FDA opens probe into University of Miami cancer research

(MiamiHerald)   The Food and Drug Administration is investigating cancer studies at the University of Miami after problems were found with one study. BY JOHN DORSCHNER

JDORSCHNER@MIAMIHERALD.COM

The University of Miami has suspended the addition of new patients to any of its cancer-research trials while UM executives and the Food and Drug Administration conduct investigations into one problematic trial.
The medical school released a statement Thursday that it had found a problem with the way one cancer study was conducted and had reported the problem to the FDA, which oversees medical-research trials. The medical school did not name the study in the statement, which was prompted by a Herald inquiry into a rumored FDA investigation.
“We have corrected the issues we reported,” the statement said, while noting that the FDA investigation is ongoing and that no patients in the study were harmed. For now, leaders of UM’s Sylvester Comprehensive Cancer Center have “voluntarily implemented a temporary “timeout’ ” on adding new patients until UM conducts “a scrupulous review of all similar procedures.”
Such cancer trials are often desperate last chances for patients who have seen all other treatments fail.
In another FDA case also announced Thursday — the university said it was unrelated — the federal agency sent a stinging warning letter to UM researcher Sean Scully, an orthopedic oncologist and surgeon who was researching a device to repair hip joints. UM said Scully is leaving the university. A spokesman for Biomet, the Indiana company developing the device Scully was studying, announced tersely: “We terminated Dr. Scully’s involvement in the clinical trial.”

Scully could not be reached for comment Thursday.

Warning letters can eventually lead to a researcher being disqualified from conducting research and perhaps other disciplinary proceedings.

Problems with the unnamed cancer trial surfaced “during a routine assessment. . . . As is routine procedure in these cases, the FDA is conducting its own review,” UM said.

An FDA spokeswoman said agency investigations are not made public until a document, called Form 483, is written about observations of problems or a warning letter is sent demanding corrective action. UM said it has not received either concerning the cancer trial, and noted that “no unfavorable clinical outcomes have been identified.”

Sylvester researchers are continuing treatments and follow-up care for all patients already enrolled in trials.

“We have already completed a rigorous review of several clinical trials and expect to begin reopening a number of studies” to new patients, UM said.

In the Scully case, one issue that emerged was that UM did not require that its faculty inform the institution when there are research problems.

The FDA warning letter was sent to Scully, 54, on July 30. The university said it did not receive a copy of Form 483 associated with Scully’s research, and it didn’t learn of the FDA letter until three weeks after it was sent, UM spokeswoman Jeanne Antol Krull said in an e-mail.

James S. Cohen, head of the FDA practice for the national law firm McDermott Will & Emery, said warning letters state “what the FDA believes are deviations from regulations.”

Krull said Thursday that UM’s policy had now changed. Researchers now must notify the university of any contact from an agency — which would include the FDA, the National Institute of Health and many others — about any audit of their research.

In the FDA’s warning letter to Scully, the agency detailed multiple problems with his experiments with ReCap Total Resurfacing System, which involves replacing damaged parts in a hip joint with metal surfaces as an alternative to full hip replacement.

FDA visits to UM in March and April found that Scully had failed to report adverse events as required, including four patients complaining after the device was implanted. One subject said he felt a grinding in the hip, a second reported lower-back pain similar to pain before the operation, while a third reported increased pain that worsened over three months. A fourth returned to UM three times complaining of increasing pain.

None of the complaints were reported to Biomet, the creator of the device and sponsor of the study, nor to the university’s institutional review board, which monitors research.

On Aug. 20, after finally learning of the Scully warning letter, UM wrote to the FDA: “Dr. Scully will be leaving the University effective Aug. 31” and therefore will no longer be involved in UM clinical trials. Krull said UM does not comment on personnel matters and would not say why Scully was leaving.

“However,” the letter to the FDA went on, “we are disturbed by the observations and will be investigating the conduct of this clinical trial to evaluate what steps might be necessary to enhance research compliance.”

In its statement to The Herald on Thursday, UM stated: “Sylvester leadership, with the full support of the Miller School of Medicine, has taken all appropriate steps to ensure that we always provide the highest quality of care to our patients.”

Read more: http://www.miamiherald.com/2010/08/26/1794300/fda-opens-probe-into-university.html#ixzz0y0KqV2I2

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