Drug Testing and the Emperor’s New Clothes
People for the Ethical Treatment of Animals - PETA
March 29, 2006
By Jessica Sandler
When six men in England signed up for the Parexel clinical trial involving a new pharmaceutical drug called TGN1412 they were probably thinking that it was a great way to earn some extra cash. Now they lie in a London hospital, fighting for their lives. What went wrong is still being investigated, but Americans should pay close attention. It’s been clear for some time that the U.S. Food and Drug Administration needs to overhaul its outdated testing system.
Ninety-two out of every 100 drugs that pass animal tests fail in clinical trials in people. Every year in the United States alone, there are more than 100,000 human deaths caused by drugs that successfully underwent testing on animals and more than 2 million people are harmed. Even the U.S. Food and Drug Administration admits that this is a crisis.
The Parexel case fits this pattern. TeGenero AG, the German firm responsible for testing and marketing this particular drug "had submitted the results from animal safety tests … [and] there had been no irregularities in the animal tests."
The problem is that drug tests on animals do not always accurately predict what will happen to people. The animal testing industry is facing a number of serious scandals, including the recall of Vioxx, which is just the latest on a long list of drugs that have been withdrawn from the market because their adverse health effects on humans were not predicted by animal studies. The use of Vioxx resulted in more than 140,000 deaths worldwide even though animal studies had shown it to be safe and even heart-protective in mice, rats and monkeys. Using animals for drug development and testing is not only ineffective, it’s downright dangerous. Differing animal and human drug responses are the rule rather than the exception
More broadly, the animal experimentation industry has to answer charges from renowned scientists, including the former head of the U.S. National Cancer Institute (NCI), who summarised the last 25 years of cancer research by admitting that "the history of cancer research has been the history of curing cancer in the mouse. We have cured mice of cancer for decades, and it simply didn’t work in humans …". Other scientists have concluded that, after studying tens of millions of animals, "many of the assumptions driving rat and mouse research do not appear to be valid" and "the problem is we don’t know what the findings really mean."
While the list of failed animal experiments grows daily, the list of human-derived discoveries and therapies is extensive and includes anaesthesia, antisepsis, germ theory, morphine, radium, x-rays, the link between cholesterol and heart disease, the link between smoking and cancer, CAT scans, PET scans and MRIs. While all animal-derived vaccines for multiple sclerosis (MS) have failed in humans, a new vaccine developed from the blood of MS patients was successful in a small clinical trial and is now being tested in larger studies.
In the realm of drug testing, microdosing and tissue engineering are two promising methods. Neither involves non-human animals. Using tissues from various organs to mimic the human condition, the former director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Carl Peck, is now working on methods that may eliminate the need for all but one human clinical trial. Microdosing allows precise evaluation of drug activity in the human body using miniscule drug doses.
The Hurel biochip, which has a series of compartments lined with cells from various organs, allows a drug to encounter human cells in the same order it would encounter them in the human body. Researchers are now looking at making the biochips from a specific patient’s cells, thus permitting doctors to predict whether a particular patient can take a specific drug safely and effectively. There is no longer any excuse to rely on crude testing methods that use terrified, neurotic and sick animals. The pharmaceutical industry loves to tell us how beautifully the Emperor is clothed. But we know he's naked; the system is broken and needs fixing.
Safety and health expert Jessica Sandler is the head of PETA’s regulatory testing division. Contact her at People for the Ethical Treatment of Animals, 501 Front St., Norfolk, VA 23510; StopAnimalTests.com.
When six men in England signed up for the Parexel clinical trial involving a new pharmaceutical drug called TGN1412 they were probably thinking that it was a great way to earn some extra cash. Now they lie in a London hospital, fighting for their lives. What went wrong is still being investigated, but Americans should pay close attention. It’s been clear for some time that the U.S. Food and Drug Administration needs to overhaul its outdated testing system.
Ninety-two out of every 100 drugs that pass animal tests fail in clinical trials in people. Every year in the United States alone, there are more than 100,000 human deaths caused by drugs that successfully underwent testing on animals and more than 2 million people are harmed. Even the U.S. Food and Drug Administration admits that this is a crisis.
The Parexel case fits this pattern. TeGenero AG, the German firm responsible for testing and marketing this particular drug "had submitted the results from animal safety tests … [and] there had been no irregularities in the animal tests."
The problem is that drug tests on animals do not always accurately predict what will happen to people. The animal testing industry is facing a number of serious scandals, including the recall of Vioxx, which is just the latest on a long list of drugs that have been withdrawn from the market because their adverse health effects on humans were not predicted by animal studies. The use of Vioxx resulted in more than 140,000 deaths worldwide even though animal studies had shown it to be safe and even heart-protective in mice, rats and monkeys. Using animals for drug development and testing is not only ineffective, it’s downright dangerous. Differing animal and human drug responses are the rule rather than the exception
More broadly, the animal experimentation industry has to answer charges from renowned scientists, including the former head of the U.S. National Cancer Institute (NCI), who summarised the last 25 years of cancer research by admitting that "the history of cancer research has been the history of curing cancer in the mouse. We have cured mice of cancer for decades, and it simply didn’t work in humans …". Other scientists have concluded that, after studying tens of millions of animals, "many of the assumptions driving rat and mouse research do not appear to be valid" and "the problem is we don’t know what the findings really mean."
While the list of failed animal experiments grows daily, the list of human-derived discoveries and therapies is extensive and includes anaesthesia, antisepsis, germ theory, morphine, radium, x-rays, the link between cholesterol and heart disease, the link between smoking and cancer, CAT scans, PET scans and MRIs. While all animal-derived vaccines for multiple sclerosis (MS) have failed in humans, a new vaccine developed from the blood of MS patients was successful in a small clinical trial and is now being tested in larger studies.
In the realm of drug testing, microdosing and tissue engineering are two promising methods. Neither involves non-human animals. Using tissues from various organs to mimic the human condition, the former director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Carl Peck, is now working on methods that may eliminate the need for all but one human clinical trial. Microdosing allows precise evaluation of drug activity in the human body using miniscule drug doses.
The Hurel biochip, which has a series of compartments lined with cells from various organs, allows a drug to encounter human cells in the same order it would encounter them in the human body. Researchers are now looking at making the biochips from a specific patient’s cells, thus permitting doctors to predict whether a particular patient can take a specific drug safely and effectively. There is no longer any excuse to rely on crude testing methods that use terrified, neurotic and sick animals. The pharmaceutical industry loves to tell us how beautifully the Emperor is clothed. But we know he's naked; the system is broken and needs fixing.
Safety and health expert Jessica Sandler is the head of PETA’s regulatory testing division. Contact her at People for the Ethical Treatment of Animals, 501 Front St., Norfolk, VA 23510; StopAnimalTests.com.
Print
Email
