UCI Chose Not to Tell FDA of Non-Approved Drug Use

University of California officials disclosed Thursday that they knew for almost a year about use of a non-approved drug at their acclaimed fertility clinic, but decided not to alert the Food and Drug Administration.

Documents released by the university show that officials there promptly investigated a whistle-blower’s February, 1994, allegation of misuse of the drug by Dr. Ricardo H. Asch. But the documents also show the university did not notify the FDA about it until last month.

An FDA spokesman said the agency should have been told.

“It is the FDA’s expectation that an institution will let us know when unapproved new drugs have been used in clinical trials,” said Lawrence Bachorik, an FDA spokesman.

UC Irvine executive vice chancellor Sydney H. Golub, however, expressed a different view in a February, 1995, letter to the Office of Protection from Research Risks, the federal agency in charge of government-funded experiments.

“The University does not believe,” he wrote, “that it has an obligation to report the matter immediately to the FDA, if indeed the University has any obligation at all to report to the FDA on any matter within the scope of our investigation.”

At issue is HMG-Massone, an internationally known fertility drug similar to the more widely known and prescribed Perganol. An extract of post-menopausal urine, Massone is known to cause ovarian stimulation.

But it also has been linked by at least one medical journal to ovarian tumors and has not been cleared for use in the United States by the FDA.

A recent lawsuit brought by the university accuses Asch of prescribing the drug, though the suit does not claim that it harmed anyone.

Ronald Brower, the lawyer retained by Asch to represent him in criminal matters, said there has been no federal investigation of his client.

Golub, however, said Thursday that FDA officials are investigating use of HMG-Massone at UCI’s fertility clinic, now that UCI officials have informed the FDA of their internal investigation.

Documents released Thursday by university officials promptly alerted the Office for Protection from Research Risks and the California State Board of Pharmacy about the allegations of Massone use.

But a pharmacy board official said Thursday that the university’s notification strategy was strange.

“They notified the wrong agency,” said Frank Van Fleet, the pharmacy board’s supervising inspector. “I don’t know whether that was intentional, so they could say, ‘Well, we notified somebody,’ or they just didn’t know who to notify.”

Van Fleet said he wasn’t familiar with details of UCI’s fertility clinic, but he was puzzled by the university’s decision not to inform the FDA.

“To me, if they didn’t know who to notify they should have notified everybody.”

Writing to the pharmacy board last August, UCI Medical Center officials conceded that “a member of the medical staff” provided a non-FDA approved drug “from Argentina” to nine patients.

Months later, the university wrote the pharmacy board saying Asch had ordered shipments of Massone via Federal Express, by way of Florida.

University officials say they told Asch to stop using the drug, and he told them that he “destroyed the remaining 10 vials in his possession.”

Ultimately, last April 13--more than a year after receiving the first whistle-blower complaint, and just after severing all ties to the fertility clinic--university officials notified the FDA.