Drugs that work in animals usually don't work in humans

[Why Syzygy]

(...)The truth--mostly hidden from public view--is that animal research is horribly cruel. Despite what the research community claims, federal regulations are extremely weak and poorly enforced, and some species -- mice, for example -- are completely excluded from any protection. Many investigations have shown just how bad conditions are.

But as someone who recently signed up for hospice, I have another major problem with animal research. I wonder if science would have found a cure for my leukemia by now if they weren't sidetracked by misleading animal tests. I wonder if the chemo that I took for breast cancer would have been safer it hadn't been tested in species that are so unlike our own. (...)

More than 90 percent of all new drugs which proved effective in animals end up not working for humans. It's because animals -- however similar they are to us -- have different physiological systems. What works in a mouse usually doesn't work in a human. (...)

The current drug approval system doesn't yet acknowledge the superiority of human-focused, nonanimal research methods (such as microdosing) and all pharmaceutical companies must use animals to get their drugs approved. Hopefully, this situation will soon change. A coalition of animal protection groups and physicians has petitioned the U.S. Food and Drug Administration to accept the results of alternative tests, when available.

If the chemo drugs I'm trying now don't work, I do have one last option. I could try a Phase One trial. That's when a drug looks promising in animals and is first tested in humans. My doctor started to tell me why so many participants die in Phase One trials -- but it turned out I already knew the answer. Drugs that work in animals, he explained, usually don't work in humans.

http://www.alternet.org/healthwellness/132999/how_an_animal_advocate_explains_her_decision_to_take_animal-tested_drugs/

[Teaser]

1. As someone who participates in "animal research"

I can't agree. Pain and suffering mitigation and elimination are standard practice for nearly every species I've worked with.

That said, the point can be made with respect to larger animals (cats, dogs, and apes) sometimes (and in the case of apes, much of the time) but with respect to smaller species (rats, mice, frogs, and turtles) animal welfare regulations are strong and strongly enforced.


And furthermore, the reason *most drugs that work in animals don't work in humans* actually makes the case for a graded testing regime, starting in animals that are far removed from humans physiologically, and working their way up the phylogenetic tree.

[Why Syzygy]

3. I never knew the FDA requires animal testing.

I'm not well informed on the conditions of animal testing.
Thanks for offering your experience.
I do have an interest in effective drug trials.

[Avalux]

2. The paradigm of clinical research is indeed shifting in the US.

Most likely due to global guidelines; otherwise we can't compete. The EU is moving from use of animal models to micro-dosing in Phase I trials (healthy individuals). I managed a Phase I trial for a novel investigational asthma medication; study was structured w/escalating micro-doses in cohorts. A good design.

I expect pre-clinical (or animal studies) will phase out over the next 5-10 years.

[sharp_stick]

10. First in Human

trials would never happen without the original animal research.

The EU requires the usual animal testing before any NDA (new drug application) or IND (investigational new drug) application is even accepted for review.

Good luck trying to get that new chemical into phase one without it.

[Avalux]

4. Another thought about animal research - efficacy not an objective.

The purpose of the trials is to monitor large organ systems - cardiac, gastrointestinal, etc. for safety of the investigational product. The product is usually given in mega-doses. Most do not make it past this stage because they can't be tolerated by the subjects (animals).

These studies are not intended to produce data on efficacy - whether or not the product "works" against the intended disease/condition.

[dropkickpa]

12. You have absolutely no idea what you are talking about

I work in animal research, and I see, every single day, studies being done to test, TA-DA!, the efficacy of drugs for specific diseases and conditions, with the specific goal of producing data for this.

[Schema Thing]

5. I know a young man who is alive after 5 years

post being diagnosed with a glioblastoma brain cancer; thanks to a Phase One trail.

[sharp_stick]

6. This article is pretty misleading

Drugs aren't tested in animals because they have the same therapeutic effects. Drugs are tested in animals in part because they will often, but not always, show side effects that can be similar to humans. These side effects are not evident before animal testing and there is not another way to do this. Microdosing does not now, nor will it ever detect the vast majority of side effects.

A phase one trial does not occur when a drug is promising in animals. It occurs when a drug is promising in humans and shows an acceptable risk profile and exposure in animal testing. The reason so many people die in early phase trials, not just phase one, has absolutely nothing to do with the difference between animals in humans, it occurs in cancer because phase one trial enrollees are usually class IV, metastatic patients. Phase one trials in non-cancer indications have very low instances of problems and they only occur after healthy human volunteer FIH trials.

Alternative testing is always preferential for everybody, including the pharmaceutical industry. If for no other reason than it's a lot cheaper to work on in-vitro, high throughput assays than it is for long term low throughput animal testing. Two year rat carcinogenicity studies are incredibly expensive, use a lot of animals and take up a lot of resources. The industry and the scientists working in it would jump at any viable alternative. The idea that research scientists are slavering nutcases that can't wait to rip apart a living animal is very wrong.

on edit: My usual number of typos

[cosmik debris]

7. Do you have a better suggestion?

Or are you just trying to throw road blocks in the one path we have available?

[trotsky]

8. A natural corollary: not everything harmful to animals is harmful to humans.

Best illustrated by the thread not too long ago asking about a rumor that a chemical used to process flour causes diabetes. Yep, it sure does - in rats. Not in humans. Unfortunately that rumor lives because it continues to be pushed by "natural" health sites.

[The2ndWheel]

9. Human testing for human progress

Always amazed at how we privatize the profits of medical research, and socialize the costs to other species. Then we complain about corporations acting the same way. Crazy.

[Warpy]

14. How do you think drugs used in veterinary practice are

being discovered?

[dropkickpa]

11. What a load of crap

The vast majority of Phase I trial patients are healthy subjects to assess safety, pharmacokinetics, pharmacodynamics, and tolerability of the drug.

Exceptions are some oncology and HIV drug trials where they allow END-STAGE patients (the dying ones) into the study in a *last ditch effort* to try to save them because NOTHING else has worked.

The person in the article is full of shit and obviously has an agenda. The reason many end-stage patients allowed into Phase I trials die is because they were the walking dead anyway before they ever even entered the trial, but often they get more time that they wouldn't have had because of the drugs.

Their participation helps further researchers ability to evaluate the drugs ability to act on the disease and is a wonderful contribution that shouldn't be looked down on. Outside of drug trials, once approved, a doctor generally doesn't wait until a person is just about dead to treat cancer or HIV, earlier treatment is always better and more efficacious.

Ask anyone living with a transplant if they think the animal research done into, oh say, tacrilimus, was ineffective. I'm sure they're VERY happy to have an anti-rejection drug that was proven, IN ANIMALS, to be able to be taken onle 1-2 times a week rather than 3-4 times a day and still be effective.

[supernova]

13. As someone who was saved by animal research

I disagree. Strongly.

I wouldn't be here if the first cardiac surgeries weren't performed in animals before they ever attempted them in human beings, much less child human beings.

It could be that someday artificially computer-generated 3-D modeling will replace animal research. That would be a great day. But I bet we are a good 100 years away from the state of the art of such technology and it being widely available.

As for trials, any new drug or device makes its way along an experimental continuum:

Phase I trials aren't concerned with efficacy and therapeutic value. Phase I trials try to answer two very basic questions:

Is this drug/technique/new gizmo safe? I.e. does it do no harm to the patient?

Are there any side effects that pop up here (that weren't evident in the animal trials, usual mice)? If so why? Adverse events must be reported to the FDA.

Yes, cancer patients in Phase I trials dying is quite common. And it's because they recruit terminal patients. Patients are made aware that they might not get any relief from their disease by participating, but they can help add to the overall body of knowledge by participating, and potentially helping someone else in a similar situation in the future. It's their choice.

[varkam]

15. What a pantload.

"I wonder if science would have found a cure for my leukemia by now if they weren't sidetracked by misleading animal tests."

The author seems to miss the point that we can conduct many test on animals that we couldn't likewise do in humans (such as preliminary trials for drug safety). In addition, many advances have come from animal studies. My guess is that, if we didn't have animal studies our state of medical knowledge would be far inferior to the knowledge that we have today.

Also, I have been involved with animal research in the past involving mice. There were strict regulations as to feeding and care for the animals.