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FDA to consumers: Burn, for all we care
Posted By Lee Hieb, M.D. On 03/18/2013 @ 12:02 pm In Diversions,Front Page,Health,Politics,U.S. | No Comments
I spent a recent week snowboarding, exposing my face to hours of snow-enhanced sunlight. Now, in general, I believe that some exposure to the sun is beneficial for general health reasons. During the summer, in my secluded garden spot, while hoeing rows, I make sure to give my skin a little sun every day – at the same time hoping the Fed-Ex man doesn’t show up unexpectedly – he’d get an eyeful more than the delivery he bargained for. But extreme sun exposure to skin that has had the winter blues is harmful, causing both aging and DNA damage leading to potentially cancerous transformation of cells. So, I religiously use sunscreen on the slopes, and during summer’s prolonged, outdoor activities.
Having the luxury to know several dermatologists, I picked their brains and the literature years ago to find the most effective type of sunscreen. At least among my derm friends and the literature I reviewed, the best sunscreen is Mexoryl XL. Only one problem: Although it has been used in Europe for over 20 years, it is banned by our great “protector,” the U.S. Food and Drug Administration.
To review, there are two types of sun rays – UVA and UVB. For years most sunscreens concentrated on UVB blocking, because UVB causes the visible changes –redness and burning of the skin. But it is UVA, which may not cause immediate alteration in the appearance of the skin, that penetrates deep into the dermis and is responsible for the long-term effects of wrinkling, discoloration and cancer.
For years, my derm friends recommended a titanium dioxide containing block because, in the absence of a chemical UVA barrier, titanium dioxide provided an actual physical barrier to both UVA and B. Remember the slightly whitish tinged sunscreens? Titanium dioxide is used in window filters for houses and cars and is effective to a degree as a sunscreen.
L’Oreal, famous in America for its make up, actually runs the largest dermatological research labs in the world. They hold countless patents, and are constantly innovating skin care. In 1982, L’Oreal patented Ecamsule, the name for the chemical Mexoryl XL, and since 1993 it has been in widespread use in sunscreens around the world except in the U.S.
As noted by Columbia University Dermatologist, Dr. Vincent DeLeo, “It produces a product [that] gives us almost perfect protection against sunshine.”
Because Mexoryl was not legally sold in America, years ago I found a source through the Internet in Canada and ordered a case of the sunscreen Ombrelle.
During many activities, such as riding the bicycle ride across Iowa, camping in the desert or snowboarding, friends would ask me how I avoided getting burned, because they were still getting sunburn after applying their own sunscreens. So, over the years, I have been able to see the gross difference between “Brand X” and Mexoryl.
When packing for the recent trip, I noticed I was down to my last bottle of Ombrelle. I also discovered that my Canadian sources have dried up and do not know what has caused the shift (I suspect some strong-arming, but who knows?). In the meantime, the FDA has been pressured to loosen its stranglehold on Mexoryl and has given recent approval to L’Oreal for the U.S. marketing of a Mexoryl containing sunscreen even though the drug itself is not approved. Typically, the marketing approval is only for the less effective SX version (water soluble) of the chemical, not the XL (oil soluble).
In an attempt to read the FDA’s own writings on the subject – i.e. to really investigate the primary source for this report – I encountered unbelievable reams of government-speak papers such as “Final Rule: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use”, a 45-page tome that was published after the marketing approval, but has only one mention of Mexoryl in a reference at the end.
On the FDA website there is a “helpful” question-and-answer page about these rulings, which again doesn’t mention the comparative effectiveness of the various chemicals in sunscreens – something I, as a non-dermatologist physician, would find helpful – but which does spout forth such helpful hints as, “[Limit] time in the sun, especially between the hours of 10 a.m. and 2 p.m. when the sun’s rays are the strongest. … [Wear] clothing to cover skin exposed to the sun.”
In its thoroughness, the FDA even explains what those safety articles of clothing are: “long-sleeved shirts, pants, sunglasses and broad-brimmed hats.” So those of you looking to the FDA for truly helpful information regarding the best and safest sunscreen are reminded to wear pants. How many tax dollars did that recommendation cost?
I and others have written numerous articles on why the FDA is such a sphincter to progress in Medicine, and I won’t repeat myself here. But it is important to point out that the FDA is a freestanding agency not accountable to Congress. Additionally, the FDA Safety and Administration Act of 1992 allows the FDA to collect fees from private companies to “fund reviews of innovator drugs and medical devices.” In other words, the FDA shakes down the pharmaceutical industry for money to do its self-appointed regulatory job.
Commissioner Margaret A. Hamburg says that these fees are “a testament to the important role FDA plays in America’s health care continuum.”
Color me cynical, but, couched in regulatory jargon, this seems like a euphemism for outright bribery. I guess L’Oreal finally coughed up enough moolah to get its product approved for marketing.
So as summer approaches and you are faced with buying sunscreen, you can rest assured that your FDA is doing everything in its power to keep your options limited and your knowledge to a minimum. My advice is to get online and buy foreign-sourced sunscreen with Mexoryl XL (I just purchased some Anthelios by L’Oreal), use common sense (I said that in three words and was not even taxpayer funded!) and keep up with the latest science by generally avoiding any bureaucratic, taxpayer-funded information source.
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