Posted by on March 17, 2013 - 9:33am

The U.S. Food and Drug Administration today approved Lymphoseek  Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumor. By surgically removing and examining the lymph nodes that drain a tumor, doctors can sometimes determine if a cancer has spread.

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug. Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (1981).

“Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma,” said Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity.”

Lymphoseek’s safety and effectiveness were established in two clinical trials of 332 patients with melanoma or breast cancer. All patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes.

Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and/or Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

The most common side effects identified in clinical trials was pain or irritation at the injection site.

Lymphoseek is marketed by Navidea Biopharmaceuticals, Inc. based in Dublin, Ohio.

For more information:

FDA Approved Drugs: Questions and Answers



Posted by on July 29, 2012 - 8:13am

A new study points to indoor tanning as a cause for melanoma, the most serious type of skin cancer,  particularly among young sunbed users.  Overall, there was a 20% increased risk for melanoma with any indooor tanning, according to Mathieu Boniol, PhD, of the International Prevention Research institute in Lyon, France, and colleagues.   The risk nearly doubled when sunbed use began before age 35.

"Powerful ultraviolet tanning units may be 10 to 15 times stronger than the midday sunlight on the Mediterranean Sea, and repeated exposure to large amounts of ultraviolet A delivered to the skin in relatively short periods (typically 10 to 20 minutes) constitutes a new experience for humans," Boniol's group observed.

The last meta-analysis on risk of melanoma with indoor tanning was conducted in 2006. It showed an increased risk, but no dose-response could be identified.  Since that time considerably more data have been published, so Boniol and colleagues performed an updated meta-analysis that included 27 studies and 11,428 cases of melanoma from 18 countries in western and northern Europe.

In studies that considered risk according to the number of tanning sessions each year, there was a 1.8% increase in melanoma risk for each sunbed exposure.  For high use of indoor tanning, the risk increased by 42%, and when initial exposure was more than 5 years before the diagnosis of melanoma, the relative risk was 1.49.

The researchers reported that melanoma could be attributed to sunbed use in 5.4% of cases overall, and was associated with 6.9% of all melanoma cases in women and 3.7% of cases in men.

This means that in the  European countries included, about 498 women and 296 men would die each year from a melanoma as a result of being exposed to indoor tanning using artificial ultraviolet light," the researchers stated.

They also noted that it was unlikely that the increases in melanoma could be explained by greater sun exposure.

"Compelling evidence that use of sunbeds can be a cause of melanoma and not just a proxy for sun exposure arises from the investigation of a melanoma epidemic in Iceland, a country located between 64 and 66 degrees North and where sunny days are uncommon," the researchers wrote.

That epidemic began in 1990, with a sharp increase in cases among young women, but began to decline 10 years later, when Icelandic regulatory authorities cracked down on tanning facilities.

The researchers noted that some data have suggested that sunbed-related melanoma may not be as aggressive as the solar-induced malignancy, but cautioned that the overall burden of disease is likely to rise because of the continuing popularity of indoor tanning, particularly among young people.
Source reference:
Boniol M, et al "Cutaneous melanoma attributable to sunbed use: Systematic review and meta-analysis" BMJ 2012; DOI: 10.1136/bmj.e4757.






Posted by on May 25, 2012 - 6:26am

The National Council on Skin Cancer Prevention has designated the Friday before Memorial Day as “Don’t Fry Day.”  This year it is May 25.   The goal?  To make sure people stay safe in the sun and protect their skin while enjoying the outdoors—on “Don’t Fry Day” and every day.

Here’s why. Skin cancer is on the rise in the United States; the American Cancer Society estimates that one American dies every hour from skin cancer. In 2012 alone, the American Cancer Society estimates there will be more than 76,250 new cases of malignant melanoma, the most serious form of skin cancer.

“Don’t Fry Day” offers simple steps that you and your family can take to prevent sun-related skin cancer, such as:

  • Slip on a shirt
  • Slop on sunscreen of SPF 15 or higher
  • Slap on a wide-brimmed hat.
  • Wrap on sunglasses.

For more information on resources available for "Don’t Fry Day" and skin safety, visit

Learn more about how to protect your skin by clicking HERE.

Posted by on November 2, 2011 - 6:39am

Next time you get a haircut, you might end up with a referral to a dermatologist.

A recent survey of Texas hair salons found more than a third of stylists check at least half of their customers for suspicious moles on the scalp, and most have referred people to a doctor lest the mole turn out to be skin cancer. What's more, half the hairdressers were keen to learn more about skin cancer to help extend the reach of doctors screening for the disease, according to findings in the Archives of Dermatology.

"What we would like to do in the next couple of years is to train as many hair professionals as possible," said Alan Geller, of Harvard's School of Public Health in Boston, who led the new work. "We think this holds a lot of promise."  He's not the only one hoping to spread the gospel of modern medicine through hair salons and barbershops, whose clientele might not otherwise see a health provider. There are many urban  programs that utilize barber shops and hair salons to spread preventive health messages related to breast and prostate screening,  heart disease and diabetes.

But other experts aren't convinced.   "As a rule, you should do what you're good at," said Dr. Martin Glud, a dermatologist at Bispebjerg Hospital in Copenhagen, Denmark. "If you're a hairdresser, that's cutting hair, with all due respect."    Earlier this year, Glud published a study showing that while the rates of melanoma—the deadliest form of skin cancer—have shot up recently, the disease's death toll has barely increased. That indicates that at least in some cases, the additional tumors being diagnosed wouldn't have gone on to kill the person.   "Some believe the rise in melanomas is really a sign of overdiagnosis," Glud told Reuters Health.

About one in 50 white Americans born today will get melanoma at some point during their life, according to the American Cancer Society. The group estimates that roughly 8,800 will die from the disease in 2011.   Because melanomas are so rare—particularly on the neck and scalp—and moles are very common, Glud worries that hairdressers might sound a lot of false alarms, contributing to the problem of overdiagnosis.   "It's a slippery slope," he said.

Geller acknowledged that having hair salons double as screening centers could end up taxing scarce health care resources.  "We would need to make sure that this doesn't lead to a tremendous drain for the health care system," he cautioned.  Suspicious moles are those that itch, bleed, change color or grow asymmetrically. A dermatologist may choose to biopsy such a mole and remove it if cancer is found. That can leave a scar, and may require a skin graft in the case of larger tumors.   Geller, who polled 203 hair professionals from a chain of 17 salons in the Houston area, said there is "circumstantial evidence" that screening for skin cancer saves lives. But he acknowledged there are no direct experiments to prove that point.

As a result, the U.S. Preventive Services Task Force, a federally appointed expert panel, says there is too little data to balance the harms and benefits of skin cancer screening at the doctor's office, let alone hair salons."I certainly can't support the implication of this study that we should be training hairdressers to do skin screenings," said Dr. Michael LeFevre from the task force.   But he added that doesn't mean they shouldn't point to moles their customers might not have noticed themselves. "To raise the individual's awareness that there is something there is not inappropriate," he told Reuters Health. "That is different from referring them to the doctor."

Editor's Note:   Interesting debate, but since I really never look at my scalp, I would appreciate my hairdresser---especially someone who has been cutting my hair for years---  pointing  out anything unusual!   A visit to a dermatologist to confirm any suspicious mole could result in early and a less costly diagnosis.