The Dry Max Diaper and The Poop from Pampers: DiaperGate Continues

Oh boy. Well, really girl. As I wrote the other day we got a real SHE SAID-SHE SAID going on with the new Pampers Dry Max nee Cruisers diapers. Been waiting since my Pampers visit to unveil my findings until I felt comfortable having all the pertinent information.  For an overview of the diaper dilemna see my previous post.
Though all the finer details have not come my way yet (and I'll point out which ones) I'm forging ahead through this diaper data because at this point I already know more about disposable diapers - their construction, wondrous absorption powers, history, testing, packaging, marketing, etc, and of course, their black sheep relation, diaper rash - than I ever thought palatable. And because my friends and family are tiring of talk about sensitive skin, super absorbent gels, and chemical burns.

Then there's the matter of consumer advocate Jeremiah, who after sheathing himself in swatches of synthetic urine and actual poop-soaked diapers has announced results in the first phase of his own skin reaction test at ZRecommends. Guess what he found? Exactly the results he sought, a reddish spot, albeit a nearly invisible one, from the poopy Dry Max. Thankfully he had his 5-year old daughter nearby to confirm it. Sure to please and enrage the by now more than 11,000 fans of Pampers Bring Back the Old Cruisers/Swaddlers on Facebook.

Did I mention he left the poopy patch on for 8 hours? All in the name of science.

On the flip side Pampers has been passing out press interviews, advertising dollars and coupons while orchestrating Daddy Play Date in New York City along with other B-list celeb promotional events (hello, the Wayan brothers, really?).

Even hipster website Gawker stepped into the **it when Nolan Hamilton took a cynical shot at the spectacle over "receptacles for baby shit".

Dear Mr. Hamilton,
I haven't been "co-opted" by anyone and yes, I am a "strident 'mommy blogger'", why thank you, you must be reading this blog.
P.S. Between you and me, I am probably the most if not the only strident member of the Pampers mommy bloggers - having parented from nearly the beginning of the vaccine-autism scare, can you blame me?

In brief, it's time I start sharing the fruits of my Diaper Quest. It'll likely take several posts but I'll kick off DiaperGate with what I learned at Pampers, namely their research. I'll leave what I learned from the Facebook faction for another post along with other Pampers intrigue, the conflict between the two, and the far-reaching socio-cultural implications of this social media-mediated mess.

As for our diaper data, it's been provided by Pampers, much of it orally and later confirmed in email. Not my usual comfort zone, nothing like reading the actual means and analyses in standard APA-style, peer-reviewed and public. Rest assured, I'll poke and prod the numbers and methods as is my usual mode.

So let's start at ground zero in Cincinnati, Ohio home of P&G headquarters, Pampers, and more precisely the Baby Care Center, mecca of diaper enthusiasts. I spent the day at the Baby Center with 9 other Mommy Bloggers along with the Pampers team, an occasion at times reminiscent of a sorority field trip minus the vodka shots. The prior evening we bloggers met up briefly in the hotel lobby before being whisked off ( in an unremarkable van) to dinner at the home of Jodi Allen, the head of Pampers, North America.

The other bloggers, a somewhat diverse group of youngish moms who unlike myself do plenty of product reviews and giveaways for Pampers and other P&G brands as well as many other brands. And who unlike me had the diaper giant pay their travel and expenses and who all had children in diapers, though one preferred cloth diapers and many used a variety of brands. Quite a few worked outside the home in addition to running their blogs, several had graduate degrees, a few were fellow psychologist, one a microbiologist.

Though our dinner hosts had been friendly and the catered meal lovely, being dropped in the suburban backyard of someone I didn't know, in a town I didn't know, with an entire cast of strangers, on a mission to ferret out clues and evidence about baby bottoms, it all started to feel like bad reality tv. So the next morning when the Pampers team, including Allen, Lisa Sanchez, the head of R&D and several of her team, and Bryan McCleary, the "tone deaf" spokesman (the lone male of our Pampers hosts), started talking about the numbers and the testing I listened up, asked a lot, and took notes on a tour through the facility.

So how do they test the diapers?

In a variety of labs including a 3D imaging theater straight out of CSI with computer generated models of actual children that show where the diaper touches the skin, where the urine goes, where it touches the diaper, the skin, etc. Yes, we wore 3D glasses to view it, no popcorn though. But here I'll focus on the labs more pertinent to DiaperGate.

A playroom-like lab does in-house studies with local children testing a wide variety of diapering situations and outcomes (e.g., fit, leakage, urine placement, rash).  Kids come in for several hours, wear the diapers, play, nap, sit, run, eat, watch tv, pee and poop while technicians who surely must have the patience of twenty-five preschool teachers measure, poke, weigh, and take notes. Kerri Hailey, one of the R&D scientists, I believe a chemical engineer, figured they ran these in-house trials nearly every weekday from a pool of 7,000 local kids whose parents receive gift cards from local stores and yes, free diapers over the course of several hours in the lab. Before you guffaw, reimbursing participants for their time and effort, be they moms or college students, is standard.

As for the Dry Max, it's been tested every which way on local bottoms. To date there's been no sign in the Baby Center of unusually frequent or severe rashes nor complaints from the participants or their parents, at least none beyond the typical common rash according to Pamps. As they like to point out the medical literature shows about 20 to 25% of babies on average have diaper rash at any given point in time. My independent snooping found estimates in fact range from 10 to 35% and might even underestimate the prevalence as most of this research involves office visits and thus misses minor cases. It peaks between 6 to 12 months as babies start eating diverse foods.

No one knew off-hand how many kids wore the Dry Max at the Baby Center. Given the 5 or 6 kids there the morning we toured, and apparently it's busy most days, though it sometimes has tests running for other diapers or wipes, I think it's safe to assume at least a couple hundred probably did. Not many subjects, but still, a start. Probably not enough to pick up a slight problem, like a minor up-tick in rashes but maybe enough to notice a moderate increase. I would guess enough to notice babies in pain and angry red blisters soon after contact with the diaper as has been reported on Facebook. So it's difficult to understand how the in-house techs would have missed severe rashes let alone chemical burns that develop rapidly.

The mother lode of evidence from diaper-clad kiddies comes from testing outside the lab in the form of "diary studies" in homes across the U.S. and abroad. Parents get diapers from Pampers then monitor and record the subsequent diaper activity and sometime send used samples back to Pampers for further investigation. The R&D folks report over 40,000 children have tested Dry Max diapers since the beginning of 2009, more than 16,500 here in the U.S. They say they checked their data over and over, especially since the rash claims mounted and have never found any evidence of more or more severe rashes.

So how could Pamps have missed severe or frequent rashes? Let's look at a few potential loop-holes in the studies:

It's possible parents either consciously or unconsciously discounted the rashes. Could some parents be so eager to receive the free diapers that they overlook not only the monotony of recording bowel movements but some nasty rashes? I suppose someone could argue it, but really, do we believe a large percentage of parents would put free diapers over their child's welfare? Especially in the presences of repeated severe rashes. Should red welts and blisters appear along with the new shipment of nappies is it possible some parents might not attribute them to the diapers? Maybe some parents might not connect the diaper and the rash. But not likely very many would miss it, especially awful rashes.

I guess these are fair questions as most of the diary studies occur outside the U.S, perhaps a fair share in economically-depressed countries. But then again, we have 16, 500 U.S. participants, that's a huge subject pool by any measure. Enough to pick up even a minor up-tick for sure. It would be difficult to miss severe rashes in that mass.

Open-ended questions, a question asking specifically about diaper rash, whatever, I would think these kind of numbers would get at even a minor reaction occurring among thousands of participants. So maybe Pampers didn't collect enough data from enough of these 40,000 babies. It's worth asking how many families submitted detailed reports. The number was repeatedly reported as test subjects, the majority in diary studies. Okay, so 40,000 got some free diapers. But how many completed and mailed back the reports? Don't know, waiting to learn. But even if it's half, that's still a lot of butts.

(FYI: Pamps also reports having sold about 2.8 billion Dry Max diapers since August 2008 - so the babies wearing them serve in some way as indirect "evidence" too, but I'll save that discussion about customer complaints, etc. for another day - we're just talking specific product testing here.)

Now let's say Pamps has done all this research properly. Assume they asked good, thorough questions about rashes and skin conditions, the parents kept detailed records for a decent period of time, and plenty sent the reports back. Let's also assume parents weren't motivated to dismiss red butts for free diapers. How could Pampers have missed the rash of rashes?

Well, there's another good explanation. Sensitive skin. Extra sensitive skin. Babies with allergies, eczema, with family histories of allergies, asthma, and the like. I'm not completely convinced at this point that Pampers sufficiently addressed the issue. Of course I asked repeatedly three different ways if they collected information about allergies, eczema, sensitive skin, medical histories, family medical histories, and was told yes, they did. But I don't know exactly how. I don't know how thorough the questions were, don't know if it was checklist that specifically asked about each of these.

The R&D team said they ran these analyses before and after the controversy began and could never find a link between sensitive skin/allergies/eczema and more rashes. I'm almost positive the sensitive skins questions were all self-reported from parents, meaning, not verified by a medical professional. At one point it was mentioned that over 40% of parents say their child has sensitive skin. Obviously, that's a problem but completely understandable considering the soft velvety skin we love so much is more delicate than ours. So I'm hoping Pamps compensated for this sensitive skin bias by asking more specific questions (e.g., about family histories, eczema). But I don't know yet.

Pampers also runs clinical safety trials in another lab to test the safety of the products used in the diapers themselves and the manufacturing process, which by the way, is half secret, proprietary interest, you know. The safety trial scientists made a point of stating they operate separate from the R&D crowd in order to prevent conflict of interests.

Apparently the Pamps skin safety patch test soon will be written up in an academic journal. According to one of the chemists the test is becoming an industry standard. It involves an adult subject wearing a behind-the-knee dry, saliva-, water-, or synthetic urine-soaked patch for 23 1/2 hours a day for 14 days straight. Yeah, imagine sleeping or worse yet, eating next to that. So after all that fun an expert skin grader checks out the results under a magnifying glass. This has been conducted with the Dry Max both in the lab and by an outside lab, both finding no indication of harm. The lab often uses subjects who report having sensitive skin. Again, I don't know the specificity of questions, medical verification, etc.

Now the safety trials never use patches with poop. Why not? The enzymes in poop interfere with the results. Blame bowel movements for the poor conditions inside diapers. They're the number one enemy of baby bottoms. So you can't assess the safety of the other ingredients with the BM interfering with the results. Poop interference plays out in the other tests, but not the safety lab. So the safety lab figures more in the hypothesis that Dry Max is causing chemical burns rather than diaper rash.

Speaking of poop and patches, Pampers advised Jeremiah over at ZRecommends on how to conduct his own skin test. According to Sanchez, head of R&D, she told Jeremiah he really needed to use BM to get a rash. Told him he wouldn't get much of a rash with pee, synthetic or otherwise. Apparently and for understandable reasons he was only going to use synthetic urine but she advised he go for it with real baby poop, which ultimately he did.

So all this by itself could not and does not satisfactorily answers our burning questions, but it is something and Pampers says this is the most-tested diaper since disposable diapers were invented. My biggest concern is skin sensitivity - did Pampers adequately identify babies prone to sensitive skin? Maybe they did, I'm still trying to find out.  And if they didn't? Means it'll be harder to refute claims that the Dry Max is causing rashes in sensitive babies.  It does not mean there's a link between skin sensitivity and rashes.  It's possible they didn't accurately access sensitivity and that there's a link to rashes, sure.  It's also possible they didn't assess it well and there is no link.  Let's not get over-excited. 

I haven't picked up much on sensitive skin references from parental rash reports on Facebook. If anything it seems parents first explain their child never had any previous problems with Pampers or any other diapers.

Of course a sturdy double-blind study could address the sensitive skin issue. But that would be challenging under the best of circumstances without looming lawsuits and governmental investigations. Hypothetically speaking, we'd like to find lots of babies with medically-verified sensitive skin and of course a control group. Half would wear the Dry Max, half another diaper (or maybe we'd include a variety of diapers if we could find enough babies with eczema!) then were monitored and if a rash developed, assessed immediately by a pediatric dermatologist. Quite difficult to carry out for a variety of ethical, methodological and logistical reasons.

Honestly, if you had a baby with food allergies or bad eczema, would you be willing to participate in a diaper study? My son looked like a burn victim at times, open wounds, infections, ugghhh. No way I'd sign him up for product testing.
Hey, moms and dads, we got this great new diaper* we 're so proud of...we created it for parents just like you who want the best for...because babies aren't our business, they're the future.
*we're really don't want to but we gotta tell you the diaper may cause (or simply coincide with) severe rash, blisters, burns, allergic reactions, dizziness, dehydration, impaired motor development...

Uh, no, thanks.

This is not the bottom line. Next post (or posts) I'll examine more, including the timeline of DiaperGate, the perspective from Facebook and my email conversations with Lisa Stone, an administrator of Please Bring Back the Old Cruisers/Swaddlers.

Also, I'll look at Pampers response to the complaints and the controversy (i.e. their follow-up analyses, the Mommy Bloggers Day, their hotline, etc.) - and several other possible explanations for the rash of rashes and several reasons why it might not be a rash of rashes.

If you'll excuse me, this momma is pooped tonight...


TherExtras said...

Worth the wait. You did not disappoint me, Polly.

Would I be correct in re-stating - Pampers offered a less-than-adequate operational definition of 'sensitive skin'? That seems to be the most-emphasized weakness in studies where most everything was explained.

Way to go - pub on Gawker, too!

Sarah in deepest, darkest Lomellina said...

It's been more than half a decade since I changed a nappy, but just wanted to leave a note to say how glad I am to have found your blog.

Ben Goldacre and the Quackometer got me back on track when I got all confused during the MMR debacle and have been very useful for a range of topics that crop up when you are a mum.

However you are the first writer I have found who focuses exclusively on demystifying studies that are strongly focused on the parenting arena, allowing us non-scientists to cast a critical eye (in the name of informed choices) rather just swallowing "this study says XYZ" whole.

I’m dead chuffed I’ve found you ( :

Polly Palumbo, Ph.D. said...

Barbara, you are correct!Spoken like a true researcher. Again, they might have but I'm not confident it was done in larger studies up to our standards! But like I said, doesn't mean we should keep the sensitive hypothesis, only that we may not be able to confidently reject it, er, nullify it.

Polly Palumbo, Ph.D. said...

Sarah, welcome and man thanks for reminding me why I keep at this blog thing (and don't accept ads or product reviews). Dead chuffed! Execellent, I think...where the heck is deepest, darkest Lomellina?

Sarah in deepest, darkest Lomellina said...

Lomellina is just south of Milan in Northern Italy.

If you ever wonder why you keep banging away at the blog remember that people like me, who once fell for hyperbole and woo, rely on you lot to keep banging the drum so people don't get ripped off, messed around, taken for a ride and whipped up into a frenzy to keep the mummy wars going at full tilt.

We can redeem ourselves, or not fall at all in the first place if blogs like yours get the higher profile they deserve in the mainstream media, if somebody shines a light to help us work out what is information and what is infomercial, be it a product or a philosophy they are selling.

La Mama Loca said...

I'm looking forward to the rest of your posts on this subject, it is nice to see a more objective view.

TherExtras said...

Came over to give you this site:

Not what you think. Barbara

Cheryl said...

Speaking as a mom of kids with eczema, both who we diagnosed with the condition as infants, I can safely say that no, I would NOT volunteer my children to test out new diapers.

As a parent and a consumer, I'm appalled at how P&G is handling the PR on this. I've had children in diapers, continuously, for 13 years. Until my 6 month old was born last winter, I was a loyal Pampers user. My youngest son was in Pampers Swaddlers from birth to 3 months old, and he had rashes more often than not, including the occasional blistery patch that in my experience wasn't "normal diaper rash" (I have 4 previous kids worth of experience to base that off of), and we were changing him as soon as he'd stool or wet. Switching diaper brands made the rashes go away, except for the time we tried Luvs. We haven't used Pampers in 3 months, and he hasn't had a rash since. My empirical data tells me that DryMax is not good for my specific child, no matter how much P&G crows that it's safe. My 4 older kids had no problems with previous iterations of Pampers Cruisers/Swaddlers/Premium.

Polly Palumbo, Ph.D. said...

Hi La Mama, thanks for reading. Will post more next week.

Hi Cheryl, thanks for posting your experience. I agree that Pamper's initial response was not sincere or concerned enough - and that's a separate issue from what's going on with the diapers. Even if the diapers are exonerated Pampers will likely loose some parents for the duration. I'm curious - what would you have wanted to hear from them? They've put out quite a bit of information. Is there anything that would change your mind? Do you think the diapers are causing more diaper rashes than usual?

Cheryl said...

What I would have just liked a more sincere and concerned response other than "all babies get diaper rash" and "oh, you must be doing something wrong".

I do think that the diapers are causing more rashes than usual, but I don't think it's due to anything sinister on P&G's part. Based on the information that P&G has released on how the diaper has changed, I think that some babies are getting contact dermatitis (which can look like chemical burns) from the increased exposure to some of the diaper materials that were previously separated from the skin more by the wood pulp and the mesh liners that were removed from the diapers. It may just be a fluke that none of the babies that tested the prototype diapers are sensitive/allergic to these materials.

Polly Palumbo, Ph.D. said...

Yes, I forgot the "you're doing something wrong" tone, thanks for the reminder. Contact dermatitis is a good guess. The saga continues...