Dr. Meryl Nass, a member of the board of directors of The Alliance for Human Research Protection (AHRP), is an acknowledged expert on anthrax, biological terrorism, and is a US authority on adverse reactions due to the anthrax vaccine. Dr. Nass has been a leading opponent of U.S. military policies that continue to treat military servicemembers as a ready pool of experimental subjects, in the absence of meaningful informed consent.

Dr. Nass will be appeaing on several national and international TV and radio programs:

In her letter in the July issue of Emergency Medicine News (below) Dr. Meryl Nass cites a body of evidence linking the anthrax vaccine with systemic adverse medical reactions, and 100,000 to possibly 200,000 veterans who suffered adverse reactions. Dr. Nass says that financial interests are propelling the government's anthrax vaccination programs and that to protect the government from liability, the Department of Defense has adopted a policy of classifying vaccines, and omitting information about them from troops' immunization records.

Dr. Meryl Nass

An estimated 500,000 first responders, lab and hospital workers will receive smallpox vaccine, the DHHS announced yesterday.

This is an interesting announcement, because to my knowledge there exist no FDA-licensed smallpox vaccines.

There are three vaccine candidates whose safety and efficacy are uncertain at this time.

The first vaccine made available was Wyeth's Dryvax, which was pulled out of storage after approximately thirty years.

REASONS FOR OPPOSITION:

Researchers would not be required to first try approved treatments, if any exist, before entering the patient into a medical experiment that may be "risky."

Researchers would not be required to consult with an independent medical expert, a non-researcher who would consider the patient's best medical interests as paramount.

Researchers would not be required to disclose their own professional and financial interests deriving from the experiment.

Researchers would not be required to fully disclose to the patient's family what happened to other patients who had already participated in the experiment.

Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine

The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people - those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.

Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.

"The voluntary consent of the human subject is absolutely essential."
[Nuremberg Code, 1947]

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [ Code of Federal Regulations 45 CFR 46.102 (f)]

On October 30, 2001, the National Human Research Protection Advisory Committee (NHRPAC) signed off on recommendations redefining the term "human subject" in an effort to accommodate research that invades people's privacy by declaring that "human subjects" are only those "who interact personally with research investigators."

A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research that is intended to be "therapeutic" (potentially beneficial) to the subject and "nontherapeutic" research, which is not intended to be beneficial to the subject. The U.S. Code of Regulations affirms that distinction for research involving children (45 CFR 46 Sections 405, 406), and the U.S. Code affirms that distinction for the military (10 USC 980).

Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That 6-to-1 landmark decision severely criticized the practice of exposing healthy children to risks of harm in health related research. Children, we must bear in mind, are powerless to exercise that inviolable human right, the right to refuse to assume risks for research.

Will this decision undermine the legitimacy of research that puts healthy children at risk in clinical trials? AHRP believes it will, and that the decision will be sustained by other courts in other states.

Following the August 16, 2001 landmark decision of the Maryland Court of Appeals, the Alliance for Human Research Protection (AHRP) became interested in the case involving exposure of children to lead paint. We were particularly drawn to the Court's clear and unambiguous recognition of the rights of children and their families to appropriate safeguards in medical research settings.
http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf