Are telabortions in compliance with the law? 1

By Tre Critelli

In September of 2000, the Food and Drug Administration (FDA) approved the marketing and use of mifepristone (brand name Mifeprex, but commonly known as RU-486) for the termination of early intrauterine pregnancy, which is defined as a pregnancy of 49 days or less counting from the last menstrual period. The FDA conditioned the distribution of the drug, however, on the performance of specified medical requirements to ensure its safe use. This is known in the legal/medical industry as a ”Subpart H” approval. See 21 CFR 314.520.

On May 17, 2006, Dr. Jane Woodcock, Deputy Commissioner for Operations at the Food and Drug Administration, testified to a subcommittee of the U.S. House of Representative’s Committee on Government Reform about the FDA’s approval of Mifeprex. It was during her tenure as the Director of the FDA’s Center for Drug Evaluation and Research that the FDA approved Mifeprex for use. As noted by Dr. Woodcock:

Some complications of medical abortion are similar to those of surgical abortion, and some of these require a surgical intervention. Comprehensive risk management of abortion therefore requires that the managing physician be able to diagnose an ectopic pregnancy, manage the risks of abortion, including bleeding and infection, and be able to conduct a surgical abortion if necessary or quickly refer a patient to a provider who is trained, qualified, and readily available to do so.Woodcock, p.2.

According to Dr. Woodcock, as part of the Subpart H approval for Mifeprex, distribution of the drug was restricted in several ways, including that it must be provided by or under the supervision of a physician who meets certain qualifications. These restrictions were designed to ensure the safe use of the drug. They include specific requirements concerning diagnosis, treatment, patient information and reporting:

Diagnostic requirements: Physician must be able to accurately assess the duration of the pregnancy and whether or not the patient has an ectopic pregnancy.

Treatment requirements: Physician must have the ability to provide either directly or through another qualified physician, surgical intervention in cases of incomplete abortion or severe bleeding, and the ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Informational requirements: Physician must understand the prescribing information about Mifeprex; must explain and discuss with the patient the procedure that will be performed, provide the patient with a Medication Guide and Patient Agreement, and obtain the patient’s signature on the Patient Agreement.

Reporting requirements: Physician must record the Mifeprex package serial number in the patient’s medical record, notify the drug’s sponsor in the event the pregnancy is not completely terminated by the procedure or if the patient needed any hospitalization, transfusion or other serious complication.

Further, the approving label for Mifeprex includes a Prescriber’s Agreement that each provider must sign before being able to receive the drug for distribution. This includes agreement with the following statement: “Under Federal law, Mifeprex must be provided by or under the supervision of a physician.”

Ordinarily, the FDA requirements are complied with and a physician is physically in attendance during the consultation, diagnosis and procedure. Under a plan pioneered and currently in practice here in Iowa by Planned Parenthood of the Heartland, however, the attending physician is no longer physically present with the patient, but is instead there virtually, by what is known as telemedicine.

What is telemedicine?

According to the American Telemedicine Association, the term telemedicine refers to “the use of medical information exchanged from one site to another via electronic communications to improve patients’ health status.” It is often used to describe the rendering of clinical services remotely through some form of electronic medium, be it a phone, fax, video or email. As noted by the ATA website:

Telemedicine is not a separate medical specialty. Products and services related to telemedicine are often part of a larger investment by health care institutions in either information technology or the delivery of clinical care. Even in the reimbursement fee structure, there is usually no distinction made between services provided on site and those provided through telemedicine and often no separate coding required for billing of remote services.

Given the ubiquity of the internet these days, telemedicine certainly offers a great benefit to both the provider and the recipient of medical services.  The use of telemedicine to perform abortions, however, goes beyond electronic medical records, remote viewing of records by radiologists and online medical prescriptions. It is aimed at creating a new method of administering an abortion, the telabortion.

What is a telabortion?

Telabortion is the remote performance of an abortion, perhaps best described as an “internet abortion.” Unlike other forms of telemedicine where medical information is exchanged, conditions diagnosed and prescriptions written, telabortion stands out because the physician is actually performing a medical procedure without being physically present with the patient.  During a telabortion, the patient is seated at a computer in one location while the attending physician is located off-premises. There is a nurse or aid present with the patient. The doctor and patient are able to see and speak to each other. After consultation, the doctor can then remotely open a drawer at the patient?s location. Inside the drawer is a dose of Mifeprex, which is then taken by the patient.

Are telabortions in compliance with the law?

The question of the legality of telabortion will ultimately turn on whether or not a physician who is virtually present can comply with the necessary requirements of Iowa law pertaining to abortions as well as the specific federal regulations concerning Mifeprex.

Iowa Code section 707.7 is quite specific that only those “licensed to practice medicine and surgery under the provisions of Chapter 148, or an osteopathic physician and surgeon licensed to practice osteopathic medicine and surgery under the provisions of Chapter 150A can terminate a human pregnancy.” If anyone else performs an abortion, it is a felony (emphasis Quiner’s Diner). Thus, in order to be in compliance with the law, proponents of telabortions must take the position that it is the physician who is performing the medical procedure. To argue that another individual is actually performing the procedure is a clear violation of the law.

The matter is further complicated when it is a minor seeking an abortion. While the State of Iowa allows abortions to be performed upon minors, there are specific requirements set forth in Iowa Code section 135L which must be fulfilled by the physician who will be performing the abortion, ranging from the obtaining a completed certificate concerning the offering of a statutorily required video to the minor to the requirement that “the licensed physician who will perform the abortion shall provide notification in person or by mailing the notification by restricted certified mail to a parent of the minor.” Such a notification has to be served at least 48 hours before the abortion is performed, except in certain circumstances. See Iowa Code section 135L.3(3)(m).  At least one of the listed exceptions (grandparent notification) requires the physician and minor to exchange written documentation. It is difficult to see how these documentation and notification requirements can be complied with during a single telabortion session. It should be noted that failure to comply with the requirements is punishable by up to a year in prison.

Practically speaking, it will be Planned Parenthood of the Heartland’s ability to comply with the FDA regulations concerning Mifeprex that will determine whether or not a telabortion can be performed. Can a virtual physician fulfill the requirements as set forth in Dr. Woodcock’s testimony?  Can such a physician “diagnose an ectopic pregnancy, manage the risks of abortion, including bleeding and infection, and be able to conduct a surgical abortion if necessary or quickly refer a patient to a provider who is trained, qualified, and readily available to do so.”

The answer will ultimately have to be decided by the Courts. Until such time, however, the default answer should be ‘no’ and all telabortions in the State of Iowa halted. The burden should be upon Planned Parenthood of the Heartland to prove that their virtually present physician can perform as ethically and legally required, not upon opponents of the procedure to prove otherwise. The cost to Planned Parenthood of the Heartland for stopping telabortions is minimal, merely one of convenience: a woman may have to drive a bit farther to receive an abortion. The cost of not stopping telabortions, however, could potentially result in the loss of her life. Given the choice, there is little doubt that she would choose a little more time in her car over the risk of suffering a life-threatening complication while her attending physician watches, helpless, over the internet.

[Telabortions will have a profound long term effect on Iowa, and eventually the entire U.S. if the practice is allowed to continue.  Guest columnist, Tre Critelli, presents a concise legal background on this issue. Mr. Critelli is an Iowa Trial Lawyer/English Barrister/Certified Fraud Examiner. Quiner’s Diner thanks him for the legal background on this abominable practice. Check out additional posts on this critical subject here. Encourage your friends to read the above article to be informed.]

Should we turn Iowa into the abortion Mecca of America? 3

By Tom Quiner

What a beautiful state, Iowa.

Our soil is black and loaded with life. We feed the world.

Our people are sensible, hard-working folks. There are no finer people in the world than Iowans. I’ve had the opportunity to travel the country over the years. Americans are great everywhere. But Iowans are always at the top of the list when it comes to friendliness, frugality, and common sense.

What is one to think of the forces at work bent on turning Iowa into the abortion Mecca of America?

Planned Parenthood is performing long-distance tela-bortions with the tacit approval of the Attorney General. The AG, Tom Miller, a Democrat, is okay with this even though Iowa law says a doctor should be present when an abortion takes place. With tela-bortions, a doctor is not present. Mr. Miller chooses not to prosecute.

The next step in expanding abortions in Iowa comes from abortionist, Dr. LeRoy Carhart. Dr. Carhart earns his living aborting babies late in their Mom’s pregnancy. His practice currently resides in Nebraska. He has stated he would like to expand his abortion business into Council Bluffs, Iowa, Indianapolis, and the Washington D.C. area.

He’s got a problem. Nebraska passed a tough anti-abortion law that restricts abortions after 20 weeks. The reasoning? At that stage of the pregnancy, the baby can feel pain as it is killed and removed from the mother’s womb. Nebraska legislators believed that to be immoral and passed this more restrictive abortion legislation.

Not to be deterred from earning a living, Dr. Carhart is now looking to Iowa and beyond for new abortion markets.

Republican legislators are interested in passing legislation similar to Nebraska’s to prevent the Dr. Cartharts of the world from setting up shop here.

Current Iowa law is lax. It prevents abortion after 24 weeks unless the doctor believes the abortion is needed to “preserve the life or health” of the mother, a loophole that increases the quantity of abortions in Iowa. Republican legislation, should it pass, would help reduce the high quantity of abortions in Iowa, which has been abetted by the Attorney General’s willingness to allow telabortions into our state.

The legislation will surely get through the Iowa House, which is controlled by Republicans. Even in the Senate, which is controlled by Democrats, there may be a chance to pass the bill. After all, how could any legislator allow someone to be killed who feels pain? We put dogs down humanely. Isn’t a baby in the womb worth as much as a dog?

Whether this piece of legislation is passed comes down to another single Democrat, Majority Leader of the Iowa Senate, Michael Gronstal. He alone determines whether this bill can come to the floor for a vote. He alone can determine whether a baby in the womb should be treated as well as a dog, or not.

Mr. Gronstal is comfortable staking out radical positions. He alone prevents our democratically-elected legislature from voting on an amendment to define marriage as being between one man and one woman. On the abortion issue, the pro-choice Gronstal isn’t saying whether he would allow a vote.

Here’s where we’re at. In this sensible state, the one man who could do something about telabortion, a Democrat, refuses to do so. The result is an expansion of abortion in Iowa.

On the issue of late term abortions, one man, a Democrat, may also determine whether abortion is allowed to expand even more into Iowa.

What is the impact of turning Iowa into the abortion Mecca of America? A slow death for our beloved state. Iowa’s replacement birth rate has fallen below replacement levels. Our population is dying. Democrats contribute to the death of Iowa by allowing abortion to flourish.

Vending machine abortions victimize women 1

By Jeane Bishop

Elizabeth Cady Stanton

Four years ago I helped my daughter and her friend with their National History Day project.  The 10 year old girls studied Dr. Nancy Hill, a pioneer female doctor in Iowa.

The girls and I discovered that Dr. Elizabeth Blackwell, (1821-1910) the first female physician in this country, became a doctor in order to help women.  She wanted to give the women of her time medical care that was equivalent to the care that men received.

The idea of Blackwell becoming a physician was suggested by a friend dying of cancer, who told her, “If I could have been treated by a lady doctor, my worst sufferings would have been spared me.”

Blackwell saw that women were not getting the same care due to archaic Victorian standards of modesty that kept physicians from adequately examining a patient.  Layers of clothing were preventing doctors from seeing what they needed to see in order to assess and treat their female patients.  Ridiculously, even mirrors were used instead of a doctor looking directly at a female body in need of examination and diagnosis.

I thought about these things as I attended the Iowa Board of Medicine meeting on October 22nd here  in Des Moines.  I listened as speakers voiced concerns about an illegal practice going on in our state which allows a woman to receive medications which will kill the developing baby within her and then send her into “labor” while at home, delivering her dead baby there.

I wondered what Dr. Blackwell, suffragists Susan B. Anthony, Elizabeth Cady Stanton and other of our foremothers would think of the shoddy way women in Iowa are being treated by this vending machine attitude to gynecological care.

Women that are not examined by a doctor are at an even higher risk as they may be experiencing an ectopic pregnancy or be unsure of the gestational age of their baby.  Failures and complications exponentially increase when the doctor does not examine her/his patient.

These feminist foremothers worked for equality without apologies.  These brave visionaries struggled for an America where women had the right to be in the workplace, school and home.  They believed women did not need to sacrifice their children to be anywhere.

Stanton, the first champion of women’s suffrage and a mother of seven, said, “When you consider that women have been treated as property, it is degrading to women that we should treat our children as property to be disposed of as we see fit.”

Interestingly, these women came from families involved in the abolition movement.  Abolishing slavery and enfranchising women made perfect sense to these clear-thinking Americans.

What makes perfect sense to me is that the remote-control abortion system discussed at the Iowa Board of Medicine meeting victimizes women further with substandard care.  Women deserve better.

The risks of a “vending-machine attitude” toward gynecological care Reply

By Tom Quiner

Maggie Dewitte is Executive Director for Iowans for L.I.F.E. She stood up before the Iowa Board of Medicine last Friday and read a statement prepared by Dr. Donna J. Harrison on the dangers of telabortions. Dr. Harrison is President of the American Association of Pro-Life Obstetricians and Gynecologists (

Here are the takeaway points from Dr. Harrison’s statement:

• Telabortions are a threat to women’s health.

• Telemed dispensing can’t properly evalute uterine and other physical abnormalities that may create a life-threatening complication to the patient.

• The “abortion pill” (RU-486) is not FDA approved for use in pregnancies beyond 49 day’s gestation due to dramatically increased risk of complications. Without an ultrasound, gestational age estimates were more than two weeks off in half of the women according to studies Dr. Harrison quotes. Telabortions do not provide women with ultrasounds or any kind of exam before dispensing the pills.

Here are Dr. Harrison’s complete remarks:

“Telemed dispensing of abortion drugs are not only a gross disservice to women seeking abortion,  but are also a real threat to women’s health, as it is not possible to either accurately assess  the stage of the pregnancy,  nor accurately screen for pregnancy abnormalities such as ectopic pregnancy, which is an absolute contraindication to the use of mifepristone.  Nor can telemed dispensing allow for evaluation of uterine, or other physical abnormalities that may present a life or health threatening complication for the woman.

The purpose of a physician or practitioner visit is to screen for contraindications to abortion.  Many of these contraindications will not be apparent from history, which is why a physical examination is critically important to adequate pre-abortion counseling.  Since mifepristone is not FDA approved for pregnancies over 49 day’s gestation, it is imperative that the gestational age of the pregnancy be accurately assessed prior to dispensing mifepristone.   Administration of mifepristone beyond the 49 day cut off exposes the woman to dramatically increased risks of hemorrhage, infection and failed procedures necessitating a subsequent surgical abortion.   Spitz, et al, one of the principle investigators in the U.S. clinical trial leading to FDA approval, investigated the ability of patient history to predict gestational age, and found that over half of the women had dates more than two weeks in error when compared to the simultaneous ultrasound required prior to mifepristone administration in the clinical trial.   Thus, depending on history alone, which is what happens with telemed abortion dispensing, will result in the use of mifepristone in women who are beyond the FDA approval limitation, and into the gestational age where failures and complications exponentially increase.

Ectopic pregnancy, which is present in approximately 3 out of every 100 pregnancies, is an absolute contraindication to mifepristone use.  It is not possible to do adequate screening for ectopic pregnancies via a telemed dispensing system. Further the side effects of prolonged bleeding and pain, which accompany the normal mifepristone abortion, are identical to the bleeding and pain experienced with ectopic pregnancies.  Masking ectopic pregnancy symptoms led to the death of one of the 8 women who died in the first two years after mifepristone approval.

The FDA, in its approval of RU-486/mifepristone for abortion, recognized that for the safety of patients, significant controls on dispensing must be in place, and required two in person visits as a condition for approval of this drug.  RU-486/mifepristone causes increased hemorrhages, infections and failed abortions as compared to surgical abortions, as has recently been documented in several recent publications in the medical literature.  And the incidence of hemorrhage, infection and failed abortion increases dramatically as gestational age increases. The CDC estimates that the risk of death from a mifepristone abortion due to clostridium sordellii infection alone is 10times the risk of death from a surgical abortion at a comparable gestational age.

The impetus for telemed abortions does not come from improving patient care, but rather from increasing profits.   The burden of proof of improved patient care via this system is on the proponents, who have not shown decreased complications or improved outcome.   And there is no logical reason to expect improved outcome from a vending-machine attitude toward gynecological care.  This is an abuse of women.   On behalf of the women of Iowa, we ask the Iowa Board of Medicine to deny endorsement of this abusive practice.”