Popular Fertility Drug Is Now In Short Supply -- Treatments With Pergonal May Be Affected

Dwindling supplies of a popular fertility drug are threatening to halt certain infertility procedures throughout the United States, adding to the anxiety of couples struggling to have a child.

The drug, Pergonal, manufactured by Laboratoires Serono SA in Aubonne, Switzerland, is used by 30 to 50 percent of infertile couples undergoing treatment. The injectable drug, made from the urine of post-menopausal women, is used by women to increase the production of egg follicles in a number of infertility treatments, including in vitro fertilization.

Analysts say that Serono is concentrating on producing a purer and less costly drug called Metrodin, which can be used as a substitute for Pergonal. But the pharmaceutical company underestimated the demand.

"Right now, there is a shortage of Metrodin as well," said Dr. Anthony Luciano, director of the Center for Fertility and Reproductive Endocrinology at New Britain (Conn.) General Hospital and a professor of obstetrics and gynecology at the University of Connecticut. "A company representative said they had not anticipated the great demand for Metrodin. They just did not make enough."

Luciano said some patients can't get the medication they need to begin fertility treatments.

"I have about 10 or 12 patients who have been scrambling around and calling every pharmacy in the country," said Dr. August Olivar, director of the reproductive endocrinology and infertility division of Hartford (Conn.) Hospital and professor of obstetrics/gynecology at the University of Connecticut Health Center. "Many of our patients are very worried."

And some doctors fear the problem could grow much worse if the supply of Metrodin dries up. Dr. David Olive, head of reproductive endocrinology at Yale School of Medicine, said Yale performs 1,800 procedures a year that require either Pergonal or Metrodin. Most patients there are now using Metrodin, but Olive is concerned that Metrodin, which is 5 percent cheaper than Pergonal, is also becoming scarce.

It's estimated that infertility affects more than 2.5 million married couples in the United States.

Of the total number, one doctor estimated that from 30 to 50 percent would require either Pergonal, Metrodin, or both.

Officials at Serono's U.S. headquarters in Massachusetts could not be reached. But pharmacists report getting letters from the company. A first round of letters, sent late last year, said the potential for a shortage existed because of manufacturing difficulties. Another letter, sent this month, said the Pergonal shortage would continue and suggested that patients switch to Metrodin.

A health-care industry analyst says that, in recent months, the company has been placing more marketing emphasis on Metrodin, a drug that is purer and will eventually replace Pergonal. Manufacturing Metrodin requires a 25 percent greater volume of urine, and Serono apparently could not make the drug fast enough.

"It all happened too fast," said Edmund Debler, an analyst for Mehta and Isaly in New York, a worldwide health-care investment company. "There has been a 60 percent growth (in sales) of Metrodin."

Serono's worldwide sales in 1994 were $637 million, and about 60 percent of that, or $380 million, were sales of fertility drugs. Although other types of fertility drugs are available from other pharmaceutical companies, Serono has a virtual corner on the U.S. market for this type of drug.

When Pergonal was first manufactured in the 1960s, Serono's source for post-menopausal urine was a convent near its Rome headquarters. Now, according to published reports, Serono collects urine twice a day from more than 100,000 European donors.

The company plans to market a synthetic, or "recombinant," version of the drug but has not yet received the go-ahead from the U.S. Food and Drug Administration. Debler said approval is likely later this year.

"Until they switch over to a recombinant product, there's going to be a bottleneck," Debler said.