Payola, Botox, Teen Tanning And Melanoma

Payola. Will medical payola be ending soon? The prestigious Institute of Medicine (IOM), a division of the National Academy of Sciences, recently issued a call for all doctors, medical schools and medical organizations—such as the American Academy of Dermatology (AAD)—to “end a number of long-accepted relationships and practices that create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy.”

More importantly, IOM President David Rothman clearly and unambiguously stated that “conflicts of interest in medicine are no longer acceptable.” In addition, the IOM called on Congress to pass legislation that would require drug and medical-device makers to disclose publicly all payments made to doctors and medical organizations.

The IOM edict explains why the AAD’s “Seal of Recognition” program, which charges sunscreen companies sizeable fees to place a seal on their products , must be outlawed. The question is: Will the AAD decide to eliminate its program or will it continue to take money from the sunscreen industry notwithstanding the fact that doing so appears to be a blatant conflict of interest? Let’s hope that the AAD pays attention to Rothman’s words .

Authors note: We found it interesting that the AAD tries to justify the money from its program by claiming that the goal of the program is to prevent skin cancer. However, the seal only states that “The American Academy of Dermatology recognizes this product for its sun-protection benefit.” There is no mention of skin-cancer prevention—which perhaps means that the AAD has accepted the fact that there are no valid scientific studies showing that the use of a sunscreen will prevent any form of skin cancer.

Another Botox warning. On April 30, the FDA issued a press release titled, “FDA Requires Boxed Warning for All Botulinum Toxin Products.” The following is an excerpt from that release:

... Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigations Strategy (REMS), are necessary for all botulinum toxin products ...

... [The FDA] took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. ...

As you may recall, in February 2008, the FDA said that botulinum toxin products (such as Botox) would be subject to further investigation because of their adverse side effects—including death. The changes and warnings described above appear to be the result of this ongoing investigation.

In an interesting coincidence, Dysport, a new botulinum toxin product from Australia that is virtually identical to Botox, was approved by the FDA for use in the U.S. This approval was given notwithstanding the fact that, in December 2008, Australian health officials said that Dysport can cause severe birth defects in children whose mothers receive injections during pregnancy.

Given the serious problems coming to light regarding the indiscriminate use of botulinum toxin products and the IOM directive to eliminate all potential conflict-of-interest relationships with commercial entities, we can’t help but wonder why dermatologists don’t spend more time taking care of their own problems and less time persecuting the indoor tanning industry.

Teenage vitamin D insufficiency. The evidence is overwhelming: More than 90 percent of teenagers in America are vitamin D-insufficient (based on a blood level of 100 nmol/L [40 ng/ml] as the minimum threshold for vitamin D sufficiency). This situation is a prescription for disaster given the fact that 40 percent of our bone strength is developed during adolescence and we now know that vitamin D sufficiency is necessary for attaining maximum height, weight and strength.

In addition, given the fact that insufficient vitamin D levels are linked to diseases such as cancer, coronary heart disease, multiple sclerosis, diabetes, osteoporosis and obesity, one can’t help but wonder why legislators aren’t taking all available steps—including encouraging more controlled ultraviolet radiation exposure and recommending the ingestion of a 1,000 to 2,000 IU vitamin D3 supplement each day—to address this serious health issue. Instead, well-meaning but misinformed legislators are passing laws that deny teens access to indoor tanning salons, the only controlled source of UVR.

Melanoma incidence among Canadian females. A new study from Canada comparing melanoma incidence rates from 1956 to 2005 showed that it began declining in 1981 for young females and in 1992 for young males. This data disproves the claim that melanoma is increasing in young Canadian women (as is often cited by Canadian dermatologists). In fact, the study showed that the only age group with a continued increase in the incidence of and mortality from melanoma was men 60 and older. (Note: We find it interesting that this study was conducted by physicians who are not dermatologists.)

Since the Canadian results are virtually identical with U.S. results, we must ask: Why do dermatologists continue to make the false and misleading claim that melanoma is increasing in young women when the evidence clearly indicates otherwise—and why do they add insult to injury by claiming that this “increase” is linked to tanning salons? Frankly, since the rate began going down in 1981, maybe it was the advent of the indoor tanning industry that was responsible for this decrease.

Melanoma incidence in East Germany. A study titled, “Skin Cancer in Germany Before and After the Post-Communist Transition,” showed that age-standardized skin-melanoma incidence and mortality rates tended to be lower in East Germany than in West Germany before reunification but that, after reunification, rates became very similar. Although the authors could not arrive at an explanation for the increase, readers of this column may remember our October 2006 article titled, “Is FM Broadcast Radiation Causing an Increase in Melanoma?” In that article, we discussed an environmental agent—frequency modulation (FM) broadcast radiation—and why that agent may be the real culprit behind an increase in the incidence of melanoma.

Moreover, we disclosed that two respected scientists had predicted that the change in the FM radio transmitters from less than 70 MHz to between 87.8 MHz and 108 MHz in Eastern (Soviet) block countries would most likely result in an increase in the incidence of and mortality from melanoma, and that this prediction has now proven to be true. (Note: The former communist block countries used transmitters less than 70 MHz prior to 1992 and had lower cutaneous malignant melanoma (CMM) incidence rates. When they switched to the range from 87.8 to 108 MHz, the early results—especially for Croatia—showed the incidence of CMM increased to a rate matching other Western countries employing the same 87.8 to 108 MHz levels.)

Thus, as was the case in Croatia, the increase in East Germany provides additional evidence that FM broadcast radiation is (somehow) involved in the process of a normal melanocyte transforming into a malignant melanoma.

In next month’s article, we will show why ultraviolet radiation is not responsible for causing the increase in the incidence of cutaneous malignant melanoma, and why UVR avoidance and sunscreen may be responsible for this increase. In addition, we will explain why most CMMs are found on areas of the body that are not exposed to UVR and how this information explains why UVR has been mistakenly blamed for causing CMM. Finally, we will discuss the relationship between cellular signaling, vitamin D and CMM, and the critically important role that frequency modulation (FM) broadcast radiation plays. You won’t want to miss this important issue.

Patricia E. Reykdal and Donald L. Smith operate the Non-Ionizing Radiation Research Institute in Tucson, Ariz. They have written many articles promoting the benefits of controlled ultraviolet radiation exposure (CURE). You can e-mail comments or questions to reyksmith@aol.com.