Bayer competes in a variety of categories, including agriculture, pharmaceuticals, chemicals and consumer products, and holds roundtable press events throughout the country. Earlier this month, for the first time, Bayer invited the press to exchange ideas with experts about the sun care market.
“Skin cancer rates are rising dramatically in the US,” noted Rigel. “And melanoma is rising faster than all of them.”
Data from the American Academy of Dermatology backs him up. According to AAD:
• Skin cancer is the most common cancer in the US.
• One in five Americans will develop skin cancer in their lifetime.
• Nearly 9,500 people in the US are diagnosed with skin cancer every day.
• Researchers estimate that 5.4 million cases of non-melanoma skin cancer, including basal cell carcinoma and squamous cell carcinoma, were diagnosed in 3.3 million people in the US in 2012.
• It is estimated that 161,790 new cases of melanoma, 74,680 noninvasive (in situ) and 87,110 invasive, will be diagnosed in the US in 2017.
• Invasive melanoma is projected to be the fifth most common cancer for men (52,170 cases) and the sixth most common cancer for women (34,940 cases) in 2017.
• Melanoma rates in the US doubled from 1982 to 2011.
• Caucasians and men older than 50 have a higher risk of developing melanoma than the general population.
• The incidence in men ages 80 and older is three times higher than women of the same age.
• The annual incidence rate of melanoma in non-Hispanic Caucasians is 26 per 100,000, compared to 5 per 100,000 in Hispanics and 1 per 100,000 in African-Americans. According to AAD, in people of color, melanoma is often diagnosed at later stages, when the disease is more advanced.
• Before age 50, melanoma incidence rates are higher in women than in men, but by age 65, rates are twice as high in men. Melanoma in Caucasian women younger than 44 has increased 6.1% annually, which may reflect recent trends in indoor tanning.
• Melanoma is the second most common form of cancer in females age 15-29. Melanoma incidence is increasing faster in females age 15-29 than in males of the same age group.
The statistics are frightening, but there are some very simple solutions; i.e., protective clothing, avoidance of the sun and regular use of sunscreen.
“They all have a role to play,” insisted Rigel.
He noted that everyone, promoters and detractors alike, agree that sunscreen protects against sunburn. Furthermore, researchers have demonstrated that regular use of sunscreen protects against basal and squamous cell carcinoma, too. However, some have argued that sunscreen is not effective against melanoma, the deadliest form of skin cancer.
Rigel admitted that melanoma efficacy is more difficult to test, due to its long latency that can range from 5 to 20 years; but researchers have still performed detailed studies on the subject. One study, involving 1,600 Australians, called for half of the test subjects to apply sunscreen religiously and the other half to apply it whenever they wanted. A quarter of the later group acquired melanoma.
“We can say that the regular use of sunscreen lowers the risk of melanoma,” Rigel concluded.
In a broader study, this one in Norway involving 140,000 women, found that regular sunscreen use of SPF 15 and higher reduced melanoma by 18%.
“That reconfirms that the regular use of sunscreen reduces melanoma risk,” according to the dermatologist.
Despite the data, a new article in Consumer Reports and a new study by the Environmental Working Group casts doubts on the effectiveness of sunscreen. Rigel said the research is disheartening for several reasons; including improper test methods, a lack of dermatological oversight and information being taken out of context.
“Consumers are confused by the Consumer Reports and EWG studies,” he told reporters. “I tell patients to use sunscreen but unfortunately, some patients say, ‘Who knows? I’ll do what I want.’ That’s dangerous!”
To combat the vat of misinformation getting published in print and appearing online, Rigel insisted that doctors, media and trade groups must do a better job of educating the public.
“We have to undo the confusion that sunscreens are bad,” he explained.
Executives at Bayer agree. According to Eduardo Ruvolo, director, US and international medical affairs, sun care and skin care, there are many mechanisms involved in creating effective sunscreens.
“I’m a biophysicist; developing sunscreens is my passion, but the topic is confusing even for scientists,” he admitted. “And with the Consumer Reports and Environmental Working Group articles, there is even more confusion out there. We have to talk about it and that’s where Bayer comes in.”
Ruvolo pointed out that compliance rates remain very low and that among people who apply sunscreen, they only use one-quarter of what they are supposed to apply. Secondly, among those who apply sunscreen, many don’t cover the skin entirely, nor do they reapply it. To improve compliance, researchers spent seven years developing Coppertone Clearly Sheer Whipped Sunscreen.
“The aesthetics are so amazing that people will use it,” he insisted.
Ruvolo and other Bayer executives are proud of their capabilities, too, which is why the company commissioned an independent "assurance assessment," designed to provide consumers with greater confidence when choosing sunscreen. A sun care industry first, Bayer retained AccountAbility, a consulting and standards firm, to undertake an independent assurance assessment of Bayer's internal processes, systems, controls and performance guidelines for the labeling accuracy of 10 of its top-selling Coppertone products in the US, and then make the report available to the public.
"Coppertone has continued its commitment to quality, excellence, innovation and truth in labeling, backed up by science, clinically relevant data and robust testing," said Ruvolo. "The results of the independent assurance assessment show that Coppertone products consistently and reliably provide the level of sun protection that our consumers expect, and trust us to deliver."
Ruvolo said Bayer commissioned the study to help demystify how sunscreens are tested.
“We opened our doors to make sure that our products are safe and comply with regulations,” he told reporters. “We are open and transparent.”
Experts recommend that consumers look for broad-spectrum, water-resistant formulas that protect against UVA and UVB rays and provide a sun protection factor of at least 30, but Rigel and other dermatologists recommend SPF 50 formulas.
“The data is clear,” reiterated Rigel. “The regular use of sunscreen lowers the risk of skin cancer. It really works. (And) the best sunscreen is the one you use!”
He told reporters patients often bring bottles of sunscreen to their appointments and ask, “This sunscreen is five years old. Is it still good?”
That’s a bewildering question to the dermatologist.
“How does a three-ounce tube of sunscreen last five years? People don’t use enough,” he told reporters. “If your sunscreen fails, you didn’t apply it correctly!”
Rigel recalled a study that he conducted a decade ago to assess how consumers apply sunscreen. Many subjects completely missed entire sections of their body, especially around the eye area.
Looking ahead, Ruvolo, other Bayer executives and the entire industry is keeping an eye on the US Food and Drug Administration’s torturous approval process for eight UV filters which are already available in Europe. According to experts, the European Union maintains a list of 27 UV actives. In contrast, the FDA’s current list contains 16 approved sunscreens. Of these, only eight are used regularly and only two offer good UVA protection.
Rigel predicted that micronized sunscreen actives will continue to gain share and wondered aloud if oral sunscreens may someday become a reality—although he insisted there is no substitute for the protection provided by topical sunscreens. Rigel added that he is against an FDA-proposed rule that would cap on SPF label values at 50.
Sunscreen use in elementary schools is also undergoing change. Because FDA classifies sunscreen as over-the-counter drugs, many states ban sunscreen in schools. But Eduardo and Rigel predicted that the ban will be overturned on a state-by-state basis. In fact, Washington schools recently made sunscreens legal.
In concluding the roundtable, Rigel urged reporters to help get the message out regarding the importance of regular sunscreen use.
“I would love to put myself out of business,” he insisted. “At least in terms of melanoma treatment!”