I develop drugs using animal research AMA

[1dayonly]

My work involves R+D, safety studies and I am a member of several national and international welfare working groups (including the EU ones until March).
Ask me anything

Are all possible steps taken to minimise animal pain? Do you think that the animals suffer?

Do you have personal views on animal testing and do they conflict with your professional duties?

Do you disclose what you do when out socialising? A friend in a similar line of work learned not to, after being harangued at a dinner table.

Not every procedure is painless. The 'cut-off' for what degree of pain, distress or potential harm is considered a regulated procedure is a needlestick.
So an injection, blood sample and/or anything more painful or distressing than that is a regulated procedure.
Anything regulated must undergo risk-benefit/ethical review before it is done.
Although we minimise what we can, yes, some animals will suffer to some degree. Our aim is that this is to the least degree and for the least time.

I think you're really brave to come in here. I'm not being judgy BTW.
Are the drugs life saving/prolonging or more basic (does that make sense?)

Do you have personal views on animal testing and do they conflict with your professional duties?
Sometimes yes. Sometimes I look at new products reaching market for an undoubted pharmaceutical but largely trivial (to my mind) reason and I do judge. But I am lucky that I'm at a level where I set the policies within my organisation, so my lights are reflected in how we operate.

Do you disclose what you do when out socialising? A friend in a similar line of work learned not to, after being harangued at a dinner table.
Not often!

Are the drugs life saving/prolonging or more basic (does that make sense?)
I mostly deal with biopharmaceuticals for rare conditions (not lots of recipients but huge ramifications for them). During my earlier career I did lots of 'more basic' drugs which impacted in a smaller way on more people.

The thing is you don't know while you are developing them how successful they will be. Animal safety studies aren't the final answer: they are basically checking out the drug before it is properly tested in clinical trials. Using animals is considered the ethical alternative to blind testing humans. Back in the early 90s I worked on some drugs which are still keeping some people alive today. At that point I could not possibly have known.

What animals do you test on?

What animals do you test on?
Different types of studies use different species, but for small molecule pharmaceuticals (NCEs) the safety toxicity study requirements are for rodent and non-rodent species. It is usual to use rats as the rodent and then the non-rodent species may be pig, dog, ferret, rabbit, monkey depending on what the drug pharmacology is. Carcinogenicity is tested in two rodent species (usually rat and mice) over a lifetime.
For large molecule (NBE) pharmacology may be very specialized indeed so one species only may be suitable for the Toxicology work(any of those listed above). It isn't necessary to do carc testing for NBE.

We are mandated under EU law (which was copied from the UK law in 2012) to use the least sentient species, further, horses, dogs and monkeys have special status. We must show relevant pharmacology (from in vitro studies) to justify the use of any species.

So you find it difficult to recruit into that area?

Do your family know /approve of your job?

Why do you think it’s ethical to test on animals and not on humans?

How do you justify to yourself getting paid to cause harm to a sentient being?

Given the differences across animal species (including humans) is animal testing a relevant safeguard for drug development?

There was a widely publicised life-changing outcome in human subject drug testing a few years ago - why did the animal testing models not identify this before human trials? In my view that indicates that animal testing is fundamentally flawed.

(Disclaimer: I am biased as am very much against animal testing).

So you find it difficult to recruit into that area?
I recruit at the post-grad level and have no problems. The people I recruit are generally focussed on developing the drug and getting it licensed to help people. The animal work is part of that process.

Do your family know /approve of your job?
Yes they do. DM was shocked when I proudly sent my first published paper (many years ago now) as she believed that animal work was unnecessary. Now she's reliant on medicine her view has changed a little.

Why do you think it’s ethical to test on animals and not on humans? How do you justify to yourself getting paid to cause harm to a sentient being?
I am openly Speciest: I believe that people are more important than animals.
I justify it as a means to an end. I work hard to minimize and ameliorate pain, distress and lasting harm. I am not paid to cause harm. I am paid to develop medicine (including veterinary medicines) which can prevent or end harm. Sometimes animals suffer as part of that process but it is never the aim.

How are things security-wise for you these days?

I studied a subject which was based in a building that housed research animals, among them primates, and on the first day we had a two hour lecture from the police advising us how to vary our routes home, check under cars for bombs and so on. I never worked with any of the animals myself, not my area, but it was quite scary to be thought of as a target just for working three floors below. That was 20 years ago at what seemed to be the height of animal rights activist protest - has it decreased any?

People are not more important than animals and the world would be a better place if there was no humans on it. You are not an animal lover. Poor things you have 0 compassion or empathy.

Did you find it difficult to begin with?

I'm not judging you in any way, I'm actually intrigued as it's a such a taboo subject IRL!

When I was younger I was vehemently against animal testing but in my line of work we rely on medication a lot and I see the difference it makes to lives so I now understand the need, although I do wish there was another option. At this time though I'm willing to take what we can get.

Given the differences across animal species (including humans) is animal testing a relevant safeguard for drug development?
I believe so. We are adding in different types of testing all the time (in vivo testing has never been done unilaterally) and although we can do wonders with modelling and cellular slides/organ replacements, even compared to when I started out in the 80s, we aren't at a point where we have any alternative closer to human than another mammal. Depending on pharmacology and physicochemical properties of the drug under development one mammal will be more suitable than another but we are always learning and our species selection gets better all the time.

There was a widely publicised life-changing outcome in human subject drug testing a few years ago - why did the animal testing models not identify this before human trials? In my view that indicates that animal testing is fundamentally flawed.
There have been two major unexpected adverse findings in clinical trials in the last 20 years.

I think the one you are referring to was in 2006: TGN1412, an immunological modifier, was tested in mice and monkeys with no clinical signs at all. Then when they went to do the first clinical trial they used the NCE rule of thumb and dosed a factor of the highest non-adverse animal dose. TGN1412 was a large molecule biologic drug designed to switch on the immune system. It caused cytokine release (storms) in the phase 1 patients. Dreadful injuries.
In 2016 one phase 1 volunteer died and 3 more were brain damaged in a trial in France: in that study the drug had already been through significant clinical testing: 64 volunteers had received the drug before the volunteer who died. The previous subjects had received up to 40mg. These subjects received 50 mg.

Hundreds of phase 1 clinical trials are undertaken across the world every year. Thousands of volunteers and patients are treated. Only 2 studies with significant adverse events in man. I'd say that the animal studies are doing pretty well to protect the volunteers and patients. Further, in both of these studies a stepwise staggered dosing was not done: in each case only one person need have been affected. We stagger animal studies, why they didn't do that for the clinical studies is astonishing.

(Disclaimer: I am biased as am very much against animal testing).
That's Ok. I'm biased because I believe that for now animal testing is the safest option for pharmaceuticals.

How are things security-wise for you these days?
I haven't been aware of any attempted murders for a few years now, Car bombs etc like when the Unis wanted to improve their labs.
Campaigning continues, but that's a good thing. No activity should be done without scrutiny or review.

People are not more important than animals and the world would be a better place if there was no humans on it. You are not an animal lover. Poor things you have 0 compassion or empathy.

I will put my hand up and say that I would kill an animal with my bare hands if it was a choice between the life of that animal or the life of my child.
I don't think I'm entirely lacking in compassion, but I will say that my view is less anthropomorphized than most.

Did you find it difficult to begin with?
Very. My background is pathology and my first post-doc placement was working for a NGO trying to develop non-animal methods from tissue samples: on my first day I had to attend autopsies. I had to excuse myself to go and cry in the loos.

I'm not judging you in any way, I'm actually intrigued as it's a such a taboo subject IRL!
And yet so many people eat meat and drink milk....

When I was younger I was vehemently against animal testing but in my line of work we rely on medication a lot and I see the difference it makes to lives so I now understand the need, although I do wish there was another option. At this time though I'm willing to take what we can get.
Ironically, I was vehemently against in vivo testing as a young person too. I was actually working on 'alternatives' as we called them back then originally. We are still working on new methods all the time: refinement, reduction, replacement of animals in research is embedded in UK law and in the pharmaceutical industry as a whole. One day. maybe.......

Are you in Newcastle?? My friend worked in the animal house there doing research and if anyone has to do this job I'd want it to be her. She definitely would make sure the animals suffered as little as possible.