Wednesday, February 01, 2006

Holly's Law Update

I thought this deserved special attention. I get press releases from my congressman Rep. Bartlett, as well as emails from various groups like the RNC and such. This one I thought was particularly interesting and worth passing on, as it was much more informative and does not appear to be a campaign ad (which is what most of the RNC emails are). Anyway, here it is:


Congress Urged to Vote on Holly's Law (H.R. 1079) to Suspend FDA Approval of RU-486

FDA Reports Eight Women Are Dead and More than 840 Injured

Washington, DC - A news conference in Washington, DC today called attention to new research analyzing reports to the Food and Drug Administration (FDA) of eight women who died and serious injuries to more than 840 others after RU-486 abortions. Congressman Roscoe Bartlett joined by around a dozen Members of Congress and representatives of more than a dozen pro-life organizations urged Congress to approve Holly's Law, H.R. 1079, a bill that would pull RU-486 from the U.S. market. H.R. 1079 is cosponsored by 79 House members. Senator Jim DeMint has sponsored a companion bill S. 511. Congressman Bartlett said, "I introduced Holly's Law because I think medicine should help people and not kill them."

Holly's Law is named in memory of Holly Patterson, a young Californian woman killed by RU-486 in 2003. Holly became pregnant at age 17 and had barely turned 18-years old when she died in the hospital from toxic shock seven days after being given RU-486. Her parents did not know that she was pregnant until after she was hospitalized and dying.

Dr. Donna J. Harrison and Dr. Margaret M. Gary, co-authors of a new study, "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient," The Annals of Pharmacothrapy, 2006 February, Volume 40 and members of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) attended the news conference. Dr. Harrison presented a summary of their study of complications from RU-486 abortions contained in Adverse Event Reports (AERs) to the FDA by Danco, the manufacturer of RU-486, filed between September 2000 and July 2005. They analyzed 607 reports between September 2000 and September 2004. Of these reports, Dr. Harrison and Dr. Gary documented five deaths and 64 life-threatening and 224 severe events according to the National Cancer Institute's Common Terminology for Coding Adverse Events (CTCAE).

Dr. Harrison said, "237 women hemorrhaged, 42 losing over half of their blood volume, one teenager died. 68 women required blood transfusions. Three women died from rapidly fatal infections and another four women were in septic shock, including two teenagers, but survived. 43 other women were hospitalized for severe infections. 237 women had emergency surgery, most often for severe bleeding. 17 women had surgery for ectopic pregnancies missed by the abortion provider. 13 women had fetuses who survived the abortion into the second trimester and of those, three were grossly deformed. 250 additional reports to the FDA since September 2004 included three more deaths. For the sake of American women, we urge Congress to suspend the approval of RU-486."

The New England Journal of Medicine on December 1, 2005 reported on the deaths of women from Clostridium sordelli infections within seven days after taking RU-486, "Fatal Infections Associated with Mifepristone-Induced Abortion," Michael F. Greene, MD and "Fatal Toxic Shock Syndrome Associated with Clostridium sordelli after Medical Abortion," by lead author Marc Fischer, MD, M.P.H.

Holly Patterson is one of the four previously healthy young American women who died from Clostridium sordelli infections after taking RU-486. Reacting to the new studies, Holly's father Monty Patterson said, "How can we expect a teenager to figure out if she's beyond the so-called normal side effects of an RU-486 abortion to serious adverse events?"

Congressman Bartlett, who earned Master's and Doctorate degrees in Human Physiology, said the rate of death and severe injuries to women from RU-486 abortions was extremely high. "RU-486 always kills babies. Today, we present stronger evidence that RU-486 kills and injures women. It is unacceptable for the FDA to expose women to the risk of serious injury, especially deadly infections whose symptoms are similar to any RU-486 abortion when we have documented cases of medical professionals who have failed to diagnose them."

Congressman Bartlett said "In his State of the Union Address last night, President Bush said, 'A hopeful society has institutions of science and medicine that do not cut ethical corners, and that recognize the matchless value of every life.' "The President's words and this research add more compelling justification for Holly's Law because the FDA slashed ethical and procedural corners when it approved RU-486 under a special 'restricted distribution' approval process known as 'Subpart H,' reserved only for drugs that treat 'severe or life-threatening illnesses.' The short list of other drugs approved under Subpart H includes Cipro used to combat bioterrorism in emergency situations and drugs used to treat cancer and AIDS -- clearly 'life-threatening illnesses.' Other drugs approved under Subpart H can have serious side effects and are only considered acceptable when the alternative is death from the life-threatening illness."

"In the face of these eight known deaths and more than 840 injuries, the continuing assertion by national abortion advocates that RU-486 abortions are safe and effective is sickening," said Congressman Bartlett. "The FDA rarely pulls drugs from the market. Responsible manufacturers pull drugs from the market. However, RU-486's manufacturer, Danco, is a shell company. Its only product is RU-486. That is why Congress must act and approve Holly's Law to protect women's lives and health from this dangerous abortion drug."

Dr. E. Hakim-Elahi is one of the few abortion advocates critical of RU-486. In a letter to the editor in Ob.Gyn.News (February 15 2005 * Volume 40 * Number 4), Dr. Hakim-Elahi wrote, "Medical abortion with the present drug regimen is unsafe...Medical abortion is not convenient, either. It is not cost-effective."

Excerpts of news releases from other news conference participants:

Rep. Joe Pitts, Chairman of the House Values Action Team (VAT)

"Though the evidence shows that RU-486 is a dangerous and even life-threatening drug, neither the drug's manufacturer nor the FDA has so far shown a willingness to pull it from the market. Faced with this reluctance to pull a known health threat from the shelf, Congress has the duty to take action. And that is exactly what Holly's Law will do."

Rep. Peter Hoekstra

"RU-486 has been described as an effective method of abortion. However, information on its potential to cause severe damage to a woman's body is not widely known."

Janet Morana, Co-Founder of the Silent No More Awareness Campaign and Associate Director, Priests for Life

"We said [RU-486] would be a chemical time bomb. We declared that the women who would use this drug, if approved, would be essentially treated as guinea pigs for the abortion industry. One cannot fill the body with powerful synthetic steroids that interrupt pregnancy and kill a child without expecting other negative consequences. Now, unfortunate events have proved these warnings to be true, and Holly's Law provides the only proper response to the injuries and deaths that RU-486 has caused."

National Right to Life Committee (NRLC), Dr. Randall O'Bannon, Educational Director

"There is independent statistical evidence that these [RU-486] usage figures may be inflated. There is also reason to believe that deaths and other adverse events are seriously undercounted. How many women never tell their families they've taken the abortion pill? How many are not even able to tell the doctor in the E.R.? The system waits for prescribers to call and report adverse events to the distributor, but a clinic may never see or hear from a woman again once she leaves their door."

Religious Freedom Coalition, Peggy Birchfield, Executive Director

"The Religious Freedom Coalition believes that with the rushed, 'fast-track' approval of this dangerous drug, RU-486, the FDA essentially allowed uncontrolled experimentation on unsuspecting women and adolescent girls who trust that the medical drugs legally available in the United States have been thoroughly tested for safety. The Religious Freedom Coalition strongly supports passage of Holly's Law, H.R. 1079, and we thank Congressman Bartlett and all the cosponsors for stepping forward to protect the lives and health of American women and girls."

U.S. Conference of Catholic Bishops (USCCB) Deirdre McQuade, Director of Planning and Information of the Secretariat for Pro-Life Activities

"The Bishop's Conference strongly supports Holly's Law. We oppose every abortion as the taking of innocent human life. But the RU-486 method compounds this offense by also threatening the lives and well-being of women. After five years of trauma and death associated with RU-486, the FDA's response has been limited to one health advisory and amended drug labeling. How many more women must die before we take a close second look at RU-486?"

Coalitions for America, Paul Weyrich, President

"The fact that the FDA stands still while young women die from having placed their trust in RU-486 as a safe drug is unacceptable. This drug is a killer and the deaths of young women such as Holly Patterson demands that the FDA be shaken out of its complacency. Rep. Roscoe Bartlett (R-MD) deserves the thanks of concerned Americans who want the FDA to do its job and thoroughly investigate this drug and the level of safety it provides its users. It's worth asking: where is the abortion lobby on this issue? They claim to want abortions that are 'safe.' If that is the case then they should put aside differences and join with Rep. Bartlett to have this drug pulled from the market."

Christian Coalition of America (CCA), Roberta Combs, President

"Christian Coalition of America wholeheartedly supports 'Holly's Law.' It is almost criminal that the federal government has refused to remove this deadly abortion pill from the market when young girls' lives have been destroyed after taking RU486. If Members of Congress really care about the lives and health of women in this country, it is long past time for the United States Congress to pass 'Holly's Law.'"