Thursday, July 22, 2010

New Guidelines Aim to Reduce Repeated C-Sections

Great reporting on an important birth issue by someone in the mainstream media! This reporter does an excellent job of thoroughly explaining the complexities of the issues surrounding giving women back the right to make their own choice to try for a vaginal birth after a previous cesarean or to go with a repeat surgical birth.

But before you read it let's put it into historical, local, political, and a doula's context.

When I was in my twenties the cesarean rate was rising. Like my sister-in-law most of these women were being sectioned the first time for something called cephalopelvic disproportion. This means the baby's head (cephalo) is too big (disproportion) to fit through mom's passageway (pelvic). How did they figure this out? Two ways. One was a labor that wasn't progressing at the rate of speed the medical community agreed was normal at that time. I say "at that time" because I have worked with plenty of local doctors who no longer practice with this older time frame model in mind. Or before she ever began labor they might xray the mom , take measurements and make a determination without even a trial of labor. Of course this practice has now been abandoned. Xraying moms; it sounds crazy doesn't it? Guess what! We still routinely ultrasound moms who have gone past their due date and one of the things the doctor does is make a recommendation to your OB or midwife about the possible size of your baby and whether you should be sectioned for...wait for it...here it comes...cephalopelvic disproportion or possible shoulder dystocia (shoulders to big to fit) before you even try!

The second reason women were being operated on to give birth was the fact that they had been operated on to give birth. This was the era of "once a cesarean, always a cesarean". The surgical technique of the time was to cut the mom vertically from below the ribs to the pubic bone. This classical cut was associated with a high rate of rupture during future labors. The ghost of this fear based on the rupture rate of classical incisions is still with us today in the doctor's office when women discuss their "options" for future births. It is still in women's hearts too, passed down to them from their mother's birth era.

When I was in my thirties things were changing. The medical community had realized the cesarean rate was sky rocketing and they needed to do something about it. Surgical technique for incisions and suturing had changed; the "bikini cut" had come into vogue, and the risk of rupture had been significantly reduced. Also consumers had put pressure on the medical establishment by taking matters into their own hands; either birthing out of hospitals all together to achieve their V-BAC, or going into the hospital late in labor and refusing to undergo a repeat surgery. Doulas were being asked to labor sit at home with these moms and try to bring them to the hospital at the last moment. These brave pioneers proved women could safely and successfully labor and birth vaginally after a previous surgical birth. They proved V-BAC was a viable option for many women. I remember Dr. Clutter and Dr. Lickness being our first local doctors to support women in this choice.

When I was in my late thirties it was the norm to at least go through a "trial of labor" before deciding to section a woman again. Some of our doctors were much more liberal in their "trials" than other local doctors. As a doula I often felt I had to match wits with some of our more scalpel ready doctors to keep my clients out of the operating room. Another positive change was our local certified nurse midwives being allowed by their supervising doctors to V-BAC women in all our hospitals. Sandy Rodriguez and JoAnne Tarkington caught many, many a successful V-BAC baby.

By my forties the pendulum was swinging back. The fear of uterine rupture was again haunting doctors' offices and labor rooms. A study came out showing that V-BAC women had a greater chance of rupturing than nonV-BAC women. This study lumped all women together without taking into account if the mom went into labor on her own or if she was induced. It also didn't make any distinction as to the method used for induction. (Remember that wonderful induction drug Cytotec? This is the era it is becoming more popular among the medical community. Don't know about Cytotec? Read my piece, Let's Talk about Off Label Use, Cytotec and You.) In reponse to the study the American College of Obstetricians and Gynecologists (ACOG) came out with guidelines requiring hospitals to have anesthesiologists waiting in the hospital the entire time a V-BAC mom labored. Most hospitals found this a financial, practical, legal and bureaucratic impossibility. For a brief time all V-BACs were shut down at our hospitals. Luckily for us Sierra Vista took the bold step of contracting with our local anesthesiologists for enough coverage to allow Sierra Vista to offer the V-BAC option to women in our community. But it is the only hospital within hundreds of miles to do so! I recently had a client who moved back from Santa Barbara to Atascadero just so she could successfully V-BAC at Sierra. ACOGs guidelines also required OBs to be standing by throughout potentially long labors. For many doctors' practices this was a practical, geographic, and financial impossibility. So if your OB's office was located physically close enough to Sierra Vista you could V-BAC, if not you could not. And of course our wonderful nurse midwives were no longer "skilled" enough to catch V-BAC babies. I will never forget the last V-BAC I was at with Sandy and JoAnn. My client had been told she could V-BAC with them but when she was in labor in the hospital she was told the supervising doctors could no longer advise she go for a vaginal birth because she was past her due date. My client decided to refuse to say yes to another surgery. Sandy supported her decision and JoAnn did a great job catching a beautiful healthy baby girl. I have never been more proud of three women in my life. Meanwhile women continue to safely V-BAC with our licensed midwives at home and with doctors at Sierra Vista every day.

When I was fifty I was hired as a doula by a woman who was trying to find some way to not end up with a second operative birth. She was caught in a terrible bind. Her due date fell at a time when one of our homebirth midwives was not practicing and the other was already over committed trying to service all the local women who wanted to birth at home. Her MediCal doctor had deemed her too great a risk for V-BAC and wanted her to have a repeat operation. He put her under extreme pressure to agree to a surgical birth, even sending her a certified letter saying he had explained the risks to her of not agreeing to a surgical birth and requiring her to get a notarized signature. Although the nurse midwives wer supportive of her desire they could not help her. It was suggested to her that she labor at home with me for as long as possible, then come to the hospital and refuse the surgery. You tell me how it can possibly be a good choice to labor at home without a skilled medical attendant, with a woman who has more risk of things going wrong, without anyone who can take the baby's heart tones or has any emergency equipment or training? This is an impossible position to put doulas in. My client called me late into her labor and when I arrived at her home it was quickly obvious to me she would be pushing soon. I told her we needed to go to the hospital and she begged me to stay with her at home and catch her baby. She told me she trusted me. I told her I couldn't do it, I had no equipment and no experience. I convinced her to go to the hospital and she ended up with another c-section. An outcome that will weigh on both our hearts forever.

In the last few months I have seen another change on the horizon. I believe we are witnessing a new V-BAC era being born. There have been a flurry of studies, articles and announcements about the concern over the rise in our national cesarean rate, balancing risks of repeat c-sections versus v-bac and a woman's right to choose. The National Institute of Health came out with their finding which has pushed ACOG to review it's guidelines and make their own announcement. Read Neergaard's great article to see where we are headed.

By LAURAN NEERGAARD
AP Medical Writer

Most women who've had a C-section, and many who've had two, should be allowed to try labor with their next baby, say new guidelines - a step toward reversing the "once a cesarean, always a cesarean" policies taking root in many hospitals.

Wednesday's announcement by the American College of Obstetricians and Gynecologists eases restrictions on who might avoid a repeat C-section, rewriting an old policy that critics have said is partly to blame for many pregnant women being denied the chance.
Fifteen years ago, nearly 3 in 10 women who'd had a prior C-section gave birth vaginally the next time. Today, fewer than 1 in 10 do.

Last spring, a National Institutes of Health panel strongly urged steps to reverse that trend, saying a third of hospitals and half of doctors ban women from attempting what's called VBAC, for "vaginal birth after cesarean."

The new guidelines declare VBAC a safe and appropriate option for most women - now including those carrying twins or who've had two C-sections - and urge that they be given an unbiased look at the pros and cons so they can decide whether to try.

Women's choice is "what we want to come through loud and clear," said Dr. William Grobman of Northwestern University, co-author of the guidelines. "There are few times where there is an absolute wrong or an absolute right, but there is the importance of shared decision-making."

Overall, nearly a third of U.S. births are by cesarean, an all-time high. Cesareans can be lifesaving but they come with certain risks - and the more C-sections a woman has, the greater the risk in a next pregnancy of problems, some of them life-threatening, like placenta abnormalities or hemorrhage.

The main debate with VBAC: That the rigors of labor could cause the scar from the earlier surgery to rupture. There's less than a 1 percent chance of that happening, the ACOG guidelines say. Also, with most recently performed C-sections, that scar is located on a lower part of the uterus that's less stressed by contractions.

Of those who attempt VBAC, between 60 percent and 80 percent will deliver vaginally, the guidelines note. The rest will need a C-section after all, because of stalled labor or other factors. Success if more likely in women who go into labor naturally - although induction doesn't rule out an attempt - and less likely in women who are obese or are carrying large babies, they say.
Thus the balancing act that women and their doctors weigh: A successful VBAC is safer than a planned repeat C-section, especially for women who want additional children - but an emergency C-section can be riskier than a planned one.

Because of those rare uterine ruptures, the obstetricians' group has long recommended that only hospitals equipped for immediate emergency C-sections attempt VBACs. Many smaller or rural hospitals can't do that, and that recommendation plus high-dollar lawsuits have been blamed for some hospital VBAC bans.

"Restricting access was not the intention," the new guidelines say. They say hospitals ill-equipped for immediate surgery should help women find care elsewhere, have a plan to manage uterine ruptures anyway, and not coerce a woman into a repeat C-section.

Educating women about their options early enough in pregnancy for them to make an informed choice is key, said Dr. F. Gary Cunningham of the University of Texas Southwestern Medical Center, who chaired the NIH panel on repeat C-sections.

It requires a fair portrayal of risks and benefits that can differ by patient, added Dr. Howard Minkoff of Maimonides Medical Center in Brooklyn, N.Y., which has women sign a special VBAC consent after counseling yet has a higher-than-average VBAC rate of 30 percent.

"There's no doubt that how things get framed influences how people act," he said.

While the guidelines cannot force hospital policy changes, some women's groups welcomed them.
"I feel like ACOG has really listened to how their previous policies have impacted women," said Barbara Stratton of the International Cesarean Awareness Network's Baltimore chapter, adding that she'll advise women seeking a VBAC to hand a copy of the guidelines to caregivers who balk.
But she called for reducing overuse of first-time C-sections, too, so that repeats become less of an issue.

Read more: http://www.sanluisobispo.com/2010/07/21/1223164/new-guidelines-aim-to-reduce-repeated.html#ixzz0uQm4tHXf

Friday, July 9, 2010

Popular Antidepressant Linked to Major Birth Defects

The history of Paxil gives us another look at how our medical system, consisting of medical researchers, drug companies, doctors and the FDA, do a poor job protecting moms and their babies. Did you know most drugs aren't even tested initially on women for safety? Men are chosen for testing because they don't have cycles and fluctuating hormones which can affect results. An added benefit to testing only on men is not risking testing on pregnant women which could be a huge liability issue. In my blog piece "Let's Talk about Off Label Use, Cytotec and You" we discussed how difficult it would be to find pregnant women who would willingly sign up to be part of a drug experiment. I explained about one of the ways the drug companies and doctors get around this thorny issue. The Paxil case illustrates another way. It is important to remember that most of what we know about the safety of any given medication taken during pregnancy and lactation is known only in hind sight.

The Story of Paxil, a cautionary tale...

Approved by the FDA in 1992 doctors begin to prescribe it to treat depression, generalized anxiety disorder (GAD), social anxiety disorder, panic disorder (PD), and obsessive compulsive disorder (OCD), and posttraumatic stress disorder (PTSD).

Six years later...

In 1998 the drug company that makes Paxil, GlaxoSmithKline, internal review found an alarmingly high number of Paxil birth defect reports. Early results of two studies showed that women who took Paxil during the first trimester of pregnancy (before they might even know they are pregnant!) were about two times as likely to have a baby with a heart defect as women who received other antidepressants. However, the information was not turned over to the FDA!!!

Seven years later...

In December 2005 the FDA (US Food and Drug Administration) issued a public health advisory warning of increased risk of Paxil birth defects if used while pregnant. Particularly, during the first trimester of pregnancy.

One year later...

The American Medical Association estimated that 40,000 pregnant women in the US were taking antidepressants in 2006. GlaxoSmithKline also stated that in that year about 25 percent of prescriptions for Paxil were written for women of childbearing age.

Two years later...

Paxil generated about $942 million in sales in 2008 from Paxil.

Eighteen years after FDA approval of safety and twelve years after GlaxoSmithKline knows the drug isn't safe for pregnant moms...

In 2010 Paxil is the only SSRI(Selective Serotonin Reuptake Inhibitor) on the market that is classified by the FDA as a Category D drug. Category D means that studies in pregnant women have demonstrated a risk to the fetus. The studies mentioned show a greater risk for babies whose moms took Paxil over other SSRIs. What about comparing the risk between moms who take any SSRIs and moms who don't take any SSRIs? Perhaps we should find out if SSRIs are simply too risky for women of childbearing age unless they are also on a very effective birth control method?

Here's why all SSRIs may be a problem. This group of antidepressants are designed to relieve the symptoms of depression by blocking the reuptake of the chemical serotonin by certain nerve cells in the brain. With more serotonin in the brain, mood is improved. However, Maternal Serotonin plays a crucial role in fetal heart, lung and brain development. Further in the case of Paxil it is known to cross the placenta. So not only are you changing the unique balance of the maternal brain chemicals that effect fetal development you are also directly drugging your growing baby's brain during critical developmental stages.

Paxil, as well as other SSRIs, have been linked to Persistent Pulmonary Hypertension in the Newborn (PPHN) – a devastating condition affecting the heart and lungs of newborn infants. Babies are unable to breathe properly due to constricted blood vessels which cut off oxygen to the blood and cause damage to other organs such as brain and kidneys.

Known Paxil birth defects include:

Spina Bifida: a developmental birth defect caused by the incomplete closure of the embryonic neural tube. Some vertebrae overlying the spinal cord are not fully formed and remain unfused and open. If the opening is large enough, this allows a portion of the spinal cord to protrude through the opening in the bones. There may or may not be a fluid-filled sac surrounding the spinal cord.

Heart Defects: atrial and ventricular septal heart defects (holes in the walls of the chambers of the heart).

Anencephaly: condition in which the portion of the neural tube which will become the cerebrum(the dominant part of the brain) does not close, and encephalocele, which results when other parts of the brain don't appropriately fuse .

These frightening scientific descriptions can never express the personal devastation and family tragedies they represent. My heart breaks.

Saturday, July 3, 2010

Let's Talk about Off Label Use, Cytotec and You

So you're pregnant. Congratulations! Guess what? Parenting starts now. It doesn't begin after you bring your baby home or even the moment your baby is in your arms. No, your role as protector and nurturer begins from the moment you first realized you were pregnant. You will have a larger role in your child's life than anyone else. You will know your child better than anyone else. You will make more decisions for your child than anyone else and those decisions are more likely to be purely out of a desire to do what is best for your child than anyone else. Being a responsible parent starts now.

What does this have to do with off label use of medications? This has to do with the protector part of your parental responsibilities. So here we go. As I explained in my previous post, "More on Why Women Need to Question Authority" a doctor can legally prescribe a medication for a use for which it has never been tested, in other words no FDA approval. This is called off label use. Apparently this practice is surprisingly common in the medical world.

So what would you do if your doctor came to you when you were pregnant and said, "I want to use drug X on you. It has never been tested for safety in pregnant women or their babies but there is some evidence that it may be effective for your situation." Unless your medical situation was dire most women would say, "Are you kidding? No way!"

What if you went to a prenatal appointment and your doctor or midwife said, "There is a new drug, X, which they are starting to test for FDA approval that might help with keeping blood pressure down during pregnancy. I'd like to sign you and your baby up to be part of the drug trial. Are you interested?" It is hard for me to imagine the mom who would answer, "Sure sign us up!"

So how do they find out if a drug is effective and safe during pregnancy, labor and birth? By doing an end run around you and the safeguards that are in place to protect us from unsafe medications. They go off label. Most medications we commonly use in pregnancy and birth were originally given experimentally on women without their real understanding or consent to the process. Then they collect data in hindsight and try to figure out what is truly OK to be using on us.

Marilyn talks about an example familiar to many of us in her comment on my earlier piece,
"I totally agree with you Jennifer. My mother was given thalidomide for nausea in the 60's and subsequently had three miscarriages and was never able to conceive again."
Most of us have heard about thalidomide babies but we make the mistake of assuming nothing like that could be happening now. That was the kind of thing they used to do in the past before women were treated as equals, right?

Now you are ready to talk about Cytotec. Do you remember the questions I posed in my earlier post?
"Are you seeing a doctor that will induce you if you go past a certain calendar date? Are you worried about being induced? Concerned about ending up on the dreaded "pit drip"? What if your doctor whom you trust said, "don't worry. We're not going to use Pitocin. We're going to use this little tiny pill instead. You won't even need to be hooked to an IV and it is perfectly safe for you and your baby." What would you think? What would you do?"

If facing a labor induction most women would say yes to their doctor or midwife. Their fear of a Pitocin induced labor, which they have heard plenty of bad things about from sisters, mothers and friends, coupled with their fear of ending up with a c-section, added to their trust in their care provider to never do anything to harm them or their babies, and their assumption this pill has been FDA tested for safety in labor, will lead most of them to say yes to their doctor. You have just become an unwitting lab rat.

The truth about Cytotec also known as Misoprostol:

From Wikipedia
In August 2000, Searle—the manufacturer of misoprostol—distributed a letter warning against the use of misoprostol in pregnant women. The letter cited reports of uterine rupture and death associated with using misoprostol to induce labor. Other rare complications include amniotic fluid embolism (a very rare complication which usually results in maternal and fetal death) It is difficult to determine if misoprostol causes a higher risk than do other cervical ripening agents. One estimate is that it would require approximately 61,000 patients enrolled in randomized controlled trials to detect a clinically significant difference in serious fetal complications and approximately 155,000 patients to detect a clinically significant difference in serious maternal complications.


Enter the lab rats. Where on earth are they going to get 155,000 pregnant women to sign up for their experiment? So instead they use Cytotec off label on many more women than 155,000. They have to use many more lab rats because no one is writing down the data. No one is setting up a control group. No one is following up! It takes much more momentum of bad outcomes for moms and babies before the collective consciousness of the medical community realizes the mistake they made.

So how did we get here with Cytotec? When they were testing this drug for it's intended use as an ulcer medication they discovered it was an abortifacient, in other words it caused women to go into labor and miscarry or abort. Someone had the bright idea to use it at the end of pregnancy to cause women to go into labor and birth their babies.

Since there had been no testing for dosing levels for labor induction they needed to wing it. Cytotec is a small white pill. It is only sold in 100ug tablets. They began placing it inside women up against their cervix's where it would slowly be absorbed into the blood stream. Through trial and error they have learned that the best dose is one quarter of one pill or 25ug. Searle the drug manufacturer continues to not sell it in 25ug because they don't want to be legally responsible for what may happen next to you and your baby.

Here comes the tricky part, Pitocin can also cause uterine hyperstimulation which left unchecked can lead to uterine rupture. Here is the difference in what I have seen with my clients. When Cytotec is used they place the pill and wait. With some of my moms absolutely nothing happens, nada, zippo, no contractions at all. Then we all have to wait many hours before they can either try placing a second dose or transfer over to Pitocin. With some moms it works like a charm. They start into strong labor and birth their baby. But what happens to the third group of moms? They get into trouble. Their contractions are coming too strong and too close together. Their baby begins to go into fetal distress. The nurse and doctor have no way of retrieving the pill. They have no way of turning it down or turning it off. With Pitocin they try to find the level of medication which will be strong enough to cause you to contract effectively enough to dilate while not causing contractions so strong they can rupture your uterus or that your baby can't handle. I have seen this dance many times with Pitocin. With Cytotec there is only one way to "rescue" the situation they have created; perform a surgical birth. The mom is rushed down to the OR and she is cut open. Voila! What a lucky thing you had your baby in the hospital otherwise who knows what would have happened!

The American College of Obstetricians and Gynecologists holds that substantial evidence supports the use of misoprostol for induction of labor, a position it reaffirmed in 2000 in response to the Searle drug company disclaimer letter.

When you google Cytotec up come all the law firms preparing cases for grieving families.

Remember Marilyn whose mom took thalidomide? Here's what she had to say as a conscientious parent, "Good rule of thumb - don't take ANYTHING while you're pregnant and before you agree to anything after your child is born - conduct a full spectrum of medical professionals - talk to top homeopathic practitioners, and SEVERAL medical practitioners before you make any decisions. You owe it to yourself and your child to do your homework - don't take anything doctors tell you at face value."

Thursday, July 1, 2010

While Waiting

This quiet mom sent along this nice note while waiting out the days to go into labor.

"Dear Jennifer,

I want to thank you for all the help you have given us in preparing for this birth & baby. Your classes were really informative & encouraging. Nothing has happened yet & its Saturday, so we're just waiting & getting ready (trying to...) Anyways, your knowledge & attitude toward birth has really helped me. I'll do my best to let you know when &  how the baby arrives. Until then, take care.

Ryanne

P.S. Thank you for having us @ your home for the last class. :)

Congratulations on a Successful V-BAC!

Dear Anna,
Thank you for letting me share in your journey. Your acceptance of the challenges and possible risks along your path are an inspiration. You never lost sight of your strong belief that women were meant to have babies. You embody true female empowerment which is vulnerable, thoughtful, physical and heroic. Congratualtions on bringing into this world your beautiful 9 pound 13 ounce baby girl, Paloma!

More on Why Women Need to Question Authority

From Joe Stover
Sent June 30th

"Hey Mom you should check out this article. It's kind of hard to believe/disturbing."

My son sent me this message and a link to a blog site the day after my post claiming women were being lied to and manipulated by the medical/money machine. He was deeply concerned about pregnant women being given a drug to prevent girl babies from growing up to have typical "masculine" traits. These girls are being labled abnormal because they show a lack of interest in playing with dolls or fantasizing about having babies and they grow up to have little interest in getting married and taking on traditional wife and motherhood roles.


So I looked into it and as justified and disturbing as his concerns were was a bigger issue for me. Once again women and their babies are being experimented upon by the medical establishment without their knowledge or consent. How can that happen you ask? It isn't like someone is sneaking in while the women sleep and are giving them a drug. Of course not; it is much more insidious than that. It involves something few women understand thoroughly called off label use. Don't believe me? Here are two women's stories excerpted from an article that just came out in Time magazine June 18th.
Jenny Westphal, 24, who took dexamethasone throughout her pregnancy at the recommendation of a doctor, says she feels misled. . . She was not asked to give informed consent. Her daughter, now 3, who has CAH (the disorder they were trying to prevent with the dexamethasone!) has had serious and mysterious health problems since birth, including feeding disorders, that are not commonly associated with her adrenal-gland disorder. . . In April, Westphal, who lives in Wisconsin, started doing research online and discovered there was some controversy over the treatment. "I was outraged, frustrated and confused. Confused, because no one had ever warned me about this. I wasn't given the chance to decide for myself, based on the risks and benefits, if I wanted the treatment or not," she says . . . Westphal may never know whether her daughter's problems were caused by dexamethasone, though she will likely always believe they were. That is why so many similar situations, in which experimental drugs are prescribed off-label without informed consent rather than in clinical trials, wind up becoming case studies — not in scientific journals, but exactly where Westphal and her husband are considering taking theirs: to court.
When Marisa Langford found out she was pregnant again, she called Dr. Maria New, a total stranger, before calling her own mother. New, a prominent pediatric endocrinologist and researcher at Mount Sinai Medical Center in New York City, is one of the world's foremost experts in congenital adrenal hyperplasia, or CAH . . . Langford and her husband learned they were silent carriers of the genetic variation that causes CAH when their son was diagnosed with the condition after birth. . . "Dr. New told me I had to start taking dexamethasone immediately," says Langford, 30, who lives in Tampa. "We felt very confident in someone of her stature and that what she was telling us was the right thing to do." . . . Langford says that neither New nor her prescribing physician mentioned that prenatal dexamethasone treatment is an off-label use of the drug (an application for which it was not specifically approved by the government) or that the medical community is sharply divided over whether dexamethasone should be used during pregnancy at all.

In animal studies, dexamethasone has been shown to cause birth defects, but proponents of the treatment note that no human birth defects have ever been associated with the treatment, and that it is uncertain whether findings in lab animals translate to humans. . . "We just don't know what we are doing to these kids," says Dr. Walter Miller, the chief of endocrinology at University of California, San Francisco. "It's not sufficient to say, The baby was born and had all fingers and toes, so it's fine."

Perhaps most controversially, prenatal dex must be given as soon as a woman learns she is pregnant, which is usually several weeks before genetic tests can determine if the fetus is in fact a female affected with CAH — the chance of which is 1 in 8 for parents who already have an affected child or know they are carriers of the genetic disorder. If the baby is healthy, treatment is stopped, but at that point, the fetus has been exposed to the steroid drug for weeks. There is no data on how many mothers receive prenatal dex, but according to the odds, 7 of 8 may be taking medication unnecessarily.

OMG!!! 7 out of 8 don't need it, no long term studies have been done on the safety of the drug for the baby when given prenatally, the women aren't being informed that this is the case? OMG! OMG! OMG! How can this be? What the hell is this off label use thing all about?

Basically it comes down to the fact that any doctor can prescribe medication for anything they want. It doesn't have to first be tested for effectiveness on what the doctor is choosing to use it to treat. It doesn't have to first be tested for safety when used for this purpose. It doesn't have to first be studied for proper dosaging when used for this purpose. In other words when you are given a drug off label they are using you to experiment upon.

So why do doctors do it? Let's head back to the Time article to find out.

It enables doctors to do human research without gaining proper approval. All participants in human medical research are, by law, entitled to the protective oversight of an institutional review board (IRB), a committee that safeguards the interests of research volunteers and ensures they have been fully informed about the potential risks and benefits of an experimental treatment. If doctors are simply treating a patient with an off-label drug, they are not required to obtain written informed consent from patients. But if doctors give treatment with the intent to gain knowledge, they are technically doing research, which must receive IRB approval. . . Ethicists say physicians may sometimes treat patients off-label, then decide later to launch a follow-up study; or, they do follow-up research on patients who have been treated by other doctors. In the process, they have converted these patients into unwitting research volunteers. Some doctors game the system this way, Caplan says, to avoid battles with IRBs.

And there are battles. In the case of prenatal use of dexamethasone there is currently a battle between a Dr. Maria New, a prominent pediatric endocrinologist and researcher at Mount Sinai Medical Center in New York and some members of the Bioethics Forum. They are doing what they can to shut her down with letters, articles and general publicity. And then of course there are the court battles. Remember Jenny Westphal and her 3 year old daughter with mysterious ailments? They are doing just that, taking the doctors to court.
So you think this doesn't effect you since you don't carry the gene for this rare disorder? Think again. Was you labor induced? Are you seeing a doctor that will induce you if you go past a certain calendar date? Are you worried about being induced? Concerned about ending up on the dreaded "pit drip"? What if your doctor whom you trust said, "don't worry. We're not going to use pitocin. We're going to use this little tiny pill instead. You won't even need to be hooked to an IV and it is perfectly safe for you and your baby." What would you think? What would you do? More on this wonder drug and off label use next time.

Time article
http://www.time.com/time/health/article/0,8599,1996453,00.html#ixzz0sNjIwE7D

Letter of concern sent to the CARES Foundation
(Congenital Adrenal Hyperplasia Research Education & Support)
http://www.fetaldex.org/letter_CARES.html

Bioethics Forum
Preventing Homosexuality (and Uppity Women) in the Womb?
Alice Dreger, Ellen K. Feder, Anne Tamar-Mattis, 06/29 http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4754&blogid=140