ValleyCare calls for national review of RU-486

Oakland Tribune, Oct 2, 2003 by Kim Santos, STAFF WRITER

PLEASANTON -- The federal government should review the safety of the RU-486 abortion pill, ValleyCare Health System officials said Wednesday, following the death of an 18-year-old Livermore woman.

In their first public statement related to the death of Holly Patterson, the Livermore woman who took RU-486, ValleyCare officials said they are confident with the emergency care the woman received and are asking the government to review the drug's safety.

Patterson was seven weeks pregnant when she visited Plan-ned Parenthood of Hayward on Sept. 10 and received a prescrip-tion for RU- 486 in the form of mifepristone and misoprostol.

She was admitted to the ValleyCare emergency room in Pleasanton on Sept. 14, complaining of severe pain and bleeding, and was given painkillers before being released, family members said.

The young woman revisited ValleyCare early Sept. 17 because her symptoms had worsened, her family said, and she died later that afternoon.

Patterson's family said a ValleyCare doctor told them she succumbed to septic shock and a massive systemic infection as a result of not expelling all of her fetus.

"Ms. Patterson came to ValleyCare after taking two drugs which have had a controversial and an extensive history of problems," said David Mertes, chairman of the ValleyCare Board of Directors, at a press conference. "Therefore, ValleyCare is asking for a complete investigation of the use of these two drugs to determine their appropriateness for general use."

Hospital officials said the organization backs an Aug. 20, 2002, citizens petition request-ing the Food and Drug Administration revoke its decision to approve mifepristone, at the very least until it can be determined the drug is safe.

In addition, ValleyCare said it is working with Sens. Barbara Boxer and Diane Feinstein to initiate an investigation of mifepristone and misoprostol at the national level.

"If they say it's OK, give us the guidelines on its use," said Marcy Feit, president and chief executive officer of ValleyCare Health System.

The Washington Times has reported that two women died last year after taking RU-486, spurring the FDA to warn physicians of the risks involved. However, Danco Laboratories, which manufactures mifepristone under the name Mifeprex, said there never was an established causal relationship between the deaths and the drug.

Danco officials could not be reached for comment Wednes-day afternoon.

The Alameda County Coroner's office said it is performing toxicology tests on Patterson and will not be able to provide an official cause of death for a few weeks. The FDA said it also is conducting its own investigation into her death.

Monty Patterson, Holly's father, said a review of the drug is in order.

"We still have many questions ourselves," he said. "Is RU-486 really safe and effective? Does the country know enough about this drug? Are clinics such as Planned Parenthood properly administering RU-486, along with proper care and counseling? Who could afford to lose another daughter? These are some of the questions we have as parents."

Also at issue is the service ValleyCare provided to Holly Patterson, in wake of her death just three days after being released from the emergency room with painkillers.

On Friday, the state Department of Health Services said it was investigating ValleyCare, but while officials would not say what the effort pertained to, they said a simultaneous investigation was being conducted at Planned Parenthood of Hayward.

"ValleyCare is very proud of the quality of service it extends to its patients and welcomes a thorough investigation of the treatment received by Ms. Patterson when she was a patient at ValleyCare," Mertes said.

Monty Patterson confirmed his daughter did tell ValleyCare personnel of her circumstances, but he declined to comment on whether he thought she got the appropriate treatment in the hospital.

"Right now we do not have enough information to come to a proper conclusion," he said. "We were told all we know about the care received here. ... Right now, until we have more answers, I'm more concerned with the future care women will receive."

Feit said the hospital has complied with two visits from the health department and is conducting its own internal investigation. Mertes added that ValleyCare is seeking an independent third party to look at the case.

"If there was any kind of problem (with our care), we want them to surface that problem," he said. "We did everything we could do here at ValleyCare. We had a role in her care. We want that role evaluated."

Feit said she did not have the proper information to be able to comment on whether ValleyCare has dealt with patients experiencing complications from RU-486 in the past, but she did say the facility has seen its share of those suffering from problems with abortions.

Meanwhile, Monty Patterson put special emphasis on the need for counseling before, during and after a woman's decision to abort -- an "intermediate force" that would encour-age talking to one's family.