- The Washington Times - Monday, December 24, 2001

BALTIMORE It has been a year of definitive challenges for one of the nation's top medical-research institutions.
Johns Hopkins University was shaken in June when a healthy 24-year-old volunteer died in an asthma experiment, leading a federal agency to temporarily suspend most studies involving human subjects.
Since then, other Hopkins-affiliated research has come under scrutiny, including research conducted on poor children exposed to lead paint. Lawsuits have been filed on behalf of two children who are said to have suffered irreversible brain damage in the study.
In August, the Maryland Court of Appeals allowed those lawsuits to go forward in a blistering ruling that compared the study to research conducted on prisoners in a Nazi concentration camp.
In November, Hopkins barred a researcher, who tested an unapproved cancer drug on patients in India, from leading future studies involving human subjects.
Despite the incidents, Nils Hasselmo says he is confident Hopkins' reputation is unsullied. Medical experimentation by its nature runs risks; thus, institutions at the vanguard may run greater risks, said Mr. Hasselmo, president of the Association of American Universities, a Washington-based group that tracks education issues for 63 research universities.
"Hopkins continues to be a national and international leader in a number of fields, and Hopkins has shown a strong resilience in dealing with the emergencies that happen from time to time," Mr. Hasselmo said.
By nearly any definition, Hopkins is at the head of the class when it comes to medical research and patient treatment.
In 2000, the university earned $301 million in grants from the National Institutes of Health tops in the nation. In November, philanthropist Sidney Kimmel donated $150 million to cancer research, the largest gift ever to the school.
And for the 11th straight year, U.S. News & World Report ranked it the nation's best hospital.
But Hopkins' pre-eminence did not stop the Office for Human Research Protections (OHRP) from shutting down more than 2,700 studies involving human subjects after the death of volunteer Ellen Roche.
After five days, the OHRP lifted the suspension, saying it was satisfied with steps Hopkins had taken to address problems that led to Miss Roche's death. Changes were made in the institutional review boards charged with overseeing such studies.
The OHRP also mandated that the suspended studies be reviewed again one by one before they continued. That process is nearly complete, said Dr. Edward D. Miller, dean of the medical school.
To expedite the process, Hopkins increased its number of review boards to six, promising that at least four would be permanent. Hopkins had two a year ago and created a third last winter.
But adding more review boards does not change their inherent conflict of interest, says Vera Sharav, president of Alliance for Human Research Protection, a nonprofit group based in New York.
Miss Sharav says all the cases, including the asthma study and the cancer study in India, are products of a culture common among all major medical research centers in which research takes priority over the well-being of the human participants. The appeals court made similar observations in its ruling.
The system, Miss Sharav says, "leaves it to the stakeholders, the researchers and the universities themselves, to police themselves."
She says external review boards, consisting of scientists and lay people from outside the institution who are not compromised by financial or professional ties, must be established. "This cannot work on an honor system," she said.
When the federally mandated shutdown was handed down, Hopkins' initial response was one of indignation, calling the action "unwarranted, unnecessary, paralyzing and precipitous."
In October, the university announced it had settled with Miss Roche's family for an undisclosed sum and pledged to do "whatever it would take to rigorously protect those who volunteered to advance medical knowledge."
But Dr. Miller also says the relationship between government regulators and academicians in medicine must become less adversarial.
"Now the challenge is to not just comply with rules governing research and patient care, but to help develop rules that are creative, meet the public's expectations, make sense and make us even better at what we already do well," he said.
September 11 presented a new challenge to Hopkins, as hospitals nationwide were forced to rethink what they needed in order to be ready to handle mass casualties from terrorist attacks. Befitting its position at the forefront of medicine, Hopkins took the lead.
In October, Ronald A. Peterson, president of the Johns Hopkins Hospital and Health System, told a congressional panel in Washington the hospital would spend at least $7 million to prepare for a bioterrorism attack, buying supplies including 1,000 respiratory masks and 50 ventilators.
D.A. Henderson, founder of Hopkins' Civilian Biodefense Center, was recruited to head a new national advisory council charged with recommending improvements to the nation's public health infrastructure to prepare for potential terrorism.
"Hopkins has been fortunate in having a deep bench full of seasoned experts to both guide our preparations and to develop models we believe will be helpful to other institutions," Mr. Peterson said.
Because of its resources and capacity, Hopkins is well-positioned to handle it, Mr. Hasselmo said. "I think that's an indication they are truly a leader in a number of very critical fields."

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