Nexus - 0225 - New Times Magazine-pages

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ment or information to soldiers was unjustifiable, unethical, some- _er, those studies were kept secret until the mid-1970s. Similarly, times illegal, and caused unnecessary suffering. the Nuremberg Code should have prevented hundreds of radiation "In addition, information about the use of these investigational experiments that several Federal agencies conducted on thousands drugs and vaccines, and adverse reactions that resulted, usually of soldiers, veterans, and civilians during the Cold War without were not included in soldiers’ medical records. As a result, veter- their knowledge or consent; however, those studies continued for ans who became ill following the use of , years and were never made public until a these medical products are often unable to ‘| few months ago.” _ er ni illness or disability was relat- | "_ information about the use BCENGAT . san to their military service. of these investigational drugs TIGATIONAL DRUGS A BACKGROUND INFORMATION and vaccines, and adverse VACCINES IN THE PERSIAN GULF reactions that resulted, usually | Under the Food, Drug and Cosmetics Act, "A few months ago, Americans were | were not included in soldiers’ | all vaccines and medical products must be shocked to learn that Federal agencies had medical records. proven safe and effective by the Food and intentionally exposed thousands of US citi- Drug Administration (FDA) in order to be zens to radiation without their knowledge or Asa result, veterans who sold and distributed in the United States. consent. Although many Americans | became ill following the use of —— expressed horror at the apparently unethical these medical products are behaviour of the Federal government, many often unable to prove that believed such experiments occurred in a wee : A gtio bygone era with less stringent ethical stan- their illness or disability was dards. related to their military "In August 1990, DoD contacted FDA to "Post-Holocaust Standards of Research: service." | review regulatory restrictions on DoD's plan The Nuremberg Code is a 10-point declara- | ] to use pyridostigmine and botulism vaccine tion governing human experimentation for US troops in the Persian Gulf. which was developed in response to the According to minutes of the meeting, "FDA inhumane experiments conducted by Nazi scientists and physi- expressed some concern about liability and the need to comply cians. The Code states that voluntary and informed consent is with the regulations" and Dr Peck, FDA's Deputy Director for absolutely essential at all times, wartime included. Additionally, Drug Review, "pointed out the need to establish an appropriate current law prevents funds appropriated to the Department of _ investigational framework to collect observational! data and evalu- Defense from being used for research involving a human being as _ate the military medical products in question". an experimental subject unless the informed consent of the subject "The major focus of the meeting was informed consent. In sum- is obtained in advance... mary, DoD did not want to abide by informed consent regulations, "The Nuremberg Code should have guided the experiments and FDA officials pointed out that pyridostigmine and botulism whereby LSD and other hallucinogens were given to military ser- vaccine were investigational and that there are laws regulating vicemen in the 1950s without their knowledge or consent; howev- _ how they can be used. DoD claimed that they had the authority to DoD/FDA Agreements to Waive Informed Consent for Investigational Drugs During the Persian Gulf War Figure 2: Veterans who could not refuse vaccines. Figure 1: Veterans who received no disclosure on vaccines. 90 80 : 70 7 60 | 50 — —S 40 1| 30 201] 10|_ | °tt f p Botulism Anthrax Pyridostigmine Experimental Vaccines & Drugs 70 60 50 40 30 20|_ +| 10 ty) | Botulism Anthrax Pyridostigmine ’ Experimental Vaccines & Drugs APRIL - MAY 1995 NEXUS ¢ 21 BACKGROUND INFORMATION ee nnn