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Test EVERY Cow in the Food Chain

Test EVERY Cow in the Food Chain
Like Other Countries Do

Sunday, December 28, 2008

Human Mad Cow; NY vet refused participation in study, discharged from vet hospital

Aug. 08
By Audrey Hudson

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.

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.

"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?"

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