Posts Tagged ‘FDA’

A Happy, HEALTHY Father’s Day for Dad AND Kids

Saturday, June 18th, 2011

Our best wishes for a happy and HEALTHY Father’s Day!  And apropos to that, WebMD posted an excellent reminder about the need to protect young children from the sun because “the changes that lead to skin cancer may actually begin during baby’s first year, when an infant’s skin is most vulnerable to burns and sun damage, according to a new report in the July issue of Pediatrics.”  So, here’s a reminder of best sun safety practices for kids…and even kids at heart:

“A child’s skin has structural quality that makes it more vulnerable to the effects of UV radiation, and this can result in an increased risk of later skin cancer,” said Roya Samuels, MD, a pediatrician at the Steven and Alexandra Cohen Children’s Medical Center of New York in New Hyde Park.

New York City dermatologist Doris Day, MD, says that “newborns, infants, and toddlers have skin that is continuing to develop…and it is really important to protect it,” she says.

However,  it’s not easy to find sunscreen for infants and toddlers: “Sunscreens for infants must be non-irritating to the skin and eyes…” For both these reasons, for the first six months, infants should be covered from direct sun via clothing, hats, etc., This is also important since harmful rays can penetrate car and home windows. (Consider clear protective window coatings.)

EWG-dadimage Then, in selecting a sunscreen, with a minimum SPF of 15, many parents “may prefer that infant sunscreen leave a temporary film so they can be sure all exposed body parts are well covered. In addition, water-resistance is an important quality for infant and toddler sunscreens….” as is the need to ensure a sunscreen blocks against both UVA and UVB rays.  The thicker zinc- or titanium-based products are more opaque and sit on skin more than getting absorbed.  “…And zinc and titanium don’t irritate the eyes as much because they tend to stay in place.”  babyganics-coverup-baby-sunscreen-mdn

We shared the Environmental Working Guide’s new rating of more than 1,000 sun products in our last post.  And The Daily Green culled through that list to post their selections from that list of the 13 most affordable natural kid and baby sunscreens with mineral sunblocks.

As mentioned in WebMD:

Ravinder Khaira, MD, a pediatrician with Sutter Independent Physicians in Sacramento, Calif., says that applying sunscreen — and reapplying it according to the directions — is the No. 1 way to prevent sunburn and sun damage that can lead to skin cancers when children grow up.

Take special care to cover their ears, nose, and scalp, he says.

Young children do have highly sensitive skin, so it’s a good idea to do a small patch test before slathering on a new sunscreen. “Test it on the forearm and wait about 30 to 40 minutes to see if any hives, swelling, redness, or itchiness occur,” Khaira says.

If children get sunscreen in their eyes, flush their eyes and face with cold water to minimize any irritation, he says.

It’s not always easy being a dad…or a mom.  But once the kids are slathered up, you can sit back and rest.  For a second.

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There’s an App – and a list – for that Sunscreen

Monday, June 6th, 2011

Note:  Since we posted the below entry, good news: the FDA has now announced their new guidelines which will include mandatory labeling by the summer of 2012.  Here’s an excellent overview from ABC:

In the meantime, please remember to review your choices, and keep applying that sunscreen!

The Environmental Working Group’s guide to effective and less-toxic or non-toxic sunscreens is out again with additional options on this 2011 version. This comprehensive list, and associated articles, does an excellent job of explaining the challenges with both the FDA’s progress in setting standards for sun-protection products…and consumers’ understanding of the elements that go into that sunscreen — good or bad.

Even since we shared their 2010 list last May, more outcry has been heard about a common ingredient in many mainstream sunscreens, that is a derivative of Vitamin A: Retinyl palmitate.  In fact, in June of last year, Senator Chuck Schumer called on the FDA to investigate it, as mentioned in this release from his office:

Retinyl palmitate is an ingredient found in most of the 500 most popular sunscreen products. Scientists at both the NCTR and the NTP have been working diligently over the last decade at the FDA’s request in order to determine whether this Vitamin A derivative, retinyl palmitate, is safe to use in sunscreen products. In one study, tumors and lesions developed up to 21 percent faster in lab animals coated in retinyl palmitate-laced cream than animals treated with a cream that did not contain RP. While these studies have been completed for almost a year now, the FDA has not issued an assessment of ruling on either of them….

Schumer added, “Millions of Americans use sunscreen to keep themselves and their families protected from the dangers of too much sun. If the product they are using is doing more harm than good, they have a right to know.”

Of course, there is NO safe way to TRY to tan, just as the American Academy of Dermatology says. But in tan PREVENTION, there are things to consider.  Here’s something from a section on their Website about sunscreen, that you might not have known:

Q: When should sunscreen be used?
A: Sunscreen should be applied every day to exposed skin, and not just if you are going to be in the sun. UVB rays cannot penetrate glass windows, but UVA rays can, leaving you prone to these damaging effects if unprotected.

For days when you are going to be indoors, apply sunscreen on the areas not covered by clothing, such as the face and hands. Sunscreens can be applied under makeup, or alternatively, there are many cosmetic products available that contain sunscreens for daily use. Sun protection is the principal means of preventing premature aging and skin cancer. It’s never too late to protect yourself from the sun and minimize your future risk of skin cancer.

Don’t reserve the use of sunscreen only for sunny days. Even on a cloudy day, up to 80 percent of the sun’s ultraviolet rays can pass through the clouds. In addition, sand reflects 25 percent of the sun’s rays and snow reflects 80 percent of the sun’s rays.

So, as the inquiry continues, we, again, are of the belief that smart skin cancer prevention tactics start with covering up and include generous use of sunscreen. Of those, perhaps making a more natural choice of mineral (titanium dioxide, for example) vs non-mineral protection is a better option.  The  introductory paragraph to the Environmental Working Group’s guide says it all:

The best sunscreen is a hat and a shirt. No chemicals to absorb through the skin, no questions about whether they work. But when you can’t get away from exposing your skin to the sun, use EWG’s top-rated sunscreens to provide broad-spectrum (UVA and UVB-sunburn) protection with fewer hazardous chemicals that penetrate the skin. Sunscreen and sunblock makers are awaiting FDA approval for a wider selection of UVA-blocking chemicals. In the meantime, all [the Guide's] top-rated products contain either zinc or titanium minerals to help cut UVA exposures for sunscreen users.

PS: And now, yes, “there’s an app for that.”  EWG Sunscreen Buyer's Guide for iPhone, iPod touch, and iPad on the iTunes App Store_1307304366893The EWG Sunscreen guide reviews some 1700 products, so keeping them straight at the point of purchase will be easier for iPhone owners now.  Check it out in iTunes app store, for free.   

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Deciphering Treatment News for Melanoma

Tuesday, September 14th, 2010

The past couple of months, some compelling new stories have circulated about promising Melanoma treatments. In June, you read about “ipi” – in the news and here on Melanoma Updates. And, this past month, more news touted early clinical trials with another targeted therapy drug, PLX4032. As always, we are cautiously optimistic, but to shed some light on two exciting, but still emerging options, I thought a basic overview might be helpful.

So, what do these drugs do? Quite simply, one attacks a gene mutation found in about 50% of all melanoma patients. And one works to modulate the immune system.

Ipi for Immunity

Ipi is an immune therapy drug: it tries to activate or stimulate the immune system to clear cancer cells. With the usual current immuno-therapy treatments, such as interleukin, we haven’t been able to significantly extend the immune response to melanoma cells. But Ipi has been shown to extend that immune protection for longer and longer time spans, for the first time ever, leading to 2-year survival rates in around 56% of a certain group of patients (again, with advanced melanoma survival rates typically not extending past 10 months.) Ipi has been in advanced trials for years, and the very promising Phase III results spurred the recent media frenzy. As such, it is on the fast track for priority approval – perhaps as soon as the end of this year – and may become the first new melanoma drug approved in decades.

Gene Mutation Therapy

First, it’s important to know that about half of patients with metastatic melanoma have a mutation in a gene called BRAF. This is a gene that seems to program the “runaway cell division that is a hallmark of cancer.” When the impact of the BRAF gene mutation was established, scientists set to work to find a way to switch it off or slow down the programming to cells, and one of those ways may be an exciting new gene therapy drug, PLX4032 (no catchy name as of yet.) A remarkable 81% of cases showed marked and in many cases immediate improvement and reduction in tumor size and growth. Granted, the news came after just a small Phase I clinical trial, but there was such excitement about the results that in a rare move, the drug has skipped Phase II and is now being tested in longer term and wider scope Phase III trials.

As reported in USA Today:

No other drug has ever helped that high a percentage of patients with melanoma or any other solid tumor, says Paul Chapman, co-author of the study in today’s New England Journal of Medicine. The results are especially striking, he says, considering that only 10% to 20% of patients respond to standard treatments for melanoma, which don’t improve overall survival.

USA Today also has a sidebar Q&A piece that does a nice job of summarizing the caution and optomisim surrounding PLX4032. They include a phone number for more information about it as well: 888-662-6728.

A One-Two Punch?

Since the back to back encouraging news broke for ipi and PLX4032, some are combining the two in other drug therapy trials. Here is a quote from the National Cancer Institute Bulletin this past week:

In June, researchers announced that ipilimumab, a treatment that targets the immune system, helped patients with advanced melanoma live longer. Together, ipilimumab and PLX4032 have changed the landscape of melanoma research and raised the prospect that the new agents could be tested in combination or sequentially, said Dr. Claudio Dansky Ullmann, who oversees melanoma trials for the NCI Cancer Therapy Evaluation Program.

"These studies have opened the doors to a lot of possibilities for treating metastatic melanoma,” said Dr. Dansky Ullmann. "We can now test many treatments that were not available or proven until recently. This area of research is taking off.”

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Melanoma Making News

Tuesday, January 26th, 2010

I thought I’d share a compilation this week of some interesting stories that have made the melanoma news alerts recently. Some very exciting developments…for people AND pets!

1. Clamping Down on Tanning Beds:

If you’ve been reading these posts, you know I’ve been mentioning the effort to increase restrictions on tanning beds. This has been championed most strongly in Great Britain and "down under,” but the US is catching up. The FDA will be reviewing guidelines in March.  Here’s a great summary, including the expected response from the Indoor Tanning Association:

Pooches to Pouches

2. Be a best friend to your dog. Keep your ears perked for release of a new therapeutic DNA vaccine designed to aid in extending survival of dogs with oral melanoma. The USDA just licensed Merial Limited for this canine melanoma vaccine.

Since melanoma is one of the most common forms of cancers in dogs, here’s a factual overview of types and symptoms.

3. A clue to a cure from Kangaroos? Aussie scientists are researching how Kangaroos auto-repair their damaged DNA for clues to how we might adapt a therapy down the road for humans.

4. Driving Down Under. A little further south of Australia, the kiwis are getting the news out about prevention while driving. We often take our cues from the southern hemisphere on skin cancer prevention as they have some of the highest rates of the disease in the world, and thus are some of the most proactive in prevention tactics. So I wanted to share this latest suggestion of theirs: a reminder to motorists that they need protection even while inside vehicles, as windows only block 37% of harmful rays.

There are a lot of fashionable driving gloves these days, so why not make a statement!?

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Facts Don’t Lie on These Beds

Thursday, December 3rd, 2009

We think of summer fun and we’re reminded to think of safe sun exposure. But what about when winter comes? Too many of us — either in pursuit of SAD relief via a warm-weather getaway, or misguided goals of maintaining a tan — don’t stay conscious of skin protection year round. And skin cancers are increasing, especially among young women.

As we noted in a previous post about tanning bed bans for teens in England, there is real danger from even “artificial sun”…and with more research findings exposed recently, it’s even worse than we thought.

Let’s face facts:

  • Nearly 30 million people tan indoors in the US, every year. And more than one-third are teens.
  • 71% of salon tanners are girls ages 16 to 29.
  • And let’s connect the dots: The American Academy of Dermatology lists melanoma as the second most common cancer in women 20 to 29 years old.

Now here is the scariest stat of all according to Peter Boyle, MD, Director of IARC (International Agency for Research on Cancer):

the link between youthful sunbed tanning and melanoma was “prominent and consistent” – a 75 percent increase in risk of melanoma among those who first used sunbeds in their twenties or teen years.”tanning-bed

Though rates of squamous cell or basal cell carcinomas are not quite as significant, possibly because of limited data, we’re nonetheless talking a 75% increase in risk in the deadliest form of skin cancer.

Our National Institute of Health was far ahead of the IARC, part of the World Health Organization, in determining sunlamps and sunbeds to be known carcinogens. In 2002 they specifically included UVA, UVB and UVC as “anticipated to be human carcinogens.” Yet, it is always good to have further awareness and validation on a global scale. This year IARC’s conclusions, listed in an excellent update on the FDA site, have led them to also move tanning beds from “probably carcinogenic to humans” into the highest cancer risk category: “carcinogenic to humans.”

This has helped pave the way for banning indoor tanning by teens. As a matter of fact, our hat is ON (a little skin cancer prevention humor) to the people of MD who have listened to their MDs. On November 12th, 2009, Howard County, MD became the FIRST IN THE NATION to ban those under 18 from using indoor tanning devices!

Remember, all exposure to UV radiation-whether from the sun, or from artificial sources such as sunlamps used in tanning beds, increases the risk of developing skin cancer, according to the National Cancer Institute (NCI). The Skin Cancer Foundation says that:

“One blistering sunburn in childhood more than doubles a person’s chances of developing the deadliest form of skin cancer later in life.”

Do you think we should ban access to tanning salons by those under 18? The statistics are continuing to pour in, but many salons still don’t abide by rules or recommendations of limiting visits for their customers by either age or frequency.

So, just say no. And monitor your kids’ skin tone!

Share

Facts Don’t Lie on These Beds

Thursday, December 3rd, 2009

We think of summer fun and we’re reminded to think of safe sun exposure.  But what about when winter comes?  Too many of us — either in pursuit of SAD relief via a warm-weather getaway, or misguided goals of maintaining a tan — don’t stay conscious of skin protection year round. And skin cancers are increasing, especially among young women.

As we noted in a previous post about tanning bed bans for teens in England, there is real danger from even “artificial sun”…and with more research findings exposed recently, it’s even worse than we thought.

Let’s face facts:

  • Nearly 30 million people tan indoors in the US, every year. And more than one-third are teens.
  • 71% of salon tanners are girls ages 16 to 29.
  • And let’s connect the dots: The American Academy of Dermatology lists melanoma as the second most common cancer in women 20 to 29 years old.

Now here is the scariest stat of all according to Peter Boyle, MD, Director of IARC (International Agency for Research on Cancer):

the link between youthful sunbed tanning and melanoma was “prominent and consistent” – a 75 percent increase in risk of melanoma among those who first used sunbeds in their twenties or teen years.”tanning-bed

Though rates of squamous cell or basal cell carcinomas are not quite as significant, possibly because of limited data, we’re nonetheless talking a 75% increase in risk in the deadliest form of skin cancer.

Our National Institute of Health was far ahead of the IARC, part of the World Health Organization, in determining sunlamps and sunbeds to be known carcinogens.  In 2002 they specifically included UVA, UVB and UVC as “anticipated to be human carcinogens.”  Yet, it is always good to have further awareness and validation on a global scale. This year IARC’s conclusions, listed in an excellent update on the FDA site, have led them to also move tanning beds from “probably carcinogenic to humans” into the highest cancer risk category: “carcinogenic to humans.”

This has helped pave the way for banning indoor tanning by teens.  As a matter of fact, our hat is ON (a little skin cancer prevention humor) to the people of MD who have listened to their MDs.  On November 12th, 2009, Howard County, MD became the FIRST IN THE NATION to ban those under 18 from using indoor tanning devices!

Remember, all exposure to UV radiation-whether from the sun, or from artificial sources such as sunlamps used in tanning beds, increases the risk of developing skin cancer, according to the National Cancer Institute (NCI).  The Skin Cancer Foundation says that:

“One blistering sunburn in childhood more than doubles a person’s chances of developing the deadliest form of skin cancer later in life.”

Do you think we should ban access to tanning salons by those under 18?  The statistics are continuing to pour in, but many salons still don’t abide by rules or recommendations of limiting visits for their customers by either age or frequency.

So, just say no.  And monitor your kids’ skin tone!

Share