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?