Tuesday, January 27, 2009

Elections have consequences (abortion, contraceptives, committees)

ABC's This Week with George Stephanopolis ran an interview with Speaker of the House Nancy Pelosi on Sunday, January 25, 2009. The transcript is here.

Stephanopolis allowed the Speaker to gloss over her policy that does not allow debate or amendments from the House floor, or that no Republicans were allowed to see or vote in Committee on last week's SCHIP Bill ("H.R. 2 is rushed legislation by the Democrat Majority that did not hold a single committee hearing or allow amendments to be offered on the bill."), and were only given a summary at 5:30 AM on the day of the vote.

STEPHANOPOULOS: The president has made it pretty clear he wants this to be a real bipartisan effort. Yet House Republicans have said they have been shut out of this process. There were no Republican votes in the appropriations Committee, no Republican votes in the Ways and Means Committee.

PELOSI: Well, because the Republicans don't vote for it doesn't mean they didn't have an opportunity to.
While I believe that true contraception, as in prevention of the union of sperm and oocyte, is ethical, I had planned to move strait to the Speaker's comments about Family Planning funds. However, it appears that the President was listening to the voters, even if the Speaker hadn't.
Posted: Tuesday, January 27, 2009 11:41 AM by Domenico Montanaro
Filed Under: White House, Congress

From NBC’s Mike Viqueira
The provision within the stimulus that would allocate money for contraceptive programs through Medicaid will be pulled out of the package.

NBC News confirms that the president called Henry Waxman, the chairman of the committee that inserted the contraception provision into the stimulus during the mark up last week, to ask him to remove the measure from the bill, according to a Democratic leadership source.

In short, the idea has simply become too controversial. Speaker Nancy Pelosi's defense of the program over the weekend, where she indicated that it would be a money saver, was not well received.

So that provision is out.

Complicating matters, both Minority Leader John Boehner and No. 2 Eric Cantor have told House Republicans that "all Republicans should vote against the stimulus" if it remains "in its current form," according to a GOP leadership aide.

They spoke inside their weekly conference meeting, behind closed doors. Afterward, both men came to the on camera stake out. The House will begin debate on the stimulus package late today, with no votes expected until tomorrow. Debate is expected to begin somewhere close to 5 p.m. ET.

The way your U.S. House works is that anyone who wants to offer an amendment to be considered on the floor has to go to a committee, the Rules Committee, beforehand.

The Rules Committee is a complete and utter tool of the majority leadership.
(Emphasis mine, BBN.) It decides which amendments will be allowed on the floor for consideration. The minority is habitually unhappy with the result, as their measures, especially the ones that have a chance of passage or contain some political mischief or "poison pill" language, are barred. The Rules committee meets this afternoon to make its decisions.
So, besides politics, what's all the fuss about?

Part of the problem is the $50 million for the National Endowment for the Arts, ACORN, $200 million for sod for Washington, DC parks, $20 Billion for electronic medical records, and the emphasis on global warming research (with its increased costs for housing, transportation, food production and all aspects of our daily life).

One day after the 36th Anniversary of Roe vs. Wade and as the number of electively aborted children in the United States alone (non-medically necessary, not associated with "rape, incest, or the life of the mother") approaches 50 Million, President Obama overturned the so-called "Mexico City Policy" or "global gag rule." US tax dollars will once again be allocated to organizations that advocate abortion as birth control, and even those that lobby to change the laws of other nations to allow abortion where it is not currently legal. Every news article I've seen conflates the gag rule with limiting non-abortifacient contraception. However, the only restriction is that on abortion.

Another Bill now in the House and Senate, would wipe out abstinence-based sex ed and mandate emergency contraception according to the Rochester, NY newspaper:

* House member Louise Slaughter submitted the Prevention First Act of 2009 (H.R. 463/S.21). In the Senate it was introduced by Democratic Senate Majority Leader Harry Reid.

The legislation focuses on reproductive and sexual health issues, and in some cases reverses Bush administration policies. It provides funding for comprehensive sex education programs, and none for abstinence-only sex ed. Other provisions include mandatory access to emergency contraception for rape survivors, and a requirement that hospital staff provide factual, science-based information on EC, including instructions that it doesn't cause abortions.

The bill would also force health insurers to offer equitable coverage for prescription contraceptives.


And then, finally (from the first link above), Speaker Pelosi on Federally funded contraception for the poor:

STEPHANOPOULOS: Hundreds of millions of dollars to expand family planning services. How is that stimulus?

PELOSI: Well, the family planning services reduce cost. They reduce cost. The states are in terrible fiscal budget crises now and part of what we do for children's health, education and some of those elements are to help the states meet their financial needs. One of those - one of the initiatives you mentioned, the contraception, will reduce costs to the states and to the federal government.

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Tuesday, January 20, 2009

ACOG: Abort or refer

The American College of Obstetricians and Gynecologists (ACOG) have finalized and published their Ethics Statement # 385. It looks like they ignored the ruling from the Department of Human Services on Conscience -- or believe it will soon be overturned.

The ACOG pdf is set so that it is not possible to copy and paste - I have typed in the first bit, myself. Click here for the full document.

ABSTRACT: Health care providers occasionally may find that providing indicated, even standare, care would present for them a personal moral problem – a conflict of conscience – particularly in the field of reproductive medicine. Although respect for conscience is important, conscientious refusals should be limited if they constitute an imposition of religious or moral beliefs on patients, negatively affect a patient’s health, are based on scientific misinformation, or create or reinforce racial or socioeconomic inequalities. Conscientious refusals that conflict with patient well-being should be accommodated only if the primary duty to the patient can be fulfilled. All health care providers must provide accurate and unbiased information so that patients can make informed decisions. Where conscience implores physicians to deviate from standard practices, they must provide potential patients with accurate and prior notice of their personal moral commitments. Physicians and other health care providers have the duty to refer patients in atimely manner to other providers if they do not feel that they can in conscience provide the standard reproductive services that patients request. In resource-poor areas, access to safe and legal reproductive services should be maintained. Providers with moral or religious objections should either practice in proximity to individuals who do not share their views or ensure that referral processes are in place. In an emergency in which referral is not possible or might negatively have an impact on a patient’s physical or mental health, providers have an obligation to provide medically indicated and requested care.

____________________________________________________________

Physicians and other providers may not always agree with the decisions patients make about their own health and health care. Such differences are expected – and, indeed, underlie the American model of informed consent and respect for patient autonomy. Occasionally, however, providers anticipate that providing indicated, even standard, care would present for them a personal moral problem – a conflict of conscience. In such cases, some providers claim a right to refuse to provide certain services, refuse to refer patients to another provider for these services, or even decline to inform patients of their existing options.

Conscientious refusals have been particularly widespread in the arena of reproductive medicine, in which there are deep divisions regarding the moral acceptability of pregnancy termination and contraception.


For more on the controversy, here are my posts on Conscience, and here is a history of the ACOG and DHHS statements.

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Wednesday, November 26, 2008

UK Teens, Abortion Rights?

The Family Planning Association in the United Kingdom is pushing a video called "Why Abortion" for use in schools teens, according to the Telegraph.co.uk website.

The laws in the United Kingdom differ in different regions. Abortion is still illegal in Northern Ireland, for instance. England and Wales, where abortion is legal and, like contraception and the morning after pill, paid for by the National Health System, has the second highest abortion rate is the second highest in Europe.

Nevertheless,
the Government announced that sex and relationships education will become compulsory in primary schools as part of a drive to cut teenage pregnancy rates. The National Children's Bureau also wants all secondary schools to have on-site sexual health clinics, while girls as young as 13 will be urged to have contraceptive injections and implants.

The FPA is offering schools the chance to buy a copy of the DVD for £25 together with a booklet that claims to explode the "myths" that having a surgical abortion can harm a woman's ability to conceive in the future, and that terminating a baby is always upsetting.


No mention that parents might not wish their daughters and sons to have sex at 13 -- and that the great majority do not. Or the risk that the 13 year old might be a victim of sexual abuse.

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Thursday, April 03, 2008

Gynecology and Obstetrics Policy makers respond to doctors on conscience

It appears that the American College of Obstetricians and Gynecologists and ABOG (the American Board of Obstetricians and Gynecologistsmay be about to abort their efforts to change laws concerning conscientious refusal in Washington. It remains to be seen whether they will deliver on their promise to support -- without limits - the Conscientious Refusal to perform or refer for certain procedures. (I'm sorry, I can't resist obvious puns, even on such a serious subject.)

LifeEthics has been covering the controversy over the American College of Obstetrics and Gynecology's "Opinion #385, Limits of Conscientious Refusal in Reproductive Medicine," which states that,
Providers with moral or religious objection should either practice in proximity to individuals who do not share their view or ensure that referral processes are in place. In an emergency in which referral is not possible or might negatively have an impact on a patient's physical or mental health, providers have an obligation to provide medically indicated and requested care."


First, "medically indicated" should be up to the physician and not dependent on autonomy - the patient's wants and wishes. Remember that Joseph Kennedy, the father of John and Robert, had his daughter lobotomized because she was too wild. At that time, according to Joe, the lobotomy was medically indicated.)

Obviously, this is not a moral obligation - but one that can be enforced by the use of the words "standard practice" and "standard reproductive services." In other words, abort, refer, or face lawsuits and risk your board certification. And the definition of "emergency" varies.

We also reported that the Secretary of Health, Michael O. Leavitt, had written to the Presidents of the American College of Obstetrics and Gynecology, the professional organization that supposedly sets the standard for these professionals, and the American Board of Obstetrics and Gynecology which certifies and tests OB/Gyns Presidents of ACOG and ABOG. He informed them that they were in danger of risking their own funding for training programs and status by any attempt to override the protections for Conscience in Federal funding regulations.


Even NPR noticed
and covered the controversy.

The leaders at the Christian Medical and Dental Association have let CMDA members know that the President of ACOG, Kenneth L. Noller, MD, responded to the Fellows (certified OB/Gyns) last week and Norman F. Gant, MD, the President of ABOG, responded to Secretary Leavitt by letter on March 19, 2008.

Dr. Gant doesn't have a clue what the Secretary is talking about:

I am responding to your letter addressed to me asking about the American Board of Obstetrics and Gynecology’s stand with respect or to a physician’s choice to violate their conscience by referring patients for abortions or taking other objectionable action, or risk losing their board certification.” I can only say that I do not know where you came up with any suggestion, much less documentation, that the American Board of Obstetrics and Gynecology has ever asked anyone to violate their own ethical or moral standards.


And Dr. Noller reassures the Fellows that in this case, an Opinion is just an Opinion (and we're supposed to forget the attempts to change the laws):

We want to be clear the Opinion does not compel any Fellow to perform any procedure he or she finds to be in conflict with his or her conscience and affirms the importance of conscience n shaping ethical professional conduct. For example, while this is not a document focused on abortion, ACOG recognizes that support of or opposition to abortion is a matter of profound moral conviction and ACOG respects the need and responsibility of its members to determine their individual position on this issue based on their personal values and beliefs. We want to assure members with a diversity of views on this issue that they have a place in our organization.
Ethics Committee Opinions provide guidance regarding ethical issues. This Committee Opinion is not part of the “Code of Professional Ethics of the American College of Obstetricians and Gynecologists.” This Committee Opinion was not intended to be used as a rule of ethical conduct which could be used to affect an individuals initial or continuing Fellowship in ACOG. Similarly, it is not cited in the American Board of Obstetrics and Gynecology’s “Bulletin for 2008,” and “Bulletin for 2008 Maintanence of Certification” and an obstetrician-gynecologist’s board certification is not determined or jeopardized by his or her adherence to this Opinion.
Conscience has an important role in the ethical practice of medicine. While this Opinion attempted to provide guidance for balancing the critical role of conscience with a woman’s right to access reproductive medicine, the Executive Committee has noted the uncertain and mixed interpretation of this Opinion. Thus, the Executive Committee has instructed the Committee on Ethics to hold a special meeting as soon as possible to reevaluate ACOG Committee Opinion #385.

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Thursday, November 29, 2007

CNN objects to conscience

This subject again.

CNN, that bastion of upstanding plants ethics, objects to doctors with morals - or at least the ones who act on them.

The CNN video (not a "news piece") shows interviews with a woman who was refused contraception by one doctor and a second interview with another doctor who is Catholic and who does not believe that contraception is moral and so he does not prescribe it.

The reporter is shocked that 60% of doctors feel that it's okay to tell patients our moral views.

The reporter asked the patient whether she felt "rejected." The woman said that she did and that she felt that the doctor was judging her and imposing his morals on her. She said that any doctor who would not do what his patients wanted should not be in practice.

The woman isn't judging or imposing her morals on every doctor, is it?

Doctors make "judgments" all the time. We are not simply dispensers of products that people want. We must "impose" our judgment on patients who smoke (a perfectly legal drug) and drink (ditto) or who have become overweight from eating legal food and choosing not to exercise enough to burn off calories faster than they take them in. We are responsible for determining whether a patient is becoming addicted to pain medications, asking for a note for missing work when they were never sick, or a handicapped parking sticker when they're not disabled.

Much more often, we make judgments about the cause of a patient's symptoms or disease and how best to treat it. Our job is not to make the patient feel good about themselves, although most doctors I've met prefer to do so. What we do is diagnose and treat in order to help the patient be as healthy as we are able.

While I don't object to non-abortifacient contraception, it is an elective service in most cases. It is very rarely necessary to maintain the health of the body of patients. It is truly a "choice."

As I've said before, it would be simpler for people who feel that contraception is important to arrange to pay doctors who will write and dispense those medications and devices to go around to the areas where they are needed.

The alternative is to find a way to trust a doctor who will act against his conscience - to do what he considers the wrong thing for your pet issue - to do the right thing every other time.


Hat Tip: Blog.bioethics.net

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Saturday, November 17, 2007

Give me liberty or give me condoms!

Where are the condom squads who go around making sure that every grocery store, drug store, and 24 hour convenience store stocks latex condoms and the appropriate lubricants, "at all times"? Condoms are a much more basic public health issue than Plan B, which only works (when it works) for about 5 days in the woman's cycle.

Siricou Raven is keeping the conversation alive as to whether or not pharmacists should be forced to stock and dispense all legal medicines. She asks,

What is the difference between a pharmacist refusing to distribute contraception because it offends his own morality, and one refusing to dispense HIV medication because it offends his own morality?


Treating disease has never been controversial. Have you ever heard of a doctor or pharmacist who refuses to treat syphilis, gonorrhea or chlamydia? Have you noticed any that have ceased doing Pap smears since we learned that abnormal Paps are due to a Sexually Transmitted Disease, Human Papilloma Viruses that are only transmitted by sexual contact?

(I do know a pulmonologist - a lung specialist - who will not take on patients who smoke. I could draw all sorts of parallels between sex and smoking, but I'll leave that to you.)

At issue is the very basic question is that of the "unalienable" individual right to liberty, expressed as following the conscience.

As Judge Lawrence wrote in the Injunction, the Washinton State law is very clear on the right to conscience and freedom to practice religion.

There is no reason to carve out contraception and "reproductive health" (a Newspeak term, if I ever heard one) as a special, protected class of medicines, devices and procedures.

For that matter, why on earth would any woman who doesn't want to become pregnant have sex without two or more contraceptives in hand/body before the act itself and/or know her fertile periods? If men didn't have the back up insurance of abortion, I'd bet they would be more careful, too. (Rape is an Emergency Room issue - the ER doc and SANE nurse can dispense and counsel on fertility risk, right along with prophylaxis for STD's).

While I'm ranting:

Ethics lesson 1: Life trumps liberty, since pretty much everything else depends on being alive.

Ethics lesson 2: The only reason the State should force action from a citizen is in cases of life and death. Each law that is enforced puts the citizen's life and liberty at risk, since the enforcement will involve the real and virtual guns of the State. There is a long history of recognizing the relationship between the right to own property and the right to liberty. If the State may take the property or restrict the livelihood of a person, the person is at risk of prison or hunger and is not free.

Ethics lesson 3: People who will do acts that they believe morally wrong for any reason other than to save lives (to stay out of jail, keep their jobs or avoid controversy) are either unethical people or insane. And I'm not too sure about the people who would force them, either.

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Friday, November 16, 2007

Some Bloggers shouldn't reproduce

They shouldn't reproduce their thoughts in writing, that is.

Take a look at the comments on "Laws, conscience, medicine and bloggers," for a perfect example of "they just don't get it."

Freedom of conscience is part of the Washington State law. The Governor threatened to replace the members of the State Pharmacy Board if they voted against an invalid law. The pharmacists do not have to dispense over the counter medications.

All sorts of red herrings have been raised to defend the law, including accusations that someone might refuse to prescribe medicines for HIV patients and insulin for diabetics.

This is also a good example of my editorial style. You would be shocked by some of the answers I've typed and erased.

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Wednesday, November 14, 2007

Laws, conscience, medicine and bloggers

In contrast to the hype that you might read on blogs and in the press, the Federal District Court judge in Washington has upheld the law of that State. The basic right to not be forced into action that one considers unethical or immoral - the right to liberty - was upheld first, by the Washington State Legislature and affirmed by the Court.

According to the Seattle Times article, there will be a trial next year and the "rules were meant as a compromise after long, contentious hearings and intervention by Gov. Christine Gregoire, who threatened to replace members of the Board of Pharmacy who didn't vote to protect women's rights." (Emphasis mine, BBN.)

The judge ruled in favor of State Law and overturned regulations passed by the Washington State Board of Pharmacy which were changed in July of this year to require that "pharmacies must maintain at all times a representative assortment of drugs in order to meet the pharmaceutical needs of its patients." The plaintiffs, two individual pharmacists and a corporate pharmacy were asking to be allowed to follow their previous practices "refuse and refer."

The Court's ruling is posted here at the Seattle Times website, which also has a fairly good review of the case to this point, here. (I've saved copies of each, so let me know if they disappear).

Judge Ronald B. Leighton issued an injunction that delays the force of the regulation, since it appears that the regulation violates laws passed by the Washington State legislature to protect the rights of individuals:

"As a part of the Health Care Access Act, the legislature expressed the recognition “that every individual possesses a fundamental right to exercise their religious beliefs and conscience.” RCW 70.47.160(1). The Legislature further acknowledged that “in developing public policy, conflicting religious and moral beliefs must be respected.” RCW 70.47.160(1). Accordingly, the Legislature provided that “no individual health care provider, religiously sponsored health carrier, or health care facility may be required by law or contract in any circumstances to participate in the provision of or payment for a specific service if they object to so doing for reason of conscience or religion.” RCW 70.47.160(2)(a). No person may be discriminated against in employment or professional privileges because of such objections. RCW 70.47.160(2)(a). The right of conscience, however, is not intended to result in a patient being denied timely access to any service included in the basic health plan. RCW 70.47.160(2)(b).

"An identical right of conscience was included within the Insurance Reform Act adopted by the Legislature in 1995. RCW 48.43.065."
(emphasis in italics are mine, BBN)


The regulation itself was poorly written.

The phrase "at all times" is a big problem. Would that mean that all pharmacies must change their hours so that they are open or on call 24/7? As to the phrase, "representative assortment," that might mean different things to different people. The wording open to the widest interpretation, however, is the phrase, "pharmaceutical needs of its patients." (Let's forget that pharmacies don't have patients, pharmacists do.)

The "pharmaceutical needs" of patients is wide open to interpretation, especially in the case of Plan B. I've covered the evidence (here) that indicates that Plan B only works to prevent ovulation and fertilization the 5 days or so of the month before and the day of ovulation and the lack of evidence that it acts in any way as an abortifacient. Unfortunately, this isn't acknowledged in the court's ruling or by any of the other parties in the case.

I depend on pharmacists to evaluate the prescriptions I write for my patients. They have often helped me by catching and refusing to fill scripts because they knew about drug interactions, allergies, and fraudulent prescriptions when I didn't. I would like for them to notify me if they refuse to fill my scripts, but their professional judgment is the very thing we physicians and patients are depending on, isn't it? If we force them to do what they believe to be wrong, the only pharmacists we'll be left with will be people who will do wrong because they were "only doing their job." (Where have we heard that before?)


There's an especially over-wrought emotional discussion over at the Women's Bioethics Project blog. No posts are published without the permission of the author, who evidently has some pretty strong feelings involved. I added to the intensity of the silliness and self-righteousness with my comments, I'm afraid. (So far, they haven't posted my remarks from 12 hours ago about cigarettes as a legitimate treatment for priapism [an old remedy - no longer advised - that was actually used as late as the '80's], prescribing of wine as a relaxant, and the fact that I make it a policy not to prescribe medications until they are on the market long enough to be proven by lots of other doctors' patients.)


As Mick Jagger sang, "You can't always get what you want. . . but you can try sometimes to get what you need."

(edit - typos fixed at 5:30 PM CST 11/14/07)

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Thursday, September 27, 2007

Catholic Bishops to Allow Plan B in Emergencies

Can anyone be forced to act against his conscience? Do religious convictions have any weight in the law? How far can the courts go to make a person do an act that he believes is unethical or immoral?

I hope these questions are not ignored due to the sensationalism that surrounds emergency contraception.

The Catholic Bishops of Connecticut have decided to allow the doctors in Emergency Rooms at the Catholic hospitals in their State to prescribe Plan B for rape victims. (More here.) The courts had ruled that the hospitals would be required to follow state law mandating that all emergency rooms prescribe the pills, even those belonging to religious organizations which object to contraception and abortion.

The law requiring all hospitals to prescribe Plan B to rape victims, which passed in June and takes effect Monday, does not allow for an ovulation test. Instead, it requires a pregnancy test.

Barry Feldman, a spokesman for the Connecticut Catholic Conference, said that since the bill passed, the bishops have questioned the feasibility of the original policy because of "further revelation by them about the state of existing science and the lack of definitive teaching by the church and the fact that there are many who are affiliated with the church that believe the ovulation test isn't necessary."

Feldman said the bishops' decision to allow Plan B to be used for all rape victims in the hospitals does not mean that the bishops' personal beliefs have changed. Also, they still believe the law is seriously flawed and should be changed to allow an ovulation test.

In June, Bridgeport Bishop William E. Lori said the new law violated religious liberties and suggested that politicians might force Catholic hospitals to perform abortions or euthanasia.

Sen. Jonathan Harris, D-West Hartford, who worked to negotiate a compromise bill with the church, said lawmakers have no interest in taking such steps.

"Our efforts had only one goal, to protect the victims of rape," he said. "There was no other agenda. It was started to just do that."

Rape crisis counselors in Connecticut said there have been unclear and inconsistent policies for supplying Plan B to victims who seek treatment in emergency rooms across the state, including some in nonreligious hospitals.

According to Connecticut Sexual Assault Crisis Services Inc., 40 percent of rape victims were not offered or did not receive the full dose of emergency contraception at the hospitals where they were treated during the first half of 2006.


Plan B, a package of pills containing levonorgestril, a progesterone, is also called "the morning after pill."

My review, "Plan B, How It Works and Doesn't Work," with links to reliable information and research papers, is here.

It appears that the bishops aren't just caving in to legal pressure, but were convinced that the pill works, when it works, by delaying ovulation or keeping the sperm from getting to the oocyte. There is quite a bit of evidence that this is true and none (from some pretty good studies in animals and ovulating women) that the Plan B formulation prevents implantation or causes an implanted embryo to be aborted.

The biggest problem now is that the courts in Connecticut dared to over-rule a religious principle and conscience issue in the first place. At what point can the state force men and women to act against their consciences?

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Thursday, June 14, 2007

Trust me: I'll act against my conscience

The title throws you for a loop, doesn't it?

Trust me to do what? Follow the law, when I can violate my own conscience? Practice ethical medicine when I promise not to have any personal convictions to guide me? What are laws and ethics to a person who has no conscience?

This month's American Journal of Bioethics - unfortunately available only by subscription - is devoted to exploring the conscientious objection of pharmacists (and by extension, doctors and nurses, and everyone of us) who refuse to dispense emergency contraception (EC).

I do not believe that there is any evidence that the progesterone-only EC, Plan B, has abortifacient post-fertilization effects. In other words, I believe that anyone who objects to Plan B on the grounds that it causes the loss of a human life is mistaken.

However, I don't believe that they should be forced to perform acts that go against their consciences or subjected to a special conscientious objector review board, as advocated by all but one of the "open peer commentary" on the "Target Article" by Robert F. Card, (Abstract here), "Conscientious Objection and Emergency Contraception."

Card obviously has a bias against those of us who believe that human life begins at fertilization and that all humans have the right not to be killed. Nevertheless, as one commenter, Farr Curlin, MD, notes (It's worth reading all this, trust me):

Card (2007) does not merely claim that practitioners are obligated to provide EC; he argues that they are obligated to do so even if they have a conscientious objection. This last clause may seem harmless on the surface, but a closer look reveals that it effectively saws off the limb on which the first clause and all medical ethics sit. To begin, what is a conscientious objection, but an individual’s judgment that it would be unethical for him or her to act in a certain way? A genuine conscientious objection, even if misinformed, is an expression of a commitment to acting morally, and although religious persons are somewhat more likely to report conscientious objections (Curlin et al. 2007), judgments of conscience need not be informed by explicitly religious ideas. Moreover, all ethical arguments are appeals to conscience. As such, acting conscientiously is the most fundamental of all moral obligations.

....


Indeed, the very act of presenting evidence and making arguments presumes that the one to whom those arguments are directed, whether practitioner or juror, is committed to acting according to their best judgment after taking all relevant considerations into account. It would be useless for an attorney to make arguments to jurors if those jurors were not committed to deciding a verdict based on their best judgment of the guilt or innocence of the defendant. Likewise, it is useless for Card or anyone else to make ethical arguments if practitioners are not committed to practicing according to their best judgment of what is in fact ethical. A commitment to acting conscientiously is as fundamental to the moral life as a commitment to judging impartially is to the work of a
juror.

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Saturday, May 26, 2007

Virtual science vs. actual experimentation (Emergency Contraception)

There's still no evidence that Plan B interferes with implantation, and lots of evidence that it doesn't.

There have been reports that Drs. Mikolajczyk and Stanford ("Levonorgestrel emergency contraception: a joint analysis of effectiveness and mechanism of action." Fertility and Sterility R. Mikolajczyk, J. Stanford, access to free abstract available, here) have proven that there is an abortifacient effect from the morning after pill ("Emergency Contraception," EC, or the levonorgestrel-only pill protocol, LNG EC).

In fact, they do not "prove" anything. Mikolajczyk and Stanford derived an equation from actual results from observing oocyte follicle development and ovulation in women. They then used statistical, "virtual" models,to estimate they effects of LNG:

We simulated random samples of 10,000 women presenting for EC for a single cycle each, and we calculated the number of ‘‘expected’’ pregnancies for each simulated cohort of women using both sets of the daily fecundity data. We assumed that women ‘‘presented’’ for EC treatment with equal probability on days –10 to +5 around the day of ovulation
(day 0).

For each of the women within the fecundity window, we used the follicular growth equation to estimate a follicular diameter, which in turn was used to estimate the disruption of ovulation by LNG EC based on the data from the Croxatto study (Table 1). We assumed that effects observed for 12–14 mm, 15–17 mm, and R18 mm groups reported by Croxatto et al. (15) apply to follicles of size up 11.51–14.5 mm, 14.51–17.5 mm, and R17.51 mm, respectively. When LNG EC was administered on a day when follicular size was below 11.5 mm, we assumed that there was zero probability of pregnancy. These conservative assumptions maximized the possible effects of LNG EC to disrupt ovulation and prevent fertilization.With this information, we estimated the ‘‘observed’’ pregnancies within the simulated cohorts.


Durand and Croxatto's teams studied how LNG EC actually worked in the bodies of real, live women, using biopsies, exams, assays of hormones and serial ultrasounds, as well as animal studies. Mikolajczyk and Stanford actually refer to the Durand study on human women, "On the mechanisms of action of short-term levonorgestrel administration in emergency contraception," (available free on line, here), but say the evidence from biopsies are "mixed."

On the contrary, Durand reported on actual labs, ultrasounds and even biopsy samples from actual observations:

The results were highly consistent with the chronological date of sampling because differences longer than 3 days between the histologic diagnosis and the day of the cycle were not observed. A total of 24 out of 33 biopsies from treated cycles with ovulatory features were studied. The rest were excluded because of insufficient tissue sample (one from Group B and D) or because sampling did not correlate with the cycle day (three from Group A and four from Group D). Table 3 summarizes the morphological findings in Groups B, C, and D. No significant changes were observed between treated and control specimens in any of the studied parameters. No significant differences among groups were observed. Of particular importance was the finding that the predecidual changes as evaluated by the
presence of prominent spiral arteries, which are considered
crucial for implantation [24], were not altered by LNG.


The post ovulatory mechanism is most likely explained by the finding in many studies, including Durands', which have demonstrated a strong effect on mucus thickness and sperm motility from the Levonorgestrel protocol (LNG EC). Practitioners of Natural Family Planning are familiar with this (natural) effect of (natural) post ovulatory rise in progesterone: when the progesterone levels rise after ovulation, the cervical mucus becomes thick and fertility goes down because the sperm can't get to the egg for fertilization. The movement of the oocyte down the fallopian tube is slowed also, because the cilia in the tube are affected. The combination of these two phenomenon explains the increased rate of ectopic pregnancy in women who do become pregnant using levonorgestrel only EC and daily pills.

There are definitely problems with EC. It only works when it works for 4 or 5 days before ovulation and, possibly on the day of ovulation. (The oocyte only lives about 24 hours.) This is the first time that contraceptive pills have been made available to men as well as women. For some reason, women don't use the pill correctly, even when they have them at home. And we have tons of evidence that neither the pregnancy rate nor the abortion rate are affected by making the pill available over the counter. And there's the increased risk of ectopic pregnancy described above.

However, this "study" appears to be statistics used to argue against observations derived from real life medical experiments in order to prove a pre-conceived position.

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Saturday, September 02, 2006

Review: Plan B, How It Works and Doesn't Work

I'm convinced that Plan B does not block implantation. Because I keep getting emails, hearing radio personalities and reading posts on various forums claiming that Plan B is an abortifacient, here's a review of information on the medical effects of the pills and on the other effects and lack of effects.

The overwhelming evidence - from several different groups of researchers - is that Plan B, the single ingredient protocol containing a synthetic progesterone called levonorgestrel, only works - when it works - the 5 days or so before and just after ovulation. Furthermore, since few women really know when they ovulate, and only slightly more women will even use the protocol when they have the pills in their medicine cabinet, easy access doesn't change anything.

The best and most ethical research evidence, "On the Mechanisms of short term levonorgestrel administration as emergency contraception" is available online free of charge at this site.

If, as I believe, the pills only work in preventing fertilization, they are only medically justified/necessary 5 days before or one or 2 days just after ovulation, the window of fertility. The other 20 days or so of the menstrual cycle, the pills are useless and un-necessary.

The best evidence is that Plan B works to prevent ovulation or to prevent the oocyte (the "egg") from being released from the ovary and passing to the fallopian tube. This is why the pill is best (and only?) functional before ovulation. In nature, the egg only lives about 24 hours and sperm can live from 2 to 5 days. If the egg is not released, is over 24 hours old, if the sperm cannot get to the egg or if they are dead or incapacitated, there can be no fertilization.

The only post-ovulation effect that has been proven that could prevent pregnancy also prevents fertilization. Levonorgestrel causes the mucus in the cervix to be thick (so sperm have a hard time getting to the uterus and then the fallopian tube where the egg is) and by making the sperm unable to penetrate the zona pellucida, the covering and nurturing cells around the oocyte or egg.

Biopsies of the uterus of women who have ovulated in spite of taking Plan B do not show any changes that would prevent implantation of the embryo. The blood flow and lining of the uterus is normal. Support for this lack of abortifacient effect in the uterine lining is the natural increase of progesterone in women after ovulation and the treatment of some infertile women with progesterone around ovulation or around transfer of the embryo in an in vitro fertilization cycle. Levonorgestrel and the other forms of progesterone actually seem to encourage implantation.

The reason I am still wary is the evidence that the "luteal" phase of the cycle - the time from ovulation to the time the woman starts shedding her uterine lining - is shortened in some women. If the lining is shed early, I can't be sure that there could not be a loss of an embryo which is beginning to implant. (late note, October 3, 2007 - the evidence indicates that if the pill is taken before ovulation, the luteal phase is shorter, but the closer to ovulation -and the greater the chance of ovulation - the less effect on the luteal phase. So that I don't worry, any more, about losing an embryo that way.)

Women continue to get pregnant - and have abortions - at about the same rates in England and other countries where Emergency Contraception is available without prescription. Part of the reason is that even when women have the medicine in their homes and have received education, they take the pills only about 20% of the time when they have unprotected sex. This month's Contraception reports that only 11% of 706 women (ages 18 to 44 years old, who knew they were part of a study and who were at risk because they did not want to be pregnant but were using other contraceptives incorrectly) used the pills, even though the medicine is available without a prescription in that country.(H. Goulard et al./Contraception 74(2006)208-213)

And while studies have shown that women and girls don't increase risky behavior, the same studies show that there is no decrease in such behavior, either.

I do wonder whether over the counter use in the US will lead to at least a short-term burst of promiscuity and abuse of women and girls, since the studies on access have all included only women and girls who went to clinics and at least received some education (and, as I said, even those women and girls didn't change their risks).

The medicine has never before been available to men in the US. At least there has been some effort to provide education to women and girls receiving the medicine in Washington, where pharmacists could dispense the meds under certain conditions.

Anecdotal information from pharmacists and doctors in the UK, Jamaica and the Far East indicates that men buy EC at least as often as women and that that it appears that some women and girls are using EC more than once a month.



Here's some links in this blog and other pro-life writers who have come to the same conclusion.


Progesterone, infertility and early pregnancy


Plan B not Abortifacient, But Doesn't Change Much


More on British Experience with OTC EC


Plan B Doesn't Change Much (Actual article reproduced - New information on the study that is often quoted to prove that promiscuity doesn't increase - in fact, there's no change at all - But that's even after going to the clinic, etc.)

Jamaica Experience with Plan B, Jamaican Teens Opt for Abortion over EC


Good (Not Prolife) Review of Emergency Contraception


Another physician's Blog and thorough review, at "LTI":
There are at least 6 articles reviewing the facts and the scientific literature. These are the first and the sixth in the series.

A non physician who does a lot of research, "Ales Rarus"
Mangling, Mishandling, and Misrepresentation of Science in the Plan B Debate (Part II)


Another unquestionably pro-life blog, "Jivin'Jehosaphat"

Note: Edited some typos 02/15/07 BBN

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