Docs, Animal-Rights Groups Urge FDA To End Tests
10 CommentsBy Ed Silverman // November 16th, 2007 // 8:50 am
A coalition submitted a petition this week to the agency that seeks an end to animal testing. And the groups are threatening legal action if the FDA doesn’t respond within six months. Their rationale - a series of recent “tragedies” in which drugs “that seemed safe in animal tests injured or killed consumers or participants in clinical trials.”
In their Mandatory Alternatives Petition, they cite as examples “hormone replacement therapy for women, development of HIV protease inhibitors, Vioxx and other COX-2 inhibitors, teratology studies, harmful effects of smoking, non-steroidal anti-inflammatory drugs, antibiotics, antivirals, antidepressants, and cardiovascular medications, among others.” They also point to Merck’s failed HIV vaccine, which appeared safe and effective when tested in monkeys., but was halted when it appeared to increase the risk that trial participants may contract HIV.
“Dangerous drugs are killing American consumers because regulators allow drug companies to use misleading animal tests,†says John Pippin of the Physicians Committee for Responsible Medicine. “The Food and Drug Administration could avert these tragedies by focusing on human-centered methods.â€
In a statement, the coalition claims “more than 90 percent of drugs tested in people after successful animal tests are not approved for wider use because they don’t work or they are unsafe. Half the drugs that are approved are later withdrawn or relabeled for adverse effects not detected by animal tests.” Here’s the petition.
To reduce such risks, the coalition is asking the FDA for wider use of what it calls “human-centered research methods such as microdosing, tissue studies, and virtual drug trials.” And they point to Europe, where they argue the use of scientifically satisfactory alternatives is mandated under European Union Directive 86/609/EEC.
The MAP is signed by more than 100 doctors, scientists, and other experts, including primatologist Roger Fouts; neurologist and public health expert Aysha Akhtar; pediatrician Roberta Gray, and economist Jeremy Rifkin. Nonprofit groups include the Association of Veterinarians for Animal Rights, the British Union for the Abolition of Vivisection, In Defense of Animals, the New England Anti-Vivisection Society, and the Physicians Committee for Responsible Medicine.
Nathan
“More than 90 percent of drugs tested in people after successful animal tests are not approved for wider use because they don’t work or they are unsafe.”
Wow — that’s great! Let’s stop testing our compound in animals and take them directly into humans instead! Oh wait, while we’re at it: most compounds that we test against cell lines and enzymes don’t work in animal models either. So lets get rid of that step too. We’ll design all are compounds with computer aided drug design and put them into humans. Oh wait, computer aided drug design is generally even less predictive than animal models, so we’ll get rid of that step too. We’ll just make a bunch of random compounds in the lab and just “see what happens” when we put them into innocent human subjects. That sounds like a great step forward for drug discovery.
Nathan
Obvious, my previous post was an attempt at sarcasm. On a more serious note, ARE THESE GUYS CRAZY??? Let me get this strait, they think that drugs are unsafe, so they want to eliminate one of the very few ways that we can actually measure safety. Of course animal studies are flawed and sometimes unpredictive — but the alternative (killing humans) is far, far, far worse!
Lisa Van S
Nathan,
Im shocked !! You care about humans being killed.I am curious, Though..are children, considered human in your book? I noticed that you didnt respond to my posts, What’s the matter, cat got your tongue.
Tristan
Great. A bunch of nuts willing to kill more humans to save more animals. I’d be happy to support their cause as soon as computer models can 100% replace animals.
Until them, all I can say is: You First.
Bob
3 posts, and a certain someone just has to pipe in…
::sigh::
Katie
Nathan, you said:
‘computer aided drug design is generally even less predictive than animal models’
where did you get this information from?
The alternatives suggested won’t kill humans, they are designed to help find cures, vaccines etc that will help. I have read ‘Vivisection Unveiled’ by Dr Tony Page, who points out that vivisection has hindered medical progress.
There are approximately 300 alternatives to animal testing that are safer, many are cheaper, and they provide more accurate results.
Finally, I would like to highlight the fact that clinical trials have taken place based on the results from animal testing for years, despite the fact that animal experiments are dangerously misleading and have lead to hundreds of drugs being pulled off the shelves every year. Getting rid of animal tests and replacing them with computer simulations, stem cell research, clinical obsercation etc can only improve testing and make it safer for those who participate in clinical trials.
Nathan
Katie,
I work in a drug discovery lab in the pharma industry — that’s where I get my information from. Computer aided modeling, in some circumstances, allows you to quickly optimize a compound in ways that allow it to bind tighhtly to it’s target protein. However, computer aided modeling does absolutely nothing that allows you to predict intestinal absoption, liver metabolism, brain penetration, teratogenicity, and many other factors that have to be built into molecules before they can become drugs. Notice I didn’t include efficacy. Getting a compound to do what you want it to do (in a disease state) is often not terribly difficult. The hard part is coming up with something that is:
1) Stable enough that it resides in the body for hours so that you don’t have to take a pill every 2 hours
2) Unstable enough that the compound is eliminated from your body and doesn’t build up in tissues over time
3) Broken down by your body (liver usually) in such a way that the byproducts (”metabolites”) are eliminated from the body quickly and are nontoxic
4) Doesn’t cause accute toxic effects (nausea, dehydration, etc)
Obviously this is a very, very, very challenging process. Animal studies can be misleading, and have been misleading. But the alternative is absolute chaos. What most of the public doesn’t recognize is that only a tiny fraction of projects that pharma companies work on go into clinical trials. I work at a company with ~250 chemists making compounds for testing. About 1-5% of the compounds we make end up getting tested in animals. Of those that get tested in animals, I would estimate that about 1% go on to clinical trials in humans. The bar is set very, very high for compounds to go into humans. How would we decide what compounds to take into humans without guidance from animal models?
Katie (different one)
ANIMALS ARE NOT ON THIS EARTH FOR TESTING!
http://www.youtube.com/watch?v=_xV72w6oEYI
Michelle
Humans are not harmed. Here is how it works — We develop better drugs by using HUMAN CELLS (very humane) from the get-go (and other information and techniques already available about humans), NOT a ENTIRE LIVE human to develop the drug at first. By doing this and bypassing the use of animal cells and live animals (they are different), we get better INITIAL drugs that have already been screened for SAFETY and EFFECTIVENESS using these non-invasive methods. These drugs can then get tested more safely in live humans using safe MICRO-dosing. Microdosing is small enough that it will not cause any harm, and it still yields useful and relevant information using highly sensitive detection methods. And it makes better sense to microdose something tested on applicable human cells than on a gamut of other species. If even humans can react so differently to drugs amongst themselves, why are we even depending on animals for drug development and testing? Also, many currently helpful and safe drugs for humans (aspirin and penicillin, to name a few) are highly poisonous to animals, and these would have been weeded out if we had used animal results. Get it?
NC Doc
This petition is long overdue. The animal studies petitioned to be replaced are a completely archaic form of science, that leads to unpredictable results at best, and lethal at worst. Anyone in question should check out publications by Dr. Ray Greek.
This petition does not encourage the use of humans as test tubes. Rather, it is designed to further the advancement of treatments that are modeled for PEOPLE and not customized for rodents.