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Pfizer Abandons Viagra Trials for Women
The drug company Pfizer Inc. has abandoned eight years of research into whether the anti-impotency drug Viagra can be used to treat female sexual problems because clinical trials on women proved inconclusive.
Karen Katen, executive vice president of Pfizer and president of Pfizer Global Pharmaceuticals, said Friday that while the company was disappointed that the program was not more successful, "this is the nature of drug development," the Associated Press reports.
Female sexuality is more complex than male sexuality, involving psychological and emotional factors that don't seem to affect males, experts agree.
Joe Feczko, president of Worldwide Developing at Pfizer, said diagnosing sexual difficulties in women "involves assessing physical, emotional and relationship factors, and these complex and interdependent factors make measuring a medicine's effect very difficult."
Since Viagra hit the market in 1998 to treat male impotence, more than 23 million men have been prescribed the drug, Pfizer said.
The company said it continues to study other treatment approaches for women, the news agency reports.
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Alzheimer's Vaccine Shows Promise
Tests on monkeys show promise for an experimental Alzheimer's disease vaccine, says a study in the March issue of Alzheimer Disease and Associated Disorders.
The vaccine was created by researchers at the Farber Institute for Neurosciences at Thomas Jefferson University in Philadelphia.
They injected the monkeys with beta-amyloid. It's a sticky protein substance that accumulates in the brains of people with Alzheimer's. Beta-amyloid is believed to play a major role in the destruction of nerve cells and in the cognitive and behavioral problems associated with the disease.
The vaccinated monkeys developed high levels of antibodies to beta-amyloid. Circulating amyloid levels in the monkeys increased five-fold to ten-fold. Nearly all of that circulating amyloid was bound to antibodies and cleared out of the monkeys' bodies.
"The amyloid in the brain seemed to be bound up to antibodies in the blood and cleared away," study leader Dr. Sam Gandy, a professor of neurology, biochemistry and molecular pharmacology, says in a prepared statement.
"Vaccinating with amyloid brings an immune response that stimulates removal of amyloid from the body," says Gandy, who is also vice chairman of the National Medical and Scientific Advisory Council of the Alzheimer's Association.
William Thies, vice president for medical and scientific affairs for Alzheimer's Association, says in a statement, "The animal model described in this study expands the way we might evaluate new vaccine products.
"Vaccination against amyloid is a reasonable strategy for preventing and possibly treating Alzheimer's, and this study brings us one step closer. Having more model systems that are closer to humans increases the likelihood that we can avoid the kind of side effects that we saw in the first human trial," Thies says.
An earlier study of Alzheimer's vaccine in humans had to be halted because of serious side effects.
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Study to Test Healing Power of Laughter
Researchers at St. Jude Children's Research Hospital want to know whether adding therapies like massage, humor and relaxation training to the standard drug regimen does more than provide short-lived relief for young cancer patients.
They also are asking whether such complementary approaches also ease pain, nausea and other treatment side effects as well as help patients recover faster and leave the hospital sooner. They landed a five-year, $2 million National Cancer Institute grant to find out.
The study will involve 282 patients ages 6 through 18 undergoing stem cell transplants at St. Jude and children's hospitals in Toronto, Philadelphia and Columbus, Ohio.
Clayton Mitchell, 18, of Paragould, Ark., is one of 16 patients enrolled so far. Like 75 percent of the expected volunteers, he is battling leukemia.
"We won't cure them with massage, but we may improve the outcome," said Dr. Sean Phipps, a clinical psychologist in St. Jude's behavioral medicine division and the study's principal investigator.
Although research is just beginning in children, studies in adult cancer patients show such strategies help ease pain, increase energy and improve mood. Some also suggest they help patients live longer, although that hasn't been clearly established.
For the St. Jude study, patients are randomly assigned to one of three groups. One-third receive standard care, including support from staff in the hospital's pastoral care, child life and psychology departments. Another third receive half-hour massages three times a week as well as weekly humor therapy and encouragement to take daily humor breaks.
Mitchell is among the final third. That group includes patients and parents. He gets humor therapy — think whoopie cushions, Three Stooges videos and silly games — and the regular massages.
His mother, Debbie Williams, is on the same massage schedule. She also gets guided imagery and relaxation training, including a compact disc designed for daily use.
During the first six weeks of Mitchell's hospital stay, mother and son are completing weekly questionnaires asking about everything from his mood to his symptoms. They'll complete another set at weeks 12 and 24.
The research reflects psychology's new appreciation of the complexity of the stress response.
"You can experience positive and negative . . . at the same time or in the course of a day. A positive experience serves as a buffer against the physical ravages of stress," Phipps explained.
It also reminds patients of how they can help themselves, even if it is just startling a nurse with a plastic cockroach.
Williams was initially skeptical she would be able to relax knowing what her son is going through. Mitchell's acute lymphoblastic leukemia (ALL) was diagnosed in 1999. He was referred to St. Jude from Arkansas Children's Hospital when the cancer returned in August. He entered St. Jude on Feb. 9.
After doctors used chemotherapy to kill Mitchell's own diseased blood-producing bone marrow, he received stem cells donated by his brother, Clinton, 23. The hope is those cells will settle into Mitchell's bone marrow and rebuild his blood and his immune system.
If he's lucky he will be able to leave the hospital in mid-March and head home in May.
Mitchell said he would miss the massages.
"I'll have to find a girlfriend who is a masseuse," he joked.
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Americans Eating More Fat, Risking Health - Experts
Americans are eating more fat and cholesterol as "low-carb" diets grow in popularity, but people do not seem to be losing weight and they are putting their health at risk, U.S. researchers said on Friday.
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Federal Court Upholds Use of Medical Marijuana
Californians may continue to grow and use marijuana in certain cases to treat illness, a federal appeals court in San Francisco has decided.
The Ninth Circuit panel of three judges denied a request by the Bush Administration to review the court's own ruling made in December. Medical marijuana advocates say the move will allow Californians and people in six other Western states to continue to use marijuana to treat illness without fear of prosecution, The New York Times reports.
In the December decision, the judges voted 2-1 to allow personal medical use of marijuana upon a doctor's recommendation, saying it was not akin to drug trafficking.
The Justice Department refused initial comment on whether it plans to appeal the latest decision to the U.S. Supreme Court, the Times reports.
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Harvard Plans $100 Million Stem Cell Research Center
Harvard University is preparing to launch a $100 million stem cell research center, which would make it the largest private effort to evade the Bush administration's strict controls on the controversial research, the Boston Globe reports.
Stem cells, which are found in human embryos, umbilical cords and placentas, help create the human body through their ability to develop into any type of tissue cell. Scientists hope to someday manipulate stem cells in laboratories to develop into replacement organs and tissues to treat a host of diseases, including Parkinson's and diabetes, the newspaper reports.
But researchers must destroy embryos to collect the stem cells, and that has led to condemnation of the practice by the Catholic Church, abortion opponents and others. President Bush, citing concerns about the use of harvesting fertilized human egg cells for research, sharply curtailed government support for stem cell research in 2001.
Dr. George Q. Daley, who is helping to develop the center and is an associate professor at Harvard Medical School and Children's Hospital in Boston, says, "Harvard has the resources, Harvard has the breadth, and, frankly, Harvard has the responsibility to be taking up the slack that the government is leaving."
The Harvard project is the latest, and by far largest, effort to circumvent the Bush administration restrictions on stem cell research. In December 2002, Stanford University said it had received a $12 million donation to study cancer by creating human embryonic stem cell lines, the newspaper reports.
Harvard officials say they will announce plans for the center on April 23, with a fund-raising goal of $100 million, the Globe says.
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Older Women's Sexual Health Needs Often Neglected
Women over age 65 have as many sexual concerns as younger women, and they're just as interested in discussing these issues with their physicians, according to a new study.
But only a third of women over 65 have ever had such a discussion with their doctors.
Because of widespread stereotypes about aging and sexuality, doctors may tend to neglect discussions of sexual issues with their older patients, Dr. Margaret R. H. Nusbaum and associates at the University of North Carolina at Chapel Hill note in a report in the Journal of the American Geriatrics Society.
To get an idea of older women's sexual concerns, the researchers surveyed 964 women seeking routine gynecological care, including 163 patients aged 65 and older.
Of 27 types of sexual issues listed in the questionnaires, older women reported on average 12 concerns, compared with 13 in younger women. The two groups were equally likely to have concerns about decreased sexual interest (87 percent), unmet sexual needs (65 percent vs. 68 percent), and needing sexual information (58 percent vs. 65 percent).
Although 97 percent of women over 65 said they would have discussed their sexual concerns with their doctors, such issues had been discussed during an office visit with only 33 percent of the older women and 52 percent of younger women.
About half the subjects in both groups reported having tried to bring up the topic, but their "physician did not seem to understand or be concerned," the report indicates.
"Sexuality should be considered an integral part of health, quality of life, and general well-being for older women and their partners," Dr. Nusbaum's group concludes.
SOURCE: Journal of the American Geriatrics Society, January 2004.
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One pill to quit smoking and lose weight
Soon the two leading health risks in the United States, obesity and smoking, could be tackled by the drug Rimonabant delivered in a single pill, according to two university studies.
Under development by the French firm Sanofi-Synthelabo, the drug is undergoing human tests by the company's drug development arm in Malvern, Pennsylvania, and could be ready for marketing approval next year, the firm's vice president Douglas Green said Wednesday.
As a weight control drug, Rimonabant helped overweight people lose nine kilograms (20 pounds) in one year, improving levels of good cholesterol and reducing triglycerides -- fatty substances -- in the bloodstream, according to a study by the University of Pennsylvania.
"It is an exciting breakthrough in basic science about body weight and appetite," said Tom Wadden, head of the university's Weight and Eating Disorders Program who led the research.
Rimonabant was also found to help smokers almost double their odds of kicking the habit in 10 weeks, with overweight smokers losing half a kilo (one pound) of fat at the same time, according to another study by the University of Cincinnati.
"We may have a very promising new approach for managing two major and preventable risk factors for cardiovascular disease with one and the same drug," said Dr. Robert Anthenelli, a psychiatry professor at Cincinnati who led the research for the smoking study.
The drug blocks specific receptors in the brain and fat cells, inhibiting the urges to eat and light up, the French company said.
Both studies found that the most common side effects of Rimonabant were nausea, dizziness and upper respiratory tract infections.
Around 2,000 people took part in the two studies, which were presented Tuesday at the annual meeting of the American College of Cardiology in New Orleans, Louisiana.
Besides these studies, Sanofi-Synthelabo is also conducting five other trials involving 11,000 patients worldwide to examine Rimonabant's effect on smoking, weight loss, diabetes and cardiovascular risks.
News of the promising drug coincided with a study by the US Centers for Disease Control and Prevention (CDC) showing that obesity could top smoking as the leading cause of preventable death among Americans by 2005.
The number of deaths from poor diet and lack of exercise jumped by 33 percent between 1990 and 2000, while smoking-related deaths grew less than 10 percent, according to CDC estimates.
If trends continue, the CDC said, the death toll from the fast-food, couch-potato lifestyle could pass the 500,000 mark next year, overtaking tobacco as the leading cause of preventable death for the first time in more than 40 years.
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More Evidence Found of How Vitamins Prevent Cancer
Vitamin E protects against at least two common forms of cancer -- prostate and bladder -- but popping supplements is probably not the best way to get the vital nutrient, researchers said on Sunday.
Two studies found that people who either ate the most vitamin E containing food or who had the highest levels in the blood were the least likely to have cancer.
But the researchers also noted that there are several different forms of vitamin E and the kind you eat -- in this case alpha tocopherol -- is key. And the best-absorbed form of alpha tocopherol is not found in supplements but in foods such as sunflower seeds, spinach, almonds and sweet peppers.
In one of the studies presented to the annual meeting of the American Association of Cancer Research in Orlando, Stephanie Weinstein of the U.S. National Cancer Institute and colleagues found men with the most vitamin E in their systems had the lowest risk of prostate cancer.
They looked at data from 29,133 Finnish men aged between 50 and 69 taking part in a smoker's study. All gave blood at the beginning of the study and then took vitamins to see whether the supplements might prevent various forms of cancer.
This study is best known for showing that smokers who took beta carotene, which the body converts to vitamin A, actually had higher rates of lung cancer.
Weinstein looked at vitamin E and prostate cancer, and they looked at how much E the men had in their blood before they ever took a supplement. They looked at 100 men with prostate cancer and 200 men who did not.
"We found that the men who had higher serum (blood) levels of vitamin E had a lower chance of getting prostate cancer," Weinstein told a news conference monitored by telephone.
NOT ALL E'S ARE EQUAL
Then they looked at the two main forms of vitamin E -- alpha tocopherol and gamma tocopherol.
Men with the highest natural levels of alpha tocopherol were 53 percent less likely to later develop prostate cancer. Men with the highest levels of gamma tocopherol, which only represents about 20 percent of the vitamin E in blood -- had a 39 percent lower chance.
Taking supplements further reduced prostate cancer rates.
"Nuts and seeds, whole grain products, vegetable oils, salad dressings, margarine, beans, peas and other vegetables are good dietary sources of vitamin E," Weinstein said.
In a similar study, Dr. Xifeng Wu of the University of Texas M.D. Anderson Cancer Center, John Radcliffe of Texas Woman's University in Houston and colleagues studied 468 bladder cancer patients and 534 cancer-free volunteers.
They asked their 1,000 volunteers what they ate, and estimated how much alpha-tocopherol and how much gamma tocopherol they got in their everyday diets and from supplements if they took them.
Those with the highest intake of alpha tocopherol from food had a 42 percent reduced risk of bladder cancer, and those who had a vitamin E-rich diet and took supplements too had a 44 percent lower risk.
But when broken down into types, they found gamma tocopherol offered no protection against bladder cancer.
"It would not be reckless to encourage people to try and meet the dietary allowance of vitamin E, which is about 50 milligrams a day," Radcliffe told the news conference. Current average U.S. intake of E is only 8 mg a day.
One of the best sources, said Radcliffe, a dietician, is a handful of sunflower seeds. Almonds, spinach, mustard greens and green and red peppers are also good sources of alpha tocopherol.
Many E supplements, he said, contain both active and inactive forms of E and may not be the best source. Plus, he said, sunflower seeds are high in selenium, another key nutrient, while greens are loaded with desirable nutrients.
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Canadian researchers start trials for new anti-AIDS vaccine
Canadian researchers announced the start of clinical trials for a new anti-AIDS/HIV vaccine aimed at replacing so-called drug cocktails.
The trials are being run in cooperation with the Strasbourg (France) based Aventus Pasteur and The Immune Response Corporation, a US company co-founded by Jonas Salk, the discoverer of the polio vaccine.
The government-backed trials will start in April and are scheduled to run for 18 months. It will involve 60 patients from Ottawa and Montreal.
The trials are being conducted by the Canadian Network for Vaccines and Immunotherapeutics (CANVAC).
Canadian Industry Minister Lucienne Robillard told a press conference that the 60 patients "have been on effective therapy and have had no detectable HIV in their blood for at least two years."
According to CANVAC, the hope is that "therapeutic vaccination" against HIV could reduce drug dependence, "thus gaining a reprieve for the important side effects" of drug cocktails.
Aventis Pasteur said it produced 1.4 billion doses of vaccines last year.
The Immune Response Corporation already produces REMUNE, an immune-based therapy designed to boost the body's natural defence mechanisms as a way to slow the progression of HIV.
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