Guinea Pig Flu

September 17, 2009 8:16 AM

Our 13 month old has been invited to participate in a clinical trial to see how the swine flu virus and the regular flu virus react in small children. Is this a good idea?

Does anyone have any more insight into this process? I'm guessing it's not a trial in the traditional 'let's see what happens' sense. They've already tested on adults and I realize there's a need for testing on kids, I'm just, in a purely selfish way, worried about it being my kid.

I'm also assuming that this is the swine flu vaccine. There aren't a couple out there that they're testing, right?

We've a very short time frame to make a decision and although we've asked these same questions of the folks administering the trial they don't have a very quick turnaround on getting the answers for us.

For what it's worth we fully intended to get the kid both vaccines if and when they were available.

posted by IanMorr to Health & Fitness (21 answers total)

Wait, you mean how the two vaccines interact, not the two viruses, right? Because as you've worded it, the answer is no.
posted by jeather at 8:20 AM on September 17, 2009 [2 favorites]

Response by poster: Uh, yeah, that would be the two vaccines of course
posted by IanMorr at 8:23 AM on September 17, 2009

If the study directors (or their assistants) aren't answering all of your questions in an immediate way that clearly responds to both the substance of and the concern behind your questions, you shouldn't enroll your child. Honestly, the way you've worded the question here suggests that you don't even really understand what they're studying, which means you should stay far, far away.
posted by amelioration at 8:25 AM on September 17, 2009

If you are planning to have your child vaccinated with the exact same drugs anyway....
then why not get any reaction carefully and meticulously documented? Please add to the body of documented evidence, and not to the body of anecdotal stories.
posted by SLC Mom at 8:26 AM on September 17, 2009

You don't seem exactly sure what they're testing and the the testing folks are not dealing with your concerns promptly and you're already worried. This all seems like a big NO to me.
posted by meerkatty at 8:27 AM on September 17, 2009 [1 favorite]

this one is not right for you or your kids at this time; the researchers should not have put such a limited time frame on your decision, and they should/ are required to be much more forthcoming about the information. Have they given you a document outlining ALL of the possible risks to your child?
posted by Think_Long at 8:28 AM on September 17, 2009 [1 favorite]

You really, really need to talk to the study coordinators. I don't know the specifics of the study you're describing, but I'm afraid that noone here can counsel you appropriately on the subject without insight about the specific study design and purpose.

That said, if the researchers running a trial are unable to give you the information you need to make an informed decision regarding enrollment, then the short answer is no, it's not a good idea. You need to understand quite clearly, what the study interventions are, what it's purpose is, what the risks are, and what the benefits may be before enrolling. It's their job to make that happen, and thus far, they are haven't succeeded. If a study is being conducted appropriately, someone is supposed to sit down with you and counsel you on the issues I just mentioned, as well as provide documentation to help answer these questions.
posted by drpynchon at 8:32 AM on September 17, 2009

What exactly does the test entail? I'm with SLC Mom. It doesn't sound like you're getting experimental treatment or drugs, just maybe having your child monitored afterward. It could mean an extra trip to the doctors office, and/or a blood draw, which wouldn't be a big deal, other than being inconvenient (depending on your child's reaction to needles, of course). But your question really doesn't say whether this is the case or not... the exact specifics of the study matter a lot here.
posted by amtho at 8:33 AM on September 17, 2009

Current research shows that young infants are fully capable of generating protective immune responses to multiple vaccines given simultaneously. “Our analysis shows that infants have the theoretical capacity to respond to about 10,000 vaccines at once. Currently, the most vaccines that children receive at one time is five,” says Dr. Offit. “Using this estimate, we could predict that even if all 11 of the routinely recommended vaccinations were given to infants at one time, only about .01 percent of the immune system would be used.”

Dr. Offit, regarding the paper she co-authored, "Addressing Parents’ Concerns: Do Multiple Vaccines Overwhelm or Weaken the Infant Immune System?"
posted by adipocere at 8:34 AM on September 17, 2009

Response by poster: Okay, my original question is getting in the way here, so apologies for that. Let me clarify:

I am exactly sure what they're testing, I just wrote virus instead of vaccine above because I'm stoopid like that.

We asked the questions yesterday, the person we spoke to didn't have immediate answers, which I'm okay with as it was late in the evening and she's probably the person responsible for getting candidates rather than the people doing the testing, etc. Still, we have to make a decision tomorrow. I'm expecting to have answers, but may not have asked the right questions. So I'm looking for additional info from anyone with similar experiences, insight into the process, all that good stuff the hive mind can provide.
posted by IanMorr at 8:35 AM on September 17, 2009

My child has participated in a clinical trials (not about vaccines) from birth and in our case, it was with a very large academic medical center. The Principal Investigator was identified and was easily researched. They were also extremely thorough in explaining what was being tested, what the potential side effects might be, what possible outcomes would be, and all of our options. They supplied lots of written documentation and were available for any questions we might have. Who is conducting your study?
posted by otherwordlyglow at 8:36 AM on September 17, 2009 [1 favorite]

Just because the person manning the phones couldn't answer your questions doesn't mean that the people running th study can't. Call them back during normal working hours and get put in touch with someone who knows what's going on.
posted by chrisamiller at 8:40 AM on September 17, 2009

There is no way you could possibly make a logical, well-researched decision by tomorrow, especially given the fact you aren't getting your questions answered promptly. Say no.
posted by LuckySeven~ at 9:42 AM on September 17, 2009

Hmm It all depends. My ex friend (big story) had to get super chemo for cancer when he was in high school (think there is another name for it) and at the time it was very very experimental. His parents decided to use it and he has been cancer free for the last 10 years.

So it all depends on what it is. How well monitored will the child be ? are they answering all the questions? Has your child ever been sick before? we cant answer those questions for you.
posted by majortom1981 at 9:54 AM on September 17, 2009

I bet the study authors are spending a lot of time answering questions right now! If you agree to the study and then withdraw before it actually begins because you are unhappy with the answers you are given to your questions you won't have lost anything.
posted by saucysault at 10:13 AM on September 17, 2009

Best answer: I was just researching the safety of the H1N1 vaccine for children online today because my pediatrician has chosen not to offer it. I took my son in for the seasonal flu vaccine and they stated that they are still concerned about the safety of the H1N1 vaccine for children. They also stated that many pediatricians in my area would not offer it. This surprised me as I have heard conflicting reports about the safety, but mostly that it would be safe and important for children to have.

Anyway, as I was looking around, I found this article which sounds exactly like what you might be looking into. Might give you a little more insight into the process, at least:

http://www.cnn.com/2009/HEALTH/08/20/h1n1.flu.kids.trial/
posted by fresh-rn at 10:42 AM on September 17, 2009

Response by poster: Thanks fresh-rn, that article has links to the study. It looked from there and has been confirmed by the study folks that my kid doesn't qualify. They had run out of vaccines before his second shot last year, so he didn't meet the prerequisites. Thanks for everyone's advice and opinions.
posted by IanMorr at 11:09 AM on September 17, 2009

I am not a pediatric research nurse, nor do I play one on TV, but my mom is one.

While allergic reactions are always a concern, trials like these are much more about effectiveness than safety. By the time they get to stick things in humans, there are enough regulations and checks in place to make sure they are as safe as can be. What trials like these are concerned with is risk/benefit analysis: if more people will get severely ill without vaccination, vs have a severe reaction from the shot.

What I can understand would cause concern is that the timeline for the H1N1 special "swine" flu virus has been compressed. However, I believe, it is not fundamentally any different from a regular seasonal flu vaccine.
posted by fontophilic at 11:27 AM on September 17, 2009 [1 favorite]

I'm just, in a purely selfish way, worried about it being my kid.

It's not selfish to be concerned about your child. As a parent it's your job. Certainly the people running this trial aren't related to your child.

I'm guessing it's not a trial in the traditional 'let's see what happens' sense.

Unfortunately, that is the definition of a trial. They want to 'see what happens'. Then they can write a scientific paper or a public health memoranda on it.

I'd never let any kid of mine, be a guinea pig in any way, shape or form, as long as there was even a smallish risk of something bad happening. Especially if my child was 13 months old...
posted by thermonuclear.jive.turkey at 12:14 PM on September 17, 2009

Let's put it this way: as part of this test, will they make you sign a waiver? if so, then the answer ought to be automatically 'no'.
posted by thermonuclear.jive.turkey at 12:15 PM on September 17, 2009

I would say no. Are the scientists testing it on their own kids?
posted by Solomon at 1:38 PM on September 17, 2009