Flibanserin for female arousal?

Flibanserin the female Viagra?

After three separate clinical trials, University of North Carolina (UNC) researchers say a drug (flibanserin) originally created as an antidepressant is effective at treating with acquired hypoactive sexual desire disorder.

The trials were the first ever to test a therapy that works at the level of the brain to enhance libido in women reporting low sexual desire, said UNC's John M. Thorp Jr., the principal investigator for North America in the studies. The results reported yesterday at the Congress of the European Society for Sexual Medicine in Lyon, France.

"Flibanserin was a poor antidepressant," Thorp explained. "However, astute observers noted that it increased libido in laboratory animals and human subjects. So, we conducted multiple clinical trials and the women in our studies who took it for hypoactive sexual desire disorder reported significant improvements in sexual desire and satisfactory sexual experiences. It's essentially a Viagra-like drug for women in that diminished desire or libido is the most common feminine sexual problem."

The trials measured changes from baseline on the following variables as reported by the women each week: number of satisfying sexual events, desire score, female sexual function index, female sexual distress and desire/libido.

The researchers say that treatment with 100 milligrams of flibanserin once a day was associated with significant improvements in the number of satisfying sexual events reported, sexual desire and a reduction in distress associated with sexual dysfunction.

"These results point to a novel approach to pharmacologic treatment of the sexual problem that plagues reproductive age women the most, and may over time prove to be an effective treatment without the side effects of androgen replacement therapy, which is the only treatment currently available," Thorp said. Flibanserin is currently only available to women taking part in clinical trials.

Low Sex Drive - Says Who?
Sexual problems? Why worry?
Sexual Showstoppers
Low Libido? Body Image Could Be To Blame
Penetrative Sex: Less Is More

LibiGel® Women's Viagra?


LibiGel® is a gel formulation of testosterone, designed to be quickly absorbed through the skin after a once-daily application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. The topical application of LibiGel has the added advantage of reduced skin reactions compared to other forms of transdermal delivery systems (i.e. patches).

The concept behind the LibiGel® development program is intriguing – to develop a product to treat women who suffer from female sexual dysfunction for which there is no clinically tested, FDA approved product, and do this with a drug that will be shown to be safe and effective, and affordable, both to develop and for women to use. The LibiGel development program has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with hypoactive sexual desire disorder (HSDD). LibiGel could be the first FDA approved product to treat FSD, specifically HSDD in menopausal women.

Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition to increasing sexual desire and activity and decreasing sexual distress, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood. The goal of testosterone treatment of women complaining of HSDD is to increase the serum testosterone towards the normal range of premenopausal women in an effort to alleviate the symptoms of this disorder.

Development / Regulatory Status

Results of Phase II
Treatment with LibiGel in BioSante's Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238% versus baseline (p<0.0001);>

Progress and Plans in Phase III
On January 24, 2008, the US FDA notified BioSante that it had completed and reached agreement with BioSante on a Special Protocol Assessment (SPA) for BioSante's Phase III safety and efficacy clinical trials of LibiGel in the treatment of HSDD. This action confirms FDA's position that FSD and HSDD are true conditions that women experience with measurable endpoints that can be evaluated and which deserve therapeutic options. The SPA process and agreement affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel. Both Phase III safety and efficacy trials are underway and are double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each for six-months of treatment.

The last issue beyond efficacy has been the question of safety of testosterone therapy in women, even though there are no data to indicate that low dose testosterone causes any serious adverse events in women. BioSante agrees with the FDA's efforts to ensure the safety of drugs in development and on the market, and has worked with the FDA to develop a program for LibiGel that is scientifically sound, affordable and realistic. BioSante is in agreement with the FDA for a clearly defined LibiGel development path that can lead to the approval of LibiGel for the treatment of FSD. Therefore, in addition to the two Phase III safety and efficacy trials described above, BioSante is conducting one Phase III cardiovascular safety study of LibiGel, which also is underway. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of 12 months, BioSante intends to submit a LibiGel NDA for review and possible approval by FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.

The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least one of a number of cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer is also being tracked throughout the study.

Clearly, it will be the safety trial that drives the NDA timeline. BioSante believes it will take approximately 12 months to enroll the women in this multi-national cardiovascular-events-driven safety trial. Therefore, BioSante expects to be able to submit the LibiGel NDA for a potential approval and launch in 2011.

For more information.....................

Papaya: Natural Cure Against Cancer

Fresh research has revealed that the papaya plant and its extracts can provide protection against cancer by slowing the growth of cancerous cells without causing harmful side effects. The discovery has been made by a University of Florida researcher in a joint project with the University of Tokyo.

The research was published in Journal of Ethnopharmacology*. University of Florida researcher, the Vietnamese Dr. Nam Dang, conducted a research project with colleagues from the University of Tokyo and their findings indicate that extracts from the papaya plant affect the regulation of the immune system. In this way, the attack on the cancerous cells does not cause harmful side effects because it acts through boosting the immune system and therefore does not have any effect upon normal cells.

Dr. Dang’s research studied the application of the papaya plant for cures in patients suffering from cancer among indigenous communities in Vietnam and Australia. He then developed four strengths of extract from the papaya leaf, which when applied clinically, slowed the growth of cancerous cells in ten different types of cancer, namely those affecting the cervix, the breast, the liver, the lungs and the pancreas. The effects were visible within 24 hours.

While the research project concentrates on the application of the papaya leaf on cancerous cases in Asia, indigenous populations in Brazil have been using the papaya leaf for thousands of years in infusions to treat ailments of the liver, including hepatitis A. The research conducted by Dr. Dang was made using dried papaya leaves.

He proved that papaya leaf extract increases the level of signalling molecules which help to regulate the immune system, attacking the cancerous cells. By boosting the Th1-type cytokines, the immune system responds to invaders while not producing toxic effects on healthy cells.

This type of treatment, according to Dr. Dang, produces results which go hand in hand with reports from indigenous communities in Australia and Vietnam.

* Source http://enervon.com/tag/journal-of-ethnopharmacology/

Every Man Should Train His Prostate Daily

There are plenty of myths about the harm of sexual abstinence, especially among men. Some say it may cause infertility. One group claims men cannot live without having regular sexual interactions, while another one believes that everything depends on a man’s body type. Specialists Rostislav Beleda, Irina Gumennikova and Yuri Prokopenko were asked direct questions to find out the truth.

Rostislav Beleda: "As of now, there is no unified opinion regarding the effect of abstinence on human body. Some believe that it causes both psychical and somatic abnormalities, others stress that it is harmless, while some think it is actually good for your body. Obviously, the truth is somewhere in the middle.

"There is a great deal of evidence showing that sexual life positively affects human health. Medical professionals claim that sexual activity reduces the risk of heart diseases, rejuvenates, burns extra calories, helps the body to produce natural pain killers and substances that improve teeth condition, strengthen the immune system, train prostate, and improve sense of smell. At the same time, sexual abstinence negatively affects sperm motility; increases risk of prostatitis and may cause problems with erection.

"If we look at the effect of sexual abstinence in its entirety, we can notice that along with positive effect of using extra energy for something else, it can be harmful. There are certain changes that cause various neurotic disorders explained by a heightened sex drive, as well as a possibility of developing an inclination for perversion," Beleda explains.

The doctor believes that the statement “men cannot live without “it” is a mere myth: "Generally, abstinence is very individual and depends on the intensity of a person’s sex drive.

Adults with weak sex drive and moderate excitability can easily survive even long periods of abstinence without any visible negative consequences.

At the same time, people with a strong sex drive and high excitability can abstain from sex for a limited time only. They may develop emotional and sexual disorders, mostly sexual neurosis."

Sexual health specialist Irina Gumennikova: "In addition to psychological consequences of sexual abstinence, sexual function suffers. Men practicing abstinence may develop problems with erection and ejaculation. The level of consequences depends on a person’s age and length of abstinence. A 25-year old man with a strong sexual drive may experience difficulties practicing abstinence for two weeks, but it will not affect his sexual function. At age 30-35 a few months of abstinence may cause premature ejaculation and problems with erection.

"Usually these problems go away once sexual activity becomes regular. Men over 40 may require treatment. Men over 50 who abstain from sex for two to three months may lose their sexual function for good."

Does this mean that men should use any opportunity to have sex?

According to recent research, men who have one partner are able to preserve their sexual function longer than those with several partners.

"Abstinence can be harmful, but don’t think that you have to have sex all day long for “health” reasons. You should have sex as often as you want,” says Yuri Prokopenko.

“If you have sex less frequently than you want, you can ruin your hormonal balance and develop blood congestion in small pelvis area. If you try to make yourself have sex when you do not want to, you may develop psychological problems. Do not make sex a “mandatory activity.”

Omega-3 Reduces Dangerous Colon Polyps

A purified form of omega-3, the so-called "good fat" found naturally in certain fish and nut oils, reduced dangerous polyps among people prone to bowel cancer, says a British study published on Thursday by Gut, a journal of the British Medical Association. read more>>>>>>>>>>>>>

Sugary Drinks Fuel Rise in Diabetes and Heart Disease

More Americans than ever drink sugary drinks daily, according to government statistics, and the increase has fueled the rise in heart disease and diabetes over the past 10 years. Scientists used a computer simulation called the Coronary Heart Disease (CHD) Policy Model to estimate that the rise in consumption has contributed to 130,000 new cases of diabetes and 14,000 new cases of coronary artery disease in adults age 35 and older. read more>>>>>>>>

Experts: Acupuncture Can Spread Diseases

Bacterial infections, hepatitis B and C, and possibly even HIV are being transmitted via acupuncture through the use of contaminated needles, cotton swabs, and hot packs, experts warned on Friday.

In an editorial published in the British Medical Journal, microbiologists at the University of Hong Kong said the number of reported acupuncture-related infections worldwide was the tip of an iceberg, and they called for tighter infection control measures. read more>>>>>>>>>>>

Frankincense: Could it be a cure for cancer?

The gift given by the wise men to the baby Jesus probably came across the deserts from Oman. The BBC's Jeremy Howell visits the country to ask whether a commodity that was once worth its weight in gold could be reborn as a treatment for cancer.

Oman's Land of Frankincense is an 11-hour drive southwards from the capital, Muscat.

Most of the journey is through Arabia's Empty Quarter - hundreds of kilometres of flat, dun-coloured desert. Just when you are starting to think this is the only scenery you will ever see again, the Dhofar mountains appear in the distance.

Map of Oman

On the other side are green valleys, with cows grazing in them. The Dhofar region catches the tail-end of India's summer monsoons, and they make this the most verdant place on the Arabian peninsula.

Warm winters and showery summers are the perfect conditions for the Boswellia sacra tree to produce the sap called frankincense. These trees grow wild in Dhofar. A tour guide, Mohammed Al-Shahri took me to Wadi Dawkah, a valley 20 km inland from the main city of Salalah, to see a forest of them.

"The records show that frankincense was produced here as far back as 7,000 BC," he says. He produces an army knife. He used to be a member of the Sultan's Special Forces. With a practised flick, he cuts a strip of bark from the trunk of one of the Boswellia sacra trees. Pinpricks of milky-white sap appear on the wood and, very slowly, start to ooze out.

Boswellia sacra
Boswellia sacra produces the highest-quality frankincense

"This is the first cut. But you don't gather this sap," he says. "It releases whatever impurities are in the wood. The farmers return after two or three weeks and make a second, and a third, cut. Then the sap comes out yellow, or bright green, or brown or even black. They take this."

Shortly afterwards, a frankincense farmer arrives in a pick-up truck. He is white-bearded, wearing a brown thobe and the traditional Omani, paisley-patterned turban.

He is 67-year-old Salem Mohammed from the Gidad family. Most of the Boswellia sacra trees grow on public land, but custom dictates that each forest is given to one of the local families to farm, and Wadi Dawkah is his turf.

Camel train

He has an old, black, iron chisel with which he gouges out clumps of dried frankincense.

"We learnt about frankincense from our forefathers and they learnt it from theirs" he says. "The practice has been passed down through the generations. We exported the frankincense, and that's how the families in Dhofar made their livings."

Salem Mohammed
Salem Mohammed: Young people prefer careers in oil or government

And what an export trade it was. Frankincense was sent by camel train to Egypt, and from there to Europe. It was shipped from the ancient port of Sumharan to Persia, India and China. Religions adopted frankincense as a burnt offering.

That is why, according to Matthew's Gospel in the Bible, the Wise Men brought it as a gift to the infant Jesus. Gold: for a king. Frankincense: for God. Myrrh: to embalm Jesus' body after death.

The Roman Empire coveted the frankincense trade. In the first century BCE, Augustus Caesar sent 10,000 troops to invade what the Romans called Arabia Felix to find the source of frankincense and to control its production. The legions, marching from Yemen, were driven back by the heat and the aridity of the desert. They never found their Eldorado.

Oman's frankincense trade went into decline three centuries ago, when Portugal fought Oman for dominance of the sea routes in the Indian and the Pacific Oceans.

The Haffa souk in Salalah
Salalah's Haffa souk: The place to buy Omani brands such as Royal Hougari

Nowadays, hardly any Omani frankincense is exported. Partly, this is because bulk buyers, such as the Roman Catholic Church, buy cheaper Somalian varieties. Partly, it is because Omanis now produce so little.

"Years ago, 20 families farmed frankincense in this area," says Salem Mohammed Gidad. "But the younger generation can get well-paid jobs in the government and the oil companies, with pensions. Now, only three people still produce frankincense around here. The trade is really, really tiny!"

Cancer hope

But immunologist Mahmoud Suhail is hoping to open a new chapter in the history of frankincense.

Scientists have observed that there is some agent within frankincense which stops cancer spreading, and which induces cancerous cells to close themselves down. He is trying to find out what this is.

Giant censer in cathedral of Santiago di Compostela
The Catholic church mostly buys Somalian frankincense

"Cancer starts when the DNA code within the cell's nucleus becomes corrupted," he says. "It seems frankincense has a re-set function. It can tell the cell what the right DNA code should be.

"Frankincense separates the 'brain' of the cancerous cell - the nucleus - from the 'body' - the cytoplasm, and closes down the nucleus to stop it reproducing corrupted DNA codes."

Working with frankincense could revolutionise the treatment of cancer. Currently, with chemotherapy, doctors blast the area around a tumour to kill the cancer, but that also kills healthy cells, and weakens the patient. Treatment with frankincense could eradicate the cancerous cells alone and let the others live.

The task now is to isolate the agent within frankincense which, apparently, works this wonder. Some ingredients of frankincense are allergenic, so you cannot give a patient the whole thing.

Boswellia sacra grows in Oman, Yemen and Somalia
Other Boswellia species grow in Africa and India
The tree may have been named after John Boswell, the uncle of Samuel Johnson's biographer
In ancient Egypt frankincense was thought to be sweat of the gods
Source: The Pharmaceutical Journal

Dr Suhail (who is originally from Iraq) has teamed up with medical scientists from the University of Oklahoma for the task.

In his laboratory in Salalah, he extracts the essential oil from locally produced frankincense. Then, he separates the oil into its constituent agents, such as Boswellic acid.

"There are 17 active agents in frankincense essential oil," says Dr Suhail. "We are using a process of elimination. We have cancer sufferers - for example, a horse in South Africa - and we are giving them tiny doses of each agent until we find the one which works."

"Some scientists think Boswellic acid is the key ingredient. But I think this is wrong. Many other essential oils - like oil from sandalwood - contain Boswellic acid, but they don't have this effect on cancer cells. So we are starting afresh."

The trials will take months to conduct and whatever results come out of them will take longer still to be verified. But this is a blink of the eye in the history of frankincense.

Nine thousand years ago, Omanis gathered it and burnt it for its curative and cleansing properties. It could be a key to the medical science of tomorrow.

Jeremy Howell reports for Middle East Business Report on BBC World News.

Singing 'rewires' damaged brain

By Victoria Gill
Science reporter, BBC News, San Diego

Mouth (file image)
Singing words made it easier for stroke patients to communicate

Teaching stroke patients to sing "rewires" their brains, helping them recover their speech, say scientists.

By singing, patients use a different area of the brain from the area involved in speech.

If a person's "speech centre" is damaged by a stroke, they can learn to use their "singing centre" instead.

Researchers presented these findings at the annual meeting of the American Association for the Advancement of Science (AAAS) in San Diego.

An ongoing clinical trial, they said, has shown how the brain responds to this "melodic intonation therapy".

Gottfried Schlaug, a neurology professor at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, US, led the trial.

The therapy is already established as a medical technique. Researchers first used it when it was discovered that stroke patients with brain damage that left them unable to speak were still able to sing.

Professor Schlaug explained that his was the first study to combine this therapy with brain imaging - "to show what is actually going on in the brain" as patients learn to sing their words.

Making connections

Most of the connections between brain areas that control movement and those that control hearing are on the left side of the brain.

"But there's a sort of corresponding hole on the right side," said Professor Schlaug.

Music engages huge swathes of the brain - it's not just lighting up a spot in the auditory cortex

Dr Aniruddh Patel, neuroscientist

"For some reason, it's not as endowed with these connections, so the left side is used much more in speech.

"If you damage the left side, the right side has trouble [fulfilling that role]."

But as patients learn to put their words to melodies, the crucial connections form on the right side of their brains.

Previous brain imaging studies have shown that this "singing centre" is overdeveloped in the brains of professional singers.

During the therapy sessions, patients are taught to put their words to simple melodies.

Professor Schlaug said that after a single session, a stroke patients who was are not able to form any intelligible words learned to say the phrase "I am thirsty" by combining each syllable with the note of a melody.

The patients are also encouraged to tap out each syllable with their hands. Professor Schlaug said that this seemed to act as an "internal pace-maker" which made the therapy even more effective.

"Music might be an alternative medium to engage parts of the brain that are otherwise not engaged," he said.

Brain sounds

Dr Aniruddh Patel from the Neurosciences Institute in San Diego, said the study was an example of the "explosion in research into music and the brain" over the last decade.

"People sometimes ask where in the brain music is processed and the answer is everywhere above the neck," said Dr Patel.

"Music engages huge swathes of the brain - it's not just lighting up a spot in the auditory cortex."

Dr Nina Kraus, a neuroscientist from Northwestern University in Chicago, also studies the effects of music on the brain.

In her research, she records the brain's response to music using electrodes on the scalp.

This work has enabled her to "play back" electrical activity from brain cells as they pick up sounds.

"Neurons work with electricity - so if you record the electricity from the brain you can play that back through speakers and hear how the brain deals with sounds," she explained.

Dr Kraus has also discovered that musical training seems to enhance the ability to perform other tasks, such as reading.

She said that the insights into how the brain responds to music provided evidence that musical training was an important part of children's education.

Do Our Organs Have Memories?

Transplant patients sometimes take on part of their donors’ personalities.

Glenda lost her husband, David, in a car crash. She made his organs available for transplant. A few years later, as part of a study by neuropsychologist Paul Pearsall, she met the young Spanish-speaking man who had received her late husband’s heart. Filled with emotion, Glenda asked if she could lay her hand on his chest. “I love you, David,” she said. “Everything’s copa­cetic.”


Studies: Belief in God relieves depression

The "Big Man Upstairs" is getting accolades from mental health specialists who say they are finding that a belief in God plays a positive role in the treatment of anxiety and depression.

University of Toronto psychologists reported last year that "believing in God can help block anxiety and minimize stress," their research showcasing "distinct brain differences" between believers and nonbelievers.

A new study released Wednesday by Rush University Medical Center in Chicago took the idea a step further.

In patients diagnosed with clinical depression, "belief in a concerned God can improve response to medical treatment," said the new research, which has been published in the Journal of Clinical Psychology.

The operative term here is "caring," the researchers said. "The study found that those with strong beliefs in a personal and concerned God were more likely to experience an improvement."

The researchers compared the levels of melancholy or hopelessness in 136 adults diagnosed with major depression or bipolar depression with their sense of "religious well-being." They found participants who scored in the top third of a scale charting a sense of religious well-being were 75 percent more likely to get better with medical treatment for clinical depression.

"In our study, the positive response to medication had little to do with the feeling of hope that typically accompanies spiritual belief," said study director Patricia Murphy, a chaplain at Rush and an assistant professor of religion, health and human values.

"It was tied specifically to the belief that a Supreme Being cared," she said.

"For people diagnosed with clinical depression, medication certainly plays an important role in reducing symptoms," Ms. Murphy added. "But when treating persons diagnosed with depression, clinicians need to be aware of the role of religion in their patients' lives. It is an important resource in planning their care."

Public opinion polls — from Gallup to the Pew Research Center — reveal that large majorities of Americans believe in God. It is a factor among the researchers as well.

Data released last year by sociologists from the University of California at Berkeley, in fact, revealed that 93 percent of the nation believes in God, a finding that has remained unchanged since 1988.

The Canadian researchers who found that belief in God lowers anxiety and stress also based their conclusions on measurements — monitoring the brain activities of believers and nonbelievers charged with some challenging tasks.

"We found that religious people or even people who simply believe in the existence of God show significantly less brain activity in relation to their own errors," said Michael Inzlicht, assistant psychology professor at the University of Toronto, who led the research.

"They're much less anxious and feel less stressed when they have made an error," he said.

Beware of McCain's Freedom-Destroying Dietary Supplement Regulatory Bill

Most are familiar with those commercials on television promoting prescription drugs that supposedly offer relief from a variety of ailments, if one would only pressure one’s doctor to obtain them. They have become a source of great entertainment and amusement to some, the kicker coming at the end of each commercial when the FDA-approved medication’s obligatory litany of warnings and dangerous side effects is recited: “Tell your doctor if....” and “Side effects may include.....” Some of the warnings are mild like diarrhea and constipation, some list serious effects like cancer or tuberculosis, and others admit that sometimes even death can result.

The point here is that these are all FDA-approved drugs being advertised and used extensively. Drugs that can cause serious diseases like lymphoma. Drugs that can kill. The FDA’s dismal safety record is well documented; even PBS ran a Frontline special that investigated and exposed the FDA’s unsafe drug record, the influence of Big Pharma inside the FDA, and lack of long-term testing and medical review of many, many dangerous drugs. The FDA seldom removes a drug from the market even after it proves to be harmful or deadly, however they do post quarterly reports with details of the latest potentially dangerous side effects of drugs currently under investigation.

Nonetheless, Senator John McCain (R-Ariz.) wants this same FDA, with its dismal safety record, to regulate dietary supplements. The Dietary Supplement Safety Act (DSSA), S. 3002 (text of this bill posted on Senator McCain's website), that McCain has introduced with one cosponsor, would repeal key provisions of the Dietary Supplement Health and Education Act (DSHEA) to “more effectively regulate dietary supplements that may pose safety risks unknown to consumers.”

Under attack by the DSSA is the once-protected field of supplements, as they have always been considered food. Potencies would have to be reduced to comply with what appears to be a plan modeled after the European Food Safety Authority. A new list of “Accepted Dietary Ingredients” would be “prepared, published, and maintained by the Secretary,” in the future. That’s a bit like being handed a blank check and told to fill it out later as one wishes. It could certainly be used to severely limit access to, and even production of, hundreds of life-sustaining and essential mineral, herb, and vitamin products.

All ingredients contained in each supplement would have to be disclosed at the time the company registers all of its “manufactured, packaged, held, distributed, labeled or licensed,” products with the FDA. An onerous burden would be placed on the shoulders of suppliers and retailers of dietary supplements, as they would have to “obtain written evidence” from the seller that the product is registered as required by law, and keep that documentation on file. Monetary penalties for non-compliance “may, in addition to other penalties imposed in this section, be fined not more than twice the gross profits or other proceeds derived from the manufacture, packaging, holding, distribution, labeling, or license of such dietary supplement.” Those are very broad dictates and most likely subject to even broader interpretation.

The McCain bill would change existing mandatory serious adverse reporting regulations, requiring minor adverse effects to be reported as well so that the FDA could arbitrarily pull supplements off the shelves or reclassify them as drugs. This immediate recall authority would be granted to the “Secretary upon determination,” that there is a “reasonable probability” that the product is “adulterated” or “misbranded.” Adulterated in this bill takes on a whole new expanded definition: “A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety.” The development of new products that contain newly discovered nutritional components may be entirely quashed.

The hypocritical contrast between the regulation of drugs that can kill and the proposed hyper-regulation for food products -- vitamins, minerals, herbs -- is as plain as the nose on everyone's face.

A Pandora’s box of intended and unintended legal complications and government harassment of nutritional supplement manufacturers and sellers could very well be unleashed if this bill is passed. There are already existing laws on the books that protect consumers from misbranded, fraudulent, or contaminated products. Granting the FDA additional regulatory authority over nutritional supplements seems a bit suspicious, especially considering the influence the enormous pharmaceutical industry has wielded over the research, development, and approval process inside the FDA. Let’s face it, the FDA has been no friend and often has been positively antagonistic toward the nutritional supplement industry. Therefore one wouldn’t set the wolf to guarding the sheep without dire consequences.

In this perverted overly-regulated country, food is now toxic, and drugs and chemicals are safe for ingestion, no matter the harm that results. This inversion should remind us that those who best have the consumers health and safety interests at heart are the consumers themselves. It is big government that has a proven track record of not protecting the public. And it is big government that is seeking to take away yet another individual freedom, the right to choose one’s own treatment. (Where is the pro-choice crowd on this one; the ones that claim, “my body, my choice?”)

Contact your federal legislators and urge them not to cosponsor, support, or vote for such a power-grabbing, bill. Let them know Americans want unrestricted access to nutritional supplements, and the government out of their health choices.

Sen. McCain described his bill as a “no brainer.” For constitutionalists it’s a “no brainer” that it should be rejected for the dictatorial, power-grabbing, choice-limiting attack on the nutritional marketplace and individual freedoms that it is.

The Autism Debate: Who's Afraid of Jenny McCarthy?

In person, surprisingly, Jenny McCarthy comes across as corn-fed cute rather than overwhelmingly beautiful. She has a common touch, and a woman even slightly more beautiful would struggle to connect as she does. When McCarthy meets a mom, when she spits forth a stream of profanity and common sense — the foulmouthed comedian from Chicago never far from the surface — she is there as a mother, not as a celebrity or starlet. That's what got her there, but that's not who she is once she's there. She speaks to so many frustrated, despairing mothers of autistic children because she is plausible, authentic. If you needed a woman to bring hope to these mothers, you couldn't ask for better casting than Jenny McCarthy.

Fighting Alzheimer's with a touch of beauty

A pioneering care project demonstates how literature, music, art and love can improve the lives of dementia sufferers

Rita Hayworth

Rita Hayworth

Image :1 of 2

In her heyday, Rita Hayworth was known as the “Love Goddess”: so explosive was her appeal that her image was placed on the first nuclear bomb to be tested on Bikini Atoll after the second world war. As befits one of the world’s most glamorous women, she danced her way through 61 movies and five husbands. She was a pin-up for American servicemen and is listed as one of the American Film Institute’s greatest stars of all time.


Study: Teen pot, alcohol use rising

Alcohol and marijuana use among teens is on the rise, ending a decade-long decline, a study being released Tuesday found.

"I'm a little worried that we may be seeing the leading edge of a trend here," said Sean Clarkin, director of strategy at the Partnership for a Drug-Free America, which was releasing the study. "Historically, you do see the increase in recreational drugs before you see increases in some of the harder drugs."

The annual survey found the number of teens in grades nine through 12 who reported drinking alcohol in the last month rose 11 percent last year, with 39 percent — about 6.5 million teens — reporting alcohol use. That's up from 35 percent, or about 5.8 million teens, in 2008.

For pot, 25 percent of teens reported smoking marijuana in the last month, up from 19 percent.

Until last year, those measures for pot and alcohol use had been on a steady decline since 1998, when use hovered around 50 percent of teens for alcohol and 27 percent for pot.

The study also found use of the party drug Ecstasy on the rise. Six percent of teens surveyed said they used Ecstasy in the past month, compared with 4 percent in 2008.

If parents suspect their teen is using, they need to act quickly, Mr. Clarkin said. Monitor them more closely, talk with them about drugs, set rules and consult outside help, such as a counselor, doctor, clergy or other resource, he said.

The researchers asked teens how they felt about doing drugs or friends who did them. The study found a higher percentage of teens than in the previous year agreed that being high feels good; more teens reported having friends who usually get high at parties; and fewer teens said they wouldn't want to hang around others who smoked pot.

Stacy Laskin, now 21 and a senior in college, said marijuana was everywhere during her high school years. She said she tried pot and drank alcohol in high school but didn't make it a habit like other teens she knew.

"The behavior I saw people go through — and to see how far people can fall — really turned me away more than anything else," Miss Laskin said in an interview with Associated Press.

Her close friend from high school died in 2008 from a heroin overdose. Miss Laskin, a psychology major at Salisbury University in Maryland, was so torn by her friend Jeremy's death that she decided to help others and is working on her second internship at a drug-treatment center.

"Just seeing the negative impact made me want to get involved," she said.

Other findings:

• Teen abuse of prescription drugs and over-the-counter cough medicine remained stable from 2008 to 2009. About one in seven teens reported abusing a prescription pain reliever in the past year, and about 8 percent of the teens questioned reported over-the-counter cough medicine abuse in the past year.

• Teen steroid and heroin use remained low at 5 percent for lifetime use.

The group's "attitude tracking" study was sponsored by MetLife Foundation. Researchers surveyed 3,287 teens in grades nine through 12. Data were collected from questionnaires that teens filled out anonymously from March to June 2009. The study has a margin of error of 2.3 percentage points.

The New York-based partnership is a nonprofit group working to reduce the use of illicit drugs.

The Great Grocery Smackdown

Will Walmart, not Whole Foods, save the small farm and make America healthy?

By Corby Kummer
Presented By

Image credit: Eli Meir Kaplan

Buy my food at Walmart? No thanks. Until recently, I had been to exactly one Walmart in my life, at the insistence of a friend I was visiting in Natchez, Mississippi, about 10 years ago. It was one of the sights, she said. Up and down the aisles we went, properly impressed by the endless rows and endless abundance. Not the produce section. I saw rows of prepackaged, plastic-trapped fruits and vegetables. I would never think of shopping there.

Not even if I could get environmentally correct food. Walmart’s move into organics was then getting under way, but it just seemed cynical—a way to grab market share while driving small stores and farmers out of business. Then, last year, the market for organic milk started to go down along with the economy, and dairy farmers in Vermont and other states, who had made big investments in organic certification, began losing contracts and selling their farms. A guaranteed large buyer of organic milk began to look more attractive. And friends started telling me I needed to look seriously at Walmart’s efforts to sell sustainably raised food.

Video: Corby Kummer tours Walmart’s produce aisles and finds unexpected variety and quality

Really? Wasn’t this greenwashing? I called Charles Fishman, the author of The Wal-Mart Effect, which entertainingly documents the market-changing (and company-destroying) effects of Walmart's decisions. He reiterated that whatever Walmart decides to do has large repercussions—and told me that what it had decided to do since my Natchez foray was to compete with high-end supermarkets. “You won’t recognize the grocery section of a supercenter,” he said. He ordered me to get in my car and find one.

He was right. In the grocery section of the Raynham supercenter, 45 minutes south of Boston, I had trouble believing I was in a Walmart. The very reasonable-looking produce, most of it loose and nicely organized, was in black plastic bins (as in British supermarkets, where the look is common; the idea is to make the colors pop). The first thing I saw, McIntosh apples, came from the same local orchard whose apples I’d just seen in the same bags at Whole Foods. The bunched beets were from Muranaka Farm, whose beets I often buy at other markets—but these looked much fresher. The service people I could find (it wasn’t hard) were unfailingly enthusiastic, though I did wonder whether they got let out at night.

During a few days of tasting, the results were mixed. Those beets handily beat (sorry) ones I’d just bought at Whole Foods, and compared nicely with beets I’d recently bought at the farmers’ market. But packaged carrots and celery, both organic, were flavorless. Organic bananas and “tree ripened” California peaches, already out of season, were better than the ones in most supermarkets, and most of the Walmart food was cheaper—though when I went to my usual Whole Foods to compare prices for local produce, they were surprisingly similar (dry goods and dairy products were considerably less expensive at Walmart).

Walmart holding its own against Whole Foods? This called for a blind tasting.

I conspired with my contrarian friend James McWilliams, an agricultural historian at Texas State University at San Marcos and the author of the new Just Food: Where Locavores Get It Wrong and How We Can Truly Eat Responsibly. He enlisted his friends at Fino, a restaurant in Austin that pays special attention to where the food it serves comes from, as co-conspirators. I would buy two complete sets of ingredients, one at Walmart and the other at Whole Foods. The chef would prepare them as simply as possible, and serve two versions of each course, side by side on the same plate, to a group of local food experts invited to judge.

I started looking into how and why Walmart could be plausibly competing with Whole Foods, and found that its produce-buying had evolved beyond organics, to a virtually unknown program—one that could do more to encourage small and medium-size American farms than any number of well-meaning nonprofits, or the U.S. Department of Agriculture, with its new Know Your Farmer, Know Your Food campaign. Not even Fishman, who has been closely tracking Walmart’s sustainability efforts, had heard of it. “They do a lot of good things they don’t talk about,” he offered.

The program, which Walmart calls Heritage Agriculture, will encourage farms within a day’s drive of one of its warehouses to grow crops that now take days to arrive in trucks from states like Florida and California. In many cases the crops once flourished in the places where Walmart is encouraging their revival, but vanished because of Big Agriculture competition.

Ron McCormick, the senior director of local and sustainable sourcing for Walmart, told me that about three years ago he came upon pictures from the 1920s of thriving apple orchards in Rogers, Arkansas, eight miles from the company’s headquarters. Apples were once shipped from northwest Arkansas by railroad to St. Louis and Chicago. After Washington state and California took over the apple market, hardly any orchards remained. Cabbage, greens, and melons were also once staples of the local farming economy. But for decades, Arkansas’s cash crops have been tomatoes and grapes. A new initiative could diversify crops and give consumers fresher produce.

As with most Walmart programs, the clear impetus is to claim a share of consumer spending: first for organics, now for locally grown food. But buying local food is often harder than buying organic. The obstacles for both small farm and big store are many: how much a relatively small farmer can grow and how reliably, given short growing seasons; how to charge a competitive price when the farmer’s expenses are so much higher than those of industrial farms; and how to get produce from farm to warehouse.

Walmart knows all this, and knows that various nonprofit agricultural and university networks are trying to solve the same problems. In considering how to build on existing programs (and investments), Walmart talked with the local branch of the Environmental Defense Fund, which opened near the company’s Arkansas headquarters when Walmart started to look serious about green efforts, and with the Applied Sustainability Center at the University of Arkansas. The center (of which the Walmart Foundation is a chief funder) is part of a national partnership called Agile Agriculture, which includes universities such as Drake and the University of New Hampshire and nonprofits like the American Farmland Trust.* To get more locally grown produce into grocery stores and restaurants, the partnership is centralizing and streamlining distribution for farms with limited growing seasons, limited production, and limited transportation resources.

Walmart says it wants to revive local economies and communities that lost out when agriculture became centralized in large states. (The heirloom varieties beloved by foodies lost out at the same time, but so far they’re not a focus of Walmart’s program.) This would be something like bringing the once-flourishing silk and wool trades back to my hometown of Rockville, Connecticut. It’s not something you expect from Walmart, which is better known for destroying local economies than for rebuilding them.

As everyone who sells to or buys from (or, notoriously, works for) Walmart knows, price is where every consideration begins and ends. Even if the price Walmart pays for local produce is slightly higher than what it would pay large growers, savings in transport and the ability to order smaller quantities at a time can make up the difference. Contracting directly with farmers, which Walmart intends to do in the future as much as possible, can help eliminate middlemen, who sometimes misrepresent prices. Heritage produce currently accounts for only 4 to 6 percent of Walmart’s produce sales, McCormick told me (already more than a chain might spend on produce in a year, as Fishman would point out), adding that he hopes the figure will get closer to 20 percent, so the program will “go from experimental to being really viable.”

Michelle Harvey, who is in charge of working with Walmart on agriculture programs at the local Environmental Defense Fund office, summarized a long conversation with me on the sustainability efforts she thinks the company is serious about: “It’s getting harder and harder to hate Walmart.”

“We support local farmers,” read a sign at an Austin Walmart. I didn’t see any farm names listed in the produce section, but I did find plastic tubs of organic baby spinach and “spring mix” greens with modern labeling that looked like it could be at Whole Foods. My list was simple to the point of stark, for a fair fight. Some ingredients seemed identical to what I’d find at Whole Foods. Organic, free-range brown eggs. Promised Land all-natural, hormone-free milk. A bottle of Watkins Madagascar vanilla for panna cotta. I couldn’t find much in the way of the seasonal fruit the restaurant had told me the chef would serve with dessert. But I did find, to my surprise, a huge bin of pomegranates, so I bought those, and some Bosc pears. The sticking points were fresh goat cheese, which flummoxed the nice sales people (we found some Alouette brand, hidden), and chicken breasts. I could find organic meat, but no breasts without “up to 12 percent natural chicken broth” added—an attempt to inject flavor and add weight. I wasn’t happy with the suppliers, either: Tyson predominated. I bought Pilgrims Pride, but was suspicious. The bill was $126.02.

At the flagship Whole Foods, in downtown Austin, the produce was much more varied, though the spinach and spring mix looked less vibrant. The chicken was properly dry, a fresh ivory color—and more than twice as expensive as Walmart’s. My total bill was $175.04; $20 of the extra $50 was for the meat.

Brian Stubbs, the tall, genial young manager of Fino, and Jason Donoho, the chef, were intrigued as they helped me carry bag after bag into the restaurant’s kitchen. They carefully segregated the bags on two shelves of a walk-in refrigerator. The younger cooks looked surprised by the Whole Foods kraft-paper bags, and slightly horrified by the flimsy white plastic ones from Walmart.

The next night 16 critics, bloggers, and general food lovers gathered around a long, high table at the restaurant. Stubbs passed out scoring sheets with bullets for grades of one (worst) to five (best) for each of the four courses, and lines for comments.

The first course, bowls of almonds and pieces of fried goat cheese with red-onion jam and honey, was a clear win for Walmart. The Walmart almonds were described as “aromatic,” “mellow,” “pure,” and “yummy,” the Whole Foods almonds as “raw,” though also more “natural”; they were in fact fresher, though duller in flavor. (Like the best of the food I saw at the Austin Walmart, the packaging for the almonds had a homegrown Mexican look.) The second course, mixed spring greens in a sherry vinaigrette, was another Walmart win: only a few tasters preferred the Whole Foods greens, calling them fresher and heartier-flavored. And only one noticed the little brown age spots on a few Walmart leaves, but she was a ringer—Carol Ann Sayle, a local farmer famous for her greens.

So far Walmart was ahead. But then came the chicken, served with a poached egg on a bed of spinach and golden raisins. A woman whose taste I already thought uncanny—she works as an aromatherapist—compared the broth-infused meat to something out of a hospital cafeteria: “It’s like they injected it with something to make it taste like fast food.” I thought it was salty, damp, and dismal. The spinach, though, was another story: even the most ardent brothy-breast haters thought the Walmart spinach was fresher.

Dessert was the most puzzling. I had thought that Walmart’s locally sourced milk and exotic-looking vanilla would be the gold standard, but the Whole Foods house brands slaughtered them (“Kicks A’s ass,” one taster wrote). People couldn’t find enough words to diss the Walmart panna cotta (“artificial, thin”) and praise the Whole Foods one (“like a good Christmas”). I wished I’d bought the identical Promised Land milk at Whole Foods, to see if there is in fact a difference in the branded food products that suppliers give Walmart, as there is in the case of other branded products. The pomegranate seeds, sadly, were wan, with barely any flavor, particularly compared with the garnet gems from Whole Foods. But Walmart got points from the chef, and from me, for carrying pomegranates at all.

As I had been in my own kitchen, the tasters were surprised when the results were unblinded at the end of the meal and they learned that in a number of instances they had adamantly preferred Walmart produce. And they weren’t entirely happy.

In an ideal world, people would buy their food directly from the people who grew or caught it, or grow and catch it themselves. But most people can’t do that. If there were a Walmart closer to where I live, I would probably shop there.

Most important, the vast majority of Walmarts carry a large range of affordable fresh fruits and vegetables. And Walmarts serve many “food deserts,” in large cities and rural areas—ironically including farm areas. I’m not sure I’m convinced that the world’s largest retailer is set on rebuilding local economies it had a hand in destroying, if not literally, then in effect. But I’m convinced that if it wants to, a ruthlessly well-run mechanism can bring fruits and vegetables back to land where they once flourished, and deliver them to the people who need them most.

Correction: The article originally stated, incorrectly, that the Agile Agriculture partnership included the National Sustainable Agriculture Coalition.

FDA Issues Processed Food Recal

A wide range of processed foods - including soups, snack foods, dips, and dressings is being recalled after salmonella was discovered in a flavor-enhancing ingredient.

Food and Drug Administration officials said Thursday that the ingredient, hydrolyzed vegetable protein (HVP), is used in thousands of food products, though it was unclear how many of them will be recalled. The FDA and the Centers for Disease Control and Prevention said no illnesses or deaths have been reported. MORE>>>>>>>>>>>>>>

Remedies From Mother Nature That Work

From honey and peppermint to vinegar and garlic, Mother Nature has a host of cures.

Centuries ago we relied on nature for treating our wounds and warding off bugs. Now the spread of antibiotic-resistant bacteria such as MRSA is reviving interest in these ancient remedies.

Our ancestors had their own antibiotics, says Dr. Serene Foster, a medical herbalist at Hydes Herbal Clinic in Leicester. They didn't know why they worked, but they found many medical uses for them.

We do need more research, because natural treatments must stand up to modern scrutiny, but it seems they boost the body's own immune system, and we should consider using them with, or even instead of conventional drugs.

To read the full Daily Express story--Go Here Now.

Can Gut Bacteria Cause Cancer, Diabetes?

Some of the hundreds of bacteria found in the digestive systems of humans may be linked to specific diseases like cancer, diabetes, and obesity, an international team of scientists said in a paper on Thursday.

Researchers, led by Chinese scientist Wang Jun, said in the latest issue of Nature they found more than 1,000 different species of bacteria in the human gut.


New Advice on Prostate Cancer Screening

New advice from the American Cancer Society puts a sharper focus on the risks of prostate cancer screening, emphasizing that annual testing can lead to unnecessary biopsies and treatments that do more harm than good.

The cancer society has not recommended routine screening for most men since the mid-1990s, and that is not changing. But its new advice goes further to warn of the limitations of the PSA blood test that millions of American men get now. It also says digital rectal exams should be an option rather than part of a standard screening.