WASHINGTON (MEDIA GENERAL) – A little, hard lump under Cassie Beisel’s arm in 2011 was her first clue that something was wrong.
Throughout the next month, she forced herself through a frightening carousel of doctors’ offices and invasive tests, which yielded no answers.
Finally, it was time for another biopsy.
Beisel remembers the doctor walking out with her tissue sample and “10 minutes later, he came back in the room, flung the door open and said, ‘Oh my gosh, you need surgery right away; I’m pretty sure you have breast cancer.’”
But it wasn’t breast cancer.
Despite no evidence of a mole, Beisel had advanced melanoma.
Like many young people, the 37-year-old bronzed during her teens using SPF 5 sunscreen and soaking in “preventative” tans to avoid summertime sunburns.
Beisel, who now works for the Melanoma Research Foundation, deeply regrets not using the best prevention product available – broad spectrum sunscreen.
But the truth is, the best sunscreen in the world might not even be available to the estimated 144,860 Americans who will be diagnosed with melanoma this year, thanks to regulatory red tape at the Food and Drug Administration, which has the power to approve or ban such products.
Melanoma cases surge
Despite melanoma cases doubling in recent decades, our investigation reveals that the FDA has delayed the approval of new, potentially life-saving sunscreen ingredients for up to 14 years.
Here are a few facts for starters:
Skin cancer is the world’s most common form of cancer.
Melanoma, the deadliest strain of skin cancer, has doubled in prevalence between 1982 and 2011, with more than 90% caused by sun exposure. Many of them will die.
Despite the rapid skin cancer spread, manufacturers and lawmakers complain that the FDA slow-walked approvals for new sunscreen formulas and effectively killed off the next generation of lifesavers.
Some industry insiders, fearing a public clash with the FDA, take a darker view, saying that embarrassed regulators are playing “hardball” with companies, slyly “slapping the hands” of manufacturers – by way of mandating onerous scientific tests – rather than earnestly considering new products as directed by Congress.
The FDA categorizes sunscreens as over-the-counter (OTC) drugs. That means they’re subject to the full approval process that other traditional medications must pass.
Novel prescription drugs for, let’s say, heart disease or erectile dysfunction go through the scrutinous approval process at an accelerated rate subsidized by the pharmaceutical manufacturers which submitted them.
Sunscreens are different.
In order to enter the catalog — in FDA parlance, the “monograph” — of 16 approved ingredients deemed safe enough to be used in any sunscreen formulation, manufacturers must submit data and then wait for regulators to get around to them.
Some of them have now waited for 14 years.
For perspective: since these sunscreen proposals were submitted, the nation met an Illinois state senator named Barack Obama, learned what an “iPod” did, and witnessed the swearing in of four new Supreme Court justices.
All the while, no approvals.
The sunscreen monograph (i.e. safe ingredients list) has remained unchanged since 1972.
Companies wait… and wait
Paul Seccomandi’s company 3V Sigma USA manufactures a popular sunscreen called UVASORB HEB at corporate headquarters in Georgetown, South Carolina.
Customers have been buying UVASORB for 20 years, Seccomandi says, for its advanced second-generation protective ingredient called Diethyl Butamido Triazone.
But they’re not buying it in the United States.
“As we speak right now, we have trucks going out of the plant. I can see them from my window,” Seccomandi lamented from his desk. “They’re going to Europe and outside the country because here, it’s not allowed.”
There are currently eight ingredients awaiting FDA approval, averaging more than a decade of wait-time.
3V submitted its original application 10 years ago. Seccomandi calls the delay “ridiculous.”
For sunscreen innovators like Seccomandi, it’s all about advancing the field one new ingredient at a time. “It’s like the iPhone 6 is better than iPhone 1. But if you never start, then you never get to the iPhone 6.”
Seccomandi acknowledges that every new product isn’t perfect, but argues they’re far better than medications from 1972.
Senator puts screws to FDA
“I know it can move faster,” asserts Republican Sen. Johnny Isakson of the FDA approval process.
Isakson speaks in a low, slow Southern drawl which conceals his no-nonsense determination to get the FDA backlog cleared in a hurry.
The Georgia senator is a two-time melanoma survivor who underwent a total of three surgeries in 1982 and 1992 to remove cancerous growths.
Isakson helped spearhead the passage of the 2014 Sunscreen Innovation Act, which set benchmarks by which the FDA had to respond to new sunscreen ingredient applications.
The FDA pins its previous delays on a host of other public safety concerns that took priority in a bureaucratic institution operating on limited resources.
Isakson concedes that public health emergencies have erupted, but demands, “You can’t tell me that you waited 12 years and still haven’t approved an additive because it wasn’t a priority.”
“They need to understand a death from melanoma is just as bad as a death from a heart attack or cancer or ALS. They ought to be dedicating their research time so that they cover all threatening and terminal illnesses.”
The FDA rejects the notion that internal foot-dragging alone led to the long delays.
Approval criteria is purposely rigorous, says non-prescription evaluation research director Dr. Theresa Michele. “We really owe that to the American people because they assume that when they pick up a drug product off the store shelf, it means that safety and effectiveness has been looked at by the FDA.”
Federal scientists are looking for very specific absorption outcomes with newer sunscreens — particularly signs of toxicity, cancer, or harmful effects on reproductive and thyroid hormones that result from a lifetime of being slathered on.
The FDA cites recent concerns in Europe about certain ingredients’ safety as evidence that the American process is justifiably cautious.
That caution comes at a cost.
The tests requested by the FDA are “very, very expensive,” says 3V Sigma president Seccomandi.
“It could easily get to $10 million” and take several years, explains an exasperated Seccomandi. “You need to run animal tests for multiple generations so you can properly evaluate all of the potential side effects.”
Now that the FDA has notified sunscreen companies which data government scientists need to see, the agency’s clock restarts.
“The Sunscreen Innovation Act gives the FDA timelines for how quickly we have to review things, but it doesn’t give industry any timelines for when they have to send things in,” explains Dr. Michele. “We’re in a waiting mode to get the data that we need from them.”
So far, the FDA hasn’t heard back from a single company — and may never.
Permanently stalled progress
Companies pursuing FDA approval are in a race against time and competitors.
After 20 years, the manufactures’ ingredient patents expire and other companies are free to legally market knockoff products at cut-rate prices.
“If you lose your patent and you lose your income, then there’s no incentive to find new breakthroughs, and there’s a disincentive for us to improve health care for the American people,” Sen. Isakson says.
Companies like Seccomandi’s now face a tough decision: move ahead with clinical trials on products with expired patents or consign their products to overseas markets.
“It’s not economically feasible to pursue this avenue, so what I expect is that all the companies with this new molecules will simply do nothing,” determines Seccomandi.
“There will never be any new alternatives to consumers,” another chemical manufacturer awaiting approval predicts. “I believe a lot of us will probably just give up.”
The FDA stands by its process, saying through a spokesperson:
Given the recognized public health benefits of sunscreen use, the FDA is committed to finding ways to facilitate the marketing of sunscreen products that include additional over-the-counter (OTC) sunscreen active ingredients. To do so, the FDA relies on industry to submit the data needed to make safety and effectiveness determinations for these ingredients. The FDA must balance the public health benefits of access to a broader range of sunscreen active ingredients against the importance of providing an adequate margin of safety for products such as sunscreens that are marketed for regular use over a lifetime, including in young children and pregnant women.
The FDA will continue to work with industry and public health stakeholders as it implements the Sunscreen Innovation Act to ensure that the sunscreens consumers use every day on themselves and their families are safe and effective for daily, life-long use.
Meanwhile, Beisel continues her advocacy work and hopes to see increased urgency from the powers that be.
“We need to go and get these ingredients for sunscreen that are approved in other countries,” she implores. “We need to bring them here to help our chances, to better our chances of survival.”
She also had one parting message for anyone desiring a deep, dark tan this summer: “Your paleness is beautiful. Having healthy skin in beautiful.”