Sunblock Blockers

The red-haired, fair-skinned Amy Alkon, who calls herself "perhaps the whitest person in Los Angeles," complains that the most effective sunblock cream, containing Mexoryl, is still not legally available in the U.S. because the FDA considers it a drug, whereas European regulators treat it as a cosmetic. The stuff has been available in Europe and elsewhere since 1993, but the FDA has been dragging its feet so long that L'Oreal, the cream's manufacturer, had to seek an extension of its patent. Alkon reports that the product's worst side effect is "skin inflammation and an itchy rash," reported in a tiny percentage of users and quite tolerable, you'd think, compared to the risk of skin cancer.

Comments

[mediageek]

In other news, the FDA has been found to cause cancer.

[Jennifer]

I read something about this awhile ago. As another redhead prone to sunburn, I'd gladly buy this. And if I get skin inflammation and an itchy rash from it, I am perfectly capable of figuring out that this product is obviously not right for me, and discontinuing its use.

[Jennifer]

Another thing: a couple of years ago I discovered, quite by accident, that I can't use Cascade brand dishwasher powder, because whenever I handled dishes washed in Cascade the skin on my hands broke out in an itchy rash. So I stopped using it and switched brands. Oh, if only the FDA had protected me from two days of mild hand irritation and the waste of the three bucks I spent on that soap!

[downstater (complete with eye]

how long ago was this obviously painful and distressing cascade incident?

was this dishwasher at your own home or at someone else's or at your place of employment?

[Number 6]

Fyodor- I've always been ok with SPF 30+ stuff, and I'm a redhead who more or less does a Dracula and busts into flames when the sun comes out. Still, if there's something better, I'd like to have the chance to use it.

[Jennifer]

It was at my house, Downstater. I was going to sue Cascade for millions and millions of dollars, but I was afraid that being nationally known as "the itchy hands lady" would result in even more emotional distress.

Well, that plus I have enough common sense and common decency to understand that a day or two of mild annoyance and the loss of three bucks is not sufficient justification for suing a business.

[David]

We all know full well that an FDA expert must consider the moral implications of a product as well as its safety and efficacy. We can't have our beaches inundated with pale girls showing off more skin because science made it safer to do so. That would lead to increased pre-marital sex and worse.

[Bee]

I'll bet you can buy it online, Jennifer. I still buy my favorite European brands online, and I've never had trouble with getting anything shipped to the US.

What could be the holdup with this product? Or is this about average for the FDA? The article didn't go into that, but I'd be curious, if anyone has more info on that.

[Jennifer]

Bee, as a New Englander I can get by with weaker American sunblock more easily than could an Angeleno. But it's a matter of principle.

[downstater]

i realize the construction of the last sentence of my post was all messed-up-like.

i will not be posting any more corrections to any grammatical or spelling errors, as i believe you all know what i meant and as i am not turning in these posts for a grade.

[Jennifer]

The more I think about it, the more this irritates me. "Skin inflammation and an itchy rash?" I could maybe see keeping this stuff off the market if it was resulting in death, or the skin peeling right off or some equally severe, long-term effect, but the FDA is now keeping things out of American's hands because it makes a couple of people itch?

[mediageek]

"I still buy my favorite European brands online, and I've never had trouble with getting anything shipped to the US."

So how's that Absinthe?

[Bee]

Jennifer, I hear ya on the principle thing. But I have seen a photo of you and hoo, is your hair red! I don't care *where* you live, you be careful! My sister has lovely deep red hair, and she is melanoma central, unfortunately. We joke about knowing how she's gonna go, someday, but really, it isn't funny.

And Number 6 has it right on the head - why shouldn't he be allowed to give this product a try if he feels like it? It has been in use for many years elsewhere.....I just can't see what the political gain/loss is for a danm sunscreen? Would its approval here put Proctor and Gamble out of countenance? Does someone well-placed dislike L'Oreal?

[bubba]

We don't need any products that encourage pasty women to expose their skin. Should we add this to the libertarian litmus test? I'm a libertarian, unless it means more nekkid pasty women. 🙂

[Jennifer]

Bee, I haven't had a tan line since I was thirteen. I expect to live a long, healthy life, and when reporters interview me on my one hundredth birthday I'll tell them I owe my longevity to the scrupulous avoidance of sunlight and children.

[SixSigma]

downstarter -

I don't know this to be true, but I think the argument goes like this:

The reason why drugs are available OTC, like antibiotics, in countries with socialized medicine is because it's less expensive in the long run to give people easier access to more effective drugs than forcing that person to see a doctor every time the need for that drug arises.

Better for the government to spend $30 on medicine, than $30 + a doctor's visit.

[Bee]

So how's that Absinthe?

In fact, I do have a bottle. I have a childish love of brightly-colored food and drink.

[Jacob Sullum]

Fyodor, according to the Washington Post article (second link), the products available in the U.S. are not very effective at blocking UVA light, which contributes to wrinkling and skin cancer but (unlike UVB light) does not cause tanning or burning. Mexoryl, which "protects against even the longest-wavelength UVA light and can block 75 percent to 90 percent of that light, is widely deemed more effective than any anti-UVA drug available in the United States."

[downstater]

Does someone well-placed dislike L'Oreal?

well, it is french y'know. and of course anything at all related to france must be inferior, or cowardly - yeah that's it - cowardly!

in all seriousness, it wouldn't surprise me at all if some domestic lobby were trying to restict their entrance into the market.

[Scott]

The FDA has only two missions under the Bush administration. One is to make sure that anything that might upset the fundie pro-lifers never makes it to market. The other is to make sure that any product that might reduce sales of products associated with friendly lobbyists never make it to market. Anyway, L'oreal sounds too French for the good people of the United States, using French sunblock is the same as supporting the terrorists.

[Jennifer]

Hmm. According to Jacob's post, maybe I should invest in that fancy European stuff after all.

[Eric the .5b]

Comment by: Bee

I just want to say you're twice the fellow I am.

[Eric the .5b]

The FDA has only two missions under the Bush administration.

And yet they've been stalling since the beginning of the Clinton administration.

[fyodor]

FUCK!!! The sunscreens I use always say they work on both types of UV light, but I've often wondered if the SPF applies to both or only to the cosmetic one. Now that I think of it, I may have heard once that it only applies to the UVB light. So maybe they hardly block any UVA light at all??? This is really fucked and stupid. So, anyone know where to get this stuff online? I'll start to research it myself....

[Scott]

Hasn't the shelf life on the "Clinton did it too" defense expired? If not, it should have.

[Captain Holly]

And yet they've been stalling since the beginning of the Clinton administration.

More evidence of the size and scope of the Vast Right-Wing Conspiracy!

[Pro Libertate]

Are you telling me that my miracle sunscreen, Bullfrog, is not protecting me as well as it might because of the federal government? And why shouldn't I be a libertarian again?

Jesus, I'm going to look ninety by the time I'm fifty, I guess. Being almost entirely of Scottish and German extraction and living in Florida is a dangerous combination. Especially when your brother insists on taking you grouper fishing in the hot, hot sun.

[Eric the .5b]

Hasn't the shelf life on the "Clinton did it too" defense expired?

Pointing out when someone trying to pin an issue on one party is talking out of his hat never expires.

Never. Sorry.

[v]

From cosmeticscop.com, the website of consumer advocate Paula Begoun:

"To be effective, sunscreens must protect skin from both the sun?s UVA and UVB radiation. In the United States, there are only three ingredients that are approved by the FDA that protect across the full UVA range: titanium dioxide, zinc oxide, and avobenzone (also called Parsol 1789 and butyl methoxydibenzoylmethane). Outside of the United States, Mexoryl SX is also used....

The SPF (sun protection factor) number on sunscreens relates only to a product?s efficacy against UVB exposure. There is no rating system for UVA protection. The only way to tell if a product can protect skin from UVA radiation is to note that at least one of the ingredients mentioned above is listed among the active ingredients on the label. Because UVA protection is so important, all sunscreen products must contain one or more UVA-protecting ingredients."

[v]

There is more info about sun protection, UVA v. UVB rays, etc., at the Cosmetics Cop site. You can find the link on the main page. It's in the bottom left menu under 'Learn/Sun Essentials.'

Begoun refers to UVA rays as "the sun's silent killers' because thoug they do not burn, they contribute the most to sun damage.

[Don Mynack]

This place seems to sell Mexoryl-based sunscreens in the U.S.

http://store.yahoo.com/skincarelab/suncare2.html

Seem a bit pricey, though.

[NoStar]

"We don't need any products that encourage pasty women to expose their skin. Should we add this to the libertarian litmus test? I'm a libertarian, unless it means more nekkid pasty women. :)"

Bubba,
Not even if she's all lathered and soaped up in the shower? You may be libertarian, but your credentials as a red blooded amer'cun are now suspect.

[Dave W.]

Time to look at people's economic motivations:

The patent term extension is in L'orleal's economic interst, but they only get this extension to the extent that things go slow in the FDA. In effect, L'oreal chooses the timing of its patent term. Ignoring the pre-approval portion of the patent term (which is meaningless anyway), L'oreal's choice is: a patent term from (roughly) '93 to 2010, or, alternatively, a patent term from (again, approximating) 2007 to 2024.

If L'Oreal would prefer the 2007 to 2024 term (I know I would, if I were a big company), then the only way to achieve this is to hope things are somehow delayed in the FDA.

Now it turns out that things are indeed delayed in the FDA. L'Oreal hasn't come out and said it is them doing the delay, so we jump to the conclusion that the delay must be the FDA's fault. However, by carefully considering about L'Oreal's economic motivations, it begins to seem likely that L'Oreal could be the responsible party.

I reserve judgement until we know how much delay L'Oreal is causing (which we probably never will).

It might be a good idea to re-write the patent law to more carefully scrutinize whether a dealay (triggering an extension) really, really is the fault of the FDA or the applicant (acting strategically). Such a fix would be a bit less disruptive of public expectations than disbanding the FDA.

Abolishing the food / drug / cosmetic distinction would also help make the system more rational from a risk avoidance standpoint, but that wouldn't "help" L'Oreal shorten its delay in this case neccessarily. Sunblock ain't cosmetic. It is used medicinely, and over exceptionally large areas of the body, to prevent skin cancer. It has more reason to be scrutinized than any other cosmetics, regardless of what (presumably stupid) roolz say.

[nmg]

It might be a good idea to re-write the patent law to more carefully scrutinize whether a dealay ... really is the fault of the FDA or the applicant (acting strategically). Such a fix would be a bit less disruptive of public expectations than disbanding the FDA.

or.. we could just get rid of the FDA

nmg

[Dave W.]

1. Let me be clear: even though I am saying that Mexoryl should be scrutized more than other, more typical cosmetics does not mean that it should take 16 plus years to check out. Maybe this 16 years is the FDA's fault. Maybe it is someone else's. In either case, it is excessive (unless there real problems, which doesn't seem to be the case here).

2. Sorry about all the spelling mistakes in the previous posts. I am not a stickler for spelling in this kind of informal writing, but that last post was downright hard to follow. Sorry about that.

[Dave W.]

nmg:

yes and let the public start using untested drugs with impunity until enuf of the fools end up dead, diseased or maimed such that they get more cautious as a groop like they should have been in the first place and like Ayn Rand would have us be.

Nope. don't like that outcome at all. Try 'gain.

[DB_Cooper_NZ]

Try buying some pepcid (not available, despite widespread use everywhere else in the EU) or hemorrhoid suppositories (OTC), with or without a prescription, in Denmark, then complain about US regulations. Smart people, pathological addiction to prohibatory government.

Anyway, sorry for the whinge that probably distracted this topic, but government obstruction of medical markets is very much annoying this scientist at the moment.

[Lowdog]

Dave - what about an underwriters' lab for drug and food testing, like they do for electronic devices? That's a nice, private regulatory system that seems to work quite well.

But I actually like your idea, too. 😉

[Dave W.]

Dave - what about an underwriters' lab for drug and food testing, like they do for electronic devices? That's a nice, private regulatory system that seems to work quite well.

I am open to evolving into a private FDA, where consumer expectations are transitioned gradually from public to private oversight. As long as there is tort liability, I think is ultimately what keeps'em honest (as anything could) on safety.

Maybe the answer is to disband the FDA, while expanding tort liability. For example, imagine that the law said: you can forego FDA testing at your option, but you will have the burden of showing safety and efficacy of your drug in any tort suits sold prior to FDA approval. (I have a feeling I know which option would be the path most taken!).

What really scares me is when the FDA disbanders also want to eliminate tort liability through things like Cheeseburger Bill. There's your real recipe for ruin, your prescription for pestilence, your something-cosmetic-related for something-doom related-that-alliterates-with-the-cosmetic-related-thing!

[B.P.]

Quasi threadjack -- So we need a Cheeseburger Bill to make up for the lack of a lengthy vetting/approval process of fatty food by an oversight body? I'd say the effects of a cheeseburger are a bit less mysterious than the effects of a drug.

[Tim Cavanaugh]

I've got a one-year-old redhead who gets a sunburn if she sleeps with the night light on. This ain't no funny business: They should let this Mexoryl stuff sell proudly from sea to shining sea.

[Jennifer]

Tim, if your child is getting sunburns in San Francisco, then I hope for his or her sake this stuff becomes available before you and your family ever move to some sunnier clime.

[Jennifer]

Ah. I see Tim's child is a "she." That's what I get for skimming.

[Dave W.]

BP:

I am saying that getting rid of food and drug related tort liability can be bad yes.

Some of the suits blocked by Cheeseburger Bill should be blocked. Other suits blocked by Cheeseburger Bill shouldn't be blocked. That is why Cheeseburger Bill is bad. Because the good it does (blocking suits that don't tend to get far under traditional tort law anyway), is outweighed by the bad (blocking future, hard-to-foresee suits that we wouldn't have blocked had we only known more about the future). In a world with no FDA either, this problem with Cheeseburger Bill would be greatly compounded.

[Stevo Darkly]

We don't need any products that encourage pasty women to expose their skin.

Dude, one man's "pasty" is another man's "fair" or "alabaster."

Re "Bee"

I just want to say you're twice the fellow I am. (Comment by: Eric the .5b at January 24, 2006 05:44 PM)

LOL!

[Kris]

Dave W,

I am saying that Mexoryl should be scrutized more than other, more typical cosmetics

Why?

Other, more "typical" cosmetics have been known to cause skin irritations as well.

[Rick Barton]

The FDA so often harms our health with their regulations. They also discourage free enterprise and aid certain big drug concerns by punishing smaller ones. In this case they aren't harming our health; they're harming our appearance.

Three words: Wide Brim Hat. I do that and also wear Shade, which has Avobenzene, an ingredient that's supposed to afford extra UVA protection. But I want to be able to use this other stuff too!

Amy Alkon appears to have beautiful skin, perhaps from limiting her skin's sun exposure out there in LA LA land. Actually, it's worse here in high altitude Colorado. And here is wisdom, my beautiful, brilliant libertarians. Eat lotsa anti-oxidants! Food and supplements. Do it for health and get an appearance benefit as well.

[Dave W.]

Kris,

Because if it somehow was discovered after approval that the new blocker did NOT prevent skin cancer, then we would have a lot of people relying on the new blocker and getting those skin cancers.

Therefore, it would make a lot of sense that the FDA would be testing for efficacy more than it would want to test for efficacy of a lipstick.

Also, people put sunblocks on small children more than they do with other cosmetics. This is an example of additional safety testing that would be rational.

There may be other reason why a sunblock would require more testing than other cosmetics, but these are two reasons that are clear and non-technical.

To repeat my earleir caveat: none of this means that testing should take 16 years or anything close to it. If the 16 years really is the FDA's fault, then it is a shame. If it is L'Oreal's fault . . . well I wonder what y'all would think about that.

[bubba]

Fair and alabaster are codes for "pasty." Meh. Lathered in the shower is ok, I guess, since you can control the lighting.

Maybe Europe puts all these things OTC so that they don't have to pay for them out of their welfare accounts. Remember Claritin? Our own insurance companies pulled that gambit.

When you buy stuff OTC in Europe, you're paying for it yourself, and you're not spending the government's money. Maybe that's not so relevant for this particular example of sunscreen, but it does help explain the European trend of OTC meds.

We don't have the same incentives here, though obviously the insurance companies are catching on.

[bubba]

You pasty folks should try a line of clothing/hats called Sun Precautions at the obvious link. I have a couple shirts I wear when snorkeling.

[Russ 2000]

Can't you see? It's a war on red heads! They're trying to kill us off so that we're removed from the gene pool!

[Jules]

If ever there was a good excuse for a trip to France this is it. However if you can't afford the airfare you can buy the sunscreen at skinbest.com which is based in Canada.

In the past it was available on ebay, but due to FDA pressure ebay cracked down on sellers.

[smacky]

You can say pale women are "pasty" if you want to, bubba, but I still prefer them over the orange-faced, leathery, tanned girls (you can call it the "fried chicken" look).

[smacky]

It's finger-lickin' godawful.

...Yes, it did take me that long to think of this joke.