FDA clears computerized pill box
Thu, 21 Jun 2007 18:40:19 GMT
WASHINGTON - A computerized pill box that patients can keep at home to dole out their drugs on schedule and in the correct doses received federal approval Thursday.
The Electronic Medication Management Assistant — EMMA — is for home use but only under the supervision of a health-care provider, the Food and Drug Administration said.
The device can be programmed to dispense individual doses of up to a month's worth of 10 different drugs, according to its manufacturer, INRange Systems Inc. The Web-connected medication box allows pharmacists, doctors and nurses to tweak both the dosing schedules and dosages of drugs loaded into the device in special blister cards. The company-described "electronic nurse" alerts patients when it's time to take a drug with visual and audible alerts.
The bread box-sized device may reduce drug identification and dosing errors, the FDA said. Expected users include aging and forgetful patients, as well as those with HIV who must adhere to complex treatment regimens.
The Altoona, Pa. company said EMMA would be available in early 2008. Company officials did not immediately return a message seeking its expected cost.
___
On the Net:
INRange Systems Inc.: http://www.inrangesystems.com
15yearold performs surgery in India
Thu, 21 Jun 2007 08:19:08 GMT
By MUNEEZA NAQVI, Associated Press Writer
NEW DELHI - The 15-year-old son of two doctors performed a filmed Caesarean section birth under his parents' watch in southern India in an apparent bid to gain a spot in the Guinness Book of World Records as the youngest surgeon.
Instead, the boy's father could be stripped of his licenses and may face criminal charges, officials said Thursday.
Dr. K. Murugesan showed a recording of his son performing a Caesarean section to an Indian Medical Association chapter in the southern state of Tamil Nadu last month, said Dr. Venkatesh Prasad, secretary of the association. The video showed Murugesan anesthetizing the patient.
"We were shocked to see the recording," Prasad told The Associated Press, adding that the IMA told Murugesan that his act was an ethical and legal violation.
Murugesan owns and runs a maternity hospital in the city of Manaparai, Prasad said in a telephone interview from Manaparai. The family could not be immediately reached for comment.
Murugesan, who could possibly be prevented from practicing and face criminal charges for allowing his son to perform the operation, expressed no regret and accused the Manaparai medical association of being "jealous" of his son's achievements, Prasad added.
"He said this was not the first surgery performed by his son and that he had been training him for the last three years," said Prasad.
Murugesan told the medical association that he wanted to see his son's name in the Guinness Book of World Records.
Prasad said that his team had reported the surgery to the state's top medical association in state capital, Chennai.
State health secretary V.K. Subburaj told reporters Thursday that the government would investigate.
"We'll get the report and then we'll see whether there are any violations ... prima facie it looks like there is a big violation," he said.
"We will definitely take action against the concerned medical officers."
Shire may get FDA approval for ADHD drug
Thu, 21 Jun 2007 10:48:35 GMT
LONDON - Pharmaceutical company Shire PLC said Thursday that the U.S. Food and Drug Administration indicated that it may approve the company's Intuniv treatment for attention-deficit hyperactivity disorder for children.
The FDA has also requested additional information on the treatment, Shire — which also makes the attention deficit hyperactivity disorder drug Adderall — said in a statement.
Unlike some ADHD treatments, the company said, Intuniv — a nonstimulant — is not a controlled substance and does not have a known mechanism for potential abuse or dependence.
"The FDA's approvable letter for Intuniv is positive news, and Shire will be working closely with the agency to address its questions," said Chief Executive Matthew Emmens.
Shire shares dipped 1.3 percent to 1,204 pence on the London Stock Exchange.
The company said Wednesday that it entered an agreement with Renovo Group PLC to develop that company's Juvista anti-scarring treatment.
Estrogen may offer some heart benefits
Thu, 21 Jun 2007 02:53:46 GMT
By MIKE STOBBE, AP Medical Writer
ATLANTA - Five years after a landmark study scared millions of women off hormones for menopause symptoms, new research suggests the pills may offer some heart benefits for certain younger women who start taking them in their 50s. Women who took estrogen suffered less hardening of the arteries than those who took dummy pills, researchers reported in Thursday's New England Journal of Medicine.
It was the latest study in recent months to suggest that women who take hormones at the start of menopause seem to gain some health benefits beyond relief from hot flashes. That is in sharp contrast to women who raise their health risks when they take hormones in their 60s and 70s.
In general, experts' advice hasn't changed: Use hormones only as needed to treat hot flashes, sleeplessness and other symptoms at the start of menopause. And use the lowest possible dose for the shortest possible time — no longer than four or five years.
The new study is the latest attempt to sort out how menopause hormones affect the risk of cancer, Alzheimer's disease, stroke and heart problems, and whether those risks and benefits differ by age.
The research concludes that women who started taking estrogen pills in their 50s were 30 to 40 percent less likely to have measurable levels of blockage-causing calcium in the arteries that lead to the heart.
"It seems to be slowing the rate of plaque buildup," said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital. She is the study's lead author.
The research is based on the Women's Health Initiative, a huge federal study started in the 1990s that focused on the risks and benefits of menopause hormones for women.
One phase of the study was suspended in 2002 after researchers detected higher rates of heart attacks, strokes, breast cancer and other problems in women who took an estrogen-progestin combination pill. Many women were startled by the findings; millions stopped taking hormones.
"The heart attack issue was really the thing that surprised us all," said Dr. Michelle Warren, a Columbia University expert who is a consultant for Wyeth Pharmaceuticals, which makes which makes top-selling hormone pills Prempro and Premarin.
Another phase of the big women's study was stopped in 2004 when researchers saw higher risks for strokes and blood clots in women who took estrogen alone.
Since then, some scientists have begun to slice the large study's data for more nuanced meaning. They note that most of the women in the study were in their 60s or 70s, several years post-menopausal when the research began. New analyses are focusing on women who were in their 50s when they joined the study.
The scientists are researching a "timing hypothesis" that proposes that estrogen can help against clogged arteries and heart disease, but only when given before problems develop and before natural estrogen levels have been low for an extended period of time. Estrogen can trigger heart attacks in women who have advanced atherosclerosis, experts said.
Warren likened it to exercise: When started earlier in life and done regularly, it can protect a heart. "But if I take a woman who's 63 years old, who's never exercised, and start her on it, I can kill her," she said.
In the new research, Manson and her colleagues focused on more than 1,000 women in their 50s who had hysterectomies. Roughly a quarter of U.S. women in that age bracket have had a hysterectomy, Manson said.
The women were either on estrogen or dummy pills for an average of about 7 1/2 years. They then had cardiac scans in 2005 to check for buildup of calcium in the arteries. The women were 64 years old, on average, at the time of the scans. There was no baseline scan of the women when the study started.
One expert who consults for Wyeth, Dr. Howard Hodis of the University of Southern California, celebrated the results as evidence that estrogen — started at the right time — could be taken for decades.
Other experts said that is going too far.
"Wishful thinking," said Dr. Jacques Rossouw, a federal researcher who oversees the Women's Health Initiative.
Risks for stroke and blood clots remain with continued hormone use, noted Dr. Nanette Wenger, an Emory University expert on heart disease in women. Still, the latest findings should provide some comfort to menopausal women who are considering taking estrogen, she said. "This is quite an important study."
The risk of serious heart problems for women in their 50s is low. An earlier study by Manson and others estimated that for women in that age group, 27 in 10,000 women would suffer a heart attack in a year, and 17 in 10,000 would have a stroke.
For women on estrogen, the estimates were 17 and 15, respectively, per 10,000.
Hardening of the arteries is considered a strong predictor of heart attacks, but heart attack reduction is the real goal. So far, for younger women, there is no conclusive medical evidence about the impact on heart attacks.
Women who want to prevent heart disease should focus instead on healthy eating, exercise and not smoking, Wenger said.
Manson agreed. "Estrogen is known to have other risks and should be used only for the treatment of menopausal symptoms at the lowest dose for the shortest duration necessary," she said.
____
On the Net:
New England Journal of Medicine: http://www.nejm.org
Women's Health Initiative study: http://www.nhlbi.nih.gov/whi/index.html
Alaskan man pleads guilty to sale of seal penises
Thu, 21 Jun 2007 14:54:13 GMT
ANCHORAGE, Alaska -
An Alaska man has pleaded
guilty to selling more than 100 fur seal &;oosiks&; -- or penises
-- to a local gift shop that intended to sell the items as an
aphrodisiac.
Michael Richard Zacharof, an Aleut and former tribal
president from the Bering Sea village of St. Paul, pleaded
guilty this week to one count of violating the Marine Mammal
Protection Act.
Federal law forbids the sale of any raw marine mammal parts
unless they have been crafted into pieces of Alaska Native
artwork.
In Zacharof's case, the former tribal leader sold the raw
seal penises to a gift shop catering to customers from Asia.
The shop then sold the items for about $100 each, according to
the Justice Department.
Assistant U.S. Attorney Andrea Steward said seal penis
bones, also known as seal sticks, are believed to have
properties similar to erectile dysfunction drugs like Viagra.
Zacharof faces a possible one-year prison term and a
$20,000 fine, the U.S. Attorney's office said.
Diet plus exercise up survival after breast cancer
Thu, 21 Jun 2007 16:06:38 GMT
By Charnicia Huggins
NEW YORK -
Among women who have been
treated for breast cancer, those who stick to a healthy diet
and are moderately active seem to live longer, results of a new
study indicate. A good diet alone or exercise alone doesn't
have the same benefit.
&;It looks like if you get your physical activity going and
get your fruits and vegetables in you can reduce your risk (of
dying) significantly,&; study co-author Dr. John Pierce told
Reuters Health.
Several studies have shown that diet and exercise may each
contribute to breast cancer survival, but little research has
looked at the effect of both diet and exercise together.
Pierce, director of the Cancer Prevention and Control Program
at the Moores UCSD Cancer Center, in La Jolla, California, and
his team looked at the combined effects of diet and exercise
for breast cancer survivors.
They studied 1,490 women who had been treated for breast
cancer 2 years earlier, on average.
Overall, only 30 percent of these women maintained the
healthiest type of lifestyle, including eating five or more
servings of fruits and vegetables daily and engaging in
physical activity equivalent to a half-hour of brisk walking
six days a week.
These women had a 44 percent lower risk of dying within a
10-year period than did their peers, Pierce and his team report
in the Journal of Clinical Oncology.
What's more, this lower risk of death remained true
regardless of whether the women were obese, study findings
indicate. The effect of physical activity and diet was &;so
strong it wiped out the body mass index effect,&; Pierce said.
However, obese women were less likely than nonobese women to
report such healthy habits.
A similarly reduced risk of death was not apparent among
non-physically active women who consumed the highest amounts of
fruits and vegetables or among physically active women who did
not eat at least five servings of fruits and vegetables a day,
the investigators note.
&;Doing each one alone didn't do it,&; Pierce said. &;There
was no benefit from each one alone, but there was a benefit
from both together.&;
SOURCE: Journal of Clinical Oncology, June 10, 2007.