Pregnancy and medical research

manic mama

I don't know if anyone knows any answers to this (we have women of all careers and interests here, I think) or if anyone else just has an opinion, but...

I've seen a few women here ask about the safety of some prescription drugs (specifically those for depression/mood stabilization) and there is little to no research on this stuff. It can be really frustrating when even the doctors can't say for sure (ok, you can never really say for sure, but I digress) the safety of a medication that is vital for a pregnant/nursing mom.

Is it that the drug companies are too busy researching the next penis enhancement pill, that it seems unethical to do studies on women about whether or not they will have a pregnancy complication, or what?

LukyNLuv

manic mama:

Is it that the drug companies are too busy researching the next penis enhancement pill, that it seems unethical to do studies on women about whether or not they will have a pregnancy complication, or what?

Are you asking if it is unethical to do a study on a pregnant woman?
Would you go into a study to see how your baby would turn out after taking a medication to help the plight of pregnant women everywhere?

This is not meant as snark at all...

Please also note that MANY (Most) Rx products have few if any safety studies on children....

Mrs D~S

No, being in the pharmaceutical industry... it's that it costs TONS of money to do research and you have people complaining about the pricing of medication.  Not only that, but the reason most drugs are even 'studied' in pregnant women is because they took the drug and didnt realize they were pregnant.  They never actively test in pregnant women - its an ethical issue. 

manic mama

I'm just asking if that would be one of the reasons... I don't know about having a woman start on a medication, but perhaps tracking the women who decide to take them anyway? But, I figure, then you wouldn't have a control group, right?

Mrs D~S

And just so you know... Penis enhancing medication (such as Viagra) came about while researching treatment for angina.  Viagra also marketed under another name as Revatio is for pulmonary hypertension (a very serious disease). 

Mrs D~S

I THINK the majority of the women wouldnt take a product to be the control group, but I am sure that the pharma industry wouldnt touch it (again due to ethical issues). 

rouge411

manic mama:

I'm just asking if that would be one of the reasons... I don't know about having a woman start on a medication, but perhaps tracking the women who decide to take them anyway? But, I figure, then you wouldn't have a control group, right?

Well, no double-blind tests, if testing on pregnant women isn't ethical... aren't most of the drugs tested on pregnant rats and rabbits first?

LukyNLuv

manic mama:

I'm just asking if that would be one of the reasons... I don't know about having a woman start on a medication, but perhaps tracking the women who decide to take them anyway? But, I figure, then you wouldn't have a control group, right?

https://www.fda.gov/cder/news/thalidomide.htm

Thalidomide (tha-lid-o-mide) was first marketed in Europe in the late 1950's. It was used as a sleeping pill and to treat morning sickness during pregnancy. At that time no one knew thalidomide caused birth defects.

 

Lulu0802

Drugs are rarely, if ever, studied in pregnant women because it is an ethical issue.  In this case, the risks far outweigh the potential benefits.  It is not worth risking the safety and health of an unborn baby for the sake of a new drug. 

I'm sure a lot of drug companies would love to conduct studies on pregnant women and be able to definitively market their product to this group (can you imagine the financial influx if they suddenly opened up a previously untapped resource), but the ethical guidelines by which all clinical research must follow pretty much prohibit studies involving pregnant women.

A lot of the information we get about the effects of drugs on pregnant women is because a woman got pregant while she was already participating in the study.  Usually, at that point, they have the woman stop taking the drug, but monitor her and the baby very closely for months, if not years.

ToBeMrsC6907

I would imagine part of the problem is that it is hard to find women/subjects willing to give informed consent to participate in a study with an investigational product/drug when the side effects are unknown.

You have to remember too- most of these studies are double blind, meaning you don't even know what you are taking and neither will the research doctor until the study is over. 

Research takes years and years to complete all 3 phases, and this requires thousands of human subjects.

Ask yourself, would YOU be willing to participate in such research and subject your unborn to potentially hazardous side effects?  I know I wouldn't.

manic mama

ToBeMrsC6907:

You have to remember too- most of these studies are double blind, meaning you don't even know what you are taking and neither will the research doctor until the study is over. 

Ask yourself, would YOU be willing to participate in such research and subject your unborn to potentially hazardous side effects?  I know I wouldn't.

Right, that was what was floating around in my head, the double-blind issue.

Wasn't trying to insult the pharmaceutical industry, just wondering where that kind of stuff stood.

Mike&Rae

I work in pharma research. First remember that animal trials are conducted before human trials. If the drug is deemed safe, it proceeds to a first in human or phase I. This stage is to determine for efficacy and safety. Next the drug is tested through to Phase III to find an appropriate dose. Trials up to this point usually exclude for pregnancy. That is, if you participate in the trial you are required to sign a consent form stating you are taking birth control. Male subjects must state that their partner is using birth control. Then if the drug is determined to be safe and if there is a pediatic indication, the drug may go on to pediatric studies. Before it is tested in pregnant women, the drug would most likely be tested on pregnant animals. It's a combination of the drug companies and the FDA ensuring that trials are conducted safely.

My personal opinion is that unless the drug caused visible birth defects, it would be difficult to link the two later on in a baby's life. There would have to be a long term follow-up study to track the children whose parents took the medication.

beanzII

As a woman with a chronic illness requiring medication, I am enrolled in a study (did the same during my last prregnancy) to study the effects of my medication on babies.  It was my impression from the clinic staff, at least for these studies, that it is difficult to get patients to become involved or keep them involved once they enroll.