$1.4 Million + To Minimize Drug Testing On Dogs

[sandgrubber]

Published online 28 June 2011 | Nature 474, 551 (2011) | doi:10.1038/474551a

News

Call to curb lab tests on dogs

Canine remains the default option in outdated pharmaceutical toxicology.

Marian Turner

Dogs make popular laboratory subjects, with uses including drug-toxicity testing, above.Y. Forestier/CorbisMan's best friend bears a heavy burden in the pharmaceutical industry. Every year, tens of thousands of dogs are subjects in drug-toxicity studies in Europe and the United States, even though many scientists think that they are poor predictors of drug effects in humans. Discussions on this sensitive issue have now been opened up by a hefty donation from Hildegard Doerenkamp, a Swiss philanthropist and passionate dog-lover, to the Zurich-based Doerenkamp–Zbinden Foundation, which supports work to reduce animal testing.

Toxicology researchers from academia and industry, and animal-welfare groups met in Budapest last week to develop an action plan and discuss how to spend Doerenkamp's donation of more than €1 million (US$1.4 million) to drive change. Scientists need to identify what information dog tests provide that tests in vitro or on rodent species cannot, they say. And regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency need to harmonize their requirements for dog testing so that pharmaceutical companies can minimize the number of animals they use.

Regulatory authorities usually require that drugs are tested for toxicity in both a rodent and a non-rodent species. The latter tends to be dogs, because they are readily available, easy to handle and in many ways physiologically similar to humans. Pharmaceutical testing accounts for around three-quarters of all dogs used in science.

But scientists inside and outside industry say that dogs are not always the best option for testing and could, in some cases, be replaced by in vitro tests. In spite of these reservations, and public disquiet over the use of dogs in testing, very little has been done to curb the practice, says Thomas Hartung, a molecular toxicologist and head of the Centre for Alternatives to Animal Testing (CAAT) at Johns Hopkins University in Baltimore, Maryland, which organized the meeting.

Regulatory agencies are nervous of changing procedures. Any adverse reactions to a new drug, for example, could be blamed on new tests failing to spot dangers. Only if a battery of in vitro alternatives can match the level of toxicity prediction that dogs can provide will regulators agree to a change, says Hartung. So far only one such test — used to predict whether a compound could lead to cardiac arrhythmias — comes close, but it has not yet been internationally validated.

In its action plan, to be published in the next few months, CAAT will call for the setting up of a database of dog-test results to help to identify more targets for in vitro tests by highlighting physiological effects seen only in dogs. It will also call for a better definition of those tests for which dogs provide the best model, and those for which another species — such as the mini-pig — should be used instead. Toxicologist Georg Schmitt of Hoffmann La-Roche in Basel, Switzerland, says that pharmaceutical companies should not use dogs by default simply because facilities and test protocols exist. "Dogs can be oversensitive to some compounds, such as hormones, and their gastro­intestinal system behaves differently to that of humans," says Schmitt. He says that studies in which dogs have proved to be poor models should be published.

The full article is posted with free access on nature.com . . . but you need to sign up and sign in to get to it.

[john.davey.1960]

Published online 28 June 2011 | Nature 474, 551 (2011) | doi:10.1038/474551a

News

Call to curb lab tests on dogs

Canine remains the default option in outdated pharmaceutical toxicology.

Marian Turner

Dogs make popular laboratory subjects, with uses including drug-toxicity testing, above.Y. Forestier/CorbisMan's best friend bears a heavy burden in the pharmaceutical industry. Every year, tens of thousands of dogs are subjects in drug-toxicity studies in Europe and the United States, even though many scientists think that they are poor predictors of drug effects in humans. Discussions on this sensitive issue have now been opened up by a hefty donation from Hildegard Doerenkamp, a Swiss philanthropist and passionate dog-lover, to the Zurich-based Doerenkamp–Zbinden Foundation, which supports work to reduce animal testing.

Toxicology researchers from academia and industry, and animal-welfare groups met in Budapest last week to develop an action plan and discuss how to spend Doerenkamp's donation of more than €1 million (US$1.4 million) to drive change. Scientists need to identify what information dog tests provide that tests in vitro or on rodent species cannot, they say. And regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency need to harmonize their requirements for dog testing so that pharmaceutical companies can minimize the number of animals they use.

Regulatory authorities usually require that drugs are tested for toxicity in both a rodent and a non-rodent species. The latter tends to be dogs, because they are readily available, easy to handle and in many ways physiologically similar to humans. Pharmaceutical testing accounts for around three-quarters of all dogs used in science.

But scientists inside and outside industry say that dogs are not always the best option for testing and could, in some cases, be replaced by in vitro tests. In spite of these reservations, and public disquiet over the use of dogs in testing, very little has been done to curb the practice, says Thomas Hartung, a molecular toxicologist and head of the Centre for Alternatives to Animal Testing (CAAT) at Johns Hopkins University in Baltimore, Maryland, which organized the meeting.

Regulatory agencies are nervous of changing procedures. Any adverse reactions to a new drug, for example, could be blamed on new tests failing to spot dangers. Only if a battery of in vitro alternatives can match the level of toxicity prediction that dogs can provide will regulators agree to a change, says Hartung. So far only one such test — used to predict whether a compound could lead to cardiac arrhythmias — comes close, but it has not yet been internationally validated.

In its action plan, to be published in the next few months, CAAT will call for the setting up of a database of dog-test results to help to identify more targets for in vitro tests by highlighting physiological effects seen only in dogs. It will also call for a better definition of those tests for which dogs provide the best model, and those for which another species — such as the mini-pig — should be used instead. Toxicologist Georg Schmitt of Hoffmann La-Roche in Basel, Switzerland, says that pharmaceutical companies should not use dogs by default simply because facilities and test protocols exist. "Dogs can be oversensitive to some compounds, such as hormones, and their gastro­intestinal system behaves differently to that of humans," says Schmitt. He says that studies in which dogs have proved to be poor models should be published.

The full article is posted with free access on nature.com . . . but you need to sign up and sign in to get to it.

The sooner this obscenity ceases the better.

[vetrg]

I use the results of drug testing on animals every day in my practice. Working in a specialist branch of the profession where drugs are rarely specifically licensed (and therefore safety tested in animals) the 'byproduct' of human testing is that it does provide useful safety and efficacy data enabling me to use human drugs 'off label'.

Careful what you wish for- no animal testing means no safety data for these drugs in animals (however useful or not that data is for human extrapolation).

Edited July 19, 2011 by vetrg

[john.davey.1960]

I use the results of drug testing on animals every day in my practice. Working in a specialist branch of the profession where drugs are rarely specifically licensed (and therefore safety tested in animals) the 'byproduct' of human testing is that it does provide useful safety and efficacy data enabling me to use human drugs 'off label'.

Careful what you wish for- no animal testing means no safety data for these drugs in animals (however useful or not that data is for human extrapolation).

If penicillin was tested in guinea pigs it would never have got on the market. thalidomide was tested in animals and was found to be safe!!!! Be careful what you wish for, close enough is not good enough. Animal testing is simply legal shenanigans to exculpate the guilty.

[sandgrubber]

The sooner this obscenity ceases the better.

'This obscenity' is not going to cease, unless some major technological breakthrough makes it obsolete or political pressure gets overwhelming.

It's good to see forces relatively close to the industry working to decrease the extent and minimize the damage.