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Researcher under FDA investigation since 2000

By Stephanie Schwartz
Arizona Daily Wildcat
Monday December 2, 2002

FDA issued a warning letter in 2001, and has continued investigation to set penalty for cardiology researcher and UA

Top UA cardiology researcher and emeritus professor of medicine Frank Marcus is under investigation by the Food and Drug Administration for 18 violations of FDA regulations, prompting the UA to make several changes to the policies involving the use of animals for research.

The violations stem from a 1997 study involving Marcus' work with dogs and cardio ablation, where devices used to regulate heartbeat were tested.

When the FDA investigated Marcus' lab in 2000, investigators found violations, including the mislabeling of dogs, equipment not being cleaned properly and people conducting research without the proper training.

Marcus said he had never done a study for the FDA ¸ which maintains stricter record-keeping regulations than the university ¸ prior to the cardio ablation study. He said the FDA is incorrect in some of its findings, such as the mislabeling of dogs.

The FDA sent President Pete Likins a warning letter in April 2001 discussing the violations found in the lab, as well as the UA's failure to establish a "quality assurance unit" for research.

The unit is responsible for monitoring each study to assure they meet "good laboratory practice" requirements, such as keeping track of how often lab instruments are cleaned.

"The comparison found significant discrepancies involving 12 of 19 dog IDs," the FDA's warning letter said. "Twelve dogs had no ╬case reports' and four dogs had no animal care or treatment records. Only 14 of 19 dog IDs were included in the FDA study report."

The FDA also stressed the significance of the violations.

"The nature and severity of these findings seriously compromises our evaluation of the reliability and integrity of data from nonclinical laboratory studies conducted at your testing facility," the FDA letter stated.

The FDA is still investigating the situation to decide on the proper penalty, and whether any penalty is necessary for Marcus and possibly the UA.

The devices used in the study are now implanted in humans.

Marcus denied the severity of the accusations, and said the problems were mostly due to not keeping proper records.

All the animals in the labs were accounted for, and all individuals who worked with them were properly trained, Marcus said.

"The information we got from the study helped to improve the instrument and it is now treating abnormal heart rhythms in humans," he said.

In response to the incident, the UA made several changes in the procedures for doing research with animals.

The UA and the Institutional Animal Care and Use Committee, IACUC, created a large group to ensure FDA regulations are met, and that the strict standards are followed regarding "good laboratory practice" studies, said Susan Wilson-Sander, director of IACUC.

Every researcher planning on doing research with animals must also go through an extensive training program to assure the awareness of quality insurance laws and the correct "good laboratory practice" procedures, Wilson-Sanders said.

Marcus said the UA has been supportive and expects the FDA to do another investigation to make sure the matter has been cleared up soon.

"He's done excellent research for 30 years," Wilson-Sanders said. "He just never has been asked to do a ╬good laboratory practice' study before."

Members of Students for the Ethical Treatment of Animals asked that an investigation be conducted on IACUC, which oversees animal research at the UA.

At least 26 percent of the dogs used in Marcus' study were not accounted for, said Patricia Haight, member of the animal rights group In Defense of Animals.

Marcus is currently working on two projects at the UA. One is designed to improve techniques to treat heart rhythm problems for people with life-threatening difficulties. The other study is to learn more about an unusual disease that causes sudden death in young people, especially athletes.


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