2004 Medical Weblog Awards

Here's your chance to let everybody know about your favorite medblogs. I like The Examining Room of Dr. Charles (for best new blog) and book of joe (for best ...[haven't figured out the category yet]...blog).

Grand Rounds

This week's Grand Rounds is up. Make sure to read this interesting commentary on Vaginal Birth After C/S (VBAC) from a surgeon:

Why shouldn't the choice of the physician or hospital carry some weight? There is always a risk/benefit calculus with such things. The physicians have found that the risk of VBAC (uterine rupture and the complications thereof) outweigh the benefit (patient satisfaction with natural childbirth). The VBAC advocates believe the benefits of a trial of labor and the "birth experience" outweigh the risks of VBAC. So much so that some, like Ms. Stratton, are willing to undergo delivery out of the hospital. Yet the choice of the provider is given short shrift.

And, for women considering a trial of labor after having had a C/S, here's the conclusion of a study that looked at out-of-hospital delivery:

"[A] cesarean-scarred uterus was associated with increases in complications that require hospital management. Therefore, birth centers should refer women who have undergone previous cesarean deliveries to hospitals for delivery."

Update: I forgot to link to this review of some of the risk factors for uterine rupture. Although a bit technical at times, please try to read it. It will give you a better understanding of what an informed consent entails.

More Misinformation

The Unborn Child Pain Awareness Act, which was introduced last May. Doctors would be required to tell women seeking an abortion after 20 weeks "about the capacity of the unborn child to experience great pain during the abortion," according to the National Right to Life Committee. The doctor would also be required to provide the woman with a consent form so she could "accept or refuse administration of a pain-relieving drug to the unborn child."

As a rule, I always try to maintain a certain degree of decorum on this blog. I shall make an exception this time. If any physician gives in to this nonsense and actually makes a woman sign this consent he/she is unworthy to take care of patients! [And, yes, I know that physicians are human, and they have monumental amounts of student loans, family expenses, mortgages, etc. However, if the only way to make a living is to lie to your patients, demean them, and harm them, it's time to look for another career.]

Politicians and religious fundamentalists can afford to treat women like garbage. Physicians cannot.

Back to our regularly scheduled educational program. A good baseline review of the scientific evidence on fetal pain here, and an overview of the legislative/judicial machinations here.

Dogma and Medicine

Religious doctrine and ideology have no place in medicine. Some health care professionals disagree, and are hard at work to take science out of medical care. Take note!

(via anne_jumps)

Ignorance Is Bliss

Ignorance is bliss, but at what cost? According to Wade Horn, assistant secretary of Health and Human Services in charge of federal abstinence funding, when it comes to sexual education we don't need no stinking science:

"We don't need a study, if I remember my biology correctly, to show us that those people who are sexually abstinent have a zero chance of becoming pregnant or getting someone pregnant or contracting a sexually transmitted disease"....

There are two possibilities here: either Mr. Horn isn't capable of logical thought [knowing the mechanism of action of a birth control method does not give us effectiveness rates], and this impairs his ability to grasp the issues involved, or he understands the science, but is being purposefully deceitful. In either case he shouldn't be employed by the HHS.

Contrary to Mr. Horn's belief-based pronouncement, we need a lot of studies [frankly, even a couple of studies would be very helpful at this point] before we can make any statements about the effectiveness of abstinence. Currently, we have no data on the typical-use effectiveness rates of continuous abstinence.

Moreover, we need more long-term studies on the effectiveness of abstinence-only programs. So far, there is no reliable evidence whether these programs are effective in reducing teen sex, pregnancy or the transmission of disease.

Mr. Horn does acknowledge that the research on the effectiveness of abstinence-only programs is not as adequate as it needs to be.

Unfortunately, the lack of facts isn't a deterrent as far as Mr. Horn is concerned, since he is not willing to wait for more evaluations, calling abstinence education "something that parents and children want." [This is almost too easy, but here it goes: If the only criteria we use is "something that parents and children want", how about free education, at all levels, for everybody?]

Am I the only one who finds it troubling that an HHS bureaucrat in charge of federal educational funds believes that what parents really want is for their children to be ignorant?

Unless you have complete and correct information, it's not possible to make an informed decision. This holds true even for lowly teenagers. Just because teenagers need guidance and supervision, doesn't mean they should be deprived of knowledge.

EC Safe For Adolescents

Update: The initial article isn't available anymore, so here's a different link to EC use in adolescents.

A new study adds to the existing body of evidence about Emergency Contraception (EC) use in adolescents:

Levonorgestrel, a drug used for postcoital emergency contraception (EC), is well tolerated by females aged 13 to 16 years and side effects are minor according to researchers in the US and Switzerland.

Note also this finding:

Treatment with the drug did not affect the duration of menses -- before and after treatment the average duration was about 5 days. Moreover, menses onset occurred within the expected time frame, the researchers note.

While this study is good news for patients and physicians alike, it's bad news for the FDA. New bogus requirements to block OTC access to EC will have to be invented. Since today is a holiday (Happy Thanksgiving everyone!), I propose a new party game, guaranteed to keep family and friends entertained: guess what made-up requirement the FDA will come up with next.

Gravity, Shmamity

A disclaimer sticker for your child's science textbook:

This textbook contains material on gravity. Gravity is a theory, not a fact, regarding a force that cannot be directly seen. This material should be approached with an open mind, studied carefully, and critically considered.

Enjoy!

(via Bookslut)

Guilderland Public Library

Someone in Guilderland is reading my book. How cool is it that I can see that?

Grand Rounds

This week's edition has lots of interesting links, and even another podcasting doc (good to know I'm not the only one who thinks this new medium is great for disseminating medical information).

A [Not So Modest] Proposal

Apropos of this post, I have a general-interest policy idea of my own: limit medical decision making to the woman and her health care professional.

The argument is simple: a woman, any woman, has the capacity to make health decisions, and to assume responsibility for her decisions. [The medical professional is there to assist, and guide.] Since birth control and abortions are health matters (not rights, beliefs, or religious/moral/philosophical concepts) this would eliminate assorted dilettantes (politicians, religious leaders, neighbors) from having any say in these matters.

Moreover, the counter-argument to this proposal--women are too stupid/incompetent/etc., to be allowed to make their own decisions--should prove to be unpopular with all [even with the people who might not have taken the time to seriously consider the implications of women being denied medical care] but the most fanatical religious fundamentalists.

Federal Refusal Clause

The Federal Refusal [to Treat Women] Clause (FRC) has passed both the House and Senate and is now the law of the land (emphasis added):

Congress made it a little easier for hospitals, insurers and others to refuse to provide or cover abortions. A provision in a $388 billion spending bill passed by the House and Senate on Saturday would block any of the measure's money from going to federal, state or local agencies that act against health care providers and insurers because they don't provide abortions, make abortion referrals or cover them.

Moreover, it appears the legal right to refuse women medical treatment is here to stay:

[Sen. Barbara] Boxer [D-Calif] said she has been promised a vote in next year's Senate to repeal the provision. But House Democrats conceded earlier this year that they lacked the votes to stop Republicans from approving the measure, and likely would not have votes to strip the measure next year either.

To refresh your memory, the timeline for this piece of legislation is here.

Specifically, the FRC (pdf, page 99) states that:

d)(1) None of the funds made available in this Act may be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortion. In this subsection, the term "health care entity" includes any individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.

So, under FRC, any federal, state or local law or regulation that preserves access to abortion services and information could be deemed discriminatory and thus not enforceable, unless the government body enforcing the law would be willing to sacrifice all federal assistance made available through the Labor-HHS-Education Appropriations bill (H.R. 5006). Any health care entity, including individual physicians or other health care professionals, hospitals, provider-sponsored organizations, HMOs, health insurance plans, or any other kind of health care facility, organization, or plan, could be allowed to refuse to perform, pay for, provide coverage of, or refer for abortion.

According to Rep. David Weldon (R-Fla) who sponsored the amendment [t]his provision is meant to protect health care entities from discrimination because they choose not to provide abortion services....

An abortion is not a consumer service. Providing an abortion, or a referral for one is medical care. And, in a civilized society, rendering appropriate medical care isn't optional, even when the patient is just a female.

At the risk of stating the obvious, the need for an abortion does not discriminate based on politics, morals, religion, geography, etc. Any woman of reproductive age who is sexually active is at risk of a spontaneous abortion. The treatment for a spontaneous abortion is providing an abortion. And in the case of elective abortions, refusing to provide medical care ups a woman's risk of death from 1:263,000, to 1:10,000.

Of course, as long as health care entities are protected from discrimination, a few dead women here and there are irrelevant.

I think an explanation of my tone is in order. In real life I am more the surgeon type (you know ... cut first, ask questions later) than the IM or psych one. When confronted with a problem my first impulse is to do something about it, rather than to ponder its philosophical aspects. As a rule, on this blog I like to offer you practical solutions, along with any criticism. Unfortunately, in this instance I'm unable to come up with anything useful.

I am totally stuck at the "I-can't-believe-this" stage. I know the FRC is now the law, but I can't understand how normal people [politicians, physicians, laypersons] think it acceptable to deny health care to women in the name of some abstract constructs.

Discussing, debating, and contemplating morality, philosophy, religion, politics, etc., are good for all of us. These activities enrich our mind and expand our horizon. And, since we're all human, it's quite possible, and understandable, for us to think that our beliefs are better than anyone else's. Of course, people can disagree and still learn something from each other; people can also adjust their beliefs. But in the end, when it comes to refusal to treat laws, surely everybody realizes we are talking about real women, and real morbidity and mortality.

Abstract concepts are irrelevant when an 18 year old is undergoing a slow, painful death from a septic abortion, while two agents of the state stand guard by her bed to prevent physicians from rendering care because abortion is not sanctioned by the politicians du jour. [This is not my imagination run wild, this is an actual case report.]

Bottom line: I don't understand how belief can trump reality. Also, not that it matters so much apparently, but as a result of the FRC many women will die, and many more will suffer long-term sequelae. And for what?

Uterine Artery Embolization

By now you might have heard that the nominee for U.S. secretary of state, Dr. Condoleezza Rice, a black woman, will undergo uterine artery embolization (UAE). UAE, a minimally invasive surgical procedure, is used in this instance as a treatment for uterine fibroids.

Why is Dr. Rice's race significant? Because black women have a three-to-five times greater risk than white women of developing fibroids.

So, what are uterine fibroids? Briefly, the wall of the uterus is made up of several tissue layers. Most of the thickness is taken up by muscle tissue called myometrium (myo means muscle, metrium means uterus). Sometimes this muscle layer starts to grow in knots instead of orderly sheets. These knots are commonly known as fibroids.

Most fibroids are noncancerous; some can grow [WARNING, graphic picture] very large, and they can cause pain, heavy bleeding, infertility, problems with urination and defecation, etc. Incidentally, fibroids are a leading indication for surgery to remove the uterus (hysterectomy) in women of childbearing age.

The medical name for fibroids is leiomyomas; some other names you might hear used are myomas, fibromyomas, fibroleiomyomas, or fibromas.

An interesting aside. Menstrual management can help women with fibroids by reducing the heavy/prolonged bleeding they experience. The role of the birth control pill in lowering a woman's risk of fibroids isn't clear--one study found a 31% risk reduction in women who had used the Pill for ten years. What is clear is that overall, if you have fibroids, using the Pill does not increase their size. This is important for you to remember because there are health professionals who think a history of fibroids is a contraindication to using the Pill. It isn't.

Back to uterine fibroid embolization, the procedure uses techniques similar to those used in heart catheterization. A needle is inserted into the femoral artery near the groin, and a catheter is guided into the uterine artery. Once in place, tiny particles of polyvinyl alcohol, about the size of grains of sand, are injected under X-ray guidance.



The particles flow to the fibroid and block its blood flow. Deprived of blood supply the fibroid shrinks, relieving symptoms.

Back to the Future

Misguided and misleading labeling changes, unscientific drug use rejections, dubious orders and announcements. And that's just the FDA.

In July of 2000 a controversial FDA draft guidance is distributed. The draft proposes labeling changes for all combined oral contraceptives. Many industry leaders call these changes overly restrictive and lacking in important information about health benefits associated with OC [oral contraceptive] use. Based on this feedback, the proposed labeling changes are revised, and the draft is redistributed in 2004.

Unfortunately, even the revisions are misguided. A few of the problems:

One complaint regarding the proposed labeling is a lack of balance and recency. The proposed labeling is simpler than the existing labeling, but a great deal of recent literature has been ignored, while many of the data cited in the draft guidance are 1-2 decades old....

Another complaint is the lack of information regarding potential benefits of OC use. The only benefits listed for OCs are more regular menses, less blood loss, and less dysmenorrhea.

[T]he recommendation to exclude the prevention of endometrial and ovarian cancer as a potential benefit of OC use is particularly egregious, given the ample evidence for this benefit.

In December of 2003 the FDA advisory committees on Reproductive Health Drugs and Nonprescription Drugs votes 23-4 to recommend Barr Labs' emergency contraceptive Plan B for OTC status. However, in May 2004, the FDA rejects Barr's application. In the words of one of the voting members of the committee:

We find it offensive that religious ideology and partisan politics have been introduced into the decision-making process regarding a public health issue.

...

[T]his action [rejecting Barr's application] is a flagrant example of the intrusion of religious ideology and conservatism activism--enveloped in a thin veneer of pseudoscience--into what should be a scientific and empirical examination of the evidence by an objective, secular, and unbiased expert government advisory committee.

And the American College of Obstetricians and Gynecologists:

[F]inds the US Food and Drug Administration's failure to approve over-the-counter status for Plan B, despite the nearly unanimous recommendation of its own advisory panels, morally repugnant.

The Food and Drug Administration's (FDA's) action is a tragedy for American women, and a dark stain on the reputation of an evidence-based agency like the FDA.

This decision to ignore an advisory panel's assessment of the scientific evidence is not only rare, but it gives credence to recent criticisms that political interference is hampering scientific review within federal agencies today.

Finally, James Trussell, director of the office of population research at Princeton University and a member of the advisory committee, comments:

[T]he agency never raised the issue of label comprehension among young teenagers when it approved other products to be sold over the counter. "The White House has now taken over the F.D.A.," Mr. Trussell said.

On November 15, 2004 the FDA announces labeling changes for mifepristone (RU-486).

Unfortunately, the changes are unclear, bordering on misleading. Infections, sepsis, ectopic, bleeding and death are side effects of ending a pregnancy, not of the drug mifepristone.

On November 17, 2004 the FDA orders the addition of a "black box" warning to the labeling of Depo-Provera. The warning highlights that prolonged use of the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered. This bone density loss may not be completely reversible after discontinuation of the drug. The FDA's justification for this action: to ensure that physicians and patients have access to this important information.

Of course, physicians and patients have had access to this information for decades. Least we forget, Depo-Provera has been available, worldwide, since the 1970s. [It's only been available in the U.S. since 1992.] Moreover, there's been access to the actual information about using this method and its impact on bone density*:

The degree and reversibility of bone loss with DMPA [Depo-Provera] are comparable to those observed with lactation [breastfeeding], which suggests that a long-term increase osteoporosis [brittle bones] risk in DMPA users is unlikely.**

In the meantime:

If you need to get the Pill.....

Pharmacists interrogate you and demand a justification; expect your justification to comply with their religious beliefs; refuse to fill your prescription and to refer you to another pharmacist; ignore requests to release your medical information to another pharmacist (one you've found on your own); and steal your prescription and refuse to give it back.

If you need EC.....

The Christian Coalition of Alabama (CCA) challenges the state's mandate to make emergency contraception (EC) available to women. CCA's stated goal is to change the health department's policy on EC. Also, Rep. Aderholt (R-Ala.) says ...he has "done all he can" to urge the health department to stop distributing EC....

As a result of the FDA's unscientific action, Barr is forced to resubmit its application to sell Plan B OTC only to women age 16 and older. According to Dr. Scott Spear, chair of the national medical committee of Planned Parenthood:

...Barr's new proposal is a "response to the political realities created by the FDA," adding that FDA's call for an age requirement for OTC status for Plan B is "bogus"....

If you expect your medical records to be private.....

Attorney General Ashcroft demands access to women's confidential medical records...and a whole lot more:

[A] subpoena filed on December 22 demanded that a doctor at New York Presbyterian Hospital identify "all persons to whom you have taught" the D and X method [dilatation and extraction, a surgical termination technique] as well as "all persons who have started using and teaching" it in the last five years. The subpoena also called for the medical record numbers of the "at least 50" women who had undergone such abortions after 19 weeks of pregnancy, as well as the records of women who had had such abortions because their fetuses had trisomy 18, a severe genetic disorder from which the vast majority of affected infants die in their first year of life, or anencephaly, a brain defect that results in death before or very soon after birth.

...

Of particular concern ... is the demand that doctors provide the names of their colleagues--including those not cited in the original [DOJ] suit.

If you need some assistance with paying for medications.....

For 2005, the proposed $2.4 trillion budget leaves family planning funding to stagnate while doubling money for abstinence-only programs.

[D]espite the great dividends--economic and otherwise--generated by family planning, the 2005 budget request for Title X, the U.S. family planning program for low-income men and women, is the same as the total for last year. At the proposed funding level of $278 million, the program's funding is not keeping up with inflation, and currently provides care for only about half of the low-income women and men who need family planning services.

Unfortunately:

Very few abstinence-only-until-marriage programs have been rigorously evaluated and, thus, there is no compelling evidence to date that they actually change sexual behavior. In the new U.S. budget, the funding level proposed for abstinence-only-until-marriage programs is doubled from last year, from $140 million in 2004 to more than $270 million in 2005. Money for "marriage promotion" is also increasing, as part of the President's proposed $1.5 billion marriage initiative.

If you'd like to learn facts.....

In Texas new sex-education textbooks are likely to ignore birth control:

The 15-member Texas Board of Education is considering and will likely approve four books, all of which extol the virtues of abstinence. Three make no mention of contraceptives at all while one makes passing reference to condoms.

If you're a woman and you'd like to receive health care.....

At the federal level, refusal to treat [female patients] laws are enacted and amended. Initially, in 1973, the law (42 U.S.C. 300a-7) is very narrowly tailored to apply only to doctors, and residency training programs, and a religious or moral basis for the refusal is required. In 1996 an amendment (42 U.S.C. 238n) that no longer requires any justification for the refusal to treat is passed.

In 2003, the Abortion Non-Discrimination Act (ANDA) (HR 3664) is passed by the House. ANDA radically changes the 1996 amendment by significantly expanding the existing refusal clauses to include not only doctors but other health professionals and health care entities--HMOs, health insurance plans, etc.

In 2004 the House passes the fiscal year (FY) 2005 Appropriations bill (HR 5006) funding the Departments of Labor, Health and Human Services and Education ("Labor-HHS-Education"). This Bill contains the Federal Refusal Clause (FRC) amendment [pdf, page 99]:

Under FRC, any federal, state or local law or regulation that preserves access to abortion services and information could be deemed discriminatory and thus not enforceable, unless the government body enforcing the law would be willing to sacrifice all federal assistance made available through the Labor-HHS-Education Appropriations bill. Any health care entity, including individual physicians or other health care professionals, hospitals, provider-sponsored organizations, HMOs, health insurance plans, or any other kind of health care facility, organization, or plan, could be allowed to refuse to perform, pay for, provide coverage of, or refer for abortion.

FRC's enforcement mechanism goes beyond ANDA's (which affects funding for all health related activity) to include all funding appropriated in the Labor-HHS-Education Appropriations bill. FRC also discriminates against states' authority to pass and enforce state laws and constitutional protections safeguarding a woman's right to chose.

In 2003, the RU-486 Suspension and Review Act is introduced [companion bills in the House (HR 3453) and Senate (S 1930)].

At the state level, 45 states have passed legislation allowing individual health care practitioners to refuse to perform abortions. Forty-one states have extended this right of refusal to health institutions (21 of these apply to any health facility and 20 apply to hospitals only). Nearly half of state abortion refusal laws require a religious or moral basis for the refusal (22 of 45 states). The majority of state exemptions require the service to be provided if a woman's life is in danger.

Bottom line: It is becoming increasingly apparent that, if you are a woman of reproductive age, you don't really matter.


*I will review the pertinent studies in a future post. [In my book, see page 194.]

**Speroff L. Bone mineral density and hormonal contraception. In: Dialogues in Contraception. Summer 2002;7(7):2-3, 8.

Breast Cancer Study Needs Your Help

The NIEHS, NIH, and DHHS are planning a breast cancer study, the Sister Study, and they need your help. The study's goal is to learn about the environmental and genetic causes of breast cancer. This is a national, long-term study of women, aged 35 to 74, who do not have breast cancer themselves but who do have at least one sister who has had breast cancer.

If you fit the criteria, please consider joining the study. If you know someone who might be eligible, please bring this study to their attention. And all of you: please help spread the word. The researchers are looking for women all across the United States; in particular, they'd like to enroll as many women as possible in New York [Manhattan and Long Island].

Who Is Leading the Study?

FAQ

Who Can Join

What Will I Be Asked to Do?

How Do I Join?

How Can I Help?

I plan to help out in my area. How about you?

Grand Rounds

This week's edition of the Grand Rounds is a must read. Please make sure to drop by.

Mifepristone (RU-486) Labeling Changes

As a result of several reports of infection, heavy bleeding, ectopic, and ?two deaths in women using mifepristone, the FDA has announced labeling changes:

The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all.

Because I think the FDA's release is a bit confusing (and odd), allow me to clarify.

The risks mentioned by the FDA (infection, bleeding, ectopic, death) have nothing to do with mifepristone. In other words, it's not the drug that causes them, it's ending a pregnancy. It doesn't matter how a pregnancy is ended--by delivery, spontaneous abortion (miscarriage), or elective (medical or surgical) abortion. Ending a pregnancy, even an early one, is associated with certain risks. For example, with both a term delivery and a 6 weeks miscarriage there is a risk of incomplete delivery of the products of conception. These retained fragments can cause infection, and/or bleeding. And, of course, there is always the risk that a pregnancy will develop in an abnormal location [an ectopic pregnancy]. An ectopic, if undiagnosed and left untreated is very dangerous because it will eventually rupture and cause massive bleeding.

As an aside, I had a young patient who, while being wheeled to the OR for a suspected ectopic, was sitting up on the stretcher, chatting and being very pleasant. Ten minutes later when we opened her up, we found almost half a liter of blood in her abdomen (the ectopic had ruptured and she was actively bleeding internally). The human body--amazing, indeed.

Returning to the FDA release, what struck me as odd (and a bit worrisome) is the fact that the FDA refers to these known and established risks associated with any termination of pregnancy as "new information". I mean, what health care professional (or, for that matter, medical student) isn't familiar with these risks?

Bottom line:

Mifepristone (Mifeprex) is one of the drugs used for early MTP. Like any medication there are side effects associated with using this drug. For mifepristone, they are:

headache/dizziness

nausea/vomiting

diarrhea

back pain

tiredness

In addition, there are certain side effects associated with ending a pregnancy. For a pregnancy that ends as a result of delivery, spontaneous abortion (miscarriage), or elective termination there is a risk of:

infection

heavy bleeding

ectopic

If you decide to carry a pregnancy to term, or terminate a pregnancy, please make sure you, and your physician are familiar with the associated risks.

TIP: Very important for an early pregnancy--ask your physician to explain to you exactly how she/he knows the pregnancy is not ectopic.

Remember, as a general rule: a pregnancy is an ectopic until proven otherwise.


(via Drudge)

The More You Know

When it comes to your health, the more you know the better off you are. And yes, this even applies to adolescents. [Why certain people insist on treating teenagers like mindless, irresponsible drones eludes me. I've always found these patients to be reasonable and quite eager to learn.]

A survey of 1,158 teenagers aged 14-19 years found that knowledge of emergency contraception (EC) was not associated with increased sexual risk-taking. When compared to those not aware of EC, those familiar with EC:

had their first sexual encounter a bit later (17.6 years vs. 16.7 years)

were significantly more likely to have used birth control during their last sexual encounter (83% vs. 17%)

Ortho Evra and [Clueless] Media Reports

Back in September, ABC aired a report about Ortho Evra, titled
Do Users of the Birth Control Patch Know Enough About Its Potential Dangers? Basically, ABC implied that using the patch increases your risk of death. The report mentioned 17 deaths, allegedly caused by blood clots in the lung (PE), in women using the patch. In my first post, I speculated that the report was inaccurate, and that ABC is either clueless, or is priming the jury pool in anticipation of a lawsuit against the patch's manufacturer. I have more information now, and it appears I was right [at a minimum, about the report being inaccurate]:

Ortho-McNeil Pharmaceutical, Inc., manufacturer of the patch, has been informed of only six deaths in patch users since its introduction in April 2002. The role of the patch in these deaths is undetermined, and several of the deaths were reported multiple times, accounting in part for the erroneous number of 17.

Little is known about the circumstances of 3 deaths. This is the information on the other 3 deaths:

One of the six deaths was due to myocardial infarction [heart attack] in a woman with both Down syndrome and Eisenmenger syndrome; her health had been deteriorating before starting contraception. Another death in Germany was due to suicide. One death in New York City was attributed at autopsy to a pulmonary embolism [lung blood clot]; the woman was not wearing a patch at the time of death. Whether she had been using the patch previously has not been determined.

Since apparently ABC couldn't be bothered with, you know, factual reporting, let alone useful context, let's review how one assesses risk and calculates incidence rates. First, you have to determine if an alleged death actually occurred. Then, you have to evaluate the potential association between a given exposure (wearing the patch) and outcome (death due to PE). This evaluation includes:

confirming the exposure--Did the woman who die use the patch at all?

identifying the temporal relationship between exposure and outcome--When was the woman who died using the patch, and for how long? Was she wearing it at the time of death, and/or for a period of time immediately preceding that?

determining the cause of death--What exactly was the cause of death?

identifying alternative causative factors--Was the patch wearer involved in a car accident, did she commit suicide, etc.?

Once you have all this information, you can calculate the risk of the outcome (the risk of PE death in patch users). So, let's assume that all 6 reported deaths were caused by PE, that they occurred in current patch users, and that there were no other alternative causes of death involved.

We know that the patch has been used by about 4 million women x 2 years (this gives us 2.2 million woman-years of patch use).

The risk of an outcome is determined by dividing the number of documented cases of that outcome (in our example, 6 PE deaths in patch users) by the number of individuals exposed per unit of time (in our example, 2.2 million woman-years); our result is 2.7 per million woman-years. What does this mean? Here's a practical way to understand this: the death rate per year from a blood clot is about 1 per million for women aged 15 to 24 years who don't use hormonal birth control; 3 per million users for women who use the combination birth control pill; and ~13.2 to 20 per 100,000 live births for pregnant women.

So, patch users have a slightly lower risk compared to Pill users, and a considerably lower risk compared to pregnant women. Women who don't use the patch or the Pill, and who aren't pregnant have the lowest risk.

Bottom line:

Case reports of deaths need to be fully investigated by formal epidemiological studies. Until this is done, a casual relationship remains questionable. At the present time, no evidence suggests that the transdermal patch is associated with an increased risk of death compared with combination oral contraceptives.

All I have to say about the ABC report is: what a sorry state of affairs!


Grimes DA, Mishell DR Jr. Assessing Rare Event Reports: A Numerator in Search of a Denominator. Dialogues in Contraception. Fall 2004;8(7):7.

Grand Rounds

A sampling of topics from this week's Ground Rounds: a review of the most common type of breast cancer, informed speculations about Yasser Arafat's condition, and transgendered patients requesting mammograms.

NuvaRing Ad, Or Curiosity Killed the Cat

Organon has launched a direct-to-consumer TV ad campaign for its birth control vaginal ring, NuvaRing. I must say, I am very curious to see how this commercial looks like. I have a call in to the pharma for more information on where they plan to air the ad.

Who's Crazy Here?

Soon, the Drug Enforcement Agency could be knocking down your door in search of that stash of coffee in your house. The National Institute on Drug Abuse has supported a review aimed at including caffeine withdrawal as a disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).

Basically, a tentative research diagnosis of caffeine withdrawal is already listed in the DSM-IV. The listing is meant to encourage additional research on the very utility of the diagnosis of caffeine withdrawal. Some scientists do a literature review in hope to empirically validate specific signs and symptoms of human caffeine withdrawal, and to describe important features of this syndrome. Their conclusion:

"The caffeine-withdrawal syndrome has been well characterized and there is sufficient empirical evidence to warrant inclusion of caffeine withdrawal as a disorder in the DSM..." the authors write.

Translation: first we get caffeine withdrawal listed as a firm disorder diagnosis in the DSM, then we generate enough hype to convince you that you can't possibly make responsible decisions about your own health without state supervision, and finally we outlaw caffeine and prosecute you for using it. Viva the nanny state!

Just In Case

Regular readers of this blog know that I am unequivocally opposed to politicians [irrespective of party affiliation] making medical decisions for women. So, just in case people you've never met [but might have voted for] decide to no longer permit you to make life and death health decisions, I thought it prudent for us to briefly review the topic of medical termination of pregnancy. A couple of points, before we start:

The risk of death/yr from a term pregnancy is 1:10,000, and the risk from an early (before 9 weeks) elective termination is 1:263,000.

An elective abortion is not a birth control method, nor should it be used as such [never, ever].

Medical termination of pregnancy (MTP) refers to non-surgical methods of terminating a pregnancy. Instead of a surgical procedure, various drugs are used to terminate the pregnancy. The drugs used for MTP end an already established pregnancy, thus they are abortifacients (they cause an abortion). [By contrast, drugs used for birth control prevent a pregnancy and have no effect on an established pregnancy.]

There are many drugs and regimens used for MTP. Only 3 of these drugs are routinely used for early terminations, meaning pregnancies up to 9 weeks (63 days): misoprostol, mifepristone (RU-486) and methotrexate. [Yes, I know, the drug names sound awfully similar ... not a good idea.]

An aside: the early MTP drugs are often confused with drugs used for birth control, especially with drugs used for emergency contraception (EC). They are not one and the same--the mechanisms of action involved are completely different. Abortifacients terminate a pregnancy. Birth control prevents it.

Before we review the individual drugs, there is one very important point you must remember. Although the early pregnancy termination drugs are easy to use and to self-administer, you should only use them under close medical supervision. Why? Because these drugs act on an already established pregnancy. A pregnancy, even an early one, can be associated with potentially deadly complications, like an ectopic.

This is in contrast to drugs used for EC that act before there is a pregnancy; this makes them safe to use without a prescription, or over-the-counter.

There are 6 main groups of MTP drugs:

1. OXYTOCIN

Oxytocin is a drug that causes uterine contractions and induces labor. High doses of oxytocin are given in small volumes of intravenous fluids.

2. HYPEROSMOTIC SOLUTIONS

Hyperosmotic solutions also induce labor. For example, 20-25% saline or 30-40% urea solutions are injected into the amnionic sac (the bag of fluid).

3. PROSTAGLANDINS AND ANALOGUES

Prostaglandins are substances naturally produced in the body. They have many actions, including induction of labor. The drugs in this group can be used vaginally, as a shot, into the amnionic sac, and orally (by mouth).

Misoprostol belongs to this group. The brand name in the U.S. is Cytotec and it is used to induce labor, to treat stomach ulcers, etc.

4. ANTIPROGESTERONES

Antiprogesterones are drugs that block the action of the body's hormone progesterone. Progesterone is very important for pregnancy.

Mifepristone (RU-486), a pill, is a drug in this group. The brand name in the U.S. is Mifeprex.

An aside. The amount of incorrect information about mifepristone (RU-486) is staggering. Unless you know the actual facts about this drug, it is impossible for you to make an informed medical decisions. Briefly: mifepristone is *not* an abortifacient (an "abortion pill"), it *is* an antiprogesterone. What's the difference? A crucial one: the mechanism of action, the way the drug works. [Important for you to understand this: what people decide to call mifepristone--"the devil's pill" or "the fluffy bunny pill"--is irrelevant. Its mechanism of action is the same, regardless.]

By definition, an "abortion pill" causes an abortion, meaning it terminates an already established pregnancy. An "abortion pill" has no mechanism by which to prevent a pregnancy from becoming established. A good example is the drug misoprostol. The only mechanism of action of this drug is to induce labor. So, this drug has no way of preventing a pregnancy; it can only terminate one. Misoprostol is an abortifacient.

Contrast this with the mechanism of action of mifepristone (RU-486). Mifepristone can either block the release of the egg from the ovary, block implantation, or cause the lining of the uterus, together with an implanted egg, to shed. So, this drug can either prevent a pregnancy, or terminate one. Mifepristone is an antiprogesterone. It can be used as birth control, or as an early pregnancy termination drug. [Obviously, the dosage and regimen vary.]

Back to our discussion. When mifepristone is used for MTP, the dosage/regimen used causes the lining of the uterus, together with the implanted egg, to shed.

5. PROGESTERONE PRODUCTION BLOCKERS

Progesterone production blockers, as the name implies, block the production of the hormone progesterone. Progesterone is very important for pregnancy.

Epostane, a pill, is an agent in this group. The usual dose is 200 mg every 6 hours, for 7 days, and you can take it up to 7 weeks (49 days) from the date of your last normal menstrual period. The rate of successful treatment with epostane is 87% - 90% , and it has a good safety profile. The main side effects are nausea and vomiting. The average length of vaginal bleeding with this regimen is 10.7 days. Once the treatment is complete, usually there is no delay in the resumption of normal periods.

6. METHOTREXATE

Methotrexate is a folic acid antagonist, a drug that stops cells from dividing. It comes in the form of a pill, or a shot.

Remember, only three of the aforementioned drugs--misoprostol, mifepristone (RU-486) and methotrexate--are used for early MTP. [Epostane can also be used, but this is an older regimen, not in common use today.]

TWO MTP REGIMENS: A COMPARISON TABLE

Regimen	MIFEPRISTONE & MISOPROSTOL	METHOTREXATE & MISOPROSTOL	Comments
How does it work?	Mifepristone: blocks the action of progesterone, causing the uterine lining to thin and detach. Misoprostol: causes uterine contractions that expel the embryo and placental tissue.	Methotrexate: stops cell division. Misoprostol: causes uterine contractions that expel the embryo and placental tissue.
When does it work?	1. Evidence-based: through 9 weeks (63 days) from the last menstrual period (LMP) 2. FDA-approved: through 7 weeks (49 days) from the LMP	Once pregnancy is confirmed, through 7 weeks (49 days) from the LMP
Dose	1. Mifepristone 200 mg by mouth, followed 1-3 days later by Misoprostol 800 mcg vaginally (self-administered, at home) 2. Mifepristone 600 mg by mouth, followed 2 days later by Misoprostol 400 mcg by mouth	Methotrexate 50 mg by mouth or a 50 mg/m2 shot, followed 3-7 days later by Misoprostol 800 mcg vaginally (self-administered, at home)
How well does it work?	1. ~97% 2. 92% to 97%	94% to 96%	If the drugs are unsuccessful, surgery is needed to complete the process.
How many office visits?	1. Two 2. Three	Two	Depending on the individual case, more visits may be needed.
Side effects	Nausea, vomiting, diarrhea, headache, dizziness, fever or chills, anemia (rare), blood transfusion needed (rarely).	Nausea, vomiting, diarrhea, headache, fever or chills, stomatitis (rare), anemia (rare), blood transfusion needed (rarely).	Bleeding and cramping are expected effects of all termination procedures.
Expected bleeding	~ 13 days	~ 10-17 days
Can it treat an ectopic?	Not an effective treatment.	~ 90% effective for early, unruptured ectopic (3.5 cm or less, initial beta hCG less than 5,000 mIU/ml).	An ectopic pregnancy can be deadly. This is why the supervision of a qualified doctor is imperative.
Follow-up	Must return to confirm termination is complete. If it isn't, surgery is necessary.	Must return to confirm termination is complete. If it isn't, surgery is necessary.
U.S. regulatory status	Mifepristone--approved for early medical termination. Misoprostol--approved for ulcer treatment.	Both drugs are approved.	Worldwide, these drugs have been safely used by millions of women for over 10 years.

In addition to the established MTP regimens, there have been reports of women using misoprostol by itself, and without medical supervision. While women are most likely to self-administer misoprostol in countries where legal termination is unavailable (e.g., Latin America), evidence suggests that women in the U.S. are also using this regimen. [To be clear: Misoprostol is not usually used as the only drug for early pregnancy termination; nor should it be used without medical supervision.]

MISOPROSTOL ALONE

The reported misoprostol-only regimens involve multiple doses, taken at 24-hour intervals. How well the regimen works depends on the time elapsed from the last menstrual period (LMP) and the number of doses. For example, 800 mcg misoprostol administered vaginally up to 49 days from the LMP, is 69.0% effective after one dose, 86.4% effective after two doses, and 91.7% effective after three doses. For the same dose administered vaginally up to 63 days from the LMP, the effectiveness is 78% after one dose, 91% after two doses, and 92% after three doses.

[Again, please don't use misoprostol on your own; consult with your doctor.]

Bottom line:

MTP is a safe and effective alternative to surgical procedures.

MTP allows one to have a termination much earlier, it affords more privacy, and a sense of greater personal control over the experience.



Williams Obstetrics 21st. ed.

Stewart FH, Wells ES, Flinn SK, et al. Early Medical Abortion: Issues for Practice. UCSF Center for Reproductive Health Research & Policy: San Francisco, California (2001)

Kariva

Kariva is a birth control pill with a shortened placebo interval--2 days vs. the regular 7 days.

I mentioned before that some combination birth control pill brands have a shortened placebo interval.

Using a brand like Kariva helps if you suffer from problems related to your period or withdrawal bleeding episode (the fake period) like painful periods, migraines, endometriosis, etc. If you recall, these problems tend to be caused/exacerbated by hormone fluctuations.

If you're on the Pill, you have less hormone fluctuations than a nonuser, at least for 3 weeks out of the month (the 3 weeks with active, hormone pills). Unfortunately, during the hormone-free week (the 7 days with placebo pills) the hormone levels start to fluctuate again, and the problems recur. So, shortening the placebo interval, for example, from 7 to 2 days, helps. But wait, there's more! [Obviously, I'm watching too much late-night TV.]

Another advantage of using a brand with a shortened placebo interval is better "real life" pregnancy protection. In real life, it's common for women to miss the first few pill days of a new pack, because they aren't able to get the new pack in time. Coming off of a placebo week, this is quite risky. Why? Because there's a danger of a mature egg being released from the ovary. [Mature egg + sperm = possible bebe.] So, after a placebo week, the more days you miss before starting a new pack, the higher your risk of an unintended pregnancy. Ideally, all combination Pill brands should be packaged with 21 days of active pills and only 2-3 days of placebo pills. This way, even if something happens and you are unable to start a new pack right away, you are still protected.

In the U.S., there is only one type of biphasic Pill with a shortened placebo interval: an estrogen (ethinyl estradiol or EE)/progestin (desogestrel or D) combination. The dosage is 21 days of 0.02 mg EE/0.15 mg D, 2 days of placebo, followed by 5 days of 0.01 mg EE. Because this type of Pill can be very useful for many women, I wanted to alert you to some [confusing] changes in the brand names.

Initially, there was Mircette, manufactured by Organon. Then Barr came up with a generic, Kariva. Now, Organon is no longer manufacturing Mircette, however they are allowing another pharma company, Prasco, to market a generic versions of Mircette (don't know the name for this version yet; it's supposed to be available next year). So, if you're interested in using a brand with a shortened interval, ask for Kariva, not Mircette.

Mircette



Kariva

ETA: Mircette is now registered to Duramed Pharmaceuticals, Inc., a subsidiary of Barr.

Reminder

Two things you mustn't forget to do today: vote, and read Grand Rounds.

Breakthrough Bleeding

Breakthrough bleeding (BTB) or spotting is the occasional, irregular bleeding/spotting you may experience while using a hormonal method of birth control. BTB is most common when you first start using a method (or when you switch brands, or regimens) and it usually stops after the first 2-6 months of use. Whether you experience BTB will depend on the brand, the method, and your body. [It depends on how fast or how slow your body metabolizes hormones, in particular estrogen.] Moreover, BTB can occur whether you're using birth control to prevent a pregnancy or to manage your period.

Like the fake period (withdrawal bleeding), BTB has nothing to do with your menstrual period. BTB is caused by the amount of hormones in birth control. Think of BTB as an "adjustment"--the bleeding/spotting occurs because the body is adjusting to the hormone dosages in the birth control method. [Of course, the BTB pattern will depend on the particular method you're using--e.g., expect a fair amount with some of the progestin-only methods.]

Practically, there are three important things you should remember about BTB:

It's not a sign that something is wrong; it's just a nuisance.

Think of it this way: if you're not using any hormonal birth control, and you start having irregular bleeding this might be a sign of a medical problem. However, while you're using, for example, the Pill, irregular bleeding is not a disease sign; it's an expected effect [granted, an inconvenient one] of the Pill hormones.

It does not cause any ill health effects.

If you experience BTB, do not stop using the Pill; it will only make it worse.

This is very important to remember, because BTB is one of the main reasons women stop taking the Pill. Instead, try to minimize the bleeding and shorten its duration. [Of course, you could just wait it out, but for most women this is impractical.] To do that, try to take the Pill at the same time each day. This minimizes the hormone fluctuations, and thus the BTB (it takes the body about 24 hours to eliminate the hormones in one pill). Here are a few other suggestions, from Dr. Miller (she's one of the principal researchers in the field of menstrual management), about what you can do if you experience BTB:

If you drink everyday, even a glass of wine, your body could be used to the alcohol, so if you stop drinking, your estrogen levels may drop and trigger spotting.

[A]t night, the pill does not have to compete with food in you stomach to be absorbed. So, if you are having persistent spotting you could try switching the time of day you take your pill.

Vitamin C, 1000 mg, taken with your pill can help increase estrogen absorption for some women, so you should try this if the spotting has gone on for more than five days. However, you should stop taking the high dose of Vitamin C either when the spotting stops, or after a week if the spotting hasn't stopped.

Grapefruit juice contains a chemical that slows estrogen metabolism if the pill is taken with a glass of juice. More estrogen may be available to your body to stop the spotting.

Update: Missy asks a very good question:

What if you're on Depo.... Any tips for curbing the bleeding when you're on a progesterone-only form?

Unfortunately, BTB is quite common with Depo-Provera. Here are a few things that help reduce/stop the BTB:

Taking a non-steroidal anti-inflammatory drug (NSAID), like ibuprofen, or aspirin for a few days. [Stop using it when the BTB stops, or after one week.]

A daily dose of conjugated estrogen (e.g., Premarin).

Adding a low-dose (20 microg) combination birth control pill for 1 to 3 months (e.g., Alesse, Loestrin).

N.B. Please don't self-medicate; discuss this with your doctor first. [In case he/she is not familiar with the regimens, point them to this page, or print this one and bring it along with you on your visit.]

Sex After Delivery: Birth Control For Breastfeeding Women

You've just given birth, you're breastfeeding, and you decide to resume having sex, possibly even before the recommended rest time of 6 weeks postpartum is up (tsk, tsk).

What method of birth control should you choose if you're breastfeeding? And do you even need to use birth control if you're breastfeeding?

First, what's going on in the early postpartum period, sexually speaking?

Women become sexually active early in the postpartum period. Researchers have reported that 66% of postpartum women are sexually active in the first 4 weeks postpartum, and 88% become sexually active within the first 8 weeks postpartum....Although lactation can suppress fertility if a woman exclusively breastfeeds for 6 months postpartum, by that time, fewer than 14.3% of new infants are exclusively being breastfed.

Second, if you're breastfeeding, how do you choose an appropriate birth control method?

In choosing a method of contraception, a woman who is breastfeeding and her clinician must consider how frequently she has sex, whether she is exclusively breastfeeding, and what type of method would be acceptable to her and her partner. You both must also remember that an unplanned pregnancy is possible if a sexually active woman breastfeeds and does not use contraception. Should the patient become pregnant, it may influence her desire and ability to continue breastfeeding.

Here's a handy table you can use as a reference when going over postpartum birth control options with your doctor [yet another thing to pack in your delivery bag, before you go to the hospital]:

Birth Control Choices for Breastfeeding Women

Keep in mind that, for breastfeeding women:

• The preferred method is the progestin-only birth control pill.

• The risk of perforation with intrauterine device (IUD) insertion is increased.

• The effectiveness of the Lactational Amenorrhea Method is greatly influenced by the breastfeeding schedule.

Third, if you wan to use breastfeeding as your birth control method (medspeak: Lactational Amenorrhea Method), do you know how to go about it?

Here's a brief overview.

What is the Lactational Amenorrhea Method (LAM)?

Lactational Amenorrhea Method (LAM) is a natural, temporary birth control method. It is based on the natural fertility reduction that occurs in most women after giving birth. The fertility reduction usually lasts up to 6 months after a delivery.

How does LAM work?

LAM prevents ovulation. Since the ovary doesn't release an egg you cannot get pregnant.

A bit more detail. Most women after giving birth do not ovulate, and do not have menstrual periods in the months immediately after delivery [medspeak for the lack of periods: physiological amenorrhea]. This happens because the hormonal processes involved in breast milk production also affect the ovarian and the uterine (menstrual) cycles.

This is a natural process called lactational amenorrhea--breast milk production (lactation) causes the absence of menses (amenorrhea).

How do you use LAM?

If you have just given birth and would like to use LAM as your temporary method of birth control you need to observe these guidelines:

• You must breastfeed exclusively and continuously (day and night).

• You must be less than 6 months postpartum.

• You should not be menstruating (you should be amenorrheic) after the first 56 days. Bleeding or spotting during the first 56 days is not considered menstruation. However, after that, if you have two or more consecutive days of bleeding your menstrual periods have probably returned.

It is important that you follow all these guidelines to insure that you are protected against an unintended pregnancy. Because ovulation may return before the menstrual period does, simply waiting for the first menses is not reliable enough, and is risky.

How well does LAM work?

LAM is a temporary method and can only be used for up to 6 months after giving birth. The failure rate is 2% during the first 6 months after delivery, with perfect use. By 6 months after giving birth, the failure rate increases to over 5%.

The efficacy of breastfeeding decreases when:

• you start giving your baby formula or foods other than breast milk

• your menstrual periods return

• 6 months have passed since delivery

Who should use LAM?

If you are less than 6 months postpartum, and you are willing to abide by the LAM guidelines, you can use this method.

Who shouldn't use LAM?

Don't use this method if:

• You cannot or do not want to observe the associated guidelines (more than 6 months have passed since the delivery, you do not plan to breastfeed continuously and exclusively, your periods have returned).

• Your ovulation returns immediately after giving birth. In about 6% of women, ovulation returns with the first cycle after delivery, so if you are one of these women, you cannot use LAM.

What are the advantages of using LAM?

• It's naturally-occurring.

• It's immunologically and nutritionally advantageous for the newborn. Breast milk is especially beneficial for the newborn because it allows passage of antibodies (infection-fighting agents) from the mother to the baby. This gives the baby greater protection against certain types of infections.

• There's minimal user involvement (other then continuously breastfeeding, of course).

And the disadvantages of using LAM?

• It's a restricted and temporary method. LAM can only be used by women who have just given birth.

• Breastfeeding continuously and exclusively may be difficult and/or impractical.

• You must be willing to adhere to a healthy diet regimen and you might not be able to take certain medications. Because most of the substances you ingest are passed to the baby in the breast milk, you have to carefully monitor what you eat and drink, and what medications you take. [If you need to take a medication on a regular basis, don't just discontinue the medication on your own; please consult with your doctor first.]

• It's difficult to tell when breastfeeding no longer provides effective birth control. Because each woman is different, it is hard to determine exactly when your fertility returns after giving birth.

• The natural reduction in fertility is not seen in all women who have given birth. Although the fertility reduction in breastfeeding women is a natural process, some women will begin to ovulate almost immediately after a delivery. Unfortunately, it is not possible to predict who will have a reduction in fertility, and who will not.

Like most of the other methods of birth control, LAM does not protect against sexually transmitted infections (STIs).

When does fertility return?

The return to fertility is hard to predict. In general, once you start having menstrual periods (approximately 6 months postpartum), you're fertile.

The problem is the menstrual period is not a very accurate indicator of fertility: it's possible to ovulate before menstruation returns. Once the mature egg is released from the ovary, you can become pregnant, period or no period. Moreover, even the 6 months interval isn't absolute--ovulation can return with the first cycle after delivery.

Bottom line: If you're breastfeeding and sexually active, it's best to use a birth control method. Set some time aside to discuss with your Ob/Gyn which method would best suit you. Last, but not least, LAM works best if you observe the guidelines.