Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine
Fri, 01 Apr 2005
Government agencies are maneuvering to weaken legal protections prohibiting the exposure of human beings to experimental drugs, vaccines and procedures without their voluntary informed consent.
Even after a federal court has ordered the Pentagon to stop vaccinating military personnel with the experimental anthrax vaccine, the FDA is maneuvering to reclassify the vaccine as licensed without the required safety and efficacy tests.
Below is the Cover Letter to Acting FDA Commissioner, Lester Crawford which accompanied comments submitted by AHRP and the National Vaccine Information Center and the National Gulf War Resource Center.
Detailed Comments Submitted to FDA Re Anthrax Vaccine: http://www.ahrp.org/ahrpspeaks/anthraxFDAcomments0305.pdf
See also: Who Is Protecting The Public Health? By Meryl Nass, Z Magazine
We are taking our concerns to the wide public, thanks to a global press conference convened by the enormously popular heavy metal band, ANTHRAX, and the Slave to the Metal Foundation.
The press conference is scheduled for 2:00 ET/11:00 AM PT today at the SIRIUS Satellite Radio’s national broadcast center in New York City. It will be broadcast live on Hard Attack/27, SIRIUS’ extreme heavy metal channel.
For information about the press conference contact:
Maria Ferrero 732-462-4262 or maria at adrenalinepr com
SIRIUS Satellite Radio:
Elise Brown 212-584-5290 or ebrown at siriusradio com
Contact: Vera Hassner Sharav
Lester Crawford, Ph.D., D.V.M.
Acting FDA Commissioner
U. S. Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857-0001
March 29, 2005
Dear Acting FDA Commissioner Crawford, Ph.D., D.V.M.
When a federal judge ruled the vaccine to be an “investigational drug and a drug being used for an unapproved purpose” on December 22, 2003, FDA hurriedly issued a Final Rule for anthrax vaccine. The agency submitted its Final Rule just eight days after a federal court injunction, having failed to do so for 19 years. In a January 7, 2004 court hearing the same judge called FDA’s actions “highly suspicious.” On October 27, 2004 FDA’s arbitrary and capricious promulgation of this Final Rule resulted in a permanent injunction, remanding the license to your agency to complete according to the law. The injunction also halted what the judge called DoD’s “illegal” mandatory anthrax vaccination program.
Since late December 2004 FDA took two major steps to bring back the use of this experimental vaccine. First, FDA complied with the Defense Department and the Department of Health and Human Services to issue rules for an Emergency Use Authorization that would permit use of the vaccine despite its lack of a license. Since the court injunction allowed voluntary immunization with informed consent, the sole purpose of the EUA is to deny military service-members knowledge of deaths, chronic autoimmune disorders, and birth defects known by FDA to be associated with this BioPort anthrax vaccine.
Second, FDA opened a ninety-day comment period as a prerequisite to consideration of licensure of the vaccine, having been sanctioned by the court for not having opened the license to comment before issuing a final rule. We are very concerned by FDA’s actions, which ignore the significant departures from Food, Drug and Cosmetic Act standards in all aspects of this vaccine’s licensing process.
Accordingly, we have prepared the accompanying detailed comments to make perfectly clear the many regulatory failures in this vaccine’s history. The quality of the data supporting licensure is very poor, and almost all of the human data was obtained using very different vaccine formulations. No valid bridging studies exist to allow FDA to extrapolate data from these studies. FDA has used animal studies to justify licensure when no valid correlate of immunity exists. There is a high degree of product variability. The BioPort anthrax vaccine has never demonstrated efficacy in humans for any route of infection, and the very different protoype vaccine used in the Brachman study did not demonstrate inhalation efficacy. We understand that the vaccine is associated with a high rate of chronic, serious illnesses.
We have provided FDA with a large number of facts about the vaccine, and have footnoted relevant documents so your staff can substantiate the scientific basis of our comments. We believe there is abundant evidence to recategorize BioPort’s anthrax vaccine as a Category II biologic, “determined to be unsafe or ineffective or to be misbranded and which should not continue in interstate commerce.” We have asked FDA to respond to a number of questions posed in our comment, and we await your answers.
Human beings — including military service-members — deserve to make informed choices about vaccines and drugs. Unfortunately, FDA’s past actions have repeatedly undermined informed consent and have aided and abetted the military’s unlawful cover-up of the very real risks of this vaccine. We implore you to insure that the agency’s future regulatory actions place respect for both the law and and the dignity of all American citizens before the demands of the Department of Defense.
Our organizations appreciate this opportunity to comment and to provide the agency our expertise with anthrax vaccines. If the FDA follows the law and the science, your licensing decision should be very simple.
Meryl Nass, M.D., Director
Vera Sharav, President
Alliance for Human Research Protection.
Barbara Loe Fisher, President
National Vaccine Information Center
Steve Robinson, Executive Director
National Gulf War Resource Center