Novel Egg Freezing Technique Opens The Door

Vitrification is a novel technique for freezing human eggs (also referred to as oocytes), which is opening the door to long-term human egg storage. Traditional methods of human egg cryopreservation have met with limited success. The scientific team at Georgia Reproductive Specialists (GRS), who were responsible for the first frozen human egg births in North America in 1997, have successfully implemented the new technique of vitrification and celebrate the birth this month of the newest baby born as a result of this technique.

It is GRS' intention to be able to offer egg freezing (oocyte cryopreservation) as a viable solution for women desiring to preserve their eggs for future use. Some of the potential applications of egg freezing are as follows:

- Egg banking for women wishing to preserve their fertility following cancer therapy

- Egg banking for women delaying pregnancy

- Establishment of a donor egg bank

- Rescue of excess eggs from an unexpectedly strong stimulation of the ovaries during an Artificial Insemination (Intrauterine Insemination - IUI) treatment cycle

Currently GRS has research programs in the last two areas; and the latest "frozen egg baby" arrived as a result of the rescue of excess eggs, which would have otherwise been discarded in an IUI cycle. Had these eggs been allowed to remain in the ovaries during the IUI cycle, the woman would have run an extremely high risk of conceiving with a multiple pregnancy potentially endangering both her and her babies.

Ovarian hyperstimulation syndrome, painful ovarian enlargement, is another potential complication that may result from an overly vigorous response to ovulation medications. While traditionally this leads to canceling the treatment cycle or converting to standard IVF, GRS' approach allows both a safe attempt at pregnancy within the IUI cycle and, if the pregnancy does not occur, then the woman is able to use her "rescued" frozen eggs to attempt pregnancy with routine in vitro fertilization.

On June 5th, the first such reported use of this exciting technology established a clear approach for the use of egg freezing to reduce the costs and risks involved in modern reproductive medicine.

Georgia Reproductive Specialists (GRS) applies medical science's most advanced fertility technologies to provide the highest standards of patient- centered, reproductive healthcare. The staff at GRS, including infertility laboratory pioneer Michael Tucker, Ph.D., is focused on providing individualized, innovative solutions for reproductive challenges and infertility, specializing in in vitro fertilization, intracytoplasmic sperm injection and other assisted reproductive technologies.

Fellowship-trained reproductive endocrinologists Dr. Susan C. Conway, Dr. Carolyn Kaplan and Dr. Mark Perloe are experts in female and male disorders including polycystic ovary syndrome (PCOS), repeated pregnancy loss, menstrual disorders and azoospermia. GRS has three offices, Atlanta, Alpharetta and Decatur, to conveniently serve patients across Metro Atlanta. For more information about Georgia Reproductive Specialists, visit http://www.ivf.com.

Studies To Date Say Erectile Dysfunction Drugs Affect Other Systems, Mostly For The Better

Since the Food and Drug Administration gave Viagra (sildenafil) its approval in 1998, "erectile dysfunction" has become a household term - probably to the chagrin of many parents fielding questions from their kids watching TV. But with sildenafil and the subsequent introduction and marketing of Levitra (vardenafil) and Cialis (tadalafil), many men have found answers to a once-unmentionable condition.

"As more and more patients seek therapy for sexual dysfunction, it is increasingly important for clinicians in a wide range of specialties to become proficient in the mechanisms and systemic effects of these medications," said Ernst R. Schwarz, M.D., Ph.D., a cardiologist at Cedars-Sinai Medical Center who specializes in therapies for men who suffer from erectile dysfunction (ED) and have heart problems, diabetes, high blood pressure or other related conditions.

Schwarz and colleagues recently concluded a review of the medical literature, as well as their own research findings and clinical data, to determine what actually is known about the effects of long-term use of this class of drugs on various organ systems. Their findings appears in the June, 2006 issue of the International Journal of Impotence Research.

Studies so far suggest the drugs, called phosphodiesterase-5 inhibitors (PDE-5i), produce mostly beneficial results, and not just for erectile dysfunction. The FDA recently approved a reformulation of sildenafil for the treatment of primary pulmonary hypertension, a disease that tends to occur in young women, causing elevated blood pressures in the lung that can lead to heart failure and early death.

"When we look at all the different organ systems - the blood, the heart, the lungs, blood flow in the brain - there are hardly any negative side effects. In fact, just the opposite is true. There are beneficial effects for primary pulmonary hypertension, as well as for conditions such as heart failure and lack of oxygen in the heart," said Schwarz. "The only issue is that the data we have are from relatively short-term studies. Viagra has been on the market since 1998 and the other two PDE-5 inhibitors were approved by the FDA in 2003. Therefore, we do not have multi-year follow-up studies. On the other hand, the drugs have been on the market for several years now and there have been no reports of negative long-term effects."

While there are some differences among the three medications, they have many properties in common and work by limiting the activity of the enzyme phosphodiesterase-5, which is found in tissues and vessels of the penis, blood platelets, and smooth muscle of blood vessels. For the treatment of erectile dysfunction, the drugs' constraint of the enzyme's action results in increased levels of cyclic guanosine monophosphate (cGMP) and nitric oxide (NO), biochemicals that promote smooth muscle relaxation and increased blood flow in erectile tissue.

According to the article, PDE-5 inhibitors can be effective in treating erectile dysfunction even for many men who also have diabetes, those who are older, and those who have co-existing ischemic heart disease (reduced blood flow to the heart caused by plaque buildup in the arteries). Furthermore, say the authors, "since PDE-5 is found in smooth muscles of the systemic arteries and veins throughout the body, use of PDE-5i has been associated with various cardiovascular effects."

"The original intention was to develop PDE-5 inhibitors as a treatment for angina, chest pain that occurs when the heart is starved for oxygen," Schwarz said. "As such, their effects on the heart appear to be all beneficial. Nitrates and other substances commonly used to improve blood flow and oxygenation to the heart muscle have a side effect that we call the 'steal phenomenon,' in which blood is taken away from underperfused (flow-restricted) areas to improve blood flow in normal areas. In contrast, PDE-5 inhibitors actually improve blood flow even in areas where there is a blockage of an artery, thereby having a protective effect on the heart muscle."

The drugs' potential impact on visual function became a matter of controversy when a suspected link between PDE-5 inhibitors and vision loss led to lawsuits filed last year against the maker of Viagra. According to the article's authors, however, "analysis of clinical trial data in more than 13,000 men and on more than 35,000 patient-years of observation" found occurrence of the visual disorder to be similar to that of the general population. "Even though individual cases have been reported for all PDE-5i, these recently published data do not suggest an increased incidence of NAION (non-arteric anterior ischemic optic neuropathy) in men who took PDE-5i for ED," the article states.

Among other findings:

* Although the enzyme PDE-5 has been found in tissue and arteries of the brain, sildenafil does not appear to dilate cerebral arteries or have an effect on cerebral blood flow or blood flow velocity, an indication that there is no increased risk of stroke or hemorrhage.
* PDE-5 exists in blood platelets, cells that play a major role in the blood clotting process, but sildenafil appears to have no direct impact on platelet function. However, the drug's effects have not been specifically evaluated in patients with bleeding disorders or in those taking drugs that reduce clotting.

"Experimental and human studies indicate that PDE-5 inhibitors are effective and well tolerated, and there is evidence that they are not being used to their utmost potential. We suggest that these drugs may prove beneficial in treating a wide variety of disorders," said Schwarz, the article's first author and a specialist in cardiology, interventional cardiology, heart failure, and transplantation. "Some studies are underway to determine the effects of long-term use of PDE-5 inhibitors, and others are warranted, especially in patients who are considered at high risk because of chronic cardiovascular disorders."

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Contact: Sandy Van
Cedars-Sinai Medical Center

Animal Studies Suggest Vegetables May Reduce Hardening Of Arteries

New research suggests one reason vegetables may be so good for us - a study in mice found that a mixture of five common vegetables reduced hardening of the arteries by 38 percent compared to animals eating a non-vegetable diet. Conducted by Wake Forest University School of Medicine, the research is reported in the current issue of the Journal of Nutrition.

"While everyone knows that eating more vegetables is supposed to be good for you, no one had shown before that it can actually inhibit the development of atherosclerosis," said Michael Adams, D.V.M., lead researcher. "This suggests how a diet high in vegetables may help prevent heart attacks and strokes."

The study used specially bred mice that rapidly develop atherosclerosis, the formation on blood vessel walls of fatty plaques that eventually protrude into the vessel's opening and can reduce blood flow. The mice have elevated low-density lipoprotein ( LDL), or "bad" cholesterol, which is also a risk factor for atherosclerosis in humans.

Half of the mice in the study were fed a vegetable-free diet and half got 30 percent of their calories from a mixture of freeze-dried broccoli, green beans, corn, peas and carrots. These five vegetables are among the top-10 vegetables in the United States based on frequency of consumption.

After 16 weeks, the researchers measured two forms of cholesterol to estimate the extent of atherosclerosis. In mice that were fed the vegetable diet, researchers found that plaques in the vessel were 38 percent smaller than those in the mice fed vegetable-free diets. There were also modest improvements in body weight and cholesterol levels in the blood.

The estimates of atherosclerosis extent involved measuring free and ester cholesterol, two forms that accumulate in plaques as they develop. The rate of this accumulation has been found to be highly predictive of the actual amount of plaque present in the vessels.

Adams said it is not clear exactly how the high-vegetable diet influenced the development of plaques in the artery walls.

"Although the pathways involved remain uncertain, the results indicate that a diet rich in green and yellow vegetables inhibits the development of hardening of the arteries and may reduce the risk of heart disease," said Adams.

He said that a 37 percent reduction in a certain marker of inflammation in mice suggests that vegetable consumption may inhibit inflammatory activity.

"It is well known that atherosclerosis progression is intimately linked with inflammation in the arteries," Adams said. "Our results, combined with other studies, support the idea that increased vegetable consumption inhibits atherosclerosis progression through antioxidant and anti-inflammatory pathways."

Numerous studies in humans have shown that a high-vegetable diet is associated with a reduced risk of cardiovascular disease, as well as with reductions in blood pressure and increases in "good" cholesterol. This is believed to be the first study to address the effect of increased vegetable consumption on the development or progression of atherosclerosis.

Despite compelling evidence supporting the health benefits of increased vegetable consumption, intake remains low, Adams said. The mean consumption is 3.2 servings per days, with about 40 percent coming from starchy vegetables such as potatoes.

Wake Forest University Baptist Medical Center

Raloxifene Reduces Breast Cancer Risk

Raloxifene, an osteoporosis drug, is effective at protecting high risk women from breast cancer. Research has found that raloxifene is as effective as Tamoxifen, the well known breast cancer drug - it is also safer.

You can read about this US nationwide study in the Journal of the American Medical Association. The University of Pittsburgh study involved almost 20,000 menopausal and post-menopausal women who were at high risk of developing breast cancer.

It seems that raloxifene, like Tamoxifen, can lower a woman's breast cancer risk by about 50%. Raloxifene treatment also causes fewer uterine cancers, blood clots, cataracts and cancers when compared to Tamoxifen.

Both Tamoxifen and raloxifene do other have side effects. Raloxifene is associated with muscle ache, bone ache, painful sexual intercourse and weight gain. Tamoxifen is associated with leg cramps and bladder control problems. However, women told researchers that raloxifene's side effects do not have a negative impact on their general quality of life.

If all goes according to plan, the FDA should approve raloxifene for breast cancer within the next twelve months. This will be good for women as they will have more choice. It is thought that raloxifene will be more indicated for post-menopausal women who are at increased risk of breast cancer.

Meditation May Improve Cardiac Risk Factors In Patients With Coronary Heart Disease

A relaxation technique known as transcendental meditation may decrease blood pressure and reduce insulin resistance among patients with coronary heart disease, according to a report in the June issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Transcendental meditation, derived from the ancient Vedic tradition in India, is taught through a standard protocol involving lectures, personal instruction and group meetings, according to background information in the article. It has previously been shown to lower blood pressure but its effect on other risk factors associated with coronary heart disease, including those linked to the metabolic syndrome, has not been thoroughly examined. The metabolic syndrome refers to a cluster of symptoms that increase cardiac risk, including high blood pressure (hypertension), abdominal obesity, high cholesterol and insulin resistance, which occurs when the body is unable to use the insulin produced by the pancreas to process sugar into energy.

Maura Paul-Labrador, M.P.H., Cedars-Sinai Medical Center, Los Angeles, and colleagues conducted a 16-week trial of transcendental meditation in patients with coronary heart disease. Fifty-two participants (average age 67.7 years) were instructed in transcendental meditation and 51 control patients (average age 67.1 years) received health education. At the beginning and end of the trial, the patients fasted overnight and then gave a blood sample, participated in a medical history review and underwent tests of blood vessel function and heart rate variability. Heart rate variability testing assesses the functioning of the autonomic nervous system, which controls the heart and other involuntary muscles.

Overall, of the 103 participants who were enrolled, 84 (82 percent) completed the study. At the end of the trial, patients in the transcendental meditation group had significantly lower blood pressure; improved fasting blood glucose and insulin levels, which signify reduced insulin resistance; and more stable functioning of the autonomic nervous system. "These physiological effects were accomplished without changes in body weight, medication or psychosocial variables and despite a marginally statistically significant increase in physical activity in the health education group," the authors write.

"These current results also expand our causal understanding of the role of stress in the rising epidemic of the metabolic syndrome," they continue. "Although current low levels of physical activity, unhealthy eating habits and resultant obesity are triggers for this epidemic, the demands of modern society may also be responsible for higher levels of chronic stress." Such stress causes the release of cortisol and other hormones and neurotransmitters, which over time damage the cardiovascular system.

"Our results, demonstrating beneficial physiological effects of transcendental meditation in the absence of effects on psychosocial variables, suggest that transcendental meditation may modulate response to stress rather than alter the stress itself, similar to the physiological impact of exercise conditioning," the authors write. This method of controlling the body's response to stress may provide a new target for the treatment and prevention of coronary heart disease, warranting further study, they conclude.

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This study was supported by grants from the National Center for Alternative and Complementary Medicine, National Institutes of Health; and a General Clinical Research Centers grant from the National Center for Research Resources.

Contact: Sandy Van
JAMA and Archives Journals

Eating Vegetables Protects Your Arteries

Eating vegetables can significantly protect your arteries from the accumulation of fatty deposits, according to a study on mice carried out at Wake Forest University School of Medicine. You can read about this study in the Journal of Nutrition.

In this study, scientists used mice that are very susceptible to developing atherosclerosis. Atherosclerosis is a condition in which fatty deposits (plaques) build up in the arteries - eventually blood flow is blocked and patients have a serious risk of heart attack or stroke.

Half the mice received a diet rich in vegetables, including peas, corn, carrots, green beans and broccoli. The rest of the mice did not have any vegetables at all. Both groups of mice were fed the diets for 16 weeks, at the end of which scientists checked them for cholesterol content, bodyweight and plaques in the arteries. The vegetable-fed mice had 38% less plaques than the vegetable-free mice. The vegetable-fed mice also had a reduction of 37% in serum amyloid levels - serum amyloid is an indicator of inflammation. It is likely, said the researchers, that a high intake of vegetable may also lower inflammatory activity.

The vegetable-fed mice also weighed less than the others and had lower levels of cholesterol. However, the scientists said the reduction in atherosclerosis was not necessarily due to the lower weight and cholesterol levels.

Dr. Michael Adams, lead researcher, said that although we all know vegetable are supposed to be good for the health, no studies have yet shown that eating lots of vegetables can actually protect you from developing atherosclerosis. He added that the pathways involved remain uncertain. However, it is more evident now that vegetables do inhibit the hardening of the arteries, which in turn reduces the risk of heart attack and stroke.

Scientists say this study is encouraging and that further studies are needed.

Nutritionists say humans should consume five portions of fruit and/or vegetables per day. Many say we should include a variety of different colours of fruit and veg.

Written by: Christian Nordqvist
Editor: Medical News Today

Menopausal Women Don't Get Enough Guidance On Treatment Options

Few women are consulting their doctors before opting to use herbal therapies and soy products to treat their menopausal symptoms, researchers at the Stanford University School of Medicine have found.

The trend is of particular note because growing numbers of women are turning to alternative therapies to relieve such symptoms as hot flashes, headaches, mood swings and sleep disruptions because of concerns about health risks associated with hormone therapy, which is still considered the most effective way of treating such difficulties. The researchers recommend that physicians learn more about these products so that they can help their patients choose safe, effective methods of treating their symptoms.

"We're not promoting the use of these alternative therapies," said lead author Jun Ma, MD, PhD, research associate at the Stanford Prevention Research Center. "We're just saying that the demand for these therapies is growing and that physicians should be prepared to talk to their patients about it."

The study appears in the May/June issue of The Journal of the North American Menopause Society. The study was funded by GlaxoSmithKline Consumer Healthcare, which had no role in the study design, data collection or preparation of the manuscript for publication. The pharmaceutical company manufactures the herbal product RemiFemin Menopause.

The study was based on a 2004 online survey of a random sample of 781 U.S. women between the ages of 40 and 60. Because the sample size was small, Ma cautioned that the findings may not accurately represent all women, but said the data provide useful insights into women's attitudes toward menopause treatments and how much physician guidance they have received in deciding which therapies to use.

Among the women surveyed, nine out of 10 reported having experienced at least one menopausal symptom at some point. When it came to treating their symptoms, 37 percent reported using hormone therapy while slightly less than that - 31 percent - used herbal products. Soy supplements were used by 13 percent.

What interested Ma and her colleagues was that three-quarters of the women who had formerly taken hormone therapy said they stopped primarily because of concern about potential risks. "A majority of the women who had discontinued their hormone therapy were not on any therapy - not because of lack of need or desire to continue, but because they didn't know which therapy would best suit their clinical needs," Ma said.

The concerns about hormone therapy stem largely from the federally funded Women's Health Initiative, a long-term study that turned the conventional wisdom about hormone therapy on its head. For many years, observational studies indicated that in addition to relieving menopausal symptoms, hormone therapy helped protect women against heart disease. However, the WHI found that neither estrogen nor the combination of estrogen and progestin helped prevent heart disease. Instead, although both forms of hormone therapy offered some benefits in easing menopausal symptoms, they both posed substantial health risks.

Despite these risks, hormone therapy is still considered the most effective approach for treating menopausal symptoms. Women are advised to use the lowest possible dose of hormones and to limit the duration of the treatment in order to minimize the risks.

But the new study shows that many women are instead turning to herbal and soy products to ease their menopausal symptoms. The most commonly used herbal products reported by survey participants were ginkgo biloba, ginseng, St. John's wort, black cohosh or a combination product.

"The reduced use of menopausal hormone therapy, while an appropriate response to the WHI findings, has left both patients and their physicians in a difficult position," said Randall S. Stafford, MD, PhD, associate professor of medicine and senior author of the study. "While other pharmaceuticals and alternative therapies are available, many physicians are not fully prepared to discuss these options, particularly given the limited data available about the effectiveness of these options."

Among the women who used herbal therapies, 55 percent chose the products because of concerns about hormone therapy while 45 percent said they wanted to use a natural remedy. But Ma said many women mistakenly equate the term "natural" with "safe," and falsely believe that herbal products won't interact with other medications. "That misperception really needs to be corrected," she said.

In fact, herbal products may have side effects. For instance, some studies have shown that St. John's wort interacts with selective serotonin-reuptake inhibitors, which are the most commonly prescribed class of antidepressants, and it is recommended that the two not be combined.

Additionally, Ma said there is little in the way of high-quality data on the efficacy of many of the alternative therapies, adding that most of the data are limited to short-term use of the products.

The women in the study regarded physicians as their most-trusted source of information about alternative therapies, yet many said they didn't get enough guidance in choosing a remedy for their menopausal symptoms. Nearly 75 percent of the women said that they - not their doctors - initiated discussions about possible treatments for their symptoms. And when it came to alternative therapies, 20 percent of the women weren't confident in their doctors' ability to discuss the treatments knowledgeably.

"Hormone therapy is unique in that patient preference is important in deciding what therapy to use," Ma said. "A balanced dialogue is essential because it's a treatment decision that a physician should make with a patient, not for a patient."

Ma suggested that physicians know enough about alternative menopause therapies to put them in four categories: those that have data suggesting some effectiveness, those that have data demonstrating concerns about side effects, those with neutral data and those lacking any data.

"It's OK to tell patients that little is known about a product, despite any anecdotal stories they may have heard. Anecdotal stories should not be taken as a substitute for rigorous clinical evidence," Ma said.

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Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu/

Contact: Susan Ipaktchian
http://med.stanford.edu/

Pregnancy Complications Still High For Women With Diabetes

Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales. The risk of death and major birth defects are still high in babies born to women with diabetes, despite an international strategy to raise standards of diabetes care, say researchers in a study published on http://www.bmj.com/

They also warn that these problems will get worse as the number of young women diagnosed with type 1 and type 2 diabetes continues to rise.

Researchers analysed deaths shortly after birth (perinatal mortality) and congenital anomalies in babies born to women with type 1 or type 2 diabetes who delivered between 1 March 2002 and 28 February 2003 in England, Wales, and Northern Ireland.

Of 2,359 women with diabetes, 1,707 had type 1 diabetes and 652 had type 2 diabetes. Women with type 2 diabetes were more likely to come from an ethnic minority group and from a deprived area.

Perinatal mortality was similar in babies of women with type 1 (31.7 per 1000 births) and type 2 diabetes (32.3 per 1000 births), and was nearly four times higher than that in the general maternity population.

The rate of major congenital anomaly (mainly heart and nervous system defects) was 46 per 1000 births in women with diabetes (48 per 1000 births for type 1 diabetes and 43 per 1000 for type 2 diabetes), more than double than that in the general maternity population.

Because of this increased risk, the authors say that women with diabetes should take a higher than usual dose (5 mg) of folic acid from before conception up to week 12 of pregnancy. They also suggest that pregnant women with diabetes should be routinely screening for heart defects.

In the past, type 2 diabetes has been viewed as a less serious condition than type 1 diabetes and may have been subject to less vigilant care, add the authors. However, in view of these findings, and the increasing prevalence of type 2 diabetes in young adults, raised awareness of the increased risk of adverse pregnancy outcomes in this group of women is needed.

This study is substantially larger than any previous ones in this field, but more work is needed to find out how women with either type of diabetes can best be enabled to improve the outcomes of their pregnancy, they conclude.

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Contact: Teresa Hagan

BMJ-British Medical Journal

Exploring New Ways To Increase Consumption Of Healthy Polyunsaturated Fats

Although eating oily fish is widely recognised to have beneficial effects on human health - including a reduced risk of coronary heart disease - most people in the UK do not eat enough of it. Now, in order to increase the consumption of the healthy n-3 polyunsaturated fats found in oily fish, scientists at the University of Reading are suggesting the possibility of ‘enriching' foods that we eat more commonly, such as meat and poultry, with these healthy fats.

Writing in the June edition of the British Nutrition Foundation's Nutrition Bulletin, Professor Ian Givens of the University's Nutritional Sciences Research Unit argues that the recommended intakes of these types of fats are not being met in the majority of the population mainly because of low consumption of oil-rich fish.

Professor Givens said: "It's an unfortunate fact that only about 27% of adults in this country eat any of the oil-rich fish which contain beneficial polyunsaturated fatty acids. It's also true that for much of the population, the contribution that animal-derived foods currently make to intake of these fatty acids, although small may be crucial.

"But in the future, animal-derived foods such as meat (especially poultry meat), dairy products and eggs are likely to have an important function in increasing intake of these fats, and studies have shown that feeding fish oils to animals can increase, or ‘enrich', the polyunsaturated fat content of the resulting food products.

"Because of this, we felt there was a real need to examine the current and projected consumption trends of meat and other animal products, which could be enriched with the fats."

There have been very large changes in the consumption of meat over the past 50 years: the decline in consumption of meat from cows and sheep, and the sustained increase in the consumption of poultry meat have been marked.

"The potential of enriched animal-derived foods, especially poultry meat, could be crucial in achieving increased intake of fatty acids," said Professor Givens. "If successful and accepted by the consumer, this could prove to be a major advance in the health of the nation. Of course in the long term sources other than fish oil will be needed to ensure a sustainable supply of these important fatty acids."

University of Reading
information@reading.ac.uk

Coffee Protects Alcohol Drinkers From Liver Disease

Drinking coffee protects alcohol drinkers from developing liver disease, says a new study carried out at the Kaiser Permanente Medical Care Program, California, USA. According to the researchers, one cup of coffee per day lowered the incidence of cirrhosis of the liver for alcohol drinkers by 22%.

Study leader, Dr. Arthur Klatsky, stressed that alcohol drinking, especially excess drinking, is linked to various different physical risks. As such, said Klatsky, the study's findings should not be interpreted as a licence to booze to your heart's content. He advised people not to consumer more than three alcoholic drinks a day.

This is not the first study to link coffee consumption to less liver disease. Another study published in Gastroentorology in December, 2005, had similar findings.

This new study was much larger than last years'. The new study was able to look more into each cause of cirrhosis and how coffee is linked a lower incidence of them.

The Kaiser Permanente study looked at information on 125,000 people with healthy livers from 1978 to 1985. Information had been collected about their alcohol, coffee and tea drinking habits. Of the 330 people who had developed cirrhosis of the liver by 2001, 199 had done so as a result of consuming alcohol. The researchers found that the incidence of cirrhosis went down 22% for each cup of coffee consumed per person per day.

You can read about this study in the Archives of Internal Medicine, June 12 issue.

Scientists are still unsure what it is in the coffee that provides the protection. It cannot be the caffeine because tea has caffeine but does not provide the same protection. Clinical trials are needed to further identify the relationship between coffee and how it lowers the incidence of liver disease.

Written by: Christian Nordqvist
Editor: Medical News Today

US Smokers Invited To Test Vaccine Against Nicotine Addiction

UCSF's Habit Abatement Clinic is testing a vaccine that enlists help from the immune system to keep nicotine away from the brain. The vaccine is designed to help smokers quit and to limit the urge to start smoking again.

Called NicVax, the investigational vaccine is being developed by Nabi Biopharmaceuticals to prevent and treat nicotine addiction and to help people quit smoking. Normally when a smoker inhales, nicotine is carried by the bloodstream to the brain, where it triggers neuro-receptors to generate positive sensations that can lead to addiction. The vaccine stimulates the immune system to produce antibodies that recognize the small nicotine molecule. Bound to these antibodies, nicotine molecules no longer can cross the blood-brain barrier and enter the brain.

"With little or no nicotine reaching the brain, smoking is less rewarding. That gives the smoker a chance to change the behavioral and social factors that also influence smoking," said Victor Reus, MD, principal investigator for the study at UCSF.

Because immune antibodies remain in the body for some time, Reus said it is hoped that the vaccine also will prevent relapse. When a vaccinated smoker lights up months after quitting, the person should not experience the nicotine-triggered reward that tempts most people back into the habit.

Northern California smokers over 18 are invited to join a national study to determine whether NicVax can help people abstain from smoking and help them avoid relapsing within the next 12 months. Participation is free and requires a one-year commitment to come to San Francisco for injections and follow-up visits. The study also includes five behavioral counseling sessions. Participants will be paid for each visit and given validated parking at the clinic.

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For information, interested persons should call the UCSF Habit Abatement Clinic at (415) 476-7453, visit http://www.ucsf.edu/ nosmoke, or email rpilato@lppi.ucsf.edu.

UCSF is one of nine centers nationwide to participate in this phase II proof-of-principle clinical trial, which is sponsored by Nabi Biopharmaceuticals of Boca Raton, Florida, and the National Institute on Drug Abuse.

The FDA granted a "fast track" designation for the NicVax vaccine in March, to speed development and review of the drug if trial results are promising.

"Most people who smoke want to quit, and they now have a number of options to help them reduce nicotine dependence and quit smoking," said Sharon Hall, PhD, co- principal investigator and director of the UCSF Habit Abatement Clinic. "A vaccine that could prevent the addictive action of nicotine is a promising alternative option."

According to the Centers for Disease Control and Prevention, cigarette smoking contributes to 440,000 deaths each year - one-fifth of all U.S. deaths. Quitting smoking has immediate as well as long-term benefits, improving overall health as well as reducing risk for diseases caused by smoking.

The mission of the UCSF Habit Abatement Clinic is to develop and evaluate innovative treatment strategies aimed at helping people quit smoking and stay quit. Funded by the National Institute on Drug Abuse and the National Cancer Institute, the Habit Abatement Clinic has been evaluating the effectiveness of smoking cessation treatment since 1980.

UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.

Contact: Janet Basu

University of California - San Francisco

Spending on specialty drugs soar

Spending on high cost specialty drugs soared 17.5 percent last year and is expected to more than double by 2009, according to a report released Wednesday.

In contrast, spending on traditional drugs increased only 10 percent.

Specialty drugs are typically biotech medications that treat complex, chronic conditions and often need to be injected. Spending on such drugs reached $40 billion last year or 19 percent of the total on all medicines, according to Express Scripts Inc., a Missouri-based pharmacy benefit manager.

By 2009, Express Scripts predicts specialty drug spending to reach $90 billion or 28 percent of $316 billion, the projected total for all medications. It expects spending on traditional medicines to grow 32 percent to $226 billion. The growth in specialty drug spending will be driven by several factors including new products, additional uses for existing medicines and more patients, said Express Scripts spokesman Steve Littlejohn.

The explosive growth is spending on specialty drugs is especially problematic because there is no pathway for generic competitors to enter the market.

Spending on injectable drugs for inflammatory diseases such as rheumatoid arthritis and crohn's disease soared 35 percent, the largest increase in the group.

An average prescription for an inflammatory disease costs $1,417.

Drugs to treat blood clotting factor deficiencies such as hemophilia registered a 25 percent spending increase, the second largest rise in the group. Annual treatment costs about $100,000 per patient.

Spending on cancer drugs known as antineoplastics, which were administered outside a doctor's office, rose 19.2 percent, the third largest jump. The price per prescription rose by almost 15 percent to nearly $1,600 on average, making inflation the primary driver of the spending increase.

Only two types of specialty drugs had spending declines_ antivirals and fertility treatments. The decreases were due to a decline in utilization.

Express Scripts based the overall projections on data from the government and IMS Health, a pharmaceutical market research firm.

The statistics on the drug categories were from its own business, which manages pharmacy benefits for more than 55 million people.

By THERESA AGOVINO, AP Business Writer
http://www.express-scripts.com

Cervical Cancer Vaccine, Gardasil, Gets FDA Approval

Gardasil, an HPV vaccine which protects women from developing 70% of cervical cancers, has been approved for sale by the FDA. This is the first vaccine designed specifically to protect patients from cancer.

The Human Papillomavirus (HPV) causes cervical cancer as well as genital warts. Cervical cancer is the second largest killer of women among cancers worldwide.

Gardasil protects women from 4 types of HPV, including types 16 and 18, which cause 70% of all cervical cancers.

According to a study carried out by Gardasil makers, Merck, less than 20% of American women know that HPV is the main cause of cervical cancer.

Over half a million women are diagnosed with cervical cancer each year worldwide. In the USA, where Pap smear screening is more widespread than in the developing world, 14,000 women are diagnosed each year. 3,900 women die each year from cervical cancer in the USA.

Estimates say about 50% of all sexually active adults are infected with HPV.

GlaxoSmithKline is developing another vaccine, Cervarix, to protect from HPV. Cervarix does not protect from genital warts, Gardasil does. Gardasil protects women from 90% of all genital warts.

How widely the vaccine will be used in the USA will be better known when the CDC makes its recommendations on June 29. They will make a recommendation on various aspects of the vaccine, among which is at what age a girl should be given the vaccine. This will then decide whether or not Pediatricians include Gardasil in their childhood and adolescent vaccinations schedules.

Globally, nearly 300,000 women die each year as a result of cervical cancer. Merck says Gardasil could save the lives of nearly 200,000 of them each year.

A course of three shots over six months will cost from $300 to $500. This will be too expensive for some countries wishing to carry out a national vaccination program.

At first, there was some opposition to Gardasil. There was concern that vaccinated girls may become more sexually active at a younger age. This opposition soon ebbed when people realised how many lives could be saved.

Merck stressed that the vaccine should not replace screening. The company would like to see vaccinations given to girls before they become sexually active.

The vaccine is not recommended for people already infected with HPV as there is a higher risk of having precursors to cervical cancer.

Written by: Christian Nordqvist
Editor: Medical News Today

Diets With Group Support May Help Keep Weight Off Longer

Commercial diets are a useful way to lose weight. And those based on group support seem to fare better at keeping the weight off in the long term, finds a study in this week's BMJ.

Researchers compared the effectiveness of four popular commercial weight loss programmes with a control group. The study was sponsored by the BBC as part of its reality TV series, BBC Diet Trials.

The diets were the Slim-Fast Plan (a meal replacement approach), Weight Watchers pure points programme (an energy controlled diet with weekly group meetings), Dr Atkins' new diet revolution (a self-monitored low carbohydrate eating plan), and Rosemary Conley's eat yourself slim diet and fitness plan (a low fat diet and weekly exercise class). The control group was asked to maintain their current diet and exercise pattern.

Weight and body fat changes were monitored over six months and dieting behaviour was checked again at 12 months.

After six months, all diets resulted in significant loss of body fat and weight compared to the control group. Average weight loss was 5.9 kg and average fat loss was 4.4. kg (5-10% of body weight). The Atkins diet resulted in significantly higher weight loss during the first four weeks, but by the end, was no more or less effective than the other diets.

There were no significant differences in cardiac risk factors between the diet groups and the control group. The Atkins diet did not lead to substantial increases in cholesterol levels.

At 12 months, 158 participants (54% of the original sample) returned data. Only 58 (45%) were still keeping to their allocated diets (nine to Atkins, 20 to Weight Watchers, nine to Slim-Fast, 20 to Rosemary Conley). More participants in the unsupported programmes (Atkins diet and Slim-Fast) withdrew from the study than in the supported group based programmes, and weight rebound after the initial six months was higher in the unsupported programmes.

The authors conclude that clinically useful weight loss and fat loss can be achieved in adults who are motivated to follow commercial diets for a substantial period. People need to find a diet that best suits them.

"Our study provides data on how much weight patients can expect to lose by dieting," they write. "These data could help practitioners in managing patients' expectations of weight loss targets."

An accompanying editorial suggests that the challenge to researchers is to take weight loss studies to the next level by evaluating long term health outcomes, cost effectiveness, and novel strategies of improving adherence and weight maintenance.

Randomised controlled trial of four commercial weight loss programmes in the UK: Initial findings from the BBC 'diet trials;' BMJ Volume 332, pp 1309-11

Emma Dickinson
edickinson@bmj.com
BMJ-British Medical Journal

Enrollment In Amoxicillin PULSYS Phase III Trial Completed

Advancis Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has completed enrollment in the Company's Amoxicillin PULSYS Phase III clinical trial for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis concluded enrollment with a total of 620 adult/adolescent patients as of close-of-business May 31, 2006.

Advancis' adult and adolescent pivotal program is designed as a 600- patient, double-blind, double-dummy, non-inferiority Phase III trial and began on November 9, 2005. Over the coming weeks, patients will complete their treatment and follow-up visits, and Advancis and its clinical research organization will collect and analyze the clinical data. The Company expects to publicly report top-line results around mid-August 2006. If the trial is successful, Advancis expects to file a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration for the product early in the first quarter of 2007.

"We are very pleased to have completed enrollment in our adult and adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D., Advancis president and CEO. "We are hopeful that, if successful, Amoxicillin PULSYS will provide physicians a tool to deliver the established safety and efficacy of amoxicillin in the first and only once-daily presentation in the U.S."

Advancis is comparing its Amoxicillin PULSYS dosage form for the treatment of pharyngitis/tonsillitis in adults delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days. The primary endpoint for the study is bacterial eradication, as measured by throat cultures obtained both before and after treatment.

More than 59 million prescriptions for Amoxicillin were written in 2005 with total retail sales of approximately $640 million. Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children.

Advancis Pharmaceutical Corporation