Nov. 2, 2005 (Bloomberg) -- Scott Scheer wasn't worried about side effects when he agreed to enroll in a federally funded test of different combinations of previously approved blood pressure medications in 1997.
At age 57, the radiologist wanted to help medical science, and he assured his wife, Beverly, that some of the best physicians in the Philadelphia suburbs were overseeing the five- year study.
``He completely trusted them,'' Beverly Scheer says. The consent form Scheer signed before starting the trial at Lankenau Hospital in Wynnewood, Pennsylvania, gave no reason for concern.
``Most people who take these drugs do not have any side effects at all,'' the document said.
Scheer told the hospital his health was ``very good,'' giving it a rating of 90 out of 100, before the drug trial. He had been taking medication for high blood pressure before the trial and was asked to stop so he could enter the study.
He suffered side effects including muscle aches and swollen ankles in the first five months of the trial, medical records show. By July 2001, four years after he entered the trial, Scheer was dead.
In the days before his death, Scheer's family grew alarmed by bruising on his arms, a rash on his feet and overall exhaustion. On July 9, 2001, six days before he died, Scheer visited a hematologist outside Lankenau Hospital, which is part of Main Line Health.
Dr. Edward Stadtmauer diagnosed Scheer with kidney failure and severe anemia that he said was probably caused by hydralazine, one of the drugs in the test.
Improper Monitoring
``Scheer most likely has hydralazine-induced systemic lupus,'' Stadtmauer, who met Scheer for the first and only time during that exam, wrote in his patient report. ``Drug-induced lupus is a common side effect of hydralazine, occurring in up to 70 percent of patients eventually.''
Stadtmauer says he suggested he stop taking hydralazine and tell the nurse in the study. In a wrongful death lawsuit filed in state court in Philadelphia, Scheer's family says he died as a result of improper monitoring during the clinical trial.
The family sued Lankenau Hospital; Drs. James Burke and Michael Duzy; and the Institutional Review Board of Main Line Hospitals Inc., which was responsible for overseeing Scheer's trial. The suit is pending.
Frieda Schmidt, a spokeswoman for Main Line Health, says she can't comment because of the litigation. George Reichard, chairman of Main Line Health's IRB, which now oversees clinical trials at Lankenau, didn't return calls.
Almost No Care
The study set out to test different types of drugs used to treat high blood pressure and high cholesterol and compare them with the benefits of Pfizer Inc.'s Norvasc and other, generic medications.
Additional drugs were added if a patient's hypertension wasn't successfully controlled. The consent form said participants would be asked to see doctors at least every three months during the first year of the study and every four months in subsequent years.
Scheer's family says his medical records show that Scheer had almost no care from the hospital and that he wasn't asked to come into the hospital every three to four months.
Phone interviews and postcard questionnaires replaced in- person visits, says his older daughter, Kirsten Scheer Bauer, 39. On at least six occasions, a nurse sent drugs to Scheer's home via Federal Express, Bauer says.
For the four years Scheer was in the test, side effects he described were included on his chart at Lankenau Hospital; none were treated by doctors overseeing the trial, his family says.
Consent Was Inadequate
The hospital conducted its own probe after the death and concluded the consent form Scheer had signed was inadequate. The hospital also found that the doctors running the study, Burke and Duzy, failed to notify the hospital and oversight groups of Scheer's side effects as required by study rules and federal regulations.
Burke and Duzy didn't return phone calls seeking comment.
Sometime from July 10 to July 13, 2001, Burke learned that Scheer had been diagnosed with severe anemia and kidney failure on July 5, according to minutes of Main Line Hospitals' Office of Regulatory Affairs' Allegations Committee. That group was formed in response to a complaint from Bauer.
She also went to the federal Office for Human Research Protections, part of the Department of Health and Human Services. The office had authority to investigate because the study was federally funded.
System Failed Him
OHRP investigators found that the hospital had failed to adequately protect Scheer and other patients in the study.
``Your father apparently was not told about the risk of hydralazine-induced lupus,'' says an OHRP letter to Bauer dated Dec. 20, 2002. The office also said the hospital's protection of participants in the study fell short.
``OHRP found that certain unanticipated problems involving risks to subjects or others were not promptly reported to appropriate institutional officials,'' the letter says.
Bauer says she had to fight to retrieve Scheer's records from the hospital. No one running the test called to follow up after the family called to report Scheer's death, she says.
``He trusted the system that ultimately failed him,'' says Laura Scheer Brooks, 38, Scheer's younger daughter.
My comment: They completley TRUST the system which does not take the time to make sure each individual person is compatible with all the drugs side effects, tests and procedures. They lump everyone in one category= guinea pig.
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