A long, long time ago, the Earth was used as a dumping ground by many different alien races. Spacecraft-loads of toxic waste were strewn about the planet. Aluminium was one of the main waste products that was dumped on the Earth.
While it was detrimental to the Earth to be loaded with aluminium, hazards increased dramatically when humans began refining the metal. Fluoride is an extremely toxic by-product of aluminium refining. Since industrialists were unable to safely dispose of fluoride, they called upon the ruling elite's assistance to set their propaganda machine into motion. Before long, university professors, dentists, health officers and many others were espousing the "marvel" of fluoride in reducing dental caries (tooth decay). The propaganda is so effectively spread that it is difficult to find a non-fluoridated tube of toothpaste in most supermarkets. Due to the mass propaganda campaign in support of fluoride, a huge number of communities have fluoridated their water supplies and a vast amount of drinking water now contains the toxin.
Fluoride is no ordinary toxin - it is a highly protected medication (poison). Many who know the truth realize that it would be unlikely for a coroner to report a suspicious death from fluoride poisoning because the ruling elite would not want to alert the public to the fact that fluoride is highly toxic. In fact, fluoride is a very effective rat poison. Hence, it can also kill people. However, non-lethal doses, such as those found in ordinary toothpaste tubes, are often responsible for dental fluorosis or bone fluorosis.
The dental professionals have been targeted for maximum programming to advance the "beneficial" properties of fluoride. They have the propaganda forced upon them during their university training, and they parrot back the "benefits" of fluoride to their patients, who blindly accept that their family dentists would certainly have researched the issue thoroughly before recommending fluoride to them. Those who have seriously examined the "benefits" of fluoride realize that the studies supporting the use of the toxin are at best inconclusive regarding prevention of tooth decay. When pressured, some dentists will admit that fluoride is toxic, but follow this up with a parroted response that while it is poisonous, there is an optimum amount of the poison that is "beneficial" as long as one does not overdose on it.
One concern that dentists do voice is that because children often swallow toothpaste, they should be given small doses for brushing their teeth. Dentists know that if a child swallows too much toothpaste, it can be very dangerous, or even fatal. Surprisingly, this knowledge and these warnings are insufficient to break through the Reptilian propaganda supporting rat poison (sodium fluoride) in water and toothpaste.
One ought to remember that dentists also recommend the use of amalgam fillings to seal dental cavities. Amalgam fillings contain mercury, which is also a deadly poison. Consumers have enough knowledge to realize they should not eat fish that contains mercury, but again, they blindly accept their neighbourhood dentists' recommendations to put the poison into their mouths.
Dentists have become so indoctrinated by the ruling elite's propaganda that they ardently believe and support the "benefits" of fluoride for healthy teeth. The main reason that the malicious propaganda on fluoride is so widely accepted and promoted is the subtle programming behind it. This is not so much a physical programming as it is subliminal. The culprits behind the fluoride conspiracy are the Anunnaki Reptilians.
The Reptilians are a horrible race of aliens that sit atop the Dark hierarchy in the Virtual Reality. One should realize that among Reptilians there is also a hierarchy - they have rulers and subjects amongst them. It is primarily the Anunnaki Elites' agenda to bring in the New World Order and to take total control of the Earth.
The Reptilian programming runs through the occult and other fields to brainwash people in many ways. So, too, it is with the fluoride issue. The ruling elite want people to believe that sodium fluoride is beneficial. This lie is intended to be 100 percent effective. That means that the programming is directed at everyone to accept the benefits of fluoride.
Once a person accepts any form of programming, he or she is subjected to the programming. Since the Reptilians are striving for 100 percent acceptance of fluoride, there is little conflict over the issue. While a small group of people resist the programming, they are not allowed to present their cases to the public. The media has sealed the issue "drum tight" and anti-fluoridationists are not given an opportunity to present their cases. There is no open debate on the issue because to do so would expose the ruling elite's long-standing poisoning plan. The propaganda is so powerful that anti-fluoridationists are scorned, ridiculed, rejected and abused for taking a stance against fluoride.
In contrast to sodium-fluoride programming, consider how the theory of evolution has been presented and widely accepted by academics, who in turn indoctrinate their students in universities throughout the world. Acceptance of the theory of evolution was never intended to be 100 percent effective. The ruling elite has other simultaneous programming that is in total conflict with the acceptance of the theory of evolution. One such programming is the fundamentalist doctrine of creation as it is presented in the Bible. The programmed fundamentalists and the programmed evolutionists were programmed to have conflict and strife, which suits the ruling elite's plans quite nicely. The ruling elite also programmes denominations of religions to be in conflict with one another, and for independent religions to be in conflict with one another. This also allows the ruling elite to manipulate and control by imposing strife upon the people of the Earth.
As many of you might have suspected, the ruling elite have infiltrated and/or taken over the esoteric and occult, including the Freemasons, Rosicrucians, theosophy, metaphysics, astrology, all the major religions of all cultures including Gnosticism etc. Likewise, the ruling elite have sponsored the New Age movement. These seemingly divided groups are headed by those with a single purpose - to control all the inhabitants of the Earth. Sadly, many sincere people in the movements have no idea that they are supporting the ruling elite's plan for a One World Order!
So critical is the acceptance of the brainwashing of fluoride that it is aimed at 100 percent of the population. This unusual type of programming should sound many alarms. Firstly, it shows how effective Reptilian programming is. Secondly, it demonstrates that there can be no free speech on issues that the ruling elite want to seal off. Thirdly, it shows how evil the ruling elite are. Finally, it demonstrates how few people on the planet can think for themselves and resist Reptilian programming.
The recent calls from various governments to impose draconian laws, supposedly to fight terrorism, means that in future anyone who dares speak the truth on important issues such as fluoridation will simply disappear without a trace. This is frightening! When people are totally under the control of draconian regimes, they will be even more robotic than they are now in this robot farm of Virtual Reality.
The Reptilians have only relatively recently (a few hundred years ago) decided to eliminate the human race. To bring this about, they called upon the co-operation of the Greys, who were promised by the Reptilians that their race would be used as the main hominid race on the planet. However, this promise to the Greys was never a genuine one.
Believing that they would become a major force on the Earth, the Greys began performing DNA and genetic manipulation, trying to form hybrids using human and Grey DNA. The Greys are busily perfecting these hybrids, which explains many of the human abductions for experimental purposes. Greys are doing this brutal, surreptitious, unethical work without the consent of their victims. The result is even cruel to the hybrids, who do not really fit in to either the alien or the human societies. However, some hybrids, when they encounter their human or their alien parents, will sometimes be drawn to them, and vice versa. In performing these horrific genetic manipulations, Greys are relying on the false promise from the Reptilians, but the Reptilians will never allow the hybrids to dominate the planet.
Many sceptics mockingly ask, "Where are the aliens?" Little do they know that many aliens are now in human, animal and hybrid bodies.
Now, the Greys on Earth are in great numbers and they are scattered all over the world. Unlike most Reptilians, who live in spacecrafts or on high ground where they employ invisibility techniques, the Greys who are still in alien bodies live under ground.
Owing to living underground over a long period of time, the Greys have developed a peculiar deficiency that mainly affects their sight. Even the hybrids that use Grey DNA are afflicted with this visual malady. Thus, the Greys needed to develop a medication that was readily available throughout the world. The optimum medication they found is sodium fluoride, which is most effective when diluted in minute quantities in drinking water.
"One person's tonic is another's poison." So it is with sodium fluoride. It is extremely harmful to humans, but necessary for the Greys. The effects of long-term consumption of fluoridated water by rats has resulted in structural changes in the neurones of their brains and in their blood vessels. Fluoride has been shown to effectively reduce IQ and is also tied to certain memory disorders. If users of fluoride are malnourished, they age prematurely. Fluoride is also detrimental to spiritual awareness. Interestingly, high concentrations of Greys are found in or near many places where fluoride "naturally" occurs in water.
One dramatic piece of government propaganda states:
Since 1950, opponents of water fluoridation have claimed it increased the risk for cancer, Down syndrome, heart disease, osteoporosis and bone fracture, acquired immunodeficiency syndrome, low intelligence, Alzheimer disease, allergic reactions, and other health conditions. The safety and effectiveness of water fluoridation have been re-evaluated frequently, and no credible evidence supports an association between fluoridation and any of these conditions. (Div of Oral Health, National Center for Chronic Disease Prevention and Health Promotion, CDC; 22 Oct. 99).
The above proclamations are typical of fluoridation proponents. Why do the ruling elite scoff, threaten and ridicule anti-fluoridationists who present real evidence concerning the dangers of fluoride? The medication (sodium fluoride) is forced upon an unsuspecting public under the guise that it reduces tooth decay. Are they really concerned about public health or do they have another agenda?
Perhaps the worst aspect of the fluoride conspiracy is that it is practically permanent pollution. Once clean water is contaminated with sodium fluoride, almost nothing short of distillation will remove it. Distillation is time-consuming, expensive and it leaves water tasteless and lacking in nutrition. So, it is a losing proposition to fight off fluoridation by distilling water.
Even when people avoid the fluoride invasion in their water at home, they face the poison everywhere they turn. It is in cosmetics, soft drinks, prepared foods and just about any food product imaginable.
The Reptilians have an elaborate scheme to convince the Greys by maintaining the illusion of their promise to them through actively programming the world to accept sodium fluoride in drinking water. In reality, the Reptilians are more interested in re-establishing a super race of Reptilians than allowing another alien race like the Greys to have any kind of foothold anywhere.
Since the Reptilians are worried about the mess on Earth and about the proliferation of the Greys, they have come to the conclusion that the Earth must be destroyed to eliminate the huge base of Greys on the planet and hopefully to resolve the many serious problems concerning the Earth. For a long time, the Greys have been subjected to the rule of the Reptilians. But this will not continue much longer. Already, friction has occurred between them because many Greys are suspecting that the Reptilian promise is an empty one. It will not be long before many, if not all, Greys will change sides and support the Vulturites. This will manifest as a shift in politics amongst nations of the world.
As I have discussed in some of my other postings, the Reptilians currently possess the Atu-waa (the device for re-starting time), but the Atu-waa is inoperable and irreparable. For many reasons, the Atu-waa cannot be removed from the Earth at this time. Even though the Earth is an ideal planet for the location of the Atu-waa, the Reptilians are worried about the growing numbers of Greys through the hybrids. No wonder the Reptilians now plan to destroy the Earth and re-locate the Atu-waa if they can re-start time.
The Reptilians have new plans for a new world that can safely house the Atu-waa without the threats from other alien races. These plans will not succeed because the Reptilians will not be able to re-start time.
To break away from any of the enslaving programming in this Virtual Reality, one has to consciously reject the programming. This can be difficult if one is not remotely suspicious of such programming. One has to employ the will of one's True Self to reject the programming. This will enable a person to automatically break any pre-set pattern or programming. To do this, a person needs to keep his or her emotions at a reasonable level so that one can bypass them.
One's will to resist Darkness and Its Dark programming is one's strongest tool to remain in the True Light.
Friday, May 7, 2010
Global Warming - Natural or Artificial
by
Amitakh Stanford
1st June 2004
There has been extensive and often controversial debate about global warming, with some scientists still arguing that it is a myth. However, the evidence of increased air and water temperatures is undeniable - global warming is happening.
The theories that have been brought forward to explain global warming are sometimes in contradiction to one another. Some scientists claim that warming temperatures will bring on a new ice age, while others claim it will bring on a considerably hotter planet. There are some that think the effects of the warming will be minimal and others that think they will be catastrophic. It is quite a spectrum.
The theories for the causes of global warming range from calling it a natural cycling phenomenon to assigning the responsibility of global warming to pollution created by industrialization and population explosion. Again, there is a wide range of speculation on the subject.
Regardless of the causes for global warming, it is a very critical issue at this time. Many people are now starting to take it seriously as they witness the climatic changes around the world and the effects of these changes.
To rationally determine why the Earth is warming, one should first consider whether global warming is natural or artificial. The vast majority of the scientific research starts from the premise that warming is a natural process brought upon by various explainable natural causes. They hypothesize that the Earth's climate goes through cyclical changes just as seasons change, and they seek to explain climatic changes with a theory similar to the one about the orbit and tilt of the Earth being the cause of the seasonal changes. Those who would go outside the conventional paradigm and seek to explain climatic changes for non-physically explainable reasons are scorned for lacking rationality and being airy-fairy.
The majority of scientists considering the issue assume there is a natural cycle of climate for the Earth. They argue that the industrial revolution has contributed greatly to pollution of the land, water and air, which have brought about, among other things, a greenhouse effect from increases in carbon dioxide. This group would argue that global warming could be reversed if people took steps to correct the problem.
However, even if people attempt to mitigate the effects of pollution on the planet, global warming will continue. In fact, if all the humans were taken off the planet tomorrow, global warming would still continue because humans are only partially responsible for it.
The real problem of global warming is artificial and beyond human solutions. It cannot be solved by human efforts in mitigating the effects of pollution because it is an artificial imposition upon the Earth by aliens.
To explain, we must digress back to the days of Lemuria and Atlantis. Both civilizations were highly advanced because they were settled and governed by the Anunnaki. The people of Lemuria and Atlantis were in a constant state of conflict because they were trying to outdo each other technologically, and they were vying for superiority. Both were populated by conquering, cruel Anunnaki beings, and both had earthling slaves.
As the conflict continued, the Atlanteans received great support from off- planet allies, and a blockade was imposed that impeded support traffic for the Lemurians. When the interference of the supply lines became obvious, the Lemurians realized that they would succumb to the more powerful Atlanteans. Hence, they secretly constructed a huge underwater "city" which phonetically sounds like "At-wo-querhe" and many of the elite of Lemuria quietly migrated there with their human slaves.
Eventually, Atlantis attacked and destroyed Lemuria, but the Anunnaki from Atlantis did not know of the secret underwater "city," so they thought that they had totally annihilated the Lemurians.
As discussed in my earlier writings, the Anunnaki Elite thereafter destroyed Atlantis and fled the Earth with most of the highly sophisticated space crafts and technology. The Anunnaki Remnants who were left for dead but survived the destruction of Atlantis are currently controlling the ruling elite of the world.
Before fleeing to At-wo-querhe, the Lemurians "parked" two mother crafts (huge space crafts) in the hills on the continent of Antarctica, where they believed they would escape detection by the Atlanteans. There was not enough time for them to build a structure underwater that was large enough to house the mother crafts.
The Lemurians did not dare try to use the mother crafts for escape because they lacked sufficient fighter support to protect them from the Atlantean allied blockade. Besides, had their enemies spotted the Lemurians' mother crafts, a search would have been made for the underwater civilization, and it would have been destroyed by the Atlanteans. The mother crafts were not discovered by anyone, however, great sheets of ice have formed over the crafts.
At-wo-querhe is surrounded by a gigantic translucent dome. Outside of the dome is water, inside is a gaseous atmosphere. There is a parameter inside the dome that is unoccupied, much like a buffer zone or a frontier. The people living inside the parameter of the domed city live very much like they would on land. These people are beige coloured, flesh-and-blood beings of the same vibrational dimension as earthlings who still live on the surface of the planet. These Anunnaki should not be confused with aliens who have gone underground or beings that are of different vibrational frequencies.
The Lemurians have secretly influenced many things on Earth from At-wo- querhe. They are always watching what is going on above them, but they are careful not to give themselves away. While remaining inconspicuous, the Lemurians, like other groups of Anunnaki, have influenced all the major religions on the surface of the Earth. They have small crafts that are moored in their underwater community which occasionally travel out of the water and into the air and over land.
The Lemurians know that the time for the Earth is short because nobody has re-started "Time," and it is quickly ticking away. The Lemurians know the date when the Earth will end, but they had expected the Anunnaki Elite to return to Earth and re-start the cycle. They also surmised that they would be safe underwater during the "re-start" of Time. However, because the Attas of Light have kept the Anunnaki Elite at bay, the cycle is counting down with no chance of a re-starting.
The Lemurians sense something has altered the Anunnaki plans to keep the Earth in an endless and pointless cycle of re-starts. Therefore, they are taking desperate measures to free their ice-encased mother crafts on Antarctica. They do not know whether the crafts will still function, but their small crafts are inadequate and impractical for deep space travel. It is so desperate that they will risk running a blockade without any support since there is no other chance of their survival. They want to make a rapid exodus from Earth and hope that their mother crafts will function despite years of "hibernation" in the ice.
The Lemurians have constructed a huge microwave device that heats the water deep under the Antarctic seas. It is a device which pulsates with whitish- purplish light. As it rises and falls it superheats the water, which rises in a bubbling fashion and spreads under the ice shelves, causing them to melt. As the ice breaks away from the shelves, the glaciers will be more exposed to the water and air temperatures, which will cause them to melt rapidly. The heated water eventually causes the rise in air temperature around the globe.
The glaciers are like crusts that are covering the mother crafts. These ice crusts are the main targets of the Lemurians because they need to be peeled away if the Lemurians are to flee the Earth before it ceases to exist. The superheated water is dispersing throughout the world's oceans, which is causing havoc by heating the water, air and land to hotter and hotter levels.
The Lemurians are now furiously running the superheater. They are unconcerned about the damage the heated water is causing because they know time is running out and that they must free their mother crafts or they will die on the Earth when it collapses. If all goes according to Lemurian plans, both mother crafts will be visible by the survivors on land. Additionally, their project is causing the production of poisonous gas on the ocean floor that will ultimately kill much of the sea life.
The Lemurian exodus plan is the main cause of the seemingly inexplicable rapid increases in air, land and water temperatures. However, there are other causes such as underwater volcanoes adding to the problem. In addition to the global warming effects brought upon the Earth by the Lemurians desperate attempt to save themselves, other catastrophes are in store for the planet.
Another reason for global warming comes from another Anunnaki group's plans on the surface to overpopulate the Earth to drain resources and for other reasons. It did this primarily by manipulating religions and cultures to encourage large families.
It is said that there are over 6 billion human beings on the planet at this time. That is not accurate. Many of the "people" on the planet are clones who are basically robots although the clones are unaware of this. They are being used to replace many of the human beings. Some are cloned from children, while others are cloned from adults. These clones are then dispersed among the unsuspecting population. In other cases, human victims are kidnapped, then murdered and clones take over their identities. This sounds like science fiction, but it goes on far more often than most could imagine. Many of the clones are in religion, politics, business, education, science, media, entertainment and medicine. This gives the alien cloners a power base to work from. One example is a well-known royal figure who has been replaced by a clone.
There will be three MAJOR cataclysmic events to befall the Earth. The first one will startle many, however, many will survive the first. The second will take out further numbers, but the third one will be horrendous and few will survive it. These will occur because Evil has reached a saturation point and it is back flushing upon itself.
Fireballs appear in the sky;
The sky cries with bloodstained eyes;
While the ocean floors give out poisonous gas,
A smooth, boulder like object is targeted at Alaska;
Many places, including Istanbul, Barcelona and several parts of Italy will be devastated;
Many of the disasters will be artificially created quakes and floods;
Alien shooting wars will be waged in the sky and on the Earth.
Those who respect Truth will be attacked even more openly. The appearance of civility by those of the Shadows will be dropped, revealing their vicious nature for all to see. The separation of the wheat from the chaff is unavoidable, but everyone has been given ample opportunity and the free will to choose where they want to be.
It is not necessary for the people or other beings to have physical knowledge of the separation process or the Message. All classes of Creation, including the animals, plants, minerals etc. are being sorted out. The spirits within all beings understand what is occurring and the respective spirits have made their choices.
The children of the Shadows will continue to mock in vain until the very end. Their scorn is of no consequence.
The Path to Liberation from Darkness is narrow, and few chose to travel it. The Path to Destruction is wide, and many chose it. Each must listen to the small, still voice within them, and not be led like sheep by those who would keep them on the Path to Destruction. Like the story of the fallen angels, the children of the Shadows want to take as many down with them as they can.
The viable ones are those who have chosen the Light. They may suffer a little longer for now, but soon they will be returning to their Pristine Home, where there is Eternal True Love, Joy, Peace and Purity.
Amitakh Stanford
1st June 2004
There has been extensive and often controversial debate about global warming, with some scientists still arguing that it is a myth. However, the evidence of increased air and water temperatures is undeniable - global warming is happening.
The theories that have been brought forward to explain global warming are sometimes in contradiction to one another. Some scientists claim that warming temperatures will bring on a new ice age, while others claim it will bring on a considerably hotter planet. There are some that think the effects of the warming will be minimal and others that think they will be catastrophic. It is quite a spectrum.
The theories for the causes of global warming range from calling it a natural cycling phenomenon to assigning the responsibility of global warming to pollution created by industrialization and population explosion. Again, there is a wide range of speculation on the subject.
Regardless of the causes for global warming, it is a very critical issue at this time. Many people are now starting to take it seriously as they witness the climatic changes around the world and the effects of these changes.
To rationally determine why the Earth is warming, one should first consider whether global warming is natural or artificial. The vast majority of the scientific research starts from the premise that warming is a natural process brought upon by various explainable natural causes. They hypothesize that the Earth's climate goes through cyclical changes just as seasons change, and they seek to explain climatic changes with a theory similar to the one about the orbit and tilt of the Earth being the cause of the seasonal changes. Those who would go outside the conventional paradigm and seek to explain climatic changes for non-physically explainable reasons are scorned for lacking rationality and being airy-fairy.
The majority of scientists considering the issue assume there is a natural cycle of climate for the Earth. They argue that the industrial revolution has contributed greatly to pollution of the land, water and air, which have brought about, among other things, a greenhouse effect from increases in carbon dioxide. This group would argue that global warming could be reversed if people took steps to correct the problem.
However, even if people attempt to mitigate the effects of pollution on the planet, global warming will continue. In fact, if all the humans were taken off the planet tomorrow, global warming would still continue because humans are only partially responsible for it.
The real problem of global warming is artificial and beyond human solutions. It cannot be solved by human efforts in mitigating the effects of pollution because it is an artificial imposition upon the Earth by aliens.
To explain, we must digress back to the days of Lemuria and Atlantis. Both civilizations were highly advanced because they were settled and governed by the Anunnaki. The people of Lemuria and Atlantis were in a constant state of conflict because they were trying to outdo each other technologically, and they were vying for superiority. Both were populated by conquering, cruel Anunnaki beings, and both had earthling slaves.
As the conflict continued, the Atlanteans received great support from off- planet allies, and a blockade was imposed that impeded support traffic for the Lemurians. When the interference of the supply lines became obvious, the Lemurians realized that they would succumb to the more powerful Atlanteans. Hence, they secretly constructed a huge underwater "city" which phonetically sounds like "At-wo-querhe" and many of the elite of Lemuria quietly migrated there with their human slaves.
Eventually, Atlantis attacked and destroyed Lemuria, but the Anunnaki from Atlantis did not know of the secret underwater "city," so they thought that they had totally annihilated the Lemurians.
As discussed in my earlier writings, the Anunnaki Elite thereafter destroyed Atlantis and fled the Earth with most of the highly sophisticated space crafts and technology. The Anunnaki Remnants who were left for dead but survived the destruction of Atlantis are currently controlling the ruling elite of the world.
Before fleeing to At-wo-querhe, the Lemurians "parked" two mother crafts (huge space crafts) in the hills on the continent of Antarctica, where they believed they would escape detection by the Atlanteans. There was not enough time for them to build a structure underwater that was large enough to house the mother crafts.
The Lemurians did not dare try to use the mother crafts for escape because they lacked sufficient fighter support to protect them from the Atlantean allied blockade. Besides, had their enemies spotted the Lemurians' mother crafts, a search would have been made for the underwater civilization, and it would have been destroyed by the Atlanteans. The mother crafts were not discovered by anyone, however, great sheets of ice have formed over the crafts.
At-wo-querhe is surrounded by a gigantic translucent dome. Outside of the dome is water, inside is a gaseous atmosphere. There is a parameter inside the dome that is unoccupied, much like a buffer zone or a frontier. The people living inside the parameter of the domed city live very much like they would on land. These people are beige coloured, flesh-and-blood beings of the same vibrational dimension as earthlings who still live on the surface of the planet. These Anunnaki should not be confused with aliens who have gone underground or beings that are of different vibrational frequencies.
The Lemurians have secretly influenced many things on Earth from At-wo- querhe. They are always watching what is going on above them, but they are careful not to give themselves away. While remaining inconspicuous, the Lemurians, like other groups of Anunnaki, have influenced all the major religions on the surface of the Earth. They have small crafts that are moored in their underwater community which occasionally travel out of the water and into the air and over land.
The Lemurians know that the time for the Earth is short because nobody has re-started "Time," and it is quickly ticking away. The Lemurians know the date when the Earth will end, but they had expected the Anunnaki Elite to return to Earth and re-start the cycle. They also surmised that they would be safe underwater during the "re-start" of Time. However, because the Attas of Light have kept the Anunnaki Elite at bay, the cycle is counting down with no chance of a re-starting.
The Lemurians sense something has altered the Anunnaki plans to keep the Earth in an endless and pointless cycle of re-starts. Therefore, they are taking desperate measures to free their ice-encased mother crafts on Antarctica. They do not know whether the crafts will still function, but their small crafts are inadequate and impractical for deep space travel. It is so desperate that they will risk running a blockade without any support since there is no other chance of their survival. They want to make a rapid exodus from Earth and hope that their mother crafts will function despite years of "hibernation" in the ice.
The Lemurians have constructed a huge microwave device that heats the water deep under the Antarctic seas. It is a device which pulsates with whitish- purplish light. As it rises and falls it superheats the water, which rises in a bubbling fashion and spreads under the ice shelves, causing them to melt. As the ice breaks away from the shelves, the glaciers will be more exposed to the water and air temperatures, which will cause them to melt rapidly. The heated water eventually causes the rise in air temperature around the globe.
The glaciers are like crusts that are covering the mother crafts. These ice crusts are the main targets of the Lemurians because they need to be peeled away if the Lemurians are to flee the Earth before it ceases to exist. The superheated water is dispersing throughout the world's oceans, which is causing havoc by heating the water, air and land to hotter and hotter levels.
The Lemurians are now furiously running the superheater. They are unconcerned about the damage the heated water is causing because they know time is running out and that they must free their mother crafts or they will die on the Earth when it collapses. If all goes according to Lemurian plans, both mother crafts will be visible by the survivors on land. Additionally, their project is causing the production of poisonous gas on the ocean floor that will ultimately kill much of the sea life.
The Lemurian exodus plan is the main cause of the seemingly inexplicable rapid increases in air, land and water temperatures. However, there are other causes such as underwater volcanoes adding to the problem. In addition to the global warming effects brought upon the Earth by the Lemurians desperate attempt to save themselves, other catastrophes are in store for the planet.
Another reason for global warming comes from another Anunnaki group's plans on the surface to overpopulate the Earth to drain resources and for other reasons. It did this primarily by manipulating religions and cultures to encourage large families.
It is said that there are over 6 billion human beings on the planet at this time. That is not accurate. Many of the "people" on the planet are clones who are basically robots although the clones are unaware of this. They are being used to replace many of the human beings. Some are cloned from children, while others are cloned from adults. These clones are then dispersed among the unsuspecting population. In other cases, human victims are kidnapped, then murdered and clones take over their identities. This sounds like science fiction, but it goes on far more often than most could imagine. Many of the clones are in religion, politics, business, education, science, media, entertainment and medicine. This gives the alien cloners a power base to work from. One example is a well-known royal figure who has been replaced by a clone.
There will be three MAJOR cataclysmic events to befall the Earth. The first one will startle many, however, many will survive the first. The second will take out further numbers, but the third one will be horrendous and few will survive it. These will occur because Evil has reached a saturation point and it is back flushing upon itself.
Fireballs appear in the sky;
The sky cries with bloodstained eyes;
While the ocean floors give out poisonous gas,
A smooth, boulder like object is targeted at Alaska;
Many places, including Istanbul, Barcelona and several parts of Italy will be devastated;
Many of the disasters will be artificially created quakes and floods;
Alien shooting wars will be waged in the sky and on the Earth.
Those who respect Truth will be attacked even more openly. The appearance of civility by those of the Shadows will be dropped, revealing their vicious nature for all to see. The separation of the wheat from the chaff is unavoidable, but everyone has been given ample opportunity and the free will to choose where they want to be.
It is not necessary for the people or other beings to have physical knowledge of the separation process or the Message. All classes of Creation, including the animals, plants, minerals etc. are being sorted out. The spirits within all beings understand what is occurring and the respective spirits have made their choices.
The children of the Shadows will continue to mock in vain until the very end. Their scorn is of no consequence.
The Path to Liberation from Darkness is narrow, and few chose to travel it. The Path to Destruction is wide, and many chose it. Each must listen to the small, still voice within them, and not be led like sheep by those who would keep them on the Path to Destruction. Like the story of the fallen angels, the children of the Shadows want to take as many down with them as they can.
The viable ones are those who have chosen the Light. They may suffer a little longer for now, but soon they will be returning to their Pristine Home, where there is Eternal True Love, Joy, Peace and Purity.
Fairies and Pixies
Fairies and Pixies
by
Thomas, P.E.
(republished from Xee-A Magazine)
Fairies and pixies are the typical inhabitants of a very different world akin to a parallel universe where they abode amidst gardens and fields, forests and mountains, rivers and seas and indeed practically anywhere they fancy. Pixies are really just another species of fairies who reside in the fairyland.
Fairyland, where pixies, gnomes, leprechauns, fairies and others of the like dwell is a "magical" place where things are simply magical and where time passes at a different pace than the human physical realm. The inhabitants of Fairyland can manifest as whirlwinds, dust storms, rainstorms, or breezes, etc. when they visit the human realm. The Australians of the aboriginal tribe of Dieri believe that the sudden whirling dust in the Australian bush are the playful act of marching armies of fairies known to them as Kutchi.
Every culture on earth has its own fairy tales. Some fairies are good while others are not. Thus, good and evil also exists in the realm of the fairies.
The best-known pixie-fairy of the Never-Never land has got to be one who was known as Currah. He presents himself as Sir Gaylord Thomas to the humans whenever he needs to make an appearance in the physical realm of humans.
Currah is a happy, fun-loving, kind pixie who is a bit like the human's legendary Robin Hood. Currah is good and helpful to well-intended humans, animals and plants but will deal harshly but justly with the black-hearted ones. He loves playing pranks at time but he is never vindictive or irresponsible with his playful tricks. In this world of unjust karma, Currah is like a gallant white knight who helps and comforts good humans/animals and other beings who are in distress.
Currah's only sweetheart was a beautiful, and equally playful pixie named Tarayakee. She now incarnates as an English "rose" in the United Kingdom. Fairies, angels and even the "gods" incarnate as humans from time to time. The argument that angels do not incarnate as humans is false.
Currah is as well known for his kindness and valour as he is for his "mischievous" tricks on the scoundrels of this world. People claim that the legendary Currah sprinkles laughter, joy and happiness wherever he scoots about. Sometimes he rings "bells" when he visits. So be ever alert to the mysterious signals that mark his presence.
by
Thomas, P.E.
(republished from Xee-A Magazine)
Fairies and pixies are the typical inhabitants of a very different world akin to a parallel universe where they abode amidst gardens and fields, forests and mountains, rivers and seas and indeed practically anywhere they fancy. Pixies are really just another species of fairies who reside in the fairyland.
Fairyland, where pixies, gnomes, leprechauns, fairies and others of the like dwell is a "magical" place where things are simply magical and where time passes at a different pace than the human physical realm. The inhabitants of Fairyland can manifest as whirlwinds, dust storms, rainstorms, or breezes, etc. when they visit the human realm. The Australians of the aboriginal tribe of Dieri believe that the sudden whirling dust in the Australian bush are the playful act of marching armies of fairies known to them as Kutchi.
Every culture on earth has its own fairy tales. Some fairies are good while others are not. Thus, good and evil also exists in the realm of the fairies.
The best-known pixie-fairy of the Never-Never land has got to be one who was known as Currah. He presents himself as Sir Gaylord Thomas to the humans whenever he needs to make an appearance in the physical realm of humans.
Currah is a happy, fun-loving, kind pixie who is a bit like the human's legendary Robin Hood. Currah is good and helpful to well-intended humans, animals and plants but will deal harshly but justly with the black-hearted ones. He loves playing pranks at time but he is never vindictive or irresponsible with his playful tricks. In this world of unjust karma, Currah is like a gallant white knight who helps and comforts good humans/animals and other beings who are in distress.
Currah's only sweetheart was a beautiful, and equally playful pixie named Tarayakee. She now incarnates as an English "rose" in the United Kingdom. Fairies, angels and even the "gods" incarnate as humans from time to time. The argument that angels do not incarnate as humans is false.
Currah is as well known for his kindness and valour as he is for his "mischievous" tricks on the scoundrels of this world. People claim that the legendary Currah sprinkles laughter, joy and happiness wherever he scoots about. Sometimes he rings "bells" when he visits. So be ever alert to the mysterious signals that mark his presence.
Fairies and Pixies
Fairies and Pixies
by
Thomas, P.E.
(republished from Xee-A Magazine)
Fairies and pixies are the typical inhabitants of a very different world akin to a parallel universe where they abode amidst gardens and fields, forests and mountains, rivers and seas and indeed practically anywhere they fancy. Pixies are really just another species of fairies who reside in the fairyland.
Fairyland, where pixies, gnomes, leprechauns, fairies and others of the like dwell is a "magical" place where things are simply magical and where time passes at a different pace than the human physical realm. The inhabitants of Fairyland can manifest as whirlwinds, dust storms, rainstorms, or breezes, etc. when they visit the human realm. The Australians of the aboriginal tribe of Dieri believe that the sudden whirling dust in the Australian bush are the playful act of marching armies of fairies known to them as Kutchi.
Every culture on earth has its own fairy tales. Some fairies are good while others are not. Thus, good and evil also exists in the realm of the fairies.
The best-known pixie-fairy of the Never-Never land has got to be one who was known as Currah. He presents himself as Sir Gaylord Thomas to the humans whenever he needs to make an appearance in the physical realm of humans.
Currah is a happy, fun-loving, kind pixie who is a bit like the human's legendary Robin Hood. Currah is good and helpful to well-intended humans, animals and plants but will deal harshly but justly with the black-hearted ones. He loves playing pranks at time but he is never vindictive or irresponsible with his playful tricks. In this world of unjust karma, Currah is like a gallant white knight who helps and comforts good humans/animals and other beings who are in distress.
Currah's only sweetheart was a beautiful, and equally playful pixie named Tarayakee. She now incarnates as an English "rose" in the United Kingdom. Fairies, angels and even the "gods" incarnate as humans from time to time. The argument that angels do not incarnate as humans is false.
Currah is as well known for his kindness and valour as he is for his "mischievous" tricks on the scoundrels of this world. People claim that the legendary Currah sprinkles laughter, joy and happiness wherever he scoots about. Sometimes he rings "bells" when he visits. So be ever alert to the mysterious signals that mark his presence.
by
Thomas, P.E.
(republished from Xee-A Magazine)
Fairies and pixies are the typical inhabitants of a very different world akin to a parallel universe where they abode amidst gardens and fields, forests and mountains, rivers and seas and indeed practically anywhere they fancy. Pixies are really just another species of fairies who reside in the fairyland.
Fairyland, where pixies, gnomes, leprechauns, fairies and others of the like dwell is a "magical" place where things are simply magical and where time passes at a different pace than the human physical realm. The inhabitants of Fairyland can manifest as whirlwinds, dust storms, rainstorms, or breezes, etc. when they visit the human realm. The Australians of the aboriginal tribe of Dieri believe that the sudden whirling dust in the Australian bush are the playful act of marching armies of fairies known to them as Kutchi.
Every culture on earth has its own fairy tales. Some fairies are good while others are not. Thus, good and evil also exists in the realm of the fairies.
The best-known pixie-fairy of the Never-Never land has got to be one who was known as Currah. He presents himself as Sir Gaylord Thomas to the humans whenever he needs to make an appearance in the physical realm of humans.
Currah is a happy, fun-loving, kind pixie who is a bit like the human's legendary Robin Hood. Currah is good and helpful to well-intended humans, animals and plants but will deal harshly but justly with the black-hearted ones. He loves playing pranks at time but he is never vindictive or irresponsible with his playful tricks. In this world of unjust karma, Currah is like a gallant white knight who helps and comforts good humans/animals and other beings who are in distress.
Currah's only sweetheart was a beautiful, and equally playful pixie named Tarayakee. She now incarnates as an English "rose" in the United Kingdom. Fairies, angels and even the "gods" incarnate as humans from time to time. The argument that angels do not incarnate as humans is false.
Currah is as well known for his kindness and valour as he is for his "mischievous" tricks on the scoundrels of this world. People claim that the legendary Currah sprinkles laughter, joy and happiness wherever he scoots about. Sometimes he rings "bells" when he visits. So be ever alert to the mysterious signals that mark his presence.
Thursday, May 6, 2010
AGAINST ANIMAL TESTING FROM A MEDICAL AND SCIENTIFIC PERSPECTIVE
>En Espanol
The most commonly held perception regarding animal experimentation is that it is necessary for the development of vaccines, cures and treatments for human illness. Proponents ask the important question, what will happen to research on AIDS, heart disease, and cancer if animal experimentation is completely stopped? Will the progress in cures and treatments for these types of illnesses also come to a halt?
There is a growing movement of health care professionals including doctors, scientists, and
educated members of the public who are opposed to non-human animal based experimentation on specifically medical and scientific grounds. They argue that animal research is based on a false premise, that results obtained through animal experimentation can be applied to the human body.
I have studied the question of vivisection for thirty-five years and am convinced that experiments on living animals are leading medicine further and further from the real cure of the patient. I know of no instance of animal experiment that has been necessary for the advancement of medical science; still less do I know of any animal experiment that could conceivably be necessary to save human life. -H. Fergie Woods, M.D.
Animals not only react differently than humans to different drugs, vaccines, and experiments, they also react differently from one another. Ignoring this difference has been and continues to be very costly to human health.
The most famous example of the dangers of animal testing is the Thalidomide tragedy of the 1960s and 1970s. Thalidomide, which came out on the German market late in the 1950s, had previously been safety tested on thousands of animals. It was marketed as a wonderful sedative for pregnant or breastfeeding mothers and it supposedly caused no harm to either mother or child. Despite this "safety testing", at least 10,000 children whose mothers had taken Thalidomide were born throughout the world with severe deformities.
Clioquinol is another example of a drug that was safety tested in animals and had a severely negative impact on humans. This drug, manufactured in Japan in the 1970s, was marketed as providing safe relief from diarrhea. Not only did Clioquinol not work in humans, it actually caused diarrhea. As a result of Clioquinol being administered to the public, some 30,000 cases of blindness and/or paralysis and thousands of deaths occurred.
"Giving cancer to laboratory animals has not and will not help us to understand the disease or to treat those persons suffering from it." - Dr. A. Sabin, 1986, developer of the oral polio vaccine
Are these two examples just isolated cases? Even though pharmaceuticals are routinely tested on animals, the Journal of the American Medical Association reported that 100,000 people every year are killed by prescription drugs and more than 2 million are hospitalized as a result of prescription drugs. The British Medical Journal recently reported that 4 out of every 10 patients who take a prescribed drug can expect to suffer severe or noticeable side effects, while numerous clinical observers agree that the incidence of iatrogenesis (medically induced disease) is now so great that approximately 1 in every 10 hospital beds is occupied by a patient who has been made ill by their doctor.
What about all the important breakthroughs, as a result of animal research, that have aided human health? The animal research industry cites many examples of treatments or cures for illness that have been found using animals. They claim that if animal research is discontinued, it will be at the expense of human health and life. Industry groups, such as Americans for Medical Progress credit animal research with advances such as the development of the polio vaccine, anesthesia, and the discovery of insulin. But a close examination of medical history clearly disputes these claims.
There are no alternatives to animal experimentation, for one can only talk of alternatives if these replace something of the same worth; and there is nothing quite as useless, misleading and harmful as animal experimentation. -Prof. Pietro Croce, M.D.
Dr. Jonas Salk and Dr. Albert Sabin, are credited with the development of a vaccine to combat poliomyelitis (polio). Yet in the medical industry itself there remains a dispute as to the means by which the development of the polio vaccine occurred and whether or not the vaccine even played a major role in stopping the virus. Dr. John Enders, Dr. Thomas H. Weller, and Dr. Frederick C. Robbins won the Nobel Prize in 1954 for proving for the first time that it was possible to grow poliovirus in laboratory cultures of non-nervous-system human tissue. This team stopped just short of creating the polio vaccine that would be released to the public. Around the time Enders, Weller, and Robbins won the Nobel Prize, Sabin and Salk began using monkey kidney cells to produce their polio vaccines despite the existence of better alternatives. It was unknown at the time that viruses commonly found in monkey kidney cells are now known to cause cancer in humans.
The claim that the polio vaccine was developed through the use of animal experimentation is misleading. Furthermore, as far as the benefits are concerned, there is ample evidence demonstrating the harmful effects the polio vaccine has had on human health. Deborah Blum, in her 1984 book, The Monkey Wars, wrote, "In the late 1980s, scientists tracking the life histories of 59,000 pregnant women all vaccinated with Salk polio vaccine found that their offspring had a thirteen times higher rate of brain tumors than those who did not receive the vaccine." (pg. 229) Many historians believe that the decline in cases in polio, like many epidemics of the past, must be attributed to factors such as improved hygiene and not solely vaccination.
Surgical anesthesia was discovered in the mid nineteenth century when Crawford Williamson Long observed the effects of ether on humans during "ether parties", a popular form of entertainment involving ether inhalation. Long observed that while etherized, people appeared impervious to pain. He transformed this observation into a more practical use in surgery. The discovery of anesthesia, like many other medical discoveries, came from the critical observation of humans.
At one time, due to the animal research based conclusions of Claude Bernard, diabetes was believed to be cause by liver damage. However, Thomas Crawley, in 1788 established the relationship between pancreatic damage and diabetes by performing autopsies on diabetic cadavers. Later on, Dr. M. Barron came to the conclusion that damage to the Islets of Langerhans causes diabetes in humans after studying the human pancreas. He concluded that insulin could be derived from an extract of the Islets of Langerhans. Then in 1920, Frederick Banting, using this knowledge, created the first extract that contained insulin.
Indeed, while conflicting animal tests have often delayed and hampered advances on the war on cancer, they have never produced a single substantial advance either in the prevention or treatment of human cancer. -Dr. Irwin Bros, director of Roswell Park Memorial
Animal research is not aiding the fight against cancer. In fact, it is diverting resources from
effective research and from the most obvious solution which is prevention. According to the National Cancer Institute, 80% of all cancers are preventable. Clinical observation and epidemiological studies have shown us that high fat diets, smoking, environmental pollutants, and other lifestyle factors are the main causes of cancer.
Animals are not good models for human cancer for 2 fundamental reasons:
1. Animals and humans do not get the same diseases. As a result, animal research focuses on artificially inducing symptoms of human cancer and attempting to treat those symptoms.
2. Experimental drugs and treatments that have been found effective on animal models will not necessarily work in people.
Moneim A. Fadali, M.D., in his book, Animal Experimentation: A Harvest of Shame, reports:
"Despite screening over half a million compounds as anti-cancer agents on laboratory animals between 1970-1985, only 80 compounds moved into clinical trials on humans. Of these, a mere 24 had any anti-cancer activity and only 12 appeared to have a 'substantial clinical role.' Actually, these so-called 'new' active agents were not so new: they are analogs of chemotherapeutic agents already known to work in humans." (pg.25)
With billions of dollars, countless animals, and well over 30 years spent on the war on cancer, concrete results should have been seen if animal research was actually working. On the contrary, the incidence of cancer continues to rise.
The progress that has been made in the study of AIDS has come from human clinical investigation and in vitro (cell and tissue culture) research. Animal models continue to be used even though they do not develop the human AIDS virus. The development of life saving protease inhibitors was delayed by misleading monkey data. Referring to efforts to develop an AIDS vaccine, leading AIDS researcher Dr. Mark Feinberg stated: "What good does it do you to test something in a monkey? You find five or six years from now that it works in the monkey, and then you test it in humans and you realize that humans behave totally differently from monkeys, so you've wasted five years".
Clearly, if we are going to make medical progress, a new approach is needed. Human medicine can no longer be based on veterinary medicine. It is fraudulent and dangerous to apply data from one species to another. There are endless examples of the differences between humans and non-human animals.
* PCP is a sedative for chimps
* Penicillin kills cats and guinea pigs but has saved many human lives.
* Arsenic is not poisonous to rats, mice, or sheep.
* Morphine is a sedative for humans but is a stimulant for cats, goats, and horses.
* Digitalis while dangerously raising blood pressure in dogs continues to save countless cardiac patients by lowering heart rate.
The National Institutes of Health alone pours well over five billion dollars annually into superfluous
animal experimentation. Abolishing animal research will mean these resources could be redirected into prevention and the types of research which actually have a chance of advancing human medicine and human health.
Animal experiments confuse the issues and their results will never have scientific precision. There is absolutely no connection between vivisection and human health. The general belief in the value of animal experimentation is the result of brainwashing that the public has been submitted to for a long time. Behind it are the pharmaceutical industries, which spend fortunes on publicity and finance the research institutes and the universities. -Arie Brecher, M.D.
NO CURES IN 45 YEARS
SHUT DOWN THE OHSU/OREGON PRIMATE CENTER
www.ohsukillsprimates.com
COALITION TO ABOLISH ANIMAL TESTING (CAAT)
mail@caatinfo.org
P.O. BOX 6716, PORTLAND, OR 97228
(503) 972-CAAT
>En Espanol
The most commonly held perception regarding animal experimentation is that it is necessary for the development of vaccines, cures and treatments for human illness. Proponents ask the important question, what will happen to research on AIDS, heart disease, and cancer if animal experimentation is completely stopped? Will the progress in cures and treatments for these types of illnesses also come to a halt?
There is a growing movement of health care professionals including doctors, scientists, and
educated members of the public who are opposed to non-human animal based experimentation on specifically medical and scientific grounds. They argue that animal research is based on a false premise, that results obtained through animal experimentation can be applied to the human body.
I have studied the question of vivisection for thirty-five years and am convinced that experiments on living animals are leading medicine further and further from the real cure of the patient. I know of no instance of animal experiment that has been necessary for the advancement of medical science; still less do I know of any animal experiment that could conceivably be necessary to save human life. -H. Fergie Woods, M.D.
Animals not only react differently than humans to different drugs, vaccines, and experiments, they also react differently from one another. Ignoring this difference has been and continues to be very costly to human health.
The most famous example of the dangers of animal testing is the Thalidomide tragedy of the 1960s and 1970s. Thalidomide, which came out on the German market late in the 1950s, had previously been safety tested on thousands of animals. It was marketed as a wonderful sedative for pregnant or breastfeeding mothers and it supposedly caused no harm to either mother or child. Despite this "safety testing", at least 10,000 children whose mothers had taken Thalidomide were born throughout the world with severe deformities.
Clioquinol is another example of a drug that was safety tested in animals and had a severely negative impact on humans. This drug, manufactured in Japan in the 1970s, was marketed as providing safe relief from diarrhea. Not only did Clioquinol not work in humans, it actually caused diarrhea. As a result of Clioquinol being administered to the public, some 30,000 cases of blindness and/or paralysis and thousands of deaths occurred.
"Giving cancer to laboratory animals has not and will not help us to understand the disease or to treat those persons suffering from it." - Dr. A. Sabin, 1986, developer of the oral polio vaccine
Are these two examples just isolated cases? Even though pharmaceuticals are routinely tested on animals, the Journal of the American Medical Association reported that 100,000 people every year are killed by prescription drugs and more than 2 million are hospitalized as a result of prescription drugs. The British Medical Journal recently reported that 4 out of every 10 patients who take a prescribed drug can expect to suffer severe or noticeable side effects, while numerous clinical observers agree that the incidence of iatrogenesis (medically induced disease) is now so great that approximately 1 in every 10 hospital beds is occupied by a patient who has been made ill by their doctor.
What about all the important breakthroughs, as a result of animal research, that have aided human health? The animal research industry cites many examples of treatments or cures for illness that have been found using animals. They claim that if animal research is discontinued, it will be at the expense of human health and life. Industry groups, such as Americans for Medical Progress credit animal research with advances such as the development of the polio vaccine, anesthesia, and the discovery of insulin. But a close examination of medical history clearly disputes these claims.
There are no alternatives to animal experimentation, for one can only talk of alternatives if these replace something of the same worth; and there is nothing quite as useless, misleading and harmful as animal experimentation. -Prof. Pietro Croce, M.D.
Dr. Jonas Salk and Dr. Albert Sabin, are credited with the development of a vaccine to combat poliomyelitis (polio). Yet in the medical industry itself there remains a dispute as to the means by which the development of the polio vaccine occurred and whether or not the vaccine even played a major role in stopping the virus. Dr. John Enders, Dr. Thomas H. Weller, and Dr. Frederick C. Robbins won the Nobel Prize in 1954 for proving for the first time that it was possible to grow poliovirus in laboratory cultures of non-nervous-system human tissue. This team stopped just short of creating the polio vaccine that would be released to the public. Around the time Enders, Weller, and Robbins won the Nobel Prize, Sabin and Salk began using monkey kidney cells to produce their polio vaccines despite the existence of better alternatives. It was unknown at the time that viruses commonly found in monkey kidney cells are now known to cause cancer in humans.
The claim that the polio vaccine was developed through the use of animal experimentation is misleading. Furthermore, as far as the benefits are concerned, there is ample evidence demonstrating the harmful effects the polio vaccine has had on human health. Deborah Blum, in her 1984 book, The Monkey Wars, wrote, "In the late 1980s, scientists tracking the life histories of 59,000 pregnant women all vaccinated with Salk polio vaccine found that their offspring had a thirteen times higher rate of brain tumors than those who did not receive the vaccine." (pg. 229) Many historians believe that the decline in cases in polio, like many epidemics of the past, must be attributed to factors such as improved hygiene and not solely vaccination.
Surgical anesthesia was discovered in the mid nineteenth century when Crawford Williamson Long observed the effects of ether on humans during "ether parties", a popular form of entertainment involving ether inhalation. Long observed that while etherized, people appeared impervious to pain. He transformed this observation into a more practical use in surgery. The discovery of anesthesia, like many other medical discoveries, came from the critical observation of humans.
At one time, due to the animal research based conclusions of Claude Bernard, diabetes was believed to be cause by liver damage. However, Thomas Crawley, in 1788 established the relationship between pancreatic damage and diabetes by performing autopsies on diabetic cadavers. Later on, Dr. M. Barron came to the conclusion that damage to the Islets of Langerhans causes diabetes in humans after studying the human pancreas. He concluded that insulin could be derived from an extract of the Islets of Langerhans. Then in 1920, Frederick Banting, using this knowledge, created the first extract that contained insulin.
Indeed, while conflicting animal tests have often delayed and hampered advances on the war on cancer, they have never produced a single substantial advance either in the prevention or treatment of human cancer. -Dr. Irwin Bros, director of Roswell Park Memorial
Animal research is not aiding the fight against cancer. In fact, it is diverting resources from
effective research and from the most obvious solution which is prevention. According to the National Cancer Institute, 80% of all cancers are preventable. Clinical observation and epidemiological studies have shown us that high fat diets, smoking, environmental pollutants, and other lifestyle factors are the main causes of cancer.
Animals are not good models for human cancer for 2 fundamental reasons:
1. Animals and humans do not get the same diseases. As a result, animal research focuses on artificially inducing symptoms of human cancer and attempting to treat those symptoms.
2. Experimental drugs and treatments that have been found effective on animal models will not necessarily work in people.
Moneim A. Fadali, M.D., in his book, Animal Experimentation: A Harvest of Shame, reports:
"Despite screening over half a million compounds as anti-cancer agents on laboratory animals between 1970-1985, only 80 compounds moved into clinical trials on humans. Of these, a mere 24 had any anti-cancer activity and only 12 appeared to have a 'substantial clinical role.' Actually, these so-called 'new' active agents were not so new: they are analogs of chemotherapeutic agents already known to work in humans." (pg.25)
With billions of dollars, countless animals, and well over 30 years spent on the war on cancer, concrete results should have been seen if animal research was actually working. On the contrary, the incidence of cancer continues to rise.
The progress that has been made in the study of AIDS has come from human clinical investigation and in vitro (cell and tissue culture) research. Animal models continue to be used even though they do not develop the human AIDS virus. The development of life saving protease inhibitors was delayed by misleading monkey data. Referring to efforts to develop an AIDS vaccine, leading AIDS researcher Dr. Mark Feinberg stated: "What good does it do you to test something in a monkey? You find five or six years from now that it works in the monkey, and then you test it in humans and you realize that humans behave totally differently from monkeys, so you've wasted five years".
Clearly, if we are going to make medical progress, a new approach is needed. Human medicine can no longer be based on veterinary medicine. It is fraudulent and dangerous to apply data from one species to another. There are endless examples of the differences between humans and non-human animals.
* PCP is a sedative for chimps
* Penicillin kills cats and guinea pigs but has saved many human lives.
* Arsenic is not poisonous to rats, mice, or sheep.
* Morphine is a sedative for humans but is a stimulant for cats, goats, and horses.
* Digitalis while dangerously raising blood pressure in dogs continues to save countless cardiac patients by lowering heart rate.
The National Institutes of Health alone pours well over five billion dollars annually into superfluous
animal experimentation. Abolishing animal research will mean these resources could be redirected into prevention and the types of research which actually have a chance of advancing human medicine and human health.
Animal experiments confuse the issues and their results will never have scientific precision. There is absolutely no connection between vivisection and human health. The general belief in the value of animal experimentation is the result of brainwashing that the public has been submitted to for a long time. Behind it are the pharmaceutical industries, which spend fortunes on publicity and finance the research institutes and the universities. -Arie Brecher, M.D.
NO CURES IN 45 YEARS
SHUT DOWN THE OHSU/OREGON PRIMATE CENTER
www.ohsukillsprimates.com
COALITION TO ABOLISH ANIMAL TESTING (CAAT)
mail@caatinfo.org
P.O. BOX 6716, PORTLAND, OR 97228
(503) 972-CAAT
Rules and Regulations
Federal Laws, Regulations and Guidelines Governing Biomedical Research Using Animals
When animals are used in biomedical research, the following laws, regulations and guidelines govern their care:
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.
A set of principles that underlie current federal regulations was developed in 1984 by representatives from all federal agencies that use or fund biomedical research. These include requirements that:
* procedures involving animals be relevant to human or animal health
* the minimum number of animals be used to obtain valid results
* alternatives to animals be considered
* animal pain or distress be avoided or minimized
* living conditions for animals be appropriate for their species
* research scientists and those caring for the animals be properly trained and qualified
These requirements are sometimes summarized as the 3R's:
1. Reduction-using the minimum number of animals necessary.
2. Refinement-enhancing animal welfare and ensuring the best conditions possible.
3. Replacement-using other models when appropriate.
Animal Welfare Act (AWA)
The Animal Welfare Act sets federal standards for all aspects of care for laboratory animals. It was enacted into law in 1966 and has been amended by the U.S. Congress several times. The act applies to all public and private research facilities in this country.
USDA licensing, reporting and inspection requirements: All research facilities covered by the law must be registered with the USDA and comply with the USDA animal welfare regulations. Each facility must report to the USDA each year verifying compliance and indicating the number and species of animals used. The USDA is required to inspect each facility at least once a year, unannounced, to ensure compliance with these standards. More frequent unscheduled inspections are made if significant deficiencies are identified. If the USDA inspectors find violations of any part of the act, they will allow the facility a limited time to correct them. If the violations are not corrected, the USDA can fine the institution or close the facility.
Institutional Animal Care and Use Committee: The 1985 amendments to the AWA required all research facilities using animals to establish an Institutional Animal Care and Use Committee (IACUC). The committee ensures that applicable federal, state, and local laws and regulations are met, reviews and approves procedures involving animals before they take place, and inspects facilities twice a year for compliance with the AWA.
IACUC.org, a resource page for IACUCs, provides a wealth of information about these important committees.
The 1996 edition of National Institutes of Health publication, Guide for the Care and Use of Laboratory Animals provides further information about the committee and its role.
Our Ohio affiliate, OSERA, provides additional information about IACUCs, including an interview with a member.
The Purpose, Procedures, and Operations Manual from the IACUC at the University of Washington is provided as an example.
Health Research Extension Act.
This 1985 federal law applies to facilities that receive funding to do research from the federal government, in contrast to the Animal Welfare Act, which applies to all facilities regardless of the source of funds. The legal and regulatory requirements of the act are very similar to those of the Animal Welfare Act, and they apply to all research supported by the U.S. Public Health Service (PHS) involving vertebrate animals, including rats, mice and birds. The PHS includes the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention. PHS grants or contracts can be suspended or revoked for non-compliance with this law.
Voluntary Professional Standards. Research animals are well cared for, under the supervision of specialized veterinarians. Since 1965, the scientific community has sponsored an independent, peer review accreditation program under the auspices of the American Association for Accreditation of Laboratory Animal Care (AAALAC). Visit their web site for a free copy of the Guide for the Care and Use of Laboratory Animals. AAALAC promotes the highest standards of animal care and use through a program of periodic inspection of research facilities that exceeds existing laws and regulations. AAALAC accreditation is considered to be the research community equivalent of the "Good Housekeeping Seal of Approval."
Federal Requirements for Animal Testing. Several federal laws require that the public be protected from hazardous products. The federal regulations that implement these laws require animal testing. There are four main federal agencies involved in administering these regulations:
Food and Drug Administration (FDA). The FDA is responsible for administering statutes regulating human and animal food and drugs, medical devices, biological products, cosmetics, color additives and radiological products. The FDA requires that laboratory animal tests be conducted for prescription and over-the-counter drugs before these products can be tested in humans.
Environmental Protection Agency (EPA). The EPA uses data derived from animal tests and other sources to identify and regulate substances in the environment, such as air or water pollutants and wastes that might be hazardous to humans and animals.
Consumer Product Safety Commission (CPSC). The CPSC relies on animal data in identifying and regulating risks to consumers from household and other products.
Occupational Safety and Health Administration (OSHA). OSHA uses data from animal tests and other sources to set regulations that protect workers in the workplace.
Some information in this section was adapted with permission from the North Carolina Association for Biomedical research (NCABR).
Federal Laws, Regulations and Guidelines Governing Biomedical Research Using Animals
When animals are used in biomedical research, the following laws, regulations and guidelines govern their care:
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.
A set of principles that underlie current federal regulations was developed in 1984 by representatives from all federal agencies that use or fund biomedical research. These include requirements that:
* procedures involving animals be relevant to human or animal health
* the minimum number of animals be used to obtain valid results
* alternatives to animals be considered
* animal pain or distress be avoided or minimized
* living conditions for animals be appropriate for their species
* research scientists and those caring for the animals be properly trained and qualified
These requirements are sometimes summarized as the 3R's:
1. Reduction-using the minimum number of animals necessary.
2. Refinement-enhancing animal welfare and ensuring the best conditions possible.
3. Replacement-using other models when appropriate.
Animal Welfare Act (AWA)
The Animal Welfare Act sets federal standards for all aspects of care for laboratory animals. It was enacted into law in 1966 and has been amended by the U.S. Congress several times. The act applies to all public and private research facilities in this country.
USDA licensing, reporting and inspection requirements: All research facilities covered by the law must be registered with the USDA and comply with the USDA animal welfare regulations. Each facility must report to the USDA each year verifying compliance and indicating the number and species of animals used. The USDA is required to inspect each facility at least once a year, unannounced, to ensure compliance with these standards. More frequent unscheduled inspections are made if significant deficiencies are identified. If the USDA inspectors find violations of any part of the act, they will allow the facility a limited time to correct them. If the violations are not corrected, the USDA can fine the institution or close the facility.
Institutional Animal Care and Use Committee: The 1985 amendments to the AWA required all research facilities using animals to establish an Institutional Animal Care and Use Committee (IACUC). The committee ensures that applicable federal, state, and local laws and regulations are met, reviews and approves procedures involving animals before they take place, and inspects facilities twice a year for compliance with the AWA.
IACUC.org, a resource page for IACUCs, provides a wealth of information about these important committees.
The 1996 edition of National Institutes of Health publication, Guide for the Care and Use of Laboratory Animals provides further information about the committee and its role.
Our Ohio affiliate, OSERA, provides additional information about IACUCs, including an interview with a member.
The Purpose, Procedures, and Operations Manual from the IACUC at the University of Washington is provided as an example.
Health Research Extension Act.
This 1985 federal law applies to facilities that receive funding to do research from the federal government, in contrast to the Animal Welfare Act, which applies to all facilities regardless of the source of funds. The legal and regulatory requirements of the act are very similar to those of the Animal Welfare Act, and they apply to all research supported by the U.S. Public Health Service (PHS) involving vertebrate animals, including rats, mice and birds. The PHS includes the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention. PHS grants or contracts can be suspended or revoked for non-compliance with this law.
Voluntary Professional Standards. Research animals are well cared for, under the supervision of specialized veterinarians. Since 1965, the scientific community has sponsored an independent, peer review accreditation program under the auspices of the American Association for Accreditation of Laboratory Animal Care (AAALAC). Visit their web site for a free copy of the Guide for the Care and Use of Laboratory Animals. AAALAC promotes the highest standards of animal care and use through a program of periodic inspection of research facilities that exceeds existing laws and regulations. AAALAC accreditation is considered to be the research community equivalent of the "Good Housekeeping Seal of Approval."
Federal Requirements for Animal Testing. Several federal laws require that the public be protected from hazardous products. The federal regulations that implement these laws require animal testing. There are four main federal agencies involved in administering these regulations:
Food and Drug Administration (FDA). The FDA is responsible for administering statutes regulating human and animal food and drugs, medical devices, biological products, cosmetics, color additives and radiological products. The FDA requires that laboratory animal tests be conducted for prescription and over-the-counter drugs before these products can be tested in humans.
Environmental Protection Agency (EPA). The EPA uses data derived from animal tests and other sources to identify and regulate substances in the environment, such as air or water pollutants and wastes that might be hazardous to humans and animals.
Consumer Product Safety Commission (CPSC). The CPSC relies on animal data in identifying and regulating risks to consumers from household and other products.
Occupational Safety and Health Administration (OSHA). OSHA uses data from animal tests and other sources to set regulations that protect workers in the workplace.
Some information in this section was adapted with permission from the North Carolina Association for Biomedical research (NCABR).
PHARMACEUTICALS
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What substances are considered to be pharmaceuticals?
The term “pharmaceuticals” refers to medicinal products such as generic, over-the-counter, and
prescription drugs.
Who regulates pharmaceuticals in the U.S. and under what laws?
Responsibility for the regulation of human pharmaceuticals lies with the Center for Drug Evaluation
and Research at the Food and Drug Administration (FDA), while the FDA Center for Veterinary
Medicine is charged with oversight of veterinary pharmaceuticals. FDA’s statutory authority is rooted
in the Federal Food, Drug and Cosmetic Act.1
What animal tests are carried out on pharmaceuticals?
“Preclinical” testing in animals is a longstanding requirement for all human and veterinary medicinal
products. U.S. testing requirements for human2-3 and veterinary pharmaceuticals4 have largely been
harmonized with those of other major markets (i.e., the Europe and Japan) under the auspices of the
International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) and the International Co-operation on Harmonization of
Technical Requirements for Registration of Veterinary Products (VICH), respectively. Both entities
publish guidelines specifying trilaterally agreed-upon methods for assessing safety, effectiveness and
quality of pharmaceutical products. ICH guidelines call for a wide array of pre-clinical (animal)
studies, followed by several phases of human clinical studies, before a new drug is deemed safe for
marketing.5 VICH guidelines likewise prescribe a significant battery of conventional toxicology
studies, but also provide for evaluations of target animal and environmental safety, since a major use
of veterinary drugs is in farm animals.6
Animal tests common to both ICH and VICH schemes include the following:7
Absorption, distribution, metabolism and elimination studies in rodents and/or other species
3 month repeated-dose general toxicity studies in rodents, dogs, and sometimes primates
12-24 month repeated-dose general toxicity studies in rodents, dogs, and sometimes primates
Lifetime (18-24 month) cancer studies in rats and mice (ICH allows for the substitution of
the 18-month mouse study with a shorter test in transgenic mice)
Genetic toxicity studies of at least 2 varieties
1 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
2 http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200321
3 http://www.fda.gov/cder/guidance/index.htm
4 http://www.fda/gov/cvm/Guidance/published.htm
5 http://www.ich.org/cache/html/250-272-1.html
6 http://www.vichsec.org/en/guidelines2.htm
7 http://www.hsus.org/animals_in_research/animal_testing/toxicity_testing_overview.html
HSUS / HSLF Fact Sheet 2
Reproductive toxicity study in at least 2 generations of rodents (ICH allows for this to be
broken into separate adult fertility and post-natal segments in the context of a 1-generation
study design)
Pre-natal developmental toxicity in rodents and rabbits
Immunotoxicity in rodents
In addition to the “core battery” above, national regulators and quality-control bodies known as
Pharmacopoeias impose additional testing requirements on a case-by-case basis. For example,
medicated skin creams are often tested in the presence of UV light to be sure they do not foster
sunlight-induced “photo”-toxicity, while drugs administered intravenously must be specially tested to
ensure that they are not contaminated with fever-causing “pyrogens.”
How many animals may be used in pharmaceutical testing?
Some of the tests above consume hundreds or thousands of animals per study, and such testing is
typically required for both the active medicinal ingredient(s) as well as each formulated
pharmaceutical product (and sometimes for each new batch of a product). Unfortunately, laboratorybred
rats and mice and non-mammalian species are not covered under the U.S. Animal Welfare Act
standards for animals used in experiments, and as such, statistics concerning their use are not
recorded or made publicly available.8 However, according to European statistics for 2005, the
“production and quality control of products for human medicine and dentistry and for veterinary
medicine” consumed approximately 15.3% of all animals used for all experimental purposes that
year.9
Are animal tests accurate predictors of pharmaceutical risks to people?
Not necessarily, as catastrophic drug failure—such as the recent TGN 1412 incident in the United
Kingdom—have revealed.10 In fact, the World Health Organization reports that in some countries,
adverse drug reactions are responsible for upwards of 10% of all hospital admissions.11 And
according to the US FDA, “a new medicinal compound entering Phase 1 testing [in humans], often
representing the culmination of upwards of a decade of preclinical screening and evaluation, is
estimated to have only an 8 percent chance of reaching the market” because animal studies so often
“fail to predict the specific safety problem that ultimately halts development.”12
What are some practical alternatives to animal testing?
A number of in vitro and other alternative methods germane to pharmaceutical safety and quality
assessment have been endorsed as scientifically valid by the European Centre for the Validation of
Alternative Methods (ECVAM) and its counterparts worldwide for endpoints including skin and eye
irritation, sunlight-induced “photo”-toxicity, genetic toxicity, fever-inducing “pyrogenicity,” toxicity
to the developing embryo, and toxicity to the blood.13
In addition, an expert group comprised of 15 international pharmaceutical companies and contract
testing facilities, together with the UK National Centre for the 3Rs, has recently concluded that “the
information obtained from conventional acute toxicity studies is of little or no value in the
pharmaceutical development process,” and has recommended that single-dose acute systemic toxicity
studies be dropped from ICH and related national guidelines for human pharmaceuticals.14
8 http://www.nal.usda.gov/awic/legislat/awa.htm
9 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf
10 http://www.hsus.org/animals_in_research/animal_testing/limitations-of-animal-methods.html
11 http://www.who.int/mediacentre/factsheets/fs293/en/index.html
12 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
13 http://www.hsus.org/animals_in_research/animal_testing/alternatives.html
14 http://www.nc3rs.org.uk/news.asp?id=512
HSUS / HSLF Fact Sheet 3
Another innovative technique with the potential to not only reduce animal use, but also to obtain
much more relevant and meaningful scientific information, is called microdosing.15 By administering
a very small dose of a candidate drug to healthy human volunteers, important human-specific
information can be obtained, without the uncertainties associated with extrapolating test results from
one species to another.
What is the Humane Society doing to help animals used in pharmaceutical
testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.16 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium to help make this landmark vision a reality as quickly as possible.
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
15 http://www.emea.europa.eu/pdfs/human/swp/259902en.pdf
16 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What substances are considered to be pharmaceuticals?
The term “pharmaceuticals” refers to medicinal products such as generic, over-the-counter, and
prescription drugs.
Who regulates pharmaceuticals in the U.S. and under what laws?
Responsibility for the regulation of human pharmaceuticals lies with the Center for Drug Evaluation
and Research at the Food and Drug Administration (FDA), while the FDA Center for Veterinary
Medicine is charged with oversight of veterinary pharmaceuticals. FDA’s statutory authority is rooted
in the Federal Food, Drug and Cosmetic Act.1
What animal tests are carried out on pharmaceuticals?
“Preclinical” testing in animals is a longstanding requirement for all human and veterinary medicinal
products. U.S. testing requirements for human2-3 and veterinary pharmaceuticals4 have largely been
harmonized with those of other major markets (i.e., the Europe and Japan) under the auspices of the
International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) and the International Co-operation on Harmonization of
Technical Requirements for Registration of Veterinary Products (VICH), respectively. Both entities
publish guidelines specifying trilaterally agreed-upon methods for assessing safety, effectiveness and
quality of pharmaceutical products. ICH guidelines call for a wide array of pre-clinical (animal)
studies, followed by several phases of human clinical studies, before a new drug is deemed safe for
marketing.5 VICH guidelines likewise prescribe a significant battery of conventional toxicology
studies, but also provide for evaluations of target animal and environmental safety, since a major use
of veterinary drugs is in farm animals.6
Animal tests common to both ICH and VICH schemes include the following:7
Absorption, distribution, metabolism and elimination studies in rodents and/or other species
3 month repeated-dose general toxicity studies in rodents, dogs, and sometimes primates
12-24 month repeated-dose general toxicity studies in rodents, dogs, and sometimes primates
Lifetime (18-24 month) cancer studies in rats and mice (ICH allows for the substitution of
the 18-month mouse study with a shorter test in transgenic mice)
Genetic toxicity studies of at least 2 varieties
1 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
2 http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200321
3 http://www.fda.gov/cder/guidance/index.htm
4 http://www.fda/gov/cvm/Guidance/published.htm
5 http://www.ich.org/cache/html/250-272-1.html
6 http://www.vichsec.org/en/guidelines2.htm
7 http://www.hsus.org/animals_in_research/animal_testing/toxicity_testing_overview.html
HSUS / HSLF Fact Sheet 2
Reproductive toxicity study in at least 2 generations of rodents (ICH allows for this to be
broken into separate adult fertility and post-natal segments in the context of a 1-generation
study design)
Pre-natal developmental toxicity in rodents and rabbits
Immunotoxicity in rodents
In addition to the “core battery” above, national regulators and quality-control bodies known as
Pharmacopoeias impose additional testing requirements on a case-by-case basis. For example,
medicated skin creams are often tested in the presence of UV light to be sure they do not foster
sunlight-induced “photo”-toxicity, while drugs administered intravenously must be specially tested to
ensure that they are not contaminated with fever-causing “pyrogens.”
How many animals may be used in pharmaceutical testing?
Some of the tests above consume hundreds or thousands of animals per study, and such testing is
typically required for both the active medicinal ingredient(s) as well as each formulated
pharmaceutical product (and sometimes for each new batch of a product). Unfortunately, laboratorybred
rats and mice and non-mammalian species are not covered under the U.S. Animal Welfare Act
standards for animals used in experiments, and as such, statistics concerning their use are not
recorded or made publicly available.8 However, according to European statistics for 2005, the
“production and quality control of products for human medicine and dentistry and for veterinary
medicine” consumed approximately 15.3% of all animals used for all experimental purposes that
year.9
Are animal tests accurate predictors of pharmaceutical risks to people?
Not necessarily, as catastrophic drug failure—such as the recent TGN 1412 incident in the United
Kingdom—have revealed.10 In fact, the World Health Organization reports that in some countries,
adverse drug reactions are responsible for upwards of 10% of all hospital admissions.11 And
according to the US FDA, “a new medicinal compound entering Phase 1 testing [in humans], often
representing the culmination of upwards of a decade of preclinical screening and evaluation, is
estimated to have only an 8 percent chance of reaching the market” because animal studies so often
“fail to predict the specific safety problem that ultimately halts development.”12
What are some practical alternatives to animal testing?
A number of in vitro and other alternative methods germane to pharmaceutical safety and quality
assessment have been endorsed as scientifically valid by the European Centre for the Validation of
Alternative Methods (ECVAM) and its counterparts worldwide for endpoints including skin and eye
irritation, sunlight-induced “photo”-toxicity, genetic toxicity, fever-inducing “pyrogenicity,” toxicity
to the developing embryo, and toxicity to the blood.13
In addition, an expert group comprised of 15 international pharmaceutical companies and contract
testing facilities, together with the UK National Centre for the 3Rs, has recently concluded that “the
information obtained from conventional acute toxicity studies is of little or no value in the
pharmaceutical development process,” and has recommended that single-dose acute systemic toxicity
studies be dropped from ICH and related national guidelines for human pharmaceuticals.14
8 http://www.nal.usda.gov/awic/legislat/awa.htm
9 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf
10 http://www.hsus.org/animals_in_research/animal_testing/limitations-of-animal-methods.html
11 http://www.who.int/mediacentre/factsheets/fs293/en/index.html
12 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
13 http://www.hsus.org/animals_in_research/animal_testing/alternatives.html
14 http://www.nc3rs.org.uk/news.asp?id=512
HSUS / HSLF Fact Sheet 3
Another innovative technique with the potential to not only reduce animal use, but also to obtain
much more relevant and meaningful scientific information, is called microdosing.15 By administering
a very small dose of a candidate drug to healthy human volunteers, important human-specific
information can be obtained, without the uncertainties associated with extrapolating test results from
one species to another.
What is the Humane Society doing to help animals used in pharmaceutical
testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.16 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium to help make this landmark vision a reality as quickly as possible.
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
15 http://www.emea.europa.eu/pdfs/human/swp/259902en.pdf
16 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
ENDOCRINE DISRUPTORS
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What does the term “endocrine disruption” mean?
Endocrine disruption refers to harmful effects on reproduction, development and/or health in
general resulting from chemically-induced interactions with the body’s hormone system. Since the
1962 publication of Silent Spring, there has been concern that chemicals in the environment could be
harmful to both wildlife populations and human health. The term “endocrine disrupter” was coined
in 1991 by former World Wildlife Fund scientist Theo Colborn, who reported that some
environmental chemicals can disrupt the body’s hormone system, and that effects of exposure during
development can be permanent and severe.
What kinds of substances have been identified as suspected endocrine
disruptors?
A range of synthetic as well as naturally occurring agents have been identified as potential endocrine
disrupters, including synthetic hormones, pesticides, compounds used in the plastics industry and in
consumer products, industrial by-products and pollutants, and even some naturally occurring
substances in plants.
What is the U.S. doing to address endocrine disruptor concerns?
In 1996, the U.S. Congress enacted the Food Quality Protection Act (FQPA),1 which introduced a
number of significant amendments to both the Federal Food, Drug and Cosmetic Act and Safe
Drinking Water Act, including a requirement that the Environmental Protection Agency (EPA)
“develop a screening program, using appropriate validated test systems and other scientifically
relevant information, to determine whether certain substances may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as
[EPA] may designate.” Congress further directed that EPA “shall provide for the testing of all
pesticide chemicals” and “may provide for the testing of any other substance that may have an effect
that is cumulative to an effect of a pesticide chemical if [EPA] determines that a substantial
population may be exposed to such substance.” In practical terms, this Congressional mandate will
lead to substantial additional testing of nearly 5,000 pesticide active and other ingredients, and
possibly thousands of other high production volume chemicals and environmental contaminants.
How has EPA responded to this mandate?
Responsibility for developing a “toolbox” of validated screens and tests for the emerging testing
program has been delegated to the EPA’s Office of Science Coordination and Policy. EPA began by
establishing a multi-stakeholder Endocrine Disruptor Screening and Testing Advisory Committee
(EDSTAC) to provide the Agency with recommendations regarding:
“Methods for chemical selection and priorities for screening”
“A set of available, validated screening assays for early application”
1 http://www.fda.gov/opacom/laws/foodqual/fqpatoc.htm
HSUS / HSLF Fact Sheet 2
“Ways to identify new and existing screening assays and mechanisms for their validation”
“Processes and criteria for deciding when additional tests beyond screening would be needed
and how to validate such tests.”
In its final report to EPA in September 1998, 2 EDSTAC called for the scope of the so-called
Endocrine Disruptor Screening Program (EDSP)3 to be significantly expanded to encompass
chemical interactions with two or more additional endocrine hormones (androgen and thyroid, as
well as estrogen) in not only humans, but also in birds, fish, amphibians and invertebrates.
EDSTAC proposed a tiered testing framework to accommodate substances with differing amounts
of available data:
Tier 1 would consist of a battery of relatively rapid, inexpensive, and largely mechanistic
screening assays, designed to detect chemical interactions with estrogen, androgen and
thyroid hormones in mammalian, amphibian and fish species
In Tier 2, substances which appear, on weight-of-evidence, to be endocrine-active may then
be subject to multigenerational reproductive toxicity studies in up to five different
taxonomic groups.
Using the EDSTAC report as a road map, EPA established a Standardization and Validation Task
Force (which was later replaced by two similar committees4) to provide advice concerning the
scientific and technical work necessary to validate the recommended screens and tests. EPA has also
been working with other national governments through the Organization for Economic Cooperation
and Development (OECD) to validate endocrine screens and tests of international interest.5
What tests are being developed to identify endocrine disrupting substances?
Screens to detect chemical interactions with estrogen, androgen and/or thyroid hormones include the
following:
Uterotrophic assay in rats or mice
Hershberger assay in rats or mice
Enhanced 28-day repeated dose toxicity study in rats
Female and male pubertal assays in rats
Intact male rat assay
Amphibian metamorphosis assay
Fish reproduction screen
In vitro receptor-binding assays
In vitro transcriptional/reporter gene activation assays
In vitro steroidogenesis assays
In vitro aromatase assays
Tests thought to provide more-definitive proof of harm to human and/or ecological health include
the following:
2-generation reproduction study in rats
2-generation reproduction study in birds
2-generation reproduction study in frogs
Fish full life-cycle test
Mysid shrimp full life-cycle test
2 http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/finalrpt.htm
3 http://www.oecd.org/document/62/0,3343,en_2649_34377_2348606_1_1_1_1,00.html
4 http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/edmvac.htm
5 http://www.oecd.org/document/62/0,3343,en_2649_34377_2348606_1_1_1_1,00.html
HSUS / HSLF Fact Sheet 3
How many animals are used in these screens and tests?
Tier 1 screening methods each consume between 20 and 80 animals6 (except for the in vitro methods,
which do not consume any animals), while Tier 2 reproduction/lifecycle tests each consume between
2,600 and 5,500 animals per chemical tested. It is estimated that for every chemical evaluated in
EPA’s Tier 1 battery, in excess of 360 animals will be consumed. Thus, to screen each of the roughly
5,000 pesticide chemicals as the FQPA requires would consume approximately 1.8 million animals.
Millions more could be consumed in follow-up Tier 2 testing of chemicals that yielded positive
results in Tier 1.
Won’t some of these tests already have been conducted on pesticides and
chemicals?
Yes. For most pesticide active ingredients, reproductive toxicity studies on rats, birds and
invertebrates, and lifecycle studies in fish, will already have been conducted, together with dozens of
other tests to characterize the substance’s potential toxicity.7 Thus, if a pesticide has already been
deemed safe on the basis of studies that are substantially equivalent to EDSP Tier 2 “definitive” tests
for endocrine disruption, it is highly doubtful that the results of Tier 1 screens (e.g., evidence of
binding to the estrogen receptor) or duplicate Tier 2 tests would lead to any change in the way a
pesticide or other substance is regulated.
Are animal tests accurate predictors of endocrine disrupting hazard to
people?
Not necessarily.8 A 2003 white paper commissioned by EPA documented that chemical effects on
the endocrine system can differ dramatically not only between animal species, but also between
strains of the same species.9 This raises serious doubt concerning the human relevance of test results
from rats or mice. Equally troubling are questions that have been raised as to whether OECD-run
studies to validate one or more animal tests has complied with the internationally agreed standards.10
What are some practical alternatives to animal testing?
A number of the screens that have been developed for use under the EDSP are in vitro (i.e., cell lines
and cellular components, such as isolated estrogen and androgen receptors), and could therefore
replace or reduce animal use in some cases if conducted as part of a “tiered” testing strategy (i.e., if
animal testing were undertaken only as a last resort). However, this is unlikely to be the case under
the EPA’s currently proposed “battery” approach, according to which all Tier 1 screens (animal and
non-animal) would be performed concurrently, thereby precluding any potential reduction in animal
use.
What is the status of testing under EPA’s EDSP?
In June 2007, EPA published a draft list of 73 chemicals to be subject to initial screening under the
EDSP, noting that “[t]he Tier 1 screening battery is expected to complete peer review and be ready
for use in early 2008.” Program implementation beyond this pilot phase (i.e., “the testing of all
pesticide chemicals,” per FQPA) will be left to the discretion of EPA’s Office of Pesticide Programs.
6 This estimate does not include the 270 or more mother rats and “surplus” offspring produced in for each pubertal assay,
nor the hundreds of eggs produced in the fish reproduction screens.
7 http://www.hsus.org/web-files/PDF/ARI/pesticides.pdf
8 http://www.hsus.org/animals_in_research/animal_testing/limitations-of-animal-methods.html
9 http://www.stopanimaltests.com/pdf/strain.slides.pdf
10 http://ecvam.jrc.it/publication/Esac%20statement%20on%20uterotrophic%20assay2.doc
HSUS / HSLF Fact Sheet 4
What is the Humane Society doing to help animals used in testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.11 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium make this landmark vision a reality as quickly as possible.
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
11 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What does the term “endocrine disruption” mean?
Endocrine disruption refers to harmful effects on reproduction, development and/or health in
general resulting from chemically-induced interactions with the body’s hormone system. Since the
1962 publication of Silent Spring, there has been concern that chemicals in the environment could be
harmful to both wildlife populations and human health. The term “endocrine disrupter” was coined
in 1991 by former World Wildlife Fund scientist Theo Colborn, who reported that some
environmental chemicals can disrupt the body’s hormone system, and that effects of exposure during
development can be permanent and severe.
What kinds of substances have been identified as suspected endocrine
disruptors?
A range of synthetic as well as naturally occurring agents have been identified as potential endocrine
disrupters, including synthetic hormones, pesticides, compounds used in the plastics industry and in
consumer products, industrial by-products and pollutants, and even some naturally occurring
substances in plants.
What is the U.S. doing to address endocrine disruptor concerns?
In 1996, the U.S. Congress enacted the Food Quality Protection Act (FQPA),1 which introduced a
number of significant amendments to both the Federal Food, Drug and Cosmetic Act and Safe
Drinking Water Act, including a requirement that the Environmental Protection Agency (EPA)
“develop a screening program, using appropriate validated test systems and other scientifically
relevant information, to determine whether certain substances may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as
[EPA] may designate.” Congress further directed that EPA “shall provide for the testing of all
pesticide chemicals” and “may provide for the testing of any other substance that may have an effect
that is cumulative to an effect of a pesticide chemical if [EPA] determines that a substantial
population may be exposed to such substance.” In practical terms, this Congressional mandate will
lead to substantial additional testing of nearly 5,000 pesticide active and other ingredients, and
possibly thousands of other high production volume chemicals and environmental contaminants.
How has EPA responded to this mandate?
Responsibility for developing a “toolbox” of validated screens and tests for the emerging testing
program has been delegated to the EPA’s Office of Science Coordination and Policy. EPA began by
establishing a multi-stakeholder Endocrine Disruptor Screening and Testing Advisory Committee
(EDSTAC) to provide the Agency with recommendations regarding:
“Methods for chemical selection and priorities for screening”
“A set of available, validated screening assays for early application”
1 http://www.fda.gov/opacom/laws/foodqual/fqpatoc.htm
HSUS / HSLF Fact Sheet 2
“Ways to identify new and existing screening assays and mechanisms for their validation”
“Processes and criteria for deciding when additional tests beyond screening would be needed
and how to validate such tests.”
In its final report to EPA in September 1998, 2 EDSTAC called for the scope of the so-called
Endocrine Disruptor Screening Program (EDSP)3 to be significantly expanded to encompass
chemical interactions with two or more additional endocrine hormones (androgen and thyroid, as
well as estrogen) in not only humans, but also in birds, fish, amphibians and invertebrates.
EDSTAC proposed a tiered testing framework to accommodate substances with differing amounts
of available data:
Tier 1 would consist of a battery of relatively rapid, inexpensive, and largely mechanistic
screening assays, designed to detect chemical interactions with estrogen, androgen and
thyroid hormones in mammalian, amphibian and fish species
In Tier 2, substances which appear, on weight-of-evidence, to be endocrine-active may then
be subject to multigenerational reproductive toxicity studies in up to five different
taxonomic groups.
Using the EDSTAC report as a road map, EPA established a Standardization and Validation Task
Force (which was later replaced by two similar committees4) to provide advice concerning the
scientific and technical work necessary to validate the recommended screens and tests. EPA has also
been working with other national governments through the Organization for Economic Cooperation
and Development (OECD) to validate endocrine screens and tests of international interest.5
What tests are being developed to identify endocrine disrupting substances?
Screens to detect chemical interactions with estrogen, androgen and/or thyroid hormones include the
following:
Uterotrophic assay in rats or mice
Hershberger assay in rats or mice
Enhanced 28-day repeated dose toxicity study in rats
Female and male pubertal assays in rats
Intact male rat assay
Amphibian metamorphosis assay
Fish reproduction screen
In vitro receptor-binding assays
In vitro transcriptional/reporter gene activation assays
In vitro steroidogenesis assays
In vitro aromatase assays
Tests thought to provide more-definitive proof of harm to human and/or ecological health include
the following:
2-generation reproduction study in rats
2-generation reproduction study in birds
2-generation reproduction study in frogs
Fish full life-cycle test
Mysid shrimp full life-cycle test
2 http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/finalrpt.htm
3 http://www.oecd.org/document/62/0,3343,en_2649_34377_2348606_1_1_1_1,00.html
4 http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/edmvac.htm
5 http://www.oecd.org/document/62/0,3343,en_2649_34377_2348606_1_1_1_1,00.html
HSUS / HSLF Fact Sheet 3
How many animals are used in these screens and tests?
Tier 1 screening methods each consume between 20 and 80 animals6 (except for the in vitro methods,
which do not consume any animals), while Tier 2 reproduction/lifecycle tests each consume between
2,600 and 5,500 animals per chemical tested. It is estimated that for every chemical evaluated in
EPA’s Tier 1 battery, in excess of 360 animals will be consumed. Thus, to screen each of the roughly
5,000 pesticide chemicals as the FQPA requires would consume approximately 1.8 million animals.
Millions more could be consumed in follow-up Tier 2 testing of chemicals that yielded positive
results in Tier 1.
Won’t some of these tests already have been conducted on pesticides and
chemicals?
Yes. For most pesticide active ingredients, reproductive toxicity studies on rats, birds and
invertebrates, and lifecycle studies in fish, will already have been conducted, together with dozens of
other tests to characterize the substance’s potential toxicity.7 Thus, if a pesticide has already been
deemed safe on the basis of studies that are substantially equivalent to EDSP Tier 2 “definitive” tests
for endocrine disruption, it is highly doubtful that the results of Tier 1 screens (e.g., evidence of
binding to the estrogen receptor) or duplicate Tier 2 tests would lead to any change in the way a
pesticide or other substance is regulated.
Are animal tests accurate predictors of endocrine disrupting hazard to
people?
Not necessarily.8 A 2003 white paper commissioned by EPA documented that chemical effects on
the endocrine system can differ dramatically not only between animal species, but also between
strains of the same species.9 This raises serious doubt concerning the human relevance of test results
from rats or mice. Equally troubling are questions that have been raised as to whether OECD-run
studies to validate one or more animal tests has complied with the internationally agreed standards.10
What are some practical alternatives to animal testing?
A number of the screens that have been developed for use under the EDSP are in vitro (i.e., cell lines
and cellular components, such as isolated estrogen and androgen receptors), and could therefore
replace or reduce animal use in some cases if conducted as part of a “tiered” testing strategy (i.e., if
animal testing were undertaken only as a last resort). However, this is unlikely to be the case under
the EPA’s currently proposed “battery” approach, according to which all Tier 1 screens (animal and
non-animal) would be performed concurrently, thereby precluding any potential reduction in animal
use.
What is the status of testing under EPA’s EDSP?
In June 2007, EPA published a draft list of 73 chemicals to be subject to initial screening under the
EDSP, noting that “[t]he Tier 1 screening battery is expected to complete peer review and be ready
for use in early 2008.” Program implementation beyond this pilot phase (i.e., “the testing of all
pesticide chemicals,” per FQPA) will be left to the discretion of EPA’s Office of Pesticide Programs.
6 This estimate does not include the 270 or more mother rats and “surplus” offspring produced in for each pubertal assay,
nor the hundreds of eggs produced in the fish reproduction screens.
7 http://www.hsus.org/web-files/PDF/ARI/pesticides.pdf
8 http://www.hsus.org/animals_in_research/animal_testing/limitations-of-animal-methods.html
9 http://www.stopanimaltests.com/pdf/strain.slides.pdf
10 http://ecvam.jrc.it/publication/Esac%20statement%20on%20uterotrophic%20assay2.doc
HSUS / HSLF Fact Sheet 4
What is the Humane Society doing to help animals used in testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.11 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium make this landmark vision a reality as quickly as possible.
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
11 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
VACCINES
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What are vaccines?
Vaccines are a type of “biological” medicinal product—derived from living organisms—that are used
to prevent or treat certain types of infectious or other diseases. Conventional vaccines are produced
from dead or inactivated organisms (e.g., viruses) or toxic compounds, or purified products derived
from them. However, more recently, several new types of vaccines have also been developed (e.g.,
recombinant, conjugate and DNA vaccination).
Who regulates vaccines in the U.S. and under what laws?
Vaccines intended for human use are regulated by the Food and Drug Administration (FDA) Center
for Biologics Evaluation and Research under the authority of the Public Health Service Act,1 whereas
vaccines intended for use in other animals (e.g., pets and farm) are regulated by the Department of
Agriculture (USDA) Center for Veterinary Biologics under the authority of the Virus Serum Toxin
Act.2
What animal tests are carried out on vaccines?
“Preclinical” testing in animals is a longstanding requirement for all human and veterinary medicinal
products, including vaccines. Specifically, vaccine manufacturers are legally required demonstrate that
their products possess the following characteristics:
Purity, meaning that it is not contaminated with viable bacteria, viruses or fungi
Safety, meaning that it is not dangerous or harmful (which is usually determined by means of
“abnormal toxicity” or similar studies, in which groups of animals are injected with a vaccine
and monitored for clinical signs of toxicity)
Potency, meaning that it is effective in preventing infection (which is usually determined by
means of a “challenge study,” in which groups of animals are first inoculated with a vaccine
and are then exposed to a virulent strain(s) of the organism against which the vaccine is
intended to protect.; animals are then monitored for clinical signs of the infectious disease in
question, which may involve considerable pain, suffering, and ultimately, death).
A further pre-marketing requirement for both human and veterinary vaccines is a series of clinical
trials in humans or “target” animals to demonstrate safety and effectiveness in the species of ultimate
interest. Even after a vaccine has been fully tested and licensed, it is common for manufacturers to
conduct additional animal testing of each individual batch of a vaccine, or for an agency to request
samples of each vaccine lot to undertake such testing independently.3
1 http://www.fda.gov/opacom/laws/phsvcact/sec262.htm
2 http://www.aphis.usda.gov/animal_health/vet_biologics/publications/VSTA.pdf
3 http://www.fda.gov/cber/vaccine/vacappr.htm
HSUS / HSLF Fact Sheet 2
How many animals may be used in vaccine testing?
Unfortunately, laboratory-bred rats and mice and non-mammalian species are not covered under the
U.S. Animal Welfare Act standards for animals used in experiments, and as such, statistics
concerning their use are not recorded or made publicly available.4 However, according to European
statistics for 2005, the “production and quality control of products for human medicine and dentistry
and for veterinary medicine” consumed approximately 15.3% of all animals used for all experimental
purposes that year.5
Are animal tests accurate predictors of chemical risks to people?
Not necessarily. In fact, some vaccines have been causally linked to severe adverse reactions in
humans (e.g., anaphylactic shock brought on by hepatitis B vaccine; poliomyelitis in a contact of
someone who received the oral polio vaccine; arthritis in recipients of the rubella vaccine; death in
some recipients of the measles vaccine).6 According to FDA, “a new medicinal compound entering
Phase 1 testing [in humans], often representing the culmination of upwards of a decade of preclinical
screening and evaluation, is estimated to have only an 8 percent chance of reaching the market”
because animal studies so often “fail to predict the specific safety problem that ultimately halts
development.”7
What are some practical alternatives to animal testing?
Relevant alternative methods validated to date include “ELISA” batch potency tests for erysipelas
and human tetanus vaccines, as well as a “toxin binding inhibition test” for human tetanus vaccine.
The European Centre for the Validation of Alternative Methods has also issued a statement calling
for an end to target animal studies for batch safety testing of veterinary vaccines.8
What is the Humane Society doing to help animals used in testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.9 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium to help make this landmark vision a reality as quickly as possible.
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
4 http://www.nal.usda.gov/awic/legislat/awa.htm
5 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf
6 http://medsafe.govt.nz/Profs/PUarticles/vaccine.htm
7 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
8 http://ecvam.jrc.it/publication/TargetAnimalSafetyT_statement.PDF
9 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What are vaccines?
Vaccines are a type of “biological” medicinal product—derived from living organisms—that are used
to prevent or treat certain types of infectious or other diseases. Conventional vaccines are produced
from dead or inactivated organisms (e.g., viruses) or toxic compounds, or purified products derived
from them. However, more recently, several new types of vaccines have also been developed (e.g.,
recombinant, conjugate and DNA vaccination).
Who regulates vaccines in the U.S. and under what laws?
Vaccines intended for human use are regulated by the Food and Drug Administration (FDA) Center
for Biologics Evaluation and Research under the authority of the Public Health Service Act,1 whereas
vaccines intended for use in other animals (e.g., pets and farm) are regulated by the Department of
Agriculture (USDA) Center for Veterinary Biologics under the authority of the Virus Serum Toxin
Act.2
What animal tests are carried out on vaccines?
“Preclinical” testing in animals is a longstanding requirement for all human and veterinary medicinal
products, including vaccines. Specifically, vaccine manufacturers are legally required demonstrate that
their products possess the following characteristics:
Purity, meaning that it is not contaminated with viable bacteria, viruses or fungi
Safety, meaning that it is not dangerous or harmful (which is usually determined by means of
“abnormal toxicity” or similar studies, in which groups of animals are injected with a vaccine
and monitored for clinical signs of toxicity)
Potency, meaning that it is effective in preventing infection (which is usually determined by
means of a “challenge study,” in which groups of animals are first inoculated with a vaccine
and are then exposed to a virulent strain(s) of the organism against which the vaccine is
intended to protect.; animals are then monitored for clinical signs of the infectious disease in
question, which may involve considerable pain, suffering, and ultimately, death).
A further pre-marketing requirement for both human and veterinary vaccines is a series of clinical
trials in humans or “target” animals to demonstrate safety and effectiveness in the species of ultimate
interest. Even after a vaccine has been fully tested and licensed, it is common for manufacturers to
conduct additional animal testing of each individual batch of a vaccine, or for an agency to request
samples of each vaccine lot to undertake such testing independently.3
1 http://www.fda.gov/opacom/laws/phsvcact/sec262.htm
2 http://www.aphis.usda.gov/animal_health/vet_biologics/publications/VSTA.pdf
3 http://www.fda.gov/cber/vaccine/vacappr.htm
HSUS / HSLF Fact Sheet 2
How many animals may be used in vaccine testing?
Unfortunately, laboratory-bred rats and mice and non-mammalian species are not covered under the
U.S. Animal Welfare Act standards for animals used in experiments, and as such, statistics
concerning their use are not recorded or made publicly available.4 However, according to European
statistics for 2005, the “production and quality control of products for human medicine and dentistry
and for veterinary medicine” consumed approximately 15.3% of all animals used for all experimental
purposes that year.5
Are animal tests accurate predictors of chemical risks to people?
Not necessarily. In fact, some vaccines have been causally linked to severe adverse reactions in
humans (e.g., anaphylactic shock brought on by hepatitis B vaccine; poliomyelitis in a contact of
someone who received the oral polio vaccine; arthritis in recipients of the rubella vaccine; death in
some recipients of the measles vaccine).6 According to FDA, “a new medicinal compound entering
Phase 1 testing [in humans], often representing the culmination of upwards of a decade of preclinical
screening and evaluation, is estimated to have only an 8 percent chance of reaching the market”
because animal studies so often “fail to predict the specific safety problem that ultimately halts
development.”7
What are some practical alternatives to animal testing?
Relevant alternative methods validated to date include “ELISA” batch potency tests for erysipelas
and human tetanus vaccines, as well as a “toxin binding inhibition test” for human tetanus vaccine.
The European Centre for the Validation of Alternative Methods has also issued a statement calling
for an end to target animal studies for batch safety testing of veterinary vaccines.8
What is the Humane Society doing to help animals used in testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.9 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium to help make this landmark vision a reality as quickly as possible.
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
4 http://www.nal.usda.gov/awic/legislat/awa.htm
5 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf
6 http://medsafe.govt.nz/Profs/PUarticles/vaccine.htm
7 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
8 http://ecvam.jrc.it/publication/TargetAnimalSafetyT_statement.PDF
9 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
FOOD ADDITIVES
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What substances are considered to be food additives?
Food additives include any substance added to food or used in the production, processing, treatment,
packaging, transportation or storage of food. Examples include natural or artificial flavorings to
improve or enhance a food’s taste, as well as other chemical additives to alter the food’s appearance
or texture, delay spoiling, and/or prevent the growth of harmful bacteria.
Who regulates food additives in the U.S. and under what laws?
Responsibility for the regulation of food additives lies with the Center for Food Safety and Applied
Nutrition at the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and
Cosmetic Act (FFDCA).1 FFDCA requires that manufacturers and packagers of processed foods
demonstrate the safety (i.e., "reasonable certainty of no harm") of all chemical additives and/or other
materials that come into contact with food prior to marketing.
What animal tests are carried out on food additives?
FDA guidance for the toxicological assessment of food ingredients (also referred to as the Redbook)2
prescribes often extensive toxicological testing based on "concern levels" as determined by chemical
structure and cumulative human exposure. Commonly required study types3 include the following:
Acute systemic toxicity in rodents
Repeated dose (1, 3 and/or 24 month) oral toxicity studies in rodents and/or dogs
Genetic toxicity in vitro and/or in rodents
Carcinogenicity (including possible in utero exposure phase) in rats and/or mice
Reproductive toxicity in at least 2 generations of rodents
Developmental toxicity in rats and/or rabbits
Neurotoxicity in rodents
Immunotoxicity in rodents
Toxicokinetics in rodents
Human clinical and/or epidemiology
Exceptions to the above testing requirements are provided under a 1958 amendment to the FFDCA
for two broad groups of substances:
Substances that FDA or the U.S. Department of Agriculture had determined safe for use in
food prior to 1958
Ingredients “generally recognized as safe” based on a long history of use and/or published
scientific evidence.4
1 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
2 http://www.cfsan.fda.gov/~redbook/red-toca.html
3 http://www.hsus.org/animals_in_research/animal_testing/toxicity_testing_overview.html
4 http://www.cfsan.fda.gov/~dms/opa-noti.html
HSUS / HSLF Fact Sheet 2
How many animals may be used in the testing of food additives?
Some of the tests above consume hundreds or thousands of animals per study. Unfortunately,
laboratory-bred rats and mice and non-mammalian species are not covered under the U.S. Animal
Welfare Act standards for animals used in experiments, and as such, statistics concerning their use
are not recorded or made publicly available.5 However, according to European statistics for 2005, the
testing of food additives consumed approximately 3.7% of all animals used in toxicological and other
safety evaluations that year.6
Are animal tests accurate predictors of risks to people from food additives?
Not necessarily. Animal tests may under- or over-estimate human health hazards. For example,
studies of acute lethality and birth defects in rats have been shown to be poor predictors of such
effects in mice and rabbits—let alone the real-world health risks for people. The same is true for
rodent cancer studies and other types of animal tests. For example, both rat and rabbit tests failed to
predict the developmental hazards of PCBs, industrial solvents, and many drugs, while cancer tests in
rats and mice failed to detect the hazards of asbestos, benzene, cigarette smoke, and many other
substances—delaying consumer and worker protection measures by decades in some cases.7
What are some practical alternatives to animal testing?
A number of in vitro and other alternative methods germane to food additive safety assessment have
been endorsed as scientifically valid by the European Centre for the Validation of Alternative
Methods and its counterparts worldwide.8 These include rapid non-animal genetic toxicity tests,
animal reduction measures for acute systemic toxicity, and a cell-based screening test for toxicity to
the developing embryo.9 In addition, an independent scientific expert group10 has recommended the
deletion of certain longstanding testing requirements (e.g., 1-year dog studies and mouse
carcinogenicity studies, which would save more than 400 animals per food additive), and the
significant scaling back of other standard tests (e.g., evaluating reproductive toxicity using one, rather
than two, generations of offspring, which would save an additional 1,200 or more animals per test).
What is the Humane Society doing to help animals used in food additives
testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.11 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium to help make this landmark vision a reality as quickly as possible.
5 http://www.nal.usda.gov/awic/legislat/awa.htm
6 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf
7 http://www.hsus.org/animals_in_research/animal_testing/limitations-of-animal-methods.html
8 http://ecvam.jrc.it/f_home.cfm?voce=m&idvoce=3
9 http://www.hsus.org/animals_in_research/animal_testing/alternatives.html
10 http://www.hesiglobal.org/Committees/TechnicalCommittees/ACSA
11 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
HSUS / HSLF Fact Sheet 3
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
QUESTIONS AND ANSWERS ABOUT U.S. ANIMAL TESTING OF
What substances are considered to be food additives?
Food additives include any substance added to food or used in the production, processing, treatment,
packaging, transportation or storage of food. Examples include natural or artificial flavorings to
improve or enhance a food’s taste, as well as other chemical additives to alter the food’s appearance
or texture, delay spoiling, and/or prevent the growth of harmful bacteria.
Who regulates food additives in the U.S. and under what laws?
Responsibility for the regulation of food additives lies with the Center for Food Safety and Applied
Nutrition at the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and
Cosmetic Act (FFDCA).1 FFDCA requires that manufacturers and packagers of processed foods
demonstrate the safety (i.e., "reasonable certainty of no harm") of all chemical additives and/or other
materials that come into contact with food prior to marketing.
What animal tests are carried out on food additives?
FDA guidance for the toxicological assessment of food ingredients (also referred to as the Redbook)2
prescribes often extensive toxicological testing based on "concern levels" as determined by chemical
structure and cumulative human exposure. Commonly required study types3 include the following:
Acute systemic toxicity in rodents
Repeated dose (1, 3 and/or 24 month) oral toxicity studies in rodents and/or dogs
Genetic toxicity in vitro and/or in rodents
Carcinogenicity (including possible in utero exposure phase) in rats and/or mice
Reproductive toxicity in at least 2 generations of rodents
Developmental toxicity in rats and/or rabbits
Neurotoxicity in rodents
Immunotoxicity in rodents
Toxicokinetics in rodents
Human clinical and/or epidemiology
Exceptions to the above testing requirements are provided under a 1958 amendment to the FFDCA
for two broad groups of substances:
Substances that FDA or the U.S. Department of Agriculture had determined safe for use in
food prior to 1958
Ingredients “generally recognized as safe” based on a long history of use and/or published
scientific evidence.4
1 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
2 http://www.cfsan.fda.gov/~redbook/red-toca.html
3 http://www.hsus.org/animals_in_research/animal_testing/toxicity_testing_overview.html
4 http://www.cfsan.fda.gov/~dms/opa-noti.html
HSUS / HSLF Fact Sheet 2
How many animals may be used in the testing of food additives?
Some of the tests above consume hundreds or thousands of animals per study. Unfortunately,
laboratory-bred rats and mice and non-mammalian species are not covered under the U.S. Animal
Welfare Act standards for animals used in experiments, and as such, statistics concerning their use
are not recorded or made publicly available.5 However, according to European statistics for 2005, the
testing of food additives consumed approximately 3.7% of all animals used in toxicological and other
safety evaluations that year.6
Are animal tests accurate predictors of risks to people from food additives?
Not necessarily. Animal tests may under- or over-estimate human health hazards. For example,
studies of acute lethality and birth defects in rats have been shown to be poor predictors of such
effects in mice and rabbits—let alone the real-world health risks for people. The same is true for
rodent cancer studies and other types of animal tests. For example, both rat and rabbit tests failed to
predict the developmental hazards of PCBs, industrial solvents, and many drugs, while cancer tests in
rats and mice failed to detect the hazards of asbestos, benzene, cigarette smoke, and many other
substances—delaying consumer and worker protection measures by decades in some cases.7
What are some practical alternatives to animal testing?
A number of in vitro and other alternative methods germane to food additive safety assessment have
been endorsed as scientifically valid by the European Centre for the Validation of Alternative
Methods and its counterparts worldwide.8 These include rapid non-animal genetic toxicity tests,
animal reduction measures for acute systemic toxicity, and a cell-based screening test for toxicity to
the developing embryo.9 In addition, an independent scientific expert group10 has recommended the
deletion of certain longstanding testing requirements (e.g., 1-year dog studies and mouse
carcinogenicity studies, which would save more than 400 animals per food additive), and the
significant scaling back of other standard tests (e.g., evaluating reproductive toxicity using one, rather
than two, generations of offspring, which would save an additional 1,200 or more animals per test).
What is the Humane Society doing to help animals used in food additives
testing?
The Humane Society of the United States and Humane Society Legislative Fund are actively working
to end animal testing—permanently. We are working to promote greater reliance on available nonanimal
testing methods, and are actively supporting the vision of “twenty-first century toxicology”
articulated by the U.S. National Research Council, which would see animal tests that are decades old,
costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and humanrelevant
non-animal methods.11 We are calling for a “big biology” project to meet this challenge, akin
to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder
consortium to help make this landmark vision a reality as quickly as possible.
5 http://www.nal.usda.gov/awic/legislat/awa.htm
6 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf
7 http://www.hsus.org/animals_in_research/animal_testing/limitations-of-animal-methods.html
8 http://ecvam.jrc.it/f_home.cfm?voce=m&idvoce=3
9 http://www.hsus.org/animals_in_research/animal_testing/alternatives.html
10 http://www.hesiglobal.org/Committees/TechnicalCommittees/ACSA
11 http://www.hsus.org/animals_in_research/animal_testing/hsus-projects/human_toxicology_initiative.html
HSUS / HSLF Fact Sheet 3
The Humane Society of the United States is the nation’s largest animal protection organization—backed by more than
10.5 million Americans. For over 50 years, HSUS has worked to reduce suffering and to create meaningful change for
animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships.
Online at HSUS.org/research
The Humane Society Legislative Fund is a social welfare organization incorporated as a separate lobbying affiliate of
the HSUS. HSLF works to pass animal protection laws at the state and federal level, to educate the public about
animal protection issues, and to support humane candidates for office.
Online at HSLF.org
A large number of laws and regulations have been enacted to control the marketing of drugs, cosmetics, pesticides, food additives, and other products that could prove to be hazardous to human health and/or the environment. Such regulations often prescribe a specific regime of laboratory testing to generate information that will enable government regulators to determine whether the benefits of a particular substance outweigh its potential harms.
Government statistics, where available, indicate that product testing accounts for approximately 10 percent of all animal use for scientific purposes, which amounts to many millions of animals per year worldwide. Such testing calls into question the ethics and humaneness of deliberately poisoning animals (sometimes to death), the appropriateness of harming animals for the sake of marketing a new brand of mascara or moisturizer, the applicability of animal data to humans, and the possibility of sparing millions of animals by developing alternatives to a handful of widely used procedures.
The HSUS considers animal-based toxicity studies to be an ethically and scientifically questionable means of evaluating potential hazards to human beings, wildlife, or the environment we all share. We are working on a national and global level to promote greater reliance on available alternative testing methods, and are actively supporting a landmark call by the US National Research Council for fundamental changes to the way product testing is conducted—to move from animal tests that are decades old, costly, slow and of dubious relevance to people, to ultra-modern, efficient and human-relevant non-animal methods.
Visit the Humane Society International (HSI) website to learn more about animals used in experiments internationally.
Animal Testing: The Beginning of the End?
The quiet evolution of alternatives to animal testing may turn into a fast-paced revolution in testing methods. And the driving force is coming from an unlikely source—the United States, which to date has largely reacted to developments in Europe. more
Current HSUS Projects
The Humane Society's campaign to end animal testing combines political and grassroots advocacy, corporate outreach, and a strong science foundation to encourage government regulators and corporations to become more accepting of new technologies and alternatives to animal use. more
Information on Test Methods
A toxicity test is designed to generate data concerning the harmful effects of a substance on human health or the environment. more
Limitations of Animal Methods
Experiments on animals are predicated on the assumption that what is true for one animal species is most likely also true for others, including humans. Yet catastrophic drug failures, such as the TGN 1412 incident, provide a sobering reminder that animal "models" often do not correctly predict real-world consequences for people. more
Non-Animal Testing Methods
The term "alternative" in the context of animal testing is used to describe any change from present procedures that will result in the replacement of animals, a reduction in the numbers used, or a refinement of techniques to alleviate or minimize potential pain, distress and/or suffering. more
Progress
For more than a half-century, the Humane Society of the United States has worked to reduce suffering and to create meaningful change for animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships. more
Resources: Scientific Publications
Humane Society scientists and policy leaders regularly contribute to the academic debate surrounding the use of animals in research and testing. more
Testing Fact Sheets
The HSUS has provided a list of factsheets on the testing of chemicals, cosmetics, endocrine disruptors, food additives, nanomaterials, pesticides, pharmaceuticals and vaccines in the United States. more
Government statistics, where available, indicate that product testing accounts for approximately 10 percent of all animal use for scientific purposes, which amounts to many millions of animals per year worldwide. Such testing calls into question the ethics and humaneness of deliberately poisoning animals (sometimes to death), the appropriateness of harming animals for the sake of marketing a new brand of mascara or moisturizer, the applicability of animal data to humans, and the possibility of sparing millions of animals by developing alternatives to a handful of widely used procedures.
The HSUS considers animal-based toxicity studies to be an ethically and scientifically questionable means of evaluating potential hazards to human beings, wildlife, or the environment we all share. We are working on a national and global level to promote greater reliance on available alternative testing methods, and are actively supporting a landmark call by the US National Research Council for fundamental changes to the way product testing is conducted—to move from animal tests that are decades old, costly, slow and of dubious relevance to people, to ultra-modern, efficient and human-relevant non-animal methods.
Visit the Humane Society International (HSI) website to learn more about animals used in experiments internationally.
Animal Testing: The Beginning of the End?
The quiet evolution of alternatives to animal testing may turn into a fast-paced revolution in testing methods. And the driving force is coming from an unlikely source—the United States, which to date has largely reacted to developments in Europe. more
Current HSUS Projects
The Humane Society's campaign to end animal testing combines political and grassroots advocacy, corporate outreach, and a strong science foundation to encourage government regulators and corporations to become more accepting of new technologies and alternatives to animal use. more
Information on Test Methods
A toxicity test is designed to generate data concerning the harmful effects of a substance on human health or the environment. more
Limitations of Animal Methods
Experiments on animals are predicated on the assumption that what is true for one animal species is most likely also true for others, including humans. Yet catastrophic drug failures, such as the TGN 1412 incident, provide a sobering reminder that animal "models" often do not correctly predict real-world consequences for people. more
Non-Animal Testing Methods
The term "alternative" in the context of animal testing is used to describe any change from present procedures that will result in the replacement of animals, a reduction in the numbers used, or a refinement of techniques to alleviate or minimize potential pain, distress and/or suffering. more
Progress
For more than a half-century, the Humane Society of the United States has worked to reduce suffering and to create meaningful change for animals in laboratories through public education, scientific outreach, legislative advocacy, and strategic partnerships. more
Resources: Scientific Publications
Humane Society scientists and policy leaders regularly contribute to the academic debate surrounding the use of animals in research and testing. more
Testing Fact Sheets
The HSUS has provided a list of factsheets on the testing of chemicals, cosmetics, endocrine disruptors, food additives, nanomaterials, pesticides, pharmaceuticals and vaccines in the United States. more
Animal Testing
Animal testing (also known as vivisection) elicits strong opinions from both those for and those against the practice. Its role in developing HIV treatments and AIDS vaccines is no less controversial.
Developing therapeutic and diagnostic products for use in humans is a long and complex process. With HIV infection, the search for effective drugs and vaccines has proven particularly difficult, as HIV is exceptionally good at changing its structure and evading destruction. In an ideal world, scientists would be able to test thousands of different compounds on human participants to see if any cured, treated or vaccinated them against HIV. However, to do this would be both highly time consuming and dangerous, as most compounds would not be effective, and some might cause illness or even death.
Researchers therefore often use animals to help them test the efficacy of drugs and vaccines, and to make sure that these products are safe. There are of course many ethical implications to animal experimentation, and many people are strongly opposed to the use of animals in any sort of experiment or study that may cause them distress or harm. So is it really necessary to use animals in the production of HIV drugs and vaccines? And are there any alternatives to animal testing?
Why are tests performed on animals?
There are three reasons why animals may be used in scientific experimentation. The first is to ensure the safety of new drugs and other pharmaceutical products. The second is to see whether such products might be effective in humans. The third is for general research into the biology of an animal, or the function and action of certain diseases within its body.
Safety trials
In many countries it is a legal requirement that all drugs and vaccines (not just for HIV) are tested on animals to ensure safety. In the United Kingdom for example, the Medicines Act of 1968 1 states that all new pharmaceutical products must be tested on at least two different species of live mammal, one of which must be a large non-rodent. This legislation was introduced shortly after the discovery that the drug Thalidomide could cause serious physical deformities in babies born to mothers who had taken it during pregnancy. Thalidomide was not thoroughly tested on animals (particularly pregnant animals) before it was prescribed to women, and this case is the root of many countries’ animal testing safety laws today.
Thousands of mice and other small rodents are used in animal experiments every year
Thousands of mice and other small rodents are used in animal experiments
every year
Animal safety tests usually come at the end of a long process of safety data collection that may include testing the product ‘in vitro’ (i.e. in a test-tube) and using a computer program to simulate what might happen to the drug inside the body. The regulations on what safety data is required for a new product vary from country to country (and also from drug to drug), but most drug authorities require all three types of data - animal, in vitro and computer- generated - for trials to be allowed to continue.
All this means that at some point, all ‘antiretroviral’ (anti-AIDS) drugs will have been tested on animals for safety.
There is an argument however that animals are actually fairly poor substitutes for humans and that some compounds that may well cause no harm to a mouse, could kill a human being. This is particularly the case for drugs that interact with the complex human immune system, such as the anti-inflammatory drug that caused major organ failure in six men involved in a trial at Northwick Park Hospital in London, England in 2006. However, such occurrences are rare.
Efficacy trials
While all drugs and vaccines have to be tested on animals to establish their safety, testing them to establish their effectiveness is a different matter.
HIV is a retrovirus specific to humans (hence the name ‘Human Immunodeficiency Virus’), which means it is not naturally found in any other animal. Some African primates, such as chimpanzees and a few species of monkey, are naturally infected with SIV (Simian Immunodeficiency Virus), which is believed to be the virus from which HIV originated. Chimpanzees can also be artificially infected with HIV in a laboratory. However most monkeys and chimpanzees have very efficient immune responses to SIV (and HIV), and do not develop AIDS, even after many years of infection. This can make it very difficult to assess whether a drug or vaccine actually works, so primates are not used as widely as human substitutes as they once were.
This said, there is one primate still commonly used to conduct efficacy testing: the Rhesus macaque monkey. Because Rhesus macaques originate from Asia, rather than Africa, they have never been exposed to SIV, and thus have no natural immune responses to it. A Rhesus macaque that is infected with SIV will therefore develop AIDS type illnesses in a relatively short time 2.
For this reason (and because they are not an endangered species like some other Asian primates), macaques are often used in HIV research. A few HIV drugs, such as AZT and tenofovir (see our Introduction to Antiretroviral Treatment page for more information about these), have been tested on macaques for efficacy, though stricter rules on the use of primates in animal testing, and greater knowledge of HIV, mean that more modern antiretrovirals are generally only tested on animals for safety reasons.
Vaccine development on the other hand makes extensive use of primates. Because it could be seen as unethical to give a healthy human a vaccine, and then expose them to HIV to see if the vaccine works (if it doesn’t, they’ll end up with HIV), animals can be used as substitutes to establish whether a vaccine is effective or not. This method can also be used to test the usefulness of current AIDS drugs (such as tenofovir) in preventing HIV infection. Such work of course raises significant questions over whether it is any more ethical to give a monkey HIV than a human, when it too may become sick with AIDS and die.
A fundamental problem with using macaques in vaccine research has been that they have different immune systems to humans. This means they cannot be infected with HIV-1 (although they are susceptible to certain strains of HIV-2), however they can be infected with SIV, or an SIV-HIV combination (‘chimeric’ virus) known as SHIV. A drug or vaccine that is effective in Rhesus monkeys infected with SIV or SHIV may not therefore be effective in humans with HIV. Conversely, a drug or vaccine that may be effective in an HIV positive human may be dropped because it appears ineffective in animals. Scientists have now constructed a simian strain of HIV-1 that differs from the human virus by only one gene and mimics early HIV infection, however the infected macaques did not develop AIDS3. Further research on this genetically engineered virus is necessary, however if successful this may make testing vaccines in primates potentially more reliable.
Monkey research has yielded significant discoveries about HIV in recent years4, including major findings that have strengthened understanding of early SIV and HIV infection5.
General research
As well as the testing of new drugs and other products, animals may also be used for more general research that aims to gain a greater understanding of a disease. Rhesus macaques, chimpanzees and even cats (who can get Feline Immunodeficiency Virus) may be used as human substitutes to see how HIV-like viruses operate within the body.
Rhesus Macaques are commonly used in HIV research
Rhesus Macaques are commonly used in HIV research
They can also be used to study natural phenomena such as transmission or disease progression, and the effects of non-therapeutic substances on HIV.
One example would be a study carried out in Rhesus macaques in 2006 6. Scientists looking at the effects of alcohol on SIV found that feeding the monkeys large quantities of alcoholic beverages over a short space of time (effectively making them ‘binge’ drink) could significantly speed up the rate at which HIV progressed to AIDS. This may well lead to a greater emphasis on moderate drinking amongst HIV positive people, and a reassessment of safe levels of alcohol. However, whether the results of this experiment could have been recreated using methods that didn’t involve animals is open to debate.
Can animal testing be justified?
Animal testing is an extremely controversial and hotly debated area, and there are many groups around the world that are strongly opposed to animals being involved in any form of experiment, even if it involves simply keeping them in captivity. Equally, there are groups who say that there is no alternative to animal testing, and that animals have saved many human lives. Some of the scientific and moral arguments for and against animal testing include:
* FOR: Animal testing is justified because of the many human lives that it can save
* AGAINST: There is no firm evidence that animal testing has saved anyone’s life directly, particularly in the case of HIV – most drugs could probably have been developed without the use of animals.
* FOR: Humans are clearly unique amongst animals in our abilities and intellect. Animals do not experience pain and emotion in the same way that we do because they lack language and the power of abstract thought
* AGAINST: An animal’s life is equal to a human’s and we have no right to assume otherwise simply because animals cannot express their pain and suffering in words
* FOR: Animals are the best way to test vaccines, because it would be unethical to give a human a vaccine, and then to try to give them HIV to see if it works.
* AGAINST: It is no more ethical to give an animal a life-threatening illness than it is to give one to a human.
* FOR: SIV-infected chimps and Rhesus macaques are good substitutes for humans, and make drug and vaccine development far more simple
* AGAINST: Monkeys and chimpanzees do not have identical immune systems to humans, and may not respond to drugs or vaccines in the same way. Rhesus macaques also cannot be directly infected with HIV. No HIV vaccine has yet been developed, despite many years of animal involvement.
* FOR: Any differences between animal and human biology are generally known, and can be factored in to experiments
* AGAINST: This overlooks the effect that stress may have on the normal functioning of an animal’s body, which may in turn affect the results of the experiment
* FOR: Not testing new pharmaceutical products on animals is highly dangerous
* AGAINST: Animals are often poor substitutes for humans, and some compounds that may well cause no harm to an animal, could seriously harm a human being. Likewise, a drug that is toxic to the animal it is tested on, may have no toxicity, and even therapeutic benefits in humans.
* FOR: There are no viable alternatives to testing pharmaceutical products for safety on animals. Scientists already use in-vitro studies and computer models, and animal testing comes only after these tests have been performed. If a drug fails either test, it will not be given to animals anyway.
* AGAINST: Studies have suggested that ‘micro-dosing’ (where only a tiny amount of a product is given to a human through the skin) could be a new and very effective alternative to animal experiments 7. The recent news that scientists have grown a small piece of human liver tissue from stem cells could also mean that it may one day be possible to perform initial 'human' safety trials in a lab8.
* FOR: There are very strong laws in place to ensure that distress and pain in animals is kept to an absolute minimum
* AGAINST: Pain and suffering still occur, and simply being in captivity can cause great distress to an animal, just as it would to a human. Plus, animal testing facilities cannot be monitored at all times, so the sort of treatment animals receive on a daily basis can never truly be known.
* FOR: It is a legal requirement that drugs are tested on animals for safety in the majority of countries. Scientists have no choice in this matter.
* AGAINST: Perhaps if laws on the necessity for animal testing were relaxed, or animal safety-testing were banned, it would encourage scientists to develop other methods of testing toxicity that were equally effective. At the moment, they have no incentive to do so, so only a small handful of alternatives are being tested.
* FOR: No scientist wants to cause any more injury to an animal than is strictly necessary. Most scientists build up strong attachments to the animals they use in their experiments.
* AGAINST: This may be the case, but it is also very easy to become blasé about something that you do every day, and forget the pain and suffering your work is inflicting. Animals may well become little more than useful objects of study, rather than live creatures, and this can mean they are treated as disposable rather than indispensable.
What do HIV+ people think of animal testing?
Many HIV positive people condone, or remain neutral on animal testing because they are aware that the drugs they take to keep them alive have very likely been tested on animals at some point in the past.
Could human 'guinea pigs' be viable alternatives to real ones when testing new drugs?
Could human 'guinea pigs' be viable alternatives to real ones when testing new drugs?
In September 2005, six well-known AIDS organisations in the USA got together to form ‘Patient Advocates Against PETA’ (PAAP), a group that opposed the strong anti-animal testing stance of People for the Ethical Treatment of Animals (PETA) 9. Formed of ACT UP DC, ACT UP Southern California, AIDS Healthcare Foundation, AIDS/HIV Health Alternatives, AmASSI and the HIV Incarcerated Task Force, PAAP argued that PETA’s constant high-profile protests were hindering scientists in their search for effective HIV vaccines.
Their work was however opposed by a number of HIV positive individuals, who declared they were strongly opposed to animal testing, and did not condone PAAP’s actions. A consensus amongst HIV positive people themselves on the benefits of animal testing is obviously not very forthcoming.
What is the future for HIV and animal testing?
In recent years, scientists have begun to investigate the possibility of genetically altering the genes of some animals (particularly mice) to give them immune systems that more closely resemble a human’s, and are thus susceptible to HIV infection. Such small animal models could be useful, both for those developing new vaccines, and for those testing drugs for safety, but such work is strongly opposed by those who do not believe that genetically modifying animals is morally right or safe, as well as by those who oppose animal testing altogether.
Another alternative recently proposed is infecting ordinary mice with a chimeric form of HIV, similar to the 'SHIV' used to infect primates. This would allow efficacy trials of drugs and vaccines to be performed on small mammals, which could perhaps be combined with safety trials to reduce the time taken to reach regulatory approval. However, this would potentially increase rather than reduce the number of animals involved in clinical testing.10
Regulations on animal testing have been tightened considerably in recent years, and animals, particularly primates, are used in far fewer experiments than they once were. In most countries (particularly the UK, which has the tightest regulations on the use of animals for science) facilities where animals are held are inspected regularly to ensure that animals are being kept in hygienic, safe and comfortable conditions.
Nonetheless, animal testing is still very strongly opposed by many groups who believe that any form of animal exploitation is wrong. The majority of anti-vivisection groups stage peaceful protests that aim to raise awareness of the harm and pain that animal testing can inflict, and raise support amongst the public for a ban on the practice. However a small minority of animal rights activists have resorted to more extreme tactics, which have included intimidation of those directly involved in experimentation, intimidation of their families, suppliers and business partners, and criminal acts, ranging from harassment and vandalism to blackmail and arson 11, 12, 13.
Unfortunately, while such groups receive substantial media coverage, their extreme actions tend to drown out the messages of more moderate groups, who are simply calling for a reassessment of the law, or greater research and assessment of alternative methods. Their behaviour creates a counter-productive situation, whereby those who conduct experiments on animals become more determined to continue with their work because of the opposition they face, and the government refuses to launch a proper investigation into the current laws in case they are seen as ‘giving in’ to extremists. It also risks portraying all animal rights campaigners as extreme activists and all scientists as cruel animal abusers.
In reality, views on animal testing are not nearly as polarised as this. There are many moderate anti-vivisection groups, just as there are many scientists who would prefer not to test on animals if they had a choice. A meaningful debate between the two may well help to further progress into ending the reliance on animals for safety and efficacy testing, but while the issue remains connected to such controversy and extremism, discussions of this kind seem to be few and far between.
It may be that one day animal research produces a vaccine or a cure for HIV that saves millions of human lives. If this is the case, then some justification can perhaps be found in using animals for our own purposes. Until this time however, anti-vivisectionists need to remain focused on finding alternatives, informing and changing legislation and keeping testing on animals to an absolute minimum. It is only through such positive action that true progress can be made.
Where Next?
AVERT.org has more about:
* Global HIV & AIDS epidemic
* AIDS vaccine
* Microbicides
* HIV structure and life cycle
* back to top
* AddThis Social Bookmark Button What's this?
Written by Bonita de Boer
References:
1. UK Medicines Act, 1968
2. NIAID Division of AIDS "Animal Models"
3. Theodora Hatziioannou et al. (2009) 'A Macaque model of HIV-1 Infection' PNAS
4. Lackner, A.A & Veasey, R.S (2007) 'Current concepts in AIDS pathogenesis: insights from the SIV/macaque model', Annual Review of Medicine, 58:461-76
5. Veazey, R.S et al (1998) 'Gastrointestinal tract as a major site of CD4+ cell depletion and viral replication in SIV infection', Science Vol.280; 427-431
6. "Chronic Binge Ethanol Consumption Accelerates Progression of Simian Immunodeficiency Virus Disease" Alcoholism: Clinical and Experimental research, October 2006, Vol. 30 Issue 10.
7. "'Safer' drug test technique hope" BBC.co.uk, 08th October 2006
8. "Liver cells grown from cord blood" BBC.co.uk, 31st October 2006
9. "AIDS Coalition Clashes with Animal Rights Activists" The New Standard, 20 September 2006
10. HADAS, Eran et al. 11 May 2007, 'Testing antiretroviral drug efficacy in conventional mice infected with chimeric HIV-1', AIDS, Vol. 21 No. 8.
11. "Man admits animal rights bombs" BBC.co.uk, 17 August 2006
12. "Four jailed in grave-theft case" BBC.co.uk, 11 May 2006
13. "3 animal-rights activists get prison time" San Francisco Chronicle, 13 September 2006
Last updated December 23, 2009
Other site information
* home
* disclaimer
* copyright
* site information
* site map
* link to us
Developing therapeutic and diagnostic products for use in humans is a long and complex process. With HIV infection, the search for effective drugs and vaccines has proven particularly difficult, as HIV is exceptionally good at changing its structure and evading destruction. In an ideal world, scientists would be able to test thousands of different compounds on human participants to see if any cured, treated or vaccinated them against HIV. However, to do this would be both highly time consuming and dangerous, as most compounds would not be effective, and some might cause illness or even death.
Researchers therefore often use animals to help them test the efficacy of drugs and vaccines, and to make sure that these products are safe. There are of course many ethical implications to animal experimentation, and many people are strongly opposed to the use of animals in any sort of experiment or study that may cause them distress or harm. So is it really necessary to use animals in the production of HIV drugs and vaccines? And are there any alternatives to animal testing?
Why are tests performed on animals?
There are three reasons why animals may be used in scientific experimentation. The first is to ensure the safety of new drugs and other pharmaceutical products. The second is to see whether such products might be effective in humans. The third is for general research into the biology of an animal, or the function and action of certain diseases within its body.
Safety trials
In many countries it is a legal requirement that all drugs and vaccines (not just for HIV) are tested on animals to ensure safety. In the United Kingdom for example, the Medicines Act of 1968 1 states that all new pharmaceutical products must be tested on at least two different species of live mammal, one of which must be a large non-rodent. This legislation was introduced shortly after the discovery that the drug Thalidomide could cause serious physical deformities in babies born to mothers who had taken it during pregnancy. Thalidomide was not thoroughly tested on animals (particularly pregnant animals) before it was prescribed to women, and this case is the root of many countries’ animal testing safety laws today.
Thousands of mice and other small rodents are used in animal experiments every year
Thousands of mice and other small rodents are used in animal experiments
every year
Animal safety tests usually come at the end of a long process of safety data collection that may include testing the product ‘in vitro’ (i.e. in a test-tube) and using a computer program to simulate what might happen to the drug inside the body. The regulations on what safety data is required for a new product vary from country to country (and also from drug to drug), but most drug authorities require all three types of data - animal, in vitro and computer- generated - for trials to be allowed to continue.
All this means that at some point, all ‘antiretroviral’ (anti-AIDS) drugs will have been tested on animals for safety.
There is an argument however that animals are actually fairly poor substitutes for humans and that some compounds that may well cause no harm to a mouse, could kill a human being. This is particularly the case for drugs that interact with the complex human immune system, such as the anti-inflammatory drug that caused major organ failure in six men involved in a trial at Northwick Park Hospital in London, England in 2006. However, such occurrences are rare.
Efficacy trials
While all drugs and vaccines have to be tested on animals to establish their safety, testing them to establish their effectiveness is a different matter.
HIV is a retrovirus specific to humans (hence the name ‘Human Immunodeficiency Virus’), which means it is not naturally found in any other animal. Some African primates, such as chimpanzees and a few species of monkey, are naturally infected with SIV (Simian Immunodeficiency Virus), which is believed to be the virus from which HIV originated. Chimpanzees can also be artificially infected with HIV in a laboratory. However most monkeys and chimpanzees have very efficient immune responses to SIV (and HIV), and do not develop AIDS, even after many years of infection. This can make it very difficult to assess whether a drug or vaccine actually works, so primates are not used as widely as human substitutes as they once were.
This said, there is one primate still commonly used to conduct efficacy testing: the Rhesus macaque monkey. Because Rhesus macaques originate from Asia, rather than Africa, they have never been exposed to SIV, and thus have no natural immune responses to it. A Rhesus macaque that is infected with SIV will therefore develop AIDS type illnesses in a relatively short time 2.
For this reason (and because they are not an endangered species like some other Asian primates), macaques are often used in HIV research. A few HIV drugs, such as AZT and tenofovir (see our Introduction to Antiretroviral Treatment page for more information about these), have been tested on macaques for efficacy, though stricter rules on the use of primates in animal testing, and greater knowledge of HIV, mean that more modern antiretrovirals are generally only tested on animals for safety reasons.
Vaccine development on the other hand makes extensive use of primates. Because it could be seen as unethical to give a healthy human a vaccine, and then expose them to HIV to see if the vaccine works (if it doesn’t, they’ll end up with HIV), animals can be used as substitutes to establish whether a vaccine is effective or not. This method can also be used to test the usefulness of current AIDS drugs (such as tenofovir) in preventing HIV infection. Such work of course raises significant questions over whether it is any more ethical to give a monkey HIV than a human, when it too may become sick with AIDS and die.
A fundamental problem with using macaques in vaccine research has been that they have different immune systems to humans. This means they cannot be infected with HIV-1 (although they are susceptible to certain strains of HIV-2), however they can be infected with SIV, or an SIV-HIV combination (‘chimeric’ virus) known as SHIV. A drug or vaccine that is effective in Rhesus monkeys infected with SIV or SHIV may not therefore be effective in humans with HIV. Conversely, a drug or vaccine that may be effective in an HIV positive human may be dropped because it appears ineffective in animals. Scientists have now constructed a simian strain of HIV-1 that differs from the human virus by only one gene and mimics early HIV infection, however the infected macaques did not develop AIDS3. Further research on this genetically engineered virus is necessary, however if successful this may make testing vaccines in primates potentially more reliable.
Monkey research has yielded significant discoveries about HIV in recent years4, including major findings that have strengthened understanding of early SIV and HIV infection5.
General research
As well as the testing of new drugs and other products, animals may also be used for more general research that aims to gain a greater understanding of a disease. Rhesus macaques, chimpanzees and even cats (who can get Feline Immunodeficiency Virus) may be used as human substitutes to see how HIV-like viruses operate within the body.
Rhesus Macaques are commonly used in HIV research
Rhesus Macaques are commonly used in HIV research
They can also be used to study natural phenomena such as transmission or disease progression, and the effects of non-therapeutic substances on HIV.
One example would be a study carried out in Rhesus macaques in 2006 6. Scientists looking at the effects of alcohol on SIV found that feeding the monkeys large quantities of alcoholic beverages over a short space of time (effectively making them ‘binge’ drink) could significantly speed up the rate at which HIV progressed to AIDS. This may well lead to a greater emphasis on moderate drinking amongst HIV positive people, and a reassessment of safe levels of alcohol. However, whether the results of this experiment could have been recreated using methods that didn’t involve animals is open to debate.
Can animal testing be justified?
Animal testing is an extremely controversial and hotly debated area, and there are many groups around the world that are strongly opposed to animals being involved in any form of experiment, even if it involves simply keeping them in captivity. Equally, there are groups who say that there is no alternative to animal testing, and that animals have saved many human lives. Some of the scientific and moral arguments for and against animal testing include:
* FOR: Animal testing is justified because of the many human lives that it can save
* AGAINST: There is no firm evidence that animal testing has saved anyone’s life directly, particularly in the case of HIV – most drugs could probably have been developed without the use of animals.
* FOR: Humans are clearly unique amongst animals in our abilities and intellect. Animals do not experience pain and emotion in the same way that we do because they lack language and the power of abstract thought
* AGAINST: An animal’s life is equal to a human’s and we have no right to assume otherwise simply because animals cannot express their pain and suffering in words
* FOR: Animals are the best way to test vaccines, because it would be unethical to give a human a vaccine, and then to try to give them HIV to see if it works.
* AGAINST: It is no more ethical to give an animal a life-threatening illness than it is to give one to a human.
* FOR: SIV-infected chimps and Rhesus macaques are good substitutes for humans, and make drug and vaccine development far more simple
* AGAINST: Monkeys and chimpanzees do not have identical immune systems to humans, and may not respond to drugs or vaccines in the same way. Rhesus macaques also cannot be directly infected with HIV. No HIV vaccine has yet been developed, despite many years of animal involvement.
* FOR: Any differences between animal and human biology are generally known, and can be factored in to experiments
* AGAINST: This overlooks the effect that stress may have on the normal functioning of an animal’s body, which may in turn affect the results of the experiment
* FOR: Not testing new pharmaceutical products on animals is highly dangerous
* AGAINST: Animals are often poor substitutes for humans, and some compounds that may well cause no harm to an animal, could seriously harm a human being. Likewise, a drug that is toxic to the animal it is tested on, may have no toxicity, and even therapeutic benefits in humans.
* FOR: There are no viable alternatives to testing pharmaceutical products for safety on animals. Scientists already use in-vitro studies and computer models, and animal testing comes only after these tests have been performed. If a drug fails either test, it will not be given to animals anyway.
* AGAINST: Studies have suggested that ‘micro-dosing’ (where only a tiny amount of a product is given to a human through the skin) could be a new and very effective alternative to animal experiments 7. The recent news that scientists have grown a small piece of human liver tissue from stem cells could also mean that it may one day be possible to perform initial 'human' safety trials in a lab8.
* FOR: There are very strong laws in place to ensure that distress and pain in animals is kept to an absolute minimum
* AGAINST: Pain and suffering still occur, and simply being in captivity can cause great distress to an animal, just as it would to a human. Plus, animal testing facilities cannot be monitored at all times, so the sort of treatment animals receive on a daily basis can never truly be known.
* FOR: It is a legal requirement that drugs are tested on animals for safety in the majority of countries. Scientists have no choice in this matter.
* AGAINST: Perhaps if laws on the necessity for animal testing were relaxed, or animal safety-testing were banned, it would encourage scientists to develop other methods of testing toxicity that were equally effective. At the moment, they have no incentive to do so, so only a small handful of alternatives are being tested.
* FOR: No scientist wants to cause any more injury to an animal than is strictly necessary. Most scientists build up strong attachments to the animals they use in their experiments.
* AGAINST: This may be the case, but it is also very easy to become blasé about something that you do every day, and forget the pain and suffering your work is inflicting. Animals may well become little more than useful objects of study, rather than live creatures, and this can mean they are treated as disposable rather than indispensable.
What do HIV+ people think of animal testing?
Many HIV positive people condone, or remain neutral on animal testing because they are aware that the drugs they take to keep them alive have very likely been tested on animals at some point in the past.
Could human 'guinea pigs' be viable alternatives to real ones when testing new drugs?
Could human 'guinea pigs' be viable alternatives to real ones when testing new drugs?
In September 2005, six well-known AIDS organisations in the USA got together to form ‘Patient Advocates Against PETA’ (PAAP), a group that opposed the strong anti-animal testing stance of People for the Ethical Treatment of Animals (PETA) 9. Formed of ACT UP DC, ACT UP Southern California, AIDS Healthcare Foundation, AIDS/HIV Health Alternatives, AmASSI and the HIV Incarcerated Task Force, PAAP argued that PETA’s constant high-profile protests were hindering scientists in their search for effective HIV vaccines.
Their work was however opposed by a number of HIV positive individuals, who declared they were strongly opposed to animal testing, and did not condone PAAP’s actions. A consensus amongst HIV positive people themselves on the benefits of animal testing is obviously not very forthcoming.
What is the future for HIV and animal testing?
In recent years, scientists have begun to investigate the possibility of genetically altering the genes of some animals (particularly mice) to give them immune systems that more closely resemble a human’s, and are thus susceptible to HIV infection. Such small animal models could be useful, both for those developing new vaccines, and for those testing drugs for safety, but such work is strongly opposed by those who do not believe that genetically modifying animals is morally right or safe, as well as by those who oppose animal testing altogether.
Another alternative recently proposed is infecting ordinary mice with a chimeric form of HIV, similar to the 'SHIV' used to infect primates. This would allow efficacy trials of drugs and vaccines to be performed on small mammals, which could perhaps be combined with safety trials to reduce the time taken to reach regulatory approval. However, this would potentially increase rather than reduce the number of animals involved in clinical testing.10
Regulations on animal testing have been tightened considerably in recent years, and animals, particularly primates, are used in far fewer experiments than they once were. In most countries (particularly the UK, which has the tightest regulations on the use of animals for science) facilities where animals are held are inspected regularly to ensure that animals are being kept in hygienic, safe and comfortable conditions.
Nonetheless, animal testing is still very strongly opposed by many groups who believe that any form of animal exploitation is wrong. The majority of anti-vivisection groups stage peaceful protests that aim to raise awareness of the harm and pain that animal testing can inflict, and raise support amongst the public for a ban on the practice. However a small minority of animal rights activists have resorted to more extreme tactics, which have included intimidation of those directly involved in experimentation, intimidation of their families, suppliers and business partners, and criminal acts, ranging from harassment and vandalism to blackmail and arson 11, 12, 13.
Unfortunately, while such groups receive substantial media coverage, their extreme actions tend to drown out the messages of more moderate groups, who are simply calling for a reassessment of the law, or greater research and assessment of alternative methods. Their behaviour creates a counter-productive situation, whereby those who conduct experiments on animals become more determined to continue with their work because of the opposition they face, and the government refuses to launch a proper investigation into the current laws in case they are seen as ‘giving in’ to extremists. It also risks portraying all animal rights campaigners as extreme activists and all scientists as cruel animal abusers.
In reality, views on animal testing are not nearly as polarised as this. There are many moderate anti-vivisection groups, just as there are many scientists who would prefer not to test on animals if they had a choice. A meaningful debate between the two may well help to further progress into ending the reliance on animals for safety and efficacy testing, but while the issue remains connected to such controversy and extremism, discussions of this kind seem to be few and far between.
It may be that one day animal research produces a vaccine or a cure for HIV that saves millions of human lives. If this is the case, then some justification can perhaps be found in using animals for our own purposes. Until this time however, anti-vivisectionists need to remain focused on finding alternatives, informing and changing legislation and keeping testing on animals to an absolute minimum. It is only through such positive action that true progress can be made.
Where Next?
AVERT.org has more about:
* Global HIV & AIDS epidemic
* AIDS vaccine
* Microbicides
* HIV structure and life cycle
* back to top
* AddThis Social Bookmark Button What's this?
Written by Bonita de Boer
References:
1. UK Medicines Act, 1968
2. NIAID Division of AIDS "Animal Models"
3. Theodora Hatziioannou et al. (2009) 'A Macaque model of HIV-1 Infection' PNAS
4. Lackner, A.A & Veasey, R.S (2007) 'Current concepts in AIDS pathogenesis: insights from the SIV/macaque model', Annual Review of Medicine, 58:461-76
5. Veazey, R.S et al (1998) 'Gastrointestinal tract as a major site of CD4+ cell depletion and viral replication in SIV infection', Science Vol.280; 427-431
6. "Chronic Binge Ethanol Consumption Accelerates Progression of Simian Immunodeficiency Virus Disease" Alcoholism: Clinical and Experimental research, October 2006, Vol. 30 Issue 10.
7. "'Safer' drug test technique hope" BBC.co.uk, 08th October 2006
8. "Liver cells grown from cord blood" BBC.co.uk, 31st October 2006
9. "AIDS Coalition Clashes with Animal Rights Activists" The New Standard, 20 September 2006
10. HADAS, Eran et al. 11 May 2007, 'Testing antiretroviral drug efficacy in conventional mice infected with chimeric HIV-1', AIDS, Vol. 21 No. 8.
11. "Man admits animal rights bombs" BBC.co.uk, 17 August 2006
12. "Four jailed in grave-theft case" BBC.co.uk, 11 May 2006
13. "3 animal-rights activists get prison time" San Francisco Chronicle, 13 September 2006
Last updated December 23, 2009
Other site information
* home
* disclaimer
* copyright
* site information
* site map
* link to us
Subscribe to:
Posts (Atom)