Medical News

The battle worth fighting.

The first drug to treat low sexual desire in women has received US Food and Drug Administration (FDA) approval.

But the little pink tablets, to be sold under the brand name Addyi, have proven controversial. Here is what you need to know about what has been dubbed the "female Viagra".

Er, it shouldn't really be called 'female Viagra'

That flibanserin - to use its chemical name - would draw comparison to its blockbuster male equivalent was inevitable but the nickname is misleading.

While a Viagra pill treats erectile dysfunction by improving blood flow to the penis, flibanserin was developed as an anti-depressant and boosts sexual desire by balancing chemicals in the brain.

Specifically, the drug treats hypoactive sexual desire disorder (HSDD), essentially a lack of libido that causes distress and is thought to affect between 5.5 million and 8.6 million US women.

By gaining approval, Addyi's makers Sprout succeeded where medical giants have failed.

Pfizer, Procter & Gamble and others have all tried to develop products treating low sexual desire in women.

While the product has its pros and cons, medical practitioners now have a new treatment available to treat a common condition.

Sprout plans to launch the product in mid-October. A rival, Palatin Technologies, has an alternative treatment for HSDD in late-stage trials.

Addyi has minimal effects, but potentially severe side-effects

Women taking the drug reported around one more sexually satisfying event a month, compared to a placebo.

But supporters say even this small benefit is worthwhile - "I want to want my husband, it is that simple,'' said Amanda Parrish, one of the women involved in trials.

The FDA's approval of Addyi comes with tough safety measures, meaning that its usage is unlikely to be as widespread as with male Viagra.

Doctors will only be able to prescribe the drug after counselling patients about potential side-effects, including low blood pressure, nausea and fainting.

Pharmacists must remind patients not to drink alcohol while taking the drug, which can make the effects more severe.

And while Viagra can be taken shortly before having sex, Addyi must be taken daily.

It is a victory for campaigners

"This is the biggest breakthrough in women's sexual health since the advent of 'the Pill' for contraception," The National Consumers League said in a statement.

Lobbying group Even the Score, which has campaigned for better treatment of women's sexual health, accused the FDA of gender bias, highlighting the numerous products available treating sexual dysfunction in men, although none of them treat low desire.

Some physicians have welcomed the approval too, such as Dr Lauren Streicher, associate professor of clinical obstetrics and gynaecology at Northwestern University.

"This is an enormous, enormous advance in women's health.

"Of all the sexual dysfunctions, this is by far the most common in every single age category and we've had no options for women up until now."

But sceptics remain

Addyi's critics argue that the FDA has approved a drug of marginal impact with potentially serious side-effects. Previous versions of the drug have been rejected by the FDA.

"Unfortunately, we haven't heard the last of this drug," warned consumer group Public Citizen.

PharmedOut, which focuses on marketing in pharmaceuticals, said the FDA has been swayed by "a clever, aggressive public relations campaign".

"This opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs: It's bad news for rational drug approval," Adriane Fugh-Berman, a pharmacology professor and director of PharmedOut told the Washington Post.

The medical status of HSDD has been disputed, with some arguing that low libido in women cannot be treated in the same way as erectile dysfunction in men.

"Women's sexuality is very complicated. It's not a matter of just taking that pill, by the way, and then all of a sudden the lights go on," Judy Kuriansky, a clinical psychologist and certified sex therapist, told CNN.

 

 

The number of people living with diabetes has soared by nearly 60% in the past decade, Diabetes UK warns.

The charity said more than 3.3 million people have some form of the condition, up from 2.1 million in 2005.

The inability to control the level of sugar in the blood can lead to blindness and amputations and is a massive drain on NHS resources.

The NHS said it was time to tackle poor lifestyle, which is a major factor behind the rise.

Diabetes UK called for the NHS to improve care for patients and for greater efforts to prevent diabetes.

Roughly 90% of cases are type 2 diabetes, which is the form closely linked to diet and obesity.

People with type 1 generally develop it in childhood and are unable to produce the hormone insulin to control their blood sugar levels.

New diagnosis

Dr Joan St John, a GP in Brent in north-west London, where diabetes levels are some of the highest in the country, said the condition had become incredibly widespread.

She told the BBC News website: "It's very noticeable in that not a week goes by that you don't make a new diagnosis of diabetes, at least one if not two or three; previously that might have been one a month."

The complications of uncontrolled blood sugar levels can be severe, including nerve damage, loss of vision and organ damage.

The condition even leads to 135 foot amputations every week across the country.

Dr St John added: "Unfortunately that historical myth that it is not a serious condition is still retained by some people and you have to dispel that myth."

"One of the most miserable complications is neuropathy [nerve damage] which can cause a constant nagging, gnawing ache, usually in the legs or feet, and this can be really disturbing and there is no cure for it," she added.

Data published last week showed that diabetes medication now accounts for 10% of the NHS drugs bill.

Nearly £869m was spent on drugs, including insulin and metformin, marking a sharp rise from the £514m being spent a decade ago, when the drugs accounted for just 6.6% of the prescriptions budget.

Part of GP pay is linked to diagnosing and treating diabetes - and has been for years. The government says this is to improve care.

The reasons why levels of type 1 diabetes are increasing are not understood.

However, the explanation for the soaring cases of type 2 are being placed squarely on the nation's ballooning waistline.

Barbara Young, the chief executive of Diabetes UK, said the government needed to act to prevent new cases and improve treatment for those already affected.

She said: "Diabetes already costs the NHS nearly £10bn a year, and 80% of this is spent on managing avoidable complications."

"So there is huge potential to save money and reduce pressure on NHS hospitals and services through providing better care to prevent people with diabetes from developing devastating and costly complications," she added.

Dr Martin McShane, NHS England's Director for Long Term Conditions, said: "These figures are a stark warning and reveal the increasing cost of diabetes.

"We've said it before and we'll say it again, it's time to get serious about lifestyle change."

 

Depression runs deep. So deep, in fact, that researchers now say the individual cells of a person with severe depression age faster than usual.

A team of researchers in the Netherlands wanted to know why people with depression are at greater risk for diseases related to aging: diabetes, obesity, cancer and heart disease. So they looked at three groups of people: 1,100 currently experiencing major depressive disorder (MDD), 800 who had MDD in the past, and 500 people who reported no signs of depression.

The researchers checked out each person’s telomeres—the protective caps on the end of their chromosomes that wear down over time. The length of a person’s telomeres is a key measure of cellular aging.

Early Aging

People with MDD had much shorter telomeres than those who didn’t. That held true whether the depression was in the present or the past. Plus, the longer the duration of depression, or the more severe its symptoms, the shorter a person’s telomeres were. (To be sure of the association, researchers took into account factors like smoking, drinking and other lifestyle differences.)

Does depression accelerate aging? It’s too early to say. The findings, published yesterday in Molecular Psychiatry, show a connection between depression and cellular aging, but not a causal relationship. And the research was limited to severe depression, excluding milder and perhaps more common forms.

The good news is that previous research suggests cellular aging can be reversed with diet and exercise. Yet another reason to strap on your sneakers.

Older women who have high levels of serum glucose are at increased risk for colorectal cancer, a longitudinal study found.

Compared with postmenopausal women whose glucose levels were in the lowest tertile, those in the highest tertile had a multivariable adjusted hazard ratio for colorectal cancer of 1.74 (95% CI 0.97 to 3.15, P for trend=0.06), according to Geoffrey C. Kabat, MD, of Albert Einstein College of Medicine in New York, and colleagues.

And the risk was even higher when the analysis was specifically for colon cancer (HR 2.25, 95% CI 1.12 to 4.51, P for trend=0.02), they reported online in the British Journal of Cancer.

Although obesity and related conditions such as diabetes and the metabolic syndrome have been linked with colorectal cancer, it has not been known whether the risk relates to levels of circulating insulin or glucose.

Insulin theoretically could contribute in that it is anti-apoptotic and mitogenic, whereas glucose might increase the risk by providing an energy source for malignant cells, the researchers explained.

But the results of epidemiologic studies looking at a possible link between insulin and glucose levels have had inconsistent findings, possibly because of differences in types of study as well as in populations and risk factors.

So to examine this prospectively, Kabat and colleagues analyzed data from a subset of women participating in the Women's Health Initiative who had baseline and serial follow-up measurements of fasting serum glucose and insulin.

Covariates in the analysis included age, body mass index (BMI), alcohol consumption, physical activity, ethnicity, and family history of colorectal cancer.

During a median of 11.9 years, there were 81 cases of colorectal cancer among the cohort of 4,902 women.

A total of 65 of the cases were colon cancer, in six the malignancy was the rectosigmoid junction, and in 10 the cancer was rectal.

Compared with women who did not develop colorectal cancer, those who did were older by about two years, were more often white, and were less likely to be physically active.

Unlike glucose, which had a "robust" association, baseline levels of insulin and the insulin resistance index were not associated with an increased risk of colorectal or colon cancer, according to the researchers.

After mutual adjustment for glucose and insulin, the hazard ratio for the highest tertile of glucose versus the lowest was 1.72 (95% CI 0.94 to 3.15, P for trend=0.07), while the hazard ratio for insulin was 0.88 (95% CI 0.47 to 1.65, P for trend=0.70).

The hazard ratio for each 1 mg/dL⁻¹ of glucose was 1.031 (95% CI 1.009 to 1.054, P for trend=0.0066).

The risk for both colorectal and colon cancer with higher levels of glucose was seen in patients whose BMI was 27.76 or higher, with a hazard ratio per mg/dL⁻¹ of 1.029 (95% CI 0.997 to 1.062, P=0.08), and also for those whose BMI was lower (HR 1.031, 95% CI 1.001 to 1.063, P=0.04).

Here, too, the baseline insulin and the insulin resistance index were not associated with cancer risk.

The researchers also did the analysis excluding patients whose cancer developed within two years of study entry to eliminate possible cases of subclinical disease, and found similar results, with a hazard ratio for the highest versus lowest tertile of glucose of 1.81 (95% CI 0.93 to 3.51, P for trend 0.07).

"In conclusion," the researchers wrote, "in this cohort study of postmenopausal women, elevated fasting serum glucose, but not insulin or [the homeostasis model assessment of insulin resistance] was associated with roughly a twofold increased risk of colorectal cancer."

A limitation of the study was the small number of cancer cases identified and the researchers' resulting inability to more thoroughly analyze subsets of cases according to cancer sites and variables.

Choline is an essential nutrient that is utilized by the body to manufacture neurotransmitters and cell membrane constituents.  Choline is found in green leafy vegetables, fish, peanuts, organ meat, soybeans, yeast, wheat germ, and lecithin.  Rhoda Au, from Boston University School of Medicine (Massachusetts, USA), and colleagues analyzed population data from the Framingham study, involving 1400 adults, ages 36 to 83 years, who completed a food survey and then underwent tests of memory and other cognitive abilities, including MRI brain imaging. The subjects who reported high choline intake performed better on the memory tasks, as compared to those reporting lower intake. Additionally, the researchers found that study participants with higher choline intake were less likely to show areas of white matter hyperintensity – an indicator of blood vessel disease in the brain. The study authors conclude that: “In this community-based population …  higher concurrent choline intake was related to better cognitive performance.”

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Statistics released today by the American Society of Plastic Surgeons (ASPS) show that more men are going under the knife. Overall cosmetic plastic surgery procedures in men were up 2 percent in 2010 compared to 2009. However, many male surgical procedures increased significantly. Facelifts for men rose 14 percent in 2010 while male liposuction increased 7 percent.

2010 ASPS statistics show that men underwent more than 1.1 million cosmetic procedures, both minimally-invasive and surgical. The majority of the the Men's Top 10 fastest-growing cosmetic procedures are surgical, which bucks the previous trend of growth in minimally-invasive treatments.

"The growth in cosmetic surgical procedures for men may be a product of our aging baby boomers who are now ready to have plastic surgery," said ASPS President Phillip Haeck, MD. "Minimally-invasive procedures such as Botox® and soft tissue fillers work to a point. However, as you age and gravity takes over, surgical procedures that lift the skin are necessary in order to show significant improvement."

Men's Top Ten: Fastest-Growing Male Cosmetic Procedures (by percentage increase)

The list is comprised of the fastest-growing surgical and minimally-invasive procedures from 2009 to 2010. Criteria for inclusion: Procedure performed on at least 1,000 men in 2010. (Surgical procedures are denoted by *).

1) Facelift* - 14% Increase
2) Ear Surgery* (Otoplasty) - 11% Increase
3) Soft Tissue Fillers - 10% Increase
4) Botulinum Toxin Type A - 9% Increase
5) Liposuction* - 7% Increase
6) Breast Reduction in Men* - 6% Increase
7) Eyelid Surgery* - 4% Increase
8) Dermabrasion* - 4% Increase
9) Laser Hair Removal - 4% Increase
10) Laser Treatment of Leg Veins - 4% Increase

Plastic surgeons say that another trend they see in male plastic surgery is the type of patient seeking their services.

"Typically people think of celebrities and high profile men going under the knife," said Stephen Baker, MD, an ASPS Member Surgeon based in Washington DC. "And while that may be true, the typical male cosmetic surgery patient that I see is an average guy who wants to look as good as he feels. Most of my patients are 'men's men,' the kind of guy you might not think would have plastic surgery."

Dr. Baker said that baby boomers who are now reaching retirement age are the new face of the male plastic surgery trend. "They want to look good. So when they have the financial means to do it, they are ready to do it now," said Dr. Baker.

In fact, one of Dr. Baker's patients is an "average Joe" named Joe Marek. Joe recently underwent a facelift and eyelid surgery. The 57-year old said, "I didn't feel that old. I felt young. I was working out. I was pretty active and I wanted to look like I felt inside."

Joe also said his 52-year-old girlfriend supported his decision to have plastic surgery.

Men's Top Ten: Most Popular Male Cosmetic Procedures (by volume)

This list is comprised of the top five surgical and top five minimally-invasive procedures by volume in 2010:

2010 Top Five Male Cosmetic Surgical Procedures:

1) Nose Reshaping (64,000)
2) Eyelid Surgery (31,000)
3) Liposuction (24,000)
4) Breast Reduction in Men (18,000)
5) Hair Transplantation (13,000)

2010 Top Five Male Cosmetic Minimally-Invasive Procedures:
1) Botulinum Toxin Type A (337,000)
2) Laser Hair Removal (165,000)
3) Microdermabrasion (158,000)
4) Chemical Peel (90,000)
5) Soft Tissue Fillers (78,000)

For more statistics released today on trends in plastic surgery including gender, age, regional, national average fees, and other breakouts, visit the ASPS Report of the 2010 Plastic Surgery Statistics here. (Stats on this site will be updated with the specific demographics and trends when embargo lifts on 3/21/11). Visitors can also find information about procedures and referrals to ASPS Member Surgeons.

Source:
American Society of Plastic Surgeons (ASPS)

Antioxidant supplements may benefit couples who have difficulty conceiving naturally, according to a new systematic review published today in The Cochrane Library. The review provides evidence from a small number of trials that suggest the partners of men who take antioxidants are more likely to become pregnant.

Male subfertility affects one in 20 men. Chemicals called reactive oxygen species (ROS) are said to cause damage to cells, and in particular sperm cells, which may result in lowered sperm counts and interfere with their ability to fertilise eggs. Antioxidants include natural and synthetic chemicals, including certain vitamins and minerals, which help to reduce the damage caused by ROS.

The review focused on 34 trials involving 2,876 couples undergoing assisted reproductive techniques such as in vitro fertilisation and sperm injections. Most men in the trials had low sperm counts or low sperm motility. The trials explored the use of many different types of oral antioxidants, including vitamin E, L-carnitine, zinc and magnesium.

Compared to controls, a couple was more likely to have a pregnancy or live birth if the man took antioxidants. However, these results are based on just 964 of the couples in the review for pregnancies and 214 couples for live births. Other trials tested the effects of antioxidants on sperm motility and concentration and showed mostly positive effects, although study group sizes were small.

"When trying to conceive as part of an assisted reproductive program, it may be advisable to encourage men to take oral antioxidant supplements to improve their partners' chances of becoming pregnant," said lead researcher Marian Showell, who works in Obstetrics and Gynaecology at the University of Auckland in Auckland, New Zealand. "However, these conclusions are currently based on limited evidence."

There were not enough data comparing different antioxidants to reach any conclusions about the relative effectiveness of supplements. "We need more head-to-comparisons to understand whether any one antioxidant is performing better than any other," said Showell.

Full citation: Showell MG, Brown J, Yazdani A, Stankiewicz MT, Hart RJ. Antioxidants for male subfertility. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD007411. DOI: 10.1002/14651858.CD007411.pub2 Article

Source: Wiley-Blackwell

New research has examined the usefulness of bone marrow stem cells for treating male infertility, with promising results. The related report by Lue et al, "Fate of bone marrow stem cells transplanted into the testis: potential implication for men with testicular failure," appears in the March issue of The American Journal of Pathology. 

When a couple experiences infertility, the man is just as likely as the woman to be the cause. Male infertility may arise from failed proliferation and differentiation of the germ cells (precursors of sperm) or from dysfunction of the supporting cells. New research is looking to stem cells as a means of replacing nonfunctioning cells, whether germ cells or supporting cells. 

Researchers, directed by Dr. Ronald S. Swerdloff of the Harbor-UCLA Medical Center, collected bone marrow stem cells from mice expressing the green fluorescent protein (GFP). These green cells, which could be easily tracked in recipient mice, were injected into the testes of infertile mice, in which infertility was induced either chemically or genetically (via mutations in a gene required for sperm production). 

The donor GFP-expressing cells took up residence in the testes and survived within the recipient mice for the entire 12-week study period. The donor stem cells displayed the characteristic shape of either germ cells or supporting cells, suggesting that the stem cells had differentiated. These differentiated donor (green) cells were also found near the native recipient cells of the same type, demonstrating that the local cellular environment likely influenced the fate of the donor stem cells. 

As further confirmation of the differentiation status of the donor cells, the expression of specific proteins on the cell surface was examined. Both germ and supporting cells expressed marker proteins known to be found only on the differentiated cells, not on stem cells. 

These data demonstrate that bone marrow stem cells have the potential to differentiate into cells of the testes involved in sperm production, both germ cells and supporting cells. Interestingly, the germ cells did not differentiate fully into sperm, suggesting that additional factors or cellular signals are needed. 


Future studies will characterize the other factors, such as hormones, required to complete sperm production in this transplant model. In addition, since the bone marrow cells used here represent a mixed population of stem cells, further studies will determine which specific stem cell type was able to colonize and differentiate in the testes. The results of future studies could have dramatic implications for treating male infertility or testosterone deficiency.

Lue YH, Erkkila K*, Liu PY*, Ma K, Wang C, Hikim AS, Swerdloff RS. Fate of bone marrow stem cells transplanted into the testis: potential implication for men with testicular failure. Am J Pathol 2007 170: 899-908. 

*These authors contributed equally to this work as second author.

The American Journal of Pathology, the official journal of the American Society for Investigative Pathology (ASIP), seeks to publish high-quality original papers on the cellular and molecular mechanisms of disease. The editors accept manuscripts which report important findings on disease pathogenesis or basic biological mechanisms that relate to disease, without preference for a specific method of analysis. High priority is given to studies on human disease and relevant experimental models using cellular, molecular, biological, animal, chemical and immunological approaches in conjunction with morphology. 

Contact: Audra Cox 
American Journal of Pathology 

Basil can protect against the harmful effects of ageing, according to research presented at the British Pharmaceutical Conference (BPC) in Manchester.

Holy basil, (Latin name Ocimum sanctum), is a close relative of the herb commonly used in Western cooking. Native to India, its extract has long been used in the ancient system of Ayurvedic medicine practiced in India and other parts of Asia as a rejuvenation drug, to promote a youthful state of physical and mental health. 

In the first formal study of the herb, pharmacy researchers found that holy basil extract was effective at actively searching for and eliminating harmful molecules and protecting against damage caused by some free radicals in key organs such as the heart, liver and brain.

The researchers, led by Dr Vaibhav Shinde from Poona College of Pharmacy, Maharashtra, India, studied the herb for anti-oxidant and anti-ageing properties. 

Dr Shinde said: "The study validates the traditional use of herb as a youth-promoting substance in the Ayurvedic system of medicine. It also helps describe how the herb acts at a cellular level." 

About the British Pharmaceutical Conference 2008 (BPC)

BPC 2008: Pharmacy in the 21st Century: Adding years to life and life to years. In 2008, as the NHS marks its 60th anniversary year, BPC will examine how pharmacy and the pharmaceutical services are helping to add years to life and life to the year of the UK population. The profession of pharmacy plays an important role in meeting the healthcare challenges associated with the UK's ageing population. 


How can pharmacists contribute to caring for the population as well as ensuring quality of life? Increasingly, scientists and practitioners have to consider the cost implications of this conundrum, and the evidence base for all interventions is becoming of paramount importance: BPC 2008 will debate these issues and open up discussion on them. Visit: http://www.bpc2008.org 

The main sponsors of BPC 2008 are: Boots The Chemists (Lead Sponsor), AstraZeneca (Associate Sponsor and BPC-PJ Careers Forum Platinum Sponsor), Pharmacists' Defence Association (PDA) (Associate Sponsor) and GSK (BPC-PJ Careers Forum Platinum Sponsor). 

Research released at BPC is published in the Journal of Pharmacy and Pharmacology (JPP). 

It is estimated that by 2025 there will be more than one billion people globally over the age of 60(1). Therefore, considerable interest focuses on the prevention of ageing and age-related diseases. World Health Organisation launches new initiative to address the health needs of a rapidly ageing population. 


1) http://www.who.int/mediacentre/news/releases/2004/pr60/en/ : Accessed 4 August 2008.