Posts Tagged ‘Radiation’

Skin Cancer Prevention: Will new FDA Rules Help?

Wednesday, June 29th, 2011

In yesterday’s post, I examined the various types of skin cancer and their prevalence in the US. Melanoma is the most deadly form of skin cancer and its incidence is on the rise. In that post, I examined some of the ways to protect yourself from the types of UV radiation that cause skin damage and cancer. One of these protection methods is the use of sunscreen. Sunscreen matters because the data is clear that sun exposure is what is causing deadly skin cancers:

  • About 90 percent of nonmelanoma skin cancers are associated with exposure to ultraviolet (UV) radiation from the sun.
  • The vast majority of mutations found in melanoma are caused by ultraviolet radiation.
  • About 65 percent of melanoma cases can be attributed to ultraviolet (UV) radiation from the sun.
  • One or more blistering sunburns in childhood or adolescence more than double a person’s chances of developing melanoma later in life.
  • A person’s risk for melanoma doubles if he or she has had more than five sunburns at any age.

Statistics from the Skin Cancer Foundation website

However, up until now, there has been very little regulation of the marketing of different sunscreens. It has been very difficult for the American public to know whether the sunscreen they were choosing was going to be effective in protecting them from both UVA and UVB rays.  There was also little way to know how much protection you were really receiving and whether the claims like “waterproof” and “sunblock” were just marketing or really claims with research behind them. Why does this matter? Check out this video from the FDA:

How the New FDA Rules Will Help

Well, some of this is going to change next summer. Last week, the FDA announced new regulations of sunscreen. If sunscreens meet the new legal standards, they can use certain marketing phrases so that consumers know what level of protection will be provided by the product. For example, “[u]nder the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Image from FDA.gov

Image from FDA.gov

The FDA explains the impact of the new regulations with the following:

  • Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
  • Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • “Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
  • Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

Information from the FDA

So what does this all mean? It means that if you want a sunscreen that will provide protection against both UVA and UVB, you need to choose one that says “broad spectrum” AND has a minimum SPF of 15. You also need to look for a time limit on the water resistance of the sunscreen. In the future, other regulations may take effect, including limiting the SPF claims to 50 since there is no evidence that a higher SPF offers greater protection. The impact of the current rules should be an easier way for consumers to know that they are getting the greatest possible protection from the sunscreen they buy.

The New Regulations Do Not Address the Safety of Ingredients

So, while the new sunscreens will make it clearer whether the sunscreen protects against both UVA and UVB rays and how long the sunscreen will remain water resistant, the regulations do not regulate the ingredients that comprise the sunscreens. The ingredients in the sunscreens have not been tested for safety. Dr. Len has written a blog on the American Cancer Society website that touches on this issue:

Many of the ingredients of sunscreens have been used for years, however the FDA acknowledged today that they have not been tested for safety using modern techniques. They did emphasize that the benefits of sunscreens containing these ingredients far outweigh the risks given their longstanding safety profile.

Nanoparticles present in sunscreen-especially those containing zinc and titanium oxides-have been another source of concern.  It is the use of “nanotechnology” that has made these effective sunscreens more acceptable since they don’t leave you with that white, pasty look that inhibited their use in the past.

Although it appeared during a news conference this morning that the FDA is satisfied at this time that products containing nanoparticles such as zinc and titanium oxides are safe when used as directed based on scientific evidence, another representative seemed a bit more cautious in his comments at second briefing held a couple of hours later by stating that nanoparticles are still being evaluated for safety.

The FDA did say they will continue to examine the science and the data regarding sunscreen ingredients, and will advise consumers promptly should they find evidence to the contrary regarding their safety profile.

One interesting outcome of the FDA’s announcement was their statement that they will be seeking further information from manufacturers and others on the safety and effectiveness of aerosol sunscreens.  The FDA apparently is concerned about inhalation risks as well as effectiveness in real-life use.  This is a sunscreen delivery method that many of us (including me) use often because of ease and convenience, and the questions regarding safety and effectiveness are certain to get some notice.

As more and more people are educated and aware of the risks of skin cancer, the use of sunscreens will presumably rise. Does it worry you that the new regulations deal more with marketing issues and confirming that the sunscreens do work effectively to minimize exposure to UVA and UVB rays than with the safety of the ingredients that provide that protection? Do you agree that since the risk of skin cancer outweighs the potential risks caused by the ingredients?

Personally, I use sunscreen and put it on my children daily. However, I also go out of the way to try to use ones that seem to have the “safest” record in terms of the chemicals involved. I also choose to use sun-shirts and other protective clothing as much as possible when at the pool or beach to minimize the amount skin I have to cover with sunscreen. Okay – honestly – it is also to minimize the amount of sunscreen smearing that I have to do every day. In order to work effectively, you are really supposed to use a lot of sunscreen all over exposed skin. As much as possible, we try to spend out time outside during the early morning and late afternoon/evening to minimize the direct exposure.

What steps do you take to protect yourself from sun exposure? What about the idea that a certain amount of sun exposure is good for Vitamin D production? What about the new FDA regulations, do they may sense? Will you shop for sunscreen differently?

Related Posts:

Skin Cancer: Types, Causes and How to Protect Yourself

CT Scans – Are You Being Properly Protected Against Radiation?

Thursday, December 2nd, 2010

According to new research presented at the annual meeting of the Radiological Society of North America, breast shields should be used for men and women undergoing CT scans of the chest/lungs. According to Terry Healey, M.D., Director of thoracic radiation at Alpert Medical School of Brown University, the breast shield is capable of reducing the level of radiation by about 30%.  This is significant considering that radiation can cause or contribute to the development of various malignancies (e.g. breast cancer, lung cancer, esophageal cancer).

Although some physicians argue that the use of breast shields may impact the quality of the CT scan (i.e., by producing artifacts such as streaks or lines making the interpretation of the study more difficult), this new research suggests that the use of breast shields does not impact the diagnostic quality of the CT scan. A breast shield is nothing more than a thin piece of heavy metal placed in front of the chest during the CT scan procedure.

Researchers studied 50 patients, who needed CT scans of the chest. Most of the patients were undergoing the study to rule-out lung cancer.  For some patient the shield was placed directly on the chest. For other patients, the shield was slightly elevated from the chest surface. Overall, some artifact was present in about 2/3 of the cases. However, in the opinion of the researchers, there were no instances where the artifact interfered with the diagnostic quality of the radiographic study.

According to Judy Yee, M.D., vice chair of radiology at the University of California: ”[T]here’s no good reason not to use breast shields. The cost is relatively low and the benefit large.”

Perhaps a larger patient population is needed for the results of this research to be more widely accepted by the radiology community. We’d appreciate anyone who has experience in this field to share their thoughts on this topic. Do such shields cause artifact that makes the study less accurate and potentially dangerous to a patient? Does the accuracy of the scan, when a shield is used, depend on which type of scanner is used or which generation of scanner is being used? Are there other techniques that can be used to protect a patient yet not run the risk of artifact “mis-read”? We’re not physicians or radiology technicians, so we welcome any insights those who are might have on this topic.

If you are concerned about excessive radiation and need to undergo a chest CT, ask your radiologist if a protective shield can be used during your CT scan. Discuss the issue and – as we always stress – take charge of your own medical care. Be an informed patient and be responsible for your own health and safety. Know what the issues, risks and benefits are and discuss it with your doctor. Then – and only then – make an informed decision.

Image from emedicine.medscape.com