review.

Christina Rudén commented on the debate afterwards:

‘This discussion was typical of the work we’ve carried out in MistraPharma. We exchange views with intensity but keep our respect for one another.’

MistraPharma has resulted in some 150 academic articles, 10 theses and 25 book chapters, along with various popular science and media publications.

The conference culminated in various recommendations for Sweden. One was that a new centre for drugs and the environment should be opened at the Medical Products Agency. This centre’s research should be associated with a range of subjects and the research should pave the way for political decisions to achieve the interim targets adopted by the Swedish Government under the national environmental quality objective ‘A Non-Toxic Environment’.

Text: Thomas Heldmark, Vetenskapsjournalisterna

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