A coalition of groups representing scientists, researchers, veterinarians, animal welfare groups, and concerned citizens filed a petition with the Food and Drug Administration on November 14 requesting that the agency promulgate a regulation mandating the use of scientifically satisfactory non-animal testing methods whenever possible to demonstrate the safety and efficacy of drugs and medical devices. The petition is signed by more than 100 individuals, organizations, scientists and academics who urge the agency to adopt the requested regulation. The regulation, if adopted, would bring the United States in line with the European Union, which already mandates the use of such non-animal alternatives.
To view the petition, go to www.alternatives-petition.org/.
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A coalition submitted a petition this week to the agency that seeks an end to animal testing. And the groups are threatening legal action if the FDA doesn’t respond within six months. Their rationale - a series of recent “tragedies” in which drugs “that seemed safe in animal tests injured or killed consumers or participants in clinical trials.”
In their Mandatory Alternatives Petition, they cite as examples “hormone replacement therapy for women, development of HIV protease inhibitors, Vioxx and other COX-2 inhibitors, teratology studies, harmful effects of smoking, non-steroidal anti-inflammatory drugs, antibiotics, antivirals, antidepressants, and cardiovascular medications, among others.” They also point to Merck’s failed HIV vaccine, which appeared safe and effective when tested in monkeys, but was halted when it appeared to increase the risk that trial participants may contract HIV.
“Dangerous drugs are killing American consumers because regulators allow drug companies to use misleading animal tests,” says John Pippin of the Physicians Committee for Responsible Medicine. “The Food and Drug Administration could avert these tragedies by focusing on human-centered methods.”
In a statement, the coalition claims “more than 90 percent of drugs tested in people after successful animal tests are not approved for wider use because they don’t work or they are unsafe. Half the drugs that are approved are later withdrawn or relabeled for adverse effects not detected by animal tests.” Here’s the petition.
To reduce such risks, the coalition is asking the FDA for wider use of what it calls “human-centered research methods such as microdosing, tissue studies, and virtual drug trials.” And they point to Europe, where they argue the use of scientifically satisfactory alternatives is mandated under European Union Directive 86/609/EEC.
The MAP is signed by more than 100 doctors, scientists, and other experts, including primatologist Roger Fouts; neurologist and public health expert Aysha Akhtar; pediatrician Roberta Gray, and economist Jeremy Rifkin. Nonprofit groups include the Association of Veterinarians for Animal Rights, the British Union for the Abolition of Vivisection, In Defense of Animals, the New England Anti-Vivisection Society, and the Physicians Committee for Responsible Medicine.
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