New FDA Guidelines Will Speed Approvals of Flu Vaccines
Guidelines to help speed approvals of new vaccines against pandemic flu have been drafted by the U.S. Food and Drug Administration.
The new rules are designed to help companies already licensed to make seasonal flu shots obtain quicker government approval for new pandemic immunizations. This could shorten the approval process by many months. However, unlicensed companies will still be required to go through the complete regulatory process, Bloomberg news reported.
The draft guidelines will be posted for a 90-day comment period before they become final.
This is the first time the FDA has established approval guidelines specifically for flu vaccine makers. It's part of an effort to encourage development and use of vaccines in anticipation of a possible influenza pandemic. Health officials fear that the H5N1 strain of bird flu could pose such a threat.
"We felt that this was timely as we try to prepare for a pandemic, increase capacity and bring in new manufacturers," Norman Baylor, head of vaccine research at the FDA's Center for Biologics Evaluation and Research, told Bloomberg news.
Bill Would Eliminate Hundreds of Food Label Warnings
A bill currently being debated by U.S. lawmakers could lead to the removal of hundreds of warnings on food labels, the Associated Press reported.
The measure would prohibit states from adding warnings that are different than those required by the federal government. Currently, states can order their own warnings on food labels.
For example, Alaska requires warning labels on farmed fish, which can contain pesticides or other chemicals, while Minnesota consumers must be alerted when alcohol is an ingredient in candy.
The bill has many opponents, including state agriculture departments, the associations of state food and drug officials, and the National Conference of State Legislators, the AP reported.
"This would be the most sweeping change in decades to our nation's efforts to protect the food supply. This is a disaster waiting to happen," warned Rep. Henry Waxman (D-Calif).
Even though there is widespread opposition, the bill has a lot of support in the House of Representatives. More than half the House members have signed on as co-sponsors. The food industry supports the bill because it wants warnings to be consistent in all states.
Gene Increases Depression Risk: Researchers
A gene that's present in up to 20 percent of humans and doubles the risk of depression has been identified by Australian scientists.
They found that people with a shorter-than-normal version of the 5-HTTLPR gene had an 80 percent chance of developing depression when faced with three or more negative life events in a year, Agence France Presse reported.
People with "genetic resilience" against depression had a 30 percent increased risk of depression when having to deal with stressful life events. The study of 127 people appears in the British Journal of Psychiatry.
The University of New South Wales researchers noted that depression was not predetermined in people with the shorter version of the gene. A series of negative effects were needed to tip these people into depression.
Researcher Kay Wilhelm said the study could prove important in treating depression. "Perhaps you could reduce the likelihood of depression amongst those with the vulnerable genotype by training them in terms of improving their coping styles and stress responses," she told AFP.
Ethicists Call for Halt of Blood Substitute Study
Medial ethicists have condemned a study that's testing a blood substitute on trauma patients without their consent and say the trial should be halted.
Northfield Laboratories of Evanston, Ill., started the study of its blood substitute Polyheme in 2004. In this study, trauma patients get Polyheme or saline fluid on the way to the hospital. Once they're at the hospital, patients receiving Polyheme continue receiving it for 12 hours, while patients who were on saline get blood transfusions, the Associated Press reported.
The study includes more than 600 patients at 31 trauma centers in 18 states. It's expected that preliminary findings from the study will be released later this year, the news service said.
In an article to appear next week on the Web site of the American Journal of Bioethics, medical ethicists write that real blood shouldn't be withheld from people without their consent.
The ethicists say that testing Polyheme against blood should be done separately in patients who can give consent or who have family members who can give consent, the AP reported.
"There is a serious ethical flaw in this complicated and novel study," they write in the article.
During a previous study of Polyheme that was halted by Northfield Laboratories, 10 heart surgery patients who received Polyheme suffered heart attacks, while patients who received real blood did not.
Erbitux Approved to Treat Head and Neck Cancers
The drug Erbitux has been approved to treat head and neck cancer, according to the U.S. Food and Drug Administration.
The drug, which received FDA approval in 2004 to treat colorectal cancer, may now be used in combination with radiation to treat squamous cell cancer of the head and neck that can't be surgically removed, the Associated Press reported.
The FDA also approved Erbitux for treatment of patients with head and neck cancer whose cancer has spread despite treatment with chemotherapy.
The approval, announced Wednesday, was based on a study that found that a combination of the drug and radiation therapy extended the lives of head and neck cancer patients by 20 months, compared to treatment with radiation alone, the AP reported.
This is the first new drug to treat head and neck cancer since the 1950s. Head and neck cancer includes cancers of the mouth, tongue, larynx and pharynx. About 29,000 Americans are diagnosed with head and neck cancer each year.
Obesity Epidemic Could Outpace Terrorism Threat: Surgeon General
If the United States doesn't take action to address the obesity epidemic, it could become a bigger threat than terrorism, said U.S. Surgeon General Richard Carmona.
"Obesity is the terror within. Unless we do something about it, the magnitude of the dilemma will dwarf 9-11 or any other terrorist attempt," Carmona said during a lecture Wednesday at the University of South Carolina.
He noted that obesity rates among U.S. children and teens have tripled over the past four decades, the Associated Press reported. Obesity increases the risk of diabetes and other diseases in young people. For the first time, U.S. children are being diagnosed with high blood pressure, Carmona said.
Changing health behaviors is essential to reducing obesity in the United States. However, Carmona said that's a challenge because many Americans are "health illiterate" -- they can't understand medical terms and directions from doctors, the AP reported.
Food Fact: Rind-boggling.
Juicy, red watermelon is not only delicious, it may help men avoid prostate cancer. As long as you spit out the seeds, watermelon is the biggest supplier among fresh fruits and vegetables in the antioxidant lycopene, which is believed to play a big role in the prevention of the killer disease. Antioxidants such as lycopene work in your body by disarming free oxygen radicals, which are thought to contribute to the development of many cancers. A 2-cup serving of watermelon contains 15 - 20 milligrams of this vital plant pigment. Other sources include tomatoes, red grapefruits and guavas.
Fitness Tip of the day: Don't just stand -- stretch!
It's easy to fit stretching into your day; try these 3 tips. Practice some stretches while waiting in shopping lines. Simple neck and shoulder rolls are a great way to release stress and relax tight muscles. And make use of the stairs -- a great tool for stretching out your calves. How important is it to stretch? The American College of Sports Medicine has added stretching to its fitness recommendations.
FAQ of the day: Do I need fiber in my diet?
While psyllium-based supplements can help relieve constipation, and have been shown to reduce high blood cholesterol, dietary changes have the same benefits. Better yet, if you get your fiber from whole foods -- whole grains, fruits and vegetables -- you'll get hundreds of health-protective compounds that your fiber supplement won't provide.