politics

RU-486: The Uncontrolled Birth Control Pill

By David Brody
Congressional Correspondent

CBN.com – (CBN News) - It is a pill that looks innocent enough. It is the size of an aspirin. But in the four and a half years it has been on the market, dozens of women have suffered serious complications from it, and three have even died.

Hoyt Samples is an attorney for a woman named Brenda. The family asked that we not share her last name or show a picture. Brenda took RU-486, and then began experiencing severe pain and bleeding.

The doctors at the abortion clinic said not to worry, that these were normal side effects. But the doctors were wrong. Brenda actually had a massive infection due to a tubal pregnancy where the fetus lives outside the uterus.

According to Samples, "She went into this clinic on a Friday afternoon very healthy, and by Monday afternoon, she was brain-dead."

The problem is, the side effects of severe pain and bleeding from a tubal pregnancy are the same as for RU-486. That is why the FDA says it should not be taken if a woman has a tubal pregnancy. But oddly enough, the FDA does not require abortion doctors to conduct an ultrasound to determine whether a woman might have a tubal pregnancy, prior to giving her the pill.

Samples said, "This drug was reviewed in a most unique and unusual fashion, and as a result, we have a drug on the market today which has probably gotten through the review process like no other drug in history."

He is not the only one to complain. The American Association of Pro-Life Obstetricians and Gynecologists, along with the Christian Medical Association and Concerned Women for America, has filed a citizen petition with the FDA requesting that RU-486 be pulled off the market.

These groups say there is clear evidence that it is harmful to women, and that the approval process was rushed back in the late 1990s. The drug was put on the fast track because it was defined as a cure for a life-threatening illness. But these groups say that being pregnant is not a life-threatening illness.

Plus, they claim that the 1996 advisory committee looked at the clinical trial data from just one French study, and that it was highly controlled. The committee never had the full data from the U.S. clinical trials at the time of the hearing.

So what about that review process? Well, that is where this 1996 committee comes in. Eleven doctors were picked to decide if this drug was safe. But how were they picked? Who were they exactly? The evidence we are about to show you indicates that this committee was packed with abortion supporters.

Of the 11 members, eight of them are either affiliated with an abortion organization or have made pro-choice statements in the past.

For example, the committee chairman, Ezra Davidson, said in a 1993 Los Angeles Times article that Planned Parenthood should be less timid when it comes to moving into poor areas, because the need for its services is so great.

He is also on Planned Parenthood's 2002 advisory board. CBN News tried for months to contact Mr. Davidson. He never responded.

Two other committee members, Jane Zones and Deborah Narrigan have been board members for the National Women's Health Network, a pro-choice lobbying group. Zones did not vote on RU-486 back in 1996, citing a conflict of interest, but Narrigan did vote in favor of it.

Narrigan lives in Nashville Tennessee. She originally agreed to do an on-camera interview with CBN News, but then, just a few days before the interview, abruptly cancelled, saying she had second thoughts.

She did provide us with a written statement. Regarding the fairness of the committee, she said, "I think the committee was balanced in background, expertise and knowledge...These are the attributes that count when something as important as this work is at issue."

Another key player in all of this is the executive secretary of the committee, Philip Corfman. He is primarily responsible for putting the committee together. It turns out that he used to be a volunteer for Planned Parenthood before joining the advisory committee. He is also listed as an advisory committee member for the pro-choice Center for Reproductive Health Research and Policy, and currently sits on the board of directors for the pro-choice group, Physicians for Reproductive Choice and Health.

Corfman would not go on camera with us, saying through an email, "I don't believe that my agreeing to appear on your show would be useful.”

Samples said, "This should have been a fair committee. They should have had the integrity to step aside and acknowledge their conflicts."

The person we really wanted to talk to is Dr. David Kessler, the former head of the Food and Drug Administration. He is recognized as the man who began the major push for RU-486 here in the U.S., and he had control over who eventually sat on that advisory committee.

After repeated attempts, he eventually agreed to an interview with us.

David Brody: "There could be a perception out there that some of these folks may not have come at it from the best scientific standpoint. Rather, there may have been an agenda along the way."

Dr. David Kessler: "Let me assure you, there was no agenda other than making sure that the very best science, that the best experts in the country, look at the question. In fact, where the individual members stood on the abortion issue, I couldn't even tell you."

Dr. Kessler says that the debate over RU-486 should not center on what you believe when it comes to abortion. It is simply about science. But Dr. Kessler's own beliefs on that issue are quite clear. Here is what he had to say at NARAL Pro-Choice America's dinner just last month.

Kessler said, "The threat to a women's right to choose concerns me gravely as a citizen and as a physician."

He was not there just to make a speech. He actually received the abortion group's lifetime achievement award. He even posed with the award for our CBN camera.

This whole debate over RU-486 has found its way to Capitol Hill. Some Republican lawmakers in both the Senate and the House plan to introduce legislation that would pull RU-486 off the market until a full safety review is done.

We showed Senator Sam Brownback (R-KS) what we uncovered about the decision to send RU-486 to market. The senator has been one of the key players in trying to get RU-486 pulled from sale to the public. Our evidence troubled him.

Brody: "How concerning is that for you?”

Sen. Sam Brownback: “It's very concerning, and why didn't that come [out] at the time?”

The senator says evidence like this makes him wonder.

Sen. Brownback said, "You would hope that the FDA drug approval process would not be a politicized one because people's health is at risk, and yet it looks like it was in this case."

Dr. Kessler says he strongly disagrees. "One of the reasons why we held a public advisory committee for hours on end,” he said, “was to make sure that anyone who wanted to present data had that opportunity to do so, so that individuals on all sides of the abortion question were able to present their data."

But the only law that addresses how a committee like this should be made up is the Federal Advisory Committee Act of 1972. It requires that the membership of the advisory committee to be fairly balanced in terms of points of view represented.

Samples says that was clearly not the case here. He says the deck was stacked.

Samples remarked, "There's an old saying, ‘You pick the game, but if you let me select the rules, I'll beat you every time.’ And in this situation, that is exactly what has happened."

It is a huge amount of controversy from such a small pill, and with the FDA reluctant to pull it off the market, it looks like it will be left to Congress to decide what the next step should be.

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