"Origami condoms" paid for by the U.S. taxpayers were first tested on female rabbits, which were killed after having pieces of silicone inserted in them for five days.
Daniel Resnic, who received more than $2.4 million to develop his brand of condoms modeled off of Japanese folding paper, and is now being accused of massive fraud, received his first grant from the National Institutes of Health (NIH) for a feasibility study in 2006. In 2007, he conducted his first clinical study.
After the initial $212,162 grant, Resnic applied for more funds to develop the "RAI [Receptive Anal Intercourse] Condom" in January 2009.
His application revealed that his first male condom prototype, aside from being tested on 10 couples, was approved by the U.S. Department of Agriculture (USDA) for testing on rabbits under the Animal Welfare Act.
Pieces of cut up condoms were inserted into New Zealand White rabbits for a "Vaginal irritation test." The fragments were "instilled into the vaginal vault of three (3) rabbits per extract vehicle for five consecutive days."
"After the five day exposure, the animals were sacrificed and the vaginal tissue removed," according to the testing report sponsored by Nelson Laboratories, Inc.
"The rabbits were sacrificed by lethal injection with a sodium pentobarbital based solution (Euthasol) the day after the last dose and the vaginal tissue was carefully removed," it said.
At least six rabbits were used, three each for the testing group and a control group.
The document said the testing satisfied the Animal Welfare Act because it was needed to fulfill a "state or federal regulatory requirement" or was "scientifically necessary."
People for the Ethical Treatment of Animals (PETA) harshly condemned the use of rabbits for the test.
"No animal should have to suffer and die to test condoms," said Jeff Brown, research associate with PETA's Regulatory Testing Division.
"If you or your neighbor did what these experimenters did to animals, they'd be charged with animal cruelty," he said. "Yet a ‘researcher’ puts on a white lab coat and suddenly this kind of animal abuse is acceptable."
Brown also questioned the legality of the testing after reviewing the lab report.
"It appears from the research plan that the developers of this product did not make any attempt to avoid using rabbits in vaginal irritation and several related tests even though medical-grade silicone has already been tested extensively, and the plan itself states that silicone has not been associated with these problems and has only minor side effects that are self-limiting," he said. "The company further subjected dozens of mice to painful skin allergy testing."
"It also appears that they failed to work with regulators to avoid the use of animals," Brown added. "The international testing standard that the US Food and Drug Administration (FDA) applies to these cases states that rabbits should not be used if safety data can be obtained by other means and there is no requirement to use any animals in order for a company to make its own version of a condom that is already on the market."
Brown referenced a 2010 International Organization for Standardization (IOS) report on evaluating medical devices, which states, "The vaginal irritation test shall only be considered for materials intended for contact with vaginal tissue and if safety data cannot be obtained by other means."
"Until companies and regulators make good science and reducing animal suffering a priority and the FDA clarifies the ways in which companies can avoid using animals, rabbits and many other animals will continue to suffer these kinds of cruel, useless, and duplicative tests," Brown said.
According to his application, Resnic asked for $731,199 to finance the entire study for his "first of its kind" anal condom on January 8, 2009. The federal government was more generous, and awarded him $828,188 just six months later.
He received an additional $302,482 in 2010. The total study cost for the RAI condom cost $1,130,670.
Tanya Espinosa, a public affairs specialist for USDA-APHIS, said her agency is not responsible for what goes on in research facilities.
"The [Animal Welfare Act] AWA regulations do not regulate what research is conducted by a facility," she said. "They do require facilities to appoint an Institutional Animal Care and Use Committee (IACUC). The IACUC is required to review a facility's program for humane use and care of animals a minimum of once every six months. They must also inspect the animal facilities a minimum of once every six months. IACUCs are required to prepare reports based on their evaluations, investigate any concerns, make recommendations and modifications, require modifications if needed and suspend activity involving animals as needed."
"As I mentioned above, USDA is not the approval authority for testing done at facilities, however, we do inspect those facilities for compliance with the Animal Welfare Act," Espinosa said. "Inspection reports for this facility and all of our regulated facilities for the last three years can be viewed on our online database and are available online at www.aphis.usda.gov."
Since the testing was conducted seven years ago, Espinosa suggested filing a Freedom of Information Act request for the records.
The NIH issued a statement that defended killing the rabbits, so their tissue could be examined, post-mortem.
"Federally-supported scientists, including Mr. Resnic, are accountable for the protection of research animals' welfare from the earliest stages of planning until the project's completion," the agency said. "Before beginning the research, scientists must provide thorough, written justification for animal use, as well as a meticulous description of how animals will be housed and cared for and how veterinary care will be provided."
"The use of animals is to ensure safety and efficacy of the product prior to clinical trials in humans and is required by federal regulations administered by the Food and Drug Administration," the NIH added. "Regarding the use of rabbits in the preclinical study, euthanasia of the animals was necessary to allow microscopic examination of the tissues to determine safety of the product."