FDA wont close field labs after all
Fri, 17 Aug 2007 19:40:53 GMTWASHINGTON - The Food and Drug Administration canceled plans Friday to close more than half its field laboratories.
The proposed closures, part of a reorganization of the agency's field operations, previously had been suspended to await recommendations from a presidential panel about how to better guarantee the safety of imported food and other products.
Congress has been investigating the plan, including whether it would give to private companies some food safety work now performed by government employees. Lawmakers also had introduced legislation to block the closures.
In a "Dear Colleagues" e-mail sent Friday, FDA regulatory affairs chief Margaret Glavin said the reorganization plan would be canceled, in part to provide a "fresh look" at the challenges facing her office and its plans for addressing them.
The FDA originally said it sought to consolidate its lab network to modernize its food safety efforts. The proposal was met with protests from lawmakers, lab employees who testified before Congress and the union that represents much of the FDA work force.
Michigan Democratic Reps. John Dingell and Bart Stupak applauded the cancellation, saying the closures would have jeopardized public health.
An FDA spokeswoman did not immediately return messages left seeking comment.
FDA Codeine risk for some nursing moms
Fri, 17 Aug 2007 15:48:44 GMTWASHINGTON - Nursing mothers who take codeine should watch their infants for increased sleepiness or other signs of overdose, federal health officials warned Friday.
The Food and Drug Administration warning of the rare but serious side effect was prompted by a 2006 report of the death of a nursing infant whose mother was given codeine for episiotomy pain.
Genetic testing later showed the woman's body converted the codeine to morphine more rapidly and completely than in other people. That led to higher-than-expected morphine levels in her breast milk.
While the rapid conversion of codeine to morphine is a very rare side effect in some mothers, it can result in high and unsafe levels of the latter drug in the blood and breast milk, the FDA said in an alert.
Codeine is among the most common drugs taken by new mothers, FDA officials said.
It is included in several prescription pain drugs and in some over-the-counter cough syrups, Dr. Sandra Kweder, the FDA's deputy director, Office of New Drugs, Center for Drug Evaluation and Research, said in a telephone briefing.
The risk of having the genetic mutation ranges from about 1 percent in Hispanics, Chinese and Japanese, to 3 percent in African-Americans, 1 percent to 10 percent in Caucasians, and as high as 16 percent to 28 percent in North Africans, Ethiopians and Saudis, Kweder said.
Given the risk, doctors should prescribe nursing mothers the smallest dose of codeine for the shortest period of time, the FDA recommended. Doctors also should closely monitor both mother and child.
In children, signs of morphine overdose, beyond increased sleepiness, include difficulty breast-feeding or breathing and limpness. Nursing mothers may also experience overdose symptoms, such as extreme sleepiness, confusion, shallow breathing or severe constipation, the FDA said.
The FDA has asked drug companies that make those products to include information about the potential risks to nursing mothers who are ultra-rapid metabolizers of codeine.
There is a test available to determine if an individual is a rapid metabolizer of codeine, but Kewder said the agency is not currently recommending routine testing.
"Our point is to pay attention," she said.
New mothers taking codeine who find themselves extremely sleepy should consult their doctor, and if their baby seems unusually sleepy or has trouble nursing they should contact their physician or take the baby to an emergency room, she said.
Alaska begins offering eprescriptions
Fri, 17 Aug 2007 08:40:59 GMTBy JAMES HALPIN, Associated Press Writer
ANCHORAGE, Alaska - Electronic drug prescriptions can be delivered to pharmacists in all 50 states for the first time this week as Alaska became the final state to join the technological bandwagon.
In the past year, Georgia, South Carolina and West Virginia have all joined the national network, and the change in Alaska regulations means doctors' hieroglyphic handwriting and prescription pads could soon be a thing of the past.
Dick Holm, a member of the state Board of Pharmacy, said the process took so long to get to Alaska because "we're a small state and we address things as they come up." He said the change was not mandated by the federal government.
After receiving several requests from doctors and businesses, he said the board investigated joining the network. Board members decided to do so, he said, because they didn't see drawbacks and thought doctors who wished to could continue to write by hand.
Using electronic prescriptions has several notable perks, Holm said.
It can reduce the risk of pharmacists incorrectly filling prescriptions because they can't understand doctors' handwriting. It promises to reduce paperwork and help thwart forgeries — the electronic delivery ensures it is delivered directly to the pharmacy from the doctor.
"Anytime you make a rule, somebody finds a way around it," Holm said. "But with the electronic prescription, the prescription is not in the individual's hands. If they don't have it, they can't copy it."
According to Drug Enforcement Agency regulations, prescriptions for some controlled substances, such as OxyContin, cannot be transmitted electronically; a printed prescription is still required.
But maintaining a database based on the electronic prescriptions could still help to "ferret out" people who are trying to get legal drugs illegally, said Jim Jordan, executive director of the Alaska State Medical Association.
"Electronic information is at the forefront to providing better health care," he said.
Some critics have said the program opens the door to new problems, such as hackers and data corruption. But Holm said the board was convinced the process is secure and individual doctors and pharmacies would be tasked with keeping it that way.
Nancy Davis, executive director of the Alaska Pharmacists Association, said she supports the change, but its cost, including the software, could hurt some practitioners.
"It's going to have a definite impact on the smaller pharmacies," Davis said. "The small, independent pharmacies are going to be the ones that lag behind, if anyone does."
Shifting to electronic prescriptions requires a high-speed Internet connection, along with a special networking service and the doctors' prescription software, she said, and those costs have made some doctors and pharmacies reluctant to switch — particularly among smaller businesses, which don't have the resources available to big corporations.
Still, doctors who want to do things the old way aren't being forced to switch.
"There's still a lot of doctors that are not used to utilizing their computers in their practice, so there's a little resistance," said Leslie Gallant of the Alaska State Medical Board. "It's the idea of being tied to the computer with an umbilical cord."
There are dozens of software vendors that offer prescription-writing products, posing a serious compatibility challenge to doctors and pharmacists. The solution could be networks like the Pharmacy Health Information Exchange, operated by SureScripts.
SureScripts is a privately held Virginia company, founded by the two main pharmacy trade groups, the National Association of Chain Drug Stores and the National Community Pharmacists Association.
The exchange acts as an interface that allows users to access and send information securely between clients using differing software applications. That includes allowing doctors to access prescription histories and send new ones to pharmacists.
That is beneficial because prescriptions can be filled between different states, said Rob Cronin, a spokesman for SureScripts. For example, people traveling can get a prescription filled without having to find a local doctor if they don't have their prescription with them.
About 10 percent to 20 percent of doctors have the technology to send prescriptions electronically and about 5 percent of doctors use the network regularly, according to SureScripts.
Democratic state Sen. Bettye Davis, chairwoman of the Health, Education and Social Services Committee, said that although it took a long time for Alaska to participate, the change will benefit everybody.
"I wish we could have been involved in it much sooner, but better late than never," she said.
Indian schools asked to ban junk food
Fri, 17 Aug 2007 12:01:10 GMTNEW DELHI - India's children are getting increasingly overweight and unhealthy and the government is asking schools to ban junk food, officials said Thursday.
The National Commission for Protection of Child Rights, a government advisory body, has drawn up healthy eating guidelines for both government and privately run schools to follow, said Sandhya Bajaj, a commission member.
"The number of overweight children in schools is growing," Bajaj said in a telephone interview. She said that the commission was getting complaints from parents who said that their children were buying unhealthy food from school cafeterias.
Obesity is emerging as a serious health problem in urban India, a paradox in a country where nearly half the children are malnourished and underweight.
The commission has issued a series of broad guidelines for all schools and parents to follow. Schools should make sure that children have access to healthy drinks like milk, water and fruit juices and that food and snacks sold at school cafeterias are hygienically prepared and nutritious.
Since a majority of Indian school children carry a packed lunch, the commission also wants schools to sit down with nutritionists and health experts and draw up guidelines for parents to follow.
"We can't tell parents what to feed their children but we can give them guidelines about healthy eating," Tambe said.
The commission will send these guidelines to the Education Ministry in each state by next week, Bajaj said.
Menopause hard on couple39s sex lives
Thu, 16 Aug 2007 19:46:55 GMTNEW YORK - When a woman enters menopause, her sex life and that of her partner may suffer, according to a survey in which more than half of the women reported a decrease in sex drive and in the amount of sex they were having since entering menopause.
Overall, 46 percent of menopausal women surveyed reported having sex less than once per month and most women felt that this was hurting their relationship.
&;Menopausal women are having less sex and it's impacting our relationships,&; Karen Giblin noted in a telephone interview with Reuters Health. &;Frankly, through the Red Hot Mamas menopause education programs, I have heard that a lot of women would rather go shoe shopping than have sex, and that concerns me.&;
The survey, including more than 1,000 women, 35 years or older, who were just beginning, just ending, or in the middle of menopause, was conducted between June 20 and July 2, 2007.
&;We are the baby-boom generation who is now entering menopause; we are the women who lived through the sexual revolution in the 60s and now we are having our own sexual revolution, of a different kind,&; said Giblin, the founder of the Red Hot Mamas organization , which commissioned the Sex and Menopause Survey. The survey was sponsored by Duramed Pharmaceuticals and conducted by Harris Interactive.
Four hundred sixty nine of these women -- about 44 percent -- reported suffering from vaginal symptoms such as vaginal atrophy , which can cause vaginal dryness and painful sex.
Eighty-eight percent of women experiencing vaginal atrophy said it was causing them problems and 47 percent said that they have avoided, made an excuse, or stopped having sex altogether because of physical discomfort during intercourse.
Vaginal dryness, in particular, plagued more than half of menopausal women surveyed and this resulted in two thirds of them having less sex. &;Seventy percent of the women did not know that therapies are available to relieve vaginal dryness,&; Giblin noted.
&;There are over-the-counter products to combat dryness and your physician has a treasure chest of prescription medications to relieve vaginal dryness,&; she added.
Giblin believes men need menopause education just as much as women. &;It's not only important that a woman have a thorough understanding of the menopause process.&; Men should also because the symptoms of menopause &;can be very hard on relationships,&; Giblin said.
&;If a partner sees a decrease in sex with their partner, often times the partner becomes resentful and feels that the woman has lost interest and it isn't necessarily true,&; Giblin said. &;It's very critical for women and their significant other to stay really connected during menopause.&;
Consulting may prevent depression after vision loss
Thu, 16 Aug 2007 19:48:45 GMTNEW YORK - Patients with age-related macular degeneration, a frequent cause of vision loss in the elderly, are less likely to develop depressive disorders in the short-term if they're taught problem-solving skills, new study findings suggest. However, the benefits don't seem to be maintained over time.
Age-related macular degeneration often leads to &;irreversible vision loss, disability, and depression,&; write Dr. Barry W. Rovner, of Jefferson Medical College, Philadelphia, Pennsylvania, and colleagues. However, depression in these patients is rarely diagnosed or treated in during visits to the eye doctor.
The researchers examined whether problem-solving treatment could prevent depressive disorders in patients with recent vision loss. Problem-solving treatment is &;a manual-driven psychological treatment&; that teaches problem-solving skills: defining problems, setting realistic goals, implementing solutions, and evaluating outcomes.
Included in the study were 206 patients at least 65 years of age who were recently diagnosed with age-related macular degeneration in one eye and had pre-existing macular degeneration in the other eye. The patients were randomly assigned to problem-solving treatment or to the usual care. Therapists conducted 6 problem-solving sessions over 8 weeks in the patients' homes.
After 2 months, the team assessed the short-term treatment effects, and after 6 months, evaluated the maintenance effects. The main outcome measures included diagnoses of major or minor depression, as defined by the Diagnostic and Statistical Manuel-IV; scores on the National Eye Institute Vision Function Questionnaire-17; and the number of patients who had to relinquish activities that were important to them.
At 2 months, the incidence of depressive disorders was significantly lower in problem-solving group compared with the control group -- 11.6 percent versus 23.2 percent, respectively. The researcher estimated that patients in the problem-solving group were 61 percent less likely to develop a depressive order compared with the control group. The number of patients needed to treat to prevent one case of depression was nine.
The odds of having to give up a valued activity were also significantly reduced with problem-solving treatment. The investigators found that this probably mediated the relationship between problem-solving treatment and depression.
The changes in scores on the National Eye Institute Vision Function Questionnaire-17, a subjective measure of vision-related task difficulty, showed that the problem-solving group improved according to patients' subjective reports, despite the fact that there were no changes in visual acuity. There were also no changes in acuity among the control patients, but these subjects did report declines in their ability to perform vision-related tasks, Rovner's team reports.
Most short-term benefits had diminished by 6 months, although subjects in the problem-solving group were less likely to suffer persistent depression. &;Booster or rescue treatments may be necessary to sustain problem-solving treatment's preventative effect,&; the investigators conclude.
SOURCE: Archives of General Psychiatry, August 2007.
