Pro-Abortion Groups Fume Over Pro-Life FDA Appointees

Capitol Hill (CNSNews.com) - The Bush administration's appointment of pro-life physicians to a federal health advisory panel on Christmas Eve prompted an outcry both from the nation's pro-abortion political lobby and from the country's largest owner of for-profit abortion facilities.

Food and Drug Administration (FDA) Commissioner Mark McClellan, M.D., praised all of the new appointees to the agency's Advisory Committee for Reproductive Health Drugs.

"Each of these 11 physicians brings strong scientific and medical backgrounds to this important advisory group," said McClellan, the administration official in charge of the appointments. "Under Dr. [Linda] Guidice's stewardship, this panel will provide sound, science-based advice on reproductive health issues that will improve women's lives across the country."

The committee was convened to study recent reports concerning the safety and efficacy of hormone replacement therapy commonly prescribed to menopausal women. But the administration, which has delayed for months making the appointments, has the discretion to expand the committee's workload to include other reproductive issues.

Guidice is the chief of reproductive endocrinology and infertility for the Department of Gynecology and Obstetrics at the Stanford University Medical Center. She holds both an M.D. and a Ph.D.

While pro-abortion groups had no comment on the choice of Guidice to chair the committee, at least three appointees drew verbal fire from abortion groups, with appointee Dr. W. David Hager, M.D. receiving the highest decibel criticism.

Hager serves as a professor of obstetrics and gynecology at the University of Kentucky College of Medicine, director of the residency program in obstetrics and gynecology (OB-GYN) at Central Baptist Hospital, and he practices as a board certified OB-GYN at the Women's Care Center, all located in Lexington, Kentucky.

Gloria Feldt, president of abortion facilities owner Planned Parenthood, called Hager's choice "a frontal assault on reproductive rights."

"President Bush's brand of ideological science will be a nightmare for women's health," Feldt claimed in a statement issued after the announcement. "If allowed to continue unchecked, they [sic] will surely turn back the clock on all reproductive health technologies."

The National Abortion and Reproductive Rights Action League (NARAL), did not issue a statement after Hager's selection, but had "warned" of the possibility of his choice in the weeks leading up to the appointment.

"Hager is the wrong choice for this important committee," NARAL wrote in the introduction to a so-called "fact sheet" about Hager on its website. "Unfortunately, his potential appointment is part of a pattern from the Bush Administration of supplanting science and objectivity with anti-choice politics and ideology."

Abortion rights supporters object to Hager's memberships in various Christian medical groups, his support for abstinence-only education and his call further testing of the abortion drug RU-486.

"As a member of the Christian Medical Association, Dr. Hager helped to draft and circulate a petition calling the FDA to reverse its decision approving RU 486," NARAL wrote in its "fact sheet" about Hager.

"While the petition purports to be concerned with women's health," NARAL continued, "Dr. Hager betrayed that his true concern is for the fetus in one press statement."

However, the statement NARAL challenged was actually made, not to the press, but in an Aug. 2002 petition filed with the FDA on behalf of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) regarding RU-486.

"I have a passion for the health and well-being of women and their unborn/newborn offspring," Hager wrote. "The use of any medication that puts the life and health of either of these individuals at risk implores me to call for a thorough and exhaustive evaluation.

"RU 486 is such an agent," he concluded, "posing risks to women and potentially to their unborn babies."

Hager is also a member of the Physicians Resource Council (PRC), which NARAL criticized as a "radical right organization" because of the mission statement of PRC's parent organization, Focus on the Family: "To cooperate with the Holy Spirit in disseminating the Gospel of Jesus Christ to as many people as possible, and, specifically, to accomplish that objective by helping to preserve traditional values and the institution of the family."

NARAL also condemned Hager's July 1996 statement to a Senate subcommittee that abstinence is "the only medically safe and morally responsible choice for unmarried persons."

Wendy Wright, senior policy director with Concerned Women for America, called the "smear campaign" against Hager "shameful" in an Oct. 18 statement.

"Dr. Hager is eminently qualified and highly respected by his peers and the women he treats," Wright said. "To attack a highly credentialed doctor over his incorporating Christian faith into the practice of medicine is nothing less than religious bigotry."

In addition to his practice and teaching credentials, Hager has served as an assistant surgeon with the U.S. Public Health Service and a clinical research investigator for the Centers for Disease Control. He has delivered more that 5500 babies and was voted one of the "Best Doctors for Women" by the readers of two women's magazines, once in 1997 and again in 2002.

Planned Parenthood's Feldt also criticized the appointment of Dr. Joseph Barney Stanford, M.D., an associate professor with the Department of Family and Preventive Medicine at the University of Utah in Salt Lake City. Stanford has described the "morning after pill" as an abortion drug.

Dr. Susan Crockett, M.D., a clinical assistant professor at the University of Texas Health Science Center at San Antonio and director of maternity services at Christus Santa Rosa Hospital was targeted by Planned Parenthood because of her service as an at-large board member of the AAPLOG.

The little-known history of the RU-486 approval process deserves some very close scrutiny, and I hope this guy starts leading the charge.

During the first Bush administration pro-abortion groups argued that RU-486 had never been approved by the FDA because of pro-life zealots in the White House. In fact, RU-486 had never been approved by the FDA because Hoechst-Celanese, the U.S. subsidiary of Roussel-Uclaf (the "RU" in RU-486) had never applied for it. The reason for this was simple -- they knew that introducing a drug with the side effects of RU-486 in a lawsuit-happy country like the U.S. would have been the equivalent of corporate suicide.

During the Clinton administration, an interesting little deal was worked out in which the patent on RU-486 was given to a "reproductive rights group" that had no assets to lose in civil court, and this group serves as the U.S. distributor of the drug.

Anyone who brought a cold medication or faulty consumer product to market in this manner would be rightly accused of having a depraved indifference toward the health and welfare of the American public.

Making America Safe for RU-486

The FDA fudged its own rules.

By Melissa Seckora, NR editorial associate
February 7, 2001 9:55 a.m.

Yesterday, Sen. Tim Hutchinson (R., Ariz.) and Rep. David Vitter (R., La.) introduced the "RU-486 Patient Health and Safety Act" — legislation meant to codify and strengthen the Food and Drug Administration's patient protections for women who take the abortion-inducing drug, RU-486. But wait: Isn't RU-486 supposed to be about giving women more "choices"? Why do women need to be "protected" from it?

"The legislation is about protecting women's health," said Rep. Vitter. "Last fall, the Clinton-Gore FDA caved in to political pressure from the abortion lobby and hurriedly approved the abortion drug without crucial health protections for those who use it." Under the proposed law, prescribing physicians must, among other things, be "qualified to handle complications of an incomplete abortion, be legally empowered to perform an abortion and trained to do so, and be properly trained in the administration of this drug."

On September 28, 2000, the FDA approved mifepristone, or RU-486, under an accelerated drug-approval process intended to provide new, safe and effective treatments for serious or life-threatening illnesses such as HIV/AIDS and cancer. But it's hard for even the most adamantine pro-abortion activists to argue that RU-486 — a drug that is neither particularly safe nor effective — should fall under the fast-track rule.

Mifepristone was approved for marketing "under 21 CFR 314 Subpart H" in a memo from an unnamed FDA official to Sandra P. Arnold, the Population Council's vice president of corporate affairs, on September 28th. Subpart H, or "Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses," was adopted by the FDA in 1992 to "accelerate approval of certain drugs…for serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary."

According to the FDA, qualification for accelerated approval depends on whether a drug is safe and effective "in treating serious or life-threatening illnesses," and whether it will "provide meaningful therapeutic benefits to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy)."

In its memo to the Population Council, the FDA stated that mifepristone should enjoy the benefit of this provision because "the termination of an unwanted pregnancy is a serious condition within the scope of Subpart H," adding that "[t]he meaningful therapeutic benefit over existing surgical abortion is the avoidance of surgical procedure."

Until RU-486 came along, only 30 drugs had ever been approved under Subpart H: Exactly half of these were for the treatment of HIV/AIDS. The rest were for other debilitating diseases, such as cancer, tuberculosis, and leprosy. This makes sense, given that the FDA's definition of a "serious condition" is one "associated with morbidity that has substantial impact on day-to-day functioning." But surely a healthy pregnancy does not fall under the rubric of disease or chronic illness? Not exactly.

Curiously, the FDA defined "[the] meaningful therapeutic benefit" of RU-486 as "the avoidance of a surgical procedure." In so doing, the FDA contradicted its very own medical findings. In a November 22, 1999, medical review of RU-486, the FDA compared mifepristone-induced abortions to surgical abortions in three countries — China, Cuba, and India — and found that mifepristone-induced abortion caused "more adverse events, particularly bleeding, than did surgical abortion."

Still other harrowing side effects, including cramping, nausea, and vomiting, were far more prevalent among the women taking RU-486 than among women undergoing regular abortions. In 1999, a smaller study comparing the experiences of American women reported similar findings.

Nevertheless, the FDA trumpets the alleged therapeutic benefits of RU-486 over existing abortion methods. And even though its own internal studies show that taking mifepristone may lead to potentially lethal side effects, the FDA stands by its decision to fast-track the drug to market. An FDA spokesman told NRO, "As with all drugs the FDA approves, in the case of mifepristone, the FDA fully met its own standards."

If that is the case, then someone may wish to reexamine those standards. Consider the fact that Searle, the manufacturer of misoprostol, the drug that must be taken two days after the ingestion of mifepristone in order to induce an abortion, objected strongly to the use of its drug in combination with mifepristone. According to the company, misoprostol "is not approved for the induction of labor or abortion." Using it in conjunction with RU-486 therefore amounts to what doctors call an "off-label" (i.e., unapproved) use — much like using beta-blockers to cure a headache.

Among the adverse events reported following the off-label use of misoprostol in pregnant women include maternal or fetal death, vaginal bleeding, and pelvic pain. Any one of these seems like an awfully high price to pay just to procure a more expedient abortion.

Abortion is still unsafe!

Jane Chastain says forget back alleys, check your medicine cabinet

WorldNetDaily.com ^ | Thursday, August 29, 2002 | Jane Chastain
Posted on 08/29/2002 0:57 AM Pacific by JohnHuang2

Abortion was not safe before Roe vs. Wade, the 1973 Supreme Court decision that legalized the procedure, and the dirty little secret is, it may be even less safe today – even in the privacy of our own homes.

We have more laws safeguarding the animals we take to the vet than we have safeguarding the health of the 1.3 million women a year who have abortions. Radical feminist groups that have aggressively promoted this $90 billion-a-year industry have contributed to the current climate.

Furthermore, the abortion drug RU-486, which was approved by the Food and Drug Administration in September of 2000, may be one of the most dangerous – as well as traumatic – ways to terminate a pregnancy.

A citizens petition was delivered to the Food and Drug Administration last week by one of this nation's largest women's organizations and two physicians groups designed to force the agency to take another look at the abortion drug RU-486, Mifeprex, and it's prostaglandin chaser, Misoprostol.

The 92-page petition from Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists and the Christian Medical Association charged that the FDA bowed to political pressure and violated the Administrative Procedure Act as well as its own "well-established standards" when approving this drug combo.
These groups charge that the trials "were not blinded, randomized or concurrently controlled." In other words, physicians or groups who were heavily biased may have conducted these trials or had a vested interest in proving that RU-486 was safe.

To be sure, the groups that delivered this petition have their own bias on abortion. They don't think the decision to take the life of a child in the womb ever is the proper decision, unless it is done to save the life of the mother. However, it's about time somebody stepped up to the plate and pointed out that these drugs are not only deadly to the child, they can be damaging, if not deadly, to the child's mother.

Where are all the groups that regularly go to the mat on women's health issues? They have assumed their usual heads buried in the sand, don't give-us-any-bad-news when it concerns abortion posture.

In April, Danco Laboratories, which manufactures [Chinese factory does and RU-486 is banned for use in CHINA!!]the drug for the Population Council, the New York group that holds the U.S. rights to Mifeprex, announced several adverse events among women who took the drugs between June of 1998 and November of 2001.

These events included ruptures of ectopic pregnancies, resulting in one death. Danco also reported two serious bacterial infections and one of those resulted in death. A 21-year-old woman suffered a heart attack after taking the deadly duo, although the manufacturer insists that there wasn't an established "causal" relationship between the drugs and these serious complications and deaths.

FDA data also reported another 22 women required hospitalization or another "intervention to prevent permanent impairment or damage" after taking Mifeprex during the same time period.

A report from the Family Research Council, "When There's Little 'Care' in Women's Health Care," chronicles how our government has failed to take the necessary steps to protect the women who go into the nation's abortion mills thinking they are perfectly safe.

Before Roe, feminists lamented that 5,000 to 10,000 women a year died because of illegal back-alley abortions – which was a lie. In 1972, the Centers for Disease Control reported that 39 women died as a result of illegal abortions. Today, how many deaths occur from "legal" abortions? The truth is we don't know and apparently the CDC isn't anxious to find out.

The CDC collects abortion statistics on a "voluntary" basis from state and local health departments. Not all states participate. Though abortion deaths increasingly are making it into our newspapers, few of these deaths have been included in these reports.

Medical data now is entered by computerized code. The FRC report states that those responsible for entering this data have found "that any attempt to code a death due to abortion under abortion yields a reject message from the computer programs provided by the National Center for Heath Statistics (a division of the CDC)."

The Supreme Court found a "right to privacy" lurking around in the secondary shadows of the Constitution and applied that "right" to abortion in Roe. Now it seems that the government is determined to keep the secrets of this largely unregulated industry in the shadows.

It's time to shine the light of truth on this subject and a good place to begin is with the FDA's approval process for RU-486.

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