EU Parliament approves new directive on animal research
Back in June we reported on the progress of the new European Union (EU) directive on the use of animals in research. Representatives of the EU Commission, Council, and Parliament had agreed on the text of the new directive, and it just awaited a final vote by the EU Parliament before becoming law.
As our colleagues at Understanding Animal Research have reported MEPs voted this morning to approve the directive. At this stage the text can no longer be ammended, and will become law as soon as it is formally signed and published by the EU Council. It will be then be the duty of the member state governments to transpose the new directive into national law.
The directive approved today represents a huge improvement on the early draft that was proposed back in 2008, and much of the credit for that improvement must go to EU scientists who took such an active part in the debates, discussions and consultations that were part of this process. Without this crucial intervention by thousands of scientists we could have been looking at a very different directive today, one very likely to be harmful to European science. Instead, we now have a directive that strike an excellent balance between ensuring good animal welfare standards and facilitating excellence in scientific research.
At this time of grave concerns about the effects of cuts in government funding of science the new EU directive is a welcome reminder of what the scientific community can achieve when it pulls together.
Addendum: Some news just in, four more animal rights extremists affiliated with the group Stop Huntingdon Animal Cruelty (SHAC) have pleaded guilty to conspiracy to blackmail. Let's hope that they receive sentences that will serve as a warning and deterrent to other activists who may be tempted to cross the line between legitimate protest and extremism.
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Home Office Statistics for 2009: Challenges ahead for UK Science
This morning the Home Office published the statistics on animal research for 2009 , and they make interesting reading. One change is that after a decade which has seen a steady rise in the number of animals used, and a sharp rise of 14% in 2008, the total number of procedures performed fell by 1% to just over 3.6 million. The rise in 2008 and subsequent fall in 2009 may represent a statistical blip, but it may also reflect the impact of the recession as projects were moved forward in anticipation of reduced funding in the future. With government funding of all scientific research in the UK facing cuts of up to 25% in the years ahead, it is likely that we will see further falls, since government funding through the research councils pays for about a third of projects involving animal research. After all, the increase we have observed over the past decade was due to a large extent to increases of about 50% in real terms in spending on biomedical research by the government, and we cannot now expect animal research to be immune from funding cuts. A lot will depend on whether spending by medical research charities and industry, which account for the remainder of the funding and also saw large increases in the past decade, can fill the gap left by government spending cuts.
One milestone passed this year was that for the first time over 50% of procedures involved the breeding or study of genetically modified animals (mainly rodents), which reflects a trend that we have noted before and reflects the growing importance they have to fields as diverse as cancer research and developing treatments for Duchenne Muscular Dystrophy.
One comment that stands out in the statement by Home Office Minister Lynne Featherstone is that the Government is“committed to ending the testing of household products on animals”, a frequent demand of animal rights groups. This would seem to be an easy promise to fulfill since, as our friends at Understanding Animal Research have pointed out, no such tests were performed in 2009, and very few, or none, in previous years of the past decade. The safety testing of household products on live animals has effectively already been ended by changes in the regulatory framework for chemicals, for example to the European REACH regulations and the recent development of alternatives that use cultured cells or tissues from dead animals and are sufficient for the evaluation of most cosmetics or household products. This is a perfect example of the 3Rs in action.
Overall this is a report that reflects both the profound changes that are happening in how and why animal research and toxicity testing is done, and the challenges facing British science as a whole in this time of austerity.
Turning to the activities of animal rights campaigners, we find that the Leicester Mercury has noted the tendency of a campaign by the National Anti-Vivisection Alliance* against a new laboratory at the University of Leicester to be economical with the truth. This will be no surprise to those of us who have been watching NAVA’s increasingly desperate attempts to stir up opposition to the new laboratory in Leicester, but will I’m sure be an eye-opener for Leicester citizens not yet familiar with degree to which some animal rights groups will misrepresent and distort the truth to advance their cause.
* NAVA is a new group, and is not to be confused with the more established National Anti-Vivisection Society
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Great news from HIV microbicide trial - thank the monkeys!
There was exciting news on Monday when it was announced at an international AIDS conference in Vienna that microbicide gel had dramatically reduced the transmission of HIV in a Phase 2 clinical trial involving 889 women in South Africa. If confirmed by larger phase 3 trials this gel will offer millions of women a way to protect themselves against this dread disease that blights communities around the world.
Unlike previous microbicide gels that failed to offer significant protection against HIV infection this gel included the anti-retroviral drug tenofovir. Tenofovir was one of several anti-retroviral drugs discussed in an article on the role of non-human primate research in developing HIV prophylaxis by virologist Dr. Koen Van Rompay that was posted on the Speaking of Research blog last year. Dr. Van Rompay’s article looked at the use of oral tenofovir in pre- and post-exposure prophylaxis rather than its use in a microbicide gel.
So did the research on preventing SIV transmission in monkeys influence the decision to use tenofovir in this microbicide gel? You betcha! In the first report of a Phase 1 trial of this tenofovir-containing microbicide gel published in 2006 (1) the authors state that the success of tenofovir in preventing SIV infection on monkeys – the same research discussed by Dr. Van Rompay – was a deciding factor when they took this gel into clinical trials.
"Tenofovir gel, 9-[(R)-9-(2-phosphonylmethoxyprophyl) propyl]adenine monohydrate, a nucleotide reverse transcriptase inhibitor, has demonstrated ability to inhibit retroviral replication in animals and humans, and it has been well tolerated when used orally, as tenofovir disoproxil fumarate, (tenofovir DF; Viread) [16–20]. Tenofovir DF has been approved for treatment of HIV-1 infection and is increasingly used as part of therapeutic regimens for HIV-positive individuals . Tenofovir has been proven to be effective in blocking the transmission of SIV in animal models when given as pre- or postexposure prophylaxis systemically or when applied as an intravaginal gel [22–25]. Tenofovir bisphosphate, the active intracellular moiety, has a very long intracellular half-life (> 72 h), which could allow for more convenient, coitally independent intravaginal use . Given the data showing animal protection with tenofovir gel, and the extensive human safety data with oral tenofovir in HIV-positive patients, the HIV Prevention Trials Network (HPTN) decided to assess the safety and tolerability of tenofovir gel in HIV-negative and HIV-positive women and their male sexual partners (HPTN 050)."
The above passage also mentions that they tested whether the microbicide gel containing tenofovir could prevent vaginal SIV transmission in monkeys*, and the finding that it could drove their subsequent decision to take the gel into clinical trials. This was an important decision, a review of HIV microbicide gels published in the journal Science (2) two years ago pointed out the failure to evaluate other microbicide gels in monkey models of HIV transmission allowed these gels to proceed into clinical trials where they subsequently failed. It is notable that the microbicide PRO 2000, also evaluated in monkeys, is the only other microbicide to demonstrate an ability (albeit less dramatic) to prevent HIV infection in clinical trials.
So what now? Well the tenofovir containing gel will go on into larger phase 3 trials to further evaluate its ability to prevent HIV infection in women. In the meantime following a study showing that it can prevent the transmission of rectal SIV transmission in macaques (3) this gel is now in phase 1 safety trials in men.
This is welcome news after years of disappointment, and further evidence that where HIV is concerned there can be no shortcuts; all therapies whether microbicide gels or vaccines must be thoroughly evaluated in stringent animal models before being taken to human clinical trials. Perhaps now we can start to turn realism into optimism.
In other good news, Mel Broughton, former spokesperson for the animal rights group SPEAK that waged an often vicious (though occasionally bizarre) campaign against the new biosciences laboratory at Oxford, was jailed for 10 years last week for conspiracy to commit arson.
The unanimous verdict highlights once again how closely so-called "above ground" extremist campaings such as SPEAK and SHAC are connected to the criminality of those who operate under the banner of the ALF. Hopefully this verdict and sentence, along with the failure of Broughton's campaign to prevent the completion of the new laboratory, will help to dissuade other activists from resorting to such terror tactics.
* Unfortunately this study was never published in the scientific literature, this is something that sometimes happens with pre-clinical studies performed by biotechnology and pharmaceutical companies…usually because they wish to keep the work confidential for commercial reasons…and is a source of great frustration to people like me who write about this work!
1) Mayer K.H. et al. “Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women.” AIDS. volume 20(4), pages 543-551 (2006), DOI:10.1097/01.aids.0000210608.70762.c3.
2) Grant R.M. “Whither or wither microbicides?” Science. Volume 321(5888), pages 532-534 (2008), PubMed Central:PMC2835691.
3) Cranage M. et al. “Prevention of SIV Rectal Transmission and Priming of T Cell Responses in Macaques after Local Pre-exposure Application of Tenofovir Gel” PLoS Med. Volume 5(8):e157(2008) DOI:10.1371/journal.pmed.0050157
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A step closer to new EU directive on animal research
Those of you who have been following the Pro-Test blog for a while will be aware that European Union (EU) is in the process of replacing Directive 86/609, the directive that covers the "laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes" with a new directive that better reflects the current state of the art of medical research and expected future developments, and does more to harmonize the regulations governing animal research in individual EU member states.
The proposed new directive on animal research was drafted by the European Commission in December 2008 and then sent to the European Parliament for its first reading. In common with the overwhelming majority of medical researchers in the EU we had grave concerns about some aspects of the proposed directive. Fortunately just before the June 2009 European elections, the EU parliament adopted a long list of amendments that it wanted incorporated, resolving many of the worries we had about the potential impact of the new directive on medical research in the EU. We were particularly pleased to see that the amendments protected the use of non-human primates in basic research, as these animals are of critical importance to fields such as neuroscience and virology.
This would usually have been sent to the European Council, a body that represents the governments of the individual EU member states, for them to give the proposal its first reading. However, to speed matters along, the Council initiated a trialogue procedure, in which representatives of the three parts of the EU legislature - the Commission, the Parliament and Council - hold private meetings to reach agreement on the text of the proposed directive.
The trialogue reached agreement on the text by December 2009, apart from a few details of committee procedure which needed to be clarified by legal experts, in the light of changes required by the Lisbon Treaty that entered into force on 1 December 2009. This agreement was marked by a formal letter from the European Parliament to the Council.
The clarification of the committee procedure points, followed by the legal checking of the text took until May, after which the Council agreed the text on 11 May and formally adopted it last week on 3 June.
We believe that the agreed directive strikes an excellent balance between the need to ensure that animals used in medical research are treated humanely, and the need to develop new treatments for terrible diseases and ensure that the EU remains at the forefront of medical science.
The next stage is that the draft directive will be sent back to the European Parliament for its second reading. Since the text is subject to a formal trialogue agreement this should be relatively swift and may involve as little as one vote in favour in the Agriculture Committee this summer and another at a plenary session of the full EU parliament probably in early autumn. At that point the Directive would be formally adopted into EU law.
There is certain to be some debate at each meeting and it is quite possible that the some EU parliamentary groups may put down amendments, but it is not thought likely that any will get the majority support they require. However, those experienced in the EU legislative process warn that one should always expect the unexpected. Some animal rights groups are continuing to lobby the parliament against the proposed text, so it would be a mistake to assume that its adoption is certain. That only happens when the ink is dry on the final document. We urge scientists to keep in touch with their MEP and to be ready to make the case for the well regulated use of animals in medical research.
Once the directive is adopted as EU legislation, all Member States must, within 2 years, pass (or amend existing) national legislation to make the provisions of the directive legally binding. It is possible that the UK parliament will need to amend the Animals (Scientific Procedures) Act 1986 that regulates animal research here, but it is more likely that any changes required will be achieved through changes to Home Office regulations, since nothing in the Animals (Scientific Procedures) Act 1986 appears to conflict with the new EU directive.
The adoption of the new directive by the EU council is excellent news, and represents one more step on the long and winding road towards an EU directive on animal research that we can all be proud of.
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Pro-Test for Science have success in LA
Read more about Pro-Test for Science
On a beautiful sunny day in Los Angeles, Pro-Test for Science (A US side project of Pro-Test) organisers arrived at the junction of Le Conte and Westwood, on the edge of the UCLA campus, with armfuls of placards in support of animal research. Within ten minutes every placard had found a new owner as hundreds of scientists, students and members of the public showed up to support the cause. Those gathering chatted together, sharing their reasons for attending the rally.
Those participating were not limited to the UCLA community. Faculty from University of Southern California, California Institute of Technology, and California State University - Los Angeles, all came out to demonstrate their support for lifesaving medical research using animals. Soon the chants began to ring out - "Penicillin? ANIMAL RESEARCH! Insulin? ANIMAL RESEARCH! Vaccines? ANIMAL RESEARCH! Anaesthetics? ANIMAL RESEARCH!" A short while later, when the crowd had swelled further, the rally set off towards the center of the UCLA campus.
The mood was one of excitement and passion. Those participating exchanged ideas for public outreach in the future - sharing the best of ways of explaining to the public the clear connection between animal research and medical benefits. The rally continued to snake along Westwood and up towards Wilson Plaza.
As the rally turned into Wilson Plaza, passing the top of Bruin Walk, hundreds of students turned their heads towards the march, many shouting words of encouragement or joining in the rally.
Eventually the tail end of the rally reached the destination (some time after the front end due to the length), and Tom Holder brought the crowd together for a picture perfect moment of solidarity before shouting "What do we need?". "Animal Research" replied the hundreds of voices in unison.
Holder then introduced the first speaker, Prof. David Jentsch - founder of Pro-Test for Science and member of the Speaking of Research committee - who took the microphone to rapturous applause. David spoke of the progress of Pro-Test for Science, and the struggle against animal rights extremists in UCLA. He took the time to thank each of the individuals who had made the 2010 rally possible eliciting a cheer from the crowd as each name was called. Jentsch then passed over to Tom Holder, founder of Speaking of Research.
Holder thanked the crowd, insisting that UCLA were winning in their battle against extremists. However he warned the crowd against complacency - saying that public outreach was the only way to win this battle in the long run. Holder also announced the success of the Pro-Test Petition, which had gained 11,621 signatures over the previous year (including Nobel Prize Laureates, and every chancellor in the UC system, including UC President Mark Yudof). He finished by announcing the presentation of the signatures to Dr. Kevin Quinn, Dr. Michael Steinmetz.
Dr. Quinn, the Chief of Behavioural Science and Intergrative Neuroscience at the National Institute of Mental Health (NIMH), accepted one copy of the petition on behalf of NIMH. Quinn spoke of the important role that animal research has in our understanding of Mental Health problems:
"Animal research conducted in a humane, ethical and responsible manner is absolutely critical … to understand, treat and cure mental disorders"
Dr. Michael Steinmetz, program director of the National Eye Institute, talked of the medical breakthroughs in vision. He spoke particularly of Leber's congenital amaurosis, a form of blindess which affects thousands of people across the United States. Through research in mice and then dogs (Briards), scientists found a way of inserting a gene into the eye through a virus, which could corect the problem.
"The National Eye Institute supports strongly the use of appropriate animal models in research, not just for the big clinical advances but for the many, many years of basic science that it takes to discover the underlying biological principles"
Jentsch then returned to the stage to introduce UC Executive Vice-Chancellor, Scott Waugh. Waugh offered his continued support to researchers at UCLA, mentioning that the Pro-Test for Science movement has played an important role in bolstering support for research. He congratulated Jentsch and Ringach for organizing the February pabel debate, explaining that "violence, threats and other criminal activity are never a viable alternative to dialogue".
Jentsch and Holder finished the rally by talking of the importance of continued education and outreach.
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