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Samstag, 22. August 2015

The CEO behind the first drug to boost women's sex drive has been working toward this her whole ...




Sprout 4

Sprout


Sprout CEO Cindy Whitehead, at center, won approval for her drug flibaserin this week.





This week’s biggest news in health has been over a controversial little pink pill designed to increase the libidos of women who struggle with chronically low sex drives.


The pill, called Addyi, is for women with chronically low sex drives. It sends chemicals to the brain to stimulate sexual desire and is taken daily, and it has some pretty serious side effects when it interacts with alcohol.


Sprout Pharmaceuticals – the company behind the pill since 2011 and got it FDA approved last week – was acquired by the drug company Valeant Pharmaceuticals on Thursday for $1 billion.


Business Insider spoke with Sprout’s CEO Cindy Whitehead over the phone about the big news, and what she thinks of the first drug approved for women’s sexual health.


Business Insider: Was the Valeant deal something you guys had hoped for in the long run for Sprout?


CW: I think we were so mission-driven just to get to finish line of completing all the science and getting to an approval of a drug. I think what this affords us is to do that in a way that we as a 34-person company wouldn’t have otherwise been able to, and I think that means … affordable access for more women.Things like copay assistance programs and those that we’ll be able to be more generous with than we would have been able to be at Sprout alone.


And ultimately having now opened this door for women in the United States, we can go into other markets in which women also don’t have a medical treatment for this condition, even if the prevalence data looks exactly the same.


[Acquisition talk] has been very recent, I think. After the [FDA] advisory committee meeting, companies saw the possibility that we were going to get to this first for women. They were interested, and that’s really when discussions started happening.


But it became clear for us I think very quickly that Valeant was the right partner because our entire team stays, and we will run this, and we will continue to do this in a way that we see is right for women.


BI: Will the acquisition effect the October 17 entry date to market or the target price range of about 400 per month?


CW: No, everything will stay on tap as we have been planning it for Sprout.


BI: Why did Sprout push so hard for this drug and what’s the significance to you?


CW: For the women. I’ve actually been in the field of sexual medicine for some time. I saw this spectacular science that was going to be abandoned, and I thought it was going to be abandoned frankly because of a society unwilling to have a frank discussion about the biology of sex for women. And the need was just too great.


I understood not only from the clinicians who see these patients every day in their office, what an important need this was but really from just women themselves, I think my greatest privilege in all of this is how many women have shared their very personal stories with me and the pain I think they have dealt with this condition.


The hallmark characteristic, the only reason you’d be considered to be treated for this is if it is causing you distress. And for many of these women it’s profound distress. It’s breaking up their marriages, it’s really having them feel lesser, and so I think the possibility of providing women access to a treatment really meant a lot to me.


BI: Most of your pipeline relies on Addyi. Are there any other drugs now that this has been approved? What’s next?


CW: First things first, we’re just going to launch this the right way. I think we’re going to get out there, we’re going to educate prescribers and pharmacies through a certification program.


We’ll stay singular in our focus for the near term, but ultimately who knows what the possibility would be? I’m deeply passionate about women’s health, and a segment that I think has been stagnant for too long.


I’d love to see this usher in a new era of interest in terms of investment and research for conditions like HSDD that uniquely impact women.


This interview has been edited for brevity and clarity.



The CEO behind the first drug to boost women"s sex drive has been working toward this her whole ...

Mittwoch, 1. Juli 2015

Helping bacteria help us: Probiotics keep your digestive system working like it should

LAS CRUCES >> Probiotics are a vital part of a healthy lifestyle, but many of us find them mysterious.


A dictionary definition of probiotic is “a preparation (as a dietary supplement) containing live bacteria (as lactobacilli) that is taken orally to restore beneficial bacteria to the body.”


“Probiotics are bacteria that help keep the natural balance of organisms (microflora) in the intestines,” according to webmd.com. “The normal human digestive tract contains about 400 types of probiotic bacteria that reduce the growth of harmful bacteria and promote a healthy digestive system. The largest group of probiotic bacteria in the intestine is lactic acid bacteria, of which lactobacillus acidophilus, found in yogurt with live cultures, is the best known. Yeast is also a probiotic substance. Probiotics are also available as dietary supplements.”




Photo courtesy thinkstockphotos.com Kimchi, a popular Korean dish, can provide healthy probiotics.

Photo courtesy thinkstockphotos.com Kimchi, a popular Korean dish, can provide healthy probiotics.




“Probiotics: Whole Body Health Begins in Your Gut,” a recent seminar at Natural Grocers in Las Cruces, focused on the idea that “gut bacteria influence how every part of your body works: weight gain or loss, immunity, even your mood and ability to focus.”


Fans of probiotics praise their efficiency in dealing with digestive issues, but experts tend to agree that their role in fighting specific disease, such as cancer and heart ailments, is not yet understood.


Our knowledge about probiotics and their function is rapidly evolving as new studies are released, said Jonathan Clinthorne, nutrition educational specialist at Natural Grocers.


“There is more and more research linking the effects of probiotics and the idea of live microorganisms when administered in adequate amounts, to reenforce and modulate bacterium in our intestinal tracts,” he said.


While experts differ on some aspects of what’s going on inside our guts, Clinthorne opines that “with the standard American diet, our microbiome (the combined genetic material of the microorganisms in a particular environment, such as our body) is not reflective of what it’s supposed to look like from an evolutionary standpoint.”


He said recent research, based on an analysis of stool samples, and sequencing of genomes from bacterium, involved gut bacteria that number in the trillions. “We are actually more bacteria than we are human,” he said.


While most of us aren’t able to access genetic sequencing to determine exactly what’s living in our guts, there are some general guidelines we can follow that will help nourish the “good guys” who live there and innovative ways “to feed your own and add some new beneficial ones,” Clinthorne said.


“You can try liquid concentrates or supplements,” said Clinthorne, who studied at Michigan State University and the University of Colorado and holds a Ph.D. in human nutrition.




Photo courtesy thinkstockphotos.com Sauerkraut contains bacteria that is good for digestive tracts.

Photo courtesy thinkstockphotos.com Sauerkraut contains bacteria that is good for digestive tracts.




There are also a variety of strategies involving adding new foods.


Yogurt is among the best known of our probiotic pals, but for those of us who are avoiding, or allergic to, dairy products, there are many alternative options, Clinthorne said.


“Yogurt is great, and there are non-dairy yogurts that contain probiotics too. But whatever you choose, make sure it contains live cultures. There are lots of kombucha products now, too. You can try things like sauerkraut and kimchi. but make sure they are fermented with bacteria. It seems no matter what our culture, we all have some sort of fermented food like miso soup, or sauerkraut or kimchi and there has been this traditional way of incorporating bacteria. Our ancestors would have eaten a lot of fruits and vegetables to provide those guys (bacteria) with fermented fiber and those foods contain bacteria themselves,” Clinthorne said.


He said we get colonies of gut bacteria from our mothers.


“There are studies that show a strong correlation between gut bacteria and the risk of developing allergies. If a child is delivered vaginally rather than by Cesarean section, the vaginal contact inoculates the child with something slightly different, in terms of gut bacteria and the training of the immune system,” he said, adding that children born vaginally and those who are breast fed with their mother’s milk seem to be less prone to allergies.


In general, he said, if a goal is to use probiotics to help the immune system, “it is more difficult to shift than to add, because your immune system gets used to seeing certain strains and becomes tolerant.”


There are other factors that can make changes in your gut bacteria.


“Exercise has been shown to have an insulin-related impact and is related to inflammations in the body. Switching over to a vegetarian diet can have a pretty substantial impact. And antibiotics can change your bacteria, not necessarily for the better,” Clinthorne said.


In the end, you need to take responsibility for finding solutions that work for you,including a healthy diet and trusted, reliable sources of supplements, should you choose to use them.


“The takeaway, what it all comes down to, is that it’s all about building a foundation of health and probiotics can be very important in supporting health. Diet is the foundation for a healthy gut bacteria and probiotics serve as reinforcements. People should make sure to stick with well-respected probiotic strains. And there should be regular consumption, not just once a month, but continuing to consume them on a regular basis. And if you make unhealthy choices, or have health issues or take medications like antibiotics, you are going to disturb gut bacteria and it’s going to need some help to come back,” Clinthorne said.


Check with your healthcare provider and then try adding one probiotic food or supplement at a time to help determine what works for you.


“Some probiotics have been used for a very long time throughout history, such as in fermented foods and cultured milk products,” webmd.com reports. “These don’t appear to cause illness. But more study is needed on the safety of probiotics in young children, the elderly, and people who have weak immune systems. As with any dietary supplement, be aware that probiotic supplements are regulated as foods, not drugs.”


S. Derrickson Moore may be reached at 575-541-5450.



Helping bacteria help us: Probiotics keep your digestive system working like it should