RU-486 Critics Counter Claims About Abortion Drug

By Robert B. Bluey | July 7, 2008 | 8:04 PM EDT

( - Nearly a month after the death of a California woman who took RU-486, pro-life groups are touting new evidence about the abortion drug in their quest to have it pulled from the market.

Three pro-life organizations say they have bolstered the legal and scientific arguments against RU-486 in a new filing with the Food and Drug Administration, which approved the drug in September 2000.

"The only way to ensure women's health and safety is to pull this drug from the market," said Wendy Wright, senior policy director at Concerned Women for America (CWA). "The drug is inherently unsafe and the way abortion clinics are administering it makes it even more dangerous to women."

The Sept. 17 death of 18-year-old Holly Patterson, who had taken the two-drug combination of mifepristone and misoprostol, has given pro-life advocates a new sense of urgency. The Christian Medical Association and the American Association of Pro Life Obstetricians and Gynecologists joined CWA in filing the new comments with the FDA.

In August 2002, the groups filed a petition with the FDA asking it to pull RU-486 from the market. The drug's maker, Danco Laboratories, rebutted those arguments in a reply to the FDA. Now, the pro-life groups are weighing in again with more evidence, Wright said.

One of the main concerns stems from the use of misoprostol, which was approved by the FDA to treat ulcers. RU-486 consists of two pills. Women take mifepristone first to kill the baby and then, two days later, take misoprostol, which induces labor and forces out the baby's remains.

Wright accused Danco of lying in its defense of the two-drug combination. She said the new information presented to the FDA sheds light on the safety concerns associated with using misoprostol.

"Danco had raised some arguments and we shot them all down," Wright said.

But Danco's medical director, Dr. Richard Hausknecht, who teaches at the Mount Sinai School of Medicine, questioned the significance of the latest filing by the pro-life groups.

"I have no information that would indicate that what they believe is correct," said Hausknecht, who also noted the inconclusiveness of Patterson's death.

"I don't know the cause of death of this unfortunate young woman," Hausknecht said, "so without that information, it seems to me one can't make a judgment or a decision about anything."

Patterson received the drug from a Planned Parenthood clinic in Hayward, Calif., near San Francisco. A spokesman at the organization's national office didn't respond to phone calls.

The Christian Medical Association signed on to the petition primarily because of safety concerns about RU-486, said Dr. Gene Rudd, the group's associate executive director.

"This is not a safe drug. It was predictably not going to be a safe drug when it was first approved," Rudd said. "The approval process was tainted and the FDA broke its own rules. Now, we're seeing the consequences of that played out in the women who take it."

Rudd accused the agency of removing some of the safety features that were in place during the clinical trials. As news spreads about the problems women are encountering, Rudd said RU-486 is losing its popularity.

In addition to the safety concerns, the petition also raises objections to the approval process. Shortly after filing its comments, CWA released a letter dated June 9, 2000, from Sen. Barbara Boxer (D-Calif.), which Wright said shows the political pressure that was facing the FDA.

Boxer's letter complains about possible "draconian restrictions" that she said would limit accessibility to RU-486. Wright said the FDA must have taken Boxer's concerns seriously because the agency dropped the restrictions when it approved the drug.

"People need to be aware that the FDA's approval of this drug was not without political strings; it was," Wright said. "There was a tremendous amount of political pressure."

Neither Boxer's office nor the FDA responded to multiple requests for comment.

Meanwhile, ValleyCare Medical Center, the emergency room where Patterson was taken, recently asked California's two senators, Boxer and Dianne Feinstein, to initiate a national investigation of mifepristone and misoprostol.

See Earlier Story:
Pro-Lifers Criticize FDA for Poor Monitoring of RU-486
(Sept. 26, 2003)

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