UCI Fertility Scandal : Drug Cited in Suit Lacks FDA Blessing

HMG Massone, the drug at the center of a key allegation against Dr. Ricardo H. Asch, is an international brand of a fertility drug that has been widely prescribed for decades.

In an amended lawsuit filed Thursday, UC Irvine contends that Asch gave the drug to at least nine patients even though it has not been approved for use by the U.S. Food and Drug Administration.

A February, 1994, complaint by a whistle-blower led the university to charge in its lawsuit that Asch had “imported, prescribed and then sold to [Center for Reproductive Health] patients, and shipped through the mail, the non-FDA approved fertility drug.”

The suit does not allege that the drug, which stimulates the production of eggs, caused patients any harm. “The university is informed and believes . . . that the dispensation of this drug did not compromise patient care,” the lawsuit notes.

Though the Massone brand of HMG has not been federally approved, other brands are widely used here.

HMG stands for “human menopausal gonadotropin,” and Massone is its international brand name. The drug, an extract of post-menopausal urine, is widely used to stimulate ovulation.

With the use of HMG, “on the average, you get 12 eggs per retrieval,” according to Hugh Hensleigh, director of the reproductive health lab at the University of Minnesota, which specializes in infertility and in vitro fertilization research.

“We often want to get that many for the obvious reason: A woman has a far better chance of getting pregnant,” Hensleigh said.

According to an April, 1993, article in the British medical journal Lancet, HMG has been used for ovarian stimulation in the United States and many European countries since the early 1960s.

The journal article warned that the growing use of HMG might be linked to an increase in ovarian tumors, but said the evidence is unclear. The article’s authors advised regulatory agencies to determine whether a such link exists.

“Of special concern is the increasing use of HMG in in vitro fertilization programs to harvest as many [eggs] as possible,” says The Lancet article.

Hensleigh speculated that only technicalities have kept HMG Massone from gaining FDA approval.

The use of drugs not yet approved is, in Hensleigh’s view, a growing problem throughout the fertility industry, “because the accepted standards for medical care are moving much faster than the FDA approval rate. In many ways, it’s a Catch-22.”