The U.S. Food and Drug Administration announced today a ban on cigarettes with flavors characterizing fruit, candy, or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America. Smoking is the leading preventable cause of death in America.

The FDA’s ban on candy and fruit-flavored cigarettes, effective today, highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.

“Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation’s public health.”

Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.1

“Flavored cigarettes attract and allure kids into lifetime addiction,” said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. “FDA’s ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily.”

The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.

The FDA has also made available today an advisory to parents on the risks associated with flavored tobacco products.

“Youth are twice as likely to report seeing advertising for these flavored products as adults are,” said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner. “Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful.”

For many women, hormone replacement therapy (HRT) can alleviate the physical symptoms associated with the change of life. But despite the initial hype generated by post-menopausal women who noticed a marked improvement in their skin’s appearance while on HRT, dermatologists argue that scientific studies of estrogen do not show definitive improvements for skin rejuvenation of photodamaged skin and the potential risks when used long-term outweigh any potential skin benefits.

At the American Academy of Dermatology’s Summer Academy Meeting 2009 in Boston, dermatologist Margaret E. Parsons, MD, FAAD, assistant clinical professor of dermatology at the University of California at Davis in Sacramento, reviewed studies that demonstrate mixed results when examining whether or not estrogen improves the appearance of the skin and why patients should opt for tried-and-true cosmetic therapies instead.

“Based on the research conducted thus far, it does not appear that topical or oral estrogens are a viable long-term solution for improving sun-damaged or aging skin,” said Dr. Parsons. “In my practice, I do not prescribe estrogens for skin rejuvenation because of the lack of consistent data to support their use and the known risks of prolonged estrogen therapy – including an increased risk of breast cancer.”

Estrogens are a group of hormones that play a key role in regulating many aspects of a woman’s overall health, including reproduction. Certain parts of the body contain cells that are more receptive to the effects of estrogen than others, including the face. Dr. Parsons noted that estrogens benefit the skin in many ways, including an increase in collagen content, water retention and elasticity. During pregnancy when estrogen levels are at their highest, women experience thicker hair and glowing skin. On the other hand, post-menopausal women may notice that their skin does not have the same elasticity as it once did and that it is drier than normal.

In order to treat the most common symptoms associated with menopause – including hot flashes, mood swings and vaginal changes – physicians often prescribe hormone replacement therapy (HRT) to boost the body’s estrogen levels that drop dramatically during this change of life. However, when the results of the Women’s Health Initiative (WHI) study were announced in 2002, the way HRT was viewed to treat post-menopausal women changed significantly. For example, the WHI study found that women on long-term HRT could be at an increased risk for breast cancer and that the overall health risks of this therapy could outweigh the possible benefits. From that point on, HRT was prescribed more conservatively with lower dosing options and individualization based on each woman’s own health history.

Since there were reports of some women on HRT noticing an improvement in their skin, studies were conducted to determine if these results could be validated. Dr. Parsons explained that results of multiple studies examining the relationship between estrogens and skin improvement were inconclusive.

For example, one study examined whether low-dose hormone therapy improved aging skin in 485 women who were on average five years post-menopausal. Published in the September 2008 issue of the Journal of the American Academy of Dermatology1, the study concluded that estrogen supplementation did not provide any significant improvement in sun-damaged skin.

“Although this study found no obvious skin benefits in this particular group of women, another study that looked at women who began HRT at the onset of menopause – and did not wait to start treatment like the other group – did experience noticeable improvements in their skin,” said Dr. Parsons. “These studies pose unanswered questions as to the timing and duration of prescribing HRT to produce skin benefits. For this reason, the jury is still out as to whether estrogens can be effective for aging skin.”

In addition, another study showed that applying topical estrogen to sun-damaged facial skin and sun-protected skin on the hip of post-menopausal women resulted in stimulated collagen production and less wrinkling in the sun- protected hip skin, but no noticeable improvement in the sun-damaged facial skin.

Dr. Parsons added that more research will likely continue in the future to examine the possible benefits of estrogen for improving aging skin. Until then, she stressed that there are many effective therapies that dermatologists regularly use to address the common signs of aging – including retinoids, alpha-hydroxy acids and other topical therapies, as well as chemical peels, lasers, botulinum toxin and skin fillers, to name a few.

“The best advice I can offer my patients to improve their overall skin health is to wear sunscreen with a sun protection factor (SPF) of at least 30, don’t smoke and use a topical retinoid,” said Dr. Parsons. “When it comes to minimizing the cumulative effects of sun damage, an ounce of prevention really does go a long way.”

For more information on improving the appearance of your skin, go to the “AgingSkinNet” section of www.skincarephysicians.com, a Web site developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.

Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.

People who suffer serious head injuries are more likely to survive if they have alcohol in their bloodstream, a new study suggests.

Data on more than 38,000 people with such injuries showed that 9.7 percent of those with no trace of alcohol in the bloodstream died in the hospital, compared to a 7.7 percent death rate for those whose tests showed the presence of alcohol, according to a report in the September issue of the Archives of Surgery.

While the injured people whose blood contained alcohol were more likely to have complications (12.9 percent versus 9.8 percent), they spent less time on a ventilator or in the intensive care unit, said researchers at Cedars-Sinai Medical Center in Los Angeles.

The information came from analysis of the 53 percent of 72,294 cases listed in the National Trauma Data Bank in which alcohol testing was done. Traces of alcohol were found in 37.9 percent of those tested.

Smaller human studies have shown the same effect, as have animal studies, the report said. The animal studies indicated several possible mechanisms for alcohol’s protective effect, such as diminished activity of catecholamines, the “fight-or-flight” hormones that include adrenaline, the researchers wrote.

“Our group has been working on blunting these catecholamine responses,” said study author Dr. Ali Salim, an associate professor of surgery at Cedars-Sinai. “We came across animal studies showing that alcohol can do that in brain injury, so we looked at our largest database to see if we could find a correlation.”

The study “raises the intriguing possibility that administering ethanol [alcohol] to patients with brain injuries may improve outcome,” the report said.

But it’s a possibility that requires intensive study before being put into medical use, said Dr. Homer C.N. Tien, an assistant professor of surgery at the University of Toronto, who led a study that found similar results three years ago.

“It just raises a possibility,” Tien said of the new study. “The message is that we should look at this more closely.”

What would be needed would be more studies in both animals and humans, he said. “Then we might propose a trial to give alcohol to people who have brain injury.”

The higher incidence of complications seen in people who have alcohol in their blood when they suffer brain injuries is understandable, Tien said. “People who drink and drive tend to have alcohol abuse or dependence problems, so they are more likely to have health issues,” he said.

And alcohol has to be handled carefully in medicine and real life, Tien said. “The report was very careful to say that alcohol has a huge potential to destroy life,” he said. “From a public health point of view, it is not something we should mess with. But ethanol may have a pharmacological role if administered in discrete amounts in certain circumstances.”

Dr. M. Sean Grady, chairman of the department of neurosurgery at the University of Pennsylvania, was even more cautious.

“I have a lot of caveats about the information they provide,” he said. “Only half the people in the database had their blood alcohol measured, so we have to worry about their conclusions.”

While Grady said “the novel use of a large database is a major contribution, I’m not confident that their observation is true or not.”

Like Tien, Grady said more research on the issue is needed. “Instead of using an administrative database, we could do a number of clinical trials for traumatic brain injury collecting ethanol data as part of the studies,” he said. “Those studies would have more detail and could give a better sense of whether ethanol plays a positive or negative role.”

“Mechanism-wise, we need to figure out more about why this happens,” Salim said. “We need to know about why it happens and how much alcohol we might need. Higher levels seem to worsen outcome. Also, we have to look at timing. A lot needs to be worked out.”

Funding for studies of alcohol in brain injury would not be easy to get “because you’re talking about an agent that contributes to brain injury,” Salim said. “The key is to look at mechanism, and try to find alternatives for that mechanism.”

U.S. health officials have issued a public health alert to pharmacists and pediatricians about potential dosing errors involving liquid Tamiflu for kids.

The alert, issued late Thursday, followed a warning by scientists that parents could give the wrong dose of Tamiflu to their children as treatment for the H1N1 swine flu because the dosing instructions don’t always coincide with the measurement markings on the syringe that comes with the liquid medication.

In its alert, the U.S. Food and Drug Administration said “the agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.” It advised health-care providers to “write doses in mg [milligrams] if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug. ”

The earlier warning, published online Wednesday in a letter in the New England Journal of Medicine, also urged doctors and pharmacists to be on the lookout for this potential dosing mismatch and to help parents figure out exactly how much Tamiflu to give their child.

The letter authors, from Northwestern University Feinberg School of Medicine in Chicago, Emory University in Atlanta and Weill Cornell School of Medicine in New York City, cited a case that they said was probably happening all over the United States: The parents of a 6-year-old girl diagnosed with the H1N1 virus received a prescription for Tamiflu Oral Suspension that told them to give her three-fourths of a teaspoon of the medicine two times a day. However, the dosing syringe inside the box was marked in milligrams. The confused parents, both of whom are health professionals, had to figure out how to convert the measurement, something most parents would find too daunting to do.

“It’s an egregious error that there is a conflict in the prescription labeling instructions and the dosage device that comes in the exact same box. It’s incredibly confusing to parents,” letter co-author Michael Wolf, an associate professor of medicine and learning sciences at Northwestern University Feinberg School of Medicine, said in a news release from the university. “Tamiflu is one of the main courses of treatment right now for H1N1, and it is being widely used among children, even infants.”

The letter’s authors recommended that all pharmacies and physicians be instructed to ensure that the prescription label instructions for use are in the same dosing units as those on the measurement device.

“Parents being prescribed Tamiflu for their children need to make sure they understand exactly how to take it at the time they pick it up at the pharmacy,” lead letter author Dr. Ruth Parker, a professor of medicine at Emory, said in the release.

Wolf warned that an overdose could be toxic, and an underdose could be ineffective.

And even more complex calculations might be necessary now that the U.S. Food and Drug Administration has approved Tamiflu for off-label use among children under the age of 1, because the syringe doesn’t include small enough measuring increments for these youngest patients.

“We need to have a better system for ensuring there are standardized directions for administering drugs to children,” letter co-author Dr. Alastair Wood, a professor of medicine and pharmacology at the Weill Cornell School of Medicine in New York City, said in the news release. “We need to move to a system where all doses are given in the same units, preferably milliliters.”

Meanwhile, a report released Thursday supported recent U.S. Centers for Disease Control and Prevention recommendations not to use negative rapid test results for management of patients that may be infected with the pandemic swine flu virus.

Researchers in Connecticut assessed the performance of the rapid influenza diagnostic test (RIDT) used during outbreaks of pandemic influenza A (H1N1) at two schools in Greenwich in May. Of the 63 people tested at Greenwich Hospital, infection was confirmed in 49 patients.

The results of the RIDT were compared with the reverse transcription –polymerase chain reaction assay. A low sensitivity of 47 percent was found for the rapid test. This poor performance couldn’t be explained by the clinical features of the patients or by the timing of the specimen collection, said Dr. James R. Sabetta, of the Greenwich Department of Health and the Connecticut Department of Public Health, and colleagues.

While a positive rapid test for influenza is helpful, a negative test doesn’t rule out pandemic swine flu, the researchers said.

The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

Folotyn was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.

Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin’s disease, and the rest are called non-Hodgkin’s lymphomas. PTCL involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in less than 9,500 patients each year in the United States.

“Folotyn’s approval demonstrates FDA’s commitment to the rapid approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

When studying a new drug, it can take time to learn whether a drug actually provides real improvement for patients – such as living longer or feeling better. This real improvement is known as a “clinical outcome.” In 1992 FDA instituted accelerated approvals which allow earlier approval of drugs based on a surrogate endpoint, a laboratory measurement or physical sign that can serve as an indirect or substitute measurement for clinical outcomes.

In the case of Folotyn, this meant the FDA approved the drug based on evidence that it reduces tumor size, because tumor shrinkage is considered reasonably likely to predict a clinical benefit such as extending the survival of cancer patients. Tumor shrinkage was seen on imaging scans in one study. Of 109 patients with PTCL in the trial, 27% had reduction in tumor size.

To speed the drug’s availability, Folotyn was granted priority review, ensuring a review within six months rather than 10 months for a standard review. The drug was also designated as an orphan drug, which provides a variety of financial incentives to manufacturers that develop drugs for a small number of patients with a rare disorder.

The most common adverse reactions seen with Folotyn were irritation or sores of the mucous membranes such as the lips, the mouth, and the digestive tract, low platelet cell counts, low white blood cell counts, fever, nausea, and fatigue.

Folotyn can harm a fetus. Women should avoid becoming pregnant while being treated with this drug and pregnant women should be informed of the potential risk.

Patients treated with Folotyn should take folate and vitamin B12 supplements to reduce mucous membrane irritation.

Folotyn is manufactured by Allos Therapeutics Inc. of Westminster, Colo.

As a condition of accelerated approval, Allos will conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer.