Doctors in bitter divide over e-cigarettes

Are e-cigarettes giving tobacco companies the means to appear benign while actually "killing people softly" or are the alternatives offering the best chance of reducing harm from cigarette smoking? Doctors are bitterly divided over the question.

Glamorizing cigarette smoking or saving lives?

An article in The BMJ reports from both sides of the debate. Simon Capewell, professor of public health and policy at the Institute of Psychology, Health and Society at the UK's University of Liverpool, tells the journal he is suspicious of big tobacco.

Prof. Capewell argues that if the big tobacco companies were genuinely concerned about the disease and the harm they caused, "they would cease production - end of discussion. They would go into e-cigarette production 100%."

Instead, tobacco companies are cynically acting to worm their ways into public bodies, pretending to be part of the solution and deflecting attention away from the harm they do, argue such public health experts.

The argument against e-cigarettes also says they help to glamorize and renormalize smoking. But such an idea is given a strongly-worded dismissal by one organization that has previously been an arch-enemy of the tobacco companies but now appears alongside them at conferences.

Deborah Arnott, chief executive of the UK charity Action on Smoking and Health (ASH), says:

"There are people in the public health community who are obsessed by e-cigarettes. This idea that it renormalizes smoking is absolute bullshit. There is no evidence so far that it is a gateway into smoking for young people."

Arnott asks: "Do you want the tobacco industry to carry on making cigarettes which are highly addictive and kill when used as intended, or do you want them to move to a product which is much nearer licensed nicotine replacement therapy and is unlikely to kill anyone?"

But the opposition remains. Public health experts against such positions include 129 who warned the World Health Organization and other public bodies not to "buy into the tobacco industry's well-documented strategy of presenting itself as a partner."

The article in The BMJ characterizes the debate as divided broadly between two types of doctor - public health experts looking at the population effects, and supposedly "idealist" about the issue, and doctors in practise who have a more "pragmatic" view of potential benefits for individuals.

While the debate rages, the reality of smoking versus vaping plays out.

A report from the Centers for Disease Control and Prevention and the Food and Drug Administration's Center for Tobacco Products revealed that the use of electronic cigarettes tripled among middle and high school students between 2013 and 2014.

The news of the findings means that the use of e-cigarettes among this population has exceeded use of all other tobacco products - including conventional cigarettes.

Much of the opposition to the developments is a result of the involvement of tobacco companies, the report in The BMJ says.

"When they first came on the market, 5 or 6 years ago, there was a positive openness and curiosity" about electronic cigarettes, says Karl Fagerström, a Swedish clinical psychologist and a founder of the Society for Research on Nicotine and Tobacco. But after the cigarette industry became involved, the attitude changed from suspicion to opposition, he adds.

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Molecular mechanisms within fetal lungs initiate labor

Researchers have identified two proteins in a fetus' lungs responsible for initiating the labor process, providing potential new targets for preventing preterm birth. They discovered that the proteins SRC-1 and SRC-2 activate genes inside the fetus' lungs near full term, leading to an inflammatory response in the mother's uterus that initiates labor.

UT Southwestern researchers found that the proteins SRC-1 and SRC-2 activate genes inside the fetus' lungs near full term, resulting in an increased production of surfactant components, surfactant protein A (SP-A), and platelet-activating factor (PAF). Both SP-A and PAF are then secreted by the fetus' lungs into the amniotic fluid, leading to an inflammatory response in the mother's uterus that initiates labor.

Credit: © Noel Powell / Fotolia

Researchers at UT Southwestern Medical Center have identified two proteins in a fetus' lungs responsible for initiating the labor process, providing potential new targets for preventing preterm birth.

Previous studies have suggested that signals from the fetus initiate the birth process, but the precise molecular mechanisms that lead to labor remained unclear. UT Southwestern biochemists studying mouse models found that the two proteins − steroid receptor coactivators 1 and 2 (SRC-1 and SRC-2) -- control genes for pulmonary surfactant components that promote the initiation of labor. Surfactant is a substance released from the fetus' lungs just prior to birth that is essential for normal breathing outside the womb.

"Our study provides compelling evidence that the fetus regulates the timing of its birth, and that this control occurs after these two gene regulatory proteins − SRC-1 and SRC-2 − increase the production of surfactant components, surfactant protein A and platelet activating factor," said senior author Dr. Carole Mendelson, Professor of Biochemistry, and Obstetrics and Gynecology at UT Southwestern.

"By understanding the factors and pathways that initiate normal-term labor at 40 weeks, we can gain more insight into how to prevent preterm labor," said Dr. Mendelson, Director of the North Texas March of Dimes Birth Defects Center at UT Southwestern.

Each year about one in every nine infants in the United States is born preterm (before 37 weeks), according to the Centers for Disease Control and Prevention. Premature birth can cause brain hemorrhage and respiratory distress for babies, as well as long-term conditions such as cerebral palsy, chronic lung disease, and impaired vision.

The study, which appears in the Journal of Clinical Investigation, was supported by the National Institutes of Health and a Prematurity Research Initiative grant from the March of Dimes Foundation.

UT Southwestern researchers found that the proteins SRC-1 and SRC-2 activate genes inside the fetus' lungs near full term, resulting in an increased production of surfactant components, surfactant protein A (SP-A), and platelet-activating factor (PAF). Both SP-A and PAF are then secreted by the fetus' lungs into the amniotic fluid, leading to an inflammatory response in the mother's uterus that initiates labor.

The current study showed that a deficiency of both SRC-1 and SRC-2 inside the fetus' lungs drastically decreased the production of SP-A and PAF, causing a one- to two-day labor delay in mouse models, comparable to a three- to four-week labor delay in women.

Researchers further found that injecting either SP-A or PAF into the amniotic fluid of the deficient mice allowed the mothers to deliver on time. Together, the findings further define the underlying molecular mechanisms by which fetuses control the timing of birth.

Future research will include defining how fetal signals are transmitted to the mother's uterus, and relating these findings to the causes of preterm labor.

The study was conducted with current and former UT Southwestern researchers, including first author Dr. Lu Gao; Dr. Elizabeth Rabbitt; Dr. Jennifer Condon; Dr. Nora Renthal; Dr. John Johnston; Dr. Matthew Mitsche; and researchers from the Institut de Génétique et de Biologie Moléculaire et Cellulaire, France, and Baylor College of Medicine in Houston.

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The above post is reprinted from materials provided by UT Southwestern Medical Center. Note: Materials may be edited for content and length.

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Over 95% of the world’s population has health problems, with over a third having more than five ailments

Just one in 20 people worldwide (4·3%) had no health problems in 2013, with a third of the world's population (2·3 billion individuals) experiencing more than five ailments, according to a major new analysis.

In 2013, low back pain and major depression ranked among the top ten greatest contributors to disability in every country, causing more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined.

Credit: © xy / Fotolia

Just one in 20 people worldwide (4·3%) had no health problems in 2013, with a third of the world's population (2·3 billion individuals) experiencing more than five ailments, according to a major new analysis from the Global Burden of Disease Study (GBD) 2013, published in The Lancet.

Moreover, the research shows that, worldwide, the proportion of lost years of healthy life (disability-adjusted life years; DALYS [1]) due to illness (rather than death) rose from around a fifth (21%) in 1990 to almost a third (31%) in 2013.

As the world's population grows, and the proportion of elderly people increases, the number of people living in suboptimum health is set to rise rapidly over coming decades, warn the authors.

The findings come from the largest and most detailed analysis to quantify levels, patterns, and trends in ill health and disability around the world between 1990 and 2013.

In the past 23 years, the leading causes of health loss have hardly changed. Low back pain, depression, iron-deficiency anemia, neck pain, and age-related hearing loss resulted in the largest overall health loss worldwide (measured in terms of YLD -- Years Lived with Disability -- ie, time spent in less than optimum health [2]) in both 1990 and 2013.

In 2013, musculoskeletal disorders (ie, mainly low back pain, neck pain, and arthritis) and mental and substance abuse disorders (predominantly depression, anxiety, and drug and alcohol use disorders) accounted for almost half of all health loss worldwide.

Importantly, rates of disability are declining much more slowly than death rates. For example, while increases in rates of diabetes have been substantial, rising by around 43% over the past 23 years, death rates from diabetes increased by only 9%.

"The fact that mortality is declining faster than non-fatal disease and injury prevalence is further evidence of the importance of paying attention to the rising health loss from these leading causes of disability, and not simply focusing on reducing mortality," [3] says Theo Vos, lead author and Professor of Global Health at the Institute of Health Metrics and Evaluation, University of Washington, USA.

The GBD 2013 Disease and Injury Incidence and Prevalence Collaborators analysed 35,620 sources of information on disease and injury from 188 countries between 1990 and 2013 to reveal the substantial toll of disabling disorders and the overall burden on health systems from 301 acute and chronic diseases and injuries, as well as 2337 health consequences (sequelae) that result from one or more of these disorders.

Key findings include:

In 2013, low back pain and major depression ranked among the top ten greatest contributors to disability in every country, causing more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined.

Worldwide, the number of individuals with several illnesses rapidly increased both with age and in absolute terms between 1990 and 2013. In 2013, about a third (36%) of children aged 0-4 years in developed countries had no disorder compared with just 0·03% of adults older than 80 years. Furthermore, the number of individuals with more than ten disorders increased by 52% between 1990 and 2013.

Eight causes of chronic disorders -- mostly non-communicable diseases -- affected more than 10% of the world population in 2013: cavities in permanent teeth (2·4 billion), tension-type headaches (1·6 billion), iron-deficiency anemia (1·2 billion), glucose-6-phosphate dehydrogenase deficiency trait (1·18 billion), age-related hearing loss (1·23 billion), genital herpes (1·12 billion), migraine (850 million), and ascariasis (800 million; giant intestinal roundworm).

The number of years lived with disability increased over the last 23 years due to population growth and aging (537·6 million to 764·8 million), while the rate (age-standardised per 1000 population) barely declined between 1990 and 2013 (115 per 1000 people to 110 per 1000 people).

The main drivers of increases in the number of years lived with disability were musculoskeletal, mental, and substance abuse disorders, neurological disorders, and chronic respiratory conditions. HIV/AIDS was a key driver of rising numbers of years lived with disability in sub-Saharan Africa.

There has also been a startling increase in the health loss associated with diabetes (increase of 136%), Alzheimer's disease (92% increase), medication overuse headache (120% increase), and osteoarthritis (75% increase).

In central Europe, falls cause a disproportionate amount of disability and health burden, ranking as the second leading cause of disability in 11 of 13 countries. In many Caribbean nations anxiety disorders ranked more highly, and diabetes was the third greatest contributor to disability in Mexico, Nicaragua, Panama, and Venezuela. Disability from past war and conflict was the leading contributor to health loss in Cambodia, Nicaragua, Rwanda, and ranked second in Vietnam.

According to Professor Vos, "Large, preventable causes of health loss, particularly serious musculoskeletal disorders and mental and behavioural disorders, have not received the attention that they deserve. Addressing these issues will require a shift in health priorities around the world, not just to keep people alive into old age, but also to keep them healthy."

FOOTNOTES:

This study was funded by the Bill & Melinda Gates Foundation.

[1] Years of healthy life lost are measured in terms of disability adjusted life years (DALYS). These are worked out by combining the number of years of life lost as a result of early death and the number of years lived with disability.

[2] Years lived with disability (YLD) calculated by combining prevalence (proportion of the population with the disorder in any given year) and the general public's assessment of the severity of health loss (disability weight).

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The above story is based on materials provided by The Lancet. Note: Materials may be edited for content and length.

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Impact of insecticides on the cognitive development of 6-year-old children

Researchers have provided new evidence of neurotoxicity in humans from pyrethroid insecticides, which are found in a wide variety of products and uses.

Exposure of children to pyrethroids is common.

Credit: © TMAX / Fotolia

In an article published in the journal Environment International, researchers from Inserm (Inserm Unit 1085 -- IRSET, the Institute of Research in Environmental and Occupational Health, Rennes), in association with the Laboratory for Developmental and Educational Psychology, LPDE (Rennes 2 University), provide new evidence of neurotoxicity in humans from pyrethroid insecticides, which are found in a wide variety of products and uses. An increase in the urinary levels of two pyrethroid metabolites (3-PBA and cis-DBCA) in children is associated with a significant decrease in their cognitive performances , particularly verbal comprehension and working memory. This study was carried out on nearly 300 mother and child pairs from the PELAGIE cohort (Brittany).

Pyrethroid exposure

Pyrethroids constitute a family of insecticides widely used in a variety of sectors: agriculture (various crops), veterinary (antiparasitics) and domestic (lice shampoo, mosquito products). Their mode of action involves blocking neurotransmission in insects, leading to paralysis. Because of their efficacy and relative safety for humans and mammals, they have replaced older compounds (organochorides, organophosphates, carbamate) considered more toxic.

Exposure of children to pyrethroids is common. It is different to adult exposure, due to the closer proximity of children to ground-level dust (which stores pollutants), more frequent hand-to-mouth contact, lice shampoos, etc. In children, pyrethroids are mainly absorbed via the digestive system, but are also absorbed through the skin. They are rapidly metabolised in the liver, and mainly eliminated in the urine as metabolites within 48 hours.

Given these elements and the mode of action (neurotoxicity) of pyrethroid insecticides, the researchers proposed the hypothesis of a possible effect of these contaminants on the nervous system and its development in children.

Contribution of the PELAGIE mother-child cohort

Pregnancy is also an important period of life for the future health of the child. For this reason, the researchers studied the PELAGIE mother-child cohort established between 2002 and 2006, which monitors 3,500 mother-child pairs. This cohort simultaneously considers exposure to pyrethroid insecticides during fetal life and childhood.

A total of 287 women, randomly selected from the PELAGIE cohort and contacted successfully on their child's sixth birthday, agreed to participate in this study.

Two psychologists visited them at home. One assessed the child's neurocognitive performances using the WISC scale (verbal comprehension index, VCI, and working memory index, WMI). The other psychologist characterised the family environment and stimuli that might have had a role on the child's intellectual development, collected a urine sample from the child, and collected dust samples.

Exposure to pyrethroid insecticides was estimated by measuring levels of five metabolites (3-PBA, 4-F-3-PBA, cis-DCCA, trans-DCCA and cis-DBCA) in urine from the mother (collected between the 6th and 19th weeks of pregnancy) and from the child (collected on his/her 6th birthday).

A decrease observed in child cognitive performances

Results show that an increase in children's urinary levels of two metabolites (3 PBA and cis-DBCA) was associated with a significant decrease in cognitive performances, whereas no association was observed for the other three metabolites (4-F-3-PBA, cis-DCCA and trans-DCCA). With respect to metabolite concentrations during pregnancy, there was no demonstrable association with neurocognitive scores.

"Although these observations must be reproduced in further studies in order to draw definite conclusions, they indicate the potential responsibility of low doses of deltamethrine in particular (since the metabolite cis-DBCA is its main metabolite, and selective for it), and pyrethroid insecticides in general (since the metabolite 3-BPA is a degradation product of some twenty of these insecticides)," explains Cécile Chevrier, Inserm Research Fellow, the main author of this work.

"The consequences of a cognitive deficit in children for their learning ability and social development constitute a handicap for the individual and for society. The research effort needs to be pursued in order to identify causes that could be targeted by preventive measures," emphasises Jean-François Viel, a co-author of this work.

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The above story is based on materials provided by INSERM. Note: Materials may be edited for content and length.

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Staggering Ebola Predictions

The WHO says more than 20,000 people could be infected by November, while the CDC estimates the epidemic will strike some 500,000 people by the end of January.

WIKIMEDIA, PLOS BIOLOGYMore than 20,000 people are likely to have been infected with Ebola by November 2, the World Health Organization (WHO) Ebola Response Team predicted in the New England Journal of Medicine today (September 23). Extrapolating data from the beginning of the outbreak and accounting for theincreased pace of infections, the team noted that “transmission has to be a little more than halved to achieve control of the epidemic and eventually to eliminate the virus from the human population.”

Meanwhile, at the current rate of transmission and without any further aid, scientists from the US Centers for Disease Control and Prevention (CDC) estimate that “the Ebola epidemic sweeping West Africa could infect up to 500,000 people by the end of January,” The Washington Post reported (via Bloomberg News). The Post also noted that the CDC prediction, which is still under development and set to be released next week, is subject to change. “One of the scary things about this outbreak is that all the general models of the past have been broken,” microbiologist John Connor of Boston University School of Medicine told the newspaper.

Update (September 23): In a Morbidity and Mortality Weekly Report article issued after this post was published, the CDC presented a worst-case scenario prediction that—assuming transmission “trends continue without additional interventions,”and correcting for under-reporting—as many as 1.4 million people could be infected with Ebola by January 20, 2015. “It is still possible to reverse the epidemic,” CDC Director Thomas Frieden said in a statment. “Once a sufficient number of Ebola patients are isolated, cases will decline very rapidly—almost as rapidly as they rose.”

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Ebola Outbreak Threatens World Security

The United Nations Security Council declares the situation in West Africa a “threat to international peace and security” and calls for even more resources to fight the spread of the Ebola virus.

Color-enhanced electron micrograph of Ebola virus particlesWIKIMEDIA, PLOS PATHOGENS, THOMAS W. GEISBERTWith more than 2,600 lives now lost to the ongoing Ebola outbreak in West Africa, according to the World Health Organization (WHO), “the gravity and scale of the situation now require a level of international action unprecedented for a health emergency,” United Nations (UN) Secretary General Ban Ki-moon said at an emergency meeting of the UN Security Council last week (September 18).

To curb the spread of the deadly virus, which is now infecting twice as many people every three weeks, the council proposed a resolution that calls for countries to provide even more aid—as much as 20 times the response that has already been put in action, BBC News reported. Specifically, the resolution, which was cosponsored by a record-setting 130 nations, asks countries to send supplies and medical staff to Liberia, Guinea, and Sierra Leone, and to lift travel restrictions in the affected countries to allow aid workers easier access.

“The UN Security Council is charged with the essential duty to maintain international peace and security,” according to a statement from the O’Neill Institute for National & Global Health Law on the resolution. “[A] UNSC resolution could establish a well-coordinated and orderly international response to this unprecedented health crisis.”

In total, the UN estimates that it will cost some $1 billion to contain the virus, Nature news blog reported. “This is likely the greatest peace-time challenge that the United Nations and its agencies have ever faced,” WHO director-general Margaret Chan told the council.

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Will 'the female Viagra' really help women?

Later today, a committee of advisors to the Food and Drug Administration will vote on whether or not the agency should approve flibanserin - the much-hyped yet controversial "female Viagra." However, the drug has already been rejected twice previously by the organization, who cite safety concerns. In the wake of those decisions, battle lines have been drawn between those who feel the agency is discriminating against the sexual health of women and those who feel the language of sexual equality has been hijacked in an attempt to force an ineffective and unsafe drug on the market. We take a look at both sides of this dramatic debate.

Campaigners for flibanserin claim that 26 drugs have been FDA-approved for male sexual dysfunction and none for women.

480 was not a viable angina treatment, Pfizer took an interest instead in its unintended effects. As a treatment for erectile dysfunction, UK-92480 was much more effective than a placebo. In 1998, the drug was approved for this use by the Food and Drug Administration (FDA), and it was rechristened Viagra.

In the 17 years since, drugs acting as variations on Viagra's mechanism have also made it to market as erectile dysfunction treatments. What has been conspicuous in its absence, however, has been "a Viagra for women."

Following the FDA's second decision not to approve flibanserin, in fall 2014, two well-funded media campaigns - Even The Score and Women Deserve - set about engaging women's groups, starting up petitions and lobbying policymakers on the issue. A mantra of these campaigns is the figure "26-0."

What 26-0 relates to is a claim made by Cindy Whitehead, the CEO of Sprout Pharmaceuticals (who now own flibanserin) - and reportedly the creative mind behind Even The Score and Women Deserve - that 26 drugs have been FDA-approved for male sexual dysfunction and none for women.

Watch Women Deserve's Viagra parody video below:

"Women have waited long enough," write Even The Score, of their pro-flibanserin petition, which is reported to have attracted more than 40,000 signatures. "In 2015, gender equality should be the standard when it comes to access to treatments for sexual dysfunction."

Accusations of data manipulation

However, critics have claimed that Even The Score's campaign is built on misinformation. The 26 products for male sexual dysfunction are actually different regional brands of the four main erectile dysfunction treatments, which themselves adhere to a similar mechanism.

Do 43% of American women really have a sexual dysfunction?

Another statistic wielded by the campaigns - the claim that 43% of American women have a sexual dysfunction - has also come under fire. The figure is drawn from a contentious 1994 survey that gave its female respondents the option of answering yes or no to whether they had any sort of sexual problem, but the survey did not collect any data on what the nature of the problem was - even the senior author of that study has reportedly claimed the statistic is misused.

A claim published on womendeserve.org that "a biological lack of desire to have sex negatively impacts 1 in 10 American women" was questioned in a high-profile LA Times piece by Kinsey Institute research fellow and sexologist Prof. Ellen Laan, and Leonore Tiefer, professor of psychiatry at NYU School of Medicine and founder of the New View Campaign.

"No diagnostic test has identified any biological cause - brain, hormone, genital blood flow - for most women's sexual problems," the pair wrote. Rather, they claim that low sexual desire in women more likely reflects a difference in desire between the two partners.

"It is unethical and unscientific to attribute a couple's discrepancy in desire to the woman's biological deficit," they continue, pointing out that studies have shown women's response to both test medications and placebo drugs is high. "These repeated findings do not support the 'unmet medical need' theory."

What Laan and Tiefer's article and the New View Campaign emphasize is that Viagra and flibanserin are false equivalents. Viagra treats erectile dysfunction, while Sprout claim that flibanserin is an antidote for low sexual desire in women. Viagra does not increase male libido; rather it acts on the mechanism that allows an erection to happen.

What flibanserin is concerned with - boosting sexual desire - is more amorphous and complex. New View even argue that male and female sexual dysfunctions are also not equivalents, so a female Viagra would therefore not be appropriate for women.

'Hypoactive sexual desire disorder' and the DSM

The New View Campaign take issue with the current sexual dysfunction classification implemented by the American Psychiatric Association (APA) in its 1980 edition of the Diagnostic and Statistical Manual of Disorders (DSM), which envisions male and sexual "dysfunction" as equivalents across four categories: sexual desire disorders, sexual arousal disorders, orgasmic disorders and sexual pain disorders.

The illness that flibanserin is purported to treat - hypoactive sexual desire disorder - was removed from the DSM in 2013.

They consider that this has led to a reductive, mechanistic perception of how female sexuality works in relation to male sexuality. They argue that women's sexual problems are less physiological and genital-focused than men's, that "women generally do not separate 'desire' from 'arousal,' women care less about physical than subjective arousal, and women's sexual complaints frequently focus on 'difficulties' that are absent from the DSM."

"The DSM takes an exclusively individual approach to sex, and assumes that if the sexual parts work, there is no problem; and if the parts don't work, there is a problem," summarize the campaigners.

Instead, the campaigners say, it has fostered a commercial drive to produce "a female Viagra" - a pharma sensation that will repeat the massive success of that drug for a new audience, regardless of whether pharmacology is the correct intervention, or to what extent there is a problem that requires treatment.

In fact, the specific illness that Sprout argue flibanserin treats - hypoactive sexual desire disorder (HSDD) - was removed from the DSM in 2013.

Medical News Today spoke to Thea Cacchioni, an assistant professor of women's studies at the University of Victoria in British Columbia, who testified against flibanserin the first time it was unsuccessfully submitted for FDA approval in 2010. She asserted bluntly of flibanserin's position in the modern pharmaceutical landscape: "there is no recognized illness it treats."

"There are many problems with the HSDD disorder, as I mentioned in the hearing," Cacchioni told us, "how could we ever come up with a baseline level of normal desire? Norms of desire vary from era to era and culture to culture. Also, research shows that most desire problems are caused by external factors - interpersonal, relationship issues, social judgements and pressures related to especially women's sexuality, feelings of inadequacy, work stress, etc."

As fascinating as the cases for and against the idea of a pharmaceutical intervention for female sexual dysfunction are, the issues that Cacchioni and others expressed the greatest concern about when testifying in 2010 were much less philosophical and more to do with hard data.

Does flibanserin work and is it safe?

Firstly, does flibanserin work? The evidence presented to the FDA was perceived as being somewhat subjective - clinical trial found that it produced an additional 0.7 "sexually satisfying events" per month.

Secondly, is flibanserin safe? The drug's clinical trials saw a 14% drop-out rate due to adverse effects. The full data were not reported on what these adverse effects were, but what is known is that women taking flibanserin had 10 times the risk of dizziness and four times the risk of sleepiness compared with a control group.

"These may sound minor," explained Cacchioni, "but since this drug was tested on a highly select group of women, there is concern over what would happen if a wide population of women take this drug on a daily basis? What drug interactions will we see? Is there a risk of impaired driving?"

Whether or not Sprout will be "third-time lucky" in today's quest for FDA approval hinges on new evidence the agency has requested the pharma company submit regarding the possibility of impaired driving.

Cacchioni, who has also written a book on the issue - "Big Pharma, Women, and the Labour of Love," out in August - is not convinced the new data will be enough to swing an FDA approval, despite the intense media attention and public interest the case has received.

"Clearly, Sprout is hiding something," she told us, "since they have followed up on this important request by submitting evidence from only 25 volunteer participants, 23 of whom are men! They claim they could not find any more women who were moderate drinkers."

She adds:

"I have faith that the FDA will stand its ground and not approve flibanserin. If they do, they are sending a very dangerous message - that drug companies and their marketing machines can pressure them into approving drugs that are unsafe and ineffective."

In a recent blog for Science 2.0, Josh Bloom - director of chemical and pharmaceutical sciences at The American Council on Science and Health in New York City, NY - says that while the statistical significance of improvement in sexual arousal was excellent in flibanserin's trial, a "statistically significant improvement in a study is not the same as a significant clinical improvement." He elaborates that, in terms of evidence of improvement, "there are no 10-fold differences as was the case with adverse effects. The differences in efficacy are roughly in the 1.5-fold range."

"Which brings up the exact same question that the FDA is faced with every time it decides whether a drug gets approved or not," Bloom writes. "Do the benefits outweigh the risks? The FDA has already said no three times. This should have been over with long ago."

So why are Sprout persisting with flibanserin? The company was founded in 2011 by Cindy and Robert Whitehead, who raised $50 million to save the drug from the scrapheap, after it was first declined by the FDA.

The drug's creators, the German pharma company Boehringer Ingelheim, gave up on flibanserin. Like Viagra, the drug was not developed to be a treatment for sexual dysfunction - it was a prospective antidepressant. Antidepressants that increase serotonin have a side effect of dampening sexual response. However, flibanserin seemed to improve it - possibly by raising the levels of the neurotransmitters dopamine and norepinephrine while decreasing serotonin.

Flibanserin as sexual equality battlefield

Sprout, via the Even The Score and Women Deserve campaigns - coordinated with the largely big pharma-funded International Society for the Study of Women's Sexual Health - have painted the battle to get flibanserin to market as an ideological struggle against a patriarchal and discriminatory regulatory system that is not fit for meeting the health needs of women.

Despite support from the National Council of Women's Organizations, the Black Women's Health Imperative, Jewish Women International and the Association of Reproductive Health Professionals, the emotive pro-flibanserin campaign has not washed with everyone. Ellen Laan and Leonore Tiefer were scathing in their dismissal of its rhetoric:

"As professional sexologists and advocates of women's sexual rights, we were horrified by the campaigns' use and abuse of the language of equality to pressure the FDA to approve a potential billion-dollar blockbuster 'pink Viagra.' The only two drugs for women's sexual dysfunctions that have come to the FDA in the 16 years since Viagra was approved were rejected. [...] The drugs for women didn't work and were unsafe. Not approving them isn't sexism, it's proper regulation."

Cacchioni concurs, suggesting that perhaps the reason why no drugs have been shown to be safe or effective "is that most sexual problems are related to interpersonal, psychological, and social factors, including the social construction of sexual norms."

"Perhaps," she concludes, "we are putting too much pressure on ourselves to realize a level of desire that is not realistic for everyone across the life course."

With several FDA rejections and $50 million of investment already behind them, it will be interesting to see how Sprout and Even The Score will continue to frame the debate for "a female Viagra" if approval today is not forthcoming.

If it does succeed in winning approval, however, the Whiteheads could have a blockbuster drug on their hands with a market value of billions.

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9 in 10 people with mental illness report high levels of discrimination

They may have the sun, sea, Hollywood and Disneyland, but in a new study Californians report encountering high levels of discrimination due to psychological stress.

Most respondents felt that recovery from mental illness is possible - more than 70% said they are satisfied with life - and that they would seek treatment for mental illness when needed.

Behavioral scientists at the nonprofit research organization RAND worked with the California Mental Health Services Administration (CalMHSA) to conduct the California Well-Being Survey as an attempt to research and create prevention and early intervention programs to improve the mental health of Californians.

"This new report from RAND researchers highlights both the need to confront stigma, and the opportunity to promote mental health in our state with the statewide stigma reduction efforts offered by CalMHSA," says Wayne Clark, executive director of CalMHSA.

The researchers surveyed 1,066 Californians who had previously reported mild to serious psychological distress in the California Health Interview Survey, which looked at a variety of health issues.

The authors say that the new California Well-Being Survey is the first population-based survey to look at people who are either currently experiencing mental health problems - or are at risk from them - but who may not have received treatment.

Majority of respondents believe the mentally ill face high levels of prejudice

The behavioral scientists found that just 41% of respondents believed that people are caring and sympathetic toward people with mental illnesses, while a huge 81% believed that those with mental illnesses experience high levels of prejudice and discrimination.

More than two thirds of respondents stated that they would definitely or probably hide a mental health problem they were experiencing from co-workers or classmates. More than one third also said they would disguise mental health problems from family and friends.

Nearly 9 in 10 of those who reported having had a mental health problem said they experienced discrimination as a result of it - most often in intimate social relationships, but also in high levels at school or work. Health care providers and law enforcement officials were also alleged to behave in a discriminatory way by the study respondents.

However, despite reporting high levels of discrimination, more than 80% of participants in the survey said they have plans in place for them to stay or become well and continue to meet personal goals.

Overall, most participants felt that recovery from mental illness is possible - more than 70% said they are satisfied with life - and that they would seek treatment for mental illness when it is needed.

One third of people in the survey said that during the previous 12 months they had been reached by CalMHSA's early intervention efforts, and 90% reported engaging with other activities related to CalMHSA campaigns during the past year.

"This survey shows that CalMHSA's partnership of California's counties is successfully reaching the population most at risk for mental health challenges to increase support and encourage help-seeking," Clark says.

RAND's Eunice Wong, lead author of the report, says that although Californians facing a mental health challenge are displaying resilience in their own attitudes to mental health, stigma remains:

"While California residents facing mental health challenges are finding ways to cope and maintain important aspects of well-being, they are substantially burdened by self-stigma and discrimination, which may significantly undermine recovery. Our overall findings show a clear need for stigma and discrimination reduction efforts in California."

The study is part of RAND's evaluation of mental health initiatives funded by California's Proposition 63 - a tax on millionaires residing in The Golden State - that are designed to reduce stigma and discrimination around mental illness and prevent suicides.

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The gut microbiome: how does it affect our health?

 We can carry up to 2 kg of microbes in our gut. Within the tens of trillions of micro-organisms that live there are at least 1,000 species of bacteria consisting of over 3 million genes. What is more, two thirds of the gut microbiome - the population of microbes in the intestine - is unique to each individual. But do you know how your gut microbiota could be influencing your health?

The bacteria in our gut are estimated to weight up to 2 kg.

Most of us are aware that the bacteria in our gut play an important role in digestion. When the stomach and small intestine are unable to digest certain foods we eat, gut microbes jump in to offer a helping hand, ensuring we get the nutrients we need.

In addition, gut bacteria are known to aid the production of certain vitamins - such as vitamins B and K - and play a major role in immune function.

But increasingly, researchers are working to find out more about how gut bacteria - particularly the bacteria that is unique to us individually - influence our health and risk of disease.

Perhaps most studied is how gut microbiota affects an individual's risk of obesity and other metabolic conditions. In November 2014, for example, Medical News Today reported on a study claiming our genetic makeup shapes what type of bacteria reside in our gut, which may affect our weight.

In this Spotlight, we take a look at obesity and some of the other - perhaps surprising - health conditions that may be driven by our gut microbiota.

The development of gut microbiota

Belief has long held that the development of gut microbiota does not start until birth, with the gastrointestinal tract of a fetus considered to be a sterile environment.

According to Gut Microbiota Worldwatch - an information service created by the Gut Microbiota and Health Section of the European Society for Neurogastroenterology & Motility, a member of the United European Gastroenterology (UEG) - the digestive tract of a newborn is rapidly colonized with micro-organisms from the mother and the surrounding environment.

An infant's gut microbiota, for example, can be influenced by breastfeeding. Gut Microbiota Worldwatch explain that the gut of breastfed babies primarily consists of Bifidobacteria - considered a "friendly" bacteria that benefits the gut - while formula fed babies are likely to have less of this bacteria.

However, some studies have challenged the belief that the fetus is a sterile environment, suggesting that the development of gut microbiota begins before birth.

A 2008 study published in the journal Research in Microbiology identified bacteria, including Enterococcus and Staphylococcus, in the early feces of baby mice - known as the meconium - indicating the bacteria was transferred to the fetus from the mother's gut during pregnancy.

In this study, a group of pregnant mice was also inoculated with the bacterium Enterococcus fecium, which was isolated from human breast milk. The baby mice were delivered by Cesarean section 1 day before the predicted labor date, and their meconium was tested. The researchers identified E. fecium in their feces, but no trace was found in the meconium of a control group.

"Based on the sum of evidence, it is time to overturn the sterile womb paradigm and recognize the unborn child is first colonized in the womb," Seth Bordenstein, a biologist at Vanderbilt University in Nashville, TN, told The Scientist last year.

The more diverse our gut bacteria, the better

While the debate over whether infants are born with gut bacteria continues, it seems scientists are in agreement about one thing: from birth until old age, our gut bacteria is constantly evolving.

As mentioned previously, two thirds of the gut microbiome is unique to each person, and what makes this unique is the food we eat, the air we breathe and other environmental factors. Some studies have even suggested the makeup of the gut microbiome is influenced by genes.

But how does this unique gut bacteria affect our health? This is a question that researchers have become increasingly interested in answering.

Past research has suggested that a broader diversity of bacteria in gut is better for human health. A recent study reported byMNT, for example, found that infants with less diverse gut bacteria at the age of 3 months were more likely to be sensitized to specific foods - including egg, milk and peanut - by the age of 1 year, indicating that lack of gut bacteria diversity in early life may be a driver for food allergies.

But the implications of a low-diversity gut microbiome do not stop there. You may be surprised to learn how lack of or overpopulation of specific bacteria may impact your health.

Obesity

More and more studies are looking at the association between the gut microbiome and weight gain, with some scientists suggesting the makeup of bacteria in the gut may influence an individual's susceptibility to weight gain.

Earlier in the article, we mentioned a 2014 study that claims our genes may determine what bacteria live in our gut, and that this bacteria may influence how heavy we are.

One study identified a specific strain of gut bacteria that may influence our weight.

In detail, the study - conducted by researchers from Cornell University in Ithaca, NY, and King's College London in the UK - found that a certain strain of bacteria - Christensenellaceae minuta - was more common in people with a low body weight, and that the presence of this particular strain is highly influenced by genes.

What is more, introducing this bacteria to the guts of mice caused the animals to gain less weight, indicating the bacteria may reduce or prevent obesity.

"Our findings show that specific groups of microbes living in our gut could be protective against obesity - and that their abundance is influenced by our genes," said study author Prof. Tim Spector of King's College London. "The human microbiome represents an exciting new target for dietary changes and treatments aimed at combating obesity."

In 2012, another study published in the Journal of Proteome Research suggested that a lack of bacteria in the large intestine may drive obesity by slowing down the activity of brown fat, which protects against weight gain when stimulated by burning calories and white fat.

A more recent study provides further evidence that gut bacteria may influence weight gain. A case report published in the journal Open Forum Infectious Diseases revealed how a women who underwent fecal microbiota transplantation (FMT) using an overweight donor rapidly became obese herself following the procedure.

While the jury is still out on whether gut bacteria is directly associated with obesity, it is an area that certainly warrants further investigation.

Cancer

In recent years, scientists have increasingly investigated the link between gut bacteria and cancer.

In a 2013 study published in The Journal of Cancer Research, US researchers claimed to discover a specific bacteria in the intestines - Lactobacillus johnsonii - that may play a role in the development of lymphoma, a cancer of the white blood cells.

Another 2013 study conducted by UK researchers found that a common gut bacteria called Helicobacter pylori may cause stomach cancer and duodenal ulcers by deactivating a part of the immune system involved in regulating inflammation.

And in 2014, MNT reported on research from the Icahn School of Medicine at Mount Sinai, New York, NY, in which investigators associated a specific combination of gut bacteria with the development of colorectal cancer.

For this study, the team gave antibiotics to mice that possessed gene mutations known to cause colorectal polyps, which can develop into cancer. The antibiotics were administered to interfere with the gut bacteria of the mice. The researchers found that these mice did not develop polyps, suggesting that gut microbes may be involved in their development.

But as well as being linked to cancer development, research has found that gut bacteria may be important for improving the effectiveness of cancer treatment.

In 2013, a study by researchers from the National Cancer Institute found that immunotherapy and chemotherapy were less effective in mice lacking gut bacteria, with such treatments working significantly better in mice with a normal gut microbiome.

Similar results were found in another 2013 study by French researchers. An antitumor drug - cyclophosphamide - was found to be much less effective in mice with limited gut bacteria, compared with mice with normal gut bacteria.

"Both studies are very exciting in that they show initial links between gut microbiota and [response to] therapies," Harvard University's Peter Turnbaugh told The Scientist. "The papers underscore the importance [of] microbes in shaping not just our initial predisposition to disease, but also our recovery from it."

Mental Health

Not many of us are likely to think about how gut bacteria affect the mental state, but they actually play a very important role.

According to the American Psychological Association (APA), gut bacteria produce an array of neurochemicals that the brain uses for the regulation of physiological and mental processes, including memory, learning and mood. In fact, 95% of the body's supply of serotonin is produced by gut bacteria, according to the APA.

Since gut bacteria produce many of the neurochemicals responsible for regulating mental processes, it is no surprise that researchers have linked gut bacteria to mental health.

With this in mind, it is perhaps unsurprising that gut bacteria has been associated with a number of mental health problems, including anxiety disorders and depression.

In 2014, for example, a study published in the journal Psychopharmacology found that prebiotics - carbohydratesthat boost healthy bacteria in the gut - may be effective for reducing stress and anxiety.

For the study, 45 healthy adults were randomized to receive the prebiotic or a placebo once a day for 3 weeks. All participants were then exposed to both negative and positive stimuli.

The team found that the participants who received the prebiotic were less likely to pay attention to the negative stimuli than those who received the placebo - suggesting lower anxiety in negative situations. They also had lower levels of the "stress hormone" cortisol.

"Time and time again, we hear from patients that they never felt depressed or anxious until they started experiencing problems with their gut," said lead study author Dr. Kirsten Tillisch, the study's lead author. "Our study shows that the gut-brain connection is a two-way street."

Autism

Autism is estimated to affect 1 in 68 children in the US. While studies have associated environmental factors - such as pollution - and genetics as potential causes of the disorder, researchers are increasingly looking at the role of gut bacteria in its development.

In 2013, a study by researchers from Arizona State University found that children with autism possessed lower levels of three types of gut bacteria - Prevotella, Coprococcus and Veillonellaceae - compared with children free of the condition.

A more recent study from the team found that concentrations of specific chemicals produced by gut bacteria - called metabolites - in fecal samples of children with autism differed to the concentrations found in the fecal samples of children without the disorder.

This led the researchers to hypothesize that gut microbes alter the metabolites associated with communication between the gut and the brain, which interferes with brain function.

Further strengthening the association between gut bacteria and autism is a 2013 study published in Cell that found the bacterium Bacteroides fragilis reduced autism-like symptoms in mice.

Can we alter our gut bacteria?

Since the gut microbiome is influenced by the food we eat and the environment around us, it makes sense that there are ways to make it healthier.

According to the Mayo Clinic, a healthy diet can encourage the presence of good gut bacteria. They note that consuming fermented foods - such as miso and sauerkraut - increases the level of fermenting bacteria in the gut. In addition, fruits and vegetables contain fibers and sugars that can boost the health of gut bacteria.

Exercise may also be key to improving gut bacteria diversity, according to a study reported by MNT in June 2014.

The study, published in the journal Gut, compared the gut bacteria of 40 professional rugby players with that of two control groups. They found that the rugby players had much higher levels of Akkermansiaceae in their gut - a bacterium that has been associated with reduced risk of obesity.

In an editorial linked to the study, Dr. Georgina Hold, of the Institute of Medical Sciences at Aberdeen University in Scotland, noted that a better understanding of ways to improve health via gut bacteria is crucial:

"As life expectancy continues to increase, it is important that we understand how best to maintain good health. Never has this been more relevant than in respect of our resident microbiota. Understanding the complex relationship among what we choose to eat, activity levels and gut microbiota richness is essential.

Developing new ways to manipulate the beneficial properties of our microbiota by finding ways to integrate health-promoting properties into modern living should be the goal."

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