Tuesday, August 14, 2012

Merck Launches National Advertising Campaign For GARDASIL®, Merck's New Cervical Cancer Vaccine

Merck & Co., Inc. announced today the launch of a national print, television and online advertising campaign for the world's first cervical cancer vaccine, GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. GARDASIL was approved by the FDA on June 8 - and provisionally recommended by the Advisory Committee on Immunization Practices (ACIP) on June 29 - for girls and women aged 9-261. GARDASIL is the world's first and only vaccine indicated for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. Adding to Merck's ongoing cervical cancer and HPV education efforts, the new campaign, called One Less, encourages females who are eligible for the vaccine to begin their vaccination series and to also continue to see their doctor for regular healthcare and screening.

"The full public health benefit of reducing the burden of cervical cancer and HPV disease may be achieved through broad public awareness and vaccination with GARDASIL, which is the driving force behind One Less," said Bev Lybrand, vice president & general manager, HPV Franchise, GARDASIL, Merck Vaccine Division. "Merck is committed to educating and providing access to women and girls who may benefit from this critical vaccine."

One Less is the continuation of Merck's commitment to disease and vaccine education. GARDASIL is for girls and women ages 9-26 years of age. If these girls and women have already been infected with HPV, they may still benefit from GARDASIL because it is unlikely that they have been infected with all four types of the virus covered by the vaccine. To inform and encourage these girls and women, the campaign focuses on a strong and positive message that is designed to empower them to want to become (or help their daughters want to become) "one less" person who will battle cervical cancer.

The campaign also focuses on important information about GARDASIL. GARDASIL may not fully protect everyone, and GARDASIL does not prevent all types of cervical cancer, so ongoing cervical cancer screenings will be important. GARDASIL is not recommended for use in pregnant women and GARDASIL will not treat cervical cancer. GARDASIL can cause injection site-pain, -swelling, -itching and -redness as well as fever, dizziness or nausea. For more information about this campaign and to view the commercials, visit http://www.gardasil.com.

Committed to public awareness

In addition to One Less, Merck will continue to separately support HPV disease education including the Tell Someone and the Make the Connection multi-lingual disease awareness programs to ensure an understanding about the important link between cervical cancer and HPV and the need to continue regular screening. Merck also provides support and grant funding to national and local organizations to help disseminate disease information to broad and diverse audiences, including those with outreach to underserved communities.

Access to GARDASIL

There is broad private and public coverage for GARDASIL. Health insurers covering approximately 94 percent of privately insured lives in the U.S. (currently more than 100 insurance plans) have decided to reimburse GARDASIL. GARDASIL was added to the Vaccines for Children (VFC) Program on November 1. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.

Merck is also actively working to accelerate the availability of GARDASIL in the developing world: Merck is working with PATH to develop HPV vaccination programs that will facilitate the introduction of GARDASIL to the most impoverished nations. This initiative is funded by a grant to PATH from the Bill & Melinda Gates Foundation. Merck has also announced a partnership with India's Council of Medical Research to study GARDASIL. Merck will make our new vaccines, including GARDASIL, available at dramatically lower prices to developing world countries.

Dosage and administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Selected important information about GARDASIL

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine HPV types.

Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).

About HPV disease

In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. It is estimated that in 2006, there will be approximately 9,700 new cases of cervical cancer and 3,700 deaths in the United States. In addition, certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately one million cases of genital warts occur each year in the United States and an estimated 32 million cases occur worldwide. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, AIS (non-invasive cervical cancer), CIN 3, VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vaginal and vulvar lesions (CIN I, VIN I and VaIN I). Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV.

Worldwide availability of GARDASIL

GARDASIL has been approved in more than 40 countries including the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil. Additional applications for GARDASIL are currently under review with regulatory agencies in more than 50 countries around the world.

Other Information about GARDASIL

In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

1 The ACIP recommended that GARDASIL be administered to 11- and 12- year-old females and to females aged 13 to 26 who have not previously been vaccinated, and that nine- and 10-year-old females can be vaccinated with GARDASIL at the discretion of their physicians.

GARDASIL® is a registered trademark of Merck & Co., Inc, Whitehouse Station, N.J., U.S.A.
Continue to Read more ...

Cell Phone Usage Linked To Lower Sperm Count

The more a man uses his cell phone the lower his sperm count is likely to be, said researchers from Cleveland, New Orleans and Mumbai, at the Annual Meeting of the American Society for Reproductive Medicine. The researchers found that every aspect of a man's sperm profile can be affected by many hours on his cell phone.

The researchers looked at the sperm count, motility and normal forms of the sperm of 364 men. They found that:

-- among men with a normal sperm count who never used a mobile phone, average sperm counts were 86 million per milliliter, 68% motility and 40% normal sperms

-- among men with a normal sperm count who used their mobiles more than four hours per day, average sperm counts were 66 million sperm per milliliter, 46% motility and 21% normal forms

The researchers believe the effect on sperm profiles may be caused by the electromagnetic radiation emitted by the devices, or their heat. They added that further studies are needed to find out exactly what the mechanisms are that undermine sperm quality.

"Relationship between cell phone use and human fertility: an observational study"
P-398 A. Agarwal, S. A. Prabakaran, G. Ranga, A. T. Sundaram, R. K. Sharma, S. C. Sikka
Continue to Read more ...

Occupational Therapy Improves Quality Of Life For Dementia Patients And Their Carers, UK

Occupational therapy can help to improve the ability of people with dementia to perform daily activities and can also reduce the pressure on their caregivers, says a BMJ study published today.

Dementia can have far reaching effects for patients and their caregivers and is a major driver of costs for both health and social care systems across the developed world. The most significant problems associated with dementia are the losses in independence, initiative and participation in social activities - factors which affect the quality of life for both patients and their caregivers and families.

Previous research had suggested that non-pharmalogical treatment could have the same or better effects than drug treatment for people with dementia.

Researchers from The Netherlands set out to measure the effect of occupational therapy on people with dementia and their main carer. A group of 135 patients with mild to moderate dementia and their caregivers were randomly split into two groups. The first group received 10 home-based sessions of occupational therapy - provided by an experienced occupational therapist - over a period of five weeks, whilst the second group received no occupational therapy. The groups were then assessed six weeks and 12 weeks after the therapy sessions.

At both six weeks and three months the patients who received occupational therapy functioned significantly better in daily life than those who did not - with 75% of those in the group showing an improvement in process skills and 82% needing less assistance in day to day tasks. Primary caregivers who received occupational therapy also felt significantly more competent than those who did not.

The authors suggest that occupational therapy is likely to be more effective than drugs or other psychosocial interventions - as the levels of improvement in their trial outstrip the effects recorded in previous trials of drugs and other interventions.

They add that they 'strongly advocate' the inclusion of occupational therapy in dementia management programmes; 'the clinical gains - obtained with occupational therapy for both patients and their caregivers underlines the importance of adequate diagnosis and pro-active management in dementia' they conclude.
Continue to Read more ...

Total Cancer Deaths Down In USA, First Time In 75 Years

For the first time since 1930, the total number of annual cancer deaths has dropped in the USA. In 2003, 556,902 people died of cancer in the USA, the total for 2002 was 557,271, according to figures published by the National Center for Health Statistics.

The greatest contributor to the fall, say experts, is the drop in the number of people in the country who smoke. Another contributor is earlier diagnosis, as well as better treatment.

This is the first drop in the number of total deaths. If calculated as deaths per 100,000 people, rates have been falling by about 1% per year for the last ten years. However, as the US population has been rising fast, it is only now that the fall in total deaths have overtaken the rise in the country's population.

The biggest falls in total deaths were seen in:

-- Lung Cancer
-- Breast Cancer
-- Prostate Cancer
--Colorectal Cancer

These four cancers account for over half of all cancers in the USA.

Cancers and drop in death rates

Breast cancer

Death rate dropping by 2% per year since 1990.

Colon cancer death

Death rates dropping by 2% per year since the mid-1980s.

Prostate cancer

Deaths rates dropping by 4% a year since 1994.

Lung cancer

Death rates dropping by 2% per year since 1991 for men, but has not dropped for women.

In fact, the total number of all cancer deaths among women increased.

Experts say they expect to see total numbers rise again. This is because people are living longer. Cancers tend to develop more in people as they get old - if there are more very old people around, there will be more cancer diagnoses.

As the American population is getting fatter, who knows whether in the medium term this will have an effect on cancer rates and cancer deaths. Obesity raises the risk of developing diabetes type 2, which in turn may raise the risk of developing some cancers.
Continue to Read more ...

Parents Who Fight May Harm Children's Future Emotional Development

How parents handle everyday marital conflicts has a significant effect on how secure their children feel, which, in turn, significantly affects their future emotional adjustment. This finding, from researchers at the universities of Notre Dame, Rochester (NY) and Catholic University of America in Washington, D.C., was published in the January/February 2006 issue of the journal Child Development. It provides powerful new evidence regarding the impact of parental behavior on children's future behavior.

"A useful analogy is to think about emotional security as a bridge between the child and the world," explained lead researcher Mark Cummings, Ph.D., professor and Notre Dame Chair in Psychology of the Psychology Department of the University of Notre Dame in Indiana. "When the marital relationship is functioning well, it serves as a secure base, a structurally sound bridge to support the child's exploration and relationships with others."

"When destructive marital conflict erodes the bridge, children may lack confidence and become hesitant to move forward, or may move forward in a dysregulated way, unable to find appropriate footing within themselves or in interaction with others." The researchers based their report on two separate long-term studies of marital conflict and children.

The first study involved 226 parents and their 9- to-18-year-old children. The researchers examined the effect of marital conflict over three years, finding that forms of destructive marital conflict, such as personal insults, defensiveness, marital withdrawal, sadness or fear, set in motion events that led to later emotional insecurity and maladjustment in children, including depression, anxiety, and behavior problems. This occurred even when the researchers controlled for any initial adjustment problems.

The second study again examined the connection between marital conflict and emotional problems over a three-year period, this time in a different group of 232 parents and much younger children (kindergarteners). Researchers again found that marital conflict sets in motion events that led to later emotional insecurity and maladjustment. Again, researchers controlled for any initial adjustment problems, further supporting the conclusion that marital conflict was related with children's emotional insecurity and adjustment problems. Both studies involved representative community samples and everyday conflict behaviors (for example, verbal hostility) about everyday sources of conflict between parents, such as childcare and household responsibilities. Because of this, the findings can likely be generalized to most American families.

Parents and even mental health professionals are likely unaware of the significance of marital conflict for the well-being of children, said Dr. Cumming, and few may know that children's security is so closely tied to the quality of parental relationships. At the same time, however, other work from Dr. Cummings and his peers find that constructive marital conflict, in which parents express or engage in physical affection, problem solving, compromise or positive feelings, may increase children's security. "Thus," Dr. Cummings noted, "this study is a warning to strongly encourage parents to learn how to handle conflicts constructively for the sake of both their children and themselves."
Continue to Read more ...

Device Dries Lice And Nits Out Of Hair

If you want to rid your children of lice and nits and don't want to use chemicals, a hairdryer-type device may be just what you are looking for. Use it on your child for 30-minutes and he/she will be infestation free, say the makers of the LouseBuster, Larada Sciences. The makers stress that their device dries the bugs out, it does not heat them. You should not try doing this at home with your hairdryer.

You can read about this in the journal Pediatrics.

Larada Sciences says the LouseBuster should be on the market within the next two years.

Currently, there are various ways of treating headlice, chemical shampoos among them. However, there is evidence that the lice are developing resistance to them. Special combs can also be effective, but the user has to follow the instructions carefully - many people don't.

Dr Dale Clayton, who co-invented the LouseBuster, stressed that it does not work by heating the nits and lice out, "We don't want kids getting burned by parents who think it is the heat. This thing is actually cooler than a hairdryer, but requires twice as much airflow, and the special hand piece is critical because, unless you expose the roots of the hair, it doesn't work. It's difficult to do that with a regular comb."

The new 30-minute treatment has been shown to eliminate 80% of lice and 98% of nits. The researchers said there was no evidence of any side-effects from this treatment.

What are Lice and Nits

The singular of Lice is Louse (one louse, two lice). The eggs of lice are called Nits. Lice are tiny, light-brown insects, they live on the human scalp. They suck blood from the scalp. They lay their greyish eggs, which stick firmly onto the shaft of your hair, very close to the scalp. The eggs hatch after about one week. As lice can start laying eggs when they are just two weeks' old, it is not long before a person has hundreds of them on his/her head (an infestation).

Lice, unlike fleas, do not jump. They go from one head to another when the two heads are touching each other (they walk over).

Lice need the warmth of the scalp to survive, that is why combs and brushes do not have live lice.

The word LOUSY, as in "I have a lousy teacher", comes from the meaning 'infested with lice'.

"An Effective Nonchemical Treatment for Head Lice: A Lot of Hot Air"
Click here to see abstract online
Continue to Read more ...

Teen Births Cost U.S. Government $9.1B In 2004 Despite Drop In Teen Birth, Pregnancy Rates, Report Says

The U.S. government in 2004 incurred at least $9.1 billion in costs related to teen births, despite significant decreases in teen pregnancy and birth rates since the early 1990s, according to a report released on Monday by the National Campaign To Prevent Teen Pregnancy, USA Today reports (Koch [1], USA Today, 10/30). The teen birth rate and teen pregnancy rate from 1991 through 2002 decreased by 30% and 36%, respectively, according to figures from the government and the Guttmacher Institute (Koch [2], USA Today, 10/30). The report -- titled "By the Numbers: The Public Costs of Teen Childbearing" and written by Saul Hoffman, an economics professor at the University of Delaware -- found that $8.6 billion of the $9.1 billion the government paid in 2004 birth-related care was for girls age 17 and younger. According to the report, the costs included $1.9 billion for health care, $2.3 billion for child welfare, $2.1 billion for incarceration and $2.9 billion in lower tax revenue. Children born to teenagers have higher health care, foster care and incarceration costs than children born to older women. In addition, children born to teen mothers on average earn a lower income as adults and pay less in taxes, the report found. In addition, girls who gave birth at ages younger than age 17 are more than twice as likely as women who had their first child at ages 20 or 21 to have a child placed in foster care, to be reported for child abuse or neglect and to have a son incarcerated, the report found. NCPTP Director Sarah Brown said, "It's important to remind people the problems [related to teen pregnancy] are very serious and expensive" (Koch [1], USA Today, 10/30). Brown also said that the drop in the teen pregnancy rate is a "combination of many factors," including welfare reform, reduced benefits, and more schools, churches and community groups offering abstinence and sex education programs. HIV and sex education programs nationwide also are contributing factors, Douglas Kirby of the health education organization ETR Associates said, adding that the most significant drop generally is in states with comprehensive sex education programs (Koch [2], USA Today, 10/30).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Continue to Read more ...

Two Soft Drinks Companies Sued For Cancer Causing Benzene

Benzene can be formed in soft drinks which contain Vitamin C (ascorbic acid), sodium benzoate or potassium benzoate. Two soft drinks companies, Polar Beverages Inc. and Zone Brands Inc., are being sued by parents in Massachusetts and Florida for selling drinks which may contain benzene. The companies are being asked to take their products off the shelves (withdraw them).

Polar Beverages makes fruit-flavoured fizzy drinks and mixers. Zone Brands makes BellyWashers and juices.

Just the presence of ascorbic acid and sodium benzoate or potassium benzoate does not necessarily result in the creation of benzene. Whether or not benzene is produced depends on such factors as light exposure and heat. Benzene is present in many settings. Forest fires contain benzene, as does cigarette smoke and gasoline.

Tim Newell, one of the plaintiffs, claims it is impossible for parents to really know which soft drinks are safe and which contain cancer-causing benzene.

(Plaintiff = The person who is suing)

The plaintiffs allege that independent lab tests found that benzene levels in those two companies' beverages were above the 5 parts per billion, the limit set nationally for drinking water.

The FDA says levels are still low. The FDA is carrying out its own investigation into levels of benzene in soft drinks in general.
Continue to Read more ...

New Study Demonstrates Dietary Supplement Lutein Increases Skin Hydration, Elasticity And Lipid Levels

Highlights from a new clinical study presented today at the "Beyond Beauty Paris" conference in France provide compelling evidence that lutein, a dietary nutrient available as a supplement and long-known for its effectiveness in promoting eye health, also provides specific skin health benefits. These include increasing the hydration, elasticity and superficial lipids of the skin, while decreasing the oxidation - a process that causes degradation - of those beneficial skin lipids.

Topline results of the study, presented by Dr. Pierfrancesco Morganti, professor of applied cosmetic dermatology at the University of Naples, on behalf of the research team, indicated that lutein and its associated molecule zeaxanthin, when taken daily as a 10 mg oral lutein supplement, increased skin hydration by 38 percent, skin elasticity by 8 percent and the level of superficial lipids present in the skin by 33 percent after adjustments for placebo. Results also showed that lutein decreased oxidation of those beneficial lipids by 55 percent after adjustment for placebo.

The study further demonstrated that the combination of oral and topical administration of lutein/zeaxanthin provided even more powerful improvements, increasing skin hydration by 60 percent, skin elasticity by 20 percent and the amount of superficial lipids present in the skin by 50 percent after adjustment for placebo, all while decreasing the oxidation of those beneficial lipids by 64 percent.

Lutein, a nutrient naturally found in dark green leafy vegetables like spinach, kale and collard greens, as well as broccoli, corn and egg yolks, is present in tissues in the eye, blood serum, skin, cervix, brain and breast. It is not produced by the human body and thus must be ingested daily through food or taken as a supplement.

The study, entitled "Clinical Evidence for Lutein and Zeaxanthin in Skin Health, Part 1: Comparison of Placebo, Oral, Topical and Combined Oral/Topical Xanthophyll Treatments," was conducted in Italy on female subjects, age 25-50, over a 12-week period. The test product utilized in the study contained FloraGLO(R) Lutein, manufactured by Kemin Health, L.C., of Des Moines Iowa. It was administered daily at 10 mg (oral supplementation) and 50 ppm (topical formulation) to subjects in the study's different test groups.

"This is the first study to determine the impact of lutein/zeaxanthin alone on the human skin," said Richard L. ("Dick") Roberts, Ph.D., senior manager of scientific affairs for Kemin Health, the leading manufacturer of lutein. "It provides strong new evidence of lutein's positive role in promoting skin health and appearance by increasing hydration, elasticity and lipid content."

"This research underscores the importance of thinking about skin health and beauty from the 'inside out,'" said Bruce Katz, M.D., a dermatologist and director of the JUVA Skin & Laser Center in New York, who is working with Kemin to educate consumers on the role of nutrition as part of a total skin health and beauty regimen. "The benefits of taking lutein daily will be of great interest to people who are looking for new ways to improve the hydration and elasticity of their skin and help reduce the appearance of premature aging."

The new study adds to an existing body of research that suggests lutein, when taken on a daily basis, may help bolster the skin's natural antioxidant defense system, helping to protect skin from potentially damaging effects of sun and artificial light exposure.

About Kemin

A nutritional ingredient manufacturer, Kemin is committed to improving the nutrition of the world with functional products that deliver maximum efficacy through superior chemistry. FloraGLO(R) Lutein is the world's leading patented, purified lutein. Products with FloraGLO(R) Lutein contain the same lutein naturally found in dark green leafy vegetables as well as eggs. Studies indicate daily lutein intake of 6 mg to 10 mg may be beneficial.

A Kemin-affiliated company, Kemin Health is ISO 9001:2000 certified and headquartered in Des Moines, Iowa, USA. Kemin has manufacturing facilities in Iowa, Texas, Belgium, India, Singapore, China and Thailand. To learn more visit http://www.luteininfo.com or http://www.kemin.com.
Continue to Read more ...

Dark Chocolate Lowers Blood Clot Risk

If you eat a little bit of dark chocolate each day you could be reducing your chances of developing a blood clot, say researchers from Johns Hopkins University, USA. They say dark chocolate helps thin the blood, in pretty much the same way as aspirin does.

The research team had started studying aspirin's effect on platelets. Platelets are tiny particles in your blood that stick to each other, eventually forming clumps which make a clot. The patients being observed had to give up eating chocolate for the study to be effective. However, 139 of them couldn't do so - they continued eating chocolates.

The scientists decided to compare the blood of the chocoholics to those who had stopped eating chocolate. They found that the chocoholics' platelets clotted at 130 seconds (when taken out), compared to 123 seconds for the other people. In other words, the platelets of the chocoholics were taking longer to clot.

They concluded that chemicals, perhaps flavonoids, in the cocoa bean have a biochemical effect similar to aspiring in reducing platelet clumping. Platelet clumping can block a blood vessel and cause heart attacks.

The scientists say we could benefit from either having a bit of dark chocolate each day or a chocolate drink. It is important its sugar and butter content is minimal. The ideal amount would be about two tablespoons of dark chocolate each day.

Many fruits and vegetables are rich in flavonoids.

Johns Hopkins University, School of Medicine
Continue to Read more ...

When Is A Woman Too Old To Have A Baby?

The announcement of a 63-year-old woman's pregnancy in England has triggered an avalanche of criticism and questions. When is a woman too old to have a baby? When is the risk too high for the woman's health? When is the risk too high for the baby's health? How will it affect the child mentally? Will the child be teased at school?

As far as the baby's mental well-being is concerned, there are many factors to take into account - the age of the parents is just one of them. There are millions of babies throughout history who have been brought up by their grandparents because the parents were not there, either due to death, imprisonment, emigration, illness or abandonment. Having an older guardian is not a new phenomenon.

Perhaps one could say that if you wait till you are over 60 to have a baby, that contingency is no longer there. The contingency of having your parents, or in-laws, step in if you are unable to be there for the child. A 63-73 year old mother is unlikely to have a mother who is able to help out or take over. One could also say that having grandparents bring someone up is rarely a first choice, it is usually something that has to be done because something unpleasant happened to the parents. Becoming pregnant at 63 is a deliberate move, not an accidental one.

Some wonder whether the child will feel different when he/she goes to school. What are the chances of being teased - are they higher because the mother is so old? The child may feel embarrassment and resentful. According to reports from children whose grandparents brought them up, the evidence for this is not there.

What about the health aspect? The older a pregnant mother is, the higher are her risks of developing hypertension, diabetes and some other illnesses during gestation. Some illnesses, acquired by the older mother during pregnancy, could undermine the health of her child. Therefore, it would be fair to say that the chances of the baby having a health problem are greater.

Would a 63-year-old woman, two years from the age of retirement, and her elderly husband, have the vigour to care for a demanding baby - one that spends half the night awake. What if the baby has a disability and requires round-the-clock attention? Could an elderly person cope? In the case of this English woman who is pregnant, Dr. Rashbrook, she can afford to have live-in help. She lives, with her husband, in a �600,000 ($1 million) house, they both earn good money.

People in their sixties are generally financially better off than younger people. Older people tend to have more patience and wisdom. 73-year-old parents will not be able to play sports with their ten-year-old children. The chances of one, or both parents dying or becoming seriously ill during the first fifteen years of the child's life are infinitely greater if the parents are aged 63-78 during those 15 years, than for parents aged 26-41.

Some argue that a child is not a commodity. It is not the same as acquiring a car or a new house. A woman in her sixties is seen as selfish to want to have a baby, because the baby will be the one to suffer. What about drug addicts, child beaters and sex-abusers who have children? If we go down the road of morals, it would not be long before a large portion of the population would be barred from having children - some people would want to include income, arguing that a child has the right to a comfortable bedroom, good nutrition, health care and education. Others would want to include IQ, general health, gene type and mental health.

Personally, I would say the greatest problem is a medical one. The likelihood of complications during the pregnancy, illnesses appearing directly as a result of a pregnancy when a woman is in her sixties, is too high. I wonder what percentage of pregnancies would go wrong if each year one million women, aged 63, had a baby. Of those one million women, how many would die or become ill during pregnancy or not long after giving birth? How many of those one million babies would have a health problem directly as a result of having a very old pregnant mother.

If it is shown that getting pregnant over 60 seriously raises the health risks for both mother and child, then we should seriously look at legislation that places an age limit on IVF. In order to prove it is more dangerous, studies will need to be carried out. To have good studies, you need a good number of elderly pregnant women you can monitor. For the moment, we just don't have the numbers to do that - there are not that many pregnant women over 60.
Continue to Read more ...

FDA Approves EMSAM(R) (selegiline Transdermal System), The First Transdermal Patch For The Treatment Of Major Depressive Disorder

Bristol-Myers Squibb Company (NYSE: BMY) and Somerset Pharmaceuticals, Inc., a joint venture between Mylan Laboratories Inc. (NYSE: MYL) and Watson Pharmaceuticals, Inc., (NYSE:WPI), announced today that the U.S. Food and Drug Administration (FDA) approved EMSAM(R) (selegiline transdermal system), the first transdermal patch for the treatment of major depressive disorder (MDD) in adults. EMSAM, a transdermal delivery system manufactured by Mylan Technologies, Inc. for Somerset, is a monoamine oxidase inhibitor (MAOI) that has been shown to relieve depressive symptoms in patients with MDD.

"We are pleased to be able to provide this important treatment to people with major depressive disorder," said Peter R. Dolan, chief executive officer, Bristol-Myers Squibb Company. "We believe EMSAM will help physicians treat their patients living with this illness through a new and unique delivery system."

"Together with Bristol-Myers Squibb, we are excited to be able to utilize transdermal technology to administer EMSAM, belonging to the MAOI class of agents that have proven antidepressant efficacy," said Mel Sharoky, M.D., president and chief executive officer, Somerset Pharmaceuticals.

About Monoamine Oxidase Inhibitors (MAOIs)

Although their mechanisms of action are not fully understood, MAOIs, including EMSAM, are presumed to work through potentiation of monoamine neurotransmitter activity in the brain by inhibiting the MAO enzyme. In an in vivo animal model, EMSAM exhibited antidepressant properties only at doses that inhibited both MAO-A and MAO-B in the brain. In the brain, MAO-A and MAO-B play important roles in the breakdown of neurotransmitter amines such as norepinephrine, dopamine and serotonin.

Oral MAOI antidepressants pass through the digestive tract, thus inhibiting intestinal MAO-A, which is needed to break down tyramine,1 a substance found in certain foods and beverages such as aged cheese and tap beer.2 If a large amount of tyramine is absorbed systemically it can lead to a sudden and large increase in blood pressure called a hypertensive crisis, which is potentially life-threatening and requires immediate medical treatment. While most foods contain negligible amounts or no tyramine, a few food products may contain large amounts of tyramine that represent a potential risk for patients with significant inhibition of intestinal MAO-A resulting from administration of MAO inhibitors. As a result, patients taking oral MAOIs for MDD are required to avoid foods high in tyramine.3

About Transdermal Delivery of EMSAM

Through transdermal delivery, EMSAM is directly and continuously absorbed into the bloodstream over a 24-hour period. As a result, initial exposure of the drug to the digestive tract is minimized. As indicated in animal studies, the EMSAM 6 mg/24 hr patch allows for levels of medicine to inhibit MAO in the brain thought to be necessary for antidepressant effect while sufficiently preserving MAO-A in the digestive tract to break down tyramine. In its entirety, the data for EMSAM 6 mg/24 hr support the recommendation that tyramine dietary modifications are not needed. To reduce the risk of hypertensive crisis, dietary modifications are required with the EMSAM 9 mg/24 hr patch and the 12 mg/24 hr patch.

Clinical Studies

The efficacy of EMSAM in relieving depressive symptoms was established in two double-blind, placebo-controlled studies of six- (N=176) and eight- (N=265) week durations that included adult outpatients ages 18- to 70-years-old with single and recurrent episodes of MDD. The antidepressant action of EMSAM in hospitalized depressed patients has not been studied.

The six-week trial showed that a 6 mg/24 hr dose of EMSAM was significantly more effective than placebo in improving depressive symptoms as determined using the 17-item Hamilton Depression Rating Scale (HAM-D).

In the eight-week dose titration trial, patients with major depressive disorder who received EMSAM or placebo at a starting dose of 6 mg/24 hr, with possible increases to 9 mg/24 hr or 12 mg/24 hr based on clinical response, showed significant improvement compared with placebo on the primary outcome measure, the 28-item HAM-D total score.

The benefit of maintaining patients with MDD on therapy with EMSAM after achieving a responder status for an average of 25 days was demonstrated in controlled clinical trial. Three hundred twenty-two patients with major depressive disorder who had responded to EMSAM 6 mg/24 hr during an initial 10-week open-label treatment phase were randomized either to continuation of EMSAM 6 mg/24 hr (n=159), or to placebo (n=163) under double-blind conditions for observation of relapse. Approximately 52 percent of the EMSAM-treated patients as well as about 52 percent of the placebo-treated patients had discontinued treatment by week 12 of the double-blind phase. Patients continually receiving EMSAM experienced a significantly longer time to relapse.

"Using an innovative antidepressant delivery system, EMSAM provides significant relief of depressive symptoms with demonstrated safety and tolerability," said Alexander Bodkin, M.D., chief of the Clinical Psychopharmacology Research Program at Harvard University-affiliated McLean Hospital. "Major depressive disorder is a serious illness and not all treatments work equally well in all patients. The FDA approval of EMSAM is important because it adds another valuable treatment option to our armamentarium."

In clinical trials with EMSAM, application site reaction was the most commonly reported adverse event (EMSAM, 24 percent; placebo, 12 percent). Most were mild to moderate in severity with only two percent resulting in discontinuation. Overall, the rate of discontinuation due to adverse events was low (EMSAM 7.1 percent; placebo 3.6 percent). Additionally, EMSAM patients reported sexual dysfunction at a rate similar to placebo and experienced minimal weight change (mean weight change from baseline: EMSAM -1.2 lbs.; placebo +0.3 lbs.).

Dosing and Dietary ModificationsThe recommended starting and target dose of EMSAM is one 6 mg/24 hr patch administered once daily without tyramine dietary modifications. EMSAM will also be available in 9 mg/24 hr and 12 mg/24 hr once-daily doses (one patch per day). The trials were not designed to assess if higher doses are more effective than the starting and target dose of 6 mg/24 hr. To reduce the risk of hypertensive crisis, which is potentially life-threatening, foods and beverages high in tyramine must be avoided while on EMSAM 9 mg/24 hr or 12 mg/24 hr, and for two weeks following discontinuation of EMSAM at these doses or reducing the dose to EMSAM 6 mg/24 hr. Patients should be instructed to inform all of their health care professionals that they are using EMSAM, and not to stop or change treatment with EMSAM without consulting their health care professional.

Important Safety Information

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at time of dose changes, either increases or decreases. Families and caregivers should be advised for the need for close observation and communication with the prescriber. EMSAM is not approved for use in pediatric patients (see Boxed WARNING).

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking and behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4 percent, twice the placebo risk of 2 percent. No suicides occurred in these trials.

To reduce the risk of hypertensive crisis, which is potentially life-threatening, foods and beverages high in tyramine must be avoided while on EMSAM 9 mg/24 hr or 12 mg/24 hr, and for two weeks following discontinuation of EMSAM at these doses or reducing the dose to EMSAM 6 mg/24 hr.

Due to the potential for serotonin syndrome, which is potentially life-threatening, EMSAM should not be used with the following antidepressants: selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), mirtazapine, and bupropion; meperidine and analgesics such as tramadol, methadone, propoxyphene, and pentazocine; the antitussive dextromethorphan; cyclobenzaprine; oral selegiline; and St. John's wort.

After stopping treatment with SSRIs, SNRIs, TCAs, MAOIs, mirtazapine, bupropion; meperidine and analgesics such as: tramadol, methadone, and propoxyphene; dextromethophan; St. John's wort; and buspirone, approximately 1 week (5 weeks for fluoxetine) should elapse before starting therapy with EMSAM. At least 2 weeks should elapse after stopping EMSAM before starting therapy with buspirone or a drug that is contraindicated with EMSAM.

Carbamazepine and oxcarbazepine are contraindicated in patients taking MAO inhibitors, including EMSAM.

The use of EMSAM is contraindicated for use with sympathomimetic amines, including amphetamines as well as cold products and weight-reducing preparations that contain vasoconstrictors (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine).

Patients taking EMSAM should not undergo elective surgery requiring general anesthesia or be given local anesthesia containing sympathomimetic vasoconstrictors.

EMSAM should not be used in the presence of pheochromocytoma since such tumors secrete pressor substances.

Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Risk of bipolar disorder should be ruled out prior to initiating antidepressant therapy. EMSAM is not approved for the treatment of bipolar depression.

Due to the potential for elevated blood pressure, the use of EMSAM with buspirone is not recommended.

As with other MAOIs, postural hypotension can occur with EMSAM therapy. Dose increases in the elderly should be made with caution and patients should be observed closely for postural changes in blood pressure throughout treatment.

EMSAM should be used with caution in patients with certain concomitant systemic illnesses that can produce altered metabolism or hemodynamic responses.

As with other psychoactive drugs, EMSAM may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain EMSAM does not impair their ability to engage in such activities.

The use of alcohol is not recommended while taking EMSAM.

EMSAM should not be used in combination with tyramine-containing nutritional supplements.

EMSAM should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when administering EMSAM to a nursing mother. EMSAM is contraindicated in patients with known hypersensitivity to selegiline or to any component of the transdermal system.

Treatment-emergent adverse events in short-term clinical trials that occurred at a greater than or equal to 2 percent incidence with EMSAM and for which the incidence was greater than placebo include: application site reaction (24 percent vs 12 percent), headache (18 percent vs 17 percent), insomnia (12 percent vs 7 percent), diarrhea (9 percent vs 7 percent), dry mouth (8 percent vs 6 percent), dyspepsia (4 percent vs 3 percent), rash (4 percent vs 2 percent), pharyngitis (3 percent vs 2 percent), and sinusitis (3 percent vs 1 percent).

Full EMSAM (Selegiline Transdermal System) Prescribing Information, including Boxed WARNING

About Major Depression

According to the DSM-IV diagnosis, major depressive disorder is characterized by one or more major depressive episodes, (i.e., at least two weeks of depressed mood or loss of interest accompanied by at least four additional symptoms of depression)4 and impairs social and occupational or other important areas of functioning.4 Major depression affects approximately 14 million American adults in a given year5 and is the most common mental health disorder after anxiety.6 It is a leading cause of disability and disease burden worldwide.7

The illness is one and a half to three times more common among people with a family history than among the general population,4 and studies indicate that depressive episodes occur twice as frequently in women as in men.4

Today many patients with MDD do not achieve adequate symptom relief.8 If depression is not treated successfully, the chances that it will become recurrent increase.8 More than 80 percent of patients who have one episode of MDD will have at least one subsequent episode.9

Bristol-Myers Squibb and Somerset Pharmaceuticals, Inc.

EMSAM was developed by Somerset Pharmaceuticals, Inc. In December 2004, Bristol-Myers Squibb and Somerset entered into an agreement that provides Bristol-Myers Squibb with exclusive distribution rights to commercialize EMSAM after approval in the U.S. and Canada.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

About Somerset Pharmaceuticals, Inc.

Somerset Pharmaceuticals, Inc. is a joint venture between Mylan Laboratories Inc. (NYSE: MYL) and Watson Pharmaceuticals, Inc. (NYSE: WPI). For more information about Somerset, visit http://www.somersetpharm.com.
Continue to Read more ...

Teenagers' brains are fired up by violent video games, while at the same time areas of the brain associated with self control become subdued, say researchers from the Indiana University School of Medicine. Dr. Vincent Mathews, head researcher, explained that this study shows, for the first time, that violent video games affect the physiology of the brain and the way it functions. He said the teenagers had increased activity in the amygdala, an area of the brain involved in emotional arousal. "At the same time, they had decreases in activity in parts of the brain which are involved in self-control," he said. Video games are big business - in the USA alone sales hit over $10 billion in 2005. 44 teenagers were randomly asked to either play a violent video game or a non-violent one, for half-an-hour, after which they underwent an fMRI (functional magnetic resonance imaging). An fMRI measures changes that take place in the active brain in real time. The teenagers of either group did not differ in age, IQ or gender. They found that those who had played the violent games had more activity going on in the amygdala, as opposed to the teenagers who played the non-violent games (who did not have more activity there). Those playing the violent games also had lower activity in prefrontal areas of the brain - these areas are associated with self control, inhibition and focus (concentration), compared to the non-violent game players (who did not have lower activity there). The researchers said further studies are needed to determine whether these physiological changes make individuals behave more violently. Dr. Mathews presented the findings at the Annual Meeting of the Radiological Society of North America. "Short-term Effects of Violent Video Game Playing: An fMRI Study" Vincent Mathews, M.D., Yang Wang, M.D., Andrew J. Kalnin, M.D., Kristine M. Mosier, D.M.D., Ph.D., David W. Dunn, M.D., and William G. Kronenberger, Ph.D Click here to view abstract online

Beta-blockers should not be routinely used for the treatment of high blood pressure, says the National Institute for Health and Clinical Excellence (NICE), UK. NICE is the NHS watchdog for England and Wales.

The new NICE guidance says there are other medications which are better for treating hypertension. 40% of adults in England and Wales suffer from high blood pressure.

(Hypertension = High Blood Pressure)

According to NICE, beta-blockers raise a patient's risk of developing diabetes.

The watchdog stresses that patients must keep taking their beta-blockers until they see their doctors.

The guidance, which was published in 2004, has been updated after NICE and the British Hypertension Society decided that the guidance's section which deals with hypertension medications needed a further update. The hypertension section was supposed to have its next update in three years' time - however, as a result of new research NICE decided to bring this forward.

Recent research carried out in 2004 showed that new drugs were much better at treating high blood pressure. According to NICE, Beta-blockers are not the best drugs around for hypertension, especially for elderly patients.

At present there are about two million patients in the UK who are receiving Beta-blockers for hypertension.

Patients need to know that Beta-blockers are also used for heart failure and angina. The drugs are still indicated for those conditions. The new guidance only refers to the use Beta-blockers for treating hypertension.

The new updaded guidelines include the following:

-- Hypertensive patients aged 55 or more, or Black patients of all ages. First line of choice of initial therapy should be either a calcium channel blocker or a thiazide-type diuretic. (Black patients - does not include patients of mixed race or Asian patients).

-- Hypertensive patients under 55. First choise initial therapy should be an ACE inhibitor ((or an Angiotensin receptor blocker if an ACE inhibitor is not tolerated).

-- If initial therapy was with a calcium channel blocker or thiazide-type diuretic and a second drug is required, add an ACE inhibitor (or an Angiotensin receptor blocker if an ACE inhibitor is not tolerated). If initial therapy was with an ACE inhibitor, add a calcium channel blocker or a thiazide-type diuretic.

-- If treatment with three drugs is required, the combination of ACE inhibitor (or an Angiotensin receptor blocker if an ACE inhibitor is not tolerated), calcium channel blocker and thiazide-type diuretic should be used.
Continue to Read more ...

Violent Video Games Fire Up Kids' Brains

Teenagers' brains are fired up by violent video games, while at the same time areas of the brain associated with self control become subdued, say researchers from the Indiana University School of Medicine.

Dr. Vincent Mathews, head researcher, explained that this study shows, for the first time, that violent video games affect the physiology of the brain and the way it functions. He said the teenagers had increased activity in the amygdala, an area of the brain involved in emotional arousal. "At the same time, they had decreases in activity in parts of the brain which are involved in self-control," he said.

Video games are big business - in the USA alone sales hit over $10 billion in 2005.

44 teenagers were randomly asked to either play a violent video game or a non-violent one, for half-an-hour, after which they underwent an fMRI (functional magnetic resonance imaging). An fMRI measures changes that take place in the active brain in real time. The teenagers of either group did not differ in age, IQ or gender.

They found that those who had played the violent games had more activity going on in the amygdala, as opposed to the teenagers who played the non-violent games (who did not have more activity there). Those playing the violent games also had lower activity in prefrontal areas of the brain - these areas are associated with self control, inhibition and focus (concentration), compared to the non-violent game players (who did not have lower activity there).

The researchers said further studies are needed to determine whether these physiological changes make individuals behave more violently.

Dr. Mathews presented the findings at the Annual Meeting of the Radiological Society of North America.

"Short-term Effects of Violent Video Game Playing: An fMRI Study"
Vincent Mathews, M.D., Yang Wang, M.D., Andrew J. Kalnin, M.D., Kristine M. Mosier, D.M.D., Ph.D., David W. Dunn, M.D., and William G. Kronenberger, Ph.D
Click here to view abstract online
Continue to Read more ...

FDA Approves Chantix For Smoking Cessation

The FDA has approved Chantix (varenicline tartrate) tablets for the treatment of smoking cessation - to help smokers give up. Varenicline tartrate, the new active ingredient, is a new type of molecule that received priority FDA review.

Chantix, which works on specific parts of the brain, helps people give up smoking in two ways:

-- It provides some satisfaction that nicotine gives, hence lessening withdrawal symptoms

-- It blocks the nicotine from entering relevant parts of the brain, thus eliminating the reward a smoker feels when he/she smokes (only happens while patient is taking the tablets)

The FDA says smoking is the most preventable cause of death in America. Not only is it the cause of a long list of cancers, but it is also the cause of heart and lung diseases. The agency says it is committed to helping smokers find effective ways of giving up.

Of the 44.5 million adult smokers in the USA, 8.6 million have a serious illness caused by smoking (Centers for Disease Control and Prevention - CDC).

Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, says nicotine addiction makes it very hard for smokers to give up. He says Chantix is a proven and effective treatment for smokers who want to quit.

Six clinical trials, involving 3659 smokers, all of whom had been smoking more than 20 a day for about 25 years, showed Chantix treatment to be significantly superior to placebo treatment in helping smokers give up.

Two of those trials also revealed that Chantix is better at helping smokers give up than Zyban (bupropion).

A typical course of Chantix treatment lasts 12 weeks. Patients may continue for a further twelve weeks if they so wish.

Side effects included:

-- Nausea
-- Headache
-- Vomiting
-- Flatulence (farting)
-- Insomnia (problems in falling asleep)
-- Abnormal dreams
-- Dysgeusia (things taste different)

Chantix is made and sold by Pfizer, Inc.
Continue to Read more ...
Related Posts Plugin for WordPress, Blogger...

Popular Posts