John Ribner

The recent Swedish (Swiss Cheese) study that has been grabbing headlines - thanks to unscrupulous newspaper reporters - has already drawn many critics from the indoor tanning industry.

Now, Bob Wagner - that tireless tanning industry advocate and FDA consultant - has decided to join the fray. Outraged by the biased and unfair reporting of the study, Wagner sent the following response to members of the Associated Press and other national and local news outlets:

Wagner's Response

The report (“Tanning Salons Linked to Cancer Risk”) that was distributed yesterday to national print and broadcast outlets was born of woefully incorrect, false and purposefully misleading information submitted to AP from the American Academy of Dermatology.

Here are the facts as were revealed at the recent NIH Conference, held on October 8th and 9th, entitled: “Vitamin D and Health in the 21st Century – Bone and Beyond” (http://www.nichd.nih.gov/about/od/prip/index.htm):

· Vitamin D is the key material required to combat rickets, cancer, diabetes and MS.
· Over 80% of Americans are today Vitamin D deficient.
· Since 1975, rickets cases have increased dramatically.
· Vitamin D cannot be generated sufficiently without exposure to sunlight, either natural or artificial.
· Sunscreen blocks UV-B, which then inhibits Vitamin D generation.
· 1.3 million internal (breast, colon, stomach) cancer cases per year are attributed to Vitamin D deficiency.
· Over 200,000 cases of diabetes and MS are attributed to Vitamin D deficiency.
· Of the 50,000 melanoma cases each year, better than 95% are completely cured.
· Given the choice, people overwhelmingly would rather deal with skin cancer versus the internal varieties.
· Internal cancers pull nearly 97 billion dollars (and increasing) per year out of the U.S. economy through Medicare.

The unofficial consensus among the renowned biochemists and molecular biologists presenting their scientific papers at The NIH conference was that the Vitamin D deficiency epidemic in the United States is probably due to the AAD’s decades-long “Stay Out of the Sun” campaign, that has kept children and young adults indoors or covered by sun block for nearly a generation. As dermatologists have little or no background in biochemistry, it seems that the AAD was unable or perhaps unwilling to understand the new science supporting exposure to sunlight, a primary aspect of nature that mankind has been living with for over 300,000 years.

Background
In June of this year, Dr. Spencer of the AAD met with members of the Food and Drug Administration’s Office of Science and Technology (FDA/ OST), the department responsible for governing regulatory polices relating to radiation-emitting devices,
including tanning equipment and individual sunlamps. When a complete ban on sunlamps was demanded by Dr. Spencer and his colleagues, Senior Research Biophysicist at FDA/OST, Dr. Howard Cyr, reiterated his insistence that there was no definitive link between sunlight or tanning beds and malignant melanoma. At best, there could be an argument made that UV-A might be a catalyst for common Basal and Squamous cell skin cancers, but nothing specifically indicting sunbeds as a causal factor could be found. In support of this, Dr. Cyr mentioned the Australian 2002 “Sturm, et. al” study that positively connected melanoma to a genetic mutation, which explained why melanoma lesions appeared on areas of the body never exposed to sunlight. The AAD has chosen to ignore those studies.

Dr. Cyr has also taken issue with the Swedish study submitted to the AP as being an outdated, extrapolative survey, conducted in a country where the vastly predominant skin type is “I” (no melanin, and therefore won’t tan), and Vitamin D is generated only 3 months of the year. Virtually every Swede and Norwegian is Vitamin D deficient during the remaining 9 months. Additionally, Swedes drink alcohol and smoke much more than Americans; both have strong, definitive links to melanoma. Using Scandinavians in such research, therefore, would be like comparing the skin reactions of nocturnal mice to those of humans.

The Inherent Danger of False Information
In a nutshell, the AAD launched this new campaign, using the AP as a veritable “Sword of Damocles”, in an effort to obfuscate the truth, deflect blame away from itself, and harm the producers of tanning equipment and lamps. One can only surmise that, after the contrarian revelations of the recent NIH – Vitamin D Conference were made public (and with his back to the wall), Dr. Spencer decided to engage in a scorched earth policy; let the devil bemoan the fallout.

This kind of academic skullduggery is the same sort that pegged Saccharin as being a carcinogen for 20 years, until it was discovered that the original study listing it as such was seriously flawed, forcing the government to take it off the list of cancer causing agents in 2001. But by then, the damage to the economy, as well as the livelihoods of 10,000 Americans employed in the artificial sweetener industry, had already been done. What happened to the researcher who published the false study? He retired, conveniently, in 2000.

In view of data emanating from such organizations as NASA, NIH, FDA and Penn State / Purdue Universities, the AAD felt compelled to stick its collective head in the sand and promulgate an overwhelmingly potent media blitz to bolster a misguided mantra. Once this information has made it to the trial lawyers, the organization may find itself the subject of a massive class action lawsuit, naming it as the cause of, among other things, the rickets and diabetes being suffered by thousands of young people today.

Academic Dr. Margherita T. Cantorna, PhD – Pennsylvania State University
Study Drs. Mona S. Calvo and C.N. Barton, PhD’s - FDA / CFSAN
Sources: Dr. Bess Dawson-Hughes – Tufts University
Dr. Hector F. DeLuca, PhD – University of Wisconsin at Madison
Dr. James Fleet, PhD – Purdue University
Dr. Robert P. Heaney, MD – Creighton University
Dr. Michael F. Holick, MD, PhD – Boston University
Kelly S. Scanlon, PhD, RD – Centers for Disease Control
Dr. William B. Grant, PhD – NASA Langley Research Center
Dr. Gerald F. Combs, Jr., PhD – USA / ARS Human Nutrition Center

This information submitted by Robert T. Wagner, President / CEO, Medical Device Listing Consultants, a Division of AEGIS, Inc., Saint Petersburg, FL (727) 471-0173, www.fdalistingconsultants.com

John Ribner

Here's even more good news: Dr. William Grant - a NASA research scientist - has also weighed in on the Swedish study debate. And he's on the pro-UV side, too!

For those of you who don't know, Dr. Grant will be the keynote speaker at Solar Seminar VI, aka SoBe '03, where he will discuss his studies that suggest UVB/vitamin D production can act as a risk reduction factor for several types of cancers.

Dr. Grant's Response


Journal of the National Cancer Institute, Vol. 95, No. 20, 1530-1538, October 15, 2003


A Scientific Critique of:
A Prospective Study of Pigmentation, Sun Exposure, and Risk of Cutaneous Malignant Melanoma in Women
Marit Bragelien Veierød, Elisabete Weiderpass, Magnus Thörn, Johan Hansson, Eiliv Lund, Bruce Armstrong, Hans-Olov Adami

So, 18/2.58 = 7, so 11 excess cases out of 6391 or 11/6391 = 0.0017 risk or 1 in 600. However, melanoma is seldom life-threatening (7,500 out of 50,000 cases in the U.S. or 0.15), especially with routine skin inspection.

For 14,377 women who used solaria between the ages of 10 and 39, 34 developed melanoma. Had they not used the solaria, 21 would have developed melanoma. Thus, the added risk of melanoma is 13/14,377 = 0.00090 or 9 cases in 10,000 indoor tanners – and that over an average observation period of 8.1 years. So, the risk is 1 case of melanoma per 10,000 person years of tanning once a month or more.

Looking at accident rates in the U.S. (Table 178 in the U.S. Statistical Atlas, 2001), for those (male and female) aged 22-44 years in 1998:
· Injured each year due to a fall - 31/1000 persons/year
· Struck by or against a person or object – 17/1000
· Transportation (motor, cycle, pedestrian) – 19/1000
· Overexertion – 23/1000
· Cutting, piercing instruments – 15/1000
· Poisoning – 5/1000
· Indoor tanning – 0.1 case of melanoma/1000 women/year

The cost of a periodic exam for melanoma is, maybe, $30, and the cost of treating a case of melanoma – approximately $1000? Suppose one had a checkup every 5 years, the risk cost of melanoma and prevention would be $6.10/woman/year.

If, on the other hand, one considers that 1 in 10 of those who develop melanoma will die from melanoma, and value a life at $100,000, the annualized risk cost for death is $10,000/1000 women, or $10/woman/year. Add the two, and one finds an annualized cost of $16.10/woman/year, the price of a good meal or filling the tank of a medium sized car in the U.S. (feel free to play with the frequency of exams and the numbers; in any event it is a small number; if a visit to a tanning facility costs $20, it could be raised to $21 with a free skin exam every n years given to the customers – maybe that is an idea you could run with).

Thus, in comparison with other risks, developing melanoma from indoor tanning, is an insignificant risk and is not worthy of worry.

I’m reminded what Mark Twain said about sins of commission and omission: sins of commission are better, because you’ve done something.

Some advantages of tanning:
· Vitamin D generation (25-Hydroxylase)
· Appearance, which could help in attraction of a mate.
· Self esteem, mood, etc.

Several things can be done to reduce the risk of melanoma:
1 – develop a good tan
2 – take antioxidants internally, or apply antioxidants to the skin; much of the risk of melanoma comes from free radical generation; antioxidants reduce the amount of free radicals (vitamins C, E, selenium, etc.), or plenty of fruits and vegetables (Norwegians and Swedes consume 2/3 as much vegetables as those in the U.S., and the vegetables are not as fresh as in the U.S., so have fewer vitamins)
3 – have periodic skin examinations for melanoma and other skin cancer.

The latest press coverage of the increased risk of melanoma due to use of indoor tanning facilities in Norway and Sweden is just the latest effort by dermatologists to scare the American public into fearing any exposure to ultraviolet radiation, whether it be from tanning lamps or from the Sun. ("Whether you get it at the indoor tanning parlor or at the beach, (UV light) is a carcinogen," he said.) This statement is patently false and dangerously misleading. Solar UV radiation is part of the natural environment, and all life on Earth that is exposed to UV radiation has developed adaptive mechanisms; for humans, UV-B (280-315 nm spectral region that produces vitamin D) is THE major source of vitamin D, except in high latitudes such as in Scandinavia, where fish and dietary supplements have to be used. Exposure to UV is not like smoking tobacco products, which have no health benefits. There are some risks associated with UV exposure, but the benefits far outweigh the risks. The sooner the dermatologists recognize that fact, the better their recommendations will be and the healthier we all will be.

Such scare tactics have led to Americans being seriously vitamin D deficient, especially those that live in urban environments and/or spend most of the day indoors, who have darker skin, and those who live in the low UV-B region of the northeast U.S. In recognition of this fact, the NIH convened a conference to determine a research program to determine better vitamin D recommendations for Americans (“Vitamin D in the 21st Century: Bone and Beyond,” held in Bethesda, MD, Oct. 9-10, 2003).

Examples of vitamin D deficiency include increasing numbers of children born to African American women who develop rickets, and the fact that mortality rates for a dozen types of internal cancers are up to twice as high in the low-solar-UV-B northeast than in the high-solar-UV-B southwest.

Living in an urban region also increases the risk of cancer due to reduced solar exposure. In the U.S., a conservative estimate is that 12,000 men and 16,000 women die each year from cancer due to insufficient solar UV-B radiation, and there are approximately 80,000 preventable cases/year (based on an extension of a study published in Cancer in March 15, 2002 and accounting for a number of other risk factors). Over a dozen studies have examined dietary vitamin D and colorectal cancer with the same conclusion: dietary sources of vitamin D in the U.S. and other countries are not sufficient to significantly reduce the risk of colorectal cancer. However, other measures, such as vitamin D supplements, serum 25(OH)D3, and solar UV-B radiation, are almost always associated with significant reductions in colorectal cancer.

In addition to cancer, adequate vitamin D is required for optimal calcium absorption and bone health, strong teeth, muscle strength, reduction of type-1 diabetes, reduced symptoms of type-2 diabetes; vitamin D has been shown to reduce blood pressure, reduce the risk of heart disease, and reduce the progression of osteoarthritis and rheumatoid arthritis. It is an outrage that the dermatology community would put their parochial vision forth as the one that should be followed by all, despite the fact that many more lives are harmed or lost due to insufficient UV radiation than are saved by reductions in melanoma and other skin cancer.

The scare tactics seem calculated to induce people to buy more sunscreen products; however, there is no convincing evidence that sunscreen reduces the risk of melanoma or other skin cancer; in fact, several meta-analyses of several studies found no relation between sunscreen use and subsequent development of melanoma. On the other hand, one study found that farmers who used sunscreen regularly during the summer were vitamin D deficient at the end of the summer. Vitamin D production is one of the primary benefits of solar UV-B exposure.

Another benefit of both solar and artificial tanning is melanogenesis or tanning: melanin has been shown to block UV-A from penetrating deeply and to actively participate in DNA repair after exposure to UV-B or free radicals produced by UV-A. Not pointed out in the AP wire story is that rates of melanoma increase with latitude among Caucasians who live in their ancestral homelands from India to Scandinavia. Over the period of millennia, skin pigmentation gradually adapts to the prevailing solar UV levels to achieve a balance between vitamin D production and protection against too much UV. In the absence of natural pigmentation, one can tan to develop protection against UV. It should be noted that the results for Norwegians and Swedes (60 deg. north) does not necessarily apply to Americans; the majority of Caucasian Americans trace their ancestral roots to Germany and the U.K., both around 50 degrees north, so have slightly darker skin and improved ability to tan. The appropriate skin pigmentation for the latitudes of the U.S. is that of those living in Mediterranean, Middle Eastern, and Southeast Asian countries.

One has to ask whether the American Academy of Dermatology is merely the “information arm” of the $350 million/year sunscreen industry, since they take a very parochial point of view and refuse to recognize any health benefits of tanning, indoors or out.

In addition, it is unprofessional to issue a warning about a product or activity without 1 – comparing the risks to the benefits; and 2 – placing the risks in context. If we look closely at the data, we see that the risk to women between the ages of 10-39 years old developing melanoma due to using an indoor tanning facility at least once a month is 0.1 cases/1000 women/year. That is much lower than accident rates from many other causes in the U.S. for the age group 22-44 years, which vary from 5/year for poisoning to 19/year from any means of transportation to 31/year from falls. No one suggests that people don’t eat, travel, or move about; they suggest that they try to do each activity in a safe manner.

There was no discussion in the article of how many times/month those who developed melanoma using indoor tanning facilities, or how much outdoors solar exposure they received. It would be very interesting to look in detail at the data relating to those who developed melanoma and also visited tanning parlors. They may have had other risk factors than merely visiting tanning facilities.

Papers by Spencer related to UV:
Spencer JM, Nossa R, Ajmeri J. Treatment of vitiligo with the 308-nm excimer laser: a pilot study. J Am Acad Dermatol. 2002 May;46(5):727-31.

Spencer JM. Nail-apparatus melanoma. Lancet. 1999 Jan 9;353(9147):84-5. No abstract available.

Spencer JM, Amonette R. Tanning beds and skin cancer: artificial sun + old sol = real risk. Clin Dermatol. 1998 Jul-Aug;16(4):487-501. Review. No abstract available.

Spencer JM, Amonette RA. Indoor tanning: risks, benefits, and future trends. J Am Acad Dermatol. 1995 Aug;33(2 Pt 1):288-98. Review.