I am currently participating in a diabetes study, where I daily inject myself with a new drug and report results to a research doctor once a week. I have been doing this for many months. The point is I had a choice to do this whereas animals do not. Those who are against animal experimentation should volunteer for studies if it is possible for them to do so; enough of us participating will show researchers there are humans willing to be tested.

Posted by: Rev. Meg Schramm | October 20, 2009 02:23 PM

Most animal experimenters are cruel socipaths with no emotions. Can they really feel scared?

Posted by: Brien Comerford | October 20, 2009 07:59 PM

I recently saw a commercial for www.ResearchSaves.org and I was appalled. I urge everyone to contact them and let them know how you feel. Oh, and don't forget to have a look at the sponsors of the site.

Posted by: Roberta Yates | October 21, 2009 02:51 AM

Rising populations, drought, famine ( in may areas of this world ) war zones, crime, surveillance, greed, and then you read this article and view the posters ! no doubt about it the world is going down the ' crapper,' sooner rather than later ! sadly the many good will go with the very many bad.

Posted by: keith | October 21, 2009 11:37 AM

Animal experiments are vile -a real life horror movie.
I often think about the millions of animals who have been tortured, abused and killed.The lives of these animals are fueled with pain, fear, anxiety , confusion and depression.Often it is all they ever know.what a horrific life experience.
No one can elude themselves totally from contributing to the cruelty of others
even simply breathing kills molecules however we can live in ways that do the least harm such as being a Vegan and not wearing, or eating animals as well as not buying products tested on animals.Most of us do not live in an igloo or remote African Village instead we live in a modern city with many many many many Vegan options.Even the smallest town has simple ways to be cruelty free.
The humans who perform animal testing are not human they are no different than any other mass murder.It takes a soul less sick disturbed mind to be able to do animal testing.To spend even one moment inflicting such cruelty on another being is sick.I look forward to all animal testing being banned along with many much needed animal cruelty free changes made.

Posted by: simara | October 21, 2009 12:11 PM

ps
I just Read a comment posted by Keith-I feel your angst and I can relate however almost all the problems that plague or planet and disease the hearts of our society can be reversed-i am well aware of the negative and it is indeed sadly the majority however the positive is here and always has been and I am going to use my knowledge of the negative as a tool to learn how to fight against it and make life choices that can help heal all the crap on the planet,the fact that animals exists is reason enough to take our angst and rage and turn it into courage and put that into compassionate action, the fact that a site like this exists with a lot of informative guidance and facts spelled out for us is reason to have hope.Anything is possible and I for one am not giving my energies into supporting an apocalyptic negative end to our planet-there is to much worth fighting for here.

Posted by: simara | October 21, 2009 12:20 PM

I'm neither a cruel sociopath, scared, or emotionless...yet I am a neuroscientist. What's with the unfair characterization?

Posted by: Gayle Peterson | October 21, 2009 12:30 PM

I hope that the day research policy changes they allow all these bastards to be tried (as there's no statute of limitations on murder). These people are no better than the folks you find on death row and deserve to be treated accordingly.

Posted by: cary | October 21, 2009 12:59 PM

Look into your soul ( if you have or ever had one ) Galye Peterson. How can any humane homo-sapien conduct or condone such atrocity on sentient beings.

'' Good posting Cary.''

Posted by: keith | October 21, 2009 03:11 PM

Bravo, PETA and Dr. Hansen!

Gayle- Seems like there's nothing to take personally, as this blog post's only issue is with "some members of the society" who perform and support animal experiments.

Posted by: Stephen | October 21, 2009 03:14 PM

Animal experimentation is truly like a horror film. Until I saw actual photos and undercover investigations on PETA's website, I didn't even know what "we do not experiment on animals" meant. I never could've imagined that SO MANY different companies and universities torture innocent animals to earn an extra buck. We really need to start informing the public about this because you'd be surprised at how many people are completely oblivious to this issue.

Posted by: Jen | October 21, 2009 06:21 PM

Keith, I work in a facility where most research is done with rats...this isn't like cosmetic testing where we spray chemicals in their eyes. Every step is taken to make sure the animals are as comfortable as possible during experiments, and they are allowed to live out their lives much as pet rats do outside of the time of experimentation. In the event that an animal needs to be sacrificed, euthanasia is carried out in a manner that is similar to how we put our own pets to sleep. Not once have I ever seen a rat afraid of a researcher, and believe me, it's easy to identify a terrified rat. Drilling a hole in their head to implant an electrode may sound terrible, but the rats behave no differently post-implantation. They still play, and will cuddle with researchers who are inclined to interact with their subjects.

Additionally, there are IACUC committees dedicated to making sure that suffering is minimalized, and that in the event an experiment must cause an animal to suffer (ie. pain treatment studies), that the knowledge to be gained is actually useful, and that any discomfort is of an ethically acceptable level. Contrary to what you may believe, we are not permitted to hurt animals repeatedly. Further, I guarantee you that suffering in most labs is magnitudes lesser than what occurs typically in the meat industry.

I doubt most of us are happy that we have no other options to study many aspects of neuroscience besides animals, but we feel that the benefit outweighs the cost.

Stephen, I take issue with us researchers being characterized in these ways because we dedicate our lives to helping our fellow man. This line of work doesn't make us rich, so believe me, we do it because we think its important--and I guarantee you that the people who are suffering much worse than our animals with various conditions will strongly disagree with us being characterized as soulless sociopaths.

Posted by: Gayle Peterson | October 21, 2009 11:11 PM

Those videos are totally atypical. Most research is carried out in much better conditions, and the motivation (at least in academia) is rarely ever an "extra buck".

Posted by: Kalama Halamezad | October 22, 2009 03:27 PM

Gayle.. you have zero emotions if you condone this. Zero.

Posted by: carla | October 22, 2009 04:51 PM

Carla,
Condone what exactly? Do you even know what typical neuroscience research is?

Just because I choose to restrict my compassion to my own species (and to animals where their use is unnecessary--ie. for food, luxury items, etc) doesn't mean I have zero emotions.

I guarantee you that watching videos of peoples with neurological disorders would be even more disturbing than what you'd see in a typical lab. Plus, as Kalama says, the videos you've been shown are highly unusual.

Would you like it if I categorized all of you along the lines of the few members who send death threats and commit acts of violence?

Posted by: Gayle Peterson | October 22, 2009 08:41 PM

John Hopkins University and their progressive scientists are trying to get scientific and medical research out of the stone age with their Center for Alternatives to Animal Testing (CAAT):

http://caat.jhsph.edu/

"CNN recently invited Drs. Jerry Vlasak and Ray Greek to debate UCLA vivisectors, albeit not physicians, Dario Ringach and David Jentsch. Vlasak and Greek jumped at the chance to dispute the medical efficaciousness and morality of animal experimentation; Ringach and Jentsch refused to appear."

What are Ringach and Jentsch scared of?

(Dr. Greek and his wife, Dr. Jean Greek, of course wrote the classic anti-vivisection text, "Sacred Cows & Golden Geese.")

Posted by: Mike Quinoa | October 22, 2009 08:42 PM

Mike,
I think the link pretty much says it all...that this group gives grants to people who try to develop non-animal models (or at least finds models that require less animals.

The simple fact that they will give money for people to find non-animal models pretty much says that there are some things that are currently not able to be researched with non-animal models.

DO you think you could give me a brain in a dish--or something that functions so similarly that I could learn about brain function? No? What do you think non-Dark Age alternatives for neuroscience studies are? I'm all for them if they'd work.

Posted by: Gayle Peterson | October 23, 2009 05:41 PM

Gayle,

You said, "The simple fact that they will give money for people to find non-animal models pretty much says that there are some things that are currently not able to be researched with non-animal models."

That doesn't necessarily follow. It could also mean some scientists are too lazy, and/or not intelligent enough, to devise other research modalities. A lot of people don't like change.

I would have more respect for vivisectors if they were willing to engage in open and scientific debate with anti-vivisectionists. In the UK, vivisectors refuse to debate with a-v Dr. Vernon Coleman, since he's never lost a debate with them.

There are hundreds of drugs that were safety approved based on animal testing, only to subsequently be found to have harmful or lethal effects on humans.

"Although some adverse drug reactions (ADR) are not very serious, others cause the death, hospitalization, or serious injury of more than 2 million people in the United States each year, including more than 100,000 fatalities. In fact, adverse drug reactions are one of the leading causes of death in the United States."

(Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. Journal of the American Medical Association Apr 15, 1998; 279: 1200 - 1205.)

These are all drugs that have passed animal testing with flying colors.

Posted by: Mike Quinoa | October 25, 2009 08:10 PM

Although I am not a neuroscientist (I only have an MD), I can attest that animal models for scientific experiments are cruel and unnecessary. Continued utilization of subjects that do not accurately reflect human physiology or response to treatments is truly dark-age "science." Plus, what has all this research and scientific advances really accomplished? Sustaining an ever aging and more sickly population (not limited to elderly patients), many of whom do not want to take any measure of responsibility for their own health is truly disturbing.

Posted by: Derek, MD | October 26, 2009 11:51 AM

Thanks Mike and Derek for your excellent comments.

Animal testing has not resulted in major medical advances. The most significant advances have come from clinical observation, autopsy, and in vitro testing.

Animals may be "similar" to humans in physiology, but that is not enough to be able to apply results across different species. Go to: http://thecelebritycafe.com/interviews/dr_ray_greek.html for more of an explanation.

Researchers may or may not make a "buck" from vivisection, but the pharmaceutical industry sure is, as well as the supporting industries (for example, the companies that supply the cages, the rats, and other equipment).

Posted by: Michele | October 26, 2009 04:40 PM

Mike, regardless of whether alternatives don't exist due to laziness or not, the point is they don't exist (which is something you never hear from animal rights organizations insisting that there are humane alternatives to everything). However, growing a brain without an animal isn't impossible because people are lazy...it's because we don't know enough about biology to do it. How do we learn to do something like this without reverse-engineering existing models?

The lack of responsiveness to anti-vivisectionists is actually encouraged in academia. Why? Because we're supposed to focus on our research--not focus on defending our methods. Everyone's specialized, so we can tell you why an animal model is appropriate for our specific line of research, but can usually only generalize as to why they might be necessary in other disciplines. To be that knowledgeable would require us to devote time to studying such issues (instead of our purposeful studies)--which is something a PETA-backed anti-vivisectionist with an agenda can afford to do. It's unlikely that many people would win in a debate with such an anti-vivisectionist, unless they were actually staunchly pro-vivisectionist. Generally, this isn't the case, since we'd actually prefer not to use animals! Problem is, there's just not always a way to avoid it.

In our opinion the anti-vivisectionist's time (and his backer's money) would be better spent looking into the creation of an alternative model for us to use instead of repeatedly pointing out that he must be right because no one wants to chat with him. For instance, do you think PETA drove the switch from animal-produced insulin to synthetic production--or do you think that this was the intended outcome after practically a century of animal research gave us a complete understanding of how insulin works (as well as the chemical knowledge of proteins and how to fabricate them)?

Posted by: Gayle Anderson | October 26, 2009 06:02 PM

Derek, being an MD you should also be aware that there are also many similarities between animals and humans. How would you recommend we test for general safety of drugs without animals? In vitro models lack the complexity to model complex tissues and the interactions between them. The only way to get a "rough" idea is from an animal test (unless you want to risk killing hundreds of humans in the first phase of a clinical trial).

An anti-animal model group concluded that animal models predicted drug safety 70-80% accurately. This level of certainty is far less than required for scientific certainty, but it's much better than 0%.

Further, even if such tests were initially carried out in humans, the same result would occur (albeit with lower frequency), since there exists plenty of physiological variability within the human population itself, just ask all the indigenous people killed by microorganisms that Europeans practically bathed in during the 1500s.

And the unhealthy, aging population has nothing to do with animal science being bad. That's just people sucking in general. Just because people whose blood is buffered with high fructose corn syrup can survive to quaff more Coke, doesn't negate the fact that children born diabetic are also given a chance at life because of the same discovery. Even if people stopped eating meat, they'd probably still find unhealthy things to eat--people problems have nothing to do with any of this.

Posted by: Gayle Anderson | October 26, 2009 06:08 PM

Michele,
Aristotle attributed the human mind to the heart, and Galen attributed the human soul to the ventricles. It wasn't until much later that Andreas Vesalius of Padua noted that this probably wasn't the case, because 'soulless' animals also have ventricles.

We learned how neurons communicate using the giant squid, and how they store information by altering their connections from the sea slug. Hardly 'useless' knowledge considering these relatively recently discovered facts are being used to rehabilitate the brain following stroke and prevent epilepsy. An associate from my university is also going into clinical trial, because he was able to capitalize on this knowledge to reverse tinnitus via an implant in rats (and the mechanisms are likely to homologous enough in humans for the same technique to work). Curing people of a disease that renders them unable to communicate and often drives them to suicide...yeah, definitely useless.

Posted by: Gayle Peterson | October 26, 2009 06:48 PM

Gayle,

You said "An anti-animal model group concluded that animal models predicted drug safety 70-80% accurately. This level of certainty is far less than required for scientific certainty, but it's much better than 0%."

But what about...?

"The U.S. Government Accountability Office found that among all new drugs marketed during a 10-year period, 52 percent had seriously toxic or fatal effects that were not predicted by animal experiments."

(A coin toss would have been as accurate.)

"More than half of the 198 new, animal-tested, medications released between 1976 and 1985 were either withdrawn or relabeled secondary to severe unpredicted side effects. These side effects included complications like lethal dysrhythmias, heart attacks, kidney failure, seizures, respiratory arrest, liver failure, and stroke, among others. All the withdrawn drugs had the successfully-animal-tested stamp of approval. (GAO/PEMD-90-15 FDA Drug Review: Postapproval Risks 1976-1985)"

"On September 30, 2004, the drug company Merck recalled its popular pain reliever Vioxx from the market because it was found to increase the risk of blood clots in patients. Evidence suggests that human observational data predicted these effects as early as 1996, and human clinical data confirmed the danger in 2001. However, animal tests supported the release and continued use of the dangerous drug, so Merck chose not to conduct human trials on Vioxx's relationship to blood clotting. Because Vioxx remained on the market, the FDA has estimated that as many as 27,000 patients may have died. Alise Reicin, vice president of clinical research at Merck Research Laboratories, has defended Merck's conduct by stating that animal studies suggested that Vioxx might actually reduce the risk of heart disease and stroke."

"Cancer Research UK asserts: “We do trials in people because animal models do not predict what will happen in humans.”

"According to the Food and Drug Administration (FDA), 92% of all drugs that pass preclinical testing on animals fail in human clinical trials. Of the eight percent that receive FDA approval, half are later withdrawn from the market or have significant side effects that were not identified during animal experimentation."

Gayle, as you pointed out "there exists plenty of physiological variability within the human population itself." Why then do we waste time with animals when we need to move to a human model of personalized medicine or pharmacogenomics?

Posted by: Mike Quinoa | October 26, 2009 09:46 PM

Mike basically laid out my reasoning - most medications serve the purpose of making money for the pharmaceutical companies rather than improving the overall long-term health of a patient...that is an indisputable fact.

In regards to the suicide risk from tinnitus, you need to read a study or medical book that was not utilized to obtain grant money. Elderly, isolated males with depression are more likely to attempt suicide with or without tinnitus.

Posted by: Derek, MD | October 27, 2009 11:52 AM

First off, the Vioxx tragedy is due more to corporate and regulatory failures than to the inefficiencies of animal modeling. Merck chose not to take action, and the feds didn't require them to do so. Both knew that animal models aren't always 100% and chose to ignore that when deciding not to check into the potential dangers earlier.

"A decade ago, the number of drugs failing preclinically due to poor pharmacokinetics was upwards of 40%, but improved in vitro and animal models have reduced that rate to about 10%. Failures due to toxicology, however, are still in the 30% to 40% range, making it the number one reason for preclinical attrition."

--That's the result of both animal models AND the humane alternatives...do you really think it would be beneficial to take the innumerable number of dangerous drugs that are eliminated during these phases and put them directly into human trials? Just because 30-40% of the drugs that pass preliminary tests fail due to toxicity doesn't mean only 30-40% the ones that failed preliminary tests would hurt people. You may lose some that would ultimately be safe, but at least you avoid the even greater loss of human life that would be associated with testing every drug that passes in vitro tests on humans.

"In vitro techniques are still often of limited predictive use because they cannot accurately reflect the complex environments that drug candidates encounter in a living organism. Overall, gene expression-based profiling is powerful yet in its infancy. Its potential has not yet been fully realized."

...and...

"Different models utilized for the determination of a specific toxicity can produce substantial differences in the results and analysis of those results. This may result in a situation that inappropriate selection of an in vitro model could lead to contradictory results. In addition, the local microenvironment of the tissues and complex interactions between adjacent tissues is difficult to be modelled in in vitro systems."

--That's why we're still stuck with animal models sadly. There's just nothing better unless you're willing to kill people on a whim. Further, non-animal models are being associated with the same weaknesses as the animal models.

In parallel development with improved in vitro models we have, "recent progress achieved in transgenic and knockout animal models has considerably increased the value of applying preclinical animal models in toxicogenomic studies. The use of such models which contain specific human genetic characteristics of interest is crucial for gaining a better understanding of the mechanism of action of candidate drugs"

"Although there is a certain degree of similarity in the biochemical and molecular pathways of different species, the biological response to drugs may certainly differ between the species...it is important to predict toxicity of candidate drugs across different species in order to minimize the risk of misinterpretation caused by species-derived differences in response to drug treatment."

--Professional recognition of the limitations of animal models, but also pointing out that the failure may lie in how the results are evaluated.

Whether you like it or not, the current paradigm is probably better than a coin toss in regards to safety. It really depends on who does your statistics. Seen the analysis on the "global cooling" in the new Freakonomics book? You can reach three different conclusions based solely on shifting the starting point of the temperature analysis from 1999, to 1998, to 1997.

Mike, I'll look at the pages you copied from since you haven't linked the original source to see if they interpreted the FDA's reported data accurately--but I'm not confident since it seems to be popularly posted on animal rights sites and not elsewhere (upon quick review). Plus, do you really think the FDA would require the testing if they had such "strong" data against it?...I mean, even if they're in the pocket of the pharmas they'd have absolutely no reason to do it...especially since "Mammalian models are key in predictive toxicity, but they are also expensive, work intensive and require large quantities of compound"

Other guy, you're right about the tinnitus and suicide--that's something I heard from a tinnitus researcher, and not something I'm familiar with. Regardless, while I'm disappointed in having been misinformed, he did say that the only people who consider people's problems to be trivial, are the people who don't have those problems. As a Dr. you should realize that just because tinnitus doesn't kill them, doesn't mean it should be discounted or considered insignificant.

...and yes, I'm still waiting to hear what the "solution" that will save animal lives without risking more human lives is--since it's basically alluded to that in vitro testing is less accurate than animal testing.

Posted by: Gayle Peterson | October 27, 2009 04:43 PM

Mike,
What I really want to see is the source for the 92% failure rate. No one who's written it seems to cite the original source.

Posted by: Gayle Peterson | October 27, 2009 04:58 PM

Gayle,

You are killing your own argument. Poor pharmacokinetics is related to efficacy (how well it works) of the drug and has nothing to do with safety. Toxicology (or safety) "failures" have been unaffected through the use of animal models. Any more statements to support the uselessness of animal testing in the development of pharmaceuticals?

Posted by: Derek, MD | October 27, 2009 05:40 PM

Gayle,

You said, "First off, the Vioxx tragedy is due more to corporate and regulatory failures than to the inefficiencies of animal modeling. Merck chose not to take action, and the feds didn't require them to do so. Both knew that animal models aren't always 100% and chose to ignore that when deciding not to check into the potential dangers earlier."

I think you're trying to gloss over the animal connection to the Vioxx tragedy. As you are well aware, animal testing (inaccurate though it may be) is required in the introduction of new drugs.

Vioxx appeared to be safe and even beneficial to the heart in animals (and passed all animal safety and efficacy tests).

The estimates for the number of adverse reactions due to Vioxx worldwide are 320,000 heart attacks and strokes, up to 140,000 of them fatal.

The successful non-human animal tests were not predictive for the human animal, with the result of untold suffering and deaths.

Alise Reicin of Merck Research Laboratories, has defended Merck's conduct by stating that animal studies suggested that Vioxx might actually reduce the risk of heart disease and stroke.

Vioxx (along with Phenactin, E-Ferol, Oraflex, Zomax, Suprol, Rezulin, Baycol and Selacryn) stands as a glaring example for the utter inadequacy, and potential lethality, of the animal drug test model.

You said, "It's basically alluded to that in vitro testing is less accurate than animal testing."

By whom?

You said, "What I really want to see is the source for the 92% failure rate."

This is the link, though it doesn't lead directly to the quote (I will look for the exact page though):

http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm

I'll leave with a few quotes from an article penned by Deborah Wilson, M.D. (gynecologist and laparoscopic surgeon)

http://www.azcentral.com/arizonarepublic/viewpoints/articles/0423wilson0423.html

"The U.S. Government Accountability Office found that among all new drugs marketed during a 10-year period, 52 percent had seriously toxic or fatal effects that were not predicted by animal experiments."

"In August 2004, the Food and Drug Administration announced that only 8 percent of drugs that pass animal tests make it to the marketplace. In other words, a remarkable 92 percent of drugs found to be safe and effective in animals have turned out to be unsafe or ineffective in humans."

"Health and Human Services Secretary Mike Leavitt expressed a similar concern earlier this year. "Currently, nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies," he said."

"Non-animal testing works better. Human cellular tests assembled by the Multicenter Evaluation of In-Vitro Cytotoxicity, an international group of scientists, have proved more predictive of human safety than animal tests."

"Pharmagene uses computer technologies built on our knowledge of human genetics and molecular biology to show the effect of drugs on the body. As Gordon Baxter, co-founder of Pharmagene, said, "If you have information on human genes, what's the point of going back to animals?" "

Posted by: Mike Quinoa | October 28, 2009 12:18 AM

Derek, I don't see how you're drawing that conclusion. The information I've provided states that both in vitro and in vivo studies cannot predict pharmacokinetics or toxicity to a level considered "predictive" (ie. greater than 95%).

However, both in vitro experiments and the animal assays have been refined so that preclinical interpretations of pharmacokinetics have been improved.

Further, animal toxicity assays have always had a better predictive outcome than pharmacokinetics--and these assays can't be carried out totally in vitro. Also, the debate is on whether animal science benefits humans...not whether it is a good predictor of pharmacokinetics, and the FDA has concluded that it is worth it to force the expense on anyone testing new drugs to carry out animal toxicity screening. Even the most progressive FDA interpretation I've encountered suggests only that a very small human trial is conducted to confirm that a proposed drug has the desired effect in humans before engaging in expensive toxicity tests that kill many animals. To me this makes 100% sense. I'm all for animal welfare, and if a nice, controlled, low-dose human trial can save the lives of many animals, then that's great. But the fact remains, that if the drug passes the small trial, it will go to toxicity testing, where animals are still part of the gold standard. Do you not recognize the value of toxicity screening? I mean, who cares if the drug has the desired effect if the sides effects aren't worth the benefits--and the best way to ascertain systemic responses is still by analyzing animals.

I agree preclinical pharmacokinetic assays have a high rate of failure both in vitro and in vivo. I don't know which has a higher rate of failure, but based on how in vitro studies often fail to predict results in vivo (same species), I'd bet on in vivo being more accurate.

Finally, why has everyone focused on drugs?...I've clearly stated this isn't my area of expertise. It seems this is generally the only argument that anyone will ever address.

...and I ask one more time. Derek, what better alternative is there?

Posted by: Gayle Peterson | October 28, 2009 03:00 PM

Mike,

You're initial quote stated that Merck didn't pull Vioxx despite human observational data suggesting that it was dangers. That statement alone makes my point. All responsible scientists would know that human observations take precedence over animal observations. As soon as that data was known to Merck they should have begun investigating the possibility that their drug was dangerous (in those who were taking it). If the observations clearly provided evidence of potential danger, the drug should have been pulled immediately.

The Merck individual using animal studies to defend himself cannot use that excuse. He chose to disregard human data. He's just trying to save himself. Final point on this issue--they didn't find this effect in the human trials either, so the blame can't be placed entirely on animals. All tested models failed to predict this outcome. This shows that either there were no detectable signs that such an outcome would occur, or that we weren't looking for the right predictors.

I'll respond to various quotes in separate posts, as I addressed the GAO quote last night, and it hasn't appeared for some reason.

Posted by: Gayle Peterson | October 28, 2009 03:11 PM

"Health and Human Services Secretary Mike Leavitt expressed a similar concern earlier this year. "Currently, nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies"

---key words here are "'Laboratory' and animal studies", suggesting a failing of all models. This statistic is only referring to pharmacokinetic failures.

If you read the report associated with this quote, it in no way suggests that animal studies are useless. It suggests that low-dose trials be conducted in humans to confirm that the drug acts on its target prior to the toxicity testing. There are multiple reasons for doing this.

Without this all potential drugs must undergo toxicity screenings before reaching humans that will kill many animals, cost much money, take much time, and discourage the relatively poor non-pharma-backed scientists from trying to pursue FDA approval due to said cost and the associated rigorous experiments.

By confirming that the drug has the desired effect in humans, researchers will have a higher likelihood of obtaining additional funding to cover the toxicity tests as well as the rest of the FDA approval process. Also, with the inherent doubt removed, the scientists will also be more confident that they are taking less of a risk.

This is a really good thing, but it doesn't prove your point. These are the types of progress activists should focus on--cutting down on excess use, and eliminating improper use.

See the link at the bottom for the CPO report from the FDA regarding it's opinion for the following. Note:

"Although traditional animal toxicology has a good track record for ensuring the safety of clinical trial volunteers, it is laborious, time-consuming, requires large quantities of product, and may fail to predict the specific safety problem that ultimately halts development. Clinical testing, even if extensive, often fails to detect important safety problems, either because they are uncommon or because the tested population was not representative of eventual recipients."

--state the FDA's conclusion that animal toxicity studies have a good track record, and that even human clinical studies fail to predict eventual outcomes.

If you read more, you'll see that the FDA had recently (and was proposing) new analytical techniques for drug studies both in vitro and in vivo. The conclusion, as usual, is not that animal experimentation is useless, but that our analytical methods need to benefit from recent advances in science regardless of the model (dish, animal, human).

http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm

Posted by: Gayle Peterson | October 28, 2009 03:50 PM

Gayle,

Drs. Ray Greek and Jean Swingle Greek (DVM) originally came up for the idea for the book "Sacred Cows And Golden Geese" by observing differences in their human and animal patients—the drug that could cure or save the life of one could injure or kill another.

Humans themselves differ in their reactions to a certain drug or food. If you want to specifically benefit the human species, the focus has to be on same.

History has shown repeatedly that animal tests offer no predictive measure of safety for humans, though they do provide a convenient legal shield for drug companies.

There are many non-animal methodologies (pharmacogenomics, epidemiology, clinical research, microdosing, DNA chips, computer modeling, autopsies and biopsies, microfluidic circuits, post-marketing surveillance, noninvasive imaging devices such as CAT, MRI, PET and SPECT scans, in vitro cell and tissue cultures, and more) that give much more accurate predictability for human use than the out-dated animal model.

Sorry I can't respond to your specific points at the moment since I'll be away from the computer until Saturday.

Posted by: Mike Quinoa | October 29, 2009 10:59 AM

Mike, there was no point in responding then, because many of your original points are invalidated by reading the reports your own quotes come from. All of the quotes that you interpret to evidence the failings of animal models also refer to the failings of in vitro and in silico methods, and one even suggests that the clinical trials themselves are bad predictors. In general, all the FDA and GAO reports attribute the failings to the approval process and the detection methods, not animal models.

PET is not really non-invasive (you want radioactive substances injected into your blood)?

Functional neuroimaging methods are useless at anything more than determining how relatively large regions of the brain modulate their function under certain conditions, and provide absolutely no clues as to the underlying cellular, molecular, or pharmacological deficits of neurological disorders on their own.

Autopsies have limited usefulness, because by the time you get the subject, they've already progressed to the end state of a disease--unless they conveniently have heart attacks during early disease phases. Trying to discover the underpinnings of diseases this way would likely take centuries, especially if a disease was relatively rare.

In vitro assays often fail to predict the behavior of single proteins even in the species from which the cells were derived (see any number of papers on neurotrophic or chemotactic proteins).

None of these assays are panacea. In vitro assays are tailored to detect very specific things, and are not preferable to animal toxicity tests (and fail quite often) according to your quoted FDA reports.

Computer modeling can't be used to extrapolate behaviors they weren't specifically designed to analyze.

Observational techniques can only find causes for problems if they have an externally detectable causative agent, and even upon detection may not provide any clues on how to deal with existing problems. (It was observed that poor people in India were often anemic during pregnancy, and it was assumed to be because of poor nutrition...a rat model allowed for the relatively quick determination that they were lacking an unknown factor that could be found in brewer's yeast, that eventually turned out to be folic acid, which was then used to treat their anemia--it also turned out to be essential in prevention of extremely serious birth defects (observed from epidemiology)...this story is a nice example of how animal research and epidemiology can augment each other)

The fact is, ALL of these methods are currently being used, and ALL have failed to cure our worst diseases. However, they also have ALL contributed to our knowledge and have brought us closer to solutions. Trying to attribute the failings of medical science to a single model (that you conveniently have ethical issues with) is beyond unreasonable.

Posted by: Gayle Peterson | October 29, 2009 04:41 PM

If people torture animals for the benefit of man, then mankind should not be saved. Most of the people I know do not want to live in a world with these evils being perpetrated on beautiful defenceless animals. Their arrogance is nauseating. Animals deserve a great life. No more torture. Maybe we should be experimenting on people that torture animals. It won't be a great loss.

Posted by: Linda | October 29, 2009 05:42 PM

Gayle, you say "what better alternative is there?".

We ALREADY rely solely on human experiments to test drugs and medical procedures...

They are called "clinical trials".

92% of drugs which pass animal experiments fail human experiments - sorry - "clinical trials".

If animal experiments accurately predicted human outcomes of new drugs and medical procedures, there would be no need for human experiments - sorry - "clinical trials", would there?

How much more simple can it be?

Different species of animals react differently to each drug... therefore we only know which species was the best human model for each drug AFTER the human experiments have been performed... if drug X kills human subjects, we say that the animal species which drug X also killed, was the best model... but what about the other species of animals which the drug was tested on, which didn't die?

We only know AFTER the fact. Which means, as simply as it can be put, that animal experiments do not predict human outcomes and are therefore a waste of time. Or a big FRAUD.

Have you any evidence to the contrary? Any drugs which have gone straight to the human MARKET without being tested on humans?

Posted by: John Seper | October 29, 2009 05:46 PM

John,
Read everything. You're referencing a quote based on an FDA report aimed at developing better analytical techniques for predicting pharmacokinetics in animal and non-animal models, and promoting low-dose pilot trials to confirm drugs have the desired effect.

The FDA concludes in that very report (and many other reports already quoted out of context by Mike) that animals testing is still beneficial for predicting toxicity.

Not even clinical trials are successful at predicting all toxicity outcomes, and without animal testing many lethal or dangerous drugs would be initially tested on humans that would have been otherwise deemed too dangerous for use in a preliminary animal study.

...and perhaps you don't understand toxicity trials. They're much more complex than giving a rat a drug and seeing if it dies. Generally, the subjects are assessed for biomarkers that are known predictors of adverse events in humans.

If you want to kill all sorts of people by neglecting to collect data that would have prevented a drug from being tested in humans, just say so...but don't sit around saying that 93% of the scientific community that believes animal testing is beneficial is wrong because your stance would only shift the deaths from animals to humans.

Posted by: Gayle Peterson | October 29, 2009 06:27 PM

We need in this world species to make a balance, please stop cruelty.
Also about the farmers way to kill they have to be evaluated by a psychiatric PH in order to have a license to operate it, inclusive the workers.

Posted by: juanita | October 29, 2009 07:23 PM

Drugs that went to market without being tested on humans, eh?

If I disregard drugs that didn't make it into something similar to the modern definition of "market", cocaine, alcohol, and nicotine come to mind.

Hundreds (if not thousands pre-"market") of years of human use before anyone concluded they were bad for ya too--and really hard to phase out of society.

Posted by: Gayle Peterson | October 29, 2009 10:22 PM

Gayle,
Reading down through your posts I am very impressed with the level of professionalism and patience you are able to keep.
Your debate with Mike and Derek is what we need in regards to this issue, not the vague, demonizing characterization that many PETA members resort to when desribing people in your field.
From what I have gathered, you seem to be a person that is pasionate about your profession who possesses a true desire to help your fellow human. Furthermore, you also care about your research and your research subjects. I'm guessing the people you work with probably share the same characteristics and traits that you posses and your place of work is not full of mindless animal torturers who really are in this line of work for the money.
Hopefully one day your line of work will be unnecessary and all of the diseases that harm man will be eliminated, but until that time keep up the good work.
To everybody else, Rome wasn't built in one day. People like Gayle are trying to reduce the need for animal testing. Until that day comes, they must learn through trial and error.

When Thomas Edison was asked how he felt about all his failures when creating the first lightbulb he said: "I have not failed. I've just found 10,000 ways that won't work."

Posted by: Kurt K | October 30, 2009 09:28 AM

I too am enjoying the debate, and I appreciate that Gayle Peterson is at least kind to her lab animals since that is so rarely the case, but there is one very important thing I'd like to point out: I don't know the percentage, but a great deal of people posting here are animal liberationists. We simply don't believe we humans have the right to use animals at all, period. I've always thought Mark Twain explained the animal rights position on vivisection best when he said, "I believe I am not interested to know whether Vivisection produces results that are profitable to the human race or doesn't. To know that the results are profitable to the race would not remove my hostility to it. The pains which it inflicts upon unconsenting animals is the basis of my enmity towards it, and it is to me sufficient justification of the enmity without looking further."

Posted by: Elphaba | October 31, 2009 06:10 AM

Why do I think that they use live animals as for experiments and tests as immoral and digesting? Anything that is suffering like the animals do just for our own selfish gains is wrong to me. It really makes me think of those days, (1800's or so), when medical students and doctors thought it was "okay" to use humans," that aren't exceptable in society," like mentally unstable and criminals for experiments and tests for education. Animals should NOT be used in such a way, they have a innocence and are defenseless against us. There is always other ways to do things!

Posted by: Crista | November 1, 2009 06:13 PM

Gayle,

You said, "All of the quotes that you interpret to evidence the failings of animal models also refer to the failings of in vitro and in silico methods, and one even suggests that the clinical trials themselves are bad predictors. In general, all the FDA and GAO reports attribute the failings to the approval process and the detection methods, not animal models."

The GAO quote provided was "The U.S. Government Accountability Office found that among all new drugs marketed during a 10-year period, 52 percent had seriously toxic or fatal effects that were not predicted by animal experiments."

They mention animal experiments specifically. Whether other methods are productive or not is irrelevant. The GAO is saying that the animal model is not predictive.

The quote I used from Deborah Wilson, M.D. regarding the FDA was, "In August 2004, the Food and Drug Administration announced that only 8 percent of drugs that pass animal tests make it to the marketplace. In other words, a remarkable 92 percent of drugs found to be safe and effective in animals have turned out to be unsafe or ineffective in humans."

Once again the efficacy or lack thereof of other modalities is not at question. This quote relates, as does the GAO quote, explicitly to the failures of animal drug testing.

When Health and Human Services Secretary Mike Leavitt says, "Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies," he's alluding to the fact that animal studies (specifically) and laboratory studies (modalities not specified) are not predictive of drug efficacy and safety in humans.

And yet, Gayle you say, "...animal models aren't always 100%."

100%? They are not even a 50% coin-toss accurate.

Also, who specifically was "the anti-animal model group that concluded animal models predicted drug safety 70-80% accurately" that you quoted earlier?

As far as your statement (rebuttal?), "PET is not really non-invasive (you want radioactive substances injected into your blood)?"

PET is considered non-invasive, as is the common nuclear stress test.

Your parting shot was, "Trying to attribute the failings of medical science to a single model (that you conveniently have ethical issues with) is beyond unreasonable."

The ethical issue is only a sidebar. Dr. Ray Greek had no problem with the ethical issues of animal medical use at the beginning of his career, but now he has plenty due to the paucity of sound science involved in most facets of AR. Sadly, he can't seem to find anyone from the Pro-Test side willing to debate him on CNN.

"In 1996, 108,000 Americans died in hospitals from adverse reactions to FDA-approved drugs properly administered by licensed medical professionals, as reported in the Journal of the American Medical Association. In the same year, 2.2 million Americans had adverse reactions to FDA-approved drugs."

These were all drugs that passed the requisite animal safety tests. Testing drugs on animals to ensure safety for humans is clearly not predictive, thus humans end up being the "guinea pigs" ultimately anyway (sometimes much to their detriment). It would make much more scientific sense to employ human testing right from the get-go using microdosing and other progressive non-animal technologies.

Posted by: Mike Quinoa | November 1, 2009 10:40 PM

'Animal model' is also a cunning,perfect ALIBY for bad researchers so as to be acquitted in case of patient fatal drama. Same story WHY doctors use the Informed Consent.
Read Naked Empress by HANS RUESCH and you'll find many answers to the BAD SCIENCE (ab)using living animals. Some Italian pathologists too admitted Informed Consent as a 'good' escamotage.
Read Empty Cages by Tom Reagan and stunning Preface by Jeffrey Moussaieff Masson).
I met Tom last October in Rome in the occasion of his conference on animal cruel mistreatments in all fields. Awesome !
Be carefully informed and use the knowhow before any health therapy.

Posted by: ANNAMARIA SETTE DE PAOLIS | November 5, 2009 02:53 PM

I was looking through this for some information for a speech I'm giving (not the best source, I know) when I realized how many times the same names popped up. I started reading to see why the name Gayle appeared everywhere and then I realized that you were all just having an argument. I don't want to get into it, but I would like to ask Gayle a question. Why did you ever post anything on here? You should know that the people who post on this website are very much against animal testing and nothing you could ever say would change that. Why even get into it? I'm not here to judge, so I'm not going to give my own opinions on what anyone had to say. I'd just like to assert my own opinion that arguing isn't going to solve anything and only gives headaches to those of us that are trying to be a bit more productive. I apologize if I've offended anyone.

Posted by: Megan | November 18, 2009 07:33 PM

I was looking through this for some information for a speech I'm giving (not the best source, I know) when I realized how many times the same names popped up. I started reading to see why the name Gayle appeared everywhere and then I realized that you were all just having an argument. I don't want to get into it, but I would like to ask Gayle a question. Why did you ever post anything on here? You should know that the people who post on this website are very much against animal testing and nothing you could ever say would change that. Why even get into it? I'm not here to judge, so I'm not going to give my own opinions on what anyone had to say. I'd just like to assert my own opinion that arguing isn't going to solve anything and only gives headaches to those of us that are trying to be a bit more productive. I apologize if I've offended anyone.

Posted by: Megan | November 18, 2009 07:33 PM