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More Information on Ethics and Clinical Trials

Public Citizen Commentary on the SUPPORT Study Involving Premature Babies, May 21, 2013
Public Citizen Report Documents Lack of Informed Consent for Risky Study on Premature Babies, May 8, 2013
Letter to the Assistant Secretary for Health and the OHRP Director Regarding Neonatal Research Network Trials, April 18, 2013
Letter to Secretary of Health and Human Services Regarding Ongoing Clinical Trials Conducted by the Neonatal Research Network, April 15, 2013
Letter to Dr. Richard Marchase at the University of Alabama at Birmingham Criticizing His Misleading Statements to the Media Regarding the Unethical SUPPORT Study, April 11, 2013
Letter to Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants, April 10, 2013
Letter to OHRP Alleging Inadequate Informed Consent for Study Involving Diabetic Children, February 27, 2013
Letter to the Secretary of Health and Human Services Criticizing Recent Action Taken by the Office for Human Research Protections, January 9, 2013
Letter to the Presidential Commission for the Study of Bioethical Issues Opposing Unethical Anthrax Vaccine Studies in Children, August 27, 2012
Letter to OHRP Criticizing the Agency’s Position Allowing CMS to Require Medicare Beneficiaries Undergoing Transthoracic Aortic Valve Replacement to Participate in Research, August 27, 2012
Letter to the FDA Opposing Resumption of Clinical Trials Testing Anti-Nerve Growth Factor Drugs, April 16, 2012
Testimony to the FDA’s Arthritis Advisory Committee on Safety Issues Related to Anti-Nerve Growth Factor Agents, March 12, 2012
Letter to OHRP Regarding Testing the Drug Canakinumab in Diabetic Children Without Adequate Informed Consent/Parental Permission, February 28, 2012
Letter to CMS and OHRP Opposing Proposal to Require Medicare Beneficiaries Undergoing an Aortic Valve Replacement Procedure to Participate in Research Without Their Informed Consent, February 28, 2012
Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research, November 7, 2011
Letter Opposing Unethical Anthrax Vaccine Studies on Children, November 1, 2011
Comments on Proposals to Revise the Regulations for Protecting Human Research Subjects, October 26, 2011
Letter Requesting Extension of ANPRM Comment Period, July 26, 2011
Letter to HHS Regarding OHRP Failure to Investigate Unethical Placebo-Controlled Trials of Indacaterol Maleate (Arcapta Neohaler), April 28, 2011
Letter on Unethical Trials of Indacaterol Maleate (Arcapta Neohaler), March 16, 2011
Testimony to IOM Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, November 9, 2010
Statement: Foreign Clinical Trials for U.S. Drugs Present Significant Threat, June 22, 2010
Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial, May 11, 2010
Letter Regarding the Draft Document Special Ethical Considerations for Epidemiological Research, April 9, 2007
Description of Efforts to Redesign Surfactant (Surfaxin) Study in Latin America, February 17, 2007
Testimony Concerning Protocol for Biopure's Blood Sub HBOC-201, December 14, 2006
Letter in Obstetrics & Gynecology: Trials of Prophylaxis to Prevent Recurrent Herpes Should Not Utilize a Placebo Arm, December 1, 2006
Letter Opposing U.S. Government Efforts to Declare Some Foreign Ethics Approval Procedures Equivalent to Those in the U.S., May 31, 2005
Comment in the Lancet: U.S. Exceptionalism Comes to Research Ethics, March 26, 2005
Letter Urging FDA Not to Undermine the Declaration of Helsinki, September 1, 2004
Letter Concerning Continuing Efforts to Amend Declaration of Helsinki, March 1, 2004
Federal Failure in Psychiatric Research: Continuing NIMH Negligence in Funding Research on Serious Mental Illnesses, November 19, 2003
Letter Opposing Proposed Changes to Declaration of Helsinki, August 28, 2003
Letter Urging an Investigation of Medical Schools Conducting Unethical Research, July 22, 2003
Testimony on Clinical Research Involving Children, July 9, 2003
Letter on Ethical Concerns with the "Alzheimer's Disease Anti-Inflammatory Prevention Trial" (ADAPT), April 15, 2003
Letter on Ethical Concerns with the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT), September 4, 2002
Article in GCPJ: Clinical Research Paradox, October 2001
Letter on CIOMS's Draft Ethical Guidelines, July 13, 2001
Comments on Draft HHS Report on the Globalization of Clinical Trials, July 5, 2001
Letter in JAMA on Problems with HIV-1 Vaccine Study, May 2, 2001
Statement on National Bioethics Advisory Commission's Endorsement of Unacceptable Ethical Standards, April 30, 2001
Press Release: Placebo-Controlled Drug Trial in Latin America Redesigned, April 4, 2001
Letter Requesting That HHS Halt Plans for Unethical Placebo-Controlled Study of Drug for Respiratory Distress Syndrome, February 22, 2001
Comments on National Bioethics Advisory Commission Report on Research Issues Involving Human Participants, February 17, 2001
Letter Criticizing Draft Report on Ethics of Research in Developing Countries, December 6, 2000
Letter Regarding Challenges Conducting Research in Developing Countries, November 13, 2000
Letter in the Washington Post on Modifications to the Declaration of Helsinki, October 17, 2000
Statement Concerning an Ethical NEJM Study, October 4, 2000
Letter on New Draft of Declaration of Helsinki, September 29, 2000
Letter on New Version of Declaration of Helsinki, July 31, 2000
Letter in AJPH Regarding Inclusion of Condoms and Counseling in Anti-HIV Microbicide Trials, July 2000
Comments on HHS Study on Recruiting Human Subjects, June 13, 2000
Letter in the Washington Post on Death of Jesse Gelsinger in Study, February 14, 2000
Letter on UNAIDS Guidance Document on HIV Preventive Vaccine Research, February 11, 2000
Letter Concerning Unethical Studies Which Used Placebos on HIV-Positive Pregnany Women in Developing Countries, October 23, 1997
Letter Concerning Funding of Unethical Trials Which Administer Placebos to HIV-infected Pregnant Women, April 22, 1997

Letter to the Presidential Commission for the Study of Bioethical Issues Opposing Unethical Anthrax Vaccine Studies in Children

August 27, 2012

View as PDF.

Public Citizen urges the Commission to recommend that the Secretary of Health and Human Services oppose the conduct of pre-event clinical trials in children of the medical countermeasures against exposures to various biologic and chemical agents, such as the pre-event clinical trials of the anthrax vaccine in children that was endorsed by the Office of the Assistant Secretary for Preparedness and Response and the National Biodefense Science Board.

August 28, 2012, Initial response from The Presidential Commission for The Study of Bioethical Issues

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HEALTH AND SAFETY

More Information on Ethics and Clinical Trials

Letter to the Presidential Commission for the Study of Bioethical Issues Opposing Unethical Anthrax Vaccine Studies in Children

Public Citizen, Inc. and Public Citizen Foundation

To become a member of Public Citizen, click here. To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.