Scientists separate medical benefits of cannabis from 'unwanted' side effects

Scientists have found a way to separate medical benefits of cannabis from its unwanted side effects. The research was carried out in mice, but it is hoped that the breakthrough will pave the way for safe cannabis-based therapies that do not cause alterations in mood, perception or memory. Last year the team discovered how the main psychoactive ingredient in cannabis, known as THC, reduces tumor growth in cancer patients.

These findings reveal how the cognitive effects of THC are triggered by a pathway which is separate from some of its other effects.

Credit: © William Casey / Fotolia

Scientists at the University of East Anglia in collaboration with the University Pompeu Fabra in Barcelona have found a way to separate the medical benefits of cannabis from its unwanted side effects.

The research comes from the team that discovered how the main psychoactive ingredient in cannabis, known as THC, reduces tumour growth in cancer patients.

Their latest findings, published today in the journal PLOS Biology, reveal how the cognitive effects of THC are triggered by a pathway which is separate from some of its other effects.

That pathway involves both a cannabinoid receptor and a serotonin receptor. When it is blocked, THC can still exert several beneficial effects -- including pain relief -- while avoiding impairment of memory.

The research was carried out in mice, but it is hoped that the breakthrough will pave the way for safe cannabis-based therapies that do not cause alterations in mood, perception or memory.

Dr Peter McCormick, from UEA's school of Pharmacy, said: "THC, the major active component of marijuana, has broad medical use -- including for pain relief, nausea and anxiety. Our previous research has also found that it could reduce tumour size in cancer patients. However it is also known to induce numerous undesirable side effects such as memory impairment, anxiety and dependence.

"There has been a great deal of medical interest in understanding the molecular mechanisms at work in THC, so that the beneficial effects can be harnessed without the side-effects.

"THC acts through a family of cell receptors called cannabinoid receptors. Our previous research revealed which of these receptors are responsible for the anti-tumour effects of THC. This new research demonstrates how some of the drug's beneficial effects can be separated from its unwanted side effects."

The research team carried out behavioural studies in mice and investigated how pathways in their brains operate under THC. They found that the absence of a particular serotonin receptor (5HT2AR) reduced some of the effects of THC -- such as its amnesic effect, based on a standard memory test. But treatment to reduce 5HT2AR did not change other effects of THC, including pain relief.

"This research is important because it identifies a way to reduce some of what, in medical treatment, are usually thought of as THC's unwanted side effects, while maintaining several important benefits including pain reduction."

But Dr McCormick added that patients should not be tempted to self-medicate.

"Patients should not use cannabis to self-medicate, but I hope that our research will lead to a safe synthetic equivalent being available in the future."

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Story Source:

The above post is reprinted from materials provided by University of East Anglia.

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Chocolate: is it really good for our health?

With the average American consuming around 4.5 kg of chocolate each year, it is safe to say it is one of the nation's most loved treats. It is not hard to fathom why; it tastes delicious and stimulates the release of endorphins - the "feel-good" hormones. And according to numerous studies in recent years, chocolate is amazingly good for our health... or is it?

The average American eats around 4.5 kg of chocolate annually.

In this Spotlight, we ask, can chocolate really be good for our health? Or are the potential health benefits of this much-loved treat overstated?

The 'food of the gods'

When we think of chocolate, many of us visualize a big, chunky bar of sweet deliciousness. But originally, chocolate was only consumed as a bitter beverage.

Chocolate - which is made using beans from the cacao tree, native to Central and South America - is estimated to date back as far as 1900 BC, when it was created by pre-Olmec cultures residing in present-day Mexico. The ancient Mesoamericans roasted the cacao beans, or cocoa beans, before grinding them into a paste that was mixed with hot water, vanilla, chili and other spices to make a frothy drink.

The Olmec, Aztec and Mayan civilizations found chocolate to be a mood-lifting drink and an aphrodisiac, so much so that they believed the beverage had spiritual qualities. The Mayans even worshipped a cacao God, and the beverage was used for religious and sacred ceremonies, hence why chocolate is often referred to as the "food of the gods."

It wasn't until 1847 that chocolate became the solid edible bar we know and love today. A British chocolate company called J.S Fry & Sons created it using cocoa butter - vegetable fat extracted from the cocoa bean - cocoa powder and sugar.

In the late 1800s and early 1900s, well-known chocolate manufacturers such as Hershey, Cadbury and Mars were formed, and they have been bringing us an array of heavenly sweet treats ever since.

But while we are thankful to these companies for catering to our chocolate needs, they are also responsible for adding potentially unhealthy ingredients to what could be an otherwise healthy - albeit less tasty - food, giving chocolate its reputation as a diet demon.

What is in our chocolate?

Cocoa beans - from which chocolate is made - are believed to contain more than 300 compounds that are beneficial to health.

They are packed full of flavanoids and flavanols, such as anthocyanidin and epicatechins. These are antioxidants, which are known to destroy free radicals in the body - chemicals that can cause damage to DNA and other cell components, accelerating aging and contributing to heart disease, cancer and other diseases.

The main ingredient in chocolate - cocoa beans - contains more than 300 compounds that are beneficial to health.

The darker the chocolate, the more flavanoids and flavanols it contains, which explains why the majority of chocolate studies have hailed dark chocolate - rather than milk or white - for its health benefits.

Cocoa beans also contain dopamine, phenylethylamine and serotonin, all of which are compounds that are known to enhance mood and promote feelings of well-being.

So if the main ingredient in chocolate is full of healthy compounds, why shouldn't we eat it by the bucketload?

Put simply, the negative health effects of chocolate primarily come from the additional ingredients that are added to it during the commercial manufacturing process. Sugar, full-fat cream and milk are just some of these ingredients, and the quantities in which they are added are not slight.

A standard 43 g bar of Hershey's milk chocolate contains 13 g of fat, 24 g of sugar and 210 calories. Eating this product in high quantities could lead to weight gain, and being overweight can increase the risk of numerous health problems, including hypertension, diabetes and heart disease.

Because of its high sugar content, chocolate may also raise the risk of dental problems - including gum disease and cavities - if consumed in high amounts.

Referring back to the Heart study, however, researchers claim that participants who consumed up to 100 g of chocolate a day were at lower risk of stroke and heart disease. This is an amount the equivalent to more than two Hershey's milk chocolate bars each day, which would take a person well above the recommended daily sugar intake of 25 g for woman and 37.5 g for men.

Can eating this amount of chocolate daily really be good for our health? Or has this study and many like it been overstated?

Are we succumbing to the media's hype?

Looking at the results of the Heart study more closely, the average daily chocolate consumption of the almost 158,000 participants studied was 7 g, while only some of the participants consumed 100 g of chocolate each day.

However, the researchers claim that higher chocolate consumption - up to 100 g daily - was associated with a greater reduction in heart disease and stroke risk. But it should be noted that most of these participants were younger with a lower body mass index (BMI) and blood pressure, and they were less likely to have diabetes.

Many studies associating chocolate with health benefits are badly conducted, but many news outlets continue to report their findings.

"It is hard to know if the lower risk comes from chocolate or those other factors," says Science Media Centre - a media watchdog based in the UK. "The authors have tried to account for these as far as possible, but the nature of the study means that it is not possible to do that perfectly. Therefore, it is possible that the protective effect might be because of something else - not chocolate."

Despite this, the Internet was engulfed with media outlets claiming, "Two bars of chocolate a day 'lowers risk of stroke and heart disease'" and "Two chocolate bars a day can SLASH the risk of heart attack and stroke."

Could such media coverage be luring the general public into potentially false beliefs that chocolate consumption can have major health benefits?

Earlier this month, news outlets around the globe reported on a study conducted by Johannes Bohannon, PhD, research director of the Institute of Diet and Health, which claimed people who ate one chocolate bar a day alongside a low-carbohydrate diet lost weight 10% faster than controls.

As MNT revealed, however, the purpose of this study was to see how easy it would be to get badly conducted research into the news. Though the study was real, it was actually conducted by a journalist called John Bohannon, and the Institute of Diet and Health does not exist.

The study, which was published in the International Archives of Medicine and covered by news outlets including the Huffington Post and The Daily Mail, was hugely flawed. It contained only 16 participants who were only assessed for a 3-week period, meaning the findings were insignificant - factors that many news reporters failed to acknowledge.

"It was terrible science," said Bohannon in an article he penned for website io9. "The results are meaningless, and the health claims that the media blasted out to millions of people around the world are utterly unfounded."

Bohannon noted, however, that the general public were very critical of the findings, asking questions that should have been addressed by the reporting journalists. This suggests that many of us are not completely taken in by attention-grabbing headlines hailing the health benefits of chocolate.

However, this is not to say chocolate consumption offers no health benefits. Some well-conducted studies have found it could be good for us.

The potential health benefits of chocolate

For years, numerous studies have associated moderate chocolate consumption with better heart health. As well as the most recent example published in Heart, in February 2014, MNT reported on a study linking daily consumption of dark chocolate to reduced risk of atherosclerosis - thickening and hardening of the arteries.

A study published in 2012, conducted by researchers from the University of California-San Diego School of Medicine, found dark chocolate may benefit patients with advanced heart failure and type 2 diabetes by enhancing the structure of mitochondria - the "powerhouses" of cells - while another study found that cocoa products may help to lower blood pressure.

The heart health benefits of chocolate have been put down to the antioxidants it contains, which, as mentioned previously, are found in cocoa beans. High levels of antioxidants can reduce the amount of low-density lipoprotein (LDL), or "bad," cholesterol that build up in artery walls, for example.

More and more studies are emerging in support of the heart health benefits of chocolate, particularly dark chocolate. However, increasingly, studies are suggesting there may be many more health benefits attached to the yummy treat.

In 2013, a study by researchers from Harvard Medical School in Boston, MA, claimed drinking two cups of hot chocolate each day may stave off memory decline in older age by preserving blood flow in working areas of the brain.

And another study, published in the Journal of Agricultural Food and Chemistry in 2014, suggested a flavanol in cocoa - called oligomeric procyandins - may protect against obesity and type 2 diabetes.

Our Knowledge Center article on the health benefits of chocolate looks at some of the other ways in which it could be good for us.

While numerous studies suggest there may be additional perks to indulging in a chocolatey treat, it should be noted that they are not conclusive, and research is ongoing to determine exactly what health benefits chocolate offers.

What is conclusive, however, is that eating excessive amounts of chocolate - as tempting as it might be - can lead to weight gain, increasing our risk of overweight and obesity and associated conditions, such as heart disease and diabetes.

But this doesn't mean we have to miss out. Like most foods high in sugar and fat, they can be consumed in moderation. As dietitian and spokesperson of the British Dietetic Association Alison Hornby says:

"As an occasional treat, chocolate can be part of a healthy diet. Eaten too frequently, it is an unhealthy choice."

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Immunotherapy heralds 'new era' for cancer treatment

A "whole new era" for cancer treatment is upon us, according to experts. Two new studies published in the New England Journal of Medicine provide further evidence that immunotherapy - the use of drugs to stimulate immune response - is highly effective against the disease.

Immunotherapy involves the use of drugs to boost patients' immune system response, increasing the attack on cancer cells.

Recently presented at the 2015 American Society for Clinical Oncology annual meeting, one study revealed that a drug combination of ipilimumab and nivolumab (an immune therapy drug) reduced tumor size in almost 60% of individuals with advanced melanoma - the deadliest form of skin cancer - compared with ipilimumab alone, while another study found nivolumab reduced the risk of lung cancer death by more than 40%.

Nivolumab is a drug already approved by the Food and Drug Administration (FDA) for the treatment of metastatic melanoma in patients who have not responded to ipilimumab or other medications. It is also approved for the treatment of non-small cell lung cancer (NSCLC) that has metastasized during or after chemotherapy.

According to cancer experts, however, the results of these latest studies indicate that nivolumab and other immune therapy drugs could one day become standard treatment for cancer, replacing chemotherapy.

Prof. Roy Herbst, chief of medical oncology at Yale Cancer Center in New Haven, CT, believes this could happen in the next 5 years. "I think we are seeing a paradigm shift in the way oncology is being treated," he told The Guardian. "The potential for long-term survival, effective cure, is definitely there."

Nivolumab plus ipilimumab reduced tumor size by at least a third for almost 1 year

Nivolumab belongs to a class of drugs known as "checkpoint inhibitors." It works by blocking the activation of PD-L1 and PD-1 - proteins that help cancer cells hide from immune cells, avoiding attack.

In a phase 3 trial, Dr. Rene Gonzalez, of the University of Colorado Cancer Center, and colleagues tested the effectiveness of nivolumab combined with ipilimumab - a drug that stimulates immune cells to help fight cancer - or ipilimumab alone in 945 patients with advanced melanoma (stage III or stage IV) who had received no prior treatment.

While 19% of patients who received ipilimumab alone experienced a reduction in tumor size for a period of 2.5 months, the tumors of 58% of patients who received nivolumab plus ipilimumab reduced by at least a third for almost a year.

Commenting on these findings, study co-leader Dr. James Larkin, of the Royal Marsden Hospital in the UK, told BBC News:

"By giving these drugs together you are effectively taking two brakes off the immune system rather than one, so the immune system is able to recognize tumors it wasn't previously recognizing and react to that and destroy them.

For immunotherapies, we've never seen tumor shrinkage rates over 50% so that's very significant to see. This is a treatment modality that I think is going to have a big future for the treatment of cancer."

Dr. Gonzalez and colleagues also demonstrated the effectiveness of another immune therapy drug called pembrolizumab in patients with advanced melanoma.

While 16% of 179 patients treated with chemotherapy alone experienced no disease progression after 6 months, the team found that disease progression was halted for 36% of 361 patients treated with pembrolizumab after 6 months.

Dr. Gonzalez notes that while a combination of nivolumab and ipilimumab shows greater efficacy against advanced melanoma than pembrolizumab, it also presents greater toxicity. Around 55% of patients treated with nivolumab plus ipilimumab had severe side effects, such as fatigue and colitis, with around 36% of these patients discontinuing treatment.

Dr. Gonzalez says such treatment may be better for patients whose cancer does not involve overexpression of the PD-L1 protein.

"Maybe PDL1-negative patients will benefit most from the combination, whereas PDL1-positive patients could use a drug targeting that protein with equal efficacy and less toxicity," he adds. "In metastatic melanoma, all patients and not just those who are PD-L1-positive may benefit from pembrolizumab."

Nivolumab almost doubled patient survival from NSCLC

In another study, Dr. Julie Brahmer, director of the Thoracic Oncology Program at the Johns Hopkins Kimmel Cancer Center, and colleagues tested the effectiveness of nivolumab against standard chemotherapy with the drug docetaxel among 260 patients with NSCLC.

All patients had been treated for the disease previously, but the cancer had returned and spread.

The team found that patients who received nivolumab had longer overall survival than those treated with standard chemotherapy, at 9.2 months versus 6 months.

At 1 year after treatment, the researchers found nivolumab almost doubled patient survival. Around 42% of patients who received nivolumab were alive after 1 year, compared with only 24% of patients who received chemotherapy.

The study results also demonstrated a longer period of halted disease progression for patients who received nivolumab compared with those who had chemotherapy, at 3.5 months versus 2.8 months.

Overall, the researchers estimated that, compared with patients who received chemotherapy, those who received nivolumab were at 41% lower risk of death from NSCLC.

Commenting on these findings, Dr. Brahmer says:

"This solidifies immunotherapy as a treatment option in lung cancer. In the 20 years that I've been in practice, I consider this a major milestone."

While both studies show promise for the use of immunotherapy in cancer treatment, experts note that such treatment would be expensive. The use of nivolumab plus ipilimumab for the treatment of advanced melanoma, for example, would cost at least $200,000 per patient.

As such, researchers say it is important that future research determines which cancer patients would be most likely to benefit from immunotherapy.

Medical News Today recently reported on a study conducted by investigators from Cancer Research UK, which reveals a class of drugs called AKT inhibitors may boost the effect of radiotherapy against various cancers, including breast, kidney, melanoma and brain cancers.

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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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Mindfulness and antidepressants offer 'similar level of protection' against depression

Mindfulness-based cognitive therapy offers a similar level of protection against relapses of depression to antidepressants, according to the results of a new trial published in The Lancet.

Mindfulness-based cognitive therapy works by teaching people the skills to identify and respond constructively to thoughts and feelings linked with depression.

"Depression is a recurrent disorder. Without ongoing treatment, as many as 4 out of 5 people with depression relapse at some point," says lead author Willem Kuyken, professor of clinical psychology at the University of Oxford in the UK.

Antidepressants are currently the key maintenance treatment for preventing relapse - studies report that antidepressants reduce the likelihood of relapse by up to two thirds when taken correctly.

"However," says study co-author Prof. Richard Byng, from the Plymouth University Peninsula Schools of Medicine and Dentistry in the UK, "there are many people who, for a number of different reasons, are unable to keep on a course of medication for depression. Moreover, many people do not wish to remain on medication for indefinite periods, or cannot tolerate its side effects."

Mindfulness-based cognitive therapy (MBCT) works by teaching people who have experienced depression the skills to identify thoughts and feelings linked with depression when they encounter them. By responding constructively to these depressive thoughts, a full relapse may be avoided.

The UK-based researchers recruited 424 adults for their study who had recurrent major depression and were taking antidepressants. The participants were randomly assigned to either stay on their medication or to slowly come off their antidepressants and receive MBCT.

The 212 participants in the MBCT group attended eight group sessions that lasted for 2.5 hours each, which also involved daily homework exercises. These participants were also given the option of attending four follow-up sessions over a year-long period.

Similar outcomes reported for both groups over 2-year follow-up

The Structured Clinical Interview for DSM-IV psychiatric diagnostic interview tool was used to assess all trial participants at regular intervals over a follow-up period of 2 years.

The researchers found that 44% of the MBCT group participants and 47% of the participants on antidepressant medication relapsed over the 2-year follow-up period.

Five adverse events - including two deaths - were reported across both groups but were not considered to be related to either the interventions or the study.

Prof. Kyuken says of the study's results:

"Whilst this study doesn't show that mindfulness-based cognitive therapy works any better than maintenance antidepressant medication in reducing the rate of relapse in depression, we believe these results suggest a new choice for the millions of people with recurrent depression on repeat prescriptions."

The authors report that theirs is the largest trial of any mindfulness-based approach to date, and that the study's validity was demonstrated through high rates of treatment adherence among both intervention groups and a relatively long follow-up.

One limitation of the study was that the recruitment strategy consisted of inviting patients who were already taking maintenance antidepressants rather than recruiting patients who were discussing their options for preventing relapse with their doctor.

In a linked comment, Prof. Roger Mulder, from the University of Otago in New Zealand, writes that as MBCT is a group treatment it may also reduce treatment costs and the number of trained staff needed:

"We therefore have a promising new treatment that is reasonably cost effective and applicable to the large group of patients with recurrent depression."

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Amphetamine-like stimulant remains in dietary supplements 2 years after FDA discovery

 In January 2014, the US Food and Drug Administration published a study in which they identified an amphetamine-like stimulant in a number of commonly used dietary supplements. More than 2 years later, a new study led by a researcher from Harvard Medical School in Cambridge, MA, finds that, not only are products containing the supplement still on the market, their abundance has increased.

"Since the FDA discovered BMPEA in supplements, the percentage of brands of Acacia rigidula supplements that contain BMPEA has appeared to increase, from 42.9% in 2012 to 52.4% in 2014," note the researchers.

The 2014 study from the Food and Drug Administration (FDA), published in the Journal of Pharmaceutical and Biomedical Analysis, revealed that nine of the tested 21 dietary supplements marketed for weight loss, improved cognitive function or enhanced athletic performance containing a plant extract called Acacia rigidula also contained beta-methylphenylethylamine (BMPEA).

BMPEA is a synthetic compound closely related to amphetamine. Though the safety of the substance has not been tested in humans, studies in cats and dogs have shown it to increase blood pressure and heart rate - conditions known to raise the risk of heart attack and stroke in humans.

But despite the FDA's findings, it seems the organization has taken no action to enforce the removal of BMPEA from dietary supplements or warn consumers about the potential risks.

Findings represent a 'profound leadership failure at the FDA'

On Tuesday, Dr. Pieter A. Cohen, of the Cambridge Health Alliance at Harvard, and colleagues published a study in the journal Drug Testing and Analysis, revealing that BMPEA was identified in 11 of the 21 Acacia rigidula dietary supplements they purchased 1 year after the FDA's findings.

"Since the FDA discovered BMPEA in supplements, the percentage of brands of Acacia rigidula supplements that contain BMPEA has appeared to increase, from 42.9% in 2012 to 52.4% in 2014," note the researchers.

"Whether this represents a true increase in the prevalence of BMPEA or is due to differences in sampling methods or other factors is not known," they add. "Regardless, the continued presence of BMPEA in mainstream supplements continues to expose consumers to potential risks."

Dr. Cohen told Medical News Today that he was "shocked" by their findings. "I had assumed that the FDA's original research would have led manufacturers to quietly withdraw this stimulant since the FDA had discovered it," he said.

He told us that the results represent a "profound leadership failure" at the FDA. "The problem starts with the commissioner ignoring supplements and continues all the way down to the supplement division, which is intertwined with the supplement industry," he added.

The team says immediate action needs to be taken to remove BMPEA from all supplements and ensure consumers avoid such products:

"We recommend that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements.

Consumers should be advised to avoid all supplements labeled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight-loss and sports supplements."

FDA: 'no specific safety concern identified at this time'

The FDA, however, have taken a different view on the issue. In a statement released yesterday, the organization said their review of products containing BMPEA "does not identify a specific safety concern at this time," though they say they "will consider taking regulatory action, as appropriate, to protect consumers."

Talking to MNT, Dr. Cohen said he was left "speechless" by the FDA's statement. "This statement is ludicrous," he added. "How could they try to spin this as if there is no safety concern? That is flying in the face of what we've heard from the Canadian and European health authorities, not to mention many independent experts."

The UK's Food Standard Agency, for example, say they have seen no evidence that Acacia rigidula is not a "novel food." As such, they say - under European Union (EU) regulations - it needs to undergo testing to ensure it is safe for human consumption.

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), agrees with Dr. Cohen, and says he sees no reason why the FDA cannot take the appropriate action against supplement manufacturers adding BMPEA to their products.

"BMPEA does not appear to be a legitimate dietary ingredient, and therefore, its inclusion in a product labeled as a dietary supplement makes the product adulterated under the Dietary Supplement Health & Education Act (DSHEA)," Mister explained in a statement.

"Although Acacia rigidula supplements represent a very small portion of the dietary supplement industry - so small that we are not aware of specific sales data - FDA has the tools it needs under the law to take action before there are serious health consequences, and CRN is asking the agency to do just that."

It seems the findings from Dr. Cohen and colleagues have triggered some positive action, however. E-commerce company Vitacost - who markets a BMPEA-containing dietary supplement called ARO-Vitacost Black Series BURN - say they are halting all online sales of the product.

"They will not be available for purchase until we can investigate further, and again have full confidence that these products are safe and effective for our customers," the company said in a statement.

But talking to CBS This Morning, Dr. Cohen said such a move is simply not enough. "This is way too little too late. We need all these products off store shelves. More importantly, we need the FDA to be enforcing the law."

Last month, Medical News Today reported on a study published in Nature Communications, in which researchers claim a popular anti-aging supplement - ubiquinone - is unlikely to have any benefits.

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