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."

10 comments:

  1. e-mailed by Jackie:

    Great article Jennifer. I had just turned 22 when I delivered my first child. Although my husband and I had planned our first pregnancy we were very uneducated about the birthing processes. I was induced with cyotec (the name of the drug was never told to me). It went wrong. Would be willing share my story some time.

    ReplyDelete
  2. e-mailed by Jora:

    Thank you for your radical rants. Those rants are paving the way to protecting my 10 year old daughter's generation who will one day be mommas having babies.

    ReplyDelete
  3. This comment has been removed by the author.

    ReplyDelete
  4. Great quote e-mailed by Steve:

    "Radical changes cannot be made 'on feathery beds of ease;' new thoughts of great
    importance cannot be born without labor."
    D.D. Palmer, D.C.

    Keep up the great work! Thank you!

    Steve Tullius, DC
    www.dr-t.net
    www.33dcs.com

    ReplyDelete
  5. Jennifer,

    Thanks for sharing my mom's story. She wants people to know that you should NOT blindly follow the instructions of doctors while you're pregnant. They have her thalidomide because she was a little nauseous. Do you think the several lifelong disabilities caused in children was a good tradeoff for throwing up a few times?

    There are other examples out there right now as well. How about the vaccine for diarrhea for babies that is now being recalled because it includes a "pig virus" that can be deadly to pig babies and human babies? Who's checking this stuff? Where's the FDA? Why aren't they protecting our kids?

    Here's another ditty - the recent recall of BOTH Tylenol for Kids and Motrin for kids. The month beore they recalled them SEVEN children died in just one month. Doctors routinely prescribe both of those medicines even though there are 775 documented side effects. If your kids have a fever try Ferrum Phos from Hylands instead - completely safe - and bring downs fever just as effectively without all of the risks.

    Now here's my final anecdote on this topic. When I was 9 months old I was given four vaccines in one day include a live polio virus. I had a SEVERE reaction to it and nearly died. Several babies in the same practice where I went actually passed away from this highly invasive treatment. Again, "EVERYBODY" gave this vaccine to their children at the time. They have now proven that there was a monkey virus in that vaccine which killed kids all over America.

    I am not trying to scare anyone, but it's important that you don't take "advice" at face value from your well-intended friends, family or medical practitioners.

    If we can allow our bodies to do what they were intended to go during childbirth and work to strengthen our children's immune system naturally so they can fight disease on their own, we will all be better off.

    Related to the pitocin topic specifically, I was lucky enough to have a very productive labor and I did not need to be induced. After my delivery I had the biggest high I ever had in my life. You will feel so PROUD of yourself that you were able to deliver such an amazing loving being. You will be able to savor every moment of the delivery and amazing moments right after the birth without a drug-induced fog.

    Some doctors will be "offended" if you question their authority. That may give you a clue about how well-informed and open-minded they really are about following your own child birth path. If you haven't yet selected your physicial you may want to ask them questions about their birth strategies and preferences. If they tell you that pitocin is their preferred path, you may want to go somewhere else.

    ReplyDelete
  6. Hi Jackie: I think it is very important for pregnant moms to hear directly from a woman who went through what I am writing about. I would love to hear your story sometime and post it on my blog if you want to share it with other women as well.

    ReplyDelete
  7. Hi Steve: I LOVE the quote you sent from Dr. Palmer about creating radiacal change. I assume he is the chiropractor from the Palmer School I have heard of? I might just permanently post this quote onto my blog page….hmmm.

    ReplyDelete
  8. Jora e-mailed: Thank you for your radical rants. Those rants are paving the way to protecting my 10 year old daughters generation who will one day be mommas having babies.

    ReplyDelete
  9. Hi Jora: I think what you say is very important. We absolutely need to protect our daughter’s birth rights.

    ReplyDelete
  10. Marilyn e-mailed:

    Jennifer,
    Thanks for sharing my mom's story. She wants people to know that you should NOT blindly follow the instructions of doctors while you're pregnant. They gave her thalidomide because she was a little nauseous. Do you think the several lifelong disabilities caused in children was a good tradeoff for throwing up a few times?

    There are other examples out there right now as well. How about the vaccine for diarrhea for babies that is now being recalled because it includes a "pig virus" that can be deadly to pig babies and human babies? Who's checking this stuff? Where's the FDA? Why aren't they protecting our kids?

    Here's another ditty - the recent recall of BOTH Tylenol for Kids and Motrin for kids. The month beore they recalled them SEVEN children died in just one month. Doctors routinely prescribe both of those medicines even though there are 775 documented side effects. If your kids have a fever try Ferrum Phos from Hylands instead - completely safe - and bring downs fever just as effectively without all of the risks.

    Now here's my final anecdote on this topic. When I was 9 months old I was given four vaccines in one day including a live polio virus. I had a SEVERE reaction to it and nearly died. Several babies in the same practice where I went actually passed away from this highly invasive treatment. Again, "EVERYBODY" gave this vaccine to their children at the time. They have now proven that there was a monkey virus in that vaccine which killed kids all over America.

    I am not trying to scare anyone, but it's important that you don't take "advice" at face value from your well-intended friends, family or medical practitioners.

    If we can allow our bodies to do what they were intended to go during childbirth and work to strengthen our children's immune system naturally so they can fight disease on their own, we will all be better off.

    Related to the pitocin topic specifically, I was lucky enough to have a very productive labor and I did not need to be induced. After my delivery I had the biggest high I ever had in my life. You will feel so PROUD of yourself that you were able to deliver such an amazing loving being. You will be able to savor every moment of the delivery and amazing moments right after the birth without a drug-induced fog.

    Some doctors will be "offended" if you question their authority. That may give you a clue about how well-informed and open-minded they really are about following your own child's birth path. If you haven't yet selected your physician you may want to ask them questions about their birth strategies and preferences. If they tell you that pitocin is their preferred path, you may want to go somewhere else.

    ReplyDelete