Pregnant Women Weigh Risks Of H1N1 Vaccine

Pregnant women are at the top of the CDC's list to receive the H1N1 vaccine. But they're under huge cultural pressures not to unless absolutely necessary. Will they get a vaccine if they're not even sick? Dr. Ruth Faden of the Berman Institute of Bioethics talks host Guy Raz through this dilemma.

GUY RAZ, host:

In Guadalajara, the three North American leaders will also work on a plan to coordinate a response to the H1N1 virus, better known as swine flu. Public health officials across North America are preparing for a major outbreak of the disease this fall and winter.

On Friday, the U.S. government began trials of a vaccine for the virus, but none of the volunteers testing this vaccine will be pregnant women, even though they have priority access to receive it. Testing vaccines and drugs on pregnant women poses an ethical dilemma.

And that's where Ruth Faden comes in. She's a bioethicist and public health expert at Johns Hopkins University. And Dr. Faden joins me.

Welcome.

Dr. RUTH FADEN (Executive Director, Berman Institute of Bioethics, Johns Hopkins University): My pleasure. Thanks for having me.

RAZ: What do we know about how the H1N1 virus affects pregnant women?

Dr. FADEN: Well, what we know is that pregnant women become ill. We know they develop high fevers. We know that high fevers are not at all good for pregnant women and not at all good for their babies. We are very keen and concerned - by we, I mean the public health community - to encourage pregnant women to take this vaccine.

RAZ: So how does the Centers for Disease Control know, you know, it'll be safe for pregnant women to receive this H1N1 vaccine?

Dr. FADEN: The recommendation is based on two things: One, pregnant women are much more likely to become seriously ill, to die and also there are concerns for their babies. So the risks of not becoming vaccinated and contracting H1N1 are serious.

The other piece of evidence that goes into the puzzle is the vaccine that pregnant women will be offered this fall is very similar to the seasonal vaccine, which has been offered to pregnant women for many years.

RAZ: Why is it so difficult to collect data on vaccines in general with respect to pregnant women?

Dr. FADEN: This is part of a bigger problem. There is a tremendous reluctance to include pregnant women in research. In fact, there is no group in the United States about which we have less evidence than pregnant women.

RAZ: Wow.

Dr. FADEN: It's staggering. It is a tragedy in many respects.

RAZ: Is it because researchers are afraid to do it?

Dr. FADEN: Well, there are solid ethical concerns when you talk about using or involving a pregnant woman in research. It's not just the pregnant woman herself, but she is also carrying a developing person, and we have to be mindful that the risks to both have to be evaluated and considered. But at the same time, the benefits to both of the knowledge that would be gained, also are enormous.

So, basically, medicine is flying blind in many cases. Many of the drugs that women take in pregnancy because they're seriously ill, we just have no evidence what the impact is for them or what the impact will be for their babies. It's a terribly unsatisfying and arguably utterly unethical situation that we're in.

RAZ: Well, what can you do?

Dr. FADEN: Well, we can do a bunch of things. There are all kinds of ways to gather evidence without putting them into a randomized clinical trial of an unproven drug. Two-thirds of pregnant women actually take somewhere in the order of three to five medications over the course of their pregnancy. If we studied what happened to women while they were taking the medications they chose to take anyway, we would understand a lot better what happens when a pregnant person takes a drug.

RAZ: Dr. Faden, we have a young baby at home. So my wife was obviously pregnant recently. You know, women are told not to drink alcohol or coffee or tea. Many over-the-counter medications have warnings. They say don't take it if you're pregnant. So, I mean, given all of this information that pregnant women are bombarded with, things not to do, do you expect them to get vaccinated with the H1N1 vaccine?

Dr. FADEN: I'm hoping they will. You're quite right. The pressures on pregnant women to basically take a deep breath and hold it for nine months are enormous in our culture.

When we're pregnant, we're told basically, you know, don't drink wine, don't go on an airplane, don't go in a room that's recently painted, don't talk to anyone, don't go anywhere. Don't - I mean, it goes on and on and on and on, and much of this advice is ill-founded and excessive. Some of it is perfectly appropriate.

Teasing the good advice from the bad advice is extremely burdensome for pregnant women, and so the path of least resistance is simply to give up and say, okay, I'm just not doing anything.

Doing nothing is not the safest course in all cases. And this is an instance when we know that we're looking at a flu that can make a pregnant woman really, seriously ill, risk her life, risk her baby's life. This is one of those times where holding your breath is a really bad idea.

RAZ: Dr. Ruth Faden is the executive director of the Berman Institute of Bioethics at Johns Hopkins University. She joined me from WAMU here in Washington.

Dr. Faden, thanks so much.

Dr. FADEN: My pleasure. Thank you.

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