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ALLIANCE FOR HUMAN RESEARCH PROTECTION - VA Secretary Apologizes over Vet Who Refused Research Study
Sunday, September 7, 2008 7:13 AM


VA Secretary Apologizes over Vet Who Refused Research Study
The secretary of the Department of Veterans Affairs has apologized to the family of an Army veteran who died last year after being turned away from a Bronx VA hospital after he refused to participate in an Alzheimer's disease study. His widow, Mrs. Aimee Fitzgerald, said that researchers at the Bronx VA wanted her husband to enroll in the Alzheimer's experiment "to observe the natural and ravaging course of the disease and his eventual death." When he (and she) refused to give consent, Mrs. Fitzgerald charges, the hospital turned her husband away without providing the care that he needed. He died within the month. Hospital officials deny it, but the documents that Mrs. Fitzgerald showed us, back her up. Mrs. Fitzgerald is demanding answers from the Department of Veterans Affairs (VA) as to whether human research testing is taking a priority over the health care of veterans at its hospitals. "I want them to be held accountable for this, to prevent this from happening to someone else," Aimee Fitzgerald said. "Nothing could have saved Joe, but the care there was hateful and incompetent." From readers' comments about this "story" it is obvious that Joe Fitzgerald is not the only veteran to have been abused by a VA facility, confirming that when medicine degenerates into a commercial enterprise patients are treated like commodities. See: [Link] "Disposable Heroes" was the title of an investigative report by The Washington Times about the VA's unethical experimentation on US troops. "Currently, the VA and other federal agencies are conducting nearly 300 clinical studies involving veterans with PTSD. Most studies are behavioral, including one that tests the effects of yoga on PTSD sufferers. Twenty-five, however, are testing drugs on 4,796 veterans, more than half (2,488) of whom are just returning from the wars in Iraq and Afghanistan, according to clinical trials filed with the National Institutes of Health (NIH) and reviewed by The Times." See: [Link] Among the controversial dangerous drugs being tested on US soldiers is Pfizer's anti-smoking drug, Chantix, whose documented serious risks include psychotic episodes, violence and suicide. The FDA acknowledged that nearly 40 suicides and more than 400 incidents of suicidal behavior have since been linked to Chantix. Yet, 1,000 soldiers were corraled as human subjects to test the effect of the drug. Iraq war veteran James Elliott, who testified before a congressional committee in July, stated that he sought treatment from the VA for post-traumatic stress disorder (PTSD) and instead was persuaded to join a smoking-cessation study. While taking a smoking-cessation drug, he suffered a psychotic episode. Mr. Elliott said the first doctor he visited at the Central Arkansas Veterans Healthcare System in Little Rock to seek treatment for PTSD "wasn't concerned about my day-to-day life. ... He wasn't concerned with my wartime experiences. He wasn't concerned about if I was going to make it home safely after the appointment." When medicine veers from its therapeutic focus and physicians and hospitals engage in commercially-driven drug trials, patients' VA needs are sacrificed.
[Link]WASHINGTON TIMES Hospital released vet who refused study Widow sees priority as research, not care Audrey Hudson Friday, August 22, 2008 An Army veteran seeking treatment for his sudden loss of motor skills was turned away from a veterans hospital in the Bronx, N.Y., in May 2007 after he refused to participate in a human subject experiment on Alzheimer's disease. Joe Fitzgerald, 74, died of Creutzfeldt-Jakob disease - the human form of mad cow disease - less than a month after being dismissed without diagnosis from James J. Peters VA Medical Center. His widow is demanding answers from the Department of Veterans Affairs (VA) as to whether human research testing is taking a priority over the health care of veterans at its hospitals. "I want them to be held accountable for this, to prevent this from happening to someone else," Aimee Fitzgerald said. "Nothing could have saved Joe, but the care there was hateful and incompetent." Mrs. Fitzgerald said the research study doctor, Christine Bergmann, told the family that her husband's participation in the study would enable researchers to make a quicker diagnosis of his condition. But VA officials said Dr. Bergmann did not have the authority to offer a diagnosis. "[The study] has very little to do with their diagnosis, and it is not consistent with what occurred," said MaryAnn Musumeci, director of the Bronx hospital. "That's mind-boggling. That's not true," Mrs. Fitzgerald said. "Dr. Bergmann made it very clear to us that the benefit of signing up for the study would be that she would develop an individual profile of Joe that would help them to arrive at a diagnosis faster." The VA made several officials available for comment, but not Dr. Bergmann. VA officials and the Fitzgerald family also differ over the circumstances of Mr. Fitzgerald's discharge and whether the hospital provided care. Miss Musumeci said Mr. Fitzgerald was admitted only for testing and clinical evaluation and that he was referred back to his physician at Castle Point VA Hospital for further care and testing. "He was released because his work-up was complete. We did all the tests we could have done," Miss Musumeci said. In an interview with The Washington Times, VA officials said they knew Mr. Fitzgerald was suffering from a rapidly debilitating disease. Asked why the hospital released instead of treating the veteran, Miss Musumeci said, "He was in need of hospice care, and that is what Castle Point provides." Castle Point VA Hospital, a part of the VA Hudson Valley Healthcare System in Dutchess County, N.Y., does not identify itself as a hospice facility and does not advertise its hospice care among its patient services. Mrs. Fitzgerald said she was advised to keep future testing appointments with Castle Point and that the Bronx hospital never recommended hospice care or said they knew her husband's health was deteriorating. Mr. Fitzgerald's discharge papers stated that he was in stable condition. The Bronx VA hospital incident is the latest to raise questions about the ethics of human subject research experiments conducted at VA facilities nationwide. A recent investigation of experiments conducted at an Arkansas veterans hospital uncovered rampant violations, including missing consent forms, secret HIV testing and failure to report more than 100 deaths of subjects participating in studies. Joe Fitzgerald, 74, died in June 2007, less than a month after being turned away. Moreover, Iraq war veteran James Elliott told a congressional committee in July that he sought treatment from the VA for post-traumatic stress disorder (PTSD) and instead was persuaded to join a smoking-cessation study. While taking a smoking-cessation drug, he suffered a psychotic episode. Mr. Elliott said the first doctor he visited at the Central Arkansas Veterans Healthcare System in Little Rock to seek treatment for PTSD "wasn't concerned about my day-to-day life. ... He wasn't concerned with my wartime experiences. He wasn't concerned about if I was going to make it home safely after the appointment." Arthur Caplan, one of the nation's premier medical ethicists and director of the Center for Bioethics at the University of Pennsylvania, said the first obligation of any caregiver is to treat the patient. "It is only when there is no therapy, or the therapy that is available is of doubtful utility, that someone can be recruited to research," Mr. Caplan said. "Every researcher and every institution that does research must be sure to make an accurate diagnosis of a patient, to then offer them whatever therapy is available at the institution, to give them all their options in terms of treatment anywhere else and then and only then to pursue the possibility of trying something new in a research study," Mr. Caplan said. "No one should ever be penalized for failing to volunteer for a study, ever," Mr. Caplan said. "The goal of any medical encounter must be first and foremost to provide the latest and best care when care is available," Mr. Caplan said. "The chance to participate as a subject in research has to take a secondary role to receiving care as a patient." Miss Musumeci, director of the Bronx hospital and a registered nurse, said participation in the studies is routinely offered to patients seeking care at the VA facility, including healthy patients who may be admitted to studies as control subjects. Mary Sano, the Bronx hospital's director of research, said that "the opportunity to participate in research is widespread" and does not interfere with clinical treatment. Veteran Joe Fitzgerald refused to participate in a human subject experiment on Alzheimer's disease at the James J. Peters VA Medical Center in the Bronx, N.Y. "The research team is completely independent of the clinical team, and the clinical team has priority and determines if a person is approachable," Miss Sano said. "If they say no, the research team goes away." Miss Musumeci said that many hospital patients welcome the opportunity to participate in studies because "they appreciate the opportunity to stay busy." Mrs. Fitzgerald said the VA researchers wanted her husband to enroll in the Alzheimer's experiment to observe the natural and ravaging course of the disease and his eventual death. Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient-advocacy group, said the circumstances faced by the Fitzgerald family are "not unique." "You come to a hospital in critical need and you want care, even if you are not cured, and instead they say they are going to observe the degeneration and death?"
THE WASHINGTON TIMES Tuesday, August 26, 2008 VA chief offers family apology Audrey Hudson The secretary of the Department of Veterans Affairs has apologized to the family of an Army veteran who died last year after being turned away from a Bronx VA hospital after he refused to participate in an Alzheimer's disease study. Joe Fitzgerald, 74, died of Creutzfeldt-Jakob disease - the human form of mad cow disease - less than a month after being dismissed without diagnosis or treatment at James J. Peters VA Medical Center, The Washington Times reported Friday. His widow, Aimee Fitzgerald, has demanded answers from the VA as to whether human research testing is taking a priority over the health care of veterans after the agency responded that the Alzheimer's study was a "mandate." "I can only apologize that Mrs. Fitzgerald perceived a sense of callousness, or a sense that there was some additional diagnostic or other measures to be offered," Veterans Affairs Secretary James B. Peake said in a letter to the editor at The Times. "It will renew our emphasis to VA staff about sensitivity in communicating." The VA has come under scrutiny and criticism over its human-subject experiments since a Washington Times/ABC News investigation revealed in July that the agency had failed to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug some participants were taking. A recent investigation of experiments conducted at an Arkansas veterans hospital uncovered rampant violations, including missing consent forms, secret HIV testing and failure to report more than 100 deaths of subjects participating in studies. Mr. Fitzgerald sought treatment for his sudden loss of motor skills at the Bronx VA hospital when his attending physician, Dr. Ruth Walker, said that enrolling in the Alzheimer's study would enable a quicker diagnosis of his disease, Mrs. Fitzgerald said. Dr. Walker introduced the family to Dr. Christine Bergmann, who headed the Alzheimer's study. VA officials said Dr. Bergmann did not have the authority to offer a diagnosis. "I can only apologize for the family's perception in this tragic case and to let them know that it will serve as a system-wide reminder about the importance of clear and compassionate communication," Mr. Peake said in his letter to the editor. The Times also reported that Arthur Caplan, one of the nation's premier medical ethicists and director of the Center for Bioethics at the University of Pennsylvania, said the first obligation of any caregiver is to treat the patient. In his letter, Mr. Peake - a physician himself - said he and his agency "completely share Mr. Caplan's view."