By Gideon Gil
The Courier-Journal

Lumpy, red tumors were spreading like a rash across Lorraine Radtke's chest, neck and face when she decided to undergo laser treatment in September 1997.

She was under no illusion that her cancer would be cured by her University of Louisville doctor.

Ms. Radtke simply hoped that the treatment, called photodynamic therapy, would improve her appearance and make her more comfortable, said her daughter, Susan Radtke.

Instead, the treatment left Lorraine Radtke, 78, with a large open wound that required painful, twice-daily dressing changes and was so unsightly she hardly left her house the last four months of her life, Susan Radtke said.

"To inflict that degree of injury on somebody who is already dying of cancer is kind of mind-boggling," she said.

Spurred by a complaint Susan Radtke filed last year, a federal watchdog agency has ruled that Lorraine Radtke's doctor, two of his colleagues and U of L violated regulations to protect research participants.

In a Sept. 24 letter to U of L officials, the U.S. Office for Human Research Protections required the university to ensure that participants in all 1,151 studies under way are completely informed about "reasonably foreseeable risks and discomforts" from the research and related procedures.

The university responded in October that it had revised documents used by scientists in preparing consent forms and would require additional training for members of its four Human Studies Committees that approve and monitor human research.

The school said it also had directed that, during the initial and annual review of all research projects, committee members should check that consent forms fully describe the risks.

U of L also has enhanced its mandatory annual training for researchers.

"I would be very confident to be a subject of research at the university," said Nancy Martin, the university's vice president for research.

Susan Radtke said she feels vindicated by the federal agency's decision, which came after a lawsuit she filed against two of the photodynamic therapy researchers was dismissed in 2000 because she and her lawyer missed filing deadlines.

"Hopefully the public is more protected," she said.

In advance of the federal findings, U of L officials imposed their toughest penalties ever on faculty members for violating federal rules to protect human research subjects, according to the Courier-Journal's review of previous cases.

The university terminated the photodynamic therapy research project conducted by Drs. T. Jeffery Wieman and Scott Taber and by U of L scientist Victor Fingar, and prohibited Dr. Wieman and Mr. Fingar from doing new human research without further training and close scrutiny. Dr. Taber left the university in 2000.

The university also halted four other studies Dr. Wieman was working on.

The federal investigation found that the researchers did not adequately inform all participants of the risks involved in the photodynamic therapy study and that they used data from patients who had not agreed to be research subjects.

In an interview last week, Dr. Wieman insisted that all participants - including Lorraine Radtke - had been told of the known risks of photodynamic therapy.

"What we tell them is that the tumor dies, and when the tumor dies it means that there's going to be a space there until it heals," he said.

The federal agency also faulted the university's Human Studies Committees for failing to conduct a required annual review of the photodynamic therapy research in 1997.

U of L documents, obtained through the Kentucky Open Records Act, show that two of the 56 participants in the five-year photodynamictherapy study died after the procedure: a 60-year-old man from an infection in 1996; and a 66-year-old man from cardiac arrest during internal bleeding in 1997.

No autopsies were done, but Dr. Wieman maintained in reports filed with the Human Studies Committees that the deaths weren't related to the therapy or the research.

The university has begun conducting random audits of selected research projects to check for compliance with federal rules. Fifty audits have been completed this year and turned up mostly minor paperwork problems, according to the university - although two participants were given wrong versions of consent forms.

An audit by the Human Studies Committees "discovered that there were numerous incomplete and missing research records," according to records of the U of L investigation. "The investigators cannot clearly distinguish between those enrolled in the research and those treated and not enrolled."

In the September letter, the Office for Human Research Protections said the researchers "failed to obtain the legally effective informed consent of certain individuals reported as research subjects."

Dr. Wieman said in an interview that all patients, whether or not they were research subjects, had been given the same information about the procedure.

Dr. Wieman has resigned as a U of L professor effective Jan. 1. He said he is taking an administrative job with a new cancer center in Kansas City and was retiring from clinical medicine.

Dr. Taber now is in private practice in South Carolina, and Mr. Fingar died last month at age 42 of an apparent heart condition.