New paper highlights pre-licensing safety testing and regulation of vet NSAIDs as urgent priorities for vulture conservation

An important study examining the effectiveness of existing approval and regulatory processes for toxic veterinary drugs has just been published in the respected journal ‘Ecological Solutions & Evidence’. Despite the concerted efforts of governments, and the Resolution of the UN Convention of Migratory Species, it demonstrates that safety testing and subsequent regulation of toxic drugs is not an effective approach to preventing the extinction of vultures as keystone scavengers. A more consistent, streamlined and precautionary approach is urgently needed. The study was led by the Swiss Federal Institute of Technology’s Natural Resource Policy Group and the University of Cambridge, UK, but required detailed local knowledge from experts on vulture conservation and the regulation of veterinary drugs from vulture range states in Asia and Europe, many of whom are members of SAVE. View the paper here or on SAVE Resources page.

The toxic NSAID (Non-Steroidal Anti-Inflammatory Drug) diclofenac was the first veterinary drug shown to pose a major threat to Old World vultures. When vultures feed on the carcass of a cow recently treated with the drug, most of them die from kidney failure within two days. Millions of doses of diclofenac were used on cattle every year in South Asia, leading to catastrophic vulture mortality rates across the Indian Subcontinent. This discovery in 2004 led to many countries (especially those in Asia), regulating against its veterinary use and some taking further steps to prevent human formulations being illegally used in veterinary practice. Unfortunately, despite significant reductions in veterinary diclofenac use, and two safe and affordable alternative options being identified (meloxicam and tolfenamic acid), there are several other approved NSAIDs being used which have also been shown to be toxic to vultures, therefore warranting further regulation.

The study drew together information obtained from regulators, conservationists, veterinarians and government officials. It found that the time and resources it takes to identify and safety-test a prospective veterinary drug, together with the lengthy process of convincing governments to implement bans to prevent the further losses of vultures, makes all current licensing processes ineffective. The time lags between discovery of the vulture-toxicity of an NSAID and its reactionary regulation mean that the vultures are meanwhile exposed to these drugs for long periods during which their populations are declining.

Safety of commonly used NSAIDs in veterinary practice in India

Sophie Cook, who led the study, said “Involving people from so many countries demonstrated very clearly how huge efforts have been made to address the unintended but devastating consequences of allowing vulture-toxic NSAIDs to be used in veterinary practice. Without a more robust system of regulation in place both before approval and after licensing, it will always be a case of playing catch-up. The last 30 years should have taught us that playing catch-up has never worked.”

Prof Rhys Green, of Cambridge University added “It has been clear for many years that getting bans in place once a drug is already in use, and then implementing them, will always be a very slow and uncertain process. Requiring that testing data is obtained on the safety or toxicity of veterinary drugs before they are approved makes much more sense and is essential. This already happens for pesticides in several jurisdictions, such as the EU. A new-to-market veterinary NSAID as toxic or more toxic to vultures could be approved tomorrow in South Asia and Europe and wipe vultures out.”

Dr Umberto Gallo-Orsi, Head of the Raptors MoU of the Convention for Migratory Species (CMS) said “The CMS Resolution recommended four years ago that safety-testing and regulation of NSAIDs need to happen before approval for veterinary use, but this publication is a key step to demonstrating why this will make so much more sense and is so urgently needed.”

Dr Gallo-Orsi added “Meanwhile, safety-testing of NSAIDs is left to NGOs and the Indian Veterinary Research Institute (IVRI), while it should be a mandatory part of the protocol of research and development, and wholly financed by the pharmaceutical industry. The appropriate decision-making process is illustrated in this important paper.”

Dr Pawde, Principal Scientist and In charge, CWL, IVRI stated that “Any drug or NSAID should be tested for safety to all species before it is released on the market for veterinary use. IVRI is ready to carry out the necessary safety-testing .”

SAVE is hopeful following recent announcements of India Drug Regulation Committee that the IVRI work demonstrating the toxicity of nimesulide will result in prompt regulation, but this paper demonstrates how a more strategic approach is needed.

A B M Sarowar Alam of IUCN Bangladesh added that “Our efforts to remove the toxic NSAID ketoprofen from use in Bangladesh have been taken very seriously and acted upon by government with a national ban in 2021 – but the gap in the market has recently been filled by another unsafe drug, flunixin, because it is not yet illegal!  It would be so much better if only known safe drugs are licensed for veterinary use, rather than waiting for market forces to take effect with untested drugs.”

SAVE Chair Jemima Parry-Jones said “Bangladesh and India have taken important steps recently, but these need taking further and much faster to secure the future of vultures, not only in Asia but also far more widely, as this paper clearly demonstrates. If we as the dominant species in the world don’t stop prevaricating and taking years to come to important decisions such as banning a known toxic drug, we risk losing not only these important vultures, but many other species on the brink of extinction. The science is there, the knowledge is there. Governments need to become proactive in conservation not reactive when it may well be too late”.

For more details of various veterinary drugs and their toxicity to vultures, and the steps taken so far are available on the SAVE webpage: https://save-vultures.org/alerts/. A useful Factsheet on NSAIDs and the threats they pose can be downloaded here

Dr Pawde of IVRI undertaking safety testing

Compiled by Chris Bowden.

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