July 8, 2011
A History of Advocating for Animals Used in Botox Testing
2011 2010 2009 2008 2007 2006 2005 2004 2003
June: Allergan announces that the company has developed, and received US Food and Drug Administration (USDA) approval for, a new procedure that avoids using animals in testing batches of Botox© products. This cell-based alternative is expected to reduce Allergan’s use of animals for testing Botox by 95 percent within three years. Hurdles remain in phasing out animal use completely, including gaining international acceptance of the procedure, as well as determining if this new test can be tailored for use with other Botox-like products (i.e. Dysport®). Read more »
June: A website is established for the Federal Institute for Risk Assessment’s (BfR) Botulinum Neurotoxin Expert Working Group (BoNT EWG).
August: The Report and Recommendations of the Federal Institute for Risk Assessment’s (BfR) April 2009 Expert Group Meeting is published in the journal ATLA. The report is titled “The Current Scientific and Legal Status of Alternative Methods to the LD50 (Lethal Dose 50 Percent) test for Botulinum Neurotoxin Potency Testing”.
February: The Humane Society of the United Sates and the Calvert Asset Management Company, Inc. withdraw a shareholder resolution submitted to Allergan—the company that manufactures Botox® Cosmetic—in light of Allergan's “Corporate Statement on Animal Testing.” The statement indicates that the company has reduced animal use in its testing protocol by 78 percent and expresses a firm commitment to developing a non-animal test to replace the animal-based test currently used to assess new batches of Botox® Cosmetic. Allergan also agrees to provide future updates on its progress. The shareholder resolution, submitted in November 2009, urged Allergan to provide publicly available annual updates on the company's efforts to eliminate the controversial LD50 (Lethal Dose 50 Percent) test and replace it with a non-animal testing alternative. The HSUS and Calvert will continue to urge Allergan to completely phase out the use of animals tests in the production of Botox. Read more »
November: The Humane Society of the United Sates, with the Calvert Asset Management Company, Inc, submit a shareholder resolution which proposes that Allergan provide "annual updates describing the Company’s recent activities and future plans in pursuit of its stated goal of eliminating the animal-based LD50 (Lethal Dose 50 Percent) test from the manufacturing process of Botox and Botox Cosmetic."
November: The British Union for the Abolition of Vivisection releases the results of an undercover investigation of a laboratory that conducts LD50 (Lethal Dose 50 Percent) testing of a Botox competitor (Dysport). The footage depicts mice suffering and dying after injection with the product. The investigation also reveals that tens of thousands of mice were used to test Dysport in just 6 months. Read more »
August: According to results released from the May 2009 shareholder meeting, the HSUS/Calvert resolution (see Nov. 2008 entry) receives an 8.4 percent vote in its favor, surpassing the 6 percent support needed to secure the right to resubmit the resolution for the following year.
May: At Allergan's annual shareholder meeting, The HSUS presents the HSUS/Calvert resolution (see Nov. 2008 entry).
April: An international expert meeting is organized by the Federal Institute for Risk Assessment (BfR) in Berlin to look at “progress in alternative methods to [the LD50 (Lethal Dose 50 Percent) test] that entails considerable suffering for animals.” From this, the Botulinum Neurotoxin Expert Working Group (BoNT EWG) is established. The HSUS gives multiple presentations at this expert meeting.
April: The US National Institutes of Health and US Food and Drug Administration announce a funding opportunity for “Development of In-Vitro Assays to Assess the Potency of Botulinum Neurotoxin Type A”. Up to $100,000 is available for Phase I research and up to $750,000 is available for Phase II research.
November: The HSUS and Calvert submit a shareholder resolution calling for Allergan to "issue a statement, updated annually and omitting proprietary information, describing the Company's recent activities and future plans in pursuit of its stated goal of eliminating the animal-based LD50 (Lethal Dose 50 Percent) test from the manufacturing process of Botox and Botox Cosmetic."
August: According to results released from the May 2008 shareholder meeting, the HSUS/Calvert resolution (see Nov. 2007 entry) receives 5.7% votes in its favor, surpassing the 3% support needed to secure the right to resubmit the resolution for the following year.
May: The HSUS presents the HSUS/Calvert shareholder resolution (see Nov. 2007 entry) at Allergan's annual shareholder meeting. Read more »
April: The Washington Post runs a front page story quoting the HSUS's Dr. Martin Stephens on Botox testing
April: The HSUS and the Fund for the Replacement of Animals in Medical Experiments present a poster on Botox testing a European Directorate for the Quality of Medicines & HealthCare symposium on "Alternatives to Animal Testing"
February: The federal government’s Interagency Coordinating Committee on the Validation of Alternative Methods releases its "Report on the ICCVAM-NICEATM/ECVAM Scientific Workshop on Alternative Methods to Refine, Reduce or Replace the Mouse LD50 Assay for Botulinum Toxin Testing"
November: HSUS and Calvert submit a shareholder resolution asking Allergan to "issue a report, updated annually and omitting proprietary information, disclosing the Corporation's recent activities and future plans to eliminate the animal-based LD50 (Lethal Dose 50 Percent) test from the manufacturing process of Botox and Botox Cosmetic"
August: The Interagency Coordinating Committee on the Validation of Alternative Methods issues its “Draft Report on Alternative Methods for Botulinum Testing Workshop”
August: The HSUS and the Fund for the Replacement of Animals in Medical Experiments present a poster on Botox testing at 6th World Congress on Alternatives & Animal Use in the Life Sciences, in Tokyo
February: The HSUS holds final negotiations with the Food and Drug Administration in connection with our 2005 lawsuit against the agency over access to documents related to government regulation of Botox testing (see June 2005 entry) but the agency fails to release any meaningful information.
November: The Interagency Coordinating Committee on the Validation of Alternative Methods holds a “Scientific Workshop on Alternative Methods to Refine, Reduce and Replace the Mouse LD50 Assay For Botulinum Toxin Testing,” which was requested by The HSUS
August: ICCVAM releases a second Federal Register notice announcing they would move forward with a workshop and requesting existing in vivo (animal) and in vitro (non-animal) data;
December: Based on an HSUS request (see Oct. 2005 entry), the Scientific Advisory Committee on Alternative Toxicological Methods concludes that "A review of the state-of-the-science for 3R alternatives to current botulinum toxin potency testing methods in a step-wise fashion should be a high priority for ICCVAM"
October: The HSUS submits a Test Method Nomination to the Interagency Coordinating Committee on the Validation of Alternative Methods regarding "Alternative Methods to Replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing"
August: The HSUS and the Fund for the Replacement of Animals in Medical Experiments give a presentation on Botox testing at 5th World Congress on Alternatives & Animal Use in the Life Sciences, in Berlin
June: The HSUS sues the Food and Drug Administration to obtain information requested in two previous Freedom of Information Act requests
October: After Allergan spurns HSUS’s repeated requests for dialogue concerning its potency testing of Botox, HSUS goes public with the information that Allergan tests every batch of Botox using a highly controversial animal test
September: In a scholarly article, the Fund for the Replacement of Animals in Medical Experiments, a British charity, reveals that each batch of Botox and similar products is testing for potency using the highly controversial LD50 (Lethal Dose 50 Percent) test, which aims to determine the dose of the product that kills half of the animals tested.
January: HSUS sends letter to Allergan expressing concern over the company's use of the LD50 (Lethal Dose 50 Percent) test for assessing of the potency of Botox® Cosmetic.
September: In a scholarly article, the Fund for the Replacement of Animals in Medical Experiments, a British charity, reveals that each batch of Botox and similar products is testing for potency using the highly controversial LD50 (Lethal Dose 50 Percent) test, which aims to determine the dose of the product that kills half of the animals tested.