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June 17th, 2010
11:55 AM ET

Should pregnant women be medical test subjects?

By Stephanie Smith
CNN Medical Producer

Citing high death rates among pregnant women during the recent H1N1 flu pandemic, researchers spelled out what they believe is an urgent need to perform clinical testing in that group, according an article in the New England Journal of Medicine.

The researchers called pregnant women "therapeutic orphans" because of their virtual exclusion from medical research.

"The importance of studying subpopulations that have previously been excluded from research is undeniable," wrote the authors. "Ironically, the effort to protect the fetus from research-related risks by excluding pregnant women from research places both women and their fetuses at great risk..."

It is both a tough argument and a paradox - and the recent H1N1 pandemic provides an interesting case study.

Pregnant women were hit hard during the pandemic. The virus was more likely to hospitalize and kill pregnant women compared with the general populace. The mantra from public health officials was for pregnant women to get vaccinated - that the potential benefits outweighed the risks - yet many mothers-to-be were worried about how the vaccine might affect the baby, and whether it could cause complications. The stark options were to get vaccinated and, with that, potentially risk the baby's health, or not get vaccinated and risk some impact from the H1N1 virus.

The same paradox exists regarding testing antidepressants on depressed pregnant women. Is it more important to address a mother's depression, which could lead to poor prenatal care - or worse, self-harm by the mother - and poor outcomes for the developing baby?  Or is it more important to protect the fetus from possible risks surrounding antidepressants?  They are vexing questions for sure.

In the NEJM article, authors attempt to address those questions by presenting ways to circumvent risks for testing pregnant women including, "...waiting to study pregnant women until adequate pre-clinical studies...have been completed...on non-pregnant women..." Or studying pregnant women who have already been prescribed a particular drug by their doctors, so that the only risk remaining would be taking a blood sample.

They say, "The complexity of studying the effects of medications in pregnant women should not stifle efforts to obtain scientifically rigorous data."

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soundoff (27 Responses)
  1. anonymous young women

    I absolutely think they should do more testing of common medications especially on pregnant and nursing women. I've read that there are only a handful of medications that have been approved for pregnant women and they are all related to pregnancy or childbirth. But there are millions of women of childbearing age on antidepressants and other medications. I am on several medications for chronic conditions and I worry about the effect they'll have on possible pregnancies or nursing babies. Scientists generally say they are safe, but I would like harder evidence. Whenever I look at the note that says "not recommended for pregnant women" I get nervous. I am on an antidepressant and several other common drugs. Going off them would be very risky for me.

    June 17, 2010 at 12:51 | Report abuse | Reply
  2. Valerie

    Just because your doctor writes you a prescription does not mean that you need it. If you are on anti-depressants or think you need them, then do your future child a favor and do not get pregnant until you are able to take NOTHING. Nothing is even better than Tylenol. I stopped taking Zyrtec when I was pregnant. Even though many doctors will tell me its okay to take it, I would rather live with allergies and a healthy baby than take the chance on what some stranger with a certification tells me I can do.

    Should pregnant women be subjected to certain drugs in new studies for the studies? No. Should we do studies on women who for whatever reason are already taking substances they should not be? Yes.

    June 17, 2010 at 14:07 | Report abuse | Reply
  3. Mother of almost 2

    When I was pregnant with my first daughter I had "over exaggerated worries" and they put me on an anti-depressant. I had the greatest pregnancy ever. AFTER my daughter was born I was told they had no proof that the medication I was on wouldn't cause problems for the fetus. I was extremely upset over that but physically my daughter was fine. We did have latching problems in the begining and she would not sleep at all through the night. As soon as I would lay her down she would start screaming, not crying but screaming. Later a doctor told me that those have been some side affects. The same doctor also told me that the only "ideas" of what medication wouldn't hurt a fetus was from when a patient called in saying "I just found out I was pregnant and I was taking (insert medicine here) until now" and then they would just keep an eye on the fetus from that point.

    June 17, 2010 at 14:29 | Report abuse | Reply
  4. cemcnair

    Yes, while more testing would benifit others, I would never consent to testing while pregnant. I am not going to put my child at risk.

    June 17, 2010 at 14:41 | Report abuse | Reply
  5. Mahkara

    It seems strange to me that tests aren't done, at least in cases where it is known that a woman *will* be on a drug. (i.e. the mother needs to be on a drug, or it's strongly recommended, for her health) Why not at the least try to watch most women in this circumstance and determine whether any of their children appear to have been harmed by the drug interaction? Not perfect science or medicine, but still a lot better than not knowing whether a drug that could save your life might harm your baby...

    June 17, 2010 at 15:03 | Report abuse | Reply
  6. Kate

    The best way to compile this information is to survey women that have already been pregnant. Find out what they did and didnt take.

    A lot of women already take numerous medications while pregnant and breastfeeding. They have already decided that the benefit outweighs the risk. All we need to do is collect and analyze that data.

    June 17, 2010 at 15:11 | Report abuse | Reply
  7. Gigi

    @cemonair – you already put your baby at risk by taking any medication not tested on pregnant women. This is a paradox as stated in the article. You can not protect pregnant women without doing the clinical trials yet you don't want to put the baby at risk by doing clinical trials. Almost every medication I was prescribed over my pregnancy had a warning about not taking it while pregnant... They are not proven or disproven to not cause more problems and I had to weigh the risk and benefits.

    @anon – it would actually be easy to conduct clinical trials on women who are producing milk as long as they are not actually nursing. As they can pump their milk and it can be tested. I would actually like to see that happen as many women discontinue breastfeeding after 6 weeks when they go back to wrk.

    June 17, 2010 at 15:44 | Report abuse | Reply
  8. Nicole

    Unfortunately, doctors perform unofficial tests on pregnant women all the time. Once a drug has been approved by the FDA, physicians are free to use it for whatever off-label use they dream up (an example of this would be Cytotec, which was approved for peptic ulcers but used to induce labor, and had an alarming tendency to occasionally cause life-threatening hemorrhages or even baby death). More rigorous testing would at least provide a more direct method of determining whether negative side effects do occur, so that the medication can be stopped quickly rather than allowing its use to continue for years for lack of official study results.

    June 17, 2010 at 15:56 | Report abuse | Reply
  9. Lisa

    I'd consent to blood tests for a medication I'm already taking or one that's been around forever that pregnant women take every day but never got the "official" seal of approval, but I'd never take a new drug while pregnant just to be the FDA's guinea pig. The lack of accurate medical information regarding pregnant and lactating women is frustrating, for sure.

    June 17, 2010 at 17:17 | Report abuse | Reply
  10. Preggers

    Pregnant women get sick too and need the medicine. Not treating may kill both.

    June 17, 2010 at 17:22 | Report abuse | Reply
  11. m

    Wow, that's a toughie. But most drugs are harmful to embryos/fetuses.

    June 17, 2010 at 17:35 | Report abuse | Reply
  12. clinical trialer

    Everybody wants safe medications available for them when they need them and nobody wants to do their share in helping to validate them. Validating is for others, right? Everybody wants blood available for them when they crash their car and go to the hospital but it is the job of others to give all that blood, right? Common medications that lots of other people take and have a good risk profile already established should definitely be allowed and even encouraged for pregnant and nursing mothers to test. The only way to make progress is to do the research. We can't learn without data. If I ever allowed myself to become pregnant, I would continue my fairly common medications because stopping them is too dangerous for me and therefore dangerous for the fetus. The data gathered from my experience would be added to the collection to benefit others. Something bad might happen, true, but that risk is present no matter what we do.

    June 17, 2010 at 17:58 | Report abuse | Reply
  13. equity

    cemcnair, if you do not wish to contribute to trials to evaluate safety for your patient population group, you don't have to. However, priveledge and responsibility are inseperable. One cannot be responsible and be denied priveledge just as others cannot receive priveledge without responsibility. Want to play, got to pay. We all contribute if we are all to benefit. If you take, you must give back.

    June 17, 2010 at 18:10 | Report abuse | Reply
    • Maria

      I think it is tacky to advertise your mafily at a crisis pregnancy center or somewhere where desperate mothers may be found. This would kind of go with your kidney story. However, most advertising that you need to do when choosing adoption is on adoption related sites like parentprofiles.com. These are places where expectant mothers would go while looking for families. This would be like going to an online medical forum and asking who needs your son's kidney. The information is actually being sought by the expected parent. To a lesser extent there other types of advertising like sending out letters to friends and mafily. Agencies want you to send out mass mailings to everyone you know, including co workers and your paperboy These are to say that you are adopting and if they know anyone making an adoption plan, please let them know you have a friend that is looking. There is usually a web address to your online profile. By no means would most people want their friends to contact a second cousin that is 17 and in a surprise pregnancy to talk them into adoption for you!If I see a commercial for a new open MRI machine at a certain hospital, do I feel I should consider going to get an MRI? No, the commercial is there to advertise for those people that need one. Same thing with adoption. When a girl chooses adoption for her baby, she needs to look for a mafily. The adoptive parents need to make sure they are visible for when this happens.ETA: Tish, I HAD put by no means would ANYONE I had to go back and edit it to most people because, yes, some people would be THAT tacky and unethical.

      March 4, 2012 at 09:58 | Report abuse |
  14. motherofthree

    If a pregnant woman is going to take a medication anyway, you might as well get some information out of it. Of course, the H1N1 vaccine could have had a very different outcome had they used thimerosal-free H1N1 flu vaccine instead of the typical thimerosal-containing one. Most mothers are more worried about the additives and preservatives in vaccines than the idea of vaccination itself, so had they made a greener vaccine, I think more pregnant women would have been onboard for getting the vaccine. I, personally, would never be vaccinated during pregnancy. I would also never take antidepressants during pregnancy, but then... I've never had depression problems during pregnancy. It's unethical to do medical trials on infants, but they could (right or wrong) pull it off if they did the trials on pregnant women who consented to allowing these things to be done to their bodies and their babies. It just needs to be made EXTREMELY clear what exactly these women would be signing themselves up for, and the potential damages to their child. Spelling all that out would probably significantly lessen the group of women willing to participate.

    June 17, 2010 at 18:32 | Report abuse | Reply
  15. HJ

    The problem with the "not putting baby at risk" attitude is that you may be required to take some sort of medication, to save your life or even your child's, whose effictiveness / harm to your baby has never been tested. The only way to determine what is and what is not safe for a baby IS to test. Would you rather participate in a clinical trial using a micro-dose of a common medication that pill X is safe for baby while pill Y is not, or would you rather find out after a hospital gave you pill Y to save your life, and you lost your baby? I'm all for skipping medication to protect baby–it's generally the best idea–but sometimes that's not really an option. Baby is never going to be born if mother dies. I would say testing life saving medications of all kinds–those given in emergencies, and those people with medical problems have to take every day of their lives–should be a priority for the medical community. The only other alternative is playing roulette with your life and your baby's.

    June 17, 2010 at 19:15 | Report abuse | Reply
  16. LEB

    Clinical trials definitely need to be done with pregnant women as subjects, though it's understandable why researches are hesitant. The medical community still remembers the disaster of Thalidomide trials in the 50s which resulted in thousands of deformed babies. No researcher with any sense of ethics wants to be part of something like that.

    However, pregnant women still have medical needs beyond what is related to their pregnancies, and these concerns need to be addressed. The best approach would probably be to conduct this research slowly and carefully, taking perhaps many years to get the same results a shorter-term study would because test administrators would use the smallest amount of medication possible. If there are women who are willing, and they receive the utmost care, then perhaps it is time to proceed.

    June 17, 2010 at 22:57 | Report abuse | Reply
  17. S

    I'm sometimes amazed that medical science has not figured out a way to determine if certain meds cross the placenta or transfer via the umbilical cord. I would certainly not want to be a test subject while pregnant and risk my child, which is why I just suffer with some symptoms instead of treating myself. But I know I've read of pregnant women being treated w/chemo and the babies are ok, but the woman can't take an aspirin. So obviously there is very little we actually know about how meds move through the body!

    June 18, 2010 at 09:05 | Report abuse | Reply
  18. Joan

    Yes, if there is no harm done or expected. Pregnant woman have problems too that need research based medicine. Drug addiction is being studied now at Thomas Jefferson University for women addicted to heroin. They are comparing methdone use vs another drug in the safty of treating addicted moms. I believe the study is coming to an end, if it has not yet ended. I would like to see the results.

    June 18, 2010 at 09:24 | Report abuse | Reply
  19. HH

    Yes. The fear caused by the thalidomide tragedy has led some doctors to be OVERLY cautious – "Now, take NOTHING, NOTHING, while you are pregnant" – which has led to needless suffering for pregnant women who really do need medication for various conditions.

    The reality is that only a handful of meds can truly harm a fetus. Not treating a mom who is horribly sick or in terrible pain is going to have an effect on baby, too.

    June 18, 2010 at 12:24 | Report abuse | Reply
  20. Valerie

    @HH – Horribly sick or in terrible pain are two of the biggest hallmarks of pregnancy. One in the very beginning and the other during the birthing process. The idea that we NEED medication is a farce perpetuated by the pharmaceutical industry. It's extremely rare that a pregnant woman needs a drug, but when she does, the doctor's won't hesitate to prescribe it. To prevent early labor, correct gestational diabetes, etc.

    June 18, 2010 at 15:13 | Report abuse | Reply
  21. Clinical Bioethics Specialist

    I am a clinical research bioethics specialist affiliated with a University.

    If you're interested in learning more about how *all* participants (not just pregnant women) are protected in research, look up "institutional review boards" Wikipedia has a good, brief explanation, or, look up "clinicaltrials.gov"

    I can share that we (in University-affiliated research) consider pregnant women to be a "special or vulnerable" population (as the article mentions) and we treat both the baby and mom (I've been there, myself) with the greatest possible care. It's not just a good idea, it's the law; for approval to conduct our research, we're required to demonstrate how we're anticipating risks, and benefits, and taking every possible precaution to protect mom & baby...

    In the past, because it was "easier" for some researchers (who needs to deal with such risk unless pushed to do so??) women, and especially pregnant women, were excluded from important research; essentially leading us into designed ignorance, which can be so much riskier than knowing, with certainty, what risks (and importantly, benefits) of certain treatments are.

    Consider this; we can't tell women that (for example) asprin is safe to take during pregnancy unless we *test* that. We can't tell them how much coffee is safe (currently; none, as far we know) unless we *test* that... We can't tell women if the H1N1 vaccine could protect their lives, or hurt them... unless we test that.. Some women have required cancer treatment during pregnancy to save both lives. How can we tell them what to expect unless we test it? Of course, nobody would subject healthy pregnant women to such testing, but if a woman needed a treatment and were willing to let us track results... Wouldn't that be useful for other women down the road?

    We can't test anything at all without putting pregnant women and their babies at (*some,* even the tiniest amount of) risk. We always do everything we can to minimize those risks, but we can never, ever assure women that there is 100% safe (because every human body is different).

    It's normal (and rather smart!) to say "YOU try it. I'm not trying it." But... without somebody participating in the research, we can't know if something can save lives, or hurt. It's important. It's hard, and it can be a little scary, but it's important.

    Please, check out more on clinicaltrials.gov and learn more about the risks, benefits, and protections of participating in biomedical research.

    June 18, 2010 at 15:49 | Report abuse | Reply
  22. Clinical Bioethics Specialist

    Kate – what you describe is called a "retrospective" analysis, or study. You're right; it's a "good" way to point ourselves in the right direction in research (we use that method to figure out what questions to ask), but it's not "the best" way of learning things.

    Retrospective studies easily lead us to believe that connections exist that might not, really. Since we can't control the variables, etc. We're essentially taking someone else's word for how things were controlled, etc.

    The "best" way of testing relationships in medicine is the "gold standard" method; a clinical research trial. Large-scale, controlled clinical research trials are, by far, the most reliable and valid ways of testing in medicine.

    For a quick run-down, search for "biostatistical study design." Wikipedia has a decent overview of the pros and cons of different study designs.

    June 18, 2010 at 16:03 | Report abuse | Reply
  23. Duval and Stachenfeld

    When I was pregnant with my first daughter I had "over exaggerated worries" and they put me on an anti-depressant. I had the greatest pregnancy ever. AFTER my daughter was born I was told they had no proof that the medication I was on wouldn't cause problems for the fetus.

    June 25, 2010 at 21:59 | Report abuse | Reply
  24. Duval and Stachenfeld

    Do you know about the Syrian hamster sarcoma transmission experiments in the early 1960s? They were, actually, trying to create leaping malignancy, and succeeded.

    June 30, 2010 at 19:42 | Report abuse | Reply
  25. Duval and Stachenfeld LLP

    Academic scholars have studied many issues that could improve journalism, though these are not of much interest within the journalism industry. This includes research on the increasing fragmentation of the news with an accompanied lack of context, an increasing emphasis on immediacy to the detriment of fact-checking, an over-emphasis on pundits and the journalism of assertion, and an over-emphasis on the routinization of objectivity in the form of “he said, she said” formats in the news.

    August 2, 2010 at 08:59 | Report abuse | Reply
  26. seo

    Throughout this great pattern of things you actually get a B- with regard to hard work. Where you actually misplaced me ended up being on your details. You know, it is said, the devil is in the details... And it could not be more accurate right here. Having said that, permit me say to you what did do the job. The text is definitely quite convincing and that is possibly why I am making an effort in order to comment. I do not really make it a regular habit of doing that. Secondly, while I can certainly see the leaps in logic you come up with, I am not necessarily certain of how you appear to connect the points which help to make the final result. For right now I will subscribe to your position however trust in the foreseeable future you link the facts better.

    January 31, 2012 at 12:23 | Report abuse | Reply

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