Thursday, July 08, 2010

The Skinny on Sensitive Skin and Pampers Dry Max: Debunking the Diaper Debate

When we last left DiaperGate, I was pondering baby skin. Could the Pampers Dry Max be causing babies with sensitive skin more rashes or more severe rashes than usual? As I see it, it's the one potential sore spot for Pampers and the denounced Diaper formerly known as Cruisers. The one that might keep this hot potato in their lap for a little longer. That and a couple lawsuits.

So I was glad to get some fresh scoop from the R&D team at Pampers about their skin testing. As my son's temp topped 104.5, the heat index nearly the same, I spared a few minutes to field a call from Leslie Hopkins and Kerri Hailey who'd just emailed some answers.

My chief concern?

The questions parents answered about skin sensitivity.

I wanted to know if Pampers collected enough good information about skin sensitivity (e.g., history of eczema, allergy, rashes, etc) to close this loophole. By the way, I don't know of a link between reports of rashes on Facebook (or complaints at The Consumer Product Safety Commission) and children with sensitive skin. I've focused on skin sensitivity because to my mind it's one possible explanation for our rash puzzle. Pampers has not found any indication of unusually frequent or severe rashes in their quite extensive testing. So the diapers look fine when we look at the general population. However there may be a small subset or subsets of children who may be at higher risk for these rashes - who not being properly identified may fall through the proverbial statistical cracks. They could explain the gap between the Pampers data and the plethora of rashes reported on Facebook's Pampers Bring Back the Old Cruisers page. Thus, the fuss about sensitive skin.

Here's the deal. When I was at the Baby Center, Leslie Hopkins mentioned 40% of parents say their children have sensitive skin. Obviously baby skin is soft and more vulnerable than the typical sun-baked epidermus on the rest of us but by definition, nearly half of all babies cannot have sensitive skin. At least not compared to other babies. Yet in their product testing Pampers routinely finds almost half of parents say their kid's got skin issues, the Dry Max tests no different. The standard does-your-kid-got-bad- skin question is not a great measure of actual sensitivity so it's not surprising no link has turned up between bad skin and rashes. It was, as Dr. Boucher summed up, a less than great "operationalization" of skin sensitivity.

Now I learned in my phone conversation that Pamps does sometimes ask parents to rate the degree of skin sensitivity - extremely, very, somewhat, slightly, or not at all - a standard 5-point scale, nice. Sometimes but not usually. When they and their outside experts looked at the data for the Dry Max versus the earlier Cruiser, they found no correlation between these more narrow and thus more sensitive skin sensitivity measures and rashes or irritation. (By the way, they did ask specific questions about rashes and skin irritations in addition to the more open-ended "anything else you'd like to tell us" ones. They also used expert "skin graders" to assess any reactions in a study including 90 babies.)

Remember, I haven't seen the actual data, graphs, figures, etc. The Pamps legal team and pending litigation stood between us and all those goodies. So we must make do with what we got. That said it appears the diaper experts have taken sound methodological steps to getting at skin stuff. Yes I would have liked a more frequent use of the more narrow skin question but when they have nothing's turned up. Sure, it's parent-reported skin sensitivity but it is something and I bet it's as good as it ever gets in child product testing. As I pointed out in my last post, it would have been better to have medical verification of bad skin but in reality it would have been difficult and odd (why would they?) if not unethical.

Imagine asking parents who've battled their infant's eczema, allergies and assorted rashes to participate in a diaper study. I had one of those babies and it required round-the-clock lathering just to keep him from tearing his eyeballs out. Not enough free diapers in the world. Daily record-keeping? Trying to get my doc to write a note to deliver to Pampers? I don't think so.

Let's say someone could convince parents of skin-challenged babies to do such a thing - would it be ethical? Possibly before the allegations began but at this point, it seems unethical. Gee, we're trying to rule out the possibility, however unlikely and we do think it is highly unlikely, that our new diapers are making some kids have the worst rashes of their young lives.

There's no reason to expect Pamps would have asked for a doc's diagnosis of bad skin (well, allergic contact dermatitis, eczema, etc.) before the brouhaha or that they would have had niggling concerns about skin sensitivity. They'd never had any skin issues in the past. Their sensitivity measures appeared adequate. It might serve them well to add it to future product testing but prior to the Dry Max, there wasn't a need. It wasn't like they didn't ask about sensitivity. Could they have been concerned and chosen not to pursue it? Anything's possible. If they did have any prior questions about skin sensitivity it would have been unethical to use babies to figure it out. Remember, the skin patch tests have been done repeatedly with adults who have sensitive skin. Given previous testing with Dry Max and Cruisers, all with the same ingredients mind you - including clinical trials on adults with sensitive skin and diaper studies and in-house studies with babies including those with sensitive skin, I wouldn't have thought much about a tighter measure.

So where are we in this skin saga?

Obviously I'd love to see results from a randomized, double-blind clinical trial using babies with medically-verified skin conditions assessed by expert skin graders. Ideally we'd have a good portion of children representing a variety of skin conditions (e.g., eczema, allergies) to examine the possibility one of these groups may be more susceptible to Dry Max rashes. But it's not gonna happen for reasons we just discussed.

The lack of a definitive gold-standard study does not prove anything except a bugger for Pampers who will never be able to hold up this hypothetical study as superb evidence the Dry Max is not adversely affecting more sensitive babies. It does not mean Pampers was negligent, unethical, hiding fears of fair-skinned bottoms or that their diapers must be harming babies with bad skin. The evidence they do have from sensitive skinned babies and adults while strong cannot ultimately rule out the scenario, albeit quite an unlikely one, the diaper gives a certain portion of children with skin issues, say the ones with family histories of food allergies or eczema, even more skin issues.

Obviously in the unlikely chance the diapers carry risks of severe diaper rashes to some small portion of kids, we should talk more about what we expect from Pampers. I bet, though, we'll will never have that kind of evidence - because it is logistically, methodologically and ethically nigh on impossible to procure now. The Consumer Products Safety Commission has one heck of a challenge. I'm afraid we'll be left with lingering concerns because definitive proof of no link ("disproving a link" in lay terms)between Dry Max and rashes remains elusive. Not to say there isn't a wealth of information from Pampers, remember it's good and to my mind convincing but not the slam dunk. It's the typical real-world research dilemna - we simply can't conduct the kinds of studies that provide definitive answers. Thus we rely on the ones we do have in conjunction with other types of evidence. Here, we're not totally helpless. We got the Pampers data and other pieces of evidence too to solve the puzzle - the level of complaints, the timeline for the Facebook fan page, the sheer number of Dry Max diapers out there.

Granted I don't have access to the babies with rashes on Facebook, so I've not seen that evidence or much from those parents. I've seen accounts from medical professional-parents about their own children's rashes, but like Pampers, I've not been able to speak with any professionals who've assessed some of the children with the reported rashes. Surely it's a daunting task for the CPSC to gather evidence from pediatricians who've seen these babies.

But back to methodological heaven. Say we do have that definitive study, the randomized double-blind one that answers all our empirical questions about Dry Max. It finds bad skin babes do have more rashes with the Dry Max. Say a lot more rashes, how about 5 times more annually. How many of you think a recall warranted? A lawsuit? An apology or refund? What if it's only 1 more rash per year. Half a rash? Then there's the possibility it's not giving individual babies any more frequent rashes but creating rashes in more babies than average. It's not clear to me where the line is for legal action, recall, better labeling, apology, etc.

It's not much easier to think of recourses with more severe rashes, providing there is some medical differentiation between mild and severe rashes (what say you, my pediatric friends?). Even with a good objective measure of diaper rash severity, we still must decide how bad it has to be to recall the nappies or to award damages. Chemical burns aside, of course. Sensitive skin is a good example, but many issues would be similiar if we identified a different subset susceptible to the rash.

You see where I'm going. Beyond the data to murkier parts....

As far as I know we don't expect companies that produce baby products to ensure all babies can use them, even those with sensitive skin, though there are probably financial incentives to casting a wide net. We do expect products to be safe, but is more frequent diaper rash a matter of safety? More severe rashes are easier to see as a safety issue but even then they're not considered a serious health conditions (again, my pediatric readers, correct me if I'm misinformed).

Having at least one child with problem skin, medically verified even, I can attest to his poor reaction to any number of products so clearly I know he can't use nor do I expect him to be able to use everything on the shelf from shampoos, sunscreens and soaps to polyester pajamas, chlorinated pools and citrus fruits. One of my girls seemed to get rashes with Huggies, the other, Pampers. I never thought much about it.

It's fair to ask how diaper rash stacks up to other childhood health issues adversely affecting a subset of children. It shares some striking similarities and differences to allergens and choking hazards, for instance. How about peanuts that qualify as both? True, unlike nuts we haven't considered the diaper to have any potential harmful side effects thus far. Parents buy it without a thought to its potential health dangers but again, the threat we're talking about is diaper rash, both common and clearly linked to diapers. Any ideas for other child health threat it resembles?

These are all fair questions beyond the rigors of the product testing. We can't look to the data for answers here, they're deeper socio-cultural public health issues. The ultimate question of diaper safety has nothing to do with how you or I feel about Pampers PR or their initially tone deaf response. Nothing to do with how they've recruited mommy bloggers or put out more coupons. It's easy to forget.

But how we respond to the pool of data from Pampers, Facebook, and the CPSC, that's another question. Where should we should draw the line on diapers? At what point do they cross over from a modern convenience and hygienic aid to a nuisance for some sensitive babies to a public health hazard? I may be obsessed with diapers right now but we all know it will be some other health threat looming soon.

So again, how do we deal with it?

10 comments:

Cheryl said...

I've got kiddos with eczema too (4 of my 5 actually) and while I don't expect my kids to be able to use everything safely, it would really make me mad if a product my children had previously used safely was no longer safe to use and the company that made that product neglected to notify consumers of that change (like Pampers did by putting DryMax cruisers in old packaging).

A couple of my kids have food allergies, and at least with foods, there are labels with ingredients that I can reference. This kind of information isn't readily available to consumers for diapers. I have access to ingredient labels for my kids medications, lotions, sunscreens, soaps and shampoos, but not the diapers.

TherExtras said...

What do you mean 'we'? *wink*

'We' cannot help Pampers - it has gone legal and there it is.

'We', however, can tell parents (as you just have) that good-enough product testing went into these diapers to put them on the market.

'We' can express our opinions that a small percentage of babies with sensitive skin may experience more rashes with this product based on the information provided by the company and your uncompensated visit with them.

'We' can express our opinions that this circumstance does not meet 'our' definition of a public health hazard.

I don't think 'we' can do any more.
Barbara
Dr. Boucher

Polly Palumbo, Ph.D. said...

Cheryl,

Yes I'm annoyed when products changes are made too, especially in cases where I no longer can or want to use them, absolutely.

Echoing your comments, many of the other mommy bloggers who visited Pampers agreed the company should have informed consumers about the Dry Max change and some even suggested that Pampers should list the ingredients on the box. I'm not sure an ingredient listing would have mattered as much here (bc the ingredients apparently are all the same) as a Dry Max label on the box - indicating there was something different with the diapers. I still am surprised they put Cruisers with Dry Max in boxes without any notice. So of course now I wonder what else has been changed in other packages and products...

emilyhall said...

hello--I just found your site (while searching for "environmental working group" and "special interest") and wanted to say thank you. This is just what I was looking for.

Polly Palumbo, Ph.D. said...

Barbara, "we" feel much better using the collective term - imparts a sense of solidarity helpful in making declarations and observations, etc...wishful thinking that it's more than me that agrees with them - or maybe it's just lazy!

Polly Palumbo, Ph.D. said...

Welcome, Emily. You looking for the low-down on diapers or were you searching for something else?? The Environmental Working Group, the peeps behind many iffy studies and conclusions? Gotta love you found a site like this after searching on that!

emilyhall said...

I was looking for reasons to ignore that sunscreen study that everyone keeps referring me to. My son has eczema, so I'm kind of limited in what I can use anyway, and vague studies like the EWG's just infuriate me.

Anyway--came searching to confirm my bias and stayed for the Pampers posts. Who knew that statistics and scientific-study literacy were necessary skills for parenting? I'm glad you're here--I have neither.

La Mama Loca said...

Diaper manufacturers are constantly making small changes to the diapers without big advertising campaigns or different labeling. Part of this has to do with practical issues -- it takes time to switch factories over to using the new material or design, and so they are changed over one-by-one. Pampers isn't the only one to do it, Huggies has made some dramatic changes to their lower end diaper (now Snug & Dry) with little to no change to the packaging. It is just what is done. I don't think that Pampers could have guessed that Dry Max was a big enough change to justify special treatment.

Polly Palumbo, Ph.D. said...

Yes, Emily, thanks for pointing out the scare du jour sunscreen study is quite iffy - I was going to post something on it but got obsessed with diapers! Maybe next week. But please let me know if you read anything good on it.

Hey La Mama! That's how Pampers explained it too though I still find it hard to understand how the switch over is so fraught with difficulty, peril, strain, etc. And really, why not just slap new labels on the boxes? Have we not come far in our box-manufacturing? Seems like if you're churning out new diapers a new label is minimal.

TherExtras said...

And I was thinking 'we' was just you and me!

Barbara

("What do you mean 'we'" is the start of a punch line of an old joke. Probably before your time.)