AHRP was incorporated in 2001. By then AHRP founder and president, Vera Hassner Sharav, an outspoken advocate for the rights of research subjects, had developed a communications network, gaining recognition as a knowledgeable source of information about medical research abuse. She had, by then, established a record of accomplishment in human rights advocacy, which has continued from the 1990s forward. [AHRP Advocacy in the News; Endorsements / Acknowledgements]
In 1993, AHRP founder opened a national debate by publicly challenging the ethics of experiments that are designed to exacerbate debilitating illness in disabled patients. Her first complaint to federal oversight authorities was filed in 1994 when she requested an investigation of an L-dopa "challenge" experiment conducted at the Bronx VA Medical Center (in 1987). In that experiment 28 veterans who had been in remission, living in the community were recruited with a consent form that misled them: it failed to disclose the purpose of the experiment or the risks of relapse. As a result of the experiment, all 28 veterans suffered a schizophrenia relapse.
How effective is the existing research protection system, if it fails to protect patients from inhumane experiments that worsen rather than treat their disabling condition?
By publicly challenging the ethics of chemical provocation experiments, AHRP founder opened Pandora's box: a "cottage industry" of government sponsored experiments designed to induce debilitating symptoms. Such experiments put the interests of the researchers above the welfare of human subjects. Thousands of disabled psychiatric patients, many of them U.S. veterans, have been subjected to inhumane experiments that exacerbate illness.
related links:
Feb 2, 2000. Bibliography
appended to Congressional Testimony by Vera Sharav
Feb 2, 1999. The Boston Globe, "Study
harmed mentally ill, agency reports."
AHRP founder has continued to apply pressure on public officials whose responsibility is to protect individuals from research abuse. Complaints filed by her have led to numerous federal investigations - several have resulted in the shut down of ethically unsupportable research projects at prestigious medical institutions. In 1997, AHRP founder organized a dozen individuals and families who had been victimized in research, but whose complaints were mostly ignored by the institutions involved and by government oversight agencies. Encouraged and guided by AHRP founder, they came from California, Ohio, Illinois, Maryland and New York to provide documented public testimony before the National Bioethics Advisory Commission (NBAC).
The Impact Of Public Testimonies & Press Reports that Followed:
Those compelling personal testimonies revealed details about ethical violations and abuse at prestigious research centers - including the National Institute of Mental Health (NIMH) - prompting several federal investigations. Those testimonies coupled with additional documents and testimony submitted by AHRP founder to NBAC, paved the way to support the Commission's recommendations for systemic change.
[See: October 10, 1997. Chronicle of Higher Education; October 16, 1997. Nature; May 19, 1998. The New York Times; August 1, 1998. Washington Post. ]
Additionally, those public testimonies served as the catalyst for the prize winning investigative series by The Boston Globe. [November 15-18, 1998. Doing Harm: Research on the Mentally Ill part 1; part 2; part 3; part 4]
In 1998, AHRP founder uncovered two fenfluramine "challenge" experiments that had been conducted on 6- to 11-year-old children. The children were put at risk by ingesting a toxic chemical that was subsequently withdrawn by the FDA because it damaged heart valves leading to deaths. The research offered the children no possible benefit, a requirement under federal regulations; they were induced with Toys R Us gift certificates and payment to parents. The rationale for conducting the experiment was to test the researchers' speculative hypothesis about a biochemical predisposition to violence. The experiment was roundly criticized, receiving wide media coverage and subject of several congressional hearings.
[April 15, 1998 The New York Times; April 22, 1998. Cong Hearing (link to April 22, 1998 NY Post article); April 26, 1998 The New York Post; June 12, 1999 The Washington Post]
Another group of experiments that were brought to public attention by AHRP founder involved Ketamine, a PCP derivative used to anaesthetize animals. Ketamine is known to induce psychosis, yet it was intravenously administered to mentally disabled patients inducing severe psychotic symptoms. The purpose was to give scientists an opportunity to study the effect on patients. Outside the confines of the psychiatric research community these experiments were severely criticized.
[May 19, 1998. The New York Times; May 30, 1998. Editorial. St. Louis Post-Dispatch]
In 1999, Dr. Steven Hyman, director of the National Institute of Mental Health acknowledged the combined impact of the 1997 testimonies and press reports that exposed research abuses in psychiatry, when he suspended 29 out of 108 clinical trials at the Institute.
In 1998, Vera Sharav began issuing informative news alerts via "veracare Infomails." The purpose is to raise public awareness about research ethics and the scope of research abuses, and to stimulate discussion. Veracare Infomails have been widely disseminated on a continuing basis to this day: they are recognized as a source of reliable information reaching government agency officials, healthcare professionals, consumer groups, media folk and Internet chatrooms; and are posted on numerous websites.
The intrusion of marketplace ethics in medical research has seriously undermined the safety of individual research subjects - most especially those who are vulnerable to coercion. An investigation by the Inspector General (IG) of the Dept. of Health and Human Services confirmed the systemic weakness that undermines the safety of human subjects of research: the system was described as "broken" in a 1998 report. [Pear R. "Study finds risks to patients in drug trials," The NY Times, May 30, 1998, p. A-9]
2001: AHRP was established as a proactive citizen's watchdog organization to further the mission for reform to improve the safety of subjects who volunteer for clinical trials.
Currently serving on the AHRP Board of Directors are David Cohen, Ph.D., Meryl Nass, M.D., John H. Noble, Jr., Ph.D., Sally Rogow, Ed.D., and Vera Hassner Sharav, M.L.S.
Our goals are
AHRP has initiated three major campaigns:
Public awareness campaign: a sustained dissemination of timely information via Infomails about research abuses and an appeal to people's moral conscience and sense of social justice. [See Infomail archive]
Informed consent campaign: provides a method for finding out what everyone has a Right to Know before signing up for research. Join our Campaign for Informed Consent
Campaign for protecting children: AHRP has publicly challenged a consortium of powerful research stakeholders who have disregarded federal prohibitions against the inclusion of children in experiments involving risk unless the research offers child subjects a potential therapeutic benefit.
On August 16, 2001, the Maryland Court of Appeals validated AHRP's position by issuing a strongly worded landmark decision - involving a lead paint poison experiment. That decision unequivocally affirmed the right of children to be protected from nontherapeutic experiments that expose them to risk.
September 17, 2001: American Medical Colleges, Association of American Universities, Johns Hopkins University, and University of Maryland, all of whom have considerable financial interests in conducting pediatric research, filed amici curiae briefs asking the Maryland Court to reconsider its decision.
October 1, 2001: AHRP filed the only amicus curiae brief in support of the Maryland Court decision, providing the Court with additional evidence in support of that resounding decision.
Nov 14, 2001: Meryl Nass, MD submitted invited testimony to the House Government Reform Committee hearing on Comprehensive Medical Care for Bioterrorism Exposure. In her testimony, "Preparing a Medical Response to Bioterrorism," Dr. Nass discussed accelerated drug licensing and abbreviated testing of vaccines and drugs intended for responding to bioterrorism. http://www.anthraxvaccine.org/response.htm
April 1, 2002: AHRP launched its website.
April 23, 2002: AHRP submitted written congressional testimony, "Protecting Human Subjects in Research: Are Current Safeguards Adequate?
May, 2002: Vera Sharav presented Conflicts of Interest paper before U.S. Armed forces clinical investigations symposium; Vera Sharav was an invited panelist at Cornell Medical Center, IRB Training Program.
April 9, 2003: Smallpox Vaccine Testing on Kids Blocked_LAT The Los Angeles Times reports that the federal government turned down the proposed clinical trial to test the controversial smallpox vaccine on 40 small children, aged 2 to 5 years old. The Alliance for Human Research Protection is proud to have played a role in averting an ill-advised experiment that would have resulted in serious harm for some children. Our public awareness campaign paid off.
The
Alliance for Human Subject Protection is
Incorporated as a 501-C-3 Tax Exempt Charitable Organization.
We seek support and financial contributions to help us maintain our
endeavors.
With adequate funding we could expand those endeavors and institutionalize
them.